Electronic Issuing (Electronic Crossmatch)

1. Electronic Issuing (Electronic Crossmatch) Robert Fallis Director Diagnostic Services 2011-11-02 robert.fallis@blood.ca

2. What will you learn today about electronic crossmatching? • What is Electronic Issuing? • What do the current Standards require? • Recent experience in Manitoba • Advantages & Disadvantages • Why two ABO/Rh on patient samples? • Trace Line Phase II Project in Manitoba

3. What is the purpose of a Crossmatch Test? • Ensure ABO compatibility of donor component and recipient • To test for antibodies in recipient plasma against donor cells to prevent untoward transfusion outcomes.

4. When Blood Hits the Ceiling

5. Long-Standing Crossmatch Testing Procedure • A review of the patient’s transfusion history • ABO & Rh D typing of the patient • Antibody Screening • The Serological Crossmatch (either IS or IAT) • 1984 AABB Standards change to allow IS crossmatch if history and current testing indicates no antibodies. • Ensures ABO compatibility • May detect additional cold reacting or low frequency antibodies (IAT)

6. What is Electronic Issuing? • The selective replacement of the conventional serological crossmatch with an electronic procedure for the release of red cell components as compatible • The Electronic Issue allows for donor red blood cell components to be issued to a patient without serological testing

7. What has changed for Electronic Issuing to be possible • Improvements in the antibody screening cells for the detection of clinically significant antibodies • LISS, PEG, Gel, Solid Phase • Instrument automation, computer software and documented quality control procedures are now in place for guaranteeing ABO compatibility

9. Standard Changes • Three sets of Standards have been published for Electronic Issuing: • AABB (15th Edition in 1993) • CSTM (Version 1 in 2004) • CSA Z902 (Initial Release 2004) • Electronic Issuing implemented at CBS Winnipeg: February 2004 • Electronic Issuing implemented at CBS Regina: September 2010

10. CSA, AABB and CSTM Standards for Electronic Issuing state that there be: • Two blood groups on the recipient • ABO/Rh confirmation of donor units • The patients serum/plasma does not contain, and has not been known to contain clinically significant red cell alloantibodies reactive at 37°C • Extensive ‘on-site’ validation prior to introduction of Electronic Issue

11. Compatibility Criteria • When all the Standard requirements for Electronic Issue have been met, red cell components can be released as compatible without serological testing • If any one of the requirements cannot be fulfilled, Electronic Issuing is not possible and a serological crossmatch must performed

12. Seven Month Data Review Winnipeg (November 2010 to July 2011) • Total Antibody Screens Performed: 33,614 • Total Serological Crossmatches: 4,086 • 126 were Incompatible (approved for Use) • Negative Antibody Screens: 29,421 • 88% of patient samples eligible for Electronic Issuing • Patient samples without historical ABO/RH on file: 11,193 or 33% • Donor ABO/Rh received and confirmed: 29,053 • 86% of red cell components electronically issued

13. Red Cell Transfusions in WRHA 2006-2010 • 84,058 red cell transfusion in WRHA • ABO mismatches errors attributed to electronic issuing: None

14. Review of 130 Transfusion Reaction Data

15. Benefits of Electronic Issue to Blood Bank • Reduction in crossmatching workload. • Staff free to work on other transfusion issues e.g. accreditation. • Increases safety and promotes a more efficient working environment. • Reduced stress levels on laboratory staff • Cost saving for laboratory consumables?? • Improved Blood Stock Management if you move to on-demand issuing (Fresher Red Cells).

16. Disadvantages of Electronic Issuing • Extensive validation prior to the introduction of Electronic Issuing. • Risk of not detecting antibodies against low frequency antigens. No National antibody database. • Unexpected system failures leading to computer downtime or disruption to the LIS. • If there is a system failure revert to serological crossmatch. • The requirement for 2 ABO/Rh type results for the same patient. • Ideal situation is to have fully automated testing instruments with LIS interface to LIS

17. Two ABO/Rh Group on Patients • Policy: if no historical ABO/Rh group available test current sample twice • Some Transfusion Services require ABO/Rh from two different collection events • The risk of taking a sample from the ‘wrong’ patient or mislabelling the sample is an inherent risk and may lead to an ABO incompatible transfusion • The risk is not peculiar to Electronic Issuing. Should it be extended to all serological methods?

18. Collecting a Sample from the correct patient and labelling correctly is a major issue • The risk of taking a sample from the ‘wrong’ patient wrong blood in the tube, or mislabelling the sample is an inherent phlebotomy risk and represents an important ‘near-miss’ error which may lead to an ABO-incompatible transfusion • *Miscollected samples occurred at a median rate of 1 in every 1986 samples • The computer cannot lie BUT it can be fed the wrong information. * D. Lundy, S. Laspina, H. Kaplan, B. Rabin Fastman, and E. Lawlor, “Seven hundred and fifty-nine (759) chances to learn: a 3-year pilot project to analyse transfusion-related near-miss events in the Republic of Ireland,” Vox Sanguinis, vol. 92, no. 3, pp. 233–241, 2007

19. TRACE LINE® Phase II Pilot Project(Manitoba) • Joint effort between Manitoba Health, Diagnostic Services Manitoba and Canadian Blood Services • Project is managed by Canadian Blood Services • Project Charter: In 15 months from project kick off (January 2011), TRACE LINE® software will be implemented at three (3) Manitoba Hospital pilot sites (Brandon, Health Sciences Centre and Selkirk) • The TRACE LINE® software will replace existing manual systems for blood component and derivative inventory management

20. Bi-directional LIS connection Health Sciences Centre Pilot (Stock Inventory) Winnipeg CanadianBloodServices Central Site Samples Selkirk General Hospital (Stock Inventory) Westman Regional Lab Brandon Crossmatch Site Manitoba Centralized Transfusion Service TRACE LINE®Connection

21. Moving to “On Demand” issuing at Hospital Sites? • Traditionally red cell components assigned as per requisition • Trace Line Phase II will allow for patients that qualify for Electronic Issue, blood components will be issued when needed • Blood components will not be held for patients who ultimately may not need it • This result in a decrease in the outdating of blood

22. Aim of Trace Line Phase II • To encourage maximizing the electronic resource • Track transfusion of plasma protein products • To deliver a quicker turnaround time to the patient’s location • Create a provincial database of transfused patients • To minimize blood component and derivate wastage

23. What could be the future with better LIS Systems • Extend electronic issuing to patients with antibodies? • Loosen time constraints on acceptable sample age for crossmatch in patients known to be no-responders? • Reduce the incidence of antibodies through genotype matching patient with genotype donor (Dry Crossmatch) • Electronic bedside issuing

24. Questions?