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- Arizona Society of Pathologists, CAP Oppose Specimen Disposal Bill
The Arizona Society of Pathologists (ASP) and the CAP urged the state legislature to reject a bill requiring a clinical laboratory to dispose of any specimen within three days after a diagnostic test has been completed unless the laboratory has obtained specific patient consent. The legislative measure, HB 2812, would prohibit a laboratory from using or sharing a specimen for any purpose other than for which the lab obtained the patient’s affirmative consent. The CAP is collaborating with the ASP to ensure that regulatory burdens are reduced for pathologists in Arizona.
In a February 8 letter to AZ State Rep. Shawnna Bolick, ASP President Richard Eisen, MD, FCAP, stated the legislation would have unintended adverse medical consequences and should not be considered. “The retention of patient specimens cannot be waived or attenuated under state law. The retained use of patient specimens is fundamental to providing accurate diagnosis and care of the patient,” wrote Dr. Eisen. “Recognizing this fact . . . the Clinical Laboratory Improvement Amendments and federal regulations contemplate and stipulate periods, for as long as 10 years, to retain certain tissue specimens.” Dr. Eisen further noted that federal law in this area preempts and supersedes any state law that is not as stringent as federal law.
In addition, Dr. Eisen said that national clinical laboratory accrediting bodies, such as the CAP, have certain specimen retention requirements that exceed standards established under federal law. The purpose of national regulations and accrediting body standards in this area is to ensure the optimal, high-quality medical diagnosis and treatment for the patient. It is also to ensure an evidentiary record should the accuracy of an initial diagnosis be subject to litigation.
An essential clinical reason to retain tissue specimens to provide a medical record of what was examined but allows for a secondary or retrospective review of a patient specimen. The retained specimen can enhance the patient's initial diagnosis, prognosis, or treatment, Dr. Eisen said.
“Patient’s lives are being saved because by retaining specimens we have the ability to identify genetic biomarkers that were previously not identified nor considered significant or even identifiable at a time a specimen was taken,” he wrote. “Furthermore, the progression of a disease in a patient, as evidenced by the chronology of a specimen, constitutes an important part of the clinical record in the care of a patient and cannot be replicated if patient specimens are destroyed. We cannot ethically undertake actions that would jeopardize the health or safety of our patients. In sum, for these many legal, scientific and clinical reasons, we strongly urge that this legislation not be considered.”
The CAP will continue to follow developments on this measure.