Medical laboratories of all types and sizes must continually navigate the regulatory requirements for performing clinical testing, and the controversies surrounding the measurement of chemistry analytes in body fluids is no exception. In a recent article in Medical Lab Management, Darci Block, Ph.D., Director of Laboratory Services and Co-Director of the Central Clinical Laboratory at Mayo Clinic in Rochester, Minnesota, discusses how to establish and maintain a compliant body fluid testing program.
According to Dr. Block, while clinical laboratories must maintain licensure via an accreditation agency, significant gray area remains regarding the extent to which body fluid tests should be validated, which tests should be considered routine and orderable, how a clinically unique test should be handled, and the best way to provide reference ranges and appropriate interpretative information to clinicians in a meaningful way.
Further, body fluid validation must meet regulatory standards; however, it is then up to each laboratory to decide which fluid type and analyte combinations need to be validated and ultimately how these tests will be orderable by providers. According to Dr. Block, a risk-based approach is best to justify actions (or lack thereof) when deciding how many samples to include and the number of data points to gather for any given study.
The article also discusses the most challenging College of American Pathology checklist item, which is defining a reference range for “routine orderable tests.” For some tests, this is a practical solution, but for many others, it is not.
According to Dr. Block, "It is easy to appreciate why many in the field would argue that having to perform analytic validation is an incredible burden on laboratories. However, it is also easy to appreciate that labs must at least make an effort. Development of an appropriate test menu and a validation plan allows laboratories to confidently offer a body fluid test that supports clinical needs. She continued, "Laboratories should also engage clinicians to offer valuable insights on how results are used and what information would be helpful in result reports. Ultimately, clinical laboratories should be aware of the total testing process and consult resources that critically review the clinical application and utility of analyte measurement in body fluids."