AUDIT AND RESTRUCTURE OF THE GASTROENTEROLOGY CANCER RESEARCH BIOREPOSITORYAmanda TanadinataJuly 9, 2016

TOPICS Project background Project description Regulatory context Project activities Work products Summary

PROJECT BACKGROUND University of Washington Department of

Medicine, Division of Gastroenterology Service Research

PROJECT BACKGROUND GICaRes Biorepository

Human Human samplesBiorepository

PROJECT BACKGROUND GICaRes approved in 2008 Operational disarray:

No quality management system (QMS) SOPs were not implemented/ outdated Disorganized data management Inefficient workflow

PROJECT DESCRIPTION Endpoint formalize the biorepository

operations based on ISBER and NCI

Audit operation and facilities

Restructure documentation of policies and procedures creation of operational handbook, and set of SOPs

REGULATORY CONTEXT Best Practices most effective practices

International Society for Biological and Environmental Repositories (ISBER)

National Cancer Institute (NCI)

Goal to achieve highest quality of biospecimen

Content Guidelines biorepository operation/ good

practice Used to create audit checklist, operational

handbook and set of SOPs.

REGULATORY CONTEXT Government regulation 45 CFR Part 46 Subpart A, Protection of

Human Subjects biorepository study needs to be approved by an

IRB retain informed consent from all subjects

REGULATORY CONTEXT Government regulation Health Insurance Portability and

Accountability Act of 1996 (HIPAA) Protect private health information about patients

GICaRes entity covered by the rules Addition from signing consent form, need to sign

HIPAA form

REGULATORY CONTEXT HIPAA continues

Subject ID de-identified, labeled with a unique barcode and patient’s research study code.

REGULATORY CONTENT ISO 9001 International Organization for

Standardization quality management standard

FDA 21 CFR 820: Quality System Regulation

These two will be used as models for creating the GICaRes operational handbook

PROJECT DESCRIPTIONEnvironment GICaRes

Overall oversight Principal Investigator 2 managers co-join with GI histology lab 1 research coordinator screen, consent patient,

and collect samples 2-3 technician process and store samples

Samples blood, buccal, tissue, brushings

Storage 2 different freezers, in case one fails

PROJECT DESCRIPTIONActivities Audit checklist created by combining topics

from the ISBER and NCI standards ISBER used as core more comprehensive and

has better structure NCI addition of topics not discussed by ISBER Deletion of topics that are not relevant to

GICaRes

PROJECT DESCRIPTION: AUDIT CHECKLIST TOPICS1. Repository planning consideration2. 3. Facilities4. Storage equipment and environments5. Quality management6. Safety7. Training8. Records management9. Cost management10.Biological material tracking11.Packaging and shipping12.Specimen collection, processing, and retrieval13.Legal and ethical issues for biospecimens14.Specimen access, utilization, and destruction

biorepository development & operations

organizations & management

PROJECT DESCRIPTION Audit findings1. Facilities OK2. Storage equipment and environments OK

for equipment, not for storage container3. Quality management Not OK

WorkflowResearch coordinator• screens and collects samples• generates labels for aliquots

Lab technician• aliquots samples• labels aliquots

• extra labels needed

Additional labels generated only by research coordinator

PROJECT DESCRIPTION Restructuring1. Recommendation based on the audit

finding: New workflow

Research coordinator• screens and collects samples• generates labels for aliquots

Lab technician• aliquots samples• labels aliquots

• extra labels needed

Research coordinator• screens and collects samples• generates labels for aliquots

Lab technician• aliquots samples• labels aliquots

• extra labels needed

Original workflow

Additional labels generated only by research coordinator

Additional labels can be generated by lab technician

New workflow

PROJECT DESCRIPTION2. Creation of GICaRes operational handbook

Created as the mainframe of the QMS Modeled based on ISO 9001 and 21 CFR 820

3. Creation of set of SOPs Based on NCI and ISBER best practice Essential components of SOP title, number,

date, version, and purpose.

WORK PRODUCTS Audit Checklist Audit Report formal letter format GICaRes Operational Handbook Set of SOPs

WORK PRODUCT Audit Checklist

WORK PRODUCT GICaRes Operational Handbook1. Biorepository development and operation2. Organization and management3. Facilities4. Biospecimen collection, processing, storage,

retrieval, and dissemination5. Quality management6. Cost management7. Safety8. Appendix

WORK PRODUCT Set of SOPs

1. QA/QM2. Labeling3. Informed consent4. Collection procedure5. Processing procedure6. Storage and mapping7. Data collection

SUMMARY GICaRes is more organized and more in line

with biorepository standards.

Learning objectives Having completed this project, I am now able

to Prepare a checklist and perform an internal audit

for a biorepository laboratory. Develop an operational handbook and set of

SOPs for a biorepository laboratory. Describe standards for biorepository operation.

ACKNOWLEDGEMENT I’d like to thank: University of Washington Department of

Medicine, Division of Gastroenterology Dr. William Grady (preceptor) Greg Cruikshank (preceptor) GICaRes team (Evelynne Bautista, Kimberly

Anderson, Wynn Burke, Megan Maass) Jean Feagin and Floyd Karp

BRAMS 2016 cohort.

QUESTION ?