Regulations on the tapping, testing, processing, storage, distribution and disclosure of human blood and blood components and the management of health information in blood donor registries (blood Regulation) date FOR-2005-02-04-80 Department health and Human Services Department Published in 2005 booklet 2 entry into force 08 February 2005 last modified FOR-2015-12-11-1444 from 01.01.2016 Change applies to Norway Pursuant LAW-1984-03-30-15-section 7, LAW-1992-12-04-132-section 27, LAW-1994-08-05-55-section 2-3, LAW-1994-08-05-55-section 8-4, LAW-1999-07-02-61-section 2-1a, LAW-1999-07-02-61-section 3-3, LAW-1999-07-02-61-section 4-1, LAW-1999-07-02-64-section 4, LAW-1999-07-02-64-section 16 , LAW-2001-05-18-24-section 6, LAW-2001-05-18-24-section 7, LAW-2001-05-18-24-section 8, LAW-2001-05-18-24-section 9, ACT-2001-05-18-24-section 16, LAW-2001-05-18-24-section 17 cf. LAW-2014-06-20-42-section 33 cf. LAW-2014-06-20-43-section 33, law-2003-02-21-12-section 9 Announced 08 February 2005 Directed 10.05.2013 (comments edited) short title Blood regulation Chapter overview: Chapter 1. Introductory provisions (§ § 1-1-1-5) Chapter 2. Authentication and Organization (§ § 2-1-2-5) Chapter 3. Traceability, hemovigilans, quality and safety for blood and blood components (§ § 3-1-3-12) Chapter 4. Information to blood donors and management of health information in blood donor records (§ § 4-1-4-9) Chapter 5. Final provisions (§ § 5-1-5-7) Attachment in the criteria for the selection of blood donors, jf. section 3-8 Annex II-quality and safety requirements for blood and blood components, jf. section 3-10 Appendix III-Storage of blood and blood components, jf. § 3-12 Appendix IV message about serious side effects, jf. § 3-4 Appendix V-notification of serious adverse events, cf. section 3-5-annex VI Standards and specifications to a quality management system, cf. § 2-4 Comments to some of the provisions of the regulations the legal authority: Provided by URkgl.res. 4. February 2005 under the legal authority of the law 30. March 1984, Nr. 15 about State oversight of health and Human Services service (health supervision) section 7, law 4. December 1992 No. 132 of medicines etc. (medicines Act) § 27, Act 5. August 1994 no. 55 on protection against infectious diseases section 2-3 fourth paragraph and section 8-4, law 2. July 1999 No. 61 about the specialist and more (specialist health service Act) § 2-1a 7th paragraph, section 3-3 seventh paragraph and section 4-1 the second paragraph letter a, law 2. July 1999 No. 64 on health personnel, etc. (helsepersonelloven) § 4 fourth paragraph and section 16 the second paragraph, law 18. May 2001 No. 24 on health records and the treatment of health information (Health Registry Act) section 6 section 7, third paragraph, second paragraph, section 8 subsection cf.. fourth paragraph, section 9 the second paragraph, section 16 fourth paragraph and section 17, third paragraph, and law 21. February 2003 No. 12 about biobanks (biobankloven) section 9 the second paragraph. Promoted by the Ministry of health and care services.
EEA EEA referrals: annex II, chap. XIII Nr. 15u (Directive 2002/98/EC), Nr. 15 Volts (Directive 2004/33/EC, amended by Directive 2011/38/EU and directive 2014/110/EU), Nr. 15va (Directive 2005/61/EC) and no. 15vb (Directive 2005/62/EC).
Changes: modified by regulations 6 april 2005 Nr. 297, 22 Dec 2006 Nr. 1577 (announced in its entirety after the changes), 16 Dec 2011 No. 1396, 26 Oct 2012 No. 991, 17 jan 2013 No. 61, 28 nov 2014 Nr. 1488, 11 Dec 2015 Nr. 1444. Corrections: 18.02.2005 (comments added), August 6, 2009 (infection protection law referrals), 10.05.2013 (comments edited).

Chapter 1. Preliminary provisions section 1-1. Purpose Forskriftens purpose is to ensure a high level of protection for blood recipients and donors, including to prevent the transmission of infection and safe security and quality of human blood and blood components regardless of the scope of the purposes.

§ 1-2. Scope the regulation applies to bottling and testing of human blood and blood components regardless of the scope of the purposes. The regulation applies on for processing, storage, distribution and disclosure of human blood and blood components, if the application purpose is transfusion. The regulation does not apply to ordinary blood test taking.
The regulation also applies to the management of health information in blood donor records and in hemovigilanssystemet.
For transfusjonsenheter only applies to the requirements of the regulations § 2-3, section 2-4, section 3-1, section 3-2, section 3-4, section 3-5, section 3-11, section 3-12, § 4-8 and § 5-1 to § 5-7.
The regulation does not apply to stem cells.

§ 1-3. Relationship to other regulations For medical devices used in connection with activities as mentioned in section 1-2 the first paragraph, apply to the requirements of the Act 12. January 1995 No. 6 If the medical equipment and regulations 15. December 2005 Nr. 1690 on medical equipment.
For human blood that is used for the manufacture of medicinal products, shall apply the rules of the Act 4. December 1992 No. 132 about drugs, etc. with the regulations.

section 1-4. Definitions in this regulation be understood with: 1. Apheresis: a method to tap one or more blood components by computer processing of blood, while the remaining blood components is given back to the blood donor during or at the conclusion of the process, 2. serious side effect: any unintended response in donor or blood recipient that occurs in relation to the donation or transfusion of blood and blood components, where the response is fatal , life-threatening, disabling, involves the inability, or causes or prolongs hospital stay or disease state, 3.

serious unwanted event: any unwanted event that occurs in relation to the tapping, testing, processing, storage, distribution and the provision of blood and blood components, where the event either leads to death or is life-threatening, disabling, or involves the inability in the patient, or causes or prolongs hospital stay or disease state, 4. autologous donation: blood or blood components tapped from an individual with the sole purpose autologous transfusion or other uses for the same dealer ,

5.

autologous transfusion: transfusion in which the donor and the recipient are the same person, and it is applied forhåndstappet blood or blood components, 6. rejection: the suspension of a person's fitness to donate blood or blood components, either permanent or temporary, 7. blood: whole blood drained from a donor and processed either for transfusion or for use in further processing, 8. blood bank: any structure or device that is responsible for any part of the bottling and testing of human blood and blood components , regardless of the scope of the purpose, and for the processing, storage, distribution and disclosure when the purpose is transfusion. Transfusjonsenheter are not covered by the definition, 9.

blood component: a therapeutic constituent of blood (erythrocytes, leukocytes, trombocytter, plasma) processed by different separasjonsmetoder, 10.

blood product: any therapeutic product where human blood or blood components are included, 11.

distribution: task in which blood or blood components are delivered to other blood banks, transfusjonsenheter, or other supplier of blood products. The activity does not include the actual dispensing of blood or blood components for transfusion, 12.

erythrocytes portrayed by Apheresis: erytrocyttene from a erytrocyttaferesetapping. Must be added before saving erytrocyttene additive solution and product must leukocyttdepleteres if leukocyttdepletering not included as part of the afereseprosedyren, 13.

erythrocytes, leukocyttdepletert, in additive solution: erytrocyttene from a single blood donation, from which a large proportion of the plasma from the draining and leukocytes are removed. It's added a business-/preservation resolution, 14.

release of blood component: the operation to ensure that a blood component can be released from quarantine, through the systems and procedures that will ensure that the end product is in compliance with the requirements that are set to the current blood product, 15.

friskfrosset plasma: plasma from a blood donation or plasma tapped by Apheresis, frozen and stored within 8 hours after the draining, 16.

whole blood: a regular blood donation, 17.

good practice: all elements in established practice that collectively will result in that blood or blood components systematically meet predefined specifications, and is in accordance with the prescribed rules, 18.

granulocytes, Apheresis: a concentrated granulocyttsuspensjon portrayed by Apheresis, 19.

hemovigilans: a collection of organised surveillance procedures to detect serious adverse reactions and serious adverse events with blood donors and blood recipients, as well as the epidemiological follow-up of donors, 20.

inspection: a formal and objective control of whether the business is run according to the current regulations, 21.

Institutions: businesses where blodtransfusjon is performed, eg. hospitals, nursing homes, clinics, manufacturers and research institutions in which biomedical blood and blood components can be delivered, 22.

The IT-based system: a system that includes the entry of data, electronic processing and the output of the information used for reporting, automatic control or documentation, 23.

quarantine: physical isolation of blood components or received materials/reagents over a variable period of time pending verification, release or rejection of the blood components or incoming materials/reagents, 24.

kryoprecipitatdepletert plasma to transfusion: the rest of the unit friskfrosset plasma after the kryopresipitatet has been removed, 25.

kryopreservering: extended shelf life of blood components by freezing, 26.

kryopresipitat: a plasma component from friskfrosset plasma by precipitation of proteins after freezing/thawing and subsequent concentration and resuspensjon of the they precipitated proteins in a small amount of plasma, 27.

qualification: as part of the validation that involves control of the staff, premises, equipment, or material works as intended and produce the expected results, 28.

quality control: a part of a quality management system that has the purpose to ensure that quality requirements are met, 29.


quality assurance: all activities from tapping to disclosure of blood, whose purposes to ensure that blood and blood components are of the quality required for the intended purposes, 30.

quality management: concerted activities to guide and control a blood bank with regard to quality at all levels within the enterprise, 31.

quality management system: organizational structure, responsibilities, procedures, processes and resources for the implementation of quality management, 32.

leukocyttdepleterte poolede trombocytter fraksjonering: a manufactured by concentrated suspension of trombocytter portrayed by treatment of blood units and pooling of trombocyttene from the portions during or after separation, and from which the leukocytes are removed. Trombocyttene is suspended in additive solution or plasma, 33.

leukocyttdepleterte trombocytter, Apheresis: a concentrated suspension of trombocytter portrayed by Apheresis, and from which the leukocytes are removed. Trombocyttene is suspended in additive solution or plasma, 34.

mobile device: a temporary or movable device used for tapping of blood and blood components, and which is located in a place that is outside of the blood bank, but under its control, 35.

Plasma: the liquid part of blood, which blood cells are suspended in a Plasma can be separated from ... blood cells in a blood donation to the therapeutic use as friskfrosset plasma or further processing. It can be used to manufacture drugs or to a storage medium for trombocytter. It can also be applied to the resuspensjon of the erythrocytes to the utskiftningstransfusjon or perinatral transfusion, 36.

processing: any step in the treatment of a blood component that performed between tapping of blood and the provision of a blood component, also known as component creation, 37.

written procedures: controlled documents that describe how specific tasks to be performed, 38.

specification: a description of the criteria that must be met in order to achieve the quality standards required, 39.

traceability: the ability to identify each device blood or blood component from the donor to its final destination, whether it is the voice of a recipient, a drug manufacturer, or other purposes, and vice versa, 40.

standard: they claim that forms the basis for comparison, 41.

statistical process control: a quality control method of a product that builds on a process of analysis of a sufficient number of samples, without it being necessary to test each product be, 42.

traceback: the process of investigating a report of a suspected transfusjonsrelatert side effect in a patient to identify a potentially implicated donor, 43.

transfusjonsenhet: hospital unit that stores, giving out and that can perform forlikelig hot testing of blood and blood components for use in the hospital's own patients, 44.

Disclosure: the delivery of blood or blood components from a blood bank or a transfusjonsenhet for transfer to the recipient, 45.

validation: provide the documented and objective evidence that the predefined requirements for a particular procedure or process can be met consistently, 46.

causation: the likelihood of a serious side effect of a recipient can be attributed to a transfundert blood unit or blood component or that a serious side effect from a donor can be attributed to the donor process.

section 1-5. Voluntary and royalty-free blood donation blood donation should be voluntary and royalty-free.
Blood banks to obtain the written consent of the donor for bottling and testing of blood and blood components, as well as for the management of health information in blood donor registry. It must be obtained specifically consent to that blood and blood components and health information to be used for research.

Chapter 2. Authentication and organization section 2-1. Requirements for approval of blood banks, terms, recall etc. Bottling and testing of blood and blood components can only take place at the blood banks that are approved by the Health Directorate. The same applies to the processing, storage, preparation and distribution of human blood and blood components where the purpose is transfusion. Health Agency can attach conditions to the approval. Health Directorate to register the information the Agency receives, according to the second paragraph.
Application for approval under subsection should contain all the necessary information for health services to be able to assess if the approval can be granted, including: 1. the name and address on the blood bank (identification), 2.
name, address and qualifications to the blood bank's head and, optionally, the one that has the daily responsibility to fulfill his or her duties, 3.
Overview of transfusjonsenheter as blood bank supplies, 4.
a description of the internal control system, cf. section 2-4, which at least include: 4.1.
Overview of how your business is organized (organization chart), 4.2.
Overview of liability and regulatory conditions, 4.3.
Overview of the company's reporting structure, 4.4.
Overview of facilities and equipment, 4.5.
the number of staff and their qualifications, 4.6.
provisions concerning the blood donor recruitment and selection, 4.7.
provisions concerning the tapping, testing, processing, preparation, distribution, disclosure and recall of blood and blood components, 4.8.
provisions for reporting and recording of serious adverse reactions and serious adverse events, 4.9.
hygiene provisions, 4.10.
provisions regarding the management of health information in blood donor records.

A blood bank can not make material changes in the business without prior written approval from the Norwegian Directorate for health.
Health Agency may withdraw the approval, if the blood bank is not operated in accordance with the requirements set out in this regulation or the terms set out under subsection third period.

section 2-2. Responsibility in blood banks the blood bank's owner is responsible for the blood bank have the necessary approval. Blood Bank's owner is responsible for the health services will be referred to the all information necessary to be able to assess whether approval should be given. Blood Bank's owner should inform the Agency immediately by changes in the blood bank's management, permanent or temporary.
Blood Bank's leader has responsibility for that every unit of blood and blood components have been tapped and tested according to current regulations, regardless of the scope of the purpose, and processed, stored, distributed and dispensed according to the regulations when the blood products to be applied to the transfusion. Blood Bank's leader has further responsibility for the requirements for blood banks in section 2-3, section 2-4, § 2-5, section 3-1, section 3-4, section 3-5 and § 3-11 are met.
Blood Bank's head should have higher education in medicine or biology and at least two years of practice from the relevant subject area upon completion of education.

§ 2-3. Competence requirements of staff in blood banks and transfusjonsenheter-Tapping, testing, processing, storage, distribution and the provision of blood and blood components according to this regulation can only be performed by staff who have received adequate training and is qualified for it, cf. Annex VI.

§ 2-4. Internal control blood banks and transfusjonsenheter shall establish internal control to ensure that the business is planned, organized, carried out and maintained in accordance with the rules set out in the Act and the regulations. Internal control should be adapted to the nature of business, activities, size and risk conditions to the extent that is necessary to comply with the requirements, as well as the standards and specifications as follows from annex VI.
Internal control should be documented. The written documentation to among other things, for the blood banks include: 1. Overview of how your business is organized, 2. Overview of the number of staff and their qualifications, 3. Overview of the responsibility-and regulatory conditions, 4. Overview of the requirements, rules and guidelines that apply to your business, including: 4.1 hygiene provisions, jf. Annex VI.

4.2 provisions concerning blood donor recruitment and selection, jf. section 3-8 and annex VI.

4.3 provisions concerning the tapping, testing, processing, storage, distribution and disclosure as well as recall of human blood and blood components, jf. Annex VI.

4.4 requirements for blood donor registers in pursuance of forskriftens Chapter 4 and health registry law § 17, 5.
routines to ensure business compliance with requirements, including procedures for how the business ensures that employees have sufficient qualifications to comply with the requirements and procedures for notices of serious side effects and serious adverse events, documentation and quality control of health information in blood donor registry and its achievement of the notification to the Data Protection Committee, cf. Health Registry Act section 29, 6.
routines included business if deviations occur and information about who is responsible for follow-up, 7.
routines included business for withdrawal of blood or blood components, which can stand in connection with a serious side effect and serious unwanted event.

8. procedures for systematic follow business monitoring and review of internal control to ensure that it works as intended and contribute to continuous improvement in the business.

The supervisory authority may issue an order of written documentation out over this, if it is considered necessary.

section 2-5. Drafting and storage of blood banks annual report blood banks should prepare annual report for the business. The annual report shall include information on: 1. the total number of active blood donors, 2. the total number of tappings, 3. updated list of the transfusjonsenheter as blood bank supplies, 4. the total number of not spent tappings, 5. number of each component produced and distributed, 6. frequency (incidence) and incidence (prevalence) of transfusjonsoverførbare infectious markers in blood and blood components in blood donors, 7.
the number of recalls of products, 8.
the number of serious side effects comprise established and serious adverse events.


The information referred to in the first paragraph should be kept in at least 15 years.

Chapter 3. Traceability, hemovigilans, quality and safety for blood and blood components section 3-1. The requirements for traceability in blood banks and blood banks transfusjonsenheter and transfusjonsenheter shall ensure that blood and blood components that tapped, tested, processed, stored, released and/or distributed, can be traced from donor to recipient and vice versa.
To meet the requirement of the first paragraph, it should be a system for the identification of each individual tapping of blood and blood components, so that they can be traced back to the blood donor, transfusion and blood recipient. System to uniquely identify each single blood donation and blood component type and the following data: data that is stored by blood banks: 1. identification of the blood bank 2.
Identification of the blood donor 3.
Identification of the blood unit 4.
Identification of each blood component 5.
Date of bottling (day/month/year) 6.
Institutions that receive blood or blood components units, or ultimate destination.

Data that is kept by the transfusjonsenheter and other institutions: 1. identification of the blood component supplier 2.
Identification of blood component 3.
Identification of the recipient who has received blood transfundert 4.
Confirmation of final destination not transfundert blood units 5.
Date of transfusion or other use (day/month/year) 6.
The component's lot number, if it exists.

Information necessary to ensure the full traceability of this provision, to be kept for at least 30 years.

section 3-2. Documentation and registration in the patient Any transfusion of blood and blood components should be documented in the patient's journal in accordance with the regulations on the patient. In addition, the recorded time of transfusjonen and identification of each single blood unit or blood component.

section 3-3. Hemovigilanssystemet to get an overview of the serious side effects and serious adverse events in recipients of blood and blood donors, it should be established a national registry, hemovigilanssystemet.
The purpose of hemovigilanssystemet is to collect and process data from blood banks and tranfusjonsenheter about serious side effects and serious adverse events in order to: 1. provide the basis for the monitoring of transfusjonstjenesten 2.
provide the basis for quality assurance, development and overall management of the transfusjonstjenesten 3.
support sporbarhetssystemet and the obligation to withdraw blood and blood components that can be associated with serious side effects and/or serious adverse events.

Health Directorate is responsible for the data processing hemovigilanssystemet.

section 3-4. Documentation and notification of serious side effects in the recipient of blood and blood components Institutions should immediately report any suspected serious side effects in the recipient during or after the transfusjonen that can be attributed to the blood or blood component's quality or safety to the blood bank, or if the wrong blood or blood component is transfundert.
Blood Bank to verify the information as soon as they are received and to notify them to the hemovigilanssystemet. The message about the information going to happen on the special form set by the Health Directorate, cf. Annex IV, part A, B, and c. the Directorate for health may decide that in the reporting shall be made electronically according to the stipulated standards.
Health trust or other entity that is responsible for the business as stated in the first and second paragraph has responsibility for duties as mentioned are met and shall ensure that there are procedures to ensure this.
It will be shown by the way to notify the duty of the County Governor concerning the significant personal injury in the specialist health service law § 3-3.

§ 3-5. Documentation and notification of serious adverse events that can affect the quality and safety of blood and blood components blood banks and transfusjonsenheter will ensure that serious adverse events in connection with the tapping, testing, processing, storage, distribution, and transfusion of blood, which can be attributed to blood or blood komponenters quality and safety are recorded.
To identify the reasons that may prevent such events to the events under investigation as soon as possible, as well as be corrected to reduce the risk of new events. The events should then be reported to the hemovigilanssystemet on the particular form set by the Health Directorate, cf. Annex V part b. Health Directorate may decide that in the reporting shall be made electronically according to the stipulated standards.
If serious adverse events can pose a danger to other donors and/or recipients than those who are directly affected by the incident, the blood bank immediately to report the event to the hemovigilanssystemet, ahead of the message described in the second paragraph according to annex V part A. or other health trust entity that is responsible for the business as stated in the first and second paragraph has responsibility for duties as mentioned in this provision are met and shall ensure that there are routines that ensures this.
It will be shown by the way to notify the duty of the County Governor concerning the significant personal injury in the specialist health service law § 3-3.

§ 3-6. Annual reporting to the hemovigilanssystemet blood banks to once per year to report the total number of serious side effects and serious adverse events to hemovigilanssystemet. It will be in accordance with the requirements rapporters set out in annex IV part D and annex V part C.

§ 3-7. The withdrawal of blood and blood components Blood Bank should immediately draw back blood and blood components that can be associated with a serious side effect as mentioned in section 3-4, or a serious unwanted event as mentioned in section 3-5. Blood Bank to further describe what measures are met with respect to the other affected blood components that have been dispensed to the transfusion or use as plasma for fraksjonering.

section 3-8. Selection of blood donors blood banks to have the evaluation procedures to ensure that potential blood donors are suitable to donate blood or blood components, jf. the selection criteria in Annex i. The results from such evaluation should be documented, and it shall be given information about any relevant abnormal findings to the blood donor. The evaluation should be carried out by using an approved questionnaire and personal interview.
Before any donation of blood or blood components should be carried out a medical assessment of the donor, including an interview. The survey will be carried out by qualified health personnel, which also will decide to whether he or she is liable to give blood or blood components. It will be shown to the annex VI.

§ 3-9. Testing of the blood donor blood and plasma blood banks will test the responsibility for blood and blood components blood type and infections in accordance with the requirements of the provision here and annex VI.
It should be made following the testing of blood and aferesetappinger, including predeponerte tappings to autotransfusjon:-ABO-type (not required by plasma only to fraksjonering)-RhD-type (not required by plasma only to fraksjonering)-Testing for the following infections in blood donors: hepatitis B (HbsAg)-hepatitis C (Anti-HCV)-Hiv-1/2 (anti-HIV 1/2).

Further testing may be required by specific components or donors or in special epidemiological situations.
Blood and blood components that are being introduced to Norway, should be tested for blood type and infections in accordance with the requirements of the provision here.

section 3-10. Quality and safety requirements for blood and blood components blood banks shall ensure that blood and blood components meet the requirements of quality and safety in Appendix II and VI.

section 3-11. The importation of blood and blood components, traceability requirements in section 3-1 the first and second paragraph apply to blood and blood components blood banks or transfusjonsenheter introduces from a country outside the European economic area.
The requirements of the messages to the hemovigilanssystemet about the serious side effects and serious adverse events pursuant to section 3-4 and § 3-5 and annexes IV and V, apply to blood and blood components blood banks and transfusjonsenheter introduces from a country outside the European economic area.
The requirements in annex VI of the standards and specifications of the quality management system in blood banks apply to blood and blood components blood banks or transfusjonsenheter introduces from a country outside the European economic area.

§ 3-12. Marking, storage, distribution and the provision of blood and blood components blood and blood components to be marked in accordance with the requirements of this provision and stored in accordance with the requirements of Appendix III.
Blood components should be labeled with the following information:-the component's official name-amount of weight/volume or number of cells in the component (depending on what is relevant)-unique numeric or alphanumeric identification of the draining-blood bank's name-ABO-type (not required for plasma intended only to fraksjonering)-RhD-type, either RhD positive or RhD negative (not required for plasma intended only to fraksjonering)-expiration date or time (depending on what is relevant)-storage temperature-name , composition and volume of anticoagulant, if any, and/or additive solution.

The labelling of blood and blood components should be included as part of the identification system under section 3-1 the second paragraph. For blood and blood components for autologous transfusion should the label be provided with an identification of the donor and the warning "autologous transfusion only".
Distribution and the provision of blood and blood components will be in all respects in transfusjonskjeden take place under such conditions that the product's integrity and quality are preserved.
Blood and blood components for autologous transfusions must be stored, distributed and are available separate from blood and blood components for allogeneic transfusion.

Chapter 4. Information to blood donors and management of health information in blood donor registries


§ 4-1. The establishment of blood donor records and purposes blood banks should lead records of blood donors and health information for these (blood donor registry).
The purpose of the blood donor registries is to collect and manage information within the frames of the forskriftens blood and blood donors in Norway to reach the purposes as mentioned in section 1-1, including help to ensure traceability from the donor to the blood recipient and vice versa.

§ 4-2. Prohibition of use information in blood donor records cannot be used for purposes that are incompatible with the purposes for which follows from § 4-1, jf. section 1-1.
Information about individuals that is framkommet by the management of health information under this regulation, cannot be used in the insurance purposes, even if the registered agrees.

section 4-3. Data processing responsible and data processor computing Health entity responsible for the individual blood donor registries that are associated with a health authority.
In blood banks that are not associated with a health authority, is the business data processing responsible, jf. section 2-1.
Data management administrator can enter into written agreement with a data processor on the treatment of health information in the registry.

§ 4-4. General information to blood donors blood banks shall ensure that potential blood donors receive information about: 1. the basic properties of the blood, the procedures in connection with the blood donation, the components that are produced on the basis of blood and aferesetappinger and the major benefits blood donation has for patients.

2. The reasons why it should be made a clinical assessment, be given information about the health and disease conditions and carried out testing of donor blood. By allogene donations to blood donor be informed of the selection criteria for blood donors. For autologous donations shall be stated about the possibility of the exclusion and the reasons for that the procedure will not take place when it may involve health risks for the affected, either as a blood donor or autologous recipient of blood or blood components. It should be stated on the importance of informed consent.

3. Treatment of information in blood donor registries, including the protection of health information, cf. section 4-6.

4. The possibility to withdraw or refrain from giving blood at any time in the process.

5. In what situations people should refrain from giving blood, because it can be harmful to the blood dealer's own health.

6. The reasons why it is important that blood donors blood bank informs about the conditions that can make earlier tappings unfit for transfusion.

7. That the blood bank is obliged to inform the donor in an appropriate way, if the test results may indicate that the donor is sick.

8. That test results that reveal markers for vira such as Hiv, HBV, HVC and other relevant microbiological agenser, that can be transmitted through the blood, will result in that the donor be ruled out, and that the tappede device for destruction.

9. That blood donors have the opportunity to ask questions at any time.

By autologous donations to blood donors, in addition to the information in the first paragraph, get information about: 1. The possibility that blood and blood components will not cover the needs in connection with the intended transfusion.

2. The reasons why unused autologous blood and unused autologt blood components are scrapped and not be used in connection with the transfusion to other blood recipients.

§ 4-5. Registration of information in blood donor registry donor registries shall with the consent from the donor must include the following information about people who want to give, give or have given blood: 1. personal information: 1.1 1.2 names, birth number, residential address municipal 1.3 sporbarhetskode 2.
administrative information: 2.1 2.2 Blood Bank's name date for blood donation 2.3 date of the consent statement 3.
medical information: 3.1 health condition, including diagnoses, diseases, drug use, etc.

3.2 information on the blood (results of the tests referred to in § 3-9 the second paragraph, the results of blodtypeserologiske and virusserologiske surveys, as well as biochemical test answers that are relevant to the various blood components) 2.1 information on the assessment of whether the donor can give and have given blood 3.4 information that emerges from the completed questionnaire, jf. section 3-8.

section 4-6. The management of health information in blood donor registers the management of health information can happen manually or with the use of electronic AIDS.
Within the purposes in section 4-1 and § 1-1 can information from blood donor records be used for drafting of the statistics.
The treatment of information as mentioned in section 4-5, may, unless otherwise provided by this regulation or the special consent of the blood donor, be processed only after the permission of the Data Protection Committee and in accordance with the General rules on confidentiality.

section 4-7. Information security and Data management to data handler responsible through the planned and systematic measures provide for satisfactory information security with regard to the confidentiality, integrity, quality and accessibility of treatment of health information after regulation, cf. Health Registry law section 16.

§ 4-8. Confidentiality Any that treats health information after this regulation, has sworn to secrecy after the health registry law § 15.
Confidentiality after the first paragraph also applies to blood donor's date of birth, social security number, address, municipality of residence and sporbarhetskode.

section 4-9. Storage of health information, rectification, cancellation and blocking of information Health information that is collected to the blood donor registries, to be kept for at least 30 years, unless otherwise provided by this regulation or health registry section 26 or section 28.
Information in the registry may not be requested deleted pursuant to the health registry law section 28 with less blood and blood components at the same time be taken out of the blood bank. The deletion or blocking of information may not be requested when the blood or blood components are used.

Chapter 5. Final provisions § 5-1. Supervision the State's drug works oversees tapping, testing, processing, storage and distribution of blood and blood components for use in fraksjonering, as well as blood components for transfusion until these have been released for use and understand the necessary resolutions, jf. law 4. December 1992 No. 132 about drugs section 28.
State health supervision leads within its area of responsibility audit of tapping, testing, processing, storage, distribution and the provision of blood and blood components for use in fraksjonering, as well as blood components for transfusion until these have been released for use, and with blood components released for transfusion and don't get the necessary resolutions, jf. law 30. March 1984, Nr. 15 about State oversight of health and Human Services service (health supervision).
Supervision of the blood banks will be carried out on a regular basis and at least every two years.

section 5-2. The supervisory authorities ' access to documentation supervisory may require the information needed to carry out their tasks.
The supervisory authorities may as part of its control require access to all sites in the business where blood and blood components are processed, tested, drain, is stored and distributed. The supervisory authorities can carry out the tests or controls as they find necessary, and require the assistance of the staff at the site to the extent that this is necessary to conduct tests or controls.
The right to request information or access to facilities and equipment in accordance with the first paragraph applies notwithstanding the confidentiality. The supervisory authorities have confidentiality about the information they receive under this section in accordance with the applicable provisions on confidentiality.

section 5-3. Exemption health can in special cases give an exemption from this regulation and set the terms for any dispensation. Such a decision must not run counter to obligations of the EEA Agreement.

§ 5-4. Complaint Resolutions hit by Health Affairs pursuant to section 2-1 and section 5-3, decision hit by the State's drug works under section 5-1 the first paragraph and the decision hit by State health supervision under section 5-1 the second paragraph, may be appealed to the Ministry.

section 5-5. Penalty infringement of this regulation or decision hit with legal authority in the regulations is punishable under the provisions of law 4. December 1992 No. 132 about drugs section 31, Act 5. August 1994 no. 55 on protection against infectious diseases section 8-1, law 2. July 1999 No. 64 on health personnel, etc. § 67, law 18. May 2001 No. 24 on health records and the treatment of health information section 34 and the law 21. February 2003 No. 12 about biobanks § 18 second paragraph.

section 5-6. Changes the Ministry may make changes to this Regulation as far as the legal authority of the Ministry of the laws.

section 5-7. Entry into force and transitional arrangements Regulation will take effect 8. February 2005.
Blood banks that were established prior to the entry into force to forskriftens, adapt to the forskriftens requirements within 8. November 2005.

Attachments in the criteria for the selection of blood donors, jf. section 3-8 1. Conditions for the approval of the blood and blood component donors in exceptional cases can a qualified person by blood bank to give permission to some donations from donors who do not meet the following conditions. All such situations should be documented clearly and be in accordance with section 2 forskriftens-4 and section 2-5. The following conditions do not apply by autologous donations. 
1.1. Donor age and body weight age 18-65 years first-time donors over 60 years-on the basis of a judgment made by the blood bank's doctor Over 65 years-with the permission every year from blood bank doctor body weight > 50 kg for blood and aferesegivere 1.2. Hemoglobin level in the blood donor's blood Hemoglobin Women ≥ 125 g/l Men ≥ 135 g/l applies to allogene blood or blood component donors 1.3. Protein level in blood donor's blood Protein ≥ 60 g/l Protein assay for plasmaaferesegivere must be made at least once annually 1.4. Trombocyttnivå of the blood dealer's blood Trombocytter Trombocyttall ≥ 150 x 109/l Nivåkrav for trombocyttaferesegivere


  2. Criteria for the exclusion of blood and blood component donors They with an asterisk (*) selected tests and exclusion periods are not required, if the draining exclusively applied to plasma intended for fraksjonering. 
2.1. Criteria for permanent exclusion of allogene blood donors heart-karsykdom Potential blood donors with an active or past serious cardiovascular karsykdom, except congenital abnormalities with complete healing disease of the central nervous system A sick story with a serious disease of the central nervous system Abnormal bleeding tendency Possible blood donors, who give information about Repeating anamnestiske koagulasjonsdefekt besvimelses fit (syncope) or seizure except staples as a child, or if the donor for at least three years have not taken medication antiepileptisk and have not had a relapse diseases of gastro-intestinal canal or in the genital and urinary system , blood diseases, immune diseases, metabolism diseases, kidney diseases or diseases of the respiratory system Possible blood donors with serious active or chronic illness or severe disease with relapse Diabetes if insulinkrevende infectious diseases Hepatitis B Hepatitis C Hiv-1/2, HTLV I/II Babesiose * Kala Azar (leishmaniasis) * infection with Trypanosoma cruzi (Chagas ' disease) * Malignant disease Except in situ cancer with complete healing Transmissible spongiforme encephalopatier (TSE), (eg. Creutzfeldt-Jakob disease (CJD), variant Creutzfeldt-Jakob disease (vCJD)) people with illnesses in the family which implies that they are at risk to develop TSE, or persons, who have undergone cornea or dura mater transplant, or who have been treated with drugs presented by human pituitary gland. For variant Creutzfeldt-Jakob disease can it is recommended additional precautions Intravenously (IV) or intramuscularly (IM) substance abuse By intravenous or intramuscular abuse of non-prescribed drugs, including muskeloppbyggende steroids or hormones People, who have received a xenotransplantat sexual behavior people because of their sexual behavior is exposed to great risk of getting serious infectious diseases, that can be transferred with the blood of people who have had malaria, people who have had a non-diagnosed febrile illness during your stay in an endemic area or less than six months then, if it Permanently exclusion is not a negative or immunological molecular genomic test 2.2. Criteria for the temporary exclusion of allogene blood donors 2.2.1. Infections: Exclusion duration period After an infectious disease possible donors should be ruled out for at least two weeks after the full clinical healing.
However, applies to the following exclusion periods for those in the table submitted infections: Brucellosis * 2 years after the date of full clinical healing Osteomyelitis 2 years after the date of the confirmed healing Q-fever * 2 years after the date of the confirmed healing Syphilis * 1 year after the date of the confirmed healing Toxoplasmosis * 6 months after the date of the clinical healing Tuberculosis 2 years after the date of the confirmed healing Gout fever 2 years after the date of the cessation symptomenes , if there are not signs of a chronic heart disorder Fever > 38 ° C 2 weeks after the date of the cessation symptomenes flu-like disease 2 weeks after the date of the cessation symptomenes Malaria *-people who in the course of the first five year of life has been living in a malaria area 3 years after returning home from the last visit in the endemic area, provided that the person concerned is still symptom free; exclusion period can nedsettes to 4 months, if an immunological or molecular genomic test is negative at each donation-asymptomatic people, who have been in an endemic area 6 months after departure from the endemic area, unless there is a negative immunological or molecular genomic test Vestnilvirus * 28 days after leaving an area with risk of transfer of vestnilvirus unless an individual nukleinsyretest (NAT) is negative 2.2.2. Exposure to the risk of getting an infection that can be transmitted by transfusion-Endoscopic examination with the application of flexible instruments-accident or mucous membrane contact with the material, which includes blood-blodtransfusjon-human tissue-or germ cell transplantation-major surgical procedure-tattoo or bodypiercing-acupuncture, unless it is exercised by authorized health care professionals and with sterile disposable needles-close contact (same household) of a person, who has hepatitis a Exclusion in 6 months or at 4 months , if there is a negative individual nukleinsyretest (NAT) for hepatitis C people, who because of their behavior or activity are at risk for serious infectious diseases, which can be transmitted through the blood Exclusion after the cessation of risk behavior in a period of time, which depends on the specific disease and the availability of relevant tests 2.2.3. Vaccination Weakened vira and bacteria 4 weeks Inactivated/killed vira, bacteria or rickettsier No exclusion, if well Toksoider No exclusion, if fresh hepatitis A or hepatitis B vaccines No exclusion, if fresh, and if it has affected the exposure Rabies No exclusion, if healthy, and if there is no exposure has occurred. If the vaccination takes place after exposure, ruled out blood donor in 1 year Vaccination against centraleuropeisk encephalitt No exclusion, if fresh, and if it has affected the exposure 2.2.4. Other temporary exclusion Pregnancy 12 months after birth or six months after the abortion.

Less surgery 1 week Tooth treatment Less treatment by dentist or dental nurse-exclusion in 1 day. (NB: Tooth extraction, root treatment and similar are considered "minor surgical procedure")

Medical treatment depending on the nature of medicine who are ordained, its behavior and the disease being treated 2.3. The exclusion in particular epidemiological situations in Particular epidemiological situations (e.g. disease outbreaks) Exclusion in accordance with the epidemiological situation 2.4. Criteria for exclusion of autologous blood donors Serious heart disease depending on the for the draining set clinical parameters people, who have or have had hepatitis B-hepatitis C-hiv-1/2 HTLV I/II Active bacterial infection annex II-quality and safety requirements for blood and blood components, jf. section 3-10 1. Blood components 1. Erytrocyttpreparater 1.1 Erythrocytes, leukocyttdepletert in additive solution made from blood.

1.2 Erythrocytes, leukocyttdepletert in additive solution made from apheresis.

1.3 Blood. Can only be used as a starting material or for technical use.

2. Trombocytpreparater 2.1 Trombocytter from Apheresis, leukocyttdepletert, kept in additive solution.

2.2 Trombocytter from Apheresis, leukocyttdepletert, kept in the plasma.

2.3 Trombocytter from fraksjonering, leukocyttdepletert, poolet, kept in additive solution.

2.4 Trombocytter from fraksjonering, leukocyttdepletert, poolet, kept in the plasma.

3. Plasma preparations 3.1 Friskfrosset plasma, released after quarantine 3.2 Friskfrosset plasma, released after pathogen inactivation 3.3 Friskfrosset plasma, kryoprecipitatdepletert 3.4 Kryoprecipitat 4. Granulocyttpreparater 4.1 Granulocytes, Apheresis Quality and security assessment of new blood components must be carried out by the Directorate for health.
Blood components that are featured in the European Union's directive but not blood, in this regulation can be used only after special approval from the Norwegian Directorate for health. 
2. Requirements for the quality control of blood and blood components 2.1. It will be for blood and blood components exist acceptable results of the following technical quality measurements. 
2.2. It should be made a sufficiently bacteriological control of tappings and production processes. 
2.3. For autologous donations are the precautions that are marked with an asterisk (*), only recommendations.

Components Requirements to quality measurements the required sampling frequency for all measurements is determined by the application of statistical process control acceptable results of quality measurements Erythrocytes in additive solution, leukocyttdepletert Volume is valid for oppbevaringskarakteristika, which can preserve the product within specifications for haemoglobin and hemolysis Hemoglobin * not < 40 g/portion of 1 x 106 Leukocyttinnhold < per unit 0.8% of Hemolysis < erytrocyttmassen at the end of holdbarhetsperioden Trombocytter, leukocyttdepletert, Apheresis Volume valid for oppbevaringskarakteristika , which can preserve the product within specifications for pH Trombocyttinnhold variations in trombocyttinnhold per single donation is allowed within the limits, which are consistent with the approved the production and preservation conditions 1 x 106 Leukocyttinnhold < per unit pH ≥ 6.4 corrected for 22 ° C, at the end of holdbarhetsperioden Trombocytter from blood tappings, poolet, leukocyttdepletert.
The volume is valid for oppbevaringskarakteristika that can save the product within specifications for pH Trombocyttinnhold variations in trombocyttinnhold per pool are permitted within the limits, which are consistent with the approved the production and preservation conditions 1 x 106 Leukocyttinnhold < per pool pH ≥ 6.4 corrected for 22 ° C, at the end of holdbarhetsperioden Friskfrosset plasma Volume Illuminated volume +/-10% Factor VIIIc * average (after freezing and defrosting) 70% or more of the value of the frisktappede plasma portion of Total protein * not < 50 g/l Content of residual cells * Erythrocytes : 6.0 x 109/l < Leukocytes: 0.1 x 109/l < Trombocytter < Friskfrosset 50 x 109/l plasma, kryoprecipitatdepletert Volume Illuminated volume: +/-10%


Content of residual cells * Erythrocytes: 6.0 x 109/l < Leukocytes: 0.1 x 109/l < Trombocytter < Kryopresipitat 50 x 109/l Fibrinogeninnhold * ≥ 140 mg per serving of Factor VIIIc-content * ≥ 70 IU per serving of Granulocytes, apheresis Volume < 500 ml Granulocyttinnhold > 1 1010 granulocytes/leap of Attachment III-Storage of blood and blood components, cf. section 3-12 1.1. Storage in liquid form Component Storage temperature Maximum retention time Erytrocyttpreparater and blood (if it applies to the transfusion as blood) + 2 to + 6 ° C 28-50 days depending on the processes for tapping, processing, and storage Trombocyttpreparater + 20 to + 24 ° C 5 days, but 7 days in combination with techniques to the detection or reduction of bacterial pollution Granulocytes + 20 to + 24 ° C 24 hours 1.2. Kryopreservering Component Storage conditions and retention period is up to 30 years Erythrocytes depending on the processes for tapping, processing, and storage Trombocytter Up to 24 months depending on the processes for tapping, treatment and storage Plasma and kryopresipitat up to 36 months depending on the processes for tapping, processing, and storage Kryopreserverte erythrocytes and trombocytter to be suspended in a suitable medium after defrosting. The maximum allowable retention period after defrosting depends on the applied method.

Appendix IV-Message about serious side effects, jf. § 3-4 part A-quick message format for suspected serious side effects Reporting institution identification of message message date (day/month/year) date of transfer (day/month/year) the recipient's age and gender date of serious side effect (day/month/year) the serious side effect is touching:-whole blood-red blood cells-platelet-plasma-other (refine). 

Side effect (e) s art-hemolysis caused by Immunological conditional ABO-incompatibility-Immunologically conditional due to hemolysis other allo-antibody-non-immunologically conditional hemolysis-Transfusjonsoverført bacterial infection-Anaphylaxis/hypersensitivity-Transfusjonsrelatert acute lung injury (TRALI)-Transfusjonsoverført viral infection (HBV)-Transfusjonsoverført virus infection (HCV)-Transfusjonsoverført virus infection (hiv-1/2)-Transfusjonsoverført virus infection, other (refine)-Transfusjonsoverført parasite infection (malaria) Transfusjonsoverført parasite infection, other (refine)-Post-transfusjons purpura-Transplant-to-host-reaction-Other/other serious reaction (s) (s) (refine). 

Level on the scale for causation (NA, 0-3).

Part B-serious side effects-scale for causation scale for causation for the assessment of serious side effects. 

Level Explanation NOW cannot be considered When there is insufficient data to assess causation.

0 out of the question when it is Unlikely conclusive proof that beyond reasonable doubt shows that the serious side effect is due to other causes.

When the evidence clearly speaks to the benefit of that the serious side effect is caused by different reason than the blood or blood components 1 possible when the evidence can not clarify if the serious side effect is due to the blood or blood components or other causes.

2 likely when the evidence clearly speaks to the benefit of that the serious side effect is due to the blood or blood components.

3 Secure when there is conclusive proof that beyond reasonable doubt shows that the serious side effect is due to the blood or blood components.

PART C-Confirmation format for serious adverse effects Reporting institution identification of message date of receipt (day/month/year) date of serious side effect (day/month/year) confirmation of serious side effect (yes/no) level for causation (NA, 0-3) the change of the serious bivirkningens art (yes/no) If Yes, refine Clinical score (if known)-Full healing-easy sequelae-serious sequelae-deaths.

PART D-Format for the annual report on serious side effects Appendix V-notification of serious adverse events, cf. § 3-5 part A-quick message format for serious adverse events Reporting institution identification of message message date (day/month/year) date of serious unwanted event (day/month/year) Clarification event that can Seriously affect unwanted blood component quality and safety due to discrepancies in: defective product Defective equipment human error else (refine) Thoroughbred tapping Aferesetapping Testing of donor blood Usage Storage Distribution Materials other (refine) part B-Confirmation format for serious adverse events Reporting institution identification of message date of receipt (day/month/year) date of serious unwanted event (day/month/year) Causal analysis (details) Improving measures implemented (details).

PART C-Format for the annual report on serious adverse events Reporting institution reporting period 1. January-31. December (year) total number of processed blood units and blood components: Clarification Serious unwanted event that can affect the blood component quality and safety due to the deviation in: the total number of defective product Defective equipment human error else (refine) Thoroughbred tapping Aferesetapping Testing of donor blood Usage Storage Distribution Materials other (refine) Appendix VI-Standards and specifications to a quality management system, cf. § 2-4 1.
Introduction and general principles 1.1.
Quality management system 1.
The responsibility for the quality people who engage the incumbent all in the blood bank's processes, under a management team that provides a systematic approach to quality, implementation and maintenance of quality management system.

2. Quality management system includes quality management, quality assurance, continuous quality improvement, human resources, facilities, and equipment, documentation, tapping, testing and processing, storage, distribution, disclosure, quality control, blood component recall, and external and internal auditing, contract management, handling of deviations and their own inspection.

3. Quality management system to ensure that all critical processes are specified in appropriate instructions and carried out in accordance with the standards and specifications in this annex. The management should periodically review the system to make sure that it is effective, and if necessary introduce corrective measures.

1.2. Quality assurance 1.
All blood banks and to their transfusjonsenheter in quality assurance work be supported by a quality assurance body, which can be internal or external. This body will be complicit in all quality-related questions, and review and approve all appropriate quality related documents.

2. all procedures, premises and all equipment that affect the quality and safety of blood and blood components, to be validated before it is taken into use and re-validated at regular intervals as a result of the validation results. 

2. Staff and organization 1.
It should be sufficient staff at blood banks to carry out activities related to tapping, control, storage, distribution and the provision of blood and blood components, and staff should be trained and assessed as competent to perform their duties.

2. All staff at blood banks to have ajourførte job descriptions that clearly describes their tasks and responsibilities. Blood banks to impose the responsibility for production and quality assurance in different individuals who perform their tasks independently of each other.

3. All staff at blood banks to undergo basic and secondary education suited to their specific work tasks. The training shall be documented. It should be released tutorials which also includes good practice.

4. The content of the training programs should be evaluated regularly, and the staff's competence should be evaluated regularly.

5. it shall be released written security and hygiene instructions that are adapted to the activities performed, and that is in accordance with the law 17. June 2005 Nr. 62 for a work environment, working time and employment etc. (the Working Environment Act) and regulation 19. December 1997 Nr. 1322 on protection against exposure to biological factors (bacteria, viruses, fungi, etc.) in the workplace. 

3. Premises 3.1.
Public Facilities, including mobile devices, should be arranged and maintained in such a way that they are suitable to the activities performed. They should make it possible to perform the work in logical order, so that the risk of error is at least possible and efficient cleaning and maintenance is facilitated, so there will be at least possible risk of contamination.

3.2. Blood donor area it should be an area for confidential personal interviews with and assessment of individuals to assess their suitability as blood donors. This site should be separated from all other treatment areas.

3.3. Blood tappings to perform site in Blood-tap an area that is designed for safe tapping of blood from blood donors, properly equipped for the first treatment of blood donors who get side effects or damages of the events associated with blood donation, and organised in such a way that the safety of both donors and personnel be ensured and it avoided the draining error.

3.4. Areas for testing and treatment of the blood it should be a dedicated laboratory area for testing that is separate from the blood donor and the area for the treatment of blood components, and with access limited to authorized personnel.

3.5. Storage area 1.
Retention areas to enable the secure and separate storage of different categories of blood and blood components and materials, including materials in quarantine and materials released from quarantine as well as blood units or blood components that is drained after a particular criteria (e.g. autologous donation).

2.

It is going to be hit in the event of measures equipment failure or power failure in the most important retention areas.

3.6. Area for disposal of the waste it should be an area for safe disposal of the waste, disposable materials used by tapping, testing and treatment, and for blood or blood components that are scrapped. 

4. Equipment and materials 1.
All equipment should be validated, calibrated and maintained so it is suitable for the intended purpose. Instruction manuals should be released and relevant documentation are archived.

2. The equipment should be selected so that the danger of blood donors, staff or blood components are at least possible.

3. Only reagents and materials from approved suppliers that meet the requirements and specifications to be used. Critical materials to be released by a person who is qualified to perform this task. If it is relevant, materials, reagents and equipment meet the requirements of regulation 15. December 2005 Nr. 1690 on medical equipment.

4. it should be kept record of the inventory and equipment in a period of time that are accepted by and agreed with the competent authority.

5. If it is applied IT-based systems, software, hardware, and backup procedures are checked regularly to ensure reliability, validated before use and maintained in the validated state. Hardware and software should be protected against unauthorized use and unauthorized changes. Procedure for backing up to prevent loss of or damage to data at expected or unexpected outages or malfunctions. 

5. Documentation 1.
Documents with the specifications, procedures and records of all activities conducted at the blood bank will be released and be kept up to date.

2. The registers shall be legible and can be handwritten, transferred to another medium such as microfilm or documented in an IT-based system.

3. all significant changes in documents to be processed immediately, and they shall be reviewed, dated and signed by a person with the authority to perform this task. 

6.-Tapping, testing and treatment of blood 6.1.
Blood donor's suitability 1.
It should be introduced and maintained procedures for secure identification of blood donors, egnethetssamtaler and egnethetsvurdering. They shall take place before each donation and shall meet the requirements of § 4-4 and annex I of the regulations.

2. Blood donor interview to be carried out in such a way that it secured familiarity.

3. Blood donor's suitability and the final assessment to be signed by a qualified health staff.

6.2. Tapping of blood and blood components 1.
The procedure of blood donation should be designed so that the blood dealer's identity be checked and registered on a secure way, and that the connection between the donor and the blood, blood components and blood samples can be determined clearly.

2. the system with sterile blood bags are used to the tapping of blood and blood components, and the processing of them shall be CE-marked or comply with equivalent standards if the blood and blood components tapped in third States. Blood to let posens number are tracked for each blood component.

3. The procedures for tapping of blood should minimize the risk of microbial contamination.

4. Laboratory samples shall be taken in connection with the draining and should be kept properly before testing is carried out.

5. The procedure used for the marking of evidence, blood bags and laboratory samples with tap number, shall be such that the risk of identification error and confusion be avoided.

6. after tapping to blood bags are handled in such a way that the blood quality, and at a storage and transport temperature appropriate for requirements for further processing.

7. There should be a system that ensures that each donation can be attached to the drain-and fraksjonerings system where the blood drained and/or treated.

6.3. Laboratory investigations 1.
All procedures for laboratory investigations should be validated before use.

2. each tapping should be checked in accordance with the requirements set out in section 3-1 the second paragraph of the regulations.

3. It should be clearly defined procedures to solve cases of diverging results and ensure that blood and blood components that have a repeating reactive result in a serological survey of infection with viraene mentioned in annex IV to the regulation, be excluded from therapeutic use and be stored separately in a thereto set aside environment. To perform satisfactory validation surveys. By confirmed positive results should it meet relevant precautions with regard to donor management, including counseling and follow up of the blood donor.

4. It should be released data confirming the suitability of any laboratory reagents used in the testing of blood and blood components.

5. The quality of laboratory investigations should be considered regular by participation in a formal system for performance testing, such as an external quality assurance program.

6. Blodtypeserologiske research should include procedures for testing specific groups of blood donors (e.g., first-time donors, donors with a history of blood transfusion).

6.4. Processing and validation 1.
All equipment and technical devices to be used in accordance with the approved procedures.

2. The processing of blood components should be performed after appropriate and validated procedures, including measures to avoid the risk of contamination and growth of microbes.

6.5. Marking 1.
All containers should be marked on all the stages of the relevant identity information. If there is a validated IT-based system for status control, should the selection clear distinction between released and not-released units of blood and blood components.

2. The selection system for the tappede the blood, blood components on the intermediate step and finished blood components and trying to uniquely identify the type of content and fulfill the selection-and sporbarhetskravene dealt with in section 3-1 and § 3-2 in regulation. The label of a finished blood component shall meet the requirements in section 3-12 the second paragraph of the regulations.

3. For autologous blood autologt and blood components to the label also comply with section 3-12 and additional requirements for autologous tappings in annex II of the regulation.

6.6. Release of blood and blood components 1.
It should be a secure system which prevents each blood unit or blood component is released before all of the mandatory requirements referred to in this regulation are met. Each blood bank should be able to demonstrate that each blood unit or blood component is formally released by an authorized person. Registers shall before each blood component is released, documenting that all current declaration forms, relevant journals, and the test results meets all the criteria for approval.

2. before release to blood and blood components be kept administratively and physically separated from released (e) blood and blood components. In the absence of a validated IT-based system for status control to the label of a blood or blood component to identify the release status in accordance with point 6.5.1.

3. If the final component is not being released because of confirmed positive result of an infectious, it shall test in accordance with the requirements of point 6.3.2 and 6.3.3 performed a control to ensure that other components from the same bottling and components prepared from previous tappings from the same blood donor is identified. Blood donor registry is maintained shall immediately. 

7. Storage and distribution 1.
Blood Bank's quality management system for blood and blood components intended for the manufacture of medicinal products ensure that the storage and distribution requirements are in accordance with § 3-12 and Appendix III of the regulations.

2. Procedures for the storage and distribution should be validated to ensure the quality of blood and blood components throughout the retention period and rule out the confusion of blood components. All transport and storage activities, including receipt and distribution, shall be defined by written procedures and specifications.

3. Autologt blood and autologous blood components as well as blood components tapped and prepared for specific purposes should be kept separate.

4. There shall be appropriate records of inventory content and distribution.

5. Packaging shall protect the blood and blood components from damage and to ensure that the storage temperature during distribution and transport is maintained.

6. Return of blood and blood components into inventory for subsequent disclosure to be accepted only if all quality requirements and procedures established by the blood bank to ensure blood component integrity are fulfilled. 

8. Contract management tasks that are performed remotely, should be defined in a separate written contract. 

9. Mismatch 9.1.
Variance components differ from the Blood that the standards set out in annex II of the regulation, should be released for transfer only under special circumstances and after written agreement with ordinerende doctor and blood bank's doctor.

9.2. Complaints All complaints and other information, including serious side effects and serious adverse events, which may indicate that it is dispensed blood components with the wrong, should be documented and carefully be investigated with a view to determine the causes of the error. If necessary, blood components should be revoked, and it should be taken corrective actions to prevent recurrence. There should be procedures to ensure that the competent authorities under the corrected about serious side effects or serious adverse events in accordance with regulatory requirements.

9.3. Recall 1.
Blood Bank to have staff with the authority to assess the need for the recall of blood and blood components and to initiate and coordinate necessary action.

2. There should be an effective procedure for revocation, including a description of the responsibilities and actions to be taken. It shall include notification to the competent authority.

3.

It shall, within advance stipulated deadlines get together measures that include the tracking of all relevant blood components and, if relevant, the traceback. The purpose of the investigation is to identify any blood donor that may have helped to cause transfusjonsreaksjonen, and to revoke all existing blood components from that person the donor as well as inform the recipients of the components from the same tapped the giver about it any risk.

9.4. Corrective and preventive measures 1.
There should be a system to ensure that it will hit the corrective and preventive measures if it for the blood components are missing compliance and quality issues.

2. Data to be routinely analyzed to identify quality problems that may require corrective action, or identify adverse trends that may require preventive action.

3. all errors and accidents should be documented and investigated in order to identify system problems so that they can be corrected. 

10. Own inspection, internal audit and improvements 1.
The system should be available for own inspection and internal audits for all parts of the business, so that the correspondence with the standards set out in this annex can be controlled. These controls should be carried out regularly by trained and competent persons in an independent manner in accordance with the approved procedures.

2. All results shall be documented and appropriate corrective action will be taken at the right time and in an effective way.

The comments of some of the provisions of the regulations notes are a guide to elaborate on the contents of some of the provisions of the regulations. The comments are not legally binding. Regulations and notes should be read in context to get the best possible understanding of the forskriftens regulations.
Directive 2002/98/EC of 27. January 2003 about the determination of standards for quality and safety by tapping, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC was incorporated into the EEA Agreement 9. July 2004. To meet the overall requirements of the directive were blood regulation laid down 4. February 2005 with entry into force 8. February 2005 (regulation 4 February 2005 No. 80 regarding the tapping, testing, processing, storage and distribution of human blood and blood components and the management of health information in blood donor records). In addition, the regulations are warranted in the seven health laws and in the EU's enforcement directive Directive 2004/33/EC of 22. March 2004 which was incorporated into the EEA Agreement 11. March 2005.
The directives are complemented by Directive 2005/61/EC of 30. September 2005 with respect to the requirements for traceability and a national system for the notification of serious adverse reactions and serious adverse events and Directive 2005/62/EC by the same date with respect to the community standards and specifications to a quality management system in blood banks. The directives were incorporated in the EEA Agreement 7. July 2006.
It will be shown by the way to the supervisor of transfusjonstjenesten in Norway, 5. Edition published by the Norwegian Directorate for health (ICE-1414, november 2006) that replaces the previous edition of the Guide (IS-1184, June 2004). In the comments to section 3-8 Selection of blood donors and attachment in in regulation, that regulation at certain points is stricter than the Directive 2004/33/EC and annex III to this directive. Beyond what is outlined here, it is forskriftens with the attachment provisions legally binding. Health authorities will continue to work with to get to the discrepancy between the content of the regulations and the Guide for transfusjonstjenesten in Norway.
Furthermore, it appears to the guidelines for GMP (good manufacturing practice) in blood banks that is managed by the State's drug works (published by State health supervision in 1996). These guidelines are, in the main, with the entry into force of the modified regulations 1. January 2007, replaced with the annex VI standards and specifications to a quality management system in blood banks and comments to some of the forskriftens regulations.

To the chapter 1. Initial provisions of section 1-2 business area to the first paragraph of the regulations applies to the tapping, testing etc. of human blood and blood components regardless of whether the scope of the purpose is production of transfusion or drugs. It does not apply for General blood test taking or for tapping of blood in the educational purposes. Example of other application purposes that are covered by the regulation are blood components used as a reagent in various tests. The regulation also applies to blood that is drained in the blood bank, even if the purpose is technical use. Forskriftens provisions do not preclude that outdated blood or blood that can no longer be applied to transfusion because it does not meet the quality requirements, can be used for technical purposes, such as the culture plates.
The regulation establishes a national registry, hemovigilanssystem, and describes the purpose and message to this registry. See also the notes to section 3-3. The regulation is extended to include all steps in the process all the way to the blood is given and received, IE. also disclosure. 
To the third paragraph Transfusjonsenheter is from blood banks in that they are not brave, but only giving out blood and blood components received from blood banks. Transfusjonsenhetene shall not perform other blodtypeserologisk than the testing required for transfusion to the patients that is located in the hospital attached to the transfusjonsenheten. See also the definitions of the regulations § 1-4 No. 8 and 43. 
To the fourth paragraph of the regulation does not apply to blood cells regardless of whether tam, these are collected from the peripheral blood, cord blood or bone marrow. By the way it appears to regulations 7. April 2006 no. 391 on the requirements to quality and safety when handling of cells and tissues. 
To § 1-3 Relationship to other regulations If blood components (see the definition in section 1-4 first paragraph No. 9) are included as raw materials in the production of pharmaceuticals, demands that drug laws set to the production of drugs.
Blood banks covered by the biobanklovens rules on diagnostic biobanks and behandlingsbiobanker. To give blood is considered to be health care after helsepersonelloven section 3, third paragraph, and patient and user rights the law § 1-3 letter c. consent to health care for the patient and user rights the law § 4-1 and § 4-2 also includes the collection, storage and treatment of human biological material, including the use of materials to the prevention, quality control and method development. It will be shown to the biobankloven section 11 the first paragraph. If the material in the blood bank will be used to research, make the rules on forskningsbiobanker followed. Research on material obtained in connection with diagnosis and treatment will as a general rule require voluntary, explicit and informed consent from the donor (biobankloven § 12) and message to the Ministry on the establishment of the forskningsbiobank (biobankloven § 4). If it is possible or very difficult to obtain new consent, the Ministry after application and assessment from the regional Committee for medical research ethics make exceptions from this (biobankloven § 13). The Ministry's authority after biobankloven § 4 and § 13 is delegated to the Directorate of health.

To section 1-5 voluntary and royalty-free blood donation To first paragraph blood donation should be royalty-free for to make sure that donors do not give blood out from economic motives. Provision of towels, bags or similar effects with negligible value, as well as the reimbursement of travel expenses, are not considered to be remuneration in this context. 
To the second paragraph With the consent of the blood donor will mean a voluntary, explicit and informed statement by the registered that he or she would like to give blood and agree to the treatment of health information about themselves, see. Health Registry law § 2 No. 11. Blood Regulation section 3-8 and § 4-4 sets requirements for the information to give blood blood donor banks, and the banks will collect information from blood blood donor. This information shall be given in advance of that consent be obtained. Only consent competent patients, cf. patient and user rights the law Chapter 4, can consent to blood donation. The written consent shall be sought in connection with the collection of information pursuant to section 3-8.

To Chapter 2. Authentication and organization to section 2-1 Requirements for approval of blood banks, terms, recall etc.

For blood banks want the requirement of authentication basically replace the current supplier of permissions from the State's pharmaceutical plant. For the blood banks that also operate with the production of drugs, still applies the system of supplier of permission from the State's drug works as well as approval from the Norwegian Directorate for health.
With the concept of provisioning refers to procedures relating to activities after the blood is processed in various blood components, but before the various blood components are released for use.

To section 2-2 responsibilities in blood banks To the first paragraph in charge of blood banks is in the provision added partly to blood-bank owner and partly to the blood bank's leader. It will be shown, among other things, that it is the owner that entity to apply for, as well as be liable to health when it comes to validation. With owner describes health trust or other legal entity wherein the individual blood bank can be used. Furthermore, it appears that there is blood-bank owner who is obliged to make sure that the blood bank's leader at any time have sufficient expertise. 
To the third paragraph, there are requirements to higher education in medicine or biology and at least two years of practice from the relevant subject area upon completion of education. With higher education refers to education beyond high school.
The requirement of higher education is a minimum requirement. In relation to the blood banks that are largely integrated in sykehusenes medical business in transfusjonssammenheng and/or within the laboratory Diagnostics can be natural that the blood bank's leader's medical professional trained.

To section 2-4 internal control


The references are not exhaustive in relation to other relevant regulations, but is intended as an aid to facilitate the use of the section 2-4 and annex VI.
Blood banks and transfusjonsenhetene is part of the health and human services the service and shall establish internal control and to make sure that business and services are planned, organised, performed, and maintained in accordance with the requirements set out in or pursuant to laws and regulations. Blood forskriftens provisions are examples of such claims. The general duty of internal control in the health and Human Services service emerges from the law 30. March 1984, Nr. 15 about State oversight of health and Human Services service § 3 and regulation 20. December 2002 No. 1731 on internal control in the health and Human Services service. Requirements on internal control for blood donor registers emerges from the health registry law § 17.
Management has the responsibility to follow up on that internal control works appropriately. This includes, for example, the follow up of the system, internal audit, inspection and management's review of internal control's effectiveness.
Blood directive sets the requirements for that blood banks should have quality management system that builds on the principles of good practice. Requirements for the quality management system is considered taken care of through the requirement of professional health and proper care services and the requirement to the internal control system that regulation builds on and annex VI. Internal control is, therefore, the quality management system that caters to government requirements.

To section 2-5 of the Drafting and storage blood banks annual report Of PT 1 it should be apparent how many active blood donors registered in the blood donor registry. With active blood donor will mean a blood donor who has given blood in the last calendar year. It may also be appropriate for blood banks to keep track of donors who are registered, but have not given blood the last calendar year (passive donors). 
To section 2 and 4 the total number of tappings includes successful tappings and failures either because of tappings error tick or for other reasons. 
To section 5 the number of blood tappings that led to the processing of blood components.
The number of successful blood tappings that did not lead to the processing of blood components.
The number of erytrocyttkonsentrater-produced-transfundert-sold to other blood banks/transfusjonsenheter-scrapped due to quality problem-scrapped due to utdatering.

The number of trombocyttkonsentrater-produced-transfundert-sold to other blood banks/transfusjonsenheter-scrapped due to quality problem-scrapped due to utdatering.

The number of units produced-plasma-transfundert as the quarantine plasma transfundert for pathogen inactivation in blood bank-delivered to fraksjonering-scrapped due to quality problem.

To Chapter 3. Traceability, hemovigilans, quality and safety for blood and blood components to § 3-1 requirements for traceability in blood banks and blood banks transfusjonsenheter and transfusjonsenheter to use a kodeverk that makes it possible to meet the requirements of traceability for the provision. Blood donor registry is an important tool to ensure traceability and storage of relevant information about the blood donor, blood and blood components. 
To the third paragraph in addition to brand products with the information which emerges from section 3-12, they should also be printed information on that it must be used with the filter transfusjonssett by transfusjonen.
Point 2. By the use of electronic blood donor form, for example, secure identification when using happen on electronic signature pad.

To section 3-2 documentation and registration in the medical records It appears to helsepersonelloven section 39 and regulations 21. December 2000 No. 1385 of the patient. With the identification of each single blood unit or blood component batch number or other means unique registration.

To section 3-3 Hemovigilanssysteme Directive 2005/61/EC sets the requirement that serious side effects and serious adverse events should be reported and registered.
The first paragraph provides the legal basis for establishing a national registry of serious adverse reactions and serious adverse events in connection with the tapping, testing, processing, storage, distribution, and transfusion of blood and blood components which may affect the blood and blood komponenters quality and safety, a hemovigilanssystem. The legal basis for the register is health registry law section 8 the second paragraph, cf.. fourth paragraph.
Hemovigilanssystemet is to some extent a continuation of the Norwegian system Association of Immunology and transfusjonsmedisin launched in 2003, and how it collects report on respectively. complications of blodtransfusjon and by tapping of blood donors from the blood banks on a voluntary basis, and it is released from this a summary to the community.
If hemovigilanssystemet are maintained as today by that also less serious side effects reported, this must be based on voluntarism and documented on the special anonymous forms so the individual can not be identified. 
To the third paragraph, third paragraph, States that health is the data processing responsible for hemovigilanssystemet.

To section 3-4 Documentation-and report about serious side effects in the recipient of blood and blood components to the second paragraph messages about serious side effects should be reported to hemovigilanssystemet. In practice, this means that the messages in the current blood regulation on serious side effects that can be attributed to blood and blood komponenters quality and safety, not to send the County Governor, but to the newly created hemovigilanssystem under the auspices of the Health Directorate.
Notify the duty of the County after the specialist health service law § 3-3, about the significant personal injury or conditions which could have led to significant injury as a result of the performance from the health and human services the service shall remain in effect on the blood area. This sign the obligation is especially topical for the serious side effects that are not natural can be attributed to blood and blood komponenters quality and safety. 
To the third paragraph with the other entity is meant in this provision such as private blood banks. 
To the fourth paragraph of the fourth paragraph is included for highlighting that there could be messages to both systems. Example of message to the Health Authority in the County after the specialist health service law § 3-3 can be errors that occur in connection with the administration of blood given to patients, as the confusion of blood bags or misidentification of HB answers that will cause the wrong patient gets blodtransfusjon. It can also be wrong by the very transfusjonsprosedyren in terms of use of the equipment, the use of the infusion set which is not intended for transfusions, or that one allows blood go along with other medications in the infusion set without filter.
When it comes to message after specialist health service law § 3-3 to circular appears in-54/2000 of the report to the County doctor about significant personal injury specialist health service law § 3-3-adjustments to the report the scheme.
In addition to the message after specialist health service law § 3-3 also apply to general duties such as unsubscribe notification of patient injury and near-accident in helsepersonelloven § 38, message about side effects from the rekvirenter of drugs, including drugs manufactured by the blood and plasma according to the regulation on medicines section 11-7, as well as provision for notification duty by infection with blood donor after the regulation on messaging system for infectious diseases (MSI-and tuberculosis registry regulations) section 3-7.

To section 3-5-report Documentation and about the serious adverse events that can affect the quality and safety of blood and blood components to the fourth paragraph reference is made to the comments under section 3-4 that also applies to serious adverse events.

To section 3-6 Annual reporting to the hemovigilanssystemet in addition to enroll the obligation of annual hemovigilanssystemet introduced the reporting duty. It's blood banks to report, and forskriftens attachment IV part D and annex V section C regulates the requirements for such reporting.

To section 3-7 withdrawal of blood and blood components Blood Bank shall have an internal control system that ensures this. The system should describe what measures including is hit with respect to other blood components, which is distributed for the purposes of transfusion or application that plasma to fraksjonering.

To section 3-8 Selection of blood donors Blood Banks are using the questionnaire from the Norwegian Directorate for health and personal interview performed by a qualified health personnel collect information about blood donor and blood donor's State of health. The information shall be recorded in the blood donor registry, jf. § 4-5. It will be under section 1-5 the second paragraph be obtained written consent from the donor to the blood donation and to registration in the register, normally going on this, that the blood donor signs on the aforementioned form.
The selection criteria in Annex i to section 3-8 of the regulations correspond mainly with attachment III to Directive 2004/33/EC (enforcement directive). At certain points, however, are the regulations stricter than the directive. This is academically justified and consistent with the previous advice and guidance on the site. This applies to the following points: 1. after point 2.1 in Annex i to the regulation to all people with hepatitis B ruled out permanently as blood donors. The directive allows for people with hepatitis B who are HBsAg-negative and documented immune, can give blood.

2. after point 2.1 in Annex i to the regulation is going to people who have had malaria ruled out permanently. The directive requires only the exclusion for 3 years (without symptoms after treatment cessation).

3.

By point 2.1 in Annex i to the regulation is going to people who have had a non-diagnosed febrile illness during your stay in an endemic area of malaria, or less than six months then, if it's not ruled out permanent is a negative or immunological molecular genomic test. The directive requires only the exclusion in the 3 years after the cessation of symptoms (exclusion period can nedsettes to 4 months, if there is a negative immunological or molecular genomic test).

4. after point 2.2.4 in Annex i to the regulation be excluded women from giving blood for 12 months after birth and for 6 months after abortion (exceptions can be made by a physician). The directive requires 6 month exclusion after both birth and abortion.

When it comes to geographic selection criteria, it appears to the chapter. 2 and annex 4 of the Guide for transfusjonstjenesten in Norway, 5. Edition (ICE-1414, november 2006) from the Norwegian Directorate for health that supersede 4. Edition (ICE-1184, June 2004). The biggest changes apply selection criteria for blood donors who continue to contribute to a high level of protection and prevent the transmission of infection. The changes build on that patient safety should be the main goals at the same time as all geographic exclusion criteria should be able to be defended from the real infection risk. In practice this happens by that world countries be divided into eight groups on the basis of the epidemiological conditions.

To § 3-9 Testing of blood donor blood and plasma in Norway performed the infectious out over the test which emerges from the regulations section 3-9. It will be shown to the chapter 3 of the Guide for transfusjonstjenesten in Norway, 5. Edition.

To section 3-11 importation of blood and blood components the provision regulates the requirements for the import of blood and blood components from a country outside the European economic area. The first paragraph about the traceability is a continuation of the current regulation. The second paragraph about the messages to the hemovigilanssystemet and the third paragraph about the quality management system is new.

To Chapter 4. Information to blood donors and the treatment of information in blood donor records to § 4-1 establishment of the blood donor registry to give blood is considered to be health care after helsepersonelloven section 3, third paragraph, and patient and user rights the law § 1-3 letter c. This implies among other things that a blood donor is to be regarded as a patient, and that the providing health assistance, have a duty to lead the journal for the individual patient after helsepersonelloven section 39 to section 47 and regulations 21. December 2000 No. 1385 of the patient, and that the rules on confidentiality, information, viewing right, correction and deletion etc. come to the application. The obligation of documentation (journal) for each blood donor and blood donation can in ordinary cases are considered to be taken care of through registration in the blood donor registry. If events occur at blood donation (complications of tapping, diseases etc..) that requires documentation beyond this, health personnel must lead in addition to the journal, the information that is recorded in the registry.

To section 4-2 the prohibition of the use Provision prohibits the use of information in the registry for certain purposes.
It is called in the first paragraph that the information in the registry may not be used for purposes that are incompatible with the purpose to the registry as mentioned in section 4-1, jf. section 1-1. The provision follows the natural of the health registry law § 11 third paragraph. The question of the use of the information is incompatible with the purpose must be determined concretely.
In the second paragraph, it follows that the information about individuals, which is framkommet by the management of health information in the registry, cannot be used in the insurance purposes, even if the registered agrees. The ban is important to maintain the people's confidence in the registry. By setting an absolute ban on the use of the information in the insurance purposes does the registered feel the pressure of an insurance company to request access to the registry to be able to provide information to the company as the basis of an insurance contract.

To § 4-3 Data managers and data processor Data processing managers can for Health Registry law § 18 designate and enter into agreements with data processor for blood donor registry. 

To section 4-4 General information to blood donors to the first paragraph Blood Banks ' obligation to inform donors also follows of the requirement to obtain informed consent to both blood donation and registration of health information in blood donor registry. 
To par. 1 blood donor to get information material about the basic properties of the blood, the procedures in connection with the blood donation, the components that are produced on the basis of blood-and aferesetappinger, and the importance of transfusion for blood recipients. To all blood donors (both allogene and autologous) should it further be informed of the reasons for it to be made selection based on clinical judgment, the reasons why the blood donor to state whether the helbreds and medical records, and the reasons for that one test donor blood. Information material should be able to be understood by the general population. 
To section 2 Blood Banks will inform about the requirement that the donor agrees to blood donation and to the registration of the information in the blood donor registry. 
To section 3 Blood Banks to provide information about the selection criteria imposed by the Regulation section 3-8 and annex I, as well as about the background of these. These criteria are provided in order to ensure that the blood donor is not exposed to health risks in connection with blood donation. Moreover, the criteria ensure that the blood that is given for transfusions of allogene is good quality so that the blood recipient is exposed to health risks. The criteria may involve people limited time or a lifetime can not donate blood or blood components, because it could involve a risk to the donor or blood recipient. 
To the section 4 information about blood donor, blood donor's State of health and the information about the blood in blood donor registry, jf. forskriftens Chapter 4. This is a person identifiable register as blood donor must give their consent to at the same time as blood donor agrees to give blood. Blood banks to notify you that the registry is in line with the requirement of the information duty to the registered in the health registry law § 23, including about the purpose of the processing of health information, and whether blood givers rights as registered, such as the right to demand transparency. 
To section 5 blood donors should be informed that they have the opportunity to change their minds about blood donation before they go further in the process, and that they have the opportunity to withdraw or refrain from giving blood at any point in the process, without having to feel embarrassment or discomfort by it. 
To section 7 if test results reveal markers for viruses such as hiv, HBV, HCV, and other relevant microbiological agenser that can be transmitted through the blood, it will cause that the donor be ruled out, and that the tappede device for destruction. 
To the second paragraph Autologous blood donation means that the drain blood that only to be applied to the blood donor myself, jf. § 1-4 No. 5. To be informed of that in some cases, autologous blood donation could not be applied, when it may involve a health risk for the affected, either as a blood donor or autologous recipient of blood or blood components.

To section 4-5 Registration of information in blood donor registry For the Regulation section 3-8 to blood banks through the questionnaire and personal interview with qualified personnel collect information from blood donor. The information is stored in the blood donor registry. It will be under section 1-5 the second paragraph be obtained written consent from the donor to the blood donation and to the registration in the registry. Normally this will happen by that blood donor signs on the aforementioned form.

To section 4-6 treatment of health information in blood donor registries for health registry section 36 apply to the personal data act with regulations as complementary provisions. Personal information in whole or in part be treated with electronic AIDS, be governed by the regulations 15. December 2000 No. 1265 on the treatment of personal information section 2-1 to section 2-16.

To § 4-9 Storage of health information, rectification, cancellation and blocking of information Information in the registry is Directive 2002/98/EC article 13 be kept in at least 15 years. To ensure full traceability, one must, however, in article 14 keep the information in at least 30 years.
In some cases, blood donors/the registered pursuant to the health registry Law § 26 require correction of health information in the registry, or require information in the registry blocked or deleted, see. Health Registry law section 28. If the information is deleted from the register, blood and blood components at the same time be removed from the blood bank so that the system of traceability be ensured. The consideration of accountability goes in front of the patient consideration in cases where the registered require the deletion of information in the registry associated with the blood that is used. The registered here can not require the information deleted or blocked. 

To Chapter 5. Final provisions of section 5-1 Supervision according to the law on government supervision section 3 the second paragraph shall ensure that all the County that provide health and care services has established internal control system and the driver's control with his own business in such a way that it can prevent the failure of the health and Human Services service. This means that the County to supervise the blood to the transfusion.
After the medicines act with regulations, it is the State's drug works to supervise the blood to the drugs. In practice, one does not know in advance about the blood will go to transfusion or to drugs, and often used the blood to both purposes. This means that there are two regulatory agencies that have overlapping supervision. It is assumed that the State health supervision and the State's drug works works closely on the audit with this business, and that the mutual holding each other informed of relevant conditions. Copy of the audit reports are sent to the Health Directorate, which is the approval authority for blood banks.

The data Inspectorate oversees the processing of person-and health information in blood banks. Health Registry law section 31.

To section 5-6 Changes the regulation is warranted in all seven laws. The provision must be interpreted on the basis of this, so the Ministry has the authority to change the regulations in the areas where the authority of the laws of is added to the Ministry or delegated Ministry in this regulation. This means that the changes to the regulations that is warranted in the infection Protection Act § 2-3 fourth paragraph and health registry law § 7 second paragraph that adds authority to the King in Council, can not be done by the Ministry.