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Patient Instruction: Steps to Mitigate Liability

Written by Nathan Fish

The process of providing patients with complex rehabilitation technology and other durable medical equipment involves numerous interactions between suppliers and their patients. While essential, such interactions are also a possible source of liability for suppliers. For example, in Jarrett v. Duro-Med Industries, the plaintiff brought her wheelchair back to her supplier because of an allegedly defective right wheel brake, but the supplier did not have a replacement brake for the wheelchair. The plaintiff later removed the allegedly defective brake and was injured after losing control of her wheelchair. The plaintiff sued the supplier for negligently failing to warn her of the seemingly obvious risk of operating the chair with only one brake. In another law suit, it was a supplier that argued a patient’s injury was the result of the negligence of a physical therapist who allegedly failed to discuss the differences in seat height and balance characteristics between the patient’s old wheelchair and her new wheelchair and failed to prescribe a threshold ramp after conducting a home assessment.

When selling a power wheelchair to a patient, a complex rehab provider must educate the patient and caregiver about the proper use of the item. As the above cases illustrate, this valuable service is a possible source of liability. Suppliers may be held liable for injury caused by complex rehab technology under various product liability causes of action, including negligence, strict liability, breach of warranty, fraud, and misrepresentation. It is therefore  imperative that suppliers take reasonable steps to minimize their exposure.

Supplier Standards
Under the supplier standards, a complex rehab provider must meet the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Quality Standards and be separately accredited in order to bill Medicare.  An accredited supplier may be denied enrollment or enrollment may be revoked for failing to  comply with the DMEPOS Quality Standards. In addition, the supplier standards require the supplier of a Medicare-covered item to document that it or another qualified party provided the patient with necessary information and instructions on how to use the item safely  and effectively.

DMEPOS Quality Standards
As noted above, suppliers of rehabilitative technology must comply with the DMEPOS Quality Standards and become accredited to
• The supplier must provide clearly written or pictorial instructions as well as oral instructions related to the use, maintenance, infection control practices for, and potential hazards of all equipment and item(s) provided;
• The supplier must provide, or coordinate the provision of, appropriate information related to the set-up, features, routine use, troubleshooting, cleaning, infection control practices, andmmaintenance of all equipment and item(s) provided;
• The supplier must provide relevant information and/or instructions about infection control issues related to the use of all equipment and  item(s) provided;
• The supplier must verify and document in the patient’s record that the patient and/or caregiver(s) has received training and written instructions on the use of the equipment and item(s);
• The supplier must ensure the patient and/or caregiver(s) can  use all equipment and item(s)  provided safely and effectively  in the settings of anticipated use;
• The training and instruction must be commensurate with the risks, complexity, and to the DMEPOS Quality  Standards risks not only the loss of Medicare billing privileges, but also exposes suppliers to potential liability. Significantly, the training and instruction must be documented.

The best way for a supplier to approach any interaction with his or her clients is to remember “if it isn’t documented, it didn’t happen.” As such, suppliers must ensure all training and communication with patients are properly documented, including documentation that the patient understood the instructions and knew how to safely operate the items provided.  It should be noted, however, that even if a supplier provides training and manufacturer’s instructions mand/or specifications for the equipment and item(s); and

• The training and instruction materials and approaches must be tailored to the needs, abilities, learning preferences, and primary language of the patient and/or caregiver(s).   

The DMEPOS Quality Standards also include training and instruction “Tips,” which encourage suppliers to:
• Provide written instructions to patients and/or caregivers for initial equipment;
• Document that the supplier provided the instructions and the patient and/or caregiver(s) understood them; and
• Document all training and communication in the patient’s record, including the date, time, and signature  of the person providing the service. Suppliers of rehabilitation technology must understand that failure to adhere instruction and maintains adequate documentation, plaintiffs may still argue that the training was inadequate, they failed to understand the supplier’s instructions, etc. Nevertheless, compliance with the DMEPOS Quality Standards can help minimize suppliers’ exposure.

Proactive Steps
To reduce the risk of liability, suppliers should take the following steps when providing complex rehabilitation technology:
• Inspect the item prior to delivery to ensure it works properly;
• In a face-to-face meeting, provide written instructions to the patient and caregiver for the item, and show the patient and caregiver how to use the item. It is equally as important to ensure the patient and caregiver understand how not to use the item;
• Have the patient and the caregiver sign a document confirming they have received the instructions described in the preceding bullet and understood such instructions;
• Document all training and communication with the patient and caregiver in the patient’s record;
• The employee who instructs the patient and caregiver on using the item needs to have prior training, which needs to be memorialized in writing and kept with the supplier’s records; and
• In the event there is an adverse incident involving an item, the supplier should immediately take statements, take photographs (if feasible), and preserve evidence. The supplier should also notify his or her liability carrier.

References:
1 Jarrett v. duro-Med industries, 2007 wl 628146 (E.d. ky. feb. 26, 2007).
2. Cont'l hosp. Supply corp. v. kubota, 2003 wl 22451981 (cal. ct. app. oct. 29, 2003).
3. 42    C.F.R.    §    424.57(c)(24).
4. 42    C.F.R.    §    424.57(c)(12).
5. ctrs. for Medicare & Medicaid Servs., dep’t of health & human Servs., durable Medical Equipment,
Prosthetics, orthotics, and Supplies (dMEPoS) Quality Standards (2013), http://www.cms.gov/outreachand-Education/Medicare-learning-Network-MlN/MlNProducts/downloads/dMEPoS_Qual_Stand_Booklet_
icN905709.pdf.

These written materials are not intended to be legal advice or legal opinion on any specific facts or circumstances. The contents are intended for general information purposes only. The law pertaining to these issues may have changed since these written materials were submitted. The reader should consult his or her own attorney for legal advice.

Nathan may be reached at nfish@bf-law.com