Advancing CLIA, Clinical Proficiency Testing & Public Health
Dr. Stanley Inhorn’s profound influence on clinical laboratory standards and proficiency testing in the United States cannot be overstated. As a twice-serving director of the Wisconsin State Laboratory of Hygiene (WSLH), he played a pivotal role in shaping the regulatory framework that ensures laboratory quality and patient safety to this day. With his recent passing, Dr. Inhorn has left behind a remarkable legacy in the field of laboratory medicine. His obituary recounts just some of his many accomplishments and ways to honor his legacy. Dr. Inhorn’s contributions to the Clinical Laboratory Improvement Act of 1967 (CLIA-67) and later to the 1988 revisions (CLIA-88) reflect just a facet of his lifelong dedication to improving laboratory practices and public health.
Laying the Foundation for Laboratory Quality Assurance
Dr. Stanley Inhorn’s dedication to cytology and laboratory best practices played a crucial role in the development of Proficiency Testing, which later became a cornerstone of CLIA regulations. In 1960, WSLH participated in a major community initiative to promote the newly introduced Pap smear test for early cervical cancer detection. Inhorn dedicated countless hours to training personnel in family planning clinics, ensuring they could properly prepare and accurately screen Pap smears—both critical steps for the test’s effectiveness.[1]
His efforts in training personnel to properly prepare and analyze Pap smears highlighted the critical need for standardized laboratory practices to ensure accuracy in diagnostic testing. As a leader in the American Society of Cytopathology, Inhorn helped establish quality benchmarks for cytology laboratories, reinforcing the importance of oversight and competency assessment. These early initiatives in cytology set the stage for the broader implementation of Proficiency Testing, ensuring that laboratories met rigorous standards and ultimately influencing the regulatory framework that CLIA would later formalize.
Dr. Inhorn’s work in clinical laboratory quality assurance began in the mid-1960s, during a period of rapid healthcare expansion in the United States. With the introduction of Medicare in 1966, the federal government took a stronger interest in ensuring that laboratory testing met rigorous quality standards. As Dr. Inhorn noted in an interview, “If the government was going to pay for health services, they determined they had to have standards.”
Recognizing the critical need for laboratory oversight, Dr. Inhorn and his colleagues at WSLH established the Laboratory Improvement Division in 1966, This division, known today as WSLH Proficiency Testing, became the first PT provider of a public university to provide external quality assurance for U.S. facilities. Under Inhorn’s leadership at WSLH, the program set a precedent for what would later become national regulatory standards.
CLIA-67 and the Role of Proficiency Testing
In 1967, Dr. Inhorn was invited to the Centers for Disease Control and Prevention (CDC) to help draft the proficiency testing standards that would become a cornerstone of Clinical Laboratory Improvement Amendments of 1967 (CLIA-67). Alongside a team of experts, he developed essential laboratory quality guidelines, including standards for personnel qualifications and test complexity categorization. His work established the three-tier classification system for laboratory tests—complex, intermediate, and waived—that remains in place today.
This early legislation mandated that U.S. facilities, primarily independent and hospital laboratories, undergo routine clinical proficiency testing to maintain certification, ensuring that test results were accurate and reliable across different facilities. Dr. Inhorn’s collaborative efforts helped shape a regulatory framework that continues to safeguard patient care by ensuring facilities across the United States get accurate and reliable testing results.
The Evolution of CLIA-88 and Beyond
As laboratory technologies advanced in the 1970s and 1980s, the need for updated regulatory standards became evident. Dr. Inhorn once again played a key advisory role in the revision process, contributing to CLIA-88, which expanded proficiency testing requirements and introduced stricter oversight for all facility types, not just independent or hospital laboratories. The updates reinforced the importance of standardized testing procedures, helping to minimize discrepancies in diagnostic results across the country.
Beyond his work with CLIA, Dr. Inhorn’s contributions to laboratory quality assurance extended into professional organizations and public health initiatives, including leading the establishment of state-wide laboratory systems, known under the L-SIP program. His leadership in this public health initiative earned him prestigious honors, including the Gold Standard Award and the Lifetime Achievement Award from the Association of Public Health Laboratories (APHL).
Beyond his work in public health laboratories, Dr. Inhorn remained active in several scientific organizations throughout his career and into retirement, including his service with the American Cancer Society, the American Medical Association, and American Society of Cytopathology (ASC). In 1981, Dr. Stanley Inhorn was awarded the Papanicolaou Award, the society’s highest honor. [2]
A Lasting Impact on Laboratory Medicine
Dr. Inhorn’s legacy endures in the systems and standards that govern laboratory medicine today. His vision for a structured, accountable, and high-quality clinical testing environment has had a lasting impact on patient safety and public health. The foundation he helped build at WSLH Proficiency Testing and beyond continues to support clinical laboratories in meeting and exceeding regulatory requirements.
As the field of laboratory medicine evolves with new technologies like molecular diagnostics and artificial intelligence, the principles Dr. Inhorn championed—accuracy, reliability, and continuous quality improvement—remain as relevant as ever. His dedication to clinical excellence set the standard for laboratory proficiency testing, ensuring that patient care is always guided by the highest standards of laboratory practice.
Dr. Inhorn’s passing marks the loss of a visionary leader, but his contributions will continue to shape the future of clinical laboratory medicine for generations to come. His impact on laboratory quality assurance and patient safety will remain a guiding force for the profession, serving as a lasting tribute to his invaluable work.
- “Interview with Stanley Inhorn”. ohms.library.wisc.edu. Retrieved February 25, 2025.
- Stanley Lee Inhorn”. com. February 21, 2025. Retrieved February 22,2025.
Barb Goodson’s journey into the world of medical laboratory science began unexpectedly. After working for 23 years in various positions at her local public health department in Hancock, Michigan, Barb found herself thrust into the frontline response at the start of the COVID-19 pandemic in 2020. She recounts how she took on so many more roles in response and “kind of did everything,” from working in the call center to contact tracing.
Caitlin Miranda’s journey into the laboratory field was sparked by her exploration as a Biology major in her college years. Initially unsure of her career path upon graduation in 2008, Caitlin was encouraged to apply for an internship in a small-town hospital laboratory in Owosso, Michigan. It was here that she discovered her passion for medical laboratory science.
Shirley Keenan’s journey into medical laboratory science began in the late 1970s, when she worked as a medical assistant for a physician in a growing practice. It was here that Shirley first encountered and learned basic laboratory skills, sparking her interest in the field. However, it wasn’t until the physician hired a medical laboratory professional that Shirley considered pursuing a career in laboratory science herself. It was her colleague who encouraged her to go to school to pursue a degree in Medical Laboratory Science at the University of Buffalo in New York.