Exploring challenges and policy considerations in point-of-care testing for hospital preparedness ahead of infectious disease emergencies: A qualitative study.

Background: Despite the uncertainty raised by several studies regarding the practicality of Point-of-Care Testing (POCT) in hospital settings, the urgency prompted by the COVID-19 pandemic led many hospitals to invest in these rapid diagnostics. As the COVID-19 pandemic showcased the potential of POCT in emergency situations, an urgent call arises to leverage the successes and lessons learned for the long-term benefit of healthcare systems, particularly in preparation for the next pandemic of viral respiratory nature.

Methods: We conducted semi-structured interviews with nine emergency care and hospital laboratory stakeholders with expertise and responsibility over POCT operations within hospital systems during the COVID-19 pandemic in Maryland, USA. The grounded theory approach was utilized, and the transcripts were thematically analyzed through an iterative process.

Results: Three distinct themes were identified as barriers to POCT implementation: Regulatory barriers encompassed inconsistencies between the federal and state regulations and a regulatory structure that lags technological advancements. Staffing and operational barriers comprised a shortage of POCT workforce including nurses and Point of Care coordinators. Economic barriers were linked to the overall cost of integrating new POCT devices into the existing testing menu at emergency departments.

Conclusion: We conclude with strategies, including policy considerations, to enable and sustain decentralized POCT programs within hospitals. Some of these strategies include expanding the workforce trained in the regulatory procedures required to support POCT; harmonizing state and federal regulations for diagnostic testing, especially for FDA-waived POCT; and sustained funding for POCT development and use for public health preparedness.