Regulations on the quality and safety of human organs intended for transplantation (regulation on human organs to transplant) Date-2015-12-07-1401 Ministry health and Human Services Department published in 2015 clips 13 entry into force 01.01.2016 last modified the Change applies to Norway Pursuant law-2015-05-07-25-section 4, law-2015-05-07-25-section 6, law-2015-05-07-25-section 17, LAW-1984-03-30-15-section 7, LAW-1994-08-05-55-section 4-4 Announced at 08.12.2015. 15.15 short title Regulations of human organs to transplant the legal authority: established by the Ministry of health and care services 7. December 2015 under the legal authority of the Act 7. may 2015 Nr. 25 about the donation and transplantation of organs, cells and tissues (transplantasjonslova) section 4, section 6 and section 17, law 30. March 1984, Nr. 15 about State oversight of health and Human Services service and more (health supervision) section 7 and Act 5. August 1994 no. 55 on protection against infectious diseases section 4-4.
§ 1. Purpose Forskriftens purpose is to secure a strong protection of human health through quality and safety standards for human organs intended for transplant to humans.
§ 2. Scope the regulation applies to the donation, testing, characterization, cashout, preserve, transport and transplantation of human organs intended for transplantation.
The regulation does not include the humane bodies that are only used in the research.
§ 3. Definitions 1.
Serious unwanted event: any unintentional or unwanted event related to any step in the chain from donation to transplantation, that could lead to the transmission of infectious diseases, death or a life-threatening or disabling condition or disability in patients, or that triggers the disease or prolongs the needs for hospital stay.
2. serious side effect: an unintended response, including infectious disease, related to any step in the chain from donation to transplantation that is fatal, life-threatening, disabling or cause disability, or that triggers the disease or prolongs hospital stay at living donor or recipient.
3. Donation: liberation of human organs for transplant to humans.
4. The Donor hospital: a business approved for the selection of donors, testing, and characterization of the donor's organs as well as the safeguarding of the donor until the withdrawal of the bodies.
5. The Donor: a person who emits one or more organs to the transplant, regardless of whether the avgivelsen happens while the competent person is alive or after the person's death.
6. Donor: collection of the characterization information about the donor is required to assess the suitability as a donor, to conduct a thorough risk assessment, minimize the risks for the recipient and to ensure an optimum allocation of organs.
7. European organ Exchange organisation: a public or private non-profit that operates with the exchange of bodies at national level and across national borders, where most of the country is a member of the EU or the EEA.
8. Receiver: a person who receives one or more organs by transplant.
9. Body: a differentiated and vital part of the human body, consisting of different tissue that maintains its structure, blood supply and capacity to develop physiological functions with an important level of autonomy. A part of a body be considered also as a body if its function to be used for the same purpose as the entire organ in the human body and maintain the requirements of structure and blood supply.
10. Body characterization: the collection of information about the body that is required to assess its suitability, to conduct a thorough risk assessment, minimize the risks for the recipient and to ensure an optimum allocation of organs.
11. Preserve: activities that will be implemented with the aim of preventing or delaying the biological or physical deterioration of the bodies from the uttaking to the transplant.
12. Transplantation: process that intends to restore the specific features in the human body by transferring an organ from a donor to a recipient.
13. Transplantasjonsvirksomhet: a business approved for withdrawals, preserve, transport and transplantation.
14. Traceability: the ability to locate and identify an organ for transplant on a each step in the chain from donation to transplantation or kassasjon, among other things, a) identify the donor and the donor's Hospital, b) identify the recipient (s) by transplantasjonsvirksomhet (s), c) locate and identify all relevant non-personally information about products and materials that come into contact with the body.
15. withdrawals: process in which human bodies taken out of the donor and made available for transplant.
16. national management service for organ transplantation: national management service approved by the Ministry after regulation 17. December 2010 No. 1706 for approval of hospital, the use of the term University Hospital and national services in the specialist section 4-1.
§ 4. The approval of the donor hospital and transplantasjonsvirksomhet selection and testing of the donor, the characterization of the donor and organ, outlet, preserve and transport of organs for transplant and transplant can only take place at the businesses that are approved by the Health Agency for this type of business.
It should be stated in the approval which tasks the appropriate business can perform.
Approval can only be given when the business meet the requirements arising from this regulation. Health Agency can attach further conditions to the approval.
Health Agency to lead a publicly available register of approved donor hospitals and transplantasjonsvirksomheter. It should be disclosed in the registry which tasks the donor hospital and transplantasjonsvirksomheten can perform.
§ 5. Annual report business that has approval under section 4 shall, within 1. April each year to report their activities to the Health Directorate. The report will inform on the number of living and deceased donors and the type and number of organs that are issued, transplanted, scrapped and exchanged with the EU and EEA Member States and third countries.
Norwegian Directorate for health will be on the basis of the reports draw up an annual report of activities. The report will be publicly available.
section 6. The staff's expertise Selection of donor, testing and characterization of donor and bodies intended to transplant into people, and uttaking, preserve, transport and transplantation of such bodies, can only be performed by qualified personnel with adequate and up-to-date expertise.
The business should have suitable training programs for personnel to participate in the tasks referred to in the first paragraph.
section 7. Internal control the businesses to establish an internal control system according to regulation 20. December 2002 No. 1731 on internal control in the health and Human Services service. Internal control system shall include: a) procedures;
-verification of the donor's identity verification of the donor's or relative's consent, etc.., cf. section 9-verification of donor and organ characterization, jf. section 11-uttaking, preserve, packing and marking, jf. section 13 and section 14 the second paragraph-the transport of organs, jf. section 14 the first paragraph-securing the traceability, jf. section 16. The procedures should clearly specify the task and the responsibility relationship between donor hospitals, transplantasjonsvirksomheten and any European organ Exchange organisation-securing the necessary information related to donor and organ characterisation reaches the transplantasjonsvirksomheten in time.
b) eligibility requirements to staff at any step in the chain from the selection of donor to transplant or kassasjon. The requirements must ensure that staff receive adequate training in business and your business's internal control system, including the current procedures and policies.
c) guidelines for continuing education, training and review of changed and new procedures and policies.
d) Instructions and procedures for notification of serious adverse events and serious adverse reactions, cf.. section 18 and section 19.
e) procedures by deviation from the quality and safety standards imposed by this regulation. When such discrepancies are detected, it shall be taken as including surveys documented include the decision about any corrective and preventive measures. Corrective action shall be documented, implemented and implemented effectively and in a timely manner. After that the preventive and corrective measures are implemented, the impact will be evaluated.
Procedures, routines and instructions shall be in compliance with the requirements of the regulations, and are continuously reviewed to ensure that they are kept up-to-date with the current decisions, organizational solutions, etc. It's going to be a historical overview of any changes in procedures, procedures and instructions. The latest version of the procedures, practices, and instructions to be in use and available for healthcare professionals.
To ensure continuous and systematic improvement, it should be released for review and control procedures of the internal control system's efficiency.
The supervisory authority may issue an order on other written documentation if it is required.
section 8. Royalty-free donation any donation of organs should be royalty-free in accordance with the transplantasjonslova section 20. Compensation for transplantasjonslova section 18 is not considered remuneration.
§ 9. Legal withdrawal Withdrawal of bodies can only be done in accordance with the provisions for consent, etc. in the transplantasjonslova section 5-section 7 and section 13.
§ 10. Confidentiality The data manager responsible for the business to make sure that all the information on the donor and the recipient are processed in accordance with the current rules on confidentiality and the treatment of health information.
Anonymity between the parties in the donation process should be ensured in accordance with the transplantasjonslova § 17. Deceased donor's identity should not be made known to the recipient or his family. The recipient's identity should not be made known to the deceased donor's relatives.
It is prohibited to unlawfully acquire information that makes it possible to identify the donor or recipient.
The use of the systems or information in order to trace the donor and recipient for purposes other than to attend to their health or to ensure traceability after this regulation is prohibited.
section 11. The characterization of the organ and donor Donor hospital shall ensure that the qualified doctor, with the relevant education or experience, is responsible for the evaluation of possible donor in partnership with representative from transplantasjonsvirksomheten.
The donor hospital shall ensure that all donors and organs before transplantation issued is characterized by the collection of information as stated in the fifth paragraph.
Health personnel who participate in the donor's characterization of the living donor should make sure to provide all the necessary information. As part of this, health personnel inform living donor in a way that makes them that they understand the implications of the donation, jf. transplantasjonslova section 7 sixth paragraph.
By the characterization of the deceased donor to health personnel seek to provide relevant information about the donor and the donor's relatives issued from bodies or other.
At each donation to the following minimum information be collected: 1. Person unique and unique code for the donor and the individual organ, jf. section 16 the second paragraph 2.
The business in which the withdrawal takes place 3.
Donor type 4.
Blood type 5.
Cause of death 7.
Year of birth or assumed age 8.
Donors earlier or existing intravenous drug abuse 11.
Donors earlier or existing 12 ondartete neoplasia.
The donor's status of infectious diseases 13.
Performed tests for HIV, HCV and HBV 14.
Basic information to evaluate the organets function.
In addition to it after a special medical evaluation and after that it is taken into account for the availability of such information and the current case, obtained the following additional information: 1. The contact information from withdrawal rather than that is needed for the coordination, allocation, and traceability from the donor to the recipient and vice versa.
2. Necessary medical information to ensure proper fit between the donor/agency and the recipient.
Transplantasjonsvirksomhet can make exceptions from the requirements of the information in the fifth paragraph, if after a risk analysis of the current case, including life-threatening emergency situations, considered that the expected benefits for the recipient outweighs the uncertainty arising from incomplete information. In such cases, an organ be considered for transplantation even when not all the minimum information referred to in the fifth paragraph is available.
When the bodies are sent other EU and EEA Member States, where appropriate, third countries, shall provide for the transplantasjonsvirksomheten in Norway that the information related to donor and organ characterization of the receiving country transplantasjonsvirksomheten is copied.
§ 12. Quality and safety requirements related to the living donor and the establishment of regional consent-based health registry living donor should be selected after an evaluation of the person's mental and physical health and medical history of qualified health personnel who have relevant education or experience in such work.
Transplantasjonsvirksomheten to implement all necessary measures to ensure the full protection of living donors so that the quality and safety of organs for transplant can be secured.
The business should have a system for follow-up of living donors.
Oslo University Hospital HF at the national management service for organ transplantation can establish a consent-based registry of living donors. The purpose of the registry is to collect and process health information for the follow up of the donor after the donation, as well as quality assurance and quality development of the characterization and assessment of donor donor, jf. the regulations section 11. All information that is relevant and necessary to reach these purposes can be processed after consent from the donor. Oslo University Hospital HF is the data management responsible for the management of information.
section 13. Quality and safety requirements related to the withdrawal and testing Businesses should make sure that the uttaking of organs is carried out in appropriate premises and in a manner that ensures their quality and safety. The premises shall have the same standard as an operation room and will be operated and maintained by the corresponding standards.
Extracting material and equipment should be handled in a way that takes the necessary attention to relevant national and international regulations, including the rules on sterilization of medical devices.
Tests that are necessary for the characterization of bodies and donors, jf. the regulations section 11, shall be performed in laboratories with the necessary qualified personnel, suitable premises and with suitable equipment.
section 14. Transport business that is approved for the transport of the bodies to make sure that organizations or businesses that are involved in transport have suitable working procedures in order to maintain the quality of the organs under the transport and that transport time is satisfactory.
The transport container should be labeled with the following information:-name, address and telephone number of the business where the body is issued-name, address and telephone number of the business where the organ to be transplanted-text "Human organs", the specification of the organ and "Gently"-popular transport, temperature and location conditions.
Report with the donor and organ shall be sent with the body characterization.
section 15. Security requirements related to the transplant before transplantation initiated, to transplantasjonsvirksomheten to verify that the donor and organ Obervation is documented, jf. section 11, and that the requirements related to the preserve and transport is taken care of, cf. section 13 and section 14.
section 16. Traceability the businesses to be within the confines of applicable law rules on confidentiality ensure that all agencies that should be able to be traced on uttas every step in the chain from the donor to the recipient or kassasjon and from the recipient or kassasjon back to the donor.
Donated bodies to allocate a unique and unique code that ensures the correct identification of each donation, each organ and the recipient of the organ. The donor's name or number shall not be disclosed in the information that follows the body. section 11 the fifth paragraph.
Data necessary to ensure traceability should be kept for a minimum of 30 years after your donation.
In the case of organs are transferred between the EU and EEA countries, and third countries to transfer business information needed to ensure the traceability and the knowledge of any serious adverse events and adverse effects to the recipient country.
§ 17. Register for messages about serious adverse events and serious side effects health services should establish a national register of serious adverse events and serious side effects (message registry for humane agencies) as mentioned in section 18 and section 19.
The registry's purpose is to collect and process data from businesses that handle human organs intended for transplantation in order to contribute to the traceability, quality and safety by the transplant.
Norwegian Directorate for health can only receive and store health information (data set) where the person's name and national identity number is removed. The information is to be stored for a minimum of 30 years.
Health Directorate is responsible for the data processing register.
§ 18. Notification of serious adverse events Serious adverse events that can affect the quality and safety of organ shall immediately be reported transplantasjonsvirksomheten. The same applies where the organs are exchanged under section 21.
The businesses will be according to established routines register and immediately notify the CDC about the serious adverse events that can affect the quality and safety of organ. The message should not contain the patient's name or identity number.
The business is to evaluate the incident to identify the causes in the process that can be prevented. Evalueringens conclusions shall be reported to the Health Agency.
The business will also provide information to the Norwegian Directorate for health about what measures are met for the tracking and eventual withdrawal of other implicated agencies that are distributed for transplant.
§ 19. Notification of serious adverse reactions according to the businesses to established routines register and immediately notify the CDC about serious adverse reactions observed during or after a transplant. The businesses to be in the same way to register and report serious side effects in living donor that can be attached to your donation. The messages should not contain the patient's name or identity number.
The side effects should also be reported between donor hospitals and transplantasjonsvirksomhet, including where the organs are exchanged under section 21.
The business to implement research to identify the causes and any consequences of the side effects. Research conclusions and analysis of cause and consequences shall be reported to the health agency.
section 20. Consent-based registry of recipients and patients on the waiting list for the transplant Oslo University Hospital HF at the national management service for organ transplantation can establish a consent-based health registry with overview of patients on the waiting list for the transplant and of recipients. The registry can only contain information that is relevant and necessary to ensure compatibility between the recipient and the organ. Related to the recipient can register also contain a person uniquely not directly identifiable donor code, cf. section 11 fifth paragraph Nr. 1 and section 16 the second paragraph. Oslo University Hospital HF is the data management responsible for the management of information.
§ 21. The exchange of organs the exchange of organs between Norway and the rest of the EU and EEA Member States and with third countries is permitted when the body can be traced from the donor to the recipient and vice versa, and meet the quality and safety standards as set by this regulation.
§ 22. European Exchange Organization for bodies Health South-East RHF, Oslo University Hospital HF at the national management service for organ transplantation can enter into agreements with European organ Exchange Organisation on the implementation of specific tasks related to the transfer of organs between Norway and the rest of the EU and EEA Member States and with third countries, including databehandleravtale after the personal data Act, section 15. It is a prerequisite that the organization meets the requirements of these regulations that apply to the tasks the Organization to attend.
§ 23. Withdrawal of approval health services may suspend or temporarily revoke an approval if the business is not operated in accordance with this regulation or the conditions set out in the decision under section 4.
section 24. Supervision the State health supervision leads in accordance with the law 30. March 1984, Nr. 15 about State oversight of health and Human Services service and more oversight of the provisions of these regulations is met, including monitoring the exchange of bodies under section 21. By violation of the requirements of the regulations also apply to transplantasjonslova § 23.
The business should make sure that all the necessary information is made available to audit.
Oversight of the businesses performed regularly.
§ 25. Ikraftsetting the regulation will take effect 1. January 2016.