As I reflect on 10 years of independent consulting, the role I fulfill that gives me the most pride is that of Laboratory Director for the CLIA/CAP labs that I serve. The values that I hold most dear as a professional and as a human are fully engaged in this role in unique ways. It is both challenging and humbling to serve these labs and our patients.
Nuts and Bolts: The CLIA Regulations
Clinical laboratories are regulated by the Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88), which comprise the regulations under which clinical laboratories must operate. The regulations specify such things as the structure and content of the laboratory’s Quality Management System (QMS), qualifications for laboratory personnel, quality control, system verification and/or validation, and special considerations by testing specialty. As with most regulatory frameworks, the CLIA regulations specify what a clinical laboratory must do to ensure high quality patient test results, but these regulations do not tell laboratories exactly how to do that.
When I look at the CLIA regulations through the lens of Laboratory Director, I focus on what the regulatory requirements mean for patient safety. Primarily, my values and the nature of all my work focuses on ensuring patient safety, at its core. For a clinical laboratory environment, the controls needed to ensure patient safety require a deep understanding of the technology underlying the diagnostic tests performed by the laboratory and the required education and training of the laboratory testing personnel (and supervisors) directly performing the tests. When I consider the CLIA requirements and all the attributes of a particular clinical laboratory holistically, the process of applying the CLIA regulations to that situation to ensure patient safety becomes more straightforward.
The Science of Diagnostic Testing
To evaluate the requirements to ensure patient safety from the perspective of the diagnostic tests on the laboratory’s menu, I draw heavily upon my scientific education and training (My experience). I am Board-certified and have completed many years of training in the clinical laboratory that qualify me to perform my role of Laboratory Director. And, my early years of scientific education and training form a solid foundation for me in this role. I am a scientist by training and by nature; I completed my PhD and postdoctoral fellowship in Biochemistry at Washington University in St. Louis. I am deeply indebted to my mentors and colleagues who grew my curiosity and refined my ability to ask testable questions. These skills allow me to trouble-shoot, assess risk, and solve complex problems quickly while minimizing impact to laboratory operations and the quality of patient testing. All the roles I manage as a consultant require these two skills daily, but my role as Laboratory Director stretches and grows those two skills more so than anything else I do (My work).
Clinical Laboratory Teams: Integrity and Trust
A good Laboratory Director relies on and further develops the expertise of the teams who perform the diagnostic tests within the laboratory. Most of the clinical laboratories that I direct perform high-complexity tests (especially laboratory developed tests, LDT). CLIA requires a high level of education, experience, and training for the named roles within the laboratory—Technical Supervisor and General Supervisor. These two roles require a high level of trust from the Laboratory Director that is earned through the demonstration of good judgment, high integrity, and technical skill over time. I have had the honor of working with some exemplary professionals, who have served patients admirably in the face of pressures. I want to emphasize the level of technical skill that is required to serve a clinical laboratory in ways that protect patients, and more so I want to express gratitude for the individuals who have worked alongside me and shown such commitment and strength of character.
Given the level of excellence I have experienced working with clinical laboratories and the people who serve them, I believe that this blog should close on a note of gratitude, communicating sincere respect for all of those I have had the honor of working alongside to generate high quality test results for our patients.
Thank you!
If your laboratory has questions about clinical laboratory diagnostics or personnel requirements for clinical diagnostic laboratories, reach out to an experienced CAP/CLIA Laboratory Director and CLIA laboratory builder (Contact us).
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