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John Rosendale - USA - Monday 28 - Data Systems and National Registries


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John Rosendale - USA - Monday 28 - Data Systems and National Registries

  1. 1. OPTN United States Data System John Rosendale, MS Biostatistician/Senior Performance Analyst United Network for Organ Sharing (UNOS) Richmond, VA USA
  2. 2. OPTN Legal and Regulatory Framework
  3. 3. OPTN National Organ Transplant Act (NOTA)  Passed in 1984  Established the Organ Procurement & Transplantation Network (OPTN)  Established the Scientific Registry of Transplant Recipients (SRTR)  Created the modern OPO system  Prohibited buying & selling organs
  4. 4. OPTN United Network for Organ Sharing (UNOS) History  UNOS incorporated in 1984  1986 – today: OPTN Contract  1987 – 2000: SRTR Contract
  5. 5. OPTN UNOS as the OPTN  Facilitates organ distribution and transplantation  Maintains the National Transplant Waiting List  Establishes equitable policies  Monitors members for compliance with policies  Collects and Reports Transplant Data  Raises awareness about donation
  6. 6. OPTN Data Submission Regulations  Final Rule of 2000 created a mechanism for OPTN Policies to be enforceable • Data Submission Policy  Medicare Conditions of Participation for transplant programs and OPOs also requires data submission to the OPTN
  7. 7. OPTN Organ Matching
  8. 8. OPTN OPTN Database
  9. 9. OPTN DATA COLLECTION PROCESS  Who submits data? • All transplant centers performing solid organ transplantation for data on transplant candidates, transplant recipients, and living donors • All organ procurement organizations for data on deceased donors • All histocompatibility laboratories for tissue typing and cross-match information for donors and recipients
  10. 10. OPTN DATA COLLECTION PROCESS  How are data submitted? • All data must be submitted electronically through either • Direct data entry into the UNetSM system or • Electronic uploads from institutional databases into UNetSM  Data submission is mandatory for all UNOS members
  11. 11. OPTN ONLINE DATA SYSTEM - UNetSM  Functions: • Manage list of waiting transplant candidates • Access and complete electronic data collection forms • Add donor information and run donor-recipient matching lists • Access various transplant data reports and policies
  12. 12. OPTN Evolution of UNetSM Waitlist Match Tiedi® Membership Secure Enterprise U N e tSM October 1999 with grandfathered rules going back to 1987 Placement DonorNetSM Phase I DonorNetSM EOP Match August 2003 Changed Technology, Added Donor Attachments and Manual Electronic Faxing and Email of Donor Info April 2007 Electronic Donor Information, Electronic Organ Offer and Acceptance
  13. 13. OPTN DATA COLLECTION PROCESS: PRE-TRANSPLANT Waiting list candidate Donor Match run list/PTR WL Data: Updates to waiting list candidate medical urgency, demographics, unacceptable antigens, etc DonorNet: Updates to donor demographics, testing results, lab results, etc If HR, LI or IN, changes in medical urgency status may result in new status justification forms GENERATES TCR FORM Organ is accepted PTR: A refusal reason or bypass code must be reported for all candidates with higher position than the acceptor Transplant center removes candidate, completes recipient feedback. OPO reports organ disposition (donor feedback)
  14. 14. OPTN DATA COLLECTION PROCESS: TRANSPLANT AND BEYOND Recipient histo lab GENERATES RH FORM Donor histo lab GENERATES DH FORM OPO GENERATES DDR FORM Transplant Center GENERATES TRR FORM GENERATES TRF FORM @ 6m and every 12m Transplant (feedback completed)
  15. 15. OPTN OPTN DATABASE Records between 1/1/88 and 12/31/10 Number Current waiting list candidates as of 11/17/2011 112,698 (72,802 Active) Transplants 504,593 Deceased donors 138,321 Living donors 109,642
  16. 16. OPTN Quality Assurance Processes  Extensive electronic edits • Forms that do not meet data standards rejected  QA computer programs • Monthly check of all elements • Cross-checking within database  Data maintenance by individual programs  Biannual deceased donor and transplant confirmation  Monthly and annual living donor confirmation
  17. 17. OPTN Data Quality  Data Quality Group within the UNOS Research Department  Monitoring of data quality (mainly waiting list and TIEDI forms data) • Investigation of potential data integrity issues • Making data modifications  Resource manager, SAS analyst, 8 data quality specialists
  18. 18. OPTN Types of Data Submitted to the OPTN
  19. 19. OPTN OPTN Principles of Data Collection Primary Goal: Improve patient outcomes  Develop transplant, donation, and allocation policies  Determine if institutional members are complying with policies  Determine member-specific performance  Ensure patient safety when no alternative sources of data exist  Fulfill the requirements of the OPTN Final Rule
  20. 20. OPTN INFORMATION SUBMITTED BY OPOS (I)  DonorNet® • Includes donor information needed to run a match • Limited data are required; most fields are optional • Accessible to view by transplant centers  Match runs • Refusal reason(s) • May be submitted by transplant centers • Bypass reasons • Final organ acceptance • Due within 30 days of match run date  Donor Feedback (donor organ disposition)
  21. 21. OPTN INFORMATION SUBMITTED BY OPOS (II)  Deceased Donor Registration (DDR) form • Submitted on all consented potential donors regardless of whether organs are recovered • Some information prefills from DonorNet. • Due within 30 days of form generation  Death Notification Registration (DNR) • Collect demographic information on all imminent neurological and eligible deaths reported to an OPO • Some information prefills from DDR if a donor.
  22. 22. OPTN Types of Data Collected on Deceased Donors (DDR)  Demographics  Cause of Death  Terminal Lab Data  Serology Data  Donor Management Medications  Inotropic Medications  Lifestyle Factors  History of Diabetes, Hypertension, Cancer  Organ Recovery Information
  23. 23. OPTN Types of Data Collected for Transplant Candidates (TCR)  Demographics  Primary source of payment  Highest education level, working for income (for adults);  Academic activity level and academic progress (for pediatrics)  Functional status (Lansky/Karnofsky)  Primary diagnosis at listing  General medical factor  Organ specific medical factors
  24. 24. OPTN Types of Data Collected for Transplant Recipients (TRR)  Demographics  Provider information  Primary source of payment  Highest education level, working for income  Functional status (Lansky/Karnofsky)  Pre-transplant clinical information:  Procedure information  Patient status at discharge  Graft status at discharge  Acute rejection between transplant and discharge  Immunosuppression
  25. 25. OPTN Types of Data Collected on Follow- up for Transplant Recipients (TRF)  Patient status  Hospitalizations  Medical/functional status  Insurance  Graft status  Risk factors  Acute Rejection  Post-transplant malignancy (diagnosis date and type)  Immunosuppression (required at 1 year follow-up and optional at 6 months and 2-5 yrs follow-up)
  26. 26. OPTN Types of Data Collected on Living Donors (I) (LDR)  Demographics  Relationship to Recipient  Pre-Donation Clinical Information • General • Organ Specific  Serology Data  History of Cancer, Smoking, Diabetes  Surgical Information • Type of Graft • Intra-Operative Complications  Post-Operative (6 weeks) Status/Complications/Reoperation
  27. 27. OPTN Types of Data Collected on Living Donors (II) (LDF)  Follow-up • 6 Months Post-Transplant • 1 Year Post- Transplant • 2 Years Post-Transplant  Demographics  Patient Status  Functional Status  Physical Capacity  Working for Income  Clinical Information  Complications
  28. 28. OPTN INFORMATION SUBMITTED BY HISTO LABORATORIES  Donor Histocompatiblity (DH) form • HLA typing: A, B, DR, Bw4, Bw6, Cw, DR51, DR52, DR53, DQ, DP • Due within 30 days of generation  Recipient Histocompatibility (RH) form • HLA typing: A, B, DR, Bw4, Bw6, Cw, DR51, DR52, DR53, DQ, DP • HLA antibody screening (class I and class II) • Crossmatch results • Donor retyping • Due within 30 days of generation
  29. 29. OPTN Public Access to Data  Final rule calls for public access to OPTN data • OPTN/SRTR Annual report published by SRTR • Public website • OPTN • SRTR • Data request system
  30. 30. OPTN Where to Find Data  OPTN Website •  SRTR Website •  UNOS Website •
  31. 31. OPTN Thank You