Top 5 OPTN Policy Violations

OPO

2.10 Additional Deceased Donor Testing

If a host OPO completes any testing in addition to what is required for a potential donor, the results of these tests must be reported to all recipient transplant hospitals as soon as possible, but no later than 24 hours after receiving the test result.

2.15.B Organ Procurement Procedures To ensure organ procurement quality, the host OPO must do all of the following:

Ensure that the deceased donor receives medications at appropriate times

Document in the deceased donor record any medications administered

Begin tissue typing and crossmatching as soon as possible

Use standard surgical techniques in a sterile environment

Maintain flush solutions, additives, and preservation media at appropriate temperatures

Document in the deceased donor record, flush solutions and additives with lot numbers, along with organ anatomy, organ flush characteristics, flush solution amount, flush solution type

Document organ abnormalities, and surgical damage, if any

1.1.D Reporting of Information to the OPTN Contractor Members must report requested information to the OPTN Contractor to fulfill membership requirements and to ensure compliance with OPTN Policies and Bylaws. The OPTN Contractor will determine the required method and format for reporting any information required by OPTN Policies and Bylaws, including the requirement to submit specific forms at defined times.

2.2 Maintaining blood specimens appropriate for serologic and nucleic acid testing (NAT), as available, for each deceased donor for at least 10 years after the date of organ transplant, and ensuring these samples are available for retrospective testing. The host OPO must document the type of sample in the deceased donor medical record and, if possible, should use qualified specimens.

The transplant center or OPO must use both internal and external transport containers to package a deceased or living donor organ that travels outside of the facility where the organ is recovered.

16.4.A Internal Packaging

A triple sterile barrier must protect organs and vessels. A sterile rigid container may be used as one layer of the triple sterile barrier for all organs and must be used as one layer when packaging kidneys, pancreas, and vessels that are packaged separately from the organ.

16.4.B Internal Labeling of Organs

The Host OPO must securely attach the completed OPTN internal label, identifying the specific contents, to the outer- most layer of the triple sterile barrier holding each organ. The OPTN Contractor distributes a standardized label that must be used for this purpose. In addition to the specific contents of the package, the label information must include the donor ID, donor blood type and blood subtype, if used for allocation

2.5 Hemodilution Assessment

OPOs should use qualified (non-hemodiluted) blood samples for deceased donor serological screening tests if available. If a qualified sample is not available for testing, a hemodiluted sample should be used for deceased donor screening tests. OPTN Policies

If serological testing occurs on a hemodiluted blood sample, the host OPO must treat the deceased donor as presenting an increased risk for disease transmission as specified in the U.S. Public Health Services (PHS) Guideline.

Prior to screening, the host OPO must assess all potential deceased donor blood samples that were obtained for serological screening tests for hemodilution using a U.S. Food and Drug Administration (FDA) approved hemodilution calculation. The host OPO must document in the deceased donor medical record a complete history of all blood products and intravenous fluid transfusions the deceased donor received since admission to the donor hospital.

5.4.B Order of Allocation The process to allocate deceased donor organs occurs with these steps: 1. The match system eliminates candidates who cannot accept the deceased donor based on size or blood type. 2. The match system ranks candidates according to the allocation sequences in the organ allocation policies. 3. OPOs must first offer organs to potential recipients in the order that the potential recipients appear on a match run. 4. If no transplant program on the initial match run accepts the organ, the host OPO may give transplant programs the opportunity to update their candidates’ data with the OPTN Contractor. The host OPO may run an updated match run and allocate the organ according to the updated candidate data. 5. If no transplant program within the DSA or through an approved regional sharing arrangement accepts the organ, the Organ Center will allocate an abdominal organ first regionally and then nationally, according to allocation Policies. The Organ Center will allocate thoracic organs according to Policy 6: Allocation of Hearts and Heart-Lungs and Policy 10: Allocation of Lungs. 6. Members may export deceased donor organs to hospitals in foreign countries only after offering these organs to all potential recipients on the match run. Members must submit the Organ Export Verification Form to the OPTN Contractor prior to exporting deceased donor organs. OPTN Policies Policy 5: Organ Offers, Acceptance, and Verification

This policy does not apply to VCA transplants; instead, members must allocate VCAs according to Policy 12.2: VCA Allocation.

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