ANNEX IIIU.K.ELIGIBILITY CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS (as referred to in Article 4)
1.ACCEPTANCE CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTSU.K.
Under exceptional circumstances, individual donations from donors who do not comply with the 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 following criteria do not apply to autologous donations.
1.1.Age and body weight of donorsU.K.
1.2.Haemoglobin levels in donor's bloodU.K.
| Haemoglobin | for females ≥ 125 g/l | for males ≥ 135 g/l | Applicable to allogeneic donors of whole blood and cellular components |
1.3.Protein levels in donor's bloodU.K.
| Protein | ≥ 60 g/l | The protein analysis for apheresis plasma donations must be performed at least annually |
1.4.Platelet levels in donor's bloodU.K.
| Platelets | Platelet number greater than or equal to 150 × 109/l | Level required for apheresis platelet donors |
2.DEFERRAL CRITERIA FOR DONORS OF WHOLE BLOOD AND BLOOD COMPONENTSU.K.
The tests and deferral periods indicated by an asterisk (*) are not required when the donation is used exclusively for plasma for fractionation.
2.1.Permanent deferral criteria for donors of allogeneic donationsU.K.
| 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-1/2 | |
| 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 |
2.2.Temporary deferral criteria for donors of allogeneic donationsU.K.
2.2.1.InfectionsU.K.
Duration of deferral periodU.K.
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 cured |
| Syphilis (*) | 1 year following the date of confirmed cured |
| Toxoplasmosis (*) | 6 months following the date of clinical recovery |
| Tuberculosis | 2 years following the date of confirmed cured |
| Rheumatic fever | 2 years following the date of cessation of symptoms, unless evidence of chronic heart disease |
| Fever > °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. Accept thereafter only if an immunologic or molecular genomic test is negative |
—asymptomatic 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 |
| West Nile Virus (WNV) (*) | [F128 days after leaving a risk area of locally acquired West Nile Virus unless an individual Nucleic Acid Test (NAT) is negative] |
Textual Amendments
2.2.2.Exposure to risk of acquiring a transfusion-transmissible infectionU.K.
| Defer for 6 months, or for 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 |
2.2.3.VaccinationU.K.
| 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 |
2.2.4.Other temporary deferralsU.K.
| 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 and the disease being treated |
2.3.Deferral for particular epidemiological situationsU.K.
| Particular epidemiological situations (e.g. disease outbreaks) | Deferral consistent with the epidemiological situation (These deferrals should be notified by the competent authority to the European Commission with a view to Community action) |
2.4.Deferral criteria for donors of autologous donationsU.K.
| Serious cardiac disease | Depending on the clinical setting of the blood collection |
| Persons with or with a history of
| Member States may, however, establish specific provisions for autologous donations by such persons |
| Active bacterial infection |