ORDER OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of December 11, 2019 No. 1486

About approval of standard regulations on the transfuziologichesky help

Based on the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" for the purpose of providing single regulations in the organization and rendering the transfuziologichesky help in the organizations of health care of the Republic of Belarus I ORDER:

1. Approve the enclosed standard regulations on the transfuziologichesky help (further - the Provision).

2. To chiefs of head departments on health care (health care) of regional executive committees, the chairman of Healthcare Committee of Mingorispolkom, heads of the state organizations of health care subordinated to the Ministry of Health of the Republic of Belarus, heads of the departmental organizations of health care, the non-state organizations of health care and individual entrepreneurs, other organizations which along with the main activities also perform medical activities according to the procedure, established by the legislation of the Republic of Belarus, to governing bodies of health care of the state organizations subordinated to the Government of the Republic of Belarus and the state organizations of health care subordinated to them to take necessary measures for execution of the Provision of this order.

3. Consider No. 519 which voided the order of the Ministry of Health of the Republic of Belarus of May 24, 2018 "About approval of forms of the direction on individual matching of blood and requests for blood, its components, medicines from plasma of blood and product of medical appointment".

4. This order becomes effective since January 1, 2020.

5. To impose control of execution of this order on the First Deputy Minister Pinevich D. L.

Approved by the Order of the Ministry of Health of the Republic of Belarus of December 11, 2019 No. 1486

Standard regulations on the transfuziologichesky help

Chapter 1. General provisions

1. This standard regulations on the transfuziologichesky help (further - the Provision) are developed for the purpose of ensuring system approach and single procedure in the organization and rendering the transfuziologichesky help (further - TP) in the Republic of Belarus, acceptances of further measures for increase in its efficiency and safety, and also to enhancement of system of audit, monitoring and quality evaluation of rendering TP for the purpose of operational regulation of organization activity of health care.

2. The provision determines procedure for the organization and rendering TP, the multi-level analysis of its amount and structure, complex quality evaluation of rendering TP.

Chapter 2. Terms, determinations and indicators of TP

3. Transfusiology - the name of specialty, the division of science and applied medicine studying and providing the organization of service of blood, including production and clinical transfusiology;

3.1. production transfusiology - the Section of medicine studying and providing:

organization of service of blood, donorship, procurement of blood, its components;

production of medicines from plasma of blood, products of medical appointment from blood, its components;

immunological typing;

quality assurance of blood, its components, medicines from plasma of blood, products of medical appointment from blood, its components (further - blood products);

cellular biotechnologies;

3.2. clinical transfusiology - the Section of clinical medicine studying the anatomo-physiological area "haematogenic bodies and blood", biological (and replacing them) liquids of organism, possibility of management of homeostasis, providing the organization and rendering TP;

3.3. TP - complex of the medical services in case of delivery of health care directed to effective and safe maintenance, management, recovery of function of the haematogenic bodies, and also structure, properties and functions of blood, maintenance of homeostasis by purposeful impact by methods and means of transfuziologichesky benefit, holding organizational actions, studying and quality evaluations of rendering TP;

3.4. transfuziologichesky benefit - the medical intervention which is carried out in case of delivery of health care, directed to management of function of the haematogenic bodies, recovery or maintenance of structure, properties and functions of blood, homeostasis (krovesberegayushchy methods and technologies, medical application of products of blood of the donor and (or) autologous, medicines (transfusion, infusion, plazmoterapiya), extra-and intrakorporalny methods of impact on blood);

3.5. transfusion - the medical intervention assuming parenteral introduction to the patient (transfusion) of blood (donor and (or) autologous), its components (including reinfusion);

3.6. reinfusion - the medical intervention assuming parenteral introduction (transfusion) to the patient of the autologous blood, its components which streamed in body cavities, wound in case of injury, transaction, drainage and (or) main blood;

3.7. plazmoterapiya - the medical intervention assuming parenteral introduction to the patient of components of plasma of blood;

3.8. zamenny (exchange) blood transfusion - the medical intervention assuming eksfuziya of blood of the patient with its simultaneous (synchronous) substitution with blood of the donor, its components (transfusion) in the amount equal or exceeding amount of eksfuziruyemy blood;

3.9. eksfuziya - the medical intervention assuming removal of blood from blood bed of the patient;

3.10. infusion - the medical intervention assuming parenteral introduction to the patient of organic and inorganic medicines;

3.11. the transfusion therapy (TT) - the treatment method consisting in medical application of blood, its components;

3.12. the infusion-transfusion therapy (ITT) - the treatment method consisting in medical application of blood, its components, organic and inorganic medicines;

3.13. the recipient - the patient to whom it is carried out (is carried out) transfusion;

3.14. the potential recipient - the patient to whom it is planned (possibly, it is not excluded) carrying out TT.

4. Transfuziologichesky activity - quantity of cases (medical interventions) of rendering transfuziologichesky benefit within one organization of health care (further - OZ) during the accounting period.

5. Transfusion activity - quantity of cases of blood transfusion, its components (transfusions) within one OZ during the accounting period;

5.1. case (one) blood transfusion, its components - transfusion of one unit (dose) of blood or component of blood (the donor, autologous, including when carrying out reinfusion, zamenny transfusion, other);

5.2. unit (dose) of component of blood - blood component amount which can be, as a rule, made by conversion of one unit (dose) of blood;

unit (dose) of blood - 450 ml +/-50 ml of blood integral without amount of the preserving solution.

6. The OZ expeditionary function, TP participating in rendering - the activities of OZ connected with planning and the organization of providing blood with products, forming of their inventories, and also obtaining, delivery, storage, suitability control, distribution and accounting of movement.

6.1. For the purpose of providing the product delivery of blood and samples of blood of patients the cars "Medical care" are used.

7. The analysis of TP is carried out to OZ on each structural division and in general on OZ in form according to appendices 2-8.

8. The list of the questions which are subject to assessment when carrying out the analysis of TP and quality evaluation of its rendering:

organizational and methodical and regular structure;

material and technical resources;

completing of donor personnel, work on propaganda and promotion of donorship, procurement of blood, its components (donor, autologous);

productive activity of subjects of service of blood;

safety and qualities of blood, its components;

analysis of providing blood with products, their target use;

medical application of products of blood (justification, safety, efficiency), application of alternative methods and means;

clinical laboratory diagnostics when rendering TP;

amount, structure and quality of rendering TP;

other questions integrated to rendering TP.

Chapter 3. The TP organization in OZ

9. TP in OZ will be organized according to requirements of the legislation, regulatory legal acts (further - the NPA) the Ministries of Health of the Republic of Belarus (further - the Ministry), instructive and methodical documents on transfusiology, other NPA, requirements to equipment according to appendix 1.

10. According to the existing approximate regular standard rates in OZ the structural (isolated) division of transfusiology (city (interdistrict) blood transfusion station, the city (interdistrict) center of transfusiology, department of transfusiology, transfusiology office is created (further - KT), other).

If the existing approximate regular standard rates do not provide creation of the structural (isolated) division of transfusiology, the order of the chief physician (director) appoints the specialist doctor and the nurse responsible for TP, from among health workers of this OZ.

11. Methodical, organizational and methodical and advice concerning TP to the structural (isolated) division of transfusiology of OZ is provided by the organization of blood transfusion, its branch, the regional center (Minsk) of blood, its branch, representation, the city (interdistrict) center of transfusiology (department of transfusiology) of OZ, other structural (isolated) division of transfusiology of other OZ responsible for clinical transfusiology, audit and monitoring of TP;

11.1. the advisory help can be performed in internal or correspondence form (by phone, system of telemedicine consultation).

12. Rendering TP in OZ is performed according to the procedure, established by the legislation, according to operating mode of OZ and includes activities for the directions:

expeditionary function;

informing, training and control of knowledge of questions of transfusiology of health workers;

coordination of activities of structural divisions, health workers concerning transfusiology, interaction with the organization of blood transfusion (its branch);

clinical laboratory blood tests;

implementation of consultations, participation in consultations, rendering transfuziologichesky benefit;

technical supply of work of the commissions of OZ on transfusiology;

implementation in medical practice of the TP modern methods;

prevention of transfusion reactions and posttransfusion complications (further - TR and PTO), undesirable reactions in case of medical application of products of blood, medical care in case of their origin, investigation of the reasons, registration and accounting, informing on origin;

development and ensuring donorship (autodonorstvo) of blood, its components, including accomplishment of donor function on a grant basis;

maintaining accounting medical documentation on transfusiology;

quality assurance of TP;

participation in forming, maintaining and operation of the Single database, information and analytical systems, information resources, bases (banks) of data and (or) registers (registers), systems of telemedicine communications in health care and service of blood;

participation in planning and holding special events in system of service of emergency medical service (further - SMP) and health service of civil defense (further - GO);

the analysis of amount, structure and quality of TP in OZ;

participation in studying and quality evaluation of rendering TP;

implementation of other activities according to the legislation.

13. The question of TP is heard on the OZ medical council at least once a year, medical and control council, medical control commission.

14. The order of the chief physician (director) of OZ affirm:

amount and structure of reserve stock (or its absence) blood products, place and conditions of its storage, ranking health workers;

algorithm of providing blood with products, the scheme of interaction with other OZ;

algorithm of the adjusting actions in case of violation of conditions of transportation and storage of products of blood;

algorithms of medical application of products of blood;

the training program and the list of questions for control of knowledge of transfusiology of health workers of OZ;

the list of the health workers allowed to rendering TP;

other requirements and (or) procedure.

14.1. The order of the chief physician (director) also determines the health workers responsible for:

quality assurance of TP, participation in rendering TP of the health workers allowed by the order of the chief physician (director) - the deputy chief physician (director) of medical part or the health worker, in accordance with the established procedure its replacement;

TP (the organization, rendering, studying and quality assurance) - the doctor-transfuziolog (manager) of the structural (isolated) division of transfusiology of OZ, or the specialist doctor responsible for TP (according to the existing staff list), or the health worker, in accordance with the established procedure its replacement;

work of the structural (isolated) division of transfusiology - the doctor-transfuziolog (manager) or the health worker, in accordance with the established procedure its replacement;

activities of health workers with secondary vocational medical education when rendering TP, observance of the sanitary and epidemiologic mode - the chief nurse or the health worker, in accordance with the established procedure its replacement;

expeditionary function - the nurse, the nurse (senior) the structural (isolated) division of transfusiology, the nurse responsible for TP (according to the existing staff list), or the health worker, in accordance with the established procedure its replacement;

clinical laboratory diagnostics, including immunohematologic, registration of discrepancies in case of determination of blood type on the AVO system in the magazine in form according to appendix 13 - the manager of kliniko-diagnostic laboratory (further - KDL) or the health worker, in accordance with the established procedure its replacement. In evening, night time, days off and holidays - the doctor on duty of clinical laboratory diagnostics or the medical technologist (according to the existing staff list);

TP in OZ in evening, night time, days off and holidays, expeditionary function, the doctor-transfuziologa challenge - the responsible doctor on duty.

14.2. The order of the chief physician (director) also determines the health workers of structural divisions responsible for:

the organization and rendering TP - the manager of structural division or the health worker, in accordance with the established procedure its replacement;

rendering TP by health workers with secondary vocational medical education, storage and accounting of movement of products of blood - the senior nurse or the health worker, in accordance with the established procedure its replacement;

the direction for immmunogematologichesky researches, matching of compatible blood and the request for blood products with document creation in forms according to appendices 10-11, medical application of products of blood, maintaining medical documentation on transfusiology, the doctor-transfuziologa challenge - the attending physician (in evening, night time, days off and holidays - the responsible doctor on duty);

fence and delivery of samples of blood of patients, obtaining and transportation in OZ of products of blood, participation in carrying out transfuziologichesky benefit, maintaining accounting medical documentation on transfusiology within the competence - the nurse of structural division (in the evening, days off and holidays - the duty nurse) according to the decision of administration;

transfuziologichesky benefit - the specialist doctor and the nurse participating in its carrying out.

14.3. The order of the chief physician (director) also determines the health workers of the operational block (department) responsible for:

the TP organization - the manager of the operational block (department) or the health worker, in accordance with the established procedure its replacement;

transfuziologichesky benefit - the specialist doctor included in structure of operational crew according to the local regulation;

blood product receipt, preparation them to medical application, execution of the current accounting medical documentation on transfusiology - the health worker of department of the patient or scrub nurses or the medical anesthesiology nurse who are not occupied in carrying out this medical (operational) intervention;

participation in rendering transfuziologichesky benefit, the equipment for transfusion (including reinfusions) - the nurse of the structural (isolated) division of transfusiology, or the medical anesthesiology nurse who is not participating in rendering anesteziologichesky benefit during this medical (operational) intervention or other health worker with secondary vocational medical education having special preparation on operation of the equipment and technique.

15. The order of the chief physician (director) creates the commissions of OZ on transfusiology:

15.1. on write-off of products of blood in structure: the deputy chief physician (director) of medical part (chairman) managing department (in which write-off), the doctor-transfuziolog (manager), the doctor-transfuziolog of the structural (isolated) division of transfusiology or the specialist doctor responsible for TP (according to the existing staff list), the epidemiologist (in the presence of position in the staff list OZ is made), the chief nurse, the pharmacy manager, the accountant;

15.2. on control of knowledge of health workers of transfusiology in structure: the deputy chief physician (director) of medical part (chairman), deputy chief physicians (director), the manager of department of anesthesiology and resuscitation, the manager of KDL, the chief nurse (for health workers with secondary vocational medical education), the doctor-transfuziolog of the structural (isolated) division of transfusiology or the specialist doctor responsible for TP (according to the existing staff list), the doctor-transfuziolog (manager), the doctor-transfuziolog responsible for clinical transfusiology, audit and monitoring of TP (the organization of blood transfusion or regional (Minsk) of the center of blood, their branches, representations, the city (interdistrict) center of transfusiology, other OZ);

15.3. on control of blood transfusion, its components in structure: the deputy chief physician (director) of medical part (chairman), deputy chief physicians (director), the manager of department of anesthesiology and resuscitation, the manager of KDL, the manager of the operational block (department), the pharmacy manager, the chief nurse, the doctor - the clinical pharmacologist and the epidemiologist (in the presence of positions in the staff list OZ), managers of other structural divisions according to the decision of administration, the doctor-transfuziolog (manager), the doctor-transfuziolog of the structural (isolated) division of transfusiology or the specialist doctor responsible for TP (according to the existing staff list), the doctor-transfuziolog responsible for clinical transfusiology, audit and monitoring of TP (the organization of blood transfusion or regional (Minsk) of the center of blood, their branches, representations, the city (interdistrict) center of transfusiology, other OZ). The commission conducts activities according to the NPA of the Ministry. Commission session is drawn up by the protocol in form according to appendix 9.

16. Training and control of knowledge of transfusiology of the health workers involved in rendering TP in OZ is performed:

regular health workers;

at least 2 times year (theoretical and practical occupations);

control of knowledge (offsetting) - at least 1 time a year, with execution of the protocol in form according to appendix 12;

the training program and the list of questions are developed for control of knowledge by the commission on control of blood transfusion, its components based on the standard program, approved with the organization of blood transfusion, affirm the order of the chief physician (director) of OZ;

training is provided by the doctor-transfuziolog (manager), the doctor-transfuziolog of the structural (isolated) division of transfusiology of OZ, the doctor of laboratory diagnostics of OZ having preparation on immunohematology, the doctor-transfuziolog of the organization of blood transfusion (its branch), regional (Minsk) of the center of blood, its branch, representation, the city (interdistrict) center of transfusiology (department of transfusiology the) of OZ, other structural (isolated) division of transfusiology of other OZ responsible for clinical transfusiology, audit and monitoring of TP.

17. Orders of the doctor-transfuziologa (manager), the doctor-transfuziologa of the structural (isolated) division of transfusiology are obligatory to execution by the health workers of OZ participating in rendering TP.

18. The health workers participating in TP bear responsibility according to the legislation;

18.1. the health workers of OZ allowed to rendering TP by the order of the chief physician (director) of OZ following the results of control of knowledge of transfusiology participate in rendering TP;

18.2. obligations, the rights and the responsibility of health workers stated in this Provision are brought in job descriptions of the health workers involved in rendering TP.

Chapter 4. The main objectives and functions of the structural (isolated) division of transfusiology of OZ

19. The structural (isolated) division of transfusiology of OZ - structural division with independent tasks, functions on the organization and rendering TP in OZ;

19.1. it is created by the order of the chief physician (director) of OZ according to approximate regular standard rates, are headed by the doctor-transfuziologom (manager);

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