PROVIDERS AND WHOLESALERS OF MEDICAL PRODUCTS

General Provisions

NAC 639.693 Definitions. (NRS 639.070) As used in NAC 639.693 to 639.6958, inclusive, unless the context otherwise requires, the words and terms defined in NAC 639.6931 to 639.6938, inclusive, have the meanings ascribed to them in those sections.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6931 “Assistive equipment” defined. (NRS 639.070) “Assistive equipment” means a medical product intended to aid a consumer in the performance of one or more bodily activities. The term includes, without limitation, a wheelchair, walker or other similar device. The term does not include respiratory equipment.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6932 “Consumer” defined. (NRS 639.070) “Consumer” means the ultimate recipient or beneficiary of services and goods provided by a medical products provider.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6933 “Health professional” defined. (NRS 639.070) “Health professional” means a practitioner, a physical therapist, an occupational therapist, a registered nurse or a respiratory therapist.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6934 “Life-sustaining equipment” defined. (NRS 639.070) “Life-sustaining equipment” means a medical product that is necessary for a consumer to avoid exposure to a medically reasonable expectation of imminent death or serious injury. The term includes, without limitation, a ventilator and an oxygen concentrator.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6935 “Medical products” defined. (NRS 639.070)
1. “Medical products” includes medical devices, equipment, supplies and gases intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease.
2. The term does not include:
(a) Controlled substances;
(b) Dangerous drugs, except medical gases and supplies that facilitate the use of a dangerous drug, including, without limitation, normal saline and other similar inert liquids; and
(c) Medical devices, equipment, supplies or gases the regulation of which is governed by any other board or agency other than the board.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6936 “Medical products provider” defined. (NRS 639.070)
1. “Medical products provider” means a person licensed pursuant to NAC 639.693 to 639.6958, inclusive, to sell, lease or otherwise provide medical products to a consumer in this state.
2. The term does not include:
(a) A health professional who sells, leases or otherwise provides medical products to a consumer for use by that consumer pursuant to the order of a practitioner;
(b) A pharmacy that sells, leases or otherwise provides medical products to a consumer for use by that consumer; or
(c) An installer of medical gas systems, as that term is defined in NAC 477.137, who is registered pursuant to chapter 477 of NAC.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6937 “Medical products wholesaler” defined. (NRS 639.070)
1. “Medical products wholesaler” means a person licensed pursuant to NAC 639.693 to 639.6958, inclusive, to sell, lease or otherwise provide medical products to a health care facility, agency, practitioner or provider in this state.
2. The term does not include:
(a) A person who sells, leases or otherwise provides medical products to a consumer; or
(b) An installer of medical gas systems, as that term is defined in NAC 477.137, who is registered pursuant to chapter 477 of NAC.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6938 “Respiratory equipment” defined. (NRS 639.070) “Respiratory equipment” means a medical product intended to assist a consumer in the act of breathing or intended to introduce a product or drug, other than a medical gas, into the lungs of a consumer.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.694 Administrator required. (NRS 639.070)
1. Each medical products provider or medical products wholesaler shall have an administrator at all times. The administrator must be a natural person who is employed by the medical products provider or medical products wholesaler at the place of business or facility of the employer at least 40 hours per week or during all regular business hours if the business or facility is regularly open less than 40 hours per week. The administrator shall ensure that the operation of the business or facility complies with all applicable federal, state and local laws, regulations and rules.
2. A medical products provider or medical products wholesaler shall notify the staff of the board of the cessation of employment of an administrator within 3 business days after such cessation. A medical products provider or medical products wholesaler shall notify the staff of the board of the employment of a new administrator within 3 business days after such employment.
3. A medical products provider or medical products wholesaler may not operate for more than 10 business days without an administrator. The board may summarily suspend the operation of a business or facility that operates without an administrator.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6941 Unprofessional conduct; responsibility of owner for acts of others. (NRS 639.070)
1. In addition to the acts described in NAC 639.945 which are applicable to medical products providers or medical products wholesalers, the following acts or practices by a medical products provider or a medical products wholesaler are declared to be, specifically but not by way of limitation, unprofessional conduct and conduct contrary to the public interest:
(a) Any violation of these regulations or violation of any applicable federal, state or local laws related to the practices of the medical products provider or medical products wholesaler.
(b) Loss of, or failure to maintain or renew, the required liability insurance.
(c) Practicing, condoning, facilitating or collaborating with any form of unlawful discrimination against any person or group on the basis of race, color, sex, sexual orientation, age, religion, national origin, marital status, or mental or physical handicap in providing any service or product to a consumer.
(d) Failing to maintain the confidentiality of information regarding a consumer and disclosing such information without valid authorization, except where such a disclosure is required by law.
(e) Performing or allowing any employee or agent of the medical products provider or medical products wholesaler to perform services beyond the training, competency, ability or knowledge of the employee or agent.
(f) Submitting any claim for payment or reimbursement to any person or entity for products or services that is fraudulent, deceitful, unnecessary, or for any products or services not actually provided to a consumer.
(g) Violating any provision of the Code of Ethics of the National Association for Medical Equipment Services, which is hereby adopted by reference, a copy of which may be obtained, free of charge, by writing to the American Association for Homecare, 625 Slaters Lane, Suite 200, Alexandria, Virginia 22314-1171.
(h) Violating any provision of the Code of Ethics of the Nevada Association of Medical Products Suppliers, which is hereby adopted by reference, a copy of which may be obtained, free of charge, by writing to the Nevada Association of Medical Products Suppliers, P.O. Box 61492, Boulder City, Nevada 89006-1492.
(i) Engaging in any knowing or willful offer, payment, solicitation or receipt of any remuneration to induce referrals of sales, leases, or other provisions of medical products or services by any medical products provider, medical products wholesaler or health professional.
(j) Violating any provision of the Standards of Practice and the Code of Ethics for the National Registry of Rehabilitation Technology Suppliers, which is hereby adopted by reference. The publication may be obtained from the National Registry of Rehabilitation Technology Suppliers, P.O. Box 4033, Lago Vista, Texas 78645-4033, for the price of $5 or free of charge at the Internet address http://www.nrrts.org/.
2. The owner of a medical products provider is responsible for the acts of his business administrator and employees. 3. The owner of a medical products wholesaler is responsible for the acts of his facility administrator and employees.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

Licensing and Fees NAC 639.6942 Application for license; license required for each location; notification of change in information; license nontransferable; expiration. (NRS 639.070)
1. An applicant for a license to engage in business as a medical products provider or medical products wholesaler must submit an application to the board on a form furnished by the board. The application must include:
(a) The name, mailing address and telephone number of the applicant;
(b) The street address of the business or facility of the applicant, if different from the mailing address of the applicant;
(c) All trade or business names used by the applicant;
(d) The type of ownership or operation of the business or facility;
(e) The name, address, telephone number and social security number of the person who manages the business or facility of the applicant;
(f) If the applicant is:
(1) A natural person, the name of the person;
(2) A partnership, the name of the partnership and the name of each general or limited partner;
(3) A corporation, the name and title of each officer and director of the corporation, the corporate name, the state of incorporation and the name of the corporation’s parent company, if any; or
(4) A sole proprietorship, the name of the sole proprietor and the name of the business entity;
(g) Proof of insurance required pursuant to NAC 639.6946;
(h) The hours and days that the business will be regularly operated; and
(i) All Medicare and Medicaid provider numbers registered to the business or its owner.
2. If a medical products provider sells, leases or otherwise provides medical products at more than one location, it must obtain a license for each location where medical products are sold, leased or otherwise provided.
3. An applicant shall notify the board in writing of any change in the information required pursuant to this section within 30 days after the change occurs.
4. A license issued by the board pursuant to this section:
(a) Is not transferable; and
(b) Expires on October 31 of each even-numbered year unless renewed before that date.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6943 Licensing of actively practicing health professionals. (NRS 639.070) The board will not issue a license to conduct business as a medical products provider or medical products wholesaler to:
1. An actively practicing health professional; or
2. A partnership, corporation or association in which an actively practicing health professional has a controlling interest or in which ownership of 10 percent or more of the available stock is held by one or more actively practicing health professionals.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6944 Licensing of applicants located outside of state. (NRS 639.070)
1. Any person who is located outside of this state and who intends to sell medical products to any consumer or medical products provider in this state on a regular basis must apply for an appropriate license pursuant to the provisions of NAC 639.693 to 639.6958, inclusive. Any medical products provider or medical products wholesaler that is located outside of this state must comply with the provisions of NAC 639.693 to 639.6958, inclusive, for any sale, lease or other disposition of medical products to any person in this state other than a medical products wholesaler or manufacturer that is licensed by the board.
2. Any medical products provider or medical products wholesaler that is located outside of this state must submit evidence with any application pursuant to the provisions of NAC 639.693 to 639.6958, inclusive, that the medical products provider is licensed, permitted, registered or otherwise lawfully authorized by the state of residence of the medical products provider to engage in the same business for which the medical products provider is seeking licensure in this state.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6945 Waiver of license fee. (NRS 639.070) The board may waive the license fee, or any part thereof, for a medical products provider that:
1. Is a tax-exempt charitable organization pursuant to 26 U.S.C. § 501(c);
2. Provides medical products to a majority of the consumers served by the medical products provider at no charge; and
3. Verifies to the satisfaction of the board that 75 percent of the funds of the medical products provider are used for bona fide charitable purposes.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001; A by R012-02, 5-31-2002)

Medical Products Providers NAC 639.6946 Duties of providers; repair and maintenance of medical products; hours of operation; consumer complaints. (NRS 639.070)
1. 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, setup, 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, setup, 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, setup 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 physical location 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 weights and measures.
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 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.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6947 Change in controlling interest. (NRS 639.070) Upon a change in the controlling interest of a medical products provider, the medical products provider shall:
1. Apply with the board for a new license within 5 days after the completion of the transaction which changes the controlling interest;
2. Ensure that all servicing, maintenance or repair obligations outstanding at the time of the purchase are addressed without interruption or disruption to the service being received by the consumer; and
3. Not operate the business, except to service, maintain, repair or otherwise satisfy the outstanding obligations of the predecessor business, until the new owner is licensed by the board.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6948 Compliance with provisions by person or business who is not medical products provider. (NRS 639.070) Any person or business that is not a medical products provider who sells, leases or otherwise provides medical products to a consumer must comply with NAC 639.693 to 639.6958, inclusive, for any sale, lease or other disposition of medical products as though that person were a medical products provider.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6949 Provision of medical products to consumer with or without bona fide order or prescription; tracking requirements. (NRS 639.070)
1. A medical products provider shall provide medical products for which an order of a practitioner is required to a consumer only after the receipt of a bona fide order or prescription from a practitioner.
2. A medical products provider may provide medical products for which an order of a practitioner is not required to a consumer with or without a bona fide order or prescription from a practitioner. If a written order or prescription is received from a practitioner or if a written record of an oral order or prescription is made by the medical products provider, the medical products provider shall keep and maintain the written record in the manner required by NAC 639.695.
3. For all medical devices and equipment to which the medical device tracking requirements of the Food and Drug Administration apply, the medical products provider must keep and maintain written records of the serial or tracking numbers for the medical devices and equipment.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.695 Maintenance of records. (NRS 639.070) The records made or kept pursuant to NAC 639.6949 must be:
1. Kept in a file, chart or other storage system allowing the record to be retrieved by reference to the name of the consumer, the name of the practitioner, the date the product was provided or the type of medical product;
2. Retained for at least 5 years from the date the records are made or received;
3. Kept at the physical location of the business; and
4. Readily retrievable upon request by a member of the board, or a person conducting an inspection or investigation on behalf of the board.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6951 Communications and advisement of options and use of medical products; written record. (NRS 639.070)
1. Before providing a medical product, a medical products provider shall identify and describe the commercially available choices and, where appropriate, custom fabricated choices available to meet the objectives of the consumer to:
(a) The consumer, his family or his agent;
(b) The primary caregiver of the consumer, if any; and
(c) The health professional of the consumer.
2. When providing medical products, a medical products provider shall communicate with and advise the consumer, his agent or his primary caregiver about the proper use of the medical products, which communication and advisement must include, as appropriate:
(a) The set up and use of the medical products;
(b) The maintenance, servicing, cleaning and repair of the medical products;
(c) The name, telephone number and related information of the medical products provider for emergency, subsequent or continuing care and service of the medical products;
(d) Cautions regarding the use or modification of the medical products;
(e) Information provided by the manufacturer of the medical products that will facilitate the optimal use of the medical products;
(f) Information regarding any warranty or other consumer protection concerning the medical products;
(g) The terms and conditions of the sale, lease or other disposition of the medical products; and
(h) Any other information that, in the judgment of the medical products provider, will facilitate the safe and optimal use of the medical products by the consumer.
3. The medical products provider shall make a written record of all communications made pursuant to this section.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6952 Communications concerning use of medical products provided by written or oral order or prescription; written record. (NRS 639.070)
1. When a medical products provider sells, leases or otherwise provides medical products to a consumer upon the written or oral order or prescription of a health professional, the medical products provider shall communicate with the health professional to ascertain:
(a) The physical, functional and associated needs of the consumer; and
(b) The therapeutic or ameliorative objectives to be met by the medical products that will be sold, leased or otherwise provided by the medical products provider.
2. When a medical products provider sells, leases or otherwise provides medical products to a consumer, the medical products provider shall communicate with the consumer, or his family, caregiver or agent to ascertain and assess:
(a) The safety of the environment in which the medical products will be used;
(b) The ability of the consumer or his family, caregiver or agent to comply with the instructions of the health professional of the consumer and medical products provider regarding the proper use of the medical products; and
(c) The ability of the consumer or his family, caregiver or agent to clean and maintain the medical products.
3. The medical products provider shall make a written record of all communications made pursuant to this section.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6953 Assistive equipment. (NRS 639.070)
1. A medical products provider that sells, leases or otherwise provides assistive equipment shall:
(a) Make measurements using the appropriate instruments and techniques to assure the optimal fit and function of the assistive equipment for the consumer;
(b) Deliver, fit and adjust the assistive equipment so that the assistive equipment is fully operable when the medical products provider leaves the premises of the consumer;
(c) Instruct the consumer, the family of the consumer or the primary caregiver of the consumer regarding the use, maintenance, servicing and cautions related to the assistive equipment;
(d) Provide all warranty information regarding the assistive equipment, including, without limitation, any warranty provided by the medical products provider or any commercial warranty available for the assistive equipment; and
(e) Respond to a request for service or repair of the assistive equipment not later than 3 business days after the request is received by the medical products provider, except that such service or repair need not be provided if the account of the consumer is not current with the medical products provider and such an exception is made in writing by the medical products provider to the consumer.
2. A medical products provider that sells, leases or otherwise provides assistive equipment shall develop and use quality assurance policies and procedures that require:
(a) A review to determine the compatibility, utility and safety of assistive equipment that is custom designed and fabricated by the medical products provider when such equipment is used with assistive equipment that is commercially made;
(b) A process of selecting materials used in custom designed and modified assistive equipment to assure that the materials are safe and durable; and
(c) The making and keeping of records regarding communications with health professionals, consumers, and the family and agents of a consumer concerning assistive equipment.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6954 Medical gases and associated equipment or respiratory equipment. (NRS 639.070)
1. A medical products provider that sells, leases or otherwise provides medical gases and associated equipment, or respiratory equipment shall:
(a) Comply with all applicable federal, state and local laws regarding the providing and transportation of such gases and equipment, including, without limitation, all requirements regarding the tracking and recalling of gases and equipment;
(b) Comply with all applicable federal, state, and local laws regarding transfilling and repackaging of such gases;
(c) Comply with all applicable federal, state and local laws, including, without limitation, fire codes, occupational safety rules, building codes and health codes;
(d) Service equipment sold, leased or otherwise provided by the medical products provider according to the directions and specification of the manufacturer, regardless of where the equipment may be located at the time that the equipment is due for servicing;
(e) Make and keep records regarding the servicing of equipment by the medical products provider; and
(f) Provide only gases that are:
(1) Medical grade; and
(2) Intended for use by humans.
2. Before providing any equipment pursuant to this section, a medical products provider shall verify that the equipment:
(a) Has been checked and is free of defects;
(b) Is operating within the specifications of the manufacturer;
(c) Has not been modified in any way that will jeopardize the effectiveness or safety of the equipment;
(d) Does not present a hazard of fire or shock; and
(e) Has all warning labels and tags that were provided by the manufacturer, wholesaler or seller of the equipment.

3. A medical products provider that sells, leases or otherwise provides medical gases and equipment or respiratory equipment shall develop and use policies and procedures that require:
(a) Making and keeping records to track and recall all gases dispensed by the medical products provider, including, without limitation:
(1) Recording the lot numbers and expiration dates for each cylinder or unit of gas provided;
(2) Maintaining a written or computerized system to track and locate all gases and equipment provided by the medical products provider; and
(3) Recording the serial numbers and model numbers of all equipment provided by the medical products provider;
(b) Maintaining and cleaning equipment provided by the medical products provider, including, without limitation:
(1) Documenting that the function and safety of the equipment was verified before the equipment was provided to the consumer;
(2) Cleaning and disinfecting equipment pursuant to an established protocol to remove aerobic and anaerobic pathogens from the equipment to the specifications of the manufacturer for that equipment;
(3) Making and keeping a material safety data sheet for the solutions and products used in cleaning and disinfecting the equipment;
(4) Designating areas at the business of the medical products provider that must be used to store separately clean and unclean equipment; and
(5) Designating a separate area at the business of the medical products provider that must be used to store quarantined equipment.
4. When a medical products provider provides oxygen, the medical products provider must also provide an emergency supply of oxygen, supplies and equipment to maintain therapy while the primary supply of oxygen and related equipment is inoperable or unusable.
5. In addition to any communication and advisement required pursuant to NAC 639.693 to 639.6958, inclusive, a medical products provider who provides medical gas and related equipment, or respiratory equipment, must advise the consumer receiving the medical gas and related equipment, or respiratory equipment, regarding:
(a) Cleaning of the equipment;
(b) Potential hazards and warning signs of malfunctioning or inadequately functioning equipment;
(c) Maintenance procedures for the equipment;
(d) The telephone number, contact name, and contact address for emergency servicing or repair of the equipment, and for routine servicing or repair of the equipment; and
(e) The written materials about the equipment that are available from the medical products provider or the manufacturer of the equipment.
6. For the purposes of this section, “material safety data sheet” has the meaning ascribed to it in 29 C.F.R. § 1910.1200.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6955 Life-sustaining equipment. (NRS 639.070) A medical products provider who sells, leases or otherwise provides life-sustaining equipment shall:
1. Maintain a sufficient number of employees who are:
(a) Trained to service and repair the life-sustaining equipment provided by the medical products provider; and
(b) Available to service and repair the life-sustaining equipment within 1 hour of any call for service or repair;
2. Inform all consumers to whom the medical products provider has sold, leased or otherwise provided life-sustaining equipment of a toll-free telephone number that the consumer may call at any time the life-sustaining equipment has malfunctioned;
3. Ensure that information and procedures in the event of an emergency are in writing and attached to the life-sustaining equipment; and
4. Provide the consumer with sufficient emergency supplies and equipment necessary to sustain the consumer until the medical products provider can service or repair the life-sustaining equipment.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

NAC 639.6956 Parenteral and enteral services and equipment. (NRS 639.070) A medical products provider who sells, leases or otherwise provides parenteral and enteral services and equipment shall:
1. Provide a consumer with an orientation and a written checklist regarding:
(a) Instructions for use of the equipment;
(b) Cleaning procedures;
(c) Safety precautions; and
(d) Maintenance procedures;
2. Return as necessary to the premises of the consumer to demonstrate the use and maintenance of parenteral and enteral services and equipment; and
3. Deliver and review written instructions with the consumer to ensure the proper use and maintenance of the parenteral and enteral services and equipment.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

Medical Products Wholesalers NAC 639.6957 Duties of wholesalers; repair and maintenance of medical products; hours of operation; consumer complaints. (NRS 639.070)
1. A medical products wholesaler shall:
(a) Employ a facility administrator and other employees sufficient to operate, set up, repair, maintain and service all medical products sold, leased or otherwise provided by the medical products wholesaler.
(b) Ensure that employees of the medical products wholesaler are trained to operate, set up, repair, maintain and service the medical products sold, leased or otherwise provided by the medical products wholesaler.
(c) Ensure that employees of the medical products wholesaler are trained to instruct medical products providers regarding the operation, set up, repair, maintenance and service of all medical products sold, leased or otherwise provided by the medical products wholesaler.
(d) Maintain an inventory of medical products necessary to serve the needs of the medical products providers served by the medical products wholesaler.
(e) Maintain a physical location at which the medical products wholesaler can:
(1) Store inventory;
(2) Repair or service any equipment which the medical products wholesaler sells, leases or otherwise provides; and
(3) Keep all current records related to the operation of the medical products wholesaler.
(f) Have a functioning lavatory with a toilet and a sink with hot and cold water at the facility of the medical products wholesaler.
(g) Maintain the facility of the medical products wholesaler in a clean, orderly and sanitary condition.
(h) Ensure that the facility of the medical products wholesaler complies with all applicable federal, state and local laws, regulations and rules, including, without limitation, 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 wholesaler:
(1) Designs, fabricates or manufactures a medical product; or
(2) Substantially modifies a commercially available medical product.
(j) Maintain a log or other record regarding all repairs made to medical products provided by the medical products wholesaler. For each medical product repaired by the medical products wholesaler, 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 wholesaler 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 wholesaler must:
(a) Determine whether the medical product can be safely and effectively used for a limited purpose, in which case the medical products wholesaler must note that the medical product can only be used for a limited purpose and must ensure that the medical product is only used for such 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 brought up to the specifications of the manufacturer; and
(3) Cannot be used for the purposes for which the medical product was intended.
3. Any device used by a medical products wholesaler 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 weights and measures.
4. The physical premises of any medical products wholesaler must be open and accessible to the board at all times during regular hours of operation.
5. The owner of a medical products wholesaler is responsible for the acts of his facility administrator and employees.
(Added to NAC by Bd. of Pharmacy by R008-01, eff. 11-1-2001)

Disciplinary Action NAC 639.6958 Summary suspension of license. (NRS 639.070)
1. The secretary of the board may summarily suspend the license of a medical products provider or medical products wholesaler upon receiving evidence sufficient to cause him to reasonably believe that a medical products provider or medical products wholesaler is:
(a) Operating without liability insurance;
(b) Operating without a license;
(c) Operating without a business administrator or a facility administrator; or
(d) Engaging in practices that are fraudulent or deceitful.
2. The secretary of the board shall immediately provide written notice to the medical products provider or medical products wholesaler that informs the medical products provider or medical products wholesaler of:
(a) The factual and legal reasons for the summary suspension; and
(b) The right of the medical products provider or medical products wholesaler to provide the board with any evidence or information that would show that either the factual or legal reasons for the summary suspension are incorrect.
3. The secretary of the board may take whatever action he deems reasonably necessary to secure the medical products and premises, and to ensure that the medical products provider or medical products wholesaler does not conduct business during the summary suspension.
4. The secretary of the board shall release the medical products provider or medical products wholesaler from the summary suspension upon receiving evidence satisfactory to the secretary of the board from the medical products provider or medical products wholesaler that the deficiency noted in the written notice has been remedied.
5. Within 10 days after summarily suspending the license of a medical products provider or medical products wholesaler, the secretary of the board shall serve upon the medical products provider or medical products wholesaler an accusation pursuant to NRS 639.241. A hearing on the accusation must be set for the next regularly scheduled meeting of the board.