Getty Images / Cecilie_Arcurs

Which point-of-care testing (POCT) governance model should you choose for your organization? Attend Governance in the Increasingly Complex World of Point-of-Care Testing (32104), a scientific session at the 2020 AACC Annual Scientific Meeting & Clinical Lab Expo, to consider this question. Two experts will discuss the challenges of POCT governance, why it’s been a largely unpopular venture, and the role clinical labs and informatics can play in creating a successful POCT governance structure.

Edward Leung, PhD, DABCC, FACB/FADLM, assistant professor of clinical pathology at The Keck School of Medicine of the University of Southern California, plans to talk about models and strategies of POCT governance and management. David McClintock, MD, associate professor, informatics with Michigan Medicine’s Department of Pathology, will discuss informatics and information technology (IT) support of POCT governance.

Leung and McClintock define POCT governance as:

  • A quality framework encompassing risk management, regulatory compliance, analytical and IT assessment and implementation, clinical and cost effectiveness, and patient outcomes.
  • Management of POCT resources within an enterprise environment, including lab instrumentation, testing personnel, POC coordinators, CLIA lab directors, and coordination with nursing and relevant medical specialties requesting/using testing.

Despite its growth, POCT lacks centralized governance, an area that laboratory medicine has neglected to a certain extent.

POCT is expanding with more devices, new technologies, a growing test menu, and more diverse testing personnel, Leung and McClintock told CLN Stat. “Along with this growth, the lab data generated by POCT and the management of this data is increasing in volume and complexity as every manufacturer appears to have their own solution. Currently, it is not uncommon to have all of these different software solutions feed into a different middleware software,” they added in a statement.

Challenges face POCT governance as test menu choices expand (both in technology, assay complexity, and assay availability), testing personnel becomes more diverse (for example, nurse, nursing assistant, EMT, MA, MD, CNA, etc.), the number of POCT settings increases (hospital units versus ambulatory care center versus small physician office versus pharmacy), and the types and quantity of POCT data become more complex.

POCT governance also struggles with multiple competing interests: Some in the field want to control it, while others just want it to work, according to Leung and McClintock. No one really wants to finance POCT governance, to maintain personnel and testing supplies. Yet it requires a dedicated budget—a challenge when things become decentralized, they added.

Clinical labs have a unique role in crafting effective governance plans, the presenters continued. Labs know about best quality lab practices, CLIA regulatory requirements, interpreting regulatory standards, and determining which tests fit specific scenarios. Laboratorians also are critical in translating workflow and processes required for clinical lab testing, such as preanalytical, analytical, and postanalytical lab testing requirements, data management issues, and CLIA issues.

Leung and McClintock offer that laboratorians should be part of a “collaboration hub” that involves healthcare providers, the clinical team, POC coordinators, device manufacturers, and information technology professionals.

Informatics and IT are also critical to POCT governance. POC testing isn’t just for bedside care anymore, nor is it primarily used by providers making clinical decisions. This calls for a POCT middleware solution that facilitates the transfer of POC testing results from the instrumentation to the electronic health record (EHR) to ensure that providers get the results in a timely manner and to ensure proper clinical documentation of test results, said Leung and McClintock.

“These systems help to ensure proper quality control is performed, to keep track of analytical quality of the instrumentation, ensure proper regulatory guidance is followed when ordering and resulting tests, etc.,” said Leung and McClintock. “Many EHR-based clinical decision support tools may use POCT results as well, necessitating consistent and accurate transmission of these results to the EHR.”

Healthcare organizations have multiple potential governance models to choose from to provide the best fit for their organization.

The scientific session takes place December 14 from 11 a.m. to 12:30 p.m. Central Standard Time. Participants earn 1.5 ACCENT credit hours.