Nev. Admin. Code § 639.6946

Current through October 11, 2024

Section 639.6946 - Duties of providers; repair and maintenance of medical products; hours of operation; consumer complaints

1. Except as otherwise provided in NAC 639.6945, a medical products provider shall:

(a) Provide services for all medical products sold, leased or otherwise provided by the medical products provider, including, without limitation, set up, repair and maintenance.

(b) Employ an administrator and other employees sufficient to provide the services described in paragraph (a).

(c) Ensure that each employee is trained to:

(1) Use, set up, repair and maintain the medical products sold, leased or otherwise provided by the medical products provider that an employee is authorized to sell, lease or otherwise provide to a consumer; and

(2) Instruct consumers concerning the use, set up and maintenance of the medical products sold, leased or otherwise provided by the medical products provider that an employee is authorized to sell, lease or provide to a consumer.

(d) Maintain an inventory of medical products that is adequate to serve the needs of the consumers served by the medical products provider.

(e) Maintain a suitable physical location, other than a residence, at which the medical products provider can:

(1) Store inventory;

(2) Repair or service any equipment which the medical products provider sells, leases or otherwise provides; and

(3) Keep all current records related to the business of the medical products provider.

(f) Have a functioning restroom containing a toilet and a sink with hot and cold water at the place of business of the medical products provider.

(g) Maintain the place of business of the medical products provider in a clean, orderly and sanitary condition.

(h) Ensure that the place of business complies at all times with applicable federal, state and local laws, regulations and rules, including, without limitation, applicable occupational safety rules, fire codes, building codes and health codes.

(i) Maintain liability insurance of at least $1,000,000, which must include product liability insurance if the medical products provider:

(1) Designs, fabricates or manufactures medical products; or

(2) Substantially modifies commercially available medical products.

(j) Maintain a log or other record regarding all repairs made to a medical product provided by the medical products provider. For a medical product repaired by the medical products provider, the log or record must identify:

(1) The type of medical product;

(2) The manufacturer;

(3) The model or model number;

(4) The serial number;

(5) The date of the repair;

(6) The specific repair made;

(7) The name of the person or company who performed the repair; and

(8) A certification that the medical product has been returned to the specifications of the manufacturer as a result of the repair.

2. If the medical products provider cannot certify that the repaired medical product has been returned to the specifications of the manufacturer as a result of the repair, the medical products provider must:

(a) Determine whether the medical product can be safely and effectively used for a limited purpose, in which case the medical products provider must note that the medical product must only be used for a limited purpose and must ensure that the medical product is only used for such a limited purpose; or

(b) Ensure that the medical product is removed from service and is not sold, leased or otherwise provided to any person without a written statement acknowledging that the medical product:

(1) Was repaired;

(2) Could not be repaired to the specifications of the manufacturer; and

(3) Cannot be used by the consumer for the purposes for which the medical product was intended.

3. Any device used by a medical products provider to calibrate or test equipment must be accurate and must be maintained according to the directions and specifications of the manufacturer. The scales used to weigh reservoirs of liquid oxygen must be accurate and must be certified annually by the State Sealer of Consumer Equitability.

4. The business premises of any medical products provider must be open and accessible to the public and the Board at all times during regular hours of operation.

5. A medical products provider shall not operate at the same location as another medical products provider.

6. A medical products provider shall develop and use a written procedure for addressing consumer complaints, including, without limitation, procedures for maintaining a complaint file that documents all complaints from consumers and the resolution of each complaint.

Nev. Admin. Code § 639.6946

Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R033-07, 8-26-2008; A by R085-22A, eff. 9/19/2022

NRS 639.070