Haemovigilance Flashcards
What is the first escription of haemovigilance as put in place by french law
A set of surveillance procedures from the collection of blood and its components to the follow up of recipients, to collect and assess information on unexpected or undesirable effects resulting from the therapeutic use of labile products and to prevent their recurrence
Who was the first to incorporate haemovigilance and when?
First put in place in France
French Law regulation no 93-5, 1993
Define haemovigillance according to WHO
A set of surveillance procedures covering the entire transfusion chain, from the donation and processing of blood and its components to their provision and transfusion to patients and their follow-up.
It includes the monitoring, reporting, investigation and analysis of adverse events related to the dontion, processing and transfusion of blood, and taking actions to prevent their occurrence or recurrence
In you own words how do you know if something is reportable to NHO or not
Only haemovigiling blood components not errors in transfusion
If its a clinical decision then its not mandatry
In ireland we will still report both mandatory and non-madatory errors in transfusion
How did haemovigialance come about?
Haemovigilance was set up in 1994 in France in response to the HIV scandal in 1980s
Greek origin ; haema=blood, vigilans = paying particular attention to:
What did the development of haemovigilance give rise to?
An increase in public scrutiny of bloodsafety
Discussions in health services regarding methods to increase safety
Give the steps through history that lead to the development of Haemovigilance
In 1975 there was a pharmocovigilance directive 75/319/EEC
In 1991 France began monitoring transfusions
In 1992 the Centre National d’Haemovigilance was set up
In 1995 the word Haemovigilance appeared in documents in english
In 1995 there was an ISBT conference in Venice
In 1996 there was a Discussion Document - Adare
Finally SHOT launched in the UK
What developments occurred between 1994 and 1999?
At this point in time transfusion seemed like a major route of transmission of HIC and Hep C
Objectives of the Haemovigilance were wrtiien into law
Germany in 1994
Greece in 1995
Luxembourg/UK 1996-Serious Hazards of Transfusion (SHOT)
In 1998 the European Network on Haemovigilance set out objectives
Ireland 1999 -> we embraced it here -> we have the largest number of reports per transfusion in europe -> very thorough
What does EHN stand for?
European Network on Haemovigilance
What does the EHN do?
Aims to increase safety in blood transfusion through the rapid transfer of information and exerience, put in place rapid alert systems
Allows for the exchange of information between members
Encourages joint activities
Undertake educational activities in relation to haemovigilance
Why was the EHN set up
Haemovigilanc quickly revealed the need for countries to share information between each other
E.g. when plastic contaminated blood packs it was first noted in one country but then other countries could be notified -> this stopped other countries using these packs before they had been filled - prevented contamination
Why and when was haemovigilance set up in Ireland
Haemovigilance was set up in 1999 in response to recommendations of the Finlay tribunal of 1997
It was set up to collect serious adverse reactions and events
Our system has features of both SHOT and the French system
Talk about our NHO system in ireland
The NHO is based at the IBTS
The NHO first reported to the Irish Medicines Board but now report to the Health Product Regulatory Authority
NHO have been reporting to SHOT since 1996
Reporting to NHO by labs was voluntary up until Nov 2005 but it is now a legal obligation for mandatory reports under EU Directive
What are the two main flaws with our NHO system in Ireland
The NHO is meant to be investigating the blood transfusion office but in Ireland they actually work under their wing -> not ideal
The NHO is also located in the IBTS which isnt ideal as the NHO might end up investigating their colleages etc -> even though people are honest its not ideal
What EU Directive do we follow in BT
EU Directive 2002/98/EC
What were the three purposes of the EU Directive 2002/98/EC
To develop a standardised quality of blood and components within the EU
To develop a standardised haemovigilance network within the EU
To restore public confidence in blood transfusion throughout the EU
What aspects of EU directive 2002/98/EC relate to haemovigilance
Article 14 and 15 required haemomvigilance to be set up in hospitals
What does article 14 and 15 of EU Directive cover
14 = traceability
15 = Notification of serious adverse events and reactions
What put the EU directive 2002/98/EC into law in ireland
Commission Directive 2005/61/EC
How did the commission directive 2005/61/EC put haemovigilance into Irish law
Member States shall ensure that those facilities where transfusion occurs … notify blood establishments without delay of any serious adverse reactions observed in recipients during or after transfusion which may be attributable to the quality or safety of blood and blood componentns
It does not cover blood derivatives such as factor concentrates, immunoglobins, albumin, SD plasma
Why does the commission directive 2005/61/EC not cover blood derivatives
This is because haemovigilance didnt want to be involved in the prescription of blood products
What is the scope of EU Directive SAE reporting
The EU Directive covers the quality and safety of blood components extending from the blood establishment (i.e. transfusion centre) to the hospital blood bank
It does not extend to clinical aspects of the transfusion chain - haemovigilance is very laboratory and processing focused
Give an example of a common error that it is not madatory to report to haemovigilance
wbits are not mandatory to report as these happen in the clinical system
What is a seriouos adverse event
Any untoward occurrence associated with the collecting, testing, processing, storage and distribution of blood and blood components that might:
- lead to death
- be life-threatening
- casuses disabling or incapacitating conditions
- results in, or, prolong, hospitilisation or morbidity
- includes grouping and compatibility testing
- does not cover issuing for transfusion
What is a serious adverse reaction
An unintended response in a donor or in a patient associated with the collection or transfusion of blood or blood components that is:
- fatal
- life threatening
- disabling
- incapacitating
- or results in or prolongs hospitilisation or morbidity
Give some examples of a serious adverse events
Not giving cmv-
IBCT
Giving incorrect blood products
Errors delays or omissions relating to anti-D or factor concentrates etc
What does IBCT stand for?
Incorrect Blood Component Transfused
What does incorrect blood component transfused mean?
The transfusion of a blood component/prioduct which did not meet appropriate requirements and/or was intended for another patient
- SHOT definition
This also includes anti-D and factor concentrates
Incidents involving errors, delays or omissions relating to anti-D or factor concentrates
Talk about the IBCT levels of security
Three levels: level 1, level 2, level 3
Level 1: those with the potential for permanent injury or are life threatening and include wrong blood for wrong patient and the transfusion of blood components/products which were not required
level 2: unlikely to cause harm
Level 3: no realistic potential for harm
How do we address Haemovigilance in the hospital?
Its up to Medical scientists to take a lead role at least for issues that are under our control
Discuss haemovigilance issues at staff meetings
Haemovigilance Committee - consultants NCHD, Medical scientist and HVO
Report incidents to NHO
Transfusion surveillance or haemovigilance officer
Hospital Transfusion Committee
Medical Scientist Student Training in Haemovigilance
what is the dual aspect of haemovigilance programme in Ireland?
Hospital based presence
National Haemovigilance Office NHO
What is the hospital based presence of haemovigilance
Transfusion Surveillance Officer TSO (used to be called this) or
Haemovigilance Office or
In UK Transfusion Practitioner
What role foes haemovigilance have in the NHO
NHO was primarily staffed by nurses
Now there is a medical scientist working in the NHO
What is the role of the haemovigilance officer in the hospitals
Co-ordinate, management, investigation and reporting of SAR and SAE/IBCT to NHO
Promote best transfusion practice (clinical)
Quality focus, policies, risk management, audit and change
Education
provide feedback, hospital transfusion committee, patients, staff etc but not directly responsible for traceability but this often occurs by default as the HVOs are always going up into the wards etc
Talk about the expanding role of the national haemovigilance officer in hospitals
They are often involved in getting patient consent forms signed etc
Their role has expanded in practice
This proves there is a need for someone in this wider role
What is the remit of NHO
Receive, collate and follow up reports from hospitals and GPs of adverse reactions to blood components
Provide feedback information to reporters as appropriate
Advise on the follow up-action necessary particularly with regard to suspected hazards
Report adverse reaction to the HPRA according to an agreed procedure
Provide medical and scientific analysis of adverse reaction reports
What were the two underpinning philosophies of the NHO when it was founded
Patient safety
Improvement in transfusion practice
What is the current focus of the NHO
Annual conference and report
Quality and safety of products
Research
Guidelines
Education
Promoting excellence in transfusion practice
Support the training of hospital based HVO
Advise on improvements on the safety of transfusion practice based on the data made available by hospitals
Advise on clinical guidelines and hospital practice in relation to the se of bood components
Advise on the recording of transfusion data by hospital staff
How many staff run the NHO
NHO only has 2 and a half staff members
Even though they have a large scope its only a tiny office
One is a part time consultant who does all the reports etc
They do everthing relating to HIQA and IT etc
How does the NHO support education and training?
The NHO supports the training of medical, nursing and technical staff in HV through:
- Induction/training programmes
- National Transfusion Advisory Group
- audio conferences
- Hospita visits
- National Audits
- E-learning
- Workshops
- National Conferences
- Presentations
- Poster Competitions
- Clinical inquires
How do medical staff undergo training in BT?
Haemovigilance programme in DCU
Talk about the DCU programme on HV ran by the NHO for nursing staff
This is no longer ran i.e. there is no longer formal education for haemovigilance
Instead HV is thought like an apprenticeship out in hospitals
In DCU it was done as part of nursing but it was seen then as a nurses profession
It use to be that a nurse got a seniour nurses salary and a MS got a senior MS salary - thus it was a very attractive role to nursing staff
Nurses got parity now though and both have the salary of a senior MS
Where does the majority of education on HV come from?
The majority is learnt from the SHOT system then our own system
ITs not that our sstems doenst do it well its just that SHOT has gotten so good at i
How was Directive 2002/98/EC implemented
A steering committee was estabished to assist the Department of Health and Children (DoH&C) to implement it
ISO 15189 was followed
However since ISO 15189 doesnt fully meet requirements of the blood directives in the areas of traceability and haemovigilance an expert group on blood and blood components was also established
