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.
