Volume 36 Number 5 | October 2022

James T. Griffith, PhD, ASCLS Past President, ASCLS Government Affairs Committee Advisor

James GriffithAs clinical laboratory professionals, we are guardians of certain scientific knowledge, a way of professional practice, as well as an infrastructure that allows for patient interaction, specimen collection, test performance, and result reporting. All of this is done to benefit a subset of the U.S. population that often knows neither who we are, what we do, nor how we do it.

Many in our field have endeavored to make the latter “fog points” clearer, albeit with mottled success. We are hampered in this quest by a lack of professional standing. The legal context for professional health practice is defined in licensure statutes, which our field has only in a handful of states. We are further hampered by our own cohesiveness, with a plethora of “professional organizations” that are most often competitors rather than enhancers. Far worse than either of these is our self-inflicted effectiveness-hampering via a lack of understanding of who we are and what we represent in the bigger scheme of things. We are NOT “techs doing tests”!!

TRUE, we may perform clinical laboratory tests on specimens derived from the human body, but the science, the context, and the import matter. The BIG picture eludes many of us. Some simple envelope edges:

  • There are 260,000 CLIA-certified clinical laboratories in the United States representing the “cornerstone of diagnostic medicine today1
  • They perform some 14 billion1 tests annually (54,000 tests per lab); this represents the highest volume healthcare service in the nation and 25 percent of all patient care quality indicators
  • These tests represent 70 percent of medical decisions that depend on our answers
  • All for a cost of $0.023 of everyone’s healthcare $1.00
  • Experts estimate that 40,000–80,000 deaths occur annually from preventable diagnostic errors2

In my arena (clinical microbiology), there are 23.6 million physician office visits per year in the United States for suspected infections (millions more in hospitals). Almost all of these require a clinical laboratory test where the treatment of the patient is likely to be improved based on our test result. More broadly, the lab has an important role to play in curtailing antibiotic resistance. According to the Wellcome Trust, 10 million people could die per year from resistant infections worldwide by 2050—that’s more people than cancer kills each year. These infectious diseases represent 25 percent of all deaths in the world3!

Our professional organization (ASCLS) advocates for clinical laboratory standards that match this great responsibility. These standards are necessary because

  1. The practice of clinical laboratory science affects the health, safety, and welfare of the public;
  2. They guard against harmful outcomes from inaccurate test results due to practitioner error because of inadequate training;
  3. They establish minimum standards of education, training and experience, and certification to ensure that all clinical laboratory practitioners are qualified and competent to provide accurate and reliable clinical laboratory testing services wherever the testing is performed;
  4. They establish requirements for continuing education as a condition of license renewal;
  5. They provide the best option for improving upon the inadequacies of federal regulations (CLIA ’88);
  6. Through the power to revoke licenses, a provision is made in each state for a level enforcement mechanism to remove incompetent personnel from practice which is not available through any other means;
  7. They will serve to reduce the escalating costs of healthcare through increased quality and consistency of laboratory services, thereby decreasing unnecessary duplication and malpractice costs; and
  8. The current path toward “personalized” (so called precision) medicine will not be fulfilled without top-notch and uniform clinical laboratory testing nation-wide.

One example. In 1998 a paper4 was published in a distinguished medical journal concluding that MMR vaccine predisposes children to all sorts of bad outcomes including autism-spectrum disorders and intestinal dysfunction. This set off a firestorm and stoked lingering fears that vaccines are bad for everyone, especially children. The paper was retracted, but not before a lot of damage was done, lingering to the present day. A significant part of discovering and dispensing with the hoax involved clinical laboratory tests. You may think that there is “just one more rack of tubes to get through” or “just a few smears,” but nothing could be further from the truth.

We need you, the professional out there, involved in this great goal to see the big picture, know what you mean to it, and advocate for everyone doing it at the highest level. This quest matters, and YOU matter as a part of it. Nothing less satisfies our responsibility.

  1. Centers for Medicare & Medicaid Services; Centers for Disease Control and Prevention; Division of Laboratory Systems; https://www.cdc.gov/csels/dls/strengthening-clinical-labs.html
  2. Leape LL, Berwick DM, and Bates DW, “Counting Deaths Due to Medical Errors—Reply,” JAMA 2002;288(19):2405.
  3. https://wellcome.org/what-we-do/infectious-disease
  4. A.J. Wakefield et.al.; Ileal-Lymphoid-Nodular Hyperplasia, Non-specific Colitis and Pervasive Developmental Disorder in Children; Lancet 351, no. 9103 (1998): 637-641

James T. Griffith is Chancellor Professor Emeritus at the University of Massachusetts.