Variability in how tissue is handled from one histopathology laboratory to another greatly affects quality of specimen and accuracy of the pathologist’s diagnosis

TORONTO, ONTARIO, CANADA—Here on the shores of Lake Ontario, pathologists and clinical laboratory professionals gathered last week for a unique conference that focused on quality issues involving how tissue is handled from collection and transport to the histopathology laboratory processing to diagnosis by surgical pathologists.

Your Dark Daily editor was here to participate in the conference and learn from a first-rank panel of speakers. As many long-time readers know, patients, physicians, and health insurers expect increasingly higher levels of accuracy in how lab specimens are handled and greater precision in the resulting diagnosis that is produced by pathologists. Thus, a conference dedicated to tissue specimen integrity and quality is both timely and appropriate.

Ways to Improve Tissue Specimen Handling and Processing

“From Patient to Paraffin: Optimizing Specimen Quality from Surgical Suite to Diagnosis” was organized by the Institute for Quality Management in Healthcare (IQMH). It took place in Toronto on April 3-4, 2014. Pathologists and laboratory professionals from across Canada were in attendance.

Two developments in healthcare and laboratory medicine underpinned the primary discussion that took place over the two days of this conference. The first development centered upon recognition by healthcare practitioners and patients that the quality and accuracy of anatomic pathology testing needs to improve continuously over time. In other words, the level of quality that may be acceptable today will not meet the expectations of patients in coming years.

Quality Needs and Expectations Are a Moving Target

The second development is the rapid take-up of molecular diagnostics and genetic testing for clinical purposes. Because of advances in molecular and next-generation gene sequencing technologies, anatomic pathology laboratories need to reassess long-standing practices in how tissue is collected, transported, processed, and diagnosed. Traditional steps in tissue handling and processing often fail to meet the quality and integrity requirements of ever-more sensitive and specific molecular assays and genetic tests.

Day one of the conference opened with two interesting sessions:

• Victor Tron, M.D., FRCPC, presented the ways that formalin-fixed, paraffin-embedded tissue (FFPE) is used in different types of molecular and genetic tests. He called attention to how variation in the way tissue is processed can directly affect the quantity and quality of DNA, RNA, and mRNA that remains once processing has been completed. Tron is the Head of Pathology and Molecular Medicine at Queen’s University in Kingston, Ontario.
• Catrina Marchió, M.D., Ph.D., provided detailed information about the pre-analytical variables that can influence molecular and proteomic lab test results. She provided data from clinical studies that showed how time of surgery is an influence for warm ischemia and transfer time, and time in the histology laboratory is influential in cold ischemia. These are factors that can reduce the quality and integrity of the tissue specimen for purposes of molecular and proteomic testing. Marchió is a Pathologist-In-Training at the Department of Medical Sciences, University of Turin in Turin, Italy.

In Toronto last week at the Institute for Quality in Management in Healthcare’s special conference about the quality of tissue specimens used in clinical diagnostics, the speakers included (above, left to right): Robert L. Michel, THE DARK REPORT; Richard J. Zarbo, M.D., DMD, Henry Ford Health System; Victor A. Tron, MD, Queen’s University; and Gregory J. Flynn, M.D., IQMH. (Photo by Rafael Ludwig of Capricorn8.com.)

Day two at the IQMH program opened with a robust discussion involving the legal and ethical issues associated with tissue specimens that are collected for clinical and research purposes. This is an area of law in Canada that is evolving as different court cases are adjudicated.

Tissue Specimen Quality

Returning to the central topic of tissue specimen quality and its integrity for clinical diagnostic purposes, two presentations presented thought-provoking issues for attendees:

• Marco Bellini put the issue of unsatisfactory molecular test accuracy directly in front of the audience. In his remarks about how tissue is handled by histology labs during the pre-analytical stage, he demonstrated how tissue processing procedures developed in the 19th and early 20th centuries are still in common use today—despite the fact that much of the actual diagnosis of tissue using IHC (immunohistochemistry) and molecular studies utilize technologies based on 21st century technology. He recommended that the pathology profession would benefit from developing a more precise “formula” for processing tissue, saying that such a formula would be “a performance-based, standardized/documented, ‘chain of custody’ of the pre-analytical steps from the patient body to fixation.” Bellini is the General Manager of the Medical Division at Milestone S.r.l., in Bergamo, Italy.
• Anne-Marie Martel, M.T., addressed the challenge of developing standards. She covered the steps required to assemble evidence, bring together experts, and the stages necessary to develop the language of a standard and have it accepted by all stakeholders. She also discussed the difference between guidelines and standards and how the pathways to acceptance and use are different. Anne-Marie Martel, M.T., is Scientific Coordinator at Ordre Professionnel des Technologistes Médicaux du Québec (OPTMQ). She is also Chair of the Canadian Standards Association (CSA) Technical Subcommittee Z252.10 on Specimen Procurement.

Conference Demonstrated Need for Improvements in Tissue Processing

The conference ended with several presentations and a panel discussion that recognized the need for more precision in how tissue used for clinical diagnostic purposes is collected, transported, and processed prior to diagnosis by a pathologist.

There were suggestions that a study team should be assembled for the purpose of assessing published medical studies and conducting necessary research and studies designed to improve how tissue specimens are handled and processed. This work would form the foundation for recommendations on guidelines or even standards that would be published to improve the performance of histopathology laboratories in how they handle tissue specimens.

Pathologists, histotechnologists, and laboratory managers interested in learning more about this conference and the work of the proposed study team on the topic of standards for the handling and processing of tissue should contact the staff working with Gregory J. Flynn, M.D., CEO of IQMH. He organized the conference and is willing to coordinate the organization and launch of this project. The email contact information can be found at https://iqmh.org.

Your Dark Daily Editor,

Robert L. Michel

Related Information:

“From Patient to Paraffin: Optimizing Specimen Quality from Surgical Suite to Diagnosis” Agenda and program details 

Medical Laboratory Quality and Anatomic Pathology Errors among Issues Discussed during Lab Quality Management Conference in Vancouver