Dr Gamini Perera, Consultant Transfusion Physician

1. Blood and Injection Safety
Dr Gamini Perera
Consultant Transfusion Physician
National Blood Centre

2. OverviewOverview of Blood Safty
• Introduction of Blood Safety
• Preventive strategies
• Testing in NBTS
• Strengthening the blood safety

3. blood safety - Definition
The degree to which the blood supply
for BLOOD TRANSFUSIONS is free of harmful
substances or infectious agents, and properly
typed and crossmatched (BLOOD GROUPING
AND CROSSMATCHING) to insure serological
compatibility between BLOOD DONORS and
recipients.
Pub med

4. SAFETY
• Safety is a RELATIVE concept
• NOTHING is 100% Safe
• It is only a POINT OF ACCEPTABILITY
between Benefits & Risks

5. BLOOD TRANSFUSION SAFETY
aims at achieving
Maximum Therapeutic benefits
of Blood Transfusion
with
minimum Risks
It is a journey, not a destination

6. Journey began in 1670s…….
During the early days transfusion from animals to humans, had been tried in many
different ways,
They were deemed to be unsuccessful, subsequently outlawed by the Paris Society of
Physicians because of reactions, many resulting in death.

7. A few important milestones ……..
1901 – Discovery of ABO blood groups by Karl Landsteiner,
1907 – Introduction of Pre transfusion testing through Blood typing and cross-matching
1939 – Discovery of Rh Blood group system by Karl Landsteiner and Wiener
1945 - Coombs, Mourant and Race described the use of antihuman globulin (the
“Coombs Test”)
1971 - Hepatitis B surface antigen (HBsAg) testing began in the United States.
1985 – Testing for HIV was started Blood banks in the US.

8. Blood Transfusion Today
It always carries potential risks for the recipient,
and should be prescribed only for conditions
with significant potential for morbidity or
mortality,
that cannot be prevented or managed
effectively by other means.
- WHO Recommendations on Blood Transfusion

9. 3 main potential risks
• Immunological risks
• Infection risks
• Procedural risks

10. Mechanisms to make sure blood safety
from Hepatitis
• Donor screening
• Donation testing
• Pathogen inactivation
• Rational use of blood
• Haemovigilance and look back

11. Transfusion Transmitted InfectionTransfusion Transmitted Infection
• A Transfusion transmitted infection (TTI) is a
virus, parasite, bacteria or other potential
pathogen that can be transmitted in donated
blood through a transfusion to a recipient.

12. Pathogens transmitted by blood transfusion
Viruses
Plasma borne Cell associated
• HIV 1&2 * HIV 1&2
• Hepatitis B * Cytomegalo virus
• Hepatitis C * Epstein Barr
• Parvovirus B 19 * Human T cell lymphotropic Virus I/II
• Hepatitis A & D
Parasites
• Plasmodium species - Malaria
• Trypanosoma cruzi - Chagas’ Disease
• Toxoplasma gondii - Toxoplasmosis
• Visceral leishmaniasis - Kala-azar
• Babesia microti - Babesiosis
Bacteria
Endogenous Exogenous
• Treponema pallidum- Syphilis * Staphylococcus epidermidis
• Brucella melitensis – Brucellosis * Pseudomonas - species
• Yersenia enterocolitica * Serratia marcescens
• Salmonella species

13. Factors Contributing to Emergence of InfectiousFactors Contributing to Emergence of Infectious
DiseaseDisease
• Human demographics and behavior
• Technology and industry
• Economic development and land use
• International travel and commerce
• Microbial adaptation and change
• Breakdown of public health measures
Institute of Medicine Report, 1992

14. Features of effective TTI causing pathogens
• Any infection with
– An asymptomatic blood-borne phase,
– The survival/persistence of the infectious agent in
collected blood or components,
– Ability to cause infection by the intravenous route,
– The agent which causes identifiable disease in the
recipient.

15. PathogensPathogens –– Known and screened byKnown and screened by
testingtesting
• HIV 1 & 2, HBV , HCV, Treponema
pallidum, malaria
• Testing
– mainly serological
– NAT - more sensitive WP

16. Strategies to reduce risk of transfusionStrategies to reduce risk of transfusion--
transmitted infectionstransmitted infections
Transfusion-transmitted infections (Review), Journal of Transfusion Medicine 2007

17. Preventive strategiesPreventive strategies -- Pre donationPre donation
• Donor/Organizer awareness
– Leaflets
– Banners
– Video clips
– Mass media programs
– Pre donation awareness programs
– Mobile organizer educational programs

18. DonorSelectionDonorSelection
• Donor Declaration Form
– `Donor Identification details

19. Patient SafetyPatient Safety
travelled abroad ?
Tuberculosis ?

20. PatientSafetyPatientSafety--STDSTD

21. Confidential Donor CounsellingConfidential Donor Counselling
• By a trained Medical Officer
• Confidential Interview
• Health check
• Decide eligibility for donation

22. WHO Recommendation for TTI testingWHO Recommendation for TTI testing
All whole blood and apheresis donations should be screened for
evidence of the presence of infection prior to the release of blood and
blood components for clinical or manufacturing use.
2. Screening of all blood donations should be mandatory for the
following infections and using the following markers:
HIV-1 and HIV-2: screening for either a combination of HIV
antigen-antibody or HIV antibodies
Hepatitis B: screening for hepatitis B surface antigen (HBsAg)
Hepatitis C: screening for either a combination of HCV antigen-
antibody or HCV antibodies
Syphilis (Treponema pallidum): screening for specific treponemal
antibodies.
3. Screening of donations for other infections, such as those causing
malaria or Chagas disease, should be based on local epidemiological
evidence.

23. WHO Recommendation for TTI testingWHO Recommendation for TTI testing
4. Screening should be performed using highly sensitive and specific
assays that have been specifically evaluated and validated for blood
screening.
5. Quality-assured screening of all donations using serology should
be in place before additional technologies such as nucleic acid
testing are considered.
6. Only blood and blood components from donations that are
nonreactive in all screening tests for all markers should be released
for clinical or manufacturing use.
7. All screen reactive units should be clearly marked, removed from
the quarantined stock and stored separately and securely until they
are disposed of safely or kept for quality assurance or research
purposes, in accordance with national policies.
8. Confirmatory testing of screen reactive donations should be
undertaken for donor notification, counselling and referral for
treatment, deferral or recall for future donation, and look-back on
previous donations.

24. TestingTesting
• Sensitive techniques
– ELISA- 3rd generation Ab testing
– 4th Generation ELISA (Ag-Ab)
– Chemiluminescence
– Nucleic acid Amplification Testing Pilot study
2014

25. Selection of test kitsSelection of test kits
• Validate with current test kits
• Evaluated by WHO or other recognized bodies
such as FDA etc.
• Registered in developed countries
• Used by other transfusion services
• Collaboration with MRI

26. Positive donorsPositive donors
• Tracing of donor & contacts
• Counselling and re-testing
• Deferrals & referrals
• Look back

27. Post TransfusionPost Transfusion
• Haemovigilance
• Trace back

28. HaemovigilanceHaemovigilance
• Haemovigilance is a set of surveillance procedures
covering the entire transfusion chain, from donation to
transfusion.
• Includes:
– monitoring, reporting, investigation and analysis of adverse
events related to the donation, processing and transfusion of
blood
– development and implementation of recommendations to
prevent their occurrence or recurrence
• National Haemovigilance Unit was established in 2009

29. Strengthening the blood safetyStrengthening the blood safety
• Future prospects
– Computerization of NBTS
• Computerized donor data base (donor details and previous
test results)
• Unique donor identity
• Improved donor deferral system ( temporary/ permanent)
• Facilitate look back & trace back
– Accreditation of testing centers – Already ISO-15189
(Laboratory Accreditation for Medical Labs in Sri Lanka)

30. Residual Risk (Remaining Risk)
Major sources of remaining risk are:
1. Window period donation
2. Viral variants not detect by current assays
Viral variant – rare among blood donors
( HIV gp O, HCV subtype, HBV mutant)
3. Immunosilent donor
4. Atypical seroconversion- 25% of total risk for HCV
5. Laboratory testing error

31. Window Period
• Time between viral infection and marker detection
• Symptoms are usually due to immune response & tissue damage to
virus
• Eclipse phase - virus replication is restricted to tissue sites with no
detectable viremia
• Infectious phase of window period is after eclipse and before
seroconversion
• Even with most sensitive NAT, exposure to seroconversion window
period will never be completely closed.

32. Future of Blood Safety will be with....
• 100% NAT non-reactive results before release
of blood products
• Automated and high-throughput systems with
computerization donor as well as patient info
• Pathogen inactivation for all products

33. Has to be achieved by Quality Assurance
from Vein to Vein
1. Safe Blood Supply
2. Safe Transfusion Practices
Two main components in Blood Transfusion safety

34. Critical Control Points in
Vein to Vein Quality Assuarance
Blood Transfusion Safety
Recruitment
Selection
Collection
Processing
TTI Testing
Dicision
Making
for Tx
Pre Tx
Testing
Issue
Administration
Hemovigilance
SAFE Tx PRACTCESAFE BLOOD SUPPLY

35. Summary –
Swiss cheese model of safety
Recognise that any system has gaps
Put systems to catch anything getting trough a gap
Donor qualification
Donor testing
Pooled plasma / ID EIA
Pooled plasma / ID NAT
Production process – Leuco depletion
Dedicated viral inactivation
TTVI
TTVI

36. Injection Safety

37. What is Injection Safety?
• Injection safety includes practices intended to prevent
transmission of infectious diseases between one patient
and another, or between a patient and healthcare provider,
and also to prevent harms such as needlestick injuries
A safe injection does not harm the
recipient, does not expose the provider
to any avoidable risks and does not
result in waste that is dangerous
for the community

38. Injection Safety
A safe injection, phlebotomy, lancet procedure,
or intravenous device insertion is one that:
1. Does not harm the recipient
2. Does not expose the provider to avoidable
risks
3. Does not result in waste that is dangerous to
other people
(WHO, 2010)

39. Injection Safety
• Unsafe injections can result in transmission of
a wide variety of pathogens.
• They can also cause non-infectious adverse
events such as abscesses and toxic reactions.
• Reuse of syringes or needles is common in
many settings exposing patients either directly
(via contaminated equipment) or indirectly
(via contaminated medication vials).
(WHO, 2010)

40. Hepatitis B
• Recommendation is to vaccinate health
workers, including waste handlers, with
hepatitis B vaccine.
• The vaccination should be given during pre-
service training for those who did not receive
it in childhood.
(WHO, 2010)

41. “Rights” of Injection Safety
1. Right patient
2. Right drug
3. Right formulation
4. Right injection
equipment
(WHO, 2010)
5. Right dosage
6. Right time
7. Right route
8. Right storage
9. Right method of
disposal
10.Right documentation

42. Best Practices
• Best injection practices described are aimed at
protecting patients, health workers and the
community.
• General safety practices include:
-hand hygiene;
-gloves where appropriate
-use personal protective equipment
-skin preparation and disinfection
(WHO, 2010)

43. Best Practices
• Perform hand hygiene (use soap and water or
alcohol rub), and wash carefully, including
wrists and spaces between the fingers, for at
least 30 seconds.
• Use a single-use device for blood sampling.
• Disinfect the skin at the venepuncture site.
(WHO, 2010)

44. Best Practices
• DO NOT touch the puncture site after
disinfecting it.
• Where recapping of a needle is unavoidable,
use the one-hand scoop technique.
• DO NOT use a syringe, needle or lancet for
more than one patient.
(WHO, 2010)

45. Best Practices
• Discard used needles and syringes
immediately into a robust sharps container.
• Seal the container with a tamper-proof lid.
• Immediately report any incident or accident
linked to a needle or sharp injury and start
PEP as soon as possible.
(WHO, 2010)

47. Best Practices
• DO NOT leave an unprotected needle lying
outside the sharps container.
• DO NOT recap a needle using both hands.
• DO NOT overfill a sharps container.
(WHO, 2010)

48. Injection Safety
• Inspect the packaging of the device to ensure
that the protective barrier has not been
breached.
• Discard the device if the package has been
punctured, torn or damaged by exposure to
moisture, or if the expiry date has passed.
(WHO, 2010)

49. Injection Safety
• DO NOT change the needle in order to reuse
the syringe.
• DO NOT use the same mixing syringe to
reconstitute several vials.
• DO NOT combine leftover medications for
later use.
(WHO, 2010)

50. Injection Safety
• Single-dose vials – Whenever possible, use a
single-dose vial for each patient.
• Multidose vials – Only use multidose vials if
there is no alternative.
• Open only one vial of a particular medication
at a time in each patient-care area.
(WHO, 2010)

51. Injection Safety
• Keep one multidose vial for each patient, and
store it with the patient’s name on the vial in a
separate treatment or medication room.
• DO NOT store multidose vials in the open
ward.
• Discard a multidose vial if sterility or content is
compromised, expiry date or time has passed.
(WHO, 2010)

52. Injection Safety
• DO NOT use bags or bottles of intravenous
solution as a common source of supply for
multiple patients.
• Ensure that the patient is adequately prepared
for the procedure.
• Do NOT bend, break, manipulate or manually
remove needles before disposal.
(WHO, 2010)

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