cap.org learn why you need cap accreditation for your biorepository katheryn shea and scott jewell,...
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Learn Why You Need CAP Accreditation for your Biorepository Katheryn Shea and Scott Jewell, PhDThursday, 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.
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The use of quality biospecimens improve patient outcomes and the quality of research
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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
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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?
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Improve patient outcomes
Advance science
Marketability/Competitive Edge/Credibility
Standardize & Strengthen practice
Meet customers’ requirements; preferred by
funders
High-quality biospecimen
s
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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
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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.
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Peers perform CAP inspections• Equal standing
(pathologist, manager, etc)
• Laboratory professional
• First-hand knowledge
• Offers constructive feedback peer-to-peer
• Inspectors with specialty expertise
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• 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
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Biospecimen Repository Lifecycle
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BiorepositoryEnsuring Fit-For-Purpose
Collect/Process/Inventory/Store
Search/Request
Publish/Submit to FDA
RNA
0
.2
.4
.6
.8
1
Cum
. Sur
vival
0 20 40 60 80 100 120 140 160Days post-transfusion
EIA 3.0
ALT
Analyze
Distribute
Clinical Study obtainsInformed consent
New research protocols developed
• Specimen collection/procurement
• Specimen processing
• Specimen storage
• Specimen distribution and agreements
• Specimen informatics
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Accreditation customized to your biorepository’s scope of services
CAP’sBiorepository Checklist
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Biorepository Accreditation Program Checklist: Example Requirements
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TEMPERATURE MONITORING AND ALARMS
BAP.08900 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.09000 Non-Certified Thermometers Phase II All noncertified thermometers in use are checked against an appropriate thermometric standard device before initial use.
BAP.10100 Alarm System Monitoring Phase II There is a mechanism for monitoring the alarm system.
BAP.10200 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
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DNA/RNA EXTRACTION/AMPLIFICATION
BAP.04800 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.04500 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.04600 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/Evidenceo SOPso Personnel training and competency assessment fileso Instrument checkso Collection and storage times documentation
• Quality management and safetyo Completeness of the Quality Management plano Personnel use of proper PPE o Mechanism for periodic assessment of the
of stored quality of stored specimenso Established specimen exception criteria
• Policies matching practices
Most Common Inspection Deficiencies 2012–2013
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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
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We asked you why a biorepositoryaccreditation 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
