North Carolina register, April 1986 - June 1998

              J?SR/ j/^/'^M/.AZ./A^ /
The
NORTH CAROLINA
REGISTER
IN THIS ISSUE
EXECUTIVE ORDERS
PROPOSED RULES
Chiropractic Examiners
Environment, Health, and Natural Resources
Human Resources
Insurance
Justice
Medical Examiners, Board of
Pharmacy, Board of
State Personnel
RRC OBJECTIONS
RULES INVALIDATED BY JUDICIAL DECISION
RECEIVED
CONTESTED CASE DECISIONS
ISSUE DATE: October 15, 1992
OCT 20 1992
LAW LIBRARY
Volume 7 • Issue 14 • Pages 1351-1463
INFORMATION ABOUT THF NORTH CAROLINA REGISTER AND ADMINISTRATIVE CODE
NORTH CAROLINA REGISTER TEMPORARY RULES
The North Carolina Register is published twice a month and
contains information relating to agency, executive, legislative and
judicial actions required by or affecting Chapter 150B of the
General Statutes. All proposed administrative rules and notices of
public hearings filed under G.S. 150B-21.2 must be published in
the Register. The Register will typically comprise approximately
fifty pages per issue of legal text.
State law requires that a copy of each issue be provided free of
charge to each county in the state and to various state officials and
institutions.
The North Carolina Register is available by yearly subscription
at a cost of one hundred and five dollars (S105.00) for 24 issues.
Individual issues may be purchased for eight dollars (S8.00).
Requests for subscription to the North Carolina Register should
be directed to the Office of Administrative Hearings,
P. 0. Drawer 27447, Raleigh. N. C. 2761 1-7447.
Under certain emergency conditions, agencies may issue
temporary rules. Within 24 hours of submission to OAH, the
Codifier of Rules must review the agency's written statement of
findings of need for the temporary rule pursuant to the provisions in
G.S. 150B-21.1. If the Codifier determines that the findings meet
the criteria in G.S. 150B-21.1, the rule is entered into the NCAC. If
the Codifier determines that the findings do not meet the criteria,
the rule is returned to the agency. The agency may supplement its
findings and resubmit the temporary rule for an additional review
or the agency may respond that it will remain with its initial
position. The Codifier, thereafter, will enter the rule into the
NCAC. A temporary rule becomes effective either when the
Codifier of Rules enters the rule in the Code or on the sixth
business day after the agency resubmits the rule without change.
The temporary rule is in effect for the period specified in the rule or
180 days, whichever is less. An agency adopting a temporary rule
must begin rule-making procedures on the permanent rule at the
same time the temporary rule is filed with the Codifier.
ADOPTION AMENDMENT, AND REPEAL OF
RULES
NORTH CAROLINA ADMINISTRATIVE CODE
The following is a generalized statement of the procedures to be
followed for an agency to adopt, amend, or repeal a rule. For the
specific statutory authority, please consult Article 2A of Chapter
150B of the General Statutes.
Any agency intending to adopt, amend, or repeal a rule must
first publish notice of the proposed action in the North Carolina
Register. The notice must include the time and place of the public
hearing (or instructions on how a member of the public may request
a hearing); a statement of procedure for public comments: the text
of the proposed rule or the statement of subject matter; the reason
for the proposed action; a reference to the statutory authority for the
action and the proposed effective date.
Unless a specific statute provides otherwise, at least 15 days
must elapse following publication of the notice in the North
Carolina Register before the agency may conduct the public
hearing and at least 30 days must elapse before the agency can take
action on the proposed rule. An agency may not adopt a rule that
differs substantially from the proposed form published as part of
the public notice, until the adopted version has been published in
the North Carolina Register for an additional 30 day comment
period.
When final action is taken, the promulgating agency must file
the rule with the Rules Review Commission (RRC). After approval
by RRC, the adopted rule is filed with the Office of Administrative
Hearings (OAH).
A rule or amended rule generally becomes effective 5 business
days after the rule is filed with the Office of Administrative
Hearings for publication in the North Carolina Administrative Code
(NCAC).
Proposed action on rules may be withdrawn by the promulgating
agency at any time before final action is taken by the agency or
before filing with OAH for publication in the NCAC.
The North Carolina Administrative Code (NCAC) is a
compilation and index of the administrative rules of 25 state
agencies and 38 occupational licensing boards. The NCAC
comprises approximately 15,000 letter size, single spaced pages of
material of which approximately 35% of is changed annually.
Compilation and publication of the NCAC is mandated bv G.S.
150B-21.18.
The Code is divided into Titles and Chapters. Each state agency
is assigned a separate title which is further broken down by
chapters. Title 21 is designated for occupational licensing boards.
The NCAC is available in two formats.
(1) Single pages may be obtained at a minimum cost of
two dollars and 50 cents (S2.50) for 10 pages or less,
plus fifteen cents (SO. 15) per each additional page.
(2) The full publication consists of 53 volumes, totaling in
excess of 15,000 pages. It is supplemented monthly
with replacement pages. A one year subscription to the
full publication including supplements can be
purchased for seven hundred and fifty dollars
(S750.00). Individual volumes may also be purchased
with supplement service. Renewal subscriptions for
supplements to the initial publication are available.
Requests for pages of rules or volumes of the NCAC should be
directed to the Office of Administrative Hearings.
CITATION TO THE NORTH CAROLINA
REGISTER
The North Carolina Register is cited by volume, issue, page
number and date. 1:1 NCR 101-201, April 1, 1986 refers to
Volume 1, Issue 1, pages 101 through 201 of the North Carolina
Register issued on April 1, 1986.
FOR INFORMATION CONTACT Office of
Administrative Hearings, ATTN: Ru es Division, P.O.
Drawer 27447, Raleigh, North Carolina 27611-7447, (919)
733-2678.
NORTH
CAROLINA
REGISTER
Office of Administrative Hearings
P. O. Drawer 27447
Raleigh, North Carolina 27611-7447
(919) 733-2678
Julian Mann III.
Director
James R. Scarcella Sr.,
Deputy Director
Molly Masich,
Director of APA Services
Staff:
Ruby Creech,
Publications Coordinator
Teresa Kilpatrick,
Editorial Assistant
Jean Shirley.
Editorial Assistant
ISSUE CONTENTS
I. EXECUTIVE ORDERS
Executive Orders 176-177 1351
II. PROPOSED RULES
Environment, Health, and
Natural Resources
Wildlife Resources Commission . 1414
Human Resources
Facility Services 1352
Medical Assistance 1391
Insurance
Actuarial Services 1411
Agent Services 1410
Departmental Rules 1405
Fire and Rescue Services 1406
Justice
N.C. Alarm Systems 1414
SBI 1413
Licensing Boards
Chiropractic Examiners 1416
Medical Examiners 1417
Pharmacy, Board of 1418
State Personnel
Office of State Personnel 1419
III. RRC OBJECTIONS 1423
IV. RULES INVALIDATED BY
JUDICIAL DECISION 1427
V. CONTESTED CASE DECISIONS
Index to ALI Decisions 1428
Text of Selected Decisions
91 OSP0315 1441
91 EHR 0402 1445
91 EHR 0909 1455
92 OSP 1421 1448
VI. CUMULATIVE INDEX 1461
NORTH CAROLINA REGISTER
Publication Schedule
(August 1992 - December 1993)
Issue
Date
Last Day
for Filing
Last Day Earliest
for Elec- Date for
tronic Public
Filing Hearing
Earliest
Date for Last Day *Earliest
Adoption to Submit Effective
by Agency to RRC Date
08/03/92
08/14/92
09/01/92
09/15/92
10/01/92
10/15/92
11/02/92
11/16/92
12/01/92
12/15/92
01/04/93
01/15/93
02/01/93
02/15/93
03/01/93
03/15/93
04/01/93
04/15/93
05/03/93
05/14/93
06/01/93
06/15/93
07/01/93
07/15/93
08/02/93
08/16/93
09/01/93
09/15/93
10/01/93
10/15/93
11/01/93
11/15/93
12/01/93
12/15/93
07/13/92
07/24/92
08/11/92
08/25/92
09/10/92
09/24/92
10/12/92
10/23/92
11/06/92
11/24/92
12/09/92
12/22/92
01/08/93
01/25/93
02/08/93
02/22/93
03/11/93
03/24/93
04/12/93
04/23/93
05/10/93
05/24/93
06/10/93
06/23/93
07/12/93
07/26/93
08/11/93
08/24/93
09/10/93
09/24/93
10/11/93
10/22/93
11/05/93
11/24/93
07/20/92
07/31/92
08/18/92
09/01/92
09/17/92
10/01/92
10/19/92
10/30/92
11/13/92
12/01/92
12 16 92
12/31/92
01/15/93
02/01/93
02/15/93
03/01/93
03/18/93
03/31/93
04/19/93
04/30/93
05/17/93
06/01/93
06/17/93
06/30/93
07/19/93
08/02/93
08/18/93
08/31/93
09/17/93
10/01/93
10/18/93
10/29/93
11/15/93
12/01/93
08/18/92
08/29/92
09/16/92
09/30/92
10/16/92
10/30/92
11/17/92
12/01/92
12/16/92
12/30/92
01/19/93
01/30/93
02/16/93
03/02/93
03/16/93
03/30/93
04/16/93
04/30/93
05/18/93
05/29/93
06/16/93
06/30/93
07/16/93
07/30/93
08/17/93
08/31/93
09/16/93
09/30/93
10/16/93
10/30/93
11/16/93
11/30/93
12/16/93
12/30/93
09/02/92
09/13/92
10 01 92
10/15/92
10/31/92
11/14/92
12/02/92
12/16/92
12/31/92
01/14/93
02/03/93
02/14/93
03/03/93
03/17/93
03/31/93
04/14/93
05/01/93
05/15/93
06/02/93
06/13/93
07/01/93
07/15/93
07/31/93
08/14/93
09/01/93
09/15/93
10/01/93
10/15/93
10/31/93
11/14/93
12/01/93
12/15/93
12/31/93
01/14/94
09/20/92
09/20/92
10/20/92
10/20/92
11/20/92
1 1 /20/92
12/20/92
12/20/92
01/20/93
01/20/93
02/20/93
02/20/93
03/20/93
03/20/93
04/20/93
04/20/93
05/20/93
05/20/93
06/20/93
06/20/93
07/20/93
07/20/93
08/20/93
08/20/93
09/20/93
09/20/93
10/20/93
10/20/93
11/20/93
11/20/93
12/20/93
12/20/93
01/20/94
01/20/94
11/02/92
11/02/92
12/01/92
12/01/92
01/04/93
01/04/93
02/01/93
02/01/93
03/01/93
03/01/93
04/01/93
04/01/93
05/03/93
05/03/93
06/01/93
06/01/93
07/01/93
07/01/93
08/02/93
08/02/93
09/01/93
09/01/03
10/01/93
10/01/93
11/01/93
11/01/93
12/01/93
12/01/93
01/04/94
01/04/94
02/01/94
02/01/94
03/01/94
03/01/94
* Tlie "Earliest Effective Date" is computed assuming that the agency follows the publication
schedule above, that the Rules Review Commission approves the rule at the next calendar
month meeting after submission, and that RRC delivers the rule to the Codifier of Rules five
(5) business day's before the 1st business day of the next calendar month.
EXECUTIVE ORDERS
EXECUTIVE ORDER NUMBER 176
AMENDMENT AND EXTENSION OF
EXECUTIVE ORDER 148
By the authority vested in me as Governor
by the Constitution and laws of North Carolina. IT
IS ORDERED:
Section 1. Extension
Executive Order Number 148 is reissued
and extended for a period of two years, unless
terminated earlier or extended by further Executive
Order.
cane Andrew and license requirements thereon.
THEREFORE, pursuant to authority
granted to the Governor by Article III, Sec. 5(3)
of the Constitution, it is ordered:
Executive Order Number 175 is hereby
extended, retroactive September 28, 1992, without
amendment and shall remain in effect until October
28. 1992.
Done in the Capital City of Raleigh, North
Carolina, this 1st day of October, 1992.
Section 2. Additional Objective
The Task Force on Health Objectives For
The Year 2000 ("Task Force") shall provide
encouragement and guidance to communities
establishing their own local groups to accomplish
the objectives developed by the Task Force.
Section 3. Governor's Community Task
Forces
The Task Force shall have the power to
designate Governor's Community Task Forces on
Health Objectives for the Year 2000 ("Community
Task Forces"). These Community Task Forces
shall be comprised of representatives of public and
private organizations which support the goals of
the Task Force. The Community Task Forces
shall seek to further the objectives of the Task
Force and they shall exist so long as the Task
Force does, unless earlier terminated.
Section 4. Effective Date
This Executive Order shall be effective
immediately.
Done in Raleigh. North Carolina, this the
24th day of September, 1992.
EXECUTIVE ORDER NUMBER 177
EXTENDING THE PROVISIONS OF
EXECUTIVE ORDER NUMBER 175
Reference is made to Executive Order
Number 175 dated August 28. 1992.
It has been determined that additional
Hurricane Andrew relief efforts necessitate an
extension of the temporary waiver of weight
restrictions on the gross weight of trucks transport-ing
food, supplies and equipment through North
Carolina to the areas of disaster caused by Hurri-
7:14 NORTH CAROLINA REGISTER October 15, 1992 1351
PROPOSED RULES
TITLE 10 - DEPARTMENT OF HUMAN
RESOURCES
l\ otice is hereby given in accordance with G.S.
150B-21.2 that the Medical Care Commission
(Division of Facility Services) intends to amend
rules cited as 10 NCAC 3C . 1902. . 1927 - . 1929;
3H .0108, .0711. .1108 - .1109.
1 he proposed effective date of this action is
February 1. 1993.
I he public hearing will be conducted at 9:30
a.m. on December 4. 1992 at the Council Build-ing,
Room 201. 701 Barbour Drive. Raleigh, NC
27603.
Keason for Proposed Actions: To make the
existing brain injury rules less restrictive and
thereby provide more beds for patients with brain
injuries.
(comment Procedures: Written comments should
be submitted to Jackie Sheppard, 701 Barbour
Drive. Raleigh. North Carolina 27603. by Novem-ber
16. 1992.
CHAPTER 3 - FACILITY SERVICES
SUBCHAPTER 3C - LICENSLNG OF
HOSPITALS
SECTION .1900 - SUPPLEMENTAL RULES
FOR THE LICENSURE OF THE SKILLED:
INTERMEDIATE: DOMICILIARY BEDS IN
A HOSPITAL
.1902 DEFINITIONS
The following definitions shall apply throughout
this Section, unless text otherwise clearly indicates
to the contrary:
( 1 I "Accident" means something occurring
by chance or without intention which has
caused physical or mental harm to a
patient, resident or employee.
1 2 ) "Administer" means the direct application
of a drug to the body of a patient by
injection, inhalation, ingestion or other
means.
(3) "Administrator" means the person who
has authority for and is responsible to the
governing board for the overall operation
of a facility.
(4) "Brain injury extended long term care" is
defined as a multi discipline an interdisci-plinary,
intensive maintenance program
for patients who have incurred brain
damage caused by eternal physical trau-ma
and who have completed a primary
course of rehabilitative treatment and
have reached a point of no gain or prog-ress
for more than three consecutive
months. Services are provided through a
medically supervised interdisciplinary
process and are directed toward maintain-ing
the individual at the optimal level of
physical, cognitive and behavioral func-tioning.
(5) "Capacity" means the maximum number
of patient or resident beds which the
facility is licensed to maintain at any
given time. This number shall be deter-mined
as follows:
(a) Bedrooms shall have minimum square
footage of 100 square feet for a single
bedroom and 80 square feet per patient
or resident in multi-bedded rooms.
This minimum square footage shall not
include space in toilet rooms, wash-rooms,
closets, vestibules, corridors,
and built-in furniture.
(b) Dining, recreation and common use
areas available shall total no less than
25 square feet per bed for skilled nurs-ing
and intermediate care beds and no
less than 30 square feet per bed for
domiciliary home beds. Such space
must be contiguous to patient and resi-dent
bedrooms.
(6) "Combination Facility" means any hospi-tal
with nursing home beds which is
licensed to provide more than one level
of care such as a combination of interme-diate
care and/or skilled nursing care and
domiciliary home care.
(7) "Convalescent Care" means care given
for the purpose of assisting the patient or
resident to regain health or strength.
(8) "Department" means the North Carolina
Department of Human Resources.
(9) "Director of Nursing" means the nurse
who has authority and direct responsibili-ty
for all nursing services and nursing
care.
(10) "Dispense" means preparing and packag-ing
a prescription drug or device in a
1352 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
>
(11)
(a)
(b)
(O
(d)
(12)
(13)
(14)
(15)
(16)
(17)
container and labeling the container with
information required by state and federal (18)
law. Filling or refilling drug containers
with prescription drugs for subsequent (19)
use by a patient is "dispensing". Provid-ing
quantities of unit dose prescription
drugs for subsequent administration is
"dispensing".
"Drug" means substances:
recognized in the official United States
Pharmacopoeia, official National For-mulary,
or any supplement to any of
them;
intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of (20)
disease in man or other animals;
intended to affect the structure or any
function of the body of man or other
animals, i.e., substances other than
food; and
intended for use as a component of any
article specified in (a), (b), or (c) of
this Subparagraph; but does not include
devices or their components, parts, or
accessories.
"Duly Licensed" means holding a current
and valid license as required under the
General Statues of North Carolina.
"Existing Facility" means a licensed (21)
facility; or a proposed facility, proposed
addition to a licensed facility or proposed
remodeled licensed facility that will be
built according to plans and specifications
which have been approved by the depart-ment
through the preliminary working
drawings stage prior to the effective date
of this Rule.
"Exit Conference" means the conference
held at the end of a survey, inspection or
investigation, but prior to finalizing the (22)
same, between the department's represen-tatives
who conducted the survey, inspec-tion
or investigation and the facility
administration representative(s).
"Incident" means an intentional or unin-tentional
action, occurrence or happening
which is likely to cause or lead to physi-cal
or mental harm to a patient, resident
or employee.
"Licensed Practical Nurse" means a
nurse who is duly licensed as a practical (23)
nurse under G.S. 90, Article 9A.
"Licensee" means the person, firm,
partnership, association, corporation or
organization to whom a license has been
issued.
"Medication" means drug as defined in
(12) of this Rule.
"New Facility" means a proposed facili-ty,
a proposed addition to an existing
facility or a proposed remodeled portion
of an existing facility that is constructed
according to plans and specifications
approved by the department subsequent
to the effective date of this Rule. If
determined by the department that more
than one half of an existing facility is
remodeled, the entire existing facility
shall be considered a new facility.
"Nurse Aide" means any unlicensed male
or female person regardless of working
title employed or assigned in a facility
for the puipose of assisting duly licensed
nurses—wrth
—
patient care or providing
pat i ent—eafe
under the—supervision or
direction of duly licen sed nurses individ-ual
providing nursing or nursing-related
services to patients in a facility, and is
not a licensed health professional, a
qualified dietitian or someone who volun-teers
to provide such services without
pay, and who js listed in a nurse aide
registry approved by the Department .
"Nurse Aide Trainee" means an individu-al
in training to become a nurse aide who
has not completed an approved nurse aide
training course and competency evalua-tion
and is demonstrating knowledge,
while performing tasks for which they
have been found proficient by an instruc-tor.
These tasks shall be performed under
the direct supervision of a registered
nurse. The term does not apply to volun-teers.
"Nursing Facility" means that portion of
a nursing home certified under Title XIX
of the Social Security Act (Medicaid) as
in compliance with federal program
standards for nursing facilities. It is
often used as synonymous with the term
"nursing home" which is the usual pre-requisite
level for state licensure for
nursing facility (NF) certification and
Medicare skilled nursing facility (SNF)
certification.
"Nurse in Charge" means the nurse to
whom duties for a specified number of
patients and staff for a specified period of
time have been delegated, such as for
Unit A on the 7-3 or 3-11 shift.
7:14 NORTH CAROLINA REGISTER October 15, 1992 1353
PROPOSED RULES
(24) "On Duty" means personnel who are
awake, dressed, responsive to patient
needs and physically present in the facili-ty
performing assigned duties.
(25) "Patient" means any person admitted for
care to a skilled nursing or intermediate
care facility.
(26) "Physician" means a person licensed
under G.S. Chapter 90. Article 1 to
practice medicine in North Carolina.
(27) "Qualified Dietitian" means a person who
meets the standards and qualification
established by the Committee on Profes-sional
Registration of the American Di-etetic
Association.
(28) "Registered Nurse" means a nurse who is
duly licensed as a registered nurse under
G.S. 90. Article 9A.
(29) "Resident" means any person admitted
for care to a domiciliary home.
(30) "Sitter" means an individual employed to
provide companionship and social inter-action
to a particular resident or patient,
usually on a private duty basis.
(31) "Supervisor-in-Charge" means a duly
licensed nurse to whom supervisory
duties have been delegated by the Direc-tor
of Nursing.
(32) "Ventilator dependence" «
—
defined—as
means physiological dependency by a
patient on the use of a ventilator for more
than eight hours a day.
Statutory Authority G.S. 131E-79.
.1927 BRAIN INJURY LONG TERM CARE
PHYSICIAN SERVICES
(a) In nursing facility beds designated as brain
injury extended long term care units,, an attending
physician shall be responsible for a patient's
specialized extended long term care program. The
intensity of the program requires that there shall be
direct patient contact by a physician at least once
a per week and more often as the patient's condi-tion
warrants. Each patient's multi-discipline,
extended long term care program shall be devel-oped
and implemented under the supervision of a
physiatrist (a physician trained in Physical Medi-cine
and Rehabilitation) or a physician of equiva-lent
training and experience.
(b) If a physiatrist or physician of equivalent
training or experience, is not available on a weekly
basis to the facility, the facility shall provide for
weekly medical management of the patient, by
another physician , witlu In addition, oversight for
the patient's multi-discipline extended long term
care program shall be provided by a qualified
consultant physician who visits patients monthly,
makes recommendations for and approves the
interdisciplinary care plan, and provides consulta-tion
as requested to the physician who is managing
the patient on a weekly basis.
(c) The attending physician shall actively partici-pate
in individual case conferences or care plan-ning
sessions and shall complete review and sign
discharge summaries and records within 15 days of
patient discharge. When patients are to be dis-charged
to either another health care facility or a
residential setting the attending physician shall
assure that the patient has been provided with a
discharge plan which incorporates optimum utiliza-tion
of community resources and post discharge
continuity of care and services.
Statutory- Authority- G.S. 131E-79.
.1928 BRAIN INJURY LONG TERM CARE
PROGRAM REQUIREMENTS
(a) The general requirements in this Subchapter
shall apply when applicable, but brain injury
extended long term care units shall meet the
supplement requirements in this Rule and Rules
.1901 (4) and .1929 of this Section. Brain injury
extended long term care is a multi discipline an
interdisciplinary, intensive maintenance program
for patients who have incurred brain damage
caused by external physical trauma and who have
completed a primary course of rehabilitative
treatment and have reached a point of no gain or
progress for more than three consecutive months.
Services are provided through a medically super-vised
interdisciplinary process as provided in Rule
.1927 of this Section and are directed toward
maintaining the individual at the optimal level of
physical, cognitive and behavioral functioning.
Following are the minimum requirements for
specific services that may be necessary to main-taining
the individual at optimum level:
( 1 ) Overall supervisory responsibility for
brain injury extended long term care
services shall be assigned to a regis-tered
nurse with one year experience jn
caring for brain injured patients .
(2) Physical Therapy therapy shall be
provided by a physical therapist with a
current valid North Carolina license
working in the brain injury unit a mini
mum of 20 hours per week plus an
additional two hours per week for each
patient in excess of ten (e.g., 20 pa
1354 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
>
ticnts, 4 hours per week) The assis
tancc of a phy s ical therapy ass i s tant or
aide shall be provided at the rate of two
hours
—
per week—per active—physical
therapy patient on a facility wide bas i s
with a minimum of 4 hours per week
regardless of how small the census.
@) Occupational therapy shall be provided
by an occupational therapist with a
current valid North Carolina License
working in the unit 20 hours per week
plus an additional two hours per week
for each patient in excess often, (e.g.:
20 pati e nts. 4 hours per week)—T-fre
assistance of an occupational therapy
aide or assistant shall be provided at the
rate of two houi3 per week per patient
with a minimum of one full time aide .
The services of a physical therapist and
occupational therapist shall be com-bined
to provide one full-time equiva-lent
for each 20 patients. The assis-tance
of a physical therapy aide and an
occupational therapy aide with appro-priate
supervision shall be combined to
provide one full-time equivalent for
each 20 patients. A proportionate
number of hours shall be provided for
a census less than 20 patients.
(4) (3) Clinical nutrition services shall be
provided by a qualified dietician with
two years clinical training and experi-ence
in nutrition. The number of hours
of clinical nutrition services on either a
full-time or part-time employment or
contract basis shall be adequate to meet
the needs of the patients. Each patient's
nutrition needs shall be reviewed at
least monthly. Clinical nutrition servic-es
shall include:
(A) Assessing the appropriateness of the
ordered diet for conformance with
each patient's physiological and
pharma cologica l pharmacological
condition;
(B) Evaluating each patient's laboratory
data in relation to nutritional status
and hydration;
(C) Applying technical knowledge of
feeding tubes, pumps and equipment
to each patient's specialized needs.
(5) (4) Clinical Social Work shall be pro-vided
by a Social Worker meeting the
requirements of Rule . 1923 of this Section.
(6) (5) Recreation therapy, when required.
shall be provided on either a full-time
or part-time employment or contract
basis by a clinician eligible for certifi-cation
as a therapeutic recreation spe-cialist
by the State Board of Therapeu-tic
Recreation Certification. The num-ber
of hours of therapeutic recreation
services shall be adequate to meet the
needs of the patients. In the event that
a qualified specialist is not locally
available, alternate treatment modalities
shall be developed by the occupational
therapist and reviewed by the attending
physician. The program designed must
be adequate to meet the needs of this
specialized population and must be
administered in accordance with Section
.1200 of this Subchapter.
(7) (6) Speech therapy, when required,
shall be provided by a clinician with a
current valid license in speech patholo-gy
issued by the State Board of Audiol-ogy
and Speech Pathology.
(8) (7) Respiratory therapy, when re-quired,
shall be provided and super-vised
by a respiratory therapist current-ly
registered by the National Board for
Respiratory Care.
(b) Each patient's program shall be governed by
a multi-discipline treatment plan incorporating and
expanding upon the health plan required under
Rules .1908 and .1909 of this Section. The plan
is to be initiated on the first day of admission.
Upon completion of baseline data development and
an integrated interdisciplinary assessment the initial
treatment plan is to be expanded and finalized
within 14 days of admission. Through an inter-disciplinary
process the treatment plan shall be
reviewed at least monthly and revised as appropri-ate.
In executing the treatment plan the interdisci-plinary
team shall be the major decision-making
body and shall determine the goals, process, and
time frames for accomplishment of each patient's
program. Disciplines to be represented on the
team shall be medicine, nursing, clinical pharmacy
and all other disciplines directly involved in the
patient's treatment or treatment plan.
(c) Each patient's overall program shall be
assigned to an individually designated program
case manager. The case manager acts as the
coordinator manager for assigned patients. Any
professional staff member involved in the patient's
care may be assigned this responsibility for one or
more patients. Professional staff may divide this
responsibility for all patients on the unit in the best
7:14 NORTH CAROLINA REGISTER October 15, 1992 1355
PROPOSED RULES
manner to meet all patients' needs for a coordinat-ed
interdisciplinary approach to care. The case
manager shall be responsible for:
(1) coordinating the development, imple-mentation
and periodic review of the
patient's treatment plan:
preparing a monthly summary of the
patient's progress:
cultivating the patient's participation in
the program;
general supervision of the patient dur-ing
the course of treatment;
evaluating appropriateness of the treat-ment
plan in relation to the attainment
of stated goals: and
assuring that discharge decisions and
arrangements for post discharge
follow-up are properly made.
(d) For each 20 patients or fraction thereof
dedicated treatment facilities and equipment shall
be provided as follows:
i2i
(3)
(4)
(5)
(6)
(1)
m
A speech therapy room with dimensions
which equal or exceed 175 square feet
and which is so designed and main
tained as to permit free movement of
three—fully—opened—reclining—wheel
chairs. A combined therapy space
equal to or exceeding 600 square feet,
adequately equipped and arranged to
support each of the therapies.
Two—occupational—physical—therapy
room s .—each—wrth
—
dimensions—which
equal or exceed 600 square foot.—Each
room—
s
hall—be
—
equipped—with
—
throe
double size mat tables, one tilt table,
and one s ot of free s tanding or fold
away parallel bars .—Each room is to be
plumbed with a si ale suitable for hand
washing.—Each room s hall open direct
ly to a wheel ehair acces s ible water
closet.
(2) Access to one full reclining wheel-chair
per patient.
(3) Special physical therapy and occu-pational
therapy equipment for use in
fabricating positioning devices for beds
and wheelchairs including splints, casts,
cushions, wedges, and bolsters.
(4 1 There shall be roll-in bath facilities
with a dressing area available to all
patients which shall afford maximum
privacy to the patient.
Statutory Authorin G.S. 131E-79.
(2)
i4i
(5)
.1929 SPECIAL NURSING REQMTS FOR
BRAIN INJURY LONG TERM CARE
Direct care nursing personnel staffing ratio
(NH/PD) established in Rule .1912 of this Section
shall not be applied to nursing services for patients
who require brain injury extended long term care,
due to their more intensive maintenance and
nursing needs
.
When s uch services arc provided
the table in thi s Rule establishes the minimum
acceptable—direct—eafe
—
nursing staff ratios—per
patient (NHPt. The minimum direct care nursing
staff shall be 5.5 hrs. per patient day allocated on
a p_er shift basis as the facility chooses to appropri-ately
meet the patient's needs. It is also required
that regardless of how low the patient census the
direct care nursing staff shall not fall below a
registered nurse and a nurse aide I at any time
during a 24;hour period. The minimum direct
care nursing staff ratios are:
STAFF ST SHIFT2ND SHIFT3D
SHIFT DAILY
POSITION STAFF RATIOS T A F F
RATIO STAFF RATIOREQUIRE
MENT
RN- .8 NHP. 4 NHP. 4 NHP
1.6 NHP
fcPN .8 NHP. 8 NH/P. 4 NH P
2.0 NHP
NA4
NHP
.75 NHP. 75 NH P.
1.9 NH/P
NA (Trainee) -6- -000
Statutory- Authority G.S. 131E-79.
SUBCHAPTER 3H - RLLES FOR THE
LICENSING OF NURSING HOMES
SECTION .0100 - GENERAL
INFORMATION
apply throughout
.0108 DEFLNITIONS
The following definitions wil
this Subchapter:
( 1
)
"Accident" means an unplanned or un-wanted
event resulting in the injury or
wounding, no matter how slight, of a
patient or other individual.
(2) "Adequate" means, when applied to
various services, that the services are at
least satisfactory in meeting a referred to
need when measured against contempo-rary
professional standards of practice.
(3) "Administrator" means the person who
1356 7:14 XORTH CAROLIXA REGISTER October IS, 1992
PROPOSED RULES
)
has authority for and is responsible for (13)
the overall operation of a facility.
(4) "Appropriate" means right for the speci-fied
use or purpose, suitable or proper
when used as an adjective. When used
as a transitive verb it means to set aside
for some specified exclusive use.
(5) "Brain injury extended long term care" is
defined as a muiti—di scipline an interdis-ciplinary,
intensive maintenance program ( 14)
for patients who have incurred brain
damage caused by external physical
trauma and who have completed a prima-ry
course of rehabilitative treatment and
have reached a point of no gain or prog- (15)
ress for more than three consecutive
months. Services are provided through a
medically supervised interdisciplinary
process and are directed toward maintain-ing
the individual at the optimal level of (16)
physical, cognitive and behavioral func-tions.
(6) "Capacity" means the maximum number (17)
of patient or resident beds for which the
facility is licensed to maintain at any
given time. (18)
(7) "Combination facility" means a combina-tion
home as defined in G.S. 131E-101.
(8) "Convalescent Care" means care given
for the purpose of assisting the patient or (19)
resident to regain health or strength.
(9) "Department" means the North Carolina (20)
Department of Human Resources.
(10) "Director of Nursing" means the nurse
who has authority and direct responsibili-ty
for all nursing services and nursing
care.
(11) "Drug" means substances:
(a) recognized in the official United States
Pharmacopoeia, official National For-mulary,
or any supplement to any of
them;
(b) intended for use in the diagnosis, cure, (21)
mitigation, treatment, or prevention of
disease in man or other animals;
(c) intended to affect the structure or any
function of the body of man or other
animals, i.e., substances other than
food; and
(d) intended for use as a component of any
article specified in (a), (b), or (c) of (22)
this Subparagraph.
(12) "Duly Licensed" means holding a current
and valid license as required under the
General Statutes of North Carolina.
"Existing Facility" means a facility cur-rently
licensed or a proposed facility,
proposed addition to a licensed facility or
proposed remodeled licensed facility that
will be built according to plans and speci-fications
which have been approved by
the Department through the preliminary
working drawings state prior to the effec-tive
date of this Rule.
"Exit Conference" means the conference
held at the end of a survey or investiga-tion
between the Department's represen-tatives
and the facility administration
representative.
"Incident" means an unplanned or un-wanted
event which has not caused a
wound or injury to any individual but
which has the potential for such should
the event be repeated.
"Interdisciplinary" means an integrated
process involving a representative from
each discipline of the health care team.
"Licensed Practical Nurse" means a
nurse who is duly licensed as a practical
nurse under G.S. 90, Article 9A.
"Licensee" means the person, firm,
partnership, association, corporation or
organization to whom a license has been
issued.
"Medication" means drug as defined in
(11) of this Rule.
"New Facility" means a proposed facili-ty,
a proposed addition to an existing
facility or a proposed remodeled portion
of an existing facility that is constructed
according to plans and specifications
approved by the Department subsequent
to the effective date of this Rule. If
determined by the Department that more
than half of an existing facility is remod-eled,
the entire existing facility shall be
considered a new facility.
"Nurse Aide" means any individual
providing nursing or nursing-related
services to patients in a facility who is
not a licensed health professional, a
qualified dietitian or someone who volun-teers
to provide such services without
pay, and listed in a nurse aide registry
approved by the Department.
"Nurse Aide Trainee" means an individu-al
who has not completed an approved
nurse aide training course and competen-cy
evaluation and is demonstrating
knowledge, while performing tasks for
7:14 NORTH CAROLINA REGISTER October 15, 1992 1357
PROPOSED RULES
which they have been found proficient by
an instructor. These tasks shall be per-formed
under the direct supervision of a
registered nurse. The term does not apply
to volunteers.
(23) "Nursing Facility" means that portion of
a nursing home certified under Title XIX
of the Social Security Act (Medicaid) as
in compliance with federal program
standards for nursing facilities. It is
often used as synonymous with the term
"nursing home" which is the usual pre-requisite
level of state licensure for nurs-ing
facility (NF) certification and Medi-care
skilled nursing facility (SNF) certifi-cation.
(24) "Nurse in Charge" means the nurse to
whom duties for a specified number of
patients, residents and staff for a speci-fied
period of time have been delegated,
such as for Unit A on the 7-3 or 3-11
shift.
(25) "On Duty" means personnel who are
awake, dressed, responsive to patient
needs and physically present in the facili-ty
performing assigned duties.
(26) "Operator" means the owner of the nurs-ing
home business.
(27) "Patient" means any person admitted for
nursing care.
(28) "Person" means an individual, trust,
estate, partnership or corporation includ-ing
associations, joint-stock companies
and insurance companies.
(29) "Proposal" means a Negative Action
Proposal containing documentation of
findings that may ultimately be classified
as violations and penalized accordingly.
(30) "Provisional License" means an amended
license recognizing significantly less than
full compliance with the licensure rules.
(31) "Physician" means a person licensed
under G.S. Chapter 90. Article 1 to
practice medicine in North Carolina.
(32) "Qualified Dietitian" means a person who
meets the standards and qualification
established by the Commission on Dietet-ic
Registration of the American Dietetic
Association.
(33) "Qualified Activities Director" means a
person who has the authority and respon-sibility
for the direction of all therapeutic
activities in the nursing facility and who
meets the qualifications set forth under
10 NCAC 3H .1204.
(34)
(35)
(36)
(37)
(38)
(39)
"Qualified Pharmacist" means a person
who is licensed to practice pharmacy in
North Carolina and who meets the quali-fications
set forth under 10 NCAC 3H
.0903.
"Qualified Social Services Director"
means a person who has the authority and
responsibility for the provision of social
services in the nursing home and who
meets the qualifications set forth under
10 NCAC 3H .1306.
"Registered Nurse" means a nurse who is
duly licensed as a registered nurse under
G.S. 90, Article 9A.
"Resident" means any person admitted
for care to a domiciliary home part of a
combination home as defined in G.S.
131E-101.
"Sitter" means an individual employed to
provide companionship and social inter-action
to a particular patient, usually on
a private duty basis.
" Supervisor- in-Charge (domiciliary
home)" means any employee to whom
supervisory duties for the domiciliary
home portion of a combination home
have been delegated by either the Admin-istrator
or Director of Nursing.
"Surveyor" means an authorized repre-sentative
of the Department who inspects
nursing facilities and combination facili-ties
to determine compliance with rules as
set forth in G.S. 131 E- 117 and applicable
state and federal laws, rules and regula-tions.
"Ventilator dependence" is defined as
physiological dependency by a patient on
the use of a ventilator for more than eight
hours a day.
"Violation" means a finding which direct-ly
relates to a patient's health, safety or
welfare or which creates a substantial
risk that death or serious physical harm
will occur and is determined to be an
infraction of the regulations, standards
and requirements set forth in G.S.
131 E- 1 17 or applicable State and federal
laws, rules and regulations.
Authority G.S. 131E-104; 42 U.S.C. 1396 r (a).
SECTION .0700 - PHYSICIAN SERVICES
.0711 BRAIN INJURY LONG TERM CARE
PHYSICIAN SERVICES
(40)
(41)
(42)
1358 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
(a) In nursing facilities wrtfr facility beds desig-nated
as brain injury extended long term care
units^ the an attending physician shall be responsi-ble
for a patient's specialized care and rehabilita
tteft program shall have specialized training in
rehabilitation . The intensity of the program
requires that there shall be direct patient contact by
a physician at least once per week and more often
as the patient's condition warrants. Each patient's
multi-discipline rehabilitation program shall be
developed and implemented under the supervision
of the attending physician a physiatrist £a physician
trained in Physical Medicine and Rehabilitation) or
a physician of equivalent training and experience.
(b) If a physiatrist or physician of equivalent
training or experience js not available on a weekly
basis to the facility, the facility shall provide for
weekly medical management of the patient by
another physician. In addition, oversight for the
patient's multi-discipline, long term care program
shall be provided by a qualified consultant physi-cian
who visits patients monthly, makes recom-mendations
for and approves the interdisciplinary
care plan, and provides consultation as requested
to the physician who js managing the patient on a
weekly basis.
(c) The attending physician shall actively partici-pate
in individual case conferences or care plan-ning
sessions and shall complete review and sign
discharge summaries and records within 15 days of
a patient discharge. When patients are to be
discharged to either another health care facility or
a residential settings the attending physician shall
assure that the patient has been provided with a
discharge plan which incorporates optimum utiliza-tion
of community resources and post discharge
continuity of care and services.
Statutory Authority G.S. 131E-W4.
SECTION .1100 - SPECIALIZED
REHABILITATIVE AND HABILITATIVE
SERVICES
.1108 BRAIN INJURY LONG TERM CARE
(a) The general requirements in this Subchapter
shall apply when applicable, but brain injury
extended long term care units shall meet the
supplement requirements in Rules . I 108 and . 1 109
of this Section. Brain injury e xtended long term
care is a
—
multi discipline an interdisciplinary.
intensive maintenance program for patients who
have incurred brain damage caused by external
physical trauma and who have completed a prima-ry
course of rehabilitative treatment and have
reached a point of no gain or progress for more
than three consecutive months. Services are
provided through a medically supervised interdisci-plinary
process as provided in Rule .0711 of this
subchapter and are directed toward maintaining the
individual at the optimal level of physical, cogni-tive
and behavioral functioning. Following are the
minimum requirements for specific services that
may be necessary to maintaining the individual at
optimum level:
(1) Overall supervisory responsibility for
brain injury extended long term care
services shall be assigned to a regis-tered
nurse with one year experience in
caring for brain injured patients .
(2) Physical Therapy therapy shall be
provided by a physical therapist with a
current valid North Carolina license
working in the brain injury unit a mini
mum of 20 hours per week plu s an
additional two hours per week for each
patient in excess
—
of ten. (e.g.: 20
patients'—40
—
hours—pef
—
week) The
assistance of a physical therapy ass i s
tant or aide s hall be provided at the rate
of two hours per week per active phys i
eal therapy patient on a facility wide
basis with a minimum of 4 hours per
week regardless of how s mall the een
sus
.
0) Occupational therapy shall be provided
by an occupational therapist with a
current valid North Carolina License
working in the unit 20 hours per week
plus an additional two hours per week
for each patient in excess often, (e.g.:
20 patients
' 4 hours per week)—T4n?
assistance of an occupational therapy
aide or assistant shall be provided at the
rate of two hours per week per patient
with a minimum of one full time aide .
The services of a physical therapist and
occupational therapist shall be com-bined
to provide one full-time equiva-lent
position for each 20 patients. The
assistance of a physical therapy aide
and occupational therapy aide, with
appropriate supervision, shall be com-bined
to provide one full-time equiva-lent
position for each 20 patients. A
proportionate number of hours shall be
provided for a census less than 20
patients.
(4) (3) Clinical nutrition services shall be
7:14 NORTH CAROLINA REGISTER October 15, 1992 1359
PROPOSED RULES
provided by a qualified dietician with
two years clinical training and experi-ence
in nutrition. The number of hours
of clinical nutrition services on either a
full time or part time employment or
contract basis shall be adequate to meet
the needs of the patients. Each
patient's nutrition needs shall be re-viewed
at least monthly. Clinical nutri-tion
services shall include:
(A) Assessing the appropriateness of the
ordered diet for conformance with
each patient's physiological and phar-macological
condition.
(B) Evaluating each patient's laboratory
data in relation to nutritional status
and hydration.
(C) Applying technical knowledge of
feeding tubes, pumps and equipment
to each patient's specialized needs.
(§) (4) Clinical Social Work shall be pro-vided
by a Social Worker meeting the
requirements of Rule .1306 of this
Subchapter.
(6) (5) Recreation therapy, when required,
shall be provided on either a full-time
or part-time employment or contract
basis by a clinician eligible for certifi-cation
as a therapeutic recreation spe-cialist
by the State Board of Therapeu-tic
Recreation Certification. The num-ber
of hours of therapeutic recreation
services shall be adequate to meet the
needs of the patients. In event that a
qualified specialist is not locally avail-able,
alternate treatment modalities shall
be developed by the occupational thera-pist
and reviewed by the attending
physician. The program designed must
be adequate to meet the needs of this
specialized population and must be
administered in accordance with Section
.1200 of this Subchapter.
(7) (6) Speech therapy, when required,
shall be provided by a clinician with a
current valid license in speech patholo-gy
issued by the State Board of Audiol-ogy
and Speech pathology.
(8) (7) Respiratory therapy, when re-quired,
shall be provided by an individ-ual
meeting the same qualifications for
providing respiratory therapy under
Rule .1 107 of this Section.
(b) Each patient's program shall be governed by
a multi-discipline treatment plan incorporating and
expanding upon the health plan required under
Section .0400 of this Subchapter. The plan is to
be initiated on the first day of admission. Upon
completion of baseline data development and an
integrated interdisciplinary assessment the initial
treatment plan is to be expanded and finalized
within 14 days of admission. Through an interdis-ciplinary
process the treatment plan shall be
reviewed at least monthly and revised as appropri-ate.
In executing the treatment plan the interdisci-plinary
team shall be the major decision making
body and shall determine the goals, process, and
time frames for accomplishment of each patient's
program. Disciplines to be represented on the
team shall be medicine, nursing, clinical pharmacy
and all other disciplines directly involved in the
patient's treatment or treatment plan.
(c) Each patient's overall program shall be
assigned to an individually designated program
case manager. The case manager acts as the
coordinator for assigned patients. Any profession-al
staff member involved in a patient's care may
be assigned this responsibility for one or more
patients. Professional staff may divide this respon-sibility
for all patients on the unit in the best
manner to meet all patients' needs for a coordinat-ed,
interdisciplinary approach to care. The case
manager shall be responsible for:
(1) coordinating the development, imple-mentation
and periodic review of the
patient's treatment plan;
(2) preparing a monthly summary of the
patient's progress;
(3) cultivating the patient's participation in
the program;
(4) general supervision of the patient dur-ing
the course of treatment;
(5) evaluating appropriateness of the treat-ment
plan in relation to the attainment
of stated goals; and
(6) assuring that discharge decisions and
arrangements for post discharge
follow-up are properly made.
(d) For each 20 patients or fraction thereof
dedicated treatment facilities and equipment shall
be provided as follows:
(1) A s peech therapy room with dimens ion s
which equal or exceed 175 square feet
and which is so designed and main
tained as to permit free movement of
three—fully—opened—reclining—wheel
chairs. A combined therapy space
equal to or exceeding 600 square feet,
adequately equipped and arranged to
support each of ffie therapies;
1360 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
&- Two occupational/phys ical therapy
rooms.—each—with—dimensions—which
ejqquuaall or excejeedd 6b0U0U square feet.—Each
room—
s
hall—be
—
equipped—wrtb
—
three
double size mat tables , one tilt table,
and one set of free standing or fold
allol bars .—Each roor to be
(4.
(5)
away par
plumbed with a sink suitable for hand
washing.—Each room s hall open direct
\y—te—a
—
whee l chair—accessible—water
clo set.
(2) Access to one full reclining wheel-chair
per patient.
(3) Special physical therapy and occu-pational
therapy equipment for use in
fabricating positioning devices for beds
and wheelchairs including splints, casts,
cushions, wedges, and bolsters.
(4) There shall be roll-in bath facilities
with a dressing area available to all
patients which shall afford maximum
privacy to the patient.
Statutory Authority G.S. 131E-104.
.1109 SPECIAL NURSING REQMTS FOR
BRAIN INJURY LONG TERM CARE
Direct care nursing personnel staffing ratios
established in Section .0500 of this Subchapter
shall not be applied to nursing services for patients
who require brain injury extended long term care^
due to their more intensive maintenance and
nursing needs . When s uch services are provided,
the table in thi s Rule establishes the minimum
acceptable—direct—eafe
—
nurs ing—
s
taff ratio s—pef
patient. The minimum direct care nursing staff
shall be 5JS hours per patient day, allocated on a
per shift basis as the facility chooses, to appropri-ately
meet the patients' needs. lt is also required
that regardless of how low the patient census, the
direct care nursing staff shall not fall below a
registered nurse and a nurse aide I at any time
during a 24-hour period. The minimum direct
care nursing staff ratios arc:
NH/P
LPN .8 NH/P
NH/P . 4 NH/P
NH/P
NA1 .75 NH/P -3-5
NH/P . 4 NH/P
NH/P
NA (Trainee) -000
Statutory Authority G.S. 131E-W4.
iSotice is hereby given in accordance with G.S.
150B-21.2 that the Medical Care Commission
(Division of Facility Services) intends to amend
rules cited as 10 NCAC 3H .0108, .0311, .0313 -
.0314. .0316 and .0505 and adopt rules cited as
10 NCAC 3C .2001 - .2008: 3H .1130- .1136.
1 he proposed effective date of this action is
February 1. 1993.
1 he public hearing will be conducted at 9:30
a.m. on December 4, 1992 at the Council Build-ing.
Room 201. 701 Barbour Drive. Raleigh. NC
27603.
Reason for Proposed Actions: To establish HIV
rules for hospitals and nursing homes which
develop HIV specialty units or facilities.
X^omment Procedures: Written comments should
be submitted to Jackie Sheppard, 701 Barbour
Drive. Raleigh, North Carolina 27603, by Novem-ber
16, 1992.
CHAPTER 3 - FACILITY SERVICES
SUBCHAPTER 3C - LICENSING OF
HOSPITALS
STAFF
SHIFT
POSITION
RATIO
REQUIRE
RN-NH/
P
1ST SHIFT
3RD SHIFT
STAFF RATIO
STAFF RATIO
.8 NH/P
. 4 NH/P
2ND
DALY
STAFF
\S5VT-SECTION
.2000 - SPECIALIZED
REHABILITATIVE AND HABILITATIVE
SERVICES
.2001 ADMISSIONS TO THE HIV
DESIGNATED UNIT
(a) No patient shall be discriminated against in
admission practices based on the diagnosis of
Human Immunodeficiency Virus disease.
(b) If a facility declines admission to a patient
7:14 NORTH CAROLINA REGISTER October 15, 1992 1361
PROPOSED RULES
known to have Human Immunodeficiency Virus
disease, the reasons for the denial shall be docu-mented.
Statutory Authority G.S. 131E-79.
.2002 DISCHARGE OF PATIENTS FROM
THE HIV DESIGNATED UNIT
A record shall be maintained of aU discharges of
patients indicating the reasons for discharge, the
physician's order for or other authorization for
discharge, and the condition of the patient at the
time of discharge.
A patient known to have Human Immunodefi-ciency
Virus disease may not be discharged solely
on the basis of the diagnosis of Human Immunode-ficiency
Virus disease except as authorized by the
provisions of N'.C. General Statute 1 3 1 E- 1 1 7 (15)
or other provisions of the N'.C. General Statutes or
regulations promulgated thereunder or provisions
of applicable federal laws and regulations.
Statutory Authority G.S. 131E-79.
.2003 HIV DESIGNATED UNIT POLICIES
AND PROCEDURES
(a) In units dedicated to the treatment of patients
with Human Immunodeficiency Vims disease,
policies and procedures specific to the specialized
needs of the patients served shall be developed.
At a minimum they shall include staff training and
education, and the availability of consultation by a
physician with specialized education or knowledge
in the management of Human Immunodeficiency
Virus disease.
(b) Policies and procedures for infection control
shall be in conformance with 29 CFR 1910
Occupational Safety and Health Standards which is
incorporated by reference including subsequent
amendments. Emphasis shall be placed on compli-ance
with 29 CFR 1910-1030 (Bloodbourne Patho-gens).
Copies of Title 29 Part 1910 may be
purchased from the Superintendent of Documents.
U.S. Government Printing Office. Washington.
D.C. 20402 for $38.00 and may be purchased with
a credit card by a direct telephone call to the
G.P.O. at (202) 783-3238. Infection control shall
also be in compliance with the Center of Disease
Control Guidelines as published by the U.S.
Department of Health and Human Services. Public
Health Service which is incorporated by reference
including subsequent amendments. Copies may be
rnnvha^cd from the Nationa l Te chnic al Information
Service. IS. Department of Commerce. 5285
Port Royal Road. Springfield. Virginia. 22161 for
S15.95.
Statutory Authority G.S. 131E-79.
.2004 PHYSICIAN SERVICES LN A HIV
DESIGNATED UNIT
In facilities with a Human Immunodeficiency
Virus designated unit the facility shall insure that
attending physicians have documented, pre-ar-ranged
access, either in person or by telephone, to
a physician with specialized education or knowl-edge
in the management of Human Immunodefi-ciency
Virus Disease.
Statutory Authority G.S. 131E-79.
.2005 SPECIAL NURSING
REQUIREMENTS FOR A HIV
DESIGNATED UNIT
(a) Facilities with a Human Immunodeficiency
Virus designated unit shall have a registered nurse
with specialized education or knowledge in the
care of Human Immunodeficiency Virus disease.
(b) Nursing personnel assigned to the Human
Immunodeficiency Virus unit shall be regularly
assigned to the unit. Rotations are acceptable to
alleviate staff burnout or staffing emergencies.
Statutory Authority G.S. 131E-79.
.2006 SPECIALIZED STAFF EDUCATION
FOR THE HIV DESIGNATED UNIT
For facilities with a Human Immunodeficiency
Virus designated unit an organized, documented
program of education specific to the care of pa-tients
infected with the Human Immunodeficiency
Virus shall be provided and include at a minimum:
( 1
)
Human Immunodeficiency Vims and
Acquired Immune Deficiency Syndrome
disease processes;
(2) transmission modes, causes, and preven-tion
of Human Immunodeficiency Vims;
(3) treatment of Human Immunodeficiency
Vims and Acquired Immune Deficiency
Syndrome;
(4) psycho-socio-economic needs of the
Human Immunodeficiency Vims and
Acquired Immune Deficiency Syndrome
patients;
(5) in addition to the general hospital orienta-tion
to Occupational Safety and Health
Administration guidelines for universal
precautions, orientation to infection
control specific to Human Immunodefi-ciency
Vims disease must be provided
1362 7:14 NORTH CAROLINA REGISTER October 15. 1992
PROPOSED RULES
16]
Ol
upon employment or permanent assign-ment
to the unit; Copies of Title 29 Part
1910 may be purchased from the Super-intendent
of Documents, U.S. Govern-ment
Printing Office, Washington, D.C.
20402 for $38.00 and may be purchased
with a credit card by a direct telephone
call to the G.P.O. at (202) 783-3238;
policies and procedures specific to the
Human Immunodeficiency Virus desig-nated
unit; and
annual continuing education jn infection
control.
Statutory Authority G.S. 131E-79.
.2007 USE OF INVESTIGATIONAL DRUGS
ON THE HIV DESIGNATED UNIT
(a) The supervision and monitoring for the
administration of investigational drugs is the
responsibility of the pharmacist and a licensed
registered nurse, acting pursuant to the orders of
a physician duly authorized to prescribe or dis-pense
such drugs. Responsibilities shall include,
but not be limited to. the following:
( 1
)
to insure the provision of written guide-lines
for any investigational drug or
study are provided; and
(2) training and determination of staffs
abilities regarding administration of
drugs, policies and procedures and
regulations.
(b) The pharmacist or physician dispensing the
investigational drug is to provide the facility with
information regarding at least the following:
( 1
a copy of the protocol, including drug
information;
a copy of the patient's informed con-sent;
drug storage;
handling;
any specific preparation and administra-tion
instructions;
specific details for drug accountability,
resupply and return of unused drug;
and
a copy of the signed consent to partici-pate
in the study.
(c) Labeling of investigational drugs shall be in
accordance with written guidelines of protocol and
State and federal requirements regarding such
drugs. Prescription labels for investigational drugs
are to be distinguishable from other labels by an
appropriate legend, "Investigational Drug" or "For
Investigational Use Only".
Ol
Ql
Mi
Ol
Ol
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Statutory Authority G.S. 131E-79.
.2008 SOCIAL WORK SERVICES IN A HIV
DESIGNATED UNIT
The facility shall provide either by direct em-ployment
or by contract for social work services to
include assistance to the patient [n identification of
supportive resources, financial services and assis-tance
with discharge and transfer arrangements. In
addition, for patients in a Human Immunodeficien-cy
Virus disease designated unit, the social worker
shall provide or arrange for the provision of
spiritual, pastoral and grief counseling for patients
and staff where appropriate. Support services
shall be provided to patient families and significant
others. Where necessary, coordination with
treatment services for substance abuse, legal
services and other community resources shall be
identified.
Statutory Authority G.S. 131E-79.
SUBCHAPTER 3H - RULES FOR THE
LICENSING OF NURSING HOMES
SECTION .0100 - GENERAL
INFORMATION
.0108 DEFINITIONS
The following definitions will apply throughout
this Subchapter:
(1) "Accident" means an unplanned or un-wanted
event resulting in the injury or
wounding, no matter how slight, of a
patient or other individual.
(2) "Adequate" means, when applied to
various services, that the services are at
least satisfactory in meeting a referred to
need when measured against contempo-rary
professional standards of practice.
(3) "Administrator" means the person who
has authority for and is responsible for
the overall operation of a facility.
(4) "Appropriate" means right for the speci-fied
use or purpose, suitable or proper
when used as an adjective. When used
as a transitive verb it means to set aside
for some specified exclusive use.
(5) "Brain injury extended care" is defined as
a multi- discipline maintenance program
for patients who have incurred brain
damage caused by external physical
trauma and who have completed a prima-ry
course of rehabilitative treatment and
have reached a point of no gain or prog-
7:14 NORTH CAROLINA REGISTER October 15, 1992 1363
PROPOSED RULES
(6)
(7)
(8)
(9)
(10)
(11)
(a)
(b)
(c)
(d)
(12)
(13)
151
ress for more than three consecutive
months. Services are provided through a
medically supervised interdisciplinary
process and are directed toward maintain- (4-S)
ing the individual at the optimal level of
physical, cognitive and behavioral func-tions.
"Capacity" means the maximum number
of patient or resident beds for which the (4-6)
facility is licensed to maintain at any
given time.
"Combination facility" means a combina-tion
home as defined in G.S. 131 E- 101. (4-?)
"Convalescent Care" means care given
for the purpose of assisting the patient or
resident to regain health or strength. (4-8)
"Department" means the North Carolina
Department of Human Resources.
"Director of Nursing" means the nurse
who has authority and direct responsibili- (4-9)
ty for all nursing services and nursing
care. (30)
"Drug" means substances:
recognized in the official United States
Pharmacopoeia, official National For-mulary,
or any supplement to any of
them;
intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of
disease in man or other animals;
intended to affect the structure or any
function of the body of man or other
animals, i.e., substances other than (34-)
food; and
intended for use as a component of any
article specified in (a), (b). or (c) of
this Subparagraph.
"Duly Licensed" means holding a current
and valid license as required under the
General Statutes of North Carolina.
"Existing Facility" means a facility cur- (33)
rently licensed or a proposed facility,
proposed addition to a licensed facility or
proposed remodeled licensed facility that
will be built according to plans and speci-fications
which have been approved by
the Department through the preliminary
working drawings state prior to the effec-tive
date of this Rule.
"Exit Conference" means the conference
held at the end of a survey or investiga- (35)
tion between the Department's represen-tatives
and the facility administration
representative.
"HIV Unit" means designated areas
dedicated to patients or residents known
to have Human Immunodeficiency Virus
disease,
(16 ) "Incident" means an unplanned or
unwanted event which has not caused a
wound or injury to any individual but
which has the potential for such should
the event be repeated.
(17 ) "Interdisciplinary" means an inte-grated
process involving a representative
from each discipline of the health care
team.
(18) "Licensed Practical Nurse" means a
nurse who is duly licensed as a practical
nurse under G.S. 90, Article 9A.
( 19 ) "Licensee" means the person, firm,
partnership, association, corporation or
organization to whom a license has been
issued.
( 20 ) "Medication" means drug as defined
in ( 1 1 ) of this Rule.
( 21 ) "New Facility" means a proposed
facility, a proposed addition to an exist-ing
facility or a proposed remodeled
portion of an existing facility that is
constructed according to plans and speci-fications
approved by the Department
subsequent to the effective date of this
Rule. If determined by the Department
that more than half of an existing facility
is remodeled, the entire existing facility
shall be considered a new facility.
(22 ) "Nurse Aide" means any individual
providing nursing or nursing-related
services to patients in a facility who is
not a licensed health professional, a
qualified dietitian or someone who volun-teers
to provide such services without
pay, and listed in a nurse aide registry
approved by the Department.
( 23 ) "Nurse Aide Trainee" means an
individual who has not completed an
approved nurse aide training course and
competency evaluation and is demonstrat-ing
knowledge, while performing tasks
for which they have been found profi-cient
by an instructor. These tasks shall
be performed under the direct supervision
of a registered nurse. The term does not
apply to volunteers.
(24) "Nursing Facility" means that por-tion
of a nursing home certified under
Title XIX of the Social Security Act
(Medicaid) as in compliance with federal
program standards for nursing facilities.
1364 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
)
It is often used as synonymous with the
term "nursing home" which is the usual
prerequisite level of state licensure for
nursing facility (NF) certification and
Medicare skilled nursing facility (SNF)
certification.
(34) (25) "Nurse in Charge" means the nurse
to whom duties for a specified number of
patients, residents and staff for a speci-fied
period of time have been delegated,
such as for Unit A on the 7-3 or 3-11
shift.
(35) (26) "On Duty" means personnel who are
awake, dressed, responsive to patient
needs and physically present in the facili-ty
performing assigned duties.
(36) (27) "Operator" means the owner of the
nursing home business.
(37) (28) "Patient" means any person admitted
for nursing care.
(38) (29) "Person" means an individual, trust,
estate, partnership or corporation includ-ing
associations, joint-stock companies
and insurance companies.
(39) (30) "Proposal" means a Negative Action
Proposal containing documentation of
findings that may ultimately be classified
as violations and penalized accordingly.
(30) (3_1) "Provisional License" means an
amended license recognizing significantly
less than full compliance with the licen-sure
rules.
(34) (32) "Physician" means a person licensed
under G.S. Chapter 90, Article 1 to
practice medicine in North Carolina.
(33) (33) "Qualified Dietitian" means a person
who meets the standards and qualification
established by the Commission on Dietet-ic
Registration of the American Dietetic
Association.
(33) (34) "Qualified Activities Director"
means a person who has the authority
and responsibility for the direction of all
therapeutic activities in the nursing facili-ty
and who meets the qualifications set
forth under 10 NCAC 3H .1204.
(34) (35) "Qualified Pharmacist" means a
person who is licensed to practice phar-macy
in North Carolina and who meets
the qualifications set forth under 10
NCAC 3H .0903.
(35) (36) "Qualified Social Services Director"
means a person who has the authority and
responsibility for the provision of social
services in the nursing home and who
meets the qualifications set forth under
10 NCAC 3H .1306.
(36) (37) "Registered Nurse" means a nurse
who is duly licensed as a registered nurse
under G.S. 90, Article 9A.
(37) (38) "Resident" means any person admit-ted
for care to a domiciliary home part of
a combination home as defined in G.S.
131E-101.
(38) (39) "Sitter" means an individual em-ployed
to provide companionship and
social interaction to a particular patient,
usually on a private duty basis.
(39) (40) "Supervisor-in-Charge (domiciliary
home)" means any employee to whom
supervisory duties for the domiciliary
home portion of a combination home
have been delegated by either the Admin-istrator
or Director of Nursing.
(40) (4J_) "Surveyor" means an authorized
representative of the Department who
inspects nursing facilities and combina-tion
facilities to determine compliance
with rules as set forth in G.S. 131 E- 117
and applicable state and federal laws,
rules and regulations.
(44) (42) "Ventilator dependence" is defined
as physiological dependency by a patient
on the use of a ventilator for more than
eight hours a day.
(43) (43) "Violation" means a finding which
directly relates to a patient's health,
safety or welfare or which creates a
substantial risk that death or serious
physical harm will occur and is deter-mined
to be an infraction of the regula-tions,
standards and requirements set
forth in G.S. 131 E- 117 or applicable
State and federal laws, rules and regula-tions.
Authority G.S. 1 31 E- 104; 42 U.S.C. 1396 r (a).
SECTION .0300 - GENERAL STANDARDS
OF ADMINISTRATION
.0311 ADMISSIONS
(a) No patient shall be admitted except under the
orders of a duly licensed physician.
(b) The Administrator shall assure tuberculosis
and other communicable disease screening on
admission and tuberculosis screening annually
thereafter until final discharge. Identification of a
communicable disease does not, in all cases, in
and of itself, preclude admission to the facility.
7:14 NORTH CAROLINA REGISTER October 15, 1992 1365
PROPOSED RULES
The facility shall provide appropriate care and
treatment.
(c) The facility shall acquire prior to or at the
time of admission orders from the attending physi-cian
for the immediate care of the patient or
resident.
(d) Within 48 hours of admission, the facility
shall acquire medical information which shall
include current medical findings, diagnosis, reha-bilitation
potential, a summary of the hospital stay
if the patient is being transferred from a hospital,
and orders for the ongoing care of the patient.
(e) If a patient is admitted from somewhere
other than a hospital, a physical examination shall
be performed either within 5 days prior to admis-sion
or within 48 hours following admission.
(f) New facilities must prepare a plan of admis-sion
which, at a minimum, assures ayailable staff
time and plans for individual patient assessment,
initiation of health care or nursing care plans, and
implementation of physician and nursing treatment
plans. This plan must be ayailable for inspection
during the initial licensure survey prior to issuance
of a license.
(g) Only persons who are 18 years of age or
older shall be admitted to the domiciliary home
portion of a combination facility.
Statutory Authority G.S. 131E-104.
.0313 DISCHARGE OF PATIENTS
A record shall be maintained of all discharges of
patients indicating the reasons for discharge, the
physician's order for or other authorization for
discharge, and the condition of the patient at the
time of discharge.
A patient known to have Human Immunodefi-ciency
Virus disease may not be discharged solely
on the basis of the diagnosis of Human Immunode-ficiency
Virus disease except as authorized by the
provisions of N.C General Statute 1 3 1 E- 1 17 (15)
or other provisions of the N.C. General Statutes or
regulations promulgated thereunder or provisions
of applicable federal laws and regulations.
Statutory Authority G.S. 131E-104.
.0314 POLICIES AND PROCEDURES
The facility Administrator shall assure written
policies and procedures which are available to and
implemented by staff. These policies and proce-dures
shall cover at least the following areas:
(1) admissions;
(2) dietary;
(3) discharges with physician orders and/or
patients or residents leaving against
physician advice;
(4) gratuities and solicitation which at a
minimum shall provide that no owner,
operator, agent or employee of a facility
nor any member of his family shall ac-cept
a gratuity directly or indirectly from
any patient or resident in the facility or
solicit for any type of contribution;
(5) housekeeping;
(6) infection control which must include, but
is not limited to, requirements for ster-ileT
and aseptic and isolation techniques;
universal and isolation precautions and
communicable disease screening includ-ing
at a minimum annual tuberculosis
screening for all staff and inpatients of
the facility;
(7) maintenance of patient medical or health
care records including charting or record
keeping;
(8) orientation of all facility personnel;
(9) patient or resident care plans, treatment
and other health care or nursing care,
including but not limited to all policies
and procedures required by rules con-tained
in this Subchapter;
(10) patients' or residents' rights;
(11) physical evaluation for residents and
patients at least annually;
(12) physician services and utilization of the
individual's private physician;
(13) procurement of supplies and equipment to
meet individual patient care needs;
(14) protection of patients from abuse and
neglect;
(15) range of services provided;
(16) recording and reporting to the Depart-ment
of accidents or incidents occurring
to patients in any part of the facility and
maintenance of such reports or records;
(17) rehabilitation services;
(18) release of medical record information;
(19) screening and reporting communicable
disease to the Department (Division of
Health Services) and local health Depart-ment;
(20) transfers.
Statutory Authority G.S. 131E-104.
.0316 SAFETY AND ENVIRONMENTAL
CONTROL
(a) A licensed facility shall have policies and
procedures for patient safety and for environmental
1366 7:14 XORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
control which at a minimum shall include infection
control.
(b) A facility with a licensed capacity of 51 beds
or more shall have a safety and environmental
control committee which includes representation
from administration; medical and nursing staff;
pharmacy; maintenance, engineering or housekeep-ing;
and dietary services.
(c) A facility with a licensed capacity of 50 beds
or less shall have a safety and environmental
control committee which at a minimum includes
the Administrator and Director of Nursing.
(d) All committee members shall be designated
in writing.
(e) Responsibilities and duties of any safety and
environmental committee shall include, but not be
limited to, the following:
(1) meet at least quarterly, maintain min-utes
insufficient detail to document
committee proceedings and actions, and
submit reports to the Administrator;
(2) establish an incident and accident re-porting
system in accordance with
facility policies which includes a mech-anism
for reviewing, investigating and
evaluating all incidents and accidents
reported. The committee shall docu-ment
all reviews and action(s) taken;
(3) conduct hazard surveillance program;
(4) conduct fire protection program which
includes:
(A) development and adoption of a com-prehensive
fire and disaster plan;
(B) instruction and fire drills for all em-ployees
in the following:
mi use of all alarms and signals;
(ii) methods of fire containment;
(iii) location and use of fire fighting
equipment;
(iv) where, when and how to shut off
oxygen and air conditioning;
(v) evacuation routes and procedures;
and
(vi) transmission of an alarm to the
fire Department or other responsi-ble
emergency services;
(C) assignment of specific responsibilities
and tasks to all personnel in response
to an alarm; and a fire drill for each
shift of employees at least quarterly;
(5) conduct water temperature surveillance
program which assures compliance with
Rule .1807(d) of this Subchapter;
(6) annually review policies and procedures
for infection and communicable disease
control;
(A) handling food;
(B) processing laundry;
(C) disposing of environmental or other
wastes and patient or resident surgical
or wound dressings, personal care
pads or other wastes;
(D) controlling pests and reporting infec-tions
and diseases;
(7) monitor overall environmental/infection
control and implementation of safety
policies and procedures; a«d
(8) monitor staff development to assure
active ongoing inservice training at
least annually which shall include uni-versal
precautions and tfi other areas of
safety and environmental/infection
control for all personnel; and
(9) acting on requirements or recommenda-tions
from Occupational Safety and
Health Administration inspectors.
Statutory Authority G.S. 131E-104.
SECTION .0500 - NURSING SERVICES
.0505 NURSING/HEALTH CARE
ADMINISTRATION AND
SUPERVISION
(a) A licensed facility shall have a Director of
Nursing service who shall be responsible for the
overall organization and management of all nursing
services and shall be currently licensed to practice
as a registered nurse by the North Carolina Board
of Nursing in accordance with G.S. 90, Article
9A.
(b) The Director of Nursing shall not serve as
Administrator or Assistant Administrator.
(c) A licensed facility, with nursing facilities or
combination facilities shall provide a full-time
Director of Nursing on duty at least eight hours
per day, five days a week. A registered nurse
shall relieve the Director of Nursing (be in charge
of nursing) during the Director's absence.
(d) A licensed facility shall employ and assign
registered nurse, licensed practical nurses and
nurse aides for duties in accordance with G.S. 90,
Article 9A.
(e) The Director of Nursing shall cause the
following to be accomplished:
(1) establishment and implementation of
nursing policies and procedures which
shall include but not be limited to the
following;
(A) assessment of the planning for
7:14 NORTH CAROLINA REGISTER October 15. 1992 1367
PROPOSED RULES
(B)
(C)
(D)
(E)
(] I
(G)
(H)
patients" nursing care or health care
needs, and implementation of nurs-ing/
health care plans;
daily charting of any unusual occur-rences
of acute episodes related to
patient care, and progress notes writ-ten
monthly reporting each patient's
performance in accordance with iden-tified
goals and objectives and each
patient's progress toward rehabilita-tive
nursing goals;
assurance of the delivery of nursing
services in accordance with
physicians' orders, nursing care plans
and the facility's policies and proce-dures;
notification of emergency physicians
or on-call physicians;
infection control to prevent cross-infection
among patients and staff
shall be in conformance with 29 CFR
1910 (Occupational Safety and Health
Standards) which is incorporated by
reference including subsequent
amendments. Emphasis shall be
placed on compliance with 29 CFR
1910-1030 (Bloodbourne Pathogens).
Copies of Title 29 Part 1910 may be
purchased from the Superintendent of
Documents. U.S. Government Print-ing
Office. Washington. D.C. 20402
for $38.00 or may be purchased with
a credit card by telephone to the
Government Printing Office at (202)
783-3238. Infection control shall also
be in compliance with the Center of
Disease Control Guidelines as pub-lished
by the U.S. Department of
Health and Human Services, Public
Health Service which is incorporated
by reference including subsequent
amendments. Copies may be pur-chased
from the National Technical
Information Service. U.S. Department
of Commerce. 5285 Port Royal Road.
Springfield. Virginia. 22161 for
$15.95.
reporting of deaths;
emergency reporting of fire, patient
or staff accidents or incidents, or
other emergency situations;
use of protective devices or restraints
to assure that each patient or resident
is restrained in accordance with physi-cian
orders and the facility's policies.
and that the restrained patient or
resident is appropriately evaluated and
released at a minimum of every 2
hours;
(I) special skin care and decubiti care;
(J) bowel and bladder training;
(K) maintenance of proper body alignment
and restorative nursing care;
(L) supervision of and assisting patients
with feeding;
(M) intake and output observation and
reporting for those patients whose
condition warrants monitoring of their
fluid balance. This will include those
patients on intravenous fluids or tube
feedings, and patients with kidney
failure and temperatures elevated to
102 degrees F. or above;
(N) catheter care; and
(O) procedures used in caring for patients
in the facility.
(2) development of written job descriptions
for nursing personnel;
(3) periodic assessment of the nursing
department with identification of per-sonnel
requirements as they relate to
patient care needs and reporting same
to the Administrator;
(4) a planned orientation and continuing
inservice education program for nursing
employees and documentation of staff
attendance and subject matter covered
during inservice education programs;
(5) obtaining and provision of appropriate
reference materials for the nursing
Department, which include a
Physician's Desk Reference or compa-rable
drug reference, policy and proce-dure
manual, and medical dictionary for
each nursing station; and
(6) establishment of operational procedures
to assure that appropriate supplies and
equipment are available to nursing staff
as determined by individual patient care
needs.
Authority G.S. 131E-104; 42 U.S.C. 1396 r (a).
SECTION .1100 - SPECIALIZED
REHABILITATIVE AND HABILITATIVE
SERVICES
.1130 ADMISSIONS TO THE HIV
DESIGNATED UNIT
(a) No patient shall be discriminated against in
<
1368 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
admission practices based on the diagnosis of
Human Immunodeficiency Virus disease.
(b) If a facility declines admission to a patient
known to have Human Immunodeficiency Virus
disease, the reasons for the denial shall be docu-mented.
Statutory Authority- G.S. 131E-104.
.1131 fflV DESIGNATED UNIT POLICIES
AND PROCEDURES
(a) In addition to .0314, in units dedicated to the
treatment of patients with Human Immunodeficien-cy
Virus disease, policies and procedures specific
to the specialized needs of the patients served shall
be developed. At a minimum they shall include
staff training and education, and the availability of
consultation by a physician with specialized educa-tion
or knowledge in the management of Human
Immunodeficiency Virus disease.
(b) Policies and procedures for infection control
shall be in conformance with 29 CFR 1910
(Occupational Safety and Health Standards) which
js incorporated by reference including subsequent
amendments. Emphasis shall be placed on compli-ance
with 29 CFR 1910-1030 (Bloodbourne Patho-gens).
Copies of Title 29 Part 1910 may be
purchased from the Superintendent of Documents.
U.S. Government Printing Office. Washington.
D.C. 20402 for $38.00 or may be purchased with
a credit card by telephone to the Government
Printing Office at (202) 783-3238. Infection
control shall also be jn compliance with the Center
of Disease Control Guidelines as published by the
U.S. Department of Health and Human Services.
Public Health Service which js incorporated by
reference including subsequent amendments.
Copies may be purchased from the National
Technical Information Service. U.S. Department
of Commerce. 5285 Port Royal Road. Springfield.
Virginia. 22161 for $15.95.
Statutory Authority G.S. 131E-104.
. 1 133 SPECIAL NURSEVG REQUIREMENTS
FOR A HIV DESIGNATED UNIT
(a) Facilities with a Human Immunodeficiency
Virus designated unit shall have a registered nurse
with specialized education or knowledge in the
care of Human Immunodeficiency Virus disease.
(b) Nursing personnel assigned to the Human
Immunodeficiency Virus unit shall be regularly
assigned to the unit. Rotations are acceptable to
alleviate staff burnout or staffing emergencies.
Statutory Authority G.S. 131E-104.
.1134 SPECIALIZED STAFF EDUCATION
FOR HIV DESIGNATED UNITS
For facilities with a Human Immunodeficiency
Virus designated unit, an organized, documented
program of education specific to the care of pa-tients
infected with the Human Immunodeficiency
Virus shall be provided and include at a minimum:
(1) Human Immunodeficiency Virus and
Acquired Immune Deficiency Syndrome
disease processes;
transmission modes, causes, and preven-tion
of Human Immunodeficiency Virus;
treatment of Human Immunodeficiency
Virus and Acquired Immune Deficiency
Syndrome;
psycho-socio-economic needs of the
Human Immunodeficiency Virus and
Acquired Immune Deficiency Syndrome
patients;
universal precautions and infection con-trol;
and
policies and procedures specific to the
Human Immunodeficiency Virus desig-nated
unit.
£21
111
£41
151
161
Statutory Authority: Q_ s. 131E-104.
Statutory Authority G. S. 131E-104.
.1132 PHYSICIAN SERVICES IN A
HIV DESIGNATED UNIT
In facilities with a Human Immunodeficiency
Virus designated unit, the facility shall insure that
attending physicians have documented,
pre-arranged access in person or by telephone to a
physician with specialized education or knowledge
in the management of Human Immunodeficiency
Virus Disease.
. 1 135 USE OF EWESTIGATIONAL
DRUGS FOR HIV DESIGNATED
UNITS
(a) The supervision and monitoring for the
administration of investigational drugs is the
responsibility of the pharmacist and a licensed
registered nurse, acting pursuant to the orders of
a physician duly authorized to prescribe or dis-pense
such drugs. Responsibilities shall include,
but not be limited to. the following:
( 1 ) insuring the provision of written guide-lines
for any investigational drug or
study are provided; and
7:14 NORTH CAROLINA REGISTER October 15, 1992 1369
PROPOSED RULES
(2) training and determination of staffs
abilities regarding administration of
drugs, policies, procedures and regula-tions.
(b) The pharmacist or physician dispensing the
investigational drug is to provide the facility with
information regarding at least the following:
03
m
m
[4]
(5]
a copy of the protocol, including drug
information;
a copy of the patient's informed con-sent;
drug storage;
handling:
any specific preparation and administra-tion
instructions;
(6) specific details for drug accountability,
resupply and return of unused drug;
and
(7) a copy of the signed consent to partici-pate
in the study.
(c) Labeling of investigational drugs shall be in
accordance with written guidelines of protocol and
State and federal requirements regarding such
drugs. Prescription labels for investigational drugs
are to be distinguishable from other labels by an
appropriate legend, "Investigational Drug" or "For
Investigational Use Only".
Statutory Authority- G.S. 131E-104.
.1136 ADDITIONAL SOCIAL WORK
REQUIREMENTS FOR fflV
DESIGNATED UNITS
]n addition to the social work services specified
in . 1307, in facilities with a Human Immunodefi-ciency
Virus disease designated unit, the social
worker shall provide or arrange for the provision
of spiritual, pastoral and grief counseling and
bereavement services for patients and staff where
appropriate. Support services shall be provided to
resident families and significant others. Where
necessary, coordination with treatment services for
substance abuse, legal sen ices and other commu-nity
resources shall be identified.
Statutory Authority G.S. 131E-104.
Notice is hereby given in accordance with G.S.
150B-21.2 that the Division of Facility Services
intends to amend rule cited as 10 NCAC 3R . 2801.
The proposed effective date of this action is
January 4, 1993.
1 he public hearing will be conducted at 2:00
p.m. on November 18, 1992 at the Council Build-ing,
Room 201, 701 Barbour Drive. Raleigh, NC
27603.
MXeason for Proposed Action: To expand the
definition of rehabilitation beds to include nursing
homes.
Ksomment Procedures: Written comments should
be submitted to Jackie Sheppard, 701 Barbour
Drive, Raleigh. NC 27603, by November 16, 1992.
CHAPTER 3 - FACILITY SERVICES
SUBCHAPTER 3R - CERTIFICATE OF
NEED REGULATIONS
SECTION .2800 - CRITERIA AND
STANDARDS FOR REHABILITATION
SERVICES
.2801 DEFINITIONS
The definitions in this Rule will apply to all rules
in this Section.
(1) "Rehabilitation Facility" means a facility
as defined in G.S. 131E-176.
(2) "Rehabilitation" means the process to
maintain, restore or increase the function
of disabled individuals so that an individ-ual
can live in the least restrictive envi-ronment,
consistent with his or her objec-tive.
(3) "Outpatient Rehabilitation Clinic" is
defined as a program of coordinated and
integrated outpatient services, evaluation,
or treatment with emphasis on improving
the functional level of the person in
coordination with the patient's family.
(4) "Rehabilitation Beds" means inpatient
beds in a facility or a unit of a facility
licensed pursuant to 10 NCAC 3C .0201-
or 10 NCAC 3H .0200.
(5) "Traumatic Brain Injury" is defined as an
insult to the brain that may produce a
diminished or altered state of conscious-ness
which results in impairment of
cognitive abilities or physical functioning.
It can also result in the disturbance of
behavioral or emotional functioning.
1370 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
These impairments may be either tempo-rary
or permanent and cause partial or
total functional disability or psychological
maladjustment.
(6) "Stroke" (cerebral infarction, hemor-rhage)
is defined as the sudden onset of a
focal neurologic deficit due to a local
disturbance in the blood supply to the
brain.
(7) "Spinal Cord Injury" is defined as an
injury to the spinal cord that results in
the loss of motor or sensory function.
(8) "Pediatric Rehabilitation" is defined as
inpatient rehabilitation services provided
to persons 14 years of age or younger.
Statutory- Authority G.S. 131E-177; 1 31 E-l 83(b).
ISotice is hereby given in accordance with G.S.
150B-21.2 that the Division of Facility Services
intends to adopt rules cited as 10 NCAC 3R .3032,
.3050 and amend rules cited as 10 NCAC 3R
.3001. .3020. .3030. .3040.
1 he proposed effective date of this action is
January 4. 1993.
1 he public hearing will be conducted at 2:00
p.m. on October 30, 1992 at the Council Building,
Room 201, 701 Barbour Drive, Raleigh, NC
27603.
txeason for Proposed Action: To establish rules
for the 1993 State Medical Facilities Plan.
Ksonvnent Procedures: Written comments should
be submitted to Jackie Sheppard, 701 Barbour
Drive. Raleigh, North Carolina 27603, by Novem-ber
16. 1992.
CHAPTER 3 - FACILITY SERVICES
SUBCHAPTER 3R - CERTIFICATE OF
NEED REGULATIONS
SECTION .3000 - STATE MEDICAL
FACILITIES PLAN
.3001 CERTIFICATE OF NEED REVIEW
CATEGORIES
The agency has established nine categories of
facilities and services for certificate of need review
and will determine the appropriate review category
or categories for all applications submitted pursu-ant
to 10 NCAC 3R .0304. For proposals which
include more than one category, the agency wi4+
may require the applicant to submit separate
applications. If it is not practical to submit sepa-rate
applications, the agency will determine in
which category the application will be reviewed.
The review of an application for a certificate of
need will commence in the next review schedule
after the application has been determined to be
complete. The nine categories of facilities and
services are:
(1) Category A. Includes proposals for acute
health service facilities including but not
limited to the following types of projects:
renovation, construction, major medical
equipment, technology and other ancil-lary
and support equipment and services,
except those proposals included in
CategoriesB through I.
(2) Category B. Includes proposals for
long-term nursing facility beds which are
reviewed against the State Medical Facili-ties
Plan.
(4) Category D. Includes proposals for new
or expanded end-stage renal disease
treatment facilities; and relocations of
existing dialysis stations to another coun-
(5) Category E. Includes proposals for new
or expanded inpatient rehabilitation facili-ties
and inpatient rehabilitation beds in
other health care facilities.
(6) Category F. Includes proposals for new
or expanded ambulatory surgical facili-ties.
(7) Category G. Includes proposals involv-ing
cost overruns; addition of one dialy
s i s s tation for i solation of patients ; expan-sions
of existing continuing care or life
eafe facilities which are applying under
exemptions from need projections in the
Pten determinations in K) NCAC 3R
.3030 ; relocations within the same county
of existing health service facilities.^ beds
or dialysis stations which do not involve
an increase in the number of health ser-vice
facility beds; with the exception of
relocating dialy s i s s tation s ; reallocation
of beds or stations ; due to withdrawal s or
relinqui shments of certificate s of need;
hospital proposals to convert acute onre
7:14 NORTH CAROLINA REGISTER October 15, 1992 1371
PROPOSED RULES
(8)
(9!
beds—te
—
short term—nursing: proposals
submitted by Academic Medical Center
Teaching Hospitals designated prior to
January 1. 1990: and any other proposal
not included in Categories A through F,
Category H, or Category I.
Category H. Includes—proposals—fef
demons tration projects identified in thi s
Plan: special allocation of 1CF MR beds
•fef
—
Thomas—&-.—cla ss
—
members—only.
Includes proposals for new continuing
care or life eafe facilities applying for
exemption under 10 NCAC 3R
.3050(bi(2i and new home health agen-cies
or offices.
<
Category I. Includes proposals for new
continuing care or life care facilitie s and
new
—
home—health—agencies—©f
—
offices.
Includes proposals for converting hospital
beds to nursing care under 10 NCAC 3R
.3050(b)(1).
Statutory Authority G.S.
131E-177(I); 131E-183(1>.
1 31 E-l 76(25):
.3020 CERTIFICATE OF NEED REVIEW SCHEDULE
The agency has established the following schedule for review of categories and subcategories of facilities
and services in 1992:
(1) Category B. Subcategory Long-Term Nursing Facilities.
County HSA CON Beginning
Review Date
. \llcghanv February 1. 1992
Cleveland February 1. 199
February 1. 1992
Burke Augus t 1. 1992
Jackson August 1. 1992
Alamanc 14 February 1. 1992
Cas wcl 14 February 1. 1992
Rockingham H February I. 1992
Devi H Augus t 1. 1992
Yadkin H August 1. 1992
Mecklenburg H4 March 1. 199:
Stanlv 144 September 1. 1992
1372 7:14 SORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
Chatham
Person
Wake
Warren
Cumberland
Moore
Robeson
Scotland
Bladen
New Hanover
Beaufort
Nesh-
Northompton
Craven
Hertford
Pamlieo
Wilson
Macon
Mitchel
Johnston
Harnett
Wayne
Duplin
Washington
Wilkes
W
IV
w
FV
v+
¥4
V4
V4
VI
V4
V4
[V
V
VI
VI
VI
March 1, 1992
March 1 , -W2 1993
September I. 1992
September 1. 1992
April 1. 1992
April 1, 1992
April 1. 1992
April 1, 1992
October 1. 1992
October 1. 1992
April 1. 1992
April 1. 1992
April 1. 1992
October 1. 1992
October 1
April 1. 1993
993
October 1. 1992
October 1. 1992
August 1. 1993
August L 1993
March 1, 1993
October 1, 1993
April 1993
October 1993
October 1. 1993
February K 1993
(2) Category C. Subcategory Intermediate Care Facilities for Mentally Retarded.
County HSA CON Beginning
Review Date
Jackson. Haywood. Macon. Cherokee. Clay.
Graham. Swain
December 1. 1992
Transylvania. Henderson December 1. 1992
Caldwe l l. Burke . Al exander. McDowell December 1. 1992
7:14 NORTH CAROLINA REGISTER October IS, 1992 1373
PROPOSED RULES
Rutherford, Polk Juno t^93
Cleveland ha +993
Mecklenburg III May 1 , 4993 1993
Surry, Yndkin H June 1, 1992
Forsyth. Stokes 14 June 1, 1992
Alamance. Cas wel 44 November 1993
Orange. Person. Chatham 4V May 1. 1992
Vance. Granville. Franklin. Warren W November W93
Davidson 44 November 4993
Cumberland December M?93
Johnston 4V May 1. 1992
Wake 4V November 1993
Randolph 44 November 1, 1992
New Hanover. Brunswick, Pender B-coomBcr 1993
Onslow V4 Juno 1. 1992
Wil son, Greene V4 k993
Edgecombe, Nas h V4 June 1, 1992
Hertford. Bertie, Gates, Northampton V4 December 1. 1992
Pasquotank. Chowan, Perquimans, Camden,
Dare, Currituck
V4 December 1, 1992
Buncombe. Madison. Mitchell. Yancey June 1. 1993
Moore. Hoke. Richmond, Montgomery,
Anson
V June L 1993
Craven. Jones. Pamlico, Carteret VI June 1. 1993
Pitt VI June 1993
Beaufort. Washington, Tyrrell. Hyde. Martin V] December 1. 1993
(3) Category D. Subcategory End Stage Renal Disease Treatment Facilitie s . Dialysis Stations.
Dialysis station review shall be conducted under the provisions of NCAC 3R .3032.
Counties uc,\ CON Beginning
Review Date
Cherokee. Clay. Graham. Jackson. Macon.
Swain
April 1. 1992
Buncombe. Haywood. Madison, Mitchell,
Yanccv
October 1, 1992
1374 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
Henderson, Polk. Transylvania October 1, 1992
Ashe, Avery, Caldwell, Watauga, Wilkes April 1, 1992
Burke, McDowell October W93
Rutherford April 1, 1992
Alexander. Catawba October W93
Alleghany, Stokes, Surry H October 1, 1992
Davidson 44 October 1, 1992
Caswell, Rockingham 44 October 1, 1992
Randolph 14 April 1, 1992
Alamance 14 April 1, 1992
Gaston 444 May 1, 1992
Lincoln 444 May 1, 1992
Rowan 444 October 1, 1992
Cabarrus 444 October 1, 1992
Montgomery. Stanly 444 October 1, 1992
Chatham, Lee W October 1. 1992
Person 4V May 1, 1992
W«4« W October HW3
Johnston W October W92
Franklin, Vance, Warren W May 1, 1992
Anson Augus t 1, 1992
Cumberland, Hoke April 1, 1992
Harnett April 1, 1992
Sampson April 1, 1992
Bladen August 1, 1992
Robeson Augus t 1, 1992
Pender August 1, 1992
Bruns wick Augus t 1, 1992
Duplin V4 April 1, 1992
Wayne V4 April 1, 1992
7:14 NORTH CAROLINA REGISTER October 15, 1992 1375
PROPOSED RULES
Edgecombe. Nash ¥4 April 1, 1992
Gates, Halifax, Hertford, Northampton ¥4 August 1, 1992
Bertie, Washington ¥4 August 1, 1992
Martin V4 April 1, 1992
Greene, Pitt ¥4 August 1, 1992
Beaufort ¥4 August 1, 1992
Carteret, Craven, Jones. Pamlico ¥4 August 1, 1992
Onslow ¥4 August 1, 1992
(4) Category I. Subcategory Home Health Agencies.
County HSA
CON Beginning
Review Date
Mecklenburg 444 February 1. 1992
Randolph 44 April I. 1992
Wilkes April 1, 1992
Davidson April 1, 1993
Forsyth April L 1993
Guilford October 1, 1993
Dare VI February 1993
(5) All categories for which review dates are not specified in Subparagraph (1), (2), (3), (4) of
this Rule.
REVIEW
PERIOD
HSA I HSA II HSA III HSA IV HSA V HSA VI
January 1
-- — - -- -- —
February 1 B. G. I B, G, I A. G, E, A, G, E,
hL I
A, G, E.
±L I
A, G, E,
March 1 - - B, G B, G — —
April 1 a, ©. g,
E, H, 4
A. ©, G.
E, FL4
-- -- B, G, © B, G, B
May 1 - -- C. G, F. © C, G, F. © -- --
1376 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
June 1 A. C, G,
F, D
A, C. G,
F, D
D D A. C, G,
F. D
A, C, G,
F, D
July 1 - - A, G, I, H A, G, 4, H -- --
August 1 B. G B, G -- -- ©, G, E,
J, H
©, G, E,
1, H
September 1 - - B, G, E B, G, E -- -
October 1 »r G, E,
H,4
Dt g, e,
H, 1
ih-9 ih-9 B. G, H B, G, H
November 1
-- A, C, G. F A, C, G. F A, C, G. F - -
December 1 A, C. EX
G, F
D D D A, C, EX.
G, F
a, c, rx
G, F
Statutory Authority G.S. 1 31 E-l 76(25); 131E-177(1); 131E-183(1).
.3030 FACILITY AND SERVICE NEED DETERMINATIONS
Facility and services allocation s need determinations are shown in Items (1) - (8) of this Rule. The
allocations are subject to reductions based on certificates of need awarded since November 15, 1991.
after September 17, 1992:
(1) Category A. Acute Health Service Facilities.
Morchead Memorial Hospital Service System HSA II 16 beds
Halifax Memorial Hos pital Service System HSA VI 17 beds
UNC Hospital Service System
C. J. Harris Community Hospital System
HSA IV 15 beds (University
students )
HSA 1 5 beds I
(2) Category B. Long-Term Nursing Facility Beds.
County HSA Number of
Nursing
Beds Allocated
Needed
Alleghany 30
Cleveland 60
pn 1 u
1 Ull^ 40
Bwke 60
Jackson 30
Alamance H 60
Caswell 14 30
Rockingham H 80
Davie 14 90
Yadkin 14 60
7:14 NORTH CAROLINA REGISTER October 15, 1992 1377
PROPOSED RULES
Mecklenburg m 4-QU
C*—1.. w 60
Chatham IV 69
Person IV 39 30
Wske IV 70
Warren FV 30
Cumberland V 90
Moore V 60
Robeson V 4
Seotland V 30
Bladen V 40
New Hanover V i nn
Beaufort V4 40
Nas4> Yi 60
Northampton V4 30
Craven Vi 60
Hertford VI 20
Pamlico V4 30
Wilson ¥i 60
Macon I 30
Mitchell I 20
Johnston IY 50
Harnett V 90
Duplin Yi 30
Washington Yl 10
Wayne YJ 50
Wilkes I 70
(3) Category' C.
(a) Psychiatric Facility Beds. ]t is determined that there is no need for additional beds and
no rev iews are scheduled.
Counties -9-
Adult Child/Adolescent
137X 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
Caldwell, Burke. Alexander-
McDowel l
jaston. Lincoln
Rowan. Iredell. Davie
Stanly. Cabarrus. Union
Surrv. Yadkin
Rockingham
Vance. Granville. Franklin.
Warren
Davidson
Lee. Harnett
Wake
Craven. Jones. Pamlico.
Carteret
Lenoir
Beaufort. Was hington. Tyrrell.
Hyde. Martin
444
444
444
44
44
FV
44
4V
V4
V4
V4
44
i-9
56
54
i€
44
444
44
444
4^
(b) Intermediate Care Facilities for Mentally Retarded Beds.
45
444
Counties HSA Allocation
Need Determina-tion
Child Adult
Jackson. Haywood. Macon. Cherokee.
Clay. Graham. Swain
45
Transylvania. Henderson 45
GfM\ Burke. Alexander. McDowel
Rutherford. Polk
Cleveland 18
Mecklenburg 111 6 48 24
Surry. Yadkin 44
Forsyth. Stokes 44 45
Alamance. Cns wcl 44 18
Orange. Person. Chatham 44- 45
Vance. Granville, Franklin. Warren 44
David son 44
7:14 NORTH CAROLINA REGISTER October 15, 1992 1379
PROPOSED RULES
Cumberland V J-8
Johnston W 6
Wake fV 43
Randolph H +3
New Hanover. Brunswick. Ponder V 6
Onslow VI +8
Wilson. Greene V4 6
Edgecombe. Nash ¥i 6
Hertford. Bertie. Gates. Northampton \4 6
Pasquotank. Chowan. Perquimans.
Camden. Dare. Currituck
VI
6
Buncombe, Madison, Mitchell. Yancev I 6 6
Moore. Hoke. Richmond. Montgomery,
y 18
Anson
Craven. Jones. Pamlico. Carteret YJ 6
Pitt YJ 6
Beaufort. Washington. Tvrrell. Hyde,
YJ 6 18
Martin
t
I
(c) Substance Abuse and Chemical Dependency Facility Beds. No allocation . It is determined
that there is no need for additional beds and no reviews are scheduled.
(4) Category D. End Stage Renal Disease Treatment Facilities. Need for end-stage renal
dialysis facilities or stations is determined as is provided in J_0 NCAC 3R .3032.
Countk UC A
1 1 >.' \ Station Allocations
If All Pending
Are Approved
Cherokee. Clay, Graham, Jackson,
—Macon, Swain
Buncombe, Haywood, Madi son,
Mitchell, Yanev
-14
Henderson. Polk, Transylvania
As he. Avery. Caldwell. Watauga.
Wilkes
Burke. MoDowi
Rutherford
Al e xander. Catawba
Alleghany. Stokes. Surry H
1380 7:14 \ORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
Davidson a a
Caswell, Rockingham u 7
4J i
Alamance H 6
Gaston 4« 6
Lincoln 44J 7
Rowan 441 4
Cabarrus 4H §
Montgomery, Stanly 444 $
Chatham. Lee W 6
Person W 8
Wake w 43
Johnston w 7
Franklin, Vance, Warren w 49
Anson V 3
Cumberland. Hoke V 47
Harnett V 3
Sampson V 4
Bladen V 7
Robeson V 4
Pender V 9
Brunswick V 49
V4 3
V4 4
Edgecombe, Nash V4 44
¥4 49
Bertie, Washington Vt 9
Martin V4 8
Greene, Pitt ¥4 3
Beaufort ¥4 9
Carteret, Craven, Jones, Pamlico ¥4 44
Onslow V4 6
Category E. Inpatient Rehabilitation Facility Beds.
7:14 NORTH CAROLINA REGISTER October 15, 1992 1381
PROPOSED RULES
HSA Beds
I 300
II 40
III 20
IV F50
V 33 21
VI ?& 29
(6) Category F. Ambulatory Surgery Facilities. It is determined that there is no need for
additional facilities and no reviews are scheduled.
Any area's need is determined by applying the following formula:
1990 Amb. Surg. Cases in 1994 Pop. Proposed Amb. Surg.
the Proposed Amb. Surg. Area—or 50.9—X of Area to
Area Population (1000' s ) be Served
Cases in Proposed
Service Area
(1000's)
Projected Ambulatory Surgical Ambulatory Surgery
Cases in Proposed Service Area rm- Rooms Needed in
600 (cases per room per year) Proposed Service Area
Thi s methodology i s not applicable to CON ambulatory surgical applications which conform to 10
NCAC 3R .21 15(c)(2) relative to access to medically underserved persons.
(3) Category H.
{*) Brain Injury Demonstration—Long Term Nursing Facility Beds.
HSA I and III
&ft HSA II. IV and V,
20 beds
20 beds
(less Bladen, Bruns wick. Columbus.
New Hanover, Pender and Sampson counties .)
(iii) HSA VI
(plus Bladen. Bruns wick. Columbus .
New Hanover, Pender and Sampson counties.)
<+H Demonstration Project, Medically Complex Children—Long Term Nurs ing Beds.
All HSAs
(8) (^Category I. New Home Health Agencies.
20 beds
10 beds
fe) Thomas S. class
—
Intermediate Care Facility beds for Mentally Retarded.
All HSAs 71 beds
County HSA Number of
Agencies Allocated
or Offices Needed
Mecklenburg W4 +
Randolph a 2
Wilkes i +
Davidson n I
Forsyth u T
Guilford U 2
1382 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
Dare VI 1
(8) Open heart surgery operating rooms - It is determined that there is no need for additional rooms and
no reviews are scheduled.
(9) Solid organ transplant and allogeneic bone marrow transplant programs - U js determined that these
programs are needed only in academic medical center teaching hospitals as defined under 10 NCAC
3R .3050(a)(3).
(10) Gamma knife - It is determined that there js no need for gamma knife stereotactic radiosurgery
services in any facility and no reviews are scheduled.
(11) Positron Emission Tomography - It is determined that there is no need for additional cyclotron-based
positron emission tomography capacity in any facility and no reviews are scheduled.
Statutory Authority G.S. 131E-176(25); 131E-177Q); 131 E-l 83(1).
.3032 DIALYSIS STATION NEED DETERMINATION
(a) The Medical Facilities Planning Section (MFPS) shall determine need for dialysis stations and facilities
two times each calendar year, and shall make a report of such determinations available to aU who request it
This report shall be called the MFPS Semiannual Dialysis Report (SDR). Data to be used for such
determinations, and their sources, are as follows:
(1) Numbers of dialysis patients, by type, county and facility, from the Southeastern Kidney Council.
Inc. (SEKC) and the Mid-Atlantic Renal Coalition. Inc.
(2) Certificate of need decisions, decisions appealed, appeals settled and awards, from the Certificate
of Need Section, DFS.
(3) Facilities certified for participation jn Medicare, from the Certification Section. DFS.
(4) Need determinations for which certificate of need decisions have not been made, from MFPS
records.
Need determinations in this report shall be an integral part of the State Medical Facilities Plan, as provided
in G.S. 131E-I83.
(b) Need for dialysis stations and facilities shall be determined as follows:
(1) County Need
(A) The average annual rate (%) of change in total number of dialysis patients resident in each county
from the end of 1988 to the end of 1992 js multiplied by the county's 1992 year end total number
of patients in the MFPS Semiannual Dialysis Report (SDR), and the product js added to each
county's most recent total number of patients reported jn the SDR. The sum js the county's
projected total 1993 patients.
(B) The percent of each county's total patients who were home dialysis patients at the end of 1992
js multiplied by the county's projected total 1993 patients, and the product js subtracted from the
county's projected total 1993 patients. The remainder js the county's projected 1993 in-center
dialysis patients.
(C) The projected number of each county's 1993 in-center patients js divided by 3.2. The dividend
js the projection of the county's 1993 in-center dialysis stations.
(D) From each county's projected number of 1993 in-center stations is subtracted the county's number
of stations certified for Medicare. CON-approved and awaiting certification, awaiting resolution
of CON appeals, and the number represented by need determinations jn previous State Medical
Facilities Plans for which CON decisions have not been made. The remainder js tlie county's
1993 station need projection.
(E) If a county's 1993 station need projection is seven or greater and the SDR shows that utilization
of each dialysis facility in the county js 80% or greater, the 1993 station need determination is
the same as the 1993 station need projection.
(2) Facility Need. A dialysis facility located in a county whose unmet need jn the reference
Semiannual Dialysis Report (SDR) js less than 7 stations js determined to need additional stations
to the extent that:
(A) Its utilization, reported jn the SDR, js greater than 3.2 patients per station.
(B) Such need, calculated as follows, js reported jn an application for a certificate of need:
7:14 NORTH CAROLINA REGISTER October 15, 1992 1383
PROPOSED RULES
(i) The facility's number of in-center patients on December 31, 1991 is subtracted from the
number of such patients on December 31 , 1992 and the remainder js divided by the number
of in-center patients on December 3 1 , 1991
.
(ii) The dividend from (2)(B)(i) is divided by 12.
(iii) The dividend from (2)(B)(ii) is multiplied by the number of months from the most recent
month reported jn the SDR until the end of calendar 1 993
.
(iv) The product from (2)(B)(iii) is multiplied by the number of the facility's in-center patients
reported jn the SDR and that product is added to such reported number of in-center patients,
(v) The sum from (2)(B)(iv) is divided by 3.2, and from the dividend js subtracted the facility's
current number of certified and pending stations as recorded in the SDR. The remainder is
the number of stations needed.
(C) The facility may apply to expand to meet the need established jn (2)(B)(v). ug to a maximum of
seven stations.
The schedule for publication of the Medical Facilities Planning Section's Semiannual Dialysis Report (SDR)
and for receipt of certificate of need applications based on each issue of this report in 1993 shall be as follows:
Data for Receipt of Publication Receipt of Beginning
Period Ending SEKC Report of SDR CON Applications Review Dates
Dec. 31, 1992 Feb. 28, 1993 March 19. 1993 May 14, 1993 June 1, 1993
June 30. 1993 Aug. 31, 1993 Sept. 20. 1993 Nov. 15, 1993 Dec. 1, 1993
An application for a certificate of need pursuant to this Rule shall be accepted only if it demonstrates a need
by utilizing one of the methods of determining need outlined jn this Rule.
Statutory Authority* G.S. 1 31 E-l 76(25); 131E-177(1); 131E-183(1).
.3040 REALLOCATIONS, ADJUSTMENTS. AND REVIEW PERIODS
(a) Reallocations re sulting from withdrawals, relinquishments, or no applications.
( 1 ) Appeals of Certificate of Need Decisions on Applications. Need determinations of beds or services
for which the CON Section decision has been appealed shall not be reallocated until the appeal js
resolved.
(A) Appeals Resolved Prior to September 17: If an appeal is resolved jn the calendar year prior to
September 17. the beds or services shall not be reallocated by the CON Section: rather the
Medical Facilities Planning Section shall make the necessary changes in the next amendment to
NCAC 3R .3030
(B) Appeals Resolved On Or After September 17: If the appeal is resolved on or after September
17 in the calendar year, the beds or services shall be made available for a review period to be
determined by the CON Section, but beginning no earlier than 60 days from the date that the
appeal is resolved. Notice shall be given by the Certificate of Need Section no less than 45 days
prior to the due date for receipt of new applications.
Dialysis stations that are withdrawn, relinquished, not applied for or decertified shall not be
reallocated. Instead, any necessary redetermination of need shall be made in the next scheduled
publication of the Semiannual Dialysis Report. allocations shall be made only to the extent that J_0
NCAC 3R . 3030 determines that a need exists after the inventory is revised and the need
determination is recalculated. Beds or services which are reallocated once in accordance with this
policy shall not be reallocated again. Rather, the Medical Facilities Planning Section shall make
any necessary' changes jn tlie next published amendment to JO NCAC 3_R .3030.
f-h (2] Withdrawals and Relinquishments. An allocation A need determination for which a certificate
of need is issued, but is subsequently withdrawn or relinquished, and nn allocation for which no
certificate of need application is received, is available for a review period to be determined by the
Certificate of Need Section, but beginning no earlier than 60 days from:
(A) the last date on which the holder of a certificate of need could have appealed a an appeal of tlie
notice of intent to withdraw h4s tlie certificate could be filed if he does not in fact if no appeal
is filed.
1384 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
(B) the date on which an appeal of the withdrawal is finally resolved against the holder, or
(C) the date that the Certificate of Need Section receives notice from the holder of the certificate of
need notice that the certificate has been voluntarily relinquished^-©^
{©)
—
for allocations for which no application was received, the last due date on which applications
could have been received.
Notice of the reallocation and the scheduled review period for which applications shall be submitted will the
reallocated services or beds shall be given no less than 45 days prior to the due date for receipt submittal of
the new applications.
{3} Reallocation of service capacity represented by a relinqui s hed or withdrawn certificate of need or
by an allocation for which no application was received will occur only to the extent of the need
indicated for the same service contained in thi s section in effect at the time of such determination,
as adjusted through the provisions of .3040(b).—The effective date of the determination of the
availability of capacity for reallocation i s the date designated in (a) (1) (A), (B), (C) or (D) of thi s
Ruler
f3} Reallocations made available through thi s Rule for which no application i s received for the revi ew
period designated in iSubparagraph (a)(1) of this Rule—will not be reallocated again.
fb)
—
Need adjustments for prior year certificate of need awards .—Need determinations in this section are
based on an inventory of facilities that existed and of certificate s of need awarded prior to preparation of thi s
Rule and will be adju sted by the amount of any s ubsequent certificate of need awards .—A record of capacity
remaining available for allocation will be maintained by the Medical Facilitie s Planning Section, based upon
information supplied by the Certificate of Need Section.—For information about the availability of these
allocations write Medical Facilities Planning Section, Division of Facility Services, P. O. Box 29530, Raleigh,
NC 27626 0530, or call 919 733 4 130.
(c) Availability of Allocations. Single month review s pecific allocation s specified in 10 NCAC 3R. 3030(2),
(3) ii, ( 4 ), and (10) are available only for the review cycles specified in 10 NCAC 3R.3020(1) (2) (3) and ( 4 )
and in the next occurring scheduled cert i ficate of need review cycle applicable to the same facility service
category for the health service area in which the county or countie s arc located, as specified in 10 NCAC
3R. 3020(5).—Allocations which are not s ingle month review specific are available only for the certificate of
need review cycles specified in 10 NCAC 3R .3020(5).
(3) Need Determinations for which No Applications are Received
(A) Services or Beds with Scheduled Review Before September 17: Need determinations, or portions
of such need, for services or beds in this category include long-term nursing care beds, home
health agencies or offices, dialysis stations, and beds in intermediate care facilities for the
mentally retarded (1CF/MR) with the exception of 1CF/MR allocations with a scheduled review
that begins after September 17. The Certificate of Need Section shall not reallocate the services
or beds in this category for which no applications were received, because the Medical Facilities
Planning Section will have sufficient time to make any necessary changes in the determinations
of need for these services or beds i_n the next annual amendment to JO NCAC 3R .3030.
(B) Services or Beds with Two Scheduled Review Periods and 1CF/MR Fall Review. Need
determinations for services or beds jn this category include acute care beds, rehabilitation beds,
ambulatory surgery operating rooms, medical technology, psychiatric beds, substance abuse beds,
and 1CF/MR beds for which review commences after September 17. A need determination m
this category for which no application has been received by the last due date for submittal of
applications shall be available to be applied for in the second Category G review period in the
next calendar year for the applicable HSA. Notice of the scheduled review period for the
reallocated beds or services shall be given by the Certificate of Need Section no less than 45 days
prior to the due date for submittal of new applications.
(4) Need Determinations not Awarded because Application Disapproved.
(A) Disapproval prior to September 17: Need determinations or portions of such need for which
applications were submitted but disapproved by the Certificate of Need Section before September
17, shall not be reallocated by the Certificate of Need Section. Instead the Medical Facilities
Planning Section shall make the necessary changes in the next annual amendment to JO NCAC
3R .3030 if no appeal ]s filed.
(B) Disapproval on or After September 17: Need determinations or portions of such need for which
applications were submitted but disapproved by the Certificate of Need Section on or after
7:14 NORTH CAROLINA REGISTER October 15, 1992 1385
PROPOSED RULES
September 17, shall be reallocated by the Certificate of Need Section. A need in this category
shall be available for a review period to be determined by the Certificate of Need Section but
beginning no earlier than 95 days from the date the application was disapproved, if no appeal ]s
filed. Notice of the scheduled review period for the reallocation shall be mailed no less than 80
days prior to the due date for submittal of the new applications.
(b) CHANGES IN NEED DETERMINATIONS. Need determinations in 10 NCAC 3R .3030 and .3032
shall be revised after the effective date of this Rule as necessary to reflect:
( 1
)
dialysis stations decertified after September 17, 1992
(2) health service facilities or beds delicensed after September 17. 1992
(3) psychiatric beds licensed pursuant to G . S . 1 3 1 E-
1
84(c).
(4) errors in inventories on which need determinations in K) NCAC 3_R .3030 are based.
(c) REVIEW PERIODS. Determinations of need for nursing facility beds, home health agencies or offices,
ICF/MR beds are available to be applied for only once during the calendar year. The review cycles for these
allocations are specified m JO NCAC 3_R .3020 ( 1 )-(4). All other allocations are available for the certificate
of need review cycles specified in 10 NCAC 3R . 3020 (5).
Statutory Authority G.S. 1 31 E-l 76(25); 131E-177(1); 131E-183(1).
.3050 NEED DETERMINATION PRINCIPLES
(a) ACUTE CARE FACILITIES AND SERVICES
( 1
Use of Licensed Bed Capacity Data for Planning Purposes. For planning purposes the number of
licensed beds shall be determined by the Division of Facility Services in accordance with standards
found in 10 NCAC 3C .1510 - Bed Capacity.
(2) Utilization of Acute Care Hospital Bed Capacity. Conversion of underutilized hospital space to
other needed purposes shall be considered to be more cost-efficient than new construction, unless
shown otherwise. Utilization targets are shown in JO NCAC 3R .3050(a)(4).
(3) Exemption from Plan Provisions for Certain Academic Medical Center Teaching Hospital Projects.
Projects for which certificates of need are sought by academic medical center teaching hospitals
may qualify for exemption from provisions of JO NCAC 3R .3030. The State Medical Facilities
Planning Section shall designate as an Academic Medical Center Teaching Hospital any facility
whose application for such designation demonstrates the following characteristics of the hospital:
(A) Serves as a primary teaching site for a school of medicine and at least one other health
professional school, providing undergraduate, graduate and postgraduate education.
(B) Houses extensive basic medical science and clinical research programs, patients and equipment.
(C) Serves the treatment needs of patients from a broad geographic area through multiple medical
specialties.
Exemption from the provisions of J_0 NCAC 3R .3030 shall be granted to projects submitted by
Academic Medical Center Teaching Hospitals designated prior to January J_^ 1990 which projects
comply with one of the following conditions:
(i) Necessary to complement a specified and approved expansion of the number or types of
students, residents or faculty, as certified by the head of the relevant associated professional
school; or
(ii) Necessary to accommodate patients, staff or equipment for a specified and approved
expansion of research activities, as certified by the head of the entity sponsoring the research:
or
(iii) Necessary' to accommodate changes in requirements of specialty education accrediting bodies,
as evidenced by copies of documents issued by such bodies.
(4) Reconversion to Acute Care. Facilities redistributing beds from acute care bed capacity to
rehabilitation or psychiatric use shall obtain a certificate oj need to convert this capacity back
to acute care. Application for such reconversion to acute care of beds converted to psychiatry or
rehabilitation shall be evaluated against the hospital's utilization in relation to target occupancies
used in determining need shown in JO NCAC 3R .3030 without regard to the acute care bed need
shown in the Rule. These target occupancies are:
Licensed Bed Capacity Percent Occupancy
1 - 49 65
1386 7:14 NORTH CAROLINA REGISTER October 15, 1992
PROPOSED RULES
.
5Q; 99 70
100; 199 75
200 z 699 80
700 + 81.5
(5) Multi-Specialty Ambulatory Surgery. After applying other required criteria, when superiority
among two or more competing ambulatory surgical facility certificate of need applications is
uncertain, favorable consideration shall be given to multi-specialty facilities over single specialty
facilities in areas where need is demonstrated in JO NCAC 3R .3030. A multi-specialty ambulatory
surgical facility means a facility providing services in at least three of the following areas;
gynecology, otolaryngology, plastic surgery, general surgery, ophthalmology, orthopedics and oral
surgery. A new multi-specialty ambulatory surgical facility shall have a minimum of two operating
rooms, and no fewer than two operating rooms with general anesthesia capabilities.
(6) Expansion of the Rehabilitation System. After applying other required criteria, when superiority
among two or more competing rehabilitation facility certificate of need applications is uncertain,
favorable consideration shall be given to applicants proposing establishment of small inpatient
rehabilitation programs so as to make these services available to the underserved populations.
(7) Geographic Distribution of Inpatient Rehabilitation Beds. After applying other required criteria,
when superiority among two or more competing rehabilitation facility certificate of need
applications js uncertain, favorable consideration shall be given to proposals that minimize the
distance that patients must travel to obtain inpatient rehabilitation services.
(8) Ambulatory Surgery Need Determination Exclusion. The determination of need for ambulatory
surgical operating rooms defined in NCAC 3R .3030(6) shall not be considered in the review of
an application for a certificate of need to convert existing operating rooms to a freestanding
ambulatory surgical facility, if submitted by a hospital designated as a Rural Primary Care Hospital
by the N^ C. Office of Rural Health Services pursuant to section 1820(f) of the Social Security Act.
lb) LONG-TERM CARE FACILITIES AND SERVICES.
(1) Provision of Hospital-Based Long-Term Nursing Care. A certificate of need may be issued to a
hospital which is licensed under G.S. 131 E, Article 5^ and which meets the conditions set forth
below and other relevant rules, to convert up to ten beds from its licensed acute care bed capacity
for use as hospital-based long-term nursing care beds without regard to determinations of need in
JO NCAC 3R .3030 if the hospital:
(A) is located in a county which was designated as non-metropolitan by the U. S^ Office of
Management and Budget on January J^ 1 993 ; and
(B) on January 1, 1993, had a licensed acute care bed capacity of 150 beds or less. The certificate
of need shall remain m force as long as the Department of Human Resources determines that the
hospital js meeting the conditions outlined in this Rule. "Hospital-based long-term nursing care"
is defined as long-term nursing care provided to a patient who has been directly discharged from
an acute care bed and cannot be immediately placed fn a licensed nursing facilit