The Missouri Society of Pathologists (MSP) and the CAP strongly oppose legislation that would make it a felony for clinical laboratories to retain a patient specimen without patient consent. The legislation mandates that any biological specimen collected or received by a laboratory shall not be released for purposes of “anonymous scientific study” unless the individual from whom the specimen was obtained consents to such a release. The CAP works with state pathology societies to enhance our advocacy strength at the state level while reducing burdens on pathologists.

At the time of collection, the individuals may direct the laboratory to return the specimen, destroy the specimen or store the specimen but not release it for anonymous scientific study. For any specimen in possession of a laboratory before the effective date of the measure (if approved), the laboratory may release the specimen for the anonymous scientific study if it contacts the individual first and receives consent. The measure was introduced on January 29 and is now pending in committee.

In February 23 testimony before the House Special Committee on Governmental Oversight, the MSP President, Chakshu Gupta, MD, FCAP argued that there are clear medical, scientific, and legal reasons by clinical laboratories must retain patient specimens:

• Regulatory requirements. CLIA requires laboratories to retain patient specimens. This federal law supersedes state law (unless the state law is more stringent).
• Patient benefits. These include the potential retrospective need to test a specimen in cases where second opinions are needed, or where advances in diagnostic science require further analysis to see if patients qualify for the most current cutting-edge treatments.
• Medicolegal issues. In legal cases of alleged medical errors, patient specimens are critical evidentiary material to document medical diagnosis accuracy or, conversely, a failure or omission in adherence to clinical standards of pathology diagnosis.
• Existing safeguards. Under the federal Health Insurance Portability and Accountability Act (HIPAA) and the Federal Policy for Protection of Human Subjects (common rule), written consent from a patient must be obtained to use an identified patient diagnostic specimen for purposes of medical research. These requirements apply to all diagnostic laboratories.

“Each patient specimen constitutes an important part of the biological chronology of disease in the patient’s medical records which cannot be replicated or destroyed,” Dr. Gupta said. “For example, the ability to retrieve an archived cancer specimen after initial diagnosis to determine whether a patient had a particular biomarker for which a new targeted therapy is available could change that patient’s prognosis and the course of treatment. For all these . . . reasons, we strongly urge your rejection of this legislation.”

The CAP will continue to track and provide updates on this legislation.