North Carolina Administrative Code
Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS
Chapter 46 - PHARMACY
Section .2600 - DEVICES
Section 46 .2609 - REHABILITATION EQUIPMENT
Universal Citation: 21 NC Admin Code 46 .2609
Current through Register Vol. 38, No. 18, March 15, 2024
(a) Rehabilitation equipment suppliers shall follow the provisions of this Rule rather than the provisions of 21 NCAC 46 .2611.
(b) Rehabilitation equipment suppliers shall:
(1) Solicit information from the physician,
physical therapist, occupational therapist, registered nurse and other medical
or educational personnel, as to the results of their assessment and evaluation
of the patient's physical, functional and associated needs as well as the
specific goals to be met by the enabling technology;
(2) In consultation with the referring health
professional(s), patient, patient's family and other primary care providers,
delineate the appropriate choices of commercially available and custom
fabricated equipment to meet the specified needs of the patient;
(3) Participate in the measurement of the
patient, utilizing appropriate instruments and techniques to assure the fit and
function of the selected equipment;
(4) Deliver, fit and adjust the prescribed
equipment;
(5) Instruct the patient
and family in the safe and proper use and care of the equipment
provided;
(6) Provide service and
support for the equipment delivered through knowledgeable, skilled and trained
service personnel and within 72 hours, provide a response to patient requests
for repair service on equipment supplied; however, such service and support
need not be provided unless the patient=s account is current;
(7) Provide a specific, written statement of
warranty on the equipment provided, including commercial warranties and those
for adapted or custom fabricated items;
(8) Maintain liability insurance of at least
one million dollars ($1,000,000) worth of coverage and when involved in the
design, fabrication or substantial modification of commercially available
equipment, also maintain product liability insurance; and
(9) Utilize written, quality assurance
procedures including, but not limited to:
(A)
Reviewing custom designed and fabricated equipment and interfacing techniques
with commercial equipment to assure compatibility and safety;
(B) Understanding the properties of the
materials being used in custom designed and modified equipment to assure long
term durability;
(C) Documenting
goals and objectives of the referring medical or education personnel, as well
as short and long term effectiveness of the equipment in meeting those goals
and objectives; and
(D) Documenting
complaints and problems as required in Rule .1608(a)(12) of this
Chapter.
Authority
G.S.
90-85.3(e),(l1),(r);
90-85.6;
90-85.22;
Eff.
September 1, 1995;
Amended Eff. April 1, 1999; April 1,
1997;
Pursuant to
G.S.
150B-21.3A, rule is necessary without
substantive public interest Eff. October 3,
2017.
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