Safety in Transfusion Medicine

1. By
Dr. Nashwa Elsayed
ClinicalPathologist,MB.BCH,M.Sc,CPHQ
Laboratory& BloodBankQualityManager
KFHM AccreditationsManager
Hemovigilance

2. Blood Transfusion Process
Hemovigilance
Dr. Nashwa Elsayed
Transfusion is a Multistep Process in which the members
of different profession mainly Doctors, Nurses, Laboratory
Scientists and also The Donors & Recipients of transfusion
are participated.

3. The Transfusion Medicine Include:
1. Laboratory Medicine,
2. Clinical Medicine,
3. Pharmaceutical-like Production.
Transfusion Services is
a Complex Process
Hemovigilance
Dr. Nashwa Elsayed

4. Blood Transfusion Process
Hemovigilance
Dr. Nashwa Elsayed
There is a chance for the development of several risk
points.
Mistakes mostly arose from the Omission Of Essential
Checks (shortcuts) andperhaps an assumption that
someone else is responsible for safety.
Comparing with the riskof infectionformtransfusion, the risk of receiving
the wrong blood was considerablyhigher.

5. Blood Transfusion Process
Hemovigilance
Dr. Nashwa Elsayed
An error in the process such as;
 At the point of blood sampling (Donor or Patient)
 In the laboratory (Testing or Component Preparation)
 At bedside administration .

6. Hemovigilance
Dr. Nashwa Elsayed
Hence, The Hemovigilance Systemwas Developed with
The Ultimate Goal of
Improving The Safety Of BloodTransfusion.

7. What is Hemovigilance?
Hemovigilance
Dr. Nashwa Elsayed
A Set Of Surveillance Procedures Covering The Entire
Transfusion Chain,
FromThe Donation, Processing of Blood & Its Components To
Their Provision & Transfusion To Patients and Their Follow-up.

8. What is Hemovigilance?
Hemovigilance
Dr. Nashwa Elsayed
Haem = Blood
Vigilance = to be alert
Awareness , Attention
Paying Particular Attention to ………..

9. Hemovigilance Milestones
1993
• FrenchHemovigilancesystemestablishedby TransfusionSafetyAct.
1996
• UnitedKingdomSHOTschemeformallyestablished.
2002
• EU Directive2002/98/ECidentifiesrequirementfor Hemovigilancesystems.
2005
• EUDirective2005/61implementsformalrequirementfor Hemovigilanceschemesin memberstates.
2008
• US Biovigilanceinitiativeannounced.
Hemovigilance
Dr. Nashwa Elsayed

10. Hemovigilance
Dr. Nashwa Elsayed
Safety of the Transfusion Chain Require
Traceability fromVeinto Vein

11. Blood Transfusion Chain
Recruitment
Collection
Transportation
Hemovigilance
Dr. Nashwa Elsayed
Issuing
Transfusion
Follow-up
Testing
Processing
Prescribing

12. Blood Safety
Hemovigilance
Dr. Nashwa Elsayed
Patient Blood
Management
HemovigilanceAccreditation

13. Hemovigilance ensure Blood Safety
Hemovigilance
Dr. Nashwa Elsayed
Right Blood
Right Patient Right Time

14. Any adverse events related to any step
related to the transfusion chain
1 • Monitoring,
2 • Reporting,
3 • Investigation
4 • Analysis
5 • Taking Actions To Prevent Their Occurrence or Recurrence.
Hemovigilance
Dr. Nashwa Elsayed

15. Type of Events
• Reactions (Donor & Patient)1
• Errors (Deviations from SOPs)2
Hemovigilance
Dr. Nashwa Elsayed

16. Events
Hemovigilance
Dr. Nashwa Elsayed
 Near Miss
 Serious Adverse Event

17.  Errors in the collectionand testing of blood samples;
 Errors in the identificationof patients;
 Inappropriate use of blood products (e.g. accidental over transfusion);
 Incorrect blood product transfused;
 Adverse reactions associatedwith the transfusionof blood products.
 Significant deviations fromprotocols; Near misses;
Hemovigilance
Dr. Nashwa Elsayed
Events in Blood Transfusion

18. Adverse Reaction Management Steps
Hemovigilance
Dr. Nashwa Elsayed
Detect
Treat
Counsel Record
Follow up
Review
Preventive
Measure
Bench Marking

19. Managing Hemovigilance
at National Level
Hemovigilance
Dr. Nashwa Elsayed

20. The NHS Process
Hemovigilance
Dr. Nashwa Elsayed
Transfusion
reaction/incident
• Report by
clinicalstaff
/transfusion
specialist to
BTS / BB
Investigation of
reaction /incident
• Reportto
hospital
transfusion
committeeand
Hemovigilance
officer
Reportingto NHS
• NHS datacollection,
analysis,confidential
feedback, annul
report and
recommendations
• Rapidalertsystem

21. Managing Hemovigilance
at Hospital Level
Hemovigilance
Dr. Nashwa Elsayed

22. Hemovigilance at Hospital Level
Hemovigilance
Dr. Nashwa Elsayed
1. Clinical Guidelines
2. Policies andProcedures
3. Resources
4. Mechanismof reporting of reactions / incidents
5. QualityIndicators
6. Hospital Transfusion Committee
7. TransfusionNurse / Hemovigilance officer
8. Awareness, Training andEducation to allstaff involvedin Transfusion Chain.
9. Management Support

23. Hemovigilance
Dr. Nashwa Elsayed
Flowof Hemovigilance Data

24. King Fahad Hospital
Experience in Hemovigilance
Hemovigilance
Dr. Nashwa Elsayed

25. Implemented Hemovigilance System in KFHM
Hemovigilance
Dr. Nashwa Elsayed
 Policies andProcedures for all stepsin Blood Transfusion Chain
 Maximum Surgical Blood Ordering Schedule
 Good reporting(Non-punitive culture)
 Active & Effective Hospital TransfusionCommittee
 TransfusionSafetyNurse (NursingAudit)
 Hemovigilance Officer (Blood BankQualityManager)
 QualityIndicators
 Investigation& Followup of all reports
 Continuous Training andEducation

26. The Adverse Donor Events
KFHM ( January – November 2019)
Hemovigilance
Dr. Nashwa Elsayed
623
516
595
695
472 474
626
480
649
687
642
0
100
200
300
400
500
600
700
800
Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19 Nov-19
Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19 Nov-19
No. of Donors 623 516 595 695 472 474 626 480 649 687 642
Adverse Doonor Reaction 21 13 11 7 7 13 19 6 6 20 8
1st Time Donation 12 4 2 4 4 7 6 3 3 6 5

27. The Adverse Transfusion Events
KFHM ( January – November 2019)
Hemovigilance
Dr. Nashwa Elsayed
594
484
591 581
601
560
606 609
525
563
578
0
100
200
300
400
500
600
700
Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19 Nov-19
Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19 Nov-19
No. of Transfusions 594 484 591 581 601 560 606 609 525 563 578
Adverse Transfusion Reaction 2 2 0 3 4 1 3 1 0 2 2

28. Blood Components Disposal
KFHM ( January – November 2019)
Hemovigilance
Dr. Nashwa Elsayed
Month
No. of
Collected
Units
No. of
Disposed
Units
Cause of Disposal
TTD +ve Rejected
Open
System
Low
Volume
High
Volume
Expired DAT +ve other
Jan 19 620 113 35 29 8 13 12 15 0 1
Feb 19 516 72 22 16 3 18 0 12 0 1
Mar 19 581 90 33 14 1 22 0 17 2 1
Apr 19 695 99 29 27 4 32 0 1 0 6
May 19 472 76 21 44 1 6 0 2 2 0
Jun 19 464 67 37 7 1 19 0 1 0 2
Jul 19 626 93 37 18 2 33 0 0 2 1
Aug 19 480 70 30 17 0 17 0 0 1 5
Sep 19 644 115 43 25 8 22 8 2 0 7
Oct 19 687 122 52 19 8 35 0 5 2 1
Nov 19 642 83 32 20 8 14 2 2 3 2

29. Blood Components Disposal
KFHM
Hemovigilance
Dr. Nashwa Elsayed

30. Hemovigilance Chart
KFHM ( January – November 2019)
Hemovigilance
Dr. Nashwa Elsayed
0
200
400
600
800
1000
1200
1400
Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19 Nov-19
Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Oct-19 Nov-19
No. of Donors 623 516 595 695 472 474 626 480 649 687 642
Adverse Donor Events 21 13 11 7 7 13 19 6 6 20 8
No. of Requests 1113 929 1134 1078 1052 936 1177 1032 996 1109 1057
No. of Transfusions 594 484 591 581 601 560 606 609 525 563 578
No. of Transfusion Reaction 2 2 0 3 4 1 3 1 0 2 2
Incidents 2 4 2 1 3 2 3 0 1 2 2

31. Major Constraints
Hemovigilance
Dr. Nashwa Elsayed
Absent legal frameworkfor transfusion service
Staff and funding for Hemovigilance is low
Weak quality systems in most transfusion facilities e.g. weak bedside
documentationpractice, few audits
Low awarenessof transfusionreactions among clinical staff
Under-reporting of blood and transfusion data

32. Conclusion
Hemovigilance
Dr. Nashwa Elsayed
• Development of efficient HV will improve Blood TransfusionSafety
• HV can be used to providea rapid alertsystemto prevent recurrenceof
transfusion hazards
• Training, educationand increasing awareness among workersin blood
transfusion facilitiesis mandatory.
• Supportand actionis needed by National Blood Authority for Managing
suchsystemat national and hospital level.

33. References
• WHO2016 Guide To EstablishingA Hemovigilance System
• AABB2016
• Faber. Hemovigilance: muchmore than a register, VoxSanguinis 2007.
• Hemovigilance, An Effective Tool ForImprovingTransfusion SafetyEditedby Rene R.P.
DE VariesandJean-Claude Faber.
• www.isbtweb.org
• www.ihn.org.com
Hemovigilance
Dr. Nashwa Elsayed