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

    • United States Data System John Rosendale, MS Biostatistician/Senior Performance Analyst United Network for Organ Sharing (UNOS) Richmond, VA USAOPTN
    • Legal and Regulatory FrameworkOPTN
    • 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 organsOPTN
    • United Network for Organ Sharing (UNOS) History  UNOS incorporated in 1984  1986 – today: OPTN Contract  1987 – 2000: SRTR ContractOPTN
    • UNOS as the OPTN  Facilitatesorgan 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 donationOPTN
    • 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 OPTNOPTN
    • Organ MatchingOPTN
    • OPTN DatabaseOPTN
    • 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 recipientsOPTN
    • 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 membersOPTN
    • 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 policiesOPTN
    • Evolution of UNetSMU WaitlistN Placement DonorNetSM Phase I DonorNetSM EOPe Match MatchtSM Tiedi® Secure EnterpriseMembership October 1999 August 2003 April 2007 with grandfathered rules going Changed Technology, Electronic Donor Information, back to 1987 Added Donor Attachments and Electronic Organ Offer and Manual Electronic Faxing and Acceptance Email of Donor Info OPTN
    • DATA COLLECTION PROCESS: PRE-TRANSPLANTWL Data: Updates to waiting listcandidate medical urgency, If HR, LI or IN, changes in medicaldemographics, unacceptable antigens, etc urgency status may result in new status justification forms Waiting list candidate Organ is Transplant center accepted removes GENERATES TCR FORM Match run candidate, completes list/PTR recipient feedback. OPO reports organ PTR: A refusal reason or bypass code disposition (donor must be reported for all candidates feedback) Donor with higher position than the acceptor DonorNet: Updates to donor demographics, testing results, lab results, etc OPTN
    • DATA COLLECTION PROCESS: TRANSPLANT AND BEYOND OPO GENERATES DDR FORM Transplant CenterTransplant (feedback GENERATES TRR FORM GENERATES TRF FORMcompleted) @ 6m and every 12m Recipient histo lab GENERATES RH FORM Donor histo lab GENERATES DH FORMOPTN
    • OPTN DATABASE Records between 1/1/88 and Number 12/31/10 Current waiting list 112,698 candidates as of 11/17/2011 (72,802 Active) Transplants 504,593 Deceased donors 138,321 Living donors 109,642OPTN
    • 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 confirmationOPTN
    • 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 specialistsOPTN
    • Types of Data Submitted to the OPTNOPTN
    • 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 RuleOPTN
    • 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)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.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 InformationOPTN
    • 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 factorsOPTN
    • 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 ImmunosuppressionOPTN
    • 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)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/ReoperationOPTN
    • 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 ComplicationsOPTN
    • 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 generationOPTN
    • 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 systemOPTN
    • Where to Find Data  OPTN Website • www.optn.transplant.hrsa.gov  SRTR Website • www.srtr.org  UNOS Website • www.unos.orgOPTN
    • OPTN Thank You