Section .0200 – reserved for future codification

Link to law: http://reports.oah.state.nc.us/ncac/title 10a - health and human services/chapter 13 - nc medical care commission/subchapter b/subchapter b rules.html
Published: 2015

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subchapter 13b – licensing of hospitals

 

10a ncac 13B .0100       reserved for future codification

Section .0200 – reserved for future

codification

 

10A NCAC 13B .0200       Reserved for future codification

section .0300 – reserved for future codification

 

10A NCAC 13B .0300       Reserved for future codification

section .0400 – reserved for future codification

 

10A NCAC 13B .0400       Reserved for future codification

 

section .0500 – reserved for future codification

 

10A NCAC 13B .0500       Reserved for future codification

 

section .0600 – reserved for future codification

 

10A NCAC 13B .0600       Reserved for future codification

 

section .0700 – reserved for future codification

 

10A NCAC 13B .0700       Reserved for future codification

 

section .0800 – reserved for future codification

 

10A NCAC 13B .0800       Reserved for future codification

 

section .0900 – reserved for future codification

 

10A NCAC 13B .0900       Reserved for future codification

 

section .1000 – reserved for future codification

 

10A NCAC 13B .1000       Reserved for future codification

 

section .1100 – reserved for future codification

 

10A NCAC 13B .1100       Reserved for future codification

 

section .1200 – reserved for future codification

 

10A NCAC 13B .1200       Reserved for future codification

 

section .1300 – reserved for future codification

 

10A NCAC 13B .1300       Reserved for future codification

 

section .1400 – reserved for future codification

 

10A NCAC 13B .1400       Reserved for future codification

 

section .1500 – reserved for future codification

 

10A NCAC 13B .1500       Reserved for future codification

 

section .1600 – reserved for future codification

 

10A NCAC 13B .1600       Reserved for future codification

 

section .1700 – reserved for future codification

 

10A NCAC 13B .1700       Reserved for future codification

 

section .1800 – reserved for future codification

 

10A NCAC 13B .1800       Reserved for future codification

 

SECTION .1900 ‑ SUPPLEMENTAL RULES FOR THE LICENSURE OF

THE SKILLED: INTERMEDIATE: adult care home BEDS IN A HOSPITAL

 

10A NCAC 13b .1901       SUPPLEMENTAL RULES

When a hospital offers nursing facility or adult care home

long‑term care services, the services shall be included under one

hospital license as provided in Rule .0201(c).  The general requirements

included in this Subchapter shall apply when applicable but in addition the

nursing facility care and adult care home care unit must meet the supplemental requirements

of this Section.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991.

 

10A NCAC 13b .1902       DEFINITIONS

The following definitions shall apply throughout this

Section, unless text otherwise clearly indicates to the contrary:

(1)           "Accident" means something occurring by

chance or without intention which has caused physical or mental harm to a

patient, resident or employee.

(2)           "Administer" means the direct application

of a drug to the body of a patient by injection, inhalation, ingestion or other

means.

(3)           "Administrator" means the person who has

authority for and is responsible to the governing board for the overall

operation of a facility.

(4)           "Brain injury long‑term care" is

defined as an interdisciplinary, intensive maintenance program for patients who

have incurred brain damage caused by external physical trauma and who have

completed a primary course of rehabilitative treatment and have reached a point

of no gain or progress for more than three consecutive months.  Services are

provided through a medically supervised interdisciplinary process and are

directed toward maintaining the individual at the optimal level of physical,

cognitive and behavioral functioning.

(5)           "Capacity" means the maximum number of

patient or resident beds which the facility is licensed to maintain at any

given time.  This number shall be determined as follows:

(a)           Bedrooms shall have minimum square footage

of 100 square feet for a single bedroom and 80 square feet per patient or

resident in multi‑bedded rooms.  This minimum square footage shall not

include space in toilet rooms, washrooms, closets, vestibules, corridors, and

built‑in furniture.

(b)           Dining, recreation and common use areas

available shall total no less than 25 square feet per bed for skilled nursing

and intermediate care beds and no less than 30 square feet per bed for adult

care home beds.  Such space must be contiguous to patient and resident

bedrooms.

(6)           "Combination Facility" means any hospital

with nursing home beds which is licensed to provide more than one level of care

such as a combination of intermediate care and/or skilled nursing care and

adult care home care.

(7)           "Convalescent Care" means care given for

the purpose of assisting the patient or resident to regain health or strength.

(8)           "Department" means the North Carolina

Department of Health and Human Services.

(9)           "Director of Nursing" means the nurse who

has authority and direct responsibility for all nursing services and nursing

care.

(10)         "Dispense" means preparing and packaging a

prescription drug or device in a container and labeling the container with

information required by state and federal law.  Filling or refilling drug

containers with prescription drugs for subsequent use by a patient is

"dispensing".  Providing quantities of unit dose prescription drugs

for subsequent administration is "dispensing".

(11)         "Drug" means substances:

(a)           recognized in the official United States

Pharmacopoeia, official National Formulary, or any supplement to any of them;

(b)           intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in man or other animals;

(c)           intended to affect the structure or any

function of the body of man or other animals, i.e., substances other than food;

and

(d)           intended for use as a component of any

article specified in (a), (b), or (c) of this Subparagraph; but does not

include devices or their components, parts, or accessories.

(12)         "Duly Licensed" means holding a current

and valid license as required under the General Statues of North Carolina.

(13)         "Existing Facility" means a licensed

facility; or a proposed facility, proposed addition to a licensed facility or

proposed remodeled licensed facility that will be built according to plans and

specifications which have been approved by the department through the

preliminary working drawings stage prior to the effective date of this Rule.

(14)         "Exit Conference" means the conference

held at the end of a survey, inspection or investigation, but prior to

finalizing the same, between the department's representatives who conducted the

survey, inspection or investigation and the facility administration

representative(s).

(15)         "Incident" means an intentional or

unintentional action, occurrence or happening which is likely to cause or lead

to physical or mental harm to a patient, resident or employee.

(16)         "Licensed Practical Nurse" means a nurse

who is duly licensed as a practical nurse under G.S. 90, Article 9A.

(17)         "Licensee" means the person, firm,

partnership, association, corporation or organization to whom a license has

been issued.

(18)         "Medication" means drug as defined in (12)

of this Rule.

(19)         "New Facility" means a proposed facility,

a proposed addition to an existing facility or a proposed remodeled portion of

an existing facility that is constructed according to plans and specifications

approved by the department subsequent to the effective date of this Rule.  If

determined by the department that more than one half of an existing facility is

remodeled, the entire existing facility shall be considered a new facility.

(20)         "Nurse Aide" means any individual

providing nursing or nursing‑related services to patients in a facility,

and is not a licensed health professional, a qualified dietitian or someone who

volunteers to provide such services without pay, and who is listed in a nurse

aide registry approved by the Department.

(21)         "Nurse Aide Trainee" means an individual

who has not completed an approved nurse aide training course and competency

evaluation and is demonstrating knowledge, while performing tasks for which

they have been found proficient by an instructor. These tasks shall be

performed under the direct supervision of a registered nurse. The term does not

apply to volunteers.

(22)         "Nursing Facility" means that portion of a

nursing home certified under Title XIX of the Social Security Act (Medicaid) as

in compliance with federal program standards for nursing facilities.  It is

often used as synonymous with the term "nursing home" which is the

usual prerequisite level for state licensure for nursing facility (NF)

certification and Medicare skilled nursing facility (SNF) certification.

(23)         "Nurse in Charge" means the nurse to whom

duties for a specified number of patients and staff for a specified period of

time have been delegated, such as for Unit A on the 7‑3 or 3‑11

shift.

(24)         "On Duty" means personnel who are awake,

dressed, responsive to patient needs and physically present in the facility

performing assigned duties.

(25)         "Patient" means any person admitted for

care to a skilled nursing or intermediate care facility.

(26)         "Physician" means a person licensed under

G.S. Chapter 90, Article 1 to practice medicine in North Carolina.

(27)         "Qualified Dietitian" means a person who

meets the standards and qualifications established by the Committee on

Professional Registration of the American Dietetic Association included in

"Standards of Practice" seven dollars and twenty-five cents ($7.25)

or "Code of Ethics for the Profession of Dietetics" two dollars and

fifteen cents ($2.15), American Dietetic Association, 216 W. Jackson Blvd.,

Chicago, IL 60606‑6995.

(28)         "Registered Nurse" means a nurse who is

duly licensed as a registered nurse under G.S. 90, Article 9A.

(29)         "Resident" means any person admitted for

care to an adult care home.

(30)         "Sitter" means an individual employed to

provide companionship and social interaction to a particular resident or

patient, usually on a private duty basis.

(31)         "Supervisor‑in‑Charge" means a

duly licensed nurse to whom supervisory duties have been delegated by the

Director of Nursing.

(32)         "Ventilator dependence" means

physiological dependency by a patient on the use of a ventilator for more than

eight hours a day.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. February

1, 1993; December 1, 1991; March 1, 1991; March

1, 1990.

 

10A NCAC 13B .1903       INSPECTIONS

(a)  Any hospital with beds licensed by the Department under

Section .1900 of these Rules may be inspected by one or more authorized

representatives of the Department at any time.  Generally, inspections will be

conducted between the hours of 8:00 a.m. and 6:00

p.m., Monday through Friday.  However, complaint investigations shall be

conducted at the most appropriate time for investigating allegations of the

complaint.

(b)  At the time of inspection, any authorized

representative of the Department shall make his presence known to the

administrator or other person in charge who shall cooperate with such

representative and facilitate the inspection.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1904       PROCEDURE FOR APPEAL

A hospital with nursing facility or adult care home beds may

appeal any decision of the Department to deny, revoke or alter a license by

making such an appeal in accordance with G.S. Chapter 150B.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire

on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1905       ADMISSIONS

(a)  No patient shall be admitted except under the orders of

a duly licensed physician.

(b)  The facility shall acquire prior to or at the time of

admission orders from the attending physician for the immediate care of the patient

or resident.

(c)  Within 48 hours of admission, the facility shall

acquire medical information which shall include current medical findings,

diagnosis, rehabilitation potential, a summary of the hospital stay if the

patient is being transferred from a hospital, and orders for the ongoing care

of the patient.

(d)  If a patient is admitted from somewhere other than a

hospital, a physical examination shall be performed either within 5 days prior

to admission or within 48 hours following admission.

(e)  Hospitals offering nursing facility or domiciliary home

care as a new service must prepare a plan of admission which, at a minimum,

assures availability of staff time and plans for individual patient

assessments, initiation of health care or nursing care plans, and

implementation of physician and nursing treatment plans.  This plan must be

available for inspection during the initial licensure survey prior to issuance

of a license.

(f)  Only persons who are 18 years of age or older shall be

admitted to adult care home beds in a facility.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire

on February 28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1906       POLICIES AND PROCEDURES

The governing board shall assure written policies and

procedures which are available to and implemented by staff.  These policies and

procedures shall cover at least the following areas:

(1)           admissions;

(2)           dietary;

(3)           discharges with physician orders and patients or

residents leaving against physician advice;

(4)           gratuities and solicitation which at a minimum

shall provide that no owner, operator, agent or employee of a facility nor any

member of his family shall accept a gratuity directly or indirectly from an

patient or resident in the facility or solicit for any type of contribution;

(5)           housekeeping;

(6)           infection control which must include, but shall not

be limited to, requirements for sterile, aseptic and isolation techniques; and

communicable disease screening including, at a minimum, annual tuberculosis

screening for all staff and inpatients of the facility;

(7)           maintenance of patient medical or health care

records including charging or record keeping;

(8)           orientation of all facility personnel;

(9)           patient or resident care plans, treatment and other

health care or nursing care, including but not limited to all policies and

procedures required by rules contained in this Subchapter;

(10)         patients' or residents' rights;

(11)         physical evaluation for residents and patients at

least annually;

(12)         physician services and utilization of the

individual's private physician;

(13)         procurement of supplies and equipment to meet

individual patient care needs;

(14)         protection of patients from abuse and neglect;

(15)         range of services provided;

(16)         recording and reporting to the department of

accidents or incidents occurring to patients in any part of the facility and

maintenance of such reports or records;

(17)         rehabilitation services;

(18)         release of medical record information;

(19)         screening and reporting communicable disease to the

local health department; and

(20)         transfers.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March

1, 1990.

 

10A NCAC 13B .1907       GENERAL

The governing board shall assure that policies and

procedures are available and implemented for assessing each patient's or

resident's health care needs and planning for meeting identified health care

needs.  There shall be a system for evaluating the effectiveness of the

assessment, planning and implementation (delivery of care processes) for each

patient or resident.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1908       FREQUENCY: METHOD AND CONTENT OF

ASSESSMENT: PLANNING

Each patient's and resident's condition must be assessed on

a regular, periodic basis, at least quarterly, with appropriate notation and

updating of the health care plan.  Health care planning for each patient and

resident shall be an on‑going process and must include, but shall not be

limited to, the following:

(1)           data which is systematically and continuously

collected about his or her health status; the data shall be recorded so as to

be accessible and communicated to all staff involved in the patient's or

resident's care;

(2)           current problems or needs identified and

prioritized from a completed assessment relevant to the patient's or resident's

response to aging, illness and general health status; and

(3)           a current plan of care developed in conjunction

with the patient or resident or legal guardian that includes measurable time

related goals and approaches, or measures to be employed by various disciplines

in order to achieve the identified goals.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March

1, 1990.

 

10A NCAC 13B .1909       IMPLEMENTATION OF HEALTH PLAN

All parts of the plan of care shall be assigned to specific

disciplines or staff as indicated in the plan of care to assure that health

care and rehabilitative services are performed daily and documented for those

patients and residents who require such services.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1910       NURSING/HEALTH CARE ADMINISTRATION AND

SUPERVISION

(a)  A licensed facility shall have a director of nursing

service who shall be responsible for the overall organization and management of

all nursing services and shall be currently licensed to practice as a

registered nurse by the North Carolina Board of Nursing in accordance with G.S.

90, Article 9A.

(b)  The Director of Nursing shall not serve as

administrator or assistant administrator.

(c)  A licensed facility with nursing facilities shall

provide a full‑time director of nursing on duty at least eight hours per

day, five days a week.  A registered nurse shall relieve the Director of

Nursing (be in charge of nursing) during the Director's absence.

(d)  A licensed facility shall employ and assign registered

nurses, licensed practical nurses, nurse aides and nurse aide trainees for

duties in accordance with G.S. 90, Article 9A.

(e)  The Director of Nursing shall cause the following to be

accomplished:

(1)           establishment and implementation of nursing

policies and procedures which shall include, but shall not be limited to the

following:

(A)          assessment of and planning for patients' nursing

care or health care needs, and implementation of nursing or health care plans;

(B)          daily charting of any unusual occurrences or acute

episodes related to patient care, and progress notes written monthly reporting

each patient's performance in accordance with identified goals and objectives

and each patient's progress toward rehabilitative nursing goals;

(C)          assurance of the delivery of nursing services in

accordance with physicians' orders, nursing care plans and the facility's

policies and procedures;

(D)          notification of emergency physicians or on‑call

physicians;

(E)           infection control to prevent cross‑infection

among patients and staff;

(F)           reporting of deaths;

(G)          emergency reporting of fire, patient and staff

accidents or incidents, or other emergency situations;

(H)          use of protective devices or restraints to assure

that each patient or resident is restrained in accordance with physician orders

and the facility's policies, and that the restrained patient or resident is

appropriately evaluated and released at a minimum of every two hours;

(I)            special skin care and decubiti care;

(J)            bowel and bladder training;

(K)          maintenance of proper body alignment and restorative

nursing care;

(L)           supervision of and assisting patients with feeding;

(M)         intake and output observation and reporting for those

patients whose condition warrants monitoring of their fluid balance.  This will

include those patients on intravenous fluids or tube feedings, and patients

with kidney failure and temperatures elevated to 102 degrees Fahrenheit or

above;

(N)          catheter care; and

(O)          procedures used in caring for patients in the

facility;

(2)           development of written job descriptions for

nursing personnel;

(3)           periodic assessment of the nursing

department with identification of personnel requirements as they relate to

patient care needs and reporting same to the administrator;

(4)           a planned orientation and continuing

inservice education program for nursing employees and documentation of staff

attendance and subject matter covered during inservice education programs;

(5)           provision of appropriate reference

materials for the nursing department, which includes a Physician's Desk

Reference or comparable drug reference, policy and procedure manual, and

medical dictionary for each nursing station; and

(6)           establishment of operational procedures to

assure that appropriate supplies and equipment are available to nursing staff

as determined by individual patient care needs.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

10A NCAC 13B .1911       VACANT DIRECTOR OF NURSING POSITION

(a)  The administrator shall notify the Department within 72

hours when the director of nursing position becomes vacant and shall provide

the name and license number of the individual who is acting director or the

replacement for the director of nursing.

(b)  A facility shall not operate without either a director

of nursing or acting director or nursing.

(c)  The administrator shall employ a director of nursing

within 30 days after a position becomes vacant.  A vacancy which exceeds 30

days shall be reviewed by the Department for action relative to licensure

status of the facility.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March

1, 1990.

 

10A NCAC 13B .1912       NURSE STAFFING REQUIREMENTS

(a)  A licensed facility shall provide licensed nursing

personnel sufficient to accomplish the following:

(1)           patient needs assessment,

(2)           patient care planning, and

(3)           supervisory functions in accordance with

the level of patient or resident care advertised or offered by the facility.

The facility also shall provide other nursing personnel

sufficient to assure that at least activities of daily living, personal

grooming, restorative nursing actions and other health care needs as identified

in each patient's or resident's plan of care are met.

(b)  A licensed multi‑storied facility (one having

more than one story) shall provide at least one person on duty on each patient

care floor at all times.

(c)  Daily direct patient care nursing staff, licensed and

unlicensed, shall equal or exceed 2.1 nursing hours per patient.  (This is

sometimes referred to as nursing hours per patient day or NHPPD or NH/PD.)

(1)           Inclusive in these figures is the

requirement that at least one licensed nurse is on duty for direct patient care

at all time; and

(2)           Nursing care shall include the services of

a registered nurse for at least eight consecutive hours a day, seven days a

week.  This coverage can be spread over more than one shift if such a need

exists.  The Director of Nursing may be counted as meeting the requirements for

both the Director of Nursing and patient and resident care staffing for

facilities of a total census of 60 beds or less.

(d)  Nursing support personnel including ward clerks,

secretaries, nurse educators and persons in primarily administrative management

positions and not actively involved in direct patient care shall not be counted

toward compliance with minimum daily requirements for direct care staffing.

(e)  All exceptions to meeting minimum staffing requirements

shall be reported to the Department at the end of each month.  Staffing waivers

granted by the federal government for Medicare and Medicaid certified beds

shall be accepted for licensure purposes.

(f)  The ratio of male to female nurse aides will be

determined by the needs of the patients, particularly the numbers of male

patients requiring assistance with personal care.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (b)(4)(C);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1913       reserved for future codification

 

10a NCAC 13B .1914       reserved for future codification

 

10A NCAC 13B .1915       adult care HOME PERSONNEL REQUIREMENTS

(a)  The administrator shall designate a person to be in

charge of the adult care home residents at all times.  The nurse in charge of

nursing services may also serve as supervisor‑in‑charge of the

adult care home beds.

(b)  If adult care home beds are located in a separate

building or a separate level of the same building, there must be a person on

duty in the adult care home areas at all times.

(c)  A licensed facility shall provide sufficient staff to

assure that activities of daily living, personal grooming, and assistance with

eating are provided to each resident.  Medication administration as indicated

by each resident's condition or physician's orders shall be carried out as

identified in each resident's plan of care.

(d)  Adult care home facilities (Home for the Aged beds)

licensed as a part of a combination facility shall comply with the staffing

requirements of 10 NCAC 42D .1407 as adopted by the Social Services Commission

for freestanding adult care homes.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991.

 

10A NCAC 13B .1916       REHABILITATIVE NURSING AND DECUBITUS

CARE

Each patient or resident shall be given care to prevent

contractures, deformities, and decubiti, including but not limited to:

(1)           changing positions of bedfast and chairfast

patients or residents every two hours and administering simple preventive

care.  Documentation of such care and outcome must be included in routine

summaries or progress notes;

(2)           maintaining proper alignment and joint movement to

prevent contractures and deformities, which must be documented in routine

summaries or progress notes;

(3)           implementing an individualized bowel and bladder

training program except for patients or residents whose records are documented

that such training is not effective.  A monthly summary for patients and

quarterly summaries for domiciliary residents shall be written relative to each

patient's or resident's performance in the bowel and bladder training program;

and

(4)           such other services as necessary to meet the needs

of the patient.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1917       MEDICATION ADMINISTRATION

(a)  A licensed facility shall have policies and procedures

governing the administration of medications which shall be enforced and

implemented by administration and staff.  Policies and procedures shall include,

but shall not be limited to:

(1)           automatic stop orders for treatment and

drugs;

(2)           accountability of controlled substances as

defined by the North Carolina Controlled Substances Act, G.S. 90, Article 5;

(3)           dispensing and administering behavior modifying

drugs, such as hypnotics, sedatives, tranquilizers, antidepressants and other

psychotherapeutic agents; insulin; intravenous fluids and medications;

cardiovascular regulating drugs; and antibiotics.

(b)  All medications or drugs and treatments shall be

administered and discontinued in accordance with signed physician's orders

which are recorded in the patient's or resident's medical record.

(1)           Only physicians, registered nurses,

licensed practical nurses or physician assistants, if in accordance with the

assistant's approved practice, shall administer medications.

(2)           To ensure accountability, any medication

shall be administered by the same licensed personnel who prepared the dose for

administration.  This Rule does not apply to the dispensing of medications from

a pharmacy utilizing a unit of use drug delivery system.

(3)           Medications shall be administered within a

half hour prior to or half hour after the prescribed time for administration

unless precluded by emergency situations.

(4)           The person administering medications shall

identify each patient or resident in accordance with the facility's policies

and procedures prior to administering any medication.

(5)           Medication administered to a patient or

resident shall be recorded in the patient's or resident's medication

administration record immediately after administration in accordance with the

facility's policies and procedures.

(6)           Omission of medication and the reason for

the omission shall be indicated in the patient's or resident's medical record.

(7)           The person administering medications which

are ordered to be given as needed (PRN) shall justify the need for the same in

the patient's or resident's medical record.

(8)           Medication administration records shall

provide identification of the drug and strength of drug, quantity of drug

administered, name of administering employee, title of employee and time of

administration.

(c)  Self‑administration of medications shall be

permitted only if prescribed by a physician and directions are printed on the

container.

(d)  The administration of one patient's or resident's

medications to another patient or resident is prohibited except in the case of

an emergency.  In the event of such an emergency, steps shall be taken to

assure that the borrowed medications shall be replaced promptly and so

documented.

(e)  Verbal orders shall be countersigned by a physician

within five days of issuance.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. December

1, 1991; March 1, 1990.

 

10A NCAC 13B .1918       TRAINING

(a)  A licensed facility shall provide for all patient or

resident care employees a planned orientation and continuing education program

emphasizing patient or resident assessment and planning, activities of daily

living, personal grooming, rehabilitative nursing or restorative care, other

patient or resident care policies and procedures, patients' rights, and staff

performance expectations.  Attendance and subject matter covered shall be

documented for each session and available for licensure inspections.

(b)  The administrator shall assure that each employee is

oriented within the first week of employment to the facility's philosophy and

goals.

(c)  Each employee shall have specific on‑the‑job

training as necessary for the employee to properly perform his individual job

assignment.

(d)  Unless otherwise prohibited, a nurse aide trainee may

be employed to perform the duties of a nurse aide for a period of time not to

exceed four months.  During this period of time the nurse aide trainee shall be

permitted to perform only those tasks for which minimum acceptable competence

has been demonstrated and documented on a skills check‑off record.  Job

applicants for nurse aide positions who were formerly qualified nurse aides but

have not been gainfully employed as such for a period of 24 consecutive months

or more shall be employed only as nurse aide trainees and must re‑qualify

as nurse aides within four months of hire by successfully passing an approved

competency evaluation.  Any individual, nursing home, or education facility may

offer Department approved vocational education for nursing home nurse aides. 

An accurate record of nurse aide qualifications shall be maintained for each

nurse aide used by a facility and shall be retained in the general personnel

files of the facility.

(e)  The curriculum content required for nurse aide

education programs shall be subject to approval by the Division of Health

Service Regulation and shall include, as a minimum, basic nursing skills,

personal care skills, cognitive, behavioral and social care, basic restorative

services, and patients' rights.  Successful course completion shall be

determined by passing a competency evaluation test.  The minimum number of

course hours shall be 75 of which at least 20 hours shall be classroom and at

least 40 hours of supervised practical experience.  The initial orientation to

the facility shall be exclusive of the 75 hour training program.  Competency

evaluation shall be conducted in each of the following areas:

(1)           Observation and documentation,

(2)           Basic nursing skills,

(3)           Personal care skills,

(4)           Mental health and social service needs,

(5)           Basic restorative services,

(6)           Residents' Rights.

(f)  Successful course completion and skill competency shall

be determined by competency evaluation approved by the Department.  Commencing July

1, 1989, nurse aides who had formerly been fully qualified under nurse aide

training requirements may re‑establish their qualifications by

successfully passing a competency evaluation test.

 

History Note:        Filed as a Temporary Rule Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (b)(5);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1919       DENTAL CARE

(a)  A dental examination shall be performed at the time of

admission with the following information being placed in the patient's or

resident's medical or health care record:

(1)           type of diet which the patient or resident can

best manage (such as normal, soft or pureed);

(2)           the presence of infection of gums, teeth,

or jaws;

(3)           brief descriptions of any removable dental

appliances and a statement of their condition; and

(4)           indications for dental treatment at the

time of admission.

(b)  Names of dentists who have agreed to render emergency

dental care shall be maintained at each nursing station and at the supervisor's

station in a adult care home.

(c)  Staff of the facility shall ensure that:

(1)           necessary daily dental care is provided;

(2)           each patient or resident possesses

appropriate toothbrushes and is encouraged and, when necessary, assisted in

their use; and

(3)           each patient or resident having a removable

denture is furnished a receptacle in which to immerse the denture in water

overnight.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March

1, 1990.

 

10A NCAC 13B .1920       AVAILABILITY OF PHARMACEUTICAL SERVICES

(a)  A licensed facility shall provide pharmaceutical

services under the supervision of a pharmacist currently licensed to practice

pharmacy in North Carolina.

(b)  A facility shall be responsible for obtaining drugs,

therapeutic nutrients and related products prescribed or ordered by a physician

for patients or residents in the facility.

(c)  Services shall include documented on‑site

pharmaceutical reviews accomplished at least every 31 calendar days for all

patients and residents.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1921       DINING FACILITIES

Patients, including wheelchair patients, shall be encouraged

to eat at the tables in the dining area and shall be assisted when necessary by

non‑dietary staff.  An overbed table shall be provided for patients who

eat in bed.  A sturdy tray stand shall be provided for those patients who eat

out of bed but are unable to go to the dining area.  An overbed table which can

be lowered to chair height may substitute for the tray stand.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1922       ACTIVITIES AND RECREATION

(a)  The administrator shall designate an activities and

recreation director to be in charge of activities and recreation for all

patients and residents.  The activities and recreation director shall have training

and experience in directing recreational and group activities.  The designated

activities and recreation director shall be under the supervision of the

administrator and shall be qualified to meet the needs of the patients and

residents.  A qualified individual shall be anyone eligible for a N.C. license

as an occupational therapist or assistant therapist under G.S. 90‑270;

anyone eligible for N.C. certification as a recreation therapist or assistant

therapist under G.S. 90C‑9; anyone with a baccalaureate degree and one

year experience; anyone who has completed an approved 36‑hour or longer

course in activities program management; or anyone not otherwise qualified but

receiving at least four hours consultation per month from one who is qualified.

(b)  The facility shall maintain and make available a

listing of local resources for activities and recreation to be utilized in

meeting the needs and interests of all patients and residents.

(c)  Restoration to self care and resumption of normal

activity shall be one of the main goals of the recreation or activity program. 

The scope of the activity program shall include:

(1)           social activities involving individual and

group participation which are designed to promote group relationships;

(2)           recreational activities, both indoor and

outdoor;

(3)           opportunity to participate in activities

outside the facility;

(4)           religious programs, including the right of

each patient and resident to attend the church or religious program of his

choice;

(5)           creative and expressive activities;

(6)           educational activities; and

(7)           exercise.

(d)  The facility shall have written policies and procedures

which are available and implemented by staff that:

(1)           attempt to prevent the further mental or

physical deterioration for those patients or residents who cannot realistically

resume normal activities;

(2)           assure opportunities for patient

involvement, both individual and group, in both planning and implementing the

activity program;

(3)           provide patients or residents the

opportunity for choice among a variety of activities; and

(4)           encourage participation by each patient or

resident in social and recreational activities according to individual need and

abilities and desires unless the patient's or resident's record contains

documentation that he is unable to participate.

(e)  Each patient's or resident's activity plan shall be a

part of his overall plan of care and shall contain documentation of periodic

assessments of the individual's activity needs and interests.  A record of

activities and individuals participating shall be maintained in the facility.

(f)  A licensed facility shall display a monthly activities

calendar which includes variety to appeal to different interest groups in the

nursing care and adult care home services.

(g)  A licensed facility shall provide:

(1)           Space for recreational and diversional

activities.  In hospitals offering new nursing home services, space shall be

provided separately from the main living and dining areas; however, these areas

may also be used for social activities.

(2)           Designated indoor and outdoor activity

areas for independent and group needs of patients and residents, and which are:

(A)          accessible to wheelchair and ambulatory patients;

and

(B)          of sufficient size to accommodate necessary

equipment and permit unobstructed movement of wheelchair and ambulatory

patients or personnel responsible for instruction and supervision.

(3)           Adequate space to store equipment and

supplies without blocking exists or otherwise threatening the health and safety

of patients and residents.

(h)  There shall be equipment and supplies sufficient to

carry out planned programs for both individual and group activities.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

1, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (a);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1923       SOCIAL SERVICES

(a)  The administrator shall designate an employee to be

responsible for the provision of social services.  This person shall be known

as the social services director.  Subsequent to the effective date of the rules

contained in this Subchapter any newly designated person must be a graduate of

a four year college or university with one year's experience in the health care

or long‑term care field or have an equivalent combination of education

and experience.  An equivalent combination of education and experience means

the number of years of education leading to a baccalaureate or associate degree

plus the number of years of long‑term nursing facility experience equal

to five years; or eligible for certification as a social worker pursuant to

G.S. 90B‑7.  The social services director shall have authority to carry

out provisions contained in Rule .1923(b) of this Section.

(b)  Each patient's or resident's plan of care shall contain

a written plan for meeting his individual social needs and involving his active

participation, the plan shall provide for:

(1)           needed assistance in meeting the patient's

or resident's physical, social and emotional needs through consultation with

the patient or resident or his legal guardian, and relative, physician or

others;

(2)           assisting the patient or resident in

adjusting to his environment, for referral to other supporting resources, for

protective services, for financial services and for assistance at the time of

discharge or transfer into a new environment;

(3)           the utilization of caseworkers employed by

the county department of social services in the case of recipients of public

assistance and for the utilization of appropriate persons with experience and

training in the general area of social work in the case of those not on public

assistance.

(c)  Discharge planning shall be in keeping with each

patient's and resident's discharge needs.  These are as follows:

(1)           The administrator shall assure that a

medical order for discharge including any special instructions for meeting

rehabilitation potential is obtained from all patients or residents except when

a patient or resident leaves against a physician's order or advice; and

(2)           The social services director shall

coordinate discharge instructions and assure that patients and residents and

their families are instructed in accordance with discharge orders.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986;

Amended Eff. March

1, 1990.

 

10A NCAC 13B .1924       RESTRAINTS

(a)  Patients and residents shall be restrained only by

physician orders.

(b)  The nurse in charge shall be responsible for making the

decision relative to necessity for, type and duration of restraint in emergency

situations requiring restraints while contacting the physician.  The nurse also

shall be responsible for documenting same in the patient's or resident's

record.

(c)  The type of restraint used and the time of application

and removal shall be recorded by a licensed nurse in the patient's or

resident's record.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1925       REQUIRED SPACES

The total space requirements shall be those set forth in

Rule .1902(5) of this Section.  Physical therapy and occupational therapy space

shall not be included in these totals.

 

History Note:        Authority G.S. 131E‑79;

Eff. February 1, 1986.

 

10A NCAC 13B .1926       NURSING HOME PATIENT OR RESIDENT RIGHTS

(a)  Written policies and procedures shall be developed and

enforced to implement requirements in G.S. 131E‑115 et seq.  (Nursing

Home Patients' Bill of Rights) concerning the rights of patients and

residents.  The administrator shall make these policies and procedures known to

the staff, patients and residents, and families of patients and residents and

shall ensure their availability to the public by placing them in a conspicuous

place.

(b)  Any violation of patient rights contained in G.S. 131E‑117

shall be determined by representatives of the Department by investigation or

survey.

(c)  If a licensed facility is found to be in violation of

any of the rights contained in G.S. 131E‑117, the Department shall impose

penalties for each violation as provided by G.S. 131E‑129.

(d)  When the Department has been notified that corrective

action has been taken for each violation, verification of same shall be made by

a representative of the Department.

(e)  The Department shall calculate a total of all fines

levied against a facility based on the number of violations and the number of

days and patients or residents involved in each violation.

(f)  The Department shall mail a statement to the facility

showing a total fine for each violation and a total of fines due to be paid for

all violations.  The facility shall pay the penalty within 60 days unless a

hearing is requested under G.S. Chapter 150B.

(g)  When it is found that a violation of G.S. 131E‑117

has occurred but corrective action was taken prior to the date of discovery,

fines shall be calculated and assessed in accordance with (e) and (f) of this

Rule.

(h)  In matters of patient abuse, neglect or

misappropriation the definitions shall have the meanings defined for abuse,

neglect and exploitation respectively as contained in the North Carolina

PROTECTION OF THE ABUSED, NEGLECTED OR EXPLOITED DISABLED ADULT ACT, G.S. 108A‑99

et seq.

 

History Note:        Filed as a Temporary Amendment Eff. October

1, 1990 For a Period of 142 Days to Expire on February

28, 1991;

Authority G.S. 131E‑79; 42 U.S.C. 1396 r (e)(2)(B);

Eff. February 1, 1986;

Amended Eff. March

1, 1991; March 1, 1990.

 

10A NCAC 13B .1927       BRAIN INJURY LONG‑TERM CARE

PHYSICIAN SERVICES

(a)  For nursing facility patients located in designated

brain injury long‑term care units, there shall be an attending physician

who is responsible for the patient's specialized care program.  The intensity

of the program requires that there shall be direct patient contact by a

physician at least once per week and more often as the patient's condition

warrants.  Each patient's interdisciplinary, long‑term care program shall

be developed and implemented under the supervision of a physiatrist (a

physician trained in Physical Medicine and Rehabilitation) or a physician of

equivalent training and experience.

(b)  If a physiatrist or physician of equivalent training or

experience, is not available on a weekly basis to the facility, the facility

shall provide for weekly medical management of the patient, by another

physician.  In addition, oversight for the patient's interdisciplinary, long‑term

care program shall be provided by a qualified consultant physician who visits

patients monthly, makes recommendations for and approves the interdisciplinary

care plan, and provides consultation as requested to the physician who is

managing the patient on a weekly basis.

(c)  The attending physician shall actively participate in

individual case conferences or care planning sessions and shall review and sign

discharge summaries and records within 15 days of patient discharge.  When

patients are to be discharged to either another health care facility or a residential

setting the attending physician shall assure that the patient has been provided

with a discharge plan which incorporates optimum utilization of community

resources and post discharge continuity of care and services.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991;

Amended Eff. February

1, 1993.

 

10A NCAC 13B .1928       BRAIN INJURY LONG‑TERM CARE

PROGRAM REQUIREMENTS

(a)  The general requirements in this Subchapter shall apply

when applicable, but brain injury long‑term care units shall meet the

supplement requirements in this Rule and Rules .1901 (4) and .1929 of this

Section.  Brain injury long‑term care is an interdisciplinary, intensive

maintenance program for patients who have incurred brain damage caused by

external physical trauma and who have completed a primary course of

rehabilitative treatment and have reached a point of no gain or progress for

more than three consecutive months.  Services are provided through a medically

supervised interdisciplinary process as provided in Rule .1927 of this Section

and are directed toward maintaining the individual at the optimal level of

physical, cognitive and behavioral functioning.  Following are the minimum

requirements for specific services that may be necessary to maintaining the

individual at optimum level:

(1)           Overall supervisory responsibility for brain

injury long‑term care services shall be assigned to a registered nurse

with one year experience in caring for brain injured patients.

(2)           Physical therapy shall be provided by a

physical therapist with a current valid North Carolina license.  Occupational

therapy shall be provided by an occupational therapist with a current valid

North Carolina License.  The services of a physical therapist and occupational

therapist shall be combined to provide one full‑time equivalent for each

20 patients.  The assistance of a physical therapy aide and an occupational

therapy aide with appropriate supervision shall be combined to provide one full‑time

equivalent for each 20 patients.  A proportionate number of hours shall be

provided for a census less than 20 patients.

(3)           Clinical nutrition services shall be

provided by a qualified dietician with two years clinical training and

experience in nutrition.  The number of hours of clinical nutrition services on

either a full‑time or part‑time employment or contract basis shall

be adequate to meet the needs of the patients. Each patient's nutrition needs

shall be reviewed at least monthly.  Clinical nutrition services shall include:

(A)          Assessing the appropriateness of the ordered diet

for conformance with each patient's physiological and pharmacological

condition;

(B)          Evaluating each patient's laboratory data in

relation to nutritional status and hydration;

(C)          Applying technical knowledge of feeding tubes, pumps

and equipment to each patient's specialized needs.

(4)           Clinical Social Work shall be provided by a

Social Worker meeting the requirements of Rule .1923 of this Section.

(5)           Recreation therapy, when required, shall be

provided on either a full‑time or part‑time employment or contract

basis by a clinician eligible for certification as a therapeutic recreation

specialist by the State Board of Therapeutic Recreation Certification. The

number of hours of therapeutic recreation services shall be adequate to meet

the needs of the patients.  In the event that a qualified specialist is not

locally available, alternate treatment modalities shall be developed by the

occupational therapist and reviewed by the attending physician.  The program

designed must be adequate to meet the needs of this specialized population and

must be administered in accordance with Section .1200 of this Subchapter.

(6)           Speech therapy, when required, shall be

provided by a clinician with a current valid license in speech pathology issued

by the State Board of Speech and Language Pathologists and Audiologists.

(7)           Respiratory therapy, when required, shall

be provided and supervised by a respiratory therapist currently registered by

the National Board for Respiratory Care.

(b)  Each patient's program shall be governed by an

interdisciplinary treatment plan incorporating and expanding upon the health

plan required under Rules .1908 and .1909 of this Section.  The plan is to be

initiated on the first day of admission.  Upon completion of baseline data

development and an integrated interdisciplinary assessment the initial

treatment plan is to be expanded and finalized within 14 days of admission. 

Through an interdisciplinary process the treatment plan shall be reviewed at

least monthly and revised as appropriate.  In executing the treatment plan the

interdisciplinary team shall be the major decision‑making body and shall

determine the goals, process, and time frames for accomplishment of each

patient's program.  Disciplines to be represented on the team shall be

medicine, nursing, clinical pharmacy and all other disciplines directly

involved in the patient's treatment or treatment plan.

(c)  Each patient's overall program shall be assigned to an

individually designated case manager.  The case manager acts as the coordinator

manager for assigned patients.  Any professional staff member involved in the

patient's care may be assigned this responsibility for one or more patients.

Professional staff may divide this responsibility for all patients on the unit

in the best manner to meet all patients' needs for a coordinated

interdisciplinary approach to care. The case manager shall be responsible for:

(1)           coordinating the development,

implementation and periodic review of the patient's treatment plan;

(2)           preparing a monthly summary of the

patient's progress;

(3)           cultivating the patient's participation in

the program;

(4)           general supervision of the patient during

the course of treatment;

(5)           evaluating appropriateness of the treatment

plan in relation to the attainment of stated goals; and

(6)           assuring that discharge decisions and

arrangements for post discharge follow‑up are properly made.

(d)  For each 20 patients or fraction thereof dedicated

treatment facilities and equipment shall be provided as follows:

(1)           A combined therapy space equal to or

exceeding 600 square feet, adequately equipped and arranged to support each of

the therapies.

(2)           Access to one full reclining wheelchair per

patient.

(3)           Special physical therapy and occupational

therapy equipment for use in fabricating positioning devices for beds and

wheelchairs including splints, casts, cushions, wedges, and bolsters.

(4)           There shall be roll‑in bath

facilities with a dressing area available to all patients which shall afford

maximum privacy to the patient.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991;

Amended Eff. February

1, 1993.

 

10A NCAC 13B .1929       SPECIAL NURSING REQUIREMENTS FOR BRAIN

INJURY LONG‑TERM CARE

Direct care nursing personnel staffing ratio (NH/PD)

established in Rule .1912 of this Section shall not be applied to nursing

services for patients who require brain injury long‑term care, due to

their more intensive maintenance and nursing needs.  The minimum direct care

nursing staff shall be 5.5 hrs. per patient day allocated on a per shift basis

as the facility chooses to appropriately meet the patient's needs.  It is also

required that regardless of how low the patient census the direct care nursing

staff shall not fall below a registered nurse and a nurse aide I at any time

during a 24‑hour period.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991;

Amended Eff. February

1, 1993.

 

10A NCAC 13B .1930       VENTILATOR DEPENDENCE

The general requirements in this Subchapter shall apply when

applicable.  In addition, facilities having patients requiring the use of

ventilators for more than eight hours a day must meet the following requirements:

(1)           Respiratory therapy shall be provided and

supervised by a respiratory therapist currently registered by the National

Board for Respiratory Care.  The respiratory therapist shall:

(a)           make, as a minimum, weekly on‑site

assessments of each patient receiving ventilator support with corresponding

progress notes;

(b)           be on‑call 24 hours daily; and

(c)           assist the pulmonologist and nursing staff

in establishing ventilator policies and procedures, including emergency

policies and procedures.

(2)           Direct nursing care staffing shall be in accordance

with Rule .1912 of this Section.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991.

 

10A NCAC 13B .1931       PHYSICIAN SERVICES FOR VENTILATOR

DEPENDENT PATIENTS

Hospitals with nursing facility beds with ventilator

dependent care patients shall contract with a physician who is licensed to

practice in North Carolina with Board Certification and who has specialized

training in pulmonary medicine.  This physician shall be responsible for

respiratory services and shall:

(1)           establish, with the respiratory therapist and

nursing staff, appropriate ventilator policies and procedures, including

emergency procedures;

(2)           assess each ventilator patient's status at least

monthly with corresponding progress notes;

(3)           be available on an emergency basis; and

(4)           participate in individual patient case planning.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991.

 

10A NCAC 13B .1932       EMERGENCY ELECTRICAL SERVICE

(a)  A minimum of one dedicated emergency branch circuit per

bed is required for ventilator dependent patients in addition to the normal

system receptacle at each bed location required by the National Electrical

Code.  This emergency circuit shall be provided with a minimum of two duplex

receptacles identified for emergency use.  Additional emergency branch

circuits/receptacles shall be provided where the electrical life support needs

of the patient exceed the minimum requirements stated in this Paragraph.  Each

emergency circuit serving ventilator dependent patients shall be fed from the

automatically transferred critical branch of the essential electrical system. 

This Paragraph shall apply to both new and existing facilities.

(b)  Heating equipment provided for ventilator dependent

patient bedrooms shall be connected to the critical branch of the essential

electrical system and arranged for delayed automatic or manual connection to

the emergency power source if the heating equipment depends upon electricity

for proper operation.  This Paragraph shall apply to both new and existing

facilities.

(c)  Task lighting connected to the automatically

transferred critical branch of the essential electrical system shall be

provided for each ventilator dependent patient bedroom.  This Paragraph shall

apply to both new and existing facilities.

 

History Note:        Authority G.S. 131E‑79;

Eff. December 1, 1991.

 

SECTION .2000 – specialized rehabilitative and habilitative

services

 

10A NCAC 13B .2001       ADMISSIONS TO THE HIV DESIGNATED UNIT

If a facility declines admission to a patient known to have

Human Immunodeficiency Virus disease, the reasons for the denial shall be

documented.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2002       DISCHARGE OF PATIENTS FROM THE HIV

DESIGNATED UNIT

A record shall be maintained of all discharges of patients

indicating the reasons for discharge, the physician's order for or other

authorization for discharge, and the condition of the patient at the time of

discharge.

A patient known to have Human Immunodeficiency Virus disease

may not be discharged solely on the basis of the diagnosis of Human

Immunodeficiency Virus disease except as authorized by the provisions of N.C.

General Statute 131E-117 (15) or other provisions of the N.C. General Statutes

or regulations promulgated thereunder or provisions of applicable federal laws

and regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2003       HIV DESIGNATED UNIT POLICIES AND

PROCEDURES

(a)  In units dedicated to the treatment of patients with

Human Immunodeficiency Virus disease, policies and procedures specific to the

specialized needs of the patients served shall be developed.  At a minimum they

shall include staff training and education, and the availability of

consultation by a physician with specialized education or knowledge in the

management of Human Immunodeficiency Virus disease.

(b)  Policies and procedures for infection control shall be

in conformance with 29 CFR 1910 Occupational Safety and Health Standards which

is incorporated by reference including subsequent amendments.  Emphasis shall

be placed on compliance with 29 CFR 1910-1030 (Bloodbourne Pathogens).  Copies

of Title 29 Part 1910 may be purchased from the Superintendent of Documents,

U.S. Government Printing Office, P.O. Box 371954, Pittsburgh, PA 15202-7954

for $38.00 and may be purchased with a credit card by a direct telephone call

to the G.P.O. at (202) 783-3238.  Infection control shall also be in compliance

with the Centers for Disease Control and Prevention Guidelines as published by

the U.S. Department of Health and Human Services, Public Health Service which

is incorporated by reference including subsequent amendments.  Copies may be

purchased from the National Technical Information Service, U.S. Department of

Commerce, 5285 Port Royal Road, Springfield, Virginia, 22161 for $15.95.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2004       PHYSICIAN SERVICES IN A HIV DESIGNATED

UNIT

In facilities with a Human Immunodeficiency Virus designated

unit the facility shall insure that attending physicians have documented,

pre-arranged access, either in person or by telephone, to a physician with

specialized education or knowledge in the management of Human Immunodeficiency

Virus Disease.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2005       SPECIAL NURSING REQUIREMENTS FOR A HIV

DESIGNATED UNIT

(a)  Facilities with a Human Immunodeficiency Virus

designated unit shall have a registered nurse with specialized education or

knowledge in the care of Human Immunodeficiency Virus disease.

(b)  Nursing personnel assigned to the Human

Immunodeficiency Virus unit shall be regularly assigned to the unit.  Rotations

are acceptable to alleviate staff burnout or staffing emergencies.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2006       SPECIALIZED STAFF EDUCATION FOR THE HIV

DESIGNATED UNIT

For facilities with a Human Immunodeficiency Virus

designated unit an organized, documented program of education specific to the

care of patients infected with the Human Immunodeficiency Virus shall be

provided and include at a minimum:

(1)           Human Immunodeficiency Virus and Acquired Immune

Deficiency Syndrome disease processes;

(2)           transmission modes, causes, and prevention of Human

Immunodeficiency Virus;

(3)           treatment of Human Immunodeficiency Virus and

Acquired Immune Deficiency Syndrome;

(4)           psycho-socio-economic needs of the Human

Immunodeficiency Virus and Acquired Immune Deficiency Syndrome patients;

(5)           in addition to the general hospital orientation to

Occupational Safety and Health Administration guidelines for universal

precautions, orientation to infection control specific to Human

Immunodeficiency Virus disease must be provided upon employment or permanent

assignment to the unit; Copies of Title 29 Part 1910 may be purchased from the

Superintendent of Documents, U.S. Government Printing Office, P.O. Box 371954,

Pittsburgh, PA 15202-7954 for $38.00 and may be purchased with a credit card by

a direct telephone call to the G.P.O. at (202) 512-1800;

(6)           policies and procedures specific to the Human

Immunodeficiency Virus designated unit; and

(7)           annual continuing education in infection control.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2007       USE OF INVESTIGATIONAL DRUGS ON THE HIV

DESIGNATED UNIT

(a)  The supervision and monitoring for the administration

of investigational drugs is the responsibility of the pharmacist and a licensed

registered nurse, acting pursuant to the orders of a physician duly authorized

to prescribe or dispense such drugs.  Responsibilities shall include, but not

be limited to, the following:

(1)           to insure the provision of written

guidelines for any investigational drug or study are provided; and

(2)           training and determination of staff's

abilities regarding administration of drugs, policies and procedures and

regulations.

(b)  The pharmacist or physician dispensing the

investigational drug is to provide the facility with information regarding at

least the following:

(1)           a copy of the protocol, including drug

information;

(2)           a copy of the patient's informed consent;

(3)           drug storage;

(4)           handling;

(5)           any specific preparation and administration

instructions;

(6)           specific details for drug accountability,

resupply and return of unused drug; and

(7)           a copy of the signed consent to participate

in the study.

(c)  Labeling of investigational drugs shall be in

accordance with written guidelines of protocol and State and federal

requirements regarding such drugs.  Prescription labels for investigational

drugs are to be distinguishable from other labels by an appropriate legend,

"Investigational Drug" or "For Investigational Use Only".

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2008       SOCIAL WORK SERVICES IN A HIV DESIGNATED

UNIT

The facility shall provide either by direct employment or by

contract for social work services to include assistance to the patient in

identification of supportive resources, financial services and assistance with

discharge and transfer arrangements.  In addition, for patients in a Human

Immunodeficiency Virus disease designated unit, the social worker shall provide

or arrange for the provision of spiritual, pastoral and grief counseling for

patients and staff where appropriate.  Support services shall be provided to

patient families and significant others.  Where necessary, coordination with

treatment services for substance abuse, legal services and other community

resources shall be identified.

 

History Note:        Authority G.S. 131E-79;

Eff. February 1, 1993.

 

10A NCAC 13B .2009       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2010       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2011       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2012       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2013       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2014       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2015       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2016       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2017       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2018       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2019       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2020       DEFINITIONS

The following definitions shall apply to inpatient

rehabilitation facilities or units only:

(1)           "Case management" means the coordination

of services, for a given patient, between disciplines so that the patient may

reach optimal rehabilitation through the judicious use of resources.

(2)           "Comprehensive, inpatient rehabilitation

program" means a program for the treatment of persons with functional

limitations or chronic disabling conditions who have the potential to achieve a

significant improvement in activities of daily living.  A comprehensive,

rehabilitation program utilizes a coordinated and integrated, interdisciplinary

approach, directed by a physician, to assess patient needs and to provide

treatment and evaluation of physical, psycho-social and cognitive deficits.

(3)           "Inpatient rehabilitation facility or

unit" means a free-standing facility or a unit (unit pertains to

contiguous dedicated beds and spaces) within an existing licensed health

service facility approved in accordance with G.S. 131E, Article 9 to establish

inpatient, rehabilitation beds and to provide a comprehensive, inpatient

rehabilitation program.

(4)           "Medical consultations" means

consultations which the rehabilitation physician or the attending physician

determine are necessary to meet the acute medical needs of the patient and do

not include routine medical needs.

(5)           "Occupational therapist" means any

individual licensed in the State of North Carolina as an occupational therapist

in accordance with the provisions of G.S. 90, Article 18D.

(6)           "Occupational therapist assistant" means

any individual licensed in the State of North Carolina as an occupational

therapist assistant in accordance with the provisions of G.S. 90, Article 18D.

(7)           "Psychologist" means a person licensed as

a practicing psychologist in accordance with G.S. 90, Article 18A.

(8)           "Physiatrist" means a licensed physician

who has completed a physical medicine and rehabilitation residency training

program approved by the Accreditation Council of Graduate Medical Education or

the American Osteopathic Association.

(9)           "Physical therapist" means any person

licensed in the State of North Carolina as a physical therapist in accordance

with the provisions of G.S. 90, Article 18B.

(10)         "Physical therapist assistant" means any

person duly licensed in the State of North Carolina as a physical therapist

assistant in accordance with the provisions of G.S. 90-270.24, Article 18B.

(11)         "Recreational therapist" means a person

certified by the State of North Carolina Therapeutic Recreational Certification

Board.

(12)         "Rehabilitation nurse" means a registered

nurse licensed in North Carolina, with training, either academic or on‑the‑job,

in physical rehabilitation nursing and at least one year experience in physical

rehabilitation nursing.

(13)         "Rehabilitation aide" means an unlicensed

assistant who works under the supervision of a registered nurse, licensed

physical therapist or occupational therapist in accordance with the appropriate

occupational licensure laws governing his or her supervisor and consistent with

staffing requirements as set forth in Rule .2027 of this Section.  The

rehabilitation aide shall be listed on the North Carolina Nurse Aide Registry

and have received additional staff training as listed in Rule .2028 of this

Section.

(14)         "Rehabilitation physician" means a

physiatrist or a physician who is qualified, based on education, training and

experience regardless of specialty, of providing medical care to rehabilitation

patients.

(15)         "Social worker" means a person certified

by the North Carolina Social Work Certification and Licensure Board in

accordance with G.S. 90B-3.

(16)         "Speech and language pathologist" means

any person licensed in the State of North Carolina as a speech and language pathologist

in accordance with the provisions of G.S. 90, Article 22.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2021       PHYSICIAN REQS FOR INPATIENT

REHABILITATION FACILITIES OR UNITS

(a)  In a rehabilitation facility or unit a physician shall

participate in the provision and management of rehabilitation services and in

the provision of medical services.

(b)  In a rehabilitation facility or unit a rehabilitation

physician shall be responsible for a patient's interdisciplinary treatment

plan.  Each patient's interdisciplinary treatment plan shall be developed and

implemented under the supervision of a rehabilitation physician.

(c)  The rehabilitation physician shall participate in the

preliminary assessment within 48 hours of admission, prepare a plan of care and

direct the necessary frequency of contact based on the medical and

rehabilitation needs of the patient.  The frequency shall be appropriate to

justify the need for comprehensive inpatient rehabilitation care.

(d)  An inpatient rehabilitation facility or unit's contract

or agreements with a rehabilitation physician shall require that the

rehabilitation physician shall participate in individual case conferences or

care planning sessions and shall review and sign discharge summaries and

records.  When patients are to be discharged to another health care facility,

the discharging facility shall assure that the patient has been provided with a

discharge plan which incorporates post discharge continuity of care and

services.  When patients are to be discharged to a residential setting, the

facility shall assure that the patient has been provided with a discharge plan

that incorporates the utilization of community resources when available and

when included in the patient's plan of care.

(e)  The intensity of physician medical services and the

frequency of regular contacts for medical care for the patient shall be

determined by the patient's pathophysiologic needs.

(f)  Where the attending physician of a patient in an

inpatient rehabilitation facility or unit orders medical consultations for the

patient, such consultations shall be provided by qualified physicians within 48

hours of the physician's order.  In order to achieve this result, the contracts

or agreements between inpatient rehabilitation facilities or units and medical

consultants shall require that such consultants render the requested medical

consultation within 48 hours.

(g)  An inpatient rehabilitation facility or unit shall have

a written procedure for setting the qualifications of the physicians rendering

physical rehabilitation services in the facility or unit.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993;

Amended Eff. December

1, 1993.

 

10A NCAC 13B

.2022       ADMISSION CRITERIA FOR INPATIENT REHABILITATION FACILITIES OR UNITS

(a)  The facility shall have written criteria for admission

to the inpatient rehabilitation facility or unit.  A description of programs or

services for screening the suitability of a given patient for placement shall

be available to staff and referral sources.

(b)  For patients found unsuitable for admission to the

inpatient rehabilitation facility or unit, there shall be documentation of the

reasons.

(c)  Within 48 hours of admission a preliminary assessment

shall be completed by members of the interdisciplinary team to insure the

appropriateness of placement and to identify the immediate needs of the

patient.

(d)  Patients admitted to an inpatient rehabilitation facility

or unit must be able to tolerate a minimum of three hours of rehabilitation

therapy, five days a week, including at least two of the following

rehabilitation services:  physical therapy, occupational therapy or speech

therapy.

(e)  Patients admitted to an inpatient rehabilitation

facility or unit must be medically stable, have a prognosis indicating a

progressively improved medical condition and have the potential for increased

independence.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2023       COMPREHENSIVE INPATIENT REHABILITATION

EVALUATION

(a)  A comprehensive, inpatient rehabilitation evaluation is

required for each patient admitted to an inpatient rehabilitation facility or

unit.  At a minimum this evaluation shall include the reason for referral, a

summary of the patient's clinical condition, functional strengths and

limitations, and indications for specific services.  This evaluation shall be

completed within three days.

(b)  Each patient shall be evaluated by the interdisciplinary

team to determine the need for any of the following services: medical, dietary,

occupational therapy, physical therapy, prosthetics and orthotics,

psychological assessment and therapy, therapeutic recreation, rehabilitation

medicine, rehabilitation nursing, therapeutic counseling or social work,

vocational rehabilitation evaluation and speech-language pathology.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B

.2024       COMPREHENSIVE INPATIENT REHABILITATION INTERDISCIPLINARY TREAT/PLAN

(a)  The interdisciplinary treatment team shall develop an

individual treatment plan for each patient within seven days after admission. 

The plan shall include evaluation findings and information about the following:

(1)           prior level of function;

(2)           current functional limitations;

(3)           specific service needs;

(4)           treatment, supports and adaptations to be

provided;

(5)           specified treatment goals;

(6)           disciplines responsible for implementation

of separate parts of the plan; and

(7)           anticipated time frames for the

accomplishment of specified long-term and short-term goals.

(b)  The treatment plan shall be reviewed by the

interdisciplinary team at least every other week.  All members of the

interdisciplinary team, or a representative of their discipline, shall attend

each meeting.  Documentation of each review shall include progress toward

defined goals and identification of any changes in the treatment plan.

(c)  The treatment plan shall include provisions for all of

the services identified as needed for the patient in the comprehensive,

inpatient rehabilitation evaluation completed in accordance with Rule .2023 of

this Subchapter.

(d)  Each patient shall have a designated case manager who

is responsible for the coordination of the patient's individualized treatment

plan.  The case manager is responsible for promoting the program's

responsiveness to the needs of the patient and shall participate in all team

conferences concerning the patient's progress toward the accomplishment of

specified goals.  Any of the professional staff involved in the patient's care

may be the designated case manager for one or more cases, or the director of

nursing or social worker may accept the coordination responsibility for the

patients.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2025       DISCHARGE CRITERIA FOR INPATIENT

REHABILITATION FACILITIES OR UNITS

(a)  Discharge planning shall be an integral part of the

patient's treatment plan and shall begin upon admission to the facility.  After

established goals have been reached, or a determination has been made that care

in a less intensive setting would be appropriate, or that further progress is

unlikely, the patient shall be discharged to an appropriate setting.  Other

reasons for discharge may include an inability or unwillingness of patient or

family to cooperate with the planned therapeutic program or medical

complications that preclude a further intensive rehabilitative effort.  The

facility shall involve the patient, family, staff members and referral sources

in discharge planning.

(b)  The case manager shall facilitate the discharge or

transfer process in coordination with the facility social workers.

(c)  If a patient is being referred to another facility for

further care, appropriate documentation of the patient's current status shall

be forwarded with the patient.  A formal discharge summary shall be forwarded

within 48 hours following discharge and shall include the reasons for referral,

the diagnosis, functional limitations, services provided, the results of services,

referral action recommendations and activities and procedures used by the

patient to maintain and improve functioning.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2026       COMPREHENSIVE REHABILITATION PERSONNEL

ADMINISTRATION

(a)  The facility shall have qualified staff members,

consultants and contract personnel to provide services to the patients admitted

to the inpatient rehabilitation facility or unit.

(b)  Personnel shall be employed or provided by contractual

agreement in sufficient types and numbers to meet the needs of all patients

admitted for comprehensive rehabilitation.

(c)  Written agreements shall be maintained by the facility

when services are provided by contract on an ongoing basis.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2027       COMPREHENSIVE INPATIENT REHABILITATION

PROGRAM STAFFING REQS

(a)  The staff of the inpatient rehabilitation facility or

unit shall include at a minimum:

(1)           The inpatient rehabilitation facility or

unit shall be supervised by a rehabilitation nurse.  The facility shall

identify the nursing skills necessary to meet the needs of the rehabilitation

patients in the unit and assign staff qualified to meet those needs.

(2)           The minimum nursing hours per patient in

the rehabilitation unit shall be 5.5 nursing hours per patient day.  At no time

shall direct care nursing staff be less than two full-time equivalents, one of

which must be a registered nurse.

(3)           The inpatient rehabilitation unit shall

employ or provide by contractual agreements sufficient therapists, licensed in North Carolina, to provide a minimum of three hours of specific (physical, occupational or

speech) or combined rehabilitation therapy services per patient day.

(4)           Physical therapy assistants and

occupational therapy assistants shall be licensed or certified and shall be

supervised on-site by licensed physical therapists or licensed occupational

therapists.

(5)           Rehabilitation aides shall have documented

training appropriate to the activities to be performed and the occupational

licensure laws of his or her supervisor.  The overall responsibility for the on‑going

supervision and evaluation of the rehabilitation aide remains with the

registered nurse as identified in Subparagraph (a)(1) of this Rule. 

Supervision by the licensed physical therapist or by the occupational therapist

is limited to that time when the therapist is on‑site and directing the

rehabilitation activities of the aide.

(6)           Hours of service by the rehabilitation aide

are counted toward the required nursing hours when the aide is working under

the supervision of the licensed nurse.  Hours of service by the rehabilitation

aide are counted toward therapy hours during that time the aide works under the

immediate, on‑site supervision of the licensed physical therapist or

occupational therapist.  Hours of service shall not be dually counted for both

services.  Hours of service by rehabilitation aides in performing nurse‑aide

duties in areas of the facility other than the rehabilitation unit shall not be

counted toward the 5.5 hour minimum nursing requirements described for the

rehabilitation unit.

(b)  Additional personnel shall be provided as required to

meet the needs of the patient, as defined in the comprehensive, inpatient

rehabilitation evaluation.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2028       STAFF TRAINING FOR INPATIENT

REHABILITATION FACILITIES OR UNIT

Prior to the provision of care, all rehabilitation

personnel, excluding physicians, assigned to the rehabilitation unit shall be

provided training or shall provide documentation of training, that includes at

a minimum the following:

(1)           active and passive range of motion;

(2)           assistance with ambulation;

(3)           transfers;

(4)           maximizing functional independence;

(5)           the psycho-social needs of the rehabilitation

patient;

(6)           the increased safety risks of rehabilitation

training (including falls and the use of restraints);

(7)           proper body mechanics;

(8)           nutrition, including dysphagia and restorative

eating;

(9)           communication with the aphasic and hearing impaired

patient;

(10)         behavior modification;

(11)         bowel and bladder training; and

(12)         skin care.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2029       EQUIPMENT REQS/COMPREHENSIVE INPATIENT

REHABILITATION PROGRAMS

(a)  The facility shall provide each discipline with the

necessary equipment and treatment methods to achieve the short and long-term

goals specified in the comprehensive inpatient rehabilitation interdisciplinary

treatment plans for patients admitted to these facilities or units.

(b)  Each patient's needs for a standard wheelchair or a

specially designed wheelchair or additional devices to allow safe and

independent mobility within the facility shall be met.

(c)  Special physical therapy and occupational therapy

equipment for use in fabricating positioning devices for beds and wheelchairs

shall be provided, including splints, casts, cushions, wedges and bolsters.

(d)  Physical therapy devices, including a mat table,

parallel bars and sliding boards and special adaptive bathroom equipment shall

be provided.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2030       PHYSICAL FACILITY REQS/INPATIENT

REHABILITATION FACILITIES OR UNITS

(a)  The inpatient rehabilitation facility or unit shall be

in a designated area and shall be used for the specific purpose of providing a

comprehensive, inpatient rehabilitation program.

(b)  The floor area of a single bedroom shall be sufficient

for the patient or the staff to easily transfer the patient from the bed to a

wheelchair and to maneuver a 180-degree turn with a wheelchair on at least one

side of the bed.

(c)  The floor area of a multi-bed bedroom shall be

sufficient for the patient or the staff to easily transfer the patient from the

bed to a wheelchair and to maneuver a 180-degree turn with a wheelchair between

beds.

(d)  Each patient room shall meet the following

requirements:

(1)           Maximum room capacity of no more than four

patients;

(2)           Operable windows;

(3)           A nurse call system designed to meet the

special needs of rehabilitation patients;

(4)           In single and two-bed rooms with private

toilet room, the lavatory may be located in the toilet room;

(5)           A wardrobe or closet for each patient which

is wheelchair accessible and arranged to allow the patient to access the

contents;

(6)           A chest of drawers or built-in drawer

storage with mirror above, which is wheelchair accessible; and

(7)           A bedside table for toilet articles and

personal belongings.

(e)  Space for emergency equipment such as resuscitation

carts shall be provided and shall be under direct control of the nursing staff,

in proximity to the nurse's station and out of traffic.

(f)  Patients' bathing facilities shall meet the following

specifications:

(1)           There shall be at least one shower stall or

one bathtub for each 15 beds not individually served.  Each tub or shower shall

be in an individual room or privacy enclosure which provides space for the

private use of the bathing fixture, for drying and dressing and for a

wheelchair and an assisting attendant.

(2)           Showers in central bathing facilities shall

be at least five foot square without curbs and designed to permit use by a

wheelchair patient.

(3)           At least one five‑foot‑by‑seven‑foot

shower shall be provided which can accommodate a stretcher and an assisting

attendant.

(g)  Patients' toilet rooms and lavatories shall meet the

following specifications:

(1)           The size of toilets shall permit a

wheelchair, a staff person and appropriate wheel-to-water closet transfers.

(2)           A lavatory in the room must permit

wheelchair access.

(3)           Lavatories serving patients shall:

(A)          allow wheelchairs to extend under the lavatory; and

(B)          have water supply spout mounted so that its

discharge point is a minimum of five inches above the rim of the fixture.

(4)           Lavatories used by patients and by staff

shall be equipped with blade-operated supply valves.

(h)  The space provided for physical therapy, occupational

therapy and speech therapy by all inpatient rehabilitation facilities or units

may be shared but must, at a minimum, include:

(1)           office space for staff;

(2)           office space for speech therapy evaluation

and treatment;

(3)           waiting space;

(4)           training bathroom which includes toilet,

lavatory and bathtub;

(5)           gymnasium or exercise area;

(6)           work area such as tables or counters

suitable for wheelchair access;

(7)           treatment areas with available privacy

curtains or screens;

(8)           an activities of daily living training

kitchen with sink, cooking top (secured when not supervised by staff),

refrigerator and counter surface for meal preparation;

(9)           storage for clean linens, supplies and

equipment;

(10)         janitor's closet accessible to the therapy

area with floor receptor or service sink and storage space for housekeeping

supplies and equipment, one closet or space may serve more than one area of the

inpatient rehabilitation facility or unit; and

(11)         hand washing facilities.

(i)  For social work and psychological services the

following shall be provided:

(1)           office space for staff;

(2)           office space for private interviewing and

counseling for all family members; and

(3)           workspace for testing, evaluation and

counseling.

(j)  If prosthetics and orthotics services are provided, the

following space shall be made available as necessary:

(1)           work space for technician; and

(2)           space for evaluation and fittings (with

provisions for privacy).

(k)  If vocational therapy services are provided, the following

space shall be made available as necessary:

(1)           office space for staff;

(2)           workspace for vocational services

activities such as prevocational and vocational evaluation;

(3)           training space;

(4)           storage for equipment; and

(5)           counseling and placement space.

(l)  Recreational therapy space requirements include the

following:

(1)           activities space;

(2)           storage for equipment and supplies;

(3)           office space for staff; and

(4)           access to male and female toilets.

(m)  The following space shall be provided for patient's

dining, recreation and day areas:

(1)           sufficient room for wheelchair movement and

wheelchair dining seating;

(2)           if food service is cafeteria type, adequate

width for wheelchair maneuvers, queue space within the dining area (and not in

a corridor) and a serving counter low enough to view food;

(3)           total space for inpatients, a minimum of 25

square feet per bed;

(4)           for outpatients participating in a day

program or partial day program, 20 square feet when dining is a part of the

program and 10 square feet when dining is not a part of the program; and

(5)           storage for recreational equipment and

supplies, tables and chairs.

(n)  The patient dining, recreation and day area spaces

shall be provided with windows that have glazing of an area not less than eight

percent of the floor area of the space.  At least one half of the required

window area must be operable.

(o)  A laundry shall be available and accessible for

patients.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. May 1, 1993.

 

10A NCAC 13B .2031       ADDITIONAL REQUIREMENTS FOR TRAUMATIC

BRAIN INJURY PATIENTS

Inpatient rehabilitation facilities providing services to

persons with traumatic brain injuries shall meet the requirements in this Rule

in addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios

established in Rule .2027 of this Section shall not be applied to nursing

services for traumatic brain injury patients in the inpatient, rehabilitation

facility or unit.  The minimum nursing hours per traumatic brain injury patient

in the unit shall be 6.5 nursing hours per patient day.  At no time shall

direct care nursing staff be less than two full-time equivalents, one of which

shall be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall

employ or provide by contractual agreements physical, occupational or speech

therapists in order to provide a minimum of 4.5 hours of specific or combined

rehabilitation therapy services per traumatic brain injury patient day.

(3)           The facility shall provide special facility or

equipment needs for patients with traumatic brain injury, including a quiet

room for therapy, specially designed wheelchairs and standing tables.

(4)           The medical director of an inpatient traumatic

brain injury program shall have two years management in a brain injury program,

one of which may be in a clinical fellowship program and board eligibility or

certification in the medical specialty of the physician's training.

(5)           The facility shall provide the consulting services

of a neuropsychologist.

(6)           The facility shall provide continuing education in

the care and treatment of brain injury patients for all staff.

(7)           The size of the brain injury program shall be

adequate to support a comprehensive, dedicated ongoing brain injury program.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. December 1, 1993.

 

10A NCAC 13B .2032       ADDITIONAL REQUIREMENTS FOR SPINAL CORD

INJURY PATIENTS

Inpatient rehabilitation facilities providing services to

persons with spinal cord injuries shall meet the requirements in this Rule in

addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios

established in Rule .2027 of this Section shall not be applied to nursing

services for spinal cord injury patients in the inpatient, rehabilitation

facility or unit.  The minimum nursing hours per spinal cord injury patient in

the unit shall be 6.0 nursing hours per patient day.  At no time shall direct

care nursing staff be less than two full-time equivalents, one of which shall

be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall

employ or provide by contractual agreements physical, occupational or speech

therapists in order to provide a minimum of 4.0 hours of specific or combined

rehabilitation therapy services per spinal cord injury patient day.

(3)           The facility shall provide special facility or

special equipment needs of patients with spinal cord injury, including

specially designed wheelchairs, tilt tables and standing tables.

(4)           The medical director of an inpatient spinal cord

injury program shall have either two years experience in the medical care of

persons with spinal cord injuries or six month's minimum in a spinal cord

injury fellowship.

(5)           The facility shall provide continuing education in

the care and treatment of spinal cord injury patients for all staff.

(6)           The facility shall provide specific staff training

and education in the care and treatment of spinal cord injury.

(7)           The size of the spinal cord injury program shall be

adequate to support a comprehensive, dedicated ongoing spinal cord injury

program.

 

History Note:        Authority G.S. 131E-79; 143B-165;

Eff. December 1, 1993.

 

10A NCAC 13B .2033       DEEMED STATUS FOR INPATIENT

REHABILITATION FACILITIES OR UNITS

(a)  If an inpatient rehabilitation facility or unit with a

comprehensive inpatient rehabilitation program is surveyed and accredited by

the Joint Commission for the Accreditation of Health Care Organizations (JCAHO)

or the Commission on Accreditation of Rehabilitation Facilities (CARF) and has

been approved by the Department in accordance with Article 9 Chapter 131E of

the North Carolina General Statutes, the Department deems the facility to be in

compliance with Rules .2020 through .2030 and .2033 of this Section.

(b)  Deemed status shall be provided only if the inpatient

rehabilitation facility or unit provides copies of survey reports to the

Division.  The JCAHO report shall show that the facility or unit was surveyed

for rehabilitation services.  The CARF report shall show that the facility or

unit was surveyed for comprehensive rehabilitation services.  The facility or

unit shall sign an agreement (Memorandum of Understanding) specifying these

terms.

(c)  The inpatient rehabilitation facility or unit shall be

subject to inspections or complaint investigations by representatives of the

Department at any time.  If the facility or unit is found not to be in

compliance with the rules listed in Paragraph (a) of this Rule, the facility

shall submit a plan of correction and be subject to a follow‑up visit to

assure compliance.

(d)  If the inpatient rehabilitation facility or unit loses

or does not renew its accreditation, the facility or unit shall notify the

Division in writing within 30 days.

 

History Note:        Authority G.S. 131E-79;

Eff. May 1, 1993.

 

SECTION .2100 – TRANSPARENCY IN HEALTH CARE COSTS

 

10A NCAC 13B .2101       definitions

In addition to the terms defined in G.S. 131E-214.13, the

following terms shall apply throughout this Section, unless text indicates to

the contrary:

(1)           "Current Procedural Terminology (CPT)"

means a medical code set developed by the American Medical Association.

(2)           "Diagnostic related group (DRG)" means a

system to classify hospital cases assigned by a grouper program based on ICD

(International Classification of Diseases) diagnoses, procedures, patient's

age, sex, discharge status, and the presence of complications or

co-morbidities.

(3)           "Department" means the North Carolina

Department of Health and Human Services.

(4)           "Financial assistance" means a policy,

including charity care, describing how the organization will provide assistance

at its hospital(s) and any other facilities. Financial assistance includes free

or discounted health services provided to persons who meet the organization's

criteria for financial assistance and are unable to pay for all or a portion of

the services.  Financial assistance does not include:

(a)           bad debt;

(b)           uncollectable charges that the organization

recorded as revenue but wrote off due to a patient's failure to pay;

(c)           the cost of providing such care to the

patients in Sub-Item (4)(b) of this Rule; or

(d)           the difference between the cost of care

provided under Medicare or other government programs, and the revenue derived

therefrom.

(5)           "Healthcare Common Procedure Coding System

(HCPCS)" means a three-tiered medical code set consisting of Level I, II

and III services and contains the CPT code set in Level I.

 

History Note:        Authority G.S. 131E-214.13;

Temporary Adoption Eff. December 31, 2014;

Eff. September 30, 2015.

 

10A NCAC 13B .2102       REPORTING REQUIREMENTS

(a)  The Department shall establish the lists of the

statewide 100 most frequently reported DRGs, 20 most common outpatient imaging

procedures, and 20 most common outpatient surgical procedures performed in the

hospital setting to be used for reporting the data required in Paragraphs (c)

through (e) of this Rule.  The lists shall be determined annually based upon

data provided by the certified statewide data processor.  The Department shall

make the lists available on its website.  The methodology to be used by the

certified statewide data processor for determining the lists shall be based on

the data collected from all licensed facilities in the State in accordance with

G.S. 131E-214.2 as follows:

(1)           the 100 most frequently reported DRGs shall

be based upon all hospital's discharge data that has been assigned a DRG based

on the Centers for Medicare & Medicaid Services grouper for each patient

record, then selecting the top 100 to be provided to the Department;

(2)           the 20 most common imaging procedures shall

be based upon all outpatient data for both hospitals and ambulatory surgical

facilities and represent all occurrences of the diagnostic radiology imaging

codes section of the CPT codes, then selecting the top 20 to be provided to the

Department; and

(3)           the 20 most common outpatient surgical

procedures shall be based upon the primary procedure code from the ambulatory

surgical facilities and represent all occurrences of the surgical codes section

of the CPT codes, then selecting the top 20 to be provided to the Department.

(b)  Information required or reported in Paragraphs (a), (c),

(d), and (i) of this Rule shall be posted on the Department's website at: http://www.ncdhhs.gov/dhsr/ahc

 and may be accessed at no cost.

(c)  In accordance with G.S. 131E-214.13 and quarterly per

year, all licensed hospitals shall report the data required in Paragraph (e) of

this Rule related to the statewide 100 most frequently reported DRGs to the

certified statewide data processor in a format provided by the certified

statewide processor.  Commencing September 30, 2015, a rolling four quarters

data report shall be submitted that includes all sites operated by the licensed

hospital.  Each report shall be for the period ending three months prior to the

due date of the report.

(d)  In accordance with G.S. 131E-214.13 and quarterly per

year, all licensed hospitals shall report the data required in Paragraph (e) of

this Rule related to the statewide 20 most common outpatient imaging procedures

and the statewide 20 most common outpatient surgical procedures to the

certified statewide data processor in a format provided by the certified

statewide processor.  This report shall include the related primary CPT and

HCPCS codes.  Commencing September 30, 2015, a rolling four quarters data

report shall be submitted that includes all sites operated by the licensed

hospital.  Each report shall be for the period ending three months prior to the

due date of the report.

(e)  The reports as described in Paragraphs (c) and (d) of

this Rule shall be specific to each reporting hospital and shall include:

(1)           the average gross charge for each DRG, CPT

code, or procedure without a public or private third party payer source;

(2)           the average negotiated settlement on the

amount that will be charged for each DRG, CPT code, or procedure as required

for patients defined in Subparagraph (e)(1) of this Rule.  The average

negotiated settlement shall be calculated using the average amount charged all

patients eligible for the hospital's financial assistance policy, including

self-pay patients;

(3)           the amount of Medicaid reimbursement for

each DRG, CPT code, or procedure, including all supplemental payments to and

from the hospital;

(4)           the amount of Medicare reimbursement for

each DRG, CPT code, or procedure; and

(5)           on behalf of patients who are covered by a

Department of Insurance licensed third-party and teachers and State employees,

the lowest, average, and highest amount of payments made for each DRG, CPT code,

or procedure by each of the hospital's top five largest health insurers.

(A)          each hospital shall determine its five largest

health insurers based on the dollar volume of payments received from those

insurers;

(B)          the lowest amount of payment shall be reported as

the lowest payment from each of the five insurers on the DRG, CPT code, or

procedure;

(C)          the average amount of payment shall be reported as

the arithmetic average of each of the five health insurers payment amounts;

(D)          the highest amount of payment shall be reported as

the highest payment from each of the five insurers on the DRG, CPT code, or

procedure; and

(E)           the identity of the top five largest health

insurers shall be redacted prior to submission.

(f)  The data reported, as defined in Paragraphs (c) through

(e) of this Rule, shall reflect the payments received from patients and health

insurers for all closed accounts. For the purpose of this Rule, "closed

accounts" are patient accounts with a zero balance at the end of the data

reporting period.

(g)  A minimum of three data elements shall be required for

reporting under Paragraphs (c) and (d) of this Rule. 

(h)  The information submitted in the report shall be in

compliance with the federal Health Insurance Portability and Accountability Act

of 1996, 45 CFR Part 164.

(i)  The Department shall provide the location of each

licensed hospital and all specific hospital data reported pursuant to this Rule

on its website.  Hospitals shall be grouped by category on the website.  On

each quarterly report, hospitals shall determine one category that most

accurately describes the type of facility. The categories are:

(1)           "Academic Medical Center Teaching

Hospital," means a hospital as defined in Policy AC-3 of the N.C. State

Medical Facilities Plan.  The N.C. State Medical Facilities Plan may be

accessed at: http://www.ncdhhs.gov/dhsr/ncsmfp at no cost.

(2)           "Teaching Hospital," means a

hospital that provides medical training to individuals, provided that such

educational programs are accredited by the Accreditation Council for Graduated

Medical Education to receive graduate medical education funds from the Centers

for Medicare & Medicaid Services.

(3)           "Community Hospital," means a

general acute hospital that provides diagnostic and medical treatment, either

surgical or nonsurgical, to inpatients with a variety of medical conditions,

and that may provide outpatient services, anatomical pathology services,

diagnostic imaging services, clinical laboratory services, operating room

services, and pharmacy services, that is not defined by the categories listed

in this Subparagraph and Subparagraphs (i)(1), (2), or (5) of this Rule.

(4)           "Critical Access Hospital," means

a hospital defined in the Centers for Medicare & Medicaid Services' State

Operations Manual, Chapter 2 – The Certification Process, 2254D – Requirements

for Critical Access Hospitals (Rev. 1, 05-21-04), including all subsequent

updates and revisions. The manual may be accessed at the website: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_a_hospitals.pdf

at no cost.

(5)           "Mental Health Hospital," means a

hospital providing psychiatric services pursuant to G.S. 131E-176(21).

 

History Note:        Authority G.S. 131E-214.4; 131E-214.13;

Temporary Adoption Eff. December 31, 2014;

Eff. September 30, 2015.

 

SECTION .2200 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2200       Reserved for future codification

 

SECTION .2300 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2300       Reserved for future codification

 

SECTION .2400 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2400       Reserved for future codification

 

SECTION .2500 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2500       Reserved for future codification

 

SECTION .2600 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2600       Reserved for future codification

 

SECTION .2700 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2700       Reserved for future codification

 

SECTION .2800 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2800       Reserved for future codification

 

SECTION .2900 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .2900       Reserved for future codification

 

SECTION .3000 - GENERAL INFORMATION

 

10A NCAC 13B .3001       DEFINITIONS

The following definitions shall apply throughout this

Section, unless the context clearly indicates to the contrary:

(1)           "Appropriate" means suitable or fitting,

or conforming to standards of care as established by professional

organizations.

(2)           "Authority having jurisdiction" means the

Division of Health Service Regulation.

(3)           "Certified Dietary Manager" or

"CDM" means an individual who is certified by the Certifying Board of

the Dietary Managers and meets the standards and qualification as referenced in

the "Dietary Manager Training Program Requirements."  These standards

include any subsequent amendments and editions of the referenced manual. 

Copies of the "Dietary Manager Training Program Requirements" may be

purchased for fifteen dollars ($15.00) from the Dietary Managers Association, 406

Surry Woods Dr., St. Charles, IL 60174.

(4)           "Competence" means the state or quality

of being able to perform specific functions well; skill; ability.

(5)           "Comprehensive" means covering

completely, inclusive; large in scope or content.

(6)           "Continuous" means ongoing or

uninterrupted, 24 hours per day.

(7)           "CRNA" means a Certified Registered Nurse

Anesthetist as credentialed by the Council on Certification of Nurse

Anesthetists and recognized by the Board of Nursing in 21 NCAC 36 .0226.

(8)           "Credentialed" means that the individual

having a given title or position has been credited with the right to exercise

official responsibilities to provide specific patient care and treatment

services, within defined limits, based primarily upon the individual's license,

education, training, experience, competence, and judgment.

(9)           "Department" means the Department of

Health and Human Services.

(10)         "Dietetics" means the integration and

application of principles derived from the science of nutrition, biochemistry,

physiology, food and management and from behavioral and social sciences to

achieve and maintain optimal nutritional status.

(11)         "Dietitian" means an individual who is

licensed according to G.S. 90, Article 25, or is registered by the Commission

on Dietetic Registration (CDR) of the American Dietetic Association (ADA)

according to the standards and qualifications as referenced in the second

edition of the "Accreditation/Approval Manual for Dietetic Education

Programs", "The Registration Eligibility Application for

Dietitians" and the "Continuing Professional Education" and

subsequent amendments or editions of the reference material.  Copies of the

"Accreditation/Approval Manual for Dietetic Education Programs" may

be purchased for twenty-one dollars and ninety-five cents ($21.95) plus three

dollars ($3.00) minimum shipping and handling from ADA 216 W. Jackson Blvd.,

Chicago, IL 60606-9-6995.

(12)         "Dietetic Technician Registered" or

"DTR" means an individual who is registered by the Commission on

Dietetic Registration (CDR) of the American Dietetic Association (ADA)

according to the standards and qualifications as referenced in the second

edition of the "Accreditation/Approval Manual for Dietetic Education

Programs" which is incorporated by reference including any subsequent

amendments and editions.  Copies of the "Accreditation/Approval Manual for

Dietetic Education Programs" may be purchased for twenty-one dollars and

ninety-five cents ($21.95) plus three dollars ($3.00) minimum for shipping and

handling from the ADA 216 W. Jackson Blvd., Chicago, IL 60606-9-6995.

(13)         "Direct Supervision" means the state of

being under the immediate control of a supervisor, manager, or other person of

authority.

(14)         "Division" means the Division of Health

Service Regulation.

(15)         "Facility" means a hospital as defined in

G.S. 131E-76.

(16)         "Free standing facility" means a facility

that is physically separated from the primary hospital building or separated by

a three hour fire containment wall.

(17)         "Full-time equivalent" means a unit of

measure of employee work time that is equal to the number of hours that one

full-time employee would work during one calendar year if the employee worked

eight hours a day, five days a week, and 52 weeks a year; i.e. 2,080 hours per

year.

(18)         "Governing body" means the authority as

defined in G.S. 131E-76.

(19)         "Imaging" means a reproduction or

representation of a body or body part for diagnostic purposes by radiologic

intervention that may include conventional fluoroscopic exam, magnetic

resonance, nuclear or radio-isotope scan.

(20)         "Invasive procedure" means a procedure

involving puncture or incision of the skin, insertion of an instrument or

foreign material into the body (excluding venipuncture and intravenous

therapy).

(21)         "LDRP" (labor, delivery, recovery,

post-partum) means a specific single occupancy obstetrical use room counted as

a licensed bed.

(22)         "License" means formal permission to

provide services as granted by the State.

(23)         "Medical staff" means the formal

organization that is comprised of all of those individuals who have sought and

obtained clinical privileges in a facility.  Those members of the medical staff

who regularly and routinely admit patients to a facility constitute the active

medical staff.

(24)         "Mission statement" means a written

statement of the philosophy and beliefs of the organization or hospital as

approved by the governing body.

(25)         "Neonate" means the newborn from birth to

one month.

(26)         "NP" means a Nurse Practitioner as defined

in G.S. 90-6; 90-18(14) and 90-18.2.

(27)         "Nurse executive" means a registered nurse

who is the director of nursing services or a representative of decentralized

nursing management staff.

(28)         "Nurse midwife" means a Certified Nurse

Midwife as defined in G.S. 90, Article 10.

(29)         "Nursing facility" means that portion of a

hospital that is approved to provide skilled nursing care.

(30)         "Nursing staff" means the registered nurses,

licensed practical nurses, nurse aides, and others under nurse supervision, who

provide direct patient care.  The term also includes clerical personnel who

work in clinical areas under nurse supervision.

(31)         "Nutrition therapy" ranges from intervention

and counseling on diet modification to administration of specialized nutrition

therapies as determined necessary to manage a condition or treat illness or

injury.  Specialized nutrition therapies include supplementation with medical

foods, enteral and parenteral nutrition.  Nutrition therapy integrates

information from the nutrition assessment with information on food and other

sources of nutrients and meal preparation consistent with cultural background

and socioeconomic status.

(32)         "Observation bed" means a bed used for no

more than 24-hours, to evaluate and determine the condition and disposition of

a patient and is not considered a part of the hospital's licensed bed capacity.

(33)         "Patient" means any person receiving

diagnostic or medical services at a hospital.

(34)         "Pharmacist" means a person licensed

according to G.S. 90, Article 4A, by the N.C. Board of Pharmacy to practice

pharmacy.

(35)         "Physical Rehabilitation Services" means

any combination of physical therapy, occupational therapy, speech therapy or

vocational rehabilitation.

(36)         "Physician" means a person licensed

according to G.S. 90, Article 1, by the N.C. Board of Medical Examiners to

practice medicine.

(37)         "Provisional license" means a hospital

license recognizing significantly less than full compliance with the licensure

rules.

(38)         "Qualified" means having complied with the

specific conditions for employment or the performance of a function.

(39)         "Reference" means to use in consultation

to obtain information.

(40)         "Special Care Unit" means a designated

unit or area of a hospital with a concentration of qualified professional staff

and support services that provide intensive or extra ordinary care on a 24-hour

basis to critically ill patients; these units may include but are not limited

to Cardiac Care, Medical or Surgical Intensive Care Unit, Cardiothoracic

Intensive Care Unit, Burn Intensive Care Unit, Neurologic Intensive Care Unit

or Pediatric Intensive Care Unit.

(41)         "Unit" means a designated area of the

hospital for the delivery of patient care services.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of Statutory Authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

section .3100 - procedure

 

10A NCAC 13B .3101       GENERAL REQUIREMENTS

(a)  An application for licensure shall be submitted to the

Division prior to a license being issued or patients admitted.

(b)  An existing facility shall not sell, lease or subdivide

a portion of its bed capacity without the approval of the Division.

(c)  Application forms may be obtained by contacting the

Division.

(d)  The Division shall be notified in writing prior to the

occurrence of any of the following:

(1)           addition or deletion of a licensable

service;

(2)           increase or decrease in bed capacity;

(3)           change of chief executive officer;

(4)           change of mailing address;

(5)           ownership change; or

(6)           name change.

(e)  Each application shall contain the following

information:

(1)           legal identity of applicant;

(2)           name or names under which the hospital or

services are presented to the public;

(3)           name of the chief executive officer;

(4)           ownership disclosure;

(5)           bed complement;

(6)           bed utilization data;

(7)           accreditation data;

(8)           physical plant inspection data; and

(9)           service data.

(f)  A license shall include only facilities or premises

within a single county.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. April

1, 2003.

 

10A ncac 13B .3102       PLAN APPROVAL

(a)  The facility design and construction shall be in

accordance with the construction standards of the Division, the North Carolina

Building Code, and local municipal codes.

(b)  Submission of Plans:

(1)           Before construction is begun, color marked

plans and specifications covering construction of the new buildings,

alterations or additions to existing buildings, or any change in facilities

shall be submitted to the Division for approval.

(2)           The Division shall

review the plans and notify the licensee that said buildings, alterations,

additions, or changes are approved or disapproved.  If plans are disapproved

the Division shall give the applicant notice of deficiencies identified by the

Division.

(3)           In order to avoid unnecessary expense in

changing final plans, as a

preliminary step, proposed plans in schematic form shall be submitted by the applicant to the Division for

review.

(4)           The plans shall include a plot plan showing

the size and shape of the entire site and the location of all existing and

proposed facilities.

(5)           Plans shall be submitted in triplicate in

order that the Division may distribute a copy to the Department of Insurance

for review of North Carolina State Building Code requirements and to the

Department of Environment and Natural Resources for review under state

sanitation requirements.

(c)  Location:

(1)           The site for new construction or expansion

shall be approved by the Division.

(2)           Hospitals shall be so located that they are

free from noise from railroads, freight yards, main traffic arteries, schools

and children's playgrounds.

(3)           The site shall not be exposed to smoke,

foul odors, or dust from industrial plants.

(4)           The area of the site shall be sufficient to

permit future expansion and to provide parking facilities.

(5)           Available paved roads, water, sewage and

power lines shall be taken into consideration in selecting the site.

(d)  The bed capacity and services provided in a facility

shall be in compliance with G.S. 131E, Article 9 regarding Certificate of

Need.  A facility shall be licensed for no more beds than the number for which

required physical space and other required facilities are available.  Neonatal

Level II, III and IV beds are

considered part of the licensed bed capacity.  Level

I bassinets are not considered part of the licensed bed capacity

however, no more bassinets shall be placed in service than the number for which

required physical space and other required facilities are available.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Temporary Amendment Eff. March

15, 2002;

Amended Eff. April

1, 2003.

 

10A NCAC 13B .3103       CLASSIFICATION OF MEDICAL FACILITIES

(a)  For purpose of this Subchapter the classification of

"hospital" shall be restricted to facilities that provide as their

functions diagnostic services and medical and nursing care in the treatment of

acute stages of illness.  On the basis of specialized facilities and services

available, the Division shall license each such hospital according to the

following medical types:

(1)           general acute care hospital;

(2)           rehabilitation hospital;

(3)           critical access hospital; or

(4)           long term acute care hospital which is a

hospital which has been classified and certified as a long term care hospital

pursuant to 42 CFR Part 412.

(b)  All other inpatient medical facilities accepting

patients requiring skilled nursing services but which are not operated as a

part of any hospital within the above meaning shall be considered to be

operating as a nursing home and, therefore, are not subject to licensure

pursuant to this Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. June 1, 2005.

 

10A NCAC 13B .3104       LENGTH OF LICENSE

Licenses shall remain in effect until one of

the following occurs:

(1)           Division imposes an administrative

sanction which specifies license expiration;

(2)           change of ownership;

(3)           closure;

(4)           change of site;

(5)           failure to comply with Rule .3105 of

this Section.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3105       STATISTICAL INFORMATION

Utilization data shall be submitted annually

upon request by the Division.  Forms for collection of this data will be

forward to each facility by the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3106       LICENSURE SURVEYS

(a)  Prior to the initial issuance of a license to operate a

facility, the Division shall conduct a survey to determine compliance with

rules promulgated pursuant to G.S. 131E-79.

(b)  The Division may conduct an investigation of a

complaint in any facility.

(c)  Facilities that are accredited through an accrediting

body approved pursuant to section 1865(a) of the Social Security Act shall not

be subject to routine inspections.

(d)  The Division shall survey non-accredited facilities at

least once every three years.

 

History Note:        Authority G.S. 131E-79; 131E-80;

Eff. January 1, 1996;

Amended Eff. October 1, 2010.

 

10A NCAC 13B .3107       DENIAL, AMENDMENT OR REVOCATION OF

LICENSE

(a)  The Department may deny any licensure application upon

becoming aware that the applicant is not in compliance with any applicable

provision of the Certificate of Need law located in G.S. 131E, Article 9 and

the rules adopted under that law.

(b)  The Department may amend a license by reducing it from

a full license to a provisional license whenever the Department finds that:

(1)           the licensee has failed to comply with the

provisions of G.S. 131E, Article 5 and the rules promulgated under that

article;

(2)           there is a probability that the licensee

can remedy the licensure deficiencies within a length of time not to exceed the

expiration date on the license; and

(3)           there is a probability that the licensee

will be able thereafter to remain in compliance with the hospital licensure

rules for the foreseeable future.

(c)  The Department shall also amend a license to

provisional status by specifically prohibiting a licensee from providing

certain services, for which it has been found to be out of compliance with G.S.

131E, Articles 5 or 9.  In all cases the Department shall give the licensee

written notice of the amendment of the license.  This notice shall be given by

registered or certified mail or by personal service and shall set forth:

(1)           the length of the provisional license;

(2)           the factual allegations;

(3)           the statutes and rules alleged to be

violated; and

(4)           notice of the facility's right to a

contested case hearing on the amendment of the license.

(d)  The provisional license shall be effective immediately

upon its receipt by the licensee and shall be posted in a prominent location,

accessible to public view, within the licensed premises in lieu of the full

license.  The provisional license shall remain in effect until:

(1)           the Department restores the licensee to

full licensure status;

(2)           the Department revokes the licensee's

license; or

(3)           the end of the licensee's licensure period.

 If a licensee has a provisional license at the time that the licensee submits

a renewal application, the license, if renewed, shall also be a provisional

license unless the Department determines that the licensee can be returned to

full licensure status.  A decision to issue a provisional license is stayed during

the pendency of an administrative appeal and the licensee may continue to

display its full license during the appeal.

(e)  The Department shall revoke a license whenever:

(1)           The Department finds that:

(A)          the licensee has failed to comply with the provisions

of G.S. 131E, Article 5 and the rules promulgated under that article; and

(B)          it is not probable that the licensee can remedy the

licensure deficiencies within a length of time acceptable to the Department; or

(2)           The Department finds that:

(A)          The licensee has failed to comply with the

provisions of G.S. 131E, Article 5; and

(B)          although the licensee may be able to remedy the

deficiencies within a reasonable time, it is not probable that the licensee

will be able to remain in compliance with hospital licensure rules for the

foreseeable future; or

(3)           The Department finds that the licensee has

failed to comply with any of the provisions of G.S. 131E, Article 5 and the

rules promulgated thereunder that endangers the health, safety or welfare of

the patients in the facility.

The issuance of a provisional license is not a procedural

prerequisite to the revocation of a license pursuant to Subparagraphs (e)(1),

(2) or (3) of this Rule.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3108       SUSPENSION OF ADMISSIONS

(a)  The Department may amend a license,

pursuant to G.S. 131E-78, by suspending the admission of any new patients to

any facility when the conditions in the facility are detrimental to the health

or safety of the patients in the facility.

(b)  The Department shall notify the facility

by registered or certified mail or by personal service of the decision to

suspend admissions.  Such notice will include:

(1)           the period of the

suspension;

(2)           factual allegations;

(3)           citation of statutes and

rules alleged to be violated; and

(4)           notice of the facility's

right to a contested case hearing.

(c)  The suspension shall be effective when

the notice is served or on the date specified in the notice of suspension,

whichever is later.  The suspension shall remain effective for the period

specified in the notice or until the facility demonstrates to the Department

that conditions are no longer detrimental to the health and safety of the

patient.

(d)  The facility shall not admit new patients

during the effective period of the suspension.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3109       PROCEDURE FOR APPEAL

A facility may appeal any decision of the

Department to deny, revoke or amend a license or any decision to suspend

admissions by making such an appeal in accordance with G.S. 150B.

 

History Note:        Authority G.S. 131E-78; 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3110       ITEMIZED CHARGES

(a)  The facility shall either present an itemized list of

charges to all discharged patients or the facility shall include on patients' bills

that are not itemized, notification of the right to request an itemized bill

within three years of receipt of the non-itemized bill or so long as the

hospital, a collections agency, or other assignee asserts the patient has an

obligation to pay the bill.

(b)  If requested, the facility shall present an itemized

list of charges to each patient or the patient's representative. This list

shall detail in language comprehensible to an ordinary layperson the specific

nature of the charges or expenses incurred by the patient.

(c)  The itemized listing shall include each specific

chargeable item or service in the following service areas:

(1)           room rate

(2)           laboratory;

(3)           radiology and nuclear medicine;

(4)           surgery;

(5)           anesthesiology;

(6)           pharmacy;

(7)           emergency services;

(8)           outpatient services;

(9)           specialized care;

(10)         extended care;

(11)         prosthetic and orthopedic appliances; and

(12)         professional services provided by the

facility.

 

History Note:        Authority G.S. 131E-79; 131E-91; S.L.

2013-382, s. 13.1;

Eff. January 1, 1996;

Temporary Amendment Eff. May 1, 2014;

Amended Eff. November 1, 2014.

 

10A NCAC 13B .3111       TEMPORARY CHANGE IN BED CAPACITY

(a)  A hospital may temporarily increase its bed capacity by

up to 10 percent over its licensed bed capacity, as determined by the

administrator, by utilizing observational beds for inpatients for a period of

no more than 60 consecutive days following approval by the Division of Health

Service Regulation. 

(b)  To qualify for a temporary change in licensed capacity,

the hospital census shall be at least 90 percent of its licensed bed capacity,

excluding beds that are under renovation or construction, and the hospital must

demonstrate conditions requiring the temporary increase that may include but

are not limited to the following:

(1)           natural disaster;

(2)           catastrophic event; or

(3)           disease epidemic.

(c)  The Division may approve a temporary increase in licensed

beds only if:

(1)           It is determined that the request has met

the requirements of Paragraphs (a) and (b) of this Rule; and

(2)           The hospital administrator certifies that

the physical facilities to be used are adequate to safeguard the health and

safety of patients.  However this approval shall be revoked if the Division

determines, as a result of a physical site visit, that these safeguards are not

adequate to safeguard the health and safety of patients.

 

History Note:        Authority G.S. 131E-79;

Eff. April 1, 2003.

 

SECTION .3200 - GENERAL HOSPITAL REQUIREMENTS

 

10A NCAC 13B .3201       HOSPITAL REQUIREMENTS

A facility shall have all of the following:

(1)           an organized governing body;

(2)           a chief executive officer;

(3)           an organized medical staff;

(4)           an organized nursing staff;

(5)           continuous medical services;

(6)           continuous nursing services;

(7)           permanent on-site facilities for the

care of patients 24 hours a day;

(8)           a hospital-wide infection control

program;

(9)           minimum on-site clinical provisions

as follows:

(a)           appropriately equipped

inpatient care areas;

(b)           nursing care units;

(c)           diagnostic and treatment

areas to include on-site laboratory and imaging facilities with the capacity to

provide immediate response to patient emergencies;

(d)           pharmaceutical services in compliance

with the Pharmacy Laws of North Carolina;

(e)           facilities to assure the

sterilization of equipment and supplies;

(f)            medical records services;

(g)           provision for social work

services;

(h)           current reference sources to

meet staff needs; and

(i)            nutrition services.

(10)         minimum supportive capabilities or

facilities as follows:

(a)           nutrition and dietetic

services;

(b)           scheduled general and

preventive maintenance services for building, services and biomedical

equipment;

(c)           capability for obtaining

police and fire protection, emergency transportation, grounds-keeping, and snow

removal;

(d)           personnel recruitment,

training and continuing education;

(e)           business management

capability;

(f)            short and long-range

planning capability;

(g)           financial plan to provide

continuity of operation under both normal and emergency conditions;

(h)           provision for patient,

employee, and visitor safety; and

(i)            policies for preventive and

corrective maintenance including procedures to be followed in the event of a

breakdown of essential equipment.

(11)         facilities must comply with

construction rules in Sections .6000 - .6200 of this Subchapter.

(12)         a risk management program as follows:

(a)           a specific staff member shall

be assigned responsibility for development and administration of the program;

(b)           a written policy statement

evidencing a current commitment to the risk management program together with

written procedures, policies and educational programs applicable to a risk

management program which are reviewed at least every three years and updated as

necessary;

(c)           established lines of

communication between the risk management program and other functions relating

to quality of patient care, safety, and professional staff performance; and

(d)           a written report of the

activities of the risk management program shall be annually submitted to the

governing body.

(13)         a quality assessment and improvement

program which provides:

(a)           continuous assessment and

evaluation of patient care and related services in all services and

departments;

(b)           a designated individual to

coordinate the quality assessment and improvement program who will assist in

the establishment of quality assessment and improvement plans and reporting

methods for each service and department;

(c)           a committee made up of representatives

of the medical and nursing staff, administration, and other services or

departments as defined by the hospital to coordinate the program, meet at least

quarterly and maintain minutes of the meetings and committee activities; and

(d)           for each service and

department as defined by the hospital to be involved in the continuous

assessment, monitoring and evaluation of patient care and related services.

 

History Note:        Authority G.S. 131E-75; 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3202       ADMISSION AND DISCHARGE

(a)  The facility shall provide written

admission and discharge, and referral policies.

(b)  There shall be on the premises at all

times an employee authorized to receive patients and to make arrangements for their

disposition.

(c)  A patient shall be admitted only under

the care of a member of the medical staff meeting the provisions of Section

.3700 of this Subchapter.

(d)  The facility shall take appropriate

precautions to protect the safety and legal rights of patients and employees.

(e)  The facility shall maintain a complete

and permanent record of all outpatients and inpatients including the date and

time of admission and discharge.  Effort shall be made to verify the full and

true name, address, date of birth, nearest of kin, provisional diagnosis,

condition on admission and discharge, referring physicians, attending physician

or service.

(f)  Facility staff shall provide at the time

of admission an identification bracelet, band, or other suitable device for

positive identification of each patient.

(g)  No mentally competent adult shall be

detained by the facility against his will, except as authorized by law.

 

History Note:        Authority G.S. 131E-75; 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3203       DISCHARGE PLANNING

(a)  Discharge planning shall be an integral

part of in-patient hospitalization.

(b)  The facility shall have written policies

and procedures governing discharge planning.  These shall include but need not

be limited to the following:

(1)           appropriate screening to

determine the need for discharge planning;

(2)           methods to facilitate the

provision of follow-up care;

(3)           information to be given to

the patient or his family or other persons involved in caring for the patient

on matters such as the patient's condition; his health care needs; the amount

of activity he should engage in; any necessary medical regimens including

drugs, nutrition therapy, appointments or other forms of therapy; sources of

additional help from other agencies; and procedures to follow in case of

complications; and

(4)           procedures for assisting the

patient and his family in gaining information regarding financial assistance in

paying bills incurred as a result of the hospitalization, including how to receive

assistance from the various federal and State government programs.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3204       TRANSFER AGREEMENT

(a)  Any facility which does not provide

hospital based nursing facility service shall maintain written agreements with

institutions offering this kind of care.  Such agreements shall provide for the

transfer and admission of patients who no longer require the services of the

hospital but do require nursing facility services.

(b)  A patient shall not be transferred to

another medical care facility unless prior arrangements for admission have been

made.  Clinical records of sufficient content to provide continuity of care

shall accompany the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3205       DISCHARGE OF MINOR OR INCOMPETENT

Any individual who cannot legally consent to

his own care shall be discharged only to the custody of parents, legal

guardian, person standing in loco parentis, or another competent adult unless otherwise

directed by the parent or guardian or court of competent jurisdiction.  If the

parent or guardian directs that discharge be made otherwise, he shall so state

in writing, and the statement shall become a part of the permanent medical

record of the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3300 - PATIENT'S BILL OF RIGHTS

 

10A NCAC 13B .3301       PRINCIPLE

It is the purpose of these requirements to promote the

interests and well-being of the patients in facilities subject to this

Subchapter even in those instances where the interests of the patients may be

in opposition to the interests of the facility.  The facility has the right to

expect the patient to fulfill patient responsibilities as may be stated in the

facilities' policies affecting patient care and conduct.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3302       MINIMUM PROVISIONS OF PATIENT'S BILL OF

RIGHTS

This Rule does not apply to patients in licensed nursing

facility beds since these individuals are granted rights pursuant to G.S.

131E-117. A patient in a facility subject to this Rule has the following

rights: 

(1)           A patient has the right to respectful care given by

competent personnel.

(2)           A patient has the right, upon request, to be given

the name of his attending physician, the names of all other physicians directly

participating in his care, and the names and functions of other health care

persons having direct contact with the patient.

(3)           A patient has the right to privacy concerning his

own medical care program.  Case discussion, consultation, examination, and

treatment are considered confidential and shall be conducted discreetly.

(4)           A patient has the right to have all records

pertaining to his medical care treated as confidential except as otherwise

provided by law or third party contractual arrangements.

(5)           A patient has the right to know what facility rules

and regulations apply to his conduct as a patient.

(6)           A patient has the right to expect emergency

procedures to be implemented without unnecessary delay.

(7)           A patient has the right to good quality care and

high professional standards that are continually maintained and reviewed.

(8)           A patient has the right to full information in

laymen's terms, concerning his diagnosis, treatment and prognosis, including

information about alternative treatments and possible complications.  When it

is not possible or medically advisable to give such information to the patient,

the information shall be given on his behalf to the patient's designee.

(9)           Except for emergencies, a physician must obtain

necessary informed consent prior to the start of any procedure or treatment, or

both.

(10)         A patient has the right to be advised when a

physician is considering the patient as a part of a medical care research

program or donor program.  Informed consent must be obtained prior to actual

participation in such a program and the patient or legally responsible party,

may, at any time, refuse to continue in any such program to which he has

previously given informed consent.  An Institutional Review Board (IRB) may

waive or alter the informed consent requirement if it reviews and approves a

research study in accord with federal regulations for the protection of human

research subjects including U.S. Department of Health and Human Services (HHS)

regulations under 45 CFR Part 46 and U.S. Food and Drug Administration (FDA)

regulations under 21 CFR Parts 50 and 56.  For any research study proposed for

conduct under an FDA "Exception from Informed Consent Requirements for

Emergency Research" or an HHS "Emergency Research Consent

Waiver" in which informed consent is waived but community consultation and

public disclosure about the research are required, any facility proposing to be

engaged in the research study also must verify that the proposed research study

has been registered with the North Carolina Medical Care Commission.  When the

IRB reviewing the research study has authorized the start of the community

consultation process required by the federal regulations for emergency

research, but before the beginning of that process, notice of the proposed research

study by the facility shall be provided to the North Carolina Medical Care

Commission.  The notice shall include:

(a)           the title of the research study;

(b)           a description of the research study,

including a description of the population to be enrolled;

(c)           a description of the planned community

consultation process, including currently proposed meeting dates and times;

(d)           an explanation of the way that people

choosing not to participate in the research study may opt out; and

(e)           contact information including mailing

address and phone number for the IRB and the principal investigator.

The Medical Care

Commission may publish all or part of the above information in the North

Carolina Register, and may require the institution proposing to conduct the

research study to attend a public meeting convened by a Medical Care Commission

member in the community where the proposed research study is to take place to

present and discuss the study or the community consultation process proposed.

(11)         A patient has the right to refuse any drugs,

treatment or procedure offered by the facility, to the extent permitted by law,

and a physician shall inform the patient of his right to refuse any drugs,

treatment or procedures and of the medical consequences of the patient's refusal

of any drugs, treatment or procedure.

(12)         A patient has the right to assistance in obtaining

consultation with another physician at the patient's request and expense.

(13)         A patient has the right to medical and nursing

services without discrimination based upon race, color, religion, sex, sexual

orientation, gender identity, national origin or source of payment.

(14)         A patient who does not speak English shall have

access, when possible, to an interpreter.

(15)         A facility shall provide a patient, or patient

designee, upon request, access to all information contained in the patient's

medical records.  A patient's access to medical records may be restricted by

the patient's attending physician.  If the physician restricts the patient's

access to information in the patient's medical record, the physician shall

record the reasons on the patient's medical record.  Access shall be restricted

only for sound medical reason.  A patient's designee may have access to the

information in the patient's medical records even if the attending physician

restricts the patient's access to those records.

(16)         A patient has the right not to be awakened by

hospital staff unless it is medically necessary.

(17)         The patient has the right to be free from

duplication of medical and nursing procedures as determined by the attending

physician.

(18)         The patient has the right to medical and nursing

treatment that avoids unnecessary physical and mental discomfort.

(19)         When medically permissible, a patient may be

transferred to another facility only after he or his next of kin or other

legally responsible representative has received complete information and an

explanation concerning the needs for and alternatives to such a transfer.  The

facility to which the patient is to be transferred must first have accepted the

patient for transfer.

(20)         The patient has the right to examine and receive a

detailed explanation of his bill.

(21)         The patient has a right to full information and

counseling on the availability of known financial resources for his health

care.

(22)         A patient has the right to be informed upon

discharge of his continuing health care requirements following discharge and

the means for meeting them.

(23)         A patient shall not be denied the right of access to

an individual or agency who is authorized to act on his behalf to assert or

protect the rights set out in this Section.

(24)         A patient has the right to be informed of his rights

at the earliest possible time in the course of his hospitalization.

(25)         A patient has the right to designate visitors who

shall receive the same visitation privileges as the patient's immediate family

members, regardless of whether the visitors are legally related to the patient.



 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

RRC Objection due to ambiguity Eff. July 13, 1995;

Eff. January 1, 1996;

Temporary Amendment Eff. April 1, 2005;

Amended Eff. January 1, 2011; May 1, 2008; November 1,

2005.

 

10A NCAC 13B .3303       PROCEDURE

(a)  The facility shall develop and implement procedures to

inform each patient of his rights.  Copies of the facilities' Patient's Bill of

Rights shall be made available through one of the following ways:

(1)           prominent displays in appropriate locations

in addition to copies available upon request; or

(2)           provision of a copy to each patient or

responsible party upon admission or as soon after admission as is feasible.

(b)  The address and telephone number of the section in the

Department responsible for the enforcement of the provisions of this part shall

be posted.

(c)  The facility shall adopt procedures to ensure effective

and fair investigation of violations of patients' rights and to ensure their

enforcement.  These procedures shall ensure that:

(1)           a system is established to identify formal

written complaints;

(2)           formal written complaints are recorded and

investigated;

(3)           investigation and resolution of formal

complaints shall be conducted; and

(4)           disciplinary and education procedures shall

be developed for members of the hospital and medical staff who are noncompliant

with facility policies.

(d)  The Division shall investigate or refer to appropriate

State agencies all complaints within the jurisdiction of the rules in this

Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3400 - SUPPLEMENTAL RULES FOR THE LICENSURE OF

critical access HOSPITALS

 

10A NCAC 13B .3401       SUPPLEMENTAL RULES

The rules of this Section pertain only to designated Critical

Access Hospitals in accordance with 42 CFR 485 Subpart F.  The general

requirements of this Subchapter shall apply to such facilities except where

they are specifically waived or modified by the rules of this Section.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

10A NCAC 13B .3402       DEFINITIONS

The following definitions shall apply throughout this

Section, unless context otherwise clearly indicates to the contrary:

(1)           "Available" means provided directly by

the facility or by written agreement with a qualified provider of the service

within one hour driving time.

(2)           "Critical Access Hospital" means a

facility designated by the North Carolina Office of Research, Demonstrations

and Rural Health Development in accordance with 42 CFR 485 Subpart F.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

10A NCAC 13B .3403       LICENSURE APPLICATION

10A NCAC 13B .3404       FEDERALLY CERTIFIED PRIMARY

CARE HOSPITAL

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Repealed Eff. November 1, 2004.

 

10A NCAC 13B .3405       DESIGNATED CRITICAL ACCESS HOSPITALS

The requirements of 10A NCAC 13B shall apply to Critical

Access Hospitals with the following modifications:

(1)           Autopsy facilities required in Rule .4907 of this

Subchapter are not required provided that the facility has in effect a written

agreement with another facility meeting Rule .4907 of this Subchapter for

providing autopsy services.

(2)           Radiological services required in Section .4800 and

Rule .6210 of this Subchapter are not required provided that the facility has a

written agreement with another licensed facility meeting the requirements of

Section .4800 and Rule .6210 of this Subchapter which makes radiological

service available.

(3)           Emergency services required in Rules .4102-.4110 of

this Subchapter are not required.  Emergency response capability set forth in

Rule .4101 of this Subchapter shall be provided.  Medical staff shall require

that facility personnel are capable of initiating life-saving measures at a

first-aid level of response for any patient or person in need of such

services.  This shall include:

(a)           Establishing protocols or agreements with

any facility providing emergency services;

(b)           Initiating basic cardio-pulmonary

resuscitation according to the American Red Cross or American Heart Association

standards;

(c)           Availability of intravenous fluids and

supplies required to establish intravenous access; and

(d)           Availability of first-line emergency drugs

as specified by the medical staff.

(4)           Anesthesia services required in Section .4600 of

this Subchapter are not required in hospitals not offering outpatient surgery

services.

(5)           Food services required in Section .4700 of this

Subchapter shall be provided for inpatients directly or made available through

contractual arrangements.

(6)           "Observation bed" as defined in Rule

.3001(32) of this Subchapter does not apply.  For purposes of this Section, "Observation

bed" means a bed used for no more than 48-hours, to evaluate and determine

the condition and disposition of a patient and is not considered a part of the

hospital's licensed bed capacity.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

SECTION .3500 - GOVERNANCE AND MANAGEMENT

 

10A NCAC 13A .3501       GOVERNING BODY

(a)  The governing body, owner or the person or persons

designated by the owner as the governing authority shall be responsible for

seeing that the objectives specified in the charter (or resolution if publicly

owned) are attained.

(b)  The governing body shall be the final authority in the

facility to which the administrator, the medical staff, the personnel and all

auxiliary organizations are directly or indirectly responsible.

(c)  A local advisory board shall be established if the

facility is owned or controlled by an organization or persons outside of North Carolina.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3502       REQUIRED POLICIES, RULES, AND

REGULATIONS

(a)  The governing body shall adopt written policies, rules,

and regulations in accordance with all requirements con­tained in this

Subchapter and in accordance with the community responsibility of the

facility.  The written policies, rules, and regulations shall:

(1)           state the purpose of the facility;

(2)           describe the powers and duties of the

governing body officers and committees and the responsibilities of the chief

executive officer;

(3)           state the qualifications for governing body

membership, the procedures for selecting members, and the terms of service for

members, officers and committee chairmen;

(4)           describe the authority delegated to the

chief executive officer and to the medical staff.  No assignment, referral, or

delegation of authority by the governing body shall relieve the governing body

of its responsibility for the conduct of the facility.  The governing body

shall retain the right to rescind any such delegation;

(5)           require Board approval of the bylaws of any

auxiliary organizations established by the hospital;

(6)           require the governing body to review and

approve the bylaws of the medical staff organization;

(7)           establish a procedure for processing and

evaluating the applications for medical staff membership and for the granting

of clinical privileges;

(8)           establish a procedure for implementing,

disseminating, and enforcing a Patient's Bill of Rights as set forth in Rule

.3302 of this Subchapter and in compliance with  G.S. 131E-117; and

(9)           require the governing body to institute

procedures to provide for:

(A)          orientation of newly elected board members to

specific board functions and procedures;

(B)          the development of procedures for periodic

reexamination of the relationship of the board to the total facility community;

and

(C)          the recording of minutes of all governing body and

executive committee meetings and the dissemination of those minutes, or

summaries thereof, on a regular basis to all members of the governing body.

(b)  The governing body shall assure written policies and

procedures to assure billing and collection practices in accordance with G.S.

131E-91.  These policies and procedures shall include:

(1)           a financial assistance policy as defined in

G.S. 131E-214.14(b)(3);

(2)           how a patient may obtain an estimate of the

charges for the statewide 100 most frequently reported Diagnostic Related

Groups (DRGs), where applicable, 20 most common outpatient imaging procedures,

and 20 most common outpatient surgical procedures.  The policy shall require

that the information be provided to the patient in writing, either

electronically or by mail, within three business days;

(3)           how a patient or patient's representative

may dispute a bill;

(4)           issuance of a refund within 45 days of the

patient receiving notice of the overpayment when a patient has overpaid the

amount due to the hospital;

(5)           providing written notification to the

patient or patient's representative at least 30 days prior to submitting a

delinquent bill to a collections agency;

(6)           providing the patient or patient's

representative with the facility's charity care and financial  assistance

policies, if the facility is required to file a Schedule H, federal form 990;

(7)           the requirement that a collections agency,

entity, or other assignee obtain written consent from the facility prior to

initiating litigation against the patient or patient's representative;

(8)           a policy for handling debts arising from the

provision of care by the hospital involving the doctrine of necessaries, in

accordance with G.S. 131E-91(d)(5); and

(9)           a policy for handling debts arising from

the provision of care by the hospital to a minor, in accordance with G.S.

131E-91(d)(6).

(c)  The written policies, rules, and regulations shall be

reviewed every three years, revised as necessary, and dated to indicate when

last reviewed or revised.

(d)  To qualify for licensure or license renewal, each

facility must provide to the Division, upon application, an attestation

statement in a form provided by the Division verifying compliance with the

requirements of this Rule. 

(e)  On an annual basis, on the license renewal application

provided by the Division, the facility shall provide to the Division the direct

website address to the facility's financial assistance policy.  This Rule

applies only to facilities required to file a Schedule H, federal form 990.

 

History Note:        Authority G.S. 131E-79; 131E-91; 131E-214.13(f);

131E-214.14; S.L. 2013-382, s. 10.1; S.L. 2013-382, s. 13.1;

Eff. January 1, 1996;

Temporary Amendment Eff. May 1, 2014;

Amended Eff. November 1, 2014.

 

10A NCAC 13B .3503       FUNCTIONS

The governing body shall:

(1)           provide management, physical resources and

personnel required to meet the needs of the patients for which it is licensed;

(2)           require management to establish a quality control

mechanism which includes as an integral part a risk management component and an

infection control program;

(3)           formulate short-range and long-range plans for the

development of the facility;

(4)           conform to all applicable federal, State and local

laws and regulations;

(5)           provide for the control and use of the physical and

financial resources of the facility;

(6)           review the annual audit, budget and periodic

reports of the financial operations of the facility;

(7)           consider the advice of the medical staff in

granting and defining the scope of clinical privileges to individuals.  When

the governing body does not concur in the medical staff recommendation

regarding the clinical privileges of an individual, there shall be a review of

the recommendation by a joint committee of the medical staff and governing body

before a final decision is reached by the governing body;

(8)           require that applicants be informed of the

disposition of their application for medical staff membership or clinical

privileges, or both, within an established period of time after their

application has been submitted;

(9)           review and approve the medical staff bylaws, rules

and regulations body;

(10)         delegate to the medical staff the authority to

evaluate the professional competence of staff members and applicants for staff

privileges and hold the medical staff responsible for recommending initial

staff appointments, reappointments and assignments or curtailments of

privileges;

(11)         require that resources be made available to address

the emotional and spiritual needs of patients either directly or through

referral or arrangement with community agencies;

(12)         maintain effective communication with the medical

staff which shall be established, through:

(a)           meetings with the Executive Committee of the

Medical Staff;

(b)           service by the president of the medical

staff as a member of the governing body with or without a vote;

(c)           appointment of individual medical staff

members to governing body committees; or

(d)           a joint conference committee;

(13)         require the medical staff to establish controls that

are designed to provide that standards of ethical professional practices are

met;

(14)         provide the necessary staff support to facilitate

utilization review and infection control within the facility and to support

quality control, any other medical staff functions required by this Subchapter

or by the facility bylaws;

(15)         meet the following disclosure requirements:

(a)           provide data required by the Division;

(b)           disclose the facility's average daily

inpatient charge upon request of the Division; and

(c)           disclose the identity of persons owning 5.0

percent or more of the facility as well as the facility's officers and members

of the governing body upon request;

(16)         establish a procedure for reporting the occurrence

and disposition of any unusual incidents.  These procedures shall require that:

(a)           incident reports are analyzed and

summarized; and

(b)           corrective action is taken as indicated by

the analysis of incident reports;

(17)         in a facility with one or more units, or portions of

units, however described, utilized for psychiatric or substance abuse

treatment, adopt policies implementing the provisions of G.S. 122C, Article 3,

and Article 5, Parts, 2, 3, 4, 5, 7, and 8;

(18)         develop arrangements for the provision of extended

care and other long-term healthcare services.  Such services shall be provided

in the facility or by outside resources through a transfer agreement or

referrals;

(19)         provide and implement a written plan for the care or

for the referral, or for both, of patients who require mental health or

substance abuse services while in the hospital;

(20)         develop a conflict of interest policy which shall

apply to all governing body members and corporate officers.  All governing body

members shall execute a conflict of interest statement;

(21)         prohibit members of the governing body from engaging

in the following forms of self-dealing:

(a)           the sale, exchange or leasing of property or

services between the facility and a governing board member, his employer or an

organization substantially controlled by him on a basis less favorable to the

facility than that on which such property or service is made available to the

general public;

(b)           furnishing of goods, services or facilities

by a facility to a governing board member, unless such furnishing is made on a

basis not more favorable than that on which such goods, services, or facilities

are made available to the general public or employees of the facility; or

(c)           any transfer to or use by or for the benefit

of a governing board member of the income or assets of a facility, except by

purchase for fair market value; and

(22)         prohibit the lease, sale, or exclusive use of any

facility buildings or facilities receiving a license in accordance with this

Subchapter to any entity which provides medical or other health services to the

facility's patients, unless there is full, complete disclosure to and approval

from the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3600 - MANAGEMENT AND ADMINISTRATION OF OPERATIONS

 

10A NCAC 13B .3601       CHIEF EXECUTIVE OFFICER

(a)  The governing body shall designate a chief executive

officer whose qualifications, authority, responsibilities and duties shall be

defined in a written statement adopted by the governing body.

(b)  The chief executive officer shall be the designated

representative of the governing body and may be given any one or more or all of

the responsibilities set out in Rule .3602 of this Section.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3602       RESPONSIBILITIES

The governing body shall adopt written

policies, rules, and regulations that specify the officer or officers that

shall:

(1)           act for the chief executive officer

in his absence;

(2)           manage the facility consonant with

its expressed aims and policies;

(3)           attend meetings of the governing

body and appropriate meetings of the medical staff;

(4)           implement policies adopted by the

governing body for the operation of the facility;

(5)           organize the administrative

functions of the facility, delegate duties and establish formal means of

accountability on the part of subordinates;

(6)           establish such facility departments

as are indicated, provide for departmental and interdepartmental meetings and

attend or be represented at such meetings, and appoint hospital departmental

representatives to medical staff committees where appropriate or when requested

to do so by the medical staff;

(7)           appoint the heads of administrative

departments;

(8)           report to the governing body and to

the medical staff on the overall activities of the facility as well as on

appropriate federal, State and local developments that affect health care in

the facility;

(9)           review the annual audit of the

financial operations of the facility and acting upon recommendations therein;

(10)         provide fiscal planning and financial

management of the facility including the provision of annual budgets and

periodic financial status reports to the governing board;

(11)         develop in cooperation with the

departmental heads and other appropriate staff, an overall organizational plan

for the facility which will coordinate the functions, services and departments

of the facility, when possible; and

(12)         require that the agreements with

service providers, such as laundry, laboratory and imaging, specifically

indicate that compliance will be maintained with applicable State rules as

would apply to the same services if provided directly by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3603       PERSONNEL POLICIES AND PRACTICES

The facility shall develop, establish and

maintain personnel policies and practices which support sound patient care. 

The policies shall be in writing and made available to all employees, and they

shall be reviewed periodically but no less often than once every three years. 

The date of the most recent review shall be indicated on the written policies. 

A procedure shall be established for notifying employees of changes in the

established personnel policies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3604       JOB DESCRIPTIONS

The facility shall develop and make available to the

employee a written job description for each type of job in the facility,

including the chief executive officer and heads of departments.  Each job

description shall include a written description of the education, experience,

license, certification, or other qualifications required for the position.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3605       PERSONNEL RECORDS

(a)  The facility shall maintain accurate and complete

personnel records for each facility employee during the term of employment and

for two years thereafter.  The chief executive officer may designate an

individual to carry out this assignment.

(b)  Personnel records shall be maintained under such

conditions as may be required by state or federal law and shall contain at

least the following:

(1)           information regarding the employee's

education, training and experience and clinical competence, including, if

applicable, professional licensure status and license number, sufficient to

verify the employee's qualifications for the job for which he is employed. 

Such information shall be kept current.  Applicants for positions requiring a

licensed person shall be hired only after obtaining verification of their

licenses from the appropriate board;

(2)           current information relative to periodic

work performance evaluations;

(3)           records of such pre-employment health

examinations and of subsequent health services rendered to the employees as are

necessary to determine that all facility employees are physically able to

perform the essential duties of their positions.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3606       EDUCATION PROGRAMS

The facility shall provide new employee orientation and

continuing education programs for all employees to maintain the skills

necessary for the performance of their duties and learn new developments in

health care.  Records shall be maintained of all orientation and educational

programs, and of the participants.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3607       PERSONNEL HEALTH REQUIREMENTS

Employees shall have pre-employment medical examinations and

interim examinations in accordance with medical criteria established by the

facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3608       INSURANCE

The governing board shall have in place an insurance program

which provides for the protection of the physical and financial resources of

the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3609       AUDIT OF FINANCIAL OPERATIONS

An audit of the financial operations of the facility shall

be performed by a public accountant at least once a year.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3700 - MEDICAL STAFF

 

10A NCAC 13B .3701       GENERAL PROVISIONS

The facility shall have a medical staff

organized in accordance with the facility's by-laws which shall be accountable

to the governing body and which shall have responsibility for the quality of

professional services provided by individuals with clinical privileges. 

Facility policy shall provide that individuals with clinical privileges shall

perform only services within the scope of individual privileges granted.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3702       ESTABLISHMENT

The medical staff shall be established in

accordance with the by-laws, rules or regulations of the medical staff and with

the written policies, rules or regulations of the facility.  The governing body

of the facility, after considering the recommendations of the medical staff,

may grant clinical privileges to other qualified, licensed practitioners in

accordance with their training, experience, and demonstrated competence and

judgment in accordance with the medical staff by-laws, rules or regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3703       APPOINTMENT

Formal appointment for membership and granting of clinical

privileges shall follow procedures set forth in the by-laws, rules or

regulations of the medical staff.  These procedures shall require the

following:

(1)           a signed application for membership, specifying

age, year and school of graduation, date of licensure, statement of

postgraduate or special training and experience with a statement of the scope

of the clinical privileges sought by the applicant;

(2)           verification by the hospital of the qualifications

of the applicant as stated in the application, including evidence of continuing

education;

(3)           written notice to the applicant from the medical

staff and the governing body, regarding appointment or reappointment which specifies

the approval or denial of clinical privileges and the scope of the privileges

granted; and

(4)           members of the medical staff and others granted

clinical privileges in the facility shall hold current licenses to practice in North Carolina.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3704       STATUS

(a)  Every facility shall have an active medical staff to

deliver medical services within the facility.  The active medical staff shall

be responsible for the organization and administration of the medical staff. 

Every member of the active medical staff shall be eligible to vote at medical

staff meetings and to hold office.

(b)  The active medical staff may establish other categories

for membership in the medical staff.  These categories for membership shall be

identified and defined in the medical staff bylaws, rules or regulations

adopted by the active medical staff.  Examples of these other categories for

membership are:

(1)           associate medical staff;

(2)           courtesy medical staff;

(3)           temporary medical staff;

(4)           consulting medical staff;

(5)           honorary medical staff; or

(6)           other staff classifications.

The medical staff bylaws, rules or regulations may grant

limited or full voting rights to any one or more of these other membership

categories.

(c)  Medical staff appointments shall be reviewed at least

once every two years by the governing board.

(d)  The facility shall maintain an individual file for each

medical staff member.  Representatives of the Department shall have access to

these files in accordance with G.S. 131E-80.

(e)  Minutes of all actions taken by the medical staff and

the governing board concerning clinical privileges shall be maintained by the

medical staff and the governing board, respectively.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3705       MEDICAL STAFF BYLAWS, RULES OR

REGULATIONS

(a)  The active medical staff shall develop and adopt,

subject to the approval of the governing body, a set of bylaws, rules or

regulations, to establish a framework for self governance of medical staff

activities and accountability to the governing body.

(b)  The medical staff bylaws, rules and regulations shall

provide for at least the following:

(1)           organizational structure;

(2)           qualifications for staff membership;

(3)           procedures for admission, retention,

assignment, and reduction or withdrawal of privileges;

(4)           procedures for fair hearing and appellate

review mechanisms for denial of staff appointments, reappointments, suspension,

or revocation of clinical privileges;

(5)           composition, functions and attendance of

standing committees;

(6)           policies for completion of medical records

and procedures for disciplinary actions;

(7)           formal liaison between the medical staff

and the governing body;

(8)           methods developed to formally verify that

each medical staff member on appointment or reappointment agrees to abide by

current medical staff bylaws and facility bylaws; and

(9)           procedures for members of medical staff

participation in quality assurance functions.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3706       ORGANIZATION AND RESPONSIBILITIES OF THE

MEDICAL STAFF

(a)  The medical staff shall be organized to accomplish its

required functions and provide for the election or appointment of its officers.

(b)  There shall be an executive committee, or its

equivalent, which represents the medical staff, which has responsibility for

the effectiveness of all medical activities of the staff, and which acts for

the medical staff.

(c)  All minutes of proceedings of medical staff committees

shall be recorded and available for inspections by members of the medical staff

and the governing body.

(d)  The following reviews and functions shall be performed

by the medical staff:

(1)           credentialing review;

(2)           surgical case review;

(3)           medical records review;

(4)           medical care evaluation review;

(5)           drug utilization review;

(6)           radiation safety review;

(7)           blood usage review; and

(8)           bylaws review.

(e)  There shall be medical staff and departmental meetings

for the purpose of reviewing the performance of the medical staff, departments

or services, and reports and recommendations of medical staff and

multi-disciplinary committees.  The medical staff shall ensure that minutes are

taken at each meeting and retained in accordance with the policy of the facility. 

These minutes shall reflect the transactions, conclusions and recommendations

of the meetings.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3707       MEDICAL ORDERS

(a)  No medication or treatment shall be administered or

discontinued except in response to the order of a member of the medical staff

in accordance with established rules and regulations and as provided in Paragraph

(f) below.

(b)  Such orders shall be dated and recorded directly in the

patient chart or in a computer or data processing system which provides a hard

copy printout of the order for the patient chart.  A method shall be

established to safeguard against fraudulent recordings.

(c)  All orders for medication or treatment shall be

authenticated according to hospital policies.  The order shall be taken by

personnel qualified by medical staff rules and shall include the date, time,

and name of persons who gave the order, and the full signature of the person

taking the order.

(d)  The names of drugs shall be recorded in full and not

abbreviated except where approved by the medical staff.

(e)  The medical staff shall establish a written policy in

conjunction with the pharmacy committee or its equivalent for all medications

not specifically prescribed as to time or number of doses to be automatically

stopped after a reasonable time limit, but no more than 14 days.  The

prescriber shall be notified according to established policies and procedures

at least 24 hours before an order is automatically stopped.

(f)  For patients who are under the continuing care of an

out-of-state physician but are temporarily located in North Carolina, a

hospital may process the out-of-state physician's prescriptions or orders for

diagnostic or therapeutic studies which maintain and support the patient's

continued program of care, where the authenticity and currency of the

prescriptions or orders can be verified by the physician who prescribed or

ordered the treatment requested by the patient, and where the hospital verifies

that the out-of-state physician is licensed to prescribe or order the

treatment.

 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

Eff. January 1, 1996;

Amended Eff. April 1, 2005; August 1, 1998.

 

10A NCAC 13B .3708       MEDICAL STAFF RESPONSIBILITIES FOR

QUALITY IMPROVEMENT REVIEW

(a)  The medical staff shall have in effect a system to

review medical services rendered, to assess quality, to provide a process for

improving performance when indicated and to monitor the outcome.

(b)  The medical staff shall establish criteria for the

evaluation of the quality of medical care.

(c)  The facility shall have a written plan approved by the

medical staff, administration and governing body which generates reports to

permit identification of patient care problems.  The plan shall establish a

system to use this data to document and identify interventions.

(d)  The medical staff shall establish and maintain a

continuous review process of the care rendered to both inpatients and

outpatients in every medical department of the facility.  At least quarterly,

the medical staff shall have a meeting to examine the review process and

results.  The review process shall include both practitioners and allied health

professionals from the facility staff.

(e)  Minutes shall be taken at all meetings reviewing

quality improvement, and these minutes shall be made available to the medical

staff on a regular basis in accordance with established policy.  These minutes

shall be retained as determined by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3800 - NURSING SERVICES

 

10A NCAC 13B .3801       NURSE EXECUTIVE

(a)  Whether the facility utilizes a centralized or

decentralized organizational structure, a nurse executive shall be responsible

for the coordination of nursing organizational functions.

(b)  A nurse executive shall develop facility wide patient

care programs, policies and procedures that describe how the nursing care needs

of patients are assessed, met and evaluated.

(c)  The nurse executive shall develop and adopt, subject to

the approval of the facility, a set of administrative policies and procedures

to establish a framework to accomplish required functions.

(d)  There shall be scheduled meetings, at least every 60

days, of the members of the nursing staff to evaluate the quality and

efficiency of nursing services.  Minutes of these meetings shall be maintained.

(e)  The nurse executive shall be responsible for:

(1)           the development of a written organizational

plan which describes the levels of accountability and responsibility within the

nursing organization;

(2)           identification of standards and policies

and procedures related to the delivery of nursing care;

(3)           planning for and the evaluation of the

delivery of nursing care delivery system;

(4)           establishment of a mechanism to validate

qualifications, knowledge, and skills of nursing personnel;

(5)           provision of orientation and educational

opportunities related to expected nursing performance, and maintenance of

records pertaining thereto;

(6)           implementation of a system for performance

evaluation;

(7)           provision of nursing care services in

conformance with the North Carolina Nursing Practice Act;

(8)           assignment of nursing staff to clinical or

managerial responsibilities based upon educational preparation, in conformance

with licensing laws and an assessment of current competence; and

(9)           staffing nursing units with sufficient

personnel in accordance with a written plan.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3802       NURSING STAFF

(a)  Licensed nurses and other nursing personnel shall be

qualified by training, education, experience and demonstrated abilities to

provide nursing care within their scope of practice.

(b)  Staffing schedules which reflect personnel assignment

by date and service unit shall be kept on file for at least three years by

hospital management.

(c)  The facility shall establish policies for the provision

of services for all contractual agreement personnel that include at a minimum

the following:

(1)           verification of licensure or certification

by the appropriate occupational board;

(2)           delivery and documentation of care;

(3)           participation on interdisciplinary care

planning activities; and

(4)           supervision of contractual agreement

personnel.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3803       NURSING POLICIES AND PROCEDURES

(a)  Nursing policies and procedures shall be available to

the nursing staff in each nursing care unit and service area and shall include

the following:

(1)           method of noting diagnostic and therapeutic

orders;

(2)           method of assigning nursing care of

patients;

(3)           infection control measures;

(4)           patient safety measurers; and

(5)           method of implementing orders for

medication or treatment.

(b)  Each unit shall have relevant clinical reference

materials available.  The following shall be provided to each unit:

(1)           a facility formulary or comparable drug

reference;

(2)           a policy and procedure manual; and

(3)           a medical dictionary.

(c)  The facility shall provide a program of inservice

education which shall be maintained and documented for all nursing staff

personnel.  Annual inservices shall include infection control measures,

cardiopulmonary resuscitation and fire and safety.

(d)  Nursing care policies and procedures shall be reviewed

at least every three years by the nursing staff and facility management and

revised as necessary.  They shall include the date to indicate the time of the

most recent review or revision.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3804       PATIENT CARE

(a)  Each patient's need for nursing care related to his or

her admission shall be determined by a registered nurse.  Patient needs shall

be reassessed when warranted by the patient's condition.

(b)  Each patient's nursing care shall be based upon

assessed needs and shall be coordinated with the therapies of other

disciplines.

(c)  The patient's medical record shall include

documentation of:

(1)           the initial assessment and reassessments of

patient clinical status;

(2)           patient care needs;

(3)           interventions performed to meet the

patient's nursing care needs;

(4)           implementation of physician's orders;

(5)           the nursing care provided; and

(6)           the patient's response to, and the outcomes

of, the care provided.

(d)  Each plan of care shall be initiated within 24 hours of

admission.  The plan of care shall become a part of the clinical record.

(e)  The nursing care plan shall be readily available to all

physicians and facility personnel involved with the care of the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .3900 - MEDICAL RECORD SERVICES

 

10A NCAC 13B .3901       ORGANIZATION

(a)  The facility shall establish a medical record service. 

It shall be directed, staffed and equipped to accurately process, index, and

file all medical records.  Orientation, on-the-job training and inservice

programs for medical records personnel shall be provided.

(b)  The medical record service shall be equipped to enable

its personnel to maintain medical records so that they are readily accessible

and secure from unauthorized use.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3902       MANAGER

(a)  The medical records service shall be directed and

supervised by a qualified medical records manager.  If the manager is not a

registered record administrator or an accredited records technician, the

facility shall retain a person with those qualifications on a part-time or

consulting basis.

(b)  The manager of the medical record service shall advise,

administer, supervise and perform work involved in the development, analysis,

maintenance and use of medical records and reports.

(c)  Where the manager is employed on a part-time or

consulting basis, he or she shall organize the department, train the regular

personnel and make periodic visits to the facility.  The manager shall evaluate

the records and the operation of the service  and document the visits by

written reports.  A written contract specifying his or her duties and

responsibilities shall be kept on file and made available for inspection by the

Division's surveyor.

(d)  The manager of the medical record service shall maintain

a system of identification and filing to facilitate the prompt location of

medical record of any patient.

(e)  The manager of the medical records service shall store

medical records in such a manner as to provide protection from loss, damage,

and unauthorized access.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of Statutory Authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .3903       PRESERVATION OF MEDICAL RECORDS

(a)  The manager of medical records service shall maintain

medical records, whether original, computer media, or microfilm, for a minimum

of 11 years following the discharge of an adult patient.

(b)  The manager of medical records shall maintain medical

records of a patient who is a minor until the patient's 30th birthday.

(c)  If a hospital discontinues operation, its management

shall make known to the Division where its records are stored. Records shall be

stored in a business offering retrieval services for at least 11 years after

the closure date.

(d)  The hospital shall give public notice prior to

destruction of its records, to permit former patients or representatives of

former patients to claim the record of the former patient.  Public notice shall

be in at least two forms: written notice to the former patient or their

representative and display of an advertisement in a newspaper of general

circulation in the area of the facility.

(e)  The manager of medical records may authorize the

microfilming of medical records.  Microfilming may be done on or off the

premises.  If done off the premises, the facility shall provide for the

confidentiality and safekeeping of the records.  The original of microfilmed medical

records shall not be destroyed until the medical records department has had an

opportunity to review the processed film for content.

(f)  Nothing in this Section shall be construed to prohibit

the use of automation in the medical records service, provided that all of the

provisions in this Rule are met and the information is readily available for

use in patient care.

(g)  Only personnel authorized by state laws and Health

Insurance Portability and Accountability Act regulations shall have access to medical

records.  Where the written authorization of a patient is required for the

release or disclosure of health information, the written authorization of the

patient or authorized representative shall be maintained in the original record

as authority for the release or disclosure.

(h)  Medical records are the property of the hospital, and

they shall not be removed from the facility jurisdiction except through a court

order.  Copies shall be made available for authorized purposes such as

insurance claims and physician review.

 

History Note:        Authority G.S. 90-21.20B; 131E-79;

131E-97;

Eff. January 1, 1996;

Amended Eff. July 1, 2009.

 

10A NCAC 13B .3904       PATIENT ACCESS

The manager of medical records shall provide patients or

patient designees, when requested, access to or a copy of their medical

records, or both.  Upon the death of a patient, the executor of the decedent's

estate, or in the absence of an executor, the next of kin responsible for the

disposition of the remains, shall have access to all medical records of the

deceased patient.  The patient or the patient's next of kin may be charged for

the cost of reproducing copies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3905       PATIENT MEDICAL RECORDS

(a)  Hospital management shall maintain medical records for

each patient treated or examined in the facility.

(b)  The medical record or medical record system shall

provide data for each episode of care and treatment rendered by the facility.

(c)  Where the medical record does not combine all episodes

of inpatient, outpatient and emergency care, the medical records system shall:

(1)           assemble, upon request of the physician,

any or all divergently located components of the medical record when a patient

is admitted to the facility or appears for outpatient or clinic services; or

(2)           require placing copies of pertinent

portions of each inpatient's medical record, such as the discharge resume, the

operative note and the pathology report, in the outpatient or combined

outpatient emergency unit record file as directed by the medical staff.

(d)  The manager of medical records shall ensure that:

(1)           each patient's medical record is complete,

readily accessible and available to the professional staff concerned with the

care and treatment of the patient;

(2)           all clinical information pertaining to a

patient is incorporated in his medical record;

(3)           all entries in the record are dated and

authenticated by the person making the entry;

(4)           symbols and abbreviations are used only

when they have been approved by the medical staff and when there exists a

legend to explain them;

(5)           verbal orders include the date and

signature of the person recording them.  They shall be given and authenticated

in accordance with the provisions of Rule .3707(c) of this Subchapter; and

(6)           records of patients discharged are

completed within 30 days following discharge or disciplinary action is

initiated as defined in the medical staff bylaws.

 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

Eff. January 1, 1996;

Amended Eff, April 1, 2005.

 

10A NCAC 13B .3906       CONTENTS

(a)  The medical record shall contain sufficient information

to justify the diagnosis, verify the treatment and document the course of

treatment and results accurately.

(b)  All in-patient records shall include the following information:

(1)           identification data (name, address, age,

sex) and, when the identification data is not obtainable, the reason for such;

(2)           date and time of admission and discharge;

(3)           medical history:

(A)          chief complaint;

(B)          details of the present illness;

(C)          relevant past, social, and family histories; and

(D)          reports of relevant physical examinations;

(4)           diagnostic and therapeutic orders;

(5)           reports of procedures, tests and their

results;

(6)           provisional or admitting diagnosis;

(7)           evidence of appropriate informed consent or

a written statement explaining why consent was not obtained;

(8)           clinical observations, including results of

therapy;

(9)           record of medication and treatment

administration;

(10)         progress notes of all disciplines;

(11)         conclusions at termination of

hospitalization or evaluation and treatment;

(12)         all relevant diagnosis established by the

time of discharge;

(13)         consultation reports;

(14)         surgical record, including anesthesia

record, pre-operative diagnosis, surgeon's operative report and post-operative

orders and any instructions given to the patient or family; and

(15)         autopsy findings, if performed.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .3907       MEDICAL RECORDS REVIEW

The medical staff shall review medical records periodically

for completeness and shall:

(1)           establish requirements regarding completion of

medical records, including a system for disciplinary actions for those who do

not complete records in a timely manner; and

(2)           make recommendations to the medical records

department regarding clinical information sufficient for medical care

evaluation.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4000 - OUTPATIENT SERVICES

 

10A NCAC 13B .4001       ORGANIZATION

(a)  The facility shall establish and maintain outpatient

care services in accordance with the facility's written mission statement.

(b)  The relationship of outpatient services to other

divisions within the facility, including channels of responsibility and

authority, shall be documented and made available for review by the facility.

(c)  The facility shall vest the direction of outpatient

services in one or more individuals whose qualifications, authority and duties

are defined in writing.

(d)  The facility shall establish and maintain procedures

for the review and evaluation of outpatient services.

(e)  Each medical staff member shall have privileges

delineated in accordance with criteria established by the medical staff

by-laws, rules, or regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4002       STAFFING

(a)  The director of outpatient services shall require that

ambulatory care services are staffed with sufficient personnel in accordance

with a written plan.

(b)  The responsibility for the delivery of outpatient

services by the professional staff shall be defined and documented by the

director of ambulatory care services.

(c)  The facility shall provide education programs

specifically related to outpatient care for the staff and document the extent

of participation in education and training programs.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4003       POLICIES AND PROCEDURES

(a)  The provision of outpatient services shall be guided by

written policies and procedures which shall be developed by the facility and

approved by the medical staff.  The policies and procedures shall be reviewed

by the medical staff at least every three years.

(b)  The policies shall include the following:

(1)           patient access to outpatient services;

(2)           the process of obtaining informed consent;

(3)           the location, storage and procurement of

medications, supplies and equipment; and

(4)           the mechanism to be used to contact

patients for necessary follow-up.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4004       OUTPATIENT SURGICAL AND ANESTHESIA

SERVICES

(a)  When surgical or anesthesia services are provided in an

outpatient setting, the facility shall require that the medical staff approve

all types of surgical procedures to be offered.  The facility shall maintain

and make available a current listing of approved outpatient procedures.

(b)  The facility shall define the scope of anesthesia

services that may be provided, the locations where such anesthesia services may

be administered and who shall provide anesthesia services.

(c)  The facility shall require that standards for informed

consent, history and physical examination, preoperative studies, administration

of anesthesia, medical records and discharge criteria meet the same standards

of care as apply for inpatient surgery unless otherwise specified by the

medical staff.

(d)  The facility shall provide for back-up service by other

departments in the case of emergencies or complications.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4005       MEDICAL RECORDS

(a)  The manager of outpatient services shall require that a

record of outpatient care and services for each patient is maintained either in

the ambulatory care services or medical records department.

(b)  The facility shall develop a system of identification

and filing to prepare for safe storage and prompt retrieval of records upon

subsequent inpatient or outpatient visits.

(c)  The facility shall establish medical records procedures

which include provisions for maintaining the confidentiality of patient

information and for the release of information to authorized individuals.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4100 - EMERGENCY SERVICES

 

10A NCAC 13B .4101       EMERGENCY RESPONSE CAPABILITY REQUIRED

The medical staff of each facility shall require that

facility personnel are capable of initiating life-saving measures at a

first-aid level of response for any patient or person in need of such

services.  This shall include:

(1)           initiating basic cardio-respiratory resuscitation

according to American Red Cross or American Heart Association standards;

(2)           availability of first-line emergency drugs as

specified by the medical staff;

(3)           availability of IV fluids and supplies required to

establish IV access; and

(4)           establishing protocols or agreements for the

transfer of patients to a facility for a higher level of care when these

services are not available on site.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4102       CLASSIFICATION OF OPTIONAL EMERGENCY

SERVICES

(a)  Any facility providing emergency services shall

classify its capability in providing such services according to the following

criteria:

(1)           Level I:

(A)          the facility shall have a comprehensive,

24-hour-per-day emergency service with at least one physician experienced in

emergency care on duty in the emergency care area;

(B)          the facility shall have in-hospital physician

coverage by members of the medical staff or by senior-level residents for at

least medical, surgical, orthopedic, obstetric, gynecologic, pediatric and

anesthesia services;

(C)          services of other medical and surgical specialists

shall be available; and

(D)          the facility shall provide prompt access to labs,

radiology, operating suites, critical care and obstetric units and other

services as defined by the governing body.

(2)           Level II:

(A)          the facility shall have 24-hour per day emergency

service with at least one physician experienced in emergency care on duty in

the emergency care area; and

(B)          the facility shall have consultation available

within 30 minutes by members of the medical staff or by senior level residents

to meet the needs of the patient.  Consultation by phone is acceptable.

(3)           Level III:  The facility shall have

emergency service available 24 hours per day with at least one physician

available to the emergency care area within 30 minutes through a medical staff

call roster.

(b)  Facilities seeking trauma center designation shall

comply with G.S. 131E-162.

(c)  The location of the emergency access area shall be

identified by clearly visible signs.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4103       PROVISION OF EMERGENCY SERVICES

(a)  Any of any facility providing emergency services shall

establish and maintain policies requiring appropriate medical screening,

treatment and transfer services for any individual who presents to the facility

emergency department and on whose behalf treatment is requested regardless of

that person's ability to pay for medical services and without delay to inquire

about the individual's method of payment.

(b)  Any facility providing emergency services under this

Section shall install, operate and maintain, on a 24-hour per day basis, an

emergency two-way radio licensed by the Federal Communications Commission in

the Public Safety Radio Service capable of establishing voice radio

communication with ambulance units transporting patients to said facility or

having any written procedure or agreement for handling emergency services with

the local ambulance service, rescue squad or other trained medical personnel.

(c)  All communication equipment shall be in compliance with

current rules established by North Carolina Rules for Basic Life

Support/Ambulance Service (10 NCAC 3D .1100) adopted by reference with all

subsequent amendments.  Referenced rules are available at no charge from the

Office of Emergency Medical Services, 2707 Mail Service Center, Raleigh,

N.C. 27699-2707.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4104       MEDICAL DIRECTOR

(a)  The governing body shall establish the qualifications,

duties, and authority of the director of emergency services.  Appointments

shall be recommended by the medical staff and approved by the governing body.

(b)  The medical staff credentials committee shall approve

the mechanism for emergency privileges for physicians employed for brief

periods of time such as evenings, weekends or holidays.

(c)  Level I and II emergency services shall be directed and

supervised by a physician with experience in emergency care.

(d)  Level III services shall be directed and supervised by

a physician with experience in emergency care or through a multi-disciplinary

medical staff committee.  The chairman of this committee shall serve as

director of emergency medical services.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4105       NURSING

(a)  Level I and Level II emergency services shall have one

or more registered nurses assigned and on duty within the emergency service

area at all times.

(b)  A Level III emergency service shall have a registered

nurse available on at least an on-call, in-house basis at all times.

(c)  The facility shall document that all emergency services

nursing personnel shall have orientation, training and continuing education in

the reception and care of emergency patients.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10 NCAC 03C .4106          POLICIES AND PROCEDURES

Each emergency department shall establish written policies

and procedures which specify the scope and conduct of patient care to be

provided in the emergency areas.  They shall include the following:

(1)           the location, storage, and procurement of

medications, blood, supplies, equipment and the procedures to be followed in

the event of equipment failure;

(2)           the initial management of patients with burns, hand

injuries, head injuries, fractures, multiple injuries, poisoning, animal bites,

gunshot or stab wounds and other acute problems;

(3)           the provision of care to an unemancipated minor not

accompanied by a parent or guardian, or to an unaccompanied unconscious

patient;

(4)           management of alleged or suspected child, elder or

adult abuse;

(5)           the management of pediatric emergencies;

(6)           the initial management of patients with actual or

suspected exposure to radiation;

(7)           management of alleged or suspected rape victims;

(8)           the reporting of individuals dead on arrival to the

proper authorities;

(9)           the use of standing orders;

(10)         tetanus and rabies prevention or prophylaxis; and

(11)         the dispensing of medications in accordance with

state and federal laws.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4107       EMERGENCY RECORDS

(a)  The facility shall require all levels of emergency

departments to maintain a continuous control register on each patient seen for

services which shall include at least the name, age, sex, date, time, and means

of arrival, nature of complaint, disposition, and time of discharge.

(b)  The facility shall maintain a record for each patient

seeking emergency care.  This shall include:

(1)           patient identification, time and means of

arrival;

(2)           pertinent history and physical findings and

patient vital signs;

(3)           diagnostic and therapeutic orders;

(4)           clinical observations including results of

treatment;

(5)           reports of procedures, tests and results;

(6)           diagnostic impression; and

(7)           discharge or transfer summary of treatment

including final disposition, the patient's condition, and any instructions

given to the patient and or family for follow-up care.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4108       OBSERVATION BEDS

When observation beds are used, the facility shall implement

written policies and procedures that address the type of patient use, the

mechanism for providing appropriate clinical monitoring, the length of time

services may be provided in this setting and documentation requirements.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4109       TRANSFER

(a)  The facility shall establish and implement protocols

for stabilization and transportation of emergency patients.

(b)  A facility with specialized capabilities, such as burn

units, shock-trauma units and neonatal intensive care units, shall not refuse

to accept an appropriate transfer for those services if the hospital has the

capacity to treat the individual.

(c)  The facility shall not transfer a patient until the

receiving organization has consented to accept the patient and the patient is

sufficiently stable for transport.

(d)  If the patient or the person acting on the patient's

behalf refuses transfer, the facility staff shall:

(1)           explain to the individual or his

representative the risks and benefits of transfer; and

(2)           shall request the patient's or his

representative's refusal of transfer in writing.

(e)  The facility shall forward at the time of transfer a

copy of all medical records related to the emergency condition for which the

individual has presented.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4110       DISASTER AND MASS CASUALTY PROGRAM

(a)  The facility shall describe:

(1)           the level of emergency services available

during an external disaster;

(2)           the emergency department's role in the

facility's external disaster plan;

(3)           procedures to be followed in the event of

an internal disaster; and

(4)           the facility's connection to other

community services such as fire, police and the American Red Cross.

(b)  The medical staff and governing body shall approve the

plan, review it and revise it if needed, annually.

(c)  The plan shall:

(1)           provide for prompt medical attention for

all emergency patients as their needs may dictate;

(2)           include protocols for handling

non-emergency cases;

(3)           establish medical staff coverage procedures

or methods;

(4)           specify drugs, solutions and equipment to

be continuously available;

(5)           provide for the evacuation and transfer for

all inpatients as their needs may indicate in the event of an internal

disaster; and

(6)           include mutual support agreements with area

providers.

(d)  Schedules, names and telephone numbers of all

physicians and others on emergency duty shall be maintained by the facility.

(e)  Names and telephone numbers of those to be contacted in

the event of an internal disaster shall be maintained by the facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4200 - SPECIAL CARE UNITS

 

10A NCAC 13B .4201       ORGANIZATION

(a)  The governing body shall approve the type and scope of

special care units.

(b)  The facility shall document the relationship of the

special care units to the other departments within the hospital, including

channels of responsibility and authority.

(c)  The facility shall provide necessary equipment and

supplies for delivery of nursing care specific to the unit population for each

special care unit.

(d)  The facility shall provide sufficient emergency drugs

and equipment to meet anticipated needs as determined by the medical staff.

(e)  The governing body shall delegate to the medical and

nursing staff the responsibility to develop policies and procedures concerning

the scope and provision of safe care in each unit.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4202       MEDICAL STAFF

(a)  The governing body shall provide that each special care

unit or group of similar units be directed by qualified members of the medical

staff whose clinical and administrative privileges have been approved by the governing

board.

(b)  The governing body shall designate the director to be

responsible for making decisions in consultation with the physician responsible

for the patient, for the disposition of a patient when patient load exceeds

optimal operation capacity.

(c)  The governing body shall require that the medical staff

provide medical staff coverage sufficient to meet the specific needs of the

patients on a 24-hour basis.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4203       NURSING STAFF

The supervision of nursing care for each special care unit

shall be provided by a qualified registered nurse and shall include the

following:

(1)           unit-specific orientation and competency evaluation

for each staff member;

(2)           a staffing plan based upon the needs of the patient

population which is implemented to ensure a sufficient number of qualified

Registered Nurses are on duty when patients are in the unit;

(3)           assessment, planning, implementation and evaluation

of nursing care which is documented according to policy; and

(4)           delivery of nursing care in accordance with the

North Carolina Nurse Practice Act.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4204       POLICIES AND PROCEDURES

(a)  The facility in conjunction with the medical and

nursing staff shall develop written policies and procedures which guide the

provision of care in a special care unit.  These policies and procedures shall

be approved by the medical staff and include:

(1)           patient admission and discharge criteria;

(2)           notification of appropriate medical staff

for changes in the condition of the patient;

(3)           use of standing orders and emergency

protocols;

(4)           designation of staff members authorized to

perform special procedures and special circumstances requiring such

authorization;

(5)           patient care procedures, including

medication administration;

(6)           infection control;

(7)           pertinent safety practices;

(8)           use of equipment and procedures to be

followed in the event of equipment failure;

(9)           regulations governing visitors and traffic

control; and

(10)         role of special care unit in internal and

external disaster plans.

(b)  The governing body shall review, update and approve

regularly, but at least every three years, its policies and procedures.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4300 - MATERNAL - NEONATAL SERVICES

 

10A NCAC 13B .4301       ORGANIZATION MATERNAL SERVICES

(a)  The governing body shall approve the scope of obstetric

services offered based upon the level of patient need, qualifications of the

credentialed staff, and resources of the facility.

(b)  The following capabilities and minimum services shall

be made available when obstetric services are provided:

(1)           identification of high-risk mothers and

fetuses;

(2)           continuous electronic fetal monitoring;

(3)           cesarean delivery capability within 30

minutes of decision;

(4)           blood or fresh frozen plasma for

transfusion;

(5)           anesthesia on a 24-hour or on-call basis;

(6)           radiology and ultrasound examination;

(7)           stabilization of unexpectedly small or sick

neonates before transfer;

(8)           neonatal resuscitation;

(9)           laboratory services on a 24-hour or on-call

basis;

(10)         consultation and transfer agreements;

(11)         assessment and care for the neonates; and

(12)         nursery or other appropriate space for care

of the neonates.

(c)  In a facility without intensive care nursery services,

the facility management shall establish and maintain a plan for the

stabilization and transportation of sick newborns to a regional neonatal unit.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4302       MEDICAL STAFF MATERNAL SERVICES

(a)  The medical staff shall require that each birth be

attended by a physician or certified nurse midwife who has documented evidence

of current competence and appropriate privileges.

(b)  At all times medical staff with obstetrical privileges

shall be available within 30 minutes to provide services and attend

deliveries.  An on-call schedule shall be available to the Division for review.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4303       NURSING SERVICES MATERNAL SERVICES

(a)  The nurse executive or the decentralized nursing

management staff shall designate a registered nurse who has education,

training, and experience in obstetrical care as supervisor of obstetrical services.

(b)  A registered nurse shall be responsible for providing

the type and amount of nursing care needed by each patient.  A staffing plan

shall be available to the Division for review.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4304       POLICIES AND PROCEDURES MATERNAL

SERVICES

(a)  The provision of patient care shall be guided by

written policies and procedures developed by the medical and nursing staff and

approved by the medical staff.

(b)  Written policies shall relate to at least the

following:

(1)           a system for informing the physician or

certified nurse midwife responsible for a patient of the following:

(A)          the patient's admission;

(B)          the onset of labor; and

(C)          pertinent information about progress of labor or changes

in patient's condition.

(2)           emergency response protocols for patients

who demonstrate evidence of maternal, fetal or neonatal distress;

(3)           a program to prevent isoimmunization of

RH-negative mothers;

(4)           administration of oxytocic agents when used

for induction or stimulation of labor;

(5)           the use and administration of analgesics

and anesthetics;

(6)           administration of magnesium sulfate when

and for the treatment preeclampsia;

(7)           the location and storage of medications,

supplies, and special equipment;

(8)           the method of identification for the

neonates;

(9)           assessment and care of the neonates;

(10)         provision of resuscitation, stabilization,

and preparation for the transport of sick neonates at any hour; and

(11)         an infection control plan.

(c)  Accurate and complete medical records shall be provided

for each obstetric patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A ncac 13B .4305       ORGANIZATION OF NEONATAL SERVICES

(a)  The governing body shall approve the scope of all

neonatal services and the facility shall classify its capability in providing a

range of neonatal services using the following criteria:

(1)           LEVEL I:

Full-term and pre-term neonates that are stable without complications.  This may include, small for gestational age

or large for gestational age neonates.

(2)           LEVEL

II: Neonates or infants that are stable without complications but

require special care and frequent feedings; infants of any weight who no longer

require Level III or LEVEL IV neonatal services, but who still

require more nursing hours than normal infant. 

This may include infants who require close observation in a licensed

acute care bed

(3)           LEVEL

III: Neonates or infants that are high-risk, small (or approximately 32

and less than 36 completed weeks of gestational age) but otherwise healthy, or

sick with a moderate degree of illness that are admitted from within the

hospital or transferred from another facility requiring intermediate care

services for sick infants, but not requiring intensive care.  The beds in this level may serve as a

"step-down" unit from Level IV.

Level III neonates or infants

require less constant nursing care, but care does not exclude respiratory

support.

(4)           LEVEL IV

(Neonatal Intensive Care Services): High-risk, medically unstable or critically

ill neonates approximately under 32 weeks of gestational age, or infants,

requiring constant nursing care or supervision not limited to continuous

cardiopulmonary or respiratory support, complicated surgical procedures, or

other intensive supportive interventions.

(b)  The facility shall provide for the availability of

equipment, supplies, and clinical support services.

(c)  The medical and nursing staff shall develop and approve

policies and procedures for the provision of all neonatal services.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Temporary Amendment Eff.

March 15, 2002;

Amended Eff. April

1, 2003.

 

10A NCAC 13B .4306       MEDICAL STAFF OF NEONATAL SERVICES

The medical staff shall require that the director or other

designated physician in charge of the neonatal special or intensive care unit

has training and experience in care of the neonate.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4307       NURSING STAFF OF NEONATAL SERVICES

(a)  The nurse executive or the decentralized nursing

management staff shall designate a registered nurse who has training and

experience in the care of neonates as supervisor of neonatal services.

(b)  A registered nurse shall be responsible for providing

the type and amount of nursing care needed by each patient.  A staffing plan

shall be available to the Division for review.

(c)  The nursing staff shall provide educational

opportunities for parents of neonates on routine care and procedures needed by

the neonate.

(d)  The nursing staff shall provide opportunities for

parental participation in care of the neonate to facilitate bonding and family

adjustment to the neonate's needs.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4308       POLICIES AND PROCEDURES OF NEONATAL

SERVICES

(a)  The provision of neonatal care at all levels shall be

guided by written policies and procedures developed and approved by the medical

and nursing staffs.

(b)  The policies and procedures shall include but are not

limited to:

(1)           emergency resuscitation and stabilization

of the neonate;

(2)           equipment for routine and emergency care of

the neonate;

(3)           continuous oxygen supply and means of

administration including ventilators;

(4)           administration of medications;

(5)           insertion and care of invasive lines;

(6)           prevention of infectious diseases or

processes; and

(7)           family involvement in care of the neonate.

(c)  The medical and nursing staff shall review, update and

approve its policies and procedures every three years.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4400 - RESPIRATORY CARE SERVICES

 

10A NCAC 13B .4401       ORGANIZATION

(a)  The governing body shall appoint a medical director of

the respiratory care service who is an anesthesiologist, pulmonologist or other

qualified physician.

(b)  The facility shall appoint a qualified individual as

the director of respiratory care services.

(c)  When the facility is without a distinct respiratory

care service, the facility shall:

(1)           designate the department responsible for

the delivery of respiratory care services;

(2)           designate a person to supervise the

delivery of respiratory care services; and

(3)           establish and maintain policies and

procedures for the delivery of respiratory care services offered.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4402       STAFFING

(a)  Staffing numbers shall be determined by the types and

complexities of the services offered.

(b)  The director of the service shall provide for the

availability of trained respiratory technicians, Certified Respiratory Therapy

Technicians, registry eligible or Registered Respiratory Therapist needed for

the scope of services offered.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4403       POLICIES AND PROCEDURES

The facility shall establish and maintain written policies

and procedures for the services offered.  These shall include but are not

limited to:

(1)           scope of services and treatment offered;

(2)           medication administration;

(3)           cleaning, assembly and storage of equipment;

(4)           safety;

(5)           infection control;

(6)           documentation of delivered care or treatments; and

(7)           care and supervision of all ventilated patients.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4500 - PHARMACY SERVICES AND MEDICATION

ADMINISTRATION

 

10A NCAC 13B .4501       PROVISION OF SERVICE

The facility shall provide for pharmaceutical services which

are administered in accordance with the pharmacy laws of North Carolina

including but not limited to G.S. 90 and G.S. 106.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4502       PHARMACIST

(a)  The pharmacy service shall be directed by a pharmacist

licensed by the State of North Carolina.  If a facility has a limited service

as defined by the N.C. Board of Pharmacy, a part-time director of pharmacy

shall have responsibility for control and dispensing of drugs.

(b)  The director of pharmacy shall be responsible to the

chief executive officer or his designee for developing, supervising, and

coordinating all the activities of pharmacy services throughout the facility.

(c)  The director of pharmacy shall require that the

pharmacists are trained in the specialized functions of facility pharmacy.

(d)  The dispensing of drugs in the absence of a pharmacist

shall be done by facility staff under the direct supervision of staff approved

by the pharmacy committee and who are responsible for following policies

established by the pharmacy committee.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4503       STAFF

The director of pharmacy shall be assisted by additional

pharmacists and such other personnel as the activities of the pharmacy may

require to meet the pharmaceutical needs of the patients served.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4504       PHARMACY COMMITTEE

(a)  A pharmacy committee or its equivalent, to include

physicians, registered nurses, pharmacists and the administrator or designee

shall be established.

(b)  The committee shall meet at least quarterly, record its

proceedings and report to the medical staff.  It shall assist in the

formulation of broad professional policies regarding the evaluation, appraisal,

selection, procurement, storage, distribution, use and safety procedures, and

all other matters relating to drugs in the facility.  This shall include a

mechanism to review and evaluate adverse drug reactions and drug usage

evaluations, offering appropriate recommendations, actions, and follow-up if

necessary.  The committee shall:

(1)           serve as an advisory group to the medical

staff and the pharmacy director on matters pertaining to drug selection;

(2)           develop an ongoing mechanism to review a

formulary or drug list for use in the hospital;

(3)           recommend and develop policies regarding

the use and control of investigational drugs and research in the use of U.S.

Food and Drug Administration approved drugs;

(4)           evaluate clinical data concerning new drugs

or preparations requested for use in the facility;

(5)           make recommendations concerning drugs to be

stocked on the nursing units and by other services;

(6)           establish mechanisms which will prevent

formulary duplication;

(7)           establish policies and procedures that

address therapeutic drug substitution;

(8)           establish a policy describing the duration

of drug therapy or number of doses for all medication orders; and

(9)           make recommendations regarding medication

administration policies and procedures.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4505       PHARMACY FACILITIES

(a)  The facility shall provide sufficient space for the

pharmaceutical service to carry out its professional and administrative

functions.

(b)  Equipment shall be provided for the storage,

preparation, dispensing, distributing and safeguarding of drugs throughout the

hospital.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4506       SUPPLIES

The director of pharmacy shall maintain an inventory of

drugs and pharmaceutical devices to meet the needs of the patients as described

in the facility's formulary.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4507       STORAGE

(a)  All drugs and related pharmaceutical supplies located

throughout the facility shall be under the control of the pharmacy service.

(b)  All areas where drugs and related pharmaceutical

supplies are stored shall be monitored at least monthly by the pharmacy

service.

(c)  The director of pharmacy shall require that

corresponding records are maintained of drug inventory variances and the

corrective action taken.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4508       RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .4509       SECURITY

(a)  The director of pharmacy shall require that all drugs

and related pharmaceutical supplies be stored in a lockable environment except

when under the direct supervision of personnel authorized by the pharmacy

committee to handle drugs.

(b)  Controlled substances and other drugs the facility

deems subject to abuse shall be stored as outlined in the U.S. Controlled

Substance Act, CFR 1301.41 and the N.C. Controlled Substances Act, G.S. 90,

Article 5.  These rules are available from the Drug Regulatory Branch of the

N.C. Division of Mental health, Development Disabilities & Substance Abuse

Services, 3016 Mail Service Center, Raleigh, NC 27699-3016 (919/715-0652)

without charge to current registrants.

(c)  All keys and other locking devices to the pharmacy and

controlled substances throughout the facility shall be under the control of the

director of pharmacy and the facility management.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4510       RECORDS

(a)  The director of pharmacy shall provide that all drug

transactions of the pharmacy shall be recorded as described in policies

approved by the pharmacy committee.

(b)  The director of pharmacy shall establish and maintain a

system of records and bookkeeping in accordance with the policies of the

facility in order to maintain adequate control over the requisitioning and

dispensing of all drugs and pharmaceutical supplies and over patient billing

for all drugs and pharmaceutical supplies.

(c)  The director of pharmacy shall maintain records for all

drugs purchased, ordered, dispensed, distributed, returned and disposed of in

accordance with the pharmacy laws of North Carolina from the pharmacy.

(d)  Verbal orders for drugs shall be subject to medical

staff policies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4511       MEDICATION ADMINISTRATION

(a)  A facility shall establish and maintain policies and

procedures governing the administration of medications which shall be enforced

and implemented by administration and staff.  Policies and procedures shall include:

(1)           accountability of controlled substances as

defined by the G.S. 90, Article 5; and

(2)           storage, distribution, administration and

monitoring the effects of medications.

(b)  All medications and treatments shall be administered

and discontinued in accordance with signed medical staff orders which are

recorded in the patient's medical record.

(c)  The categories of staff that are privileged to

administer medications shall be delineated by the operational policies of the

facility.  These policies shall be in agreement with current rules of North

Carolina Occupational Boards for each category of staff.

(d)  Medications shall be scheduled and administered

according to the established policies of the facility.

(e)  Variances to the medication administration policy shall

be reviewed and evaluated by the nurse executive or her designee.

(f)  The person administering medications shall identify

each patient in accordance with the facility's policies and procedures prior to

administering any medication.

(g)  Medication administered to a patient shall be recorded

in the patient's medication administration record immediately after

administration in accordance with the facility's policies and procedures.

(h)  Omission of medication and the reason for the omission

shall be indicated in the patient's medical record.

(i)  The person administering medications which are ordered

to be given as needed (PRN) shall justify the need for the same in the

patient's medical record.

(j)  Medication administration records shall provide

identification of the drug and strength of drug, quantity of drug administered,

route administered, name and title of person administering the medication, and

time and date of administration.

(k)  Self-administration of medications shall be permitted

only if prescribed by the medical staff.  Directions must be printed on the

container.

(l)  The administration of one patient's medications to

another patient is prohibited except in the case of an emergency.  In the event

of such as emergency, steps shall be taken by a pharmacist to ensure that the

borrowed medications shall be replaced and so documented.

(m)  Verbal orders shall be signed in accordance with Rule

.3707(c) of this Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2005; May 1, 2005.

 

10A NCAC 13B .4512       MEDICATIONS DISPENSED

(a)  Except as provided in Paragraph (c) of this Rule, the

pharmacy shall dispense only those drugs which are listed in one or more of the

references listed in Paragraph (b) of this Rule.  No drug which is listed in

Paragraph (b) of this Rule shall be used for any purpose which is not approved

by the U.S. Food and Drug Administration unless the use has been approved by

the facility's pharmacy committee.

(b)  References:

(1)           United States Pharmacopoeia;

(2)           National Drug Formulary;

(3)           Evaluations of Drug Interactions by the

American Pharmaceutical Association;

(4)           American Hospital Formulary Service; and

(5)           Other references approved by the Pharmacy

Committee.

(c)  Any drug approved for use as an investigational drug or

otherwise by the U.S. Food and Drug Administration but not listed in Paragraph

(b) of this Rule may be used in accordance with standards established by the

facility's pharmacy committee, or its equivalent and approved by the U.S. Food

and Drug Administration, Dockets Management Branch, FDS, Room 4062, 5600

Fishers Lane, Rockfield, Maryland 20857, at a cost dependent on the material

requested.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4513       DRUG DISTRIBUTION SYSTEMS

(a)  The pharmacy committee shall develop written policies

and procedures pertaining to the intra-facility drug distribution system.  In

developing such policies the committee shall utilize representatives of other

disciplines within the facility, including nursing services.

(b)  The label of each patient's individual medication

container shall bear all information required by the Pharmacy Laws of North

Carolina.

(c)  The pharmacist, with the advice and guidance of the

pharmacy committee or its equivalent, shall be responsible for specifications

as to quality, quantity and source of supplies of all drugs.

(d)  There shall be a formulary or list of drugs accepted

for use in the facility which shall be developed and amended as necessary by

the pharmacy committee.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4514       EMERGENCY PHARMACEUTICAL SERVICES

The director of pharmacy shall be responsible for emergency

pharmaceutical services as currently described in the Pharmacy Laws of North

Carolina.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4515       DISPOSITION

Drugs, and pharmaceutical devices which are outdated,

visibly deteriorated, unlabeled, inadequately labeled, recalled, discontinued

or obsolete shall be identified by a pharmacist and shall be disposed of in

compliance with applicable state and federal laws and regulations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4516       COMMERCIAL PHARMACEUTICAL SERVICE

A facility using an outside pharmacist or pharmaceutical

service must have a contract with that pharmacist or service.  As part of the

contract, the pharmacist or service shall be required to maintain at least the

standards for operation of the pharmaceutical services outlined in this

Subchapter.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4600 - SURGICAL AND ANESTHESIA SERVICES

 

10A NCAC 13B .4601       ORGANIZATION

(a)  The governing body shall approve the types of surgery

and types of anesthesia services to be available throughout the hospital

consistent with identified needs and resources.

(b)  The facility shall require that surgical or anesthesia

procedures are performed only when the necessary equipment and personnel are

available.

(c)  A facility that provides surgical or obstetric services

shall provide anesthesia services on a 24-hour basis.

(d)  The requirements and standards identified in this

Section apply when any patient, in any setting, receives for any purpose, by

any route:

(1)           general, spinal or other major regional

anesthesia; or

(2)           sedation or analgesia that may result in

the loss of protective reflexes; or

(3)           surgery or other invasive procedure while

receiving such anesthesia.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4602       DIRECTOR OF SURGICAL SERVICES

(a)  Each department or service providing surgical services

shall be directed by members of the medical staff whose clinical and

administrative privileges have been approved by the governing body.

(b)  The medical staff shall establish and maintain a system

for monitoring and evaluating the quality and appropriateness of the care and

treatment of surgical patients, and for monitoring the clinical performance of

all individuals with clinical privileges.

(c)  In facilities where there is no anesthesiologist on

staff the facility shall:

(1)           with review of the medical staff, establish

a consultation agreement with a board-certified or board-eligible

anesthesiologist for the purpose of establishing policies and procedures that

relate to the safe administration of anesthesia in all departments or services

of the facility;

(2)           assume the responsibility for establishing

general policies for anesthesia services; and

(3)           establish a line of communication and

supervision for staff.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4603       SURGICAL AND ANESTHESIA STAFF

(a)  The facility shall develop processes which require that

each individual provides only those services for which proof of licensure and

competency can be demonstrated.

(b)  The facility shall require that:

(1)           when anesthesia is administered, a

qualified physician is immediately available in the facility to provide care in

the event of a medical emergency;

(2)           a roster of practitioners with a

delineation of current surgical and anesthesia privileges is available and

maintained for the service;

(3)           an on-call schedule of surgeons with

privileges to be available at all times for emergency surgery and for

post-operative clinical management is maintained;

(4)           the operating room is supervised by a

qualified registered nurse or doctor of medicine or osteopathy; and

(5)           an operating room register which shall

include date of the operation, name and patient identification number, names of

surgeons and surgical assistants, name of anesthetists, type of anesthesia given,

pre- and post-operative diagnosis, type and duration of surgical procedure, and

the presence or absence of complications in surgery is maintained.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4604       DIRECTION OF ANESTHESIA SERVICES

(a)  The facility shall be organized, directed and

integrated with other related services or departments of the facility.

(b)  The department of anesthesia shall require that all

anesthetics are administered according to procedures established in medical

staff rules.  In facilities where there is no department of anesthesia, the

medical staff shall assume the responsibility for establishing general policies

and for supervising the administration of anesthetics.

(c)  The facility shall provide that anesthesia services be

directed by a member, or members, of the medical staff whose responsibilities

shall be approved by the governing body and shall include:

(1)           establishment of criteria and procedures

for the evaluation of the quality of all anesthesia care rendered;

(2)           review of clinical privileges for all

licensed practitioners whose primary clinical activity is the provision of

anesthesia services; and

(3)           establishment of written policies and procedures

for anesthesia services.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4605       POLICIES AND PROCEDURES

(a)  The director of surgical services shall develop

policies and procedures for surgical and anesthesia services which shall be

available to the medical, surgical, anesthesia staff and nursing personnel.

(b)  The facility shall require that policies on anesthesia

procedures include the delineation of pre-anesthesia and post-anesthesia

responsibilities.

(c)  The facility shall require that the policies listed in

this Paragraph are followed and that each surgical patient's record contain the

following documentation:

(1)           a complete history and physical documented

in the record of every patient prior to surgery, including clinical indications

for the surgical procedure;

(2)           written evidence of informed consent, in the

patient's record before surgery.  If prior written consent was not obtained,

the record shall contain a written explanation of why prior consent was not

obtained;

(3)           an evaluation of the patient and anesthesia

planned, documented according to medical staff bylaws by an individual

qualified to administer anesthesia services.  Re-evaluation of the patient

immediately prior to the induction of anesthesia shall be performed prior to

surgery;

(4)           an operative report describing techniques,

findings, tissue removed or altered, and pre and post-surgical diagnosis.  This

report must be written or dictated following surgery and signed by the surgeon

in compliance with medical staff rules;

(5)           an intraoperative anesthesia record

including the dosage of all drugs and agents used, the duration of anesthesia,

and the type and amount of all fluids or blood and blood products administered

shall be documented;

(6)           evaluation and documentation of the

postoperative status of the patient on admission to and discharge from the

post-anesthesia recovery area.

(d)  The director of anesthesia services shall establish

criteria for discharge and facility management shall require that a physician

or CRNA with appropriate clinical privileges be responsible for the decision to

discharge a patient from a post-anesthesia recovery area.

(e)  The facility shall establish regulations governing

visitors and traffic control.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4700 - NUTRITION AND DIETETIC SERVICES

 

10A NCAC 13B .4701       PROVISION OF SERVICES

The nutrition and dietetic services shall be organized,

directed, staffed and integrated with other facility departments to provide

optimal nutritional therapy and quality food service to patients.  Nutrition

therapy shall apply the principles of the science of nutrition and be

administered in accordance with the law and rules including but not limited to

G.S. 90, Article 25.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4702       ORGANIZATION

(a)  The nutrition and dietetic services shall be under the

full-time direction of a person who is trained or experienced in food services

administration and therapeutic diets.  The director shall be one of the

following:

(1)           A qualified dietitian;

(2)           Bachelor's degree in Foods and Nutrition or

Food Service Management;

(3)           Dietetic Technician Registered (DTR); or

(4)           Certified Dietary Manager (CDM); or

(5)           An individual who is enrolled in a program

to complete the minimum qualifications in Paragraph (a)(1)(2)(A)(B)(C) of this

Rule.

(b)  The nutrition and dietetic services of the facility

shall have at least one dietitian either full-time, part-time, or as

consultant.  The qualifications of the dietitian shall be included in the

personnel files.  If the director of nutrition and dietetic services is not a

registered dietitian, there shall be an established method of communication

between the director and the dietitian which ensures that the dietitian

supervises the nutritional aspects of patient care and ensures that quality

nutritional care is provided to patients.  Dietitians or qualified designees

shall attend and participate in meetings relevant to patient nutritional care,

including but not limited to patient care conferences and discharge planning.

(c)  When a dietitian serves only in a consultant capacity,

the facility management shall establish and maintain a written contract with

the individual defining the responsibilities of the dietician including

requirements for submission of written reports to the hospital administrator

and the director of the nutrition and dietetic services describing the extent

and quality of the services provided.  Frequency of visits of the consultant

dietitian shall be defined in the contract.  The consultant dietitian shall

provide, on site, no less than eight hours of service every two weeks to

provide the nutritional aspects of patient care including but not limited to

the following:

(1)           approval of regular and modified menus,

including standardized recipes;

(2)           performance of nutritional assessments;

(3)           development of nutrition care plans;

(4)           provision of nutrition therapy;

(5)           participation in development of policies

and procedures; and

(6)           monitoring and evaluation of the

effectiveness and appropriateness of nutrition and dietetic services.

(d)  The facility shall establish and maintain written

policies and procedures to govern all nutrition and dietetic service

activities.  These policies shall be developed by the nutrition and dietetic

services in cooperation with personnel from other departments or services which

are involved with nutrition and dietetic services and they shall be reviewed at

least every three years, revised as necessary, and dated to indicate the time

of last review.  Administrative policies and procedures concerning food

procurement, preparation, and service shall be written by the director of the

nutrition and dietetic services.  Nutritional care policies and procedures

shall be written by the qualified dietitian.  The nutrition and dietetic

service policies and procedures shall include, but not be limited to the

following:

(1)           provision of food and nutrition therapy

prescriptions/orders;

(2)           development, approval and provision of

regular and modified menus, including standardized recipes;

(3)           food purchasing, storage, inventory,

preparation and service;

(4)           identification system designed to ensure

that each patient receives appropriate diet as ordered;

(5)           ancillary dietetic services, as

appropriate, including food storage and kitchens on patient care units, formula

supply, cafeterias, vending operations and ice making;

(6)           preparation, storage, distribution, and

administration of enteral nutrition programs;

(7)           assessment and monitoring of patients

receiving enteral and total parenteral nutrition;

(8)           personal hygiene and health of dietetic

personnel;

(9)           infection control measures to minimize the

possibility of contamination and transfer of infection, including establishment

of monitoring procedure to ensure that personnel are free from communicable

infections and open skin lesions; and

(10)         pertinent safety practices, including

control of electrical, flammable, mechanical, and radiation hazards.

(e)  Nutrition and dietetic services shall be provided by

qualified personnel under supervision to meet needs of patients.  The director

of the nutrition and dietetic services shall require that personnel assigned to

the department perform all functions necessary to meet the nutritional needs of

patients.  The director or qualified designee shall attend and participate in

meetings, including that of department heads, and function as an integral

member of the facility.

(f)  A facility which has a contract with an outside food

management service, shall require as a part of the contract that the company

complies with all applicable requirements and standards outlined in Section

.4700 of this Subchapter for such service.  The contract shall be available for

review by the Division.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4703       SANITATION AND SAFETY

(a)  The nutrition and dietetic service shall comply with

current laws and rules for sanitation as promulgated by the Commission for Public

Health, including but not limited to 15A NCAC 18A .1300.  Copies of 15A NCAC

18A .1300 may be obtained at no charge from the Environmental Health Services Section,

Division of Environmental Health, N.C. Department of Environment and Natural

Resources, 1630 Mail Service Center, Raleigh, NC 27699-1630.  The facilities

and equipment of the nutrition and dietetic services shall also comply with

applicable and safety laws and rules.

(b)  Sufficient space and equipment shall be provided for

the nutrition and dietetic services to accomplish the following:

(1)           store food and nonfood supplies under

sanitary and secure conditions;

(2)           store food separately from nonfood

supplies.  When storage facilities are limited, paper products may be stored

with food supplies;

(3)           prepare and distribute food, including

therapeutic diets;

(4)           clean and sanitize utensils and dishes

apart from food preparation areas; and

(5)           allow personnel to perform their duties.

(c)  Cleaning schedules and instructions for cleaning all

equipment and work and storage areas shall be posted and followed in the

nutrition and dietetic services area and accessible to all nutrition and

dietetics staff.  Procedures for cleaning all equipment and work areas shall be

followed consistently and documented to safeguard the health of the patient.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4704       DISTRIBUTION OF FOOD

(a)  Food shall be transported and displayed pursuant to the

rules adopted by the Commission for Public Health.

(b)  At the time of serving, the temperature of hot foods

shall be no less than:

(1)           Hot liquids - 150 degrees Fahrenheit

(minimum);

(2)           Hot Cereal - 150 degrees Fahrenheit

(minimum);

(3)           Hot Soups - 130 degrees Fahrenheit

(minimum); and

(4)           Other hot foods - 110 degrees Fahrenheit

(minimum).

(c)  At the time of serving, the temperature of cold foods

shall be no more than:

(1)           Cold liquids - 50 degrees Fahrenheit

(maximum); and

(2)           Other cold foods - 65 degrees Fahrenheit

(maximum).

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4705       NUTRITIONAL SUPPORT

(a)  The administration of the nutritional support shall be

directed by a qualified dietitian.  Observations and information pertinent to

nutrition therapy shall be documented in the medical record of the patient.

(b)  The facility shall have a current nutrition care manual

accessible to hospital personnel.  The nutrition care manual shall be reviewed

every three years, revised as necessary by a qualified dietitian, and approved

jointly by the nutrition service and medical staff.

(c)  Therapeutic diets and enteral and parenteral nutrition

therapy shall be prescribed in written orders on the medical records and

provided as ordered.

(d)  The nutrition care manual shall reflect the standards

for nutrition care in accordance with those referenced in the most current

edition of "Recommended Dietary Allowance" of the Food and Nutrition

Board of the National Research Council of the National Academy of Sciences

which are hereby incorporated by reference.  These standards include any

subsequent amendments and editions of the referenced material and are available

from the National Academy Press, 2101 Constitution Avenue, N.W., Lockbox 285, Washington, D.C. 20055 at a cost of six dollars ($6.00) per copy.  The nutrition

deficiencies of any modified diet that is not in compliance with the

recommended dietary allowances shall be specified in the nutrition care manual.

(e)  The qualified dietitian shall be responsible for the

development of a nutritional care plan in compliance with medical staff's

orders to meet the nutritional needs of the patient.  The nutrition care plan

shall be included in the medical record of the patient on his discharge plan

and transfer orders to the extent necessary for continuity of care.  Facilities

with long term care units shall have at least a three week menu cycle in the

long term care units.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

SECTION .4800 - DIAGNOSTIC IMAGING

 

10A NCAC 13B .4801       ORGANIZATION

(a)  Imaging services shall be under the supervision of a

full-time radiologist, consulting radiologist, or a physician experienced in

the particular imaging modality and the physician in charge must have the

credentials required by facility policies.

(b)  Activities of the imaging service may include

radio-therapy.

(c)  All imaging equipment shall be operated under

professional supervision by qualified personnel trained in the use of imaging

equipment and knowledgeable of all applicable safety precautions required by

the North Carolina Department of Environment and Natural Resources, Division of

Environmental Health Radiation Protection Section.  Copies of regulations are

available from the N.C. Department of Environment and Natural Resources,

Radiation Protection Section, 3825 Barrett Drive, Raleigh, NC  27609

at a cost of sixteen dollars ($16.00) each.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority and

ambiguity Eff. July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .4802       RECORDS

(a)  A documented record on each imaging examination shall

be included in the patient's medical record.

(b)  Imaging reports shall be signed by the physician

interpreting the study.

(c)  Copies of current reports made by private physicists or

governing authority surveying the radiographic facilities shall be available to

the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4803       STAFFING

(a)  The staffing of the imaging department shall be

determined by the radiologist in charge or by another person designated by

hospital management.

(b)  There shall be a minimum of one radiologic technologist

available to the department on at least an on-call basis.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4804       MONITORING RADIATION EXPOSURE OF

PERSONNEL

(a)  The facility shall establish procedures for the

monitoring of personnel and shall maintain a record for each individual working

in the area of radiation where there is a reasonable probability of receiving

one-fourth of the maximum permissible dose.

(b)  Records documenting the monitoring of personnel

receiving radiation exposure through the use of film badges or dosimeters must

also be maintained by the facility.  Readings from badges or dosimeters shall

be recorded on at least a monthly basis.

(c)  Upon termination of employment, each employee shall be

provided with a summary of his exposure record.

(d)  Permanent records of radiological exposure on all

monitored personnel shall be maintained for review by the Division.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4805       SAFETY

(a)  The facility shall require that all imaging equipment

is operated under the supervision of a physician and by qualified personnel.

(b)  The facility shall require that proper caution is

exercised to protect all persons from exposure to radiation.

(c)  Safety inspections of the imaging department, including

equipment, shall be conducted by the North Carolina Division of Environmental

Health, Radiation Protection Services Section.  Copies of the report shall be

available for review by the Division.

(d)  The governing authority shall appoint a radiation

safety committee.  The committee shall include but is not limited to:

(1)           a physician experienced in the handling of

radio-active isotopes and their therapeutic use; and

(2)           other representatives of the medical staff.

(e)  All radio-active isotopes, whether for diagnostic,

therapeutic, or research purposes shall be received, handled, and disposed of

in accordance with the requirements of the North Carolina Department of

Environment and Natural Resources, Division of Environmental Health, Radiation

Protection Services Section.  Copies of regulations are available from the

North Carolina Department of Environment, Health, and Natural Resources,

Division of Radiation Protection, 3825 Barrett Drive, Raleigh, NC

27609 at a cost of six dollars ($6.00) each.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4806       NUCLEAR MEDICINE SERVICES

When nuclear medicine services are offered, the facility

shall establish and maintain written policies and procedures for the provision

of those services which shall provide for the safety of patients and staff,

management of radioactive isotopes and the maintenance of equipment according

to the manufacturers' recommendations.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .4900 - LABORATORY SERVICES AND PATHOLOGY

 

10A NCAC 13B .4901       ORGANIZATION

The laboratory shall be under the supervision of a clinical

pathologist, or a physician who has training in clinical laboratory diagnosis

designated by the governing body.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4902       RECORDS

(a)  All requests for laboratory services shall be

documented.

(b)  All reports of laboratory services performed, including

autopsy, shall be placed in the patient's medical record.

(c)  Records of proficiency testing appropriate to the scope

of services offered shall be available to the Division for review.

(d)  Records of equipment calibration and quality controls

as recommended by the manufacturer shall be maintained and be available to the

Division for review.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4903       STAFFING

The laboratory supervisor or his appointed designee, shall

require that:

(1)           procedures and tests conducted are within the scope

of the laboratory as approved by the hospital;

(2)           at least one qualified medical technologist is available

at all times; and

(3)           qualified staff are available to carry out the

functions of the laboratory.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4904       TESTS

(a)  Laboratory tests to be performed on a patient at the

time of admission (if any) shall be established by the medical staff and be

approved by the governing board of the hospital.  In the event the medical

staff and governing body elect not to establish routine laboratory tests for

new admissions, the request for such tests shall be left to the discretion of

the attending medical staff members.

(b)  Serological tests for patients admitted shall be

optional with the hospital.  However, there shall be records indicating that

obstetrical patients have had a serological test during their current

pregnancy.

(c)  When laboratories outside of the facility are used,

such laboratories shall be approved by the governing body and medical staff of

the facility.  In case of such usage, a legible copy of the laboratory report

must be included in the patient record.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4905       TISSUE REMOVAL AND DISPOSAL

(a)  The medical staff shall establish and maintain written

policies for pathological examination of tissue and specimens removed during

surgery.

(b)  Pathological waste disposal shall comply with the rules

Governing the Sanitation of Hospitals, Nursing and Rest Homes, Sanitariums,

Sanatoriums, and Educational and Other Institutions, contained in 15A NCAC 18A

.1300.  Copies of 15A NCAC 18A .1300 may be obtained at no charge from the

Environmental Health Services Section, Division of Environmental Health, N.C.

Department of Environment and Natural Resources, 1630 Mail Service Center,

Raleigh, NC 27699-1630.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4906       BLOOD BANK

(a)  Facilities which provide for procurement, storage and

transfusion of blood shall meet the standards of the American Association of

Blood Banks as outlined in the most current edition of Standards of Blood Banks

and Transfusion Services, which is incorporated by reference, including all

subsequent amendments and additions, and which is available from the American

Association of Blood Banks, 8101 Glenbrook Road, Bethesda, Maryland 20814-2749

at a cost of thirty-three dollars and fifty cents ($33.50) per copy.

(b)  The governing body shall approve the pathologist or

physician as physician-in-charge of the blood bank service.

(c)  Records shall be kept on file indicating the receipt

and disposition of all blood handled.  Care shall be taken to ascertain that

blood administered has not exceeded its expiration date, and meets all criteria

for safe administration.

(d)  The facility shall make arrangements to secure on short

notice all necessary supplies of blood, typed and cross-matched as required,

for emergencies.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .4907       MORGUE AND AUTOPSY FACILITIES

(a)  Morgue and autopsy services shall be provided either on

site or by written agreement with a facility that provides those services.

(b)  Procedures for the transport and storage of deceased

patients shall be established and maintained by the facility.

(c)  Procedures for post mortem cleaning of patients with

diagnosed contagious diseases shall be established and maintained by the

facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5000 - PHYSICAL REHABILITATION SERVICES

 

10A NCAC 13B .5001       ORGANIZATION

The facility shall designate an individual responsible for

the administration and supervision of each rehabilitation service.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5002       DELIVERY OF CARE

(a)  A member of the medical staff shall be responsible for

the general medical care of the inpatient.

(b)  The delivery of all rehabilitation services shall be

provided by practitioners credentialed or licensed in their respective fields.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .5003       POLICIES AND PROCEDURES

The facility shall establish and maintain written policies

and procedures that include but are not limited to:

(1)           provision for assessment and evaluation of the

services performed;

(2)           safety measures;

(3)           infection control measures; and

(4)           procedures for referral to other facilities for

services not available on site.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5004       PATIENT RECORDS

The patient record shall contain documentation of physical

rehabilitation services utilized that include but is not limited to:

(1)           diagnosis to support the services requested;

(2)           assessment of patient's rehabilitative status;

(3)           re-assessment and progress of patient's

rehabilitative status;

(4)           individualized plan of care and goals of

rehabilitation; and

(5)           discharge plan.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5005       CARDIAC REHABILITATION PROGRAM

When a facility elects to provide an outpatient cardiac

rehabilitation program, the program shall be subject to 10 NCAC 3S, Sections

.0300 - .1000, which are incorporated by reference with all subsequent

amendments.  Referenced rules are available from the North Carolina Department

of Health and Human Services, Division of Health Service Regulation, Licensure and

Certification Section, 2711 Mail Service Center, Raleigh, NC 27699

at a cost of three dollars ($3.00) each.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5100 - INFECTION CONTROL

 

10A NCAC 13B .5101       ORGANIZATION

(a)  The governing body shall establish and maintain an

infection control program that includes all patient care and patient care

support services and departments for the surveillance, prevention and control

of infection.

(b)  The infection control committee shall include

representatives of the medical staff, nursing staff, administration and the

person directly responsible for the surveillance program activities.

(c)  The infection control committee shall assume

responsibility for the infection control program.

(d)  The facility shall designate a person to manage the

infection control, prevention and surveillance program.

(e)  The infection control committee shall involve facility

departments and services as needed to maintain the infection control program.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5102       POLICY AND PROCEDURES

(a)  Each facility department or service shall establish and

maintain written infection control policies and procedures.  These shall

include but are not limited to:

(1)           the role and scope of the service or department

in the infection control program;

(2)           the role and scope of surveillance

activities in the infection control program;

(3)           the methodology used to collect and analyze

data, maintain a surveillance program on nosocomial infection, and the control and

prevention of infection;

(4)           the specific precautions to be used to

prevent the transmission of infection and isolation methods to be utilized;

(5)           the method of sterilization and storage of

equipment and supplies, including the reprocessing of disposable items;

(6)           the cleaning of patient care areas and

equipment;

(7)           the cleaning of non-patient care areas; and

(8)           exposure control plans.

(b)  The infection control committee shall approve all

infection control policies and procedures.  The committee shall review all

policies and procedures at least every three years and indicate the last date

of review.

(c)  The infection control committee shall meet at least

quarterly and maintain minutes of meetings.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5103       LAUNDRY SERVICE

The facility shall provide, directly or by contract, a

laundry service or department that provides the following:

(1)           24 hour a day availability of clean linen for

patient care needs; and

(2)           delivery of clean linen and removal of soiled linen

in a manner that reduces the spread of infection.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5104       ENVIRONMENTAL SERVICES

The facility shall require that environmental services

(housekeeping) provide the following:

(1)           24 hour a day availability of personnel or supplies

and equipment for the cleaning of patient rooms, patient care equipment, and

the cleaning of spills;

(2)           a routine cleaning schedule for all areas of the

facility to assist in the prevention and spread of disease; and

(3)           removal and appropriate disposal of waste materials

including biologicals.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5105       STERILE SUPPLY SERVICES

The facility shall provide for the following:

(1)           decontamination and sterilization of equipment and

supplies;

(2)           monitoring of sterilizing equipment on a routine

schedule;

(3)           establishment of policies and procedures for the

use of disposable items; and

(4)           establishment of policies and procedures addressing

shelf life of stored sterile items.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5200 - PSYCHIATRIC SERVICES

 

10A NCAC 13B .5201       PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES:

APPLICABILITY OF RULES

The rules contained in this Section shall apply to all

psychiatric and substance abuse services provided by any facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5202       DEFINITIONS APPLICABLE TO PSYCHIATRIC OR

SUBSTANCE ABUSE SERVICES

(a)  "Certified counselor" means an

alcoholism, drug abuse or substance abuse counselor who is certified by the

North Carolina Substance Abuse Professional Certification Board.

(b)  "Certified substance abuse

counselor/supervisor" means an individual who is a "certified

counselor" as defined in 10 NCAC 3C .5202(a) and is designated by the

North Carolina Substance Abuse Professional Certification Board as a qualified

substance abuse supervisor.

(c)  "Clinical/professional

supervision" means regularly scheduled assistance by a qualified mental

health, professional or a qualified substance abuse professional to a staff

member who is providing direct, therapeutic intervention to a client or

clients.  The purpose of clinical supervision is to ensure that each client

receives appropriate treatment or habilitation which is consistent with

accepted standards of practice and the needs of the client.

(d)  "Detoxification service" means

a unit or department whose primary purpose is the medical management or care of

persons who are under the influence of alcohol or drugs.

(e)  "Direct care staff" means an

individual who provides active direct care, treatment, or rehabilitation or

habilitation services to clients on a continuous and regularly scheduled basis.

(f)  "Psychiatric nurse" means an

individual who is licensed to practice as a registered nurse in North Carolina by the North Carolina Board of Nursing; and has:

(1)           a graduate degree from an

accredited master's level program in psychiatric mental health nursing with two

years of experience; or

(2)           a master's degree in

behavioral science with two years of supervised clinical experience in

psychiatric mental health nursing; or

(3)           a baccalaureate degree in

behavioral science with four years of supervised clinical experience in

psychiatric mental health nursing.

(g)  "Psychiatric service" means an

inpatient or outpatient unit or department whose primary purpose is the

treatment of mental illness.  It also means the mental health treatment

provided in such a unit or department.

(h)  "Psychiatric social worker"

means an individual who holds a master's degree in social work from an

accredited school of social work and has two years of clinical social work

experience.

(i)  "Psychiatrist" means an

individual who is licensed to practice medicine in North Carolina and who has

completed an accredited training program in psychiatry.

(j)  "Psychologist" means an

individual licensed to practice psychology in North Carolina by the North

Carolina State Board of Examiners of Practicing Psychologists.

(k)  "Qualified mental health

professional" means any one of the following: psychiatrist, psychiatric

nurse, practicing psychologist, psychiatric social worker, an individual with

at least a masters degree in a related human service field and two years of

supervised clinical experience in mental health services or an individual with

a baccalaureate degree in a related human service field and four years of supervised

clinical experience in mental health services.

(l)  "Qualified substance abuse

professional" means an individual who is:

(1)           certified by the North

Carolina Substance Abuse Professional Certification Board;

(2)           certified by the National

Consortium of Chemical Dependency Nurses, Inc;

(3)           certified by the National

Nurses Society on Addictions; or

(4)           a graduate of a college or

university with a baccalaureate or advanced degree in a human service related

field with documentation of at least two years of supervised experience in the

profession of alcoholism and drug abuse counseling.

(m)  "Restraint" means the

limitation of one's freedom of movement and includes the following:

(1)           mechanical restraint which

means restraint of a client with the intent of controlling behavior with

mechanical devices which include, but are not limited to, cuff, ankle straps,

sheets or restraining shirts; or

(2)           physical restraint which

means restraint of a client until calm.  As used in these Rules, the term

physical restraint does not apply to the use of professionally recognized

methods for therapeutic holds of brief duration (five minutes or less).

(n)  "Restrictive facility" means a

facility so designated by the Division of Health Service Regulation which uses

mechanical restraint or seclusion in accordance with G.S. 122C-60 in order to

restrain a client's freedom of movement.

(o)  "Seclusion" means isolating a

client in a separate locked room for the purpose of controlling a client's

behavior.

(p)  "Substance abuse service" means

inpatient or outpatient unit or department whose primary purpose is the

treatment of chemical dependency.  It also means the chemical dependency

treatment provided in such a unit or department.

 

History Note:        Authority G.S. 131E-79;

RRC objection due to lack of statutory authority Eff.

July 13, 1995;

Eff. January 1, 1996.

 

10A NCAC 13B .5203       STAFFING FOR PSYCHIATRIC OR SUBSTANCE

ABUSE SERVICES

(a)  General Requirements:

(1)           A physician shall be present in the

facility or on call 24 hours per day.  The medical appraisal and medical

treatment of each patient shall be the responsibility of a physician;

(2)           Each facility shall determine its overall

staffing requirements based upon the age categories (child, adolescent, adult,

elderly), clinical characteristics, treatment requirements and numbers of

patients;

(3)           There shall be a sufficient number of

appropriately qualified clinical and support staff to assess and address the

clinical needs of the patients;

(4)           Staff members shall have training or

experience in the provision of care in each of the age categories assigned for

treatment.

(b)  Psychiatric Services:

(1)           Staff coverage for psychiatric services

shall include at least one each of the following: psychiatrist, psychiatric

nurse, psychologist, and psychiatric social worker;

(2)           A qualified mental health professional shall

be available by telephone or page and able to reach the facility within 30

minutes on a 24 hour basis;

(3)           Each clinical or direct care staff member

who is not a qualified mental health professional shall receive professional

supervision from a qualified mental health professional;

(4)           When detoxification services are provided,

there shall be liaison and consultation with a qualified substance abuse

professional prior to the discharge of a client.

(c)  Substance Abuse Services:

(1)           At least one registered nurse shall be on

duty during each shift;

(2)           Certified substance abuse counselors or

qualified substance abuse professionals shall be employed at the ratio of one

staff member for each 10 inpatients or fraction thereof.  In documented

instances of bona fide shortages of certified persons, uncertified individuals

expecting to become certified may be employed for a maximum of 38 months

without qualifications;

(3)           The facility shall have a minimum of two

staff members providing care, treatment and services directly to patients on

duty at all times and maintain a shift ratio of one staff member for each 20 or

less inpatients with the following exceptions:

(A)          When there are minor inpatients there shall be staff

available on the ratio of one staff member for each five minor inpatients or

fraction thereof during each shift from 7:00 a.m. - 11:00 p.m.;

(B)          When detox services are offered there shall be no

less than one staff member for each nine inpatients or

fraction thereof on each shift.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5204       PSYCHIATRIC OR SUBSTANCE ABUSE SERVICES

RECORD REQUIREMENTS

(a)  In addition to the general record keeping requirements

of 10A NCAC 13B .3906, specialized assessment and treatment plans for

individuals undergoing psychiatric or substance abuse treatment are as follows:

(1)           Within 24 hours following admission each

individual shall have a completed admission assessment.  The initial assessment

shall include the reason for admission, admitting diagnosis, mental status

including suicide potential, diagnostic tests or evaluations, and a

determination of the need for additional information to include the potential

for the physical abuse of self or others and a family assessment when a minor

is involved;

(2)           Within 72 hours following admission, a

preliminary individual treatment plan shall be completed and implemented; and

(3)           Within five days following admission, a

comprehensive individual treatment plan shall be developed and implemented. 

For outpatient services, the plan shall be developed and implemented within 30

days of admission to treatment.

(b)  Individual treatment plans for psychiatric and

substance abuse patients shall be developed in partnership with the patient or

individual acting on behalf of the patient.  Clinical responsibility for the

development and implementation of the plan shall be clearly designated. 

Minimum components of the comprehensive treatment plan shall include diagnosis

and time specific short and long term measurable goals, strategies for reaching

goals, and staff responsibility for plan implementation.  The plan shall be

revised as medically or clinically indicated.

(c)  Progress notes shall be entered in each individual's

record.  Included is information which may have a significant impact on the

individual's condition or expected outcome such as family conferences or major

events related to the patient.  Patient status shall be documented each shift

for any inpatient psychiatric or substance abuse services, and on a per visit

basis for outpatient psychiatric and substance abuse services.

(d)  For each individual to whom substance abuse services

are provided, a written plan for aftercare services shall be developed which

minimally includes:

(1)           plan for delivering aftercare services,

including the aftercare services which are provided; and

(2)           provision for agreements with individuals

or organizations if aftercare services are not provided directly by the

facility.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5205       SECLUSION

At least one seclusion room shall be provided in all

hospitals licensed to provide a psychiatric program, a substance abuse program

or both.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5206       COMPLIANCE WITH STATUTORY REQUIREMENTS

(a)  Facilities providing psychiatric or substance abuse

services shall develop procedures to protect the rights of psychiatric and

substance abuse patients in accordance with North Carolina statutes addressing

the rights of psychiatric and substance abuse patients.  Statutes addressing

such rights are as follows:

(1)           G.S. 122C-51.  Declaration of policy on

clients' rights;

(2)           G.S. 122C-52.  Right to confidentiality;

(3)           G.S. 122C-53.  Exceptions; client;

(4)           G.S. 122C-54.  Exceptions; abuse reports

and court proceedings;

(5)           G.S. 122C-55.  Exceptions; care and

treatment;

(6)           G.S. 122C-56.  Exceptions; research and

planning;

(7)           G.S. 122C-57.  Right to treatment and

consent to treatment;

(8)           G.S. 122C-58.  Civil rights and civil

remedies;

(9)           G.S. 122C-59.  Use of corporal punishment;

(10)         G.S. 122C-60.  Use of physical restraints or

seclusion;

(11)         G.S. 122C-61.  Treatment rights in 24-hour

facilities;

(12)         G.S. 122C-62.  Additional rights in 24-hour

facilities;

(13)         G.S. 122C-65.  Offenses relating to clients;

and

(14)         G.S. 122C-66.  Protection from abuse and

exploitation; reporting.

(b)  Facilities providing psychiatric or substance abuse

services shall develop procedures to protect confidentiality of information

regarding communicable disease and conditions in compliance with G.S. 130A-143.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .5207       PSYCHIATRIC OR SUBSTANCE ABUSE

OUTPATIENT SERVICES

Partial hospitalization, outpatient and day treatment

facilities shall be subject to 10A NCAC 27G .1100, 10A NCAC 27G .3500, and 10A

NCAC 27G .3700 respectively, which are incorporated by reference with all

subsequent amendments.  Referenced rules are available from the N.C. Division

of Mental Health, Developmental Disabilities, and Substance Abuse Services,

Advocacy, Client Rights and Quality Improvement Section, 3009 Mail

Service Center, Raleigh, NC 27699-3009 at a cost of five dollars and

seventy-five cents ($5.75) per copy.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .5300 - NURSING AND ADULT CARE HOME BEDS

 

10A NCAC 13B

.5301       THE LICENSURE OF NURSING AND ADULT CARE HOME BEDS IN A HOSPITAL

When a facility has nursing facility beds or adult care home

beds, the beds shall be provided under the hospital's license as provided in

Rule .3101 of this Subchapter.  The nursing facility beds and the adult care

home beds shall be subject to the rules in 10A NCAC 13D with the exception that

the following rules shall not apply: 10A NCAC 13D .2001(5); .2101 - .2108;

.2201; .2208; .2209; .2211; .2212; .2302; .2401; .2402; .2503; .2504; .2602;

.2607; .2701; and .2901.  With these exceptions, the rules in 10A NCAC 13D are

incorporated by reference with all subsequent amendments.  Referenced rules are

available from the NC Division of Health Service Regulation, 2711 Mail

Service Center, Raleigh, N.C. 27699-2711 at a cost of six dollars ($6.00) per

copy.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

SECTION .5400 - COMPREHENSIVE INPATIENT REHABILITATION

 

10A NCAC 13B .5401       DEFINITIONS

The following definitions shall apply to inpatient

rehabilitation facilities or units only:

(1)           "Case management" means the coordination

of services, for a given patient, between disciplines so that the patient may

reach optimal rehabilitation through the judicious use of resources.

(2)           "Comprehensive, inpatient rehabilitation

program" means a program for the treatment of persons with functional

limitations or chronic disabling conditions who have the potential to achieve a

significant improvement in activities of daily living.  A comprehensive,

rehabilitation program shall utilize a coordinated and integrated,

interdisciplinary approach, directed by a physician, to assess patient needs

and to provide treatment and evaluation of physical, psycho-social and

cognitive deficits.

(3)           "Inpatient rehabilitation facility or

unit" means a free-standing facility or a unit (unit pertains to

contiguous dedicated beds and spaces) approved in accordance with G.S. 131E,

Article 9 to establish inpatient, rehabilitation beds and to provide a

comprehensive, inpatient rehabilitation program within an existing licensed

health service facility.

(4)           "Medical consultations" means consultations

which the rehabilitation physician or the attending physician determine are

necessary to meet the acute medical needs of the patient and do not include

routine medical needs.

(5)           "Occupational therapist" means any

individual licensed in the State of North Carolina as an occupational therapist

in accordance with the provisions of G.S. 90, Article 18D.

(6)           "Occupational therapist assistant" means

any individual licensed in the State of North Carolina as an occupational

therapist assistant in accordance with the provisions of G.S. 90, Article 18D.

(7)           "Psychologist" means a person licensed as

a practicing psychologist in accordance with G.S. 90, Article 18A.

(8)           "Physiatrist" means a licensed physician

who has completed a physical medicine and rehabilitation residency training

program approved by the Accreditation Council of Graduate Medical Education or

the American Osteopathic Association.

(9)           "Physical therapist" means any person

licensed in the State of North Carolina as a physical therapist in accordance

with the provisions of G.S. 90, Article 18B.

(10)         "Physical therapist assistant" means any

person licensed in the State of North Carolina as a physical therapist

assistant in accordance with the provisions of G.S. 90-270.24, Article 18B.

(11)         "Recreational therapist" means a person

certified by the State of North Carolina Therapeutic Recreational Certification

Board.

(12)         "Rehabilitation aide" means an unlicensed

assistant who works under the supervision of a registered nurse, licensed

physical therapist or occupational therapist in accordance with the appropriate

occupational licensure laws governing his or her supervisor and consistent with

staffing requirements as set forth in Rule .5508 of this Section.  The

rehabilitation aide shall be listed on the North Carolina Nurse Aide Registry

and have received additional staff training as listed in Rule .5509 of this

Section.

(13)         "Rehabilitation nurse" means a registered

nurse licensed in North Carolina, with training, either academic or on-the-job,

in physical rehabilitation nursing and at least one year experience in physical

rehabilitation nursing.

(14)         "Rehabilitation physician" means a

physiatrist or a physician who is qualified, based on education, training and

experience regardless of specialty, of providing medical care to rehabilitation

patients.

(15)         "Social worker" means a person certified

by the North Carolina Social Work Certification and Licensure Board in

accordance with G.S. 90B-3.

(16)         "Speech and language pathologist" means

any person licensed in the State of North Carolina as a speech and language

pathologist in accordance with the provisions of G.S. 90, Article 22.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff.

January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5402       PHYSICIAN REQUIREMENTS FOR INPATIENT

REHABILITATION FACILITIES OR UNITS

(a)  In a rehabilitation facility or unit, a physician shall

participate in the provision and management of rehabilitation services and in

the provision of medical services.

(b)  In a rehabilitation facility or unit, a rehabilitation

physician shall be responsible for a patient's interdisciplinary treatment

plan.  Each patient's interdisciplinary treatment plan shall be developed and

implemented under the supervision of a rehabilitation physician.

(c)  The rehabilitation physician shall participate in the

preliminary assessment within 48 hours of admission, prepare a plan of care and

direct the necessary frequency of contact based on the medical and

rehabilitation needs of the patient.  The frequency shall be appropriate to

justify the need for comprehensive inpatient rehabilitation care.

(d)  An inpatient rehabilitation facility or unit's contract

or agreements with a rehabilitation physician shall require that the rehabilitation

physician shall participate in individual case conferences or care planning

sessions and shall review and sign discharge summaries and records.  When

patients are to be discharged to another health care facility, the discharging

facility shall ensure that the patient has been provided with a discharge plan

which incorporates post discharge continuity of care and services.  When

patients are to be discharged to a residential setting, the facility shall

ensure that the patient has been provided with a discharge plan that

incorporates the utilization of community resources when available and when

included in the patient's plan of care.

(e)  The intensity of physician medical services and the

frequency of regular contacts for medical care for the patient shall be

determined by the patient's pathophysiologic needs.

(f)  Where the attending physician of a patient in an

inpatient rehabilitation facility or unit orders medical consultations for the

patient, such consultations shall be provided by qualified physicians within 48

hours of the physician's order.  In order to achieve this result, the contracts

or agreements between inpatient rehabilitation facilities or units and medical

consultants shall require that such consultants render the requested medical

consultation within 48 hours.

(g)  An inpatient rehabilitation facility or unit shall have

a written procedure for setting the qualifications of the physicians, rendering

physical rehabilitation services in the facility or unit.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff.

January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5403       ADMISSION CRITERIA FOR INPATIENT

REHABILITATION FACILITIES OR UNITS

(a)  The facility shall have written criteria for admission

to the inpatient rehabilitation facility or unit.  A description of programs or

services for screening the suitability of a given patient for placement shall

be available to staff and referral sources.

(b)  For patients found unsuitable for admission to the

inpatient rehabilitation facility or unit, there shall be documentation of the

reasons.

(c)  Within 48 hours of admission, a preliminary assessment

shall be completed by members of the interdisciplinary team to insure the

appropriateness of placement and to identify the immediate needs of the

patients.

(d)  Patients admitted to an inpatient rehabilitation facility

or unit must be able to tolerate a minimum of three hours of rehabilitation

therapy, five days a week, including at least two of the following

rehabilitation services: physical therapy, occupational therapy or speech

therapy.

(e)  Patients admitted to an inpatient rehabilitation

facility or unit must be medically stable, have a prognosis indicating a

progressively improved medical condition and have the potential for increased

independence.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5404       COMPREHENSIVE INPATIENT REHABILITATION

EVALUATION

(a)  A comprehensive, inpatient rehabilitation evaluation is

required for each patient admitted to an inpatient rehabilitation facility or

unit.  At a minimum this evaluation shall include the reason for referral, a

summary of the patient's clinical condition, functional strengths and

limitations, and indications for specific services.  This evaluation shall be

completed within three days.

(b)  Each patient shall be evaluated by the interdisciplinary

team to determine the need for any of the following services: medical, dietary,

occupational therapy, physical therapy, prosthetics and orthotics,

psychological assessment and therapy, therapeutic recreation, rehabilitation

medicine, rehabilitation nursing, therapeutic counseling or social work,

vocational rehabilitation evaluation and speech-language pathology.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B

.5405       COMPREHENSIVE INPATIENT REHABILITATION INTER-DISCIPLINARY

TREAT/PLAN

(a)  The interdisciplinary treatment team shall develop an

individual treatment plan for each patient within seven days after admission. 

The plan shall include evaluation findings and information about the following:

(1)           prior level of function;

(2)           current functional limitations;

(3)           specific service needs;

(4)           treatment, supports and adaptations to be

provided;

(5)           specified treatment goals;

(6)           disciplines responsible for implementation

of separate parts of the plan; and

(7)           anticipated time frames for the

accomplishment of specified long-term and short-term goals.

(b)  The treatment plan shall be reviewed by the

interdisciplinary team at least every other week.  All members of the

interdisciplinary team, or a representative of their discipline, shall attend

each meeting.  Documentation of each review shall include progress toward

defined goals and identification of any changes in the treatment plan.

(c)  The treatment plan shall include provisions for all of

the services identified as needed for the patient in the comprehensive

inpatient rehabilitation evaluation completed in accordance with Rule .5404 of

this Section.

(d)  Each patient shall have a designated case manager who

shall be responsible for the coordination of the patient's individualized

treatment plan.  The case manager shall be responsible for promoting the

program's responsiveness to the needs of the patient and shall participate in

all team conferences concerning the patient's progress toward the

accomplishment of specified goals.  Any of the professional staff involved in

the patient's care may be the designated case manager for one or more cases.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5406       DISCHARGE CRITERIA FOR INPATIENT

REHABILITATION FACILITIES OR UNITS

(a)  Discharge planning shall be an integral part of the

patient's treatment plan and shall begin upon admission to the facility.  After

established goals have been reached, or a determination has been made that care

in a less intensive setting would be appropriate, or that further progress is

unlikely, the patient shall be discharged to an appropriate setting.  Other

reasons for discharge may include an inability or unwillingness of patient or

family to cooperate with the planned therapeutic program or medical

complications that preclude a further intensive rehabilitative effort.  The

facility shall involve the patient, family, staff members and referral sources

in discharge planning.

(b)  The case manager shall facilitate the discharge or

transfer process in coordination with the facility social worker.

(c)  If a patient is being referred to another facility for

further care, appropriate documentation of the patient's current status shall

be forwarded with the patient.  A formal discharge summary shall be forwarded

within 48 hours following discharge and shall include the reasons for referral,

the diagnosis, functional limitations, services provided, the results of services,

referral action recommendations and activities and procedures used by the

patient to maintain and improve functioning.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5407       COMPREHENSIVE REHABILITATION PERSONNEL

ADMINISTRATION

(a)  The facility shall have qualified staff members,

consultants and contract personnel to provide services to the patients admitted

to the inpatient rehabilitation facility or unit.

(b)  Personnel shall be employed or provided by contractual

agreement in sufficient types and numbers to meet the needs of all patients

admitted for comprehensive rehabilitation.

(c)  Written agreements shall be maintained by the facility

when services are provided by contract on an ongoing basis.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff.

January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B

.5408       COMPREHENSIVE INPATIENT REHABILITATION PROGRAM STAFFING

REQUIREMENTS

(a)  The staff of the inpatient rehabilitation facility or

unit shall include at a minimum:

(1)           the inpatient rehabilitation facility or

unit shall be supervised by a rehabilitation nurse.  The facility shall

identify the nursing skills necessary to meet the needs of the rehabilitation

patients in the unit and assign staff qualified to meet those needs;

(2)           the minimum nursing hours per patient in

the rehabilitation unit shall be 5.5 nursing hours per patient day.  At no time

shall direct care nursing staff be less than two full-time equivalents, one of

which must be a registered nurse;

(3)           the inpatient rehabilitation unit shall

employ or provide by contractual agreements sufficient therapist to provide a

minimum of three hours of specific (physical, occupational or speech) or

combined rehabilitation therapy services per patient day;

(4)           physical therapy assistants and

occupational therapy assistants shall be supervised on-site by physical

therapists or occupational therapists;

(5)           rehabilitation aides shall have documented

training appropriate to the activities to be performed and the occupational

licensure laws of his or her supervisor.  The overall responsibility for the

on-going supervision and evaluation of the rehabilitation aide remains with the

registered nurse as identified in Subparagraph (a)(1) of this Rule. 

Supervision by the physical therapist or by the occupational therapist is

limited to that time when the therapist is on-site and directing the

rehabilitation activities of the aide; and

(6)           hours of service by the rehabilitation aide

are counted toward the required nursing hours when the aide is working under

the supervision of the nurse.  Hours of service by the rehabilitation aide are

counted toward therapy hours during that time the aide works under the

immediate, on-site supervision of the physical therapist or occupational

therapist.  Hours of service shall not be dually counted for both services. 

Hours of service by rehabilitation aides in performing nurse-aide duties in

areas of the facility other than the rehabilitation unit shall not be counted

toward the 5.5 hour minimum nursing requirement described for the

rehabilitation unit.

(b)  Additional personnel shall be provided as required to

meet the needs of the patient, as defined in the comprehensive inpatient

rehabilitation evaluation.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff.

January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5409       STAFF TRAINING FOR INPATIENT

REHABILITATION FACILITIES OR UNIT

Prior to the provision of care, all rehabilitation

personnel, excluding physicians, assigned to the rehabilitation unit shall be

provided training or shall provide documentation of training that includes at a

minimum the following:

(1)           active and passive range of motion;

(2)           assistance with ambulation;

(3)           transfers;

(4)           maximizing functional independence;

(5)           the psycho-social needs of the rehabilitation

patient;

(6)           the increased safety risks of rehabilitation

training (including falls and the use of restraints);

(7)           proper body mechanics;

(8)           nutrition, including dysphagia and restorative

eating;

(9)           communication with the aphasic and hearing impaired

patient;

(10)         behavior modification;

(11)         bowel and bladder training; and

(12)         skin care.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff.

January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B

.5410       EQUIPMENT REQUIREMENTS/COMPREHENSIVE INPATIENT REHABILITATION

PROGRAMS

(a)  The facility shall provide each discipline with the

necessary equipment and treatment methods to achieve the short and long-term

goals specified in the comprehensive inpatient rehabilitation interdisciplinary

treatment plans for patients admitted to these facilities or units.

(b)  Each patient's needs for a standard wheelchair or a

specially designed wheelchair or additional devices to allow safe and independent

mobility within the facility shall be met.

(c)  Special physical therapy and occupational therapy

equipment for use in fabricating positioning devices for beds and wheelchairs

shall be provided including splints, casts, cushions, wedges and bolsters.

(d)  Physical therapy devices shall be provided, including a

mat, table, parallel bars, sliding boards, and special adaptive bathroom

equipment.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5411       PHYSICAL FACILITY REQUIREMENTS/INPATIENT

REHABILITATION FACILITIES OR UNIT

(a)  The inpatient rehabilitation facility or unit shall be

in a designated area and shall be used for the specific purpose of providing a

comprehensive inpatient rehabilitation program.

(b)  The floor area of a single bedroom shall be sufficient

for the patient or the staff to easily transfer the patient from the bed to a

wheelchair and to maneuver a 180 degree turn with a wheelchair on at least

one-side of the bed.

(c)  The floor area of a multi-bed bedroom shall be

sufficient for the patient or the staff to easily transfer the patient from the

bed to a wheelchair and to maneuver a 180 degree turn with a wheelchair between

beds.

(d)  Each patient room shall meet the following

requirements:

(1)           maximum room capacity of no more than four

patients;

(2)           operable windows;

(3)           a nurse call system designed to meet the special

needs of rehabilitation patients;

(4)           in single and two-bed rooms with private toilet room,

the lavatory may be located in the toilet room;

(5)           a wardrobe or closet for each patient which is

wheelchair accessible and arranged to allow the patient to access the contents;

(6)           a chest of drawers or built-in drawer storage with

mirror above, which is wheelchair accessible; and

(7)           a bedside table for toilet articles and personal

belongings.

(e)  Space for emergency equipment such as resuscitation

carts shall be provided and shall be under direct control of the nursing staff,

in proximity to the nurse's station and out of traffic.

(f)  Patients' bathing facilities shall meet the following

specifications:

(1)           there shall be at least one shower stall or one

bathtub for each 15 beds not individually served.  Each tub or shower shall be

in an individual room or privacy enclosure which provides space for the private

use of the bathing fixture, for drying and dressing and for a wheelchair and an

assisting attendant;

(2)           showers in central bathing facilities shall be at

least five feet square without curbs and designed to permit use by a wheelchair

patient;

(3)           at least one five-foot-by-seven-foot shower shall

be provided which can accommodate a stretcher and an assisting attendant.

(g)  Patients' toilet rooms and lavatories shall meet the

following specifications:

(1)           the size of toilet room shall permit a wheelchair,

a staff person and appropriate wheel-to-water closet transfers;

(2)           a lavatory in the room shall permit wheelchair

access;

(3)           lavatories serving patients shall:

(A)          allow wheelchairs to extend under the lavatory; and

(B)          have water supply spout mounted so that its

discharge point is a minimum of five inches above the rim of the fixture; and

(4)           lavatories used by patients and by staff shall be

equipped with blade-operated supply valves.

(h)  The space provided for physical therapy, occupational

therapy and speech therapy by all inpatient rehabilitation facilities or units

may be shared but shall, at a minimum, include:

(1)           office space for staff;

(2)           office space for speech therapy evaluation and

treatment;

(3)           waiting space;

(4)           training bathroom which includes toilet, lavatory

and bathtub;

(5)           gymnasium or exercise area;

(6)           work area such as tables or counters suitable for

wheelchair access;

(7)           treatment areas with available privacy curtains or

screens;

(8)           an activities of daily living training kitchen with

sink, cooking top (secured when not supervised by staff), refrigerator and

counter surface for meal preparation;

(9)           storage for clean linens, supplies and equipment;

(10)         janitor's closet accessible to the therapy area with

floor receptor or service sink and storage space for housekeeping supplies and

equipment (one closet or space may serve more than one area of the inpatient

rehabilitation facility or unit); and

(11)         hand washing facilities.

(i)  For social work and psychological services the

following shall be provided:

(1)           office space for staff;

(2)           office space for private interviewing and

counseling for all family members; and

(3)           work space for testing, evaluation and counseling.

(j)  If prosthetics and orthotics services are provided, the

following space shall be made available as necessary:

(1)           work space for technician; and

(2)           space for evaluation and fittings (with provisions

for privacy).

(k)  If vocational therapy services are provided, the

following space shall be made available as necessary:

(1)           office space for staff;

(2)           work space for vocational services activities such

as prevocational and vocational evaluation;

(3)           training space;

(4)           storage for equipment; and

(5)           counseling and placement space.

(l)  Recreational therapy space requirements shall include

the following:

(1)           activities space;

(2)           storage for equipment and supplies;

(3)           office space for staff; and

(4)           access to male and female toilets.

(m)  The following space shall be provided for patient's

dining, recreation and day areas:

(1)           sufficient room for wheelchair movement and

wheelchair dining seating;

(2)           if food service is cafeteria type, adequate width

for wheelchair maneuvers, queue space within the dining area (and not in a

corridor) and a serving counter low enough to view food;

(3)           total space for inpatients, a minimum of 25 square

feet per bed;

(4)           for outpatients participating in a day program or

partial day program, 20 square feet when dining is a part of the program and 10

square feet when dining is not a part of the program;

(5)           storage for recreational equipment and supplies,

tables and chairs; and

(6)           the patient dining, recreation and day area spaces

shall be provided with windows that have glazing of an area not less than eight

percent of the floor area of the space, and at least one-half of the required

window area must be operable.

(n)  A laundry shall be available and accessible for

patients.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

10A NCAC 13B .5412       ADDITIONAL REQUIREMENTS FOR TRAUMATIC

BRAIN INJURY PATIENTS

Inpatient rehabilitation facilities providing services to

persons with traumatic brain injuries shall meet the requirements in this Rule

in addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios

established in Rule .5408 of this Section shall not be applied to nursing

services for traumatic brain injury patients in the inpatient, rehabilitation

facility or unit.  The minimum nursing hours per traumatic brain injury patient

in the unit shall be 6.5 nursing hours per patient day.  At no time shall

direct care nursing staff be less than two full-time equivalents, one of which

shall be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall

employ or provide by contractual agreements physical, occupational or speech

therapists in order to provide a minimum of 4.5 hours of specific or combined

rehabilitation therapy services per traumatic brain injury patient day.

(3)           The facility shall provide special facility or

special equipment needs for patients with traumatic brain injury, including

specially designed wheelchairs, tilt tables and standing tables.

(4)           The medical director of an inpatient traumatic

brain injury program shall have two years management in a brain injury program,

one of which may be in a clinical fellowship program and board eligibility or

certification in the medical specialty of the physician's training.

(5)           The facility shall provide the consulting services

of a neuropsychologist.

(6)           The facility shall provide continuing education in

the care and treatment of brain injury patients for all staff.

(7)           The size of the brain injury program shall be

adequate to support a comprehensive, dedicated ongoing brain injury program.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff.

January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5413       ADDITIONAL REQUIREMENTS FOR SPINAL CORD

INJURY PATIENTS

Inpatient rehabilitation facilities providing services to

persons with spinal cord injuries shall meet the requirements in this Rule in

addition to those identified in this Section.

(1)           Direct-care nursing personnel staffing ratios

established in Rule .5408 of this Section shall not be applied to nursing

services for spinal cord injury patients in the inpatient rehabilitation

facility or unit.  The minimum nursing hours per spinal cord injury patient in

the unit shall be 6.0 nursing hours per patient day.  At no time shall direct

care nursing staff be less than two full-time equivalents, one of which shall

be a registered nurse.

(2)           The inpatient rehabilitation facility or unit shall

employ or provide by contractual agreements physical, occupational or speech

therapists in order to provide a minimum of 4.0 hours of specific or combined

rehabilitation therapy services per spinal cord injury patient day.

(3)           The facility shall provide special facility or

special equipment needs of patients with spinal cord injury, including

specially designed wheelchairs, tilt tables and standing tables.

(4)           The medical director of an inpatient spinal cord

injury program shall have either two years experience in the medical care of

persons with spinal cord injuries or six months minimum in a spinal cord injury

fellowship.

(5)           The facility shall provide continuing education in

the care and treatment of spinal cord injury patients for all staff.

(6)           The facility shall provide specific staff training

and education in the care and treatment of spinal cord injury.

(7)           The size of the spinal cord injury program shall be

adequate to support a comprehensive, dedicated ongoing spinal cord injury

program.

 

History Note:        Authority G.S. 131E-79;

RRC Objection due to lack of statutory authority Eff.

January 18, 1996;

Eff. May 1, 1996.

 

10A NCAC 13B .5414       DEEMED STATUS FOR INPATIENT

REHABILITATION FACILITIES OR UNIT

(a)  If an inpatient rehabilitation facility or unit with a

comprehensive inpatient rehabilitation program is surveyed and accredited by

the Joint Commission for the Accreditation of Health Care Organizations (JCAHO)

or the Commission on Accreditation of Rehabilitation Facilities (CARF) and has

been approved by the Department in accordance with G.S. 131E, Article 9, the

Department deems the facility to be in compliance with Rules .5401 through

.5413 of this Section.

(b)  Deemed status shall be provided only if the inpatient

rehabilitation facility or unit provides copies of survey reports to the

Department.  The JCAHO report shall show that the facility or unit was surveyed

for rehabilitation services.  The CARF report shall show that the facility or

unit was surveyed for comprehensive rehabilitation services.  The facility or

unit shall sign an agreement (Memorandum of Understanding) with the Department

specifying these terms.

(c)  The inpatient rehabilitation facility or unit shall be

subject to inspections or complaint investigations by representatives of the

Department at any time.  If the facility or unit is found not to be in

compliance with the rules listed in Paragraph (a) of this Rule, the facility

shall submit a plan of correction and be subject to a follow-up visit to ensure

compliance.

(d)  If the inpatient rehabilitation facility or unit loses

or does not renew its accreditation, the facility or unit shall notify the

Division in writing within 30 days.

 

History Note:        Authority G.S. 131E-79;

Eff. March 1, 1996.

 

section .5500 – supplemental rules for hospitals providing

living organ donation transplant services

 

10A NCAC 13B .5501       applicability of rules

The rules contained in this Section shall apply to hospitals

providing living organ donation transplant services.

 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

Eff. April 1, 2006.

 

10A NCAC 13B .5502       INDEPENDENT DONOR ADVOCATE TEAM

(a)  The facility shall appoint an Independent Donor

Advocate Team (IDAT) whose sole purpose is to represent and ensure the

well-being of the potential donor, making sure he or she is aware of the risks

and benefits of donation and that the choice to donate is voluntary.  The IDAT

shall ensure the potential donor learns about the entire donation process. 

This would include the selection of recipients for the transplant, the

procedures to be employed for both the donor and recipient, and possible

outcomes.  Sufficient time for the discussion, supplemented with written

materials, must be allowed for comprehension and assimilation of the

information about transplantation and the ramifications of donation.  Written

and verbal presentations shall be in language in accordance with the person's

ability to understand. 

(b) The IDAT shall consist of a physician, a clinical transplant

coordinator, and a social worker or qualified mental health professional as

defined in Rule .5202(k) of this Subchapter.  The physician shall be the leader

of the IDAT.  The IDAT members shall have experience in organ transplantation

processes and programs and shall be able to act for the interests of the

potential donor independent of any financial or facility influence.  Based on

the outcome of the evaluation of the potential donor pursuant to Rule .5504 of

this Section, if the IDAT determines any potential donor is unsuitable for

donation, it shall provide the reasons both verbally and in writing. 

(c)  In order to ensure the well-being of the potential donor,

the IDAT shall:

(1)           Protect and represent the interests of the

potential donor;

(2)           Make it clear to the potential donor that

the choice to donate is entirely his or hers;

(3)           Inform and discuss with the potential donor

the medical, psychosocial and financial aspects related to the live donation;

(4)           Explain to the potential donor the evaluation

process, what it means and his or her option to stop at any time;

(5)           Determine the intellectual and emotional

ability of the potential donor to understand the legal and ethical aspects of

informed choice;

(6)           Assess if the potential donor has understood

the risks and the benefits and how they impact on his or  her own core beliefs

and values; and

(7)           Identify for the potential donor resources

that will be available to provide continuous care during hospitalization and

referrals in medicine, psychiatry or social work, which may be needed or

required following discharge.

 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

Eff. May 1, 2006.

 

10A NCAC 13B .5503       INFORMED CHOICE

(a)  The potential donor must be free to make an informed

independent decision, which has been termed informed choice. Informed choice

addresses the decision process of the potential donor as he or she determines

whether or not to donate.  Informed choice has several aspects.  First, the

potential donor must know he or she has a choice, meaning he or she can freely

decide either to donate or not to donate an organ.  Second, the potential donor

must be aware of both the risks and benefits of donation.  The potential donor

must be able to weigh the positive aspects of the donation as well as take into

account the technical aspects such as the surgery, recovery, financial impact

and any unexpected but potential consequences that may result such as a change

in the patient's life, health, insurability, employment or emotional stability.



(b)  The person who consents to be a live organ donor shall

be:

(1)           Legally competent;

(2)           Willing to donate;

(3)           Free from coercion, including financial

coercion, actual or implied;

(4)           Medically suitable;

(5)           Informed and able to express understanding

of the risks and benefits of donation; and

(6)           Informed of the risks, benefits and

alternative treatment regimens available to the recipient.

(c)  A statement signed by the potential donor that his or

her participation is completely voluntary and may be withdrawn at any time

shall be placed in the medical record.

(d)  Understanding

(1)           The potential donor shall be able to

demonstrate that he or she understands the essential elements of the donation

process with emphasis on the risks associated with the procedure;

(2)           With the potential donor's permission, the

donor's designee, family or next of kin shall be given the opportunity to

openly discuss the donor's concerns in a safe and non-threatening environment;

and

(3)           The potential donor shall understand, agree

to, and commit to postoperative follow-up and testing by the facility

performing the surgical removal of the organ and subsequent organ transplant.

(e)  Disclosure

(1)           The donor surgical team and the IDAT shall

disclose any facility affiliations to the potential donor;

(2)           The potential donor shall have a period of

reflection appropriate to the acuity of the clinical condition of the recipient

and reaffirmation of the decision to donate subsequent to the completion of the

medical work-up and final approval to proceed by the IDAT.  After the period of

reflection the potential donor may sign the consent for the donation procedure;

(3)           Non-English speaking candidates and hearing

impaired candidates must be provided with a non-family interpreter who

understands the donor's language and culture;

(4)           A member of the IDAT shall witness the

potential donor signing the consent documents for removal of the donor organ;

and

(5)           The overall donation process and experience

shall be explained to the potential donor and shall be provided in writing to

include:

(A)          Donor evaluation procedure;

(B)          Surgical procedure;

(C)          Recuperative period;

(D)          Short-term and long term follow-up care;

(E)           Alternative donation and transplant procedure;

(F)           Potential psychological benefits to donor;

(G)          Transplant facility and surgeon-specific statistics

of donor and recipient outcomes;

(H)          Confidentiality of the donor's information and

decisions;

(I)            Donor's ability to opt out at any point in the

process;

(J)            Information about how the facility performing the

transplant will attempt to follow the health of the donor; and

(K)          Need for the donor to review potential personal

insurability for future insurance coverage.

(f)  The IDAT shall make the potential donor aware of the

following risk factors:

(1)           Physical

(A)          Potential for surgical complications including risk

of donor death;

(B)          Potential for organ failure and the need for future

organ transplant for the donor;

(C)          Potential for other medical complications including

long-term complications and complications currently unforeseen;

(D)          Scars;

(E)           Pain;

(F)           Fatigue; and

(G)          Abdominal or bowel symptoms such as bloating and

nausea.

(2)           Psychosocial

(A)          Potential for problems with body image;

(B)          Possibility of transplant recipient death;

(C)          Possibility of transplant recipient rejection and

need for re-transplantation;

(D)          Possibility of recurrent disease in a transplant

recipient;

(E)           Possibility of post surgery adjustment problems;

(F)           Impact on the donor's family or next of kin;

(G)          Impact on the transplant recipient's family or next

of kin; and

(H)          Potential impact of donation on the donor's

lifestyle.

(3)           Financial

(A)          Out of pocket expenses;

(B)          Child care costs;

(C)          Possible loss of employment;

(D)          Potential impact on the ability to obtain future

employment; and

(E)           Potential impact on the ability to obtain or afford

health and life insurance.

(g)  The potential donor shall provide assurance and consent

that the following areas have been addressed:

(1)           That there is no monetary profit to the

potential donor.  Coverage for expenses incurred as a result of the organ

donation is not considered monetary profit;

(2)           That family members or others did not

coerce the potential donor into making his or her decision;

(3)           That the potential donor has been provided

with a general statement of unsuitability for donation if requested.  Medical

information regarding the potential donor shall not be falsified to provide the

donor with an excuse to decline donation;

(4)           That the potential donor is intellectually

and emotionally capable of participation in a discussion of potential risks and

benefits;

(5)           That the potential donor has been provided

adequate information to ensure his or her understanding regarding the risks of

the donation;

(6)           That the potential donor has been educated

regarding the recipient's options for organs from deceased persons, including

risks and outcomes; and

(7)           That the potential donor understands that

he or she may decline to donate at any time.

(h)  Documentation

(1)           A medical record, separate and distinct

from the transplant recipient's record, shall be maintained to protect donor confidentiality;

and

(2)           The informed choice process and evaluation

protocol shall be documented and placed in the potential donor's medical

record.

(i)  Decision to Donate.  Once the IDAT determines the

suitability of the potential donor the IDAT shall discuss with the potential

donor's surgical team and transplant team its decision prior to its

presentation to the potential donor.  If the potential donor wishes to donate,

but the IDAT does not agree, the IDAT's opposition shall be so noted in a

report to the donor surgeon, who shall document reasons for proceeding against

the IDAT advice.  The reason why the IDAT has objections shall be explained to

the potential donor.  For example, the potential donor may not have the ability

to understand the information provided to him or her or the donor may be unable

to integrate the degree of risk pertinent to his or her situation or there may

be a lack of balance between the risks to the potential donor and potential

benefits to the transplant recipient.  Even if the potential donor is willing

to donate his or her organ, the final review and decision whether or not to

proceed with the donation rests with the donor surgical team and transplant

team.

(j)  In cases involving living liver donation, prior to

reaching a decision to donate the potential donor shall be provided in writing

the U.S. Department of Health and Human Services Advisory Committee on Organ

Transplantation (ACOT) recommendations entitled "Living Liver Donor

Initial Consent for Evaluation" which is hereby incorporated by reference

with all subsequent amendments.  The ACOT recommendations can be obtained free

of charge via the internet at: http://www.organdonor.gov/acotrecs.html. 

The items contained in the ACOT recommendations must be explained to the

potential donor in language and terms which he or she can understand and then

be signed by the donor and the signature witnessed.  Subsequent to this, if all

the facts show that the potential donor is, in fact, in all respects a viable

potential donor, then he or she shall execute the ACOT recommended form

entitled "Living Liver Donor Informed Consent for Surgery" which is

hereby incorporated by reference with all subsequent amendments.  In addition,

this form shall comply with G.S. 90-21.13 Informed Consent which is hereby

incorporated by reference with all subsequent amendments.

 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

Eff. May 1, 2006.

 

10A NCAC 13B .5504       EVALUATION PROTOCOL FOR LIVING ORGAN

DONORS

Hospitals shall complete the following evaluation protocols

prior to living organ donation:   

(1)           The facility shall confirm the potential donor's

ABO blood type.

(2)           Only individuals 18 years of age or older shall be

considered for living organ donation. The facility shall complete a screening

interview with the potential donor which confirms the donor's age, height,

weight, demographic information, medical and surgical history, medications,

drug or alcohol history, smoking history, and a family or social history. 

Insurance issues (health and life) shall also be discussed with the potential

donor and an attempt shall be made to answer any questions asked by the donor. 

Written information on the living donor process shall be made available to the

potential donor.

(3)           The donor surgical team shall determine whether the

potential donor shall be excluded based on the medical information or family

history: for example, exclusionary criteria may include the presence of

diabetes, uncontrolled hypertension, liver, pulmonary or cardiac disease, renal

dysfunction or high Body Mass Index (BMI).

(4)           An IDAT shall be assigned for the potential donor

pursuant to Rule .5502(c) of this Section.  The IDAT leader shall not be a

physician who is the primary physician of the potential transplant recipient.

(5)           The IDAT leader shall conduct a medical evaluation

of the potential donor.  The medical evaluation shall include a full and frank

discussion of the risks associated with the evaluation tests with the potential

donor and the donor's chosen designee.  If the potential donor wishes to

proceed, laboratory and diagnostic tests shall be ordered as necessary.

(6)           An IDAT member shall conduct a psychosocial evaluation

of the potential donor.  The IDAT member shall also discuss financial

considerations.

(7)           The IDAT shall review the laboratory and diagnostic

test results, as well as psychosocial evaluation and discuss them with the

donor to decide whether to move forward with the potential donor's evaluation. 



(8)           The donor surgeon shall evaluate the mortality and

morbidity risks associated with donation and disclose those risks to the

potential donor with adequate time for any questions to be answered in detail.

The donor's designee shall also be present at this appointment.

(9)           The IDAT shall perform a final review and makes its

recommendation as set out in Rule .5503(i) of this Section. 

(10)         The hospital shall schedule an appointment for

pre-operative screening with the potential donor after the entire process of

evaluation is complete.  An informed consent as required in Rule .4605(c)(2) of

this Subchapter is necessary for the donation and surgical procedure and shall

be completed by this time.  In addition, where applicable, the potential donor

shall be given ample time for autologous blood donation through the American

Red Cross.

 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

Eff. May 1, 2006.

 

10A NCAC 13B .5505       Perioperative Care and Facility Support

(a)  The donor surgical team shall have primary concern and

responsibility for the donor's care and welfare throughout his or her entire

hospital stay.  The donor surgical team consists of the donor surgeon, his or

her surgical and medical partners, fellows, residents, and physician assistants

or nurse practitioners. 

(b)  Preoperative Preparation

(1)           The facility shall have the ability to

allow donors to bank a minimum of one unit of blood before surgery.  Facilities

shall have the ability to store and transfuse autologous blood;

(2)           The transplant coordinator or another team

member shall be assigned the responsibility of providing updates to the

families of both the donor and transplant recipient during the surgical procedures;

and

(3)           For live donor liver procedures, surgeries

shall be scheduled only when staffing will be available for the postoperative

period.  If surgery is scheduled on a Thursday or Friday, the hospital shall

ensure that there is adequate attending physician, resident physician,

physician assistant or nurse practitioner, and registered nursing coverage

during the weekend.

(c)  Postoperative Care

(1)           After live donor nephrectomy, the patient

shall receive post-operative care equivalent to that provided for abdominal

procedures under general anesthesia; and

(2)           For live liver donors:

(A)          Day 0-1: The live adult liver donor shall receive

care in the intensive care unit (ICU) or post-anesthesia care unit (PACU);

(B)          Day 2: If stable and cleared for transfer by the

donor surgical team, the donor shall be cared for in a hospital unit that is

dedicated to the care of transplant recipients or a hospital unit in which

patients who undergo hepatobiliary resectional surgery are provided care. 

Liver donors shall not at any time be cared for on any other unit unless a

specific medical condition of the donor warrants such a transfer;

(C)          The donor shall be evaluated at least daily by a

liver transplant attending physician with documentation in the medical record;

(D)          The donor surgical team shall be responsible for the

clinical management of the donor;

(E)           The patient care staff shall be familiar with the

common complications associated with the donor and transplant recipient

operations and have appropriate monitoring in place to detect these problems if

they arise; and

(F)           If there is an emergent complication requiring

re-operation, these patients shall be prioritized for access to the operating

room based on the facility's operating room policies and guidelines.

(d)  Medical Staffing.   For live donor nephrectomy

patients, there shall be continuous physician coverage available for patient

evaluation as needed.  These patients shall be provided post-operative care

equivalent to patients undergoing a nephrectomy. 

(e)  Nurse Staffing

(1)           Nursing staff shall be familiar with

recovery of nephrectomy patients.  They shall be aware of the signs and

symptoms of hypovolemia due to post-operative bleeding or to excessive

diuresis.   They shall have ready access to the surgical team responsible for

the patient's post-operative care;

(2)           For live liver donors, nursing staff shall

have ongoing education and training in live donor liver transplantation nursing

care for both donors and recipients.  This shall include education on the pain

management issues particular to the donor.  The registered nursing to patient

ratio in the ICU or PACU level setting shall be appropriate for the acuity

level of the patients.  For live liver donors, the same registered nurse shall

not take care of both the donor and the recipient.  For live liver donors, the

nursing service shall provide the potential donor with pre-surgical information

including, if possible, a tour of the unit before surgery; and

(3)           For all donors, the names and beeper

numbers of the donor surgical team or team responsible for the donor's

post-operative surgical care (e.g. urology service or laparoscopic general

surgery service for some donor nephrectomy patients) shall be posted on all

units receiving transplant donors.

(f)  Radiology.  For facilities performing live donor

nephrectomies, radiological staff shall be available for pre-operative

assessment, peri-operative care, and post-operative follow-up as required.

 

History Note:        Authority G.S. 131E-75; 131E-79; 143B-165;

Eff. April 1, 2006.

 

10A NCAC 13B .5506       DISCHARGE PLANNING

(a)  Pre-Donation.  At the time of evaluation by the IDAT, a

discussion shall be held between the IDAT social worker and the potential donor

and his or her family or next of kin to address the following areas:

(1)           Living arrangements after discharge from

the surgery or while the donor recuperates until able to travel;

(2)           Transportation arrangements from the

hospital to the donor's accommodations or back to follow up appointments;

(3)           Caregivers to provide assistance or support

upon discharge; if the donor has children or other dependents, a plan for the

children's or dependent's care while the donor recuperates;

(4)           Financial considerations:  Encourage donor

to discuss with employer about medical leave or disability. This discussion

shall include checking with health or life insurance carriers about future

"pre-existing conditions" or "exclusions" that may result

from donation;

(5)           Provided consent is first obtained,

referrals to other living organ donors from that particular facility and

suggestions from other resources such as publications and websites; and

(6)           Emotional issues surrounding the organ

donation process.

(b)  Day of Discharge

(1)           A written discharge plan shall be provided

to the donor with the following instructions:

(A)          Restrictions on activities;

(B)          Permitted activities (i.e. return to work);

(C)          Diet;

(D)          Pain medication with prescription;

(E)           Follow up appointments with surgeon;

(F)           Contact numbers for the Independent Donor Advocate

Team should the donor have questions, concerns or problems; and

(G)          Additional instructions for caregivers, if any.

(2)           The discharge plan shall be reviewed with

the donor by the facility discharge planner or primary care nurse.

(c)  Post Discharge medical follow-up, social, psychological

and financial support

(1)           Post-operative visits shall be scheduled by

the donor with the surgeon to assess the following:

(A)          Wound healing;

(B)          Signs and symptoms of infections; and

(C)          Laboratory results as appropriate to the organ type,

as well as any imaging or other diagnostic findings.

(2)           Dictated summaries of surgery and follow-up

visits shall be sent to the donor's primary care physician by the facility to

ensure appropriate medical care.

(3)           Referrals shall be made to community

agencies to address the donor's emotional and psychological issues if needed or

requested by the donor, his or her designee, family, next of kin or the IDAT

to;

(A)          Provide the donor the opportunity to participate in

a support group; and

(B)          Provide the donor recognition as determined by the

facility.

(d)  Any questions or concerns regarding the discharge plan

or discharge planning process by the donor, the donor's designee, the donor's

next of kin or legally responsible party shall be addressed by facility staff.

 

History Note:        Authority G.S. 131E-75; 131E-79;

143B-165;

Eff. April 1, 2006.

 

SECTION .5600 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5600       Reserved for future codification

 

SECTION .5700 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5700       Reserved for future codification

 

SECTION .5800 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5800       Reserved for future codification

 

SECTION .5900 - RESERVED FOR FUTURE CODIFICATION

 

10A NCAC 13B .5900       Reserved for future codification

 

SECTION .6000 - PHYSICAL PLANT

 

10A NCAC 13B .6001       LOCATION

(a)  The site of any facility shall be accessible to service

vehicles, fire protection and emergency apparatus.

(b)  The water supply system available to the site shall be

tested to determine the mineral and salts content and their effect on the

various water systems in the facility.  When these tests indicate the facility

will have problems in maintenance and upkeep, the facility shall provide a

water treatment system.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6002       ROADS AND PARKING

(a)  Paved roads shall be provided within the property lines

to provide access to the main entrance, emergency entrance, and to service

entrances, including loading and unloading docks for delivery trucks.

(b)  Facilities having an organized emergency services

department shall have the emergency entrance well marked to facilitate entry

from the public roads or streets serving the site.

(c)  Paved walkways shall be provided for necessary

pedestrian traffic.

(d)  Off-street parking shall be made available for

patients, staff, and visitors.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .6100 - GENERAL REQUIREMENTS

 

10A NCAC 13B .6101       GENERAL

The design, construction, maintenance and

operation of a facility shall be in accordance with those codes and standards

listed in Rule .6102, LIST OF REFERENCED CODES AND STANDARDS of this Section,

and codes, ordinances, and regulations enforced by city, county, or other state

jurisdictions with the following requirements:

(1)           Notify the Division when all

construction or renovation has been completed, inspected and approved by the

architect and engineer having responsibility, and the facility is ready for a

final inspection.  Prior to using the completed project, the facility shall

receive from the Division written approval for use.  The approval shall be

based on an on-site inspection by the Division or by documentation as may be

required by the Division;

(2)           In the absence of any requirements

by other authorities having jurisdiction, develop a master fire and disaster

plan with input from the local fire department and local emergency management

agency to fit the needs of the facility.  The plan shall require:

(a)           Training of facility

employees in the fire plan implementation, in the use of fire-fighting

equipment, and in evacuation of patients and staff from areas in danger during

an emergency condition;

(b)           Conducting of quarterly fire

drills on each shift;

(c)           A written record of each

drill shall be on file at the facility for at least three years;

(d)           The testing and evaluation of

the emergency electrical system(s) once each year by simulating a utility power

outage by opening of the main facility electrical breaker(s).  Documentation of

the testing and results shall be completed at the time of the test and retained

by the facility for three years; and

(e)           Disaster planning to fit the

specific needs of the facility's geographic location and disaster history, with

at least one documented disaster drill conducted each year.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6102       LIST OF REFERENCED CODES AND STANDARDS

The following codes and standards are adopted by reference

including subsequent amendments.  Copies of these publications can be obtained

from the various organizations at the addresses listed:

(1)           The North Carolina State Building Code, current

edition, all volumes including subsequent amendments.  Copies of this code may

be purchased from the N.C. Department of Insurance Engineering and Codes

Division located at 410 North Boylan Avenue, Raleigh, NC 27603 at a cost of two

hundred fifty dollars ($250.00).

(2)           The National Fire Protection Association codes and

standards listed in this Paragraph, current editions including subsequent

amendments.  Copies of these codes and standards may be obtained from the

National Fire Protection Association, 1 Batterymarch Park, PO Box 9101, Quincy,

MA  02269-9101 at the cost shown for each code or standard listed.

(a)           10                           Portable Fire

Extinguishers                                                ($22.50)

(b)           12                           Carbon Dioxide

Extinguishing Systems                                          ($20.25)

(c)           12A                        Halon 1301 Fire

Extinguishing Systems                                         ($22.25)

(d)           12B                        Halon 1211 Fire

Extinguishing Systems                                         ($20.25)

(e)           13                           Installation of

Sprinkler Systems                                                     ($28.50)

(f)            13D                        Installation

of Sprinkler Systems in One- and

Two-Family

Dwellings and Manufactured Homes                       ($20.25)

(g)           13R                        Installation of

Sprinkler Systems in Residential

Occupancies up

to and including Four Stories

in Height                                                                                                ($20.25)

(h)           14                           Installation

of  Standpipe and Hose Systems                                                ($20.25)

(i)            15                           Water Spray

Fixed Systems                                                              ($20.25)

(j)            17                           Dry Chemical

Extinguishing Systems                                              ($20.25)

(k)           17A                        Wet Chemical

Extinguishing Systems                                             ($16.75)

(l)            20                           Installation

of Centrifugal Fire Pumps                                            ($20.25)

(m)          22                           Water Tanks for

Private Fire Protection                                          ($22.25)

(n)           25                           Water-Based Fire

Protection Systems                                             ($22.25)

(o)           30                           Flammable and

Combustible Liquids Code                                  ($22.25)

(p)           31                           Installation of

Oil-Burning Equipment                                            ($20.25)

(q)           37                           Stationary

Combustion Engines and Gas Turbines                      ($16.75)

(r)            45                           Fire

Protection for Laboratories Using Chemicals                         ($20.25)

(s)            49                           Hazardous

Chemicals Data                                                              ($26.50)

(t)            50                           Bulk Oxygen

Systems at Consumer Sites                                       ($16.75)

(u)           53                           Fire Hazards in

Oxygen-Enriched Atmospheres                            ($22.50)

(v)           54                           National Fuel

Gas Code                                                                     ($26.50)

(w)          55                           Compressed and Liquefied

Gases in Portable Cylinders             ($16.75)

(x)           58                           Storage and

Handling of Liquefied Petroleum Gases                  ($26.50)

(y)           59A                        Liquefied Natural

Gas (LNG)                                                            ($20.25)

(z)           72                           National Fire

Alarm Code                                                                  ($32.25)

(aa)         80                           Fire Doors and

Windows                                                                    ($22.50)

(bb)         82                           Incinerators,

Waste and Linen Handling Systems

and Equipment                                                                                    ($16.75)

(cc)         88A                        Parking Structures

                                                                              ($16.75)

(dd)         90A                        Installation of

Air Conditioning and Ventilating Systems           ($20.25)

(ee)         90B                        Installation of

Warm Air Heating and Air Conditioning

Systems                                                                                                 ($16.75)

(ff)          92A                        Smoke-Control

Systems                                                                    ($20.25)

(gg)         92B                        Smoke Management

Systems in Malls, Atria, Large Areas        ($20.25)

(hh)         96                           Ventilation

Control and Fire Protection of Commercial

Cooking

Operations                                                                            ($20.25)

(ii)           99                           Health Care

Facilities                                                                         ($32.25)

(jj)           99B                        Hypobaric

Facilities                                                                            ($20.25)

(kk)         101                         Safety to Life

from Fire in Buildings and Structures                    ($39.50)

(ll)           101M                     Alternative

Approaches to Life Safety                                           ($22.25)

(mm)      105                         Smoke-Control Door

Assemblies                                                     ($16.75)

(nn)         110                         Emergency and

Standby Power Systems                                       ($20.25)

(oo)         111                         Stored Electrical

Energy Emergency and Standby

Power Systems                                                                                     ($16.75)

(pp)         204M                     Smoke and Heat

Venting                                                                  ($20.25)

(qq)         220                         Types of Building

Construction                                                        ($16.75)

(rr)           221                         Fire Walls and

Fire Barrier Walls                                                      ($16.75)

(ss)          241                         Construction,

Alteration, and Demolition Operations                  ($20.25)

(tt)           251                         Fire Tests of

Building Construction and Materials                        ($20.25)

(uu)         255                         Test of Surface

Burning Characteristics of Building

Materials                                                                                               ($16.75)

(vv)         321                         Basic

Classification of Flammable and Combustible

Liquids                                                                                                   ($16.75)

(ww)       325                         Fire Hazard

Properties of Flammable Liquids, Gases,

and Volatile

Solids                                                                              ($22.25)

(xx)         407                         Aircraft Fuel

Servicing                                                                        ($20.25)

(yy)         418                         Roof-top Heliport

Construction and Protection                            ($16.75)

(zz)         704                         Identification of

the Fire Hazards of Materials                             ($16.75)

(aaa)      705                         Field Flame Test

for Textiles and Films                                          ($16.75)

(bbb)      780                         Lightning

Protection Code                                                                 ($20.25)

(ccc)       801                         Facilities

Handling Radioactive Materials                                      ($20.25)

(3)           American Society of Heating, Refrigerating &

Air Conditioning Engineers Inc., (ASHRAE) HVAC APPLICATIONS, current edition

including subsequent amendments.  Copies of this document may be obtained from

the American Society of Heating, Refrigerating & Air Conditioning

Engineers, Inc. at 1791 Tullie Circle NE, Atlanta, GA 30329 at a cost of one

hundred nineteen dollars ($119.00).

(4)           Rules and Statutes Governing the Licensure of

Ambulatory Surgical Facilities, current edition including subsequent

amendments.  Copies of this document may be obtained from the N.C. Department

of Health and Human Services, Division of Health Service Regulation, Licensure

and Certification Section, 2711 Mail Service Center, Raleigh, NC  27699-2711

at a cost of three dollars ($3.00).

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6103       APPLICATION OF PHYSICAL PLANT

REQUIREMENTS

The physical plant requirements for each facility shall be

applied as follows:

(1)           New construction shall comply with the requirements

of Section .6000 of this Subchapter;

(2)           Existing buildings shall meet licensure and code

requirements in effect at the time of construction, alteration, or

modification;

(3)           New additions, alterations, modifications, and

repairs shall meet the technical requirements of Section .6000 of this

Subchapter, however, where strict conformance with current requirements would

be impractical, the authority having jurisdiction may approve alternative

measures where the facility can demonstrate to the Division's satisfaction that

the alternative measures do not reduce the safety or operating effectiveness of

the facility;

(4)           Rules contained in Section .6000 of this Subchapter

are minimum requirements and not intended to prohibit buildings, systems or

operational conditions that exceed minimum requirements;

(5)           Equivalency: Alternate methods, procedures, design

criteria, and functional variations from the physical plant requirements,

because of extraordinary circumstances, new programs, or unusual conditions,

may be approved by the authority having jurisdiction when the facility can

effectively demonstrate to the Division's satisfaction, that the intent of the

physical plant requirements are met and that the variation does not reduce the

safety or operational effectiveness of the facility; and

(6)           Where rules, codes, or standards have any conflict,

the most stringent requirement shall apply.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6104       ACCESS AND SAFETY

Projects involving replacement, alterations of, and

additions to existing facilities shall be planned and phased so that

construction will minimize disruptions of essential facility operations. 

Facility access, exit ways, safety provisions, and building and life safety

systems shall be maintained so that the health and safety of the occupants will

not be jeopardized during construction.  Additional safety and operating

measures shall be planned and executed to compensate for hazards related to

construction or renovation activities to maintain an equivalent degree of

health, safety, and operational effectiveness to that required by rules,

standards, and codes for a facility not under construction or renovation.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

SECTION .6200 - CONSTRUCTION REQUIREMENTS

 

10A NCAC 13B .6201       MEDICAL, SURGICAL AND POST-PARTUM CARE

UNIT

The following requirements shall apply to licensed beds:

(1)           Each patient room shall meet the following

requirements:

(a)           Maximum room capacity shall be four

patients;

(b)           Minimum room areas exclusive of toilet

rooms, closets, lockers, wardrobes, bathing room, or vestibules less than six

feet wide shall be 100 square feet in single bed rooms and 80 square feet per

bed in multi-bed rooms;

(c)           A minimum of three feet of clear working

space on three sides of each bed shall be provided;

(d)           A window which can be opened from the inside

shall be provided.  The window sill shall not be higher than three feet above

the floor and shall be above grade;

(e)           A nurses' calling station at each patient

bed and toilet room shall be provided;

(f)            At least one lavatory shall be provided in

each patient room.  In a single bedroom other than post-partum rooms, the

lavatory may be omitted from the patient room when a lavatory is located in an

adjoining toilet room which serves that room only;

(g)           A toilet room containing a water closet and

a lavatory shall be provided to serve no more than four beds or two patient

rooms;

(h)           A wardrobe, locker or closet shall be

provided for each patient suitable for hanging garments as well as for storage

of personal effects; and

(i)            Provision shall be made for the visual

privacy of each patient in multi-bed rooms.

(2)           The following service areas shall be located no

further than 120 feet travel distance from each patient bedroom door:

(a)           Nurses' station with work counter and

storage facilities;

(b)           Hand washing facilities located at the

nurses' station;

(c)           Charting facilities;

(d)           A clean workroom or a clean holding room for

storage and distribution of clean supply materials.  The clean workroom shall

contain a work counter and hand washing and storage facilities.  A clean

holding room shall be similar to a clean workroom except it shall be a part of

a clean supply system and the work counter and hand washing facilities may be

omitted;

(e)           A soiled workroom or a soiled holding room

as a part of a system for the collection and disposal of soiled materials.  The

soiled workroom shall contain a clinical sink or other suitable flushing

device, sink equipped for hand washing, a work counter, a waste receptacle, and

a linen receptacle.  A soiled holding room shall be similar to the soiled

workroom except that it shall be a part of the soiled disposal system. The

waste receptacle clinical sink and work counter may be omitted;

(f)            A drug distribution station that meets the

current minimum requirements of governing state and federal agencies regulating

controlled substances including a lavatory;

(g)           A clean linen storage closet.  This may be a

designated area within the clean workroom.  If a closed cart system is used,

storage may be in a controlled alcove out of corridor traffic;

(h)           A separate nourishment station that contains

a lavatory, equipment for serving nourishment between meals, refrigerator and

storage facilities.  Ice dispensing facilities for patient service and

treatment shall be of a type that will not require use of scoops;

(i)            Storage of equipment including emergency

equipment shall be provided to insure corridors are kept clear; and

(j)            Parking for stretchers and wheelchairs

located out of corridor widths.

(3)           The following service areas shall be provided for

each nursing unit:

(a)           Nurses office;

(b)           Closets or compartments for the safekeeping

of coats and personal effects of staff;

(c)           Conference room;

(d)           Room for examination and treatment of

patients.  This room may be omitted if all patient rooms are single-bed rooms. 

This room shall have a minimum floor area of 100 square feet, excluding space

for vestibule less than six feet wide, toilet, closets and work counters

(whether fixed or movable).  The minimum room dimension shall be 10 feet.  The

room shall contain a lavatory, a work counter, storage facilities and a desk,

counter or shelf space for writing;

(e)           Lounge and toilet room for staff;

(f)            Janitors' closet.  This room shall contain

a floor receptor or service sink and storage space for housekeeping supplies

and equipment; and

(g)           Individually enclosed bathtubs or

individually enclosed showers at the rate of one for each 12 beds or fraction

thereof which are not otherwise served by bathing facilities within the patient

rooms.

(4)           Each facility shall make provisions for at least

one room for patients needing close supervision including provisions to

minimize the chance of a patients' hiding, escape, injury or suicide.

(5)           Isolation Rooms.  Rooms for patients requiring

protective or infectious isolation for infection control purposes shall be

provided at the ratio of one isolation room for each 30 acute care licensed

beds or major fraction thereof.  These may be located within each nursing unit

or placed together in a separate unit.  Each isolation room shall be a

single-bed room and shall conform to the requirements of Item (1) of this Rule

except as follows:

(a)           A private toilet room containing a water

closet and a bath or shower for the exclusive use of the patient which can be

entered directly from the patient bed area without passing through the

vestibule or anteroom shall be provided;

(b)           A lavatory for the exclusive use of the patient

shall be provided.  It may be located in the patient room or in the private

toilet room;

(c)           Entrance from the corridor shall be through

a closed anteroom which contains facilities to assist staff personnel in

maintaining aseptic conditions.  The anteroom shall contain a lavatory equipped

for hand washing, storage for clean and soiled materials, and gowning

facilities; and

(d)           A view window in the door for nursing

observation of the patient from the anteroom shall be provided.

(6)           Provision shall be made for delivery of medications

to patients.  All medications and related items shall be stored in compliance

with current Federal and State laws and rules and made accessible only to

authorized personnel.  A medication preparation area, alcove, room or other

designated area shall be under the direct supervision of the nursing staff when

not in use.  It shall contain at least a work counter, lavatory,

medication-only refrigerator and designated locked area for controlled

substances; if mobile systems are used, storage in corridors is prohibited

except when in use by the nursing staff.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6202       SPECIAL CARE UNIT

(a)  Each patient room shall meet the following

requirements:

(1)           Clearance between beds in multi-bed rooms

shall be not less than 7 feet with provision for visual privacy of patients. 

Each patient bed space shall have a minimum of 130 square feet with a minimum

dimension of 11 feet;

(2)           One single isolation bedroom meeting the

requirements of Rule .6201(5) of this Section shall be provided for each 12

special care beds or fraction thereof;

(3)           Glazing in all viewing panels in partitions

and doors shall be safety glass, wire glass, or fire rated glass;

(4)           A lavatory shall be provided in each

patient room.  In multi-bed rooms, lavatories shall be provided within 10 feet

of each bed;

(5)           A nurse call system is required except in

neonatal units;

(6)           Each single-bed cubicle or room shall have

a window to the outdoors.  In the case of ward-type patient bed areas of two or

more patients where cubicle privacy curtains are used, at least one window

shall be provided for every two beds.  Windows shall be positioned to provide a

maximum distance of 18 feet between the normal head position of each patient

and a window.  Window sills shall not exceed five feet above the floor; and

(7)           Toilet facilities provided for each special

care unit shall be accessible from within the unit. Portable toilets may be

used within the patient room.  Storage and service of portable toilets shall be

provided, if used.  Fixed toilets shall have sufficient clearance to facilitate

use by patients needing assistance.

(b)  The service elements and areas listed below shall be

provided within each special care unit:

(1)           A nurses' station located to permit visual

observation of each patient served;

(2)           Hand washing facilities convenient to

nurses' station;

(3)           Designated charting space in addition to

monitoring service space;

(4)           A staff toilet room containing a water

closet and a lavatory;

(5)           Facilities for the safekeeping of coats and

personal effects of staff;

(6)           A clean workroom or a system for storage and

distribution of clean supplies.  The clean area shall contain a work counter,

hand washing facilities and storage facilities;

(7)           A soiled workroom, or a soiled holding room

as part of a system for the collection and disposal of soiled materials.  The soiled

workroom shall contain a clinical sink or other flushing device, a sink

equipped for hand washing, and a work counter.  A soiled holding room shall be

similar to the soiled workroom except that the clinical sink and work counter

may be omitted;

(8)           A drug distribution station that meets the

current minimum requirements of governing state and federal agencies including

lavatory;

(9)           A clean linen storage closet or alcove. 

This may be a designated area within the clean workroom.  If a closed cart system

is used, storage may be in a controlled alcove clear of corridor width;

(10)         A separate nourishment area with a sink,

equipment for serving nourishment between meals, a refrigerator, and storage

facilities.  New or replacement ice dispensing equipment for patient service

shall be of a self-dispensing type that will not require use of utensils;

(11)         Storage area for emergency and other rolling

equipment outside of corridor width;

(12)         Secure facilities for storage of patients'

personal effects;

(13)         Bedpan washing devices; and

(14)         A separate waiting room with seating

accommodations for visitors, a toilet room, and a public telephone.  The

waiting room may serve more than one special care unit.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6203       NEONATAL LEVEL I AND LEVEL II NURSERY

UNIT

(a)  Neonatal infant units shall be on the same floor as

post-partum nursing units. No nursery shall open directly into another

nursery.  Each nursery shall contain the following:

(1)           Lavatory located within 20 feet travel

distance of each bassinet;

(2)           Emergency calling system;

(3)           Glazed observation windows for viewing

infants from public areas; and

(4)           Charting facilities.

(b)  A full term nursery shall contain not more than 24

bassinets.  The minimum floor area per bassinet shall be 30 square feet

exclusive of fixed work or storage counters, toilet rooms, or vestibules less

than six feet wide.  There shall be available three feet clear in all

directions for each bassinet.

(c)  Each nursery shall be served by a connecting workroom. 

It shall contain gowning facilities at the entrance for staff and housekeeping

personnel, lavatory, and storage area.  One workroom may serve more than one

nursery.

(d)  Space for examination and treatment shall contain a

counter, storage, and a lavatory.  It may serve more than one nursery room and

may be located in a workroom.

(e)  If commercially-prepared formula is not used, space and

equipment to accommodate the handling, storage, and preparation of formula shall

be provided.

(f)  A janitor's closet for the exclusive use of the

housekeeping staff in maintaining the nursery suite shall be provided.  It

shall contain a floor receptor or service sink and storage space for

housekeeping equipment and supplies.

(g)  Doors to nurseries shall be no less than three feet

wide.  If doors are provided directly from nurseries to public corridors or

public spaces, they shall be equipped with "one-way" hardware for

exit only to prevent unauthorized entry.

(h)  Smoke detection shall be provided in each nursery bed

space.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6204       NEONATAL LEVEL III AND LEVEL iv NURSERY

(a)  Units shall be accessible to post-partum nursing and

delivery units.

(b)  The nursery shall be located and arranged to preclude

unrelated traffic through the nursery.

(c)  Each nursery shall contain the following:

(1)           Lavatory located within 20 feet travel

distance of each bassinet;

(2)           Emergency calling system; and

(3)           Charting facilities.

(d)  There shall be six feet between bassinets for Neonatal

Level IV units and five feet between bassinets for Neonatal Level III units. 

Neonatal Level IV nurseries shall have 80 square feet per bassinet not

including corridors and cabinets.  Neonatal Level III nurseries shall have 50

square feet per bassinet not including cabinets and corridors.  Corridors or

aisles shall have at least eight feet of clear width for access to bassinets.

(e)  Each nursery shall be served by a connecting workroom. 

It shall contain gowning facilities at the entrance for staff and housekeeping

personnel, lavatory, and storage.  One workroom may serve more than one

nursery.  The workroom may be omitted if equivalent work area and facilities

are provided within the nursery.  Gowning and hand washing facilities shall be

provided at the entrance to each nursery.

(f)  Space for examination and treatment shall be provided

and shall contain a counter, storage, and lavatory. It may serve more than one

nursery room and may be located in a workroom.

(g)  If commercially prepared formula is not used, space and

equipment to accommodate the handling, storage, and preparation of formula

shall be provided.

(h)  A janitor's closet for the exclusive use of the

housekeeping staff in maintaining the nursery suite shall be provided.  It

shall contain a floor receptor or service sink and storage space for

housekeeping equipment and supplies.

(i)  Doors to nurseries shall be no less than three feet

wide.  If doors are provided directly from nurseries to public corridors or

public spaces, they shall be equipped with "one-way" hardware for

exit only to prevent unauthorized entry.

(j)  Smoke detection shall be provided in each nursery bed

space.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. November 1, 2004.

 

10A NCAC 13B .6205       PSYCHIATRIC UNIT

When a facility elects to establish an identifiable

psychiatric unit, the following requirements shall be met:

(1)           Patient rooms shall meet the requirements of Rule

.6201 of this Section with the following exceptions:

(a)           Patient room doors shall be designed with

hardware that will permit the doors to swing into the corridors by the use of a

special tool for emergency purposes;

(b)           Patient room doors shall be lockable from

the corridor side only;

(c)           Outside wall corners shall be omitted where

possible;

(d)           The ceiling shall be of monolithic

construction and the air distribution devices, lighting fixtures, sprinkler

heads, and other appurtenances shall be of the security type;

(e)           Oxygen and suction outlets are not required;

(f)            All windows shall have security screens or

be designed to prevent escape and shall be openable without keys or tools; and

(g)           Each patient room shall be provided with a

private toilet that meets the following requirements:

(i)            The door shall not be lockable;

(ii)           The door shall be capable of swinging

outward;

(iii)          Where provided, electrical outlets shall be

protected by ground fault interrupting devices;

(iv)          A nurse call system is not required where

the documented programmatic demands of the facility prohibit its use; and

(v)           The ceiling shall comply with the

requirements of Subitem (1)(d) of this Rule.

(2)           Where provided, a seclusion room shall meet the

following requirements:

(a)           The room shall meet the requirements of

Subitems (1)(a), (b), (c), (d) and (f) of this Rule;

(b)           The room shall have a view window of impact

resistant glass in the door that permits visual observation of the entire room;

(c)           The floor space of the room shall not be

less than 50 square feet in area with a ceiling height of not less than eight

feet; and

(d)           The walls shall be completely free of

objects.

(3)           The service areas noted in Rule .6201 of this

Section and the following shall be provided:

(a)           Consultation room;

(b)           Examination and treatment room for exclusive

use of the psychiatric unit located within the unit;

(c)           A conference room for exclusive use of the

psychiatric unit located within the unit;

(d)           Space for dining and recreation with a total

area of 35 square feet per patient;

(e)           Storage closets or cabinets for recreational

and occupational therapy equipment; and

(f)            Storage facilities for patients' personal

effects.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6206       SURGICAL DEPARTMENT REQUIREMENTS

(a)  Each operating room shall have an emergency

communication system connected to the operating suite control station.

(b)  A separate room for direct observation of

post-anesthesia surgical patients shall be provided.  This space shall include

medicine dispensing facilities, hand washing facilities, charting facilities,

clinical sink with flushing device, and storage space for supplies and

equipment.  A toilet room for nursing staff with water closet and lavatory

shall be provided adjacent to the recovery room.  Provisions shall also be made

for observation and isolation of infectious patients.

(c)  Service areas shall be provided in individual rooms

when so noted; otherwise, alcoves or other open space which will not interfere

with traffic may be used.  Services, except for the soiled workroom and the

janitor's closet, may be shared with and organized as a part of the obstetrical

facilities.  The following service areas shall be provided:

(1)           An operating suite control station.  The

station shall be located to permit visual surveillance of all traffic which

enters the operating suite or provisions shall be made to prevent unauthorized

entry into the suite;

(2)           Supervisor's office or station;

(3)           Sterilizing facilities with a high speed

autoclave located to serve the operating rooms;

(4)           Medicine dispensing facilities;

(5)           Scrub stations adjacent to each operating

room and arranged to minimize any incidental splatter on nearby personnel or

supply carts.  A minimum of two scrub sinks per operating room shall be

provided.  Facilities with no more than three operating rooms may reduce the

number of scrub sinks to four;

(6)           A soiled workroom containing a flushing

device, a work counter, and a sink equipped for hand washing;

(7)           A soiled linen holding room with a sink

equipped for hand washing.  This service may be combined with soiled workroom

and/or trash holding room;

(8)           A trash holding room with a sink equipped

for hand washing.  This service may be combined with the soiled workroom and/or

soiled linen holding room;

(9)           Clean workroom or clean supply room when

clean materials require assembly prior to use and this assembly is performed

within the surgical suite.  This room shall contain a work counter, a sink

equipped for hand washing and space for clean and sterile supplies.  A clean

supply room shall be provided when the program defines a system for the storage

and distribution of clean and sterile supplies which would not require the use

of a clean workroom;

(10)         Anesthesia storage.  If facility bylaws do

not prohibit flammable anesthetics, a separate room shall be provided for

storage of flammable gases;

(11)         Anesthesia workroom with a work counter and

sink for cleaning, testing, and storage of anesthesia equipment;

(12)         A room for storage of medical gas reserve

cylinders;

(13)         Equipment storage room for equipment and

supplies used in surgical suite;

(14)         Staff clothing change areas appropriate for

male and female personnel working within the surgical suite.  These areas shall

contain lockers, showers, toilets, lavatories, and space for donning scrub

suits and boots.  These areas shall be arranged to provide a one-way traffic

pattern so that personnel entering from outside the surgical suite can change,

shower, gown and move directly into the surgical suite;

(15)         Patients' holding area to accommodate

stretcher patients waiting for surgery.  This waiting area shall be under the

visual control of operating room staff and shall be in a room or in an alcove

out of the direct line of normal traffic;

(16)         Storage area for stretchers out of the

corridor width;

(17)         Staff lounges and toilet facilities for

staff located to facilitate use without leaving the surgical suite; and

(18)         Janitors' closet containing a floor receptor

or service sink and storage space for housekeeping supplies and equipment for

the exclusive use of the surgical suite.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6207       OUTPATIENT SURGICAL FACILITIES

(a)  When a facility elects to share outpatient surgical

facilities with inpatient surgical facilities, the outpatient operating room

and support areas shall meet the same physical plant requirements as inpatient,

general operating rooms and support areas.

(b)  When a facility elects to provide separate,

non-sharable outpatient surgical facilities, the operating rooms and support

areas shall meet the physical plant construction requirements of Outpatient Surgical

Licensure requirements of 10A NCAC 13C .1400.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6208       OBSTETRICAL DEPARTMENT REQUIREMENTS

(a)  The obstetrical unit shall be located so as to prevent

unrelated traffic through the unit and to provide for reasonable protection of

mothers from infection and from cross-infection.

(b)  An emergency communication system connected to the

operations and control station shall be provided by the facility.

(c)  Resuscitation facilities for neonates shall be provided

within the obstetrical unit and convenient to the delivery room.

(d)  A labor room shall be provided and shall meet the

following requirements:

(1)           A minimum of 80 sq. ft. of area shall be

provided per labor bed;

(2)           The labor rooms shall be located so as to

permit visual observation of each room from the nurses' work station;

(3)           Labor rooms shall afford privacy, and shall

be conveniently located with reference to the delivery room;

(4)           If labor rooms also serve as birthing

rooms, they shall be equipped to handle obstetric and neonatal emergencies;

(5)           A labor room shall contain facilities for

medication, hand washing, charting, and storage for supplies and equipment;

(6)           At least one shower with direct access from

within the delivery unit shall be provided;

(7)           At least two labor beds with adjacent

toilet shall be provided for each delivery room; and

(8)           No more than two labor beds may be located

in one labor room.

(e)  A toilet with hand-washing facilities shall be provided

for the staff.

(f)  A separate recovery room may be omitted in facilities

with less than 1500 births per year.  When provided, the recovery room shall

meet the following requirements:

(1)           A recovery room shall contain not less than

two beds and shall have charting facilities located so as to permit visual

observation of all beds;

(2)           Provisions for medicine dispensing, hand

washing, clinical sink with bedpan washer, and storage for supplies and

equipment shall be provided; and

(3)           A toilet with hand washing facilities shall

be provided for staff.

(g)  When a facility elects to provide labor, delivery and

recovery room (LDR) service as a part of its total services, the following

requirements shall be met:

(1)           Each LDR room shall have a minimum of 250

square feet of floor space exclusive of toilet room, closet, or vestibule;

(2)           A toilet directly accessible from each LDR

room shall be provided for use by that room only and equipped with a clinical

sink or other suitable flushing device for emptying bed pans;

(3)           Each LDR room shall be provided with

directly accessible shower for use by that room only;

(4)           Each LDR room shall be equipped with

oxygen, suction, medical air, and electrical outlets; and

(5)           Each LDR room shall contain facilities for

medication storage, hands-free hand washing, charting, and storage for supplies

and equipment.

(h)  When a facility elects to provide labor, delivery,

recovery and postpartum (LDRP) service as a part of its total services the

following requirements shall be met:

(1)           Each LDRP room shall meet the requirements

listed in Paragraph (g) of this Rule; and

(2)           Each LDRP room shall be counted as a single

patient room for purposes of determining the facility's bed capacity.

(i)  The following shall be provided:

(1)           If analgesia is used, beds shall be

equipped with side rails; and

(2)           There shall be facilities for examination

and preparation of patients.

(j)  The obstetrical (OB) unit shall be provided with the

following services either in individual rooms, alcoves, or other open spaces

not subject to traffic:

(1)           Scrub facilities with stations located

adjacent to each pair of delivery rooms and arranged to minimize incidental

splatter on nearby personnel or supply carts;

(2)           A storage room for equipment and supplies;

(3)           One delivery room with support services

meeting the requirements of a surgical operating room and support services

referenced in Rule .6206 of this Section if caesarean sections are to be

performed in the obstetrical delivery unit; and

(4)           One janitor's closet exclusively for use by

the obstetrics unit.

(k)  The obstetrical unit shall be provided with the

following services either in individual rooms, alcoves, or other open spaces

not subject to traffic, however, they may be located either in the obstetrics

unit or may be shared with the surgical unit if arranged so as to avoid cross

traffic between the surgical and obstetrics units:

(1)           Delivery unit control station located so as

to permit visual surveillance of all traffic which enters the obstetrical unit;

(2)           Supervisor's office or station;

(3)           Medicine dispensing facilities;

(4)           Scrub facilities with stations located

adjacent to each pair of delivery rooms and arranged so as to minimize

incidental splatter on nearby personnel or supply carts;

(5)           Soiled workroom or a soiled holding room as

a part of a system for the collection and disposal of soiled materials:

(A)          A soiled workroom may not be shared with the

surgical unit and shall contain a flushing device, a work counter and sink

equipped for hand washing, a waste receptacle, and a linen receptacle; and

(B)          A soiled holding room may be shared with the

surgical unit and shall be similar to the soiled workroom except that the

flushing device and work counter may be omitted.

(6)           Fluid waste disposal facilities convenient

to the delivery rooms; the flushing device in a soiled workroom meets this

requirement;

(7)           Staff clothing change areas appropriate for

male and female personnel working within the obstetrics unit including lockers,

shower, toilet, and lavatory, and space for donning scrub suit and boots;

(8)           Lounge and toilet facilities for

obstetrical staff;

(9)           Stretcher storage provisions out of direct

line of traffic;

(10)         Clean workroom, or clean supply room:

(A)          A clean workroom or supply room is required when

clean materials require assembly prior to use and this assembly is performed

within the obstetrics unit; and

(B)          Clean workroom shall contain a work counter, a sink

equipped for hand washing, and space for clean and sterile supplies;

(11)         Anesthesia workroom for the cleaning,

testing, and storage of anesthesia equipment with a work counter and sink;

(12)         Space for storage of nitrous oxide and

oxygen cylinders;

(13)         A storage room for equipment and supplies

used in a surgical unit;

(14)         Delivery room(s) used for no other purpose

than for the completion of labor and delivery and including a minimum clear

area of 300 square feet, exclusive of fixed and movable cabinets and shelves. 

The minimum room dimension shall be 16 feet; and

(15)         One delivery room meeting the following

requirements if caesarean sections are to be performed in the obstetrics unit:

(A)          The delivery room shall meet the requirements for

surgical operating rooms; and

(B)          Support services required for surgical operating

rooms shall be provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996;

Amended Eff. July

1, 1996.

 

10A NCAC 13B .6209       EMERGENCY SERVICES

(a)  The minimum requirements for emergency care required

under Section .4100 of this Subchapter shall determine the type facilities to

be provided.

(b)  When a facility provides emergency services under one

of the classifications listed in Section .4100 of this Subchapter, the

following shall be provided:

(1)           Level I, II, III:

(A)          a drive at grade level with provision for ambulance

and pedestrian service and a well marked covered entrance with a minimum clear

passage height of 12 feet 8 inches and a clear width of 16 feet;

(B)          public waiting space with toilet facilities,

telephone, drinking fountain, stretcher, and wheelchair storage;

(C)          nurses' work and charting space shall be provided. 

This may be combined with reception and control area for Level III;

(D)          storage for clean supplies and equipment. 

Facilities shall be available for the administration of blood, blood plasma,

and intravenous medication as well as for the control of bleeding, emergency

splinting of fractures, and the administration of oxygen, anesthesia, and

suction;

(E)           soiled holding area with flushing device;

(F)           janitor's closet with service sink;

(G)          patient toilets; and

(H)          staff toilets.

(2)           Level I, II:

(A)          a reception and control area that is staffed around

the clock;

(B)          visual control of the entrance, waiting room, and

treatment area shall be maintained;

(C)          communication with other facility departments;

(D)          at least one treatment room shall be available

around the clock for the examination and initial treatment of emergency

patients.  This room shall be independent of the operating room;

(E)           treatment rooms or areas shall contain cabinets,

medication storage, work counters, X-ray film illuminators, and space for

storage of emergency equipment;

(F)           the size of the rooms or areas shall allow for a

minimum of 3 feet clear on three sides of each stretcher; and

(G)          hand washing facilities shall be provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6210       IMAGING SERVICES

Imaging services include fluoroscopy, radiography,

mammography, computerized tomography scanning, position emission tomography,

ultrasound, magnetic resonance imaging, angiography, cardiac catheterization

and other similar techniques.

(1)           Radiology services are required for all facilities

and shall contain the following:

(a)           Radiographic and fluoroscopic rooms;

(b)           Film processing equipment;

(c)           Administration and viewing areas;

(d)           Provisions for film storage;

(e)           Toilet room with hand washing facilities

directly accessible to each fluoroscopy and radiography room where

gastrointestinal or genitourinary system procedures are performed;

(f)            Dressing area with immediate access to

toilets;

(g)           Waiting room or alcove for patients;

(h)           Holding area for stretcher patients out of

corridor width; and

(i)            A shielded control alcove with a view

window for full view of patient.

(2)           Angiography or cardiac catheterization services are

not required for licensure; however, when either service is offered, the

following shall be provided:

(a)           Procedure room sized to accommodate and

service the equipment purchased but having a minimum area of 400 square feet;

(b)           A control room with a view window that

permits a full view of the patient;

(c)           A designated radiographic view area having a

minimum length of 10 feet (3.05 meters);

(d)           Scrub sink outside staff entrance to the

procedure room;

(e)           Patient holding area large enough to

accommodate two stretchers out of the corridor width;

(f)            Storage area for portable equipment and

supplies out of the corridor width; and

(g)           Post procedure observation area for

patients.

(3)           Computerized Tomography (CT) Scanning or positron

emission tomography service is not required for licensure; however, when either

service is offered, the following shall be provided:

(a)           Procedure room sized to accommodate and

service the equipment purchased;

(b)           Control room with a view window to permit

full view of the patient;

(c)           Film processing area adjacent to the control

room;

(d)           Patient toilet with hand washing facilities,

located within 50 feet of the procedure room door; accessible to the procedure

room located to permit the patient to exit the toilet without reentering the

procedure room;

(e)           At least one emergency light located in the

procedure room; and

(f)            Hand washing sink within the procedure

room.

(4)           Magnetic Resonance Imaging (MRI) service is not

required for licensure; however, when this service is offered, the following

shall be provided:

(a)           Procedure and support rooms sized to

accommodate and service the equipment purchased;

(b)           A control room with full view of the patient

and MRI unit and having a minimum area of 100 square feet;

(c)           A patient holding area located near the MRI

unit and large enough to accommodate stretchers out of the corridor width;

(d)           Patient toilet with hand washing facilities,

located within 50 feet of the procedure room door;

(e)           At least one emergency light located in the

procedure room; and

(f)            Hand washing sink adjacent to the entrance

to the procedure room.

(5)           Design and performance specifications related to

the radiation shielding of imaging rooms shall be furnished by a qualified

physicist approved by the Radiation Protection Division of the N.C. Department

of Environment and Natural Resources.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6211       LABORATORY SERVICES

Laboratory services may be provided within the facility or

through contract with a laboratory service.  If laboratory services are offered

within the facility, then the following shall be provided:

(1)           Laboratory work counter with sink, vacuum, gas and

electrical outlets;

(2)           Lavatory or counter sinks equipped for hand

washing;

(3)           Blood storage equipment with temperature monitoring

and alarm signals; and

(4)           Specimen collection:

(a)           Urine collection rooms shall be equipped

with a water closet and lavatory; and

(b)           Blood collection area shall have space for a

chair, work counter, and hand washing sink.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6212       MORGUE

(a)  Where facilities have an agreement to transfer bodies

within six hours of death, a single room large enough to contain a stretcher is

acceptable.

(b)  When autopsies are conducted at the facility, the

morgue shall be directly accessible to the service entrance or an outside

entrance, and shall be located to avoid movement of bodies through lobbies and

other public areas.  The following elements shall be provided:

(1)           Refrigeration equipment for body-holding;

and

(2)           Autopsy room containing:

(A)          Work counter with sink equipped for hand washing;

(B)          Storage space for supplies, equipment, and

specimens;

(C)          Autopsy table;

(D)          A deep sink for washing of specimens;

(E)           Clothing change area with shower, toilet, and

lockers; and

(F)           Janitor's closet with service sink or receptor.

(c)  Where no transfer agreement exists with another

facility, or bodies cannot be transferred within six hours or autopsies are not

conducted at the facility, a well ventilated, temperature controlled

body-holding room shall be provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6213       PHARMACY SERVICES

The size of the pharmacy and the type of services to be

provided in the pharmacy will depend upon the facility mission statement, the

type of drug distribution system to be used in the facility, and the extent of shared

or purchased services.  When pharmacy services are planned, provisions shall be

made for the following:

(1)           Administrative functions including pick-up and

receiving, requisition processing, drug information and storage for general

supplies, volatile fluids and alcohol;

(2)           Quality control area with sufficient counter space

when bulk compounding and packaging functions are performed;

(3)           Secure storage for controlled substances;

(4)           An area for temporary storage, exchange and

restocking of carts; and

(5)           Hand washing facilities within each separate room

where open medication is handled.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6214       DIETARY SERVICES

(a)  Construction, equipment, and installation shall comply

with the standards of the N.C. Department of Environment and Natural Resources.

(b)  The following shall be provided to implement the type

of food service system outlined in the hospital's mission statement:

(1)           Control station for receiving food

supplies;

(2)           Space for four days' food supply including

refrigeration space is required for a conventional food preparation system;

(3)           Food preparation space for conventional

food preparation equipment needed in preparing, cooking, and baking foods;

convenience food service systems (frozen prepared meals, bulk packaged entrees,

individual packaged portions, etc.) or systems utilizing contractual commissary

services require space and equipment for thawing, portioning, cooking and

baking.  In addition, a lavatory shall be provided in the food preparation

area;

(4)           Tray assembly and distribution space;

(5)           Dining space for ambulatory patients,

staff, and visitors;

(6)           Dietary office;

(7)           Locker room and toilet facilities for

dietary staff;

(8)           Storage space for housekeeping equipment

and supplies located within the dietary department, including a floor receptor

or service sink; and

(9)           Ice making equipment convenient to salad

preparation area and cafeteria.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6215       ADMINISTRATION

(a)  The facility entrance shall be at grade level,

sheltered from the effects of inclement weather, and able to accommodate

wheelchairs and stretchers.

(b)  The entrance lobby shall contain:

(1)           Reception and information counter or desk;

(2)           Waiting space;

(3)           Storage area(s) for wheelchairs and

stretchers;

(4)           Public toilets;

(5)           Public telephone; and

(6)           Drinking fountain.

(c)  Private interview space shall be provided.

(d)  Office spaces for administrative staff shall be

provided.

(e)  Medical library shall be provided.

(f)  Staff toilets shall be provided.

(g)  Storage for office equipment and supplies shall be

provided.

(h)  A janitor's closet containing a floor receptor or

service sink and storage space for housekeeping equipment and supplies shall be

provided.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6216       MEDICAL RECORDS SERVICES

Medical records services shall include the following:

(1)           Medical record director's office or space;

(2)           A separate review and dictating room;

(3)           Work area for sorting, recording, or microfilming

records;

(4)           Storage area for records; and

(5)           A smoke detection system, approved by the authority

having jurisdiction, interconnected with the facility fire alarm system if

medical records are stored in a separate building.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6217       CENTRAL MEDICAL AND SURGICAL SUPPLY

SERVICES

(a)  A separate receiving room shall be provided and shall

contain work space and equipment for initial sterilization and disinfection of

medical and surgical equipment and for disposal or processing of unclean

articles.  Hand washing facilities shall be provided.

(b)  A separate clean workroom shall be provided and shall

contain work space and equipment for sterilizing medical and surgical equipment

and supplies. Storage areas for clean supplies and for sterile supplies shall

be included in this room.

(c)  A separate storage room for assembly, final packaging,

and storage of sterile supplies and equipment shall be provided.

(d)  A storage room for unsterile supplies and equipment

shall be provided but may be located in another area of the facility.

(e)  Provisions shall be made for cleaning and sanitizing

carts serving the central supply services, dietary services, and linen services

departments and may be centralized or departmentalized.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6218       GENERAL STORAGE

General storage room(s) shall have a total area of not less

than 20 square feet (1.86 square meters) per inpatient bed and shall be

concentrated in one area but may be divided in a multiple building complex and

shall include:

(1)           Receiving area; and

(2)           Off street loading area.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6219       LAUNDRY SERVICES

(a)  When the facility elects to provide its own laundry,

the laundry shall contain the following:

(1)           A soiled linen holding room;

(2)           A designated clean linen storage area

unless a closed linen cart system is utilized;

(3)           A linen cart cleanup and storage area;

(4)           Toilet facilities accessible to employees

from soiled linen, clean linen, and laundry processing;

(5)           Laundry processing area with hand washing

facilities and commercial type equipment which can process seven days' needs

within a scheduled work week;

(6)           A janitor's closet containing a floor

receptor or service sink and storage space for housekeeping equipment and

supplies; and

(7)           Supply storage.

(b)  When the facility elects to contract for laundry service

off premises it shall provide the following:

(1)           Soiled linen holding room;

(2)           Clean linen holding room;

(3)           Linen cart cleanup and storage room; and

(4)           Hand washing facilities.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6220       PHYSICAL REHABILITATION SERVICES

When physical rehabilitation services are offered in the

facility, the following shall be provided:

(1)           Patient waiting space, with provisions for

wheelchair patients and stretcher patients;

(2)           Office space;

(3)           Patients' toilet;

(4)           Hand washing facilities;

(5)           Treatment areas or room that provides visual

privacy (visual privacy not required for Occupational Therapy and Speech

Therapy);

(6)           Soiled linen storage (not required for Occupational

Therapy and Speech Therapy);

(7)           Clean linen storage (not required for Occupational

Therapy and Speech Therapy);

(8)           Equipment storage; and

(9)           Wheelchair and stretcher storage.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6221       ENGINEERING SERVICES

The following provisions for engineering services shall be

included:

(1)           A room or separate building for boilers, mechanical

equipment, and electrical equipment;

(2)           Office;

(3)           Maintenance shop;

(4)           Maintenance supplies storage room; and

(5)           Locker and toilet rooms for engineering service

employees.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6222       WASTE PROCESSING

Each facility shall provide for the processing and disposing

of all waste products in accordance with local city or  county requirements and

the requirements of the N.C. Department of Environment Health and Natural Resources

and shall produce evidence of approval from each regulatory agency having

jurisdiction prior to the start of facility operation.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6223       DETAILS AND FINISHES

(a)  All details and finishes for modernization projects as

well as for new construction shall meet the following requirements:

(1)           All rooms containing baths, showers, and

toilets, subject to patient occupancy, shall be equipped to open from the

outside without the use of a key in any emergency.  When such rooms have only

one opening, the door shall open outward from the room or shall be designed so

that the door can be opened without need to push against the occupant in the

room;

(2)           Doors in all openings between corridors and

rooms or spaces subject to occupancy shall be of the side hinged type or an

approved sliding type door;

(3)           No doors shall swing into corridors in a

manner that might obstruct traffic flow or reduce the required corridor width

except for doors to spaces such as closets less than 25 square feet in floor

area, which are not subject to occupancy;

(4)           Grab bars shall be provided at all patient

toilets, showers, and tubs.  Grab bars shall have not less than 1-1/2 inch

clearance to the wall or support and shall be capable of supporting not less

than a 250 pound concentrated load;

(5)           Single use soap dispensers, towel

dispensers or air driers shall be provided at all hand washing fixtures except

scrub sinks;

(6)           All rooms shall have not less than 8 foot

high ceilings except that ceilings of corridors, storage rooms, toilet rooms,

and other minor rooms shall be no less than 7 feet 6 inches high.  Suspended

tracks, rails, pipes, etc., located in the path of normal traffic, shall be no

less than 7 feet 6 inches above the floor;

(7)           Rooms containing equipment shall be

insulated or ventilated to prevent any patient use floor surface above from

exceeding a temperature 10 degrees F. above the ambient room temperature; and

(8)           Fire extinguishers shall be provided

throughout the building to comply with National Fire Protection Association

Standard 10 as found in Rule .6102(2) of this Section.

(b)  Finishes shall meet the following requirements:

(1)           Floors in areas used for food preparation

or food assembly shall be water, oil and slip resistant.  Joints in tile and

similar material in such areas shall be resistant to food acids.  In all areas

subject to frequent wet cleaning, floors shall not be physically affected by

germicidal and cleaning solutions.  Floors that are subject to traffic while

wet, as in kitchens, showers, and bath areas and similar work areas, shall have

a non-slip surface;

(2)           Floors and wall bases in operating and

delivery rooms shall be joint free.  Wall bases shall be tightly sealed within

the wall and constructed without voids that can harbor vermin;

(3)           Floors and wall bases in kitchens, soiled

workrooms, and other areas subject to frequent wet cleaning, shall be made

integral with the floor, tightly sealed to the wall, and constructed without

voids that can harbor vermin;

(4)           In patient care areas, walls shall be

washable; in the immediate area of plumbing fixtures, the finish shall be

smooth, moisture resistant, and easily cleanable;

(5)           Floor and wall penetrations and joints of

structural elements shall be tightly sealed to minimize entry of rodents and

insects;

(6)           Ceilings throughout shall be easily

cleanable.  Ceilings in operating and delivery rooms, nurseries, isolation

rooms, sterile processing rooms, and other sensitive areas shall be readily

washable and without crevices that can retain dirt particles.  Dietary and food

preparation areas shall have a finished ceiling covering all overhead

structural elements and building systems.  Finished ceilings may be omitted in

mechanical and equipment spaces, shops, general storage areas, and similar

spaces except where required for fire rating;

(7)           Rooms used for protective isolation shall

not have carpet.  Ceilings shall be of monolithic construction; and

(8)           Rooms where impact noises are generated

shall not be located directly over or under patient bed areas, and delivery or

operating suites unless special provisions are made to minimize noise.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6224       ELEVATOR REQUIREMENTS

Elevators shall meet the following:

(1)           Facilities with patient areas located on other than

the grade-level entrance floor shall have at least one hospital-type elevator;

(2)           In the absence of an engineered traffic study, the

following guidelines for number of elevators shall apply:

(a)           At least one hospital-type elevator shall be

installed when 60 patient beds or less are located on any floor other than the

main entrance floor;

(b)           At least two hospital-type elevators shall

be installed when 61 to 200 patient beds are located on floors other than the

main entrance floor, or where inpatient services are located on a floor other

than those containing patient beds.  Elevator service may be reduced for those

floors providing only partial inpatient services;

(c)           At least three hospital-type elevators shall

be installed where 201 to 350 patient beds are located on floors other than the

main entrance floor, or where inpatient services are located on a floor other

than those containing patient beds.  Elevator service may be reduced for those

floors providing only partial inpatient services; and

(d)           For facilities with more than 350 beds, the

number of elevators shall be determined from an engineering study of the

facility plan and the expected vertical transportation requirements.

(3)           Hospital-type elevator cars shall have inside

dimensions that will accommodate a patient's bed with attendants. Cars shall be

at least five feet (1.52 meters) wide by seven feet six inches (2.29 meters)

deep.  Car doors shall have a clear opening of not less than four feet (1.22

meters) wide and seven feet (2.13 meters) high; and

(4)           Elevators, except freight elevators, shall be

equipped with a two-way service switch for staff use for bypassing all landing

button calls and traveling directly to any floor.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6225       MECHANICAL REQUIREMENTS

(a)  Prior to occupancy of the facility, the facility shall

obtain documentation verifying that all mechanical systems have been tested,

balanced, and operated to demonstrate that the installation and performance of

these systems conform to the approved design.  Test results shall be maintained

in the facility maintenance files.

(b)  Upon completion of equipment installation, the facility

shall acquire and maintain a complete set of manufacturers' operating, maintenance,

and preventive maintenance instructions, parts lists, and procurement

information including equipment numbers and descriptions.

(c)  Operating staff shall be provided with instructions for

properly operating systems and equipment.

(d)  The facility structure, component parts, and building

systems shall be kept in good repair and maintained with consideration for the

safety and comfort of patients, staff and visitors.

(e)  There shall be a definite assignment of maintenance

functions to qualified personnel under supervision.

(f)  General design requirements shall meet the following:

(1)           Heating plants shall be adequate to

maintain a cold weather temperature of 70 degrees F. (21.1 degrees C.) in all

rooms used by patients;

(2)           Boilers shall have capacity to supply all

the heating functions of the facility.  The number and arrangement of boilers

shall accommodate the facility's needs despite the breakdown or routine

maintenance of any one boiler;

(3)           Insulating materials shall be provided

within the facility to conserve energy, protect personnel, prevent vapor

condensation, and reduce unnecessary noise and vibration;

(4)           Facility design considerations shall

include recognized energy saving measures.  When using variable air volume

systems within the facility special care shall be taken to assure that minimum

ventilation rates and pressure relationships between various departments are

maintained;

(5)           The general air pressure relationships,

ventilation rates, and relative humidity requirements of Table 1 shall be

maintained;

 

Table 1

Ventilation Requirements for Areas Affecting Patient Care in

Hospitals and Skilled Nursing Units and Outpatient Facilities in Hospitals1



Area Designation

 

 

 

 





Air

movement relationship to

adjacent area2





Minimum air changes of outdoor

air per hour3





Minimum total air changes

per hour4





All air exhausted directly

to outdoors5





Recirculated by means of

room units6





Relative humidity (%)7





Design temperature (o

F/o C)8







 

Surgery and Critical Care





 

 





 

 





 

 





 

 





 

 





 

 





 

 







Operating room9





Out





3





15





--





No





50





70-75/21-24







Delivery room9





Out





4





15





--





No





45





70-75/21-24







Recovery room9





--





2





6





--





No





30





70/21







Special care





--





2





6





--





No





30





70-75/21-24







Treatment room10





--





--





6





--





--





 





75/24







Trauma room10





Out





3





15





--





No





45





70-75/21-24







Anesthesia gas storage





--





--





8





Yes





--





 





--







 

NURSING

Patient room

Toilet room

Newborn nursery suite

Protective isolation when

provided11

Infectious isolation when

provided12

Isolation alcove or anteroom11

12

Labor/delivery/recovery

Labor/delivery/recovery/postpartum

Patient corridor





 

 

--

In

--

Out

In

In/Out

--

--

--





 

 

1

--

2

1

1

--

--

--

--





 

 

2

10

6

6

6

10

2

2

2





 

 

--

Yes

--

--

Yes

Yes

--

--

--





 

 

--

Yes

No

No

No

No

--

--

--





 

 

--

--

30-60

--

--

--

--

--

--





 

 

70-75/21-24

--

75/24

70-75/21-24

70-75/21-24

--

70-75/21-24

70-75/21-24

--







 

ANCILLARY

Radiology13

  X-ray (surg/critical care)

  X-ray (diagnostic &

treat.)

  Darkroom

Laboratory

  General14

  Biochemistry14

  Cytology

  Glass Washing

  Histology

  Microbiology14

  Nuclear medicine13

  Pathology

  Serology

  Sterilizing

Autopsy room

Non refrigerated

body-holding room15

Pharmacy





 

 

 

Out

--

In

 

--

Out

In

In

In

In

In

In

Out

In

In

In

--





 

 

 

3

--

--

 

--

--

--

--

--

--

--

 

--

--

--

--

--





 

 

 

15

6

10

 

6

6

6

10

6

6

6

6

6

10

12

10

4

 





 

 

 

--

--

Yes

 

--

--

Yes

Yes

Yes

Yes

Yes

Yes

--

Yes

Yes

Yes

--





 

 

 

No

--

No

 

--

No

No

--

No

No

No

No

No

--

No

Yes

--





 

 

 

45-60

--

--

 

--

--

--

--

--

--

--

--

--

--

--

--

--





 

 

 

70-75/21-24

75/24

--

 

--

--

--

--

--

--

--

--

--

--

--

70/21

--







 

DIAGNOSTIC AND TREATMENT

Examination Room

Medication room

Treatment room

Physical therapy and

hydrotherapy

Soiled workroom or soiled

holding

Clean workroom or clean

holding





 

 

--

--

--

In

In

--





 

 

--

--

--

--

--

--





 

 

6

4

6

6

10

4





 

 

--

--

--

--

Yes

--





 

 

--

--

--

--

No

--





 

 

--

--

--

--

--

--





 

 

75/24

--

75/24

75/24

--

--







 

STERILIZING AND SUPPLY

ETO-sterilizer room16

Sterilizer equipment room16

Central medical and surgical

supply

Soiled or decontamination

room

Clean workroom and sterile

storage





 

 

In

In

Out

In

Out





 

 

--

--

--

--

--





 

 

10

10

6

4

6





 

 

Yes

Yes

--

Yes

--





 

 

No

--

No

--

No





 

 

--

--

--

--

(Max) 70





 

 

75/24

--

--

--

75/24







 





 





 





 





 





 





 





 







 

SERVICE

Food preparation center17

Warewashing

Dietary day storage

Laundry, general

Soiled linen (sorting and

storage)

Clean linen storage

Soiled linen and trash chute

room

Bedpan room

Bathroom

Janitor's closet





 

 

--

In

In

--

In

--

In

In

--

In





 

 

--

--

--

--

--

--

--

--

--

--





 

 

10

10

2

10

10

2

10

10

10

10





 

 

--

Yes

--

Yes

Yes

--

Yes

Yes

--

Yes





 

 

No

No

--

--

No

--

No

Yes

--

No





 

 

--

--

--

--

--

--

--

--

--

--





 

 

--

--

--

--

--

--

--

--

75/24

--





 

Table Notes:

 

1                      The ventilation rates in this

table cover ventilation for comfort, as well as for asepsis and odor control in

areas of acute care hospitals that directly affect patient care and are

determined based on health care facilities being predominantly "No Smoking"

facilities.  Where smoking may be allowed, ventilation rates will need

adjustments.  Specialized patient care areas, including organ transplant units,

burn units, specialty procedure rooms, etc., shall have additional ventilation

provisions for air quality control as may be appropriate. 

2                      Design of the ventilation system

shall provide that air movement is from "clean to less clean" areas. 

However, continuous compliance may be impractical with full utilization of some

forms of variable air volume and load shedding systems that may be used for

energy conversation.  Areas that do require positive and continuous control are

noted with "Out" or "In" to indicate the required direction

of air movement in relation to the space named.  Rate of air movement may be

varied as needed within the limits required for positive control.  Air movement

for rooms with dashes and non-patient areas may vary as necessary to satisfy

the requirements of those spaces.  Additional adjustments may be needed when

space is unused or unoccupied and air systems are de-energized or reduced.

3                      To satisfy exhaust needs,

replacement air from outside is necessary.  Table 1 does not attempt to

describe specific amounts of outside air to be supplied to individual spaces

except for certain areas such as those listed.  Distribution of the outside

air, added to the system to balance required exhaust, shall be as required by

good engineering practice.

4                      Number of air changes may be

reduced when the room is unoccupied if provisions are made to ensure that the

number of air changes indicated is reestablished any time the space is being

utilized.  Adjustments shall include provisions so that the direction of air

movement shall remain the same when the number of air changes is reduced. 

Areas not indicated as having continuous directional control may have

ventilation systems shut down when space is unoccupied and ventilation is not

otherwise needed.

5                      Air from areas with contamination

and/or odor problems shall be exhausted to the outside and not recirculated to

other areas.  Note that individual circumstances may require special

consideration for air exhaust to outside, e.g., in intensive care unit in which

patients with pulmonary infection are treated, and rooms for burn patients.

6                      Because of cleaning difficulty

and potential for buildup of contamination, recirculating room units shall not

be used in areas marked "No."  Isolation and intensive care unit

rooms may be ventilated by reheat induction units in which only the primary air

supplied from a central system passes through the reheat unit.  Gravity-type

heating or cooling units such as radiators or connectors shall not be used in operating

rooms and other special care areas.

7                      The ranges listed are minimum and

maximum limits where control is specifically needed.

8                      Dual temperature indications

(such as 70-75/21-24) are for an upper and lower variable range at which the

room temperature shall be controlled.  A single figure indicates a heating or

cooling capacity of at least the indicated temperature.  This is usually

applicable when patients may be undressed and require a warmer environment. 

Nothing in these rules shall be construed as precluding the use of temperatures

lower than those noted when the patients' comfort and medical conditions make

lower temperatures desirable.  Unoccupied areas such as storage rooms shall

have temperatures appropriate for the function intended.

9                      For Information Only - National

Institute of Occupational Safety and Health (NIOSH) Criteria Documents

regarding Occupational Exposure to Waste Anesthetic Gases and Vapors, and

Control of Occupational Exposure to Nitrous Oxide indicate a need for both

local exhaust (scavenging) systems and general ventilation of the areas in

which the respective gases are utilized.

10                   The term trauma room as used here is

the operating room space in the emergency department or other trauma reception

area that is used for emergency surgery.  The first aid room and/or

"emergency room" used for initial treatment of accident victims may

be ventilated as noted for the "treatment room."

11                   The protective isolation rooms

described in these rules are those that might be utilized for patients with a

high susceptibility to infection from leukemia, burns, bone marrow transplant,

or acquired immunodeficiency syndrome and that require special consideration

for which air movement relationship to adjacent areas would be positive rather

than negative.  For protective isolation the patient room shall be positive to

both anteroom and toilet.  Anteroom shall be neutral to corridor.   Where

requirements for both infectious and protective isolation are reflected in the

anticipated patient load, ventilation shall be modified as necessary.  Variable

supply air and exhaust systems that allow maximum isolation room space

flexibility with reversible air movement direction would be acceptable only if

appropriate adjustments can be ensured for different types of isolation

occupancies.  Control of the adjustments shall be under the supervision of the

medical staff.

12                   The infectious isolation rooms

described in these rules are those that might be utilized in the average

community hospital.  The assumption is made that most isolation procedures will

be for infectious patients and that the room is suitable for normal private patient

use when not needed for isolation.  This compromise obviously does not provide

for ideal isolation.  The design shall consider types and numbers of patients

who might need this separation within the facility.  Isolation room shall be

negative to anteroom and positive to toilet.  Anteroom shall be neutral to

corridor.

13                   Large hospitals may have separate

departments for diagnostic and therapeutic radiology and nuclear medicine.  For

specific information on radiation precautions and handling of nuclear

materials, refer to appropriate sections of requirements developed by the

Division of Radiation Protection, NCDEHNR.

14                   When required, appropriate hoods and

exhaust devices for the removal of noxious gases shall be provided.

15                   A non-refrigerated body-holding room

would be applicable only for health care facilities in which autopsies are not

performed on-site, or the space is used only for holding bodies for short

periods prior to transferring.

16                   For Information Only - Specific OSHA

regulations regarding ethylene oxide (ETO) use have been promulgated. 29CRF

Part 1910.1047 includes specific ventilation requirements including local

exhaust of the ETO sterilizer area.

17                   Food preparation centers shall have

an excess air supply for "out" air movements when hoods are not in

operation.  The number of air changes may be reduced or varied to any extent

required for odor control when the space is not in use.

 

(6)           Air duct liners exposed to the air stream

shall not be used in ducts serving special care areas or special procedure

rooms when such liners are constructed with frangible materials that will enter

the air stream;

(7)           All central ventilation or air conditioning

systems shall be equipped with filters with efficiencies equal to, or greater

than, those specified in Table 2.  Where two filter beds are required, filter

bed No. 1 shall be located upstream of the air conditioning equipment and filter

bed No. 2 shall be downstream of any fan or blowers.  A manometer shall be

installed across each filter bed having a required efficiency of 75 percent or

more;

 

Table 2

Filter Efficiencies

for Central Ventilation and Air Conditioning Systems in General Hospitals



                Area Designation





No. filter beds





Filter bed No. 1





Filter bed No. 2







All areas for inpatient care, treatment, and diagnosis,

and those areas providing direct service or clean supplies such as sterile

and clean processing, etc.





                2





                25%o





                90%o







Protective isolation room when used





                2





                25%o





                99.7%5







Laboratories





                1





                80%o





                --







Administrative, bulk storage, soiled holding areas, food

preparation areas, and laundries





                1





                25%o





                --





Table notes:          Note 1 - Ratings based on ASHRAE 52-76

Note 2 - Rating based on DOP (Dioctyl-phthalate) test method

 

(8)           Any system utilized for occupied areas

shall include provisions to avoid air stagnation in interior spaces where

comfort demands are met by temperatures of surrounding areas;

(9)           All rooms and areas in the facility used

for patient care shall have provisions for year round mechanical ventilation;

(10)         Each patient's room shall have at least one

openable window, opening to the outside to permit ventilation; and

(11)         In psychiatric units, all convectors, HVAC enclosures,

or air distribution devices that are exposed in the room shall be constructed

with rounded corners and shall be fastened with tamper-proof screws.

(g)  Mechanical air intakes shall meet the following:

(1)           Air intakes shall be located not less than

30 feet (9.14 m.) from exhaust outlets of combustion equipment stacks,

ventilation exhaust outlets from the facility or adjoining buildings,

medical-surgical vacuum system exhausts or areas that may be subject to

vehicular exhaust or other noxious fumes; and

(2)           The bottom of the outdoor air intakes shall

be at least 6 feet (1.83 m.) above ground level, or if installed above the

roof, at least 3 feet (.91 m.) above roof level.

(h)  Mechanical air exhaust/ventilation systems shall meet

the following:

(1)           Fans serving exhaust duct systems shall be

located at the discharge end of the duct and shall be readily accessible for

servicing; and

(2)           Exhaust outlets shall be located a minimum

of 10 feet (3 m.) above ground and directed away from occupied areas, doors, or

openable windows.  Prevailing winds, adjacent buildings, and discharge

velocities shall be taken into account when designing such outlets.

(i)   Surgery and special care areas shall meet the

following:

(1)           All air shall be supplied at or near the ceiling

and removed from at least two remote locations near the floor;

(2)           Bottom of exhaust or return registers shall

be no less than 3 inches (7.62 cm.) above the finished floor level; and

(3)           Exhaust grilles for anesthesia evacuation

and other special applications shall be permitted to be installed in the

ceiling.

(j)  Nursery, labor, delivery, recovery, postpartum, and

invasive procedure rooms shall meet the following:

(1)           Air supply shall be at or near the ceiling.

Return or exhaust air registers shall be near the floor;

(2)           Bottom of exhaust or return registers shall

be no less than 3 inches (7.62 cm.) above the finished floor level; and

(3)           Exhaust grilles for anesthesia evacuation

and other special applications shall be permitted to be installed in the ceiling.

(k)  Isolation units shall meet the following:

(1)           Rooms for isolation of patients shall meet

the ventilation requirements of Table 1 (See 10A NCAC 13B .6225);

(2)           A separate anteroom used as an air lock to

minimize the potential for airborne particulates from the patients' area

reaching adjacent areas shall be provided; and

(3)           Air supply shall be introduced at or near

the ceiling, flowing past the patient, and exhausted or returned at the floor.

(l)  Smoke control/evacuation system(s) shall meet the

following:

(1)           When an engineered smoke control/evacuation

system is provided, the system shall incorporate a design of the air duct

system(s) and controls to inhibit the migration of smoke from the fire zone to

the required means of egress and refuge areas;

(2)           When an emergency manual control stop

switch is provided to shut down supply, return, and exhaust fans, the switch

shall be incorporated into the smoke control system in a manner that will not

jeopardize the effectiveness or dependability of the smoke control/evacuation

system;

(3)           Static pressure sensors, freeze-stats, or

other operating controls shall not jeopardize the effectiveness of the smoke

control system during emergency operation;

(4)           Where smoke dampers are required to be

installed as part of a passive smoke control system, smoke dampers shall be

installed in ducts that are capable of communicating smoke between floors; and

(5)           Smoke dampers shall have a maximum air

leakage of 10 cubic feet per minute per square foot of damper opening when

tested at one inch water gauge of duct pressure.  Smoke dampers shall be

fail-safe to the emergency position.  Dampers shall close upon activation of

the fire alarm system unless a part of an engineered smoke control system.

(m)  Laboratories shall meet the following:

(1)           In new construction and renovation work,

each hood used to process infectious or radioactive materials shall have a

minimum face velocity of 150 feet per minute with static pressure operated

dampers and audio-visual alarms to alert staff of ventilation system failure. 

Each hood shall also have filters with a 99.7 percent efficiency (based on the

DOP, dioctyl-phthalate test method) in the exhaust stream, and be designed and

equipped to permit the safe removal, disposal, and replacement of contaminated

filters; and

(2)           Each installation shall have an exhaust fan

located at the discharge end of the duct system to maintain a negative pressure

in the exhaust duct.

(n)  Where ethylene oxide is used, the following

requirements shall be met:

(1)           Equipment utilizing ethylene oxide shall be

installed in accordance with equipment manufacturer's installation

instructions; and

(2)           An air flow sensing device shall be

installed in the exhaust duct.  The sensor shall activate a visible and audible

signal to alert personnel of ventilation system failure.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

 

10A NCAC 13B .6226       PLUMBING AND OTHER PIPING SYSTEMS

REQUIREMENTS

(a)  A toilet room shall be directly accessible from each

patient room and from each central bathing area without going through the

general corridor. One toilet room may serve two patient rooms but not more than

eight beds. The lavatory may be omitted from the toilet room if one is provided

in each patient room.

(b)  All plumbing systems shall be installed in such a

manner as to completely prevent the possibility of cross connections between

safe and unsafe supplies or back siphonage.

(c)  The following standards shall apply to plumbing

fixtures:

(1)           Lavatories and sinks installed in patient

care areas shall have the water spout mounted so that its discharge point is a

minimum distance of 5 inches (12.7 cm.) above the rim of the fixture;

(2)           All fixtures used by medical and nursing

staff and all lavatories used by patients and food handlers shall be trimmed

with valves that can be operated without hands (single-lever devices may be

used).  Blade handles used for this purpose shall not exceed 4.5 inches (11.4

cm.) in length.  Handles on scrub sinks and clinical sinks shall be at least 6

inches (15.2 cm.) long; and

(3)           Showers and tubs shall have non-slip

walking surfaces.

(d)  The following standards shall apply to potable water

supply systems:

(1)           Vacuum breakers shall be installed on hose

bibbs and supply nozzles used for connection of hoses or tubing;

(2)           Bedpan-flushing devices shall be provided

in each inpatient toilet room; installation is optional in psychiatric and

substance-abuse treatment units where patients are ambulatory;

(3)           Potable water storage vessels (hot and

cold) not intended for constant use shall not be installed; and

(4)           All piping, except control-line tubing,

shall be identified.  All valves shall be tagged, and a valve schedule shall be

provided to the facility owner for permanent record and reference.  Where the

functional program includes hemodialysis, continuously circulated filtered cold

water shall be provided.

(e)  The following standards shall apply to hot water

systems:

(1)           The water-heating system shall have

sufficient supply capacity at the temperatures and amounts indicated in Table

3.  Water temperature is measured at the point of use or inlet to the

equipment; and

 

Table 3

Minimum Hot Water

Capacity Requirements



 





 





Use





 







 





Clinical





Dietary





Laundry







Gallons/Hour/Bed





6.5





4





4.5







Liters/Second/Bed





.007





.004





.005







Temperature EF





116





180





180







Temperature EC





46.7





82.2





82.2





 

(2)           Hot-water distribution systems serving patient

care areas shall be under constant recirculation to provide continuous hot

water at each hot water outlet with a temperature range of 100EF to 116EF

(37.8EC to 46.6EC).

(f)  The following standards shall apply to drainage

systems:

(1)           Drain lines serving some types of automatic

blood-cell counters shall be of carefully selected material that will eliminate

the potential for undesirable chemical reactions or explosions between sodium

azide wastes and copper, lead, brass, and solder;

(2)           Drainage piping shall be installed to avoid

installations in the ceiling directly over operating and delivery rooms,

nurseries, food preparation centers, food serving facilities, food storage

areas, central services, electronic data processing areas, electrical closets,

and other sensitive areas.  Where overhead drain piping in these areas is

unavoidable, special provisions such as auxiliary drain pans shall be installed

to protect the space below from leakage;

(3)           Floor drains shall not be installed in

operating and delivery rooms, but may be installed in cystoscopic operating

rooms;

(4)           Drain systems for autopsy tables shall be

designed to avoid splatter or overflow onto floors or back siphonage and for

easy cleaning and trap flushing;

(5)           Kitchen grease traps, unless of the

self-skimming type, shall be located and arranged to permit access without the

need to enter food preparation or storage areas; and

(6)           Where plaster traps are used, provisions

shall be made for routine access and cleaning.

(g)  The performance, maintenance, installation, and testing

of medical gas systems, laboratory gas systems, and clinical vacuum systems

shall comply with the requirements of the latest edition of National Fire

Protection Association Standard 99 and Table 4 for medical gas station outlet

requirements.  When any piping or supply of medical gases is installed,

altered, or augmented, the altered zone shall be tested and certified as

required by National Fire Protection Association Standard 99.  Testing shall be

conducted by the facility and at least one other independent testing

organization to ensure that the system is safe for patient use.

 

Table 4

Minimum Medical Gas

Station Outlets and Vacuum Station Inlets



Location





Oxygen





Vacuum





Medical Air







Operating Room





2/room





3/room





1/room







Delivery Rooms





2/room





3/room





1/room







Cystoscopy Room





1/room





3/room





-







Special Procedures Room





1/room





3/room





1/room







Other anesthetizing Locations





1/room





3/room





1/room







Recovery Room





1/bed





3/bed





1/bed







Intensive Care Unit





2/bed





3/bed





1/bed







Cardiac Intensive Care Unit





2/bed





2/bed





1/bed







Emergency Room





1/bed





1/bed





1/bed







Trauma Room





2/bed





3/bed





1/bed







Catheterization Lab





1/bed





2/bed





-







Labor Room





1/bed





1/bed





-







Nurseries





1/bassinet





1/bassinet





1/bassinet







Patient Room





1/bed





1/bed





-







Exam & Treatment Rooms





1/bed





1/bed





-







Anesthesia Workroom





1/room





1/room





1/room







Autopsy Room





-





1/room





-





 

(h)  The line pressure for the medical gases shall be set in

the following order:

(1)           Oxygen, highest pressure;

(2)           Medical air, next to lowest pressure; and

(3)           Nitrous oxide, lowest pressure.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.

10A NCAC 13B .6227       ELECTRICAL REQUIREMENTS

(a)  All material and equipment, including conductors,

controls, and signaling devices, shall be installed in compliance with

applicable sections of North Carolina State Building Code, Electrical Code as

found in Rule .6102(1) of this Subchapter.  A written record of performance

tests on electrical systems and equipment shall show compliance with applicable

codes and standards.

(b)  The main switchboard shall be located in an area

separate from plumbing and mechanical equipment and shall be accessible to

authorized persons only.  The main switchboard shall be located in a dry,

ventilated space free of corrosive or explosive fumes, gases, or any

combustible material.

(c)  Panelboards serving normal lighting and appliance

circuits shall be located on the same floor as the circuits they serve. 

Panelboards for emergency system critical branch and equipment system branch

circuits shall be located on each floor that has service requirements.  Only

panels for emergency system life safety branch circuits may serve floors other

than the floor that the panel is located on.

(d)  Lighting shall be provided as follows:

(1)           Approaches to buildings and parking lots,

and all occupied spaces within buildings shall have fixtures for lighting;

(2)           Patient rooms shall have general lighting

and night lighting.  A reading light shall be provided for each patient.  At

least one night light fixture in each patient room shall be controlled at the

room entrance.  All light controls in patient areas shall be quiet-operating. 

Lighting for special care bed areas shall permit staff observation of the

patient but shall minimize glare;

(3)           Nursing unit corridors shall have general

illumination with provisions for reducing light levels at night; and

(4)           Consideration shall be given to controlling

lighting intensity to prevent harm to the patients' eyes (i.e., retina damage

in premature infants and cataracts due to ultraviolet light).

(e)  Receptacles shall be provided as follows:

(1)           Each operating room and delivery room shall

have at least eight 120 volt duplex receptacles;

(2)           In areas where mobile X-ray equipment is

intended to be used, single receptacles marked for X-ray equipment only shall

be installed;

(3)           Neonatal Level I nurseries shall have a

minimum of one 120 volt duplex receptacle located on each nursery wall

connected to the critical branch of the emergency electrical system in addition

to the receptacles for each bassinet required by Section 517-18 of the North

Carolina State Building Code Volume IV;

(4)           Emergency department examination and

treatment rooms shall have a minimum of two 120 volt duplex receptacles located

convenient to the head of each bed. Trauma rooms shall have a minimum of three

120 volt duplex receptacles convenient to the head of each bed;

(5)           120 volt duplex receptacles for general use

shall be installed 50 feet (15.2 m.) apart in all corridors and within 25 feet

(7.6 m.) of corridor ends; and

(6)           Inhalation anesthetizing locations and

other areas where patients are intended to have a direct electrical path to the

heart muscle shall be equipped with an isolated power system, approved by the

authority having jurisdiction including the following requirements:

(A)          The line isolation monitor shall be visible to

attending staff while caring for the patient;

(B)          No more than one patient may be served by an

isolated power system serving emergency power receptacles;

(C)          Transformers shall not be located over any patient

bed location; and

(D)          Branch circuit wiring for isolated power systems

shall have a dielectric constant of less than 3.5.

(f)  Emergency electrical service shall be provided as

follows:

(1)           To provide electricity during an

interruption of normal electrical service, a generating set or sets located on

the facility site capable of carrying the full emergency load shall be

installed;

(2)           Fuel shall be stored on the site in

sufficient quantity to provide for not less than 24 hours of operation;

(3)           Where the generator sets are in close

proximity to the heating plant, the emergency generator fuel storage capacity

may be included in the standby fuel storage tank for the heating burners when

the fuels are the same;

(4)           All devices, switches, receptacles, etc.,

connected to the automatically started generator shall be distinctively

identified so that personnel can easily select which device is expected to

operate during a failure of the normal source of power; and

(5)           As a minimum, the following areas shall be

connected to the essential electrical system:

(A)          Task lighting connected to the critical branch of

the emergency system to serve boiler rooms, main switchgear rooms, electrical

closets, fire pump rooms, central fire alarm and control rooms, central

telephone switchboard room; and

(B)          Heating equipment and associated controls to provide

heating for patient care areas shall be connected to the equipment system.

(g)  A nurses' calling system shall be provided as follows:

(1)           Each patient room shall be served by at

least one calling station for two-way voice communication.  Each bed shall be

provided with a call device.  Two call devices serving adjacent beds may be

served by one calling station.  Calls shall activate a visible signal in the

corridor at the patient's door, in the clean workroom, in the soiled workroom,

and at the nursing station of the nursing unit.  In multi-corridor nursing

units, additional visible signals shall be installed at corridor

intersections.  In rooms containing two or more calling stations, indicating

lights shall be provided at each station.  Nurses calling systems at each

calling station shall be equipped with an indicating light which remains

lighted as long as the voice circuit is operating;

(2)           An emergency calling station shall be

provided at each patient-use toilet, bath, sitz bath, and shower.  This station

shall be accessible to a patient lying on the floor.  Inclusion of a pull cord

approved by the authority having jurisdiction will satisfy this standard.  The

emergency call system shall be designed so that a signal activated at a patient's

calling station will initiate a visible and audible signal distinct from the

regular nurse calling system that can be turned off only at the patient calling

station.  The signal shall activate an enumerator panel at the nurse station,

and a visible signal in the corridor at the room;

(3)           In areas such as special care where

patients are under constant visual surveillance, the nurses' call system may be

limited to a bedside button or station that activates a signal readily seen at

the control station; and

(4)           A staff emergency assistance system for

staff to summon additional assistance shall be provided in each operating,

delivery, recovery, emergency examination or treatment area, and in special

care units, nurseries, special procedure rooms, stress-test areas, triage,

out-patient surgery admission and discharge areas, and areas for mental

patients, including seclusion and security rooms, anterooms and toilet rooms

serving them, communal toilet and bathing facility rooms, therapy, exam, and

treatment rooms.  This system shall annunciate at the nurse station with

back-up to another staffed area from which assistance can be summoned.

 

History Note:        Authority G.S. 131E-79;

Eff. January 1, 1996.