The role of pathologists is changing in clinical and research laboratories. New demands in testing require better quality specimens, and the limited storage options for those specimens foster the need for new methods and modalities. As advances in human tissue storage continue to change the industry, pathologists are doubling as biobankers in healthcare facilities across the country. In a recent interview, James Robb, MD, FCAP, a consulting pathologist and former governor of the College of American Pathologists (CAP), referred to pathologists as “the custodians of the specimen,” citing them as a key component in standardizing specimen storage options.
“It’s very important that pathologists and pathology departments take charge and be responsible for implementing the processes through which quality biospecimens are obtained, processed and stored,” said Robb.
As freezing specimens is both expensive and impractical, the transition from frozen tissue to ambient storage methods is becoming more and more of a necessity. Storage practices like paraffin-embedded tissue and dry ambient storage are unique as long term options because they allow for specimen preservation while cutting down on the energy and space required for tissues to be stored frozen. The ability to store biospecimens in safe conditions for reliable results without the energy and expenses necessary in the freezing process allows for a larger database of high quality samples available for more accurate testing.
“It’s very well accepted that to do genetically informed precision molecular healthcare today, you have to have a high quality biospecimen,” continued Robb. “Several US and international organizations are developing best practices to collect quality biospecimens supported by the necessary biospecimen research, so that everyone will be able to optimally create, process and store each type of specimen.”
While vapor-phase liquid nitrogen frozen storage still remains the standard, more cost-effective and efficient processes are on the rise. From variations on frozen methods, like the shift from liquid nitrogen-based freezing to ultra-cold (minus-80C storage) to the emergence of dry, ambient storage, which can be catalogued and kept at room temperature, the culture of biobanking and biorepositories is evolving with the clinical and research laboratory industries. Margaret Gulley, MD, director of molecular pathology at the University of North Carolina, described the emergence of new storage technologies and their impact on human tissue storage.
“It’s pretty expensive to store things long term and to keep track of where they are in your storage so you can later retrieve them, but storing things at ambient temperature would be a lot cheaper than storing them in a freezer or in a temperature-regulated environment,” explained Gulley. “So, there’s been a lot of interest in drying nucleic acid and then storing it at room temperature because it’s less expensive.”
Issues and Protocols
Apart from the changing technology, there are many challenges and obstacles facing the healthcare community in regards to both regulatory and legislative protocols. One issue that has affected all testing methods from visual modalities to genetic testing options is privacy, specifically privacy issues regarding consent and ethical inquiries. The US Department of Health and Human Services’ (HHS) Office of Human Research Protections (OHRP) deals in issues like informed consent, in which a patient is made aware and agrees to the storage of their tissue for potential use in testing. Robb remarked on the evolution of informed consent policies, such as the “one-tiered” informed consent that the National Cancer Institute’s (NCI) Biorepositories and Biospecimen Research Branch (BBRB) has developed. This “one-tiered consent form,” which evolved from the “multi-tiered” form, greatly simplifies the process and still gives the patient complete control of the consenting process.
“BBRB is the only office at the National Institutes of Health [NIH] that is devoted to developing practices and policies for biospecimen usage and basic research and clinical research,” said Jim Vaught, PhD, Chief, BBRB, and Editor-in-Chief of Biopreservation and Biobanking journal.
Organizations like the BBRB are taking the lead in developing biospecimen standards and practices. While the quality of individual storage facilities in healthcare settings largely rests on the shoulders of pathologists, the universal guidelines for practices and international record-keeping standards are regulated by groups like the BBRB, who develop best practice standards, which biobanking organizations can use to develop Standard Operating Procedure (SOP) manuals.
“One of the things that is really at the top of most people’s lists in the biobanking world is international harmonization of standards for collecting and using biospecimens,” explained Vaught. “And, partly, this is an economic issue as well, but we found within our program and in collaborative studies around the US and internationally, that the standards in the US – within the NIH, in fact – and around the world are just not well-coordinated.”
Like all new technologies and techniques, modern biobanking has some catching up to do. With samples available from more efficient and durable storage methods, the potential of an international database of specimens annotated with information is exciting for the research community and the healthcare industry as a whole. Pathologists have the knowledge and expertise to improve specimen quality for particular downstream uses, and they are stepping up to guide the evolution of the collection of biospecimens for storage practices.
Michael Jones is on staff at ADVANCE. He can be reached at firstname.lastname@example.org.
- U.S. Department of Health and Human Services’ Office of Human Research Protections. OHRP Home. HHS.gov. Available at: www.hhs.gov/ohrp. Last accessed June 11, 2013
- U.S, National Institutes of Health. BBRB Biorepositories and Biospecimens Research Branch. www.cancer.gov. Available at: http://biospecimens.cancer.gov/default.asp. Last accessed June 11, 2013.