Patient Care Facility Accreditation Guide

The Product Safety Standards require your organization to affirm the safety and appropriateness of DMEPOS items and services. The business must establish a product safety program to promote safe use and minimize risks, infections, and hazards.

1. Product Safety

2. Patient Safety

3. Equipment and Device Failures, Repairs, Recalls and Preventative Maintenance

4. Infection Control

PS.1

You must have written policies and procedures that address the following:

1. Patient safety

2. Equipment and device failures

3. Repairs

4. Product recalls

5. Infection control

Tip

These policies are intended to promote the safe use of equipment and items and minimize safety risks, infections, and hazards for both staff and patients.

PS.2

You may only provide items that meet applicable Food and Drug Administration (FDA) regulations.

Tip

You may maintain a log to help you identify equipment and supplies that are subject to Food and Drug Administration (FDA) regulations.

PS.2.1

Before you distribute or deliver items to a patient, you must verify and document that the items are not altered, counterfeit, suspected of being counterfeit, misbranded, are appropriately labeled for their intended use or distribution, and have not been obtained by fraud or deceit.

Tip

You can inspect and document that upon receipt, all items are in their original manufacturer packaging and include original packing slips. Verify that wholesalers and billing companies are not included on the OIG exclusion entity list.

PS.2.2

To document the verification of the authenticity of items purchased for use in providing patient care, you must obtain from the manufacturer copies of the features, warranties, and instructions for each type of non-custom fabricated item or equipment.

Tip

Document that all purchased items are genuine. This documentation must include copies of the features, warranties, and instructions for every type of equipment or item obtained from a manufacturer that is provided to your patients. This information is often found in instruction guides or care-and-use materials. You must maintain these copies and keep them easily accessible.

PS.3

You must have written policies and procedures that promote the safe use of equipment and items and minimize safety risks, infection, and hazards for your staff and patients.

Tip

You must implement policies and procedures that promote facility safety, including the promoting and using universal precautions, minimizing safety risks and hazards, and cleaning the facility. You must document all periodic safety management training programs that you provide for your staff. 

PS.4

You must have a written policy for identifying and monitoring equipment and item failures, repairs, and recalls and communicating these to your staff.

Tip

Documentation of the policy may include logs to identify equipment and items that are defective, require repair or maintenance or have been recalled. Any such failures, repairs or recalls must be communicated to your staff.

PS.5

You must have a policy in place for the investigation and documentation of adverse events, including incidents, injuries and/or infections that may have been caused by the item you provided.

If an adverse event results in the patient’s hospitalization or death, you must initiate an investigation within 24 hours of becoming aware of the situation. For other adverse events, you must investigate within 72 hours of becoming aware of the incident, injury, or infection.

Your investigation must include all necessary information, pertinent conclusions, and whether changes in processes are needed. You must consider any possible links between the items and services provided and the adverse event.

PS.6

You must implement a policy to ensure that the patient and/or caregiver can use all equipment and items you provide safely and effectively in the settings where the item will be used.

Tip

Patient and/or caregiver training on the safe and effective use of all provided equipment and items is essential. The patient’s record must reflect the patient or caregiver’s acknowledgment that they received equipment training. 

PS.7

When providing equipment to patients, you must provide your contact information and options for rental or purchase of the equipment.

Tip

You must provide patients with contact telephone numbers so they can reach the appropriate person. If applicable, you must have a written rental policy and patient records must reflect that equipment rental or purchase options have been explained to the patient. Include a copy of the Medicare capped rental form.

PS.8

You must maintain written policies and procedures that define the requirements for the setup, delivery, pickup, cleaning, disinfection, and proper disposal of all equipment and returned items. These procedures must ensure that all equipment and supplies are handled in a timely and compliant manner, that any entity performing delivery or setup is a DMEPOS-accredited supplier, and that all returned items are processed using appropriate cleaning, disinfection, or disposal methods to ensure safety and regulatory compliance.

Tip

You must have procedures for storaging patient equipment and supplies. Provide training to all staff and document it with meeting minutes or other records.  Consult the manufacturer's guidelines to ensure accurate maintenance and patient readiness.

PS.9

You must deliver and setup all equipment and supplies in a timely manner.The patient/caregiver, the healthcare prescriber, and your organization must agree on the timeframe. Delivery and setup activities may be coordinated through another entity; however, any entity performing these functions must be a DMEPOS-accredited supplier. You must also maintain policies and procedures that clearly document the requirements and processes for the setup, delivery, and pickup of equipment to ensure consistency, accountability, and compliance.

Tip

You must establish policies for home delivery and setup to ensure patients receive equipment and supplies in a timely manner. If you use outside services, you must have contracts, proof of sub-contractor accreditation, and appropriate Business Associate Agreements. Additionally, provide policy training to all staff and document it with meeting minutes or other records. 

PS.9.1

Prior to final delivery of the item, you must:

1. Document that the item meets the specifications of the current prescription

2. Check the item for structural safety

3. Ensure that manufacturer guidelines have been followed

PS.9.2

If you provide complex rehabilitative wheelchairs and assistive technology, you must implement procedures for assembly and setup of equipment as well as have a process to verify that the final device meets the specifications of the original device recommendation approved by the healthcare prescriber.

PS.9.3

If patients are evaluated in your facility, you must have an appropriate designated area and equipment for assembly, modification, adjustment and repair of provided equipment and/or items in your facility or in a facility in close and easily accessible proximity.

PS.9.4

If you provide complex rehabilitative wheelchairs and assistive technology, you must provide the patient with equipment for trial and simulation, when applicable.

PS.10

You must track and document on a report the status of all equipment and supplies provided to patients. You must know at all times the condition and location of all equipment in the event that a recall or other similar events were to occur.

The status report must accurately reflect critical information including:

1. Contact and emergency contact information for all persons to whom equipment or items have been sold or rented

2. The manufacturer’s model, serial number and/or lot number for each piece of equipment

Tip

You should maintain a database or log that contains contact information for all persons to whom equipment or items have been sold or rented and the manufacturer’s model and serial number for each piece of equipment. Use the Equipment Maintenance Log in the online Resource Kit to document this information.

PS.11

You must have written policies and procedures for cleaning, sanitizing, function testing, maintaining and preparing items or equipment for reuse. The area in which the equipment is stored in a patient-ready status must be clearly identified as clean.

Tip

You must have policies and procedures in place to ensure that any equipment you intend to make available for patients reuse is cleaned, functions properly, is clearly labeled and is stored in a clearly identified clean area. Policies should include universal precautions and cross-contamination procedures.

PS.12

You must implement and document a policy for identifying, monitoring, and reporting repair and preventive maintenance for equipment and supplies provided to patients in accordance with manufacturer’s specifications.

Tip

This might include an equipment maintenance log that tracks preventive maintenance and repairs and an inventory of manufacturer instruction manuals/specifications. Use the Equipment Maintenance Log in the online Resource Kit.

PS.13

You must provide or arrange for loaner equipment similar to the original equipment during any repair period.

Tip

You must have the inventory on hand or be able to obtain the equipment from another source. Your procedures should include a list of other equipment sources if you do not have the inventory available.

PS.13.1

You must provide all supplies that are necessary to operate the equipment and perform any necessary adjustments.