Clinical Labs in the Spotlight: Compliance Is More Important Than Ever

Steffini Stalos, DO, MS, FACP

Steffini Stalos, DO, MS, FACP, is the chief medical officer of Blood Associates LLC, a consulting company that assists clinical laboratories with medical laboratory directorship. The company is based in Dallas-Fort Worth, Texas, but serves clinical laboratories throughout the US.

Q: The COVID-19 pandemic has raised the profile of clinical laboratories. People who rarely gave a thought to laboratory testing have now become familiar with such terms as “false positive,” “sensitivity,” and “specificity.” Besides COVID-19, what are some other factors that make conversations about the clinical laboratory a part of everyday language for the layperson?

A: While the visibility of the clinical lab has not quite swung 360 degrees, the clinical lab no longer lives a life shrouded in obscurity. COVID-19 and the United States v. Elizabeth A. Holmes court case, which involved an independent reference lab in California—Theranos—claiming to be able to perform hundreds of tests on a drop of blood, thrust clinical labs into the spotlight. While the FDA has asserted government authority in the form of “eminent domain” in years past for laboratory developed tests (LDTs), which are in vitro diagnostic tests that are designed, manufactured, and used within a single laboratory, a newer law (the VITAL Act) would remove LDTs from FDA oversight and place them squarely under Clinical Laboratory Improvement Amendment (CLIA) oversight during a state of emergency , while the VALID Act would create FDA oversight over LDT design and manufacturing but leave lab operations oversight to CLIA when the nation is not under a state of emergency. With COVID-19, the Theranos court case, and new laws regarding LDTs, there is a new sense of urgency to laboratory regulatory compliance, which actually involves three separate components—billing, regulatory, and legal compliance.

Q: What is the relationship between medicine and business in the clinical laboratory?

A: Although the clinical laboratory is a branch of medicine, it is also a business. Medical laboratory directors need to know not only how to perform tests, but also how to run a laboratory efficiently and profitably. This means knowing your target market, how your lab differs from your competitors, what return on investment you are getting, what your sales and marketing strategy is, how to put together and read a financial statement, and how to measure milestones.

Q: Why do you think clinical laboratories run into compliance challenges?

A: In my experience, dysfunctional hiring practices are the number one cause of why clinical laboratories fall into regulatory quicksand. This is why it is important to equip the hiring entity with vetting strategies that are laboratory specific. This can be difficult if the hiring entity themselves lack clinical laboratory experience. CLIA specifies the roles and responsibilities of lab personnel. For a high complexity laboratory, the law requires that the lab has a laboratory director, clinical consultant, technical supervisor, general supervisor, and testing person. I recommend that labs make use of the medical laboratory director in vetting candidates for the clinical lab, as one of the Code of Federal Regulations (CFR)-defined duties of a lab director is to ensure the hiring of competent people.

"Passing a laboratory inspection is only the beginning of laboratory compliance, not the end."

One of the problems facing clinical laboratories right now is the shortage of laboratory personnel, largely due to attrition and retirement. The Bureau of Labor Statistics says there have been 8,000 laboratory personnel lost per year since 2002. This issue cannot be fixed overnight or even in the next few years, but it is something that must be addressed. While many clinical laboratories have been intimately aware of the massive shortage of laboratory professionals during the pandemic, we need to be prudent in the resolution. By that, I mean a government-authored playbook that quantifies the gap between the available and the desired numbers of laboratory personnel during the current pandemic so that a coalition forms between government, laboratory professionals, and training programs to use the playbook to scale appropriately for non-pandemic and pandemic environments. The existing Laboratory Response Network (LRN) needs more infrastructure to safely and commensurately scale in times of pandemic (since pandemics recur), and we need the plan to scale the LRN before the next pandemic hits.

Q: What advice do you have for a clinical laboratory to ensure it is in compliance with all applicable laws and regulations?

A: The CLIA regulations (or any accrediting body regulations, for that matter) really all boil down to only two types of rules—those that address who should be making a lab decision (i.e., a lab director, technical supervisor, and so on) and those that address what needs to be done to ensure accuracy and precision from that lab based on its test menu. That’s it!

I encourage clinical labs to get the best personnel they can afford. This way, they can be comfortable knowing that instrument purchases, reagent/control purchases, validations, instrument maintenance, quality control and assurance procedures, and proficiency testing are handled competently.

I also recommend that clinical laboratories participate in retrospective mock inspections, which are part of a healthy laboratory culture. A mock inspection could include major categories such as instrument repair and maintenance, instrument performance verification and validation, quality management (preanalytical, analytical, and postanalytical variables), proficiency testing, personnel and training records and competency assessments, environment control, and laboratory information system/informatics specific issues.

Clinical labs, even those with the same test menu, are different from one another because of the differences in workflow. Laboratory inspections are a snapshot in time, much like a photo, and that means the inspection does not necessarily capture all the workflow elements that are noncompliant or that could lead to noncompliance. In a perfect world, you want to prevent noncompliance, not just catch it retroactively, and this requires laboratory-trained people at the helm.

Passing a laboratory inspection is only the beginning of laboratory compliance, not the end.

Correction: An earlier version of this article stated that both the VALID and VITAL Acts would remove FDA oversight over the LDTs when in fact, only the VITAL Act would remove FDA oversight over LDTs, while the VALID Act would permit FDA oversight over LDT design and manufacturing.