subchapter 13J – the licensing of home care agencies
section .0100 – reserved for future codification
10A NCAC 13J .0100Reserved for future codification
section .0200 – reserved for future codification
10A NCAC 13J .0200Reserved for future codification
section .0300 – reserved for future codification
10A NCAC 13j .0300Reserved for future codification
section .0400 – reserved for future codification
10A NCAC 13j .0400Reserved for future codification
section .0500 – reserved for future codification
10A NCAC 13j .0500Reserved for future codification
section .0600 – reserved for future codification
10A NCAC 13j .0600Reserved for future codification
section .0700 – reserved for future codification
10A NCAC 13j .0700Reserved for future codification
section .0800 – reserved for future codification
10A NCAC 13j .0800Reserved for future codification
SECTION .0900 - GENERAL
10A NCAC 13J .0901DEFINITIONS
Terms used in this Subchapter have the meanings as defined in G.S. 131E-136 and as follows:
(1)"Activities of Daily Living" (ADL) means mobility, eating, bathing, dressing, and toileting.
(2)"Agency" means a home care agency.
(3)"Agency director" means the person having administrative responsibility for the operation of the agency.
(4)"Client" means as defined in G.S. 131E-136 (2b).
(5)"Clinical respiratory services" means the provision of respiratory equipment and services that involve the assessment of a client's pulmonary status, monitoring of a client's response to therapy, and reporting to the client's physician. Procedures include: oximetry, blood gases, delivery of medication via aerosolization, management of ventilatory support equipment, pulmonary function testing, and infant monitoring.
(6)"Department" means the North Carolina Department of Health and Human Services.
(7)"Extensive Assistance" means a client is totally dependent or requires hands on assistance more than half the time while performing part of an activity, and meets one of the following criteria:
(a)requires extensive assistance in more than two activities of daily living (ADLs), as defined in Item (1) of this Rule;
(b)needs an in-home aide to perform at least one task at the nurse aide II level; or
(c)requires extensive assistance in more than one ADL and has a medical or cognitive impairment as defined in Item (19) of this Rule.
(8)"Follow-up care" means services provided to a licensed hospital's discharged client in their home by a hospital's employees. No servicesshall exceed three visits in any two month period and shall not extend beyond a 12 month period following discharge, except pulmonary care, pulmonary rehabilitation, or ventilator services.
(9)"Governing body" means the person or group of persons having legal authority for the operation of the agency.
(10)"Hands-on care" means any home care service that involves touching the patient in order to implement the patient's plan of care.
(11)"Health care practitioner" means as defined in G.S. 90-640(a).
(12)"Infusion nursing services" means those services related to the administration of pharmaceutical agents into a body organ or cavity. Routes of administration include sub-cutaneous intravenous, intraspinal, epidural, or intrathecal infusion. Administration shall be by or under the supervision of a registered nurse in accordance with their legal scope of practice.
(13)"In-home aide services" are hands-on services that assist individuals, their family, or both with home management tasks, personal care tasks, or supervision of the client's activities to enable the individual, their family, or both to remain and function at home.
(14)"In-home caregiver" means any individual who provides home care services as enumerated in G.S. 131E-136.
(15)"Instrumental Activities of Daily Living" (IADL) means meal preparation, housekeeping, medication reminders, shopping, errands, transportation, money management, phone use, reading, and writing.
(16)"Licensed Clinical Social Worker" means as defined in G.S. 90B-3(6a).
(17)"Licensed practical nurse" means as defined in G.S. 90-171.30 or G.S 90-171.32.
(18)"Limited Assistance" means care to a client who requires hands-on care involving guided maneuvering of limbs with eating, toileting, bathing, dressing, personal hygiene, self-monitoring of medications, or other tasks assigned that require hands on assistance half the time or less during the activity and does not meet the definition of extensiveassistance.
(19)"Medical or cognitive impairment" means a diagnosis and client assessment that documents at least one of the following:
(a)pain that is present more than half the time that interferes with an individual's activity or movement;
(b)dyspneic or short of breath with minimal exertion during the performance of ADLs and requires continuous use of oxygen; or
(c)individual is not alert and oriented or is unable to shift attention and recall directions more than half the time.
(20)"Nursing registry" means a person or organization that maintains a list of nurses, in-home aides, or both that is made available to persons seeking nursing care or in-home aide service, but does not collect a placement fee from the worker or client, coordinate the delivery of services, or supervise or control the provision of services.
(21)"Nursing services" means professional services provided by a registered nurse or a licensed practical nurse under the supervision of a registered nurse.
(22)"Occupational therapist" means as defined in G.S. 90-270.67(2) or G.S. 90-270.72.
(23)"Occupational therapist assistant" means as defined in G.S. 90-270.67(3) or G.S. 90-270.72.
(24)"Occupational therapy" means as defined in G.S. 90-270.67(4).
(25)"On-call services" means unscheduled home care services made available to clients on a 24-hour basis.
(26)"Personal care" means assistance to an individual withADL and medical monitoring.
(27)"Physical therapist" means as defined in G.S. 90-270-24(2), G.S. 90-270-30, or G.S. 90-270-31(b).
(28)"Physical therapist assistant" means as defined in G.S.90-270.24(3) or G.S. 90-270-31(b).
(29)"Physical therapy" means as defined in G.S. 90-270.24(4).
(30)"Physician" means as defined in G.S.90-9.1 or G.S. 90-9.2.
(31)"Plan of care" means the written description of the authorized home care services and tasks to be provided to a client.
(32)"Practice of respiratory care" means as defined in G.S.90-648(10).
(33)"Premises" means the location or licensed site that the agency provides home care services or maintains client service records or advertises itself as a home care agency.
(34)"Qualified" means suitable for employment as a consequence of having met the standards of education, experience, licensure, or certification established in the applicable job description created and adopted by the agency.
(35)"Registered nurse" means as defined in G.S.90-171.30 or G.S. 90.171.32.
(36)"Respiratory care practitioner" means as defined in G.S. 90-648(12).
(37)"Scope of services" means those specific services provided by a licensed agency as listed on their home care license.
(38)"Survey" means an inspection by the Division of Health Service Regulation in order to assess the compliance of agencies with the home care licensure rules.
(39)"Social worker" means as defined in G.S 90B-3(8).
(40)"Speech and language pathologist" means as defined in G.S. 90-293(5).
(41)"Skilled Services" means all home care services enumerated in G.S. 131E-136(3) with the exception of in-home aide services.
(42)"The practice of speech and language pathology" means as defined in G.S. 90-293(7).
History Note:Authority G.S. 131E-136; 131E-140;
Eff. July 1, 1992;
RRC Objection due to lack of statutory authority Eff. November 16, 1995;
Amended Eff. January 1, 2010; February 1, 1996;
Readopted Eff. June 1, 2018.
10A NCAC 13J .0902LICENSE
Each agency premises shall obtain a license unless exempted by G.S. 131E136(3).
History Note:Authority G.S. 131E140;
Eff. July 1, 1992;
Amended Eff. February 1, 1996;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 25, 2016.
10A NCAC 13J .0903APPLICATION FOR AND ISSUANCE OF LICENSE
(a) An application for the operation of an agency premises shall be submitted to the Department prior to the scheduling of an initial licensure survey or the issuance of a license. The agency shall establish, maintain and make available for inspection such documents, records and policies as required in this Section and statistical data sufficient to complete the licensure application and upon request of the Department, to submit an annual data report, as noted in Rule .1002(b) of this Subchapter. If the applicant cannot demonstrate to the Division of Health Service Regulation that he or she has ever owned or operated a home care agency prior to submission of the application, the Division shall not issue a license until the applicant has received training approved by the Division which shall include the requirements for licensure, the licensure process, and the rules pertaining to the operation of a home care agency.
(b) The Department shall issue a license to each agency premises. Initial and ongoing licensure inspections may include all premises of an agency. Licensure shall be for a period of one year. Each license shall expire at midnight on the expiration date on the license and is renewable upon application.
(c) The license shall be posted in a prominent location accessible to public view within the premises. The agency shall also post a sign at the public access door with the agency name.
(d) The license shall be issued for the premises and persons named in the application and shall not be transferable. The name and street address under which the agency operates shall appear on the license. The license shall reflect the services provided by the agency.
(e) Prior to change of ownership or the establishment of a new agency, the agency must be in compliance with all the applicable statutes and rules. If the agency is authorized to provide Medicare certified Home Health Services, it shall also be in compliance with statutes and rules established under G.S. 131E, Article 9.
(f) The licensee shall notify the Department in writing of any proposed change in ownership or name at least 30 days prior to the effective date of the change.
(g) Any agency adding a new service category as outlined in G.S. 131E-136(3)(a) through (f) shall notify the Department in writing at least 30 days prior to the provision of that service to any clients. The Department shall approve the added service upon determining the agency is in compliance with the rules specific to the service being provided as contained in Section .1100 of this Subchapter.
(h) An agency shall notify the Department in writing if it discontinues or is unable to provide for a period of six continuous months any service category as outlined in G.S. 131E-136(3)(a) through (f) that is listed on the agency's license.
History Note:Authority G.S. 131E140;
Eff. July 1, 1992;
Amended Eff. February 1, 1996; May 1, 1993;
Temporary Amendment Eff. April 1, 2006;
Amended Eff. November 1, 2006;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 25, 2016.
10A NCAC 13J .0904INSPECTIONS
(a) Any agency licensed by the Department shall be subject to proper inspections by authorized representatives of the Department at any time as a condition of holding such license.
(b) Any organization subject to licensure which presents itself to the public as a home care agency, which does not hold a license, and is or may be in violation of Rule .0902 of this Section and G.S. 131E138 shall be subject to inspections at any time by authorized representatives of the Department.
(c) Authorized representatives of the Department shall make their identities known to the person in charge prior to inspection.
(d) Inspection of service records shall be carried out in accordance with G.S. 131E141(b).
(e) An inspection shall be considered proper whenever the purpose of the inspection is to determine whether the agency complies with the provisions of this Subchapter or whenever there is reason to believe that some condition exists which is not in compliance with the rules in this Subchapter. The agency shall allow immediate access to its premises and the records necessary to conduct an inspection and determine compliance with the rules of this Subchapter. Failure to do so shall result in termination of the survey and may result in injunctive relief as outlined in G.S. 131E-142(b).
(f) An agency shall file a plan of correction for cited deficiencies within 10 working days of receipt. The Department shall review and respond to a written plan of correction within 10 working days of receipt.
(g) Representatives of the Department may visit clients in their homes to assess the agency's compliance with the clients' plans of care and with the licensure rules. Clients will be contacted by the agency staff in the presence of Department staff for permission to visit.
History Note:Authority G.S. 131E140;
Eff. July 1, 1992;
Amended Eff. February 1, 1996;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 25, 2016.
10A NCAC 13J .0905MULTIPLE PREMISES
If a person operates multiple agency premises:
(1)the Department may conduct inspections at any or all of the premises and may issue a license to each of the premises based upon a sample inspection of any of the premises;
(2)with 72 hours advance notice, the Department may request records from any of the premises necessary to ensure compliance with the rules of this Subchapter be brought to the site being inspected, including the portions of personnel records subject to review. For agencies for whom a business or government policy precludes the disclosure of employee evaluations, a statement signed by the employee's supervisor attesting to its completion shall be accepted.
(3)the premises may share handson care staff or administrative staff, and may centralize the maintenance of records.
History Note:Authority G.S. 131E140;
Eff. July 1, 1992;
Amended Eff. February 1, 1996;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 25, 2016.
10A NCAC 13J .0906COMPLIANCE WITH LAWS
(a) The agency shall be in compliance with all applicable federal, state, and local laws, rules, and regulations including Title XI Part A Section 1128B of the Social Security Act - Criminal penalties for acts involving Federal health care programs. A failure to comply with Federal law may subject the agency to civil or criminal penalties as set forth in 42 U.S.C. §1320a-7a - Making or causing to be made false statements or representations - and 42 U.S.C. §1320a-7b - Illegal remunerations.
(b) Staff of the agency shall be currently licensed or registered in accordance with applicable laws of the State of North Carolina.
(c) Nothing in this Rule shall prohibit the Department from conducting inspections as provided for in Rule .0904 of this Section.
(d) Any agency deemed to be in compliance by virtue of accreditation by one of the specified accrediting bodies listed in G.S. 131E-138(g)shall submit to the Department a copy of its accreditation report within 30 days after the agency receives its report each time it is surveyed by the accrediting body. The agency shall notify the Department of any action taken that affects its accreditation status, either temporarily or permanently. The Department may conduct annual validation surveys to assure compliance.
History Note:Authority G.S. 131E-138; 131E140;
Eff. July 1, 1992;
Amended Eff. October 1, 2006; February 1, 1996;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 25, 2016.
10A NCAC 13J .0907ADVERSE ACTION
(a) An agency may appeal any adverse decision made by the Department concerning its license by making such appeal in accordance with the Administrative Procedure Act, G.S. 150B and departmental rules 10A NCAC 01 et seq.
(b) The Department may amend a license by reducing it from a full license to a provisional license whenever the Department finds that:
(1)the licensee has substantially failed to comply with the provisions of G.S. 131E, Part C of Article 6 and the rules promulgated under that Part; and
(2)there is a reasonable probability that the licensee can remedy the licensure deficiencies within a reasonable length of time; and
(3)there is a reasonable probability that the licensee will be able thereafter to remain in compliance with the home care licensure rules for the foreseeable future.
The Department shall give the licensee written notice of the amendment of its license. This notice shall be given by registered or certified mail or by personal service and shall set forth the reasons for the action.
(c) The provisional license shall be effective immediately upon its receipt by the licensee and must be posted in a prominent location, accessible to public view, within the licensed premises in lieu of the full license. The provisional license shall remain in effect until:
(1)the Department restores the licensee to full licensure status; or
(2)the Department revokes the licensee's license; or
(3)the end of the licensee's licensure year. If a licensee has a provisional license at the time that the licensee submits a renewal application, the license, if renewed, shall also be a provisional license unless the Department determines that the licensee can be returned to full license status. A decision to issue a provisional license is stayed during the pendency of an administrative appeal and the licensee may continue to display its full license during the appeal.
(d) The Department may revoke a license whenever:
(1)The Department finds that:
(A)the licensee has substantially failed to comply with the provisions of G.S. 131E, Part C of Article 6 and the rules promulgated under those parts; and
(B)it is not reasonably probable that the licensee can remedy the licensure deficiencies within a reasonable length of time; or
(2)The Department finds that:
(A)the licensee has substantially failed to comply with the provisions of G.S. 131E, Part C of Article 6; and
(B)although the licensee may be able to remedy the deficiencies within a reasonable time, it is not reasonably probable that the licensee will be able to remain in compliance with the home care licensure rules for the foreseeable future; or
(3)The Department finds that there has been any failure to comply with the provisions of G.S. 131E, Part C of Article 6 and the rules promulgated under those parts that endangers the health, safety or welfare of the clients receiving services from the agency.
The issuance of a provisional license is not a procedural prerequisite to the revocation of a license pursuant to Subparagraphs (d)(1)(2) and (3) of this Rule.
History Note:Authority G.S. 131E140;
Eff. July 1, 1992;
Amended Eff. February 1, 1996;
Pursuant to G.S. 150B-21.3A, rule is necessary without substantive public interest Eff. June 25, 2016.
SECTION .1000 ADMINISTRATION
10A NCAC 13J .1001AGENCY MANAGEMENT AND SUPERVISION
(a) The governing body or its designee shall establish and implement written policies governing agency operation. Such policies shall be available for inspection by the Department. The policies shall include:
(1)a description of the scope of services offered;
(2)admission and discharge policies;
(3)supervision of personnel;
(4)development of, and updates to, the plan of care;
(5)management of emergency care situations in the home;
(6)time frame for completion and return of service records to the agency;
(7)personnel qualifications;
(8)an organizational chart;
(9)program evaluation;
(10)employee and client confidentiality; and
(11)coordination of and referral to and from other community agencies and resources.
(b) The agency shall designate an individual to serve as agency director. The agency director shall have the authority and responsibility for administrative direction of the agency and shall meet one or more of the following qualifications:
(1)a health care practitioner as defined in G.S. 90640(a);
(2)an individual who has at leasttwo years of supervisory or management experience in home care or any other provider licensed pursuant to G.S. 131E or G.S. 122C; or