One of the fastest growing components of laboratory medicine is biobanking, which involves the collection, processing, storage, inventory, and distribution of biologic specimens. Pathology departments routinely process two categories of specimens: (1) patient blood/serum used for routine analysis; and (2) tissue biopsies and resections, often of tumors, submitted for diagnosis. Biobanking software is sold by various vendors to support these efforts. The field has its own well-established society (International Society for Biological and Environmental Repositories; ISBER) that provides a web page listing the various biobanking software products available in the market.
Relevant to all of this is that I recently came across a press release indicating that the biorepository of the Quest Diagnostic Clinical Trials business unit has now been accredited by the CAP (see: Quest Diagnostics Clinical Trials' Biorepository Accredited by the College of American Pathologists). Below is an excerpt from it:
Quest Diagnostics....announced that the specimen biorepository of its Quest Diagnostics Clinical Trials business....has been accredited by the College of American Pathologists (CAP), the international laboratory accrediting organization. Based at the Quest Diagnostics clinical laboratory in Valencia, Calif., the biorepository maintains de-identified tissue, blood and urine specimens, including molecular and genetic material, collected from the United States and internationally for use primarily by pharmaceutical and biotechnology companies in clinical trials to research and develop new drug treatments.The CAP program is the first-of-its-kind peer-based accreditation program developed to improve and standardize quality and consistency in collecting, processing, storing, distributing, and computerizing information for biospecimens while ensuring the quality of human specimens and genetic material....With central laboratory facilities in North America and Europe, and alliance laboratories in China, Australia, and South America, Quest Diagnostics Clinical Trials supports investigative sites in over 4,000 cities across 80 countries.
CAP has posted on the web a list of FAQs about its biorepository accreditation program (see: Frequently Asked Questions About CAP’s Biorepository Accreditation Program). The first question is why the CAP got into this component of the accreditation business. Here's the answer:
Excellence and quality measures in biorepositories are interrelated concerns that have a direct bearing on research that can help advance health care. The CAP is introducing multiple, scalable tools specifically designed to improve and validate the quality of biospecimens and biorepositories. Our new Accreditation for Biorepositories Program will help ensure consistent, industry-wide verification of biospecimen quality. Thousands of biorepositories exist, varying in size, nature of collections, specimen types, purpose, quality, and age. Recently, there has been a realization that some biorepositories do not fulfill research requirements (most importantly personalized medicine); a high degree of heterogeneity exists in the methods used to collect, process, and store biospecimens.
Many pathology departments do not fully understand that they are sitting on a treasure trove of tumor specimens. Particularly in larger academic departments, many of these specimens have been extensively genotyped in the process of diagnosing the lesions. Moreover, if and when links can be established between the biobanking system and the corresponding patient records in the hospital EHR, additional information can be obtained about the success of the treatment regimens used to treat these tumors. To restate the obvious, these patients must have appropriately consented for all of this information to be used in subsequent studies and clinical inquiries.