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Guidance on Blood Type Determination

Proposal Overview

Status: Public Comment

Sponsoring Committee: Operations and Safety

Strategic Goal: Promote living donor and transplant recipient safety

Read the guidance document (PDF; 01/2020)

Contact: Pete Sokol

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What is current practice and why address it?

Blood type determination is one of the most crucial components of the process for matching donor organs to transplant candidates. Failure to accurately determine blood type can result in significant adverse events, including graft failure or patient death. The intent of this guidance document is to increase patient safety and create awareness of the importance of addressing all issues that may affect the accuracy of blood type determination.

What’s the guidance?

  • Reviews conventional methods for blood type determination.
  • Identifies factors impacting blood type reliability.
  • Lists acceptable blood type and transfusion sources.
  • Identifies alternative genetic testing methods and when they should be used.
  • Outlines practices to resolve donor blood type conflicts.

What’s the anticipated impact of this document?

  • What it’s expected to do
    • Help OPOs and transplant programs:
      • Develop procedures when conventional methods of blood testing result in indeterminate or conflicting results.
      • Identify triggers for when to use alternative testing methods.
      • Identify practices to resolve conflicting blood typing results.
  • What it won’t do
    • This guidance document is not a mandate. It provides recommendations for members to consider when resolving conflicting or indeterminate blood typing results.
    • It will not detail procedures for OPOs or transplant programs or take the place of clinical judgment on blood type determination.
    • It does not create or change OPTN policy. There is an accompanying proposal that addresses policy changes.

Themes to consider

  • Living donor safety
  • Recipient safety
  • Organ Procurement Organization (OPO) and transplant program quality improvement

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 present with different blood typing results.
  • Indeterminate: A blood test that does not provide a clear result.
  • Protocol: a predefined written procedural method.
  • 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: Guidance on Blood Type Determination: 7 yes, 2 no, 7 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)

Region 2 | 02/28/2020

5 Strongly Support, 28 Support, 0 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Region 1 | 03/10/2020

Strongly support (3), Support (5), Neutral/Abstain (0), Oppose (0), Strongly Oppose (0) No comments or questions

AMERICAN SOCIETY FOR HISTOCOMPATIBILITY AND IMMUNOGENETICS | 03/13/2020

ASHI values the opportunity to comment on the proposed guidance on blood type determination. The proposed guidance provides a concise overview of blood typing methods and factors influencing the accuracy of blood type determinations. This information will be useful for transplant programs and OPOs. ASHI supports this guidance.

American Nephrology Nurses Association (ANNA) | 03/18/2020

ANNA supports.

Region 11 | 03/19/2020

Strongly support (4), Support (12), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0)

Membership & Professional Standards Committee | 03/20/2020

The MPSC thanks the Operations and Safety Committee for presenting its proposals “Modify Blood Type Determination and Reporting Policies” and “Guidance on Blood Type Determination.” Members of the MPSC offered the following questions and comments on both proposals: • What circumstances might cause someone to have an indeterminate blood type other than a massive blood transfusion or bone marrow transplant? • In a previous policy proposal, the OPO Committee removed specific lab values and detailed requirements from policies so they wouldn’t have to be frequently updated to keep up with new technology. Did the Operations and Safety Committee consider that practice with these proposals? • How expensive is the DNA-based typing assay mentioned in the guidance document, and would it add significant costs for OPOs? How quickly can results be obtained from that type of assay? • Since more than one lab may perform typing, did the committee look at discrepancies between different labs that might result from the use of different testing methodologies? • Since some OPOs are transporting donors to a central recovery facility, it is important to clarify that the requirement to document all blood products received since admission to the donor hospital means from the start of the death event, not when the donor arrives at the OPO recovery facility. • Did the committee discuss documenting blood products delivered in the field? Did the committee discuss anything about the time that the OPO had a qualified sample? • Did the committee discuss requiring patient safety event reporting of indeterminate blood typing results in order to track trends and gain a better understanding of these events? Would the committee consider adding that recommendation to the guidance document? The results of the sentiment poll for “Modify Blood Type Determination and Reporting Policies” were 14 Strongly Support, 20 Support, 2 Neutral/Abstain, 0 Oppose, and 0 Strongly Oppose. The results of the sentiment poll for “Guidance on Blood Type Determination” were 18 Strongly Support, 17 Support, 0 Neutral/Abstain, 0 Oppose, and 0 Strongly Oppose.

OPTN Region 3 | 03/22/2020

Vote: 6 strongly support, 12 support, 2 neutral/abstain, 0 oppose, 0 strongly oppose

NATCO | 03/23/2020

NATCO supports and appreciates the proposed guidance and overview of blood typing methods and factors influencing the accuracy of blood type determinations utilized for discrepancy resolution.

American Society of Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) strongly supports this proposal and recognizes the hard work and contribution of this guidance document. It provides important information for all clinicians caring for transplant patients. Accurate ABO typing is crucial for the safety of our patients. Transplant centers and OPOs should review and incorporate new and more reliable assays as they become commercially available. In addition, this information needs to be reviewed when considering deceased donation from a prior stem cell recipient. While currently rare, it is possible that this situation could more commonly arise in the future.

OPTN Living Donor Committee | 03/23/2020

The OPTN Living Donor Committee appreciates the opportunity to provide feedback on this public comment item. The Committee is supportive of the Operations and Safety Committee’s efforts to align policy language for living donors.

American Society of Transplantation | 03/23/2020

The American Society of Transplantation is supportive of this excellent guidance document. We believe it should provide significant assistance to OPOs, Transplant Centers, and Laboratories in addressing the complexities of ABO determination, especially in cases where results are indeterminant or discrepant. This type of document is invaluable and as such we would ask that consideration be given by the OPTN Committees to the creation of comparable documents to assist in similar scenarios such as indeterminant testing for infectious diseases We have a few comments, some minor, for your consideration and one question: 1. Under Conventional Methods for ABO Determination, we are confused as to why Rh (D) typing is included in the forward group assessment, since Rh typing is not required or performed for organ transplant purposes. Alternatively, many labs also utilize Anti AB commercial reagent to confirm the results of Anti A or Anti B commercial typing reagents, and this is not mentioned. If the decision is made to still include Rh, please consider stating that Rh typing is not required. A minor point is the addition that the endpoint assessment for the tube method is agglutination graded 0 – 4 +. 2. On page 7 under Transfusion, patients who receive emergency blood group O transfusions when the blood type of the patient is not known may also have significant amounts of Anti A or B transfused, which could lead to discordant results. Also, if a large amount of AB plasma is transfused, this could also lead to discordant results, since the expected Anti A or B antibodies for a group O patient may be weak or absent. The word native is confusing here. 3. Under Alternative Testing Methods for Determination of Blood Type: DNA based… a note should be added regarding donors that might have received stem cell transplants previously, suggesting that buccal swabs also be used as a source of DNA when using DNA based methods for ABO determination. 4. Throughout the document different terms are used to describe ABO discrepancies: (discordant, incongruent, inconsistent, conflicting). We suggest using discrepancy, which is the term most often used in the blood bank field. 5. When DNA testing is needed does the Committee have any estimate of how this will impact timing of transplant and CIT?

OPTN Region 9 | 03/24/2020

Strongly support (2), Support (9), Neutral/Abstain (1), Oppose (0), Strongly Oppose (0)

Region 10 | 03/24/2020

2 Strongly Support, 11 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

Region 7 | 03/24/2020

6 Strongly Support, 6 Support, 3 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose

OPTN Transplant Coordinators Committee | 03/24/2020

The Committee is highly supportive of this guidance document. Their only concern was addressing any potential changes in the site survey process. 10 Strongly Support, 3 Support, 0 Neutral/Abstain, 0 oppose, 0 Strongly Oppose