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L.S. 483.02 Regolamenti dwar il-Kwalità u s-Sigurezza tad-Demm

BLOOD (QUALITY AND SAFETY) [ S.L.483.02 1 SUBSIDIARY LEGISLATION 483.02 BLOOD (QUALITY AND SAFETY) REGULATIONS 10th November, 2006 LEGAL NOTICE 272 of 2006, as amended by Legal Notice 7 of 2016, and 362 of 2017. 1.

(1)The title of these regulations is the Blood (Quality and Safety) Regulations.
(2)These regulations transpose: Citation and scope. Amended by: L.N. 7 of 2016; L.N. 362 of 2017 (
  1. a)the European Parliament and Council Directive 2002/ 98/ EC of the of 27th January, 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components; (
  2. b)Commission Directive 2004/33/EC of the 22nd March, 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components; (
  3. c)Commission Directive 2004/33/EC of the 22nd March, 2004 implementing 2005/62/EC implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community Standards and specifications relating to a quality system for blood establishments; (
  4. d)Commission Directive 2014/110/EU of 17th December 2014 amending Directive 2004/33 /EC as regards temporary deferral criteria for donors of allogeneic blood donations; and (
  5. e)Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments. 2. In these regulations unless the context otherwise requires: "the Act" means the Human Blood and Transplants Act; "autologous transfusion" means transfusion in which the donor and the recipient are the same person and in which predeposited blood and blood components are used; "blood" means whole blood collected from a donor and processed either for transfusion or for further manufacturing; "blood component" means a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods; Interpretation. Amended by: L.N. 362 of 2017. Cap. 483. 2 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) "blood component release" means a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification; "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. This does not include hospital blood banks; "blood product" means any therapeutic product derived from human blood or plasma; "computerised system" means a system including the input of data, electronic processing and the output of information to be used either for reporting, automatic control or documentation "deferral" means suspension of the eligibility of an individual to donate blood or blood components, such suspension being either permanent or temporary; "distribution" means the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusions; good practice" means all elements in established practice that collectively will lead to final blood or blood components that consistently meet predefined specifications and compliance with defined regulations " h a e m o v i g i l an c e " m e a n s a s e t o f o rg a n is e d s u r v e il l an ce procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological followup of donors; "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; "inspection" means formal and objective control to identify problems in accordance with standards adopted to assess compliance with these regulations; "mobile site" means a temporary or movable place used for the collection of blood and blood components which is in a location outside of but under the control of the blood establishment; "processing" means any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component; "qualificatio n" as par t o f validatio n, m ean s th e actio n of verifying that any personnel, premises, equipment or material works correctly and delivers the expected results "qualified health professional" includes a doctor and a nurse; "quality assurance" means all the activities from blood collection to BLOOD (QUALITY AND SAFETY) [ S.L.483.02 distribution made with the object of ensuring that blood and blood components are of the quality required for their intended use; "quality control" means part of a quality system focussed on fulfilling quality requirements; "quality management" means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment; "quality system" means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management; "quarantine" means the physical isolation of blood components or incoming materials/reagents over a variable period of time while awaiting acceptance, issuance or rejection of the blood components or incoming materials/reagents; " s e r io u s ad v e r se e v e n t" m e a n s an y u n t o wa r d o c c u r r e n c e associated with the collection, testing, processing, storage, and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolong s, h ospitalisatio n or morbidity; "specification" means a description of the criteria that must be fulfilled in order to achieve the required quality standard; "standard" means the requirements that serve as the basis for comparison; "trace-back" means the process of investigating a report of a suspected transfusion-associated adverse reaction in a recipient in order to identify a potentially implicated donor; "valid atio n" mean s the establish ment o f d ocum ented an d objective evidence that the pre-defined requirements for a specific procedure or process can be consistently fulfilled; "written procedures" means controlled documents that describe how specified operations are to be carried out; "serious adverse reaction" means an unintended response in donor or in patient associated with the collection or transfusion of b loo d an d blo od com p on ents that i s f at al, lif e- thr eatenin g, d isab lin g , in c a pa c it atin g, o r wh ich res ul ts i n, o r pr o lo ng s, hospitalisation or morbidity. 3. An application for a licence to operate a blood establishment shall include all the information referred to under Schedule I. Information on application. Amended by: L.N. 7 of 2016. 4.
(1)A blood establishment shall designate a person who is responsible for the following tasks: Responsible person. (
  1. a)ensuring that every unit of blood or blood component that has been collected or tested for any purpose has been collected and tested in accordance with the requirements of these regulations; (
  2. b)ensuring that every unit of blood or blood components 3 4 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) intended for transfusion has been processed, stored and distributed in accordance with the requirements of these regulations; (
  3. c)providing information to the Authority relating to the licence of the blood establishment for the purposes of regulation 3; and (
  4. d)the implementation in the blood establishment of the requirements of articles 10,11, 12, 13, 14 and 15 of the Act.
(2)A blood establishment shall not designate a person as a responsible person unless that person has (
  1. a)a diploma, certificate or other evidence of formal qualification in the field of medical or biological sciences awarded on completion of (
  2. i)a university course of study, or (
  3. ii)a course recognised as an equivalent course by the Authority; and (
  4. b)practical post-graduate experience in areas of work relevant to the responsibilities of the responsible person under these regulations for at least two years, in one or more establishments licenced in any Member State to undertake activities related to the collection and, or testing of blood and blood components, or to their preparation, storage and distribution.
(3)The responsible person may delegate any of the tasks specified in sub-regulation
(1)to other persons who shall be qualified by training and experience to perform them.
(4)Blood establishments shall notify the Authority of the name o f a n y p er s o n s t o w h o m t a s k s h a v e b e e n d el e g a t e d b y t h e responsible person under sub-regulation
(3), and the specific tasks which have been delegated to such persons.
(5)Where the responsible person or a person to whom tasks have been delegated under sub-regulation
(3)is permanently or temporarily replaced, the blood establishment shall immediately provide the Authority with the name of the replacement, details of his qualifications and the date on which the replacement began his duties.
(6)If the Authority considers that the responsible person does not meet the requirements of sub-regulation
(2), it may serve a notice to that effect on the blood establishment.
(7)If, within fourteen days of receiving a notice in accordance with sub-regulation
(7), a blood establishment is not able to demonstrate to the reasonable satisfaction of the Authority that the responsible person does meet the requirements of sub-regulation
(2), it shall, without delay (
  1. a)relieve him of the duties of responsible person in respect of the establishment; (
  2. b)appoint a new responsible person in his place; and BLOOD (QUALITY AND SAFETY) [ S.L.483.02 (
  3. c)notify the Authority that it has appointed a new responsible person and provide details of the name and qualifications of the person appointed. 5.
(1)A blood establishment shall - (
  1. a)ensure that the personnel directly involved in the collection, testing, processing, storage and distribution of human blood and blood components for the blood establishment are qualified to perform those tasks and are provided with timely, relevant and regularly updated training; (
  2. b)establish and maintain a quality system for blood establishments laid down in the Schedule IX; (
  3. c)ensure that all testing and processes of the blood establishment which are referred to in Schedules V and VIII are validated; (
  4. d)maintain documentation on operational procedures, guidelines, training and reference manuals and reporting forms so that they are readily available for inspection; (
  5. e)notify the Authority of (
  6. i)any serious adverse events related to the collection, testing, processing, storage and distribution of blood and blood components by the blood establishment which may have an influence on their quality and safety, and (
  7. ii)any serious adverse reactions observed during or after transfusion which may be attributable to the quality or safety of blood or blood components collected, tested, processed, stored or distributed by the blood establishment; and (
  8. f)establish and maintain a procedure, which is accurate, efficient and verifiable, for the withdrawal from distribution of blood or blood components associated with any notification referred to in paragraph (e).
(2)A blood establishment shall, in relation to the donation of blood (
  1. a)give all prospective donors of blood or blood components information in accordance with Part A of Schedule V; (
  2. b)obtain from all persons who are willing to provide blood or blood components, information in accordance with Part B of Schedule V; (
  3. c)put and keep in place procedures for the evaluation of donors; (
  4. d)apply eligibility criteria for all donors of blood and blood components in accordance with Schedule VI; (
  5. e)maintain records of the results of donor evaluations and report to donors any relevant abnormal findings Duties of blood establishments. Amended by: L.N. 7 of 2016. 5 6 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) from the evaluations; (
  6. f)ensure that (
  7. i)an examination of the donor, including an interview, is carried out before any donation of blood or blood components, (
  8. ii)a qualified health professional is responsible for giving to and gathering from donors the information which is necessary to assess their eligibility to donate, and (iii) on the basis of that information, a qualified health professional assesses the eligibility of all donors to donate; and (
  9. g)encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are, in so far as possible, provided from such donations.
(3)A blood establishment shall ensure that, in relation to the blood and blood components which it collects, processes, stores or distributes: (
  1. a)each donation of blood and blood components, including blood and blood components which are imported into the European Community, is tested in conformity with the requirements listed in Schedule IV; (
  2. b)the storage, transport and distribution conditions of blood and blood components comply with the requirements of Schedule VII; and (
  3. c)quality and safety requirements for blood and blood components meet the standards specified in Schedule VIII.
(4)A blood establishment shall, in relation to the information required by Schedules II, IV, V and VI, maintain records, for a minimum period of fifteen years.
(5)As soon as practicable after the end of the reporting year, each blood establishment shall provide to the Authority a report specifying (a) the information referred to in sub-regulation
(3)for that year; and (b) details of the steps it has taken during that year to comply with the provisions of sub-regulation
(2)(g). Labelling and traceability of blood and blood components. Amended by: L.N. 7 of 2016. 6.
(1)A blood establishment shall ensure that the label on each unit of blood or blood component supplied by it, or imported by it from outside the European Community, shall contain all the information referred to under Schedule III.
(2)A blood establishment shall, for a period of not less than thirty years, keep such records of the information referred to in sub-regulation
(1)and such additional records as are necessary (
  1. a)for the identification of each single blood donation and BLOOD (QUALITY AND SAFETY) [ S.L.483.02 each single blood unit and its components, including blood and blood components which are imported into the European Community; and (
  2. b)to ensure full traceability to the point of delivery to a hospital. 7. The person responsible for the management of a hospital blood bank shall (
  3. a)ensure that personnel directly involved in the testing, storage and distribution of human blood and blood components for the hospital blood bank are qualified to perform those tasks and are provided with timely, relevant and regularly updated training; (
  4. b)establish and maintain a quality system for the hospital blood bank which is based on the principles of good practice; (
  5. c)ensure that all processes referred to in Schedule VII, which are applicable to activities carried out by the hospital blood bank, are validated; (
  6. d)maintain documentation on operational procedures, guidelines, training and reference manuals and reporting forms so that they are readily available for inspection; (
  7. e)maintain, for not less than thirty years, the data needed to ensure full traceability of blood and blood components, from the point of receipt of the blood or blood component by the hospital blood bank; (
  8. f)notify the Authority and the blood establishment from whom the blood and blood components were procured of (
  9. i)any serious adverse events 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, and (
  10. ii)any serious adverse reactions 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; (
  11. g)establish and maintain a procedure, which is accurate, efficient and verifiable, for the withdrawal from distribution of blood or blood components associated with any notification referred to in paragraph (f); and (
  12. h)ensure that the storage, transport and distribution conditions of blood and blood components by the hospital blood bank comply with the requirements of Schedule VII. Hospital blood banks. Amended by: L.N. 7 of 2016. 7 8 [ S.L.483.02 Requirement for hospital blood banks to provide information to the Authority. BLOOD (QUALITY AND SAFETY) 8.
(1)As soon as practicable after the end of the reporting year, the person responsible for management of a hospital blood bank shall submit an annual report to the Authority, which shall (
  1. a)include a declaration that the hospital blood bank has in place appropriate systems to ensure compliance with the requirements of these regulations; and (
  2. b)provide details of the systems which it has in place to ensure such compliance.
(2)The person responsible for management of a hospital blood bank shall without delay notify the Authority of any changes to the matters in respect of which evidence has been supplied pursuant to su b -r e g ulat ion
(1)wh ic h m igh t aff e c t co m pli anc e wit h th e requirements of these regulations. Data protection and confidentiality. 9.
(1)A blood establishment and the person responsible for m a n a g e m e n t o f a h o s p i tal b l o o d b a n k s h a ll e n s u r e t h a t a l l information which is collected for the purposes of these regulations is held securely so that it is (a) available for the purpose of tracing donations; (b) not disclosed except: (i) in accordance with one or more of the requirements of sub-regulation
(2), or (
  1. ii)where they have been rendered anonymous, so that donors are no longer identifiable; (
  2. c)subject to safeguards against unauthorised additions, deletions or modifications.
(2)The requirements referred to under sub-regulation
(1)(b)(
  1. i)are that: (
  2. a)the disclosure is made in accordance with an order of a court or is otherwise required by law; (
  3. b)the disclosure is to an inspector appointed by the Authority; or (
  4. c)the disclosure is for the purpose of tracing a donation from donor to recipient or recipient to donor.
(3)The responsible person of the blood establishment and the person responsible for management of the hospital blood bank shall ensure that they put in place a procedure to ensure that any discrepancies relating to data which are brought to their attention are resolved without delay. Good Practice Guidelines. Added by: L.N.362 of 2017. 10.
(1)A quality system for blood establishments laid down in the Annexes to Directive 2005/62/EC implementing Directive 2002/98/EC of the European Parliament and the Council as regards Community Standards and specifications relating to a quality s y s t em f o r B lo o d E s t a b li s h m e n t s s h a l l b e e s t ab l i s h e d a n d m a i n ta i n e d , ta k i n g in t o a c c o u n t , wh e r e r e l e v a n t f o r b l o o d establishments, the detailed principles and guidelines of good manufacturing practice, as referred to in the first sub-paragraph of Article 47 o f Dir ective 2 001 /8 3/EC , and the Go od Pr actice BLOOD (QUALITY AND SAFETY) [ S.L.483.02 Guidelines in the Guide to th e preparation, u se an d quality assurance of blood components, Appendix to Recommendation No. R
(95)15 of the Committee of Minsters on the preparation, use and quality assurance of blood components adopted on 12 October 1995 jointly developed by the Commission and the European Directorate for the Quality of Medicines and Healthcare of the Council of Europe and published by the Council of Europe.
(2)Any blood or labile blood products imported from third countries and intended for the use or distribution in the Community must also adhere to the Quality system as specified in Commission Directive (EU) 2016/1214 of 25 July 2016 amending Directive 2005/62/EC as regards quality system standards and specifications for blood establishments, even in the stages prior to importation. 9 10 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) SCHEDULE I Added by: L.N. 7 of 2016. INFORMATION TO BE PROVIDED BY BLOOD ESTABLISHMENT TO THE COMPETENT AUTHORITY FOR THE PURPOSES OF DESIGNATION, AUTHORISATION, ACCREDITATION OR LICENSING (Regulation 3) Part A General Information: - Identification of the blood establishment; - Name, qualification and contact details of responsible persons; - A list of hospital blood banks which it supplies. - A description of the quality system, to include: Part B - Documentation, such as an organisation chart, including responsibilities of responsible persons and reporting relationships; - Documentation such as site master file or quality manual describing the quality system in accordance with Schedule IX; - Number and qualification of personnel; - Hygiene provisions; - Premises and equipment; - List of standard operating procedures for recruitment, retention and assessment of donors, for processing and testing, distribution and recall of blood components and for the reporting and recording of serious adverse reactions and events. Added by: L.N. 7 of 2016. SCHEDULE II REPORT OF THE BLOOD ESTABLISHMENT’S PRECEDING YEAR’S ACTIVITY The annual report will include: - Total number of donors who give blood and blood components; - Total number of donations; - An updated list of the hospital blood banks which it supplies; - Total number of whole donations not used; - Number of each component produced and distributed; - Incidence and prevalence of transfusion transmissible infectious markers in donors of blood and blood components; - Number of product recalls; - Number of serious adverse events and reactions reported. BLOOD (QUALITY AND SAFETY) [ S.L.483.02 SCHEDULE III LABELLING REQUIREMENTS 11 Added by: L.N. 7 of 2016. The label on the component must contain the following information: - The official name of the component; - The volume or weight or number of cells in the component (as appropriate); - The unique numeric or alphanumeric donation identification; - The name of producing blood establishment; - The ABO Group (not required of plasma intended only for fractionation); - The Rh D Group, either Rh D positive or Rh D negative (not required for plasma intended only for fractionation); - The date or time of expiry (as appropriate); - The temperature of storage; - The name, composition and volume of anticoagulant and/or additive solution (if any). SCHEDULE IV BASIC TESTING REQUIREMENTS OR WHOLE BLOOD AND PLASMA DONATIONS Added by: L.N. 7 of 2016. The following tests must be performed for whole blood and apheresis donations including autologous predeposit donations: - ABO Group (not required for plasma intended only for fractionation); - Rh D Group (not required for plasma intended only for fractionation); Testing for the following infections in the donors: - Hepatitis B (HBs-Ag) - Hepatitis C (Anti-HCV) - HIV 1 and 2 (Anti-HIV 1 and 2) A d d i ti o n a l t es t s m ay b e r e q u i r e d f o r s p e ci f i c c o m p o n e n t s o r d o n o r s o r epidemiological situations. 12 [ S.L.483.02 Added by: L.N. 7 of 2016. BLOOD (QUALITY AND SAFETY) SCHEDULE V INFORMATION REQUIREMENTS (Regulation 5) Part A Information to be provided to prospective donors of blood and blood components 1. Accurate educational materials, which are understandable for members of the general public, about the essential nature of blood, the blood donation procedure, the components derived from whole blood and apheresis donations, and the important benefits to patients. 2. For both allogeneic and autologous donations, the reasons for requiring an examination, health and medical history, and the testing of donations and the significance of ‘informed consent’. For allogeneic donations, self-deferral, and temporary and permanent deferral, and the reasons why individuals are not to donate blood or blood components if there could be a risk for the recipient. For autologous donations, the possibility of deferral and the reasons why the donation procedure would not take place in the presence of a health risk to the indiv id ual wheth er as don or o r r ecipient of the autologous blood or blood components. 3. Information on the protection of personal data: no unauthorised disclosure of the identity of the donor, of information concerning the donor's health, and of the results of the tests performed. 4. The reasons why individuals are not to make donations which may be detrimental to their health. 5. Specific information on the nature of the procedures involved either in the allogeneic or autologous donation process and their respective associated risks. For autologous donations, the possibility that the autologous blood and blood compo nents m ay not suffice for the intended transf usion requirements. 6. Information on the option for donors to change their mind about donating prior to proceeding further, or the possibility of withdrawing or selfdeferring at any time during the donation process, without any undue embarrassment or discomfort. 7. The reasons why it is important that donors inform the blood establishment of any subsequent event that may render any prior donation unsuitable for transfusion. 8. Information on the responsibility of the blood establishment to inform the do no r, t hr o ug h an app r op r iate m echan is m, i f test resu lts sh ow any abnormality of significance to the donor's health. 9. Information why unused autologous blood and blood components will be discarded and not transfused to other patients. 10. Information that test results detecting markers for viruses, such as HIV, HBV, HCV or other relevant blood transmissible microbiologic agents, will result in donor deferral and destruction of the collected unit. 11. Information on the opportunity for donors to ask questions at any time. BLOOD (QUALITY AND SAFETY) [ S.L.483.02 13 PART B Information to be obtained from donors by blood establishments at every donation 1. Identification of the donor Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details. 2. Health and medical history of the donor Health and medical history, provided on a questionnaire and through a personal interview performed by a qualified healthcare professional that includes relevant factors that may assist in identifying and screening out persons whose donation could present a health risk to others, such as the possibility of transmitting diseases, or health risks to themselves. 3. Signature of the donor Signature of the donor, on the donor questionnaire, countersigned by the health care staff member responsible for obtaining the health history confirming that the donor has: (
  1. a)read and understood the educational materials provided; (
  2. b)had an opportunity to ask questions; (
  3. c)been provided with satisfactory responses to any questions asked; (
  4. d)given informed consent to proceed with the donation process; (
  5. e)been informed, in the case of autologous donations, that the donated blood and blood components may not be sufficient for the intended transfusion requirements; and (
  6. f)acknowledged that all the information provided by the donor is true to the best of his/her knowledge. SCHEDULE VI ELIGIBITITY CIRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS 1. Added by: L.N. 7 of 2016. Amended by: L.N. 362 of 2017. ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENT Under exceptional circumstances, individual donations from donors who do not comply with the following criteria may be authorised to donate blood by a qualified healthcare professional in the blood establishment. All such cases must be clearly documented and subject to the quality management provisions in accordance with regulation 5. The following criteria do not apply to autologous donations. 1.1 Age Age and body weight of donors 18 to 65 years 17 to 18 years - Unless classified as a minor by law, or with written consent of parent of legal curator [ S.L.483.02 14 BLOOD (QUALITY AND SAFETY) F ir s t t i m e d o n o r s over 60 years Over 65 years Body weight 1.2 ≥ 60 g/l for males ≥ 135 g/l A p p l i c a b l e to allogeneic donors of whole blood and cellular components The protein analysis for apheresis plasma donations must be performed at least annually Platelet level in donor’s blood Platelets 2. for females ≥ 125 g/l Protein levels in donor’s blood Protein 1.4 At the discretion of the physician in the blood establishment - With permission of the physician in the blood establishment, given annually ≥ 50 kg for donors either for whole blood or apheresis blood components Haemoglobin levels in donor’s blood Haemoglobin 1.3 - P l a t e l e t n u m b e r g r e a t e r Level required for apheresis platelet than or equal to 150 x 10 9/ l donor DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS The tests and deferral periods indicated by an asterisk (*) are not required when the donation is used exclusively for plasma for fractionation. 2.1 Permanent deferral criteria for donors of allogeneic donations Cardiovascular disease Prospective donors with active or past serious cardiovascular disease, except, congenital abnormalities with complete cure Central nervous system disease A history of serious CNS disease Abnormal bleeding tendency Prospective donors who give a history of a coagulopathy Repeated episodes of syncope, or a Other than childhood convulsions or history of convulsions where at least three years have elapsed since the date the donor last took anticonvulsant medication without any recurrence of convulsions Gastrointestinal, genitourinary, Prospective donor with serious haematological, immunological, metabolic, active, chronic, or relapsing disease renal, or respiratory system diseases Diabetes If being treated with insulin Infectious diseases Hepatitis B, except for HBsAgnegative persons who are demonstrated to be immune Hepatitis C HIV-1 and 2 BLOOD (QUALITY AND SAFETY) [ S.L.483.02 15 HTLV I/II Babesiosis (*) Kala Azar (visceral leishmaniasis) (*) Tr y p a n o s o m i a s i s c r u z i ( C h a g a s ’ disease)(*) Malignant diseases Except in situ cancer with complete recovery Persons who have a family history Transmissable spongiform Encephalapathies (TSEs), (e.g. Creutzfeldt which places them at risk of developing Jakob Disease, variant Creutzfeldt Jakob a TSE, or persons who have received a corneal or dura m ater gr aft, or who Disease) have been treated in the past with medicine made from human pituitary glands. For variant Creutzfeld Jacob diseases, further precautionary measures may be recommended. Intravenous (IV) or intramuscular (IM) Any history of non-prescribed IV or drug use IM drug use, including body-building steroids or hormones Xenotransplant recipients Sexual behaviour Persons whose sexual behaviour puts them at high risk of acquiring severe infectious diseases that can be transmitted by blood 2.2 Temporary deferral criteria for donor of allogeneic donations 2.2.1 Infections Duration of deferral period After an infectious illness, prospective donors shall be deferred for at least two weeks following the date of full clinical recovery. However, the following deferral periods shall apply for the infections listed in the table: Brucellosis (*) Osteomyelitis Q fever (*) Syphilis (*) Toxoplasmosis (*) Tuberculosis Rheumatic fever Fever > ºC Flu-like illness 2 years following the date of full recovery 2 years after confirmed cured 2 years following the date of confirmed cure 1 year following the date of confirmed cure 6 months following the date of clinical recovery 2 years following the date of confirmed cure 2 weeks following the date of cessation of symptoms, unless evidence of chronic heart disease 2 weeks following the date of cessation of symptoms 2 weeks after cessation of symptoms 16 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) Malaria (*) - individuals who have lived in a malarial area within the first five years of life - individuals with a history of malaria - asymptomatic visitors of endemic areas - individuals with a history of undiagnosed febrile illness during o within six months of a visit to an endemic area West Nile Virus (WNV) (*) 3 years following return from last visit to any endemic area, provided person remains symptom free; may be reduced to 4 months if an immunologic or molecular genomic test is negative at each donation 3 years following cessation of treatment and absence of symptoms. Accept thereafter only if an immunological or molecular genomic test is negative 6 months after leaving the endemic area unless an immunologic or molecu lar genomic test is negative 3 years following resolution of symptoms; may be reduced to 4 months if an immunologic or molecular test is negative 28 d ays after leav ing a risk area of locally acquired West Nile Virus unless an individual Nucleic Acid Test (NAT) is negative. 2.2.2 Exposure to risk of acquiring a transfusion-transmissible infection - Endoscopic examination using flexible instruments, - Mucosal splash with blood or needle stick injury, Defer for 6 months, or for 4 months provided a NAT test for hepatitis C is negative - Transfusion of blood components, - tissue or cell transplant of human origin, - major surgery, - tattoo or body piercing, - acupuncture unless performed by a qualified practitioner or with sterile single- use needles, - person at risk due to close household contact with persons with hepatitis B Persons whose behaviour or activity places them at risk of acquiring diseases that may be transmitted by blood Defer after cessation of risk behaviour for a period determined by the disease in q uestion, an d by the availability of appropriate tests 2.2.3 Vaccination Attenuated viruses or bacteria Inactivated/ killed viruses, bacteria, or rickettsiae 4 weeks No deferral if well BLOOD (QUALITY AND SAFETY) Toxoids Hepatitis A or hepatitis B vaccines Rabies Tick-borne encephalitis vaccines [ S.L.483.02 17 No deferral if well No deferral if well and if no exposure No deferral if well and if no exposure If vaccination is given following exposure defer for one year No deferral if well and if no exposure 2.2.4 Other temporary deferrals Pregnancy Minor surgery Dental treatment Medication 2.3 Deferral for particular epidemiological situations Particular epidemiological situations (e.g. disease outbreaks) 2.4 6 months after delivery or termination, except in exceptional circumstances and at the discretion of physician 1 week Minor treatment by dentist or dental hygienist – defer until next day (NB: Tooth ext racti on, root-f il ling and s imi lar treatment is considered as minor surgery) Based on the nature of the prescribed medicine, its mode of action and the disease being treated Deferral consistent with the epidemiological situation (These deferral should be notified by the competent authority to the European Commission with a view to Community action) Deferral criteria for donor of autologous donations Serious cardiac disease Persons with or with history of - hepatitis B, except for HBsAgnegative persons who are demonstrated to be immune - hepatitis C - HIV -1 and 2 HTLV I/II Active bacterial infection Depending on the clinical setting of the blood collection Member States may, however, establish specific provisions for autologous donations by such persons [ S.L.483.02 18 Added by: L.N. 7 of 2016. BLOOD (QUALITY AND SAFETY) SCHEDULE VII STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS (Regulations 3 and 7) 1. STORAGE 1.1 Liquid storage Component Temperature of storage Red cell preparations and + 2 to + 6 º C wh ole bloo d ( if used fo r transfusion as whole blood) Platelet preparations + 20 to + 24º C Granulocytes 1.2 + 20 to + 24º C Maximum storage time 28 to 49 days according to the process used for collection, processing and storage 5 days; may be stored for 7 days in conjunction with detection or reduction of bacterial contamination 24 hours Cryopreservation Components Red blood cells Storage conditions and duration Up to 30 years according to processes used for collection, processing and storage Platelets Up to 24 months according to processes used for collection, processing and storage Plasma and cryoprecipitate Up to 36 months according to processes used for collection, processing and storage Cyropreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allowable storage period after having to depend on the method used. 2. TRANSPOSRT AND DISTRIBUTION Transport and distribution of blood and blood components at all stages of the transfusion chain must be under conditions that maintain the integrity of the product. 3. ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS 3.1 Autologous blood and blood components must be clearly identified as such and stored, transported and distributed separately from allogeneic blood and blood components. 3.2 Autologous blood and blood components must be labelled as required by Sc h e d u l e s I , I I , I I I , I V a n d i n ad d i ti o n t h e l a b e l m u s t i n c lu d e t h e id e n t if i c a t io n o f t h e d o n o r an d t h e war n i n g ‘ F OR AU TO L OG OU S TRANSFUSION ONLY’. BLOOD (QUALITY AND SAFETY) SCHEDULE VIII [ S.L.483.02 19 Added by: L.N. 7 of 2016. QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS (Regulation 3) 1. THE BLOOD COMPONENTS 1. Red cell preparations 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 2. Platelet preparations 2.1 2.2 2.3 2.4 2.5 2.6 3. Plasma preperations 3.1 3.2 3.3 4 5. New components The components listed in points 1.1 to 1.8 may be further processed within blood establishment and must be labelled accordingly. Red cells Red cells, buffy coat removed Red cells, leucocyte-depleted Red cells, in additive solution Red cells, buffy coat removed, in additive solution Red cells, leucocyte-depleted, in additive solution Red cells, apheresis Whole blood The components listed in points 2.1 to 2.6 may be further processed within blood establishments and must be labelled accordingly Platelets, apheresis Platelets, apheresis, leucocyte-depleted Platelets, recovered, pooled Platelets, depleted Platelets, recovered, single unit P l a te l e t s , r e c o v e r ed , s i n g l e u n i t , l e u c o cy t edepleted The components listed in 3.1 to 3.3 may be further processed within blood establishments and must be labelled accordingly Fresh-frozen plasma Fresh-frozen plasma, cryoprecipitate-depleted Cryoprecipitate Granulocytes, apheresis Quality and safety requirements for new blood components must be regulated by the competent national authority. Such new components must be notified to the European Commission with a view to Community action 2. QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS 2.1 Blood and blood components must comply with the following technical quality measurement and meet acceptable results. 2.2 Appropriate bacteriological control of the collection and manufacturing 20 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) process must be performed. 2.3 The competent authority must take all necessary measures to ensure that all imports of blood and blood components from third countries, including, those used as starting material/raw material for the manufacture of medicinal products derived from human blood or human plasma, shall meet equivalent standards of quality and safety to the ones laid down in these regulations. 2.4 For autologous donations, the measures marked with an asterisk (*) are recommendations only. Component Quality measurements required Acceptable results for quality measurements The required frequency of sampling for all measurements shall be determined using statistical process control Red cells Volume Va l i d for storage characteristics to maintain product within specification for haemoglobin and haemolysis Haemoglobin (*) Not less than 45 g per unit Haemolysis Less than 0,8% of red cell mass at the end of the shelf life R ed ce l l s , b u ff y co a t Volume Va l i d for storage removed characteristics to maintain product within specification of haemoglobin and haemolysis Haemoglobin (*) Not less than 43 g per unit Haemolysis Less than 0,8% of red cell mass at the end of the shelf life R ed cells, leucocy te- Volume Va l i d for storage depleted characteristics to maintain product within specifications for haemoglobin and haemolysis Haemoglobin (*) Not less than 40g per unit Luecocyte content Less than 1 X 10 6 per unit Haemolysis Less than 0,8% of red cell mass at the end of the shelf life BLOOD (QUALITY AND SAFETY) Red cells, in additive Volume solution Haemoglobin (*) Haemolysis R e d c el l s , b u ff y c o a t Volume removed, in additive solution Haemoglobin (*) Haemolysis Red cells, leucocyte- Volume d ep le t ed , i n ad d i ti v e solution Haemoglobin (*) Leucocyte content Haemolysis Red cells, apheresis Volume Haemoglobin (*) Haemolysis [ S.L.483.02 21 Va l i d for storage characteristics to maintain product within specification for haemoglobin and haemolysis Not less than 45 g per unit L ess than 0,8% of red cell mass at the end of the shelf life Va l i d for storage characteristics to maintain product within specification for haemoglobin and haemolysis Not less than 43g per unit L ess than 0,8% of red cell mass at the end of the shelf life Va l i d for storage characteristics to maintain product within specification for haemoglobin and haemolysis Not less than 40g per unit Less than 1 x 106 per unit L ess than 0,8% of red cell mass at the end of the shelf life Va l i d for storage characteristics to maintain product within specification for haemoglobin and haemolysis Not less than 40 g per unit L ess than 0,8% of red cell mass at the end of the shelf life 22 [ S.L.483.02 Whole blood BLOOD (QUALITY AND SAFETY) Volume Haemoglobin (*) Haemolysis Platelets, apherisis Volume Platelet content pH P l a t e l e t s , a p h e r e s i s , Volume leucocyte-depleted Platelet content Leucocyte content pH Va l i d for storage characteristics to maintain product within specifications for haemoglobin and haemolysis 450 ml +/- 50 ml F o r p a e d i at r ic a u t o l o g o u s whole blood collections – not to exceed 10,5 ml per kg body weight Not less than 45 g per unit Less than 0,8% of red cell mass at the end of the shelf life Va l i d for storage characteris tics to maintain product within specifications for pH Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions 6,4 - 7,4 corrected for 22ºC, at the end of the shelf life Va l i d for storage characteris tics to maintain product within specifications for pH Variations in platelet content per single donation are permitted within limits that comply with validated preparation and preservation conditions Less than 1 x 10 6 per unit 6,4 - 7,4 corrected for 22ºC, at the end of the shelf life BLOOD (QUALITY AND SAFETY) P l a t e l e t s , r e c o v e r e d , Volume pooled Platelet content Leukocyte content pH P l a t e l e t s , r e c o v e r e d , Volume pooled leukocytedepleted Platelet content Leucocyte content pH P l a t e l e t s , r e c o v e r e d , Volume single unit Platelet content Leucocyte content pH [ S.L.483.02 23 Va l i d for storage characteristics to maintain product within specifications for pH Va r i a t i o n s i n p l a t e l e t content per pool are permitted within limits that comply with validated preparation and preservation conditions Less than 0,2 × 109 per single unit (platelet-rich plasma method) L e s s th an 0 ,0 5 × 1 0 9 p er single unit (buffy coat method) 6,4 - 7,4 corrected for 22°C, at the end of the shelf life Va l i d for storage characteristics to maintain product within specifications for pH Va r i a t i o n s i n p l a t e l e t content per pool are permitted within limits that comply with validated preparation and preservation conditions Less than 1 × 106 per pool 6,4 - 7,4 corrected for 22°C, at the end of the shelf life Va l i d for storage characteristics to maintain product within specifications for pH Va r i a t i o n s i n p l a t e l e t content per single unit are permitted within limits that comply with validated preparation and preservation conditions Less than 0,2 × 109 per single unit (platelet-rich plasma method) L e s s th an 0 ,0 5 × 1 0 9 p er single unit (buffy coat method) 6,4 - 7,4 corrected for 22°C, at the end of the shelf life 24 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) P l a t e l e t s , r e c o v e r e d , Volume single unit, leukocytedepleted Platelet content Leukocyte content pH Plasma, fresh-frozen Volume Factor VIII c (*) Va l i d for storage characteristics to maintain product within specifications for pH Va r i a t i o n s i n p l a t e l e t content per single unit are permitted within limits that comply with validated preparation and preservation conditions Less than 1 × 10 6 per unit 6, 4 - 7,4 corrected for 22°C, at the end of the shelf life Stated volume +/- 10% Average (after freezing and thawing): 70% or more of the value of the freshly collected plasma unit Total protein (*) Not less than 50 g/l Residual cellular content Red cells: less than 6,0 × 109/ (*) l Leucocytes: less than 0, 1 × 10 9/l Platelets: less than 50 ×10 9/l Plasma, fresh- frozen, Volume Stated volume: +/- 10% cryoprecipitateResidual cellular content Red cells: less than 6,0 × 109/ depleted (*) l Leucocytes: less than 0,1 × 10 9/l Cryoprecipitate Fibrinogen content (*) Factor VIIIc content (*) Granulocytes, aphaeresis Volume Granulocyte content Platelets: less than 50×10 9/l Greater than or equal to 140 mg per unit Greater than or equal to 70 international units per unit Less than 500 ml Greater than 1 × 1010 granulocytes per unit BLOOD (QUALITY AND SAFETY) SCHEDULE IX [ S.L.483.02 25 Added by: L.N. 7 of 2016. QUALITY SYSTEM STANDARDS AND SPECIFICATIONS 1. INTRODUCTION AND GENERAL PRINCIPLES 1.1 Quality system 1. Quality shall be recognised as being the responsibility of all persons involved in the processes of the blood establishment with management ensuring a systematic approach towards quality and the implementation and maintenance of a quality system. 2. The quality system encompasses quality management, quality assurance, continuous quality improvement, personnel, premises and equipment, documentation, collection, testing and processing, storage, distribution, quality control, blood component recall, and external and internal auditing, contract management, non-conformance and self-inspection. 3. The quality system shall ensure that all critical processes are specified in appropriate instructions and are carried out in accordance with the standards and specifications set out in this Schedule. Management shall review that system at regulation intervals to verify its effectiveness and introduce corrective measures if deemed necessary. 1.2 Quality assurance 1. All blood establishments and hospital blood banks shall be supported by a quality assurance function, whether internal or related, in fulfilling quality assurance. That function shall be involved in all quality-related matters and review and approve all appropriate quality related documents. 2. All procedures, premises, and equipment that have an influence on the quality and safety of blood and blood components shall be validated prior to introduction and re-validated at regular intervals determined as a result of these activities. 2. PERSONNEL AND ORGANISATION 1. Personnel in blood establishments shall be available in sufficient numbers to carry out the activities related to the collection, testing, processing, storage and distribution of blood and blood components and be trained and assessed to be competent to perform their tasks. 2. All personnel in blood establishments shall have up to date job descriptions which clearly set out their tasks and responsibilities. Blood establishments shall assign the responsibility for processing management and quality assurance to different individuals and who function independently. 3. All personnel in blood establishments shall receive initial and continued training appropriate to their specific tasks. Training records shall be maintained, Training programmes shall be in place and shall include good practice. 4. The contents of training programmes shall be periodically assessed and the competence of personnel evaluated regularly. 5. There shall be written safety and hygiene instructions in place adapted to the activities to be carried out and are in compliance with Council Directive 89/ 391/EEC and Directive 2000/54/EC of the European Parliament and the 26 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) Council. 3. PREMISES 3.1 General Premises including mobile sites shall be adapted and maintained to suit the activities to be carried out. They shall enable the work to proceed in a logical sequence so as to minimise the risk of errors, and shall allow for effective cleaning and maintenance in order to minimise the risk of contamination. 3.2 Blood donor area There shall be an area for confidential personal interviews with assessment of individuals to assess their eligibility to donate. This area shall be separated from all processing areas. 3.3 Blood collection area Blood collection shall be carried out in an area intended for the safe withdrawal of blood from donors, appropriately equipped for the initial treatment of donors experiencing adverse reactions or injuries from events associated with blood donation, and organised in such a way as to ensure the safety of both donors and personnel as well as to avoid errors in the collection procedure. 3.4. Blood testing and processing area There shall be a dedicated laboratory area for testing that is separate from the blood donor and blood components processing area with access restricted to authorised personnel. 3.5 Storage area 1. Storage areas shall provide secure and segregated storage of different catego ries of b lood an d bloo d com pon en ts an d materials in clu ding quarantine and units of blood or blood components collected under special criteria (e.g. autologous donation). 2. Provisions shall be in place in the event of equipment or power failure in the main storage facility. 3.6. Waste disposal area An area shall be designated for the safe disposal of waste, disposal items used during the collection, testing and processing and for rejected blood or blood components. 4. EQUIPMENT AND MATERIALS 1. All equipment shall be validated, calibrated and maintained to suit its intended purpose. Operating instructions shall be available and appropriate records kept. 2. Equipment shall be selected to minimise any hazard to donors, personnel or blood components. 3. Only reagents and materials from approved supplies that meet the documented requirements and specifications shall be used. Critical materials shall be released by a person qualified to perform this task. Where relevant materials, reagents and equipment shall meet the requirements of Council Directive 93/42/EEC for medical devices and Directive 98/79/EC of the European Parliament and of the Council for in vitro diagnostic medical BLOOD (QUALITY AND SAFETY) [ S.L.483.02 27 devices or comply with equivalent standards in the case of collection in third countries. 4. Inventory records shall be retained for a period acceptable to and agreed with the competent authority. 5. When computerised systems are used, software, hardware and back-up procedures must be checked regularly to ensure reliability, be validated before use, and be maintained in a validated state. Hardware and software shall be protected against unauthorised use or unauthorised changes. This back-up procedure shall prevent loss of or damage to data at expected and unexpected down times or function failures. 5. DOCUMENTATION 1. Documents setting out specifications, procedures and records covering each activity performed by the blood establishment shall be in place and kept up to date. 2. Records shall be legible and may be handwritten, transferred to another medium such as microfilm or documented in a computerised system. 3. All significant changes to documents shall be acted upon promptly and shall be reviewed, dated and signed by a person authorised to perform this task. 6. BLOOD COLLECTION, TESTING AND PROCESSING 6.1 Donor eligibility 1. Procedures for safe donor identification, suitability interview and eligibility assessment shall be implemented and maintained. They shall take place before each donation and comply with requirements set out in Schedule V and Schedule VI. 2. The donor interview shall be conducted in such a way as to ensure confidentiality. 3. The donor suitability records and final assessment shall be signed by a qualified health professional. 6.2 Collection of blood and blood component 1. The blood collection procedure shall be designed to ensure that the identity of the donor is verified and securely recorded and that the link between the donor and the blood, blood components and blood samples is clearly established. 2. The sterile blood bag systems used for the collection of blood and blood components and their processing shall be CE-marked or comply with equivalent standards if the blood and blood components are collected in third countries. The batch number of the blood bag shall be traceable for each blood component. 3. Blood collection procedures shall minimise the risk of microbial contamination. 4. Laboratory samples shall be taken at the time of donation and appropriately stored prior to testing. 5. The procedure used for the labelling of records, blood bags and laboratory samples with donation numbers shall be designed to avoid any risk of identification mix-up. 6. After blood collection, the blood bags shall be handled in a way that 28 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) maintains the quality of the blood and at a storage and transport temperature appropriate to further processing requirements. 7. There shall be a system in place to ensure that each donation can be linked to the collection and processing system into which it was collected and/or processed. 6.3. Laboratory testing 1. All laboratory testing procedures shall be validated before use. 2. Each donation shall be tested in conformity with requirements laid down in Schedule IV. 3. There shall be clearly defined procedures to resolve discrepant results and ensure that blood and blood components that have a repeatedly reactive result in a serological screening test for infection with the viruses mentioned in Schedule IV shall be excluded from therapeutic use and be stored separately in a dedicated environment. Appropriate confirmatory testing shall take place. In case of confirmed positive results, appropriate donor management shall take place including the provision of information to the donor and follow-up procedures. 4. There shall be data confirming the suitability of any laboratory reagents used in the testing of donor samples and blood component samples. 5. The quality of the laboratory testing shall be regularly assessed by the participation in a formal system of proficiency testing, such as an external quality assurance programme. 6. Blood group serology testing shall include procedures for testing specific g r o u p s o f d o n o r s ( e . g . f i r s t t i m e d o n o r s , d o n o r s wi t h a h is t o r y o f transfusion). 6.4 Processing and validation 1. All equipment and technical devices shall be used in accordance with validated procedures. 2. The processing of blood components shall be carried out using appropriate a n d v al i d a t e d p r o c e d u r e s i n c l u d i n g m e a s u r e s t o a v o i d t h e r is k o f contamination and microbial growth in the prepared blood components. 6.5 Labelling 1. At all stages, all containers shall be labelled with relevant information of their identity. In the absence of a validated computerised system for status control, the labelling shall clearly distinguish released from non-released units of blood and blood components. 2. The labelling system for the collected blood, intermediate and finished blood components and samples must unmistakably identify the type of content, and comply with the labelling and traceability requirements referred to in regulation 6. The label for a final blood component shall comply with the requirements of Schedule III. 3. For autologous blood and blood components, the label shall comply with Schedules I, II and III and the additional requirements for autologous donations specified in Annex VII. 6.6. Release of blood and blood components 1. There shall be a safe and secure system to prevent each single blood and BLOOD (QUALITY AND SAFETY) [ S.L.483.02 29 blood component from being released until all mandatory requirements have been fulfilled. Each blood establishment shall be able to demonstrate that each blood or blood component has been formally released by an authorised person. Records shall demonstrate that before a blood component is released, all current declaration forms, relevant medical records and test results meet all acceptance criteria. 2. Before release, blood and blood components shall be kept administratively and physically segregated from released blood and blood components. In the absence of a validated computerised system for status control the label of a unit of blood or blood component shall identify the release status in accordance with 6.5.1. 3. In the event that the final component fails release due to a confirmed positive infection test result, in conformity with the requirements set out in sectio n 6.3.2 an d 6.3.3 , a ch eck sh all be made to en sure that other components from the same donation and components prepare from previous donations given by the donor are identified. There shall be an immediate update of the donor card. 7. STORAGE DISTIRBUTION 1. The quality system of the blood establishment shall ensure that, for blood and blood components intended for the manufacture of medical products, the storage and distribution requirements shall comply with the Medicines Act. 2. Procedures for storage and distribution shall be validated to ensure blood and blood component quality during the entire storage period and to exclude mix-ups of blood components. All transportation and storage actions including receipt and distribution, shall be defined by written procedures and specifications. 3. Autologous blood and blood components as well as blood components collected and prepared for specific purposes shall be stored separately. 4. Appropriate records of inventory and distribution shall be kept. 5. Packaging shall maintain the integrity and storage temperature of blood and blood components during the distribution and transportation. 6. Return of blood and blood components into inventory for subsequent reissue shall only be accepted when all quality requirements and procedures laid down by the blood establishment to ensure blood component integrity are fulfilled. 8. CONTRACT MANAGEMENT Tasks that are performed externally shall be defined in a specific written contract. 9. NON-CONFORMANCE 9.1 Deviations Blood components deviating from required standards set out in Schedule VIII shall be released for transfusion only in exceptional circumstances and with the recorded agreement of the prescribing physician and the blood establishment physician. 9.2 Complaints All complaints and other information, including serious adverse reactions 30 [ S.L.483.02 BLOOD (QUALITY AND SAFETY) and serious adverse events, which may suggest that defective blood components have been issued, shall be documented, carefully investigated for causative factors of the defect and, where necessary followed by recall and the implementation of corrective actions to prevent recurrence. Procedures shall be in place to ensure that the competent authorities are notified as appropriate of serious adverse reactions or serious adverse events with regulatory requirements. 9.3 Recall 1. There shall be personnel authorised with the blood establishment to assess the need for blood and blood component recall and to initiate and coordinate the necessary actions. 2. An effective recall procedure shall be in place, including a description of the responsibilities and actions to be taken. This shall include notification to the competent authority. 3. Actions shall be taken with pre-defined periods of time and shall include tracing all relevant blood components and, where applicable, shall include trace-back. The purpose of the investigations is to identify any donor who might have contributed to causing the transfusion reaction and to retrieve available blood components from that donor, as well as to notify consignees and recipients of components collected from the same donor in the event that they might have been put at risk. 9.4 Corrective and preventive actions 1. A system to ensure corrective and preventive actions on blood component non-conformity and quality problems shall be in place. 2. Data shall be routinely analysed to identify quality problems that may require corrective action or to identify unfavourable trends that may require preventive action. 3. All errors and accidents shall be documented and investigated in order to identify system problems for correction. 10. SELF-INSPECTION, AUDITS AND IMPORVEMENTS 1. Self-inspection or audit systems shall be in place for all parts of the operations to verify compliance with the standards set out in this Schedule. They shall be carried out regularly by trained and competent persons in an independent way according to approved procedures. 2. All results shall be documented and appropriate corrective actions shall be taken in a timely and effective manner.

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