Formulating a vision for the future of laboratory medicine

Aug. 18, 2014

Earlier this summer, an extraordinary industry summit took place in San Francisco: COLA’s 2014 Leadership Summit brought more than 30 thought leaders in healthcare, including physicians, public health experts, medical laboratory scientists, manufacturers, nurse practitioners and others. Government regulators were represented, too; Judith Yost, MA, MT(AJCP), Director, Division of Laboratory Services, Centers for Medicare and Medicaid Services, attended, as did Nancy Anderson, Chief, Laboratory Practice & Standards Branch, Centers for Disease Control and Prevention. This talented and committed group convened to discuss the future of laboratory medicine in the context of the Affordable Care Act (ACA). The Summit focused on the importance of quality, what it means to laboratory professionals, and how to promote a continuous culture of excellence within the laboratory field.  

The importance and value of such a Summit is clear. Nearly 13 billion lab tests are performed annually in the United States, and laboratory tests influence approximately 70% of all medical decisions. At the same time, the industry is experiencing profound change—including implementation of the Affordable Care Act, an influx of 33 million new patients into the healthcare system, increased reliance on preventive care, increased use of electronic medical records (EMRs), a shortage of qualified workers, and the rise of healthcare delivery models such as Accountable Care Organizations (ACOs) and the Patient Centered Medical Home (PCMH).

Participants in the Summit began a conversation in the hope that, by outlining a strategic blueprint now, laboratory medicine will be better positioned to face tomorrow’s challenges. The café style approach of the meeting allowed for small conversational rounds, focused on questions related to six key topic areas, one of which pertained to the Role of Regulatory Oversight. The summit unfolded in three café sessions: Appreciating the Context; Choosing the Direction, and Closing the Gap.

The group’s conclusions related to the role of regulation were extremely insightful. In the Appreciating the Context discussion, for example, the attendees found that regulations provide a baseline for quality, but unfortunately are far too slow to keep up with the constantly evolving and expanding environment of the healthcare industry. “While quality concerns propelling the regulatory framework are valid, the political process of compromise that yields the regulations rarely provides a sufficient solution or the necessary details for implementation,” the group concluded. “The current regulatory system is reactionary, slow to adapt, and dominated by political influences.”

Next, in the café discussion of Choosing the Direction, the group debated what new collaborations between private and regulatory organizations would be useful in catalyzing quality and learning. While there always will be a need for regulating compliance with lab processes, the attendees concluded that regulators could also help stimulate cooperation throughout the laboratory community, especially in relation to education matters. Such an approach could help “usher in a regulatory regime in which a dynamic focus on quality and patient-centered outcomes is more important than simple adherence to regulatory processes.”

Finally, in the café on Closing the Gap, the group explored what concrete ideas could be implemented today to create conditions for quality and learning in laboratory medicine tomorrow. Their findings: “Regulatory oversight is important, and regulatory compliance is often a starting point for quality. However, an alternative to the current regime is one which engages different stakeholders—the lab, nurse practitioners, professional societies, maternal medicine, pharmacy, patient advocates, the patient, social workers, dieticians, physical therapists, payers,  accrediting organizations, the government—in a process in which improved quality and better patient outcomes are the ultimate desired outcomes.”

By bringing together leaders from across professional disciplines to discuss the role of lab medicine, attendees were able to set a direction grounded in real-world dynamics. It is critical that we continue this “whole system” dialogue so that, as we make decisions impacting the quality of patient care, we don’t create unintended consequences.

Douglas Beigel is Chief Executive Officer, COLA, Inc. Mr. Beigel invites lab and other allied health professionals everywhere to take part in the important conversation begun at the 2014 Leadership Summit by visiting “Join the online discussion forums to share your personal experiences and make your opinions known on regulatory and other critical issues affecting lab quality.”