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Explanatory Memorandum
Quality and Safety of Blood and Blood Components Regulations, 2005
(Note – this is not a legal interpretation of the Regulations)
PART 1 – PRELIMINARY
Citation
The title of the Regulations is: European Communities (Quality and Safety of Human Blood and Blood Components) Regulations 2005
Interpretation
This section gives definitions for terminology used throughout the Regulations.
Two important definitions are “blood establishment” and “hospital blood bank”.
"Blood establishment" means any structure or 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. Comment – the Irish Blood Transfusion Service comes within the definition of blood establishment. Only a small number of hospitals are blood establishments, for example because they perform autologous transfusion. Most hospitals fall into the category of “hospital blood banks”.
"Hospital blood bank" means 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.
Comment. The word "person" is used in various places in the Regulations but is not defined. In Acts of the Oireachtas and Statutory Instruments, the word “person” has a legal meaning which includes a corporate body, an unincorporated body as well as an individual, unless the legislation clearly states otherwise (ref. Section 11 (c) of the Interpretation Act of 1937).
Application
The Regulations apply to the collection and testing of blood and blood components, whatever their intended purpose. The Regulations also apply to the processing, storage and distribution of blood and blood components, but only when they are intended to be used for transfusion. The Regulations do not apply to stem cells.
Competent Authority
The Irish Medicines Board (IMB) is designated as the competent authority for all aspects of the Regulations. The Irish Blood Transfusion Services (IBTS) and the National Haemovigilance Office (NHO) are required to give the IMB whatever assistance they may reasonably need to assist them in carrying out their functions. The IMB may contract with other agencies to assist them in performing their functions, but will retain overall responsibility for these functions.
PART 2 - PROVISIONS APPLICABLE TO BLOOD ESTABLISHMENTS
All the provisions of the Regulations are applicable to blood establishments (but only a subset apply to hospital blood banks).
Requirement for authorisation
All blood establishments will require to be authorised by the IMB.
Authorisation of blood establishment
Blood establishments must apply to the IMB for authorisation, and submit extensive information with their applications, together with an application fee. The IMB may grant an authorisation for some or all of the activities requested on the application, or may refuse an application or attach conditions to it. The IMB may, at any time, revoke an establishment’s authorisation, vary any conditions already specified, or apply new conditions. Blood establishments may not make any major changes to its activities without prior authorisation to the IMB.
Suspension or revocation of authorisation
The IMB can suspend or revoke an authorisation on a number of grounds, giving seven days prior notice. If there is a safety consideration, the suspension or revocation can take immediate effect. For less serious breaches of the regulations, the IMB can serve a notice on the establishment setting out the actions that must be taken to rectify the problem and the timescales for taking these actions. If the establishment fails to comply with a notice, the IMB can then suspend or revoke its authorisation.
Responsible person for blood establishment
Each blood establishment must designate an individual who is responsible for ensuring that the requirements of the Regulations are being met, and must notify the IMB of this individual’s name. This person must have a formal qualification in a medical or biological discipline, together with relevant post-graduate experience.
Blood establishment requirements
Each blood establishment must:
Labelling of blood and blood components and traceability
Blood establishments must ensure that all blood and blood components are labelled with specified information.
PART 3 - PROVISIONS APPLICABLE TO HOSPITAL BLOOD BANKS
Hospital blood bank requirements
Hospital blood banks must:
Requirement for hospital blood banks to provide information to IMB
Hospital blood banks must report annually to the IMB, including a declaration that the blood bank has in place appropriate systems to ensure compliance with the requirements of the Regulations.
Service of notices relating to hospital blood banks
Under specified circumstances the IMB can serve a notice on hospital blood banks requiring that the blood bank stops certain activities, including the administration of blood to patients, until specified requirements are met.
PART 4 - PROVISIONS APPLICABLE TO BLOOD ESTABLISHMENTS AND HOSPITAL BLOOD BANKS
Objections to suspension, revocation, etc.
Blood establishments and blood banks may object to decisions of the IMB and ask to make written or oral submissions to a third party, nominated by the IMB. The third party will determine their own procedures, consider any submissions made, and make a recommendation to the IMB. The IMB must take the recommendations into account, and if they do not accept the recommendations, must inform the establishment or blood bank in writing of the reasons for their decision. Any suspension, revocation or notice made by the IMB will not take effect until this process is complete, unless it is in the interests of public safety.
Disclosure of information by blood establishments and hospital blood banks
Establishments and blood banks must ensure that all data collected is held securely, and that the confidentiality of personal data is maintained (Comment - the general provisions of the Data Protection Acts will also apply). Disclosure may be made if required by law, if the disclosure is to an authorised officer appointed by the IMB or if the disclosure is necessary to trace a donor or recipient.
Inspections, etc.
The IMB must inspect blood establishments at least once every two years to ensure that the requirements of the Regulations are being met. The Board may also ask establishments for information at any time regarding its compliance with the Regulations. The IMB, or an authorised person acting on their behalf, may inspect hospital blood banks, and may request whatever information is necessary regarding compliance with the Regulations.
By 8th November 2008 all hospital blood banks must operate to ISO 15189, which is an international standard for medical laboratories.
When blood establishments and hospital blood banks notify the IMB of adverse events or reactions, the IMB must seek whatever information it considers necessary, or conduct an inspection if appropriate.
Records to be kept by IMB
The IMB must retain records on authorisations, responsible persons in blood establishments, notification of serious adverse events and reactions, inspections and requests for information.
PART 5 - AUTHORISED OFFICERS AND TESTING, ETC. OF SAMPLES, ETC.
Interpretation (Part 5)
This section of the Regulations gives definitions for terminology used in Part 5 only.
Authorised officers
The IMB may appoint as many authorised officers as it thinks necessary to enable it to carry out its functions under the Regulations. Authorised officers may enter premises, inspect, copy or remove relevant documentation, carry out tests and take samples. If necessary an authorised officer may be accompanied by another authorised office, a Garda, or a person with relevant expertise. If access to a premises is denied, the authorised officer may apply to the District Court for a warrant.
Taking of samples, etc. by authorised officers
If the authorised officer takes samples, the sample will be divided into three parts, and sealed (or if this is not feasible, three samples from the same batch will be taken). One part will be given to the blood establishment or blood bank, one retained by the officer, and one sent for testing.
Certificate of result of test, etc. of sample, etc
Samples will be tested by a specified person, who will sign a certificate setting out the results.
PART 6 - OFFENCES, ETC.
Offences
Contravention of the Regulations will be a summary offence. Breaking some of the Regulations will be punishable by a fine not exceeding €2,000 or a term of imprisonment not exceeding 6 months, or both. Infringing other Regulations will attract a fine of up to €1,000, imprisonment of up to 3 months, or both.
Offence to import below standard blood, etc. into State
It will be an offence to import blood which does not meet the quality and safety standards set out in the Regulations.
Offence by body corporate
If an offence was committed with the consent of, or through the neglect of, an official of the blood establishment or blood bank, then proceedings may be taken against both the establishment or blood bank and that individual officer.
Defence of due diligence
Anyone charged with an offence may make the case that he/she took all reasonable precautions and exercised all due diligence. If such a case is made, the court or jury must find in their favour unless the prosecution proves otherwise beyond all reasonable doubt.
Proceedings may be brought by IMB
The IMB may bring and prosecute proceedings under these Regulations within two years of the date of the offence.
PART 7 - MISCELLANEOUS
Reports by IMB
The IMB will report to the Commission by the end of 2006 and every 3 years thereafter.
Specific epidemiological situations
Where the IMB becomes aware of a disease outbreak which may affect the safety of blood donations, it may notify blood establishments of additional donor deferral criteria to be implemented, and must report on the disease outbreak and the new criteria to the Commission.
Fees
The IMB may charge fees to cover the estimated cost of performing its functions under the Regulations. If the fees charged are greater or smaller than the actual costs involved, then the IMB may charge the balance or refund the difference, as appropriate.
Transitional provisions
The Regulations will apply from 8th November 2005.