The Blood Safety and Quality Regulations 2005

• (4) Where the Secretary of State carries out an inspection of a hospital blood bank or a facility he may charge the person responsible for management of the hospital blood bank or the facility and that person shall, if so charged, pay to the Secretary of State a fee calculated in accordance with paragraph (5).

• (5) The fees payable by hospital blood banks or facilities in respect of inspections are—

• (a) for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £5,324; and

• (b) for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of £2,662, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.

• (5A) Where the Secretary of State carries out an inspection of a contract laboratory, he may charge the person having control of that laboratory and that person shall, if so charged, pay to the Secretary of State a fee calculated in accordance with paragraph (5B).

• (5B) Subject to paragraph (5C), the fee payable under paragraph (5A) shall be—

• (a) for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £5,324; and

• (b) for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of £2,662, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.

• (5C) Where an inspection referred to in paragraph (5A) takes place at the same time as an inspection by a person appointed by the Good Laboratory Practice Monitoring Authority under regulation 3(4) of the Good Laboratory Practice Regulations 1999, for the purposes of ascertaining whether the contract laboratory complies with the principles of good laboratory practice, the fee payable under paragraph (5A) shall be—

• (a) for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £5,324; and

• (b) for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of £2,662, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.

• (5D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

• (5E) The fee payable by a blood establishment or a person who is responsible for the management of a hospital blood bank who gives a notification under regulation 12(1) of its desire to make written representations to, or appear before and be heard by, a person appointed by the Secretary of State, is £11,974.

• (5F) The Secretary of State will refund to that person—

• (a) 60% of that fee if the person withdraws the notification two weeks before the commencement of the hearing before the person appointed;

• (b) 100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the Secretary of State is—

• (i) not to suspend or revoke, as the case may be, the authorisation pursuant to regulation 5;

• (ii) to withdraw any notice served pursuant to regulation 4(8), 5 or 11; or

• (iii) to overturn the refusal of authorisation or the imposition of any condition pursuant to regulation 4(5).

• (6) In this regulation—

• “contract laboratory” means a laboratory carrying out testing of blood or blood components on behalf of, and pursuant to a contractual arrangement with—a blood establishment which is authorised under these Regulations; ora person responsible for management of a hospital blood bank;

• ...

• ...

• ...

• ...

• (6A) For the purposes of this regulation if an inspection is carried out by more than one inspector, the time taken by the Secretary of State to carry out the inspection is the aggregate of times taken by each inspector in carrying out the inspection at the site.

• (7) Subject to paragraph (7A), any fee payable under this regulation shall be payable at the following times—

• (i) the fee payable pursuant to paragraph (2)(a) in respect of an application for authorisation to operate a blood establishment, and the fee payable pursuant to paragraph (2)(b) in respect of an application to make a substantial change, shall, in each case, be payable at the time the application is made;

• (ii) the periodic fee payable pursuant to paragraph (2)(c) shall be payable on the first anniversary of the grant by the Secretary of State of authorisation to operate as a blood establishment, and whilst the blood establishment continues to be authorised to operate as such pursuant to these Regulations, annually thereafter;

• (iia) any fee payable pursuant to paragraph (2)(bb) or (3B) shall be payable—

• (aa) if it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, and

• (bb) if it is payable in respect of any subsequent reporting year, on 30th April during that year;

• (iib) the fee payable pursuant to paragraph (3A) shall be payable—

• (aa) if it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, and

• (bb) if it is payable in respect of any subsequent reporting year, on 30th April following the end of that year;

• (iic) the fee payable pursuant to paragraph (5E) shall be payable at the time the notification is given;

• (iii) any other fee payable under this regulation shall be payable within fourteen days following written notice from the Secretary of State requiring payment of the fee.

• (7A) In the case of a blood establishment granted an authorisation under regulation 4 before 8th November 2005, the periodic fee payable pursuant to paragraph (2)(c) shall be payable on 8th November 2006 and, while the blood establishment continues to be authorised to operate as such pursuant to these Regulations, annually thereafter.

• (8) All unpaid sums due by way of, or on account of, any fees payable under this regulation shall be recoverable as debts due to the Crown.

• (9) Save in respect of the fee payable under paragraph (5E), the Secretary of State may in exceptional circumstances where it appears to him to be in the interests of safety or otherwise appropriate to do so—

• (a) waive any fee or reduce any fee or part of a fee otherwise payable under this regulation; or

• (b) refund the whole or part of any fee paid pursuant to this regulation.

Specific epidemiological situations

23

• (1) Where the Secretary of State is aware of a specific epidemiological situation, such as an outbreak of a disease, which may affect the safety of blood donations, and as a result of which he considers that specific deferral criteria for the collection of blood donations should be adopted, the Secretary of State must, in relation to Great Britain, notify blood establishments that those criteria must be adopted.

• (2) A blood establishment shall adopt and comply with any criteria for additional tests notified to them by the Secretary of State pursuant to paragraph (1).

Transitional provisions

24

• (1) Subject to paragraph (2), these Regulations, other than regulations 13 and 16, shall not apply before 8th November 2005 in relation to—

• (a) any blood establishment licensed under section 8 of the Medicines Act 1968 ;

• (b) any hospital blood bank.

• (2) From the date these Regulations come into force, a blood establishment licensed under section 8 of the Medicines Act 1968 may apply for, and the Secretary of State may grant, an authorisation under regulation 4 to have effect as from 8th November 2005.

Consequential amendments

25

• (1) The Medicines Act 1968 shall be amended as follows—

• (a) in section 7 (general provisions as to dealing with medicinal products) omit paragraph (a) of subsection (6A) ;

• (b) in section 8 (provisions as to manufacture and wholesale dealing), omit paragraph (a) of subsection (4) ;

• (c) in section 130 (meaning of “medicinal product” and related expressions) in subsection (5), after paragraph (b), insert the following new paragraph—

(ba) whole human blood and human blood components;

• (d) In section 130, after subsection (5A) insert the following new subsection—

(5B) For the purposes of this section, “human blood component” means any of the following constituents of human blood: red cells, white cells, platelets and plasma.

• (2) The Medicines (Standard Provisions for Licenses and Certificates) Regulations 1971 shall be amended as follows—

• (a) in regulation 2 (interpretation), after the definition of “BCG vaccine” insert the following definitions—

“blood” means whole human blood; “blood component” means a therapeutic constituent of blood (red cells, white cells, platelets and plasma);

; and

• (b) in Schedule 2 insert the following new paragraph—

(5C) The licence holder shall ensure that any blood or blood component imported into the United Kingdom and used by him as a starting material or raw material in the manufacture of a medicinal product, shall meet equivalent standards of quality and safety to those laid down in Commission Directive 2004/33/EC, implementing Directive 2003/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components.

• (3) In the Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994 , in regulation 1 (citation, commencement and interpretation), in paragraph (2), in the definition of “the 2001 Directive”, after “as amended by” insert— “ Directive 2002/98/EC of the European Parliament and of the Council setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC, ”.

SCHEDULE

PART 1

Definitions

1

“Autologous donation” means blood and blood components collected from an individual and intended solely for subsequent autologous transfusion or other human application to that same individual.

PART 2 — INFORMATION REQUIREMENTS FOR DONORS

Part A – Information to be provided to prospective donors of blood or blood components

1

Accurate educational materials, which are written in terms which can be understood by 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 and health and medical history, and the testing of donations, and the significance of “informed consent”.

3

For allogeneic donations, the criteria for 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.

4

Individual blood component identification

5

Date of collection (year/month/day)

6

Facilities to which blood units or blood components are distributed, or subsequent disposition.

7

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.

8

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.

9

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.

10

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.

11

Information as to why unused autologous blood and blood components will be discarded and not transfused to other patients.

12

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.

13

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

Identification of the donor

14

Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.

Health and medical history of the donor

15

Health and medical history, provided on a questionnaire and through a personal interview performed by a qualified health 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.

Signature of the donor

16

Signature of the donor, on the donor questionnaire, countersigned by the qualified health professional 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 knowledge.

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

Acceptance criteria for donors of whole blood and blood components

1

Haemoglobin levels in donor's blood

1.1

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

1.2

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

1.3

Protein levels in donor’s blood

Protein	≥ 60 g/l	The protein analysis for apheresis plasma donations must be performed at least annually

1.4

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

1

Protein levels in donor's blood

2.1

Permanent deferral criteria for donors of allogeneic donations

Cardiovascular disease	Prospective donors with active or past serious cardiovascular disease, except congenital abnormalities with complete cure
Central nervous system disease	A history of serious CNS disease
Abnormal bleeding tendency	Prospective donors who give a history of a coagulopathy
Repeated episodes of syncope, or a 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

2.2

Temporary deferral criteria for donors of allogeneic donations

2.2.1

Infections

Duration of deferral period

1

Platelet levels in donor's blood

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
West Nile Virus (WNV) (*)	28 days after leaving an area with ongoing transmission of WNV to humans

2.2.2

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.

2.2.3

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

2.2.4

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

2.3

Deferral for particular epidemiological situations

Particular epidemiological situations (e.g. disease outbreaks)	Deferral consistent with the epidemiological situation

2.4

Deferral criteria for donors of autologous donations

Serious cardiac disease	Depending on the clinical setting of the blood collection
Active bacterial infection

PART 4 — STORAGE, TRANSPORT AND DISTRIBUTION CONDITIONS FOR BLOOD AND BLOOD COMPONENTS

1

STORAGE

1.1

Liquid storage

Component	Temperature of storage	Maximum storage time
Red cell preparations and whole blood (if used for transfusion as whole blood)	+2 to +6°C	28 to 49 days according to the processes used for collection, processing and storage
Platelet preparations	+20 to +24°C	5 days, may be stored for 7 days in conjunction with detection or reduction of bacterial contamination
Granulocytes	+20 to +24°C	24 hours

1.2

Cryopreservation

Component	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
Cryopreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allowable storage period after thawing to depend on the method used.	Cryopreserved red blood cells and platelets must be formulated in a suitable medium after thawing. The allowable storage period after thawing to depend on the method used.

TRANSPORT AND DISTRIBUTION

2

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.

ADDITIONAL REQUIREMENTS FOR AUTOLOGOUS DONATIONS

3

3.1

Autologous blood and blood components must be clearly identified as such and stored, transported and distributed separately from allogeneic blood and blood components.

3.2

Autologous blood and blood components must be labelled as required by regulation 8, and, in addition, the label must include the identification of the donor and the warning “FOR AUTOLOGOUS TRANSFUSION ONLY”.

PART 5 — QUALITY AND SAFETY REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

1

THE BLOOD COMPONENTS

2

QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

2.1

Blood and blood components must comply with the following technical quality measurements and meet the acceptable results.

2.2

Appropriate bacteriological control of the collection and manufacturing process must be performed.

2.3

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

Component	Quality measures required	Acceptable results for quality measures
	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 specifications for haemoglobin and haemolysis
	Haemoglobin (*)	Not less than 45g per unit
	Haemolysis	Less than 0.8% of red cell mass at end of the shelf life
Red cells, buffy coat removed	Volume	Valid for storage characteristics to maintain product within specifications for 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, leucocyte-depleted	Volume	Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
	Haemoglobin (*)	Not less than 40g per unit
	Leucocyte content	Less than 1 x 10⁶ per unit
	Haemolysis	Less than 0.8% of red cell mass at the end of the shelf life
Red cells, in additive solution	Volume	Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
	Haemoglobin (*)	Not less than 45g per unit
	Haemolysis	Less than 0.8% of red cell mass at end of the shelf life
Red cells, buffy coat removed, in additive solution	Volume	Valid for storage characteristics to maintain product within specifications for haemoglobin and 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, leucocyte-depleted, in additive solution	Volume	Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
	Haemoglobin (*)	Not less than 40g per unit
	Leucocyte content	Less than 1 x 10⁶ per unit
	Haemolysis	Less than 0.8% of red cell mass at the end of the shelf life
Red cells, apheresis	Volume	Valid for storage characteristics to maintain product within specifications for haemoglobin and haemolysis
	Haemoglobin (*)	Not less than 40g 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 450ml +/- 50ml For paediatric autologous whole blood collections – not to exceed 10.5ml per kg body weight
	Haemoglobin (*)	Not less than 45g per unit
	Haemolysis	Less than 0.8% of red cell mass at the end of the shelf life
Platelets, apheresis	Volume	Valid for storage characteristics to maintain product within specifications for pH
	Platelet content	Variations in platelet content per single donation are permitted within the limits that comply with validated preparation and preservation conditions
	pH	6.4 -7.4 corrected for 22°C, at the end of the shelf life
Platelets, apheresis, leucocyte-depleted	Volume	Valid for storage characteristics to maintain product within specifications for pH
	Platelet content	Variations in platelet content per single donation are permitted within the limits that comply with validated preparation and preservation conditions
	Leucocyte content	Less than 1 x 10⁶ per unit
	pH	6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, pooled	Volume	Valid for storage characteristics to maintain product within specifications for pH
	Platelet content	Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions
	Leucocyte content	Less than 0.2 x 10⁹ per single unit (platelet-rich plasma method) Less than 0.05 x 10⁹ per single unit (buffy coat method)
	pH	6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, pooled, leucocyte-depleted	Volume	Valid for storage characteristics to maintain product within specifications for pH
	Platelet content	Variations in platelet content per pool are permitted within limits that comply with validated preparation and preservation conditions
	Leucocyte content	Less than 1 x 10⁶ per pool
	pH	6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, single unit	Volume	Valid for storage characteristics to maintain product within specifications for pH
	Platelet content	Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions
	Leucocyte content	Less than 0.2 x 10⁹ per single unit (platelet-rich plasma method) Less than 0.05 x 10⁹ per single unit (buffy coat method)
	pH	6.4-7.4 corrected for 22°C, at the end of the shelf life
Platelets, recovered, single unit, leucocyte-depleted	Volume	Valid for storage characteristics to maintain product within specifications for pH
	Platelet content	Variations in platelet content per single unit are permitted within limits that comply with validated preparation and preservation conditions
	Leucocyte content	Less than 1 x 10⁶ per unit
	pH	6.4-7.4 corrected for 22°C, at the end of the shelf life
Plasma, fresh-frozen	Volume	Stated volume +/- 10%
	Factor VIIIc(*)	Average (after freezing and thawing): 70% or more of the value of the freshly collected plasma unit
	Total protein	Not less than 50g/l
	Residual cellular content(*)	Red cells: less than 6.0 x 10⁹/l Leucocytes: less than 0.1 x 10⁹/l Platelets: less than 50 x 10⁹/l
Plasma, fresh-frozen, cryoprecipitate-depleted	Volume	Stated volume +/-10%
	Residual cellular content(*)	Red cells: less than 6.0 x 10⁹/l Leucocytes: less than 0.1 x 10⁹/l Platelets: less than 50 x 10⁹/l
Cryoprecipitate	Fribrinogen content(*)	Greater than or equal to 140mg per unit
	Fractor VIIIc content (*)	Greater than or equal to 70 international units per unit
Granulocytes, apheresis	Volume	Less than 500ml
	Granulocyte content	Greater than 1 x 10¹⁰ granulocytes per unit

Signed

Signed by authority of the Secretary of State for Health

Melanie Johnson — Parliamentary Under Secretary of State, — 2005-01-12

We consent,

Joan Ryan — Nick Ainger — Two of the Lords Commissioners' of Her Majesty's Treasury — 2005-01-13

Explanatory note

(This note is not part of the Regulations)

Footnotes

Definitions

The following definitions apply for the purposes of this Schedule.

2

“Allogeneic donation” means blood and blood components collected from an individual and intended for transfusion to another individual, for use in medical devices or as starting material or raw material for manufacturing into medicinal products.

3

“Whole blood” means a single blood donation.

4

“Cryopreservation” means prolongation of the storage life of blood components by freezing.

5

“Plasma” means the liquid portion of the blood in which the cells are suspended. Plasma may be separated from the cellular portion of a whole blood collection for therapeutic use as fresh-frozen plasma or further processed to cryoprecipitate and cryoprecipitate-depleted plasma for transfusion. It may be used for the manufacture of medicinal products derived from human blood and human plasma or used in the preparation of pooled platelets, or pooled, leucocyte-depleted platelets. It may also be used for re-suspension of red cell preparations for exchange transfusion or perinatal transfusion.

6

“Cryoprecipitate” means a plasma component prepared from plasma, fresh-frozen, by freeze-thaw precipitation of proteins and subsequent concentration and re-suspension of the precipitated proteins in a small volume of the plasma.

7

“Washed” means a process of removing plasma or storage medium from cellular products by centrifugation, decanting of the supernatant liquid from the cells and addition of an isotonic suspension fluid, which in turn is generally removed and replaced following further centrifugation of the suspension. The centrifugation, decanting, replacing process may be repeated several times.

8

“Red cells” means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed.

9

“Red cells, buffy coat removed” means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed.

10

“Red cells, leucocyte-depleted” means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed.

11

“Red cells in additive solution” means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. A nutrient or preservative solution is added.

12

“Additive solution” means a solution specifically formulated to maintain beneficial properties of cellular components during storage.

13

“Red cells, buffy coat removed, in additive solution” means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed. The buffy coat, containing a large proportion of the platelets and leucocytes in the donated unit, is removed. A nutrient or preservative solution is added.

14

“Buffy coat” means a blood component prepared by centrifugation of a unit of whole blood, and which contains a considerable proportion of the leucocytes and platelets.

15

“Red cells, leucocyte-depleted, in additive solution” means the red cells from a single whole blood donation, with a large proportion of the plasma from the donation removed, and from which leucocytes are removed. A nutrient or preservative solution is added.

16

“Red cells, apheresis” means the red cells from an apheresis red cell donation.

17

“Apheresis” means a method of obtaining one or more blood components by machine processing of whole blood in which the residual components of the blood are returned to the donor during or at the end of the process.

18

“Platelets, apheresis” means a concentrated suspension of blood platelets obtained by apheresis.

19

“Platelets, apheresis, leucocyte-depleted” means a concentrated suspension of blood platelets, obtained by apheresis, and from which leucocytes are removed.

20

“Platelets, recovered, pooled” means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation.

21

“Platelets, recovered, pooled, leucocyte-depleted” means a concentrated suspension of blood platelets, obtained by processing of whole blood units and pooling the platelets from the units during or after separation, and from which leucocytes are removed.

22

“Platelets, recovered, single unit” means a concentrated suspension of blood platelets, obtained by processing of a single unit of whole blood.

23

“Platelets, recovered, single unit, leucocyte-depleted” means a concentrated suspension of blood platelets, obtained by processing of a single whole blood unit from which leucocytes are removed.

24

“Plasma, fresh-frozen” means the supernatant plasma separated from a whole blood donation or plasma collected by apheresis, frozen and stored.

25

“Plasma, cryoprecipitate-depleted for transfusion” means a plasma component prepared from a unit of plasma, fresh-frozen. It comprises the residual portion after the cryoprecipitate has been removed.

26

“Granulocytes, apheresis” means a concentrated suspension of granulocytes obtained by apheresis.

27

“Statistical process control” means a method of quality control of a product or a process that relies on a system of analysis of an adequate sample size without the need to measure every product of the process.

Part A – Information to be provided to prospective donors of blood or blood components

1

Accurate educational materials, which are written in terms which can be understood by 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.

4

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.

5

Information on the protection of personal data, including confirmation that there will be no disclosure of the identity of the donor, of information concerning the donor's health, and of the results of the tests performed, other than in accordance with the requirements of these Regulations.

6

The reasons why individuals are not to make donations which may be detrimental to their health.

7

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.

8

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.

9

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.

10

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.

11

Information as to why unused autologous blood and blood components will be discarded and not transfused to other patients.

12

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.

13

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

14

Personal data uniquely, and without any risk of mistaken identity, distinguishing the donor, as well as contact details.

15

Health and medical history, provided on a questionnaire and through a personal interview performed by a qualified health 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.

16

Signature of the donor, on the donor questionnaire, countersigned by the qualified health professional 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 knowledge.

1

1

Age and body weight of donors

2

Permanent deferral criteria for donors of allogeneic donations

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
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

Exposure to risk of acquiring a transfusion-transmissible infection

2

Vaccination

2

Other temporary deferrals

2

Deferral for particular epidemiological situations

2

Deferral criteria for donors of autologous donations

1

STORAGE

1

Liquid storage

1

Cryopreservation

3

3

Autologous blood and blood components must be clearly identified as such and stored, transported and distributed separately from allogeneic blood and blood components.

3

Autologous blood and blood components must be labelled as required by regulation 8, and, in addition, the label must include the identification of the donor and the warning “FOR AUTOLOGOUS TRANSFUSION ONLY”.

2

QUALITY CONTROL REQUIREMENTS FOR BLOOD AND BLOOD COMPONENTS

2

Blood and blood components must comply with the following technical quality measurements and meet the acceptable results.

2

Appropriate bacteriological control of the collection and manufacturing process must be performed.

2

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

Editorial notes