The OPTN database contains pre-transplant information that pertains to transplant candidates on the OPTN Waiting List, donor/recipient matching, deceased and living donors, histocompatibility, and potential recipients. Much of the data are collected via electronic data collection forms which include the Transplant Candidate Form, Deceased Donor Registration Form, Living Donor Registration Form, Donor Histocompatibility Form, Recipient Histocompatibility Form, Potential Recipient Form, and the Liver Status 1, 2a and 2b Justification Forms. Other data are derived from the computer Patient Waiting List, Feedback Records, and Match Run programs.
The 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 registered UNOS transplant professional members. Renal candidate data elements include name, gender, race, age, ABO blood group, peak and current panel reactive antibody (PRA) levels, and patient human leukocyte antigens (HLAs). Information regarding non-renal candidates includes patient status codes (reflecting degree of medical urgency) for heart and liver, ABO blood group, patient age, gender, number of previous transplants, and acceptable donor characteristics. Each time a new patient is added to the waiting list, a Transplant Candidate Registration Form is generated for the member. When completed, this form adds additional clinical data about the potential transplant recipient.
Each time a deceased donor organ becomes available, a computer program compares donor information with transplant candidate characteristics stored on the 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 organ allocation policies, transplant center acceptance criteria, and local variances (OPTN/UNOS-approved variations of OPTN/UNOS allocation policies).
Organ Procurement Organizations (OPOs) submit donor information on Deceased Donor Registration and Living Donor Registration Forms. Deceased donor data include information about the donor OPO, donor demographics, consent for donation, organ recovery and preservation, donor serology, and intended organ recipients. Basic data pertinent to living donor transplants are provided by the transplant program at the time of transplant through Living Donor Feedback service. UNet then generates appropriate data collection forms for the transplant program. Living donor data collected include information regarding donor OPO, donor demographics, organ recovery, donor serology and certain data about the recipient.
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 relationship of donor to recipient and 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.
After each deceased donor organ is allocated, the donor OPO initiates completion of a Potential 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.
Initial confirmation that a transplant has been performed occurs during the feedback process. The Feedback Record is an online electronic data file created after the Match Run. During the feedback process, the OPO or its representative enters information regarding the donor and the organs recovered for transplantation. For each organ, the recipient transplant center or its representative enters data pertaining to the actual organ recipient. 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 process, are sent to the appropriate members; OPOs are sent forms pertaining to donors, and transplant centers are sent forms pertaining to recipients.
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 Form is generated. Additional follow-up data are collected at six months and 1 year post-transplant and annually thereafter.
Kidney data collected on the Transplant Recipient Registration Form include transplant date, patient description (at time of transplant), primary renal diagnosis, pre-transplant serology, organ preservation description, and surgical information. Additional data collected as part of the Transplant Recipient Follow-Up Form include patient description (at time of follow-up), immunosuppressive medication, graft status, cause of graft loss, patient status, and cause of death.
Liver data collected at the time of recipient registration include transplant date, patient description (at time of transplant), recipient's primary liver disease, pre-transplant serology, organ preservation information, and pre-transplant lab work pertaining to liver function. Follow-up data include patient status, cause of death, patient description (at time of follow-up), most recent lab information, immunosuppressive medication, graft status, and cause of graft failure.
Pancreas transplant registration information includes transplant date, information about the patient's diabetes, patient pre-transplant status, pre-transplant lab data, pre-transplant serology, organ preservation data, and information about the surgical procedure. Follow-up data include post-transplant patient status, 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, cause of graft failure, and status of patient's diabetes.
Data collected at the time of recipient registration include transplant center information, recipient demographics, organ type transplanted (heart, lung, or heart-lung combination), patient description, pre-transplant serology, and factors that increase the patient's risk for a poor transplant outcome.
Intestine data collected at the time of recipient registration include transplant date, patient description (at time of transplant), recipient's primary and secondary diagnosis, pre-transplant serology, organ preservation information, and pre-transplant lab work. Follow-up data include patient status, cause of death, patient description (at time of follow-up), most recent lab information, immunosuppressive medication, graft status, and cause of graft failure.