Chapter 1	Scope and purpose
Chapter 2	Definitions
Chapter 3	Responsibility
Chapter 4	The quality and safety of organisms for taking and transplantation-living donors
Chapter 5	The quality and safety of bodies for taking and transplantation-deceased donors
Chapter 6	Common requirements for donation, transplantation and reporting-living and deceased donors
Chapter 7	Reporting of statistical data
Chapter 8	Punishment and entry into force
Appendix 1	Donors
Appendix 2	Organ and donor characterisation
Appendix 3
Appendix 4
Appendix 5
Appendix 6
Appendix 7
Appendix 8
Appendix 9

Completion of the quality and safety of organ donation, sampling and testing (human organs) 1)

In accordance with section 4, section 6 (4). 2, section 7 (4). Paragraph 1, section 8, paragraph 8. 6, section 10, section. 3 and section 15 (3). 2 in Law No 151 of 28. February 2012 on the quality and safety requirements of the handling of human organs for transplantation shall be fixed :

Chapter 1

Scope and purpose

§ 1. This notice includes donation, testing, characterisation, evisceration, serenation, transport and transplantation of human organs from living and deceased donors intended for transplantation.

Paragraph 2. The commuting shall also include the part of a body to be used in the human body for the same purpose as the whole body and which meets the structure and vascular conisation requirements.

Paragraph 3. The notice shall not apply to tissues, cells, blood and other biological material.

Paragraph 4. The announcement shall apply to the exchange of organs in Denmark and with other countries.

Chapter 2

Definitions

§ 2. In this notice, the following concepts are used in the meanings indicated :

1) Serious adverse reaction : an unintended complication, including a transmissible disease, in the living donor or recipient of the organ in any part of the process from donation to transplantation that is lethal, life-threatening, invalidity, causes incapacity or triggering, or prolongs, hospital or sickness.

2) Second disponation : the final disposal of a body when it is not used for transplantation.

3) Severe unwanted event : Any unwanted and unintended existence in any part of the process from donation to transplantation that could result in the transfer of communicable diseases, death, life-threatening or invalidity ; or incapacity of donor or recipients of organs, or which triggers or extend hospital-side or sickness.

4) Donation : Forgiveness of organs intended for transplantation.

5) Donor : A person who donates one or more bodies, regardless of whether donation is taking place, while the person is alive, or after he is dead.

6) Donor characterisation : Collecting the relevant information on the characteristics of the donor necessary to assess its donor fitness in order to carry out a detailed risk assessment and minimise the risks to the recipient of the organ and ensure that : optimal allocation of organs.

7) " Body characterisation " means a collection of the relevant information concerning the body ' s characteristics necessary to assess its suitability, in order to be able to carry out a detailed risk assessment and minimise the risks to the recipient of the body and to ensure optimum, the allocation of the organ.

8) Organ : a differentiated part of the human body, which is triggered by various tissues that maintain its structure, vascaparisation and the ability to develop physiological functions with a high degree of autonomy. Part of a body shall also be considered to be a body if it is intended to be used for the same purpose as the whole body of the human body and its structure and vascular culture.

9) Pre-serving : the use of chemical substances, changes in the surrounding environment or other means to prevent or delay biological or physical deterioration of organs from withdrawal to transplantation.

10) Recipient : A person who receives a body for transplantation.

11) Traceability : The ability to locate and identify the organ in any part of the process from donation to transplantation or other predisposition, including the possibility of

a) identify the donor and the sampling point ;

b) to identify recipient / recipients and grafts center / centers ; and

c) locate and identify all relevant non-personal information about products and materials that come into contact with the relevant body.

12) Transplantation : To seek to restore certain functions in the human body by transferring an organ from a donor to a recipient.

13) Transplantation centre : A health care institution, a hospital unit, a hospital unit or a body that deals with the transplantation of human organs and approved for it under the rules in force.

14) Commissioning : A process whereby the donated bodies are provided.

15) A collection organisation : A health care institution, a hospital unit, a hospital unit, a person, or a body that deals with or coordinate the evisceration, which has been approved for this purpose under the applicable rules.

16) Default procedure : A written instruction that describes the different stages of a particular process, including the materials and methods to be used, as well as the expected end product.

17) Third Party : Any other natural or legal person other than the donor and the natural or legal persons, as in the sampling organisation, the transplant centre, etc. in concrete terms are empowered to carry out such tasks related to handling organs from the donor, which include the processing of personal data, including information concerning health conditions.

18) Third country : countries other than EU/EEA countries.

(19) The person responsible for the establishment : the management of the hospitals where evisceration and / or transplantation is carried out.

20) DETOR-DEDETOR-DETOR-DETOR

Chapter 3

Responsibility

§ 3. The person responsible for the establishment in which the donation and withdrawal and / or transplantation of human organs is carried out shall be responsible for ensuring the requirements laid down in the notice.

Paragraph 2. The person responsible for the establishment must appoint a responsible doctor who is responsible for providing advice and guidance to the doctor who is responsible for the sampling of the body or the doctor responsible for the transplant in connection with it, clinical assessment of donor and recipient.

Paragraph 3. The one in paragraph 1. 2 the doctor responsible for guidance and guidance shall have relevant practical experience and must be specialized in its territory and have the approval of the Board of Health in accordance with Article 54 (54) of the Health Code. 1.

§ 4. Risk assessment and selection of donor, cf. Annexes 2 and 3 shall be carried out by a doctor.

Paragraph 2. The one in paragraph 1. 1 the doctor responsible for the clinical evaluation of the donor ' s suitability in accordance with the selection criteria referred to in Annexes 2 and 3 must be consulted, where necessary, with the designated responsible doctor, as set out in Annex 2. Section 3, paragraph 3. 2.

Chapter 4

The quality and safety of organisms for taking and transplantation-living donors

Sampling

Requirements for risk assessment and selection of organ donations, including testing and evaluation requirements

§ 5. There must be

1) for each donor, a journal (the donor journal) shall be set up containing the information referred to in Annex 1 (1.1). The journal shall have an independent annex to the donor journal having a set-aside report containing the information referred to in Annex 1 (1.2),

2) the donor record shall record the information obtained in accordance with Annex 2, 3 and point 5.1.1, and

3) on the basis of the information obtained after No, 2, assessed on donor is suitable.

Paragraph 2. Risk assessment and selection of organ donors in accordance with paragraph 1. 1 shall be carried out by a doctor.

Paragraph 3. The doctor who is responsible for the clinical evaluation provided for in paragraph 1. 1 shall consult the designated responsible doctor, if necessary, in accordance with the case of the designated responsible doctor. Section 4 (4). 2.

Paragraph 4. The information in the donor journal shall always follow the organ.

Requirements for the sampling organisation procedures for evisceration, including in respect of the consent of donor consent, donor identification, documentation and staff professional qualifications ;

§ 6. Donor must be informed of

1) the purpose and nature of the operation, the related consequences and risks, of any possible contamination of the market, the registration and protection of donations, the purposes and the potential benefits of the health professional staff, the confidentiality of the health professional staff and the conditions of professional secrecy ; applicable safety rules to protect the donor, cf. Annex 5,

2) the donor has the right to obtain information on the results of the infection market studies, etc., including a thorough explanation of these, and

3) that test results if they show an abnormal condition of the health status of the donor, unless the donor is waistcoys of this in advance.

Paragraph 2. The information referred to in paragraph 1 shall : 1 shall be given by a doctor, cf. Annex 4. The relevant doctor must provide information in a clearly and considerate manner and shall ensure that the donor has understood the information, cf. The health of the health officer. The relevant doctor must, at the time of the information, comply with the conditions laid down in Section IV of the Health Code on information and consent in connection with transplantation.

§ 7. It must be ensured,

1) the withdrawal of organs from the donor will take place in appropriate facilities, in accordance with procedures and with the choice of instruments, sterile equipment, etc., which minimizes the risk of bacterial or other contamination of the bodies to be taken and, incidentally, under conditions which : ensure donor health, security and privacy ;

2) the removal of organs from the donor is taking place in accordance with the procedural requirements referred to in Annex 5, point 2,

3) the procedures for packaging, marking and dispatch of made bodies meet the requirements laid down in Annex 6 ;

4) standard procedures are used for :

a) acceptance of donor on the basis of risk assessment (screening, testing),

b) verification of the identity of the donor ;

c) verification of information on the consent of donor or consent from the donor's closest,

d) verification of donor fitness,

(e) eviscering,

(f) the packaging, marking and transport of eviscerated bodies from the set-aside to receive, cf. Annex 6,

g) the reporting of serious adverse events and adverse reactions to the respective authorities ;

(h) evaluation and internal audits of standard procedures,

5) there are procedures for ensuring that the information in Appendix 2 and Annex 3 follows the body to the destination, cf. Section 5 (5). 2,

6) they are in no. 4 that standard procedures also specify which professional qualifications are required to carry out the procedures described, and how it is ensured that the persons designated to perform the procedures also possess these qualifications ; and

7) there are procedures for ensuring that third countries have the same quality, safety and traceability requirements within the EU/ES territory before the exchange of organs with the country.

Transplantation

Procedures and documentation requirements for the transplant centre

§ 8. The transplantation must be carried out before the transplant is completed, cf. Annex 7 :

1) the characterisation of donor and bodies has been correctly implemented, cf. Annexes 2 and 3,

2) proper registration of donor and bodies has been completed, cf. Annex 1,

3) the conditions for the preparation and transport of the body have been properly fulfilled, cf. Annex 6,

4) the patient file for the recipient has been created for the recipient, cf. Annex 1, point 1.1, and

5) that third countries have the same quality, safety and traceability requirements within the EU/ES territory, before the exchange of organs with the country.

Paragraph 2. It must be ensured where a body in special cases is approved for use for transplantation, although the conditions laid down in paragraph 1 shall be applied. 1 in this provision is not satisfied that the competent doctor shall prepare documentation of the risk assessment. The assessment must indicate the expected benefits that are for the recipient. The assessment must analyse the relationship between risk and benefits in the specific case, including life-threatening emergencies, and weigh the risks associated with the incomplete information are greater than the benefits of the recipient.

Paragraph 3. It is a doctor who is responsible for the clinical evaluation after the number of substances and 2, which shall consult the designated responsible doctor, as necessary, in accordance with the relevant medical examiner. Section 4 (4). 2.

Chapter 5

The quality and safety of bodies for taking and transplantation-deceased donors

Sampling

Requirements for risk assessment and selection of organ donations, including testing and evaluation requirements

§ 9. There must be

1) for each donor, a journal (the donor journal) shall be set up containing the information referred to in Annex 1 (1.1). The journal shall have an independent annex to the donor journal having a set-aside report containing the information referred to in Annex 1 (1.2),

2) the donor record shall record the information obtained in accordance with Annex 2, 3 and point 8.1.1, and

3) on the basis of the information obtained after No, 2 assesses of the donor character is appropriate.

Paragraph 2. Risk assessment and selection of organ donors in accordance with paragraph 1. 1 shall be carried out by a doctor.

Paragraph 3. The doctor who is responsible for the clinical evaluation after the last paragraph 1. shall, where necessary, consult with the designated responsible doctor, cf. Section 4 (4). 2.

Paragraph 4. The information in the donor journal shall always follow the organ.

Requirements for sampling procedures for sampling bodies, including for the conception of donor consent, donor identification, documentation and staff professional qualifications ;

§ 10. It must be ensured, cf. Annexes 4 and 8,

1) the terms of the Health Act, 2) in the case of transplantation from the deceased persons, including the information on and consent to the intervention of the donor or the donor's closest, are fulfilled as a prerequisite for the completion of the intervention,

2) that the information is provided by a doctor who is able to disseminate information in an appropriate and clear manner. The person concerned shall ensure that the donor's closest person has understood the importance of the information provided, cf. The health of the health officer. 12, and

3) the information contained in the donor journal shall always follow the organ.

Paragraph 2. In the case of transplantation of the deceased, the person shall be 1 the abovementioned doctor on relevant scopes and, in accordance with Title IV of the Health Code, inform the donor's immediate relatives.

§ 11. It must be ensured that,

1) evisceration from donors takes place in appropriate facilities, in accordance with procedures and with the choice of instruments, sterile equipment, etc. that minimise the risk of bacterial or other contamination of the bodies set up ;

2) the evisceration of organs from donors takes place under the observation of the procedural requirements referred to in Annex 8, 8.3, in appropriate facilities, and

3) the procedure for packaging, marking and dispatch of the bodies set out complies with the requirements referred to in Annex 6.

4) standard procedures are used for :

a) acceptance of donor on the basis of risk assessment (screening, testing),

b) verification of the identity of the donor ;

c) verification of information on the consent of donor or consent from the donor's closest,

d) verification of donor fitness,

(e) eviscering,

(f) the packaging, marking and transport of eviscerated bodies from the set-aside to receive, cf. Annex 6,

g) the reporting of serious adverse events and adverse reactions to the respective authorities ;

(h) evaluation and internal audits of standard procedures.

5) there are procedures for ensuring that the information in Appendix 2 and Annex 3 follows the organ up to the transplant centre, cf. Section 5 (5). 2,

6) the in no. 4 that standard procedures also specify which professional qualifications are required to carry out the procedures described, and how it is ensured that the persons designated to perform the procedures also possess these qualifications ; and

7) there are procedures for ensuring that third countries have the same quality, safety and traceability requirements within the EU/ES territory before the exchange of organs with the country.

Transplantation

Procedures and documentation requirements for the transplant centre

§ 12. It must, before the transplant be carried out, be assured, cf. Annex 7 :

1) the characterisation of donor and bodies has been correctly implemented, cf. Annexes 2 and 3,

2) proper registration of donor and bodies has been completed, cf. Annex 1,

3) the conditions for the preparation and transport of the body have been properly fulfilled, cf. Annex 6,

4) The patient journal has been created for the recipient, cf. Annex 1, point 1.1, and

5) that third countries have the same quality, safety and traceability requirements within the EU/ES territory, before the exchange of organs with the country.

Paragraph 2. It must be ensured in which a body in special cases is released for use for transplantation even if the conditions laid down in paragraph 1 are applied. 1 in this provision is not satisfied that the competent doctor shall prepare documentation of the risk assessment. The assessment must indicate the expected benefits and disadvantages for the recipient. The assessment must analyse the relationship between risk and benefits in the specific case, including life-threatening emergencies, and weigh the risks associated with the incomplete information are greater than the benefits of the recipient.

Paragraph 3. It is a doctor who is responsible for the clinical evaluation provided for in paragraph 1. 1 and 2 and, where necessary, consult with the designated responsible doctor, cf. Section 4 (4). 2.

Chapter 6

Common requirements for donation, transplantation and reporting-living and deceased donors

24 Hour Access

§ 13. It must be ensured that

1) who are always available for information on organ and donor ;

2) 24 hours a day shall be available to qualified personnel responsible for :

a) to coordinate the taking and / or transplantation ;

b) to prepare a report, which contains information of the importance of the characterisation and traceability of the deceased donors ;

c) notifying the receiving transplant centre and giving the removal organisation of serious adverse events and adverse reactions ;

d) to receive information on serious adverse events and adverse reactions from the receiving transplant centre and the sampling organisation ; and

(e) to disclose immediately the information on serious adverse events and adverse reactions to relevant authorised health professionals.

Quality assurance

§ 14. It must be ensured that

1) a quality assurance system shall be established and continuously maintained to ensure that the requirements for the donor characterisation, procurement, storage and distribution of organs and transplantation are in accordance with the provisions of this notice ;

2) the sampling organisations and transplantation centres in their quality assurance work are supported by a quality management function, which may be either located internally or linked to the organization. This function must be involved in all quality-related issues and review and approve all relevant quality-related documents ;

3) all the procedures, premises and equipment that affect the quality and safety of the organs must be validated before they are used, and then revalidated at regular intervals to be determined by the activities ;

4) there shall be systems for the internal audit of no. One to three. The internal audit shall be carried out regularly by trained and competent persons in an independent manner in accordance with approved procedures ;

5) documented studies, including, inter alia, a decision on possible corrective and preventive measures, where deviations from the quality and safety standards prescribed by the prescribed standards are found ; and

6) that all results in paragraph 1 : 1 to 4 shall be documented and timely and effective corrective and preventive measures are taken.

Organizational traceability

§ 15. It must be ensured that the donor files necessary to ensure full traceability are kept for at least 30 years after the clinical use / expiration date of an appropriate archive.

Requirements for anonymisation of all information collected for the handling of human organs

§ 16. It must be ensured that,

1) all information collected from the evisceration of organs obtained from a living or deceased donor and has access to, including information obtained as part of a suitability assessment, is anonymized in a way, in such a way that : donor or recipient may be identified by a third party ; and

2) the necessary safety measures for such information are taken, including in order to prevent the addition, deletion or modification of information in the records of donors and to prevent the transmission of the information.

Notification of serious adverse reactions and serious adverse events

§ 17. Authorized health workers must, without delay, report serious adverse reactions or serious adverse incidents that may be related to the safety of the organs and are observed in the recipient or donor.

Paragraph 2. The obligation to report shall include the donor or recipient as the authorized health expert in patient processing.

§ 18. The extraction organisation shall immediately inform the transplant centre immediately reporting serious adverse reactions and serious adverse events for testing, processing, preservation, storage, distribution, import or export and withdrawal ; bodies that may have an effect on the quality and safety of organs.

§ 19. The Board of Transplantation shall immediately report serious adverse reactions and serious adverse events related to testing, transplantation, processing, preservation, storage, distribution, import or export ; organs.

Paragraph 2. The Transplantation Centre shall report immediately on the basis of section 18 (1). 1 or 19 (1). 1 received reports to the Board of Health.

Paragraph 3. The reporting of the Transplant Centre in accordance with paragraph 1. 1 must be carried out on a special schema, with the content printed in Annex 9 to this notice. The scheme may be obtained from the network of health services or by contacting the Management Board.

Paragraph 4. Where the body was received from a country other than Denmark, the transplant centre shall immediately inform the transplant centre (s) in the given country of the reported serious adverse reactions and serious adverse events. The format of Annex 9 shall be used for the notification.

Paragraph 5. Where the body is passed on to a country other than Denmark, the transplant centre must immediately inform the transplant centre (s) in the other country concerning the serious adverse reactions and serious undesirable substances ; events. The format of Annex 9 shall be used for the notification.

Paragraph 6. Where a body has been extramediated and transplanted in Denmark, the transplant centre must immediately inform each other of serious adverse reactions and serious adverse events related to the recipient, donor or the donated body.

20. The Recipient or the donor of organs and their relatives may report to the Board of Health reports of serious adverse reactions and serious adverse events occurred during or after the clinical use of bodies.

Chapter 7

Reporting of statistical data

§ 21. The transplant centres and set-aside organisations shall draw up a report on the transplant establishment annually, in which, inter alia, the total numbers of live and deceased donors and on which and how many bodies have been taken and how many bodies are taken and, transplanted or otherwise dispose of, and a statement and conclusions of any serious complications and serious adverse incidents. The report shall cover the activity from 1. 1 January to 31. December.

Paragraph 2. The report shall be submitted to the Board of Health in electronic form at the latest at 30. April of the following calendar year.

Paragraph 3. The Board of Health shall prepare guidance for the annual reporting of the centers.

Chapter 8

Punishment and entry into force

§ 22. Unless more penalties are imposed on other legislation, the penalty shall be penalized for the penalty which is in violation of section 4 to 19 and section 21.

Paragraph 2. Companies can be imposed on companies. (legal persons) punishable by the rules of the penal code 5. Chapter.

-23. The announcement will enter into force on the seventh. June 2013.

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Appendix 1

Donors

1. Donor / recipient Documentation and Traceability

1.1. A journal containing the following information shall be provided for each donor and recipient (s) :

a) donor / recipientidentification : given name, last name, and date of birth and unique donor / recipient identification number. In the donor journal, the recipient's unique identification number and the corresponding registration, the identification number of the recipient ' s record shall be registered.

b) age and gender, as well as the medical and behavioral history (the information collected must be sufficient to provide for application of the exclusion criteria) ;

c) the results of an objective medical examination of the body, where available,

d) the blood dilution algorithm, if applicable ;

(e) consent / permission form

(f) clinical data, laboratory test results and results of other tests carried out ;

1.2. The sampling organisation that is taking the set-aside shall draw up a set-aside report, which is sent to the transplant centre. The report shall contain at least the following information :

a) the identification and name and address of the transplant centre to receive the organ (s) ;

b) Donoridentification number (including information on how and by whom donor has been identified)

c) description of and identification details of the bodies set out (including tests for testing),

d) identification details of the doctor responsible for the set-aside procedure, including the signature of the person concerned ;

(e) date and time (if necessary start and end time) for the set-aside, set-aside and applied procedure (standard procedure) and any details of any encountered complications, where appropriate, information on the conditions of the sampling site (physical description of the area in which the set has been taken),

(f) Identity/batch numbers on reagents and transport solutions used.

1.3. All the records must be clearly written and legible, and must be kept protected from unauthorised changes and could easily be provided in this form throughout the fixed withdrawal period, cf. applicable data protection legislation.

1.4. Journal (s) necessary to ensure full traceability shall be kept for at least 30 years after the clinical use / expiration date of an appropriate archive approved by the competent authority.

Decdied donors

In the case of the deceased donors, the following information shall be obtained in addition to the information provided under Title 1 of living donors :

a) the conditions under which the body of the deceased is kept ;

b) the report shall, if possible, include information on the date and time of the brain-death date.

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Appendix 2

Organ and donor characterisation

The person responsible for the establishment must ensure that all the necessary information is obtained from live donors.

Part A

The minimum of information, for the characterisation of organs and donors, to be collected for each donation.

Minimum Information

1. The sampling point and other general information

2. Donortype

3. Blood type

4. Gender

5. Date of birth or estimated age

6. Weight

7. Height

8. Formerly or current intravenous drug addiction

9. Formerly or present malign neoplasi

10. Heave 1 and 2

11. Hepatitis B

12. Hepatitis C

13. Syphilis-must be carried out, even if the result is available after the transplant is carried out,

14. EBV + CMV-must be run-even if the result is available after the transplant is being carried out

15. Other infectious diseases

Basic information for assessing the operation of the donated body

In the case of the deceased donors, the following information shall also be obtained :

1. Cause of death

2. Date of death

Part B

Supplementary information-living and deceased donors

The person responsible for the establishment shall ensure the collection of additional information for the characterisation of organs and donors. This information shall be information in addition to information collected in Part A, the basis for the collection of the data on a medical professional decision in the sampling organisation or the transplant centre, taking into account the availability of : such information and the specific circumstances of the case in accordance with section 6 of this notice.

Donors ' medical history, including in particular circumstances which may affect the suitability of the bodies to be transplanted and present a risk of infection of the disease.

1. Results from the clinical examination or evaluation of the physiological condition of the donor ;

2. Donors who live in or come from high quality areas, have sexual partners coming from such areas, or are the children of parents coming from such areas, are tested for antibodies against HLTV 1 and HLTV 2.

3. Donors travel habits, including residence in areas of local geographical occurrence of infectious infectious diseases.

4. Donors exposure to risks, including sexual risks, which are important for the characterisation of the organ.

5. Laboratory results which may be relevant to the identification of potential infectious diseases or other diseases.

6. Photodiagnosis studies and analyses which show the anatomical status of the body.

7. Previous or present medical treatment, which may affect the organisation ' s characterisation.

8. Past or present cancer disease

9. Earlier or present disease caused by prions, such as

a) Variants of Creutzfeldt-Jakob ' s disease in the donor

b) Swift forward dementia or degenerative neurological disorder of known or unknown origin

c) Hormones like the donor have received from another human's pituitary gland-e.g. growth hormone, transplanted hornhinde mv.

10. Current systemic infection-bacterial disease, virus, fungi, or parasitic infection or severe infection in the body to be donated.

11. Fresh vaccination with live weakened viruses

12. Systemic autoimmune diseases which may affect the quality of the body ;

13. Exposure or intake of cyanide, lead, copper and gold if it can be transferred to the body to a degree that it can be transferred to the recipient and risk the health of the recipient.

14. Past xenotransplants with live cells, tissue or organs, for example, biological corpses or dura mats with brain surgery.

15. If the donor is a child less than 18 months or has been breast-fed within the last 12 months, the donor ' s biological mother has been carrying or has been carrying a contagious disease and the risk of transmission of infection to the child has not yet been carried out ; the end can be excluded.

16. In particular, for the deceased donors, the donor has received inotropic support or transfusion therapy.

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Appendix 3

1. General requirements to be complied with in the determination of biological marklet

1.1. Where there are Danish donors, the tests must be carried out by a competent laboratory and which make use of the CE marked test kit in the necessary scope. The test type used must be validated for the purpose on the basis of the current scientific knowledge.

1.2. The biological tests are carried out on the donor ' s serum or plasma. Test of blood samples from potential donors who have lost blood and cards before have received blood, blood components, colloids or crystalloids may be invalid due to the blood dilution of the sample. An algorithm is used to assess the degree of blood dilution in the following circumstances :

a) taking of ante-mortem blood sample : if blood, blood components and / or colloids have been taken within 48 hours prior to the sampling of the blood sample or if crystalloids have been taken within the last hour before the sampling of the blood sample.

b) post-mortem sampling : if blood, blood components and / or colloids have been added within 48 hours of death or whose crystalloids have been taken within an hour prior to the entry into the death of death. When the examination of samples shows a plasma dilution of more than 50%, transplantation centres may only accept organs from the donors concerned if the test procedures are validated for such plasma or if a sample is taken before the test is available ; the feed.

The following infectees must be tested for the following :

Laboratory tests to be carried out where, on the basis of the donor ' s background, it is necessary :

• Malaria

• Tuberculosis

• Toxoplasmosis

• Trypanosoma Cruzi

• Chikungunya

• West Nile virus

• Leishmaniasis

• HLTV I-and HLTV II infection

• Other relevant (e.g. Hantaan fever, febris manrillar mev.)

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Appendix 4

1. The professional qualifications of health professionals

1.1. The person responsible for the establishment must ensure that the set-aside organisation and transplant centres have sufficient staff to carry out the activities relating to the donation, testing, characterisation, procurement, preservation, transport and the transplantation of human organs, and the persons concerned must be trained and approved to carry out their duties.

1.2. The person responsible for the establishment must ensure that all staff in the set-aside organisation and the transplant centre have updated job descriptions that will carefully determine their duties and responsibilities in the case of taking and transplantation.

1.3. The person responsible for the establishment must ensure that all personnel in the set-aside organisation and the transplant centre are undergoing basic training / further training relevant to their tasks. Education must be documented continuously. Education programmes must be available, which also include good practice.

1.4. The content of the training programmes shall be regularly evaluated and the skills of the staff shall be regularly assessed.

1.5. The person responsible for the establishment shall ensure that all medical activities are carried out in consultation with and under the guidance of a doctor, as mentioned in Directive 2005 /36/EC of the European Parliament and of the Council of 7. September 2005 on the recognition of professional qualifications.

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Appendix 5

The procedure for the donation and withdrawal of organs, etc. -living donors

Donations and sampling procedures

1. Contuse and donoridentification

1.1. Before taking bodies, a doctor shall confirm and register :

a) the consent of the set-aside must be obtained in accordance with the Health Act.

b) how and by whom the donor has been identified has been identified.

1.2. The doctor who is responsible for obtaining the information that makes up the donor's medical history shall ensure that donor has :

a) understood the information provided.

b) had the opportunity to ask questions and received these replies in a satisfactory manner ;

c) confirm that the information supplied by the donor shall be verified by the best of his or her best convictions.

1.3. A designated person shall collect and record the relevant medical and behavioral-related information relating to the donor in accordance with Annexes 1, 2 and 3.

1.4. When the relevant information is obtained, various relevant sources shall be used, including in any case a call with a donor and, where applicable, the following :

a) donor health records,

b) a conversation with the attending physician,

c) and, as far as possible, a conversation with the practitioner practitioner ;

1.5. In addition, an objective medical examination of the body is carried out in order to reveal any signs that may in themselves result in the exclusion of donor or which can be assessed in the light of the sickness and personal history of the donor.

1.6. The Journal is reviewed in its entirety and is evaluated in terms of the suitability of the donor and is signed by a doctor.

1.7 prior to an organ being given to 3. Member States must ensure that the country has at least the same requirements for quality, safety and traceability, which are applicable within the EU/EEA territory.

2. Sampling procedures

2.1. The application procedures must be used to make their own into the donor category and the bodies that are donated. Procedures must be operated with procedures to protect the safety of the living donor.

2.2. The application procedures shall ensure the protection of the characteristics required for the bodies required for the final clinical use of their final clinical use, while minimizing the process of microbiological contamination.

2.3. Undesired events that take into account or may have harmed a living donor and the results of investigations into covering the cause of such incidents shall be recorded and assessed.

2.4. sterile and cleansed instruments and sterile equipment are used for the sampling of bodies. Instruments and equipment must be of good quality and must be validated or specifically approved for the purpose and must at all times be maintained so that they / it are suitable for the taking of bodies.

2.5. If use instruments are necessary, a validated cleaning and sterilisation procedure must be used for the removal of infectious agents.

2.6. As far as possible, only CE-labelled medical equipment is used, as well as all affected personnel must be properly trained in the use of this equipment.

2.7. All equipment must be validated, calibrated and maintained, so that it is equivalent to that intended purpose. Instruction books must be available, and appropriate documentation must be archived.

2.8. Equipment must be selected to minimise the damage to donors, personnel or bodies.

2.9. Reagents and materials from approved suppliers shall be used only for the performance of the documented requirements and specifications. Critical materials must be released by a person who is qualified to perform this task.

2.10. Where applicable, materials, reagents and equipment must comply with the requirements of the medicinal products in accordance with the law on medical equipment, or equivalent standards in the case of withdrawal in third countries.

2.11. If computer systems are used, software, hardware and backup procedures must be periodically checked to ensure their reliability, validated before use and kept in authenticated state. Hardware and software must be protected against non-approved use or changes. The backup procedure shall prevent any loss of or damage to data if the system is orally or unintentionally out of operation, or if there is malfunction.

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Appendix 6

Packaging, labelling and transport

1. Packaging

1.1. After the sampling, all samples must be packed in a manner that minimizes the risk of contamination and must be kept at a temperature to ensure that the required properties and biological function of the bodies are preserved. The packaging must, in addition, be such that those responsible for packing and transporting the organs are not contaminated.

1.2. The embed bodies must be transported in a sealed container suitable for the transport of biological material and ensure that the safety and quality of the bodies concerned are preserved.

1.3. All accompanying bodies to be tested must be properly labelled in order to ensure identification of the donor and must be provided with information on sampling time and place.

2. Labelling of evicted bodies

2.1. All packages of organs must be marked at the time of sampling. In the primary container, the donor identification data / code and type of organ must be specified. If the size of the package permits it, the following information shall also be given :

a) the date (and, if possible, the time) of the donation,

b) warnings

c) details of added pre-server resources,

d) for recipient specific donations on the label of whom the donation is intended for :

If there is no room for the information referred to in (a) to (d) on the primary ballast note, they shall be given on a separate accompanying note accompanying the primary ballagen.

3. the labelling of the transport container by transit

3.1 In the case of consignments of organs through the intermediary, all transport containers shall bear at least the following :

a) ORGANER/ORGANS and HANDLE WITH CARE.

b) identification of the container sender (address and telephone number) and of the person who is to be contacted in the event of problems ;

c) identification of the receiving transplant centre (address and telephone number) and of the person who is to be contacted for delivery of the container ;

d) information on the date and time of transport,

(e) details of the importance of transport matters for the quality and safety of the body ;

(f) instruction MAY NOT BE PROCESSED TO AVOID RADIATION

g) the specifications relating to storage conditions (such as MAY NOT REMAINING)

4. Requirements for transport, by the way,

4.1. Organs must be transported quickly and safely and the organisations, bodies or undertakings involved in the transport of bodies must have appropriate working procedures to ensure that the body is not deteriorated during transport and that ; The transport time is appropriate.

5. Transport of organs between surgical rooms in the same hospital

5. 1 When the body is transported between surgical rooms in the same hospital, section 1.1 of this Annex shall apply as a minimum.

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Appendix 7

1. the receipt of organs at the transplant centre

1.1. Before a body is received from 3. land the transplantation centre shall ensure that the country has the same quality, safety and traceability requirements within the EU/EEA region and can guarantee full traceability for 30 years.

1.2. When the bodies arrive at the transplant centre, a documented verification shall be carried out to ensure that the consignment, including the transport conditions, the packaging, the labelling and the associated documentation and the associated tests, comply with the requirements of : the specifications of this Directive and the specifications of the consigliation.

1.3. Each centre must ensure that the notified bodies are kept in quarantine until inspection or other checks have been demonstrated that the organs and the associated documentation are in accordance with the laws in force. The review of the relevant information on the donor / procurement and thus the approval of the donation shall be carried out by a doctor.

1.4. Each transplant centre shall operate with a documented policy and specifications, which shall be used for the control of each consignment of bodies, including samples. These must include the technical requirements and other criteria which the transplantation Centre is considered to be of crucial importance for maintaining an acceptable level of quality. the Centre shall operate with documented procedures for the handling and isolation of consignments which do not comply with the provisions in force, or which are not fully tested, in order to exclude the risk of contamination ; any other bodies treated, praseted or stored.

1.5. The Transplantation Centre shall keep the register of the following information :

a) the consent / authorization, including the indication of what the body must be used for, the organs must be used and any specific instructions for disposal which must be followed if the organs are not used for the purposes of which consent is obtained ;

b) all required journals / registries concerning the sampling and the collection of information on the donor background, cf. the chapter on donor documentation

c) results of medical examinations, laboratory tests and other tests (such as the autopsy report if it is used in accordance with Annex 5 to 1.14) ;

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Appendix 8

The procedure for the donation and withdrawal of organs, etc. -deceased donors

Donations and sampling procedures

1. Contuse and donoridentification

1.1. Before any organ is taken, a doctor shall confirm and record :

a) the consent of the set-aside must be obtained in accordance with the Health Act.

b) how and by whom the donor has been identified has been identified.

1.2. A doctor shall obtain and record the relevant medical and behavioral-related information relating to the donor in accordance with Annexes 1, 2 and 3.

1.3. When the relevant information is obtained, various relevant sources are required, including the following :

a) donor health records

b) a conversation with a person who knew the donor well

c) a conversation with the attending physician,

d) and, as far as possible, a conversation with the practitioner practitioner ;

1.4. In addition, an objective medical examination of the body must be carried out in order to reveal any signs that may in themselves result in the exclusion of donor or which can be assessed in the light of the sickness and personal history of the donor.

1.5. The Journal shall be reviewed in its entirety and shall be evaluated in terms of the suitability of the donor and shall be signed by qualified health experts.

1.6 Before a body is submitted to 3. Member States must ensure that the country has the same quality, safety and traceability requirements within the EU/EEA territory.

2. Sampling procedures

2.1. The application procedures shall ensure the protection of the characteristics required for the bodies required for the final clinical use of their final clinical use, while minimizing the process of microbiological contamination. The sampling point shall be recorded, in the same way as the time interval from the date of entry into the sampling period to be specified, so that the necessary biological and / or physical characteristics of the organs can be preserved.

2.2. When the organs are removed from the donor body, this must be reconstruated, so that the outer accounts, as far as possible, get their original appearance.

2.3. Unwanted events that take place in the procurement field, and the results of investigations into covering the cause of such incidents should be recorded and assessed.

2.4. sterile instruments and sterile equipment are used for the sampling of bodies. Instruments and equipment must be of good quality and must be validated or specifically approved for the purpose and must at all times be maintained so that they / it are suitable for the taking of bodies.

2.5. If use instruments are necessary, a validated cleaning and sterilisation procedure must be used for the removal of infectious agents.

2.6. As far as possible, only CE-labelled medical equipment is used, as well as all affected personnel must be properly trained in the use of this equipment.

2.7. All equipment must be validated, calibrated and maintained, so that it is equivalent to that intended purpose. Instruction books must be available, and appropriate documentation must be archived.

2.8. Equipment must be selected in order to minimise damage to staff or bodies.

2.9. Reagents and materials from approved suppliers shall be used only for the performance of the documented requirements and specifications. Critical materials must be released by a person who is qualified to perform this task.

2.10. Where applicable, materials, reagents and equipment must comply with the requirements of the medicinal products in accordance with law on medical equipment, or equivalent standards in the event of a third-country action.

2.11. If IT systems are used, software, hardware and backup procedures must be periodically checked to ensure their reliability, validated before use and kept in authenticated state. Hardware and software must be protected against non-approved use or changes. The backup procedure shall prevent any loss of or damage to data if the system is orally or unintentionally out of operation, or if there is malfunction.

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Appendix 9

Notification of serious adverse reactions and serious unwanted incidents for other countries

1. Quick report of suspicion of serious adverse reactions

2. Rapid report of suspicion of serious adverse events

1) This notice implements provisions implementing the European Parliament and Council Directive 2010 /53/EC of 7. July 2010 on the quality and safety standards of human organs for transplantation, EU-Official Journal. 14-29.

2) Law No 546 of 24. June 2005, Health Law.