Protect Your ASC from DME Law Suits Attend ASCA 2016 to learn what you can do pro-actively to safeguard your center BY WILLIAM MILLER


Dispensing durable medi- cal equipment (DME) and devices post-operatively has placed ASCs in the crosshairs of legal claims.


During my session “Legal Liability and Protective Measures Regarding Prod- uct Defects/Failures” at ASCA 2016 in Dallas, Texas, May 19–22, I will iden- tify scenarios frequently giving rise to potential liability and explore real- world solutions to minimize your lia- bility. I also will provide tools, tech- niques and strategies to reduce risk. As an ASC, you use or dispense


DME that could fail or have defects. Ask yourself: What is our responsibility as an ASC when we dispense products at the order of a physician and what steps should we take if an adverse event, including complications, occurs? The session will address lessons learned from litigation, including alleged “cold- induced injuries” from cold therapy devices and the potential


negative


impact on your ASC. The typical scenarios giving rise to liability include financial self-interests and the accuracy and appropriateness of instructions regarding the use and precautions pertaining to the devices. If a physician—whether partner of the ASC or not—issues an order for the use of medical devices and DME, and there are financial interests involved, are you aware of the repercussions? Similarly, the failure to provide appro- priate and accurate use instructions, as well as use precautions, can form the basis for claims against the ASC. Other scenarios ripe for potential liability include the failure to warn patients of known prior adverse events involving the devices and the steps to be taken once an adverse outcome has


10 ASC FOCUS JANUARY 2016


patient with a meaningful opportunity to decline use of the device or seek an alternate source for the device. Additionally, consider requiring the physician, and his/her staff, to discuss the risks and benefits of the particular device, and delivery of the device, pre- operatively at the physician’s office. Similarly, resist the request that DME be inventoried at your ASC rather than at the office of the physician who may be regularly “leasing” or ordering such devices to be dispensed to their patients. Last, ask the ordering physician’s office to pre-operatively provide the patient with appropriate use instructions, and precautionary warnings, as to the particular device. Despite your best efforts,


if you


The typical scenarios giving rise to liability include financial self- interests and the accuracy and appropriateness of instructions regarding the use and precautions pertaining to the devices.”


— William Miller, Higgs Fletcher & Mack, LLP


been discovered. Implementing appro- priate Peer Review/Quality Assurance (PR/QA) efforts in the investigation of potential adverse outcomes can reduce the risk of both future adverse patient outcomes and potential legal liability. You can take a few other simple steps to protect your ASC from potential liability. First, disclose any financial interests to the patient that you, or the ordering physician, may have in the device(s). Then, provide the


cannot minimize the role of the ASC in dispensing the devices to the patient, make the physician provide your ASC with the exact instructions and warn- ings to be provided to the patient, including the manufacturer’s instruc- tions and warnings. To protect your ASC, make copies of all written warnings/instructions provided to the patient, place the copies in the patient’s chart, maintain an inventory system to track reusable devices given to the patient, and perform periodic PR/QA regarding potential complaints and adverse events relating to the device. I will elaborate on these points and


provide tools you can use to protect your ASC from potential liability arising out of DME use at my session. Looking forward to seeing you at ASCA 2016.


William Miller is a partner at Higgs, Fletcher & Mack, LLP, in San Diego, California. Write him at wmiller@higgslaw.com.


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