Faculty Bibliography

This case study describes, for the time frame of June 2021 through August 2022, the U.S. Veterans Health Administration (VHA) organizational response to a manufacturer's recall of positive airway pressure devices used in the treatment of sleep disordered breathing. VHA estimated it could take over a year for Veterans to receive replacement devices. Veterans awaiting a replacement faced a dilemma. They could continue using the recalled devices and bear the product safety risks that led to the recall, or they could stop using them and bear the risks of untreated sleep disordered breathing. Using a program monitoring approach, we report on the processes VHA put in place to respond to the recall. Specifically, we report on the strategic, service, and operational plans associated with VHA's response to the recall for Veterans needing replacement devices. In program monitoring, the strategic plan reflects the internal process objectives for the program. The service plan articulates how the delivery of services will intersect the customer journey. The operational plan describes how the program's resources and actions must support the service delivery plan. VHA's strategic plan featured a clinician-led, as opposed to primarily legal or administrative response to the recall. The recall response team also engaged with VHA's medical ethics service to articulate an ethical framework guiding the allocation of replacement devices under conditions of scarcity. This framework proposed allocating scarce devices to Veterans according to their clinical need. The service plan invited Veterans to schedule visits with sleep providers who could assess their clinical need and counsel them accordingly. The operational plan distributed devices according to clinical need as they became available. Monitoring our program processes in real time helped VHA launch and adapt its response to a recall affecting more than 700,000 Veterans.

In this Ethics Rounds we present a conflict regarding discharge planning for a febrile infant in the emergency department. The physician believes discharge would be unsafe and would constitute a discharge against medical advice. The child's mother believes her son has been through an already extensive and painful evaluation and would prefer to monitor her well-appearing son closely at home with a safety plan and a next-day outpatient visit. Commentators assess this case from the perspective of best interest, harm-benefit, conflict management, and nondiscriminatory care principles and prioritize a high-quality informed consent process. They characterize the formalization of discharge against medical advice as problematic. Pediatricians, a pediatric resident, ethicists, an attorney, and mediator provide a range of perspectives to inform ethically justifiable options and conflict resolution practices.

ABSTRACT/UNASSIGNED:It is unknown if changes in the rate of discharges against medical advice (DAMA) are related to the implementation of the Medicare Hospital Readmissions Reduction Program (HRRP). We performed an interrupted time series analysis of monthly DAMA rates per 1,000 discharges of all enrolled individuals 18-64 years old with a hospitalization between January 1, 2006, and December 31, 2015, in a commercially insured population. We performed a segmented linear regression with two interruptions: (1) April 2010 to coincide with the passage of the HRRP and (2) October 2012 to coincide with the implementation of HRRP penalties. There were 1,087,812 discharges representing 668,823 individuals over 120 months. The downward trend in monthly DAMA rates was reversed significantly after April 2010 with a sustained 0.1 increase in the monthly rate that continued after the implementation of penalties in October 2012. Allowing for the two interruptions, there was a statistically significant positive trend (0.10; 0.06-0.13, p < .01) in April 2010. Relative to the first interruption, there was no statistically significant change in the slope in October 2012; the estimated slope was -0.04 (-0.08 to 0.002). Monthly DAMA rates increased in anticipation of and after HRRP implementation, suggesting a potential relationship between the HRRP and DAMA.