Hemovigilance

Safety in Transfusion Medicine

1. By
Dr. Nashwa Elsayed
Clinical Pathologist, MB.BCH, M.Sc, CPHQ
Laboratory & Blood Bank Quality Manager
KFHM Accreditations Manager


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) and perhaps an assumption that
someone else is responsible for safety.
Comparing with the risk of infection form transfusion, the risk of receiving
the wrong blood was considerably higher.

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 bed side administration .

6. Hemovigilance
Dr. Nashwa Elsayed

Hence, The Hemovigilance System was Developed with
The Ultimate Goal of
Improving The Safety Of Blood Transfusion.

7. What is Hemovigilance?
Hemovigilance
Dr. Nashwa Elsayed

A Set Of Surveillance Procedures Covering The Entire
Transfusion Chain,

From The 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
•French Hemovigilance system established by Transfusion Safety Act.
1996
•United Kingdom SHOT scheme formally established.
2002
•EU Directive 2002/98/EC identifies requirement for Hemovigilance systems.
2005
•EU Directive 2005/61 implements formal requirement for Hemovigilance schemes in member states.
2008
•US Biovigilance initiative announced.
Hemovigilance
Dr. Nashwa Elsayed

10. Hemovigilance
Dr. Nashwa Elsayed

Safety of the Transfusion Chain Require
Traceability from Vein to 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
Hemovigilance Accreditation

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 collection and testing of blood samples;
Errors in the identification of patients;
Inappropriate use of blood products (e.g. accidental over transfusion);
Incorrect blood product transfused;
Adverse reactions associated with the transfusion of blood products.
Significant deviations from protocols; 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
clinical staff
/transfusion
specialist to
BTS / BB
Investigation of
reaction /incident
• Report to
hospital
transfusion
committee and
Hemovigilance
officer
Reporting to NHS
•NHS data collection,
analysis, confidential
feedback , annul
report and
recommendations
•Rapid alert system

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

22. Hemovigilance at Hospital Level
Hemovigilance
Dr. Nashwa Elsayed
1.Clinical Guidelines
2.Policies and Procedures
3.Resources
4.Mechanism of reporting of reactions / incidents
5.Quality Indicators
6.Hospital Transfusion Committee
7.Transfusion Nurse / Hemovigilance officer
8.Awareness, Training and Education to all staff involved in Transfusion Chain.
9.Management Support

23. Hemovigilance
Dr. Nashwa Elsayed
Flow of Hemovigilance Data

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

25. Implemented Hemovigilance System in KFHM
Hemovigilance
Dr. Nashwa Elsayed

Policies and Procedures for all steps in Blood Transfusion Chain
Maximum Surgical Blood Ordering Schedule
Good reporting (Non-punitive culture)
Active & Effective Hospital Transfusion Committee
Transfusion Safety Nurse (Nursing Audit)
Hemovigilance Officer (Blood Bank Quality Manager)
Quality Indicators
Investigation & Follow up of all reports
Continuous Training and Education

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 framework for transfusion service
Staff and funding for Hemovigilance is low
Weak quality systems in most transfusion facilities e.g. weak bedside
documentation practice, few audits
Low awareness of transfusion reactions among clinical staff
Under-reporting of blood and transfusion data

32. Conclusion
Hemovigilance
Dr. Nashwa Elsayed

•Development of efficient HV will improve Blood Transfusion Safety

•HV can be used to provide a rapid alert system to prevent recurrence of
transfusion hazards

•Training, education and increasing awareness among workers in blood
transfusion facilities is mandatory.

•Support and action is needed by National Blood Authority for Managing
such system at national and hospital level.

33. References

•WHO 2016 Guide To Establishing A Hemovigilance System
•AABB 2016
•Faber. Hemovigilance: much more than a register, Vox Sanguinis 2007.
•Hemovigilance, An Effective Tool For Improving Transfusion Safety Edited by Rene R.P.
DE Varies and Jean-Claude Faber.
•www.isbtweb.org
•www.ihn.org.com
Hemovigilance
Dr. Nashwa Elsayed