Who Has Responsibility for Clinical Laboratory Regulations? Bench Staff and Managers Diverge
However, effective communication can bring more harmony to medical lab managers and scientists when it comes to compliance
Depending on how lab professionals view it, clinical laboratory regulations can be characterized as a series of checklists to fill out or an opportunity to grow an organization.
That theme played heavily into this week’s Lab Manager Leadership Summit during a session titled, “Leading Clinical Labs during Challenging Regulatory Times.” The Leadership Summit, which concludes on Wednesday in Pittsburgh, is hosted by Dark Daily’s publisher, LabX Media Group.
“Is your focus on checking boxes or building a stronger lab?” asked speaker Kelly VanBemmel, MS, MB(ASCP)CM, laboratory operations supervisor at Devyser Genomic Laboratories in Roswell, Ga.
Leaning into the latter option will preserve regulatory compliance while also ensuring the operational health of the clinical laboratory.
At the Lab Manager Leadership Summit, Kelly VanBemmel, MS, MB(ASCP)CM (above) pressed attendees to open the lines of communication between bench scientists and lab managers when it comes to clinical laboratory regulations. (Photo copyright: Scott Wallask.)
‘There’s a Gap’ in How Both Sides View Regulatory Compliance
VanBemmel spent her presentation aiming to bridge the rift between how bench scientists look at clinical laboratory regulations compared to the views of medical lab managers.
“There’s a gap between how staff experience regulations and how management does,” she noted. “Staff typically think of compliance as a checklist to do their jobs.” Managers, however, need to understand a wider compliance picture. She illustrated her point by comparing views on the following regulatory bodies.
Centers for Medicare and Medicaid Services (CMS), which oversees the Clinical Laboratory Improvement Amendments of 1988 (CLIA):
- Staff typically recognize that the CLIA regulations are the minimum standards a lab needs to operate in a patient testing environment.
- Managers recognize that CMS develops, publishes, and implements CLIA rules and guidance.
Centers for Disease Control and Prevention (CDC), which provides labs with technical standards and safety guidelines that tie to CLIA:
- Staff may not know that the CDC is involved with CLIA.
- Managers know that the CDC manages the Clinical Laboratory Improvement Advisory Committee.
Food and Drug Administration (FDA), which categorizes medical laboratory devices and in vitro diagnostics:
- Staff understand that the FDA clears tests and devices for use in non-research environments, though not all consumables or equipment are in that setting.
- Managers understand that the FDA develops rules and guidance for CLIA complexity categorization.
College of American Pathologists (CAP), COLA, and The Joint Commission, which accredit clinical laboratories on behalf of CMS:
- Staff typically recognize the name of their lab’s accrediting body and that the group sends inspectors.
- Managers recognize that CLIA dictates that an accrediting body inspects labs based on exceeding minimum standards to conduct patient testing.
(Readers of The Dark Report can check out past coverage about frequent deficiencies cited by accrediting bodies.)
Communication Leads to Common Ground with Clinical Laboratory Regulations
Given the above differences among managers and staff, VanBemmel explained that both sides must frequently talk to each other to fill in the missing details.
“When you’re in the thick of regulations, communication becomes critical,” she said.
For example, bench staff may feel it is solely their manager’s responsibility to comply with clinical laboratory regulations. Savvy lab leaders will point out non-compliant conditions—such as diagnostic analyzer malfunctions and sample cross contamination—over which bench staff have direct control, helping workers better understand their responsibility when it comes to compliance.
On the other hand, lazy communication from managers to their bench scientists can stunt compliance efforts. She recalled a prior supervisor who often answered questions about regulations by asking: What does the standard operation procedure state?
“That answer wasn’t particularly helpful,” VanBemmel recalled. “That made me think that my supervisor didn’t understand nuance.”
Thorough communication builds greater trust, and seasoned clinical laboratory professionals of all ranks will quickly recognize the compliance benefits when the worker-manager relationship gels.
—Scott Wallask
