Published on September 29, 2011
Contact: Joe Schramm
Phone: 800-323-4040, ext. 7445
CAP MOVES FORWARD WITH NEXT GENERATION SEQUENCING INITIATIVES
NORTHFIELD, ILL. — The College of American Pathologists (CAP) is actively engaged in updating its Laboratory Accreditation Program (LAP) molecular pathology checklist to include clinical application of genomic analysis, more specifically next generation sequencing (NGS), to prepare its laboratory customers for advancements in genomic testing.
The CAP checklists are used in the accreditation inspection process to help laboratories meet Centers for Medicare and Medicaid Services (CMS) requirements. CMS regulates all human clinical laboratory testing, other than research and clinical trials, in the United States through the Clinical Laboratory Improvement Amendments (CLIA). The CAP accredits more than 7,000 laboratories in the United States and abroad.
As pathologists have the training to provide medical direction of NGS testing, the CAP is actively developing laboratory accreditation content for NGS clinical applications, covering technical, bioinformatics, and interpretative methods to report findings. It plans to engage other professional organizations, such as the American College of Medical Genetics (ACMG) and Association for Molecular Pathology (AMP), in content development.
Earlier this year, the Food and Drug Administration (FDA) held a meeting to begin gathering comments on NGS regulation. In its comments following the meeting, the CAP urged the FDA to actively engage pathologists as NGS moves from research settings to clinical use to ensure appropriate medical use and patient safety.
“The CAP has provided molecular pathology checklists and has accredited molecular laboratories for more than 18 years. Pathologists have the training and practical experience with the clinical needs and regulatory requirements of clinical laboratories to assist the FDA to reach our common goal of assuring that genomic analysis using NGS platforms is applied safely and effectively in clinical care,” said David L. Booker, MD, FCAP, Chair of the CAP’s Council on Accreditation, and Chair, Pathology Department, Trinity Hospital, Augusta, Georgia. “The successful transition of NGS from the research setting to patient care requires that this testing meet the quality standards of clinical laboratories.”
At the FDA meeting, participants stated that CLIA provides the necessary framework to assure quality laboratory testing through its accreditation requirements. CLIA requires assessment of analytical validity for all of a laboratory’s assays regardless of whether they are regulated. The CAP’s accreditation program supports rigorous attention that goes beyond CLIA standards of quality and practice.
The CAP’s efforts to further clinical adoption of NGS go beyond accreditation and will include:
- Further expansion of proficiency testing products in molecular genetics and expansion into appropriate challenges for NGS.
- Standards development and implementation. The CAP supports and continues to work with other organizations, including ACMG, AMP and Health Level 7 (HL-7), to develop standards for reporting genetic variants, for their interpretation for clinical use, and for interoperability of results in healthcare information systems.
“The CAP’s work in accreditation, proficiency testing and standards ensures that laboratories implement and maintain quality processes covering pre-analytic, analytic and post-analytic methods to deliver reliable results for use in patient care,” said Karl V. Voelkerding, MD, FCAP, Professor of Pathology, University of Utah, and Medical Director for Genomics and Bioinformatics, ARUP Laboratories, Salt Lake City, Utah. Dr. Voelkerding chairs the CAP’s NGS Working Group that is developing the accreditation checklist. “As the CAP did with its PT and accreditation programs, the College is proactively moving forward in producing quality metrics for forthcoming clinical use in the burgeoning field of genomics.”
The updated molecular pathology checklist is estimated to be released in 2012.
The College of American Pathologists (CAP) is a medical society serving about 17,000 physician members and the laboratory community throughout the world. It is the world’s largest association composed exclusively of pathologists and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high quality and cost-effective patient care.