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Modify ABO Determination, Reporting, and Verification Requirements (Resolution 14) Operations and Safety Committee Ms. Theresa Daly.

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Presentation on theme: "Modify ABO Determination, Reporting, and Verification Requirements (Resolution 14) Operations and Safety Committee Ms. Theresa Daly."— Presentation transcript:

1 Modify ABO Determination, Reporting, and Verification Requirements (Resolution 14) Operations and Safety Committee Ms. Theresa Daly

2  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 The Problem

3 Strengthen policy to reduce risk for unintended ABO incompatible transplant #4- Promote Transplant Patient Safety Strengthen policy to reduce risk for unintended ABO incompatible transplant #5- Promote Living Donor Safety Provide clarity to requirements and promote electronic solutions to support policies #6-Promote Efficient Management of OPTN Strategic Plan

4  Reduce risk of accidental ABO incompatible transplants  Increase transplant safety  Improve policy consistency and clarity  Align requirements Goal of the Proposal

5  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 How the Proposal will Achieve its Goal

6 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 Overall Project Impact

7 Public Comment Response Tally Type of Response Response Total In Favor In Favor as Amended Opposed No Vote/ No Comment/ Did Not Consider Individual 2416 (67%)03 (13%)5 (20%) Regional 117 (64%)04 (36%)0 Committee 191 (5%) 16 (85%) Public Comment Feedback

8  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 Comment Themes

9 Death Accidental ABO Transplant: 5 Wrong Organ Arrived Wrong Organ/Wrong Patient: 9 Not On Match Run: 240 Data entry issues: 9 ABO Testing issues: 9 Communication issues: 8 Labeling errors: 63 Changes to ABO data: 329 Near Misses Never Event 1/2012- 6/2014 Since 2006 2009-2012

10  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 Comment Themes

11 ABO Process Steps

12 RankNumberFailure ModeProces s Step 11OPO releases organ to recipient not on match run6 12Blood type verification does not occur prior to implantation8 23Candidate erroneously listed as accepting an ABO incompatible (pediatric heart, liver) 2 24Wrong organ arrived-not checked at arrival to verify correct organ arrived for the correct potential recipient 8 25If intended recipient surgery begins prior to arrival, no requirement for blood source documentation availability to confirm compatibility prior to anesthesia 8 36Blood samples are mislabeled (candidate)1 37Verification occurs without both source documents for recipient and donor 8 48One blood sample sent and tested twice1 49Only one sample drawn and tested prior to match (no ABO confirmation by second sample) 4 510No pre-transfusion specimen is available for testing4 511Blood samples are mislabeled (donor)4 Top Failure Modes

13 ABO Determination: Core Principles Reduce chance of allocation being done on one erroneous lab result (FMEA #9) Blood type and subtype results based on two laboratory tests Reduce chance of “wrong blood in tube” due to misidentification or label error (FMEA # 6,8, and 11) Samples drawn on different occasions. With each collection, a separate patient identification and labeling procedure conducted prior to the blood draw

14  Remove OPO option to have one blood draw sent to two labs  Post public comment to align with CMS  Require protocol to have process when ABO primary types do not match  Post public comment  Exception clause for accelerated deceased donation cases ABO Determination: Changes from current policy

15 Deceased Donor 2 Blood types on separate occasions Living Donor 2 Blood types on separate occasions Blood type must be done not specific Candidate 2 Blood types on separate occasions Blood type must be done not specific ABO Determination: Alignment with CMS CMS OPTN Safer

16  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: Core Principles

17  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: Changes from current policy

18 ABO Reporting: Timing Changes Deceased Donor Living Donor Candidate Prior to Incision Before organ recovery Before recovery Prior to Active OPTN Wait List Medical eval prior to donation Before on tx hospital wait list OPTN CMS Prior to Match Run Prior to generate Donor ID Safer

19 ABO Verification (Time Out): Core Principles Reduce chance of delayed or missed communication Confirmation of critical information includes surgeon Reduce chance of “wrong patient/wrong organ” and chance for accidental ABOi transplant Confirmation done at critical points of hand-off or introduction of risk Changes will address FMEA 1, 2, 4, 5, and 7

20  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

21  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

22  All verification requirements now listed in responsible party policy  Post public comment for clarity  Includes list of ID elements and acceptable verification sources  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 ABO Verification (Time Out): Changes from current policy

23 Information to Verify:Acceptable Verification Sources: Donor ID  External and internal organ package labels  Documentation with organ Organ (and laterality if applicable)  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 Donor and recipient are blood type compatible (or intended incompatible)  OPTN computer system  Recipient medical record  Attestation following verification of donor and recipient blood types Correct donor organ has been identified for the correct recipient  Recipient medical record  OPTN computer system Sample Table of Verification Requirements

24 ABO Verification: Alignment with CMS Deceased Donor Living Donor Candidate If organ in same suite: Before leave room and when enter recipient room Intended Recipient is Known: Prior to recovery If organ in same facility; Before leave room and when enter recipient room After organ arrival prior to transplant All: Before removal donor organ After organ arrival, prior to transplant OPTN CMS Intended Recipient is Known: Prior to recovery All: Prior to general anesthesia Safer

25 Requirement CurrentProposedAlign with CMS Timing Changes 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 Practice Expanded to All Cases Deceased donor pre recovery verification (time out) must be conducted If organs remain in same OR suite All cases OPO Living donor recovery verification (time out) must be conducted If organs remain in same OR facility All cases Eliminates verification when leaving donor OR New Conditional Actions Organ check-inNoneIf organ arrives from different OR suite no rule Pre-procedure ABO verification NoneIf recipient surgery starts prior to organ receipt no rule Substantive ABO Policy Changes

26 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 Programming

27  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)

28  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. Resolution 14 (page 31)

29 Thank you! Theresa Daly, Committee Chair thd9003@nyp.org thd9003@nyp.org Susan Tlusty, Committee Liaison susan.tlusty@unos.org susan.tlusty@unos.org Questions?


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