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Transplant Statistics: Annual Report
APPENDIX H
The OPTN Data Collection System
The Health Resources and Services Administration (HRSA) contracts with UNOS to operate the national Organ Procurement and Transplantation Network (OPTN). UNOS is responsible for collecting, processing, and validating pre- and posttransplant data. Data coordinators working in transplant centers, organ procurement organizations (OPOs), and histocompatibility laboratories provide the information stored in the OPTN database. Donor and recipient data files can be linked, allowing the most complete data analysis possible for each transplant performed. OPTN data are transmitted weekly and monthly to the Health Resources and Services Administration (HRSA) and the Centers for Medicare and Medicaid Services (CMS, formerly HCFA). In compliance with the Privacy Act (P.L. 93-579), UNOS also provides data to OPTN members, to other members of the scientific and medical community, and to the public.
Data utilized in preparation of this report were collected primarily on OPTN electronic data collection forms implemented on October 25, 1999, and designed in conjunction with the Scientific Advisory Committee and organ- or donor-specific work groups. On October 25, 1999, UNOS implemented UNetsm, an online, electronic database that, in part, enables member institutions to electronically enter and validate their own data. Currently, 95% of OPTN members submit their data to UNOS via the electronic data system.
Data flow within the OPTN database begins with the initial waiting list registration and is identical for paper and UNetsm forms (Figure H-1 on the following page illustrates the data flow process). OPTN members can add potential transplant recipients to the waiting list through a variety of means, as described in the UNetsm User's Manual. Following waiting list registration, the Transplant Candidate Registration (TCR) Form is generated. Information on this form is used to create the initial record for each potential recipient. Demographic information supplied by members on the TCR form will provide the basis for the creation of all subsequent transplant records and donor-recipient links.
When a donor organ becomes available, the match process begins. Matching uses donor information entered by OPTN members at the time of the match and existing potential recipient data from the OPTN waiting list. Using an allocation algorithm, the matching process generates a list of potential recipients for each available organ. The match run is used to allocate the donor organs and document refusal reasons for each potential recipient listed before the actual recipient on the match list.
Electronic feedback records are created using data from each potential donor added to the database. OPTN members provide the disposition for each donor organ. The feedback process enables UNOS to produce the necessary data collection forms for each donor referral and organ donor. When the disposition of each donor organ is completed, the feedback record is closed and the donor forms are generated for completion online or for mailing to the appropriate OPTN member. Transplant Recipient Registration Forms are generated when the recipient feedback process is completed by removing the patient from the active waiting list. Instructions for online completion of feedback records are found in the UNetsm User's Manual.
The Cadaver Donor Registration, Potential Transplant Recipient, and Donor and Recipient Histocompatibility Forms are completed by the OPO recovering the donor organs and the labs typing the donor and recipient. These forms are completed online or are returned to UNOS for processing.
The organ-specific Transplant Recipient Registration and Follow-up Forms are completed by the center performing the transplant. Transplant Recipient Follow-up Forms for each organ are generated at 6 months (with the exception of thoracic organs), 1 year, and at annual intervals thereafter until death, graft failure, or "lost to follow-up" is reported. Follow-up Forms are generated by UNOS based on the transplant date. The follow-up forms are available online or mailed to the center currently following the transplant recipient. Follow-up data use the same flow as registration data.
Living donor transplants are reported to UNOS by the transplant center performing the living donor transplant, via Living Donor Feedback completed online or through submission of the Living Donor Feedback Fax Sheet. These data are entered as feedback and generate the necessary forms as described for cadaveric transplants.
Pretransplant data in the OPTN database contains information pertaining to transplant candidates on the OPTN waiting list, donor/recipient matching, cadaveric and living donors, histocompatibility, and potential recipients. Much of the data are collected on the forms described above and include the Transplant Candidate Registration Form, Cadaver Donor Registration Form, Living Donor Registration Form, Donor Histocompatibility Form, Recipient Histocompatibility Form, Potential Transplant Recipient Form, and the Liver, Heart, and Intestine Status Justification Forms. Other data are derived from the computer patient waiting list, feedback records, and match run programs (see below).
Waiting List. The OPTN patient waiting list contains information used by the computer system to match potential organ recipients with available organ donors. Waiting list data can be entered online into the waiting list database by the UNOS Organ Center staff or by OPTN members. Renal candidate data elements include name, gender, race/ethnicity, date of birth, ABO blood group, medical urgency status, peak and current panel reactive antibody (PRA) levels, patient human leukocyte antigens (HLAs), maximum acceptable number of HLA mismatches, number of previous transplants, and dialysis information. Information regarding non-renal candidates includes patient status codes (reflecting degree of medical urgency) for liver and heart, name, ABO blood group, patient date of birth, gender, race/ethnicity, number of previous transplants, acceptable donor characteristics, and patient human leukocyte antigens (HLAs) for pancreas. Each time a new patient is added to the waiting list, a Transplant Candidate Registration Form is generated for completion by the member. When completed, this form adds additional clinical data about the potential transplant recipient.
Match Run. Each time a cadaveric organ becomes available, a computer program compares donor information with transplant candidate characteristics stored on the OPTN waiting list. The computerized comparison process is known as a match run. For each donor organ, computerized matching algorithms are used to produce rank ordered lists of potential recipients. The matching algorithms used are based on OPTN organ allocation policies, transplant center acceptance criteria, and local variances (OPTN-approved variations of allocation policies).
Donors. OPTN members submit donor information on Cadaveric Donor Registration and Living Donor Registration Forms. Cadaveric donor data include information about the donor OPO; donor demographics; donor management; cardiac function (for heart donors); cancer history; consent for donation; organ disposition, recovery, and preservation; donor serology; and organ recipients.
Data pertinent to living donor transplants are entered online or sent in reports faxed to UNOS at the time of transplant. After the basic information provided in the report is entered, appropriate data collection forms are generated and are available online or are sent to the transplant program. Living donor data collected include information regarding donor demographics, organ recovery, donor serology, the relationship of the donor to the recipient, and basic data about the recipient.
Histocompatibility. Histocompatibility laboratories submit data to UNOS on the Donor Histocompatibility Form and the Transplant Recipient Histocompatibility Form. Donor data include OPO information and donor HLA typing. If the donor is living, information is provided regarding the degree of haplotype match. Recipient data include transplant center information, recipient HLA typing, recipient PRA level, crossmatch data, and information about non-local donor HLA retyping.
Potential Recipients. After each cadaveric organ is allocated, the donor OPO initiates completion of a Potential Transplant Recipient Form. Included on the form is a partial rank-ordered listing of potential organ recipients indicated by the match run print out. For each individual on the list with higher priority than the actual recipient, a refusal code is entered indicating the reason the organ was not accepted for transplant.
Feedback Record. Initial confirmation that a transplant has been performed occurs during the feedback process. The donor Feedback Record is an online electronic data file created after the donor is added to the database. During the donor feedback process, the OPO or its representative enters disposition information regarding the donor organs. The recipient transplant center or its representative enters recipient feedback data pertaining to the actual organ recipient when the patient is removed from the active waiting list. Once these data are entered, UNOS uses them to generate forms for collection of additional data about the transplants. Data collection forms generated as a result of the feedback processes are available to the appropriate OPTN members; forms pertaining to donors are sent to OPOs while recipient forms are sent to transplant centers.
Posttransplant data in the OPTN database contains information pertaining to organ recipients and living donors. Data are collected on organ-specific Transplant Recipient Registration Forms and Transplant Recipient Follow-Up Forms. After a transplant has been performed and the feedback process is complete, the organ-specific Transplant Recipient Registration Forms are generated. Additional follow-up data are collected at 6 months (with the exception of thoracic organs) and 1 year posttransplant and annually thereafter. Living donor data are collected on the Living Donor Follow-up Form after organ donation. Data are collected at 6 months and at 1 year after donation.
Kidney. Kidney data collected on the Transplant Recipient Registration Form include transplant date, patient medical condition at the time of transplant, primary renal diagnosis, pretransplant serology, ischemic time, and surgical information. Additional data collected as part of the Transplant Recipient Follow-Up Form include patient status at the time of follow-up, immunosuppressive medication, graft status, cause of graft loss, information about organ rejection, and/or cause of death.
Pancreas. Pancreas data collected on the Transplant Recipient Registration Form include transplant date, primary pancreas diagnosis, information about the patient's diabetes, patient medical condition at the time of transplant, pretransplant lab data, pretransplant serology, ischemic time, and information about the surgical procedure. Follow-up data include patient status at the time of follow-up, most recent lab data, information about organ rejection, complications related to the pancreas transplant, information about the kidney transplant (whether a kidney transplant accompanied or preceded the pancreas transplant), immunosuppressive medication, data regarding graft status, the cause of graft failure, and/or the status of the patient's diabetes.
Liver. Liver data collected on the Transplant Recipient Registration Form include transplant date, patient medical condition at the time of transplant, primary liver disease, pretransplant serology, ischemic time, and pretransplant lab work pertaining to liver function. Follow-up data include patient status at the time of follow-up, most recent lab information, immunosuppressive medication, information about organ rejection, graft status, and/or the cause of graft failure.
Intestine. Intestine data collected on the Transplant Recipient Registration Form include transplant date, patient medical condition at the time of transplant, pretransplant serology, pretransplant lab work, organ type transplanted (i.e., stomach, small intestine, duodenum, large intestine), ischemic time, and factors that increase the patient's risk for a poor transplant outcome. Follow-up data include patient status at the time of follow-up, most recent lab information, immunosuppressive medication, information about organ rejection, graft status, and/or the cause of graft failure.
Heart and Lung. Thoracic data collected on the Transplant Recipient Registration Form include transplant date, organ type transplanted (i.e., heart, lung, or heart-lung combination), patient medical condition at the time of transplant, pretransplant serology, and factors that increase the patient's risk for a poor transplant outcome. Follow-up data include patient status at the time of follow-up, immunosuppressive medication, data regarding graft status, and information about organ rejection.
Living Donor. Living donor data collected on the Follow-up Form include donor status at the time of follow-up, information on complications, and the number of hospitalizations during the follow-up period.
Policy 7.0 outlines data submission requirements for each form type and is summarized in Table H-1. To assist members in compliance with this policy, UNOS notifies each OPO, transplant program, and histocompatibility lab of overdue forms via a monthly outstanding forms report. The report consists of a summary of forms by form type that were expected but not received by the due date, and annual data submission compliance rates. The report also provides instructions for viewing through UNetsm a detailed list of overdue forms. Members can request reprints of each overdue form and/or a detailed listing of all overdue forms.
Prior to data entry, each paper form returned to UNOS is reviewed for missing information and illogical errors. If any data fields (e.g., patient age, patient gender, and patient status) have been left blank or if illogical data errors are detected, forms are returned to members. Forms without missing or obviously erroneous data are entered into a computer database. The computer also examines interdependent fields (e.g., patient gender and number of previous pregnancies) for inconsistencies.
If a form fails an edit during the data entry process, the form is forwarded to quality assurance staff, which research and correct the error. If member assistance is needed, 1 week is generally required to resolve a data problem. If UNOS staff alone can correct the error, only 1 hour is generally required per form.
The UNetsm system provides integration of all data from waiting list registration to transplant, and from donor identification to matching with potential recipients. Data entered during the wait listing and donor matching processes are edited for accuracy and completeness. The Tiedi electronic data collection application in UNetsm simplifies the data collection process by providing a single point of data entry at the transplant center, OPO, or histocompatibility lab. The UNOS data system generates records containing basic demographic data whenever forms are due, available electronically through the Tiedi system. To complete a record, the user clicks on the patient's name, which then presents the electronic form on the computer screen. Centers enter required data and Tiedi validates the information. Following validation, forms are automatically updated in the OPTN database.
A unique advantage of the Tiedi system is that it provides a direct connection to the master database at UNOS. Centers can modify data previously sent to UNOS at any time and revalidate the modified form to ensure the record continues to adhere to established data standards. The modified data are then automatically updated in the OPTN database.
Living donor confirmation mailings are conducted in order to verify and validate data received and processed during the previous month. The mailings are helpful in identifying transplant recipients and donors not previously reported (e.g., donors and recipients of living donor grafts for which match runs are not performed).
Annual confirmation of cadaver donors, living donors, and transplant recipients by organ type are conducted to ensure an accurate accounting of each donor and recipient prior to reporting final numbers. During the first quarter of each year, lists of donors and recipients for the previous calendar year are sent to OPOs and transplant centers for verification. Personnel at each center and OPO review, validate, and certify the information contained in the report. Reports are signed by the data coordinator and program director and returned to UNOS.
UNOS Policy Compliance staff also performs periodic on-site data audits at transplant centers, OPOs, and histocompatibility labs. During these visits, auditors compare data in member files with data the member reported on OPTN forms.
The current UNetsm data collection forms, as of May 2001, can be viewed at www.unos.org by first selecting "Data" then selecting "Data Collection".
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