Volume 36 Number 6 | December 2022

Miles Tompkins, MLT(ASCP)CM, ASCLS Board of Directors

Miles TompkinsWith the challenges that shortages bring to an already exhausted laboratory workforce, it can become easily justifiable for some facilities to grab anyone off the street who can hold a pipette to sit at a bench and put them to work. As of writing this article, government and regulatory agencies are considering relaxing the language and interpretations of who can call themselves a medical laboratory scientist or a medical laboratory technician. Not only is this an insult to the hundreds of thousands of laboratory professionals that have put in the hours of educational and practical experience, but it is a massive risk to patient safety and an erosion of the ethical principles our field is built on. Does anybody remember Theranos?

One of the duties in my current profession is to provide onboard training to new medical laboratorians and students. In this role, I facilitate training and guidance on compliance and the duty to report. I always start by asking the question, “Who in this room knows about Theranos?” As time has progressed, the number of raised hands has dwindled from over half the room, to sometimes none. In a brief synopsis I will explain.

Theranos was a private health technology company that about 10 years ago was discovered to have committed fraud on multiple levels to basically every agency imaginable. They intentionally hired inexperienced or non-laboratory educated individuals who did not have firm knowledge of things such as CLIA, CMS, proficiency testing, or the duty to report. Those they did hire who had that knowledge were quickly replaced or gaslighted into believing their limited, albeit correct, information was wrong. Theranos leaders, especially its famous CEO, Elizabeth Holmes, were eventually found out and are even to this day still in the court systems facing potential imprisonment.

How can something that was such a huge and policy-changing story be forgotten? One of the many reasons I am proud to be a member, and more recently a director, of ASCLS is because our organization has always been at the forefront of promoting laboratory quality, ethics, and standards of practice. With a plethora of resources available to ASCLS members and the public, including entire sections of our website dedicated to patient safety, position papers, and advocacy for our profession, one of the most important of these is our ASCLS Code of Ethics. Under the section “Duty to the Patient,” it states:

Medical Laboratory Professionals are accountable for the quality and integrity of the laboratory services they provide. This obligation includes maintaining the highest level of individual competence as patient needs change, yet practicing within the limits of their level of practice. Medical Laboratory Professionals exercise sound judgment in all aspects of laboratory services they provide. Furthermore, Medical Laboratory Professionals safeguard patients from others’ incompetent or illegal practice through identification and appropriate reporting of instances where the integrity and high quality of laboratory services have been breached.

It is through our Code of Ethics, along with our Mission Vision Statement, that ASCLS challenges not just our own members, but the laboratory science community, to provide clear, immersive education to medical laboratory professionals of all levels of practice on the importance of compliance with regulatory and moral standards of care. While we may have a continuously younger and newer workforce that doesn’t remember the story of Elizabeth Holmes and Theranos, ASCLS will continue to provide the education, and by its members, the example, so that it will never happen again.

Author’s note: On November 18, 2022, the U.S. District Court for the Northern District of California sentenced Elizabeth Holmes to 135 months in prison, with an additional three years of supervised release. While she is expected to appeal the ruling, Elizabeth is to surrender herself to custody by April 27, 2023.

Miles Tompkins is a Medical Technology Recruiting and Retention Specialist at the Diagnostic Laboratory of Oklahoma in Oklahoma City.

Elizabeth Holmes, CEO of Theranos

Theranos Chairman, CEO, and Founder Elizabeth Holmes speaks onstage at TechCrunch Disrupt on September 8, 2014, in San Francisco. (Photo by Steve Jennings/Getty Images for TechCrunch)