Rules For Human Blood And Blood Components Collection, Testing, Processing, Storage And Distribution Of The Quality And Safety Standards, And Compensation For Expenses In The Amount Of Blood Lost Restore

Original Language Title: Noteikumi par cilvēka asiņu un asins komponentu savākšanas, testēšanas, apstrādes, uzglabāšanas un izplatīšanas kvalitātes un drošības standartiem un kompensāciju par izdevumiem zaudētā asins apjoma atjaunošanai

Read the untranslated law here: https://www.vestnesis.lv/ta/id/125683

Cabinet of Ministers Regulations No. 1037 in Riga in 2005 (December 27. 77 60. §) rules on human blood and blood components collection, testing, processing, storage and distribution of the quality and safety standards Issued under the medical treatment Act 34. the third paragraph of article i. General questions 1. determine the collection, testing, processing, storage and distribution of standards of quality and safety of donated whole blood derived that are processed for transfusion or for further manufacturing (blood), and blood components therapeutic manufactured by using different methods (blood components), and intended for transfusion the same donor or any other person for use in medical devices or as starting materials for medicinal products.
2. Human blood and blood components comply with the voluntary principles in the collection, but the human blood and blood components distribution and transfusion respects the anonymity and the non-profit principle.
3. Human blood and blood components imported into the country. Plasma is used for the manufacture of preparations for raw materials in the country.
4. Distribution is a blood or blood components blood establishments shall supply to the public, the preparatory departments of blood or of blood treatment services offices. Dissemination does not include blood or blood components for transfusion service.
5. serious adverse reaction is a donor or patient's unexpected reaction associated with blood or blood component collection or transfusion, and that is fatal, life-threatening, disabling, incapacitating, or which results in or disability or prolongs, hospitalisation or morbidity.
6. Adverse event any adverse event associated with the blood or blood component collection, testing, processing, storage and distribution, and that could lead to the death of a patient or endanger his life or cause patient's incapacity or disability, or which results in or prolongs, hospitalisation or morbidity.
II. Evaluation of conformity 7. the health statistics and medical technologies State Agency (hereinafter the Agency) to assess the hospital's blood Office (hereinafter referred to as the blood study), national blood establishments blood preparation Department and compliance with the requirements laid down in these provisions.
8. to assess the State of the Agency, the blood establishment, blood and blood of preparatory Department compliance office requirements laid down in these provisions, the national blood center, blood and blood of the preparatory Division office supply: 8.1 the following general information: 8.1.1 name, registration number, if any, and the legal address;
8.1.2. the responsible person name, qualification and contact details;
8.1.3. the medical authorities, where blood center, blood and blood of the preparatory Division office supply of blood and blood components;
8.2. a description of the quality system, including: 8.2.1. documentation of estimate preparation Department of blood and blood in the Office, including the persons responsible for obligations and commitments on reporting;
8.2.2. the Preparatory Department of blood and blood study quality manual describing the quality system in accordance with the provisions of paragraph 15 and 36.1. section;
8.2.3. the number and qualifications of staff;
8.2.4. the rules of hygiene;
8.2.5. premises and equipment;
8.2.6. the list of SOPs, which shall contain the following information: 8.2.6.1. donor involvement, and investigation;
8.2.6.2. blood and blood component preparation and testing, issue and withdrawal;
8.2.6.3. reporting arrangements concerning serious adverse reactions and adverse events and the tracking of this information.
9. conformity assessment By the agency determines what actions and under what conditions can make the national blood center, blood and blood of the preparatory Division Office.
10. the national blood center, blood and blood of the preparatory Division Office must not change the operating conditions without the written approval of the Agency.
III. Officer 11. national blood establishments and blood preparation departments designate a responsible person (hereinafter person responsible). The person responsible is: 11.1. higher education diploma in medical or biological sciences, awarded on completion of a university course;
11.2. the required qualifications, as evidenced by the certificate of transfuziolog;
11.3. at least two years of post-graduate practical experience in the field of transfuzioloģij.
12. The responsible person shall organise measures to ensure the following requirements are met: 12.1. any operation for transfusion of blood or blood components shall be in accordance with these rules and regulations;
12.2. the Agency receives information necessary to carry out the conformity assessment procedure in accordance with the provisions of point 7 and 8;
12.3. blood and blood components in the preparation, testing, processing, storage and distribution of the personnel directly involved in is adequate, and the staff is to ensure early learning the development of qualifications;
12.4. compliance with these rules 15, 16 and 20, as well as the requirements referred to in chapter VI.
13. If the national blood establishments and blood preparations section 8 of these regulations, paragraph tasks assigned by several persons, the Agency provides additional information about a specific person responsible for the tasks that are their responsibility.
14. Replacing the owner, temporarily or permanently, the national blood center blood preparation Department and agency shall notify of the new responsible person name and the date on which the designated person in charge.
IV. National blood establishment and preparation of blood chapter 15. national blood establishments and blood preparation Department shall establish and maintain a quality assurance system in accordance with the principles of good practice.
16. national blood establishment and preparatory Department of blood and five years for storing documentation on operational procedures, staff training, sample forms, as well as provide officials carrying out control measures, access to documents.
17. the national blood center and preparatory Department provides blood: 17.1. blood sample testing or investigation in accordance with the provisions of annex 1. National blood establishments and the Preparatory Department of blood may provide additional testing, if necessary according to national or international institutions or in accordance with the objectives set by the specific epidemiological situation;
17.2. blood and blood components quality and security requirements in conformity with the provisions of annex 2;
17.3. autologous blood preparation requirements applicable to the establishment and maintenance;
17.4. blood and blood components, storage, transport and distribution requirements in accordance with the provisions of annex 3;
17.5. human blood and blood components donor acceptance criteria in accordance with the provisions of annex 4;
10.9. the requirement for blood and plasma donor eligibility criteria in accordance with the provisions of annex 5. The criteria include: 17.6.1. regular blood and blood components the criteria for refusal of transfer and the associated potential donor rejection;
17.6.2. temporary blood and blood components the transfer refusal criteria;
17.7. the quality system establishment and maintenance of the specification in accordance with the provisions of annex 6;
11.1. This provision of the procedures laid down in chapter VI of serious adverse reactions and events and sample of the message;
11.1. This provision is referred to in chapter VI of the traceability requirements and compliance;
17.10. quality of blood or blood components distribution, where possible threats to their quality and safety.
18. national blood establishments each year to 15 February and blood preparation Department each year up to January 25, prepare a report on the activities of the previous year. The report shall contain the following information: 18.1. number of donors;
18.2. blood or blood components for transfer of number of times;
18.3. the medical authorities, where the blood establishment or blood supply in the preparatory Division by blood and blood components;
18.4. the total of unused blood or blood components, the number of doses;
18.5. all prepared and served to the blood or blood components, the number of doses;
18.6. the blood transfusion (transfūzij) portable marker of infection incidence and prevalence of donors;
11.6. withdrawn (revoked) number of doses;
12.8. serious adverse reactions and the number of events reported to the Agency.
19. preparation of blood chapter annual report submitted to the national blood Centre. The national blood Centre shall prepare a summary and each year up to February 15, submit it to the Agency.
20. the national blood center blood preparation Department and information associated with this rule 17., 18., 38, and 39 actions referred to in store for 15 years.
21. the national blood center developed and submitted for approval to the Agency technology for blood and blood components preparation and use.
V. rights and obligations of the Agency. The Agency provides 22:22.1. blood and blood components quality and security control requirements;
22.2. serious adverse reactions and events tracking, registration and analysis;

22.3. of organised surveillance procedures relating to serious adverse reactions or adverse events in donors or recipients, and the epidemiological follow-up of donors of observation (hemovigilanc);
22.4. the national blood establishments and blood preparations Chapter submitted registration data;
22.5. the annual review report (31. these provisions and information referred to in paragraph 32) of the European Commission to provide up to 30 June the following year;
22.6. the control measures for the transmission of the report to the Commission every three years.
23. in order to ensure compliance with these provisions, the Agency regularly, but not less frequently than once every two years: 23.1. State control of the blood establishment, blood and blood of the preparatory Division Office, as well as third party equipment used for blood and blood components in the preparation, testing, storage and transportation;
23.2. the examination and take samples for analysis;
23.3. check all controls related documents.
24. the Agency shall organise control measures, if found serious side effects or adverse events or are suspicious of them.
25. If control measures reveals that the national blood center, blood or blood of the preparatory Division Office does not comply with this provision in annex 6 and 7, the Agency shall adopt a decision on eligibility is granted the suspension or withdrawal of the exact deadline during which the national blood center, blood or blood of the preparatory Division Office addresses found.
26. the national blood center, blood or blood of the preparatory Division Office of the Agency specified by the non-compliance with prevention shall notify the Agency. The Agency shall adopt a decision on the national blood center, blood or blood of the preparatory Division Office of compliance and the trading on the writing of the national blood center, blood or blood of the preparatory Division Office.
Vi. the traceability requirements and notification of serious adverse reactions and adverse events 27. national blood establishments and blood preparation departments in accordance with the provisions of annex 6 is a system in place to identify every donor, every blood unit cast and everyone prepared blood components, whatever their intended purpose, and the authorities to which the blood component is delivered.
28. the national blood center, blood and blood in the Preparatory Department offices in accordance with the provisions of annex 6 and 7 have a system in place to record all the received blood and blood components units (regardless of whether it is processed in the respective institution or not) and its units received the destination, which is either the transfused, or destroyed, or returned to the establishment that it has supplied.
29. Medical institutions that are transfused blood and blood components, has introduced procedures to ensure transfusion data tracking and reporting of operational national blood center or a blood preparation Department, which prepared the specific dose, of any serious adverse reactions to blood transfusions during or after the observed in persons who received blood or blood components (recipients), and which can apply to either the quality or safety of blood and blood components.
30. Blood offices have procedures in accordance with which the agency notifies all information about potential serious adverse reactions immediately after they are placed. To provide this information, use the 8 (A) and (C) of the annex contains the notification form.
31. the blood study: 31.1. in accordance with part B of Annex 8 shall communicate all information to the Agency about serious second and third level reactions attributable to blood and blood components quality and reliability;
31.2. as soon as it has become known, notify the Agency of any infections with blood and blood components;
31.3. describes the actions taken with respect to other implicated blood components that have been distributed for the purposes of transfusion or plasma for fractionation;
19.5. assess the possible severe adverse reactions according to the imputability levels set out in part B of Annex 8;
19.6. to complete the investigations of serious adverse reactions to approval in accordance with part C of Annex 8;
19.6. each year, shall submit to the Agency, notification of serious adverse reactions, in accordance with paragraph (D) of Annex 8.
32. the national blood center, blood and blood of the preparatory Division Office in regard to adverse events shall ensure that procedures are in place: 32.1. to register all your unwanted events that may affect the blood and blood components quality and reliability;
32.2. with assistance from Annex 9 part A model form of notification provided, all the information about adverse events, which may put in danger donors or people who receive blood or blood components (recipient), provide to the Agency as soon as it has become known, but not later than 48 hours.
33. The provision in paragraph 32 of that authority: 33.1. assess unwanted events to determine the causes of the gaps;
33.2. to complete the investigation provide unwanted event approval in accordance with Annex 9, part B;
33.3. each year, submit to the Agency a notification of adverse events in accordance with Annex 9, part C.
34. the national blood center blood preparation Department and marked all prepared, tested, processed, stored, distributed blood and blood components and in the labelling shall bear the following information: 34.1. the official name of the component;
21.3. the volume, weight or number of cells in the component;
21.3. the donation of a numeric or alphanumeric identification code;
21.4. blood preparation institution name;
34.5. Abo group and Rh nationality (not noted for plasma intended for fractionation);
21.5. the use of expiry date or time;
21.6. the storage temperature;
21.6. the anticoagulant or additive solution name, composition and volume.
35. the national blood Centre and preparation of blood units is determined according to the rules of procedure 6. requirements set out in the annex, to careful, efficient and compelling removed from distribution blood or blood components when this rule 31.5. and 33.2. the information referred to in point.
VII. Treatment of blood study 36. Blood Office: 36.1. According to competence, implement and maintain a quality system in accordance with the provisions of annex 7;
36.2. receiving blood components from a national blood donation centres or departments, preparation of blood stored them, ensure the successful issuance of transfūzij blood component (transfusion) and responsible for their movement.
37. in the study of blood and blood components work impeded must only be trained in the treatment of transfuzioloģij persons in the last five years to train eligible transfuziolog is issued a certificate of training. Medical training is paid from the trainees ' or third party products. Are assessed and recognised in other Member States of the European Union issued receipts for the training visit in the past five years.
VIII. Donor information 38. national blood establishments and blood preparation Department prospective donors provide the following information: 38.1. the general public to understand, accurate, educational materials on the characteristics of blood donation procedure, blood and blood components and patient benefits, transfer of blood;
38.2. the homologous or from the individual for blood and blood components intended for transfusion to another individual, for use in medical devices or as raw materials for medical products, and autologous or from the individual for blood and blood components intended for transfusion or for use only for the same individual, blood or blood components, the donor and the history of the investigation of the reasons for the collection, the need to investigate the blood samples and the How is informed consent;
23.8. homologous blood or blood components-when to refuse to transfer the blood and never on time and permanently prohibited from putting the blood, and the reasons why individuals are not to put blood or blood components if it could endanger patient health;
23.9. the potential of autologous blood or blood component for the transfer ban and the reasons why the blood donation procedure is permissible, if autologous blood or blood components donor or recipient can thereby be compromised health;
38.5. the reasons why individuals are not to put blood or blood components, if it could be damaging to their health;
24.0. for blood or blood components for transfer of the nature of the procedure and the risks associated with them, about the potential of autologous blood and blood components for transfusion of non-compliance;
donor rights 24.0. before initiation of the refuse put the blood, as well as on the possibility without difficulty and inconvenience during the transfer process, stop the blood or blood components for transfer or surrender it;
24.1. why it is important that donors inform the blood donation before national blood establishments or blood preparation Department personnel for all the reasons the blood or blood components may be invalid for transfusion;
24.2. The National Centre for blood and blood preparations Department staff the obligation to inform donors, the donor testing results demonstrate that the deviation from the rules;
38.10. in any event, unused autologous blood and blood components shall be destroyed, rather than pour;

38.11. If tests revealed the virus HIV, HBV, HCV markers or other microbiological agents, and transfer with the blood donor ban to pass blood blood unit collected and destroyed. The donor evaluation and testing results are documented;
38.12. the donor's right to ask questions.
39. national blood establishments and the Preparatory Department of blood from the potential donors receive the following information: 24.3. personal data that can identify unmistakably the donor (name and surname), as well as contact information.
24.4. the donor's written submissions and personal treatment in consultation with the donor information, including details of his medical condition and previous illnesses, as well as other important data that can help identify persons who passed the blood or blood components could cause a health risk to others (such as the likelihood of disease transmission or to the donor's health);
39.3. the donor in writing and signed, as well as on the acquisition of medical treatment of the person responsible certifying that: the donor is 39.3.1. read and understood the educational materials provided;
39.3.2. the donor had the opportunity to ask questions;
39.3.3. a donor answers to all the questions asked;
39.3.4. a person knowingly agreed to be a donor;
39.3.5. for autologaj blood or blood components donors aware of the blood and blood components may not match the intended transfusion requirements;
39.3.6. the donor confirms all his truthfulness of information provided.
IX. Data protection 40. national blood establishment and preparation of blood chapter provides personal data, as well as the protection of genetic information and privacy, organizing: 24.9. security measures to prevent unauthorised data additions, deletions, or modification of the donor files or registers and ensure safe transfer of information;
40.2. the procedure, if the data does not conform;
40.3. non-disclosure of personal data while ensuring traceability.
41. the national blood center blood preparation Department and ensure that information on human blood and blood components, traceability is stored for 30 years. This information includes: 41.1. the name and address of the institution;
41.2. the donor's name, surname, personal code, and the declared place of residence;
41.3. blood unit identification code;
25.7. individual blood component identification code;
25.8. preparation date (date, month, year);
25.8. news on blood and blood components distribution, medical institutions or their destruction;
25.9. to the supplier, the number assigned to a blood component;
41.8. recipient's name, surname, personal code, and the declared place of residence;
41.9. pārlietaj units – not the approval of destruction;
41.10. transfusion or disposal date (date, month, year);
41.11. blood component lot number, if any.
X. transitional issue 42. the Agency this rule 22.6. referred to in the report for the previous period for the first time the European Commission sends to March 1, 2007.
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 27 January 2003 of Directive 2002/98/EC setting standards of quality and safety for human blood and blood components collection, testing, processing, storage and distribution, as well as amending Directive 2001/83/EC;
2) Commission of 22 March 2004, Directive 2004/33/EC of Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components;
3) Commission of 30 September 2005, directives 2005/61/EC of the European Parliament and of the Council Directive 2002/98/EC as regards traceability requirements and notification of serious adverse reactions and events;
4) Commission of 30 September 2005, directives 2005/62/EC implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments.
Prime Minister-economic Minister A.r. Kariņš Health Minister – Finance Minister in place of o. Spurdziņš Editorial Note: rules shall enter into force on 14 January 2006.
 
1. the annex to Cabinet of 27 December 2005, regulations No 1035 blood sample testing requirements each blood sample is tested for the following: 1. determine the ABO group and Rh, except for plasma intended only for fractionation.
2. Check that the donor is not: 2.1. HBV marker (HBS Ag);
2.2. antibodies against the hepatitis C virus (anti-HCV);
2.3. antibodies against HIV ½ (anti-HIV ½).
The Health Minister, the Minister of finance Spurdziņš o. Annex 2 Cabinet of 27 December 2005, regulations No 1035 blood and blood component quality and security control requirements for blood and blood components perform collection and production process according to the bacteriological control. Quality control and quality control results must meet the following requirements: no PO box
The required component quality measurement (the frequency of sampling for all measurements determined using statistical process vadību19)) quality control the corresponding results 1.
Erythrocyte volume masa3) according to criteria that ensure the haemoglobin and haemolysis value specification of hemoglobin * not less than 45g per dose of less than 0.8% in haemolysis value from red cells mass at the end of the period of validity of the 2.
The red cells leucocyte-free mass of platelet slāņa4) capacity according to the criteria that ensure the haemoglobin and haemolysis value specification of hemoglobin * no less than 43 g in one dose of less than 0.8% in haemolysis value from red cells mass at the end of the period of validity of 3.
Erythrocyte mass without leikocītiem5) capacity according to the criteria that ensure the haemoglobin and haemolysis value specification of hemoglobin * not less than 40 g per dose in the leucocyte content is Less than 1 × 106 per dose is less than 0.8% in haemolysis value from red cells mass at the end of the period of validity of 4.
Erythrocyte mass substitution šķīdumā6) capacity according to the criteria that ensure the haemoglobin and haemolysis value specification of hemoglobin * not less than 45 g single dose of less than 0.8% in haemolysis value from red cells mass at the end of the period of validity of 5.
Erythrocytes leukocytes-free mass platelet layer substitution šķīdumā7) capacity according to the criteria that ensure the haemoglobin and haemolysis value specification of hemoglobin * no less than 43 g in one dose of less than 0.8% in haemolysis value from red cells mass at the end of the term of validity of 6.
Red cells, leucocyte-depleted mass substitution šķīdumā8) capacity according to the criteria that ensure the haemoglobin and haemolysis value specification of hemoglobin * not less than 40 g per dose in the leucocyte content is Less than 1 × 106 per dose is less than 0.8% in haemolysis value from red cells mass at the end of the period of validity 7.
Erythrocyte mass, prepared according to aferēzē9) volume criteria which ensure haemoglobin and haemolysis value specification of hemoglobin * not less than 40 g per dose is less than 0.8% in haemolysis value from red cells mass at the end of the period of validity of the 8.
Pilnasinis1) volume according to the criteria that ensure the haemoglobin and haemolysis value specification of 450 ml +/-50 goals for Paediatric autologous blood – shall not exceed 10.5 ml/kg of hemoglobin * not less than 45 g single dose of less than 0.8% in haemolysis value from red cells mass at the end of the period of validity of the 9.
Platelet mass, prepared aferēzē10) capacity according to the criteria that maintain pH specification number of platelets, platelet change one of the transfer time are permitted, provided they do not exceed the limits that comply with validated preparation and preservation conditions of pH 6.4-7.4 at the end of the term of validity at 22 ° C 10.
Platelet, leucocyte-depleted, mass aferēzē11) volume prepared according to the criteria that maintain pH specification number of platelets, platelet change one of the transfer time are permitted, provided they do not exceed the limits that comply with validated preparation and preservation conditions of the Leukocyte count less than 1 × 106 per dose, pH 6.4-7.4 at the end of the term of validity at 22 ° C 11.
Platelet mass, prepared from several pilnasiņ devām12) of capacity according to the criteria that maintain pH specification number of platelets, platelet change in one sample together are permitted if they do not exceed the limits that comply with validated preparation and preservation conditions of leucocyte count less than 0.2 × 109 per dose (preparing of platelet-rich plasma).
Less than 0.05 × 109 per dose (preparing of Leukocyte-platelet layer) pH 6,4-7,4 expiration at 22 ° C 12.
Platelet, leucocyte-depleted mass, prepared from several pilnasiņ devām13) of capacity according to the criteria that maintain pH specification number of platelets, platelet change in one sample together are permitted if they do not exceed the limits that comply with validated preparation and preservation conditions of the Leukocyte count less than 1 × 106 per sample pH 6,4-7,4 together at the end of the period of validity at 22 ° C 13.
Platelet mass, prepared from one of devas14 pilnasiņ) capacity according to the criteria that maintain the pH of platelet number specification

Change in the number of platelets in one dose, are allowed if they do not exceed the limits that comply with validated preparation and preservation conditions of leucocyte count less than 0.2 × 109 per dose (preparing of platelet-rich plasma).
Less than 0.05 × 109 per dose (preparing of Leukocyte-platelet layer) pH 6,4-7,4 expiration at 22 ° C 14.
Platelet, leucocyte-depleted mass, prepared from one of devas15 pilnasiņ) capacity according to the criteria that maintain pH specification number of platelets, platelet change in one dose are permitted if they do not exceed the limits that comply with validated preparation and preservation conditions of the Leukocyte count less than 1 × 106 per dose, pH 6.4-7.4 at the end of the term of validity at 22 ° C 15.
Fresh frozen plazma16) volume Indicate the volume +/-10% factor VIII * average (after freezing and thawing): 70% or more of fresh plasma factor VIII, the value of the total protein content of not less than 50 g/l residual cell number * red – less than 6.0 x 109/l white-less than 0.1 × 109/l, platelets less than 50 × 109/l 16.
The plasma without krioprecipitāta17) volume Indicate the volume +/-10% residual cell number * red – less than 6.0 x 109/l white-less than 0.1 × 109/l, platelets less than 50 × 109/l 17.
Krioprecipitāts2 Fibrinogen content) ≥ 140 mg per unit VIIIfaktor content ≥ 70 IU/dose of 18.
Granulocytes, prepared aferēzē18) less than 500 ml capacity granulocytes content greater than 1 × 1010 granulocytes per dose notes. 1. In respect of autologaj blood or blood components with the requirements in these notes are recommended.
2.1) Pilnasin is obtained in the procedures for the preparation of blood blood.
3.2 Cryoprecipitate plasma component) is made from fresh frozen plasma freezing-thaw precipitation of proteins and then are re-suspended by concentrating and precipitating the proteins on the plasma small quantities.
4.3) erythrocyte mass of red cells from pilnasin, with a large proportion of the plasma from the donation removed.
5.4) erythrocyte mass without leukocyte-platelet layer is red from the pilnasin, with a large proportion of the plasma from the donation removed, leucocytes and platelets.
6.5), the mass of red cells, leucocyte-depleted erythrocytes from pilnasin, is with a large proportion of the plasma from the donation removed, and white.
7.6) erythrocyte mass substitution in solution is red from the pilnasin States, of which a large part of the plasma is separated and connected the replacement solution.
8.7) erythrocyte mass without leukocyte-platelet layer solution is replacing the red cells of pilnasin, with a large proportion of the plasma from the donation removed, leukocyte-platelet layer containing white cells and platelets in the most part, and added the replacement solution.
9.8) mass of red cells, leucocyte-depleted solution is replacing the red cells of pilnasin, with a large proportion of the plasma from the donation removed, and white. Added replacement solution.
10.9) mass of red blood cells Apheresis is prepared erythrocytes obtained from erythrocytes Apheresis procedure.
11.10) platelet mass, prepared concentrated platelet Apheresis is the suspension, which prepared the apheresis.
12.11) mass of Platelets, Apheresis, leucocyte-depleted prepared is concentrated platelet suspension produced a leukocyte Apheresis, separating.
13.12) platelet mass, prepared from several pilnasiņ doses, is concentrated platelet suspension obtained by treating pilnasiņ dose and dose of pooling the platelets sequestration during or after separation.
14.13) mass of leucocyte-depleted platelets prepared from several doses of pilnasiņ, is concentrated platelet suspension obtained by treating pilnasiņ dose and the dose of platelets by combining their isolation during or after separation, and separation of the leucocytes.
15.14) platelet mass, prepared from one pilnasiņ, is concentrated platelet suspension, obtained by processing of a single dose of pilnasiņ.
16.15) mass of leucocyte-depleted platelets prepared from one pilnasiņ, is concentrated platelet suspension, obtained by processing of a single dose of pilnasiņ and separation of leucocytes.
17.16) fresh frozen plasma, the plasma is separated from the pilnasin centrifugation, or plasma obtained by Apheresis and frozen storage.
18.17) plasma Cryoprecipitate plasma without is part remaining from one freshly frozen plasma unit after removal of cryoprecipitate.
19.18), prepared Granulocytes, Apheresis is a concentrated suspension of granulocytes, Apheresis procedure prepared.
20.19) statistical process control is the product or process quality control method based on sufficient control analysis system and not for each process involved in the control of the product.
The Health Minister, the Minister of finance Spurdziņš o. Annex 3 Cabinet of 27 December 2005, regulations No 1035 blood and blood component storage, transport and distribution 1. Blood and blood component storage: 1.1. liquid component storage temperature maximum storage time of products and Rbcs pilnasin (if used for transfusion pilnasiņ) + 2 to + 6 ° C 28 to 49 days, depending on the collection, processing and storage of the products of the process of Platelet + 20 to + 24 ° C for five days; can be stored for seven days, if kept, subject to the determination of microbiological contamination or reducing pollution Granulocytes + 20 to + 24 ° C for 24 hours in the frozen form 1.2 component storage conditions and duration of red cells to 30 years, depending on the collection, processing and storage of platelets to 24 provisions, depending on the collection, processing and storage of plasma and cryoprecipitate rules To 36mēneš, depending on the collection, processing and storage rules in the case of frozen red cells and platelets URPiezīme.* to service after thawing prepared in a suitable environment. Expires after defrosting depends on the method of preparation.
2. The transport and distribution of blood and blood components blood establishments and State blood preparation departments ensure product integrity at all stages.
3. Storage, transport and distribution of autologous blood and blood components blood establishments and State blood preparation Department the following additional requirements: 3.1. autologous blood and blood components shall be identified, stored, transported and distributed separately from the homologaj blood and blood components;
3.2. autologous blood and blood components, the label indicates the identification number of the donor and the warning: "for autologous transfusion Only".
The Health Minister, the Minister of finance Spurdziņš o. Annex 4 of the Cabinet of Ministers of 27 December 2005, the provisions of no. 1037 of blood and blood components donor acceptance criteria 1. Donor age and body weight 1.1. Age 18 to 65 years from 17 to 18 if in accordance with the law a donor is not a minor or if a parent or legal guardian's written consent, to comply with the statutory requirements of donors , over 60 years that pass the blood/blood components for the first time at the doctor's discretion, older than 65 years with a doctor's permission, which is issued every year 1.2. ≥ 50 kg body weight in blood or Apheresis blood components donors 2. Hemoglobin level in the blood of the donor Haemoglobin in women ≥ 125 g/l men ≥ 135 g/l of blood and cells Applied component donors 3. homologous protein levels in the blood of the donor protein ≥ 60 g/l of protein determination for apheresis plasma donors must be carried out at least once a year 4. Platelet level donor blood platelets Platelets is 150 × 109/l or greater Apheresis platelet donors required level note. The criteria do not apply to autologaj blood and blood components.
The Health Minister, the Minister of finance Spurdziņš o. Annex 5 Cabinet of 27 December 2005, regulations No 1035 criteria under which blood and blood component donors prohibits putting blood and blood components 1. criteria for permanent ban put in homologous blood or blood components 1.1. Cardiovascular disease potential donors who have or have had cardiovascular disease, except congenital abnormalities that is totally healed 1.2. Central nervous system disease was serious central nervous system disease 1.3. Increased tendency to bleed potential donors who have had a koagulopātij 1.4. fainting or a history of seizures except cramps during childhood or, after at least three years from the date of the last time donors used the medicine for seizures, and seizures are no longer in detention, being only 1.5 Uro, haematological, immunological , metabolic, renal, or respiratory system diseases of potential donors who have acute or chronic disease flare period 1.6. Cukurslimīb treatment of the donor uses insulin 1.7. Infectious diseases hepatitis B, except persons who are HBsAg test results are negative and that immunity is proven hepatitis C HIV-1/2, HTLV I/II * Babeoz Kala Azar (visceral leishmaniasis in) by Trypanosomias cruz (Marc disease) 1.8. Malignancies except in situ cancer cases If complete recovery occurred

1.9. the transmissible spongiform encephalopathy (TSE) (e.g., Creutzfeldt-Jakob disease To Creutzfeldt-Jakob disease To) persons whose relatives was to assess the risk of disease, the group, which can spread the TSE, or persons who have a corneal or brain hard skin graft, or persons who previously treated with medicines derived from human pituitary. For variant Creutzfeldt-Jakob disease should be advised additional precautionary measures 1.10. Intravenous (i/v) or intramuscular (i/m) drug use all the data on a doctor's prescription i/v and not i/m drug use, including anabolic steroids, or hormone use in individuals with ksenotransplant-1.11 1.12. Dzimumuzvedīb personal dzimumuzvedīb due to which there is a high risk that they could get serious infectious diseases being transferred by blood 2. criteria for temporary prohibition put in homologous blood or blood components 2.1. infectious diseases infectious After prospective donors prohibited put the blood or blood components at least two weeks of complete clinical convalescence days other than infectious diseases covered by such provisional prohibition period: 2.1.1. Brucellosis * two years from the date of full recovery 2.1.2. Osteomyelitis two years from the date of the approved recovery 2.1.3. Q fever * two years from the date of the approved cure 2.1.4. Syphilis, one year from the date of the approved cure 2.1.5. Toxoplasmosis * six months from the date of the clinical recovery 2.1.6. Tuberculosis two years from the date of the approved cure 2.1.7. Rheumatic fever two years from disease symptoms the day of the disappearance, when there is no evidence of chronic heart disease fever > ° C 2.1.8. two weeks from disease symptoms disappearing days 2.1.9. Colds for two weeks from the day of the disappearance of the symptoms of malaria: 2.1.10 2.1.10.1. individuals who, during the first five years of life lived in the area affected by malaria, three years from the day after the last endemic areas visit if the person is not found in the symptoms of the disease; This period may be reduced to four months, or if the test molekulārģenētisk in Immunology in blood donation each time gets negative results 2.1.10.2. individuals who was with malaria, three years from the date of the end of treatment and the clinical symptoms have disappeared. This period shall be determined, if Immunology or molekulārģenētisk test results negative 2.1.10.3. endemic area visitors without disease symptoms six months from the date of departure from endemic areas if Immunology or molekulārģenētisk test results negative 2.1.10.4. individuals who had not been diagnosed, but six months after the fever endemic areas visit, three years from the disappearance of the symptoms of the disease; This period may be reduced to four months if Immunology or molekulārģenētisk test results negative 2.1.10.5. West Nile virus (WNV) (*) 28 days after pulling out of the territory in which distributed West Nile virus (WNV) 2.2. risks of transfusion transmissible infections get 2.2.1. Endoscopic investigation using flexible instruments prohibit donor put the blood/blood components six months or, if the NAT test for Chepatīt is negative -four months 2.2.2. Mucous contact with blood or injury from needles get 2.2.3. Blood component transfusion 2.2.4. Human tissue or cell transplant 2.2.5. large surgical interventions 2.2.6. Tattoo or body piercing, Acupuncture not 2.2.7. done the qualified medical practitioner with sterile disposable needles 2.2.8. Persons at risk in close contact with the Municipal Board for persons infected with Hepatitis virus 2.2.9. whose lifestyle presents a risk of getting an infectious disease that can be transmitted by blood donor ban to pass the blood/blood components after a risky way of life down to the time of termination, depending on the disease and the availability of the test 2.3. Vaccination 2.3.1 Weakened viruses or bacteria in four weeks 2.3.2. Inactivated/dead viruses, bacteria or rickettsiae are not prohibited to transfer the donor blood, if he is an Toksoīd donors to 2.3.3. not prohibited to pass blood If he is an Ahepatīt or Hepatitis 2.3.4. vaccines are not prohibited to transfer the donor blood, if he is healthy and is not subjected to the exposure of communicable disease donor 2.3.5. not prohibited to put the blood, if he is healthy and is not exposed to infection. If vaccination shall be carried out after the donor has already been exposed to the infection, he prohibited to put blood in one year 2.3.6. Tick encephalitis vaccine is not prohibited by the donor put the blood, if he is healthy and is not subjected to the exposure of infection 2.4. Other temporary bans put blood 2.4.1. Pregnancy six months after childbirth or pregnancy termination, except in exceptional circumstances and at the discretion of the physician 2.4.2. Minor surgery one week 2.4.3. dental treatment for minor treatment at the dentist or dental higiēnist-prohibition put the blood until the following day. Dental surgery, tooth sealing and similar treatment is considered a small surgical intervention 2.4.4. Medications, depending on the specifics of prescriptions, exposure and treat diseases 3. Prohibition to transfer blood special epidemiological situations of particular epidemiological situation (e.g. disease outbreaks) the prohibition to transfer blood meets the epidemiological situation. (The following prohibitions put blood in the competent authorities shall notify the European Commission, to identify community action)
4. the criteria for prohibition put autologous blood/blood components 4.1. serious heart disease depending on the clinical situation, the Person who was 4.2 with the following diseases: Member States may lay down specific provisions on the possibility to transfer 4.2.1. autologous blood, hepatitis, except persons who are HBsAg test results are negative and that immunity is proven hepatitis C 4.2.2 4.2.3 4.2.4. HIV-1/2 HTLV I/II 4.2.5. Acute Bacterial infection in phase URPiezīme.* the specified test and the period of prohibition shall not apply to If the blood or blood components are used for plasma for fractionation.
The Health Minister, the Minister of finance Spurdziņš o. Annex 6 Cabinet of 27 December 2005, regulations No 1035 quality system standards and specifications of the national blood Centre and the preparation of chapters of blood 1. quality system 1.1. Quality support all national blood establishments and the Preparatory Department of blood involved in the management, which is responsible for the quality system implementation and maintenance.
1.2. quality system includes quality management, quality assurance, continuous quality improvement, personnel, premises and documentation of medical devices, blood and blood component preparation, investigation and handling, storage, distribution, quality control, blood component recall internal and external audits, contract management and compliance management.
1.3. quality system up, ensuring that all processes are appropriate SOPs descriptions. National blood establishments and blood preparations chapter management regularly review the quality system by checking its efficiency and identifying corrective actions, if necessary.
2. the quality of All procedures, premises and medical devices that affect the blood and blood components quality and safety, in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures are validated before they are implemented and validated again after planned, regular periods.
3. personnel and organisation 3.1. national blood establishments and blood preparations chapter management determines the number of personnel to ensure the quality of blood and blood components preparation, testing, processing, storage and distribution.
3.2. The staff is trained and recognized as competent to perform the tasks.
3.3 personnel have adequate knowledge to get the medical treatment person's certificate. The medical institution or Department Manager assess the treatment person's competence.
3.4. the staff determines the duties and responsibilities of the individual position descriptions, which, if necessary, updated.
3.5. national blood establishments and blood preparations chapter leadership appoint several persons responsible for blood and blood components processing and the quality of the organisation and which operate independently.
3.6. national blood establishments and blood preparations chapter management ensure regular staff training and stored with the associated skills training supporting documents. Training programmes include good practice issues.
3.7. national blood establishments and blood preparations chapter management periodically review the curriculum and assess staff competency.
3.8. the national blood establishments and blood preparations chapter management provides written safety and hygiene instruction being.
4. Space 4.1. Premises, including mobile sites, are appropriate and maintained according to the activities to be carried out.

4.2. premises must be well cleaned and clean, to minimize the risk of contamination.
4.3. the work is organised in a logical sequence, to minimise the risk of error.
5. Blood donor room national blood establishments and blood preparation Department premises be single place where you can take a confidential conversation with the person, in order to assess the suitability of the person the donation.
6. Blood preparation room blood preparation room is equipped to provide both donors and personnel security, as well as avoid mistakes blood sampling process. The room has everything you need to blood from donors could take safely and, if necessary, be able to provide first aid donors who have adverse reaction or adverse event associated with blood donation.
7. the investigation and processing of blood site 7.1 laboratory investigation of blood (lab) is from the blood donor and blood component processing sites individually separated by space.
7.2. National Blood Center blood preparation Department and arrange the necessary measures to ensure that the laboratory can penetrate only staff who are duly authorised.
8. Blood and blood components stored 8.1. Blood and blood components are stored in separate and secure provides different categories of blood and blood components, including the blood or blood component units collected by specific criteria (e.g. autologous blood).
8.2. Blood and blood components are stored in the organized measures to prevent damage to the device or to the power shortages.
9. Medical waste disposal site national blood establishments and blood preparation Department of the place where the equipment safely discard medical waste, disposable items used blood sampling, investigation and treatment, and where to put the bad blood or components.
10. Medical devices, materials and reagents 10.1. All national blood establishments and the Preparatory Department of blood for medical devices in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures should be validated, calibrated and maintained according to the intended use.
10.2. the staff are available for blood service medical equipment instructions (manuals).
10.3. the national blood center blood preparation Department and take the necessary measures to all this annex 10.1. activities referred to in point fixed in writing.
10.4. the national blood center blood preparation section and choose the medical device to minimize any risk to the donor, personnel, blood or blood components.
10.5. the national blood Centre and blood preparations chapter will use the reagents and materials supplied to the recognised (registered) suppliers in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical supervision procedures meet the documented requirements and specifications.
10.6. the critical materials (materials that directly affect blood and blood component quality) issues the person recognised as competent. Personnel has the appropriate knowledge to receive the medical treatment person's certificate. The medical institution or Department Manager assess the treatment person's competence.
10.7. the national blood center blood preparation Department and medical devices shall be made and kept in accordance with the requirements of the Agency.
10.8. If the national blood Centre and the preparation of the blood used in the computer system then organises regular verification of software and hardware, and provide a record of the backup procedure. Record assurance system validates before use and staying in the State in which they were at the time of validation.
10.9. Record the backup procedure is organised in such a way as to prevent data (recorded information) loss or damage to the computer system does not function properly.
10.10. the national blood Centre and blood preparations chapter organizes measures to ensure hardware and software protection against unauthorized use and modification.
11. Documentation 11.1. National blood establishments and blood preparation Department documents containing specifications, procedures and notes for each step are available to staff and is updated regularly.
11.2. the notes are clearly legible.
11.3. Any significant changes to the documents out, reviewed, dated and signed by the authorised person of the scope of their authorisation which determines the national blood establishments, blood or blood of the preparatory Division Office Manager.
12. Donor evaluation of conformity 12.1. national blood establishments and blood preparations the Department develop and implement specific procedures to ensure safe donor identification, implementation of the debate on donor suitability and assess the compliance of the donor. Before each donation provides the procedure.
12.2. the discussions with the donor happens throughout, and ensuring confidentiality.
12.3. the comments on the evaluation of the eligibility of donors sign a medical person recognized as competent. Personnel has the appropriate knowledge to receive the medical treatment person's certificate. The medical institution or Department Manager assess the treatment person's competence.
13. Blood preparation, testing and Blood processing 13.1. sampling procedure is organised to ensure the donor's identity check, the donor data logging and clear link between donor tracking, blood, blood components and blood samples.
13.2. Blood and blood components used in the preparation and processing of sterile blood preparation system with CE marking. Serial number of the system must be traceable at all blood or blood component bags.
13.3 Blood preparation procedures performed to avoid bacterial contamination risk.
13.4. Blood samples for blood during transfer and storage, in accordance with the requirements of its stores to the investigation.
13.5. The procedure used, blood or blood component bags and labelling of laboratory samples with blood gave numbers, created to avoid the risk of mistaken identification.
13.6. following the preparation of the blood with the blood or blood component bag Act in order to maintain the quality of the blood. Blood or blood component bag stored and transported at a temperature corresponding to the subsequent processing requirements in accordance with the provisions of annex 2 and 3.
8.5. the national blood center blood preparation Department and provides a framework for each blood unit linkage to the national blood center or specific blood preparation Department, in which blood is prepared or processed.
14. Laboratory investigation laboratory procedures 14.1 All before being validated.
14.2. Each blood sample being investigated in accordance with the provisions of annex 1.
14.3. the national blood center blood preparation Department and clearly defined procedures to minimize the results not matching and ensure that blood and blood components with the repeatedly reactive for serological screening test results are not used for transfusion and stored separately, as well as the appropriate laboratory to ensure appropriate confirmatory investigations in accordance with the laws and regulations concerning minimum requirements for medical institutions and their departments. If the investigation confirms the positive results, in accordance with the approved procedure shall inform the donor.
14.4. Should be data confirming the suitability of the laboratory reagents used for blood donors in the investigation.
14.5. the quality of laboratory tests monitored regularly by the head of the laboratory in the periods laid down by participating in formal skills test, for example, the external quality assurance programme.
14.6. Blood serological investigation includes special donor group (first-time donors or donor who had a blood transfusion).
15. processing and validation 15.1. All medical and technical devices to be used in accordance with validated procedures.
15.2. Blood components shall be processed in accordance with appropriate validated procedures, including measures to ensure the avoidance of contamination of blood components prepared.
16. labelling 16.1. all blood or blood component bags are labelled with the appropriate information about their identity in accordance with paragraph 34 of these rules. If there is not a validated, computerized blood or blood component bag identification control system, blood or blood component bag marked it to be served can be clearly distinguished in the blood or blood components from izsniedzamaj not blood or blood components.
16.2. The prepared blood, blood components, intermediate products and the labelling system is organised, to uniquely identify the content and to meet the labelling and traceability requirements.
16.3. Autologous blood and blood components label meets certain requirements, approved in accordance with the laws and regulations on treatment of medical technology used in the approval and introduction of new medical technology.
17. Blood and blood components for use in the service of

17.1. the national blood Centre and preparation of blood chapter organizes the safe and protected to prevent the blood or blood components for use before issuing the compulsory enforcement. Must be evidence that each blood or blood component is issued by the use of doses authorised person. Records should show that before the issue of the use of the component all relevant forms, medical records and test results meet all admissibility criteria.
17.2. the issue Before the use of blood and blood components stored separately from the components to be served. If there is not a validated, computerized blood or blood component identification and control system for blood or blood components, the label must identify the release status.
17.3. If the blood or blood components are not issued for use, as confirmed positive infection test, then a check shall be made to ensure that the same dose and previous times released blood and blood components, and documentation of identification shall forthwith make a record.
18. Storage and distribution of 18.1. national blood establishments and the Preparatory Department of blood down the blood component storage and distribution requirements.
18.2. the storage and distribution procedures are validated to ensure blood component quality during storage and prevent the mixing of blood components. All transport and storage procedures and specifications, including receipt and distribution, determined by the writing.
18.3. Autologous blood and blood components, as well as blood components prepared for special purposes kept separate.
18.4. make necessary entries on medical devices, equipment and blood or blood components, as well as maintain it.
18.5. Blood and blood components shall be packed according to the packing to ensure blood and blood component integrity and not the temperature in accordance with the provisions of annex 3.
18.6. Blood and blood components return back the national blood Centre and the Preparatory Department of blood to them issued for use is permissible if it is meet all quality requirements and procedures established to ensure blood component integrity not.
19. Non-conformity 19.1. Blood components that do not conform to the requirements laid down in accordance with the provisions of annex 2 to transfuse only in exceptional circumstances with the referring physician and physician, who is responsible for the operation of the departments concerned, written consent.
19.2. All complaints and other information, including serious adverse reactions, and adverse events, which may lead to suspicion of issue of blood components damaged for use, is documented, carefully investigated by assessing the reasons of damage and, if necessary, then taking corrective actions to prevent recurrence. There is a specific procedure to ensure that the Agency is reported serious adverse reactions or serious adverse events.
19.3. the authorised person can assess the need to withdraw the blood or blood components and coordinate future action.
19.4. Is defined in the effective use of the invalid of blood and blood components the rejection procedure which includes an obligation and a description of the action to be taken in the event of rejection, including reporting to the Agency.
19.5. Certain periods is taken to cover all traces of blood components and, where appropriate, disclosure of origin. The purpose of the investigation is to identify every donor who might be involved in causing the reaction, pouring blood components and select available blood components from that donor, as well as announce their component recipients and recipients who received the same components from the donor that they might be at risk.
20. Corrective and preventive action 20.1. national blood establishments and blood preparation Department set up a system to ensure the necessary corrective and preventive action, if blood components do not meet the eligibility requirements, as well as does not meet the quality requirements.
20.2. to identify quality problems and ensure that the necessary remedial action, as well as identify adverse trends and ensure the necessary preventative action for prevention, analyze the available data.
20.3. Provide all error and accident investigation, documentation and to identify issues that need to be resolved.
21. the internal audit and the development of national blood Centre 21.1 and blood preparations chapter introduces internal audit system to ensure compliance with requirements for blood service maintenance. Internal audit performs independent, appropriately trained personnel.
21.2. All internal audit results documented and specified time take effective corrective and preventive action.
The Health Minister, the Minister of finance Spurdziņš o. Annex 7 Cabinet of 27 December 2005, regulations No 1035 blood study quality system standards and specifications 1. Quality assurance of blood components 1.1 from national blood establishments or blood preparation Department (hereinafter referred to as the draftsman), storage, transfusion service of the constituents engaged in their medical institution provides, as well as the assistance of the transfūzij medical institution supervised by the authorities of a certain treatment unit (hereinafter referred to as the blood study).
1.2. the blood for the operation of the Cabinet introduced a quality system.
1.3. all blood used in the procedures, the Office space and equipment, which may affect the quality of blood components and security, in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures are validated before they are used and validated by repeatedly planned, regular periods.
2. personnel and organization 2.1. Blood Office staff numbers down to ensure the quality of all activities linked to the continuity of blood components from preparers and transfusion service.
2.2. The staff is trained and recognized as competent to execute the tasks.
2.3. the staff has the appropriate knowledge to receive the medical treatment person's certificate. The medical institution or Department Manager assess the treatment person's competence.
2.4. the staff determines the duties and responsibilities of the individual position descriptions, which, if necessary, updated. The study on blood work was the responsibility of the person who is not employed in the preparation of the blood.
2.5. the staff provides initial and further training (training) according to their specific tasks. Staff training plans, organizes and monitors in accordance with documented training program, which includes the principles of good practice.
2.6. study of blood management periodically review the curriculum and assess staff competency.
3. Space 3.1. Blood study have enough space to freely deploy those personnel and medical devices. The room must be easy to clean and clean.
3.2. the work is organised in a logical sequence, to minimise the risk of error.
3.3. storage sites provide enough safe and separate the different categories of blood component storage.
3.4. Blood and blood components at the place of storage shall take measures to prevent damage to the device or to the power shortages.
4. Medical devices and materials 4.1. All blood Cabinet medical devices in accordance with the regulations on the registration of medical devices, conformity assessment, distribution, operation and technical monitoring procedures should be validated or calibrated and maintained in accordance with the intended use.
4.2. personnel in blood are available to study medical equipment instructions (manuals).
4.3. Blood in the Office shall take the necessary measures to all this annex 4.1. actions referred to in point fixed in writing.
4.4. the blood study chosen for medical devices, to minimize any risk to personnel, blood or blood components.
4.5. If the use of a computer with a regular verification of software and hardware, as well as record the backup procedure. Record assurance system validates before use and staying in the State in which they were at the time of validation.
4.6. Record the backup procedure is organised in such a way as to prevent data (recorded information) loss or damage to the computer system does not function properly.
4.7. Blood in the Cabinet organizes measures to ensure hardware and software protection against unauthorized use and modification.
4.8. Blood in the Office establishes and maintains a quality system of communication (internal and external).
5. Documentation 5.1. Blood in the Cabinet provides the following information in writing: 5.1.1 news about blood component requesting, receiving and issuing a transfusion;
5.1.2. details of blood component storage conditions (continuous temperature monitoring);
5.1.3. news about the issuing of blood components, the recipient and the recipient;
5.1.4. details of serious adverse reactions and adverse events blood or blood components for transfusion during or after transfusion;
5.1.5. details of resolved cases;
5.1.6. news on the traceability of blood components, which include: 5.1.6.1. blood components, the name and address of the establishment;

5.1.6.2. delivered the number assigned to a blood component;
5.1.6.3. the recipient's name, surname, personal code, the declared place of residence;
5.1.6.4. pārlietaj units – not the approval of destruction;
5.1.6.5. transfusion of blood components or disposal date (date, month, year);
5.1.7. details of personnel and training of treatment.
5.2. the blood study written documents the procedures of: 5.2.1. blood component transportation, receipt, storage, issue, in order to ensure the quality of blood components to the transfusion. Blood Office documents that contain specifications, procedures and notes for each step includes conditions for the control of the storage parameters and blood components for transfer, if necessary;
5.2.2. operational cooperation with the blood establishments and agencies of serious adverse reactions and events where blood or blood components for transfusion during or after;
5.2.3. the action when the permissible mass not betrothed erythrocytes transfusion service;
5.2.4. the conditions of blood components for transfusion, issued not issued or if blood components do not conform to this provision in annex 2;
5.2.5. the condition that every unit of blood components issued to the intended recipient or parlay, parlay, if not of blood components, check it;
5.2.6. cooperation with laboratories, to ensure successful issue of blood components for transfusion;
5.2.7. the blood components transfused not return back.
5.3. Blood of Cabinet documents, which include specifications, procedures and notes for each step are available to staff and are updated (if necessary).
5.4. all significant changes made, review the documents, dated and signed by the authorised person.
5.5. the records are clearly legible. Blood Office ensure that records are available in the blood to the staff of the Cabinet regardless of the information (the data). Record keeping in place ensure the right conditions to prevent their deterioration, destruction or unauthorized use.
6. Storage and service 6.1. Blood component storage and issuance procedures validated to ensure blood component quality throughout the storage period and to prevent the mixing of blood components.
6.2. Autologous blood and blood components, as well as blood components prepared for special purposes kept separate.
7. Corrective and preventive action 7.1. Blood in the Cabinet set up a system to ensure that the necessary remedial action, if blood components do not conform to the quality requirements.
7.2. Regularly analysed the available data (information) to identify quality problems and ensure that the necessary remedial action.
7.3. the blood Office ensures that all error and accident investigation, documentation and to identify issues that need to be resolved.
7.4. Blood in the Cabinet document and maintain preventive action procedures to determine the blood or blood component non-conformity might cause.
8. Self-test and improvement 8.1. Blood study implemented and maintains self-inspection system to verify compliance with the study of blood requirements of these provisions.
8.2. All documented results of the self-monitoring, and time take effective corrective and preventive action.
The Health Minister, the Minister of finance Spurdziņš o. 8. Annex a Cabinet of 27 December 2005, regulations No 1035 notification of serious adverse reactions (A) Urgent report about potential serious adverse reactions reporting agents report the number reporting date (date, month, year) date of Transfusion (date, month, year) of the Recipient age _____ years Recipient gender (necessary to underline): 1) man 2 woman serious adverse reactions) date (date, month, year) serious adverse reaction refers to the (necessary to underline) : 1) pilnasin States 2) erythrocytes) platelet 3 4) plasma 5) other (specify) serious adverse reactions (necessary to underline): immunological haemolysis value of both-incompatibility-immunological haemolysis value of other aloantiviel-not due to immunological haemolysis value-transfer of bacterial infections with transfusion-anafilaks/hypersensitivity-transfusion-related acute lung injury-virus infection (HBV) transmission by blood transfusion-virus infection (HCV) transmission by blood transfusion-virus infections (HIV-I/II) with blood transfusions-virus infections (specify) with blood transfusion-transmission of infection with the parasitic blood transfusion (malaria)-other parasitic infection (specify) with blood transfusion transmission-pēctransfūzij-purple-Graft versus disease (GVHD)-other (s) a serious adverse reaction (s) (s) (specify) the imputability level (NN, 0-3) part B serious adverse reactions incidence levels of imputability level explanation is not invaluable If NN insufficient data for estimating incidence 0 off if there is compelling evidence to relate the side effects for other reasons it is unlikely if the evidence clearly indicates that adverse reactions most likely apply to other causes rather than to blood and blood components 1 may if there is no clear evidence to relate the adverse reactions to blood, blood components, or to other causes of 2 Reliable, where the evidence clearly indicates that the adverse reactions most likely probable refers to blood and blood components 3 safe if there is compelling evidence to relate the adverse reactions to blood or blood components (C) serious adverse reactions reporting agents report approval number date (date of approval , month, year) serious adverse reactions date (date, month, year) serious adverse reactions approval (yes/no) the imputability level (NN, 0-3) serious adverse reactions change (necessary to underline): 1) Yes 2) No if yes, specify: Clinical outcome (if known) (underline the appropriate):-a complete recovery-not significant complications-complications-death serious health Minister, Minister of finance Spurdziņš o. 9. Annex a Cabinet of 27 December 2005, regulations No 1035 notification of adverse events (A) the urgent report on adverse events reporting agents report the number reporting date (date , month, year) junk event date (date, month, year) adverse event affecting the quality of blood components Specifications and equipment product safety other people, due to the failure fault failure error (specify) in the following stages: preparation of the Apheresis procedure Pilnasiņ blood sample testing processing storage Distribution materials other (specify) part b: confirmation of an adverse event reporting agents report the number of approval date (date, month, year) an adverse event date (date , month, year) of the initial causes analysis (detailed): (C) the part of the annual notice of adverse events by reporting agents reporting period 1 January – 31 December the total processed blood and blood components: adverse event affecting the overall specification of the quality of blood components and the number of people of other equipment products for safety, due to the failure fault failure error (specify) in the following stages: preparation of the Apheresis procedure Pilnasiņ blood sample testing processing storage Distribution materials other (specify) Health Minister: the Minister of finance Spurdziņš o.