Audit & Restructure. Gastroenterology Cancer Resource Biorepository. Amanda Tanadinata May 19, 2016

Transcription

1 Audit & Restructure Gastroenterology Cancer Resource Biorepository Amanda Tanadinata May 19, 2016

2 Outline Biorepository Regulation Gastroenterology Project Activities

3 Biorepository Human subject Samples Biorepository/ Biobank

4 Biorepository Human subject Samples Biorepository/ Biobank

5 Biorepository MD BIOREPOSITORY! This is Dr. John

6 Biorepository MD BIOREPOSITORY! This is Dr. John

7 Regulatory Context Regulation 45 CFR Part 46 Subpart A, Protection of Human Subjects Health Insurance Portability and Accountability Act of 1996 (HIPAA) Best Practices International Society for Biological and Environmental Repositories (ISBER) National Cancer Institute (NCI)

8 Regulatory Context Regulation 45 CFR Part 46 Subpart A, Protection of Human Subjects Health Insurance Portability and Accountability Act of 1996 (HIPAA) Best Practices International Society for Biological and Environmental Repositories (ISBER) National Cancer Institute (NCI)

9 Regulatory Context STUDY CONSENT FORM HIPAA FORM Amanda Tandinata 1545 NW 57 th St. Seattle, WA GICaRes 777 5/21/2016 Serum

10 Best Practices: The most effective standard practices Goal: Regulatory Context Highest quality of biospecimen Recommendation Contents: Development models, organization, facilities, operation, quality management, training, documentation

11 Gastroenterology Services 1. Diagnosis 2. Endoscopic treatments 3. Transplant services Research 1. Colon cancer 2. Esophageal cancer 3. Gastric cancer 4. IBD 5. Exploration of new diagnostic methods

12 Gastroenterology Problems QMS

13 Project Activities: Audit Checklist Topic Yes No N/A Comments Section A: Biorepository Development and Operations 1. Was the biorepository developed based on existing local or national models (e.g. Procurement Service, Banking Service, Population-Based Collections, Virtual Repositories)? x GI CaRes is developed as a banking service. Banking involves the storage of samples in anticipation of current and future needs. Banked specimens are received into the repository through agreements with hospitals (DDC) Section B: Organization and Management 1. Does the biorepository have documentation about educational/ technical background (for proof of qualification) for all personnel involved in the biorepository? x However, it is scattered in the department. Some located in histology lab, some in the CTR group.

14 Project Activities: Audit STUDY CONSENT FORM HIPAA FORM Amanda Tandinata 1545 NW 57 th St. Seattle, WA GICaRes 777 5/21/2016 Serum

15 Project Activities: Audit Operation Screening Informed consent Sample collection Sample processing Storage

16 Project Activities: Restructure Workflow

17 Project Activities: Restructure Based on the audit: QMS Quality Management System

18 Project Activities: Restructure Operational Handbook 1. Biorepository Development And Operation 2. Organization And Management 3. Facilities 4. Biospecimen Collection, Processing, Storage, Retreival, And Dissemination 1. Type of specimen to collect 2. Pre-Analytic and Analytic Variables 3. Method 4. Workflow (collection and processing) 5. Biospecimen storage 6. Biospecimen retrieval 7. Shipping 5. Quality Management 1. Quality management system 2. Quality assurance/ control 3. Standard Operating Procedure (SOP) Manual 4. Protocol 5. Consent form 6. Testing 6. Cost Management 7. Safety 8. References

19 Project Activities: Restructure SOP Developed 18 SOPs: QA/QM Labeling Informed consent Collection procedure Processing procedure Storage and mapping Data collection

20 Time s Up! About you: Name: Amanda Tanadinata Department: Medicine, Division of Gastroenterology Contact Information: antuw@uw.edu Twitter/URL: Quick bio: Amanda s program is under SOP even though she s being funded under Dept. of Medicine. She loves dancing, drawing, and going to shows