1. [TAILOR AN INTRODUCTION TO YOUR SPECIFIC AUDIENCE
[TAILOR AN INTRODUCTION TO YOUR SPECIFIC AUDIENCE. TELL THEM YOU ARE GOING TO:]  Define the problem  Talk about the development of a solution  Describe the process to make it happen
Learn Why You Need CAP Accreditation for your Biorepository Katheryn Shea and Scott Jewell, PhD Thursday, April 18, 2013

2. 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.
[SPEAKER NOTES:]  Science-driven work in support of a medical mission – goals we share with you
 Standardization of best practices  Ability of biorepositories to measure quality
 Improved confidence in and utility of biospecimens
 Your work and ours ultimately benefit patients
[SAMPLE SCRIPT:]
Science-driven, evidence-based work like yours and ours supports a larger medical mission: these key themes underscore nearly every point of our discussion today. Standardization of best practices. The ability of biorepositories to measure quality. Improved confidence in and utility of biospecimens. And, ultimately, improved patient outcomes.
We (at the CAP) believe accreditation of biorepositories will promote the consistent application of best practices and evidence-based standards, will drive the adoption of standards and will build greater confidence in the quality and consistency of biospecimens – thus enabling more rapid use and greater impact of personalized medicine.
© 2013 College of American Pathologists. All rights reserved.

3. High-Quality Biospecimens Collection and Processing
Market situation limits biorepositories’ ability to meet the growing demand for high-quality biospecimens
High-Quality Biospecimens
Legal
Ethical
Economical
Technological
Collection and Processing
Insert some of the challenges that limit.
Another key importance is clinical annotation of the biological specimen itself. SOPs are critical components.
Lack of standardization across institutions is a key challenge. Multi-site collections. Local site challenges as well as multi-institutional challenges. Impact on consensus protocols. Example: BAL collections. BM collections. Even the diameter can have an impact some that may be not apparent.
Interject those industry detractors of relevance that negatively impact research to obtain samples. Purpose to set the stage/problem that accreditation will prove to affect later in the presentation.
Consider Importance of biospecimens – quantity and quality
© 2013 College of American Pathologists. All rights reserved.

4. 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
Goal to link the stated values with overcoming the industry challenges.
[SAMPLE SCRIPT:]
Research, personalized medicine, and the curing of disease all depend on access to quality biospecimens. Differing practices – even when rigorous within themselves – limit the industry’s ability to share like information that could lead to attainable progress in biospecimen science and medicine. In short, biorepository accreditation is needed to improve patient outcomes.
© 2013 College of American Pathologists. All rights reserved.

5. 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
Past: CAP faced similar challenge 50 years ago  Laboratories lacked universal quality standards  Oversight by third-party needed  Solution was accreditation
Present:  Gold Standard  CAP accredits 7,000 laboratories  Many handle blood, tissue, embryos, other biological materials  Peer inspection model proven effective for accreditation – first for laboratories, now for biorepositories
[SAMPLE SCRIPT:]
Over 50 years ago, The College of American Pathologists was facing a challenge remarkably similar to that of biorepositories today. Medical laboratories lacked universal standards against which to measure quality; oversight by an objective third-party was needed; and the stage was set for the solution of accreditation.
Today, the CAP accredits over 7,500 laboratories, many of which handle blood, tissue, embryos and other biological materials. We are clearly positioned to lead the way in accreditation of biorepositories. In fact, we will rely on our proven processes and systems to do so, the centerpiece of which is our peer inspection model.
Nobody knows any industry better than its own practitioners. This is the insight behind the development of a network of peers in a given specialized field – first laboratories, now biorepositories – to evaluate and support one another’s adherence to best practices. It is clear that the time has come to apply the CAP’s peer inspection model to the biorepository industry.
© 2013 College of American Pathologists. All rights reserved.

6. 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
**Please address the hierarchy** This is a good slide to spend some time on.
1st time right. Regardless of segment
© 2013 College of American Pathologists. All rights reserved.

7. CAP Accreditation Checklists represent a collaboration of industry best practices
The CAP Biorepository Accreditation Program integrates rigorous biorepository guidelines and best practices from:
International Society for Biological and Environmental Repositories, third edition
NCI’s Office of Biorepositories and Biospecimen Research
Organization for Economic Co-Operation and Development
Center for Medicare & Medicaid Services
College of American Pathologists
Mention the involvement of the working group’s role in developing the checklist.
Mention the balancing act of incorporating the “right” level of requirement… not too simple that it could not achieve quality.. But not too high, that most biorepositories could not attain the requirements…
© 2013 College of American Pathologists. All rights reserved.

8. 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.

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
Scientific resources
New technology
Ongoing monitoring
Education and improvement
Gains insight through interacting with peer professionals
© 2013 College of American Pathologists. All rights reserved.

10. CAP accreditation is a three-year, continuous cycle of quality
Switching gears now to process….
After they your application is received and processed conference to address and questions and determine the set of readiness. Avoid surprises. Want to make sure they succeed.
Interactive –
Checklist update on annual basis to make sure people are aware of any new requirements/standards ) continuously improving
Overall timeframe 3-6 months from application submission to the 1st inspection based on your state of readiness.
Make sure to discuss quality monitors with self assessment
© 2013 College of American Pathologists. All rights reserved.

11. Biospecimen Repository Lifecycle
Collect/Process/Inventory/Store
Search/Request
Clinical Study obtains
Informed consent
[SPEAKER NOTES:]  Potential problems at every stage, from patient consent and specimen collection through sample release and scientific analysis  Accreditation designed to address them
[SAMPLE SCRIPT:]
A given specimen can pass through a long and complex chain of handlers in its journey from patient consent and collection to sample release and scientific analysis. A breakdown in proper handling or consistent annotation at any single point can render a viable specimen’s quality “unknown”.
This can happen before it ever reaches your facility. Or while it’s there.
Variables that alter specimens’ molecular structure may be present at any stage of handling or storage. Identification of these variables is crucial; accreditation is designed to address this, so you can take appropriate corrective action.
Biorepository
Ensuring Fit-For-Purpose
New research
protocols developed
Distribute
Publish/Submit to FDA
Analyze
© 2013 College of American Pathologists. All rights reserved.

12. Accreditation customized to your biorepository’s scope of services
Specimen collection/procurement    
Specimen processing                              
Specimen storage             
Specimen distribution and agreements             
Specimen informatics
Customizable and accreditation covers your services
© 2013 College of American Pathologists. All rights reserved.

13. CAP’s Biorepository Checklist
Purpose to show the extent of the checklist topics covered
Very nimble - Evolving based on inputs from participating laboratories and experts
© 2013 College of American Pathologists. All rights reserved.

14. Biorepository Accreditation Program Checklist: Example Requirements
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.
Viewpoint that accreditation is about technology that we may not think are critical.
Detail is unknown.
Just another example of the level of detail. Checklists are prescriptive and serve as a blueprint of quality.
© 2013 College of American Pathologists. All rights reserved. 14

15. Biorepository Accreditation Program Checklist: Example Requirements
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.
point out how Evidence of compliance guides the inspection
Provides the requirement but doesn’t dictate HOW compliance must be done.
Important about how to QC material to know you have a good prodcut.
It is not dictorial. It is not. Process must be in place and be following them.
© 2013 College of American Pathologists. All rights reserved.

16. Most Common Inspection Deficiencies 2012–2013
Documentation/Evidence
SOPs
Personnel training and competency assessment files
Instrument checks
Collection and storage times documentation
Quality management and safety
Completeness of the Quality Management plan
Personnel use of proper PPE   
Mechanism for periodic assessment of the of stored quality of stored specimens
Established specimen exception criteria
Policies matching practices
Interaction with CAP staff.
© 2013 College of American Pathologists. All rights reserved.

17. We asked you why a biorepository accreditation program would be valuable*
Accreditation provides and affects many aspects of work such as;
Establishes a level of competence and standardization
Creates institutional awareness among senior management of the value for personnel training and infrastructure investment
Improves funding opportunities
Personal Experiences
Checklist requirements are specific to biorepository operations rather than quality practice guidelines that require interpretation
Peer review process provides for inspectors that are experienced in a biorepository environment
Educational focus unique to CAP program
Independent measure to objectively evaluate our strengths and weaknesses.
Quality Management Program
Improve personnel performance
This slide is intended to have a conversation around.
Cost to value experience. Cost not to be accredited. Documentation streamlines cost. First time right. No rework. Standardization
*Survey conducted by the CAP in 2010 and sent to biorepository leaders in the US
© 2013 College of American Pathologists. All rights reserved.

18. Ongoing Status as a CAP Accredited Biorepository
[SPEAKER NOTES:]  Commercial benefits as well as contributions to patient care
[SAMPLE SCRIPT:]
Establishing your institution at the leading edge of biorepository accreditation will have broad and far-reaching benefits, both as a commercial entity and as a contributor to the advancement of biospecimen science and the resultant improvement of patient outcomes.
Photo courtesy of Precision Bioservices
High-quality standards are verified
Quality biorepository standards establish a foundation for institutional support
Marketable –
CAP accreditation certification mark is a marketing tool
Recognition and trust in your quality practices
© 2013 College of American Pathologists. All rights reserved.

19. For questions or to request an application: Email: Biorepository-accreditation@cap.org