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10.07.05.00.htm 10.07.05.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 07 HOSPITALS Chapter 05 Residential Service Agencies Authority: Health-General Article, Title 19, Subtitle 4A, Annotated Code of Maryland
10.07.05.01.htm 10.07.05.01. 01 Purpose.. The purpose of this chapter is to establish minimum standards for licensure of residential service agencies that conduct business in Maryland.
10.07.05.02.htm 10.07.05.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) “Activities of daily living” means normal daily activities including:. a) Eating or being fed;. b) Grooming, bathing, oral hygiene including brushing teeth, shaving, and combing hair;. c) Mobility, transferring, ambulation, and access to the outdoors, when appropriate;. d) Toileting; and. e) Dressing in clean, weather-appropriate clothing..
10.07.05.03.htm 10.07.05.03. 03 License Required.. A. A person, partnership, corporation, association, or other entity may not conduct or operate an agency in this State without first obtaining a license from the Secretary and complying with the regulations of this chapter.B. An agency that provides only household or family support services as defined in Regulation .02B(14) of this chapter does not require licensure.C. Separate License Required..
10.07.05.04.htm 10.07.05.04. 04 Licensing Procedures.. A. Application for License.. 1) To obtain and maintain a license, an applicant shall meet all of the requirements of:. a) This chapter; and. b) Other applicable federal, State, and local laws and regulations.. 2) An applicant shall submit:. a) An application on a written or electronic form developed by the Department;. b) Verification that the applicant or corporate representative is 21 years old or older;. c) Documentation of any prior denial, suspension,
10.07.05.05.htm 10.07.05.05. 05 Changes in an Agency That Affect the Operating License.. A. Change of Services or Name.. 1) During the licensure period, a licensee may not:. a) Provide services for which it has not been approved to provide; or. b) Change the name under which the program is doing business without the Department’s approval.. 2) When the licensee wants to provide additional services which require a license under this chapter, before offering the services, the licensee shall
10.07.05.05-1.htm 10.07.05.05-1. 05-1 Special Requirements for the Provision of Home Medical Equipment Services.. A. A provider of home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .02-03 of this chapter.B. An agency shall:. 1) Ensure that personnel demonstrate competency in delivering and installing the equipment;. 2) Provide education, training, and written instructions to the patient and his or her caregivers on
10.07.05.06.htm 10.07.05.06. 06 Public Representation.. A. An agency shall include the following information in all of the agency’s advertising and marketing materials:1) The agency’s license number; and. 2) The statement “Licensed as a residential service agency by the Maryland Department of Health and Mental Hygiene, Office of Health Care Quality”B. Misleading or False Advertising.. 1) A person may not advertise, represent, or imply to the public that an agency is authorized to provide a service that the a
10.07.05.07.htm 10.07.05.07. 07 Inspection by the Department.. A. Residential Service Agency to be Open for Inspection.. 1) The Department or its designee may conduct announced or unannounced licensure inspections or complaint investigations to ensure compliance with the requirements of this chapter.2) The agency shall be open for inspection by the Department during all hours identified in the agency’s application as routine business hours.B. Access to Agency and Sites Where Services Are O
10.07.05.08.htm 10.07.05.08. 08 Administration.. A. Governing Authority.. 1) The agency shall have a governing authority.. 2) The governing authority shall:. a) Convene at least annually with management staff to review and advise the agency on policies; and. b) Keep minutes, including:. i) The participants of any meeting;. ii) Agenda items considered; and. iii) Actions taken.. B. Policies and Procedures.. 1) An agency shall develop and implement policies and procedures, including but not limited to:.
10.07.05.09.htm 10.07.05.09. 09 Complaint Process.. A. Internal Complaint Process. An agency shall institute an internal client complaint process that includes:1) Notice to the client or the client representative of the complaint process;. 2) Protocols to investigate complaints; and. 3) A mechanism for the receipt and timely investigation of written complaints that ensures that the client’s services will not be disrupted due to the filing of a complaint.B. Internal Complaint Investigations..
10.07.05.10.htm 10.07.05.10. 10 Employee, Independent Contractor, and Contractual Employee Requirements.. A. An agency shall develop and implement policies and procedures to screen a prospective employee, independent contractor, or contractual employee who will provide services to clients.B. Screening.. 1) Screening shall include:. a) A State criminal history records check or a private agency background check as required under Health-General Article, Title 19, Subtitle 19, Annotated Code of Maryland;
10.07.05.11.htm 10.07.05.11. 11 Training.. A. An agency shall ensure that individuals that are referred are trained appropriately to provide care that is needed by the agency’s clients.B. Sources other than the agency may provide training, as approved in writing by the Office of Health Care Quality.C. At a minimum, training for individuals providing care in clients’ homes shall include:. 1) Instruction and supervised practice in relevant personal care services of the sick or disabled at2) Identification of situ
10.07.05.12.htm 10.07.05.12. 12 Services Provided.. A. An agency shall take reasonable measures to ensure that all individuals who are referred to provide services to clients do so in accordance with Maryland laws and regulations, including but not limited to the Health Occupations Article, Annotated Code of Maryland.B. Provision of Services.. 1) A registered nurse shall assess each new client who requires skilled services and assistance with the activities of daily living.2) The registered nurse shall also:.
10.07.05.13.htm 10.07.05.13. 13 Client Representative.. A. An agency shall recognize the authority of:. 1) A guardian of the person under Estates and Trusts Article, §13-705, Annotated Code of Maryland;. 2) A guardian of the property under Estates and Trusts Article, §13-201, Annotated Code of Maryland;. 3) An advanced directive that meets the requirements of Health-General Article, §5-602, Annotated Code of Maryland;4) A surrogate decision maker with the authority under Health-General Artic
10.07.05.14.htm 10.07.05.14. 14 Clinical Records.. A. With the exception of §B of this regulation, an agency shall ensure that a clinical record is maintained for each client in a manner that ensures security and confidentiality, and includes at a minimum:1) The documentation required by §D of this regulation;. 2) Any currently effective health care orders;. 3) Nurse’s assessment. 4) Rehabilitation plans, if appropriate;. 5) The care plan;. 6) Medications administered or taken, including:. a) Dosage;.
10.07.05.15.htm 10.07.05.15. 15 Maintenance of Records.. A. The agency shall maintain a client’s record for 5 years after the client is discharged. For a client younger than 18 years old, the agency shall maintain the client’s record after discharge until the resident is 21 years old, or for 5 years after the record is made, whichever is later, except as otherwise provided in Health-General Article, §4-403, Annotated Code of Maryland.B. If an agency ceases operation, the agency shall make arrangements to ret
10.07.05.16.htm 10.07.05.16. 16 Client’s Rights and Responsibilities.. A. The agency shall ensure that agency staff develops and implements written policies and procedures concerning clients’ rights and responsibilities.B. The agency shall make the policies and procedures available to clients or client representatives.. C. The policies and procedures shall ensure that the agency provides the client or client representative with:1) An estimate of costs associated with the services requested by the client;.
10.07.05.17.htm 10.07.05.17. 17 Special Requirements for the Provision of Intravenous or Related Therapies.. A. This regulation applies to intravenous or related therapy provided in the home.. B. A provider of intravenous or related therapies shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01―16 of this chapter.C. Specialized intravenous therapies and nutritional support services administered enterally or parenterally shall be conside
10.07.05.18.htm 10.07.05.18. 18 Special Requirements for the Provision of Ventilator Services.. A. A provider of ventilator services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01―16 of this chapter.B. This regulation applies to ventilator services provided in the home, including:. 1) Volume ventilation;. 2) Pressure ventilation;. 3) Emergency back-up power systems;. 4) Alarms and troubleshooting equipment;. 5) Emergency resuscitation; and.
10.07.05.19.htm 10.07.05.19. 19 Special Requirements for the Provision of Home Medical Equipment Services.. A. An agency that provides home medical equipment services shall meet the requirements of this regulation in addition to meeting the requirements of Regulations .01―16 of this chapter.B. Education and Training. When an agency provides home medical equipment services, the agency shall:1) Ensure that its personnel demonstrate competency in delivering and installing the equipment;. 2) Provide education, tra
10.07.05.20.htm 10.07.05.20. 20 Sanctions.. A. If the Secretary determines that an agency has violated this chapter, the Secretary, in addition to the sanctions set forth in Regulations .21.27 of this chapter may:1) Restrict the number of clients the agency may serve;. 2) Limit the types of clients an agency may serve;. 3) Require the licensee, and any of its staff, to receive remedial instruction in a specific area;.
10.07.05.21.htm 10.07.05.21. 21 Civil Money Penalties.. A. The Secretary may impose a civil money penalty on an agency if a deficiency or continuing pattern of deficiencies exists in the residential service agency.B. In determining whether a civil money penalty will be imposed, the Secretary shall consider the following factors:1) Nature, number, and seriousness of the deficiencies;. 2) The extent to which the deficiency or deficiencies are part of a continuing pattern during the preceding 24 months;
10.07.05.22.htm 10.07.05.22. 22 Amount of Civil Money Penalties.. A. A civil money penalty imposed on a person under this chapter may not exceed $10,000 per instance or, as provided in Regulation .21 of this chapter, $1,000 per day.B. In setting the amount of the civil money penalty under this chapter, the Secretary shall consider the following factors:1) Nature, number, and seriousness of the deficiencies;. 2) The degree of risk to the health, life, or safety of the clients of the agency that is caused by
10.07.05.23.htm 10.07.05.23. 23 Civil Money Penalties ― Hearings.. A. A hearing on the appeal shall be held consistent with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland.B. The Secretary shall have the burden of proof with respect to the imposition of the civil money penalties under this chapter.
10.07.05.24.htm 10.07.05.24. 24 Emergency Suspension.. A. The Secretary may immediately suspend a license on finding that the public health, safety, or welfare imperatively requires emergency actionB. The Department shall deliver a written notice to the licensee:. 1) Informing the licensee of the emergency suspension;. 2) Giving the reasons for the action, and the regulation or regulations with which the licensee has failed to comply that forms the basis for the emergency suspension; and
10.07.05.25.htm 10.07.05.25. 25 Denial or Revocation of a License.. The Secretary, for cause shown, may deny, revoke, or refuse to reissue any license issued for inability or failure to comply with the regulations of this chapter. This action is subject to the provisions of the Administrative Procedure Act, State Government Article, §10-201 et seq. Annotated Code of Maryland.
10.07.05.26.htm 10.07.05.26. 26 Notice to Clients.. Unless otherwise ordered by the Secretary, the agency shall notify each competent client and each client representative within at least 30 days of:A. Any significant change of licensure status;. B. A voluntary surrender of its agency license; or. C. Denial, revocation, or suspension of the license..
10.07.05.27.htm 10.07.05.27. 27 Penalty for Unlicensed Operation.. A person that operates a residential service agency without a license may be assessed a civil money penalty by the Department not to exceed $10,000 per violation and, additionally, is guilty of a misdemeanor and, on conviction, is subject to a criminal fine not exceeding $1,000 for the first offense and $10,000 for each subsequent offense. Each day that a violation is continued after the first conviction is a separate offense.
10.07.05.28.htm 10.07.05.28. 28 Hearings.. A. An agency shall file a request for a hearing with the Office of Administrative Hearings, with a copy to the Office of Health Care Quality, not later than 30 days after receipt of notice of the Secretary’s action. The request shall include a copy of the Secretary’s action.B. A hearing requested under this chapter shall be conducted in accordance with State Government Article, Title 10, Subtitle 2, Annotated Code of Maryland, and COMAR 10.01.03 and 28.02.01.
10.07.05.9999.htm 10.07.05.9999. Administrative History Effective date: January 17, 1994 (21:1 Md. R. 33). Regulation .01B amended effective June 2, 1997 (24:11 Md. R. 793). Regulation .02 amended effective June 2, 1997 (24:11 Md. R. 793). Regulation .03C repealed effective June 2, 1997 (24:11 Md. R. 793). Regulation .05-1 adopted effective June 2, 1997 (24:11 Md. R. 793) ―. Regulations .01―08 repealed and new Regulations .01―28 adopted effective May 1, 2012 (38:21 Md. R. 1277)Regulation .04A amended e
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