Human Tissues and Cells (Quality and Safety)

L.N. 222 of 2014

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Human Tissues and Cells (Quality and Safety)

(Amendment) Regulations, 2014

IN exercise of the powers conferred by article 16 of the Human

Blood and Transplants Act, the Minister for Energy and Health, after

consultation with the Licensing Authority, has made the following

regulations:-

The title of these regulations is the Human Tissues and

Cells (Quality and Safety) (Amendment) Regulations, 2014, and

these regulations shall be read and construed as one with the Human

Tissues and Cells (Quality and Safety) Regulations, hereinafter

referred to as "the principal regulations".

Selection Criteria for Donors of Tissues and/or Cells

(except Donors of Reproductive Cells)

as referred to in paragraph (a) of regulation 13.

Selection criteria for donors are based on an analysis of the risks

related to the application of the specific cells/tissues.

Indicators of these risks must be identified by physical

examination, review of the medical and behavioural history,

biological testing, post-mortem examination (for deceased donors)

and any other appropriate investigation. Unless justified on the basis

of a documented risk assessment approved by the responsible person

as defined in regulation 3, donors must be excluded from donation if

any of the following criteria applies

1. Deceased Donors

1.1.

General criteria for exclusion

1.1.1. Cause of death unknown, unless autopsy provides

information on the cause of death after procurement and none of the

general criteria for exclusion set out in the present section applies.

1.1.2.

History of a disease of unknown aetiology.

1.1.3. Presence, or previous history, of malignant disease,

except for primary basal cell carcinoma, carcinoma in situ of the

uterine cervix, and some primary tumours of the central nervous

system that have to be evaluated according to scientific evidence.

Donors with malignant diseases can be evaluated and considered for

cornea donation, except for those with retinoblastoma,

haematological neoplasm, and malignant tumours of the anterior

segment of the eye.

1.1.4. Risk of transmission of diseases caused by prions. This

risk applies, for example, to

(a)

people diagnosed with Creutzfeldt-Jakob disease,

or variant Creutzfeldt-Jacob disease, or having a family history

of non-iatrogenic Creutzfeldt-Jakob disease;

(b)

people with a history of rapid progressive dementia

or degenerative neurological disease, including those of

unknown origin;

(c)

recipients of hormones derived from the human

pituitary gland (such as growth hormones) and recipients of

grafts of cornea, sclera and dura mater, and persons that have

undergone undocumented neurosurgery (where dura mater may

have been used).

For variant Creutzfeldt-Jakob disease, further precautionary

measures may be recommended.

1.1.5. Systemic infection which is not controlled at the time

of donation, including bacterial diseases, systemic viral, fungal or

parasitic infections, or significant local infection in the tissues and

cells to be donated. Donors with bacterial septicaemia may be

evaluated and considered for eye donation but only where the corneas

are to be stored by organ culture to allow detection of any bacterial

contamination of the tissue.

1.1.6. History, clinical evidence, or laboratory evidence of

HIV, acute or chronic hepatitis B (except in the case of persons with a

proven immune status), hepatitis C and HTLV I/II, transmission risk

or evidence of risk factors for these infections.

1.1.7. History of chronic, systemic autoimmune disease that

could have a detrimental effect on the quality of the tissue to be

retrieved.

1.1.8. Indications that test results of donor blood samples will

be invalid due to

(a)

the occurrence of haemodilution, according to the

specifications in Schedule III, section 2, where a pre-transfusion

sample is not available; or

(b)

treatment with immunosuppressive agents.

1.1.9. Evidence of any other risk factors for transmissible

diseases on the basis of a risk assessment, taking into consideration

donor travel and exposure history and local infectious disease

prevalence.

1.1.10. Presence on the donor’s body of physical signs

implying a risk of transmissible disease(s) as described in Schedule V,

point 1.2.3.

1.1.11. Ingestion of, or exposure to, a substance (such as

cyanide, lead, mercury, gold) that may be transmitted to recipients in

a dose that could endanger their health.

1.1.12. Recent history of vaccination with a live attenuated

virus where a risk of transmission is considered to exist.

1.1.13. Transplantation with xenografts.

1.2.

Additional exclusion criteria for deceased child donors

1.2.1. Any children born from mothers with HIV infection or

that meet any of the exclusion criteria described in section 1.1 must

be excluded as donors until the risk of transmission of infection can

be definitely ruled out.

(a)

Children aged less than 18 months born from

mothers with HIV, hepatitis B, hepatitis C or HTLV infection, or

at risk of such infection, and who have been breastfed by their

mothers during the previous 12 months, cannot be considered as

donors regardless of the results of the analytical tests.

(b)

Children of mothers with HIV, hepatitis B, hepatitis

C or HTLV infection, or at risk of such infection, and who have

not been breastfed by their mothers during the previous 12

months and for whom analytical tests, physical examinations,

and reviews of medical records do not provide evidence of HIV,

hepatitis B, hepatitis C or HTLV infection, can be accepted as

donors.

2. Living donors

2.1.

Autologous living donor

2.1.1. If the removed tissues and cells are to be stored or

cultured, the same minimum set of biological testing requirements

must apply as for an allogeneic living donor. Positive test results will

not necessarily prevent the tissues or cells or any product derived

from them being stored, processed and reimplanted, if appropriate

isolated storage facilities are available to ensure no risk of cross-

contamination with other grafts and/or no risk of contamination with

adventitious agents and/or mix-ups.

2.2.

Allogeneic living donor

2.2.1. Allogeneic living donors must be selected on the basis

of their health and medical history, provided on a questionnaire and

through an interview performed by a qualified and trained healthcare

professional with the donor, in compliance with point 2.2.2. This

assessment must include 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. For any donation, the collection process

must not interfere with or compromise the health or care of the donor.

In the case of cord blood or amniotic membrane donation, this applies

to both mother and baby.

2.2.2. Selection criteria for allogeneic living donors must be

established and documented by the tissue establishment (and the

transplanting clinician in the case of direct distribution to the

recipient), based on the specific tissue or cells to be donated, together

with the donor’s physical status and medical and behavioural history

and the results of clinical investigations and laboratory tests

establishing the donor’s state of health.

2.2.3. The same exclusion criteria must be applied as for

deceased donors with the exception of point 1.1.1. Depending on the

tissue or cell to be donated, other specific exclusion criteria may need

to be added, such as

(a)

pregnancy (except for donors of umbilical cord

blood cells and amniotic membrane and sibling donors of

haematopoietic progenitors);

(b)

breastfeeding;

(c)

in the case of haematopoietic progenitor cells, the

potential for transmission of inherited conditions.

Immediately after sub-regulation (2) of regulation 1 of the

principal regulations, there shall be added the following new sub-

regulation

"(3)

The scope of these regulations is also to transpose

Commission Directive 2012/39/EU of 26 November 2012

amending Directive 2006/17/EC as regards certain technical

requirements for the testing of human tissues and cells.".

Laboratory Tests required for Donors (except Donors of Reproductive

Cells) as referred to in paragraph (a) of regulation 13.

1. Biological tests required for donors

1.1. The following biological tests must be performed for all

donors as a minimum requirement

HIV 1 and 2

Anti-HIV-1,2

Hepatitis B

HBsAg

Anti HBc

Hepatitis C

Anti-HCV-Ab

Syphilis

See 1.4 (below)

1.2. HTLV-I antibody testing must be performed for donors

living in, or originating from, high-prevalence areas or with sexual

partners originating from those areas or where the donor’s parents

originate from those areas.

1.3. When anti-HBc is positive and HBsAg is negative, further

investigations are necessary with a risk assessment to determine

eligibility for clinical use.

1.4. A validated testing algorithm must be applied to exclude

the presence of active infection with Treponema pallidum. A non-

reactive test, specific or non-specific, can allow tissues and cells to be

released. When a non-specific test is performed, a reactive result will

not prevent procurement or release if a specific Treponema

confirmatory test is non-reactive. A donor whose specimen tests

reactive on a Treponema-specific test will require a thorough risk

assessment to determine eligibility for clinical use.

1.5. In certain circumstances, additional testing may be

required depending on the donor’s history and the characteristics of

the tissue or cells donated (e.g. RhD, HLA, malaria, CMV,

toxoplasma, EBV, Trypanosoma cruzi).

1.6. For autologous donors, Schedule II, point 2.1.1, applies.

2. General requirements to be met for determining biological

markers

2.1. The tests must be carried out by a qualified laboratory,

authorised as a testing centre by the Licensing Authority, using EC-

marked testing kits where appropriate. The type of test used must be

validated for the purpose in accordance with current scientific

knowledge.

2.2. The biological tests will be carried out on the donor’s

serum or plasma; they must not be performed on other fluids or

secretions such as the aqueous or vitreous humour unless specifically

justified clinically using a validated test for such a fluid.

2.3. When potential donors have lost blood and have recently

received donated blood, blood components, colloids or crystalloids,

blood testing may not be valid due to haemodilution of the sample.

An algorithm must be applied to assess the degree of haemodilution

in the following circumstances

(a)

ante-mortem blood sampling: if blood, blood

components and/or colloids were infused in the 48 hours

preceding blood sampling or if crystalloids were infused in the

hour preceding blood sampling;

(b)

post-mortem blood sampling: if blood, blood

components and/or colloids were infused in the 48 hours

preceding death or if crystalloids were infused in the hour

preceding death.

Tissue establishments may accept tissues and cells from donors

with plasma dilution of more than 50 % only if the testing procedures

used are validated for such plasma or if a pre-transfusion sample is

available.

2.4. In the case of a deceased donor, blood samples must have

been obtained just prior to death or, if not possible, the time of

sampling must be as soon as possible after death and in any case

within 24 hours after death.

2.5. (a)

In the case of living donors (except allogeneic bone

marrow stem-cell and peripheral blood stem-cell donors, for practical

reasons), blood samples must be obtained at the time of donation or, if

not possible, within seven days post donation (this is the ‘donation

sample’).

(b)

Where tissues and cells of allogeneic living donors

can be stored for long periods, repeat sampling and testing is required

after an interval of 180 days. In these circumstances of repeat testing,

the donation sample can be taken up to 30 days prior to and 7 days

post donation.

(c)

Where tissues and cells of allogeneic living donors

cannot be stored for long periods and repeat sampling is therefore not

possible, point 2(5)(a) above applies.

2.6. If in a living donor (except bone marrow stem-cell and

peripheral blood stem-cell donors) the ‘donation sample’, as defined

in point 2(5)(a) above, is additionally tested by the nucleic acid

amplification technique (NAT) for HIV, HBV and HCV, testing of a

repeat blood sample is not required. Retesting is also not required if

the processing includes an inactivation step that has been validated

for the viruses concerned.

2.7. In the case of bone marrow and peripheral blood stem-cell

collection, blood samples must be taken for testing within 30 days

prior to donation.

2.8. In the case of neonatal donors, the biological tests may be

carried out on the donor’s mother to avoid medically unnecessary

procedures upon the infant.

In regulation 2 of the principal regulations, for the

definition "Directive 2006/17/EC", there shall be substituted the

following new definition

" "Directive 2006/17/EC" means the Directive of the

European Parliament and of the Council of the 8th February

2006 as regards certain technical requirements for the donation,

procurement and testing of human tissues and cells as amended

by Commission Directive 2012/39/EU of 26 November 2012

amending Directive 2006/17/EC as regards certain technical

requirements for the testing of human tissues and cells;".

Selection Criteria and Laboratory Tests required for Donors of

Reproductive Cells as referred to in regulation 13(b)

and regulation 14(c)

1. Partner donation for direct use

Donor selection criteria and laboratory testing do not need to be

applied in the case of partner donation of reproductive cells for direct

use.

2. Partner donation (not direct use)

Reproductive cells that are processed and/or stored and

reproductive cells that will result in the cryopreservation of embryos

must meet the following criteria

2.1. the clinician responsible for the donor must determine and

document, based on the patient’s medical history and therapeutic

indications, the justification for the donation and its safety for the

recipient and any child(ren) that might result;

2.2. the following biological tests must be carried out to assess

the risk of cross-contamination

HIV 1 and 2

Anti-HIV-1,2

Hepatitis B

HBsAg

Anti-HBc

Hepatitis C

Anti-HCV-Ab

In case of sperm processed for intrauterine insemination and not

to be stored, if the tissue establishment can demonstrate that the risk

of cross contamination and staff exposure has been addressed through

the use of validated processes, biological testing may not be required;

2.3. where HIV 1 and 2, hepatitis B or hepatitis C test results

are positive or unavailable, or where the donor is known to be a

source of infection risk, a system of separate storage must be devised;

2.4. HTLV-I antibody testing must be performed for donors

living in or originating from high-prevalence areas or with sexual

partners originating from those areas or where the donor’s parents

originate from those areas;

2.5. in certain circumstances, additional testing may be

required depending on the donor’s travel and exposure history and the

characteristics of the tissue or cells donated (e.g. Rh D, malaria,

CMV, T. cruzi);

2.6. positive results will not necessarily prevent partner

donation in accordance with national rules.

3. Donations other than by partners

The use of reproductive cells other than for partner donation

must meet the following criteria

3.1. donors must be selected on the basis of their age, health

and medical history, provided on a questionnaire and through a

personal interview performed by a qualified and trained healthcare

professional. This assessment must include 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 (such as sexually transmitted infections), or health risks to

themselves (e.g. superovulation, sedation or the risks associated with

the egg collection procedure or the psychological consequences of

being a donor);

3.2. the donors must be negative for HIV 1 and 2, HCV, HBV

and syphilis on a serum or plasma sample, tested in accordance with

Schedule III, point 1.1, and sperm donors must additionally be

negative for chlamydia on a urine sample tested by the nucleic acid

amplification technique (NAT);

3.3. HTLV-I antibody testing must be performed for donors

living in or originating from high-prevalence areas or with sexual

partners originating from those areas or where the donor’s parents

originate from those areas;

3.4. in certain circumstances, additional testing may be

required depending on the donor’s history and the characteristics of

the tissue or cells donated (e.g. RhD, malaria, CMV, T. cruzi).

3.5. for autologous donors, SCHEDULE II, point 2.1.1 applies;

3.6. genetic screening for autosomal recessive genes known to

be prevalent, according to international scientific evidence, in the

donor’s ethnic background and an assessment of the risk of

transmission of inherited conditions known to be present in the family

must be carried out, after consent is obtained. Complete information

must be provided, in accordance with the requirements in force in

Member States. Complete information on the associated risk and on

the measures undertaken for its mitigation must be communicated and

clearly explained to the recipient.

4. General requirements to be met for determining biological

markers

4.1. The tests must be carried out in accordance with Schedule

III, points 2.1 and 2.2.

4.2. (a)

For donations other than by partners, blood

samples must be obtained at the time of each donation.

(b)

For donation by partners (not for direct use), blood

samples must be obtained within three months before the first

donation. For further partner donations by the same donor, further

blood samples must be obtained according to these regulations, but no

later than 24 months from the previous sampling.

4.3. Sperm donations other than by partners will be quarantined

for a minimum of 180 days, after which repeat testing is required. If

the blood donation sample is additionally tested by the nucleic acid

amplification technique (NAT) for HIV, HBV and HCV, testing of a

repeat blood sample is not required. Retesting is also not required if

the processing includes an inactivation step that has been validated

for the viruses concerned.

Paragraph (c) of sub-regulation (1) of regulation 3 of the

principal regulations shall be substituted by the following

"(c)

ensuring that appropriate control measures are in

place within the tissue establishment and implementing the

requirements of regulations 4, 5, 7, 8, 11, 12, 13, 14, 15 within

the tissue establishment;".

Cell and/or Tissue Donation and Procurement Procedures and

Reception at the Tissue Establishment as referred to in regulation 15

1. Donation and procurement procedures

Consent and donor identification

1.1.1. Before the procurement of tissues and cells proceeds, an

authorised person must confirm and record

(a)

that consent for the procurement has been obtained

in accordance with regulation 9(a) and (b); and

(b)

how and by whom the donor has been reliably

1.1.2. In the case of living donors, the health professional

responsible for obtaining the health history must ensure that the donor

(a)

understood the information provided;

(b)

had an opportunity to ask questions and been

provided with satisfactory responses;

(c)

confirmed that all the information provided is true

to the best of his/her knowledge.

Donor evaluation (this section does not apply to partner

donation of reproductive cells or to autologous donors)

1.2.1. An authorised person must collect and record the

donor’s relevant medical and behavioural information according to

the requirements described in section 1.4.

1.2.2. In order to acquire the appropriate information, different

relevant sources must be used, including at least an interview with the

donor, for living donors, and the following when appropriate

(a)

the medical records of the donor;

(b)

an interview with a person who knew the donor

well, for deceased donors;

(c)

an interview with the treating physician;

(d)

an interview with the general practitioner;

(e)

the autopsy report.

1.2.3. In addition, in the case of a deceased donor, and in the

case of a living donor when justified, a physical examination of the

body must be performed to detect any signs that may be sufficient in

themselves to exclude the donor or which must be assessed in the

light of the donor’s medical and personal history.

1.2.4. The complete donor records must be reviewed and

assessed for suitability and signed by a qualified health professional.

1.3.

Procurement procedures for tissues and cells

1.3.1. The procurement procedures must be appropriate for the

type of donor and the type of tissue/cells donated.

There must be procedures in place to protect the safety of the

living donor.

1.3.2. The procurement procedures must protect those

properties of the tissue/cells that are required for their ultimate

clinical use, and at the same time minimise the risk of microbiological

contamination during the process, particularly when tissues and cells

cannot subsequently be sterilised.

1.3.3. For deceased donation, the area of access must be

restricted. A local sterile field using sterile drapes must be used.

Staff conducting procurement must be clothed appropriately for

the type of procurement. Usually, this will extend to being scrubbed,

gowned in sterile clothing and wearing sterile gloves, face shields and

protective masks.

1.3.4. In the case of a deceased donor, the place of

procurement must be recorded and the time interval from death to

procurement must be specified so as to ensure that the required

biological and/or physical properties of the tissues/cells are retained.

1.3.5. Once the tissues and cells have been retrieved from a

deceased donor body, it must be reconstructed so that it is as similar

as possible to its original anatomical appearance.

1.3.6. Any adverse event occurring during procurement that

has or may have resulted in harm to a living donor and the outcome of

any investigation to determine the cause must be recorded and

reviewed.

1.3.7. Policies and procedures must be in place to minimise

the risk of tissue or cell contamination by staff who might be infected

with transmissible diseases.

1.3.8. Sterile instruments and devices must be used for tissue

and cell procurement. Instruments or devices must be of good quality,

validated or specifically certified and regularly maintained for the

procurement of tissues and cells.

1.3.9. When reusable instruments must be used, a validated

cleaning and sterilisation procedure for removal of infectious agents

has to be in place.

1.3.10. Wherever possible, only CE marked medical devices

must be used and all concerned staff must have received appropriate

training on the use of such devices.

1.4.

Donor documentation

1.4.1. For each donor, there must be a record containing

(a)

the donor identification (first name, family name

and date of birth - if a mother and child are involved in the

donation, both the name and date of birth of the mother and the

name, if known, and date of birth of the child);

(b)

age, sex, medical and behavioural history (the

information collected must be sufficient to allow application of

the exclusion criteria, where required);

(c)

outcome of body examination, where applicable;

(d)

haemodilution formula, where applicable;

(e)

the consent/authorisation form, where applicable;

(f)

clinical data, laboratory test results, and the results

of other tests carried out;

(g)

if an autopsy was performed, the results must be

included in the record (for tissues and cells that cannot be stored

for extended periods, a preliminary verbal report of the autopsy

must be recorded);

(h)

for haematopoietic progenitor cell donors, the

donor’s suitability for the chosen recipient must be documented.

For unrelated donations, when the organisation responsible for

procurement has limited access to recipient data, the transplanting

organisation must be provided with donor data relevant for

confirming suitability.

1.4.2. The organisation performing the procurement must

produce a procurement report, which is passed on to the tissue

establishment. This report must contain at least

(a)

the identification, name and address of the tissue

establishment to receive the cells/tissues;

(b)

donor identification data (including how and by

whom the donor was identified);

(c)

description and identification of procured tissues

and cells (including samples for testing);

(d)

identification of the person who is responsible for

the procurement session, including signing;

(e)

date, time (where relevant, start and end) and

location of procurement and procedure (SOP) used, including

any incidents that occurred; where relevant, environmental

conditions at the procurement facility (description of the

physical area where procurement took place);

(f)

for deceased donors, conditions under which the

cadaver is kept: refrigerated (or not), time of start and end of

refrigeration;

(g)

ID/batch numbers of reagents and transport

solutions used.

The report must also contain the date and time of death where

possible.

Where sperm is procured at home, the procurement report must

state this and must contain only

(a)

the name and address of the tissue establishment to

receive the cells/tissues;

(b)

the donor identification.

The date and time of procurement may be included, where

possible.

1.4.3. All the records must be clear and readable, protected

from unauthorised amendment and retained and readily retrieved in

this condition throughout their specified retention period in

compliance with data protection legislation.

1.4.4. Donor records required for full traceability must be kept

for a minimum of 30 years after clinical use, or the expiry date, in an

appropriate archive acceptable to the Licensing Authority.

1.5.

Packaging

1.5.1. Following procurement, all recovered tissues and cells

must be packaged in a manner which minimises the risk of

contamination and must be stored at temperatures that preserve the

required characteristics and biological function of the cells/tissues.

The packaging must also prevent contamination of those responsible

for packaging and transportation of the tissues and cells.

1.5.2. The packaged cells/tissues must be shipped in a

container which is suitable for the transport of biological materials

and which maintains the safety and quality of the contained tissue or

cells.

1.5.3. Any accompanying tissue or blood samples for testing

must be accurately labelled to ensure identification with the donor,

and must include a record of the time and place the specimen was

taken.

1.6.

Labelling of the procured tissues/cells

At the time of procurement, every package containing tissues

and cells must be labelled. The primary tissue/cell container must

indicate the donation identification or code and the type of tissues and

cells. Where the size of the package permits, the following

information must also be provided

(a)

date (and time where possible) of donation;

(b)

hazard warnings;

(c)

nature of any additives (if used);

(d)

in the case of autologous donations, the label must

state ‘for autologous use only’;

(e)

in the case of directed donations, the label must

identify the intended recipient.

If any of the information under points (a) to (e) above cannot be

included on the primary package label, it must be provided on a

separate sheet accompanying the primary package.

Labelling of the shipping container

When tissues/cells are shipped by an intermediary, every

shipping container must be labelled at least with

(a)

TISSUES AND CELLS and HANDLE WITH

(b)

the identification of the establishment from which

the package is being transported (address and phone number)

and a contact person in the event of problems;

(c)

the identification of the tissue establishment of

destination (address and phone number) and the person to be

contacted to take delivery of the container;

(d)

the date and time of the start of transportation;

(e)

specifications concerning conditions of transport

relevant to the quality and safety of the tissues and cells;

(f)

in the case of all cellular products, the following

indication: DO NOT IRRADIATE;

(g)

when a product is known to be positive for a

relevant infectious disease marker, the following indication

BIOLOGICAL HAZARD;

(h)

in the case of autologous donors, the following

indication: ‘FOR AUTOLOGOUS USE ONLY’;

(i)

specifications concerning storage conditions (such

as DO NOT FREEZE).

2. Reception of the tissue/cells at the tissue establishment

When the retrieved tissues/cells arrive at the tissue

establishment, there must be documented verification that the

consignment, including the transport conditions, packaging, labelling

and associated documentation and samples, meet the requirements of

this Schedule and the specifications of the receiving establishment.

Each establishment must ensure that the tissue and cells

received are quarantined until they, along with the associated

documentation, have been inspected or otherwise verified as

conforming to requirements. The review of relevant donor/

procurement information and thus acceptance of the donation needs

to be carried out by specified/authorised persons.

2.3.

Each tissue establishment must have a documented

policy and specifications against which each consignment of tissues

and cells, including samples, are verified. These must include the

technical requirements and other criteria considered by the tissue

establishment to be essential for the maintenance of acceptable

quality. The tissue establishment must have documented procedures

for the management and segregation of non-conforming

consignments, or those with incomplete test results, to ensure that

there is no risk of contamination of other tissues and cells being

processed, preserved or stored.

2.4.

The data that must be registered at the tissue

establishment (except for donors of reproductive cells intended for

partner donation) include

(a)

consent/authorisation; including the purpose(s) for

which the tissues and cells may be used (i.e. therapeutic or

research, or both therapeutic use and research) and any specific

instructions for disposal if the tissue or cells are not used for the

purpose for which consent was obtained;

(b)

all required records relating to the procurement and

the taking of the donor history, as described in the donor

documentation section;

(c)

results of physical examination, of laboratory tests

and of other tests (such as the autopsy report, if used in

accordance with point 1.2.2.);

(d)

for allogeneic donors, a properly documented

review of the complete donor evaluation against the selection

criteria by an authorised and trained person;

(e)

in the case of cell cultures intended for autologous

use, documentation of the possibility of medicinal allergies

(such as to antibiotics) of the recipient.

2.5.

In the case of reproductive cells intended for partner

donation, the data to be registered at the tissue establishment include

(a)

consent; including the purpose(s) for which the

tissues and cells may be used (such as reproductive only and/or

for research) and any specific instructions for disposal if the

tissue or cells are not used for the purpose for which consent

was obtained;

(b)

donor identification and characteristics: type of

donor, age, sex, presence of risk factors and, in the case of a

deceased donor, the cause of death;

(c)

partner identification;

(d)

place of procurement;

(e)

tissues

and

cells

obtained

and

relevant

characteristics.".

B

€2.16

Regulation 4 of the principal regulations shall be amended Amends

regulation 4 of

as follows

the principal

regulations.

(a)

for paragraphs (b), (c) and (d) thereof there shall be

substituted the following

"(b) ensure that all donations of human tissues and

cells are subjected to tests in accordance with the

requirements referred to in these regulations and any

schedules and any amendments thereto and that the

selection and acceptance of tissues and cells comply with

the requirements referred to in these regulations and any

schedules and any amendments thereto;

(c) ensure that human tissue and cells and

associated documentation comply with the requirements

referred to in these regulations and any schedules and any

amendments thereto;

(d) verify and record the fact that the packaging

of human tissue and cells received complies with the

requirements referred to in these regulations and any

schedules and any amendments thereto;";

(b)

for paragraph (k) thereof there shall be substituted

the following

"(k) ensure that the equipment used, the working

environment and process design, validation and control

conditions are in compliance with the requirements

referred to in these regulations and any schedules and any

amendments thereto;";

(c)

for paragraph (n) thereof there shall be substituted

the following

"(n) ensure that all procedures associated with the

storage of tissues and cells are documented in the standard

operating procedures and that the storage conditions

comply with the requirements referred to in these

regulations and any schedules and any amendments

thereto;";

(d)

for paragraph (q) thereof there shall be substituted

the following

"(q) not to distribute processed tissues and cells

until all the requirements laid down in these regulations

and any schedules and any amendments thereto have been

met;"; and

(e)

for paragraphs (s) and (t) thereof there shall be

substituted the following

"(s) ensure that labelling and documentation and

packaging conform to the requirements set by these

regulations and any schedules and any amendments

thereto; and

(t) ensure that the quality of tissues and cells

during distribution and that the distribution conditions

comply with the requirements set by these regulations and

any schedules and any amendments thereto.".

Paragraph (b) of sub-regulation (1) of regulation 5 of the

principal regulations shall be substituted by the following

"(b)

evaluate and select third parties on the basis of

their ability to meet the standards laid down in these regulations

and any schedules and any amendments thereto;".

Paragraph (c) of regulation 6 of the principal regulations

shall be substituted by the following

"(c)

all tissues and cells are identified with a label that

contains the information or references allowing a link to the

information referred to in the schedules to these regulations and

any amendments thereto; and".

Sub-regulation (1) of regulation 7 of the principal

regulations shall be substituted by the following

"(1)

Tissue establishments shall keep a record of their

activities, including the types and quantities of tissues and, or

cells procured, tested, preserved, processed, stored and

distributed, or otherwise disposed of, and on the origin and

destination of the tissues and cells intended for human

applications, in accordance with the requirements referred to in

these regulations and any schedules and any amendments

thereto.".

Regulation 9 of the principal regulations shall be amended

as follows

(a)

for paragraph (c) thereof, there shall be substituted

the following

"(c) put and keep in place procedures for the

evaluation of donors in accordance with the requirements

set by these regulations and schedules and any

amendments thereto;"; and

(b)

for paragraph (h) thereof, there shall be substituted

the following

"(h) the tissues and cells are procured, packaged

and transported in accordance with the requirements set by

these regulations and any schedules and any amendments

thereto.".

In sub-regulation (4) of regulation 10 of the principal Amends

regulations, for the words "the Annex to Directive 2004/23/EC" there regulation

the principal

shall be substituted the words "Schedule I".

regulations.

Regulation 12 of the principal regulations shall be Amends

regulation 12 of

amended as follows

the principal

regulations.

(a)

in sub-regulation (2) thereof, for the words "Annex

I of Directive 2006/17/EC" there shall be substituted the words

"Schedule II";

(b)

in sub-regulation (6) thereof, for the words "Annex

IV, section 1.3 of Directive 2006/17/EC" there shall be

substituted the words "section 1.3 of Schedule V"; and

(c)

in sub-regulation (11) thereof, for the words

"section 1.4 of Annex IV of Directive 2006/17/EC" there shall

be substituted the words "section 1.4 of Schedule V".

Regulation 13 of the principal regulations shall be Substitutes

regulation 13 of

substituted by the following

the principal

regulations.

"13. Tissue and cells establishments shall in respect of

donors adopt the selection criteria set out in these regulations

namely

(a) Schedule II for donors of tissues and cells,

except donors of reproductive cells;

(b)

Schedule IV for donors of reproductive

cells.".

Regulation 14 of the principal regulations shall be

substituted by the following

"14.

It shall be the duty of the establishment to ensure

that

(a) donors of tissues and cells, except donors of

reproductive cells, undergo the biological tests set out in

point 1 of Schedule III;

(b) such tests are carried out in compliance with

the general requirements set out in point 2 of Schedule III;

(c) donors of reproductive cells undergo the

biological tests set out in points 1, 2 and 3 of Schedule IV;

(d) such tests are carried out in compliance with

the general requirements set out in point 4 of Schedule

IV.".

In regulation 15 of the principal regulations, for the words

"Annex IV of Directive 2006/17/EC" there shall be substituted the

words "Schedule IV".

Immediately after regulation 16 of the principal

regulations, there shall be added the following new schedules

"SCHEDULE 1

Information to be provided on the Donation

of Cells and/or Tissues

A.

Living donors

1. The person in charge of the donation process shall ensure

that the donor has been properly informed of at least those aspects

relating to the donation and procurement process outlined in

paragraph 3. Information must be given prior to the procurement.

2. The information must be given by a trained person able to

transmit it in an appropriate and clear manner, using terms that are

easily understood by the donor.

3. The information must cover: the purpose and nature of the

procurement, its consequences and risks; analytical tests, if they are

performed; recording and protection of donor data, medical

confidentiality; therapeutic purpose and potential benefits and

information on the applicable safeguards intended to protect the

donor.

4. The donor must be informed that he/she has the right to

receive the confirmed results of the analytical tests, clearly explained.

5. Information must be given on the necessity for requiring

the applicable mandatory consent, certification and authorisation in

order that the tissue and/or cell procurement can be carried out.

B.

Deceased donors

1. All information must be given and all necessary consents

and authorisations must be obtained in accordance with the National

legislation in force.

2. The confirmed results of the donor's evaluation must be

communicated and clearly explained to the relevant persons in

accordance with the relevant national legislation.