Pathology by the rules
Donald S. Karcher, MD
May 2025—This won’t be news to CAP TODAY readers, but it bears saying: Pathology and laboratory medicine are among the most heavily regulated parts of the health care system in the United States. This regulation is so ingrained in our culture as pathologists that we sometimes deal with it without even thinking. It’s part of our training as residents and remains part of our daily work as pathologists for our entire career.
If you’re a member of the CAP, you have essentially self-identified as a pathologist who prioritizes quality in the laboratory. That’s where the CAP began, in an era long before laboratory medicine was regulated at the federal level. The CAP was founded in 1947 in part to “improve medical laboratory service to patients, to physicians, to hospitals, and to the public” (from the CAP Constitution). The young College quickly developed proficiency testing as a way to improve the quality of laboratory testing. Doing PT based on CAP guidelines definitely started making a difference, with lab testing quality improving through the 1950s and 1960s, but at that time it was still voluntary and not all labs participated. In the early 1960s the CAP began to accredit clinical labs, but this was also a voluntary process.
Eventually, the federal government stepped in, establishing some of the regulations that continue to govern our labs today. Congress passed the Clinical Laboratories Improvement Act of 1967 (CLIA ’67) to establish basic standards for clinical lab testing, though the new law didn’t yet apply to all U.S. clinical labs. The CDC (then called the Communicable Disease Center) was initially charged with overseeing CLIA ’67, followed later by the Health Care Financing Administration, which was eventually renamed the Centers for Medicare and Medicaid Services. In 1988, CLIA ’67 was amended based in part on concerns about “Pap mills” that generated low-quality results for Pap tests and led to women dying from undetected cervical cancers. The Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88) significantly expanded laboratory standards and required all clinical labs in the U.S. to meet these standards.
As a highly regulated part of medicine, we’re under the jurisdiction of several U.S. agencies. Beyond the CMS, there’s also the Food and Drug Administration, which oversees all commercially marketed clinical lab test kits and testing equipment through its purview over medical devices. All test kits and instruments manufactured and sold by companies must be FDA approved or FDA cleared before they can be used for clinical testing on patients.
Of course, FDA oversight of laboratory-developed tests is a huge issue in the pathology and clinical lab community, and I’ve written about it before in this column. An FDA LDT regulatory rule finalized a year ago was recently vacated by a federal court in response to multiple lawsuits, supported by an amicus brief filed by the CAP, in opposition to the FDA rule. Although the federal court ruling is a significant victory, federal oversight of LDTs is still being debated in Washington, DC, and will likely require congressional action to provide final resolution.
The FDA is also charged with protecting the safety of the blood supply in the U.S., which includes regulating the facilities that collect and process blood products and overseeing hospital blood banks and transfusion services that are typically part of clinical laboratories.
And let’s not forget two more rule-makers: As the leaders of our laboratories, pathologists are required to comply with worker safety standards developed by the Occupational Safety and Health Administration and with regulations from the Department of Transportation pertaining to shipping procedures for hazardous specimens.
It’s not enough to keep up with the current regulatory landscape—we also have to think about the anticipated evolution of regulations in the future. FDA regulation of LDTs is a great example: While we were all preparing for the first phase of the FDA’s LDT rule to be implemented this month, the outcome of the federal lawsuits has made that unnecessary. We will now need to remain vigilant for any subsequent regulatory changes regarding LDTs. Emerging technologies are another aspect of regulatory evolution. As we bring new tools into our practices and labs—such as advanced genomic analysis, digital pathology, and AI—we have to be aware of the regulatory frameworks that may affect our ability to use them, and to expect new rules to come out regarding these tools. Oversight from the CMS and the FDA will almost certainly expand to ensure that these technologies are safe and effective for patients.
One of the original and still most important ways the CAP supports pathologists and clinical labs is to provide programs and products to ensure services of the highest possible quality, helping us meet and even exceed the extensive regulatory requirements we all must deal with. As new technologies emerge and new regulations appear, the CAP will continue to advocate strongly for what’s best for our practices, our labs, and our patients, and will keep pathologists and clinical labs ready to comply.
Dr. Karcher welcomes communication from CAP members. Write to him at president@cap.org.