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.