Blood working group

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The Blood Working Group of the Federal Ministry of Health and Social Security (BMGS), abbreviated as "AK Blood", is based at the Robert Koch Institute in Berlin and, in accordance with the Transfusion Act, advises the Federal Government on questions of safety when using blood and blood products . The members of the committee are recruited from a wide variety of specialist disciplines, whose office is then located at the Robert Koch Institute. The office organizes the work of the committee and implements the resolutions.

International, anglicized names are “German National Advisory Committee Blood”, “National Advisory Committee Blood (Germany)” or “Advisory Committee Blood (Germany)”.

History of the foundation

In September 1993 the “Blood” working group was launched at the Robert Koch Institute in Berlin. The first chairmanship was held in 1993 by the university professor and microbiologist Reinhard Burger . When, in 1998, the Transfusion Act (TFG) was issued in the Federal Republic of Germany that regulates the extraction of blood, blood components and blood products as well as their use in humans during blood transfusions , the "AK Blood" was also laid down in Section 24 . The members of the body are appointed by the Federal Ministry . It also determines the chairman.

Working method, calling, members

In its working method, the working group sees itself as a committee of experts that advises the federal and state authorities on issues relating to the safety of blood and blood products and thus the safe supply of the population. The committee is composed of all important expert or affected groups, such as the German Medical Association (BÄK) , the blood donation services of the German Red Cross , the working group of doctors from state and municipal blood transfusion services, the Federal Ministry of Defense , the supervisory authorities of the states ( Federal Institute for Drugs and Medical products ), as well as the relevant specialist societies, the pharmaceutical industry and the associations in which patients have come together (such as the Haemophile Interest Group , German Haemophilia Society (DHG eV) ) who have to regularly use blood products. Representatives of the following institutions and associations take part in an advisory capacity; for example the Robert Koch Institute , the Paul Ehrlich Institute , the German Organ Transplantation Foundation , the Federal Institute for Drugs and Medical Devices, the National Association of Health Insurance Funds and the European Directorate for the Quality of Medicines and Healthcare .

The research institute publishes the results of its deliberations on current aspects of transfusion medicine and transfusion safety as so-called votes . These are published in the Federal Health Gazette or Federal Gazette . However, members are obliged to maintain confidentiality about the content and process of the deliberations.

According to § 1 of the rules of procedure - it was adopted at the 72nd meeting of the Blood Working Group on March 30, 2012 and replaces an original version of September 17, 1998 - the members of the Blood Working Group and their deputies are appointed by the Federal Ministry of Health for a period of 3 years, this also applies to the term of office of the chair, which is determined and appointed by the Federal Ministry of Health. Membership begins on the day of the first meeting after the appointment and ends at the latest on the day before the first meeting of the newly appointed Blood Working Group. Members and deputies can declare their departure in writing to the Federal Ministry of Health at any time.

The meetings of the "AK Blood" are called according to § 4 of the rules of procedure by the respective chairman as required, usually two to three times a year. According to Section 7, Paragraph 2 , the “Blood Working Group” has a quorum if all members are invited and more than half of the members are present. All votes published after November 8, 2000 are also available in English. The pronouncements, i.e. the votes of the Blood Working Group, are to be continuously checked with regard to the effects on the guidelines work of the German Medical Association in its "Guidelines for the Collection of Blood and Blood Components and for the Use of Blood Products (Hemotherapy) (RiliBÄK-Blut)". Although the votes have no legally binding effect, they still have application-related effects via the “RiliBÄK-Blut” of the German Medical Association and according to Sections 12 and 18 of the “TFG”. But also in the participating professional societies, such as the blood donation services , the drug manufacturers, generally implement the results of the votes directly in their standard instructions (SOP) , Standard Operating Procedures .

Since 2014, the university professor and transfusion specialist Ruth Offergeld has been the chairwoman of the “AK Blut”. Ms. Offergeld was the managing director of the “AK Blut” from 2002 to 2014.

The individual votes (selection)

  • Vote 45 (05.2015)

Determination of donor suitability and suitability for donation of haemochromatosis trait carriers

  • Vote 44

Hygiene conditions for donation processes and their microbiological monitoring "(see Section 31 (4) AMWHV)

  • Vote 43 (11.2012)

Update of vote 16 "Minimum requirements for the microbiological control of blood components for transfusion"

  • Vote 42 (11.2012)

Update of Votes 34 and 35 "Procedure for tracing (" look back ") (according to § 19 Transfusion Act)" from June 14, 2006 with regard to hepatitis B infections

  • Vote 41 (06.2010)

Use of a standardized questionnaire for blood and plasma donors

  • Vote 40 (11.2009)

Federal Health Gazette 1, 2010 p. 84

  • Vote 39 (01.2009)

Measures to avoid transfusion-induced lung insufficiency ( TRALI )

  • Vote 38 (06.2008)

Bundesgesundheitsblatt 12, 2008 p. 1484 Determination of the shelf life of platelet concentrates with the aim of reducing life-threatening septic transfusion reactions through bacterial contamination (PDF, 298 kB)

  • Vote 37 (06.2008)

Bundesgesundheitsblatt 10, 2008 p. 1219 Notification of donors with antibodies against the hepatitis B core antigen ( anti-HBc )

  • Vote 36 (10.2007)

Bundesgesundheitsblatt 12, 2007 p. 1591 Confusion-proof documentation through uniform identification code for blood components in Germany

  • Vote 35 (11.2006)

Bundesgesundheitsblatt 2, 2007 pp. 246–247 Supplement to vote 34 "Procedure for tracing back (" look back ") (in accordance with Section 19 of the Transfusion Act)" of June 14, 2006

  • Vote 34 (06.2006)

Bundesgesundheitsblatt 9, 2006 pp. 940–957 Procedure for tracing back ("look back")

  • Vote 33 (01.2006)

Procedure for variant Creutzfeldt-Jakob disease (vCJD) in connection with blood, plasma and blood products

  • Vote 32 (03.2005)

Current recommendations for autologous hemotherapy

  • Vote 31 (03.2005)

Increasing the safety of cellular blood components and fresh plasma stored in quarantine by testing blood and plasma donations for antibodies against the hepatitis B core antigen (anti-HBc)

  • Vote 30 (10.2003)

No determination of alanine aminotransferase (ALT) as a release criterion for blood components for transfusion and plasma for fractionation

  • Vote 29 (05.2003)

Student training in transfusion medicine and hemostaseology (hemotherapy)

  • Vote 28 (11.2002)

Reduction of the quarantine storage period for fresh frozen plasma (GFP) from 6 months to 4 months

  • Vote 27 (07.2002)

Introduction of "Predonation Sampling"

  • Vote 26 (10.2001)

On the European discussion about the expense allowance for blood and plasma donors

  • Vote 25 (04.2001)

Recommendation for the introduction of a new cross-sectional area with a compulsory course "Transfusion Medicine with Hemostaseology " as part of the amendment to the licensing regulations

  • Vote 24 (12.2000)

Procedure for tracing back (“look back)” - in accordance with Section 19 of the Transfusion Act and laboratory schemes

  • Vote 23 (05.2000)

Recommendation on reporting according to the Transfusion Act § 22 (epidemiological data): Erratum (V23) III. Laboratory diagnostics for blood donor screening to clarify a hepatitis C virus infection

  • Vote 22 (11.1999)

Recommendation on reporting in accordance with Section 22 of the Transfusion Act (epidemiological data) Laboratory diagnostics for blood donor screening to clarify HIV , HBV or HCV infection II. Laboratory diagnostics for blood donor screening to clarify hepatitis B virus infection III. Laboratory diagnostics for blood donor screening to clarify a hepatitis C virus infection. Registration forms according to Section 22 of the Transfusion Act National questionnaire for infection screening in blood and plasma donors: Data sheet for test results from positive donors - version 2002 National questionnaire for infection screening in blood and plasma donors - version 2002 donor data in connection with a positive marker result

  • Vote 21 (09.1999)

Supplementary recommendations for the testing of blood and plasma donations and for the traceability procedure HIV test scheme for the tracing procedure HCV test scheme for the tracing procedure HBV test scheme for the tracing procedure

  • Vote 20 (09.1998)

Testing of blood donations for hepatitis C virus using nucleic acid detection techniques

  • Vote 19 (03.1998)

Nucleic Acid Detection Techniques in Transfusion Medicine: Requirements

  • Vote 18 (09.1997)

Nucleic Acid Detection Techniques in Transfusion Medicine: Requirements

  • Vote 17 (09.1997)

Coordinated reporting system and reporting forms: Supplement and update of the recommendation (supplement to the vote of the Blood Working Group of May 16, 1994, "Ten-point recommendation for establishing a coordinated reporting system", Federal Health Gazette 7/1994, p. 319) Recommendations for follow-up samples of therapeutic Blood components and reserve samples from plasma pools

  • Vote 16 (07.1997)

Minimum requirements for sterility testing of blood components At the 21st meeting of the Blood Working Group on January 16, 1997, the following vote (V 15) was passed.

  • Vote 15 (01.1997)

Transfusion medicine training in medical studies

  • Vote 14 (09.1996)

Recommendations for the “look back” of suspected infected plasma donations for plasma for fractionation

  • Vote 13 (05.1996)

Supplement to the recommendations of the Blood Working Group on the procedure for reactive screening tests for HIV or HCV antibodies or HBV surface antigen in blood and plasma donations Batch-related documentation of blood products

  • Vote 12 (01.1996)

Opinion on product recalls due to the risk of Creutzfeldt-Jakob disease being transmitted through blood products

  • Vote 11 (10.1995)

Hyperimmune plasma (plasma for special purposes) for the production of hyperimmunoglobulins (special immunoglobulins )

  • Vote 10 (09.1995)

Improvement of screening tests for the detection of infectious agents and risk defense (procedure in the event of a change in approval) Responsibility of trained or further trained doctors for transfusion-related immunohematology

  • Vote 9 (06.1995)

Recommendations for the procedure for reactive screening tests for HIV or HCV antibodies or HBV surface antigen for blood and plasma donations. (Supplement and modification of the "Recommendations of the ad hoc commission of the blood working group on the tracing procedure (" look back ") for individual donors and small pool blood preparations", as a vote of the blood working group published in the Federal Health Gazette 37/12 (1994) 513.) Recommendation on the appointment and tasks of transfusion officers, transfusion officers, transfusion commissions and working groups for haemotherapy Discarding unused autologous blood donations and rejection of donations made

  • Vote 8 (05.1995)

Prevention of bacterial contamination in blood products

  • Vote 7 (11.1994)

How to change the approval of screening tests for antibodies against HIV

  • Vote 6 (09.1994)

Reduction of the risk of transmission of hepatitis B by testing for anti-HBc antibodies Labeling of blood products to facilitate batch documentation for the user Recommendations of the ad hoc commission of the blood working group on the look-back process for individual donors and small-pool blood preparations Minimum requirements for autologous blood production ( in addition to the vote of the Blood Working Group of March 14, 1994, published in the Federal Health Gazette 4/1994, p. 176).

  • Vote 5 (07.1994)

Use of the PPSB preparation Beriplex only if there is a vital indication

  • Vote 4 (05.1994)

Reduction of the risk of infection with blood and blood products through optimized screening of donors Batch documentation when using recombinant factor VIII. Ten-point recommendation for the establishment of a coordinated reporting system

  • Vote 3 (03.1994)

Quarantine storage of plasma for fractionation Quarantine storage of fresh plasma obtained by frequent plasmapheresis. Requirements for managers of blood and plasma donation facilities. Batch documentation for albumin Recommendations for autologous blood donation. Opinion on directed blood donation and relative donation

  • Vote 2 (01.1994)

Efficient regulatory control of blood donation and plasma donation institutions. Limitation of pool size when processing blood plasma. Evaluation of the HIV-1 p24 antigen test for blood and plasma donations

  • Vote 1 (11.1993)

Compensation for blood and plasma donors Exclusion of drug addicts from the donor population Transfer of data from HIV-positive donors to other blood and plasma donation services

literature

Individual evidence

  1. ↑ Dr. med. Reinhard Burger, curriculum vitae ( Memento of the original dated December 22, 2015 in the Internet Archive ) Info: The archive link was automatically inserted and not yet checked. Please check the original and archive link according to the instructions and then remove this notice. @1@ 2Template: Webachiv / IABot / www.bundesaerztekammer.de
  2. ↑ Birgit Schmidt am Busch: Health security in the multi-level system. Vol. 168 of Jus Publicum Series, Mohr Siebeck, Tübingen 2000, ISBN 3-16-149308-7 , pp. 366-367.
  3. ↑ In 2002 it was expanded to include the social area (pension and long-term care insurance) and was called the Federal Ministry for Health and Social Security (BMGS).
  4. ^ 10 years of the Haemophiler eV interest group , Bonn , April 4, 2011.
  5. ^ German Haemophilia Society (DHG eV) .
  6. ↑ Votes by the blood group .
  7. ↑ Rules of Procedure of the Blood Working Group of the Federal Ministry of Health adopted at the 72nd meeting of the Blood Working Group on March 30, 2012.
  8. ↑ Guidelines for the collection of blood and blood components and for the use of blood products (haemotherapy) . Set up according to §§ 12a u. 18 Transfusion Act by the German Medical Association in agreement with the Paul Ehrlich Institute. Second amendment of the guidelines in 2010 in the version approved by the Board of Directors of the German Medical Association on April 16, 2010. The agreement of the Paul Ehrlich Institute was made on May 4, 2010.
  9. ↑ Dr. med. Ruth Offergeld, curriculum vitae (PDF).
  10. ↑ List of members of the Blood Working Group (as of 03/2014). Members of the working group appointed by the Federal Ministry of Health .
  11. ↑ colloquially also Voten , on Votum consultativum or expert opinion