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cap.org Learn Why You Need CAP Accreditation for your Biorepository Katheryn Shea and Scott Jewell, PhD Thursday, April 18, 2013
Biological cellular pathways respond to change while biospecimens are being processed. The severity of the change is dependent on the length or degree of the processing. Well-managed collection procedures and biorepositories promote effective use and long-term storage of biological materials needed to support research and health care. Technologic advances in personalized medicine, outcomes management and genetic interpretation require high-quality biospecimens. Molecular diagnostics require quality biospecimens. The importance of assurance in the management, of quality biospecimens is accelerating. © 2013 College of American Pathologists. All rights reserved.2 The use of quality biospecimens improve patient outcomes and the quality of research
© 2013 College of American Pathologists. All rights reserved.3 Market situation limits biorepositories’ ability to meet the growing demand for high-quality biospecimens High-Quality Biospecimens Legal Ethical Economical Technological Collection and Processing
Establishes an organized and national measure of evaluation Validates biorepository practices to ensure the quality of biospecimens Establishes processes to have continuous oversight Establishes a competitive advantage Promotes advances in biorepository science and basic and translational research, leading to better patient outcomes © 2013 College of American Pathologists. All rights reserved.4 Accreditation will meet the challenges faced by biorepositories
50-year track record of success and leadership in the accreditation industry Proven peer-inspector model combines scientific biorepository expertise with third-party validation of standards 7,500 global CAP-accredited customers, many that handle biospecimens Prescriptive accreditation requirements offer a roadmap to quality practices Regarded by the industry as the leading experts in accreditation Why CAP? © 2013 College of American Pathologists. All rights reserved. 5
Improve patient outcomes Advance science Marketability/Competitive Edge/Credibility Standardize & Strengthen practice Meet customers’ requirements; preferred by funders High-quality biospecimens © 2013 College of American Pathologists. All rights reserved.6 CAP accreditation delivers value
The CAP Biorepository Accreditation Program integrates rigorous biorepository guidelines and best practices from: o International Society for Biological and Environmental Repositories, third edition o NCI’s Office of Biorepositories and Biospecimen Research o Organization for Economic Co-Operation and Development o Center for Medicare & Medicaid Services o College of American Pathologists © 2013 College of American Pathologists. All rights reserved.7 CAP Accreditation Checklists represent a collaboration of industry best practices
CAP Inspector/Peer Model The inspectors comprise pathologists, PhDs, or managers of biorepositories (typically with a medical technology, biomedical background). Most critical is their current experience in an active biorepository. Inspectors may be qualified through a CAP training program. During early program development, CAP staff inspectors will supplement peer inspectors to aid in uniformity and quality assessment. One to two inspectors will inspect most biorepositories. 8© 2013 College of American Pathologists. All rights reserved.
9 Peers perform CAP inspections Equal standing (pathologist, manager, etc) Laboratory professional First-hand knowledge Offers constructive feedback peer-to-peer Inspectors with specialty expertise © 2013 College of American Pathologists. All rights reserved. Scientific resources New technology Ongoing monitoring Education and improvement Gains insight through interacting with peer professionals
CAP accreditation is a three-year, continuous cycle of quality © 2013 College of American Pathologists. All rights reserved.10
Biospecimen Repository Lifecycle © 2013 College of American Pathologists. All rights reserved.11 Biorepository Ensuring Fit-For-Purpose Collect/Process/Inventory/Store Search/Request Publish/Submit to FDA Analyze Distribute Clinical Study obtains Informed consent New research protocols developed
Specimen collection/procurement Specimen processing Specimen storage Specimen distribution and agreements Specimen informatics © 2013 College of American Pathologists. All rights reserved.12 Accreditation customized to your biorepository’s scope of services
CAP’s Biorepository Checklist 13© 2013 College of American Pathologists. All rights reserved.
14© 2013 College of American Pathologists. All rights reserved. Biorepository Accreditation Program Checklist: Example Requirements 14 TEMPERATURE MONITORING AND ALARMS BAP NIST Thermometer Phase II An appropriate thermometric standard device of known accuracy (eg, guaranteed by manufacturer to meet NIST Standards) is available. NOTE: Thermometers should be present on all temperature-controlled instruments and environments and checked daily. Thermometric standard devices should be recalibrated or recertified prior to the date of expiration of the guarantee of calibration; documentation of recalibration/certification should be maintained for review. BAP Non-Certified Thermometers Phase II All noncertified thermometers in use are checked against an appropriate thermometric standard device before initial use. BAP Alarm System Monitoring Phase II There is a mechanism for monitoring the alarm system. BAP Alarm System Contingency Plan Phase II There is a contingency plan in place for monitoring if the alarm system fails. Note: downtime procedures should exist and staff should be trained on these procedures. This contingency procedure should be periodically tested.
Biorepository Accreditation Program Checklist: Example Requirements 15© 2013 College of American Pathologists. All rights reserved. DNA/RNA EXTRACTION/AMPLIFICATION BAP Nucleic Acid Quantity Phase II The quantity of nucleic acid is measured. NOTE: The quantity of nucleic acid must be measured prior to use by a standard procedure that allows for the accurate determination of the concentration/quantity of the nucleic acid. Evidence of Compliance: Records detailing the concentration and yield of nucleic acid per specimen, per extraction BAP Specimen Identification Phase II There is a system to positively identify all participant specimens, specimen types, and aliquots through all phases of the analysis, including specimen receipt, nucleic acid extraction, nucleic acid quantification, hybridization, detection, documentation, and storage. BAP Isolation/Preparation Procedures Phase II The adequacy of nucleic acid isolation/preparation procedures is evaluated. NOTE: Adequacy of nucleic acid isolation/preparation procedures (manual or automated) must be evaluated through the use of periodic positive controls. To the extent possible, controls must be processed through all steps of the assay, including the extraction phase.
Documentation/Evidence o SOPs o Personnel training and competency assessment files o Instrument checks o Collection and storage times documentation Quality management and safety o Completeness of the Quality Management plan o Personnel use of proper PPE o Mechanism for periodic assessment of the of stored quality of stored specimens o Established specimen exception criteria Policies matching practices Most Common Inspection Deficiencies 2012–2013 © 2013 College of American Pathologists. All rights reserved.16
Accreditation provides and affects many aspects of work such as; o Establishes a level of competence and standardization o Creates institutional awareness among senior management of the value for personnel training and infrastructure investment o Improves funding opportunities Personal Experiences o Checklist requirements are specific to biorepository operations rather than quality practice guidelines that require interpretation o Peer review process provides for inspectors that are experienced in a biorepository environment o Educational focus unique to CAP program o Independent measure to objectively evaluate our strengths and weaknesses. o Quality Management Program o Improve personnel performance © 2013 College of American Pathologists. All rights reserved.17 We asked you why a biorepository accreditation program would be valuable* *Survey conducted by the CAP in 2010 and sent to biorepository leaders in the US
Ongoing Status as a CAP Accredited Biorepository High-quality standards are verified Quality biorepository standards establish a foundation for institutional support Marketable – o CAP accreditation certification mark is a marketing tool o Recognition and trust in your quality practices 18© 2013 College of American Pathologists. All rights reserved. Photo courtesy of Precision Bioservices
For questions or to request an application: cap.org
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