SCHEDULE

PART 3ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

Acceptance criteria for donors of whole blood and blood components1

Under exceptional circumstances, individual donations from donors who do not comply with following criteria may be authorised by a qualified healthcare professional in the blood establishment. All such cases must be clearly documented and subject to the quality management provisions in Articles 11, 12 and 13 of Directive 2002/98/EC.

The criteria in this paragraph do not apply to autologous donations.

1

Age and body weight of donors

Age

18 to 65 years

 

 

17 years

Where, in the opinion of a qualified health professional, the donor has sufficient knowledge and understanding of what is involved in the process of blood donation to give their informed consent, or otherwise with the written consent of a person with parental responsibility.

 

First time donors over 60 years

— at the discretion of the doctor in the blood establishment

 

Over 65 years

— with permission of the doctor in the blood establishment, given annually

Body weight

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

1

Haemoglobin levels in donor's blood

Haemoglobin

For females ≥ 125 g/l

For males ≥ 135 g/l

Applicable to allogeneic donors of whole blood and cellular components

1

Protein levels in donor's blood

Protein

≥ 60 g/l

The protein analysis for apheresis plasma donations must be performed at least annually

1

Platelet levels in donor's blood

Platelets

Platelet number greater than or equal to 150 x 109 /1

Level required for apheresis platelet donors

DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS

Deferral criteria for donors of whole blood and blood components2

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 history of convulsions

Other than childhood convulsions or where at least three years have elapsed since the date the donor last took anticonvulsant medication without any recurrence of convulsions

Gastrointestinal. Genitourinary, haematological, immunological, metabolic, renal, or respiratory system diseases

Prospective donors with serious active, chronic, or relapsing disease

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

Transmissible spongiform encephalopathies (TSEs) (e.g. Creutzfeldt Jakob Disease, variant Creutzfeldt Jakob Disease)

Persons who have a family history which places them at risk of developing a TSE, or persons who have received a corneal or dura mater graft, or who have been treated in the past with medicines made from human pituitary glands. For variant Creutzfeldt Jacob disease, further precautionary measures may be recommended.

Intravenous (IV) or intramuscular (IM) drug use

Any history of non-prescribed IV or IM drug use, including body-building steroids or hormones

Xenotransplant recipients

 

Sexual behaviour

Persons whose sexual behaviour puts them at high risk of acquiring severe infectious diseases that can be transmitted by blood

2

Temporary deferral criteria for donors of allogeneic donations

2

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 years following the date of cessation of symptoms, unless evidence of chronic heart disease

Fever >38°C

2 weeks following the date of cessation of symptoms

Flu-like illness

2 weeks after cessation of symptoms

Malaria (*)

 

— individuals who have lived in a malarial area within the first five years of life

3 years following return from last visit to any endemic area, provided person remains symptom free;

may be reduced to 4 months if an immunologic or molecular genomic test is negative at each donation.

— individuals with a history of malaria

3 years following cessation of treatment and absence of symptoms.

Donations may be accepted thereafter only if an immunologic or molecular genomic test is negative

— asymptomic visitors to endemic areas

6 months after leaving the endemic area unless an immunologic or molecular genomic test is negative

— individuals with a history of undiagnosed febrile illness during or within six months of a visit to an endemic area

3 years following resolution of symptoms;

may be reduced to 4 months if an immunologic or molecular test is negative

F1West 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

Exposure to risk of acquiring a transfusion-transmissible infection

— Endoscopic examination using flexible instruments,

— mocusal splash with blood or needlestick 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 and with sterile single-use needles,

— persons at risk due to close household contact with persons with hepatitis B.

Defer 6 months, or 4 months provided a NAT test for hepatitis C is negative

Persons whose behaviour or activity places them at risk of acquiring infectious diseases that may be transmitted by blood.

Defer after cessation of risk behaviour for a period determined by the disease in question, and by the availability of appropriate tests.

2

Vaccination

Attenuated viruses or bacteria

4 weeks

Inactivated/killed viruses, bacteria or rickettsiae

No deferral if well

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

Other temporary deferrals

Pregnancy

6 months after delivery or termination, except in exceptional circumstances and at the discretion of a 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 an the disease being treated

2

Deferral for particular epidemiological situations

Particular epidemiological situations (e.g. disease outbreaks)

Deferral consistent with the epidemiological situation

2

Deferral criteria for donors of autologous donations

Serious cardiac disease

Depending on the clinical setting of the blood collection

Active bacterial infection