Registry Agent for UNOS and CIBMTR: OTTR's New Solution

1. Registry Agent for UNOS and CIBMTR OUI 2014

2. Registry Agent • Registry Agent Solid Organ is OTTR’s newest solution for completing UNOS Tiedi forms • Available for both Solid Organ Transplant and Blood and Marrow Transplant • Registry Agent Solid Organ product became available in 2014 • Enlisted the help of 3 Customer Input Sites (CI sites) for Registry Agent - Solid Organ Transplant

3. Panel Solid Organ Transplant • Angelica Starkey RN, MSN • Senior Clinical Analyst at OTTR • Tamara Radar, RN, BSN, CCTC, CCRN • Living Donor Renal Transplant Coordinatorat St. Vincent Transplant Center Blood and Marrow Transplant • Stella Harnden RN, BSN • Clinical Analyst at OTTR, specializing in BMT • MaritaWehde, RN, BSN, C.H.T.C • Program Manager, Outpatient Division of Stem Cell Transplant, Leukemia and Lymphoma at Barnes-Jewish Hospital Technical • Matt Harriger • IT Systems Engineer at OTTR

4. RA Experience at St. Vincent Transplant Program Tami Rader, RN, BSN, CCRN, CCTC Renal Transplant Living Donor Coordinator

6. RA Experience • Training • CI Site • Preparation • Correct encounters in place • Completion of encounters (required fields “*”) • Usage • Began May 2014

7. Quality of Data • Data is only as good as entered • If entered correctly, RA will pull data over correctly • Always check data prior to submitting

8. Decreased Workload • Candidate Registration forms (8-10/hr) • Post Follow-up forms(6/hr) • LD forms (6-8/hr) • TIEDI forms (ALL DAY!!!!!)

9. Responsiveness of OTTR Staff • Always available • E-mail • Phone • Quick return response • Partner to find solutions • Open for suggestions for improvement

10. TIEDI vs RA • RA !!!

11. The Need for Registry Agent - SOT • The Waitlist • As of September 7, 2014 http://optn.transplant.hrsa.gov/data/

12. The Need for Registry Agent - SOT • The Transplants http://optn.transplant.hrsa.gov/data/ Recipients Living Donors 2,280 x 2 (forms minimum) ------------------------- 4,560 forms 11,845 x 3 (forms minimum) ------------------------- 35,535 forms

13. The Need for Registry Agent - SOT • 35,535 recipient forms • +4,560 living donor forms • ------------ • 40,095 forms • This does not include the 6 month follow-up forms or the annual forms due • When did the transplant program you are currently working at start doing transplants?

14. Registry Agent – Solid Organ Transplant • Ability to download all of the UNOS required forms via UNet without ever leaving OTTR • Recipient Forms • Transplant Candidate Registration - TCR • Transplant Recipient Registration - TRR • Transplant Recipient Follow up – TRF • Living Donor Forms • Living Donor Registration - LDR • Living Donor Follow up – LDF • Total of 76 Forms Available for use • Includes Adult and Pediatric Forms

15. Registry Agent – Solid Organ Transplant • Registry Agent collects the patient data already documented within OTTR through everyday workflow • Auto-populates the form fields • Sends the completed form to UNOS • Users can complete the form manually • Updates or changes take only minutes to complete. • All the forms are validated against the UNOS business rules.

16. Registry Agent – Solid Organ Transplant • When UNOS modifies a form, OTTR Chronic Care Solutions takes care of all the changes. • Changes are coming in 2015 to several of the forms • OTTR is currently working on the form changes • OTTR Registry Agent keeps a historical record of all the forms submitted to UNOS. • OTTR’s Registry Agent’s commitment is all fields, for all forms available for submission by third party tools.

17. Registry Agent – Data Collection • * Required • SRTR • Demographics

18. Registry Agent Workflow - Listing

19. Registry Agent Workflow - Transplant • General Tab  Surgery Tab  Liver Tab

20. Registry Agent Workflow – Encounter • Post Transplant Follow Up Encounter • Source Links • “Recalc” button • Full encounter and abbreviated encounters • Post Transplant Follow-up tab • Encounter tab • Scanned Documents tab

21. Registry Agent Workflow – Donors • Donor Info • Living Donor Registration form • New tabs or changes • Pre-Donation “Organ”Clinical Information • “Organ” Surgical Information • “Organ” Related Post-Operative Complications • Pre-Donation Clinical Information • Post Operative Information • Post –Operative Clinical Information

22. Registry Agent – The Process • Tiedi Forms Life Cycle

23. Registry Agent – The Workflow • UNOS Generates a Form • Download Form Using OTTR • Repopulate • Validate • If passes – Submit to UNOS • If fails – correct the errors • Submit to UNOS • Based on OPTN policy • Receive an email from UNOS • Pass or Fail • Processing and validation response • Once accepted • Change form status to “Accepted”

24. Registry Agent – Tabs • Forms Details/Options • IMR or IMF Form • Submission History

25. Registry Agent – Form layout • Decorated Fields • Required fields only • Source Links • Indented Fields • Parent Child relationship of questions

26. Registry Agent – Form Repopulation • Side by Side comparison • Data on the form • Data pulled from the workflow • Select the response you want to keep/submit

27. Registry Agent – Form Validation • Validation provides a list of “Violations” • Double click on the violation to go to the field that needs to be reviewed • Best Practice – Do not make changes on the form • Utilize source links • Note: OTTR does not prevent users from submitting with violations

28. Registry Agent – Improvements • Validation rules • Improved the quality and consistency of the violations • Added a Registry Agent Toolbar • Forms • Registry Agent Flowsheet • UNOS.org launches the UNOS portal website

29. Registry Agent – Demo

30. Registry Agent – Help • User who need assistance with the forms • UNOS Help Desk: 1-800-978-4334 • Online help is also available in UNet • User who need assistance with the forms in OTTR • Registry Agent Quick User’s Guide • General overview • OTTR Support: 1-800-636-6498

31. Registry Agent Registry Agent - BMT

32. The Need for Registry Agent - BMT • Transplant Need: • Each year nearly 20,000 people are diagnosed with life-threatening illnesses where blood stem cell transplantation is their best treatment option • Transplants in US: 2011: >17,900 bone marrow, stem cell or umbilical cord blood transplants b – Voluntary reporting of Autologous transplants http://bloodcell.transplant.hrsa.gov/about/general_faqs/index.html#1990 number tx in US

33. Registry Agent – BMT Definitions • NMDP: National Marrow Donor Program • Operates “Be the Match” donor registry • 22.5 million potential donors/ 601,000 cord blood units worldwide • CIBMTR: Center for International Blood and Marrow Transplant Research • Research program of the NMDP and the Medical College of Wisconsin • Collects outcomes data on every allogeneic transplant in the US and accepts voluntary data on autologous transplants • Clinical database contains information on more than 370,000 transplant recipients • FormsNet3: Clinical research management system for CIBMTR • AGNIS: A Growable Network Information System • Messaging system to exchange hematopoietic cell transplant data • Data collected in a center’s database (OTTR) directly into FormsNet3

34. Registry Agent – BMT Form Requirements • CIBMTR Form Requirements • Varies based on the: • Type of transplant • Donor source • CIBMTR Algorithm placement • CRF Track (Comprehensive Report Forms) • TED Track (Transplant Essential Data) • First year post transplant: Minimum of 6 required forms • Annually: 1-2 required forms • 103 CIBMTR Forms via FormsNet3 • 15 CIBMTR Forms supported via AGNIS platform (available for use in OTTR)

35. Registry Agent - BMT • OTTR is certified by CIBMTR and NMDP to submit and retrieve data using the AGNIS application and framework • Ability to download all completed forms supported by AGNIS for a center • Ability to complete and submit AGNIS supported forms from within OTTR • Two BMT centers in production with 3 forms that auto-populate in OTTR • Several more centers will go-live this fall • Additional forms currently in development (2400, 2450, 2000) • When CIBMTR modifies a form, OTTR will update the form version and modify workflow fields as they are released through AGNIS

36. Registry Agent – BMT Workflow - Evaluation

37. Registry Agent – BMT Workflow - Transplant

38. Registry Agent – BMT Workflow - Encounter

39. Registry Agent – BMT - The Workflow • Document during work-flow • Add new form in OTTR • Populate • Review/verify • Fix any errors and repopulate until correct • Submit • Receive validation result • Accepted • Rejected / accepted with errors – make corrections, repopulate, verify and submit • Timeliness

40. Registry Agent – BMT Form Layout • Decorated Fields • No work flow field/unable • Source Links • Help Text • Question Numbering • Indentation

41. Registry Agent – BMT Form Submission • Populate and re-populate identical to Solid Organ • Validation rules are stored in FormsNet3, not within OTTR • Form Submission Results: • Rejected – a key data element is either missing or is invalid • Accepted with errors – form passed through validation rules and violations are returned to the form within OTTR • Accepted – form passed through validation rules and was accepted

42. Registry Agent – Other Form Tabs

43. CIBMTR Data Dates Tab • Ability to track the forms completed by Transplant • OTTR Lists facilitate managing forms due and tracking forms completed

44. Registry Agent – BMT Toolbar • Registry Forms • Review all forms for this patient • Add new form • Download/Update individual form • NMDP Connect • Opens http for Connect NMDP (vpn) • FormsNet3 • Opens http for FormsNet3 if you are already logged into Connect NMDP

45. Registry Agent – Workflow Field Changes • Form mapping is dependent on doc kind name, table name and field name DO NOT MODIFY

46. Registry Agent – Help • User who need assistance with the forms • Contact your Clinical Research Coordinator • User who need assistance with the forms in OTTR • Registry Agent - BMT Quick User’s Guide • General overview • Call Support 800-636-6498

47. Registry Agent Experience at Barnes-Jewish Hospital and St. Louis Children’s Hospital Stem Cell Transplant Program Marita Wehde, RN, BSN, CHTC Transplant Program Manager

48. Registry Agent Experience • Preparation • Collaborative effort • Training • On site training • Implementation • One on one review and training • Workflow changes • Completion of OTTR data fields

49. Usage • First form submitted in late May, 2014 • Forms include: • Form 2804: Recipient ID assignment • Form 2004: Infectious Disease Markers • Form 2900: Recipient Death Data

50. Support and Guidance • OTTR Chronic Care Solutions • Always available • Open to suggestions and changes • Internal support • OTTR Administrator • Clinical Champion