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Molecular Assessment Program - MAP

Molecular Assessment Program - MAP. Christopher N. Greene, PhD. Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences NCEH, CDC Tuesday, 28th June 2011. National Center for Environmental Health . U.S. Centers for Disease Control and Prevention.

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Molecular Assessment Program - MAP

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  1. Molecular Assessment Program - MAP Christopher N. Greene, PhD Newborn Screening and Molecular Biology Branch, Division of Laboratory Sciences NCEH, CDC Tuesday, 28th June 2011 National Center for Environmental Health U.S. Centers for Disease Control and Prevention

  2. NBS Molecular Assessment Program (MAP) • Provide quality management guidance and support for molecular testing in NBS laboratories • Partnership between MQIP, NBS laboratories and APHL • Gaps in current CLIA guidelines for molecular testing • CMS does not provide a genetic testing specialty – recommends use of general guidelines for high-complexity tests • Standard regulatory framework does not allow for complexity involved in molecular testing • Rapidly changing field would render CLIA specialty guidance obsolete • Inflexible regulations may prevent use of new technologies • Provide management component for NBS quality improvement program specific for molecular testing

  3. MAP: Molecular Assessment Program Evaluation Phase of Testing Components

  4. NBS Molecular Assessment Program Overview • Detailed assessment criteria is modeled from the following documents: • NNSGRC Performance Evaluation Assessment Scheme (PEAS) • CLIA regulations • Molecular Pathology Checklist (CAP) • Standards and Guidelines for Clinical Genetics Laboratories (ACMG) • Clinical Laboratory Standards of Practice (NYSDOH) • Good Laboratory Practices for Molecular Genetic Testing for Heritable Diseases and Conditions (MMWR)

  5. MAP Evaluation Categories • Assessment categories for evaluation of entire molecular testing process: • Establish mechanism to communicate and transfer molecular testing laboratory best practices

  6. MAP Model

  7. Benefits of MAP • CDC NSMBB • Support for state programs to enhance NBS • Identify the molecular QA/QC needs for NBS • Guide future training and educational opportunities for NBS programs • State NBS Programs • Continual Quality Improvement process • Address specific concerns • Support from stakeholders

  8. Current State of MAP • MAP pilot program • Assessment team • CDC NSMBB • State NBS partners • APHL • Site visits to state NBS laboratories • Wisconsin • New York State • Washington State • Presentation of MAP at APHL NBSGT 2011 meeting

  9. Future of MAP • NBS programs can request MAP visits to start in 2012 • Information for program and program participation will be available through APHL and NSMBB

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