BLOOD (QUALITY AND SAFETY) REGULATIONS

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) The title of these regulations is the Blood (Quality and

Safety) Regulations.

(2) These regulations transpose

(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;

(b) Commission Directive 2004/33/EC of the 22 nd 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;

(c) Commission Directive 2004/33/EC of the 22 nd March,

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;

(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

(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.

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.

Part B

A description of the quality system, to include

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.

L.N. 7 of 2016.

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;

"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 follow-

up 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

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.

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)

An application for a licence to operate a blood

establishment shall include all the information referred to under

Schedule I.

Added by

L.N. 7 of 2016.

LABELLING REQUIREMENTS

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).

(1) A blood establishment shall designate a person who is

responsible for the following tasks

(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;

(b) ensuring that every unit of blood or blood components

intended for transfusion has been processed, stored

and distributed in accordance with the requirements of

these regulations;

(c) providing information to the Authority relating to the

licence of the blood establishment for the purposes of

regulation 3; and

(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 -

(a) a diploma, certificate or other evidence of formal

qualification in the field of medical or biological

sciences awarded on completion of -

(i) a university course of study, or

(ii) a course recognised as an equivalent course by

the Authority; and

(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 -

(a) relieve him of the duties of responsible person in

respect of the establishment;

(b) appoint a new responsible person in his place; and

(c) notify the Authority that it has appointed a new

responsible person and provide details of the name and

qualifications of the person appointed.

Added by

L.N. 7 of 2016.

BASIC TESTING REQUIREMENTS OR WHOLE

BLOOD AND PLASMA DONATIONS

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.

(1)

A blood establishment shall -

(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;

(b) establish and maintain a quality system for blood

establishments laid down in the Schedule IX;

(c) ensure that all testing and processes of the blood

establishment which are referred to in Schedules V and

VIII are validated;

(d) maintain documentation on operational procedures,

guidelines, training and reference manuals and

reporting forms so that they are readily available for

inspection;

(e) notify the Authority of -

(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

(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

(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 -

(a) give all prospective donors of blood or blood

components information in accordance with Part A of

Schedule V;

(b) obtain from all persons who are willing to provide

blood or blood components, information in accordance

with Part B of Schedule V;

(c) put and keep in place procedures for the evaluation of

donors;

(d) apply eligibility criteria for all donors of blood and

blood components in accordance with Schedule VI;

(e) maintain records of the results of donor evaluations

and report to donors any relevant abnormal findings

BLOOD (QUALITY AND SAFETY)

from the evaluations;

(f)

ensure that -

(i)

an examination of the donor, including an

interview, is carried out before any donation of

blood or blood components,

(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

(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

(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;

(b) the storage, transport and distribution conditions of

blood and blood components comply with the

requirements of Schedule VII; and

(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).

Added by

L.N. 7 of 2016.

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 self-

deferring 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.

(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 -

(a) for the identification of each single blood donation and

each single blood unit and its components, including

blood and blood components which are imported into

the European Community; and

(b) to ensure full traceability to the point of delivery to a

hospital.

Added by

L.N. 7 of 2016.

ELIGIBITITY CIRITERIA FOR DONORS OF

Amended by

L.N. 362 of 2017.

WHOLE BLOOD AND BLOOD COMPONENTS

1. 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.

Age and body weight of donors

Age

18 to 65 years

17 to 18 years

-

Unless classified as a minor by law,

or with written consent of parent of

legal curator

F ir s t t i m e d o n o r s

-

At the discretion of the physician in

over 60 years

the blood establishment

Over 65 years

- With permission of the physician in

the blood establishment, given

annually

Body weight

≥ 50 kg for donors either for whole blood or apheresis blood

components

Haemoglobin levels in donor’s blood

Haemoglobin

for females ≥ 125 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

Protein levels in donor’s blood

Protein

≥ 60 g/l

The protein analysis for apheresis

plasma donations must be performed at

least annually

Platelet level in donor’s blood

Platelets

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

2. 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.

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 HBsAg-

negative persons who are demonstrated

to be immune

Hepatitis C

HIV-1 and 2

BLOOD (QUALITY AND SAFETY)

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

Transmissable spongiform

Persons who have a family history

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

Disease)

corneal or dura m ater gr aft, or who

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

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 (*)

2 years following the date of full recovery

Osteomyelitis

2 years after confirmed cured

Q fever (*)

2 years following the date of confirmed

cure

Syphilis (*)

1 year following the date of confirmed

cure

Toxoplasmosis (*)

6 months following the date of clinical

recovery

Tuberculosis

2 years following the date of confirmed

cure

Rheumatic fever

2 weeks following the date of cessation

of symptoms, unless evidence of

chronic heart disease

Fever > º C

2 weeks following the date of cessation

of symptoms

Flu-like illness

2 weeks after cessation of symptoms

BLOOD (QUALITY AND SAFETY)

Malaria (*)

- individuals who have lived in a

3 years following return from last

malarial area within the first five

visit to any endemic area, provided

years of life

person remains symptom free; may be

reduced to 4 months if an immunologic

or molecular genomic test is negative at

each donation

- individuals with a history of

3 years following cessation of treatment

malaria

and absence of symptoms. Accept

thereafter only if an immunological or

molecular genomic test is negative

- asymptomatic visitors of endemic

6 months after leaving the endemic area

areas

unless an immunologic or molecu lar

genomic test is negative

- individuals with a history of

3 years following resolution of

undiagnosed febrile illness during

symptoms; may be reduced to 4 months

o within six months of a visit to an

if an immunologic or molecular test is

endemic area

negative

West Nile Virus (WNV) (*)

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

Defer for 6 months, or for 4 months

flexible instruments,

provided a NAT test for hepatitis C is

negative

- Mucosal splash with blood or

needle stick injury,

- 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

Defer after cessation of risk behaviour

places them at risk of acquiring

for a period determined by the disease in

diseases that may be transmitted by

q uestion, an d by the availability of

blood

appropriate tests

2.2.3 Vaccination

Attenuated viruses or bacteria

4 weeks

Inactivated/ killed viruses, bacteria,

No deferral if well

or rickettsiae

BLOOD (QUALITY AND SAFETY)

Toxoids

No deferral if well

Hepatitis A or hepatitis B vaccines

No deferral if well and if no exposure

Rabies

No deferral if well and if no exposure If

vaccination is given following exposure

defer for one year

Tick-borne encephalitis vaccines

No deferral if well and if no exposure

2.2.4 Other temporary deferrals

Pregnancy

6 months after delivery or termination,

except in exceptional circumstances and at

the discretion of physician

Minor surgery

1 week

Dental treatment

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)

Medication

Based on the nature of the prescribed

medicine, its mode of action and the

disease being treated

2.3

Deferral for particular epidemiological situations

Particular epidemiological situations

Deferral consistent with the

(e.g. disease outbreaks)

epidemiological situation (These deferral

should be notified by the competent

authority to the European Commission

with a view to Community action)

2.4

Deferral criteria for donor of autologous donations

Serious cardiac disease

Depending on the clinical setting of the

blood collection

Persons with or with history of -

Member States may, however, establish

specific provisions for autologous donations

- hepatitis B, except for HBsAg-

by such persons

negative persons who are

demonstrated to be immune

-

hepatitis C

-

HIV -1 and 2

-

HTLV I/II

Active bacterial infection

The person responsible for the management of a hospital

blood bank shall -

(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;

(b) establish and maintain a quality system for the hospital

blood bank which is based on the principles of good

practice;

(c) ensure that all processes referred to in Schedule VII,

which are applicable to activities carried out by the

hospital blood bank, are validated;

(d) maintain documentation on operational procedures,

guidelines, training and reference manuals and

reporting forms so that they are readily available for

inspection;

(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;

(f)

notify the Authority and the blood establishment from

whom the blood and blood components were procured

of -

(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

(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;

(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

(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.

Added by

L.N. 7 of 2016.

STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD

AND BLOOD COMPONENTS

(Regulations 3 and 7)

1. STORAGE

Liquid storage

Component

Temperature of

Maximum storage time

storage

Red cell preparations and + 2 to + 6 º C

28 to 49 days according to the

wh ole bloo d ( if used fo r

process used for collection,

transfusion as whole blood)

processing and storage

+ 20 to + 24 º C

Platelet preparations

5 days; may be stored for 7

days in conjunction with

detection or reduction of

bacterial contamination

+ 20 to + 24 º C

Granulocytes

24 hours

Cryopreservation

Storage conditions and duration

Components

Red blood cells

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

Autologous blood and blood components must be clearly identified as such

and stored, transported and distributed separately from allogeneic blood and

blood components.

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)

(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 -

(a) include a declaration that the hospital blood bank has

in place appropriate systems to ensure compliance

with the requirements of these regulations; and

(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.

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

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

2. Platelet preparations

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 e-

depleted

3. Plasma preperations

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

5. New components

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

Blood and blood components must comply with the following technical

quality measurement and meet acceptable results.

Appropriate bacteriological control of the collection and manufacturing

process must be performed.

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.

For autologous donations, the measures marked with an asterisk (*) are

recommendations only.

Component

Quality measurements

Acceptable results for quality

required

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

Less than 1 X 10 6 per unit

Luecocyte content

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

Va l i d

for

storage

solution

characteristics to maintain

product within specification

for haemoglobin

and

haemolysis

Haemoglobin (*)

Not less than 45 g per unit

Haemolysis

L ess than 0,8% of red cell

mass at the end of the shelf

life

R e d c el l s , b u ff y c o a t Volume

Va l i d

for

storage

removed, in additive

characteristics to maintain

solution

product within specification

for haemoglobin

and

haemolysis

Haemoglobin (*)

Not less than 43g per unit

Haemolysis

L ess than 0,8% of red cell

mass at the end of the shelf

life

Red cells, leucocyte- Volume

Va l i d

for

storage

d ep le t ed , i n ad d i ti v e

characteristics to maintain

solution

product within specification

for haemoglobin and

haemolysis

Haemoglobin (*)

Not less than 40g per unit

Less than 1 x 10 6 per unit

Leucocyte content

Haemolysis

L ess than 0,8% of red cell

mass at the end of the shelf

life

Red cells, apheresis

Volume

Va l i d

for

storage

characteristics to maintain

product within specification

for haemoglobin and

haemolysis

Haemoglobin (*)

Not less than 40 g per unit

Haemolysis

L ess than 0,8% of red cell

mass at the end of the shelf

life

BLOOD (QUALITY AND SAFETY)

Whole blood

Volume

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

Haemoglobin (*)

Not less than 45 g per unit

Haemolysis

Less than 0,8% of red cell

mass at the end of the shelf

life

Platelets, apherisis

Volume

Va l i d

for

storage

characteris tics to maintain

product within specifications

for pH

Platelet content

Variations in platelet content

per single donation are

permitted within limits that

comply with validated

preparation and preservation

conditions

pH

6,4 - 7,4 corrected for 22ºC,

at the end of the shelf life

P l a t e l e t s , a p h e r e s i s , Volume

Va l i d

for

storage

leucocyte-depleted

characteris tics to maintain

product within specifications

for pH

Platelet content

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

Leucocyte content

pH

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

Va l i d

for

storage

pooled

characteristics to maintain

product within specifications

for pH

Platelet content

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 × 10 9 per

Leukocyte content

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)

pH

6,4 - 7,4 corrected for 22°C,

at the end of the shelf life

P l a t e l e t s , r e c o v e r e d , Volume

Va l i d

for

storage

pooled leukocyte-

characteristics to maintain

depleted

product

within

specifications for pH

Platelet content

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 × 10 6 per pool

Leucocyte content

pH

6,4 - 7,4 corrected for 22°C,

at the end of the shelf life

P l a t e l e t s , r e c o v e r e d , Volume

Va l i d

for

storage

single unit

characteristics to maintain

product

within

specifications for pH

Platelet content

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 × 10 9 per

Leucocyte content

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)

pH

6,4 - 7,4 corrected for 22°C,

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

Va l i d

for

storage

single unit, leukocyte-

characteristics to maintain

product

within

specifications for pH

Platelet content

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

Leukocyte content

pH

6, 4 - 7,4 corrected for

22°C, at the end of the shelf

life

Volume

Stated volume +/- 10%

Factor VIII c (*)

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 × 10 9 /

(*)

l

Leucocytes: less than 0, 1 ×

10 9 /l

Platelets: less than 50 ×10 9 /l

Plasma, fresh- frozen, Volume

Stated volume: +/- 10%

Residual cellular content Red cells: less than 6,0 × 10 9 /

(*)

l

Leucocytes: less than 0,1 ×

10 9 /l

Platelets: less than 50×10 9 /l

Fibrinogen content (*)

Greater than or equal to 140

mg per unit

Factor VIIIc content (*)

Greater than or equal to 70

international units per unit

Volume

Less than 500 ml

Greater than 1 × 10 10

Granulocyte content

granulocytes per unit

BLOOD (QUALITY AND SAFETY)

(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

(ii) where they have been rendered anonymous, so

that donors are no longer identifiable;

(c) subject to safeguards against unauthorised additions,

deletions or modifications.

(2) The requirements referred to under sub-regulation (1)(b)(i)

are that

(a) the disclosure is made in accordance with an order of a

court or is otherwise required by law;

(b) the disclosure is to an inspector appointed by the

Authority; or

(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.

Added by

L.N. 7 of 2016.

QUALITY SYSTEM STANDARDS AND SPECIFICATIONS

1. INTRODUCTION AND GENERAL PRINCIPLES

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.

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

Council.

3. PREMISES

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.

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.

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.

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)

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

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.

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

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).

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.

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)

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

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.

Complaints

All complaints and other information, including serious adverse reactions

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.

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.

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.

(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

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.

Information on the opportunity for donors to ask questions at any time.

BLOOD (QUALITY AND SAFETY)

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

(a) read and understood the educational materials provided;

(b) had an opportunity to ask questions;

(c) been provided with satisfactory responses to any questions asked;

(d) given informed consent to proceed with the donation process;

(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

(f)

acknowledged that all the information provided by the donor is true to

the best of his/her knowledge.