Learn Why You Need CAP
Accreditation for your Biorepository
Katheryn Shea and Scott Jewell, PhD
Thursday, April 18, 2013
cap.org
The use of quality biospecimens improve
patient outcomes and the quality of research
• 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
Market situation limits biorepositories’ ability
to meet the growing demand for
high-quality biospecimens
Legal
Ethical
High-Quality
Biospecimens
Collection and
Processing
Economical
Technological
© 2013 College of American Pathologists. All rights reserved.
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Accreditation will meet the challenges
faced by biorepositories
• 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.
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Why CAP?
• 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
© 2013 College of American Pathologists. All rights reserved.
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CAP accreditation delivers value
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.
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CAP Accreditation Checklists represent a
collaboration of industry best practices
•
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.
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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.
© 2013 College of American Pathologists. All rights reserved.
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Peers perform CAP inspections
• Equal standing
(pathologist, manager,
etc)
• Scientific resources
• Laboratory
professional
• Ongoing monitoring
• First-hand knowledge
• Offers constructive
feedback peer-to-peer
• New technology
• Education and
improvement
• Gains insight through
interacting with peer
professionals
• Inspectors with
specialty expertise
© 2013 College of American Pathologists. All rights reserved.
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CAP accreditation is a three-year,
continuous cycle of quality
© 2013 College of American Pathologists. All rights reserved.
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Biospecimen Repository Lifecycle
Collect/Process/Inventory/Store
Clinical Study obtains
Informed consent
New research
protocols developed
Search/Request
Biorepository
Ensuring Fit-For-Purpose
Distribute
Publish/Submit to FDA
Analyze
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E IA 3 . 0
.4
A LT
.2
RNA
0
0
20
40
60
80
100
120
140
160
D a y s p o s t - t r a n s fu s i o n
© 2013 College of American Pathologists. All rights reserved.
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Accreditation customized to your
biorepository’s scope of services
• Specimen collection/procurement
• Specimen processing
• Specimen storage
• Specimen distribution and agreements
• Specimen informatics
© 2013 College of American Pathologists. All rights reserved.
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CAP’s
Biorepository
Checklist
© 2013 College of American Pathologists. All rights reserved.
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SAMPLE PAGES
t
Biorepository Accreditation Program
Checklist: Example Requirements
Every patient
deserves the
GOLD
STANDARD…
Biorepository Accreditation
Program Checklist
CAP Accreditation Program
TEMPERATURE MONITORING AND ALARMS
College of American Pathologists
325 Waukegan Road
Northfield, IL 60093-2750
www.cap.org
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.
0
9
.
2
7
.
2
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.
© 2013 College of American Pathologists. All rights reserved.
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SAMPLE PAGES
t
Biorepository Accreditation Program
Checklist: Example Requirements
Every patient
deserves the
GOLD
STANDARD…
Biorepository Accreditation
Program Checklist
CAP Accreditation Program
DNA/RNA EXTRACTION/AMPLIFICATION
College of American Pathologists
325 Waukegan Road
Northfield, IL 60093-2750
www.cap.org
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.
0
9
.
2
7
.
2
 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.
© 2013 College of American Pathologists. All rights reserved.
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Most Common Inspection Deficiencies
2012–2013
• 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
© 2013 College of American Pathologists. All rights reserved.
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We asked you why a biorepository
accreditation program would be valuable*
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.
*Survey conducted by the CAP in
2010 and sent to biorepository
leaders in the US
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Ongoing Status as a CAP Accredited
Biorepository
Photo courtesy of Precision Bioservices
• 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
© 2013 College of American Pathologists. All rights reserved.
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For questions or to request an application:
Email: Biorepository-accreditation@cap.org
cap.org