Current through April 3, 2024
(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 nonparticipation; 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.
Authority: T.C.A. §§
4-5-202,
4-5-204,
68-11-202, 68-11-206, 68-11-209,
68-11-226, and 68-11-304.