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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 Ol 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
Object Description
Description
Title | North Carolina register |
Date | 1992-10-15 |
Description | Vol. 7, issue 14 (October 15, 1992) |
Publisher | Raleigh, N.C. : Office of Administrative Hearings |
Digital Characteristics-A | 120 p.; 8.31 MB |
Digital Format | application/pdf |
Pres File Name-M | pubs_serial_ncregister19921015.pdf |
Pres Local File Path-M | \Preservation_content\StatePubs\pubs_serial_ncregister\images_master |
Full Text | 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 Ol 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 |