EU Blood Directive Flashcards
What years are the EU Blood Directive were interested in from?
EU Blood Directive 2002/98/EC
In general what does the EU Blood directive do?
It makes it a legal requirement of all BT labs to be INAB accredited
Puts in place really strict guidelines for all blood establishments
List the articles were most interested in and what they covered
10: Personnel
11: Quality system
12: Documentation
14: Traceability - LIS
15: Notification of serious adverse reactions and events
22: Storage, transport and distribution
24: data protection and confidentiality
What is the aim of the EU Directive
To ensure that blood and its components are of comparable quality and safety throughout the tranfusion chain in all Member States
Setting minimum community standards
What did the EU directive stop
Stopped autologous transfusion as any hospital offereing these would have to work as a blood manufacturing plant and hosps couldnt afford this etc
Why was the EU Directive needed
Needed to standardise blood transfusion
Wanted to be able to send blood between countries and all components would be of comparable quality etc
Meant labelling would be the same in each country e.g. barcodes should scan in every country in europe etc
When did the EU get involved in BT
In 1994 there was an EU meeting where an agenda was set to formulate a community blood strategy aimed at improving confidence in the safety of the BT chain
What led to the need for EU involvement in BT?
Scandals occurred in the 80s with HIV and HepC in the 90s which lead to massive comensation payouts
These kind of scandals happened all across europe and meant staff imprisonment etc
It meant massive staff shortages and lack of funding etc - no conference days etc - hence why knowledge on heat inactivation of products wasnt heard of in Ireland and thus spread of HepC in anti-D occurred
When were the two important tribunals and what were they?
The Finlay and Lindsay Tribunals occurs between 1997 and 1999
What did the Tribunals of 1997 and 1999 lead to ?
Culmination in EU directive 2002/1998/EC
-> done between 2002 and 2008 but published in Feb 2003
What was the Finlay tribunal
Hepatitis C contamination of anti-D products
What was the Lindsay tribunal
HIV and Hepatitis C contamination in products for haemophiliacs
What has been the history of regulation of blood in ireland
IBTS inspected bi-annually by the Irish Medicine Board since the Finlay Tribunal report 1997
Prior to the EU directive there was no mandatory regulation of hospital blood banks and only some blood banks were accredited -> some labs sought out accreditation to assure hospitals they were doing quality work etc
How many people were affected by the Finlay tribunal?
1600 women affected
How much have the tribunals cost Ireland so far?
Expected to be 997 million in payouts
Actually though to be over 2.2 billion due to legal fees etc
How many women died as a result of the Finlay scandal
77 women died
What preceded the EU directive of 2002/98/EC
A more broad directive 2002/83/EC (Medical products for human use) which was signed in by European parliment on 6th November 2001
This broad directive was then split into three smaller more specialised directives
These were still just directives though and not law
What was the EU directive 2001/83 EC subdivided into. and when?
- standards of quality and safety for human blood (2002/98/EC)
- A directive concerning herbal medicinal products for human use (31st March 2008)
- A directive concerning medicinal products for human use (31st March 2008)
How does an EU directive become law?
Each individual contry has to do so
Done though statutory instrument
When was the EU directive 2002/98/EC signed in and what is it composed of?
11 pages
4 annexes comprising 34 articles
No pictures
In general what was the point of the EU Directive 2002/98/EC?
To set standards of quality and safety for the collection, processing, storage and distribution of human blood components and amending Directive 2001/83/EC
What are the three main daughter directives of the EU Directive 2002/98/EC
Commission Directive 2004/33/EC
Commission Directive 2005/61/EC
Commission Directive 2005/62/EC
What did the Commission Directive 2004/33/EC, one of the daughter directives of EU Directive 2002/98/EC do?
Regards certain technical requirements for blood and blood components
What did the Commission Directive 2005/61/EC, one of the daughter directives of EU Directive 2002/98/EC do?
Regards traceability and notification of serious adverse reactions and events
When did commission directive 2005/61/EC become law?
Transposed into national law by SI 547 of 2006
What did the Commission Directive 2005/62/EC, one of the daughter directives of EU Directive 2002/98/EC do?
regards community standards and specifications relating to a quality system for blood establishments
When was the commission directive 2005/62/EC put into Irish law
Transposed into natinal law by SI 562 od 2006
What Statutory instrument was responsible for putting in place the EU Directive 2002/98/EC?
SI no. 360 of 2005
It was effective from the 9th of november 2005 but labs got a derogation until 8th november 2008
What was the objective of the EU Directive 2002/98/EC ?
To set high standards of quality and safety in collection, testing, processing and storage of blood
What was the aim of the EU Directive 2002/98/EC?
To reassure the public that human blood and blood components derived from donation in another member state meet the same requirements as their own country
What was the scope of the EU Directive 2002/98/EC?
Blood establishments activities, plasma facilities and certain activities of hospital blood banks
NB: does not cover the clinical aspects of blood transfusion chain
What is the definition of a blood establishment?
Any structure of body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage and distribution when intended for transfusion
What are the three blood establishments in Ireland?
IBTS
First Direct Couriers
GBTE-Galway
Where do we usually import blood from if we have to
Netherlands
How is GBTE-Galway a blood establishment?
They make serum eye drops here
Concentration of protein and antibodies etc
Treatment of GvHD for dry eyes
Since setting up as a blood establishment theyre now looking at doing autologous donation as well
What is the definition of a hospital blood bank?
A hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities
Who is the responsible person in a publically funded hospital, private hospitals and blood establishments?
The Health Service Executive in a public hospital
Generally someone managing the hospital or a consultant haematologist in a private hospital
The person who has been designated the role according to regulation 8 in a blood establishment
NB: doesnt matter who it is as long as they ensure compliance
What are the roles of the responsible persons?
Implementation of the directive
Implementation of the quality system
Ensuring 100% traceability
Report adverse reactions and events on time
Full brief
Who is the competent authority for the EU Directive 2002/98/EC?
Health Products Regulatory Authority - HPRA
Formerly the Irish Medicines Board (IMB)
What is the role of the HPRA?
They are the designated competent authority in the State for the purposes of the Directive
Both the IBTS and NHO shall render to the HPRA such assistance as may be required to perform its function under these regulations
They may enter into a contractual arrangement with a person for the purposes of the person assisting the HPRA to perform its function
They dont get involved with hospitals unless they have to, they have a contract with INAB who inspect hospitals and send on a report
What does article 10 of the EU Directive 2002/98/EC encompass?
Personnel should be qualified and be provided with timely, relevant and regularly updated training
Covers training issues such as:
- facilities
- cost (staff time)
- training officer (appropriately qualified)
- number of On-call staff
- level of training is not defined
What are some of the benefits the labs saw with accreditation?
Labs could argue that they needed more staff i.e. couldnt keep accreditation without new recruits etc
Meant better training- conference days etc
Meant people had to be properly qualified - training officer grade came out of this
UK colaberative was set up - set up criteria for what was suitable qualifications in BT e
What does article 11 encompass?
Establishment and maintenance of a quality system based on principles of good practice
The HPRA may inspect hospital blood banks with a view to ensure such
From 8th Nov 2–8 hospital blood banks have to follow ISO 15189
Pre-pre/Pre audits, inspections, accreditation/licensing is now a requirement
Who enforces the quality system?
HPRA
What should a quality system?
Quality Policy, Management System and Objectives
Personnel Responsibilities
Premises and Environment
Equipment, Information Systems and Reagents
Examination Processes
Quality Control, Evaluation and Quality Assurance
Quality Improvement
Why was there a need to implement quality systems?
There were a lot of “system failures” without quality systems in place
If there are gaps in the system then it will be abused - nobody was blamed
What does article 12 encompass?
Documentation
Member states shall take all necessary measures to maintain documentation on operating procedures, guidelines, training and reference manuals, and reporting forms
Changing records or SOPS and that everyone knows about these changes
How has documentation changed in BT labs?
CPA accreditation used to be used
Cross over from CPA to ISO 15189
Document control is an on-going process
Electronic documentation now through Qpulse etc
What does article 14 encompass?
Traceability - the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal and vice verse
Must maintain record from vein to vein for not less than 30 years, data needed to ensure full traceability of blood and blood components from the point of receipt of the blood or blood components by the hospital blood bank
What is the definition of traceability?
Traceability - the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal and vice verse
How was article 14 on traceability implemented?
Specified by COmmission directive 2005/61/EC
Implemented through SI no 547 of 2006
What were some features issued through article 14 - traceability
Fridge tracking systems
Manual systems of traceability (only a short term option)
Electronic traceability (long term option)
What part of the SI no 547 of 2006 refers to traceability
SI part 3, 11E and 11G
Establish and maintain a procedure which is accurate, efficient and verifiable, for the withdrawal from distribution of blood or blood components associated with any notifcation
What are some benefits of laboratory information systems?
Provide positive confirmation that a particular product has been received by the hospital
Can place an ultimate “fate” against a unit
BUT confirmation that transfusion has actually taken place relies often on manual systems e.g. checking sign-out ledgers and looking at patient charts etc
What are some features of electronic traceability?
Bar-Coded patient wristbands
Print sample ID at bedside
In lab, bar-coded sample info is wanded into LIS
Crossmatch label includes barcoded patient information
At bedside, crossmatch label cross-checked with patient wristband
Confirmation that transfusion has actually taken place
Benefit of safer transfusion for patient
BloodTrack now used!
What does article 15 encompass?
Notification of serious adverse events and reactions
Notify the HPRA of SAEs and SARs
Haemovigilance falls under this
What two things are reported to the HPRA under article 15?
Any SAE related to the testing, storage and distribution of blood and blood components by the hospital blood bank which may have an influence on their quality and safety
Any SARs observed during or after transfusion which may be attributable to the quality or safety of blood or blood components issued for transfusion by the hospital blood bank
What does article 22 encompass?
Storage, transport and distribution
Temperature and humidity in storage areas must be controlled, monitored and checked
Alarm systems must be in place e.g. Centron or Reese
Access must be restricted
Environmental monitoring must be conducted
Give an example of where a lab failed INAB due to lack of adherance to article 22
Lab had a back door
anyone could walk in - access not restricted
What does article 24 encompass?
Data protection and confidentiality
Software must be validated
Users must be trained and appropriate levels of authorisation defined
Backup procedures must be in place in the event of failure
There must be provision for archiving
No unauthorised disclosure of information
Also GDPR impacts here
How does Data protection and confidentiality differ in Japan
Everyone has a personal identifier code
You have the same code in every hospital etc
It means any staff member could nosey into anyones data
There are wall systems in place though that block access
What information must be reported to HPRA
Annual reports must include:
- declaration that the hospital is compliant with the regulations
- provide details of the systems which it has in place to ensure such compliance
- the responsible person must without delay notify the HPRA of any changes to the above
Give an example of where HPRA had to get involved with a hospital
Lab failed an INAB inspection when it was noticed that a platelet incubated temperature was too high -> the lab was warned and asked to fix the issue
Issue was not amended by re-inspection so HPRA got invovled
Hospital was ordered to fix issue within 7 days of hospital was going to have to stop issueing platelets
An air conditioning system was introduced immediately
What three notices can HPRA issue?
Instruct the RP to cease to conduct activities specified in the notice
Specify the date from which prohibition shall take effect which shall be not less than 7 days from the date on which the notice is served
Can specify with immediate effect objections ot suspensions, revocation and offences etc
What is haemovigilance
The set of surveillance procedures covering the entire blood transfusion chain, from the donation and processing of blood and its components through to their provision and transfusion to patients, and including their follow-up
When was haemovigilance introduced?
1990s
Introduced through the transfusion safety act of 1993
What is the history behind haemovigilance?
Scandals over tainted whole blood in France brough on a thorough reorganisation of french transfusion service in 1992
Haemovigilance was introduced through the transfusion safety act of 1993 and implemented by french blood agency
The aim was to detect, gather and analyse all untoward effects of BT in order to correct their cause and prevent reoccurrence
Where was the fist HV officer in Ireland, who was it and why
First HVO was a nurse in the Mater
- nurse and not a MS as clinical team hated scientists looking at charts etc
Nowadays teams are 50:50 nurses and BT MSs as nurse only reports tended to lack scientific information
Talk about the national haemovigilance office
NHO was established in the IBTS in Oct 1999
It is mandatory that any SAE or SARs that effect the quality or safety og blood components are reported to the NHO
Haemovigilance programme identifies any unexpected or undesirable effects of transfusion of components by ensuring they are reported in a timely and reliable manner
The NHO is responsible for the promotion of best practice in hosps throughout ireland through advice, guidelines and education
What legal framework is currently in place in Ireland
Irish legislation, SI 360 of 2005 and 547 of 2006, requires blood banks operate to ISO 15189 according to EU directive
Mimimum Requirements for Blood Bank Compliance with Article 14 and article 15 through AML-BB
INAB is responsible for accrediting medical testing laboratories to ISO 15189
What is the main issue reported to SHOT, how are we trying to resolve this?
140 patient identification errors occurred in 2019
The use of electronic patient identification systems has been shown to result in a lower incidence of wrong component transfused and wrong blood in tube (WBIT) when compared to manual processes
It is important to note that errors can still occur even with electronic patient identification systems due to a system being used incorrectly, porrle located or staff inappropriately trained
