Cabinet of Ministers Regulations No. 70 in 2013 (January 29. Nr. 6 15. §) rules on the use of human organs in medicine, as well as the human organ and the dead man's body using medical studies Issued in accordance with the law "on the dead man's body and human tissues and organs for medical use" in the fourth paragraph of article 4.1, article 12, first paragraph, point 1 and 3, and article 14, paragraphs 1 and 3 General questions 1. determines: 1.1. procedure a What state agency of medicines in the hospital and University, which implements an accredited medical study programme (hereinafter referred to as graduate school), the issue of authorization of the organ and its duplicate, revoke the permission, suspended and renewed its activity; 1.2. the requirements for obtaining the authorization of the use of the organ and the organ in the conditions of use; 1.3. the authorisation of the use of the organ sample form; 1.4. the use of organs of evaluation, monitoring and control procedures; 1.5. organ transplantation procedures, as well as the donor intended for transplantation organ quality and safety standards; 1.6. the order in which the organs, as well as the dead person's body used for medical studies. 2. The terms used in the following terms: 2.1 authorization of organs – a document showing the medical institution or University compliance with the requirements laid down in these provisions and allow the recipient the right to carry out the actions specified in the permit; 2.2. operating procedures-written instructions that describe the use of a particular organ of the process, including the materials and methods used, as well as the expected outcome; 2.3. the donor-a person who donates one or more organs for transplantation, and the person who donates one or more organs or body medical studies for the implementation of the programme of the University, regardless of whether the donation is happening or will happen in the life after death; 2.4. Description of the donor-a collection of information about donors, needed to assess the suitability of the donor organ donation, assess and reduce the risks to the recipient, as well as ensure optimal use organ; 2.5. European organ Exchange organisations, public or private non-profit organization that deals with the exchange of organs in the country and internationally, and in which most of the members are members of the European Union; 2.6. the procurement organisation, medical institution or body or a set of professionals who obtain organs or coordinate their acquisition and with permission of the organ; 2.7. traceability – a collection of actions that enable you to find and identify the organ at each stage in its use from donation to transplantation or disposal, including provide opportunities to identify the donor and the procurement organisation, identify the recipient of the transplant center, as well as locate and identify all relevant information (other than personal information) relating to products and materials that come into contact with that organ; 2.8. serious adverse reaction – not for the living donor or recipient response (including infectious disease), in connection with any use of organs from donation to transplantation and may endanger life, cause or prolong the illness, death, disability or incapacity for work or hospitalisation is required or its extension; 2.9. serious adverse event: any untoward and unexpected occurrence associated with any stage of use of organs from donation to transplantation and may cause infectious disease transmission, cause or prolong the illness, death or endanger life, cause incapacity for work or disability to the patient or which requires hospitalization or prolongation thereof; 2.10. organ – parts of the human body, formed by different tissues, that maintains its structure, trimester may compromise foeto and ability to develop physiological functions in the high level of autonomy, as well as the organ part, if it is intended for use in the human body for the same purpose as the organ as a whole, and if it preserves the structure and trimester may compromise foeto; 2.11. Description of organs – a collection of information about characteristics of the organs, which are required to assess the suitability of organs for transplantation, assess and reduce the risks to the recipient, as well as ensure optimal use organ; 2.12. the acquisition of organs, the organ part of the application process, which results in an organ becomes available for transplantation; 2.13. organ destruction – the final destruction of the organ, if it is not used for transplantation; 2.14. organ preservation – the use of the organ in which uses chemical substances, environmental conditions and other activities to prevent or inhibit the biological or physical deterioration during the period from the acquisition to transplantation; 2.15. the recipient – a person who is transplanted organ; 2.16. the potential donor — a person who is made in the health assessment to find out if the person has no medical contraindications to donation. 2.17. transplantation-a process designed to restore certain functions of the human body during the recipient donor organs; 2.18. the transplant center – medical institution or body or specialist that has permission to perform the transplant and organ transplantation; 2.19. the donation, organ donation, as well as organs for transplantation or body (tissue and whole organ) donation of medical studies. 3. the rules also apply to the transplant process for research use of the organ transplant center, where the organs are intended for transplantation into the human body. 4. the national agency of medicinal products (hereinafter referred to as the Agency) estimates the procurement organisations and transplantation centres, University compliance with the requirements contained in these provisions (including conducting follow-up checks (also extraordinary and unannounced)) (conformity assessment), as well as the supervision of these rules, in that order. 5. the use of Organs in the field of treatment treatment according to the laws and regulatory requirements, monitor and control the health inspection. 6. the requirements laid down in these provisions in the field of protection of personal data, monitor the data State Inspectorate. Data State Inspectorate shall inform the Agency of procurement organisations or transplantation centres found in violation of the laws and facts of physical persons in the field of data protection.
2. the use of organs intended for transplantation in the authorization, suspension and revocation 7. organs intended for transplantation shall be entitled to make use of procurement organisations and transplantation centres that meet the requirements set out in these provisions and have received authorisation to use organs (annex 1). 8. The medical establishment that wants to get permission for the use of the organ, prepays for conformity assessment and authorisation of the laws on public fees of the Agency service price list and submitted to the Agency specified in the following documents: 8.1. hospital's Manager signed submission. The application specifies the following information: 8.1.1. hospital's name, registration number, registered and actual address; 8.1.2. the cooperation with the Agency in charge of the medical treatment person's name and contact information (phone number, e-mail address); 8.1.3. planned use of organs; 8.1.4. proof of compliance with the treatment services regulations on the use of the organ concerned activities; 8.2. a description of the quality system. Description shall include quality manual describing the quality system and specify at least the following information: 8.2.1. procedures; 8.2.2. the guidelines; 8.2.3. staff training and reference manuals; 8.2.4. report form; 8.2.5. donor records; 8.2.6. organ transportation arrangements; 8.3. a copy of the decision on registration of the processing of personal data or a copy of the decision on personal data protection specialist registration data State Inspectorate. 9. the Agency shall examine the application and receive information and, if it is incomplete or does not meet the requirements of this regulation, within 10 working days from the date of receipt of the application, a written request to the medical authority to address deficiencies. The medical establishment eliminates gaps and two weeks from the date of receipt of the request, provide the Agency with information that confirms it. 10. the Agency a month from 8 or 9 of these regulations, paragraph document receipt check the submitted information, find out whether the medical establishment is registered in the medical register of the institutions and meet the minimum requirements for medical institutions and their departments, assesses the compliance of treatment requirements of these regulations relating to the use of organs, and shall take a decision on the authorisation of the use of the organ, or of the refusal to issue a permit. 11. In order to make this provision in paragraph 10 and 19 of the said decision, the Agency official has the right to visit the hospital. The medical establishment supports the Agency's official approach to decision making requires the documentation, premises, equipment, as well as on cooperation with the Agency in charge of medical treatment person's presence during a visit. 12. The decision on the refusal to issue a permit for the use of the organs of the Agency shall be adopted if there was at least one of the following conditions: 12.1 the medical establishment is not made within the time limit under this provision the Agency the information referred to in paragraph 9; 12.2. the treatment of documents submitted contain false information; 12.3. the medical establishment does not meet the requirements of these regulations relating to the use of the organ, and failing to ensure that it is complied with. 12.4. the medical establishment has not been registered in the register of medical institutions; 12.5. the medical establishment does not meet the minimum requirements for medical institutions and their departments. 13. Where a decision has been taken on the refusal to issue a permit for the use of the organ, pay for conformity assessment and authorisation of medical authority will not be refunded. 14. authorization of the use of the organ, the Agency shall indicate what actions regarding the use of organ procurement organisations or transplantation centres shall be entitled to make. 15. If the authorization of the use of the organ is damaged, destroyed, lost or stolen, the procurement organisation or transplant center within three working days to inform the Agency in writing, submitting an application for replacement authorization and payment of a fee for the issue of a replacement authorization legislation for public service charges specified in the price list. The agency within three working days after receipt of the application, be issued by the procurement organisation or transplant center replacement. 16. the Agency shall suspend the authorisation to use the organ if it finds that the procurement organisations or transplantation centres will ensure that these regulations requirements, or if the Agency of data State Inspectorate has received information about the procurement organisation or transplant center found in violation of the laws of the physical person in the field of data protection, and set a time limit for the correction of deficiencies. 17. If the treatment area is suspected of regulatory breaches of the laws of procurement organisations or transplantation centres, the Agency shall inform the health inspection. 18. in order to restore the suspended permit the use of the organ, the procurement organisation or transplant center prepays for the assessment of conformity with the law on the Agency's public service charges specified in the price list and submit the following documents: 18.1. an application for renewal of the authorisation suspended; 18.2. documents certifying that they have rectified the shortcomings, which permits operation suspended; 18.3. personal data protection effectiveness evaluation (audit) results if authorisation suspended due to the data of the national inspection found violations of the laws of the physical person in the field of data protection. 19. the agency within one month of this provision in paragraph 18 of document receipt check the documents submitted, assess the procurement organisations or transplantation centres in conformity with the requirements of these regulations relating to the use of the organ, and if shortcomings are remedied, which permit the use of the organ stopped, shall decide on the renewal of the authorisation. 20. the Agency shall revoke the authorization for the use of the organ, if there was at least one of the following circumstances: 20.1. procurement or transplant center has asked to withdraw the authorisation to use the organ; 20.2. the procurement organisations or transplantation centres violated those rules set quality and safety requirements for the use of the organ; 20.3. the procurement organisations or transplantation centres do not comply with the authorization of the use of these organs; 20.4. the procurement organisations or transplantation centres that rule 16 time limit referred to in paragraph do not resolve shortcomings, which permit the use of the organ stopped; 20.5. the Agency became known that procurement organisations or transplantation centres are excluded from the medical register of the institutions; 20.6. the Agency became known that procurement organisations or transplantation centres do not comply with the legislation on minimum requirements for medical institutions and their departments; 20.7. the Agency became known that procurement organisations or transplantation centres are excluded from the register of personal data processing or procurement organisations or transplantation centres of data protection specialist is excluded from the data protection officer of the register; 12.9. the procurement organisations or transplantation centres shall provide the Agency with false information. 21. the Agency shall set up and maintain a list of procurement organisations and transplantation centres, which have been granted a permit for the use of the organ. Information on permits (procurement organisations or transplantation centres name, phone number, authorized the use of the organ, organ of the operational use of space in the actual address, permit number and date), the suspension of authorisation or cancellation of permit agency within three working days after the decision, the Agency put the website and inform the data state inspection. 22. the Agency's decisions about organ utilization of the authorization or refusal to issue the permit, as well as the suspension of an authorisation or cancellation of procurement organisations or transplantation centres in the Ministry of health can challenge the administrative procedure law. 23. The Ministry of health decision may appeal to the Court of Justice of the administrative procedure law.
3. Procurement organisations and transplantation centres monitoring agency 24. to ensure that these regulations requirements, the Agency shall periodically, but not less frequently than every three years, do the following: 24.1. evaluate procurement organisations and transplantation centres premises and equipment subject to the requirements of this regulation; 24.2. evaluate operational procedures and operations that are performed by the procurement organisations and transplantation centres and equipment subject to the requirements of this regulation; 24.3. measure all notes, operating procedures and activities related to these requirements in these rules; 15.2. evaluate procurement organisations and transplantation centres and the quality of the security system and its compliance with this provision, 37.2, 37.3 37.1...,.,., 37.5 23.4 23.2., 37.7 and 37.9 23.5..., the above mentioned requirements. 25. Procurement organisations and transplantation centres may not change operating conditions without the written approval of the Agency.  26. the Agency has established a reporting system and procedures concerning procurement organisations and transplantation centres reports of serious adverse reactions and serious adverse events according to that rule 68 and 69 points. 27. the Agency shall ensure that a reporting system in which, in accordance with this rule 68 are received information from the procurement organisations or transplantation centres of any serious adverse reactions and serious adverse events and, where appropriate, the results of the investigation, is linked to the reporting system, on which the Agency receives information about serious adverse reactions and serious adverse events associated with the use of tissues and cells. 28. the Agency provides guidance to procurement organisations and transplantation centres, including the collection of important information about the need for a transplant to evaluate the transplanted organ quality and safety. 29. the procurement organisations and transplantation centres to prepare and each year up to June 1 to provide the Agency with a report on activities for the previous year. The report includes information on the living and deceased donors, acquired and transplanted, or destroyed the type and number of organs. The Agency gathers information and reports shall be published on its website. The information obtained by the Agency in the appropriate laws and regulations to the requirements of natural persons in the field of data protection. 30. the Agency shall draw up and every three years thereafter until 27 august the European Commission a summary report on the activities relating to the use of the organ, and the experience gained. 31. the Agency shall provide the other Member States of the European Union and the European Commission information on serious adverse reactions or serious adverse events, as well as by a Member State of the European Union or the European Commission's request to the procurement organisations and transplantation centres who issued permission for the use of the organ, and provides information on the laws of the Republic of Latvia, the requirements for the authorisation of organ and the results of the monitoring activities carried out in connection with these rules that requirements in the use of the organ. 32. the Agency running the European Commission created a network of the competent authorities.
4. the organs intended for transplantation use 4.1 General conditions for the use of organs in All 33. use medical devices in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures are validated, calibrated and maintained according to the intended use, the purpose. Medical equipment, calibration and validation of the technical results of the monitoring. 34. The procurement organization and transplant center staff defined hygiene and the use of personal protective equipment requirements. 35. the use of organs used in medical devices according to their type and intensity of use maintained, serviced, cleaned, disinfected and sterilized according to the laws and regulations concerning minimum requirements for medical institutions and their departments and these activities are documented. 36. in order to ensure optimal use organ procurement organisations and transplantation, the Center supports the use of organs according to immunological criteria. 37. The procurement organization and transplant center has developed a quality and safety system, which covers all the stages of the use of organs from donation to transplantation or disposal, and which have been developed, documented, and implemented the following procedures: 37.1. donor identity; 37.2. living donor consent in writing; 37.3. deceased donor authorization or verification of validity of prohibition or of a deceased donor, the nearest being the prohibition of non-testing pursuant to the law "on the dead man's body and human tissues and organs for use in medicine", as well as the coming of a deceased donor to inform the rights belonging to the deceased during his lifetime expressed the will; 37.4. organ and donor description describes the performance under these rules 40, 41, 42 and 43; 37.5. the organ retrieval, preservation, packaging, labelling and transport in accordance with the provisions laid down in these terms and conditions of use of organs; 23.4. the traceability of the organs under this provision, 66 and 65.67, as well as the procurement organisation, European organ Exchange organisations or transplantation centres of responsibility; 37.7. accurate, fast and reliable reporting of serious adverse reactions and serious adverse events in accordance with the provisions of 68, 69 and 77, as well as the procurement organisation, European organ Exchange organisations or transplantation centres of responsibility; 23.5. serious adverse reactions and serious adverse event management in accordance with the provisions of paragraph 77, as well as the procurement organisation, European organ Exchange organisations or transplantation centres and the duty of determining the procedures under which the procurement organisation, European organ Exchange organisations and transplantation centres shall report to the Agency on management measures regarding serious adverse reactions and serious adverse events; 23.5. staff education and training, which shall include the following requirements: 37.9.1. of qualified personnel is established an organizational structure with detailed obligations, powers and responsibilities, to ensure that the use of organs according to the requirements of these regulations; 37.9.2. personnel have appropriate professional qualifications, in order to ensure the use of organs in accordance with the requirements laid down in these provisions. Annual procurement organisations and transplantation centres manager ensures personnel competence assessment; 37.9.3. staff are provided initial training and professional development to ensure the use of organs in accordance with the requirements laid down in these provisions. Documented staff training programme and assess the competence of staff; 37.10. protection of personal data in the technical and organisational requirements, as well as the evaluation of their effectiveness. 4.2. organ donor selection, getting 38. organ on live organ donors can be a person who has no medical contraindications to donation. Opinion on the State of health of the living donor and organ removal options, assessing their health and medical history, provided the acquisition organization created the doctor konsilij, which is also included in the composition of the transplantation Centre specialist. About organ donations inappropriate recognizes a person whose donation can cause serious health damage. The opinion added to the donor's medical documents (hospital patient medical card (form No. 003/u)). 39. Of dead organ donors can be the person who found or organic brain death. Or organic brain death as death is recorded during the donor's medical documents (hospital patient medical card (form No. 003/u)). 40. in order to assess the suitability of the donor organ donation and organ suitability, assessing and reducing the risks to the donor and the recipient, as well as to ensure optimal use organ procurement organisation shall prepare a description of the donor and the organ. Both the donor and the organ in the description the description shall include the following information: 24.9. hospital's name in which the organ is obtained; 40.2. the donor's type; 40.3. the donor blood type and rhesus; 25.1. the donor's sex; 25.2. the cause of death of the donor (deceased donors); 25.2. the donor's death date and time (deceased donors); 40.7. the donor's date of birth; 25.4. the donor's weight, length; 25.4. is dependence on intravenous narcotic substances used (currently or in the past); 40.10. is not malignant oplāzij (currently or in the past); 40.11. other donor diagnosed earlier portable disease; HIV, HCV and HBV 34.64. test results; 40.13. information organ performance evaluation (specific organ function tests). 41. in the light of the information available, the medical people can make a decision about this rule referred to in paragraph 40 of the replenishment information with the following information: 25.5 24.9. these provisions. referred to treatment services contact information that is necessary for and coordinating organ traceability from donor to recipient and recipient to the donor from; 41.2. demographic and antropometrisk data needed in order to guarantee the compatibility of the donor and the organ with the recipient; 41.3. donor history, particular donor earlier diagnosed with the disease, which can affect the suitability of organs for transplantation, and lead to the risk of disease transmission; 25.7. clinical study data, which need donor physiological, as well as the assessment of the findings about the disease, which is not open to the examination of the donor's medical records, and who can influence the suitability of organs for transplantation, and lead to the risk of disease transmission; 25.8. the necessary data to evaluate the functional characterisation of the organ and to determine any diseases and possible portable contraindications in relation to organ donation; 25.8. Visual evaluation is required to assess the organs intended for transplantation to the anatomical position; 25.9. the donor a lifetime get treatment, which is essential to evaluate the content and function of organs organ donation, especially suitability – the use of antibiotics, inotropisk or support blood transfusion therapy. 42. This provision in paragraph 40 and 41 of that information collection organization of treatment people turn to the donor or the donor is dead, at the nationals or other persons such information may be provided, explaining them in a meaningful way such rapid delivery. 43. If delay with a transplant recipient's life is in danger, the acquisition organization and transplant center can take a decision on the use of organs for this provision before all the information referred to in paragraph 40. 44. The procurement organisation treatment person before obtaining the human life of organ donors informed about: 44.1. organ procurement medical objectives, potential benefits and risks; 44.2. the donor's possible protective measures; 44.3. the donor-type data, data protection and privacy; 27.6. laboratory studies (if performed) and the right to receive the results of the study and their explanations understandable way; 27.7. the need to obtain the consent of the donor before a compulsory organ procurement. 45. This provision of treatment a person referred to in paragraph 44, the information is provided to the donor in an appropriate, clear and easy to understand way and donor acknowledgement of receipt of the information added to the donor's medical documents (hospital patient medical card (form No. 003/u)). 46. The procurement organisation treatment person before living donor organ: 46.1. receive written consent from the donor organ donation. Consent to add donor medical documents (hospital patient medical card (form No. 003/u)); 46.2. testing the donor's identity, on the basis of identity documents; 46.3. ensure that the donor has: 46.3.1., what that rule the information referred to in paragraph 44; 46.3.2. used the opportunity to ask questions and receive answers; 46.3.3. She confirmed that all information provided is true. 47. This rule 46.1. referred to donor consent may be withdrawn at any time up to the organ removal. Written cancellation adds donor medical documents (hospital patient medical card (form No. 003/u)). 48. before obtaining the organ from a deceased donor procurement organisation obtains information from the population register for permission or prohibition of use the donor's organs. If the population register is not a post about the dead man a prohibition or permission to use their organs after death, the use of organs is carried out, pursuant to the law "on the dead man's body and human tissues and organs for use in medicine". 49. The acquisition organization creates, maintains and complements the living donor database in which each donor is created. Case include the following: 49.1. donor's name; 30.6. the age of the donor; 30.6. the donor's sex; 49. the written proof of consent to become organ donors; 30.8. life and disease history; 30.8. health examination results; 49.7. blood group and rhesus; 49.8. clinical and laboratory examination results. 50. The evaluation of each potential deceased donor organ transplant suitability, procurement of treatment of the person shall take into account: 50.1. information obtained in a conversation with a potential donor's closest relatives or the person who knew the donor well, and what is the documentary evidence; 50.2. information obtained in a conversation with a potential donor's family doctor or treating doctor and is a documentary evidence; 50.3. the potential donor's disease history data: 50.3.1. life and disease history; 50.3.2. physical, clinical and laboratory examination results; 50.3.3. the results of the autopsy; 50.3.4. the law "on the dead man's body and human tissues and organs for medical use" in certain conditions for the use of the organ. 51. The evaluation of each potential deceased donor organ transplant suitability, procurement of therapeutic personal takes account of the following criteria to prevent the use of the deceased donors: 51.1. cause of death unknown; 51.2. history of unknown etiology; malignant tumors, 51.3. except for primary basal cell carcinoma and cervical carcinoma in situ, as well as of primary central nervous system tumors; 51.4. prion diseases transmission risk: 51.4.1. diagnosed with variant Creutzfeldt-Jakob disease or variant Creutzfeldt-Jakob disease, as well as family history, not iatrogenic Creutzfeldt-Jakob originating in disease; 51.4.2. history the rapidly progressive dementia or degenerative disease of the nervous system, also unknown etiology; 51.4.3. used in the human pituitary hormones (such as growth hormones)-containing preparations; 51.4.4. the cornea, cīpslen or hard shell brain transplant; 51.4.5. made in neurosurgical operations, for which no potential donor's medical records documentation (there is a possibility that previously made hard brain membrane transplantation); 51.5. bacterial, viral, fungal or parasitic infections, also infected organs intended for transplantation be obtained; 51.6. history or clinical laboratory confirmed HIV infection, acute or chronic hepatitis B (except persons with approved immunity) or hepatitis C and this infection transmission risk or evidence found on this infection transmission risk factors; 32.1. history of chronic, systemic autoimmune connective tissue disease that affects the quality of organs intended for transplantation be obtained; 32.2. the risks of transmissible disease (found in the donor's body view); 51.9. poisoning by chemical substances (lead, mercury, gold, cyanide) which affect the quality of organs intended for transplantation, or get the recipient's health; 51.10. recently, vaccination with live attenuated virus vaccine containing; 51.11. the ksenotransplantācij (still used in preparations). 52. The evaluation of each potential deceased donor (the child's) suitability of organs for transplantation, medical procurement organisation people take into account that the dead children under the age of 18 months and born to a mother with HIV infection, hepatitis B or hepatitis C or who have found the infection transmission risk and who fed with breast feeding for at least 12 months, is not allowed as a donor. The dead child that is born to a mother with HIV infection, hepatitis B or hepatitis C or who have found the infection transmission risk and who is not fed with breast feeding for at least 12 months, allowed as a donor, if the clinical and laboratory tests found that the child does not have HIV infection, hepatitis B or hepatitis C virus infection. 53. prior to the acquisition of potential organ donors organ laboratory inspection: 53.1. antibodies against HIV ½ (anti-HIV ½); 53.2. HBV marker (Ag HBS, anti-HBc); 53.3. antibodies against the hepatitis C virus (anti-HCV-ab); 53.4. antibodies to syphilis agent (positive test, specific active syphilis). 54. This rule 36, 40, 41 and 53 of those laboratory investigations performed in the medical laboratory, which comply with the laws and regulations concerning minimum requirements for medical institutions and their departments. Procurement organisation, in collaboration with the medical laboratory has developed a procedure to ensure that the transplantation Centre in time for receiving these rules 40 and 41 of the laboratory examination referred to in paragraph 1. 55. the organ procurement organisation shall be obtained only in the medical institutions that have laws about the minimum requirements for medical institutions and their departments according to the intensive care unit and operation block. 56. Information about potential donors ' procurement organisation receives from the medical authorities, where a potential donor is located. Information on the treatment of acquisition of the organ donor leave procurement organisations create a specialized Brigade, which has required medical device, preservative solutions, containers for organs, organ removal operation of materials needed, as well as the necessary transport. The team is composed of two doctors (one of them-transplantolog), transplant Coordinator and nurse who according to competency provided or carried out the organ. The work of the team led by a certified transplantolog. 57. A specialised team ensures preservation of organs. 58. Deceased donor organ removal operation removed also: 58.1. tissues and organs imunobioloģisk investigation (spleen and lymph nodes); 58.2. venous blood biochemical, immunological and virological investigation; 58.3. tissue and organ donor specimens for the diagnosis of possible diseases. 59. Deceased donor body appearance after organ procurement updating for the original appearance. 60. the proposed donor organs for transplantation of a specialized Brigade served Mining Organization and draw up legislation on human organ procurement and transfer of Mining Organization (annex 2). Act shall be drawn up in duplicate. One copy to accompany the donor's medical documents (hospital patient medical card (form No. 003/u)) and kept in a medical institution, which obtained the donor's organs, but the second procurement organisation. 61. Transplantation for donor organs transplantation procurement organisations shall, for each of the organ by drawing up legislation on human organ transplantation for transfer (annex 3). Act shall be drawn up in triplicate. Keep one copy in another transplantation Centre adds the recipient's medical documents (hospital patient medical card (form No. 003/u)), and the third store in procurement organisation. 4.3. organ transportation 62. Mining Organization has developed procedures to ensure the integrity of the organ during transport and suitable transport duration. 63. During transport, procurement organisation shall ensure that the following requirements are met: 39.2. organs suitable for organ transport transport the containers that are marked. The labelling shall bear the following information: 63.1.1. news about the treatment, in which the organ was obtained, and the organization-name, legal and actual address and telephone number; 63.1.2. news about the transplant center that organ will be used, the name, the legal and actual address and telephone number (if known); 63.1.3. indication that the tank is an organ, specifying the type of organ and even organs for use in organ stating the location of the body side, and "handle with care"; 63.1.4. the recommended transport conditions, including instructions for keeping the tank into a suitable temperature and position; 39.3. organs, that are transported, accompanied by a description of the donor organ and description. 64. This provision 39.2. the requirements referred to in subparagraph do not apply to cases where the acquisition and transplantation of organs out of one hospital. 4.4. requirements for traceability of the organ and the reporting of serious adverse reactions and serious adverse events 65. to protect the health of the donor and recipient, the acquisition organization and Transplant Center provides all the organs used for traceability from donor to recipient and donor of recipient to. To ensure that the donor identification, each resulting organ assigned identification number. 66. The provisions referred to in paragraph 65 of the traceability system includes: 66.1. donor identification; 66.2. the identification of the procurement organisation; 66.3. the identification of the transplantation Centre; 66.4. organ type and identification; 41.3. their products and material identification, who have been in contact with that organ; 66.6. the identification of the recipient; 66.7. the transplant date. 67. The procurement organization and transplant center to ensure traceability necessary information as well as information about donor and organ description description stored in the quality and safety system. 68. The procurement organization and transplant center is a system in place to be able to report serious adverse reactions and serious adverse events which may affect the quality and safety of organs, and can be linked with organ (also of any serious adverse reactions observed on it during or after use and can be linked to the quality and safety of organs), as well as to investigate and register the following serious undesirable effects and serious adverse events. 69. the procurement organisations have procedures in order to ensure the transplantation Centre and informing the Agency of any suspected serious adverse reactions and serious adverse events immediately after they are placed, as well as to communicate the results of the investigation. Transplant Center has implemented procedures to ensure that procurement organisations and agencies informed of any potential serious adverse reactions and serious adverse events immediately after they are placed, as well as to communicate the results of the investigation. 4.5. Data storage and protection 70. Procurement organisations and transplantation centres provide the organ donor anonymity, as well as the processing of personal data according to the law on the protection of physical persons ' data requirements, including: 70.1. ensure that personal data is handled confidentially and that has made all the necessary security measures to prevent the processing of personal data is not according to the purpose of the processing and protection of personal data against unauthorised access , replenishment, deletion, destruction, loss, alteration or distribution; 70.2. ensure that donors and recipient are not identifiable to any third party, except where the ID is permitted according to the regulations on the physical protection of personal data; 70.3. ensure personal data in compliance with the principles of the quality according to laws and regulations on individual data protection. 71. the procurement organisations and transplantation centres shall ensure that the information on the donor's personal data are not disclosed to the recipient and his relatives, but information about the recipient of the personal data will not be disclosed to the donor and his relatives (except when the donor and the recipient are the closest relations). 72. Data required for donor and recipient for full traceability, procurement and transplantation centres shall be kept for at least 30 years after the donation. Allowed to store information electronically. 4.6. the Transplantation procedure 73. Transplantation centres shall document the acceptance or rejection of the organ. 74. The transplant recipient selection Centre based on immunological and medical criteria. 75. before the commencement of the transplantation transplantation centres shall ensure that: 75.1. organ donors attached to the description and the description of the organs is drawn up according to the requirements of these regulations; 75.2. the organ preservation and transport of organs according to the requirements of these regulations; 75.3. the donor and recipient's immunological compatibility. 76. the transplantation Centre creates, maintains and adds database of organ transplantation, indicating for each recipient and the organ is created. Case include the following: 76.1. organ and identification code; 76.2. the recipient name, surname and personal code; 76.3. the age of the recipient; 76.4. sex of the recipient; 76.5. blood group and rhesus; 47.6. recipient specific diagnosis; 47.7. transplantation date; 76.8. human body side from which of the organ (kidney and lung transplant cases); 76.9. cold ischemia time; 76.10. transplant results; 76.11. complications; 76.12. long-term results. 77. The transplant center has introduced a system for living donor and recipient monitoring, to identify, report and address any events that may be associated with a donated organ quality and safety and security of the recipient, as well as any serious undesirable effects which results in a donation to the donor and the recipient. 78. the Transplantation of organs not used to transplant center, reassigns morphological investigation and draw up legislation on human organ transplantation of non-use (annex 4). Keep the law transplant center. 4.7. the exchanges of organs with other countries. The exchanges of organs with 79 other Member States of the European Union or the European organ Exchange organisations and third countries monitored by the Agency. To ensure the monitoring, the Agency may conclude cooperation agreements with third countries ' competent authorities. 80. the exchanges of organs with other Member States of the European Union or European organ Exchange organisations or third countries, procurement organisation ensure that organs are added to the description of the organs and donors. 81. The exchanges of organs with third countries the Agency shall be allowed only if: 81.1. organs can be traced from the donor to the recipient and the recipient to the donor from; 81.2. organs meet these rules laid down in the quality and safety requirements. 82. the exchanges of organs with the Member States of the European Union or the European organ Exchange organisations, procurement organisation provides: 82.1. organ traceability from donor to recipient and recipient of the donor according to this provision, 66 and 67 65. arrangements referred to in paragraph 1; 82.2. the reporting of serious adverse reactions and serious adverse events. 5. Medical study programmes provided for in the universities and organs of dead human body use the authorization, suspension and revocation of 83. Use organs and the dead man's body in the medical study program graduate is entitled meeting the requirements laid down in these provisions and has received the authorisation to use organs medical study programmes (annex 5). 84. the University seeking to have these rules permit referred to in paragraph 83, prepays for conformity assessment and authorisation of the laws on public fees of the Agency service price list and submitted to the Agency specified in the following documents: the University Rectors signed 84.1. submission. The application specifies the following information: 84.1.1. school name, registration number, registered and actual address; 84.1.2. about cooperation with the person responsible for the Agency name, title, contact information (phone number, e-mail address); 84.1.3. proof of compliance with this provision of the University requirements for organ and the dead man's body using medical study programmes; 52.3. Description of the procedures for its operation, associated with the organ and the dead man's body using medical study programmes. 85. the Agency shall examine the application and receive information and, if it is incomplete or does not meet the requirements of this regulation, within 10 working days from the date of receipt of the application, a written request to the University to address deficiencies. The University prevents gaps and two weeks from the date of receipt of the request, provide the Agency with information that confirms it. 86. the Agency a month from 84. these provisions or paragraph 85 of document receipt check the information submitted, whether the University is registered in the register of educational institutions, assess the adequacy of those rules the University requirements for organ and the dead man's body and decides on the rules referred to in paragraph 83 of the authorization or refusal to issue the permit. 87. In order to make this provision 86. and the decision referred to in paragraph 93, the Agency official has the right to attend University. The University provides access to the Agency's official decision the necessary documentation, premises, equipment, as well as on cooperation with the person responsible for the Agency's presence during a visit. 88. the decision on refusal to issue that rule 83, paragraph permits the Agency takes, if there was at least one of the following circumstances: 88.1. graduate school is not made within the time limit under this provision the Agency the information referred to in paragraph 85; 88.2. University documents submitted contain false information; 88.3. graduate school does not meet the requirements of these regulations relating to the organ and the dead man's body and failing to ensure that it is complied with. 88.4. University is not registered in the register of educational institutions. 89. Where a decision has been taken on the refusal to issue a rule 83, paragraph permits, pay for conformity assessment and authorisation of a University is not refunded. 90. If the rules permit referred to in paragraph 83 is damaged, destroyed, lost or stolen, the school within three working days to inform the Agency in writing, submitting an application for replacement authorization and payment of a fee for the issue of a replacement authorization legislation for public services charges price list specified. The agency within three working days after receiving the application, issue a permit in duplicate to the University. 91. the Agency shall suspend that rule 83, paragraph permissions if it finds that the University does not guarantee that these rules, requirements, and set a time limit for the correction of deficiencies. 92. in order to restore the suspended that rule 83, paragraph permits the operation of University prepays for conformity assessment and authorisation of the laws on public fees of the Agency service price list and submitted to the Agency specified in the following documents: 57.2. an application for renewal of the authorisation suspended; 92.2. documents certifying that they have rectified the shortcomings which permissions the action stopped. 93. the Agency, in the month following that rule 92, paragraph document receipt check the documents presented, evaluated the University's compliance with requirements of these regulations relating to the organ and the dead man's body and, if you have rectified the shortcomings which permit suspended, shall decide on the terms of the authorisation referred to in paragraph 83 of the restore. 94. the Agency rescinded that rule 83, paragraph authorization if there was at least one of the following circumstances: 94.1. University asked to withdraw the authorisation issued to it; 94.2. graduate school does not follow the steps specified in the authorisation; 58.6. these provisions 91 universities. the time limit referred to in paragraph 1 is not prevented, which permits operation suspended; 94.4. Agency become aware that school is excluded from the education register; 94.5. University has submitted false information.  95. Information on this provision issued 83. Permissions referred to in points (a high school name, telephone number, organ and the dead man's body to the place of use, actual address, permit number and date), the suspension of authorisation or cancellation of permit agency within three working days after the decision, the Agency put on the website. 96. the Agency's decisions about this rule referred to in paragraph 83 of the authorization or refusal to issue the permit, as well as the suspension of an authorisation or cancellation of graduate school can be a challenge in the Ministry of health of the administrative procedure law. 97. The Ministry of health decision may appeal to the Court of Justice of the administrative procedure law. 6. Medical study programmes provided for in the universities and organs of dead human body conditions and procedures. The organs and the 98 dead human body uses appropriate study programs. 99. the organs and the dead person's body medical study programmes the University uses the appropriate University developed operational procedures. 100. the University has written in staff and student hygiene and the use of personal protective equipment requirements. 101. the organs of a dead human body or institution of higher education is obtained by drawing up legislation on organ and the dead man's body to transfer to universities (annex 6). Act shall be drawn up in duplicate. One copy is kept at the institution, which has transferred or deceased organ of the human body, but the second University. 102. Organs and the dead person's body kept in a special school laboratory, established operating procedures. 103. The dead person's body stored in dead storage space provided for in the relevant temperature laid down the operating procedures. 104. If the organs and the dead person's body for study process is no longer used, what's bothering them or bury. 7. Medical study programmes provided for in the universities and organs of dead human body 105. monitoring of the use the Agency shall set up and maintain a list of universities which issued the authorisation of organs.  106. in order to ensure that the requirements of these regulations are complied with, the Agency, on a regular basis, but not less frequently than every three years, do the following: 106.1. University premises and assess equipment, subject to the requirements of this regulation; 106.2. measure all notes, operating procedures and activities related to these requirements in these rules. 8. concluding issues 107. Procurement organisations and transplantation centres the provision referred to in paragraph 29 of the report for the previous period for the first time shall submit to the Agency until June 1, 2013. 108. This provision, the Agency referred to in paragraph 30 of the report for the previous period for the first time shall submit to the European Commission by august 27, 2013. Informative reference to European Union Directive provisions included in the law arising from the European Parliament and of the Council of 7 July 2010 the EU directive 2010/53/for human organs intended for transplantation to the quality and safety standards. Prime Minister v. Minister of health I dombrovsky. Cricket is annex 1 of the Cabinet of Ministers of 29 January 2013 the Regulation No. 70 (enhanced small national coat-of-arms of the Republic of Latvia) the State Agency of medicines (legal address, registration number, contact information) the use of Organs permission no ___ ___ ___ Riga medicine State Agency certify that (name of the medical establishment, domicile, place of use of an organ actual address, contact details, the registration number, the registration number in the trade register, medical authorities in the registry) is assessed (s) and comply with the Cabinet of Ministers of 29 January 2013 by Regulation No 70 "rules on the use of human organs in medicine as well as the human organ and the dead man's body to the medical studies use "requirements, and has the right (s) to carry out such operations using organs (mark the appropriate): the extraction of organs (including in donor selection, organ removal, testing, preservation, export, import and transport);   organ transplantation (including the use of the organ transplant process to research, if they are intended for transplantation into the human body).

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The State Agency of medicines (name, surname, signature) Health Minister i. Z.v. Cricket 2. Annex to the Cabinet of Ministers of 29 January 2013 the Regulation No. 70 on human organ procurement and transfer of Mining Organization 1. Hospital's name by which the organs Donor-2 (name) (ID code) Donor code 3 4. fixed on the patient's medical record number 5. biological or brain death determination date (yyyy URdd.mm.).   .      time (URh.min).    6. The Donor's blood group 7. Transplantolog, who even during the (name) (name of the procurement organisation) 8. Surgical method (operations) For the following 9 organ (organ and identification code) 10. organ acquisition date (URdd.mm. yyyy).  .      operation start time (URh.min).  surgery end time (URh.min).  11. The anaesthetist, visit his acquaintance Peteris Klava, who removed organs in the presence of (signature and transcript) transplant procurement organisation Coordinator who passed to the organs (signature and transcript) 13. Operating the doctors: (signature and transcript) (signature and transcript) (signature and transcript) (signature and transcript) 14. Date (URdd.mm. yyyy).  .    . Note the. Act shall be drawn up in duplicate. Health Minister i. Cricket 3. Annex to the Cabinet of Ministers of 29 January 2013 the Regulation No. 70 on human organ for transplantation statement of transfer for the procurement of Human organs Intended for Transplantation 1. Mining Organization name/procurement organization 2. Transplant Center name/Transplantation Centre or procurement organization 3. Donor code/code of the donor's blood group of the Donor/4 Blood group of the donor Organs 5. name and number/name and code of the organ organ cold ischemia 6 start date (URdd.mm. yyyy)/StartDate of cold ischemi (URdd.mm. yyyy).  .    (URh.min)/time (URh.min).  7. The procurement organisation, who passes the Transplant Coordinator organ/transplant coordinator of the procurement organization (the person who hands over the organ) (signature and transcript/name, surname and signature) 8. Transplantation Center representative who takes/Representatives of organs of the transplantation Centre or procurement organization (persons who receive the organ) (signature and transcript/name, surname and signature) the organ transfer date 9 (URdd.mm. yyyy)/Exchange date (URdd.mm. yyyy).  .    . (URh.min)/time (URh.min).  Note the. Act shall be drawn up in triplicate./Note. Statement drawn up in three COPA.
Health Minister i. Cricket 4. Annex to the Cabinet of Ministers of 29 January 2013 the Regulation No. 70 on the use of human organs for transplantation, and not putting the morphological investigation of the transplantation Centre 1 name 2. Donor identification code 3. organ and identification code 4. organ acquisition date (URdd.mm. yyyy).  .    .   time (URh.min).  5. the reasons for non-use Organs Chapter 6 (signature and transcript) the Minister of health I. Annex 5 Cricket Cabinet of 29 January 2013 the Regulation No. 70 (enhanced small national coat-of-arms of the Republic of Latvia) the State Agency of medicines (legal address, registration number, contact information) the use of organs authorized medical study for the implementation of the programme no ___ ___ ___ Riga medicine State Agency declares that (name of the University, registered office, organs and the body of a deceased person's use of the site's actual address , contact information, number of registration in the register of taxable persons, number of registration in the register of educational institutions) is assessed (s) and comply with the Cabinet of Ministers of 29 January 2013 by Regulation No 70 "rules on the use of human organs in medicine, as well as the human organ and the dead man's body using medical Studios ' requirements and are eligible to take the organ (s) and the dead man's body using medical study program (s).
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The State Agency of medicines (name, surname, signature) Health Minister i. Z.v. Cricket 6. Annex to the Cabinet of Ministers of 29 January 2013 the Regulation No. 70 on the organ and the dead man's body transfer University 1. Body organs or the deceased served in the human body (name) school, which for 2 organs or dead human body is passed (name) 3. Transfers (specify the appropriate): 3.1 the organ (s) (specify type (s) of organs) 3.2 a deceased human body 4. information about the deceased person (fill in If the University is transferred to the dead man's body): 4.1 4.2 4.3. surname first name. ID code-4.4. the death certificate number 4.5. death certificate issue date (URdd.mm. yyyy). . . 5. transfer date (URdd.mm. yyyy). . time (URh.min). 6. Notes 7. a representative of the institution shall transmit to the authorities or dead human body (signature and transcript) 8. University representative who receives organs or dead human body (signature and transcript) Note. Act shall be drawn up in duplicate. Minister of health of Cricket.