HIPAA, Tissue Banking, and Data Aggregation: New Tools to Solve Old Problems

1. HIPAA, Tissue Banking, and Data Aggregation: New Tools to Solve Old Problems Rajiv Dhir, M.D. Director, Health Sciences Tissue Bank Ashokkumar A. Patel, MD Data Manager, Health Sciences Tissue Bank

2. Key Objective Reveal methods for developing a Collaborative Honest Broker Service in the Informatics environment to support: Tissue Banking Research Information Services Clinical Trials Research Outcomes Analysis

3. Agenda • Introduction – The Need for Collaboration • Define Honest Broker Services • Identify Need for Honest Broker Services • Define the Process for Developing a Collaborative Honest Broker Service • Review of a Data Request Tracking Tool • Examples of De-Identification Processes • Current Status and Future Direction

4. Tissue Banking: implies banking of tissue and biological specimens Pathology: the study of tissue for the presence and nature of disease Genomics, tissue engineering, modern biology has generated an unprecedented demand for qualified tissue for research Access to qualified tissue is more important than ever before IntroductionThe Importance of Tissue

5. IntroductionThe Importance of Tissue • Tissue is rare and coveted, hard (& expensive) to manage, manipulate and store • Tissue needed in different flavors • Frozen tissue and biological materials • Paraffin tissue • TMA construction • New techniques allow tapping into archival repositories • Pathology should be driving tissue banking across the entire health system!

6. The many roles of the tissue bank • Pro-actively acquiring research samples and banking samples • Inventory management and sub-sampling tissue • Managing Consents and IRB • Honest broker activities • Annotating information

7. The many roles of the tissue bank • Pro-actively acquiring research samples and banking samples • Inventory management and sub-sampling tissue • Managing Consents and IRB • Annotating information • Honest broker activities

8. Tissue Bank Workflow • Current Workflow of the Tissue Banking Patient consented. Pt. in OR for surgery. Tech. paged Tissue labeled, annotated and stored. Specimen brought to Pathology Tissue collected for research & clinical

9. Tissue Bank initiatives and Issues • Acquire tumor/ normal pairs with minimal warm ischemia • Donor tissue • Warm Autopsy program • Blood and biological specimen collection • Project focused collection (special consent forms) • Aberrant crypt foci (EDRN project). • Carinal biopsy (Lung SPORE) • Freezers

10. QA Standards and Protocols • We do not triage tissue for processing of DNA/ RNA/ protein up front • Changing needs every year • Provide fresh tissue • Do not process tissue for clients • Every investigator has own best practices • Focus on minimal “warm ischemia” time • Recorded in the Tissue Bank.

11. Tissue Banking - Role of the Bank • Specimen Documentation, Pathology examination and Sampling & QA/ QC • Tissue frozen/ triaged for cell culture • Macro and Micro-dissection (LCM) • Tissue Microarrays • Whole Slide Imaging

12. The many roles of the tissue bank • Pro-actively acquiring research samples and banking samples • Inventory management and sub-sampling tissue • Managing Consents and IRB • Honest broker activities • Annotating information

13. Inventory/ bar coding • Provide an efficient system for • Recording specimen acquisition. • Tracking of specimen storage and usage. • Linked to other systems with additional annotating information. • Provides tools for an electronic mechanism for setting limits on specimens. • Last specimen/ for specific end user or project etc. • De-Id/ HIPAA

14. Inventory management • Categorize and flag samples based on perceived value (primary and associated metastatic samples much more valuable) • Bar coding and Web based Inventory tracking system • Three flagship hospitals and the Cancer Institute and approximately 20 freezers • Query capability • Can place restrictions on amount of information an individual can access

15. Inventory management • Currently using system developed in-house. • Moving to Ca Tissue Core for future management of the inventory • Submitted a proposal in response to the RFA for “Testing sites”.

24. The many roles of the tissue bank • Pro-actively acquiring research samples and banking samples • Inventory management and sub-sampling tissue • Managing Consents and IRB • Honest broker activities • Annotating information

25. The IRB related role of the Bank • Tissue Bank Director HAS to be very cognizant of issues pertaining to consenting/ IRB/ ethics/ Patient Consent • The bank should take the lead in developing a uniform consent for banking tissue and fluid • Specialized consent forms

26. Policy and Procedures • Tissue request form with details of specimen and annotating data requirement. • IRB approval as well as IRB submissionneeded for complete assessment of protocol. • Feedback to requesting investigator with anticipated time needs to fulfill request.

27. The many roles of the tissue bank • Pro-actively acquiring research samples and banking samples • Inventory management and sub-sampling tissue • Managing Consents and IRB • Honest broker activities • Annotating information

28. Honest Broker • Purpose • De-identification • Honest research • Functioning • Tissue banker has the linkage codes • Strips identifiers (de-identifies) • Provides additional clinical/ pathology information • Should not be a co-investigator on that project • Maybe invest in a dedicated honest broker (volume dependent)

29. IRB Issues • Who has access to identified data • Clinical usage • Research use only after de-identification • IRB for collection of materials is different from IRB for usage. • Any research use of collected materials has to have prior IRB approval • New OHRP guidelines

30. Tissue Bank Issues and initiatives • IRB initiative • Eliminate need for IRB submission and approval for most research • The role and importance of honest brokers • OHRP memorandum defining human research • IRB needed for new prospective collection initiatives

31. Introduction • Tissue resource IRB approved for tissue collection • Individual investigators need IRB approval when requesting tissue/ data for research use from the tissue resource collection • IRB submission currently is generally in the expedited category, since it involves usage of existing resources

32. “Human Research” • The Federal Policy defines “human subject” research as a process where an investigator conducting research obtains • data through intervention or interaction with the individual OR • identifiable private information

33. New OHRP guidelines • New guidance from the Office of Human Research Protection (OHRP): August 10, 2004 • Research activity involving "de-identified" specimens and data • Would not be considered as research involving human subjects • Would not need specific IRB approval

34. HSTB Current status and relationships • Tissue/ biological specimens collected in two major categories • Consented • Non-consented • Impacts amount of annotating information

35. HSTB Current status and relationships • HSTB is a certified Honest Broker facility • This is a collaborative approval with other important facilities • Cancer registry, Outcomes group, Medical and Radiation Oncology, and Pathology and Oncology Informatics

36. HSTB New initiative • Most investigator requests are for de-identified tissue/ data • Personal identity not needed in almost 100% of cases, in our current experience • Honest broker entity essentially covers all aspects of biological specimen and data needs for researchers

37. HSTB New initiative • Combined capabilities of the HSTB and this honest broker facility should be able to address almost all needs of researchers, in a manner compliant with current legal and ethical considerations, consistent with current OHRP recommendations

38. New initiative: What it means to the researcher • Submit request to the HSTB • HSTB triages request to the TUC for that organ system • Approval should be within a week • Researcher then provided the tissue/ biological specimens/ data with TAT depending on the volume of activity

39. New initiative: What it means to the researcher • The researcher has to sign a usage agreement. • Can not triage material to others (internal/ external collaborations not permissible) • Submit additional request for internal use • External collaboration HAS to be IRB approved

40. When does a researcher need to file an IRB • External collaboration HAS to be IRB approved • Specific focused (non-random) prospective collection • Collection of specimens only for research • The typical specimen in the HSTB is “excess” tissue

41. IRB initiative • Limitation on what is done with the sample • Stays in the Institution • Can not be forwarded to other investigators • Tissue resource provides annual update to IRB • Streamlines research with decreased TAT

42. Paraffin archive issues • Paraffin research is considered exempt • Should involve an honest broker • Institutional policies on access • COE model at UPMC • Can have data annotation via an honest broker

43. De-identification • Ensure removal of identifiers when providing research material. • Can be manual or electronic. • Make copy of report that has been blacked out. • Software tools allow de-identification and enable electronic tracking. • Pathology LIS systems may have De-ID capabilities.

44. HIPAA (Research) Summary • Section 164.514 of HIPAA – “Other requirements relating to the uses & disclosures of protected health information” • Section (b)(2)(i) lists 18 identifiers of individuals or of relatives, employers, or household members to be removed • Section(c) provides implementation specifications for re-identification

45. Names Geographical Locations Dates and Ages Telephone numbers Fax Numbers Email Addresses Social Security numbers Medical Record Numbers Health Plan Numbers Account Numbers Certificate/License Nos. Vehicle Identifiers Device Identifiers URLs IP Numbers Biometric Identifiers Full-Face Images Any Other Identifier The 18 are…

46. De-identification • Co-Path does limited De-ID. • Our own efforts through MARS. • Use an honest broker. • Ongoing joint Project of the Office of Clinical Research and the Center for Biomedical Informatics to • Create a HIPAA complaint engine (De-identification Engine Development).

47. De-identification Engine Development • The engine has been certified by the IRB at University of Pittsburgh and University of Pittsburgh Medical Center (UPMC) Security Office as generating de-identified output from a variety of free text medical reports • Developed in collaboration with Melissa Saul and the Information Services Division

48. De-identification Engine • When a name is identified it is replaced by a name tag and some replacement letters. • When the same person is encountered in multiple places in the same report, the same replacement letters are used for every occurrence. • Dates are replaced by some offset. This offset is calculated as a function of the patients medical record number. • Since the dates are not real, they cannot be used for patient identification.

49. De-ID Report Example S_O_H Counters Record Type 56,38 DS E_O_H [Record de-identified by: de-ID v. 3.25]  CONSULTANTS:  Dr. **NAME<XXX WWW> and Dr. **NAME<VVV UUU>.  REASON FOR ADMISSION: Brief history and physical: Mr. **NAME<AAA> is a **AGE<in 40s>-year-old gentleman,previously healthy, who was working in a cherry picker on a truck hanging banners when he fell from the cherry picker.   HOSPITAL COURSE: He presented to the trauma bay at the **ADDRESS of **ADDRESS with complaints of back pain and left leg pain.

50. Linkage File • Counter created for each patient and each report based on medical record number • Linkage file contains counter plus medical record number and unique document number as stored in MARS (our EMR). • Linkage file is stored on IPS server and not publicly available