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Terms and procedures for performing immunohaematological tests

Issuer:Minister of Social Affairs
Type:regulation
In force from:10.03.2011
In force until:20.01.2013
Translation published:09.10.2014

Terms and procedures for performing immunohaematological tests

Passed 29.04.2005 No. 61
RTL 2005, 50, 703
Entry into force 15.05.2005

Amended by the following legal instruments (show)

PassedPublishedEntry into force
23.02.2011RT I, 07.03.2011, 110.03.2011

Chapter 1 GENERAL TERMS 

§ 1.  Scope of application

  The Regulation establishes the terms and procedure for immunohaematological tests on patient blood and donor blood performed for the determination of donor blood products suitable for treatment of a patient.

§ 2.  Documents related to immunohaematological tests

 (1) Documents related to immunohaematological tests are patient’s blood chart, order form of blood product and transfusion report.

 (2) Filling of the documents provided in section 1 takes place according to the requirements established in section 2 of § 42.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 3.  Requirements to reagents used in immunohaematological tests

 (1) Reagents used in immunohaematological tests shall be prepared or manufactured according to the requirements established in legal acts, and they shall be used according to the instructions of the manufacturer, except if validated otherwise.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (2) For determination of ABO blood group by direct reaction monoclonal anti-A and anti-B reagents are used, for confirming determination the negative control of the direct reaction with reversed reaction is used. For the reversed reaction, suspension of at least A1 and B standard erythrocytes is used.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (3) Upon determination of antigen D on erythrocytes (hereinafter Rh(D) typing) monoclonal, polyclonal (human) or mixed type (IgG/IgM) anti-D reagent must be used.

 (4) Monoclonal anti-K reagent is used for determination of antigen K.

 (5) In screening of antibodies, polyspecific anti-human globulin reagent and typified suspension of standard erythrocytes of group O.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (6) In screening of donor blood antibodies standard erythrocytes are used, which must have the following antigens present: D, C, E, c, e, K, k, Fya, Fyb, Jka, Jkb, P1, M, N, S, s.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (7) In screening of antibodies of patients’ blood, suspension containing at least two typified standard erythrocytes of group O are used if serological matching is applied, and suspension containing at least three typified standard erythrocytes of type O if compatibility of blood components based on database (hereinafter VAS) is applied. The following antigens shall be present for standard erythrocytes: D, C, E, c, e, K, k, Fya, Fyb, Jka, Jkb, Lea, Leb, P1, M, N, S, s, of which C, E, c and e are represented homozygotically. In the event of applying VAS, the standard erythrocytes shall also have the following antigens represented homozygotically: Fya, Fyb, Jka, Jkb, S and s.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 4.  Place of performing immunohaematological tests

  Immunohaematological tests of donor blood are carried out in the laboratory of immunohaematological tests of the Blood Centre. Immunohaematological tests of patient blood are carried out in the laboratory of immunohaematological tests of the health care service provider or the Blood Centre.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 5.  Performer of immunohaematological tests

  Immunohaematological tests may be carried out and evaluated by a doctor or a person having passed a relevant training.

§ 6.  Marking and preserving of a blood sample drawn for immunohaematological tests

 (1) The tube of blood sample shall be marked with the following information:
 1) first and last name of the patient;
 2) ID number of the patient, personal ID code or time of birth.

 (2) A donor blood test shall be marked with unique blood donation bar code.

 (3) A blood sample drawn for immunohaematological tests is preserved at temperature +2 – +6 °C. A blood sample subject to testing shall be without signs of haemolysis.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

Chapter 2 TERMS AND PROCEDURES FOR PERFORMING IMMUNOHAEMATOLOGICAL TESTS OF DONOR BLOOD 

Section 1 Obligatory immunohaematological tests of donor blood 

§ 7.  Obligatory immunohaematological tests of donor blood

  The ABO blood group, Rh(D) typing and existence of antigen K shall be determined in donor blood, and screening of erythrocytic antibodies (hereinafter screening of antibodies) shall be carried out.

§ 8.  Determination of ABO blood group

 (1) The ABO blood group of donor blood is determined upon every donation of blood, upon the first time with the reverse reaction.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (2) The ABO blood group of a donor donating blood for the first time is determined from two separate blood samples.

 (3) The ABO blood group of a donor’s blood may be determined on a level surface on test plates, in tube, on micro plates or by column agglutination technique.

§ 9.  Determination of Rh(D) typing

 (1) The Rh(D) typing of donor blood is determined upon every blood donation.

 (2) The Rh(D) typing of a donor donating blood for the first time is determined by two different reagents.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (3) The combination of reagents and methods selected to determine the Rh(D) typing of donor blood must ensure the issuing of donor blood with weak and partial antigen D as Rh(D)
positive.

 (4) The Rh(D) typing of donor blood may be determined in a tube, on micro plates or by column agglutination technique.

§ 10.  Determination of antigen K

 (1) Antigen K of donor blood is determined in the blood of a donor upon the two first donations of blood.

 (2) The antigen K of donor blood may be determined in a tube, on micro plates or by column agglutination technique.

§ 11.  Screening of antibodies

 (1) Screening of antibodies in the donor blood is performed upon at least the first two donations of blood. Upon the following donations of blood, screening of antibodies of donor blood is performed in the event that the donor has had a transfusion or has been pregnant after the last donation of blood.

 (2) A doctor of the Blood Centre determines the need for screening for antibodies in the blood of a donor, relying on the information of the donor’s questionnaire.

 (3) Screening of antibodies in a donor’s blood shall be carried out by an indirect antiglobulin test in a tube, on micro plates or by column agglutination technique.

 (4) Upon finding antibodies in the blood of a donor they shall be identified and the blood product destroyed.

Section 2 Additional immunohaematological tests of donor blood 

§ 12.  Additional immunohaematological tests of donor blood

 (1) In addition to the provision of § 7, also the Rh phenotype and phenotypes of other systems of blood groups (i.e. the extended phenotype) are determined for a sufficient number of donors to ensure the performance of compatibility tests according to the phenotype for patients in whose blood antibodies were detected.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (2) Upon the determination of the Rh phenotype and the extended phenotype of donor blood the erythrocytes of donor blood are tested with reagents containing the relevant antibodies.

 (3) The Rh phenotype and the extended phenotype of donor blood may be determined in a tube, on micro plates or by column agglutination technique.

Chapter 3 TERMS AND PROCEDURES FOR PERFORMING IMMUNOHAEMATOLOGICAL TESTS OF PATIENT BLOOD 

§ 13.  Obligatory immunohaematological tests of patient blood

  The ABO blood group and Rh(D) typing of patient blood shall be determined, screening of antibodies and compatibility tests of patient blood and donor blood shall be carried out.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 14.  Patient identification obligation

  A patient shall be identified upon the drawing of every blood sample. For checking the identification of a patient, the ABO blood group and Rh(D) typing shall be determined from every blood sample tested before the performance of other immunohaematological tests.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 15.  Determination of ABO blood group

 (1) The ABO blood group of a patient is initially determined at the patient by direct reaction. [RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (2) For confirming determination of the ABO blood group of a patient, both direct and reversed reaction shall be performed. The ABO blood group of a patient may be checked by direct reaction. (3) The ABO blood group of a patient’s blood is determined on a level surface on test plates, in tube, on micro plates or by column agglutination technique.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (3) For newborns and babies until 4 months of age the ABO blood group is determined only by direct reaction.

 (4) In a laboratory of immunohaematological tests, the result of determination of the ABO blood group of a patient is compared to an earlier result of determination of the ABO blood group.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (5) If the results of tests performed in a laboratory of immunohaematological tests do not match with an earlier determination of the ABO blood group, a new blood sample shall be drawn from the patient to determine the ABO blood group.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 16.  Determination of Rh(D) typing

 (1) The Rh(D) typing of a patient’s blood is determined by direct agglutination reaction in a tube, on micro plates or column agglutination technique, using an anti-D (IgM) reagent that does not highlight the DVI category. Reagents and methods highlighting weak or partial D are not used in testing of a patient’s blood.

 (2) The Rh(D) typing of the blood of newborns is determined by anti-D reagent determining the DVI category.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 17.  Screening of antibodies

 (1) Screening of antibodies in the blood of a patient is carried out from the first blood sample with determination of the ABO blood group and Rh(D) typing for patients undergoing a transfusion, and for all pregnant women.

 (11) Screening of antibodies is carried out on pregnant women upon registration. If the initial screening proves negative, another screening of antibodies in the blood shall be carried out between the 28th and 36th week of pregnancy.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (2) Screening of antibodies in the blood is performed by an in vitro indirect antiglobulin test, on micro plates or by column agglutination technique.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (3) For newborns and babies until 4 months of age, a direct antiglobulin test is performed instead of screening for antibodies in blood.

 (4) In the event of repeated transfusions, screening of antibodies in a patient’s blood shall be repeated at least every 5 days if serological matching is applied, and at least every 72 hours if VAS is applied.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (5) If a patient has not undergone a transfusion within the past three months or she has not been pregnant, the screening results for antibodies in blood are valid for three months.

§ 18.  Positive screening of antibodies

 (1) In the event of a positive screening of patient’s blood for antibodies, the antibodies detected in the patient’s blood shall be identified in the laboratory of immunohaematological tests of the Blood Centre.

 (2) If a transfusion is necessary for a patient in whose blood antibodies have been detected, a serological matching of blood shall be performed on the patient, if necessary, according to the Rh phenotype and extended phenotype. It is allowed to carry out a scheduled transfusion on a patient after the antibody has been identified and it has been verified that a corresponding erythrocytic antibody is not present in the blood of the matched donor.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (3) If the identification of the antibody detected in a patient’s blood fails, the transfusion shall be carried out based on serological matching. If possible, identification of antibodies shall be repeated in 3 – 4 weeks.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (4) If antibodies were detected in the blood of a patient, in the event of every following transfusion, particularly antigen-negative blood shall be selected for him/her and serological matching shall be carried out. Before matching the blood, the performer of serological matching shall determine whether antibodies have been found in the blood of the patient in the course of prior immunohaematological tests, based on documents or information available.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (5) For pregnant women, the level of titre of identified antibodies shall be monitored upon serological titration by antiglobulin method in a tube, or by method where potentiators are not used to highlight antibodies.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 19.  Compatibility tests

  [RT I, 07.03.2011, 1 – entered into force 10.03.2011]

 (1) Before the performance of compatibility tests, the ABO blood groups of patient blood and donor blood shall be determined according to the provisions of § 8 and § 15.

 (2) A new blood sample drawn from a patient for compatibility tests must not be older than three days at the moment of matching.

 (3) For performing of serological matching, an indirect anti-human globulin test shall be used. For VAS, a locally validated special information system shall be used.

 (4) The results of compatibility tests are valid for 5 days from drawing of blood sample from a patient.

 (5) Donor blood having produced a negative result on serological matching or blood checked with VAS shall be deemed suitable for transfusion.

 (6) Blood sample of a patient from which compatibility tests were run, as well as the erythrocytes of the matched donor shall be preserved at the laboratory at least for 7 days at temperatures between +2 and +6 °C.

 (7) In the event of a haemolytical disease of a newborn, serological matching shall be carried out also with the blood of the mother.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]

§ 20.  Performance of immunohaematological tests of patient’s blood in the event of providing help in emergency situation

  In the event of providing help in an emergency situation, when the time spent on immunohaematological tests and the risk of a mistake in identification of patient are minimized, it is allowed to perform all immunohaematological tests from one blood sample of the patient.

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