Modify ABO Determination, Reporting, and Verification Requirements (Resolution 14) Operations and Safety Committee Ms. Theresa Daly The Problem Accidental ABO incompatible transplants – rare but devastating Safety gaps and risk Varying requirements and complex language: Deceased and living donation Candidate and donor OPTN and CMS Compliance issues Strategic Plan #4- Promote Transplant Patient Safety • Strengthen policy to reduce risk for unintended ABO incompatible transplant #5- Promote Living Donor Safety • Strengthen policy to reduce risk for unintended ABO incompatible transplant #6-Promote Efficient Management of OPTN • Provide clarity to requirements and promote electronic solutions to support policies Goal of the Proposal Reduce risk of accidental ABO incompatible transplants Increase transplant safety Improve policy consistency and clarity Align requirements How the Proposal will Achieve its Goal Align policies with CMS where possible Address safety gaps with policy changes identified by FMEA Consistent requirements and language between: Donors and candidates Deceased and living donation Develop educational tools including proficiency testing Programming enhancements Overall Project Impact Product Policy Programming Professional Education Target Population Impact: All donors and candidates Total IT Implementation Hours 750/10,680 Total Overall Implementation Hours 2,240/17,885 750 0 0 1000 2000 3000 4000 5000 2240 2000 4000 6000 Public Comment Feedback Public Comment Response Tally Type of Response No Vote/ In Favor No Response as In Favor Opposed Comment/ Total Amended Did Not Consider Individual 24 16 (67%) 0 3 (13%) 5 (20%) Regional 11 7 (64%) 0 4 (36%) 0 Committee 19 1 (5%) 1 (5%) 1 (5%) 16 (85%) Comment Themes Concerns related to OPO requirements o Ability to conduct verification at recovery when the intended recipient is not known o Requirement to have on-site surgical team participate in verification Concerns that the proposed policy was too prescriptive Concerns that additional requirements were not needed given the infrequency of accidental ABO incompatible transplants Never Event Death Accidental ABO Transplant: 5 Since 2006 Wrong Organ Arrived Wrong Organ/Wrong Patient: 9 2009-2012 Not On Match Run: 240 Data entry issues: 9 ABO Testing issues: 9 Communication issues: 8 Near Misses 1/20126/2014 Labeling errors: 63 Changes to ABO data: 329 2009-2012 Comment Themes Request for updated templates and electronic solutions Desire to postpone policy requirements until after ETT implementation Concerns that the entire process has been redesigned Desire to have no differences from CMS requirements ABO Process Steps Top Failure Modes Rank Number Failure Mode 1 1 2 1 2 3 2 4 2 5 3 3 6 7 4 4 8 9 5 5 10 11 OPO releases organ to recipient not on match run Blood type verification does not occur prior to implantation Candidate erroneously listed as accepting an ABO incompatible (pediatric heart, liver) Wrong organ arrived-not checked at arrival to verify correct organ arrived for the correct potential recipient If intended recipient surgery begins prior to arrival, no requirement for blood source documentation availability to confirm compatibility prior to anesthesia Blood samples are mislabeled (candidate) Verification occurs without both source documents for recipient and donor One blood sample sent and tested twice Only one sample drawn and tested prior to match (no ABO confirmation by second sample) No pre-transfusion specimen is available for testing Blood samples are mislabeled (donor) Proces s Step 6 8 2 8 8 1 8 1 4 4 4 ABO Determination: Core Principles Blood type and subtype results based on two laboratory tests •Reduce chance of allocation being done on one erroneous lab result (FMEA #9) Samples drawn on different occasions. With each collection, a separate patient identification and labeling procedure conducted prior to the blood draw •Reduce chance of “wrong blood in tube” due to misidentification or label error (FMEA # 6,8, and 11) ABO Determination: Changes from current policy Remove OPO option to have one blood draw sent to two labs Require protocol to have process when ABO primary types do not match Post public comment to align with CMS Post public comment Exception clause for accelerated deceased donation cases ABO Determination: Alignment with CMS OPTN CMS Deceased Donor Living Donor Candidate 2 Blood types on separate occasions 2 Blood types on separate occasions 2 Blood types on separate occasions 2 Blood types on separate occasions Blood type must be done not specific Blood type must be done not specific Safer Safer ABO Reporting: Core Principles Reports based on two results Source documents used for reports Reports entered independently by two different users Reports completed prior to becoming active in OPTN system Address FMEA #1 and #9 ABO Reporting: Changes from current policy Must be done by “qualified health care professional” as defined in member’s protocol Exception clause for accelerated deceased donation cases Timing is made safer for deceased and living donors Address living donor VCA reporting Post public comment ABO Reporting: Timing Changes Safer OPTN CMS Before organ recovery Medical eval prior to donation Deceased Donor Prior to Match Run Prior to Incision Living Donor Prior to generate Donor ID Before recovery Candidate Prior to Active OPTN Wait List Before on tx hospital wait list ABO Verification (Time Out): Core Principles Confirmation of critical information includes surgeon • Reduce chance of delayed or missed communication Confirmation done at critical points of hand-off or introduction of risk •Reduce chance of “wrong patient/wrong organ” and chance for accidental ABOi transplant Changes will address FMEA 1, 2, 4, 5, and 7 ABO Verification (Time Out): Changes from current policy Deceased donor when the intended recipient is known Post public comment to align with CMS Living donor all cases prior to general anesthesia Timing and scope is made safer for deceased and living donors ABO Verification (Time Out): Changes from current policy Organ Check In New-Conditional when organ received from outside OR suite Addresses FMEA #4 Pre-Transplant Verification New-Conditional when surgery starts prior to organ arrival Addresses FMEA # 5, # 2 ABO Verification (Time Out): Changes from current policy All verification requirements now listed in responsible party policy Includes list of ID elements and acceptable verification sources Post public comment for clarity Post public comment more detailed for clarity Transplant surgeon and licensed health care professional included in pre-transplant verification Post public comment to align with CMS Sample Table of Verification Requirements Information to Verify: Acceptable Verification Sources: Donor ID Organ (and laterality if applicable) External and internal organ package labels Documentation with organ Organ received Donor blood type and subtype (if used for allocation) Donor blood type and subtype source documents Recipient unique identifier Recipient identification band Recipient blood type Recipient blood type source documents Recipient medical record OPTN computer system Recipient medical record Attestation following verification of donor and recipient blood types Recipient medical record OPTN computer system Donor and recipient are blood type compatible (or intended incompatible) Correct donor organ has been identified for the correct recipient ABO Verification: Alignment with CMS Safer OPTN CMS Intended Recipient is Known: Prior to recovery If organ in same suite: Before leave room and when enter recipient room Intended Recipient is Known: Prior to recovery Living Donor All: Prior to general anesthesia If organ in same facility; Before leave room and when enter recipient room All: Before removal donor organ Candidate After organ arrival prior to transplant Deceased Donor After organ arrival, prior to transplant Substantive ABO Policy Changes Requirement Timing Changes Current Proposed Align with CMS Two ABO results must be obtained for deceased and living donors • Prior to incision • Prior to recovery • Prior to match run • Prior to generation of donor ID incision Living donor recovery verification must be conducted Prior to leaving OR Prior to general anesthesia for donor incision Current Deceased donor pre Practice recovery verification (time Expanded to out) must be conducted All Cases Living donor recovery verification (time out) must be conducted If organs remain in All cases same OR suite New Organ check-in Conditional Actions Pre-procedure ABO verification None If organ arrives from different OR suite no rule None If recipient surgery starts prior to organ receipt no rule If organs remain in All cases same OR facility Eliminates verification when leaving donor OR OPO Programming Liver ABOi Registrations • Add warning • Address FMEA #3 Match Run • Add candidate blood type on view • Highlight ABO compatibility status with symbol ! ! • Human factors tool will assist with verifications Resolution 14 (page 31) RESOLVED, that additions and modifications to Policies 1.2 (Definitions), 2.6 (Deceased Donor Blood Type Determination and Reporting), 2.15.B (Organ Procurement Procedures) 3.3 (Candidate Blood Type Determination and Reporting before Waiting List Registration), 5.4.B (Order of Allocation), 5.5.A (Receiving and Reviewing Organ Offers), 5.6 (Blood Type Verification Upon Receipt), 5.7 (Released Organs), 13.6.A (Requirements for Match Run Eligibility for Candidates), 13.6.B (Requirements for Match Run Eligibility for Potential KPD Donors), 14.4.A (Medical Evaluations for Living Donors), 14.6 (Registration and Blood Type Verification of Living Donors before Donation), 16.1 (Organs Not Requiring Transport), and 16.4.C (Internal Labeling of Blood and Tissue Typing Materials) as set forth below, effective May 1, 2015. and… Resolution 14 (page 31) FURTHER RESOLVED, that programming modifications to ABO incompatible liver registrations and match run displays for candidate blood type and compatibility status as set forth in Exhibit B are hereby approved, effective pending programming and notice to the OPTN membership. Questions? Thank you! Theresa Daly, Committee Chair thd9003@nyp.org Susan Tlusty, Committee Liaison susan.tlusty@unos.org