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John Rosendale - USA - Monday 28 - Data Systems and National Registries
1. OPTN
United States Data System
John Rosendale, MS
Biostatistician/Senior Performance Analyst
United Network for Organ Sharing (UNOS)
Richmond, VA
USA
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. OPTN
United Network for Organ Sharing
(UNOS) History
UNOS incorporated in 1984
1986 – today: OPTN Contract
1987 – 2000: SRTR Contract
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. 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
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. 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. 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. 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. 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. 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. 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. 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. 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
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. OPTN
Where to Find Data
OPTN Website
• www.optn.transplant.hrsa.gov
SRTR Website
• www.srtr.org
UNOS Website
• www.unos.org