FAQs about upcoming OPTN policy changes related to blood type determination, reporting, and verification.

Transcription

1 FAQs about upcoming OPTN policy changes related to blood type determination, reporting, and verification. Why are we changing ABO policies when it s one of the safest things we do in medicine? Have patients been adversely affected under the current system? ABO blood type is a primary characteristic used to match organ donors and recipients. Correct determination, reporting, and verification of blood type is a major safety principle present in policy and programming. This is to ensure that the correct organ will be transplanted into the correct recipient with an ABO compatible (or planned incompatible) match. Having this system be clear, robust, and minimize human error is critical to safe transplantation and maintaining public trust. Failure in any area can have significant consequences including graft failure or patient death. In 2003, an accidental ABO incompatible (ABOi) transplant resulted in patient death, made national headlines and prompted development of further policy and programming safeguards. It is true that unintended ABO incompatible transplants are very rare events. Unintentional ABOi transplants that have occurred since the 2003 event may not be as well known within the transplant community. Since 2006, there have been two unintended ABOi kidney transplants both leading to hyperacute graft rejection and three unintended ABOi liver transplants. These involved several different root causes including lab, documentation, communication, and verification errors. The number of near misses is unknown. Policy changes will add steps to avoid adverse events that include unintended ABOi transplantation as well as wrongorgan/wrong-patient procedures. Compliance with policy has been identified as a concern by both the OPTN and CMS. Policy violations for blood type requirements have been the most frequent type of compliance issue for both organizations. Some of the issues can be attributed to lack of policy clarity, lack of member understanding, and incomplete documentation. Not all OPTN transplant programs are certified transplant providers under CMS. As of September 16, 2014, there were 104 organ specific transplant programs, including 12 kidney programs, that were not CMS certified (as of June 30, 2014) for transplantation. The proposed policies will provide rules for these programs that are not bound to CMS transplant-specific requirements. How many centers were cited for significant adverse events with ABO mismatched allocation? Survey data on (former) Policy (ABO verification upon receipt of the organ and prior to implantation) found that only 32 of 139 (23%) reviewed programs showed compliance. Demonstrating the organ was present at the time of verification was identified as the most significant challenge for transplant centers. Another relatively common issue was that site surveyors were unable to determine that the donor and/or recipient ABO and/or UNOS ID was verified upon receipt and prior to implant. These data are from 147 programs audited up to nine

2 months before April and July 2013 MPSC meetings. Random samples of records examined were from 3-year cohorts of transplants performed. Survey data on (former) Policy , (ABO verification prior to listing) reveals that compliance rates with this policy appear to be increasing over time. Between January 2007 and March 2010, 12% of 5,937 listings reviewed had errors. Approximately 91% were due to only one typing present in the documentation. The most recent data, while not directly comparable, showed that 86% (118 out of 138 programs) of programs reviewed demonstrated compliance with this policy. The remaining 14% of programs had between one and four potential discrepancies identified. Data analysis reveals that 99.2% of the total number of records reviewed demonstrated compliance. The most frequent type of error has gone from being only one typing present to site surveyors being unable to determine that ABOs were from separate samples. The most recent data are from 147 programs audited up to nine months before April and July 2013 MPSC meetings. Random samples of records examined were from 3-year cohorts of transplants performed. In 2011, CMS published responses to frequently asked questions verifying recipient and donor blood type and other vital data. This memo stated, The verification of blood type and other vital data between the organ donor and recipient is currently the most frequently cited condition-level deficiency during the transplant program surveys. Why are policies being added that are not CMS requirements and are not in alignment? The decision to implement requirements (e.g. timing of verification) is based on findings from a Failure Modes and Effects Analysis (FMEA). The policy will help reduce prioritized areas of risk. Complying with proposed OPTN policy will not place members out of alignment with CMS. OPTN and CMS rules will differ always on some points. It is unrealistic to expect no variation. First, OPTN policy includes allocation principles that are out of scope for CMS. Part of OPTN ABO policy addresses subtyping because it is used in allocation to increase transplant opportunities. CMS rules do not address reporting processes to the OPTN as that also would be out of scope. An important component of OPTN policy is reporting (e.g. using source documents with double user entry and verification). This process contains safety checks approved several years ago. This proposal retools some of the reporting language for clarity and consistency but does not change the core principles. CMS does not require two blood type determinations for candidates or living donors. OPTN policy already has this requirement for redundancy and consistency. To undo this existing requirement would remove critical safety checks and programming. It would not make sense for the OPTN to remove these requirements to match with CMS. The Committee worked to ensure that OPTN and CMS requirements are not in conflict but rather work in harmony. CMS participated in the ABO workgroup to answer questions on their requirements. CMS agreed to collaborate and update templates and other materials should this proposal pass.

3 What are acceptable source documents for showing compliance with OPTN ABO policies? There is no requirement in policy to record the documentation used. Members are required to retain documentation that two source documents were referenced by each person entering blood type. Data entry in UNet is not sufficient documentation of this element. A hospital's electronic medical record (EMR) can be a source document for lab results when the performing lab's results are directly uploaded into the EMR. Should we include the specific source documents that we will use to report and verify ABO in our internal policies? Policy requirements OPOs and Transplant Hospitals to develop and comply with a written protocol for blood type determination and reporting that includes all of the requirements noted in policy. It does not specify that you must have protocols that specify what source documentation you will use to conduct blood type entry and verification. What should be documented for organ check-in procedures? Visual appearance of the organ? Policy requires that transplant hospitals develop and comply with a written protocol to perform organ check-ins. The transplant hospital must document that the organ check-in was completed. The organ check-in must be completed upon arrival at the transplant hospital prior to opening the organ s external transport container. The transplant hospital must use the OPTN external organ label to confirm that the label contains the expected: 1. Donor ID 2. Organ type and laterality (if applicable) If the transplant hospital determines that the donor ID, organ type or laterality label information conflicts with the expected information, then notify the host OPO as soon as possible, but within one hour. When will the ABO policy modifications become effective? After programming becomes available but not before June 1, 2016.

4 What are the system enhancements that will be programmed and released with ABO policy implementation? To help members comply with requirements, the Committee has proposed several items including UNet SM programming. This programming is to support existing, not new, policy. These three programming enhancements will assist members in meeting existing requirements: 1. Adding a warning when registering liver candidates willing to accept ABOi organs. When liver candidates are registered as willing to accept an ABOi organ, only one person is required to conduct data entry. A warning will be added when yes is checked for these candidates. 2. Adding recipient blood type and donor/recipient compatibility symbol to match run results The match run view will be modified to add candidate blood type and ABO compatibility status. This will provide a visual cue highlighting ABOi candidates and assist with verifications. 3. Adding second user verification for subtyping so that data entry supports current policy Second user verification for donor subtypes will be programmed. The current system enforces second user verification of primary blood type for listing donors and candidates. Although current policy requires second user verification when reporting subtype, the system will allow one person to add a subtype to the primary blood type. What does OPTN-approved electronic method mean? TransNet SM How can TransNet help? TransNet SM will provide significant assistance in reducing labeling errors. Currently, labels may be handwritten in the donor management phase. TransNet SM will produce barcode and printed human readable labels for blood specimens. These labels will be produced on demand to help avoid batching errors on specimens being sent for ABO blood typing. Blood transfusion error reports have found that wrong blood in tube is the most frequent error type in this procedure with parallels to organ transplantation. Patient misidentification accounted for 182 out of 253 blood transfusion safety events. Specimen mislabeling during collection was associated with batching of specimens and printed labels (n = 35), and misinformation from manual entry on laboratory forms (n = 14) were nearly 20% of errors. TransNet SM could also be programmed to support verification and organ check-in requirements using bar-code technology that is currently used in other areas with success such as medication administration. It could assist with documentation and process. The Committee will continue collaborative efforts in developing TransNet SM to help members comply with policy.

5