BTS

Haemovigilance in Developing Countries

Dr Neelam Dhingra Coordinator Blood Transfusion Safety WHO, Geneva

Haemovigilance in Developing Countries

Outline 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 Essential Blood Transfusion Safety Health Technologies

WHO Guidelines on Adverse Event Reporting and 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

Blood Transfusion Safety

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Transfusion - a Multistep Process

Blood donor
Recruitment Testing Prescribing

Patient

Transportation Follow-up Transfusion

Collection

Processing

Issuing

BTS

Hospital Blood Bank Clinical Area

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 Essential Blood Transfusion Safety transfusion chain from donor to recipient Health Technologies

Haemovigilance System

A system of haemovigilance is dependent on:

Information generated through this system is a key to: traceability of blood and introduce required blood products from changes in the transfusion donors to recipients policies spontaneous reports of improve transfusion transfusion adverse standards events/reactions assist in the formulation of transfusion guidelines rigorous management of information related to the to increase the safety and transfusion process quality of the entire transfusion process Essential Blood Transfusion Safety Health Technologies

Global Database on Blood Safety

Blood Safety Indicators

Blood Transfusion Safety

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National Haemovigilance Systems

35 30 No of countries 25 20 15 10 5 0 Low (n=12) Medium (n=48) HDI 1 3 8 11 14 23

30

High (n=45)

Yes

In process

No

Yes: 42; In Process: 24; No: 39

Essential Blood Transfusion Safety Data from 105 countries: WHO Global Database on Blood Safety 2004-05 Health Technologies

Yes: 42; In Process: 24; No: 39

Essential Blood Transfusion Safety Data from 105 countries: WHO Global Database on Blood Safety 2004-05 Health Technologies

Hospital Transfusion Committees

16 14

64%
10 8 5 1 8 4 0 1 2 0

15

No of Countries

12 10 8 6 4 2 0

~25%

~50%

~75%

~100%

% Hospitals
Low (n=6)
<50% in 36 countries and >50% in 21 countries

Essential Blood Transfusion Safety Data from 57 countries: WHO Blood Safety Indicators 2006-07 Health Technologies

Medium (n=22)

High (n=29)

<50% in 36 countries and >50% in 21 countries

Essential Blood Transfusion Safety Data from 57 countries: WHO Blood Safety Indicators 2006-07 Health Technologies

% Hospitals Reporting Adverse Transfusion Events/Reactions

30 25 N o. of C ountries 20 15 10 5 0
~25% ~50% ~75% ~100%

26 19 13 8 9 3 3 3 0 0 5 2

% Hospitals
Low HDI
<50% in 45 countries and >50% in 46 countries

Medium HDI

High HDI

Blood Transfusion Safety WHO Blood SafetyEssential Data from 91 countries: 2006-07 HealthIndicators Technologies

<50% in 45 countries and >50% in 46 countries

Blood Transfusion Safety WHO Blood SafetyEssential Data from 91 countries: 2006-07 HealthIndicators Technologies

Mechanism 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
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% of Hospitals with SOPs for Blood Administration

60

No of countries

50

50 40 30 20 10 0

26 18 9 1 100% 1 4 <100% 3 5 0 3

27

25

unanswered

Low

Medium

High

Essential Blood Transfusion <50% in 18 countries and >50% in 52 countries Data from 70 Safety countries: WHO Blood Safety Indicators 2006-07 Health Technologies

<50% in 18 countries and >50% in 52 countries

Essential Blood Transfusion Data from 70 Safety countries: WHO Blood Safety Indicators 2006-07 Health Technologies

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

Essential Blood Transfusion Safety Courtesy: Mbanya, D: University of Yaound Health Technologies

Blood Safety in Sub-Saharan Africa

Only 3 countries (Cte 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 Lefrre J-J Essential Blood Transfusion Safety Blood safety in Sub-Saharan Africa: a multi-factorial problem. Transfusion 2008

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Barriers to Monitoring Transfusion Outcomes & Data 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 eventsBlood Transfusion Safety Essential Health Technologies

Barriers to Monitoring Transfusion Outcomes & Data Collection in Hospitals

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??)
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Preventable Errors related to Transfusion

Tertiary care hospital in India, one yr period
No. of blood/blood components transfused: 60,500 Total errors detected: 123 In the BB : 16 (13%)
Clerical = 12 Technical = 4

Outside the BB : 107 (87%) Patient bedside

Labeling errors = 73 Inadequate transfusion details = 19 Non-uniform ID number = 9 In-transit errors = 8

Result of errors
Delay in issue Incorrect B/C issue AHTR in 3 patients

Blood Transfusion Safety

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

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Challenges and Barriers to Establishing Haemovigilance 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 Essential Blood Transfusion Safety Health Technologies

Major Problems Insufficient knowledge / Ignorance System defects Attitude problems / Carelessness

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Different 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 Blood Transfusion Safety Essential Health Technologies

Haemovigilance Systems in Countries with Limited Resources

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 J Clinical guidelines, audits and haemovigilance in managing blood transfusion needs. Transfusion Essential Blood Transfusion Safety Alternatives in Transfusion Medicine 2008; 10: 619.

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Addressing 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
Blood Transfusion Safety Essential Health Technologies

WHO Blood Transfusion Safety Programme

Vision

Universal access to safe blood transfusion

Mission

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

Blood Transfusion Safety

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WHO Initiatives to Support Developing Countries on Haemovigilance

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 Essential Blood Transfusion Safety Health Technologies

Blood Transfusion Safety

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Blood Transfusion Safety

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WHO Global Consultation on Universal 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 Blood Transfusion Safety

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WHO Global Collaboration for Blood Safety

Recognized the importance of haemovigilance as an element of TQM for blood programmes GCBS participants engaged in haemovigilance networking agreed to cooperate 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

Blood Transfusion Safety

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WHO 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
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WHO Recommendations: Basic requirements for BTSs (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 Essential Blood Transfusion Safety
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WHO Recommendations: Basic requirements for BTSs (Haemovigilance)

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 Blood Transfusion Safety
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Key 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 actions Blood Transfusion Safetyand timely Essential

Health Technologies

Vigilance systems required for known threats Need for ongoing surveillance for unknown threats Thank you
bloodsafety@who.int www.who.int/bloodsafety

www.who.int/worldblooddonorday Essential Blood Transfusion Safety Health Technologies

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