Address These HME Regulations to Avoid In-Store Issues

For years, I have launched both new and remodeled retail HME showrooms with a focus on location, layout, merchandising, sales training, referral marketing and advertising. A recent consultation with Bob Weir—a surveyor for two major accrediting organizations—has urged me to address concerns outside of obtaining a retail business license. The following are Bob’s recommendations on these operating procedures. Licensing—Some states require a license or credential for dispensing HME equipment. Some also require a furniture and bedding license and documentation for the proper sanitation of rental beds. Both state and federal postings should be placed at your facility and readily accessible to your staff. Legend devices—Some states require an HME license or exemptee license for selling such items. Legend devices are clearly marked from the manufacturer for medical products that require a prescription to dispense. If you provide oxygen your state may require additional licensing, and a written prescription must be obtained prior to dispensing. Some states require a secure area for storage of legend devices that are only accessible by the person(s) named on the license. Store layout—The store should comply with existing fire department requirements for its space. A formal fire department inspection may be required for your facility. If you provide oxygen, your fire department can confirm warehouse layout requirements and placard requirements. Issues include but are not limited to fire extinguishers; exit signs and diagrams; smoke detectors; flashlights/safety lights; documentation of an annual fire drill and emergency contact information available to all staff. Employee files—Separate employee documents into two secure files. The first file should include general files such as employment applications, job descriptions, evidence of an interview, references and dates contacted, orientation, criminal background check, annual performance review and annual training documentation. The second file should include medical files such as documents referencing medical conditions and documents including an employee’s date of birth and social security number. Clean room/storage area—If you 
allow the return of rental equipment, you should designate a dirty area for staging of this equipment. This area should be isolated from clean inventory and large enough to store the largest piece of rental equipment. Equipment should be tagged for repairs or maintenance that needs to be completed. New equipment should be placed in inventory as “patient ready” in a plastic barrier/bag or the original box. Equipment cleaning and disinfecting—All equipment that is not patient-ready should be cleaned with an appropriate cleaning solution and disinfected with an approved germicidal cleaner. You should keep a current copy of material safety data sheets in a binder detailing all chemicals and disinfecting solutions used, and maintain a cleaning/disinfecting log as 
well. Personal protective equipment should also be available for all techs or employees that clean, disinfect, pick-up or repair equipment. In-store repairs—If repairs are made at your facility, you should have a designated area for them. All training for repair staff should be documented and kept in a binder for easy organization and reference. Log all repair and maintenance work, and tag all repair and maintenance equipment. Additional procedures—These 
include but are not limited to tagging all equipment with your company’s contact information; documenting LOT/serial numbers for potential 
future product recall; logging all 
repairs, maintenance, cleaning/disinfecting; development of a formal complaint and resolution process; development of an employee handbook and 
an after-hours log if you provide 24-hour service and development of 
a delivery log if you provide home 
delivery.