Recomendados
Más contenido relacionado
La actualidad más candente
La actualidad más candente (20)
Similar a Audit and Restructure Gastroenterology Cancer Research Biorepository
Similar a Audit and Restructure Gastroenterology Cancer Research Biorepository (20)
Audit and Restructure Gastroenterology Cancer Research Biorepository
- 1. AUDIT AND RESTRUCTURE OF THE GASTROENTEROLOGY CANCER RESEARCH BIOREPOSITORY Amanda Tanadinata July 9, 2016
- 2. TOPICS Project background Project description Regulatory context Project activities Work products Summary
- 3. PROJECT BACKGROUND University of Washington Department of Medicine, Division of Gastroenterology Service Research
- 4. PROJECT BACKGROUND GICaRes Biorepository Human Human samples Biorepository
- 5. PROJECT BACKGROUND GICaRes approved in 2008 Operational disarray: No quality management system (QMS) SOPs were not implemented/ outdated Disorganized data management Inefficient workflow
- 6. 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
- 7. 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.
- 8. 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
- 9. 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
- 10. REGULATORY CONTEXT HIPAA continues Subject ID de-identified, labeled with a unique barcode and patient’s research study code.
- 11. 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
- 12. PROJECT DESCRIPTION Environment 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
- 13. PROJECT DESCRIPTION Activities 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
- 14. PROJECT DESCRIPTION: AUDIT CHECKLIST TOPICS 1. Repository planning consideration 2. 3. Facilities 4. Storage equipment and environments 5. Quality management 6. Safety 7. Training 8. Records management 9. Cost management 10. Biological material tracking 11. Packaging and shipping 12. Specimen collection, processing, and retrieval 13. Legal and ethical issues for biospecimens 14. Specimen access, utilization, and destruction biorepository development & operations organizations & management
- 15. PROJECT DESCRIPTION Audit findings 1. Facilities OK 2. Storage equipment and environments OK for equipment, not for storage container 3. Quality management Not OK Workflow Research 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
- 16. PROJECT DESCRIPTION Restructuring 1. Recommendation based on the audit finding: New workflow
- 17. 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
- 18. PROJECT DESCRIPTION 2. 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.
- 19. WORK PRODUCTS Audit Checklist Audit Report formal letter format GICaRes Operational Handbook Set of SOPs
- 20. WORK PRODUCT 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.
- 21. WORK PRODUCT GICaRes Operational Handbook 1. Biorepository development and operation 2. Organization and management 3. Facilities 4. Biospecimen collection, processing, storage, retrieval, and dissemination 5. Quality management 6. Cost management 7. Safety 8. Appendix
- 22. WORK PRODUCT Set of SOPs 1. QA/QM 2. Labeling 3. Informed consent 4. Collection procedure 5. Processing procedure 6. Storage and mapping 7. Data collection
- 23. 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.
- 24. 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.
- 25. QUESTION ?
Notas del editor
- Hi everyone, my name is Amanda Tanadinata, and today I am going to talk about my project: Audit and restructure of Gastroenterology Cancer Research Biorepository
- Here are the topics we will discuss today: -Project background for why I did the project -The description of the project -The regulatory context of the project -Project activities for what I did during the practicum -The work products And the summary of my experience
- The practicum took place at the University of Washington Department of Medicine, Division of Gastroenterology (GI) On top of providing service and treatments for patients with GI diseases, the GI division has been involved with a lot of research to improve methods in diagnosing and treating GI diseases.
- In order to support these studies, the division established a Gastroenterology Cancer Resource (GICaRes) biorepository in 2008. The GICaRes biorepository is basically a biobank, a library of biological samples that have been collected from patients and are preserved for current and future research purposes.
- Even though the GICaRes was approved by the UW IRB in 2008, the biorepository was in operational disarray at the beginning of this project. The GICaRes didn’t have a quality management system to ensure high-quality, consistent biospecimens. A lot of the SOPs were not implemented or have not been updated since 2008. A lot of documentation and paper work was disorganized and because the specimen labeling system was not properly established, there was a lot of miscommunication and misunderstanding among personnel, creating inefficiencies in the biorepository workflow..
- Because the GICaRes was “messy”, the endpoint intended for this project was to formalize the biorepository operations according to the ISBER and NCI biorepository guidelines. I’ll explain this in a bit To achieve this, I performed an audit for the GICaRes operation and facilities to assess which areas met the guidelines and which areas need improvements. After the audit, I restructured the GICaRes biorepository by documenting policies and procedures that met the best practices, and suggested changes to other policies that weren't in compliance. A formalized set of operational policies and procedures were compiled into the GICaRes biorepository operational handbook, and I also developed a set of SOPs regarding how to carry out procedures.
- Currently there are no specific government regulations regarding the biorepository operations. However, there are best practice documents established by several organizations. Best practice is known as the most effective practice and has been proven for its credibility. The 2 best practices that I used are from ISBER and NCI. Although there are other organizations that has other biorepository guidelines such as College of American Pathologist, I chose ISBER and NCI because they have been known for their best practices for years. The goal of this best practice is to achieve highest quality of biospecimen. These best practices provide guidelines on how a biorepository should function, what to consider for biorepository operation, and what is needed for good biorepository practice. The ISBER and NCI’s list are very similar, but not quite identical. I will explain more about it later on in the talk. These best practices helped me created the audit checklist, operational handbook, and set of SOPs in my project
- Although biorepository operations are not government-regulated, biorepository activities involving human subjects are regulated. Since GICaRes are collecting human samples, it is regulated under 45 CFR Part 46 Subpart A, protection of human subjects. According to 45 CFR Part 46 Subpart A, the biorepository study that involve human subjects needs to be approved by an IRB. The biorepository also needs to retain informed consent from all subjects participating in the study using the appropriate version of the consent form that has been approved by the IRB. On top of that, biorepository researchers must make sure that every subject understands the study aims, requirements of participation, and potential risks/ consequences before donating. These actions are mandated by the Office of Human Research Protection (OHRP) to protect the rights of human subjects involved in research.
- Another regulation is The Health Insurance Portability and Accountability Act of 1996, or we’ve known it as (HIPAA) privacy rules. The HIPAA privacy rules protect private health information about patients, such that an institution that is subject to the act cannot release any individual’s personal or health information unless the individual agrees to the release. The GICaRes biorepository is an entity that is covered under the HIPAA privacy rule. Therefore, in addition to agreeing to sign the consent form, participating subjects also need to sign the HIPAA authorization form to give permission to the research team to obtain and use their health information.
- In order to follow the HIPAA privacy rules, each subject’s ID will be de-identified and the specimens collected for the project are labeled with unique barcodes as well as with the patient’s research study code number, not with patient names. A file linking code numbers with patient names is maintained, but only a limited number of GICaRes biorepository staff, such as the study’s principal investigator and research coordinators, have access to patient’s information. Performing an audit was helpful to identify whether the GICaRes biorepository is in compliance with these regulations.
- On top of regulation revolving in human subjects, because I wanted to create a quality management system for the GICaRes, I looked up some regulation and guidance for QMS. The two I was using were International Organization for Standardization 9001 or ISO 9001, which is an internationally recognized quality management standard, and FDA’s 21 CFR 820: Quality System Regulation. They both establish criteria which are essential for an effective QMS. They are fairly similar in suggesting what elements are important for having a good QMS. and I chose to have both as my references to reassure the crucial elements for QMS are accurate. These two will be used as models for creating the GICaRes operational handbook with incorporation of the ISBER and NCI best practices topics.
- The project was done at UWMC. The GICaRes is being oversight by the principal investigator, which is also my preceptor, Dr. Grady. There are 2 managers (one for GICaRes and one from GI histology lab) because we are co-joint lab, and the technician comes from histology lab We have 1 research coordinator who does the screening, consent patient, and collect samples. From there, samples are being passed on to the lab technician (2-3 people in rotation) to be processed and stored. The samples collected are blood, buccal, tissue, and brushings, and once processed, they’re all stored in 2 different freezers (in case one fails, the other one serves as backup)
- Because the beginning state of this biorepository was an operational disarray, I had to do an audit before trying to fix anything, to make sure all problems were addressed. In order to do that, I created the audit checklist by combining topics from ISBER and NCI. ISBER’s list of topics was utilized as the checklist core topics because it has more comprehensive materials and has better structure. I also incorporated NCI’s list of topics within the same area of focus. Items mentioned by NCI that were missing in ISBER list were added. For example, ISBER doesn’t specify examples of essential topics for creating a quality manual but NCI does. I added the NCI’s list for quality manual section in my quality management checklist. Points that were mentioned in NCI and ISBER that were not relevant with the GICaRes operation were removed. For example, ISBER has guidelines for dealing with urine samples. GICaRes biorepository does not collect urine samples so that section was not included in the audit checklist.
- From ISBER’s recommended thirteen topics, I divided the first topic, which is the repository planning consideration into two topics. The two topics are biorepository development & operations and organization & management. I believe biorepository development and operation should be a topic of its own because it covers how the GICaRes established as an entity, while the organization and management section covers the GICaRes organization structure and staff responsibilities. This concluded fourteen topics of the audit checklist.
- Here are examples of some audit findings based on my audit: 1. Facilities. ISBER has list of criteria for expected spaces for biorepository operation, and the GICaRes met all the checklist. 2. For storage equipment and environments, I reviewed the storage container used for biospecimens. NCI recommends screw-cap cryovials for long-term, long-temperature storage, and the GICaRes biorepository had been using microcentrifuge pop-up tubes. So it was not ok. 3. Quality Management I found some SOPs in old biorepository computer files. They were written in casual languages, written by multiple people, and never been updated. Not ok. Biorepository workflow was also not efficient. Because the research coordinator have to print aliquotted biospecimen labels in addition to screening and collecting samples. the laboratory personnel also had to call the research coordinator to get more labels if needed so it created jam in the workflow
- After the audit, the next step is to restructure the biorepository. For restructuring, I gave suggestions based on the audit findings. For example, I suggested the GICaRes to have new workflow, because the previous workflow was not efficient.
- As I explained earlier how the action of research coordinator printing labels created jams in the workflow, I suggested for the lab to create and print labels as needed in regards to how much biospecimen the research coordinator collects. My suggestion was welcomed and we did a test of performance on this new workflow for a week to see whether the new workflow increase the efficiency of research coordinators and lab personnel in utilizing their time. It created a smoother workflow between the research coordinator and laboratory personnel, and created better control in biospecimen tracking. This revised workflow was approved and implemented
- I also created GICaRes operational handbook that serves as a quality manual. It provides guidelines for how to satisfy QA/QC objectives, description for roles and responsibilities of all personnel, and their connection within the GICaRes biorepository operation. I modeled the organization of the operational handbook based on the ISO 9001 and 21 CFR 820 elements for QMS, with incorporation of the ISBER and NCI best practices topics, although it only covered the topics relevant to the GICaRes repository. I developed a standardized set of SOPs based on NCI and ISBER best practice. I made sure every SOP fulfills all the essential components of SOP from ISBER and NCI’s list, such as title, number, date, version, and purpose.
- In general, I have four forms of work products, Audit Checklist, Audit Report, GICaRes Operational Handbook, and Set of SOPs. The audit report was made as a formal letter addressed to the responsible manager of the GICaRes biorepository
- The checklist was presented as a table constructed of five columns. Topic, which indicates the audit topic Yes, no, and N/A column so you can mark it as you audit And comments column for additional information during the audit
- The GICaRes operational handbook consisted of policies and procedures about GICaRes operations. This handbook will be used as the mainframe of GICaRes quality management system. Here are examples of the topics covered in the operational handbook. This handbook has 64 pages total.
- This is example of the format of the SOP. It has as title, number, date, version, purpose, and other essential SOP components. I created 18 SOPs total in these categories (point at the 7 categories)
- In summary, I am satisfied with the result of my project. The GICaRes is now more organized and more in line with biorepository standards, although there are still some areas that need to be improved. 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.