7 tal-2016 - Regolamenti tal-2016 li jemendaw ir-Regolamenti dwar il-Kwalità u s-Sigurezza tad-Demm

L.N. 7 of 2016

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Blood (Quality and Safety) (Amendment) Regulations, 2016

BY virtue of article 16 of the Human Blood and Transplants

Act the Parliamentary Secretary for Health, after consultation with

the Licensing Authority, has made the following regulations

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

Safety) (Amendment) Regulations, 2016 and these regulations shall

be read and construed as one with the Blood (Quality and Safety)

Regulations, hereinafter referred to as the "principal regulations".

(2) The scope of these regulations is to amend the principle

regulations and transpose Commission Directive 2014/110/EU of

17th December 2014 amending Directive 2004/33/EC as regards

temporary deferral criteria for donors of allogeneic blood donation.

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.

In regulation 3 of principal regulations for the "Annex I

to Directive 2002/98/EC and any amendments thereto", there shall

be substituted the words "Schedule I".

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.

Regulation 5 of the principal regulations shall be

amended as follows

(a)

sub-regulation (1) thereof shall be amended as

follows

(i) in paragraph (b) thereof for the words

"Annexes to Directive 2005/62/EC implementing

Directive 2002/98/EC of the European Parliament and the

Council as regards Community Standards and

specification relating to a quality system for Blood

Establishments;" there shall be substituted the words

"Schedule IX"; and

(ii) in paragraph (c) thereof for the words

"Annexes II and V to Directive 2004/33/EC" there shall

be substituted the words "Schedules V and VIII".

(b)

sub-regulation (2) thereof shall be amended as

follows

(i) in paragraph (a) thereof for the words

"Annex II to Directive 2004/33/EC and any amendments

thereto" there shall be substituted the words "Schedule

V";

(ii) in paragraph (b) thereof for the words

"Annex II to Directive 2004/33/EC and any amendments

thereto" there shall be substituted the words "Schedule

V"; and

(iii) in paragraph (d) thereof for the words

"Annex III to Directive 2004/33/EC and any amendments

thereto" there shall be substituted the words "Schedule

VI".

(c)

sub-regulation (3) thereof shall be amened as

follows

(i) in paragraph (a) thereof for the words

"Annex IV to Directive 2002/98/EC and any amendments

thereto" there shall be substituted the words "Schedule

IV";

(ii) in paragraph (b) thereof for the words

"Annex IV to Directive 2004/33/EC and any amendments

thereto" there shall be substituted the words "Schedule

VII"; and

(iii) in paragraph (c) thereof for the words

"Annex V to Directive 2004/33/EC and any amendments

thereto." there shall be substituted the words "Schedule

VIII.";

(d)

in sub-regulation (4) thereof for the words

"Annexes II and IV to Directive 2002/98/EC and Annexes II

Part A and Part B and Annex III to Directive 2004/33/EC"

there shall be substituted the words Schedules II, IV, V and

VI".

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).

In sub-regulation (1) of regulation 6 of the principal Amends

regulations for the words "Annex III to Directive 2002/98/EC" there regulation

the principal

shall be substituted the words "Schedule III".

regulations.

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)

Additional tests may be required for specific components or

donors or epidemiological situations.

Regulation 7 of the principal regulations shall be Amends

regulation 7 of

amended as follows

the principal

regulations.

(a)

paragraph (c) thereof for the words the words

"Annex IV to Directive 2004/33/EC and any amendments

thereto" there shall be substituted the words "Schedule VII";

and

(b)

paragraph (h) thereof for the words the words

"Annex IV to Directive 2004/33/EC and any amendments

thereto" there shall be substituted the words "Schedule VII".

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 individual whether

as donor or recipient 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 components may not suffice for the

intended transfusion 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.

Immediately after regulation 9 of the principal

regulations, there shall be added the following new Schedules

ELIGIBITITY CIRITERIA FOR DONORS OF 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

First time donors over 60

-

At the discretion of

the physician in the

years

blood establishment

Over 65 years

-

With permission of

the physician in the

blood establishment,

given annually

Body weight

≥ 50 kg for doors either for whole blood or apheresis

blood components

Haemoglobin levels in donor’s blood

Haemoglobin

for females ≥ 125

for males ≥ 135

Applicable

to

allogeneic donors of

g/l

g/l

whole blood and

cellular components

Protein levels in donor’s blood

≥ 60 g/l

The protein analysis for apheresis

plasma donations must be performed at

least annually

Platelet level in donor’s blood

Platelet number greater

Level required for

apheresis platelet donor

than or equal to 150 x 10 9 / l

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 active,

haematological, immunological,

chronic, or relapsing disease

metabolic, 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

HTLV I/II

Babesiosis (*)

Kala Azar (visceral leishmaniasis) (*)

Trypanosomiasis cruzi (Chagas’

disease)(*)

Malignant diseases

Except in situ cancer with complete

recovery

Transmissable spongiform

Persons who have a family history which

Encephalapathies (TSEs), (e.g.

places them at risk of developing a TSE,

Creutzfeldt Jakob Disease, variant

or persons who have received a corneal

Creutzfeldt Jakob Disease)

or dura mater graft, 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 IM

drug use, including body-building steroids

drug use

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 recover

Osteomyelitis

2 years after confirmed cured

2 years following the date of confirmed cure

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

2 weeks following the date of cessation of

symptoms

Flu-like illness

2 weeks after cessation of symptoms

individuals who have lived in a

3 years following return from last visit to

malarial area within the first five

any endemic area, provided person remains

years of life

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 and

malaria

absence of symptoms. Accept thereafter

only if an immunological or molecular

genomic test is negative

asymptomatic visitors of

6 months after leaving the endemic area

endemic areas

unless an immunologic or molecular genomic

test is negative

-

individuals with a history of

3 years following resolution of symptoms;

undiagnosed febrile illness

May be reduced to 4 months if an

during o within six months of a

immunologic or molecular test is negative

visit to an endemic area

West Nile Virus (WNV) (*)

28 days after leaving 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

Defer for 6 months, or for 4 months

-

Endoscopic examination using

provided a NAT test for hepatitis C is

flexible instruments,

- Mucosal splash with blood or needle negative

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 who behaviour or activity places Defer after cessation of risk behaviour for

them at risk of acquiring diseases that

a period determined by the disease in

may be transmitted by blood

question, and by the availability of

appropriate tests

2.2.3 Vaccination

Attenuated viruses or bacteria

4 weeks

Inactivated/ killed viruses, bacteria, or

No deferral if well

rickettsiae

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 extraction, root-filling

and

similar 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

- hepatitis B, except for HBsAg-

donations

by such persons

negative persons who

are

demonstrated to be immune

- hepatitis C

HIV ‐1 and 2

‐

- HTLV I/II

Active bacterial infection

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.

STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS

FOR BLOOD AND BLOOD COMPONENTS

(Regulations 3 and 7)

1. STORAGE

Liquid storage

Component

Temperature of storage

Maximum storage time

Red cell preparations and

28 to 49 days according

+ 2 to + 6 0 C

whole blood (if used for

to the process used for

transfusion as whole

collection,

processing

and storage

Platelet preparations

5 days; may be stored for

+ 20 to + 24 0 C

7 days in conjunction

with

detection

or

reduction of bacterial

contamination

Granulocytes

24 hours

+ 20 to + 24 0 C

Cryopreservation

Components

Storage conditions and duration

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 Schedules I, II, III, IV and in addition the

label must include the identification of the donor and the

warning ‘FOR AUTOLOGOUS TRANSFUSION ONLY’.

Information on the responsibility of the blood

establishment to inform the donor, through an appropriate

mechanism, if test results show any abnormality of

significance to the donor's health.

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

Platelets, recovered, single unit, leucocyte-

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.

2.2 Appropriate bacteriological control of the collection and

manufacturing 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

Acceptable results for quality

required

measurements

The required frequency of

sampling for all

measurements shall be

determined using

statistical process control

Red cells

Volume

Valid 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

Red cells, buffy

Volume

Valid for storage characteristics to

coat removed

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

Red cells,

Volume

Valid for storage characteristics to

leucocyte-

maintain

product

within

depleted

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

Red cells, in

Volume

Valid for storage characteristics to

additive soution

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

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, buffy

Volume

Valid for storage characteristics to

coat removed,

maintain

product

within

in additive

specification for haemoglobin and

solution

haemolysis

Haemoglobin (*)

Not less than 43g per unit

Haemolysis

Less than 0,8% of red cell mass at

the end of the shelf life

Red cells,

Volume

Valid for storage characteristics to

leucocyte-

maintain

product

within

specification for haemoglobin and

depleted, in

haemolysis

additive

solution

Haemoglobin (*)

Not less than 40g per unit

Leucocyte 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

Red cells,

Volume

Valid for storage characteristics to

apheresis

maintain

product

within

specification for haemoglobin and

haemolysis

Haemoglobin (*)

Not less than 40 g per unit

Haemolysis

Less than 0,8% of red cell mass at

the end of the shelf life

Whole blood

Volume

Valid for storage characteristics to

maintain

product

within

specifications for haemoglobin

and haemolysis 450 ml +/- 50 ml

For paediatric autologous 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

Component

Quality measurements

Acceptable results for quality

required

measurements

The required frequency of

sampling for all

measurements shall be

determined using

statistical process control

Platelets,

Volume

Valid for storage characteristics to

apherisis

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 22 0 C, at

the end of the shelf life

Platelets,

Volume

Valid for storage characteristics to

apheresis,

maintain product within

leucocyte-

specifications for pH

depleted

Platelet content

Variations in platelet content per

single donation are permitted

within limits that comply with

validated

preparation

and

preservation conditions

Leucocyte content

Less than 1 x 10 6 per unit

pH

6,4 – 7,4 corrected for 22 0 C, at

the end of the shelf life

Platelets,

Volume

Valid for storage characteristics

recovered,

to maintain product within

pooled

specifications for pH

Platelet content

Variations in platelet content per

pool are permitted within limits

that comply with

validated

preparation and

preservation

conditions

Leukocyte content

Less than 0,2 × 10 9 per single

unit (platelet-rich plasma

method)

Less than 0,05 × 10 9 per single

unit (buffy coat method)

pH

6,4 – 7,4 corrected for 22 °C, at

the end of the shelf life

Component

Quality measurements

Acceptable results for quality

required

measurements

The required frequency of

sampling for all

measurements shall be

determined using

statistical process control

Platelets,

Volume

Valid for storage characteristics

recovered,

to maintain product within

pooled

specifications for pH

leukocyte-

Platelet content

Variations in platelet content per

depleted

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

Platelets,

Volume

Valid for storage characteristics

to maintain product within

recovered,

specifications for pH

single unit

Platelet content

Variations in platelet content per

single unit are permitted within

limits that comply with validated

preparation

and preservation

conditions

Less than 0,2 × 10 9 per single

Leucocyte content

unit (platelet-rich plasma

method)

Less than 0,05 × 10 9 per single

unit (buffy coat method)

pH

6,4 – 7,4 corrected for 22 °C, at the

end of the shelf life

Platelets,

Volume

Valid for storage characteristics

recovered, single

to maintain product within

specifications for pH

unit, leukocyte-

depleted

Platelet content

Variations in platelet content per

single unit are permitted within

limits that comply with validated

preparation

and preservation

conditions

Leukocyte content

Less than 1 × 10 6 per unit

pH

6, 4 -7,4 corrected for 22 °C, at

the end of the shelf life

Component

Quality measurements

Acceptable results for quality

required

measurements

The required frequency of

sampling for all

measurements shall be

determined using

statistical process control

Plasma, fresh-

Volume

Stated volume +/- 10%

frozen

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

Red cells: less than 6,0 ×

10 9 /l

content (*)

Leucocytes: less than 0, 1 ×

10 9 /l

Platelets: less than 50 ×10 9 /l

Volume

Stated volume: +/- 10 %

Plasma, fresh-

frozen,

cryoprecipitate-

Residual cellular content (*)

Red cells: less than 6,0 × 10 9 /l

depleted

Leucocytes: less than 0,1 ×

10 9 /l Platelets: less than

50×10 9 /l

Cryoprecipitate

Fibrinogen content (*)

Greater than or equal to 140 mg

per unit

Greater than or equal to 70

Factor VIIIc content (*)

international units per unit

Granulocytes,

Volume

Less than 500 ml

aphaeresis

Granulocyte content

Greater than 1 × 10 10

granulocytes per unit

Information why unused autologous blood and blood

components will be discarded and not transfused to other

patients.

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

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 categories of blood and blood components

and materials including 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 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 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 groups of donors (e.g. first time donors,

donors with a history of 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 and validated procedures including

measures to avoid the risk of 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 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 section 6.3.2 and 6.3.3, a

check shall be made to ensure 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 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.

B

€2.88

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.

Information on the opportunity for donors to ask

questions at any time.

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.