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Outside the Lab Profession, Regulation and standards

Cultivating Pathology’s Future

Advocating for the pathology profession and those working within it to ensure the protection of patients is an integral part of ASCP’s mission. Although it’s easy to sit on the sidelines and discuss what needs to be done, it’s more difficult to put those words into action. Doing so requires not only intention and motivation, but informed engagement – we have to know what the issues are so we can work together to ensure positive outcomes. I’d like to take this opportunity to highlight some of our activities over the past year.

At home, we’re in the early stages of the genetic diagnostic era. It’s an exciting time for the profession, but it’s also imperative that we provide accurate patient results while encouraging new technologies. Sometimes, these advances in diagnostics come by way of laboratory developed tests (LDTs) – diagnostics developed and validated by individuals within laboratories. In particular, molecular genetic tests – the results of which help predict disease or guide lifestyle choices – are commonly developed in-house, due to the low availability of commercial products. As such, ASCP and its members have a vested interest in their regulation.

It is vital that the FDA strike the right balance in asserting its authority over the regulation of LDTs. The regulatory infrastructure adopted must be sufficient to safeguard the public health without being so burdensome that it impedes emerging technology. Recently, we wrote a letter to the FDA outlining our position on LDT regulation and offering our expertise as these policies are debated by legislatures, the FDA, and other interested parties.

Pathologists, residents, and laboratory professionals play a vital role in healthcare and, as such, it’s imperative to address their emotional and mental health.

Burnout, a feeling of emotional and mental exhaustion brought on by prolonged stress, is a very real occurrence today’s laboratory. Pathologists, residents, and laboratory professionals play a vital role in healthcare and, as such, it’s imperative to address their emotional and mental health. We recently completed a survey of our membership regarding job satisfaction, wellbeing, and burnout in the laboratory. Findings from our study will provide insight on how health care institutions can address these challenges and will inform ASCP’s initiatives going forward.

Abroad, our goal is to create a sustainable presence in pathology and laboratory medicine around the world, which means we need to find solutions for the challenges we encounter. To address one challenge, HIV diagnosis, we’re working with the US Centers for Disease Control and the President’s Emergency Plan for AIDS Relief (PEPFAR) – and we’ve received over US$50 million to facilitate improvements in HIV testing in laboratories around the world. In addition, we’re setting our sights on cancer diagnostics in low-resource settings. This includes performing site assessments, training, creation and support of online resources, and – perhaps most importantly – whole slide image telepathology, which allows collaborating pathologists to consult on cases within 24 hours. Instead of weeks or even months, patients can now receive a diagnosis in days.

These are just a few of the issues ASCP is working on for the medical laboratory community at large. Advocating for the profession requires constant vigilance, but with that vigilance comes great rewards. No one will do this work for us; it’s our responsibility to have an active hand in shaping our future. I’m proud ASCP is on the forefront of these efforts, and I look forward to working with you to create the future we desire.

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About the Author

E. Blair Holladay

CEO of the American Society for Clinical Pathology

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