Tuesday, August 22, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.4.1. ACTIVITIES

1. The activities related to tissue procurement shall be carried out in such a way as to ensure that donor evaluation and selection is carried out in accordance with the requirements referred to in this text and that the tissues and cells are procured, packaged and transported in accordance with the requirements referred to in the regarding sections.

2. In the case of an autologous donation, the suitability criteria shall be established in accordance with the requirements referred to in the regarding sections.

3. The competent authority or authorities shall ensure that all activities related to tissue procurement are carried out in accordance with the requirements referred to in the regarding sections.[1]

4. In order to prevent any infectious disease contamination or cross contamination, the recovery process should not be performed with more than one donor simultaneously unless it is possible to ensure that there is no risk of such contamination.

A.4.1.1. Access to the operating room

1. 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 mask.[2]

2. The personnel should enter the operating room following written gowning procedures. It is advisable to use an airlock as a protection barrier.

3. The materials should enter the operating room with an adequate grade of cleanliness according to D grade classification.  It is advisable to use an airlock as a protection barrier or a segregated storage room inside the classified operating room.

4. It is recommended that the donor is moved into the operating room using a specific transport element.  The transport element used to move the donor into the operating room should only be used in this area.  It is advisable to use an airlock as a protection barrier.

A.4.1.2. Access to an unusual place of recovery

1. For the cadaveric donation, the area of access must be restricted.  A local sterile field using sterile drapes must be used.  The persons conducting the procurement must be clothed appropriately.  Usually, this will extend to being scrubbed, gowned in sterile clothing and wearing sterile gloves, face shields and a protective mask.

2. The personnel should enter the procurement area following written gowning procedures for the respective recovery area.

3. The materials should enter the procurement area after an appropriate description of conditions for tissue recovery in an unusual place of recovery.

4. The donor should be moved into the procurement area using a specific transport element.  The transport element used to move the donor into the unusual recovery area should be appropriate to the needs and specification for the respective tissue recovery.

 

A.4.1.3. Recovery

A.4.1.3.1. General

1. ‘The procurement of human tissues or cells shall be authorised only after all mandatory consent or authorisation requirements in force in the Member State concerned have been met.

2. There shall also be SOPs describing the procedures for procurement, packaging, labelling and transportation of the tissues and cells to the point of arrival at the tissue establishment or, in the case of direct distribution of tissues and cells, to the clinical team responsible for their application or, in the case of tissue/cell samples, to the laboratory for testing.[3]

3. The TE or ORHA must have a written protocol on the practical organization of the donor screening and tissue/cells recovery.

4. When the organization of donor screening and the recovery of tissues and cells are done by a third party, there is a need for a written agreement between that party and the TE or ORHA.  The contract will determine the type of tissues and cells that must be recovered as well as the protocols that need to be followed.  This party must be qualified for this purpose and must have the competent clinical equipment to carry out the recovery of tissues and cells.

5. The recommended general recovery flow is: skin, corneas, cardiovascular and musculoskeletal.  Some cardiovascular tissues (femoral arteries) may be recovered at the same time with the musculoskeletal tissues.

6. The tissues/cells retrieval should be performed so as to prevent any contamination during recovery or to increase the risk of disease transmission from donor to recipient. Measures to prevent infectious disease contamination or cross contamination should be established taking into account the possible sources: air contamination, contamination coming from the recovery personnel, contamination coming from the donor (e.g. skin, intestinal bacteria), or contamination of the tissues/cells already recovered.

7. The quality control tests should be described defining the test, the analytical method, the sample size and the acceptance criteria.

8. See specific paragraphs for the minimum evaluation requirements for each kind of tissue.

A.4.1.3.2. Deceased donors
A.4.1.3.2.1. Recovery procedure of tissues

1. The personnel in charge of tissue recovery must have the experience and knowledge specifically needed for each tissue type.  Standard operating procedures (SOP's) must be in place to ensure the preservation of the characteristics of the tissues and cells for their final use, and to minimize the risk of microbiological contamination or spreading of transmissible diseases.

2. For this purpose:

a)     Recovery must be done in conditions equivalent to those in force for surgery;

b)    The materials and equipment must be disposable or properly sterilised;

c)     When the recovery of NHBD is carried out in the mortuary, it cannot be done simultaneously with the autopsy and must be done within controlled environmental conditions.  It is advisable to recover the tissue before the autopsy takes place.

3. Any special circumstances (such as recovery after autopsy) or any other incident during recovery that can affect the quality of the tissues and cells recovered, must be reported and analysed by the physician in charge of the TE or ORHA.

A.4.1.2.3.2. Reconstruction of the donor's body

1. Where appropriate, the staff and equipment necessary for body reconstruction of deceased donors shall be provided. Such reconstruction shall be completed effectively.

2. 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.[4]

3. The reconstruction of the body must be made respecting the corpse, whatever its final destination.

A.4.1.3.3. Living donors

1. Procurement of tissues and cells from living donors shall take place in an environment that ensures their health, safety and privacy.

2. For recovery of living donors, procedures should be in place for each tissue type and comply with the specific standards of quality.  The procedure should ensure the safety of the living donor and minimize the risk of contamination and infection by diseases.

3. The tissues should be retrieved in a way as to fulfil the criteria of the final destination (e.g. quality, length, size etc.), depending on the specific criteria for the type of tissue.

 

A.4.1.4. Processing during recovery

1. The competent authority or authorities may authorise the direct distribution of specific tissues and cells from where the procurement is carried out to a health care establishment for immediate transplantation.  Even in this case, all the tissues should be evaluated according to the specific requirements for each kind of tissue (see specific paragraphs).  

2. As long as any tissue/cells processing is performed in the operating room, the grade A surrounded by at least grade D should be respected attending the air quality conditions..  These processing activities should be considered as exceptional situations that should be sufficiently justified in writing, and authorised if required by local regulation.

A.4.1.5. Packaging and labelling

1. The procured tissue must be appropriately inspected and rinsed before the processing in the TE is initiated, so as to avoid the presence of blood that might be a source of bacterial contamination.

2. Packaging of the procured human body material must be appropriate and conform to the standards for the respective tissue.  Double or triple wrapping is necessary, depending on the tissue-specific requirements.

3. A unique identifying code shall be allocated to the donor and the donated tissues and cells, during procurement or at the end of the recovery process, to ensure proper identification of the donor and the traceability of all donated material.  The coded data shall be entered in a register maintained for the purpose.

4. 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.

5. 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. [5]

The temperature conditions between the recovery and processing must be appropriate to the type of tissue so as to preserve its required characteristics and biological function.

6. 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.[6]

7. The type of packaging and labelling for each tissue/cells will be established in the specific tissue type section.

8. All packaging and labelling materials should be stored and managed in a safe manner in order to avoid any cross contamination or mix-up, which could result in incorrectly identified / packaged tissues / cells.

9. Critical printed materials (i.e. primary and secondary packaging and leaflets) should be stored in segregated and access-controlled areas.

10. The respective donor information file should be placed in an envelope, sealed, marked ‘Medical Secret’ and addressed to the TE to which the tissue is destined for processing.

A.4.1.5.1. Primary packaging and labelling operation

1. The packaging of tissues and cells after recovery must (i) minimize the risk of contamination of tissues and cells (ii) minimize risk of contamination of the persons in charge of transportation and (iii) ensure the necessary conditions (i.e. temperature) for the preservation of the tissues and cells.

Each tissue is packed separately in a sterile packaging as soon as possible after recovery.  Double (triple)-packaging should be used when possible.

3. The package is then placed in a suitable container to ensure the preservation of the tissues and cells, and the physical protection of the recovered human material during transportation.  It is essential that the container is properly closed and not opened until the graft is received by the TE.  The conditions in the container must be appropriate to the standards and conditions for the respective tissue (i.e. temperature and duration of transport to the tissue establishment where the tissue processing will take place).

4. 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)    Name of the persons involved in the tissue recovery and their coordinates (phone, fax, mail);

c)     Type of the tissues recovered;

d)    Other tissues/cells/organs recovered and eventually their destination;

e)     Blood transfusion before the recovery and hemodilution risk;

f)      hazard warnings;

g)    nature of any additives/transport medium (if used);

h)    in the case of autologous donations, the label must state ‘for autologous use only’;

i)      in the case of directed donations, the label must identify the intended recipient;

5. 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.[7]

A.4.1.5.2. Secondary packaging and labelling operation

1. When tissues/cells are shipped by an intermediary, every shipping container must be labelled at least with:

a)    TISSUES AND CELLS and HANDLE WITH CARE;

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).[8]

A.4.1.6. Storage and transport

A.4.1.6.1. Storage

1. The recovered tissues/cells should be stored in a segregated and designated area following the specific storage conditions for each tissue/cells. (See tissue specific sections)

2. Storage areas should be of sufficient capacity to allow orderly storage of the various categories of materials and products: starting and packaging materials as well as tissues/cells in quarantine, released for processing, rejected, returned, recalled or for investigative use.

3. Storage areas should be designed or adapted to ensure good storage conditions.  In particular, they should be clean and dry and maintained within acceptable temperature limits.  Where special storage conditions are required (e.g. temperature, humidity) these should be provided, checked and monitored.

4. Segregated areas should be provided for the storage of rejected, recalled or returned materials or products.[9]

5. Printed packaging and labelling materials may be considered critical and special attention should be paid to their safe and secure storage.

A.4.1.6.2. Transport

1. The choice of transport mode is made according to general regulations governing transportation.  The transportation of tissues is done following a validated procedure according to the safety and preservation criteria for each tissue type.  These conditions are reflected in the tissue specific GTPs.

2. When the temperature must be maintained at a certain level during transportation, maintenance control must be validated first.

3. The maximum transportation time will be determined considering each tissue and cells type.  The place, date and time of departure and arrival, packaging integrity at departure and arrival, identity of the person receiving the tissues should be recorded and kept in the TE or ORHA.

4. If the transport is sub-contracted, a written agreement must be signed by the transporter and TE or ORHA.

5. Any transportation must be accompanied by a transport document that will be attached to the file.

6. The date and time of pick up and the date and time of arrival at the destination (TE) must be indicated by the person who carries out the tissue transport.

7. Samples of tissue and blood sampling included in the transport must be carefully identified.

A.4.1.7. Documentation and release for processing

A.4.1.7.1. General

1. The TE or ORHA must develop a system to maintain a record of each step of donation, donor selection, collection, control, preparation, storage and distribution of tissues and cells. The decision to release (validation for human use) is taken on the basis of data contained in this dossier.

2. The records and documents must be completed in a legibly and indelibly manner.

3. The records and any other documentation can also be saved on a reliable system such as a digital or microfilm system.  When data are managed by the TE personnel, a declaration must be made to the European Commission responsible for personal data protection according to current regulations.

4. The recording of relevant data in the record must allow the identification of the author and the date of these entries.

5. Data security and confidentiality must be guaranteed.

A.4.1.7.2. Release

1. The items indicated in the Recovery File Contents should be required for the release or rejection of the tissues/cells and thus should be documented.  The tissue/cells recovered dossier should include the contents presented in the Recovery File Contents paragraph.

2. The responsible TE should make the final decision on the tissue release or rejection on the basis of the following criteria:

a)   donor information concerning his behaviour conditions;

b)   donor acceptance/rejection criteria (age, post mortem delay, exclusion clinical criteria);

c)   donor informed consent;

d)   the tissue related criteria (morphology, processing conditions, storage conditions);

e)   the quality control of the donor blood (bacteriological and virology analyses) and tissue (bacteriology, histology).

A.4.1.7.3. Recovery File Contents

1. 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 Donor Screening File and/or release statement of Donor Screening Responsible Person with an analysis of all exclusion criteria for the respective tissue donation;

b)    The transfusion of blood products or other solutions during last 24 to 48 hours and estimation of the risk for hemodilution;

c)     The identification, name and address of the tissue establishment to receive the cells/tissues;

d)    Donor identification data (including how and by whom the donor was identified);

e)     Description and identification of procured tissues and cells (including samples for testing) and the institution to which the other tissues, organs or cells are dedicated;

f)      Identification of the person who is responsible for the procurement session, including signing;

g)    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);

h)    For deceased donors, conditions under which the cadaver is kept: refrigerated (or not), time of start and end of refrigeration;

i)      ID/batch numbers of reagents and transport solutions used;[10]

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

3. The date and time of procurement may be included, where possible.[11]

Access to registers and data must be restricted to authorised persons.  This File must be kept for a minimum of 30 years after clinical use.

A.4.1.7.4. Availability for inspection

1. The records must be accessible at any time for inspections conducted by the competent authority.  Access to the donor's identity and related data is limited to persons responsible for the TE or ORHA, but must, if necessary, be available to inspectors.

A.4.1.7.5. Traceability

1. The TE or ORHA should be able to assure the traceability of the donor.

2. The traceability requirement applies to all relevant data related to the donor, critical products and materials coming into contact with the donor.

3. Corrections, changes or amendments made to a file should be carried out according to a written change control management procedure.

4. When electronic data is affected, any critical change should be recorded and available through an audit trail. 



[1] Directive 2004/23/EC of the European Parliament and of the Council (Art.15)

[2] Commission Directive 2006/17/EC (Annex IV)

[3] Commission Directive 2006/17/EC (Art.2)

[4] Commission Directive 2006/17/EC ( Art.2)

[5] Commission Directive 2006/17/EC (Annex IV)

[6] Commission Directive 2006/17/EC (Annex IV)

[7] Commission Directive 2006/17/EC ( Annex IV)

[8] Commission Directive 2006/17/EC ( Annex IV)

[9] EU Good Manufacturing Practices Guidelines

[10] Commission Directive 2006/17/EC (Annex IV)

[11] Commission Directive 2006/17/EC (Annex IV)

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