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Modify Blood Type Determination and Reporting Policies

Proposal Overview

Status: Public Comment

Sponsoring Committee: Operations and Safety

Strategic Goal: Promote living donor and transplant recipient safety

Read the proposal (PDF; 01/2020)

Contact: Pete Sokol

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eye iconAt a glance 

What is current policy and why change it?

Currently, host Organ Procurement Organizations (OPOs) must ensure two donor blood type samples are used to determine blood type. They also must develop and comply with written procedures to resolve any conflicts with results and to verify key information prior to organ recovery. 

Recent reports of events affecting patient safety led to the decision to re-evaluate the requirements for blood type determination.

What’s the proposal?

  • Require host OPOs, transplant programs, and recovery hospitals (for living donors) to include a process in their written protocols for addressing indeterminate blood typing results.
  • Require host OPOs to document all blood products the donor received since admission to the donor hospital.
  • Align deceased donor, candidate, and living donor policies.

What’s the anticipated impact of this change?

  • What it’s expected to do
    • Trigger updates of written protocols to include plan for “indeterminate” results.
    • Provide more thorough policy guidance to ensure patient safety.
    • Changes to the candidate and living donor policies to provide consistency in policy language.
  • What it won’t do
    • This proposal will not specify a comprehensive list of information that should be included in protocols and procedures for OPOs or transplant programs.

Themes to consider

  • Living Donor Safety
  • Recipient Safety
  • Blood Type Verification

Terms you need to know

  • ABO Blood Type: The classification of human blood into four groups: A, B, AB, and O.
  • Blood Products:  Any therapeutic substance prepared from human blood.  This includes: whole blood, blood components, and plasma.
  • Conflicting: Two blood tests from the same donor or candidate that show different blood types.
  • Indeterminate: A blood test that does not provide a clear result.
  • Organ Procurement Organization: An organization designated by the Centers for Medicare and Medicaid Services (CMS) and responsible for the procurement of organs for transplantation and the promotion of organ donation.
  • Protocol: A predefined written procedural method.
  • Transplant Center: A hospital that performs transplants, including qualifying patients for transplant, registering patients on the national waiting list, performing transplant surgery and providing care before and after transplant.
  • Click here to search the OPTN glossary

Comments

OPTN Histocompatibility Committee | 02/17/2020

The Histocompatibility Committee appreciates the opportunity to provide feedback on modifying blood type determination and reporting policies and its associated guidance. The Committee supports use of DNA-based determination of ABO in combination with traditional serological typing and utilized for discrepancy resolution. It is important to note, however, that testing requires additional expertise and carries additional CLIA requirements, in addition to various state testing requirements. Please consider providing a hemodilution calculation every time a sample is sent in for testing. This could create additional documentation and reporting burden on the organ procurement organization, but it would help ensure that the sample quality is sufficient for definitive testing. It is recognized that guidance is not prescriptive of practice, and appreciate the steps the Operations and Safety Committee is taking toward clarifying the process. Histocompatibility Committee Vote: Modify Blood Type Determination and Reporting Policies: 7 yes, 3 no, 6 abstain

Region 4 | 02/20/2020

Strongly support (11), Support (9), Neutral/Abstain (2), Oppose (0), Strongly Oppose (0)

Region 8 | 02/20/2020

8 Strongly Support, 10 Support, 2 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Region 6 | 02/21/2020

Strongly support (8), Support (9), Neutral/Abstain (0), Oppose (0), Strongly Oppose (0)

Region 5 | 02/21/2020

Strongly support (13), Support (8), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0)