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Modify Blood Type Determination and Reporting Policies

Proposal Overview

Status: Implemented

Sponsoring Committee: Operations and Safety (OSC)

Strategic Goal: Promote living donor and transplant recipient safety

Read the proposal (PDF; 01/2020)

View the Board Briefing Paper (PDF; 06/2020)

Contact: Pete Sokol

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

Region 7 | 03/24/2020

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

Region 10 | 03/24/2020

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

OPTN Region 9 | 03/24/2020

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

American Society of Transplantation | 03/23/2020

The American Society of Transplantation is supportive of the proposal to Modify Blood Type Determination and Reporting Policies put forth by the OPTN Operations and Safety Committee. The AST provides the following commentary and questions for consideration: 1. The proposal under consideration requires the OPO document “a complete history of all blood products that the deceased donor received since admission to the donor hospital in the deceased donor medical record.” We believe this should also include transfusions that may have occurred at other institutions in cases where donors may have been transferred into the eventual donor hospital. We suggest consideration of additional wording/modification of the proposal e.g.; “In the event that the donor’s hospitalization involves more than one facility, the history should include blood products received at all facilities.” 2. We suggest clarification of the term “source documents” that must be reviewed prior to listing candidates for transplant or determining ABO type of deceased or living related donors. For example, HLA labs often repeat and report ABO typing of donors and recipients during routine workups and will include such results on report forms along with HLA typing results. Does the statement “all source documents” then set up a requirement that all HLA reports will need to be available to the 2 healthcare professionals prior to listing? Or will this result in labs refraining from indicating recipient/donor ABO types so that it will less paperwork to review? 3. We understand that a pre-transfusion sample must be tested for A subtyping, but should consideration be given to requiring, if available, pre-transfusion samples for ABO typing as well? 4. We suggest that the Operations & Safety Committee ensure that the policy specifically address scenarios where massive transfusions have occurred. There may be enhanced safety in classifying such donors as AB for the purpose of a match run. 5. Should the definition of blood products include plasma derivatives?

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 Transplant Surgeons | 03/23/2020

The American Society of Transplant Surgeons (ASTS) strongly supports this proposal to enhance the safety of recipients. Accurate ABO typing is important and patients with discordant results need to be addressed. We would suggest that the OPTN Operations and Safety Committee provide best practice guidance documents (e.g. repeat testing, genetic testing, etc.) to guide OPOs and transplant programs in developing policies necessary to meet this requirement.

NATCO | 03/23/2020

NATCO supports the proposed changes to clarify requirements related to resolution of conflicting or indeterminate blood types for candidates, deceased and living donors. This will help OPOs, transplant hospitals, and recovery hospitals to include a process in their written protocols and increase patient safety.

OPTN Region 3 | 03/22/2020

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

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.

Region 11 | 03/19/2020

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

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

ANNA supports. We feel this is important from a safety perspective.

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

ASHI values the opportunity to comment on the Policy Proposal to modify blood type determination and reporting policies. The proposed changes clarify requirements related to resolution of discordant or indeterminate blood types for candidates, deceased and living donors. ASHI concurs that the proposal clarifies practices and increases patient safety by requiring OPOs, transplant hospitals, and recovery hospitals to include a process in their written protocols for addressing indeterminate blood typing results; to document all blood products the deceased donor received since admission to the donor hospital, and: to align deceased donor policies with candidate and living donor policies. ASHI supports the policy proposal.

Region 1 | 03/10/2020

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

Transplant Coordinators Committee | 03/04/2020

Ops and Safety Committee: Modify Blood Type Determination and Reporting Policies & Guidance on Blood Type Determination The Committee is highly supportive of this proposal. 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

Anonymous | 02/28/2020

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

Region 5 | 02/21/2020

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

Region 6 | 02/21/2020

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

Region 8 | 02/20/2020

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

Region 4 | 02/20/2020

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

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

OPTN Region 4 | 02/07/2020

Strongly Support