haemovigilance implementation

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Haemovigilance in

Developing Countries

Haemovigilance in

Developing Countries

Dr Neelam DhingraCoordinator

Blood Transfusion SafetyWHO, Geneva

Dr Neelam DhingraCoordinator

Blood Transfusion SafetyWHO, Geneva

BTSBTSBTS

Essential Health Technologies

Blood Transfusion Safety

Haemovigilance in Developing CountriesOutline of the Presentation

Haemovigilance in Developing CountriesHaemovigilance in Developing CountriesOutline of the PresentationOutline of the Presentation

Why haemovigilance?

Where are we?

– data from WHO Blood Safety Indicators

What are the problems?

– challenges and barriers to monitoring transfusion outcomes and to data collection in hospitals

– country stories

What should be done to address these challenges?

– country stories

– WHO Blood Transfusion Safety programmatic activities



WHO Guidelines on Adverse Event Reporting and Learning Systems 'From Information to Action'

WHO Guidelines on Adverse Event Reporting and WHO Guidelines on Adverse Event Reporting and Learning Systems 'From Information to Action'Learning Systems 'From Information to Action'

Emphasize the fundamental role of reporting systems in enhancing patient safety by learning from failures of the health care system

Effectiveness of such systems should be measured not only by data reporting and analysis but by the use of such systems to improve patient safety

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Transfusion - a Multistep ProcessTransfusion Transfusion -- a Multistep Processa Multistep Process

Recruitment Testing Prescribing Transportation Follow-up

Collection Processing Issuing Transfusion

BTSHospital

Blood Bank Clinical Area

Blood donor

Patient

To identify and prevent occurrence/recurrence of transfusion related unwanted events, to increase the safety, efficacy and efficiency of

blood transfusion, covering all activities of the transfusion chain from donor to recipient



Haemovigilance SystemHaemovigilance SystemHaemovigilance System

A system of haemovigilance is dependent on:

– traceability of blood and blood products from donors to recipients

– spontaneous reports of transfusion adverse events/reactions

– rigorous management of information related to the transfusion process

Information generated through this system is a key to:– introduce required

changes in the transfusion policies

– improve transfusion standards

– assist in the formulation of transfusion guidelines

to increase the safety and quality of the entire transfusion process



Blood Safety Indicators Global Database on Blood SafetyBlood Safety Indicators Blood Safety Indicators

Global Database on Blood SafetyGlobal Database on Blood Safety

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National Haemovigilance Systems

1

11

30

3

14

78

23

8

05

101520253035

Low (n=12) Medium (n=48) High (n=45)

HDI

No

of c

ount

ries

Yes In process No

Yes: 42; In Process: 24; No: 39 Data from 105 countries: WHO Global Database on Blood Safety 2004-05


Blood Transfusion SafetyYes: 42; In Process: 24; No: 39 Data from 105 countries: WHO Global Database on Blood Safety 2004-05



Hospital Transfusion Committees

5

10 0

108

13

8

42

15

0

2

4

6

8

10

12

14

16

~25% ~50% ~75% ~100%

% Hospitals

No

of C

ount

ries

Low (n=6) Medium (n=22) High (n=29)

<50% in 36 countries and >50% in 21 countries Data from 57 countries: WHO Blood Safety Indicators 2006-07

64%64%

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Blood Transfusion Safety<50% in 36 countries and >50% in 21 countries Data from 57 countries: WHO Blood Safety Indicators 2006-07



% Hospitals Reporting Adverse Transfusion Events/Reactions

8

30

19

30

13

9

35

26

2

0

5

10

15

20

25

30

~25% ~50% ~75% ~100%

% Hospitals

No.

of C

ount

ries

Low HDI Medium HDI High HDI




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Mechanism of Reporting Adverse Transfusion EventsMechanism of Reporting Adverse Transfusion EventsMechanism of Reporting Adverse Transfusion Events

41/91 countries (26 H, 13 M, 2 L) reported all hospitals in the country with a system of reporting adverse transfusion events

Only 29/41 countries (3 countries - AFRO, 16 countries -EUR, 1 country - EMR, 2 countries - SEAR and 7 countries - WPR) provided data on serious adverse transfusion events, varying from 0 to 923 during the year 2006-07

Altogether 3895 serious adverse transfusion events were reported from 27990 hospitals in 29 countries collecting 15, 808, 738 blood donations



% of Hospitals with SOPs for Blood Administration

1 1 3

2718

95

50

26

4 3

25

0

10

20

30

40

50

60

100% <100% 0 unanswered

No

of c

ount

ries

Low Medium High




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Case Study: Cameroun(Maternity Ward, 1977)

Case Study: Cameroun(Maternity Ward, 1977)

Nurse randomly picks out a unit of blood from refrigerator for a 32 yr female patient

No procedure in place, no bedside check…

Patient restless within 3 min of onset of transfusion

Staff ties her up to the bed

Receives all blood; renal failure, death

While this is an old story of 1977, even today, such stories are ongoing & may be more common than realized or reported

Courtesy: Mbanya, D: University of Yaoundé



Blood Safety in Sub-Saharan AfricaBlood Safety in Sub-Saharan Africa

Only 3 countries (Côte d'Ivoire, Morocco and South Africa) in the entire African continent reported a national haemovigilance system

Almost half of the countries of the region lack data collection and quality control systems for their blood banks

Very limited data on transfusion outcome/adverse events in Africa

Rare studies show numerous and frequent transfusion incidents

In Cameroon, 5 yr evaluation on 40,000 transfusions showed adverse transfusion reactions (mainly fever and urticaria) in >50% whole blood transfusions

Tayou Tagny C, Mbanya D, Tapko J-B, and Lefrère J-JBlood safety in Sub-Saharan Africa: a multi-factorial problem. Transfusion 2008



Barriers to Monitoring Transfusion Outcomes & Data Collection in Hospitals

Barriers to Monitoring Transfusion Outcomes & Barriers to Monitoring Transfusion Outcomes & Data Collection in HospitalsData Collection in Hospitals

Ignorance: major barrier for monitoring outcomes & data collection - relevance of reporting not recognized

Problems related to system, resources, tools, coverage and quality of data, staff availability and training

Lack of, or failure to implement, policies and procedures

Chronic staff shortage overstretches few

Poor salaries, lack of career structure, lack of training or frequent transfers of trained staff

Non-identification of signs and symptoms of adverse transfusion events

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Lack of clarity on roles and responsibilities, channels of communication

– Who reports? What? How? When? Where?

– Who manages the collected data?

– Is there a central repository?

Lack of tools or mechanism of data collection, few data analysed, little action taken based on data analysed

Lack of feedback mechanisms to the concerned (corrective action??)

Barriers to Monitoring Transfusion Outcomes & Data Collection in Hospitals

Barriers to Monitoring Transfusion Outcomes & Barriers to Monitoring Transfusion Outcomes & Data Collection in HospitalsData Collection in Hospitals



Preventable Errors related to TransfusionPreventable Errors related to TransfusionTertiary care hospital in India, one yr period

Sharma RR, Kumar S, Agnihotri SK Vox Sang 2001; 81: 37-41

No. of blood/blood components transfused: 60,500

Total errors detected: 123

In the BB : 16 (13%) Outside the BB : 107 (87%)

Clerical = 12Technical = 4 Labeling errors = 73

Inadequate transfusion details = 19Non-uniform ID number = 9In-transit errors = 8

Result of errors

Delay in issueIncorrect B/C issueAHTR in 3 patients

Patient bedside



Challenges and Barriers to Establishing Haemovigilance Systems

Challenges and Barriers to Establishing Challenges and Barriers to Establishing Haemovigilance SystemsHaemovigilance Systems

While TTIDs continue to attract considerable attention, no significant advances to minimize preventable transfusion errors in developing countries

Transfusion errors always remain under-reported due to:

– a lack of awareness about transfusion-related adverse events among the hospital staff

– inadequate feedback systems

Paucity of transfusion data and presence of major gaps in systems for monitoring transfusion practices

'Blood usage' and 'monitoring of transfusion practice' issues of global concern

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Major ProblemsMajor ProblemsMajor Problems

Insufficient knowledge / Ignorance

System defects

Attitude problems / Carelessness



Different Haemovigilance SystemsDifferent Haemovigilance SystemsDifferent Haemovigilance Systems

Over the last 15 years, several countries have established haemovigilance systems in order to improve the safety of transfusion process

Significant differences in haemovigilance systems around the world

– organizational models

– reporting requirements

– coverage of entire or limited part of the transfusion chain, and

– level of development of the health care system as a whole



Haemovigilance Systems in Countries with Limited Resources

Haemovigilance Systems in Countries with Limited Haemovigilance Systems in Countries with Limited ResourcesResources

Can be achieved more readily through a stepwise implementation

Need to adapt tools and systems used in developed countries

Most initiatives will be unattainable and will fail if initiated at an inappropriate level

Approach in South Africa

– started with identifying the hazards of transfusion with greatest risk to transfusion recipients in South Africa

– Using a manual process, information on serious reactions collected retrospectively using a questionnaire

Advice for resource-limited countries: Start at a smaller level with a simple basic approach, acknowledge shortcomings and improve continuously

Nel Teresa JClinical guidelines, audits and haemovigilance in managing blood transfusion needs. Transfusion

Alternatives in Transfusion Medicine 2008; 10: 61–9.

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Addressing ChallengesAddressing ChallengesAddressing Challenges

As initial stages, these systems may not be established as national level, but at institutional or regional level due to

– lack of national mechanisms to report and manage data related to the transfusion process

– poor traceability between the donors and patients

Set up systems, even if unsophisticated, which work, despite persistent obstacles

Produce institutional transfusion guidelines

Ongoing Training

Set up Transfusion Committees



WHO Blood Transfusion Safety Programme

WHO Blood Transfusion Safety WHO Blood Transfusion Safety ProgrammeProgramme

VisionVision

Universal access to safe blood transfusion

MissionMission

Facilitate equitable access and appropriate use of safe and quality blood/blood products worldwide

Ensure donor and patient safety, and contribution of BT to patients' health and survival



WHO Initiatives to Support Developing Countries on Haemovigilance

WHO Initiatives to Support Developing Countries on WHO Initiatives to Support Developing Countries on HaemovigilanceHaemovigilance

Goal to strengthen and expand national systems for:

– data collection and management

– risk assessment and management

– surveillance and vigilance

for policy decisions and programme planning for safe blood transfusion

Norms, standards, recommendations, guidelines, materials and tools

Global Database on Blood Safety (GDBS) and Blood Safety Indicators (BSI), data on situation of BTSs and key blood safety indicators from 194 countries

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WHO Global Consultation on Universal Access to Safe Blood Transfusion

WHO Global Consultation on WHO Global Consultation on Universal Access to Safe Blood TransfusionUniversal Access to Safe Blood Transfusion

Developing Quality Systems throughout the Blood Transfusion Chain

Build national and regional capacity for the implementation of quality systems in BTSs

Encourage national health authorities to establish systems bi-directional traceability of all blood/blood products

Provide guidelines, tools and technical support for the establishment of national haemovigilance systems

Foster and support the creation of a Global Haemovigilance, Surveillance and Alert Network

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WHO Global Collaboration for Blood SafetyWHO Global Collaboration for Blood SafetyWHO Global Collaboration for Blood Safety

Recognized the importance of haemovigilance as an element of TQMfor blood programmes

GCBS participants engaged in haemovigilance networking agreed tocooperate in the dissemination of established definitions and tools of haemovigilance applicable in different settings

GCBS tasked interested participants to:

– Identify existing gaps and potential duplication of initiatives for a global haemovigilance network

– Consider strategies for:

Local monitoring of complications of donations and transfusions

International benchmarking of rates of donation and transfusion incidents

Rapid alert systems



WHO Initiatives to Support Developing CountriesWHO Initiatives to Support Developing CountriesWHO Initiatives to Support Developing Countries

Global Steering Committee on Haemovigilance (GloSH), a collaborative effort of WHO, Federal Govt. of Canada, EHN, ISBT and other key partners

– Focus on the needs of developing countries in establishing haemovigilance systems

– explore the possibilities of international data and information sharing

Capacity Building and training for the implementation of quality systems, data management and haemovigilance systems



WHO Recommendations: Basic requirements for BTSs(Haemovigilance)

WHO Recommendations: Basic requirements for WHO Recommendations: Basic requirements for BTSsBTSs(Haemovigilance)(Haemovigilance)

Use patient wristband to reduce incorrect patient identification

Establish traceability (document trail) from the blood donor and blood unit to recipient and vice versa, for adverse events to be investigated and corrective action taken

Organize as efficient national system, involving all relevant stakeholders

Include an integral part of quality system of health care establishment, covering entire transfusion chain

Define adverse events, near-misses and reactions

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Establish voluntary and non-punitive system

Maintain system to minimize recurrence

Analyse reported events in a timely way

Act upon recommendations for corrective and preventive actions in a timely manner

Have written procedures to initiate and coordinate to retrieve and recall

Maintain Confidentiality

Have a standardized report format

WHO Recommendations: Basic requirements for BTSs(Haemovigilance)

WHO Recommendations: Basic requirements for WHO Recommendations: Basic requirements for BTSsBTSs(Haemovigilance)(Haemovigilance)



Key MessagesKey MessagesKey Messages

A national haemovigilance system can be set up only when effective mechanisms exist for data collection in hospitals and coordination at national level

Stepwise and locally suitable implementation

Requires data to be collected using standardized tools from:

– blood centres

– hospital blood banks

– hospitals practising transfusion at provincial/regional and district levels

to improve national coverage, data quality and monitoring to identify and implement appropriate and timely actions



Vigilance systems required for known threats

Need for ongoing surveillance for unknown threats

[email protected]@who.int

www.who.int/bloodsafetywww.who.int/bloodsafety

www.who.int/worldblooddonordaywww.who.int/worldblooddonorday

Thank you

haemovigilance implementation

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