Published: 2011-03-10
Key Benefits:
Passed 29.04.2005 Annex 62
RTL 2005, 50, 704
Entry into force 15.05.2005
| 23.02.2011 | RT I, 07.03.2011, 1 | 10.03.2011 |
The Regulation is established under subsection 9 (2) of the Blood Act.
(1) Documents related to transfusion include blood chart, order form of blood product, transfusion report and report of reaction following the transfusion.
(2) Filling of the documents provided in section 1 takes place according to the requirements established in section 2 of § 42of the Health Services Organization Act.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
(1) In selection of blood products for transfusion, the following shall be considered:
1) in the event of blood products prepared from erythrocytes the ABO blood type of patient and donor blood, determination of antigen D on erythrocytes (hereinafter Rh(D) typing), screening of erythrocytic antibodies (hereinafter screening of antibodies) and compatibility tests of patient blood and donor blood;
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
2) in the event of blood products prepared from fresh frozen plasma and thrombocytes the ABO blood group of patient and donor blood and Rh(D) typing;
3) in the event of cryoprecipitate the ABO blood type of patient and donor blood.
(2) If it is not possible to rely on the provisions of section 1 in selection of blood products for transfusion, it is necessary to rely on the immunohaematological compatibility of the blood products to be transfused.
(3) Before the transfusion of blood products the following needs to be carried out:
1) determination of the ABO blood type and Rh(D) typing of the patient and performance of screening for antibodies;
2) in the event of transfusion of blood products prepared from erythrocytes, performance of compatibility tests.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
(4) The necessary blood product, amount thereof and the time of transfusion are determined by a doctor, considering the condition of the patient’s health and modern treatment principles.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
(1) It is not permitted to assign transfusion of blood products prepared from patient’s own blood (i.e. autologous transfusion) for treatment of the patient, if the patient suffers from the following:
1) serious heart disorder;
2) hepatitis B (except for immune HBsAg negative persons);
3) hepatitis C;
4) positive markers of HI infection;
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
5) HTLV III;
6) active bacterial disease.
(2) Blood products prepared for autologous transfusion must not be used for the treatment of other patients.
(1) 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.
(2) When the ABO blood group and Rh(D) typing are determined in the blood of a patient, screening of antibodies performed and blood chart has been created for the patient, suspension of erythrocytes may be transfused to the patient without a compatibility test, considering only the ABO blood group and Rh(D) typing of the patient.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
(3) Without immunohaematological tests on the blood of a patient it is allowed to transfuse O Rh(D) negative suspension of erythrocytes and AB (Rh(D) negative fresh frozen plasma to the patient.
(4) In events provided in sections 2 and 3, also a blood sample drawn from a patient prior to the transfusion shall be sent to the laboratory of immunohaematological tests of the hospital blood bank together with the order form of blood products. The immunohaematological tests not carried out before the transfusion shall be carried out during the transfusion or thereafter.
(5) If alloantibodies or autoantibodies have been identified in the blood of a patient, it is allowed to transfuse compatible donor blood with unknown antigen structure, or if no such blood is available, incompatible donor blood to the patient.
(6) In the event of massive transfusion, if during 24 hours more of suspension of erythrocytes has been transfused to a patient than equals to his/her one quantity of blood, no compatibility tests are required.
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(1) After having received an order from doctor for carrying out immunohaematological tests, a nurse or a bioanalyst shall complete the patient’s blood chart.
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(2) [Repealed - RT I, 07.03.2011, 1 – entered into force 10.03.2011]
(3) The nurse or bioanalyst identifies the patient before drawing of the blood sample, asking his/her first name, last name and date of birth. In the event of an unconscious patient the nurse checks the personal information from a wrist band or another device used to identify the patient.
(4) After the identification of the patient the nurse or bioanalyst draws a blood sample and marks the sample tube without leaving the patient.
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(5) In the event of a transfusion of blood products prepared from erythrocytes, the nurse or bioanalyst draws a new blood sample for compatibility tests, following the requirements established in sections 1 to 4.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
(1) Blood products are issued from the hospital blood bank according to an order form of blood products after the preparation thereof and performance of the necessary tests.
(2) Upon issuing, a blood product shall be supplied with the information of the patient for whom the blood product is issued.
(3) Preservation of blood products is allowed only in dedicated refrigerators supplied with an alarm and temperature control.
(4) Blood products prepared for transfusion are transported in thermal containers within the hospital to ensure the preservation of the temperature of blood products within the limits necessary for the transfusion.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
(1) After the arrival of blood products into a department of the hospital the nurse visually inspects the quality of the blood products. The nurse also checks the expiry date of the blood products and accordance thereof to the order form, as well as the results recorded in the blood chart of the patient.
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(2) The nurse fills the transfusion report and pastes the removable label on the bag of the blood product into the transfusion report.
(3) Before starting the transfusion, the nurse identifies the patient according to the provisions of § 5.
(4) In the event of transfusion of blood products prepared from erythrocytes, the nurse performs an immediate check of ABO blood group from the blood of the patient and the bag segment of the blood product.
(5) A doctor verifies the accordance of the check of the blood group described in section 4 and the blood products to be transfused to the documentation and grants a permission to start the transfusion.
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(1) A special transfusion system containing a filter for removing micro aggregates is used for the transfusion of blood products prepared from erythrocytes, plasma and thrombocytes.
(2) Transfusion of a blood product prepared from thrombocytes shall always be carried out with a new transfusion system.
(3) In the event of a transfusion of newborns and toddlers special transfusion systems for children must be used, which enable very precise dosing.
(4) It is allowed to add only physiological solution into the transfusion system.
(5) Transfusion systems must be exchanged at least every 6 hours.
(1) To ensure the effectiveness and safety of transfusion, blood products shall be prepared in manner suitable for the type of blood product, considering the universal practices of transfusion.
(2) Generally, blood products prepared from erythrocytes do not need to be heated before the transfusion. The transfusion must be started within 30 minutes after the removal from the refrigerator, and the transfusion must be terminated within 4 hours.
(3) Blood products prepared from erythrocytes must be heated to 37 °C in a device designed for that purpose in the following events:
1) massive transfusion;
2) if the transfusion to a child exceeds 15 ml per kg of body weight per hour;
3) transfusion to foetus or newborn;
4) blood exchange of newborn;
5) patient has clinically significant cold agglutinins;
6) patient has hypothermia.
(4) Blood products prepared from thrombocytes must be mixed by gentle shaking before the transfusion. The transfusion must be started immediately upon the arrival of the blood product to the department, and it shall be terminated within 30 minutes.
(5) Frozen plasma products shall be melted to room temperature in a special device prior to the transfusion. The transfusion of melted plasma product is started within 30 minutes after the melting thereof, and in order to obtain the best haemostatic effect a plasma product is transfused within 20 minutes. A transfusion of a plasma product must not last over 4 hours.
(6) Plasma products must be melted to 37 °C in following events:
1) massive transfusion;
2) if the transfusion to a child exceeds 15 ml per kg of body weight per hour;
3) transfusion to foetus or newborn;
4) blood exchange of newborn;
5) patient has hypothermia.
(7) Cryoprecipitate must be immediately transfused as a stream after melting.
(8) Adding of medicinal products to transfused blood products is not permitted.
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(1) Before the transfusion a nurse evaluates the general well-being and state of the patient, registering the body temperature and arterial blood pressure of the patient prior to the transfusion in the transfusion report.
(2) The nurse registers the start time of transfusion of every dose into the transfusion report and monitors the patient during and after the transfusion. In the event of any deviation from the state of the patient’s health the nurse stops the transfusion and immediately informs the doctor.
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(3) At the beginning of transfusion of every dose of blood product it is necessary to monitor the patient continually for 15 minutes.
(4) In the event of transfusions lasting less than one hour, the body temperature and blood pressure shall be registered in the transfusion report upon the termination of the transfusion. In the event of transfusions lasting longer than one hour, the body temperature and blood pressure shall be registered after each hour and upon the termination of the transfusion.
(5) After the transfusion, the nurse shall evaluate the general state of the patient and register the body temperature and arterial blood pressure of the patient in the transfusion report after one, two and three hours from the termination of the transfusion.
(6) Upon the completion of the transfusion and 24 hours after the completion of the transfusion the nurse shall register the quantity and colour of urine excreted by the patient in the transfusion report.
(7) If the time interval and monitored parameters are suitable for the monitoring during and after the transfusion, the nurse can use other parts of the case history for recording the parameters monitored.
[RT I, 07.03.2011, 1 – entered into force 10.03.2011]
In the event of blood products prepared from erythrocytes, the transfusion system and bag of blood product shall be preserved sealed in refrigerator at temperature between +2 to +6 °C for 72 hours after the transfusion.
