Clinical Licensure and Certification — The Need for an Overhaul

Clinical licensure and certification is a notoriously complex process. While most states do not require a license to work in a clinical lab, a few states have licensing requirements that are incredibly difficult to follow.

When I try to track down state requirements, I often find that employment agencies, certification societies, and even state representatives are unclear on exactly what the requirements are. Some of these requirements are also catch-22, requiring several years of experience in a particular job in order to get the license to do the job.

It is understandable for a state to require that any individual running clinical tests is qualified, and knows what they are doing. Regardless of one’s political persuasion, it is easy to at least understand why a state may require a clinical or science degree and a certification before running tests on a patient’s blood sample.

That said, one should not have to pull teeth to figure out what those requirements are.

Even with a B.S. in Biotechnology and Molecular Bioscience, an AMT molecular certification, a Florida molecular license, 19 months of experience as a molecular technologist in a molecular lab, and an ASCP in molecular, I am still not “qualified” to run a PCR instrument in NY State. I can apply for a temporary “restricted” license in NY State, but even with advanced qualifications, I do not qualify for a permanent molecular license in NY State.

And the requirements in California are even worse. I could move to California and work in R&D designing new assays for a PCR instrument, however, in the State of California, I could not run the same test that I would be qualified to design.

What we have is a situation where someone with a two-year clinical degree is qualified to run a PCR test, but someone with a master’s in molecular biology is not. The latter can’t even get a license, because that person is not “qualified.”

It is understandable that states want to make sure that those working in clinical labs are qualified to be there, however requiring that workers jump through arbitrary hoops does not necessarily guarantee quality work, it only thins the pool of workers available to an employer.

Beyond arbitrary requirements is also the problem of requirements being vaguely defined and hard to track down. Requirements should be easy to identify such as “Do you have a bachelor’s in chemistry or the life sciences?” “Do you have an AMT or ASCP in molecular?” — very simple “yes” or “no” questions that are easy to access.

Ideally, a simple questionnaire should also be available to identify which certifications and licensures one would qualify for.

The Solution

I propose that moving forward, state boards and private certification societies set out simple checklists that lay out in clear terms what the qualifications are for each license or certification. I also propose simple questionnaires to help identify certifications and licenses for those who are looking to qualify.

Finally, those who are in charge of such boards should reconsider what qualifications are actually necessary, and which are simply “red tape.” As it stands, even very well-qualified individuals do not “qualify” for roles that less qualified individuals do “qualify” for.

If we want to have a field with the best talent, arbitrary restrictions should be taken down, and those who genuinely and objectively qualify for a role should have a clear path to certification and licensure for that role.