Chapter Phar 14

Chapter Phar 14

HOME MEDICAL OXYGEN PROVIDERS

Phar 14.01   Application.

Phar 14.02   Standards of Professional Conduct.

Phar 14.01 Phar 14.01 Application. Each applicant for licensure as a home medical oxygen provider shall submit all of the following:

Phar 14.01(1) (1) An application for licensure on a form provided by the board.

Phar 14.01(2) (2) The fee specified in s. 440.05 (1), Stats.

Phar 14.01(3) (3) Evidence of accreditation by an organization deemed an accreditation organization for suppliers of durable medical equipment, prosthetics, orthotics, and supplies by the United States department of health and human services, centers for medicare and medicaid services.

Phar 14.01 History History: CR 16-072: cr. Register November 2017 No. 743, eff. 12-1-17; correction in (1), (2) made under s. 35.17, Stats., Register November 2017 No. 743.

Phar 14.02 Phar 14.02 Standards of Professional Conduct. Licensed home medical oxygen providers and their employees and agents shall do all of the following:

Phar 14.02(1) (1) Maintain accreditation status by an organization deemed an accreditation organization for suppliers of durable medical equipment, prosthetics, orthotics, and supplies by the United States department of health and human services, centers for medicare and medicaid services.

Phar 14.02(2) (2) Comply with all federal and state laws regarding transporting oxygen in cylinder or liquid form.

Phar 14.02(3) (3) Comply with the United States food and drug administration rules and regulations regarding transporting medical oxygen systems.

Phar 14.02(4) (4) Demonstrate that oxygen provided to cylinder or liquid form meets purity standards for medical grade oxygen.

Phar 14.02(5) (5) Meet safety inspection requirements including all of the following:

Phar 14.02(5)(a) (a) Maintain documentation demonstrating each piece of oxygen or respiratory equipment has been checked, is free of defect, and operates within the manufacturer’s specifications.

Phar 14.02(5)(b) (b) Equipment shall not be modified to the extent that the modification may reasonably cause harm.

Phar 14.02(5)(c) (c) Maintain all electrical components so that they do not present a fire or shock hazard.

Phar 14.02(5)(d) (d) Ensure that all appropriate warning labels, including tags, are present on the equipment provided.

Phar 14.02(6) (6) Maintain recall procedures including all of the following:

Phar 14.02(6)(a) (a) Ensure that lot numbers and expiration dates are affixed to each cylinder delivered.

Phar 14.02(6)(b) (b) Maintain a tracking system for all medical oxygen and gas delivered.

Phar 14.02(6)(c) (c) Document all equipment serial numbers and model numbers to ensure that equipment can be retrieved if a recall is initiated.

Phar 14.02(6)(d) (d) Maintain records for equipment that requires food and drug administration tracking.

Phar 14.02(7) (7) Comply with the all of the following maintenance and cleaning requirements:

Phar 14.02(7)(a) (a) Maintain documentation demonstrating that a function and safety check of equipment was performed prior to set up.

Phar 14.02(7)(b) (b) Maintain an established protocol for cleaning and disinfecting equipment which address both aerobic and anaerobic pathogens.

Phar 14.02(7)(c) (c) Maintain a material safety data sheet on file for solutions and products used in cleaning and disinfecting procedures.

Phar 14.02(7)(d) (d) Maintain segregated areas on the premises and in delivery vehicles for clean, dirty, and contaminated equipment.

Phar 14.02(7)(e) (e) Clean and disinfect equipment according to manufacturers’ specifications.

Phar 14.02(7)(f) (f) Instruct the patient on proper cleaning techniques as specified by the manufacturer.

Phar 14.02(8) (8) Implement a comprehensive preventative maintenance program that includes all of the following:

Phar 14.02(8)(a) (a) Procedures for problem reporting, tracking, recall, and resolution.

Phar 14.02(8)(b) (b) Performance of service as specified by the manufacturer and the documentation of such performance in the service records.

Phar 14.02(8)(c) (c) Routine inspection, service, and maintenance of equipment located in the patient’s or customer’s residence according to manufacturer’s specifications.

Phar 14.02(9) (9) Maintain repair logs to document repair and maintenance of equipment, including oxygen concentrators, infant monitors, and mechanical ventilators. The repair log shall include all of the following:

Phar 14.02(9)(a) (a) Type of equipment.

Phar 14.02(9)(b) (b) Manufacturer.

Phar 14.02(9)(c) (c) Model.

Phar 14.02(9)(d) (d) Serial number.

Phar 14.02(9)(e) (e) Date of repair.

Phar 14.02(9)(f) (f) Specific repair made.

Phar 14.02(9)(g) (g) Name of person or company performing the repair.

Phar 14.02(10) (10) Maintain testing equipment to ensure accurate calibration. Testing equipment shall be appropriate for the level of service offered. Scales used to weigh liquid oxygen reservoirs shall be properly maintained to ensure accuracy.

Phar 14.02(11) (11) Provide counseling including all of the following:

Phar 14.02(11)(a) (a) Utilize orientation checklists for review of all of the following:

Phar 14.02(11)(a)1. 1. Instructions for use of the equipment.

Phar 14.02(11)(a)2. 2. Safety precautions.

Phar 14.02(11)(a)3. 3. Cleaning procedures.

Phar 14.02(11)(a)4. 4. Maintenance procedures.

Phar 14.02(11)(a)5. 5. Return demonstrations on back up oxygen systems.

Phar 14.02(11)(b) (b) Instruct the patient about emergency and routine contact procedures.

Phar 14.02(11)(c) (c) Deliver and review written instruction materials to ensure that the patient receives information regarding the operation of the equipment.

Phar 14.02(12) (12) Develop, implement, and document a written plan of services in the patient record, including an assessment of the safety of the home environment, the caregiver or patient ability to comply with the prescription and the caregiver or patient ability to operate and clean the equipment as instructed.

Phar 14.02(13) (13) Maintain all required home medical oxygen records for a period of 5 years.

Phar 14.02 History History: CR 16-072: cr. Register November 2017 No. 743, eff. 12-1-17; correction in (8) (intro.) made under s. 35.17, Stats., Register November 2017 No. 743.