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

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subchapter 13C – licensing of ambulatory surgical

facilities

 

section .0100 – general

 

10A NCAC 13C .0101       RESERVED FOR FUTURE CODIFICATION

10A NCAC 13C .0102       reserved for

future codification

 

10A ncac 13C .0103       DEFINITIONS

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

following terms shall apply throughout this Subchapter, unless the context

clearly requires otherwise:

(1)           "Adequate" means, when applied to various

areas of services, that the services are satisfactory in meeting a referred to

need when measured against professional standards of practice.

(2)           "AAAASF" means American Association for

Accreditation of Ambulatory Surgery Facilities.

(3)           "AAAHC" means Accreditation Association

for Ambulatory Health Care.

(4)           "Ancillary nursing personnel" means

persons employed to assist registered nurses or licensed practical nurses in

the care of patients.

(5)           "Anesthesiologist" means a physician

whose specialized training and experience qualify him or her to administer

anesthetic agents and to monitor the patient under the influence of these

agents.  For the purpose of this Subchapter, the term "anesthesiologist"

shall not include podiatrists.

(6)           "Anesthetist" means a physician or

dentist qualified, as defined in Items (10) and (24) of this Rule, to

administer anesthetic agents or a registered nurse qualified, as defined in Items

(25) and (27) of this Rule, to administer anesthesia.

(7)           "Authority having jurisdiction" means the

Division of Health Service Regulation.

(8)           "Chief executive officer" or "administrator"

means a qualified person appointed by the governing authority to act in its

behalf in the overall management of the facility and whose office is located in

the facility.

(9)           "Current Procedural Terminology (CPT)"

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

(10)         "Dentist" means a person who holds a valid

license issued by the North Carolina Board of Dental Examiners to practice

dentistry.

(11)         "Department" means the North Carolina

Department of Health and Human Services.

(12)         "Director of nursing" means a registered

nurse who is responsible to the chief executive officer or administrator and

has the authority and direct responsibility for all nursing services and

nursing care for the entire facility at all times.

(13)         "Financial assistance" means a policy,

including charity care, describing how the organization will provide assistance

at its facility. 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 (13)(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.

(14)         "Governing authority" means the

individual, agency, group, or corporation appointed, elected, or otherwise

designated, in which the ultimate responsibility and authority for the conduct

of the ambulatory surgical facility is vested.

(15)         "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.

(16)         "JCAHO" or "Joint Commission"

means Joint Commission on Accreditation of Healthcare Organizations.

(17)         "Licensing agency" means the Department of

Health and Human Services, Division of Health Service Regulation.

(18)         "Licensed practical nurse (L.P.N.)" means

any person licensed as such under the provisions of G.S. 90-171.20(8).

(19)         "Nursing personnel" means registered

nurses, licensed practical nurses, and ancillary nursing personnel.

(20)         "Operating room" means a room in which

surgical procedures are performed.

(21)         "Patient" means a person admitted to and

receiving care in a facility.

(22)         "Person" means an individual, a trust or

estate, a partnership or corporation, including associations, joint stock

companies and insurance companies; the State, or a political subdivision or

instrumentality of the state.

(23)         "Pharmacist" means a person who holds a

valid license issued by the North Carolina Board of Pharmacy to practice

pharmacy in accordance with G.S. 90-85.3A.

(24)         "Physician" means a person who holds a

valid license issued by the North Carolina Medical Board to practice medicine. 

For the purpose of carrying out these Rules, a "physician" may also

mean a person holding a valid license issued by the North Carolina Board of

Podiatry Examiners to practice podiatry.

(25)         "Qualified person," when used in

connection with an occupation or position, means a person:

(a)           who has demonstrated through experience the

ability to perform the required functions; or

(b)           who has certification, registration, or

other professional recognition.

(26)         "Recovery area" means a room used for the post-anesthesia

recovery of surgical patients.

(27)         "Registered nurse" means a person who

holds a valid license issued by the North Carolina Board of Nursing to practice

nursing as defined in G.S. 90-171.20(7).

(28)         "Surgical suite" means an area that includes

one or more operating rooms and one or more recovery rooms.

 

History Note:        Authority G.S. 131E‑149; 131E-214.13;

Eff. October 14, 1978;

Amended Eff. April 1, 2003; November 1, 1989;

Temporary Amendment Eff. December 31, 2014;

Eff. September 30, 2015.

 

SECTION .0200 ‑ LICENSING PROCEDURES

 

10A NCAC 13C .0201       APPLICATION

(a)  A person shall submit an application for a license to

establish or maintain an ambulatory surgical facility to the Department in

writing on the form provided by the Department.  Each application shall contain

all necessary and reasonable information that the Department may by rule

require, including the following and other pertinent information the Department

may deem appropriate to carry out its responsibilities for statistical data

collection and long range health planning:

(1)           name of facility,

(2)           address of facility,

(3)           telephone number of facility,

(4)           names of owners,

(5)           names of operator and governing authority,

(6)           name of chief executive officer,

(7)           composition of medical and paramedical

staff,

(8)           name of chief of staff,

(9)           director of nursing service,

(10)         number of operating rooms and recovery beds,

(11)         list of surgical procedures to be performed

in facility,

(12)         qualification of persons responsible for

anesthesia services,

(13)         information regarding use and storage of

flammable anesthesia,

(14)         description of laboratory and pathology

services,

(15)         name of hospital(s) with which transfer

agreement has been made,

(16)         description of arrangements for emergency

transportation of patients from the facility,

(17)         description of arrangements for food

service, and

(18)         information regarding sanitation inspection

and fire inspection.

(b)  The person shall make application for a license for a

new facility or for the renewal of a license for an existing facility. 

Applications for licensure for a new facility shall be submitted at least 120

days prior to opening.

(c)  Any ambulatory surgical facility desiring licensure

which is in operation at the time of promulgation of any applicable rules or

regulations shall be given a reasonable time, not to exceed one year from the

date of such promulgation, within which to comply with such rules and

regulations.

 

History Note:        Authority G.S. 131E‑147; 131E‑149;

Eff. October 14, 1978;

Amended Eff. November

1, 1989.

 

10A ncac 13C .0202       REQUIREMENTS FOR ISSUANCE OF LICENSE

(a)  Upon application for a license from a facility never

before licensed, a representative of the Department shall make an inspection of

that facility. Every building, institution, or establishment for which a

license has been issued shall be inspected for compliance with the rules found

in this Subchapter.  An ambulatory surgery facility shall be deemed to meet

licensure requirements if the ambulatory surgery facility is accredited by The

Joint Commission (formerly known as "JCAHO"), AAAHC or AAAASF.  Accreditation

does not exempt a facility from statutory or rule requirements for licensure

nor does it prohibit the Department from conducting inspections as provided in

this Rule to determine compliance with all requirements.

(b)  If the applicant has been issued a Certificate of Need

and is found to be in compliance with the Rules found in this Subchapter, then

the Department shall issue a license to expire on December 31 of each year.

(c)  The Department shall be notified at the time of:

(1)           any change of the owner or operator;

(2)           any change of location;

(3)           any change as to a lease; and

(4)           any transfer, assignment, or other

disposition or change of ownership or control of 20 percent or more of the

capital stock or voting rights thereunder of a corporation that is the operator

or owner of an ambulatory surgical facility, or any transfer, assignment, or

other disposition of the stock or voting rights thereunder of such corporation

that results in the ownership or control of more than 20 percent of the stock

or voting rights thereunder of such corporation by any person.

A new application shall be submitted to the Department in

the event of such a change or changes.

(d)  The Department shall not grant a license until the

plans and specifications that are stated in Section .1400 of this Subchapter,

covering the construction of new buildings, additions, or material alterations

to existing buildings are approved by the Department.

(e)  The facility design and construction shall be in

accordance with the licensure rules for ambulatory surgical facilities found in

this Subchapter, the North Carolina State Building Code, and local municipal

codes.

(f)  Submission of Plans.

(1)           Before construction is begun, schematic

plans and specifications and final plans and specifications covering

construction of the new buildings, alterations, renovations, or additions to

existing buildings 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)           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.

(4)           Plans shall be submitted in duplicate. The

Division shall distribute a copy to the Department of Insurance for review of

the North Carolina State Building Code requirements if required by the North

Carolina State Building Code which is hereby incorporated by reference,

including all subsequent amendments. Copies of the Code may be accessed

electronically free of charge at

http://www.ecodes.biz/ecodes_support/Free_Resources/2012NorthCarolina/12NorthCarolina_main.html.



(g)  To qualify for licensure or license renewal, each

facility shall provide to the Division, with its application, an attestation

statement in a form provided by the Division verifying compliance with the

requirements defined in Rule .0301(d) of this Subchapter.

 

History Note:        Authority G.S. 131E-91; 131E‑147;

131E‑149; S.L. 2013-382, s. 13.1;

Eff. October 14, 1978;

Amended Eff. April 1, 2003;

Temporary Amendment Eff. May 1, 2014;

Amended Eff. November 1, 2014.

 

10A NCAC 13C .0203       SUSPENSION OR REVOCATION: AMBULATORY

SURGICAL FACILITY

(a)  The license may be suspended or revoked at any time for

noncompliance with the regulations of the Department.

(b)  Suspension or revocation of the license shall be

covered by the rules regarding contested cases as found in 10 NCAC 3B .0200.

(c)  Notwithstanding Subsection (a) and (b) of this Rule,

the Department may summarily suspend the license pursuant to General Statute

150B‑3(c).

 

History Note:        Authority G.S. 131E‑148; 131E‑149;

143B‑165; 150B‑3(c);

Eff. October 14, 1978;

Amended Eff. November

1, 1989.

 

10A NCAC 13C .0204       TYPE OF FACILITY DEEMED TO BE LICENSED

An ambulatory surgical facility shall be deemed a suitable

facility for the performance of abortions pursuant to G.S. 14‑45.1(a).

 

History Note:        Authority G.S. 14‑45.1; 131E‑147;

Eff. June 30, 1980;

Amended Eff. November

1, 1989.

 

10A NCAC 13C .0205       ITEMIZED CHARGES

(a)  The facility shall either present an itemized list of

charges to all discharged patients or 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 facility,

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 his or her 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 listing shall include each specific chargeable item

or service in the following service areas:

(1)           Surgery (facility fee);

(2)           Anesthesiology;

(3)           Pharmacy;

(4)           Laboratory;

(5)           Radiology;

(6)           Prosthetic and Orthopedic appliances; and

(7)           Other professional services.

(d)  The facility shall indicate on the initial or renewal

license application that patient bills are itemized, or that each patient or his

or her representative is formally advised of the patient's right to request an

itemized listing within three years of receipt of a non‑itemized bill.

 

History Note:        Authority G.S. 131E‑91; 131E-147.1;

S.L. 2013-382, s. 13.1;

Eff. December 1, 1991;

Temporary Amendment Eff. May 1, 2014;

Amended Eff. November 1, 2014.

 

10A NCAC 13C .0206       REPORTING REQUIREMENTS

(a)  The Department shall establish the lists of the

statewide 20 most common outpatient imaging procedures and 20 most common

outpatient surgical procedures performed in the ambulatory surgical facility

setting to be used for reporting the data required in Paragraphs (c) and (d) 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 20 most common imaging procedures shall

be based upon all outpatient data for 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

(2)           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)  All information required by 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 ambulatory surgical facilities shall report the data

required in Paragraph (d) 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.  Each report shall be for the

period ending three months prior to the due date of the report.

(d)  The report as described in Paragraph (c) of this Rule

shall be specific to each reporting ambulatory surgical facility and shall

include:

(1)           the average gross charge for each 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 CPT code or procedure as required for

patients defined in Subparagraph (d)(1) of this Rule.  The average negotiated

settlement shall be calculated using the average amount charged all patients

eligible for the facility's financial assistance policy, including self-pay

patients;

(3)           the amount of Medicaid reimbursement for

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

ambulatory surgical facility;

(4)           the amount of Medicare reimbursement for

each 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 CPT code or

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

(A)          each ambulatory surgical facility 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 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 CPT code or

procedure; and

(E)           the identity of the top five largest health insurers

shall be redacted prior to submission.

(e)  The data reported, as defined in Paragraphs (c) and (d)

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.

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

reporting under Paragraph (c) of this Rule. 

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

compliance with the federal Health Insurance Portability and Accountability Act

of 45 CFR Part 164.

(h)  The Department shall provide all specific ambulatory

surgical facility data reported pursuant to this Rule on its website. 

 

History Note:        Authority G.S. 131E-147.1; 131E-214.4;

131E-214.13;

Temporary Adoption Eff. December 31, 2014;

Eff. September 30, 2015.

SECTION .0300 – GOVERNING AUTHORITY MANAGEMENT

 

10A NCAC 13C .0301       GOVERNING AUTHORITY

(a)  The facility's governing authority shall adopt bylaws

or other operating policies and procedures to assure that:

(1)           a named individual is identified who is

responsible for the overall operation and maintenance of the facility.  The

governing authority shall have methods in place for the oversight of the

individual's performance;

(2)           at least annual meetings of the governing

authority are conducted if the governing authority consists of two or more

individuals.  Minutes shall be maintained of such meetings;

(3)           a policy and procedure manual is created

that is designed to ensure professional and safe care for the patients.  The

manual shall be reviewed annually and revised when necessary.  The manual shall

include provisions for administration and use of the facility, compliance,

personnel quality  assurance, procurement of outside services and

consultations, patient care policies and services offered; and

(4)           annual reviews and evaluations of the

facility's policies, management, and operation are conducted.

(b)  When services such as dietary, laundry, or therapy

services are purchased from others, the governing authority shall be

responsible to assure the supplier meets the same local and state standards the

facility would have to meet if it were providing those services itself using

its own staff.

(c)  The governing authority shall provide for the selection

and appointment of the professional staff and the granting of clinical

privileges and shall be responsible for the professional conduct of these

persons.

(d)  The governing authority shall establish 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 20 most common outpatient imaging procedures and 20

most common outpatient surgical procedures based on the primary Current

Procedure Code (CPT).  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 facility;

(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 ambulatory surgical facility 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 ambulatory surgical facility to a minor, in

accordance with G.S. 131E-91(d)(6).

 

History Note:        Authority G.S. 131E-91; 131E-147.1; 131E-149;

131E-214.13(f); 131E-214.14; S.L. 2013-382, s. 10.1; S.L. 2013-382, s. 13.1;

Eff. October 14, 1978;

Amended Eff. November

1, 1989; November 1, 1985; December 24, 1979;

Temporary Amendment Eff. May 1, 2014;

Amended Eff. November 1, 2014.

 

10A NCAC 13C .0302       CHIEF EXECUTIVE OFFICER OR ADMINISTRATOR

(a)  The governing authority shall appoint a qualified

person as chief executive officer of the facility to represent the governing

authority and shall define his authority and duties in writing.  He shall be

responsible for the management of the facility, implementation of the policies

of the governing authority and authorized and empowered to carry out the

provisions of these regulations.

(b)  The chief executive officer shall designate, in writing,

a qualified person to act in his behalf during his absence.  In the absence of

the chief executive officer, the person on the grounds of the facility who is

designated by the chief executive officer to be in charge of the facility shall

have reasonable access to all areas in the facility related to patient care and

to the operation of the physical plant.

(c)  When there is a planned change in ownership or in the

chief executive officer, the governing authority of the facility shall notify

the Department.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0303       ADMINISTRATIVE RECORDS

(a)  The following essential documents and references shall

be on file in the administrative office of the facility:

(1)           appropriate documents evidencing control

and ownerships, such as deeds, leases, or corporation or partnership papers;

(2)           bylaws of policies and procedures of the

governing authority;

(3)           minutes of the governing authority meetings

if applicable;

(4)           minutes of the facility's professional and

administrative staff meetings;

(5)           a current copy of these regulations;

(6)           reports of inspections, reviews, and

corrective actions taken related to licensure; and

(7)           contracts and agreements related to

licensure to which the facility is a party.

(b)  All operating licenses, permits and certificates shall

be appropriately displayed on the licensed premises.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0304       SURGICAL PROCEDURES PERFORMED

A current listing of all types of surgical procedures

offered by the facility shall be available.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0305       PERSONNEL

(a)  Personnel Records

(1)           A record of each employee shall be

maintained which includes the following:

(A)          employee's identification;

(B)          resume of education and work experience;

(C)          verification of valid license (if required),

education, training, and prior employment experience; and

(D)          verification of references.

(2)           Personnel records shall be confidential.

(3)           Notwithstanding the requirement found in

Subparagraph (a)(2) of this Rule, representatives of the Department conducting

an inspection of the facility shall have the right to inspect personnel

records.

(b)  Job Descriptions

(1)           Every position shall have a written

description which adequately describes the duties of the position.

(2)           Each job description shall include position

title, authority, specific responsibilities and minimum qualifications. 

Qualifications shall include education, training, experience, special abilities

and license or certification required.

(3)           Job descriptions shall be reviewed

annually, kept current and given to each employee when assigned to the position

and whenever the job description is changed.

(c)  Orientation shall be provided to familiarize each new

employee with the facility, its policies, and job responsibilities.

(d)  All persons having direct responsibility for patient

care shall be at least 18 years of age.  All other employees working in the

facility shall be not less than 16 years of age.

(e)  The governing authority shall be responsible for

insuring health standards for employees which are consistent with recognized

professional practices for the prevention and transmission of communicable

diseases.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. November

1, 1989; December 24, 1979.

 

10A NCAC 13C .0306       QUALITY ASSURANCE

(a)  The governing authority shall establish a quality

assurance program for the purpose of providing standards of care for the

facility.  The program shall include the establishment of a committee which

shall evaluate:

(1)           appropriateness and necessity of surgical

procedures performed, and

(2)           compliance with facility procedure and

policies.

The committee shall determine corrective action if

indicated.

(b)  The committee shall consist of at least one physician or

dentist (who is not an owner), the chief executive officer (or his designee),

and other health professionals as indicated.  There shall be at least one

meeting of the committee quarterly.

(c)  The functions of the committee shall include

development of policies for selection of patients, review of credentials for

staff privileges, peer review, tissue review, establishment of infection

control procedures, and approval of additional surgical procedures to be

performed in the facility.

(d)  Records shall be kept of the activities of the

committee.  These records shall include as a minimum:

(1)           reports made to the governing authority;

(2)           minutes of committee meetings including

date, time, persons attending, description and results of cases reviewed, and

recommendations made by the committee; and

(3)           information on any corrective action taken.

(e)  Appropriate orientation, training or education programs

shall be conducted as necessary to correct deficiencies which are uncovered as

a result of the quality assurance program.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .0400 ‑ MEDICAL AND SURGICAL SERVICES

 

10A NCAC 13c .0401       MEDICAL SERVICES

(a)  All patients admitted to the facility shall be under

the direct care of a physician or dentist.

(b)  The facility shall have available an anesthetist and he

or she shall be available to administer regional or general anesthesia.

(c)  Any patient undergoing general or regional anesthesia

shall, prior to surgery, have a history and physical examination, relative to

the intended procedure, performed by a licensed physician or a dentist who has

successfully completed a postgraduate program in oral and maxillofacial surgery

accredited by the American Dental Association.  Results of the examination and

the preoperative diagnosis shall be recorded in the patient's chart prior to

surgery.

(d)  The attending physician and dentist, prior to surgery,

shall obtain written, informed consent of the patient or legal guardian for

surgery and shall record this in the patient's medical record.

(e)  The facility shall have the capability of obtaining

blood and blood products to meet emergency situations.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. November

1, 1985.

 

10A ncac 13C .0402       SURGICAL SERVICES

(a)  The governing authority shall delineate surgical

privileges for each physician and dentist performing surgery in accordance with

criteria which it has established provided, however, that no physician or

dentist may be given privileges to perform surgical procedures for which he or

she does not have privileges to perform at the hospital with which the facility

has a transfer agreement as provided in Paragraph (a) in Rule .0403 of this

Section.

(b)  A roster of medical personnel having surgical and

anesthesia privileges at the facility specifying the privileges and limitations

of each, shall be readily obtainable by the person in charge of the surgical

suite.

(c)  The administrator or his designee shall maintain a chronological

register of all surgical procedures performed.  This shall include type of

procedure performed, type of anesthesia used, personnel participating, post

operative diagnosis and any unusual or untoward occurrence.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. April

1, 2003.

 

10A NCAC 13C .0403       EMERGENCY CASES

(a)  Each facility shall have a written plan for the

transfer of emergency cases to a nearby hospital when hospitalization becomes

necessary.

(b)  There shall be procedures, personnel and suitable

equipment to handle medical emergencies which may arise in connection with

services provided by the facility.

(c)  There shall be a written agreement between the facility

and a nearby hospital to facilitate the transfer of patients who are in need of

emergency care.  A facility which has documentation of its efforts to establish

such a transfer agreement with a hospital which provides emergency services and

has been unable to secure such an agreement shall be considered to be in

compliance with this Rule.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .0500 ‑ ANESTHESIA SERVICES

 

10A NCAC 13C .0501       PROVIDING ANESTHESIA SERVICES

Only a physician, dentist or qualified anesthetist shall

administer anesthetic agents (general and regional).  Podiatrists shall

administer only local anesthesia.  The governing authority shall establish

written policies and procedures concerning the provision of anesthesia

services, including the designation of those persons authorized to administer

anesthetics.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0502       EQUIPMENT

All equipment for the administration of anesthetics shall be

readily available, kept clean or sterile, and maintained in good working

condition.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0503       POST ANESTHESIA NOTE

Patient's anesthesiologist or anesthetist shall write a post

anesthetic follow‑up note prior to the patient's discharge.  The note

shall include the general condition of the patient and any instructions to the patient

pertaining to his care and protection.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0504       REQUIREMENT OF PERSON TRAINED IN CPR

A person with training and experience in cardio‑pulmonary

resuscitation shall be on the premises of the facility until all surgical

patients are discharged.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .0600 ‑ PATHOLOGY SERVICES

 

10A NCAC 13C .0601       PROVISION FOR LABORATORY TESTS

(a)  Each facility shall have the capability of providing or

obtaining laboratory tests required in connection with the surgery to be

performed.

(b)  The governing authority shall establish written

policies requiring examination by a pathologist of all surgical specimens

except for those types of specimens which the governing authority has

determined do not require examination.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0602       DISPOSAL OF WASTE

Methods for the disposal of pathological waste, contaminated

dressings and other similar material shall meet the approval of governing local

and state authorities.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .0700 ‑ RADIOLOGY SERVICES

 

10A NCAC 13c .0701       PROVISION FOR RADIOLOGY SERVICES

Each facility shall have the capability of providing or

obtaining diagnostic radiology services in connection with the surgery to be

performed.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13c .0702       REGULATIONS FOR PERFORMED SERVICES

Radiation protection shall be provided in accordance with

the rules and regulations adopted by the Radiation Protection Commission found

in 10 NCAC 3G, and the recommendations of the National Council on Radiation

Protection and Measurements.  Records shall be kept of at least annual checks

and calibration of all ionizing radiation therapy equipment used in the

facility.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .0800 ‑ PHARMACEUTICAL SERVICES

 

10A NCAC 13C .0801       DRUG DISPENSING

The governing authority, with the advice of a registered

pharmacist, shall assure that there are appropriate methods, procedures and

controls for obtaining, dispensing, and administering drugs and biologicals.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .0802       REGULATIONS FOR DISPENSING

When the facility maintains its own pharmaceutical services,

it shall comply with applicable regulations adopted by the North Carolina Board

of Pharmacy pursuant to General Statute 90‑62.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .0900 ‑ NURSING SERVICES

 

10A NCAC 13C .0901       NURSING ADMINISTRATION

(a)  The facility shall have an organized nursing Department

under the supervision of a director of nursing who is currently licensed as a

registered nurse and who has responsibility and accountability for all nursing

services.

(b)  The director of nursing shall be responsible and

accountable to the chief executive officer for:

(1)           provision of nursing services to patients;

(2)           developing a nursing policy and procedure manual

and written job descriptions for nursing personnel.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. December

24, 1979.

 

10A NCAC 13C .0902       NURSING PERSONNEL

(a)  An adequate number of licensed and ancillary nursing

personnel shall be on duty to assure that staffing levels meet the total

nursing needs of patients based on the number of patients in the facility and

their individual nursing care needs.

(b)  At least one registered nurse shall be in the facility

during the hours it is in operation.  Nursing personnel shall be assigned to

duties consistent with their training and experience.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .1000 ‑ MEDICAL RECORDS SERVICES

 

10A NCAC 13C .1001       MEDICAL RECORD SYSTEM

The facility shall maintain a medical record system designed

to provide readily available information on each patient.  The medical record

system shall be under the supervision of a designated qualified person.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13c .1002       INDIVIDUAL PATIENT RECORDS

(a)  Each patient's medical record shall be maintained in

accordance with professional standards and shall include at least the following

information:

(1)           patient's identification, including name,

address, date of birth, next of kin and a patient number;

(2)           admitting diagnosis;

(3)           preoperative history and physical

examination pertaining to the procedure to be performed;

(4)           anesthesia report;

(5)           surgeon's operative report;

(6)           anesthesiologist's or anesthetist's report

if applicable;

(7)           pertinent laboratory, pathology and X‑ray

reports;

(8)           postoperative orders and follow‑up

care;

(9)           discharge summary, including discharge

diagnosis;

(10)         record of informed consent; and

(11)         physician's, dentist's, and nurse's progress

notes.

(b)  The administrator shall be responsible for safeguarding

information on the medical record against loss, tampering, or use by

unauthorized persons.

(c)  Medical records shall be the property of the facility

and shall not be moved from the premises wherein they are filed except by

subpoena or court order.

(d)  For licensing purposes the length of time that medical

records are to be retained is dependent upon the need for their use in

continuing patient care and for legal, research, or educational purposes.  This

length of time shall not be less than 20 years.

(e)  Should a facility cease operation, there shall be an

arrangement for preservation of records to insure compliance with these

regulations.  The Department shall be notified, in writing, concerning the

arrangements.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .1100 ‑ SURGICAL FACILITIES AND EQUIPMENT

 

10A NCAC 13C .1101       OPERATING SUITE

(a)  Each operating suite shall be adequately equipped for

the types of procedures to be performed.

(b)  Each recovery area shall be adequately equipped for the

proper care of post anesthesia recovery of surgical patients.

(c)  The following equipment shall be available in the

operating suite and recovery area:

(1)           cardio‑pulmonary resuscitation drugs

and intubation equipment,

(2)           cardiac monitor,

(3)           resuscitator including oxygen and suction

equipment,

(4)           suitable surgical instruments customarily

available for the planned surgical procedure,

(5)           defibrillator, and

(6)           tracheostomy set.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .1102       CARE OF OPERATING SUITE

(a)  Dry sweeping and dusting shall be prohibited in

treatment areas.

(b)  Adequate and conveniently located spaces shall be

provided for the storage of janitorial supplies and equipment.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .1200 ‑ FUNCTIONAL SAFETY

 

10A NCAC 13c .1201       GENERAL

(a)  The governing authority shall develop written policies

and procedures designed to enhance safety within the facility and on its

grounds and minimize hazards to patients, staff and visitors.

(b)  The policies and procedures shall include establishment

of the following:

(1)           safety rules and practices pertaining to

personnel, equipment, gases, liquids, drugs;

(2)           provisions for reporting and the

investigation of accidental events regarding patients, visitors and personnel

(incidents) and corrective action taken;

(3)           provision for dissemination of safety‑related

information to employees and users of the facility; and

(4)           provision for syringe and needle storage,

handling and disposal.

(c)  Smoking shall be permitted only in designated areas

which shall not include patient care and treatment areas.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. December

24, 1979.

 

10A ncac 13C .1202       PREVENTIVE MAINTENANCE

A schedule of preventive maintenance shall be developed for

all of the medical and surgical equipment in the facility to assure

satisfactory operation when needed.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. April

1, 2003.

 

SECTION .1300 ‑ CONTROL AND SANITATION

 

10A NCAC 13c .1301       GENERAL

The governing authority shall employ procedures to minimize

sources and transmission of infections.  Professionally recognized surveillance

methods shall be used. The governing authority shall provide space, equipment,

and personnel to assure safe and aseptic treatment and protection of all

patients and personnel against cross‑infection.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. November

1, 1989.

 

10A NCAC 13C .1302       STERILIZATION PROCEDURES

(a)  Policies and procedures shall be established in writing

for storage, maintenance and distribution of sterile supplies and equipment.

(b)  Sterile supplies and equipment shall not be mixed with

unsterile supplies, and shall be stored in dust proof and moisture free units.

They shall be properly labeled.

(c)  Sterilizing equipment shall be available and of the

necessary type and capacity to sterilize instruments and operating room

materials, as well as laboratory equipment and supplies.  The sterilizing

equipment shall have design control and safety features intact.  The accuracy

of instrumentation and equipment shall be checked quarterly by any

professionally recognized method and periodic calibration and preventive

maintenance shall be provided as necessary, and a log maintained.

(d)  The date of expiration shall be marked on all supplies

sterilized in the facility.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. November

1, 1989.

 

10A NCAC 13C .1303       HOUSEKEEPING

Operating rooms shall be appropriately cleaned in accordance

with established written procedures after each operation.  Recovery rooms shall

be maintained in a clean condition.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .1304       LINEN AND LAUNDRY

(a)  An adequate supply of clean linen or disposable

materials shall be maintained.

(b)  Provisions for proper laundering of linen and washable

goods shall be made.  Soiled and clean linen shall be handled and stored separately.

(c)  A sufficient supply of cloth or disposable towels shall

be available so that a fresh towel can be used after each handwashing.  Towels

shall not be shared.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

10A NCAC 13C .1305       SANITATION

(a)  All parts of the facility, the premises and equipment

shall be kept clean and free of insects, rodents, litter and rubbish.

(b)  All garbage and waste shall be collected, stored and

disposed of in a manner designed to prevent the transmission of disease. 

Containers shall be washed and sanitized before being returned to work areas.

Disposable type containers shall not be reused.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978.

 

SECTION .1400 ‑ PHYSICAL PLANT CONSTRUCTION

 

10A NCAC 13c .1401       OPERATING SUITE

The size and design of the suite shall be in accordance with

individual programs, but the following basic elements designed to ensure no

flow of through traffic must be incorporated in all facilities:

(1)           Operating Room(s).  The number shall depend on the

projected case load and types of procedures to be performed.  Rooms used for

surgery shall have adequate space to accommodate necessary equipment and

personnel.

(2)           Service Areas.  The following supporting services

shall be provided:

(a)           scrub‑up facilities with foot or knee

controls;

(b)           personnel locker and dressing areas so

located that personnel enter from uncontrolled areas and exit directly into a

surgical suite.  Locker space shall be provided for each employee; and a

toilet, shower, and dressing area shall be provided in each personnel dressing

room;

(c)           separate rooms for clean and for soiled

supplies and equipment;

(d)           anesthesia workroom;

(e)           one clerical‑control station; and

(f)            a janitor's closet conveniently located to

serve only the licensed facility.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. December

24, 1979.

 

10A NCAC 13C .1402       RECOVERY AREA

Recovery area with handwashing facilities, secured

medication storage space, clerical work space, storage for clerical supplies,

linens, and patient care supplies and equipment shall be provided.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. December

24, 1979.

 

10A ncac 13C .1403       SUPPORTING ELEMENTS

In addition to those areas covered in Rules .1401 and .1402

of this Section, the facility shall provide space for the following:

(1)           the receiving and registering of patients in

privacy for obtaining confidential information;

(2)           waiting space with public toilets, public

telephone, drinking fountain, and wheelchair storage;

(3)           preoperative preparation and post operative space

for both males and females with dressing rooms and toilet facilities; and

(4)           secure storage for patients' personal effects.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. April

1, 2003.

 

10A NCAC 13C .1404       DETAILS AND FINISHES

All details and finishes must meet the following

requirements:

(1)           Details

(a)           The type of construction shall meet the

requirement of the current edition of the North Carolina State Building Code

for "Business Occupancy‑(B)," except that in the construction

of new facilities required exit doors to stairs or to the outside shall be no

less than 44" wide doors.

(b)           Exit corridors, in addition to meeting the

appropriate requirements of the North Carolina State Building Code, shall:

(i)            be no less than 7'0" clear width

between doors from the recovery area or operating rooms and required exit

doors; or

(ii)           if in a one‑story building or on the

ground floor of a multi‑story building and is less than 7'0" clear

width be so arranged as to allow a stretcher to exit from the recovery area or

operating room directly into the corridor without turning and move to the

required exit without having to make a turn.

(c)           Doors between preoperative preparation,

operating rooms and recovery areas and recovery rooms and corridors shall be no

less than 44" wide.  All recovery areas shall have at least one door

opening to an exit passage way meeting the requirements of (b)(i) and (b)(ii)

of this Rule.

(d)           Items such as drinking fountains, telephone

booths, vending machines, and portable equipment shall be located so as not to

restrict corridor traffic or reduce the corridor width below the required

minimum.

(e)           No doors shall swing into corridors in a

manner that might obstruct traffic flow or reduce the required corridor width

except doors to spaces such as small closets which are not subject to

occupancy.

(f)            Thresholds and expansion joint covers shall

be made flush with the floor surface to facilitate use of wheelchairs and

carts.

(g)           Single use towel dispensers or air driers

shall be provided at all handwashing fixtures except scrub sinks.

(h)           All other rooms shall have not less than

8'0" (2.44 m.) high ceilings except that corridors, storage rooms, toilet

rooms, and other minor rooms may be not less than 7'‑8" (2.34 m.). 

Suspended tracks, rails, pipes, etc., located in the path of normal traffic,

shall be not less than 7'‑6" (2.28 m.) above the floor.

(2)           Finishes

(a)           Floors shall be easily cleanable and have

wear resistance appropriate for the locations involved.  Joints in tile and

similar material in such areas shall be resistant to food acids.

(b)           Wall bases in operating rooms, soiled

workrooms, and other areas subject to frequent wet cleaning shall be integral

and covered with the floor, tightly sealed within the wall, and constructed

without voids that can harbor vermin.

(c)           Walls shall be washable; and, in the

immediate area of plumbing fixtures, the finish shall be smooth, moisture

resistant, and easily cleaned.

(d)           Floor and wall penetrations by pipes, ducts,

conduits, etc., shall be tightly sealed to minimize entry of rodents and

insects.  Joints of structural elements shall be similarly sealed.

(e)           Ceilings in operating rooms shall be readily

washable and without crevices that can retain dirt particles.  Finished

ceilings may be omitted in mechanical and equipment spaces, shops, general

storage areas, and similar spaces except where required for fire rating.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. November

1, 1989; December 24, 1979.

 

10A ncac 13C .1405       MECHANICAL REQUIREMENTS

(a)  Temperatures and Relative Humidity

(1)           The heating and air conditioning systems

shall be designed to provide the temperature and humidities shown below:

Area Designation                                 Temperature                                         Relative

Humidity

Percent

Operating                                              70‑75° F*  21‑24° C*                         50‑60

Recovery                                               70-75° F*  21-24°

C*                         30-60

 

*Variable

Range Required

 

(2)           For all other occupied or use areas, a

minimum design temperature of 72°F. (22°C) at winter design conditions shall be

provided.

(b)  All air‑supply and air‑exhaust systems for

the operating suite and recovery area shall be mechanically operated.  All fans

serving exhaust systems shall be located at the discharge end of the system. 

The ventilation rates shown in this Paragraph shall be minimum acceptable rates

and shall not be construed as precluding the use of higher ventilation rates.

(1)           Outdoor intakes for operating rooms shall

be located not less than 30 feet (9.14 m.) from exhausts from other ventilating

systems, combustion equipment and plumbing vents and at least 3 feet 0 inches

(.92 m.) above the roof and 6 feet (1.83 m.) above ground level.

(2)           The ventilation systems shall be designed

and balanced to provide the pressure relationship as shown in this Paragraph.

(3)           All air supplied to operating rooms shall

be delivered at or near the ceiling of the area served and all exhaust from the

area shall be removed near floor level. At least two exhaust outlets shall be

used in all operating rooms.

(4)           The bottom of any room supply air inlets,

recirculation, and exhaust air outlets shall be located not less than 3 inches

(7.62 cm.) above the floor.

(5)           Corridors shall not be used to supply air

to or exhaust air from any room, except that exhaust from corridors may be used

to exhaust‑ventilate bathrooms, toilet rooms, janitors' closets and

electrical or telephone closets opening directly on corridors.

(6)           All ventilation or air conditioning systems

serving operating rooms shall have a minimum of two filter beds:

(A)          Filter bed No. 1 shall be located upstream of the

air conditioning equipment and shall have a minimum efficiency of 25 percent. 

Filter bed No. 2 shall be downstream of the supply fan and of recirculating

spray water and water reservoir‑type humidifiers. Filter bed No. 2 shall

have a minimum efficiency of 90 percent.

(B)          All filter efficiencies shall be certified by an

independent testing agency and shall be based on the atmospheric dust spot

efficiency determination in accordance with ASHRAE Standard 52‑68; except

that the exhausts from all laboratory hoods in which infectious or radioactive

materials are processed shall be equipped with filters having a 99 percent

efficiency based on the DOP (dioctyophthalate) test method and there shall be

equipment and procedure for the safe removal of contaminated filters.

(C)          Filter frames shall provide an airtight fit with the

enclosing ductwork.  All joints between filter segments and the enclosing

ductwork shall be gasketed or sealed to provide a positive seal against air

leakage.  Each filter bed serving sensitive areas or central air systems shall

have a manometer installed across each filter bed.

(D)          Ventilation systems serving recovery rooms shall not

be tied in with soiled holding or work rooms, janitors' closets, or waiting

rooms if the air is to be recirculated in any manner except through approved

filters.

(7)           Air handling duct systems shall not have

duct linings.

(8)           The following general air pressure

relationships and ventilation shall apply:

 

Minimum

Pressure                 Total

Air                 All Air

Relationship         Changes

per          Exhausted             Recirculated

Area                                       to

Adjacent           Hour Supplied      Directly to             Within

Designation                           Areas                      to

Room                                Outdoors               Room Units

____________________________________________________________________________________

Operating Room                  P                              25                           Optional                Only

with

approved

filters.

Recovery Room                  E                             6                              Optional                See

Sub-

paragraph

(b)(6)(D)

of this

Rule.

Soiled Workroom

or

Soiled Holding                      N                             10                           Yes                          No

Clean Workroom

or

Clean Holding                      P                              4                              Optional                Optional

Examination Room            +/-                           6                              Optional                Optional

Treatment Room                 +/-                           6                              Optional                Optional

Medication room                 P                              4                              Optional                Optional

X-Ray (Diagnostic

And Treatment)                   +/-                           6                              Optional                Optional

Laboratory (general)           N                             6                              Optional                Optional













 

P = Positive                           N

= Negative      E = Equal     +/-   = continuous Directional control not

required

 

(9)           Operating rooms or procedure rooms which

are used with either life sustaining electrical equipment or identified as a

critical care location shall comply with the requirements for ventilation in

NFPA 99, Chapter 5, Environmental Systems.

(10)         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.

(11)         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. 

(12)         Operating

staff shall be provided with instructions for properly operating systems and

equipment.

(c)  Medical gases:  The performance, maintenance,

installation, and testing of medical gas systems shall comply with the

requirements of National Fire Protection Association Standard 99.  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.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. April

1, 2003; December 24, 1979.

 

10A ncac 13C .1406       PLUMBING AND OTHER PIPING SYSTEMS

(a)  All building plumbing systems shall be installed in

accordance with the requirements of the North Carolina State Building Code,

Volume II.

(b)  Plumbing Fixtures

(1)           The material used for plumbing fixtures

shall be of non‑absorptive acid‑resistant material.

(2)           Lavatories and sinks required shall have

the water supply spout mounted so that its discharge point is a minimum

distance of five inches (12.7 cm.) above the rim of the fixture.  All fixtures

used by medical and nursing staff shall be trimmed with valves which can be

operated without the use of hands.  Where blade handles are used for this

purpose, they shall not exceed four and one-half inches (11.43 cm.) in length,

except that handles on scrub sinks and clinical sinks shall be not less than

six inches (15.24 cm.) long.

(3)           Clinical sinks shall have an integral trap

in which the upper portion of a visible trap seal provides a water surface.

(c)  Water Supply Systems

(1)           Systems shall be designed to supply water

to the fixtures and equipment at a sufficient pressure to operate all fixtures

and equipment during maximum demand periods.

(2)           Each water service main, branch main, riser

and branch to a group of fixtures shall be valved.  Stop valves shall be

provided at each fixture.

(3)           Backflow preventers shall be installed on

hose bibbs and on all fixtures to which hoses or tubing can be attached.

(4)           Hot water distribution systems shall be

arranged to provide hot water at each hot water outlet at all times.  Hot water

at the handwashing and bathing facilities shall not exceed 116° F (46.6°C).

(d)  Drainage Systems

(1)           Drain lines from sinks in which acid wastes

may be poured shall be fabricated from an acid‑resistant material.

(2)           Piping systems shall be designed to avoid,

insofar as is possible, installations in the ceiling directly over operating

rooms.

(3)           Floor drains shall not be installed in

operating rooms.

(4)           Building sewers shall discharge into a

community sewerage system.  Where such a system is not available, a facility

providing sewage treatment which conforms to applicable local and state

regulations is required.

(e)  Non‑flammable medical gas system installations

shall be in accordance with the requirements of NFPA Standard 99 and NFPA 50.

Clinical vacuum (suction) system installations shall be in accordance with the

requirements of NFPA Standard 99.  The minimum number of outlets is shown

below.

 

Minimum

Medical Gas Station Outlets and Vacuum Station Inlets



 



Location





Oxygen





Vacuum





Medical Air







Operating Room





2/room





3/room





1/room







Recovery Room





1/bed





3/bed





1/bed





 

(f)  Service outlets for built‑in housekeeping vacuum

systems, if used, shall not be located within operating rooms.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. April

1, 2003.

 

10A ncac 13c .1407       ELECTRICAL REQUIREMENTS

(a)  General

(1)           All material including equipment,

conductors, controls and signaling devices shall be installed to provide a

complete electrical system with the necessary characteristics and capacity to

supply the electrical facilities shown in the specifications or indicated on

the plans.  All materials shall be listed as complying with applicable

standards of Underwriters' Laboratories, Inc., or other similarly established

standards, where such standards have been established.

(2)           All material and equipment, including

conductors, controls, and signaling devices, shall be installed in compliance

with applicable sections of North Carolina State Building Code, Volume VII IV,

Electrical.   A written record of performance tests on electrical systems and

equipment shall show compliance with applicable codes and standards.

(3)           Lighting and appliance panelboards shall be

located on the same floor as the circuits they serve.

(b)  Lighting

(1)           All spaces occupied by people and equipment

shall have electric lighting.

(2)           Operating rooms shall have general lighting

for the room in addition to local lighting provided by special lighting units

at the surgical and obstetrical tables.  Each fixed special lighting unit at

the tables, except for portable units, shall be connected to an independent

circuit.

(c) Power

(1)           If non-flammable anesthetics are to be used, the facility shall meet the

requirements of NFPA 99, Health Care Facilities Code. 

(2)           Procedures that create a direct electrical

pathway to the heart or create conditions meeting the definition of a wet

location shall be provided with an isolated power system (IPS) in the patient

care area.

(3)           Procedures that require electrically

powered devices that because of patient safety cannot tolerate an outage due to

equipment faults shall be provided with an isolated power system (IPS) in the

patient care area.

(4)           Procedures that can be safely carried out

with conventional grounded power systems shall be provided with ground fault

circuit interrupters on each circuit installed in the operating or procedure

room serving the patient care area.

(5)           Critical care areas require a Type 1

essential electrical system.

(6)           Procedures requiring the use of electrical

life support equipment require a Type 1 essential electrical system.

(7)           All facilities shall have as a minimum a

Type 3 essential electrical system.

(8)           All devices, switches, receptacles

connected to the essential electrical system shall be distinctively identified

so that personnel can easily select which device is expected to operate during

failure of normal source of power.

(9)           Fuel for the essential electrical system

generator shall be stored on site in sufficient quantity to provide for not

less than 24 hours of operation.

(d)  Receptacles

(1)           Each operating or procedure room shall have

at least eight 120 volt duplex receptacles.

(2)           In locations where mobile X‑ray is

used, an additional receptacle, distinctively marked for X‑ray use, shall

be provided.

(3)           Fixed and mobile X‑ray equipment

installations shall conform to Article 660 of the North Carolina State Building

Code, Electrical.

 

History Note:        Authority G.S. 131E‑149;

Eff. October 14, 1978;

Amended Eff. April

1, 2003.

 

10A NCAC 13C .1408       GENERAL

The design, construction, maintenance and operation of a

facility shall be in accordance with those codes and standards listed in Rule

.1409, LIST OF REFERENCED CODES AND STANDARDS, and codes, ordinances, and

regulations enforced by city, county, or other state jurisdictions with the

following requirements:

(1)           The facility shall 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.

(2)           In the absence of any requirements by other

authorities having jurisdiction, the facility shall 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;

(3)           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; and

(4)           There shall be a definite assignment of maintenance

functions to qualified personnel under supervision.

 

History Note:        Authority G.S. 131E‑149;

Eff. April 1, 2003.

 

10A ncac 13C .1409       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.  Copies of this code may be purchased from the N.C.

Department of Insurance Engineering Division located at 410 North Boylan Avenue,

Raleigh, NC 27603 at a cost of four hundred eight dollars ($408.00).

(2)           The National Fire Protection Association codes and

standards listed below, current editions. 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                                                                                $29.75

(b)           13           Installation of Sprinkler

Systems                                                                     $42.75

(c)           20           Installation of Centrifugal

Fire Pumps                                                            $29.75

(d)           22           Water Tanks for Private Fire

Protection                                                          $29.75

(e)           25           Water-Based Fire Protection

Systems                                                             $32.75

(f)            30           Flammable and Combustible

Liquids Code                                                  $32.25

(g)           31           Installation of Oil-Burning

Equipment                                                            $29.75

(h)           37           Stationary Combustion Engines

and Gas Turbines                                      $26.75

(i)            50           Bulk Oxygen Systems at

Consumer Sites                                                       $22.25

(j)            53           Fire Hazards in

Oxygen-Enriched Atmospheres                                            $29.75

(k)           54           National Fuel Gas Code                                                                                     $35.25

(l)            55           Compressed and Liquefied Gases

in Portable Cylinders                             $22.25

(m)          58           Storage and Handling of

Liquefied Petroleum Gases                                  $35.25

(n)           59A        Liquefied Natural Gas (LNG)                                                                            $26.75

(o)           72           National Fire Alarm Code                                                                                  $42.75

(p)           80           Fire Doors and Windows                                                                                    $29.75

(q)           82           Incinerators, Waste and Linen

Handling Systems and Equipment           $22.25

(r)            90A        Installation of Air Conditioning

and Ventilating Systems                           $26.75

(s)            90B        Installation of Warm Air Heating

and Air Conditioning Systems              $22.25

(t)            92A        Smoke-Control Systems                                                                                    $26.75

(u)           92B        Smoke Management Systems in

Malls, Atria, Large Areas                        $26.75

(v)           99           Health Care Facilities                                                                                         $42.75

(w)          101         Safety to Life from Fire in

Buildings and Structures                                    $53.50

(x)           101A      Alternative Approaches to Life

Safety                                                           $35.25

(y)           105         Smoke-Control Door Assemblies                                                                     $22.25

(z)           110         Emergency and Standby Power

Systems                                                       $26.75

(aa)         221         Fire Walls and Fire Barrier

Walls                                                                      $22.25

(bb)         241         Construction, Alteration, and

Demolition Operations                                                  $26.75

(cc)         780         Lightning Protection Code                                                                                 $29.75

(dd)         801         Facilities Handling Radioactive

Materials                                                      $26.75

(3)           American Society of Heating, Refrigerating &

Air Conditioning Engineers, (ASHRAE) HVAC APPLICATIONS, current edition. 

Copies of this document may be obtained from the American Society of Heating,

Refrigerating & Air Conditioning Engineers at United Engineer Center,

345 East 47th Street, New York, NY 10017 at a cost of one hundred forty-four

dollars ($144.00).

 

History Note:        Authority G.S. 131E‑149;

Eff. April 1, 2003.

 

10A ncac 13C .1410       APPLICATION OF PHYSICAL PLANT

REQUIREMENTS

The physical plant requirements for each facility shall be

applied as follows:

(1)           All newly licensed facilities shall comply with the

requirements of Section .1400;

(2)           Existing licensed facilities shall meet licensure

and code requirements in effect at the time of construction, alteration, or

modification;

(3)           New additions, alterations, modifications, and

repairs of existing licensed facilities shall meet the technical requirements

of Section .1400, however, where strict conformance with current requirements

would be impractical, the authority having jurisdiction shall 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 .1400 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,

shall 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‑149;

Eff. April 1, 2003.

 

10A ncac 13C .1411       ACCESS AND SAFETY

Projects involving replacement of, alterations of, and

additions to existing licensed facilities shall be planned and phased so that

construction will minimize disruptions of 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, documented, 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‑149;

Eff. April 1, 2003.