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
What did the Steering Committee set up to implement Directive 2002/98 do
They agreed that ISO15189 would be the quality system required for hospital blood banks and this was specified in S. I No 360 of 2005
What did the Expert group on Blood and Blood components do?
Their aims were to specify the minimum requirements that need to be in place to ensure that hospital blood banks comply with the requirements of Article 14 and article 15
The ‘Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) and Article 15 (Notification of Serious Adverse Reactions and Events) of EU Directive 2002/98/EC’ -> AML-BB was compiled by this Group
Why did an expert group on blood and blood components need to be set up
as ISO15189 didnt meet the requirements of the blood directives in relation to article 14 and article 15
What is AML-BB
The Mimimum requirements for blood bank complicance with article 14 and 15
A document intended to assist INAB Assessors during the assessment of hospital blood banks to ISO 15189 Accreditation
It was set up with INAB, The academ and the NHO all working together
The name has changeed over the years
Talk abouot trends in Near miss events
We have had a high frequence of NMEs since 2010
This is because before 2007 we didnt have to capture NMEs
What were the laboratory implications of SI 360/2005 and SI 547/2006 for hospital blood banks and facilities
Laboratory:
- qualified/trained personnel/documentation
- quality system in place
- processes are validated
What were the hospital implications of SI 360/2005 and SI 547/2006 for hospital blood banks and facilities
Traceability of each unit to be kept for 30 yers
Mandatory reporting of SARs observed during or after transfusion which may be attributable to the quality and safety of blood and blood components
Mandatory reporting of serious adverse events related to testing (including compatibility testing), storage and distribution which may have an influence on their quality and safety
Covers compatiblity testing, selection of componens, labellin, storage in laboratory blood fridges
Distribution between hospitals not cromssmatched blood for hospital patient i.e. not on the ward
Does not cover SAEs in clinica areas
Explain the system of reporting in Ireland
Hospitals and Blood Estabishments report to the NHO
The NHO and INAB report to HPRA (the competent authority)
the HPRA report to the EU comission
In your own words what does the AMl-BB do
It decides what needs to be reporte to the NHO
Give two examples of what might be reported to the NHO
If a donor collapses
If a pack is contaminated
Comment on trends in reports send to the NHO year on year
Since the NHOs introduction reports rose year on year as we were finding new errors etc however they began to fall of from 2013 - finding ways of solving errors etc
There was a spike in 2010 as this is when we started including near miss events
Numbers decrease as we put in meaure to prevent mistakes etc
Now have between 300 and 400 reports a yar
What reactions are most common in transfusion?
Figures in adverse reaction lecture but:
- febrile most common
- allergic also common
SHOT combines febrile and allergic reactions together for stats hile ireland keeps them separate
What was the near miss study 2003-2005
A study done in Ireland by the NHO
Its famous
Looked at 759 near miss events over 3 years
What were the findings of the near miss study, what was the significance of these
They found that 55% of near misses involved doctors
27 % involved nursing
19% involved laboratory staff
4% inolved phlebotomy
3% involved clerical staff
2% invoved portering staff
1% involved patient
At this time these near misses were being seen but werent being reported -> this paper helpe back the need for reporting of them
Talk about the need for a group check sample
87.2% of errors are detected in the lab
This is the point in the process where a wrong blood in tube incidence could be detected
At first there was resistance to the 2 sampl rule - its a pain to have to rebleed the patient
What % of all SHOT reports are due to laboratory errord
20%
This is because we only report on when the error was first detected not where it was made
Talk about the breakdown of where errors occur?
About 10% in A/E
20-50% in the lab
approx 5% in theatre
30-40% in wards
about 1% in ICU
From 2010 we now report near misses, define a near miss and what exactly is reported
Any error which if undetected could result in the determination of a wrong blood group or transfusion of an incorrect component, but was recognised before the transfusion took place
SAE and near miss from the IBTS and other blood establishments are reported
Talk about trends in near miss reports between 2014 and 2021
Numbers started high at about 45 a year but then droped to 29 in 2017
Numbers grew again and had a second peak of 43 in 2019 but are decreasing again
Give a breakdown in the reports received by the NHO between 2019 and 2022
In general reports have increased from 332 in 2019 to 372 in 2022
SARs and wbits have remained the same but SAEs and near misses have increased
However even though numbers go up and down not a lot of these will progress
You might think theres a big increase but not many of these will actually be progressed
Give the SHOT UK figures on transfusion
2, 224,834 units transfused per year
compared to only 150,000 units transfused a year in Ireland
-> hence why we avor UK SHOT figures over ours
According to SHOT UK figures 2022 what is the risk of death and serious harm associated with transfusions
Risk of serious harm is 1 in 15,449 components issued
Risk of feah is 1 in 63,563 components issued
Talk about preventable vs non preventable errors
Not everything is preventable
We cant allways prevent errors i.e. febrile reactions are always going to happen
What are the most common causes of transfusion related deaths
Delays and TACO
They are consistently high over the years - have yet to iron these out
What is the most common cause of transfusion related death in the USA and why?
TRALI is most common as they dont use LD products
Talk about delays in transfusion
Between 2011-2022 reports of delays are increasing
In 2022 30.2% of delays were due to laboratory errors i.e. delays in getting blod to the patient
17.7% were due to referral to specialist laboratories
What are some causes of delays in transfusion?
Communication failure
Logistical issues
Technical issues
Clinical decision making
Sample error
Recognition f bleed
Insufficient trained staff
Component not in stock
What are some reasons for referral to a specialist lab
Complicated cases requiring extra work
Might have to order in bood
Might have to send sample out
Nothing we can really do for these dalays
What are the 9 steps of the transfusion process and who might be involved?
- request -> midwife/nurse etc
- sample -> phlebotomist
- sample receipt -> lab admin
- Testing -> trainee or scientist
- Component selection -> scientist
- Labelling -> lab aide
- collection -> porter
- prescription -> doctor
- administration -> nurse
What are some potential hold-up points in the transfusion pathway
Recognition of bleeding
Haemorrhage call
Communication between clinical area and laboratory
Blood samples to laboratory -> porter availability and distance
Transport of components to patient
Components received and transfused - poor venous access etc
Give some real examples of delays in transfusion
Post partum haemorrhage - might not notice a woman has lost any blood - might have lost 1 or 2 litres before anyone has noticed - this can be a large problem - late haemorrhage call
Some hospitals might be really far away from the ward - not always quick to get blood over and back etc
What are some factors contributing to transfusion delays in bleeding patients
Staffing shortages (major)
Errors in interpretation of test results
Delays in requesting investigations
Failure to recognise bleeding e.g. gastrointestinal bleedds
Poor safety culture
Gapas in knowledge and limited experience in handling major haemorrhage
IT equipment issues
Ineffective and suboptimal incident investigations
Lack of team drills and learning
Poor or no debriefs following events
What are the critical points in the lab in preventing errors
4: sample and request receipt
5: testing
6: component selection
7: component labelling
What might cause erors at sample and request receipt
Information available on LIMS not heeded
Data available on request form or other IT platforms not considered or accessed
e.g. patient record recorded on paper cards -> what wouold you do if card has been filled wrong etc
IT systems are better at preventing this from happening etc -> pop up if giving a K- person K+ blood etc
What might cause errors at testing stage
Failure to follow procedure
Incomplete testing
Inappropriate electronic issue of red cells
Invalid sample used
Red cells not phenotyped
What might cause erorrs at the component selection stage?
Failure to follow information readily available within the LIMS e.g. irradiated or K- red cells, transplant recipient etc
What might cause errors at the component labelling stage
Most errors at this step were cold chain errors and transposed labels
This is the last point where the component is under the control and care of the laboratory and should be treated as a critical safety step
How do you know when and what to report?
As SAR and SAE/IBCT occur
Rapid Alert - where harm might occur to another patient or donor - STTI, TRALI
Mandatory/non-mandatory
Annual basis
what is it mandatory to report
serious adverse events affecting quality and safety of blood components
Errors occuring in the hospita blood bank
Give some examplesof serious adverse events that must be reported?
Sample receipt acceptance
Group identification
Antibody identification
Crossmatch of unit
Unit selection
Unit labelling
Issue of unit
Storage
Distribution to another facility
Talk about the reporting of serious adverse events
Non mandatory but the NHO still needs to hear about them
List the non mandatory serious adverse events
Wrong/incorrect component given to patient due to a clinical erro
Errrors surrounding storage i.e. ward fridge
Errors surrounding collection, handling, occurring outside the HBB
Failure to give CMV negative/irradiated products (prescription or request errors)
Unnecessary Transfusions where not needed
Anti-D or factor concentrate errors
What has the NHO said is the reason for all the 133 SAE reports in 2022
Failure to adhere to policies and procedures noted as the main issue
How does the NHO work with the HVO to provide feedback to the reporting hospital
HVO send initial report to NHO
Report is reviewed and processed
- if it meets criteria for reporting a detailed report is sent back to reporting hospital
- if not then report not progressed
At the end of the year a completed detailed report is sent to the NHO for data analysis
NHO then provides feedback to the rporting hospital as well as :
- recommendations on transfusion practice
- publication of the annual report
- annual conferance
Give some examples of serious adverse reactions that must be reported
Haemolysis due to ABO incompatibiltiy
Haemolysis due to alloantibody acute or delayed
Non-immunological haemolysis
Anaphylaxis or hypersensititvity
Bacterial infection
TRALI
TACO
TAD
HCV/HIV/HBV/viral infection
Malaria or other parasites
Prion infection
Hypotensive reactions
Post transfusion purpua
GVHD
Pre-deposit autologous donation
Febrile non haemolytic transfusion reaction
Previously unreported complication of transfusion
Unclassified SAR
How many ABO incompatible ttransfusions were reported to SHOT UK from 2016 to 2022
24 ABO incompatible red cell transfusion
- they are decreasing year on year
2118 ABO incompatible near miss events occured
In 2022 there were 6 reported cases of ABOI to shot UK, explain these
5 out of the 6 were due to errors outside of the lab
2 of the clinical errors resulted in death and 1 in major morbidity, 2 had no clinical reaction
the laboratory error was a group O FFP being given to a group A patient -> no clinical reaction occurred though
3 of the errors were due to sample collection errors, 2 were administration, 1 was lab
Talk about trends in the types of WBITs reported to the NHO from 2019 to 2023
Total WBITs increasing
Mislabelling errors are increasing
Talk about our TACO case study of 2023
A female>70yrs old was admitted with anaemia secondary to persistant PR bleed, Hb was 7.6gd/l and patient was prescribed 1 unit of red blood cells
Patient had a history of aortic stenosis and COPD
Transfusion was stopped at 45 minutes as patient became agitated and developed tachycardia
Transfusion was discontinued completely after a further 40 minutes due to respiratory distress (desaturation and dyspnoea)
A bilateral wheeze was identified on auscultation of the chest and chest-x-ray was consistent with TACO showing pleural effusions
Furthermore, BNP levels were elevated however pre transfusion BNP levels were not available
The patient received oxygen and a diuretic post transfusion and suffered minor sequelae
What is the main acheivement of haemovigilance
Haemovigilance has been recognised in the last 20 years as one of the most important activities in the field of blood transfusion because of its contribution to increased transfusion safety and improved quality
List the four achievements of haemovigilance
Mortality
TRALI
TTI
Ta GVHD
What have been the IBTS measures to reduce risk of TRALI
In 2002 the NHO issued a leaflet on TRALI in 2002 warning of the risks and the need for appropriate transfusion
In March 2002 the IBTS introduced SD plasma in March 2002 as a vCJD risk reduction measure, SD plasma has not been convincingly implicated in TRALI
In late 2002 plasma from male donors only is used for suspension of pooled platelets and as FFP/Cryoprecipitate since late 2002
From early 2004 the IBTS has deferred new and lapsed female platelet apheresis donors with a history of pregnancy
Since SD plasma, what has been the only form of TRALI really seen
TRALI only really seen in platelets due to anti-HLA antibodies
What are the only female platelet donors left?
Still some women donors left -> but were no longer recruiting women
These women have been typed for atibodies
How has Haemovigilance made its achievements
Implementation of the correct patient ID: 2nd sample
Increased governance of HTC/NTC
Increased specific education in blood transfusion
- E learning
- International collaboration through IHN, ISBT and WHO
Who does the NHO report to
EU working party (with HPRA)
- these brought about definitions of serious adverse events and reactions EU 2007-2009
Submissions to reports:
- Commission on Patient Safety and Quality Assurance NHO submission on promotion of safe transfusion practice/adverse event reporting (2008)
- the HIQA
How does the NHO work with HIQA
HIQA put in place:
- Recommendations for the implementation of unique patients health identifiers in Ireland (2009)
- The NHO was ale to provide detailed information on areas of transfusion which would benefit from the introduction of a unique patient health identifier
What is the future of haemovigilance
Presently almost all European Countries have established a haemovigilance system
Outside of Europe-steadily increasing-Globalisation
More than safety of blood transfusion
- optimal blood usage - patient blood management - can we prevent need for transfusion by treating anaemia before surgery etc
Members of NTAG (National Transfusion Advisory Group)
Who does HPRA report to?
EU
Who do we also report to other than SHOT in the UK
NHRA gets less reports than SHOT - not sure why as we do report to both
What is SABRE
Serious Adverse Blood Reactions and Events
Its the MHRAs online system for report safety incidents
It has been specifically designed to provide registered reporters with a simple electronic means o submitting haemovigilance reports to the MHRA
Where does ireland stand in terms of SARE reports to SHOT
Ireland was has the highest number of reports - were very thorough
Ireland set their criteria very tightly
Why are SARs so low in some countries such as Denmark
Denmark patients have unique patient identifiers
These can be used in any hospital
Every previous record of antibodies can reduce reactions etc
It also reduces errors as there are more people double checking details etc
What are some possible reaons explaining discrepancies between SAR reporting in different countries
System in place: voluntary vs mandatory
Type of staff reporting: nurse, doctors, haemovigilance agents
Different type and quality of bloof components
Extend and performance of filtration (producer vs bedside)
Standard of residual leukocytes in products
Extent of bacterial contamination detection
Extend of NAT screening
Local epidemiology i.e. HBV, HIV, immigratoin
What is the place of the haemovigilance in EU
High priority in most member states
In place and running in most EU member states
Significant conceptual differences
Potential to be a powerful tool to increase blood safety
Needs standardisation and increased networrking EHN
What are the conclusions on HV
HV is now more or less a universal tool to monitor transfusion
Systems in place are differently structured
Strucure considerably impacts on results and costs
Comparisons between systems is more informative on systems than on blood safety
Harmonisation is necessary to obtain meaningful comparions
Impact likely to grow
Importance of investigation of SAR at hospital level
Importance of HVO audits is clear
HV role now firmly established in Ireland
The impact of new measures is visible
Changes in scope and central delivery ikely due to regulatory environment
Haemovigilance has potential for clinical improvements for patients
