Human biospecimens are the starting materials for all anatomic pathology analyses, but the quality bar for specimens has been set by morphological standards, not molecular standards. With the exception of practice metrics mandated by the American Society of Clinical Oncology-College of American Pathologists (CAP) guidelines for breast cancer samples, pre-analytical variables in anatomic pathology are neither controlled nor recorded.
As a result, the "fitness" of most routine specimens for molecular analysis is frequently compromised in variable ways. Similar issues exist for cytology specimens and for blood biospecimens in the clinical pathology laboratory. As molecular testing becomes more critical to medical decision-making, the pervasive problem of pre-analytical variation threatens to compromise the practice of precision medicine.
In 2015, the CAP Preanalytics for Precision Medicine Project Team (PPMPT) began to address this issue with the goal of setting baseline standards for the most important pre-analytical variables in everyday pathology practice. The PPMPT verified the key variables causing most of the molecular compromise in patient samples and determined the performance metrics needed to control them.
These metrics can serve as best practices that can confer a baseline level of quality and consistency across all patient biospecimens that is currently lacking.
- Identify the top 5 pre-analytical variables that have the greatest detrimental impact on molecular quality of tissue, cellular, and blood biospecimens, respectively
- Describe the performance metrics that need to be met to control these key variables in the pathology laboratory
Presenter:Carolyn Compton, MD, PhD, FCAP