201 KAR 2:350. Home medical equipment service providers.


      RELATES TO: KRS 315.512, 315.514, 315.518, 314.520

      STATUTORY AUTHORITY: KRS 315.191, 315.518(1), (4), 315.520(4)

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191 authorizes the Board of Pharmacy to promulgate administrative regulations governing home medical equipment and service providers. This administrative regulation establishes the minimum requirements for the licensing of a home medical equipment service provider.


      Section 1. General Requirements. (1) A home medical equipment company engaged in providing services in the Commonwealth shall apply for a license from the board in accordance with KRS 315.518 and this administrative regulation.

      (2) An agent or employee of a licensee shall not be required to obtain a license if the agent or employee is acting in the usual course of business or employment.

      (3) A license shall not be issued or renewed unless the applicant demonstrates or continues to demonstrate acceptable operational procedures, including:

      (a) Adequate maintenance and storage conditions to ensure proper lighting, ventilation, temperature, and humidity control, sanitation, space, and security;

      (b) Establishing and providing records of annual continuing education for personnel engaged in the delivery, maintenance, repair, cleaning, inventory control, and financial management of home medical equipment and services; and

      (c) Providing accurate and precise records of all goods shipped or received including source of receipt, date, quantity, itemized description, and any other information pertinent to the transaction.

      (4) An applicant for a home medical equipment license shall prepare and adopt a policy and procedure manual that sets forth a detailed description of how the:

      (a) Operation will comply with applicable federal, state, or local laws or administrative regulations; and

      (b) Licensees will maintain the premises so that the home medical equipment remains secure.


      Section 2. Sanitation and Safety Requirements. (1) An applicant for a home medical equipment license located in the Commonwealth of Kentucky shall be inspected by the board prior to the issuance of the license.

      (2)(a) The designated business area shall be used exclusively for the sale, rental, and distribution of home medical equipment.

      (b) Repairs and cleaning shall be done in a confined, properly ventilated area.

      (c) All areas shall be adequately lighted and all areas kept in a clean and sanitary manner.

      (3) A home medical equipment supplier shall comply with the maintenance and cleaning requirements established in this subsection. A home medical equipment supplier shall:

      (a) Maintain documents demonstrating that a function and safety check of equipment was performed prior to set up;

      (b) Maintain an established protocol for cleaning and disinfecting equipment which addresses both aerobic and anaerobic pathogens;

      (c) Maintain a Material Safety Data Sheet (MSDS) on file for solutions and products used in cleaning and disinfecting procedures;

      (d) Maintain segregated areas on the premises and in delivery vehicles for clean, dirty, and contaminated equipment;

      (e) Clean and disinfect equipment according to manufacturer’s specifications;

      (f) Instruct the patient on proper cleaning techniques as specified by the manufacturer; and

      (g) Perform routine inspection, service, and maintenance of equipment located in the patient’s or customer’s home according to manufacturers’ specifications.

      (4) The supplier’s services shall be available twenty-four (24) hours, seven (7) days per week if it is essential to the maintenance of life or lack of service might reasonably cause harm.

      (5) The supplier shall:

      (a) Demonstrate that each piece of equipment has been checked, is free of defects, and operates within the manufacturer’s specifications;

      (b) Maintain documentation, which shall include the following:

      1. The type of equipment;

      2. The manufacturer;

      3. The model number;

      4. The serial number;

      5. The date of repair;

      6. The specific repair made; and

      7. The name of the person or company performing the repair;

      (c) Refrain from modifying equipment to the extent that the modification might reasonably cause harm;

      (d) Maintain all electrical components so that they do not present fire or shock hazard;

      (e) Ensure that all appropriate warning labels or labeling, including tags, are present on the equipment provided;

      (f) Document all equipment serial numbers and model numbers to ensure that equipment can be retrieved if a recall is initiated; and

      (g) Affix an identifying label that contains the name of the provider, address, and phone number.

      (6) The supplier shall implement and maintain a written procedure at each location for handling complaints and problems. The procedure shall include a complaint file documenting complaints and problems and resolution of the complaints and problems.


      Section 3. License Fee; Renewals. (1) A home medical equipment and services provider shall be licensed by the board prior to engaging in providing home medical equipment and services in the Commonwealth.

      (2) An applicant shall submit:

      (a)1. A completed Application for Home Medical Equipment License; and

      2. The initial application fee established by 201 KAR 2:050, Section 1(21); or

      (b)1. A completed Application for Home Medical Equipment License Renewal; and

      2. The renewal application fee established by 201 KAR 2:050, Section 1(22).


      Section 4. Incorporation by Reference. (1) The following material is incorporated by reference:

      (a) "Application for Home Medical Equipment License", Form 1, 10/2012; and

      (b) "Application for Home Medical Equipment License Renewal", Form 2, 10/2012.

      (2) This form may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Board of Pharmacy, State Office Building Annex, Suite 300, 125 Holmes Street, Frankfort, Kentucky 40601, Monday through Friday, 8:00 a.m. to 4:30 p.m. (39 Ky.R. 655; 1375; eff. 2-1-2013.)