1. OPTN
United States Data System
John Rosendale, MS
Biostatistician/Senior Performance Analyst
United Network for Organ Sharing (UNOS)
Richmond, VA
USA

2. OPTN
Legal and Regulatory
Framework

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

7. OPTN
Organ Matching

8. OPTN
OPTN Database

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

18. OPTN
Types of Data Submitted to
the OPTN

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

31. OPTN Thank You