Focus Areas
The Center for Healthcare Delivery and Policy supports the national goal of greater precision and higher value in healthcare. In this era of molecular medicine, the patient biospecimen (e.g., tissue, blood, cells) is the starting point for quality. All molecular data about patients and their diseases is derived from their biospecimens, and the quality of that data is dependent on the molecular quality of the specimens used in molecular assays.
At present, there are no enforced standards for ensuring the molecular integrity of patient specimens. For patients, safety and treatment efficacy are at stake. With the goal of resolving this issue, the Center is working with stakeholders in all sectors, public and private, to:
- Understand the impact of preanalytical variation in the collection, handling and processing of patient biospecimens, on molecular analysis data downstream and how the current lack of standardization may affect the validity and reproducibility of analysis results.
- Understand what is required to ensure the molecular quality of patient specimens used for management of care and biomedical research.
- Get commitment to develop, implement, and coordinate procedural guidelines to ensure the integrity of patient samples in the preanalytical pipeline.
- Gather thoughts on methods to enforce and incentivize professional behaviors that will ensure the quality and consistency of patient samples in their custody.
Preanalytics is a systems-wide problem in biomedicine the resolution of which requires the commitment and coordinated effort of all parties who are part of the specimen chain of custody. The efforts to initially explore this problem and posit solutions began with two convergence conferences sponsored by the National Biomarker Development Alliance. Since those meetings, the College of American Pathologists (CAP) has made a deep investment in the development of evidence-based recommendations for preanalytics for tissue and blood specimens, recently published in the Archives of Pathology and Laboratory Medicine (Compton et al. Preanalytics and precision pathology: Pathology practices to ensure molecular integrity of cancer patient biospecimens for precision medicine. Arch Pathol Lab Med 2019; 143:1346-1363) and has committed to enforcing them through their Laboratory Accreditation Program. Although this is an essential first step, pathologists do not control the entire preanalytical process. Full resolution requires that all biomedical personnel who are part of the specimen chain of custody be committed to the same goals and coordinated in their efforts to achieve them.
To this end, the Center convened a Preanalytics Summit Conference in Washington DC in December 2019. Representatives from all stakeholder groups, public and private, were in attendance and made commitments to action to resolve outstanding issues. The Personalized Medicine Coalition, a nonprofit organization based in Washington, DC, made the commitment to partner with the Center to convene a group of major pharmaceutical companies and patient advocacy organizations to share and harmonize educational materials on preanalytics. The group, called the Preanalytics Pharma Working Group (PPWG), has been meeting ever since.
Related Projects
Currently, the PPWG has 3 ongoing projects.
- The PPWG Education Committee has defined 5 goals and is rapidly moving towards their completion:
- a. Identifying key participants in their parent companies
- b. Sharing existing educational material
- c. Identifying library assets
- d. Harmonizing their individual messaging around preanalytics for companion diagnostic tests
- e. Developing new educational content in concert
- The PPWG executive committee has developed and successfully completed a Request for Proposal (RFP) entitled “The Imprecision under the Hood of Precision Medicine: What Is It Costing Us?”. The research will assess the economic effects of variability in compliance with published recommendations and standards of preanalytical biospecimen practices. Currently, the cost and impact on society, healthcare systems, payers, funders, and patients of the failure to safeguard the molecular integrity of patient samples on which molecular analyses are performed is largely unknown. A greater understanding of the consequences that result from compromised data generated from compromised patient specimens, expressed in financial terms, can help inform process improvement strategies that will generate greater value in healthcare delivery and better outcomes for patients. The PPWG is currently in fund-raising mode to finance this RFP project.
- An international research project on the molecular effects of formalin fixation on DNA, RNA and protein in clinical samples is under development. Research partners include QIAGEN, University of Graz, Austria, the NCI Molecular Pathology Laboratory and the European Center for Genomic Regulation in Spain. The PPWG has the goal of funding this project, publishing the results and using the results to design evidence-based standards of practice for pathology laboratories worldwide.