Tenn. Comp. R. & Regs. 1200-08-29-.06 - BASIC AGENCY FUNCTIONS

(1) Patient Instruction. The agency shall have written guidelines relating to patient and/or caregiver training and education that includes at a minimum:
(a) Financial responsibilities;
(b) Equipment use and maintenance;
(c) Patient rights and responsibilities;
(d) Emergency/back-up systems and trouble shooting procedures, if applicable; and
(e) How to contact the agency during regular business hours and after hours, if applicable.
(2) Infection Control. The agency shall have written policies and procedures relating to infection control. Employees shall consistently follow infection control procedures in the provision of care to the agency's patients. The written policies and procedures at a minimum must address standards and education of staff about:
(a) Infection control measures;
(b) Handwashing;
(c) Use of universal precautions and personal protective equipment;
(d) Appropriate cleaning and disinfection of reusable equipment and supplies; and,
(e) Disposal of regulated waste.
(f) A Home Care Organization Providing Home Medical Equipment shall have an annual influenza vaccination program which shall include at least:
1. The offer of influenza vaccination to all staff and independent practitioners at no cost to the person or acceptance of documented evidence of vaccination from another vaccine source or facility. The Home Care Organization Providing Home Medical Equipment will encourage all staff and independent practitioners to obtain an influenza vaccination;
2. A signed declination statement on record from all who refuse the influenza vaccination for reasons other than medical contraindications (a sample form is available at http://tennessee.gov/health/topic/hcf-provider);
3. Education of all employees about the following:
(i) Flu vaccination,
(ii) Non-vaccine control measures, and
(iii) The diagnosis, transmission, and potential impact of influenza;
4. An annual evaluation of the influenza vaccination program and reasons for non-participation; and
5. A statement that the requirements to complete vaccinations or declination statements shall be suspended by the administrator in the event of a vaccine shortage as declared by the Commissioner or the Commissioner's designee.
(3) In-Home Safety. The agency shall educate staff, patients, and caregivers about basic home safety related to the use of equipment delivered to the home. There shall be a procedure for reporting and documenting all incidents. There shall be an incident report form and identification of the types of situations that should be reported and documented.
(4) Equipment Management.
(a) Client-ready equipment shall be durable in nature, sanitized, and in proper working order. The agency shall have clearly defined guidelines for the cleaning, storage, and transportation of client-ready equipment. These guidelines shall include, but are not limited to:
1. Separation of clean and unclean equipment;
2. Appropriate warehousing and tagging of equipment;
3. Use of appropriate cleaning agents, as directed by the manufacturer;
4. Routine maintenance of equipment; and
5. Separation of inoperative equipment.
(b) Except for mail order companies, agency employees shall be qualified to deliver, perform environmental assessments, set up, and demonstrate safe and proper use of all home medical equipment according to manufacturer's guidelines.
(c) Agency guidelines shall clearly define training, qualifications, and skills validation required by employees to perform routine maintenance and repairs of all home medical equipment. Routine maintenance, preventive maintenance, and repairs shall be performed according to manufacturer's guidelines. Agency employees shall only perform repair services within their respective areas of documented training and expertise. There shall be guidelines that define appropriate use of outside repair sources.
(d) The agency shall have written guidelines for accurate performance quality tracking of equipment in compliance with the FDA's Medical Device Tracking program and facilitate any recall notices sent by the manufacturer. These guidelines shall address the:
1. Immediate removal from equipment inventory;
2. Notification to the client; and
3. Exchange of equipment in the field.
(e) Disposition of recalled inventory shall be handled according to manufacturer's guidelines.
(f) Only durable medical equipment shall be returned to the company for processing. The agency shall have written policies and procedures for processing contaminated or soiled durable medical equipment and shall be in compliance with universal precautions. Guidelines shall specify the separation of dirty equipment from client ready equipment in the warehouse and delivery vehicles.
(5) Physical Location. Each parent and/or branch shall:
(a) Be located in Tennessee;
(b) Be staffed during normal business hours and have a working telephone;
(c) Be used for the dispensing, servicing, and storage of home medical equipment or be used to provide home medical equipment services;
(d) Meet all local zoning requirements; and
(e) Have all required current licenses and/or permits conspicuously posted in the agency.
(6) Additional Compliance Requirements. The agency shall comply with all federal, state, and local laws and regulations.
(a) Written policies and procedures shall be established and implemented by the agency regarding compliance with all applicable federal, state, and local laws and regulations.
(b) An agency providing prescribed wheeled mobility devices shall obtain a complete face-to-face written evaluation and recommendation by a qualified rehabilitation professional for consumers of prescribed wheeled mobility devices.
(c) The agency must have on staff, or contract with, a qualified rehabilitation professional.
(d) As of July 1, 2007, a one hundred eighty (180) day grace period shall be provided to agencies that provide prescribed wheeled mobility devices if the qualified rehabilitation professional on staff ceases to be employed and the agency has no other qualified rehabilitation professional on staff.
(e) All agencies making available prescribed wheeled mobility devices to consumers in Tennessee shall have a repair service department or a contract with a repair service department located in the state. The agency shall have a qualified technician with knowledge and capability of servicing the product provided to the consumer. As used in this section, "consumer" means an individual for whom a wheeled mobility device, manual or powered, has been prescribed by a physician, and required for use for a period of six (6) months or more.
(f) Delivery and final fitting of a wheeled mobility device shall be determined by a qualified rehabilitation professional. Exempt are wheeled mobility devices under category Group 1 Medicare codes.
(g) The agency shall comply with the following supplier standards:
1. Fill orders from its own inventory or inventory of other companies with which it has contracts to fill such orders, or fabricates or fits items for sale from supplies it buys under a contract;
2. Oversee delivery of items that the supplier ordered for the patient. The supplier is also responsible to assure delivery of large items to the patient;
3. Honor all warranties, express or implied, under applicable state law;
4. Answer questions or complaints about an item or use of an item that is sold or rented to the patient. If the patient has questions, the supplier will refer the patient to the appropriate carrier;
5. Maintain and repair directly, or through a service contract with another company, items it rents to a patient;
6. Accept returns for substantial medical equipment;
7. Provide the following disclosure information to the department:
(i) The identity of each person having a five percent (5%) or more ownership or controlling interest in the agency.
(ii) The identity of subcontractors in which the agency has a five percent (5%) or more ownership interest;
(iii) At the time such information is disclosed or at any time during the three (3) year period preceding the date such information is supplied, managing employees of the agency, persons having five percent (5%) or more ownership or controlling interest, and subcontractors in which the agency has five percent (5%) or more ownership interest must disclose any other entity providing items or services that receives payment under title XVIII; and
(iv) Managing employees of the agency, persons having five percent (5%) or more ownership or controlling interest, and subcontractors in which the agency has five percent (5%) or more ownership interest must disclose any penalties, assessments, or exclusions assessed against such person under Section 1128, 1128A, or 1128B of the Social Security Act;
8. Maintain general and product liability insurance; and
9. Disclose consumer information to each patient. This consists of a copy of the supplies standards to which it must conform.


Tenn. Comp. R. & Regs. 1200-08-29-.06
Original rule filed August 24, 2000; effective November 7, 2000. Amendment filed October 11, 2007; effective December 25, 2007. Amendment filed December 23, 2009; effective March 16, 2010. Amendment filed December 16, 2013; effective March 16, 2014. Amendments filed July 18, 2016; effective October 16, 2016. Amendments filed January 7, 2019; to have become effective April 7, 2019. However, the Government Operations Committee filed a 60-day stay of the effective date of the rules; new effective date 6/6/2019.

Authority: T.C.A. ยงยง 4-5-202, 4-5-204, 68-11-202, 68-11-206, 68-11-209, 68-11-226, and 68-11-304.

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