Republic of Latvia Cabinet Regulation No. 70 Adopted 29 January 2013

Regulations Regarding Use of Human Organs in Medicine, as well as Use of Human Organs and Body of Deceased Human Being for Medical Studies

Issued pursuant to
Section 4.¹, Paragraph four, Section 12, Paragraph one, Clauses 1 and 3 and
Section 14, Clauses 1 and 3 of
the Law On the Protection of the Body of Deceased Human Beings and
the Use of Human Tissues and Organs in Medicine

1. General Provisions

1. This Regulation prescribes:

1.1. procedures in accordance with which the State Agency of Medicines issues an authorisation for use of organs and duplicate thereof for a medical treatment institution and institution of higher education, which implements accredited medical study programme (hereinafter - institution of higher education), cancels the authorisation, suspends and renews validity thereof;

1.2. requirements to be complied with in order to receive an authorisation for use of organs and conditions for use of organs;

1.3. a sample form of an authorisation for use of organs;

1.4. procedures for the assessment, supervision and control of use of organs;

1.5. procedures for transplantation of organs, as well as quality and safety standards of donor's organs intended for the transplantation; and

1.6. procedures for using of organs, as well as body of deceased human being in medical studies.

2. The following terms are used in this Regulation:

2.1. authorisation for use of organs - a document that certifies the conformity of medical treatment institution or institution of higher education with the requirements laid down in this Regulation and gives the right to a recipient of the authorisation to perform the activities indicated in the authorisation;

2.2. operating procedures - written instructions describing the steps in a specific process, including the materials and methods to be used and the expected end outcome;

2.3. donor - a person who donates one or several organs for transplantation and a person who donates one or several organs or body for the implementation of medicinal study programme in an institution of higher education, whether donation occurs during lifetime or after death;

2.4. donor characterisation - the collection of the relevant information on the characteristics of the donor needed to evaluate his/her suitability for organ donation, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;

2.5. European organ exchange organisation - a non-profit organisation, whether public or private, dedicated to national and cross-border organ exchange, in which the majority of its member countries are Member States;

2.6. procurement organisation - a medical treatment institution or a unit thereof, or an aggregate of specialists which undertakes or coordinates the procurement of organs, and which has an authorisation for procurement of organs;

2.7. traceability - an aggregate of activities providing the ability to locate and identify the organ at each stage in the chain from donation to transplantation or disposal, including the ability to identify the donor and the procurement organisation, identify the recipient at the transplantation centre, as well as locate and identify all relevant information (except personal) relating to products and materials coming into contact with that organ;

2.8. serious adverse reaction - an unintended response (including a communicable disease), in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity;

2.9. serious adverse event - means any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity;

2.10. organ - a part of the human body, formed by different tissues, that maintains its structure, vascularisation, and capacity to develop physiological functions with a significant level of autonomy, as well as a part of an organ, if it is to be used for the same purpose as the entire organ in the human body, maintaining the requirements of structure and vascularisation;

2.11. organ characterisation - the collection of the relevant information on the characteristics of the organ needed to evaluate its suitability, in order to undertake a proper risk assessment and minimise the risks for the recipient, and optimise organ allocation;

2.12. organ procurement - a part of the process of use of organ by which the donated organ becomes available for the transplantation;

2.13. organ disposal - final disposal of an organ, if it is not used for the transplantation;

2.14. organ preservation - the stage of use of an organ in which chemical agents, alterations in environmental conditions or other means are used to prevent or retard biological or physical deterioration of organ from procurement to transplantation;

2.15. recipient - a person who receives a transplant of an organ;

2.16. potential donor - a person for whom assessment of health condition is carried out in order to find out whether a person has medical contraindications with respect to organ donation;

2.17. transplantation - a process intended to restore certain functions of the human body by transferring an organ from a donor to a recipient;

2.18. transplantation centre - a medical treatment institution or a unit thereof or an aggregate of specialists which has an authorisation for performance of transplantation and which performs organ transplantation;

2.19. donation - donation of organs for transplantation, as well as donation of organs or body (an aggregate of tissues and organs) for medical studies.

3. This Regulation applies also to use of organs intended for research of transplantation process at the transplantation centre, where organs are intended for transplantation into the human body.

4. The State Agency of Medicines (hereinafter - Agency) shall assess the conformity of procurement organisations, transplantation centres and institutions of higher education with the requirements referred to in this Regulation (including shall carry out further repeated inspections (also extraordinary and previously non-notified)) (hereinafter - conformity assessment), as well as carry out supervision thereof in accordance with the procedures laid down in this Regulation.

5. Use of organs in medical treatment in conformity with the requirements of the laws and regulations regulating the field of medical treatment shall be supervised and controlled by the Health Inspectorate.

6. The requirements laid down in this Regulation in the field of personal data protection shall be supervised by the Data State Inspectorate. The Data State Inspectorate shall inform the Agency regarding the fact of infringement of the laws and regulations detected in a procurement organisation or transplantation centre in the field of personal data protection.

2. Issuance of an Authorisation for Use of Organs Intended for Transplantation, Suspension of Validity and Cancellation Thereof

7. Procurement organisations and transplantation centres conforming to the requirements laid down in this Regulation and which have obtained an authorisation for use of organs (Annex 1) shall be entitled to perform use of organs intended for transplantation.

8. A medical treatment institution wishing to obtain an authorisation for use of organs shall carry out payment for the conformity assessment and issuance of the authorisation in the amount laid down in the laws and regulations regarding a pricelist of public paid services of the Agency and shall submit the following documents to the Agency:

8.1. a submission signed by the Head of the medical treatment institution. The following information shall be indicated in the submission:

8.1.1. name of the medical treatment institution, registration number, legal address and actual address;

8.1.2. given name, surname and contact details of a medical practitioner responsible for the co-operation with the Agency (phone number, electronic mail address);

8.1.3. planned activities of use of organs;

8.1.4. certification regarding conformity of a medical treatment institution with the requirements of this Regulation for the performance of the relevant activities of use of organs;

8.2. description of a quality system. Quality manual, where the quality ensuring system is described and at least the following information is indicated, shall be included in the description;

8.2.1. procedures;

8.2.2. guidelines;

8.2.3. personnel training and reference manuals;

8.2.4. report sample forms;

8.2.5. procedures for record-keeping of donors;

8.2.6. procedures for organ transportation;

8.3. a copy of the decision to register processing of personal data or a copy of the decision to register a specialist of personal data protection with the Data State Inspectorate.

9. The Agency shall review the received submission and information appended thereto and, if it is incomplete or does not conform to the requirements of this Regulation, within 10 working days from the day of receipt of the submission shall request in writing the medical treatment institution to rectify deficiencies. The medical treatment institution shall rectify deficiencies and submit the information certifying thereof to the Agency within two weeks from the receipt of the request.

10. The Agency shall verify the submitted information within a month following the receipt of the documents referred to in Paragraph 8 or 9 of this Regulation, find out whether the medical treatment institution is registered with the Register of Medical Treatment Institutions and complies with the mandatory requirements for medical treatment institutions and structural units thereof, assess the conformity of the medical treatment institution with the requirements laid down in this Regulation in respect of the use of organs and take a decision to issue an authorisation for use of organs or to refuse to issue such authorisation.

11. In order to take a decision referred to in Paragraphs 10 and 19 of this Regulation, an official of the Agency has the right to visit medical treatment institution. The medical treatment institution shall ensure an access for the official of the Agency to the documentation, premises, equipment necessary for taking of a decision, as well as presence of a medical practitioner responsible for the co-operation with the Agency during the visit.

12. The Agency shall take a decision to refuse to issue authorisation for use of organs, if at least one of the following conditions have set in:

12.1. a medical treatment institution fails to submit the information referred to in Paragraph 9 of this Regulation to the Agency;

12.2. documents submitted to a medical treatment institution contain false information;

12.3. a medical treatment institution fails to comply with the requirements laid down in this Regulation in respect of use of organs and cannot ensure compliance with them;

12.4. a medical treatment institution is not registered in the Register of Medical Treatment Institutions;

12.5. a medical treatment institution does not comply with the mandatory requirements for medical treatment institutions and structural units thereof.

13. If a decision to refuse to issue an authorisation for use of organs is taken, payment made for the assessment of conformity and issue of the authorisation is not refunded to the medical treatment institution.

14. The Agency shall indicate in an authorisation for use of organs what activities a procurement organisation or transplantation centre is entitled to carry out in respect of use of organs.

15. If an authorisation for use of organs is damaged, destroyed, lost or stolen, a procurement organisation or transplantation centre shall inform the Agency in writing thereof within three working days, by submitting a submission for the obtaining of a duplicate of the authorisation and performing payment for the issue of a duplicate of the authorisation in the amount laid down in the laws and regulations regarding a pricelist of public paid services of the Agency. The Agency shall issue a duplicate of the authorisation to a procurement organisation or transplantation centre within three working days.

16. The Agency shall suspend the operation of the authorisation of use of organs, if it determines that a procurement organisation or transplantation centre fails to ensure the performance of the requirements referred to in this Regulation, or if the Agency has received the information from the Data State Inspectorate regarding infringement of the laws and regulations established in the procurement organisation or transplantation centre in the field of personal data protection and shall determine a time period for rectification of the deficiencies.

17. If there are any doubts regarding infringements of the laws and regulations governing the field of medical treatment in a procurement organisation or transplantation centre, the Agency shall inform the Health Inspectorate thereof.

18. In order to renew the operation of the suspended authorisation for use of organs, a procurement organisation or transplantation centre shall perform payment regarding conformity assessment in the amount laid down in the laws and regulations regarding a pricelist of public paid services of the Agency and submit the following documents to the Agency:

18.1. a submission regarding renewal of operation of the suspended authorisation;

18.2. documents attesting that deficiencies have been rectified due to which operation of the authorisation has been suspended;

18.3. results of personal data protection efficiency assessment (audit), if operation of the authorisation has been suspended in relation to the infringement of the laws and regulations established by the Data State Inspectorate in the field of personal data protection.

19. The Agency shall, within a month following the receipt of the documents referred to in Paragraph 18 of this Regulation, verify the submitted documents, assess the conformity of a procurement organisation or transplantation centre with the requirements laid down in this Regulation in respect of use of organs and if the deficiencies, due to which operation of the authorisation has been suspended, are rectified, take a decision to renew operation of the authorisation.

20. The Agency shall cancel an authorisation for use of organs, if at least one of the following conditions has set in:

20.1. a procurement organisation or transplantation centre has requested to cancel the authorisation for use of organs issued to it;

20.2. a procurement organisation or transplantation centre has infringed the quality and safety requirements for use of organs laid down in this Regulation;

20.3. a procurement organisation or transplantation centre fails to observe the activities referred to in the authorisation for use of organs;

20.4. a procurement organisation or transplantation centre has not rectified the deficiencies within the time period referred to in Paragraph 16 of this Regulation due to which the operation of the authorisation for use of organs has been suspended;

20.5. it has become known to the Agency, that a procurement organisation or transplantation centre is deleted from the Register of Medical Treatment Institutions;

20.6. it has become known to the Agency that a procurement organisation or transplantation centre fails to comply with the laws and regulations regarding mandatory requirements for medical treatment institutions and structural units thereof;

20.7. it has become known to the Agency that a procurement organisation or transplantation centre is excluded from the Register of Personal Data Processing or a data protection specialist of the procurement organisation or transplantation centre is deleted from the Register of Personal Data Protection Specialists;

20.8. a procurement organisation or transplantation centre has provided false information to the Agency.

21. The Agency shall establish and maintain a list with procurement organisations and transplantation centres to which an authorisation for use of organs has been issued. The Agency shall place the information regarding issued authorisations (name, phone number of a procurement organisation or transplantation centre, authorised activities for use of organs, actual address of the place of use of organs, number and date of the authorisation), suspension of operation of the issued authorisations or cancellation of authorisations on the website of the Agency within three working days following the taking of the relevant decision and inform the Data State Inspectorate thereof.

22. A procurement organisation or transplantation centre may contest the decisions taken by the Agency to issue authorisation for use of organs or to refuse to issue such authorisation, as well as to suspend validity of the authorisation or to cancel the authorisation in the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law.

23. A decision of the Ministry of Health may be appealed to a court in accordance with the procedures laid down in the Administrative Procedure Law.

3. Supervision of a Procurement Organisation and Transplantation Centre in the Agency

24. In order to ensure the compliance with the requirements referred to in this Regulation, the Agency shall, on regular basis, however not less than once in three years, take the following actions:

24.1. assess premises and equipment of a procurement organisation and transplantation centre to which the requirements of this Regulation apply;

24.2. assess activity procedures and activities which are carried out in the premises and equipment of procurement organisations and transplantation centres to which the requirements of this Regulation apply;

24.3. assess all notes, activity procedures and activities related to the performance of the requirements referred to in this Regulation;

24.4. assess quality and safety system of the procurement organisation and transplantation centres and conformity thereof with the requirements referred to in Sub-paragraphs 37.1, 37.2, 37.3, 37.4, 37.5, 37.6, 37.7, 37.8 and 37.9 of this Regulation.

25. Procurement organisations and transplantation centres may not change the conditions of activity without a written approval by the Agency.

26. A reporting system shall be established and procedures for notifications of procurement organisations and transplantation centres regarding serious adverse reactions and serious adverse events shall be introduced in accordance with Paragraphs 68 and 69 of this Regulation.

27. The Agency shall ensure that a reporting system, where information in accordance with Paragraph 68 of this Regulation is received from a procurement organisation or transplantation centre regarding any serious adverse reactions and serious adverse events and the results of investigation of the relevant case, is connected with a reporting system, where the Agency receives information regarding serious adverse reactions and serious adverse events in relation to use of tissues and cells.

28. The Agency shall provide guidance to procurement organisations and transplantation centres including regarding necessity of collection of relevant post-transplantation information to evaluate the quality and safety of the organs transplanted.

29. Each year by 1 July procurement organisations and transplantation centres shall prepare and submit a report regarding activity in the previous year to the Agency. The report shall include information regarding number of living and deceased donors, type and number of procured and transplanted or disposed organs. The Agency shall compile received information and publish the report on the website thereof. The Agency shall keep the acquired information in accordance with the requirements of the laws and regulations in the field of personal data protection.

30. The Agency shall prepare and submit a report summary regarding performed activities, which are related to use of organs, and experience acquired to the European Commission once in three years by 27 August.

31. The Agency shall provide information to other European Union Member States and the European Commission regarding serious adverse reactions or serious adverse events, as well as upon request of the European Union Member State or the European Commission submit the list of those procurement organisations and transplantation centres, to which an authorisation for use of organs has been issued, and provide information regarding the requirements of the laws and regulation of the Republic of Latvia in respect of authorisations for use of organs and results of supervision measures taken in relation to meeting the requirements referred to in this Regulation.

32. The Agency shall act in the network of competent institutions established by the European Commission.

4. Conditions for Use of Organs Intended for Transplantation

4.1. General Provisions

33. All medical devices used in organ use shall be validated, calibrated and maintained pursuant to the intended purpose of use in accordance with the laws and regulations regarding the procedures for registration, conformity assessment, distribution, operation and technical supervision of medical devices. Results of validation, calibration and technical supervision of medical devices shall be documented.

34. The hygiene and personal protective equipment use requirements shall be laid down for the personnel in writing in a procurement organisation and transplantation centre.

35. Medical devices used in use of organs in conformity with their type and use intensity shall be maintained, serviced, cleaned, disinfected, as well as sterilised in conformity with the laws and regulation on mandatory requirements for the medical treatment institutions and structural units thereof and such activities shall be documented.

36. In order to ensure optimal use of organ, a procurement organisation and transplantation centre shall ensure the use of organ in conformity with immunology criteria.

37. The framework for quality and safety shall be established in a procurement organisation and transplantation centre, which covers all stages of use of organ from donation to transplantation or disposal and within the framework of which the following procedures are developed, documented and implemented:

37.1. the verification of donor identity;

37.2. the verification of the receipt of the donor's written consent;

37.3. the verification of presence of the authorisation or prohibition by a deceased donor or verification of presence of the prohibition by the next of kin of a deceased donor, by taking into account the requirements laid down in the Law On the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine, as well as provision of the rights of the next of kin of a decease donor to inform regarding the will expressed during his or her life;

37.4. performance of the characterisation of organ and characterisation of donor in accordance with Paragraphs 40, 41, 42 and 43 of this Regulation;

37.5. procurement, preservation, packaging, labelling and transportation of organ in accordance with the conditions for use of organs laid down in this Regulation;

37.6. provision of traceability of organs in accordance with Paragraphs 65, 66 and 67 of this Regulation, as well as determination of obligations for a procurement organisation, European organ exchange organisation or transplantation centre;

37.7. the accurate, rapid and verifiable reporting of serious adverse reactions and serious adverse events in accordance with Paragraphs 68, 69 and 77 of this Regulation, as well as determination of obligations for a procurement organisation, European organ exchange organisation or transplantation centre;

37.8. the management of serious adverse reactions and serious adverse events in accordance with Paragraph 77 of this Regulation, as well as determination of obligations and procedures of the European organ exchange organisation or transplantation centre, in accordance with which a procurement organisation, European organ exchange organisation and transplantation centre notify the Agency regarding the management measures in respect of serious adverse reactions and serious adverse events;

37.9. education and training of staff which include the following requirements;

37.9.1. an organisational structure of qualified personnel with detailed distribution of duties, powers and responsibilities is established in order to ensure the use of organs in conformity with the requirements laid down in this Regulation;

37.9.2. the personnel have the appropriate professional qualification in order to ensure the use of organs in conformity with the requirements laid down in this Regulation. The manager of the procurement organisation and transplantation centre shall, once a year, ensure an evaluation of staff competence;

37.9.3. the initial training of the personnel and improvement of professional qualification in order to ensure the use of organs in conformity with the requirements laid down in this Regulation. Personnel training programme shall be documented and personnel competence shall be assessed;

37.10. ensuring of the technical and organisational requirements of the personal data protection, as well as assessment of efficiency thereof.

4.2. Selection of Organ Donors, Organs Procurement

38. A living donor may be a person having no medical contraindications for organ donation. An opinion regarding health state of a living donor and possibility to extract organs, by assessing his or her health and medical history, shall be provided by a council of medical practitioners established by a procurement organisation in the composition of which shall be included also a specialist of the transplantation centre. A person whose donation may case a serious health risks shall be recognised as non-suitable for organ donation. The opinion shall be appended to the donor's medical documents (inpatient medical card (sample form No.003/u)).

39. A decease organ donor may be a person for whom the fact of brain or biological death has been established. The time of brain or biological death shall be recorded as the time or person's death in the donor's medical documents (in an inpatient medical card (sample form No.003/u)).

40. In order to assess suitability of a donor for organ donation and organ suitability, by assessing and reducing risks for a donor and recipient, as well as by ensuring optimal use of organs, a procurement organisation shall prepare a donor characterisation and organ characterisation. The following information shall be included in both, the donor description and organ description:

40.1. name of the medical treatment institution where the relevant organ is procured;

40.2. type of donor;

40.3. blood group and Rh factor of donor;

40.4. gender of donor;

40.5. cause of death of donor (for deceased donors);

40.6. date and time of death (for deceased donors);

40.7. date of birth of donor;

40.8. weight, height of donor;

40.9. intravenous drug abuse (present or past);

40.10. malignant neoplasia (present or past);

40.11. other transmissible diseases diagnosed for a donor earlier;

40.12. HIV, HCV and HBV test results; and

40.13. information to evaluate the function of the donated organ (specific investigations of the functions of organs).

41. By assessing the availability of information, medical practitioners may take a decision to supplement the information referred to in Paragraph 40 of this Regulation with the following information:

41.1. contact details of the medical treatment institution referred to in Sub-paragraph 40.1 of this Regulation that is necessary for co-ordination of activities and traceability of organ from a donor to recipient and from recipient to donor;

41.2. demographic and anthropometrical data required in order to guarantee an appropriate matching between the donor and organ;

41.3. medical history of the donor, in particular - the conditions which might affect the suitability of the organs for transplantation and imply the risk of disease transmission;

41.4. data from clinical examination which are necessary for the evaluation of the physiological maintenance of the potential donor as well as any finding revealing conditions which remained undetected during the examination of the donor's medical history and which might affect the suitability of organs for transplantation or might imply the risk of disease transmission;

41.5. data needed for the assessment of the functional characterisation of the organs and for the detection of potentially transmissible diseases and of possible contraindications with respect to organ donation;

41.6. image explorations necessary for the assessment of the anatomical status of the organs for transplantation;

41.7. treatments administered to the donor and relevant for the assessment of the functional status of the organs and the suitability for organ donation, in particular the use of antibiotics, inotropic support or transfusion therapy.

42. In order to acquire the information referred to in Paragraphs 40 and 41 of this Regulation, medical practitioners of a procurement organisation shall turn to a donor or, if a donor is deceased to his or her family or other persons who may provide such information, by explaining them in comprehensible way the significance of rapid provision of such information.

43. Where delay in transplantation threatens the recipient's life, a procurement organisation and transplantation centre may take a decision to use organ before all the information referred to in Paragraph 40 of this Regulation is acquired.

44. A medical practitioner of a procurement organisation shall inform a donor before procurement of organs of a living human regarding:

44.1. therapeutic purpose of procurement of organs, possible benefits and risks;

44.2. the potential safeguard measures of the donor;

44.3. the form of registration of donor's data, data protection and observance of confidentiality;

44.4. laboratory tests (if any) and the right to receive the results of such tests and explanations thereof in a comprehensible way; and

44.5. necessity to receive mandatory donor's consent before procurement of organs.

45. A medical practitioner shall provide the information referred to in Paragraph 44 of this Regulation in a suitable, clear and easily comprehensible way and a donor's certification regarding the receipt of information shall be appended to the donor's medical documents (inpatient medical card (sample form No.003/u)).

46. Before procurement of organs from a living donor a medical practitioner of a procurement organisation shall:

46.1. receive a written consent by a donor for organ donation. The consent shall be appended to the donor's medical documents (inpatient medical card (sample form No.003/u)).

46.2. verify the identity of the donor on the basis of a personal identification document;

46.3. ascertain that the donor has:

46.3.1. understood the information referred to in Paragraph 44 of this Regulation;

46.3.2. used the opportunity to ask questions and received answers; and

46.3.3. confirmed that all the information provided to him or her is true.

47. A donor may revoke the consent referred to in Sub-paragraph 46.1 of this Regulation at any time until extraction of the organ. A written revocation shall be appended to the donor's medical documents (inpatient medical card (sample form No.003/u)).

48. Before procurement of organ from a deceased donor a procurement organisation shall acquire data from the Population Register regarding an authorisation or prohibition to use organs of donor. If there are not data in the Population Register regarding prohibition or authorisation to use his or her organs after the death, use of organs shall be performed taking into account the requirements laid down in the Law On the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine.

49. A procurement organisation shall establish, maintain and supplement a database of living donors where a file is established for each donor. A file shall include the following information:

49.1. given name, surname of the donor;

49.2. age of donor;

49.3. gender of donor;

49.4. a written certification for consent to become an organ donor;

49.5. anamnesis of life and diseases;

49.6. results of health examination;

49.7. blood group and Rh factor;

49.8. results of clinical and laboratory tests.

50. When assessing the suitability of each potential deceased donor for organ transplantation, a medical practitioner of a procurement organisation shall take into account:

50.1. the information acquired during conversation with the next of kin of a potential donor or a person who has known the donor well and that may be proved by documentary evidence;

50.2. the information acquired during conversation with the family doctor or attending physician of the potential donor and that may be proved by documentary evidence;

50.3. data of the medical history of the potential donor:

50.3.1. anamnesis of life and diseases;

50.3.2. results of physical, clinical and laboratory tests;

50.3.3. autopsy results;

50.3.4. conditions for use of organs laid down in the Law On the Protection of the Body of Deceased Human Beings and the Use of Human Tissues and Organs in Medicine.

51. When assessing the suitability of each potential deceased donor for organ transplantation, medical practitioners of a procurement organisation shall take into account the following criteria that prohibit using the deceased person as donor:

51.1. unknown cause of death;

51.2. anamnesis of a disease of unknown aetiology;

51.3. malignant tumours, except primary basal cell carcinoma and carcinoma in situ of the uterine cervix, as well as primary tumours of the central nervous system;

51.4. the risk of transmission of diseases caused by prions:

51.4.1. diagnosed Creutzfeldt-Jakob disease or variant Creutzfeldt-Jakob disease, as well as in family anamnesis - non-iatrogenic Creutzfeldt-Jakob disease;

51.4.2. in anamnesis rapid progressive dementia or degenerative nervous system diseases, as well as illness of unknown aetiology;

51.4.3. preparations containing hormones derived from a human gland (for example, growth hormone) used;

51.4.4. transplantation of cornea, sclera or dura mater has been performed;

51.4.5. neurosurgical operations have been performed, regarding which records in the medical documentation of the potential donor have not been made (there is a possibility that transplantation of dura mater has been performed previously);

51.5. bacterial, viral, fungal or parasitic infections, as well as infected tissues and cells, which are intended to be procured for transplantation;

51.6. the anamnesis confirmed by clinical evidence or laboratory evidence of HIV infection, acute or chronic hepatitis B (except persons with a proven immune status) or hepatitis C and the risk of transmission of these infections or proofs regarding factors of the risk of transmission of these infections have been detected;

51.7. anamnesis of chronic, systemic auto-immune diseases of the connective tissue system, which affect the quality of the organs, which are intended to be procured for transplantation;

51.8. the risk of transmission of transmitted diseases (detected during examination of the body of the donor);

51.9. poisoning with chemical substances (lead, mercury, gold, cyanides), which affect the quality of the organs, which are intended to be procured for transplantation, or health of the recipient;

51.10. recently vaccination, using vaccines containing live attenuated viruses, has been performed; and

51.11. transplantation with xenografts has been recently performed (immunosuppresive agents have been used).

52. When assessing the suitability of each potential deceased donor (child) or organ transplantation, medical practitioners of a procurement organisation shall take into account that a deceased child who is younger than 18 months and who has born to a mother with HIV infection, hepatitis B or hepatitis C or for whom the risk of transmission of these infections have been detected and who has been breastfed for at least 12 months, is not allowed to be used as donor. It shall be allowed to use the deceased child who has been born to a mother with HIV infection, hepatitis B, hepatitis C or for whom the risk of transmission of these infections have been detected and who has not been breastfed for at least 12 months as a donor if it is detected during clinical and laboratory tests that the child does not have HIV infection, hepatitis B or hepatitis C.

53. Before procurement of organs a potential organ donor shall undergone the following laboratory tests:

53.1. HIV ½ antibodies (anti-HIV ½);

53.2. HBV marker (HBsAg, anti-HBc);

53.3. C hepatitis virus antibodies (anti HCV Ab); or

53.4. antibodies to syphilis agents (positive specific test, active syphilis).

54. Laboratory tests referred to in Paragraphs 36, 40, 41 and 53 of this Regulation shall be carried out by a medical laboratory which conforms to the laws and regulations regarding mandatory requirements for medical treatment institutions and structural units thereof. Procedures to ensure that a transplantation centre receives the results of laboratory tests referred to in Paragraphs 40 and 41 of this Regulation in a timely manner shall be developed for a procurement organisation in co-operation with a medicine laboratory.

55. The procurement organisation shall procure organs only in such medical treatment organisations where an intensive therapy department and surgery department conforming to laws and regulations regarding mandatory requirements for medical treatment institutions and structural units thereof.

56. A procurement organisation shall receive information regarding a potential donor from a medical treatment institution where a potential donor is located. Upon receipt of information a specialised team, at the disposal of which is required medical devices, preservation solutions, organ containers, materials necessary for organ extraction operation, as well as the necessary transport, and which is established by the procurement organisation, shall depart to a medical treatment institutions for the procurement of a donor organs. The composition of the team shall contain two medical practitioners (one of them - transplantologist), transplantation co-ordinator and nurse who ensure or carry out organ procurement in conformity with the competence thereof. The activities of the team shall be managed by a certified transplantologist.

57. A specialised team shall ensure organ conservation.

58. The following shall be extracted during an organ extraction operation of a deceased donor:

58.1. tissues and organs for immune-biological test (spleen and lymphatic gland);

58.2. venous blood for bio-chemical, virusological and immunological investigation; and

58.3. tissue and organ samples for diagnostics of possible diseases of a donor.

59. Outer appearance of the body of a deceased donor shall be renewed in its initial appearance after procurement of organs.

60. The specialised team shall transfer the organs of a donor intended for transplantation to the procurement organisation and draw up a statement regarding the procurement and transfer of human organs to procurement organisation (Annex 2). The statement shall be drawn up in two copies. One copy shall be appended to medical documents of the donor (inpatient medical card (sample form No. 003/u)) and stored in a medical treatment institution where donor organs has been acquired, but another - at the procurement organisation.

61. A procurement organisation shall transfer donor organs intended for transplantation to a transplantation centre by drawing up a statement regarding transfer of human organs for transplantation (Annex) for each transferred organ. A statement shall be drawn up in triplicate. One copy shall be stored at the transplantation centre, second copy shall be appended to medical documents of the recipient (inpatient medical card (sample form No.003/u)), but the third copy shall be stored at the procurement organisation.

4.3. Transport of Organs

62. A procurement organisation shall have developed procedures for ensuring of integrity of the organs during transport and a suitable transport time.

63. When transporting organs, a procurement organisation shall ensure that the following requirements are met:

63.1. organs are transported in containers suitable for transport of organs which are labelled. The following information shall be indicated in the labelling:

63.1.1. information regarding a medical treatment institution where the organ was procured, and a procurement organisation - name, legal address and actual address and phone number;

63.1.2. information regarding a transplantation centre where the organ will be used - name, legal address and actual address and phone number (if known);

63.1.3. a statement that the container contains an organ, specifying the type of organ and, where applicable, its left or right location and marked "Handle with care";

63.1.4. recommended transport conditions, including instructions for keeping the container at an appropriate temperature and position;

63.2. the organs transported are accompanied by a report on the organ and donor characterisation.

64. The requirements referred to in Sub-paragraph 63.1 of this Regulation shall not applicable to the cases, when organ procurement and transplantation is carried out within one medical treatment institution.

4.4. Requirements for Traceability of Organs and Reporting System Regarding Serious Adverse Reactions and Serious Adverse Events

65. In order to safeguard the health of donors and recipients, a procurement organisation and transplantation centre shall ensure traceability of all organs used therein from a donor to recipient and from recipient to donor In order to ensure donor's identification, an identification code shall be granted to each procured organ.

66. The traceability system referred to in Paragraph 65 of this Regulation shall include:

66.1. identification of the donor;

66.2. identification of the procurement organisation;

66.3. identification of the transplantation centre;

66.4. type and identification of the organ;

66.5. identification of those articles and materials which have been in contact with the organ;

66.6. identification of the recipient;

66.7. date of the transplantation.

67. A procurement organisation and transplantation centre shall keep the data needed to ensure traceability at, as well as the information on organ and donor characterisation shall keep within the framework of quality and safety system.

68. A system shall be in place in a procurement organisation and transplantation centre to report regarding serious adverse reactions and serious adverse events that may influence the quality and safety of organs and that may be attributed to the use of organs (also any serious adverse reactions observed during or after use thereof and which may be connected to the quality and safety of organs), as well as to investigate and register the following serious adverse reactions and serious adverse events.

69. Procedures shall be in place in a procurement organisation in order to ensure notification of the transplantation centre and Agency regarding any possible serious adverse reactions and serious adverse events immediately after becoming aware of them, as well as to notify the results of the tests of such cases. Procedures shall be in place in a transplantation centre in order to ensure notification of the procurement organisation and Agency regarding any possible serious adverse reactions and serious adverse events immediately after becoming aware of them, as well as to notify the results of the tests of such cases.

4.5. Data Storage and Protection

70. A procurement organisation and transplantation centre shall ensure anonymity of the organ donor, as well as personal data processing in conformity with the requirements laid down in the laws and regulations regarding personal data protection, including:

70.1. ensure that the personal data processed are kept confidential and that all the necessary security measures are performed in order not to allow personal data processing in non-conformity with the processing purpose thereof and to protect personal data against unauthorised access, supplementation, deletion, destruction, lost, modification or distribution;

70.2. ensure that donors and recipients are not identifiable for the third person, except for the cases, where identification is permissible in conformity with the laws and regulations regarding personal data protection;

70.3. ensure the compliance with the personal data quality principles in conformity with the laws and regulations regarding personal data protection.

71. A procurement organisation and transplantation centre shall ensure that information regarding the personal data of a donor is not disclosed to the recipient and his or her relatives and information regarding the personal data of a recipient is not disclosed to the donor and his or her relatives (except for the case when a donor and recipient are the next of kin).

72. Data, that are required for full traceability of a donor and recipient, shall be kept for a minimum of 30 years after donation of the relevant organ. It shall be allowed to store the information electronically.

4.6. Procedures for Transplantation

73. A transplantation centre shall document acceptance or refusal of an organ.

74. A transplantation centre shall carry out selection of recipients on the basis of immunological and medical criteria.

75. Before commencement of the transplantation a transplantation centre shall ensure that:

75.1. a donor description and organ description appended to an organ is drawn up in conformity with the requirements laid down in this Regulation;

75.2. an organ preservation has been carried out and organ is transported in conformity with the requirements laid down in this Regulation; and

75.3. a donor and recipient have immunological compatibility.

76. A transplantation centre shall establish, maintain and supplement a database of organ transplantation where a file is established for each recipient and organ. A file shall include the following information:

76.1. organ type and identification code;

76.2. given name, surname and personal identity number of a recipient;

76.3. age of a recipient;

76.4. gender of a recipient;

76.5. blood group and Rh factor;

76.6. the diagnosis specified for a recipient;

76.7. date of the transplantation;

76.8. side of a human body from which the organ is procured (for the transplantation of kidneys and lungs);

76.9. cold ischemia time;

76.10. transplantation result;

76.11. complications;

76.12. long-term results.

77. A system for monitoring of living donors and recipients shall be established in a transplantation centre in order to determine, report and solve any events that may be related to the quality and safety of the donated organ and safety of recipient, as well as any serious adverse reactions that may be caused for a donor or recipient in the result of organ donation.

78. A transplantation centre shall transfer organs not used in the transplantation for morphological test and draw up a statement regarding non-utilisation of human organs for transplantation (Annex 4). A statement shall be kept in a transplantation centre.

4.7. Exchange of Organs with other Countries

79. Exchange of organs with other European Union Member State or European organ exchange organisations and third countries shall be supervised by the Agency. In order to ensure supervision the Agency may enter into co-operation agreements with competent institutions of third countries.

80. When carrying out exchange with other European Union Member States or European organ exchange organisations or third countries, a procurement organisation shall ensure that organ characterisation and donor characterisation are appended to organs.

81. The Agency shall allow organ exchange with third countries only where:

81.1. organs are traceable from a donor until recipient and from recipient until donor;

81.2. organs conform with the quality and safety requirements laid down in this Regulation.

82. When carrying out exchange or organs with the European Union Member States or European organ exchange organisations, a procurement organisation shall ensure:

82.1. organ traceability from a donor until recipient and from a recipient until donor in conformity with the procedures laid down in Paragraph s 65, 66 and 67 of this Regulation; and

82.2. reporting regarding serious adverse reactions and serious adverse events.

5. Issuing of an Authorisation for Use of Organs and Body of Decease Human Being for Implementation of Medical Study Programmes in the Institution of Higher Education, Suspension and Cancellation of the Validity Thereof

83. An institution of higher education shall be entitled to use organs and body of deceased human being for the implementation of medical study programmes which conforms with the requirements laid down in this Regulation and has received and authorisation of use of organs for implementation of medicinal study programmes (Annex 5).

84. An institution of higher education wishing to obtain an authorisation referred to in Paragraph 83 of this Regulation shall carry out payment for the conformity assessment and issuance of the authorisation in the amount laid down in the laws and regulations regarding a pricelist of public paid services of the Agency and shall submit the following documents to the Agency:

84.1. a submission signed by a rector of the institution of higher education. The following information shall be indicated in the submission:

84.1.1. name of the institution of higher education, registration number, legal address and actual address;

84.1.2. given name, surname, position and contact details of a person responsible for the co-operation with the Agency (phone number, electronic mail address);

84.1.3. a certification regarding conformity of the institution of higher education with the requirements of this Regulation in respect of use of organs and body of deceased human being for the implementation of medical study programmes;

84.2. a description of the procedures of the activity related to use of organs and body of deceased human being for the implementation of medical study programmes.

85. The Agency shall review the received submission and information appended thereto and, if it is incomplete or does not conform to the requirements of this Regulation, within 10 working days from the day of receipt of the submission shall request in writing the institution of higher education to rectify deficiencies. The institution of higher education shall rectify deficiencies and submit the information certifying thereof to the Agency within two weeks from the receipt of the request.

86. The Agency shall within a month following the receipt of the documents referred to in Paragraph 84 or 85 of this Regulation verify the submitted information, find out whether the institution of higher education is registered with the register of educational institutions, assess the conformity of the institution of higher education with the requirements laid down in this Regulation in respect of use of organs and body of deceased human being and take a decision to issue an authorisation referred to in Paragraph 83 of this Regulation or to refuse to issue an authorisation.

87. In order to take a decision referred to in Paragraphs 86 and 93 of this Regulation, an official of the Agency has the right to visit an institution of higher education. The institution of higher education shall ensure an access for the official of the Agency to the documentation, premises, equipment necessary for taking of a decision, as well as presence of a person responsible for the co-operation with the Agency during the visit.

88. The Agency shall take a decision to refuse to issue the authorisation referred to in Paragraph 83 of this Regulation, if at least one of the following conditions have set in:

88.1. an institution of higher education does not submit the information referred to in Paragraph 85 of this Regulation by the specified time limit;

88.2. documents submitted to an institution of higher education contain false information;

88.3. an institution of higher institution fails to comply with the requirements laid down in this Regulation in respect of use of organs and body of deceased human being and cannot ensure compliance with them;

88.4. an institution of higher education has not been registered with the register of educational institutions.

89. If a decision to refuse to issue the authorisation referred to in Paragraph 83 of this Regulation is taken, payment made for the assessment of conformity and issue of the authorisation is not refunded to the institution of higher education.

90. If the authorisation referred to in Paragraph 83 of this Regulation is damaged, destroyed, lost or stolen, an institution of higher education shall inform the Agency in writing thereof within three working days, by submitting a submission for the obtaining of a duplicate of the authorisation and performing payment for the issue of a duplicate of the authorisation in the amount laid down in the laws and regulations regarding a pricelist of public paid services of the Agency. The Agency shall issue a duplicate of the authorisation to the institution of higher education within three working days following the receipt of the submission.

91. The Agency shall suspend the validity of the authorisation referred to in Paragraph 83 of this Regulation, if it determines that the institution of higher education fails to ensure the compliance with the requirements referred to in this Regulation and determines the time period for rectification of deficiencies.

92. In order to renew the validity of the authorisation referred to in Paragraph 83 of this Regulation, the institution of higher education shall carry out payment for the conformity assessment and issuance of the authorisation in the amount laid down in the laws and regulations regarding a pricelist of public paid services of the Agency and shall submit the following documents to the Agency:

92.1. a submission regarding renewal of operation of the suspended authorisation;

92.2. documents certifying that deficiencies have been rectified due to which validity of the authorisation has been suspended.

93. The Agency shall, within a month following the receipt of the documents referred to in Paragraph 92 of this Regulation, verify the submitted documents, assess the conformity of the institution of higher education with the requirements laid down in this Regulation in respect of use of organs and body of deceased human being and, where deficiencies are rectified due to which the authorisation has been suspended, take a decision to renew the authorisation referred to in Paragraph 83 of this Regulation.

94. The Agency shall cancel the authorisation referred to in Paragraph 83 of this Regulation, if at least one of the following conditions has set in:

94.1. an institution of higher education has requested to cancel the authorisation issued to it;

94.2. an institution of higher education does not comply with the activities referred to in the authorisation;

94.3. an institution of higher education has not rectified the deficiencies within the time limit referred to in Paragraph 91 of this Regulation, due to which the activities of a certificate have been suspended;

94.4. it is known to the Agency that the institution of higher education has been deleted from the register of educational institutions;

94.5. an institution of higher education has provided false information.

95. The Agency shall put information regarding issued authorisations referred to in Paragraph 83 of this Regulation (name of the institution of higher education, telephone number, actual address of the place of use of organs and body of deceased human being, number and date of the authorisation), suspension of the validity of the issued authorisations or cancellation of authorisation within three working days following the taking of the relevant decision on the website of the Agency.

96. An institution of higher education may contest decisions taken by the Agency to issue authorisation referred to in Paragraph 83 of this Regulation or to refuse to issue such authorisation, as well as to suspend validity of the authorisation or to cancel the authorisation in the Ministry of Health in accordance with the procedures laid down in the Administrative Procedure Law.

97. A decision of the Ministry of Health may be appealed to a court in accordance with the procedures laid down in the Administrative Procedure Law.

6. Conditions and Procedures for Use of Organs and Body of Deceased Human Being Intended for Implementation of Medical Study Programmes in the Institution of Higher Education

98. Organs and body of deceased human being shall be used in conformity with study programmes.

99. Organs and body of deceased human being for the implementation of medical study programme in the institution of higher education shall be used in conformity with the procedures for activities developed in the institution of higher education.

100. Hygiene and personal protective equipment use requirements for personnel and students shall be laid down in writing in the institution of higher education.

101. Organs or body of deceased human being shall be acquired by the institution of higher education by drawing up a statement regarding transfer of organs and body of deceased human being to the institution of higher education (Annex 6). The statement shall be drawn up in two copies. One copy shall be stored at the institution which has transferred the organs or body of a deceased human being and the other - at the institution of higher education.

102. Organs and body of deceased human being shall be stored by the institution of higher education under laboratory conditions which are laid down in the activity procedures.

103. A body of deceased human being shall be stored in the room intended for the storage in appropriate temperature that is laid down in the activity procedures.

104. If organs and body of deceased human being are no used anymore in the study process, they shall be cremated or buried.

7. Supervision of Use of Organs and Body of Deceased Human Being Intended for Implementation of Medical Study Programmes in the Institution of Higher Education

105. The Agency shall establish and maintain a list with institution of higher education to which authorisation for use of organs has been issued.

106. In order to ensure the compliance with the requirements referred to in this Regulation, the Agency shall, on regular basis, however not less than once in three years, take the following actions:

106.1. assess premises and equipment of the institution of higher education to which the requirements of this Regulation apply;

106.2. assess all notes, activity procedures and activities related to the performance of the requirements referred to in this Regulation;

8. Final Provisions

107. A procurement organisations and transplantation centres shall submit the report referred to in Paragraph 29 of this Regulation for a preceding period to the Agency for the first time by 1 June 2013.

108. The Agency shall submit the report summary referred to in Paragraph 30 of this Regulation regarding the preceding period to the European Commission for the first time by 27 August 2013.

Informative Reference to the European Union Directive

These Regulations contain legal norms arising from Directive 2010/45/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation.

Prime Minister V. Dombrovskis

Minister for Health I.Circene

 

Annex 1
Cabinet Regulation No. 70
29 January 2013

(supplemented lesser State Coat of Arms of the Republic of Latvia)

State Agency of Medicines

(legal address, registration number, contact information)

Authorisation of Use of Organs
No.__________________

Riga

The State Agency of Medicines certifies that		,
	(name of the medical treatment institution,
legal address, actual address of use of organs, contact details,
		,
registration number in the Commercial Register, registration number in the Register of Medical Treatment Institutions)

has been assessed and complies with the requirements laid down in the Cabinet Regulation No. 70 of 29 January 2013, Regulations Regarding Use of Human Organs in Medicine, as well as Use of Human Organs and Body of Deceased Human Being for Medical Studies, and is entitled to carry out the following activities of use of organs (mark as appropriate):

	organ procurement (including selection of donors, extraction, testing, preservation, export, import and transportation of organs);
	transplantation of organs (including use of organs for research of the transplantation process, if they are intended for transplantation into a human body).

	(date)

Director of the State Agency of Medicines
	(given name, surname, signature)
	Place for a seal

Minister for Health I.Circene

 

Annex 2
Cabinet Regulation No.70
29 January 2013

Statement regarding the Procurement and Transfer of Human Organs to Procurement Organisation

1. Name of the medical treatment institution where organs are procured

2. Donor			-
	(given name, surname)		(personal identity number)

3. Donor code

4. Number of the inpatient medical card

5. Date of the establishment of biological or brain death (dd.mm.yyyy)	..
Time (h.min)	.

6. Blood group of the donor

7. Transplantologist who performed the surgery
	(given name, surname)
(name of the organisation)

8. Surgical method
	(description of the surgery)

9. The following organs were extracted (organ type and identification code)

10. Date of organ procurement (dd.mm.yyyy)	..
start time of the surgery (h.min)	.
end time of the surgery (h.min)	.

11. Anaesthetist reanimatologist in whose presence the organs were extracted
	(signature and full name)

12. Transplant coordinator of the procurement organisation to whom the organs were transferred
	(signature and full name)

13. Surgeons:
	(signature and full name)
	(signature and full name)
	(signature and full name)
	(signature and full name)

14. Date (dd.mm.yyyy)

..

Note. The statement shall be drawn up in two copies.

Minister for Health I.Circene

 

Annex 3
Cabinet Regulation No.70
29 January 2013

Akts par cilvēka orgānu nodošanu transplantācijai

Statement for the Procurement of Human Organs Intended for Transplantation

1. Ieguves organizācijas nosaukums/ Procurement organization
2. Transplantācijas centra nosaukums/ Transplantation centre or procurement organization
3.Donora identifikācijas kods/ Identification code of the donor
4. Donora asinsgrupa/ Blood group of the donor
5. Orgāna nosaukums un kods/ Name and code of the organ
6. Orgāna aukstuma išēmijas sākuma datums (dd.mm.gggg)/ Beginning date of cold ischemia (dd.mm.yyyy)		..
laiks (h.min)/time (h.min)		.
7. Ieguves organizācijas transplantācijas koordinators, kurš nodod orgānu/ Transplant coordinator of the procurement organization (person who hands over the organ)
		(paraksts un tā atšifrējums/ name, surname and signature)
8. Transplantācijas centra pārstāvis, kurš orgānu pieņem/ Representative of the transplantation centre or procurement organization (person who receives the organ)
		(paraksts un tā atšifrējums/ name, surname and signature)
9. Orgāna nodošanas datums (dd.mm.gggg)/ Exchange date (dd.mm.yyyy)		..
laiks (h.min)/time (h.min)		.

Piezīme. Aktu sastāda trijos eksemplāros./Note. Statement drawn up in three copies.

Minister for Health I.Circene

 

Annex 4
Cabinet Regulation No. 70
29 January 2013

Statement regarding the Non-utilisation of Human Organs for Transplantation and Transfer for Morphological Test

1. Name of the transplantation centre
2. Identification code of the donor
3. Organ type and identification code
4. Date of organ procurement (dd.mm.yyyy)			..
time (h.min)			.
5. Reasons for non-use of the organ
6. Head of the department
	(signature and full name)

Minister for Health I.Circene

 

Annex 5
Cabinet Regulation No.70
29 January 2013

(supplemented lesser State Coat of Arms of the Republic of Latvia)

State Agency of Medicines

(legal address, registration number, contact information)

Authorisation of Use of Organs for Implementation of Medicinal Study Programmes
No.__________________

Riga

The State Agency of Medicines certifies		,
	(name of the institution of higher education,
legal address, actual address of use of organs and body of deceased human body, contact details,
		,
registration number in the taxpayer register, registration number in the register of educational institutions)

has been assessed and complies with the requirements laid down in the Cabinet Regulation No. 70 of 29 January 2013, Regulations Regarding Use of Human Organs in Medicine, as well as Use of Human Organs and Body of Deceased Human Being for Medical Studies, and is entitled to carry out the use of organs and body of deceased human being for the implementation of medicinal study programme(s).

	(date)

Director of the State Agency of Medicines
	(given name, surname, signature)
	Place for a seal

Minister for Health I.Circene

 

Annex 6
Cabinet Regulation No.70
29 January 2013

Statement regarding the Transfer of Organs and Body of Decease Human Being to Institution of Higher Education

1. Institution which transfers organs or body of deceased human being
(name)

2. Institution of higher education to which organs or body of deceased human being is transferred
(name)

3. Transfers (mark as appropriate):
3.1. organ(s)
		(indicate type of organ(s))
3.2. body of deceased human being

4. Information regarding deceased human being (shall be completed, if the body of decease human being is transferred to the institution of higher education):
4.1. given name
4.2. surname
4.3. personal identity number		-
4.4. number of the death certificate
4.5. date of issue of the death certificate (dd.mm.yyyy)		..

5. Date of transfer (dd.mm.yyyy)		..
time (h.min)		.

6. Notes

7. Representative of the institution, which is transferring the organs or body of a deceased human being

(signature and full name)

8. Representative of the institution of higher education who is receiving the organs or body of a deceased human being

(signature and full name)

Note. The statement shall be drawn up in two copies.

Minister for Health I.Circene

 

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Translation © 2015 Valsts valodas centrs (State Language Centre)