MEETING SUMMARY

Region 7 Meeting

February 12, 2015

The UNOS Region 7 meeting was held on February 12, 2015 in Chicago, IL. There were 36 individuals in attendance representing 73 percent of institutional voting members. Dr. Julie Heimbach, Regional councilor, opened the meeting and presented the following information:

  • Goal and purpose of Regional Meetings
  • Overview of the 2015 committee selection process
  • Overview of today’s meeting activities

OPTN/UNOS Update

Dr. David Klassen, UNOS Chief Medical Officer, provided the OPTN/UNOS Update which included the following information:

  • OPTN and UNOS Strategic Planning
  • Updating the 2012 Strategic plan
  • Planning for 2015-2018
  • KAS implementation update
  • “Out of the Gate” Data – so far the initial data shows changes predicted
  • Redesigning liver distribution
  • Town Hall Meeting Sept. 2014
  • Ad Hoc Subcommittee meeting between Nov. 2014 – April 2015
  • Develop recommendations to refine the concept of Redistricting
  • Deliver to the committee and the public at a Public Forum in Spring 2015
  • IT projects nearing completion
  • 2015 BOD project plan
  • TransNet labelling and tracking app
  • New public comment tool
  • Blog-Style public comment

Non-Discussion Agenda **Proposals not presented or discussed

Proposal to Improve UNetsm Reporting of Aborted Procedures and Non-Transplanted Organs (Living Donor Committee)

This proposal is intended to clarify and simplify reporting requirements for aborted living donor recovery procedures and incidents when a living donor organ is recovered but not transplanted and to ensure that follow-up forms are generated so no living donor is lost to follow-up.

Region 7 vote: 23 yes, 0 no, 0 abstentions

This proposal was approved during the June 2015 OPTN/UNOS Board of Directors meeting.

Effective Date: Pending implementation and notice to members

Clarify Policy Language and Process for Individual Wait Time Transfer (Patient Affairs Committee)

Policy 3.6.C: Waiting Time Transfer does not completely and accurately describe the process that occurs when a candidate transfers primary waiting time from one transplant program to another. The Patient Affairs Committee (hereafter, the Committee) proposes modifications to Policy 3.6.C so that it details the current process and defines waiting time that is eligible for transfer. This proposal promotes the efficient management of the OPTN by describing the responsibilities of both transplant programs and the OPTN Contractor in the individual waiting time transfer process. By defining waiting time that is eligible for transfer, this proposal also ensures that the waiting time transfer calculations are accurate and that the process is fair for all candidates.

Region 7 vote: 23 yes, 0 no, 0 abstentions

This proposal was approved during the June 2015 OPTN/UNOS Board of Directors meeting.

Effective Date: September 1, 2015

Proposal to Collect Ex Vivo Lung Perfusion (EVLP) Data for Transplant Recipients (Thoracic Organ Transplantation Committee)

Ex vivo lung perfusion (EVLP) is an emerging technology that can be used during transport, and to preserve and condition lungs prior to transplantation. The utilization of EVLP is not currently reported to the OPTN, so the OPTN cannot determine how many lungs have been perfused or transplanted. In the spring of 2015, the OPTN will implement changes to the OPTN Tiedi forms, including the Deceased Donor Registration form (DDR). Through the modified DDR, Organ Procurement Organizations (OPOs) will report whether an accepting transplant program intends to perfuse the lungs prior to transplant. However, there is no corresponding field on the Transplant Recipient Registration form (TRR) for transplant programs to report whether lungs were perfused prior to transplant. The Thoracic Committee believes it is important to capture this information to monitor lung allocation, recipient safety, and organ and patient outcomes. This information will also be important for future policy development and risk adjustment for member-specific performance measures.

Region 7 vote: 23 yes, 0 no, 0 abstentions

This proposal was approved during the June 2015 OPTN/UNOS Board of Directors meeting.

Discussion Agenda

Operations and Safety Committee

Proposed ABO Blood Type Determination, Reporting, and Verification Policy Modifications

This proposal seeks to:

  1. Clarify requirements related to ABO blood type determination, reporting, and verification for donors and candidates
  2. Strengthen current key system safety components to ensure the correct organ is transplanted into the correct recipient and that the match is ABO compatible or planned incompatible
  3. Align OPTN/UNOS and Centers for Medicaid and Medicare Services (CMS) blood type requirements more closely

This proposal was originally released in the spring 2014 public comment cycle and has been modified to address concerns raised by the transplant community.

Region 7 vote: 20 yes, 0 no, 0 abstentions

Comments:

To better align with CMS, ABO verification should be done after the organ arrives in the OR and prior to induction of anesthesia. This is the current CMS requirement.

Committee Response:

Seven of the eleven regions approved this proposal. This proposal, however, was widely debated. The ASTS, ASHI, and American Nephrology Nurses Association support the proposal. AST opposes the proposal. AOPO commented that they appreciate the work but had several concerns they would like addressed. The OPO, Transplant Administrators, Membership and Professional Standards, Patient Affairs, Pediatric, Thoracic, Living Donor, and VCA Committees reviewed this proposal. The Committees were generally supportive although several committees did have suggestions or substantive comments that they wanted to be addressed.

Identified concerns and requests and subsequent OSC responses are summarized below and organized by proposal goal.

Goal 1:Clarify requirements for ABO blood type determination, reporting, and verification and better assist members in complying with the requirements.

The following issues were raised for proposed actions that address this goal:

  1. Concerns over complexity
  2. Concerns about documentation. Confusion or misunderstanding over acceptable verification information sources. Concerns about site survey requirements.
  3. Wait to adopt with TransNetsm/Phase in with TransNetsm
  4. Concerns over time out fatigue, too many verifications, effort to implement

Goal 2:Align OPTN/UNOS and Centers for Medicaid and Medicare Services (CMS) requirements

The following issues were raised for proposed actions that address this goal:

  1. Concerns over living donor verification prior to anesthesia (versus prior to incision)/verification in OR
  2. Concerns over OPO requirements to perform verification at recovery
  3. Only change to align with CMS

Goal 3: Strengthen current key safety components to ensure correct organ/correct recipient and blood type compatibility or planned incompatibility

The following issues were raised for proposed actions that address this goal:

  1. Need to focus on right organ/right recipient (not ABO)
  2. Concerns about organ check-in
  3. Concerns about adding verification if surgery starts prior to organ arrival

Goal 1:Clarify requirements for ABO blood type determination, reporting, and verification and better assist members in complying with the requirements.

  1. Concerns over complexity

ABO policy touches over a dozen policies. The Committee did propose many non-substantive changes to make each type of policy (e.g. determination) have the same structure and terminology across donation types. Having all of these changes in one proposal may seem complex. Details were added to address repeated transplant community questions (e.g. acceptable sources). Basic steps already in policy for determination, reporting, and verification remain. Core principles were also applied more uniformly to increase consistency.

OSC is committed to providing members with the tools needed to comply with these policies.

  1. Concerns about documentation. Confusion or misunderstanding over acceptable verification information sources. Concerns about site survey requirements.

The OSC will provide education about acceptable sources. A verification is a confirmation of information. Because two people are required independently to enter blood type in UNet for both donors and candidates, the OPTN computer system is allowed to be the verification source in some cases. While some people disagreed with that philosophy and had concerns they could not trust the data, the OSC believes if it is strong enough to be used for the match run then this data can be used in some verification areas. The final pre-transplant verification does require that source documents be used.

  1. Wait to adopt with TransNetsm/Phase in with TransNetsm

While OPOs have started a voluntary national deployment, a beta testing version for transplant hospitals will not be available until summer 2015. Approximately 15 transplant hospitals will test but this number is less than 10% of all transplant hospitals. A voluntary national roll out for transplant hospitals will not occur until perhaps late 2016. This would be too long to wait to implement some of the proposal. By implementing these steps now, transplant hospitals can be better prepared to implement TransNetsm when it is ready. Several requirements will not be impacted by TransNetsm.

  1. Concerns over time out fatigue, too many verifications, effort to implement

Many transplant hospital staff will not be doing any additional verifications. Various programs have some type of check-in process already. The check-in is nota verification. It is similar to when a package is received. A process exists where the receiver checks to see where it is from and if it was expected. This is done for receipt of medical supplies and numerous other procedures.

If transplant hospitals are performing the Joint Commission universal protocol time out prior to the start of surgery, then they could incorporate or add elements such as ABO into this process to reduce burden perceived for the proposed verification if surgery starts prior to organ arrival. No one has spoken against the final pre-transplant verification. This verification remains in both CMS and OPTN policy. Several have commented that they appreciate the spelling out of requirements.

OSC will provide educational tools to assist with implementation.

Goal 2:Align OPTN/UNOS and Centers for Medicaid and Medicare Services (CMS) requirements

  1. Concerns over living donor verification prior to anesthesia (versus prior to incision)/ verification in OR.

Several commenters were concerned that the timing proposed would not align with CMS and cause confusion. Living donation is a well-planned, elective event. There should always be adequate time to conduct this verification. Anesthesia is not without risk. These risks are outlined in the supporting evidence section.

The OSC strongly feels that living donors should not be exposed to unnecessary risk, especially for an elective case. Should an issue be discovered during a verification conducted after administration of general anesthesia but prior to incision, then the living donor would be exposed to unnecessary risk. The Committee continues to support keeping this timing at prior to the induction of general anesthesia.

The Committee has dropped the requirement that the verification occur in the operating room but has added that it must occur on the same day as surgery.

  1. Concerns over OPO requirements to perform verification at recovery

Several commenters stated that they could not verify any recipient information because they do not have access to source documents. It is acknowledged that the OPO will not have recipient source documents. The OPTN computer system is named as an acceptable source. This allows the OPO to use DonorNet and the match run to verify this information. A verification is a confirmation of information and does not always require source documents. When source documents are required, the table of acceptable sources will be specific. It is acknowledged that the intended recipient might change. The information verified is what is known at the time of recovery.

The proposal places the responsibility of conducting a verification at recovery with the OPO in order to be congruent with CMS. The CMS rule, §486.344 Condition: Evaluation and management of potential donors and organ placement and recovery, includes the following:

(d) Standard: Collaboration with transplant programs.

(1) The OPO must establish protocols in collaboration with transplant programs that define the roles and responsibilities of the OPO and the transplant program for all activities associated with the evaluation and management of potential donors, organ recovery, and organ placement, including donation after cardiac death, if the OPO has implemented a protocol for donation after cardiac death.

(2) The protocol must ensure that:

(i) The OPO is responsible for two separate determinations of the donor's blood type;

(ii) If the identify of the intended beneficiary is known, the OPO has a procedure to ensure that prior to organ recovery, an individual from the OPO's staff compares the blood type of the donor with the blood type of the intended beneficiary, and the accuracy of the comparison is verified by a different individual;

(iii) Documentation of the donor's blood type accompanies the organ to the hospital where the transplant will take place.

(3) The established protocols must be reviewed regularly with the transplant programs to incorporate practices that have been shown to maximize organ donation and transplantation.

(e) Documentation of beneficiary information. If the intended beneficiary has been identified prior to recovery of an organ for transplantation, the OPO must have written documentation from the OPTN showing, at a minimum, the intended organ beneficiary's ranking in relation to other suitable candidates and the recipient's OPTN identification number and blood type.

  1. Only change to align with CMS

The OPTN and CMS will always have some differences in regulations due to varying areas of focus such as the OPTN is responsible for allocation. Subtyping policy is to increase allocation and therefore CMS will not address this area as it would be out of scope.

The other areas the OSC proposed to change that are different from CMS are based on findings from the FMEA and are needed to address safety gaps. They will not cause anyone to be out of alignment with CMS.

Goal 3: Strengthen current key safety components to ensure correct organ/correct recipient and blood type compatibility or planned incompatibility

  1. Need to focus on right organ/right recipient (not ABO)

The OSC agrees that this is the proper focus. This policy includes identification of the correct organ and correct recipient as part of the process proposed as well as critical data such as ABO.

  1. Concerns about organ check-in

Some comments indicated that the organ check-in needed to be more specific or occur at the operating room. The OSC has deliberately left the place of check-in up to the transplant hospital to accommodate varying practices.

Some commenters mistakenly thought that the check-in required an ABO verification. This check does not include ABO. It is a check of expected donor and actual donor ID on the external label and organ type to make sure that the right organ has been sent to the correct transplant hospital without accruing unnecessary cold ischemic time. The supporting evidence section provides additional data in support of this step.

  1. Concerns about adding verification if surgery starts prior to organ arrival

Some commenters felt this was an unnecessary step and that the universal precaution time out required by the Joint Commission would take care of this need. This was seen as burdensome by some and not adding value to the process.

The OSC suggests that this verification can be combined with the universal precaution time out. The Joint Commission check requires that vital data be checked. Transplant hospitals can add expected donor ID and ABO as well as recipient ID and ABO to this check. Conducting a verification takes a very limited amount of time—an estimated 1 to 2 minutes. This was suggested in a previous response.

This check is important as no candidate should start surgery and then have a verification past the point where harm could have been avoided. Anesthesia is not without risk. There has been a case where the intended recipient surgery started prior to organ arrival. The patient was put on a heart-lung bypass machine and then ABO incompatibility was discovered. The transplant was not performed, however, organ removal had taken place and the patient later died. The pre-transplant verification check is a step to protect the patient from unnecessary risks.

This proposal was approved during the June 2015 OPTN/UNOS Board of Directors meeting.

Effective Date: February 1, 2016

Proposal to Modify the Sterile Internal Vessels Label

This proposal seeks to modify the requirements for the sterile internal vessels label. The amount of information required on this label will be reduced. Currently all infectious disease results are required by policy to be handwritten on a “2 x 4” or “2 x 5” label in a sterile field. This process is difficult for OPOs to complete and prone to transcription errors. Infectious disease results on this label will be reduced to whether the donor is positive for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) and whether the donor is at increased risk in accordance with US Public Health Service Guidelines for HIV, HBV, or HCV. Requirements for the hangtag poly-plastic internal label attached to the outermost layer of the triple sterile barrier will not change and all infectious disease results still must be completed on this label.