Post on 08-Jul-2020
transcript
Proposal to Modify ABO Determination, Reporting, and
Verification Requirements Operations and Safety Committee
Spring 2015
§ 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
§ Reduce risk of accidental ABO incompatible transplants
§ Increase transplant safety
§ Improve policy consistency and clarity
§ Further align requirements with CMS
Goal of the Proposal
§ Address safety gaps
§ Provide clarity and consistency in policy
§ Further align policies with CMS
§ UNetsm changes enhance system safeguards for intentional ABOi transplants
How the Proposal will Achieve its Goal
§ OPOs conducting verification at recovery when the intended recipient is not known
§ Requiring on-site recovering surgeon to participate in verification
§ Additional requirements not needed given infrequency of unintended ABOi transplants
§ Proposed policy too prescriptive
§ Entire process was redesigned
Concerns noted in Public Comment
§ Requests for the following: § no differences from CMS requirements § updated templates and electronic solutions § postpone policy requirements until after ETT (TransNetsm)
implementation
§ Concerns about clarity of policy
General Public Comment Themes
Requirement Current Proposed Align 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
Living donor recovery verification (time out) must be conducted
Prior to leaving OR
Prior to general anesthesia for donor
Current Practice Expanded
Deceased donor recovery verification (time out) must be conducted
If organs remain in same OR suite
• Donor and organ info: All cases
• Recipient info: When intended
recipient is known 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-in None If organ arrives from different OR suite
no rule
Pre-procedure ABO verification
None If recipient surgery starts prior to organ receipt
no rule
Substantive ABO Policy Changes
ABO Determination: Core Principles
• Reduce chance of allocation being done on one erroneous lab result
Blood type and subtype results based on two laboratory tests
• Reduce chance of “wrong blood in tube” due to misidentification or label error
Samples drawn on different occasions. With each collection, a separate patient identification and labeling procedure conducted prior to the blood draw
§ Remove OPO option to have one blood draw sent to two labs
§ Require protocol to have process when ABO primary types do not match
§ Exception clause for accelerated deceased donation cases
ABO Determination: Changes from current policy
Deceased Donor
2 Blood types on separate occasions
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
§ Base reports on two lab results
§ Use source documents
§ Enter reports independently by two different users
§ Complete reports before becoming active in OPTN system
ABO Reporting: Core Principles
§ “Qualified health care professional” must report
§ Safer timing
§ Exception clause for accelerated deceased donation cases
§ Addresses living donor VCA reporting
ABO Reporting: Changes from current policy
ABO Reporting: Timing Changes
Deceased Donor
Living Donor
Candidate
Prior to Incision
Before organ recovery
Before recovery
Prior to Ac7ve OPTN Wait List
Medical eval prior to dona7on
Before on tx hospital wait list
OPTN CMS
Prior to Match Run
Prior to generate Donor ID
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
§ Deceased donor: Donor and organ info (All cases) Recipient info (When the intended recipient is known)
§ Living donor: All cases prior to general anesthesia
§ Timing and scope safer for all
ABO Verification (Time Out): Changes from current policy
§ Organ Check In § New § Conditional: When organ received from outside OR
suite
§ Pre-Transplant Verification § New § Conditional: When surgery starts before organ arrives
ABO Verification (Time Out): Changes from current policy
§ All verification requirements now listed in responsible party policy
§ What must verified and what can be used as a verification source put in table format
§ Transplant surgeon and licensed health care professional included in pre-transplant verification
ABO Verification (Time Out): Changes from current policy
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
AHer organ arrival, prior to transplant
All: Before removal
donor organ
AHer organ arrival, prior to transplant
OPTN CMS
Intended Recipient is Known: Prior to recovery
All: Prior to general
anesthesia
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
Subtype Second User Verification
• Align programming with current policy
• Program subtype to verified by second user
• Same process as is currently done for primary type
Programming
§ OPOs and Transplant Hospitals : § Define “qualified health care professional” in protocols and
process for resolving primary blood type conflicts § Be familiar with required verification information and
acceptable sources
§ OPOs : § Assure two blood type determination and reports completed
before match run § Conduct deceased donor organ recovery verification § Rerun match if organ not allocated on initial run or if data are
updated/reported
What Members will Need to Do
§ Transplant hospitals : § Conduct living donor organ recovery verification
before anesthesia § Conduct organ check-in when organs arrive from
different OR suite § Conduct pre-procedure verification when surgery
starts before organ arrives
What Members will Need to Do
§ Theresa Daly, MS, FNP Committee Chair thd9003@nyp.org § Regional Rep Name
Region X Representative email address
§ Susan Tlusty
Committee Liaison susan.tlusty@unos.org
Questions?
Extras if needed
Death
Accidental ABO
Transplant
Wrong Organ Arrived Wrong Organ/Wrong
Patient
Not On Match Run
Labeling errors
ABO Testing issues Communication issues
Changes to ABO data
Near Misses
Never Event
Number Failure Mode
1 OPO releases organ to recipient not on match run 2 Blood type verification does not occur prior to implantation 3 Candidate erroneously listed as accepting an ABO incompatible (pediatric heart,
liver) 4 Wrong organ arrived-not checked at arrival to verify correct organ arrived for the
correct potential recipient 5 If intended recipient surgery begins prior to arrival, no requirement for blood
source documentation availability to confirm compatibility prior to anesthesia 6 Blood samples are mislabeled (candidate) 7 Verification occurs without both source documents for recipient and donor 8 One blood sample sent and tested twice 9 Only one sample drawn and tested prior to match (no ABO confirmation by second
sample) 10 No pre-transfusion specimen is available for testing 11 Blood samples are mislabeled (donor)
Top Failure Modes