HSRD Annual Meeting Baltimore, MD February 12, 2009

1. Research Access to VA DataWorkshop HSR&D Annual Meeting Baltimore, MD February 12, 2009

2. Moderator Denise M. Hynes, PhD, MPH, RN Center Principal Investigator VA Information Resource Center Edward Hines Jr. VA Hospital

3. Panelists Stephen D. Fihn, MD, MPH John Quinn, BA Seth Eisen, MD, MSc Shawn Hardenbrook, MSW, CIPP/IT Linda Kok, MA Stephan Fihn will discuss OQP data and access requirements. John Quinn will present procedures for obtaining access to datasets where access is managed by NDS, e.g., MedSAS, DSS, CDW, MDS and Vital Status. Brenda Cuccherini will discuss ORD procedures for reviewing and authorizing access to VA data containing real SSNs. Shawn Hardenbrook will present current HIA policy and describe efforts to streamline authorization for and tracking of access to national VA databases. Linda Kok will discuss the status and proposed plan for research use of CMS data in the VA. Researchers may discuss their recent experiences and questions about obtaining authorization to use VA data. Stephan Fihn will discuss OQP data and access requirements. John Quinn will present procedures for obtaining access to datasets where access is managed by NDS, e.g., MedSAS, DSS, CDW, MDS and Vital Status. Brenda Cuccherini will discuss ORD procedures for reviewing and authorizing access to VA data containing real SSNs. Shawn Hardenbrook will present current HIA policy and describe efforts to streamline authorization for and tracking of access to national VA databases. Linda Kok will discuss the status and proposed plan for research use of CMS data in the VA. Researchers may discuss their recent experiences and questions about obtaining authorization to use VA data.

4. Research Access to VA Data Workshop Objectives Review current process for research authorization to access/use VA databases Describe initiatives aimed at streamlining the authorization process Target Audience VA researchers who use VA databases Minimum familiarity with VA databases and the distinction between use of real SSN data and data with scrambled SSNs

5. 5 Office of Quality & Performance:Overview & Focus on Data Access Stephan D. Fihn, MD, MPH* Chief Quality & Performance Officer Department of Veterans Affairs

6. 6 Outline Find Us: OQP Website OQP’s Approach Evidence-based Data-driven OQP Functions OQP Roles Data Resources Expansion of Scientific Collaborations Data Use Agreement Processes & Contact Questions

7. 7

8. 8 Roles of OQP Promote transparency, learning & accountability Support evidence-based, patient-centered care and improvements in population health Manage and mitigate risks to population health, safety and professionalism Support continuing development of a high performance health care delivery system

9. 9 Across OQP Functions…Evidence is the Basisfor Clinical Policy

10. 10 OQP Functions Measurement, Analysis and Reporting Performance Measurement System QUERI-OQP Links sought Evidence Based Practice Assessing the Experience of Patients Other clinical quality initiatives Utilization Management & Systems Redesign Quality and Risk Management Peer Review Medical and Professional Staff Processes Expansion of Scientific Collaborations

11. 11 OQP Team Leadership Steve Fihn, Joe Francis, Roxane Rusch, Mark Enderle Programs Evidence-Based Practice: Carla Cassidy Performance Measurement: Tammy Czarnecki Analysis: Steve Wright (acting) Scientific Collaborations: Lynn McQueen C&P: Kate Enchelmayer Accreditation: Dody Tyler Pt. Experience: Risk Management: Yuri Walker Utilization management: Mary Ann Ford Collaborations: ORD, PCS, 10N, PHEH, ONS

12. 12

13. 13 Focus of OQP-ORD Collaboration: Performance Measurement

15. 15 Rationale for Performance Measurement Accelerate introduction of proven interventions e.g., flu vaccine, ß-blockers post AMI Reduce practice variation Move “bad apple” thinking to industrial QI Provide accountability Professional vs Pay-based incentives (Marketing)

16. 16 VA Perspective on PM VA adopted PM in 1996 Initially manual abstraction of clinical data from randomly selected records (EPRP) Evolved to include data from additional sources (SHEP, DSS, VISTA) Multiple domains Reliance largely on audit/feeback, performance contracts w SES Performance contracts with senior leadership

17. Performance Improvement

18. VHA Care Compares favorably with others

19. 19

20. 20 VA Performance Measures, 2009 120 Performance Measures: 81 Clinical 29 Access 7 Functional status 3 Patient satisfaction 193 Supporting Indicators 177 Clinical 11 Access 5 Functional Various other monitors (10N, PCS)

21. 21 Many Other Sources of Primary and Meta-Data IPEC OPES PCS (800 monitors) NSQIP CICSP CART-CL Public & Env. Hlth Women’s Health Occ. Health ONS – VANOD DSS PBM BCMA VSSC

22. 22

23. Executive Briefing Book (EBB)

24. EPRP Performance Cube: Login

25. EBB Facelift using Data Cube

26. 26 ProClarity Cube – Dozens of pre-built Graphical views for the field

27. 27 Changing Focus of OQP-ORD Collaboration: Experiences of Patients Past, Present, and Future

28. 28 HCAHPS CAHPS? Hospital Survey for inpatients HCAHPS Composites: Communication with nurses Communication with doctors Communication about Medications Responsiveness of Hospital Staff Cleanliness and Quietness of the Hospital Environment Pain Management Discharge Information Single Question ratings Overall rating of the hospital (SHEP performance measure) Willingness to recommend hospital

29. 29 Benefits of SHEP Transition Benchmarking with private and other federal healthcare including DoD, TriCare, Medicare Modularization – Most veterans will receive much shorter survey Alignment with DOD promotes seamless transition Will shorten the delay getting fully adjusted and weighted satisfaction information to the field CAHPS is in the public domain

30. 30 Other OQP Functions Utilization Management & Systems Redesign Quality and Risk Management Peer Review Medical and Professional Staff Processes

31. 31 Renewed Focus of OQP-ORD Collaboration: Scientific Collaborations

32. 32 OQP Function:Scientific Collaborations

33. 33 Overview of Scientific Collaborations Major Collaborations Now With ORD, PCS, 10N, PHEH, ONS New emphasis on partnerships Seeking to expand collaborations and facilitate use of data that promotes quality improvement Key Staff: Steve Wright, Dede Ordin, Lynn McQueen, John Strathman, Sharon Goodman

34. 34 Data Use Agreement PolicyData Use Agreement Form

35. 35 Initiating Scientific Collaborations Download Data Use Agreement Policy and Forms from OQP Website Contact Lynn McQueen for informal discussion and guidance DUA forms instructs investigator to return the study protocol and other descriptions, IRB approval or exemption and the DUA form. The DUA Form contains: 1) Project Information Sheet 2) Personal Agreement Statement 3) Data Access List Send all documents to: OQPDUARequest@va.gov (Note: ***Electronic formats are preferred.)

36. 36 OQP Review OQP reviews all reports, publications, and presentations derived from OQP datasets prior to submission or presentation The purpose is to assure accuracy in contextual interpretation The purpose is not to provide a critique or editorial commentary Submit at least ten business days in advance Contact Lynn McQueen to discuss, as needed

37. Conclusion Emphasis on evidence Developing new meaningful, patient-centered measures and data resources Clinically linked Population-based (cohorts) EBB: New approaches to analysis & aggregation Emphasis on improving the delivery model: Episodic/visit-based ? Continuous/ comprehensive Cross-sectional ? Longitudinal Individual ? Bundled Transitioning from SHEP ? HCAHPS Expanding scientific collaborations

38. 38 Questions?

39. Access to VA Data for Research

40. Presentation Topics Data Sources – What’s covered? Obtaining Access or an Extract Required Documentation Process Improvement

41. Data Sources – Access/Extract Common Attribute - Physical Location Austin Information Technology Center Customer User Provisioning System (CUPS) Mainframe SAS Data Sets (VISN or National Real SSN) Medical SAS or Workload Files Inpatient, Outpatient Encounters & Occasions of Service Patient Treatment File Other related data such as Primary Care Management Module DSS National Data Extracts (NDEs) Only for VISN or National Real SSN Vital Status All access, whether scrambled or real SSN BIRLS Death Real SSN access

42. Data Sources – continued VHA Support Service Center and DSS Reports Web based reporting (e.g., ProClarity Data Cubes) VISN or National Real SSN Access Using National Social Security Database (NSSD) for security Corporate Data Warehouse All access Resident Assessment Instrument/Minimum Data Set Database (RAI/MDS) All extracts

43. Functional Task Codes

44. Request a Tracking number from NDS by sending an E-mail to VHA Real SSN Access Requests Mailbox. Include Name of Principal Investigator and exact name of Protocol (Detailed instructions are available on the VA Intranet NDS Web site.) Compile Research Request Package and send documents electronically to VHA Real SSN Access Requests Mailbox Single E-mail is preferable if size allows Scanned documents should be in individual files with the File Name representing the type of document Package cannot be processed if documents are missing Insure the Subject of the E-mail is the complete Tracking Number 9957 forms must be current and on the April 2008 version of the form. Names and Titles of individuals signing the form must be typed and have Wet Signatures approving the access. Single E-mail is preferable if size allows Scanned documents should be in individual files with the File Name representing the type of document Package cannot be processed if documents are missing Insure the Subject of the E-mail is the complete Tracking Number 9957 forms must be current and on the April 2008 version of the form. Names and Titles of individuals signing the form must be typed and have Wet Signatures approving the access.

45. Required Documentation Research Study Protocol Research and Development (R&D) Committee Approval Letter(s) Original one and Current one Research Study Institutional Review Board (IRB) Approval Letter(s) Original one and Current one Sample Informed Consent and HIPAA Authorization, if applicable to the Research Study IRB Approval of Waiver of HIPAA-compliant Authorization, if no Informed Consent is required for the Research Study Signed Privacy Statements DSS Non-Disclosure (if applicable) Vital Status Rules of Behavior (if applicable) Data Use Agreement Approved 9957 forms for each individual accessing/using the data

46. Requirements for Data Access are Multi-Departmental VHA Office of Research and Development Brenda Cuccherini, Ph.D., reviews all requests for national real SSN data. VHA Privacy Office NDS has asked VHA Privacy, Health Information Access, to conduct review of documentation package to ensure meets HIPAA and Privacy Act requirements VHA Security Liaison Office Reviews Data Use Agreements for technical details VA OI&T, Information Security Officer Reviews for technical data transfer/storage VHA National Data Systems Information Custodian VHA Local Management Director, VISN Director, etc

47. NDS Reviews the Research Package Determines if all needed documentation is included (if not Researcher is requested to submit missing documents) NDS sends complete package to VHA Privacy/Security and ORD for review NDS Receives Approvals from ORD & VHA Privacy/Security As Information Custodian, NDS approves the Data Use Agreement NDS Arranges for Access to the data or for an extract to be generated and given to the Data Requestor NDS Tracks and Reviews approved access

48. VHA Real SSN Access Requests (mailbox for requesting Data) VHA Vital Status Access (mailbox for requesting Vital Status File Access only, must have approved protocol and complete Research Documentation Package) VHA Real SSN Access Recertification (mailbox to be used only if you receive a Recertification Notice) VA Intranet NDS Web Site Link for Detailed Instructions and Forms for NDS supported Data Access Requests available on the VA Intranet NDS Web site

49. Process Improvement Rely more on local IRB Fully trained Privacy Officers and ISOs Attach to the new Central IRB Route requests through this oversight group Use IT solution to manage documents and access/extract status Health Information Access Corporate Data Warehouse Suggestions Discuss at end of presentation, conference, or call me or send me email.

50. ORD Data Seth Eisen, MD* Director, Health Services Research & Development *with thanks to Brenda Cuccherini

51. ORD Review What data access requests require ORD review/approval? Real SSN data See functional task code list included on NDS slides VistAWeb

52. ORD Review for Access What is reviewed?  The protocol to ensure that access is really needed.  We have found that the research at times can be done without this specific access.   The IRB and R&D approvals -- ensuring they are valid and current.  For multi-site studies the IRB and R&D approvals should be from all sites if the researchers at the other sites will have access to the SSNs or will also request VistAWeb access.

53. ORD Review for Access What is reviewed, continued…    The HIPAA authorization (or waiver) to ensure that, if granted, the waiver is documented in accordance with HIPAA requirements. Also, if the subject is consented and also signs an authorization the two documents should match and both inform the subject who will have access, where it will be stored, and will it go outside the VA or used for future research.   The consent -- check to see if the IRB waived the requirement for access, if access is needed before the subject is consented.  

54. ORD Review for Access Review criteria for data security plans: Where the data and all copies (electronic or hard copies) will reside, including building & room #, Who will have access to them, Whether any data will be sent out of the VA and if so, a clear indication of the "authority" permitting the release

55. Research Access to VHA Data VHA Health Information Access (HIA) Program

56. HIA PROGRAM OBJECTIVES HIA’s focus is on “special user” access to VA Electronic Health Record (EHR) data. VA Researchers may potentially obtain direct access to VistA medical Records from multiple VistA systems with a single access/verify code. Compensation and Pension Record Interchange (CAPRI) data VistAWeb Requests for extracts involving “real-SSN” by VA Researchers are reviewed by HIA staff for Privacy compliance. HIA can facilitate approval for extracts of VHA data for non-VA researchers.

57. HIA Program Objectives (cont’d) HIA oversees the DUA process for VHA and provides guidance on DUA-related issues. The team provides consultation for those seeking EHR data and aren’t sure how to get it or what’s available. HIA provides consultation to PO’s and ISO’s who sit on local IRB’s.

58. Comparing EHR Options Single sign-on to multiple systems at national level Looks like CPRS Full set of CPRS EHR data is available Search feature to find a specific patient throughout the enterprise Clinical notes can be searched for terms. VistA Imaging integration planned for FY ‘09 Requires installation of a client Access is through Internet browser Looks different from CPRS. Full set of CPRS EHR data is available. No search features. No installation required. No planned support for VistA Imaging

59. Privacy Officer’s (PO) Role In Research Sits on local IRB as non-voting member Reviews protocols for privacy language Verifies for informed consent – “hands on patient” Verifies for HIPAA waiver of authorization – “review of records only” Verifies compliance with Federal Privacy law and VHA policy is maintained in protocol description. Helps create and concur with local DUA’s, when a DUA is deemed necessary Reviews and provides concurrence with DUA’s from national Information Custodians when a DUA is deemed necessary by the IC

60. Data Use Agreement (DUA) In simplest terms, a Data Use Agreement (DUA) is an agreement that governs the sharing of data between an Information Custodian and a requestor. It can be considered a form of contract between a researcher and Information Custodian.

61. Data Use Agreement (DUA) Formerly called a “DTA” (Data Transfer Agreement) when used within VHA. Referred to as “DUA” when used with an Information Custodian outside VHA. “DTA” was a type of “DUA.” “DUA” is now the standard term for all agreements, in and outside VHA. DUA Handbook is in development, expected to be published in Spring 2009. DUA Handbook contains: Decision Tree – Is DUA required or not? Process Tree – How does a DUA get created and approved? Sample DUA templates

62. Data Use Agreement (DUA) General features: Description of data transferred Physical location of the data Method of transport Encryption/security requirements Names of individuals with access rights Statement prohibiting sharing/re-use for other purposes Description of incident reporting Description of destruction requirements Signatures of Information Custodian, Requestor, PO, ISO

63. DUA Decision Tree Keeping it simple, VHA researchers are not required to have a DUA and non-VHA researchers are required UNLESS the requested data is FOIA-able. VHA policy (the DUA Handbook and VHA 1605.1) allows an Information Custodian to use discretion as to whether a DUA is required or not required for VA-funded research. CMS data may or may not require a DUA. The VHA Handbook does not address DUA’s with external IC’s. If an IC requires a DUA, HIA can assist with templates and negotiation of DUA language. HIA assists with national-level concurrences when national IC requires a DUA. HIA tracks all DUA’s for reporting purposes.

64. Expediting Research Requests HIA is developing specifications for a national DUA tracking system DUA tracker may be used by national IC’s to expedite DUA processing A VHA Access Board is being established that will be attended by national IC’s – a conduit for research-related issues to be addressed

65. Research Access to CMS Data Linda Kok Technical & Privacy Liaison VIReC CMS Data Project How many of you have used Medicare or Medicaid data in your research? How many of you have gotten those data from VIReC?How many of you have used Medicare or Medicaid data in your research? How many of you have gotten those data from VIReC?

66. Research Access to CMS Data Status Since January 2007, VIReC has been working closely with CMS, ADUSH-PP, Office of Privacy Compliance Assurance, OGC, ORD, and a Research Advisory Board (RAB) to resume distribution of CMS data for research VIReC is currently unable to process requests for CMS data. Currently, VA researchers cannot obtain CMS data directly from CMS

67. Research Access to CMS Data Proposed Plan MAC and VIReC submit to CMS Privacy Board Review to receive raw data. VIReC releases all available data (merged and raw) under re-use DUA to researchers. Where data is not available from VIReC, researchers purchase and receive the data from CMS in raw form. Oversight within the VA oversight to be determined: Local IRB/ACOS-R, plus VHA Privacy Office? Research Advisory Board? MAC and VIReC submit to CMS Privacy Board Review to receive raw data. VIReC releases all available data (merged and raw) under re-use DUA to researchers. Where data is not available from VIReC, researchers purchase and receive the data from CMS in raw form. Oversight within the VA oversight to be determined: Local IRB/ACOS-R, plus VHA Privacy Office? Research Advisory Board?

68. Researcher Access to CMS Data Proposed Plan For Current Projects with CMS data from VIReC DUA with CMS for data re-use may be required For New Projects Contact the VIReC Helpdesk at virec@va.gov to request a pre-application DUA with CMS may be required

69. Researcher Access to CMS Data Frequently Asked Questions: What happened to the compliance documentation I submitted to VIReC? First requested prior to CMS’s policy changes. Provided the RAB and CMS a complete list of VHA research projects using CMS data from VIReC and CMS. Provided both VHA & CMS a better understanding of the scope of CMS data use in the VA during the policy negotiation process. I am working on a grant proposal that includes use of CMS data. What should I do? You may continue to submit VA grant proposals that include use of CMS data in the research plan. Grant applications will be reviewed under the assumption that CMS data are available.

70. Research Access to CMS Data Frequently Asked Questions cont… I have a recently reviewed project that includes use of CMS data. What should I do? Specific issues about data availability will be dealt with on a case by case basis, and should be discussed with your HSR&D Portfolio Manager. I have a funded project that includes use of CMS data. What should I do? You may want to contact your HSR&D Portfolio Manager for guidance on how to address issues due to delays in the availability of CMS data for your specific research project.

71. Research Access to CMS Data Frequently Asked Questions cont… I have a multi-site study, can I share CMS data with another VA researcher? If the proposed plan is adopted, a process for providing copies of data to more than one site for the same project will be established. I know another researcher has already received CMS data that would be useful for my study. Is there a way I can use this data? If the proposed plan is adopted, sharing might be allowed with an approved DUA from CMS for data re-use. A process for providing data for situations like this will be established.

72. Research Access to CMS Data More Questions?