Legislative framework of the Russian Federation. What you need to know about the rules of blood transfusion? Organization of the expert’s work

In accordance with the Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens, the Law of the Russian Federation "On medical insurance of citizens in the Russian Federation" and in order to improve quality control of medical care to the population of the Russian Federation, in agreement with the Social Insurance Fund of the Russian Federation, we approve:

Regulations on the system of departmental quality control of medical care in healthcare institutions of the Russian Federation (Appendix 1).
Regulations on the system of non-departmental quality control of medical care in the Russian Federation (Appendix 2).
Regulations on a freelance medical expert (Appendix 3).
Regulations on the expert of the medical insurance organization (Appendix 4).

We order:

1. The heads of health care management bodies of the constituent entities of the Russian Federation should develop a system of organization and procedure for monitoring the quality of medical care in subordinate medical and preventive institutions.

2. To the heads of healthcare authorities of the constituent entities of the Russian Federation and territorial compulsory health insurance funds:

2.1. Organize a system for quality control of medical care to the population in accordance with this Order.

2.2. In agreement with interested organizations and institutions, develop and approve a procedure for non-departmental quality control of medical care on the territory of a constituent entity of the Russian Federation.

3. The Department of Educational Institutions of the Ministry of Health of Russia (N.N. Volodin) and the Department of Scientific and Methodological Support and Personnel Training of the Federal Compulsory Medical Insurance Fund to develop and, in the prescribed manner, approve training programs for freelance medical experts and experts from insurance medical organizations that monitor the quality of medical care to the population.

4. The Department for organizing medical care to the population of the Ministry of Health of Russia (A.A. Karpeev) and the Department for organizing compulsory medical insurance of the Federal Compulsory Medical Insurance Fund (N.D. Tegai) provide organizational and methodological assistance to health authorities and institutions, territorial compulsory health insurance funds, medical insurance organizations on issues of organizing quality control of medical care to the population.

5. Control over the implementation of the Order shall be entrusted to the Deputy Minister of Health of the Russian Federation V.I. Starodubov and First Deputy Executive Director of the Federal Compulsory Medical Insurance Fund V.Yu. Semenov.

Minister of Health
Russian Federation
T.B. Dmitrieva

Executive Director
Federal Mandatory Fund
health insurance
V.V. Grishin

Annex 1
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund

Regulations on the system of departmental quality control of medical care in healthcare institutions of the Russian Federation

1. General Provisions

1.1. These Regulations have been developed in accordance with the Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens, the Laws of the Russian Federation “On medical insurance of citizens in the Russian Federation”, “On the protection of consumer rights” and other regulations. It establishes general organizational and methodological principles of departmental quality control of medical care provided to the population in health care institutions, regardless of departmental subordination and form of ownership on the territory of the Russian Federation.

1.2. The purpose of implementing departmental quality control of medical care is to ensure the rights of patients to receive medical care of the required volume and proper quality based on the optimal use of human and material and technical resources of health care and the use of advanced medical technologies.

1.3. The object of control is medical care, which is a complex of preventive, therapeutic, diagnostic and rehabilitation measures carried out using a certain technology in order to achieve specific results.

1.4. The system of departmental quality control of medical care includes the following elements:

assessment of the condition and use of human and material and technical resources of a medical and preventive institution;
examination of the process of providing medical care to specific patients;
studying patient satisfaction from their interaction with the healthcare system;
calculation and analysis of indicators characterizing the quality and effectiveness of medical care;
identification and substantiation of defects, medical errors and other factors that had a negative effect and resulted in a decrease in the quality and effectiveness of medical care;
preparation of recommendations for managers of medical and preventive institutions and health care authorities aimed at preventing medical errors and defects in work and helping to improve the quality and efficiency of medical care;
selection of the most rational management decisions and implementation of operational corrective actions;
control over the implementation of management decisions.

2. Organization and procedure for departmental quality control of medical care

2.1. Departmental quality control of medical care is carried out expertly by officials of treatment and preventive institutions and health care authorities, clinical expert commissions and chief staff and freelance specialists at all levels of health care. If necessary, employees of universities, research centers, research institutes and other institutions may be involved in conducting the examination on a contractual basis.

2.2. At the level of medical and preventive institutions, in accordance with Order of the Ministry of Health and Medical Industry of Russia No. 5 of January 13, 1995 “On measures to improve the examination of temporary disability,” examination of the quality of medical care is the function of the heads of departments (the first stage of examination), deputy heads of the institution for clinical and expert work, medical work, outpatient care (second stage of examination), clinical and expert commissions of the institution (third stage of examination).

2.3. An examination of the process of providing medical care is carried out on individual cases completed in this unit. The examination, as a rule, is carried out according to medical documentation (inpatient medical record, outpatient record, etc.). If necessary, an in-person examination can be carried out.

2.4. The following must be subject to expert control:

cases of death;
cases of nosocomial infection and complications;
cases of primary disability of persons of working age;
cases of repeated hospitalization for the same disease within a year;
cases of diseases with extended or shortened treatment periods (or temporary disability);
cases with discrepant diagnoses;
cases accompanied by complaints from patients or their relatives.
All other cases of medical care should have the same opportunity to be subjected to expert assessment, which is ensured by the statistical method of “random” sampling.

2.5. Within a month, the head of the inpatient unit conducts an examination of at least 50% of completed cases, the deputy heads of the institution for clinical expert work, medical work, outpatient care - at least 30 - 50 examinations during the quarter. The scope of work of clinical and expert commissions is determined by the tasks in the field of ensuring the quality and effectiveness of medical care, set both by this medical and preventive institution and by higher-level health care authorities. The scope of work of heads of outpatient departments is specified at the regional level.

2.6. An examination of the quality of medical care for a specific patient involves comparing it with standards, which, as a rule, contain a unified set and scope of diagnostic and therapeutic measures, as well as requirements for the timing and results of treatment for specific nosological forms of diseases.

The leading role in assessing the quality of medical care belongs to the expert’s opinion, which, in addition to meeting the standards, takes into account all the features of a given individual case.

2.7. An expert during an examination of the quality of the treatment and diagnostic process:

mandatory evaluates the completeness and timeliness of diagnostic measures, the adequacy of the choice and compliance with treatment measures, the correctness and accuracy of the diagnosis;
identifies defects and establishes their causes;
prepares recommendations for eliminating and preventing identified deficiencies.

2.8. For each case of expert assessment, a “Medical Care Quality Assessment Card” is filled out. As a result of their statistical processing, indicators characterizing the quality and effectiveness of medical care are calculated.

2.9. The methodology for expert assessment of the quality of medical care and a set of indicators characterizing it are developed, approved and agreed upon at the regional level.

2.10. The study of satisfaction with medical care is also carried out according to the methodology adopted in the region.

2.11. When assessing the work of a structural unit, a medical and preventive institution, as well as regional healthcare, indicators of the quality and effectiveness of medical care are supplemented by indicators of the performance of the healthcare institution and the health status of the population, such as the prevalence and late detection of socially significant diseases, primary disability and mortality of people of working age age, childhood disability, effectiveness of rehabilitation of sick and disabled people, coverage of newborns with screening for phenylketonuria and congenital hypothyroidism, young children with audiological screening, abortion rates, infant and child mortality, etc.

2.12. Information obtained as a result of assessing the quality and effectiveness of medical care is brought to the attention of the heads of the institution and health care authorities and is the subject of discussion among employees.

3. Conclusion

3.1. Departmental control of the quality and effectiveness of medical care is the main type of control, closest to the providers of medical services. Its results are used and compared with the data of non-departmental examination.

3.2. Indicators of the quality and efficiency of medical care can be used for differentiated remuneration of medical workers.

Head of Organization Department
medical assistance to the population
Ministry of Health of Russia
A.A. Karpeev

Appendix 2
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund
dated October 24, 1996 N 363/77

Regulations on the system of non-departmental quality control of medical care in the Russian Federation

1. General Provisions

A system of non-departmental quality control of medical care is being created in the constituent entities of the Russian Federation in accordance with current legislation in order to protect the rights of citizens to health care and assist government authorities in solving problems of improving the activities of healthcare institutions.

The system of non-departmental control refers to the assessment of the quality of medical care by entities outside the state healthcare system, within their competence.

The right to conduct non-departmental control is assigned to the named subjects by the Fundamentals of the Legislation of the Russian Federation on the Protection of Citizens' Health, the Law of the Russian Federation "On Medical Insurance of Citizens in the Russian Federation", the Decree of the Government of the Russian Federation "On Approval of the Regulations on Licensing of Medical Activities", Instructions on the Procedure for Issuing Documents certifying temporary disability of citizens, Model Rules of Compulsory Health Insurance.

This Regulation establishes uniform organizational and methodological principles for non-departmental quality control of medical services provided by healthcare institutions, regardless of departmental subordination and form of ownership, as well as by persons engaged in private medical practice on the territory of the Russian Federation.

Non-departmental quality control of medical care is carried out on the basis of an assessment of the resource and personnel capabilities of treatment and preventive institutions, the technologies used, as well as indicators of the volume and effectiveness of their activities.

To increase the efficiency of expert activities on the territory of a constituent entity of the Russian Federation, a professional medical association (or a licensing and accreditation commission) forms a register of freelance experts in agreement with the territorial compulsory health insurance fund, the executive body of the Social Insurance Fund of the Russian Federation and the healthcare management body.

Responsibility for the organization and condition of non-departmental quality control of medical care lies with the heads and officials of organizations and institutions that have the right to conduct it, in accordance with job descriptions and current legislation.

2. Subjects of the system of non-departmental quality control of medical care and their competence

Non-departmental control over the activities of healthcare institutions, as well as individuals, is carried out by:

licensing and accreditation commissions;
medical insurance organizations;
territorial compulsory health insurance funds (if they perform the functions of an insurer);
policyholders;
executive bodies of the Social Insurance Fund of the Russian Federation;
professional medical associations;
society (association) for the protection of consumer rights.

The main task of subjects of non-departmental quality control of medical care is to organize, within their competence, a medical and medical-economic examination in order to ensure the right of citizens to receive medical care of proper quality and to check the effectiveness of the use of health care resources, as well as financial resources of compulsory medical insurance and social insurance.

Non-departmental quality control is carried out in the following areas:

analysis of the results of providing medical care to the population;
preparation of recommendations for improving the organization and quality of medical care and monitoring their implementation;
studying patient satisfaction with medical care provided;
checking the fulfillment of contractual obligations between healthcare institutions and medical insurance organizations;
checking the fulfillment of contractual obligations between the policyholder and the insurer;
compliance with the Instructions on the procedure for issuing documents certifying temporary disability of citizens;
assessing the capabilities of a healthcare institution to guarantee the required level of quality of medical care;
correct application of tariffs and compliance of bills presented for payment with the volume of medical care provided;
other types of control carried out by subjects within their competence.

Competence of the licensing and accreditation commission:

In accordance with their powers, licensing and accreditation commissions carry out:

control over the safety of medical services for patients and staff and their compliance with established standards during licensing and accreditation of healthcare institutions and certification of specialists;
monitoring compliance by healthcare institutions and individuals with licensing conditions;
issuance of licenses and certificates to legal entities and citizens;
participation in the formation of non-departmental medical examination and a register of experts on the territory of a constituent entity of the Russian Federation.

Competence of a medical insurance organization<*>:

<*>Applies to territorial compulsory medical insurance funds when they perform the functions of an insurer.

organization and implementation, within the framework of concluded contracts of compulsory and voluntary medical insurance, of monitoring the quality, volume and timing of medical care by in-house experts, as well as by attracting freelance experts included in the register on a contractual basis;
determining the compliance of bills issued for payment for medical services provided with their true volume and quality, and for compulsory health insurance - with the territorial compulsory medical insurance program, with the right not to partially or completely reimburse the costs of providing medical services;
filing claims and lawsuits with medical and preventive institutions for compensation of damage caused to insured citizens;
informing healthcare authorities, licensing and accreditation commissions about shortcomings identified during expert work in the activities of medical and preventive institutions;
concluding agreements for the performance of medical quality assessments with competent organizations and specialists;
participation in the development of tariffs for medical services;
participation in licensing and accreditation of medical and preventive institutions and individuals;
applying in the prescribed manner to the licensing and accreditation commission with an application for suspension or termination of the license;
re-conclusion of an agreement for the provision of treatment and preventive care (medical services) under health insurance in cases of detection of repeated and serious violations in the provision of medical care to the insured.

Competence of the insurer:

monitoring compliance with the terms of the health insurance contract;
obtaining the necessary information about the organizations existing in the territory that have the right to carry out an examination of the quality of medical care to the population, and the procedure for their activities;
receiving information from insurers about the state of medical care for the insured and measures to improve it;
bringing to the attention of the insured the results of an expert assessment of the quality of medical care and measures taken to improve it;
re-conclusion of a health insurance contract in cases of repeated and serious violations in the provision of medical care to the insured.

Competence of the executive bodies of the Social Insurance Fund of the Russian Federation:

Carrying out, within the scope of competence, control over the validity of the issuance, extension, and correct execution of documents confirming the temporary disability of citizens, including when identifying:

cases of temporary disability with long-term stay of patients on sick leave exceeding the average by 30% or more;
cases resulting in disability;
cases of untimely referral for medical and social examination.

The competence of professional medical associations within the limits determined by the constituent documents and charter:

organizing an examination of the quality of medical care provided to citizens by medical and preventive institutions and persons engaged in private practice who are members of this association;
participation in the development of quality standards for medical care, programs and criteria for training and advanced training of medical personnel, agreements on tariffs for medical services;
participation in the formation of a register of experts;
participation in the work of commissions for the certification of medical workers, accreditation and licensing of the activities of healthcare institutions, and qualification examination commissions.

The competence of the society (association) for the protection of consumer rights:

studying public opinion about the quality of medical care provided;
informing subjects of non-departmental quality control and health care authorities about defects in the provision of medical care;
protecting the rights of patients by representing and defending their interests in administrative and judicial authorities.

3. Organization of interaction between subjects of non-departmental quality control and healthcare institutions to carry out examination of the quality of medical care

Subjects of non-departmental quality control in cases of detection of defects in the process of providing medical care within their competence:

clearly formulate issues that require resolution during a medical examination;
organize additional examination.

To improve the interaction between departmental and non-departmental examination of the quality of medical care, subjects of non-departmental control make a request to the clinical expert commission of a medical and preventive institution or the relevant health care management body about the results of the departmental examination on the issues raised, evaluate the results of the departmental examination and, if they agree with them, take the necessary decisions or appropriate measures without conducting additional examination.

The main reasons for appointing a non-departmental medical examination

For medical insurance organizations:

complaints from patients or insurers about the quality and culture of medical care;
unfavorable outcome of the disease directly related to deficiencies in medical interventions;
inconsistency of the submitted invoices for payment of medical services with territorial medical and economic standards or inclusion in the invoice of medical services that are not included in the territorial compulsory medical insurance program;
the presence of numerous defects in the provision of medical care by individual specialists, departments, and institutions;
inconsistency of the treatment provided with the diagnosis of the disease, which affected the cost of treatment.

For the executive bodies of the Social Insurance Fund of the Russian Federation:

submission for payment of documents certifying the temporary disability of citizens, issued in violation of the established procedure;
doubts about the validity of issuing documents certifying the temporary disability of citizens, the terms of temporary disability, the terms of referral for medical and social examination.

For licensing and accreditation commissions:

the need for licensing and accreditation of legal entities and individuals and certification of specialists with the involvement of freelance experts;
ensuring control over the implementation of licensing conditions with departmental and non-departmental examination.

Organizations and institutions that have the right to conduct non-departmental medical examination are obliged to:

interact with health authorities and institutions on the organization of medical care to the population;
keep records of all claims made, the results of their analysis and expert control;
organize, within the limits of their competence, the development and implementation of their own measures to improve the organization of medical care to the population and improve its quality, and monitor their implementation.

Organizations and institutions that have the right to conduct non-departmental examinations can:

participate in the development of proposals to improve the organization and improve the quality of medical care to the population and submit them for consideration by the competent authorities;
promote the training and advanced training of personnel in medical and preventive institutions;
receive from medical and preventive institutions information necessary to resolve controversial cases;
conclude contracts for examination with interested persons, organizations and institutions;
organize meetings on improving the organization of non-departmental quality control of medical care.

4. Organization and procedure for non-departmental quality control of medical care

Subjects of non-departmental quality control organize their expert activities in accordance with the legislation of the Russian Federation, departmental regulations and these Regulations. Non-departmental quality control of medical care is carried out by full-time experts, as well as freelance experts included in the register and admitted to expert activities in the prescribed manner.

Examination of the quality of medical care in the system of non-departmental control should be carried out on the territory of a constituent entity of the Russian Federation according to uniform methodological principles and technology, agreed upon with all subjects of non-departmental control.

Financing of expert activities in the system of non-departmental quality control is carried out at the expense of these entities, as well as part of the penalties imposed on legal entities and individuals in accordance with the Regulations on the procedure for payment for medical services in the compulsory health insurance system.

Non-departmental control can be carried out in the form of:

preventive control;
control the result;
target control;
planned control.

Preventive control is carried out by the licensing and accreditation commission before licensing and accreditation of a medical institution or individual.

The purpose of preventive control is to determine the ability of a medical institution or individual to provide the declared types of medical care, as well as the compliance of their activities with established standards.

Preventive control is designed to assess the quality and level of safety of a medical institution for a patient before receiving permission to provide medical services to the population.

During preventive control, the following are assessed:

1. Structure of the medical institution, including assessment:

organizing the work of structural units of a medical institution and organizing the work of personnel;
qualifications of medical personnel;
material, technical and resource support;
financing.

2. The quality of the treatment and diagnostic process, including assessment:

organization of examination, treatment and care for patients, volume of activities and interaction of medical and paraclinical units;
scientific and technological level of the treatment and diagnostic process;
quality of medical documentation;
outcomes and results of treatment.

Preventive control is carried out on the basis of standards, for which the following is used as an assessment tool:

state educational standards;
technological standards;
equipment standards;
standards for the volume of treatment, diagnostic and rehabilitation measures and terms of treatment for various nosological forms of diseases.

In cases where there are no federal standards, territorial standards approved by the health care management body of the constituent entity of the Russian Federation are used.

The results are monitored by subjects of non-departmental control.

The purpose of outcome monitoring is to assess the quality of the medical service provided to a specific patient. During the examination of the quality of medical services, the following are assessed:

medical effectiveness of the service;
its economic efficiency;
compliance of the selected medical technology with the pathological process, its severity and course.

Medical effectiveness refers to the degree to which a given goal is achieved. Medical effectiveness is higher, the closer a medical worker, based on treatment results, approaches the criteria and parameters of treatment effectiveness laid down in the standard for a given pathology.

Cost-effectiveness is assessed based on an economic standard that characterizes the maximum allowable cost of treating a typical case for each nosology. If, when performing a treatment and diagnostic process and achieving the maximum possible, for a given case, medical efficiency, costs do not exceed the maximum limit of the norm, then economic efficiency should be considered achieved.

The quality of the treatment and diagnostic process is assessed according to a standard that includes the main elements:

high-quality collection of information about the patient (diagnostic measures for a given nosology);
correct formulation and substantiation of the diagnosis;
high-quality treatment measures.

In addition, the entity exercising non-departmental control has the right to study the opinions of patients about the quality of the medical services provided, since the patient’s opinion is one of the components of the concept of “quality medical service.”

Result control, as well as preventive control, is based on an expert opinion.

If necessary, to resolve a controversial case, the subject of non-departmental control may decide to conduct targeted control with the involvement of freelance experts.

A medical insurance organization has the right to inspect only cases of medical care provided to patients who have a compulsory medical insurance policy issued by this insurance organization, and for types of medical care included in the territorial compulsory medical insurance program.

Based on the results of the inspection, an “Expert Control Report” of the established form is drawn up.

Planned quality control of medical care by the medical insurance organization is carried out in accordance with the contract for the provision of treatment and preventive care (medical services) under health insurance. In these cases, the medical insurance organization draws up a schedule of planned monitoring of medical institutions, which is brought to the attention of the latter.

The planned control schedule is drawn up with the expectation that during the year each medical institution is subject to planned control at least once a year. In order to reduce the number of scheduled inspections carried out in a medical institution, it is desirable that subjects of non-departmental control coordinate their work and, if possible, carry out joint inspections.

Disputes between the parties on issues of financial and economic examination are resolved in the interdepartmental conciliation tariff commission, medical examination - in the conciliation interdepartmental commission of the constituent entity of the Russian Federation in accordance with the Regulations on the work of these commissions.

Controversial issues arising among the parties at this level can be considered in court in the prescribed manner.

Head of Department
medical organization
assistance to the population
Ministry of Health of Russia
A.A. Karpeev

Head of Department
organization of compulsory
health insurance
Federal Compulsory Medical Insurance Fund
N.D. Tegay

Appendix 3
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund
dated October 24, 1996 N 363/77

Position
about a freelance medical expert<*>

(as amended by Order of the Ministry of Health of the Russian Federation No. 20, FFOMS No. 13 dated January 21, 1997)

1. General Provisions

An expert can be a specialist with a higher medical education, who has received training in a medical specialty and has at least 10 years of experience in it, a highest qualification category or academic degree, who has undergone special training in examination and has received a document authorizing him to carry out expert activities in his chosen specialty.

(paragraph as amended by Order of the Ministry of Health of the Russian Federation No. 20, FFOMS No. 13 dated January 21, 1997)

The expert carries out work on the examination of the quality of medical care on the basis of an agreement with organizations and institutions that have the right to carry out expert activities.

The procedure and amounts of remuneration for experts are determined at the level of the constituent entity of the Russian Federation in accordance with the established procedure.

To confirm his authority, an expert must have a certificate indicating its validity period and an order to conduct an examination.

The main task of the expert is to assess the correctness of the choice of medical technology, the timing and quality of the medical services provided in accordance with the established standards and terms of the contract.

The expert works with organizations and institutions that have the right to carry out expert activities on a contractual basis.

The expert’s working hours under the contract are agreed upon by the organization that entered into the contract with the expert and the administration of the institution at the expert’s main place of work.

If necessary, for the duration of the examination, the expert is relieved of his main work on the basis of an order from the head of the institution at the request of the organization engaging the expert in the examination.

The expert carries out the examination in accordance with the received order to conduct an expert examination in compliance with the uniform principles and technology of non-departmental quality control of medical care adopted in the territory of the constituent entity of the Russian Federation.

An expert can conduct an examination only in his main medical specialty within the competence defined by the specialist’s certificate.

The expert conducts the examination individually or jointly with other experts.

An expert does not have the right to carry out examinations in medical institutions with which he has an employment or contractual relationship, and to participate in the analysis of expert cases when the patient is his relative or a patient in whose treatment the expert took part.

Upon completion of the examination, the expert submits the “Expert Control Report” within the time limit according to the contract.

The medical and preventive institution is obliged to provide the expert with free familiarization with the activities of the institution related to the fulfillment of the terms of the contract.

3. Rights, duties and responsibilities of an expert

The expert has the right:

carry out on-site examinations in accordance with the established procedure and terms of the contract;
use the documents necessary to evaluate the expert case;
refuse to conduct the examination before it begins, without motivating the reason for the refusal;
refuse further examination with notification to the sending party of the specific reasons for its refusal;
participate in the preparation of claim and claim materials for consideration by additional examination;
when working in a group of experts, draw up a special opinion, different from the opinion of other experts, based on the results of quality control of medical care and require additional examination;
make proposals to the competent authorities to improve the organization and quality of medical care;
receive information about the implementation of their recommendations and, in cases where their failure to comply threatens the health or life of patients, inform the appropriate authorities;
Regularly improve your professional level.

The expert is obliged:

Conduct an expert assessment in the presence of an authorized representative of the healthcare institution being examined;

Give a competent and objective assessment of the quality of medical care based on the study of medical documentation, and, if necessary, personal examination of patients;

if necessary, apply for the involvement of other experts in the examination;
discuss the preliminary results of the examination with the attending physician and the management of the healthcare institution;
prepare recommendations for improving the level and quality of medical care, improving the work of specialists and healthcare institutions, including eliminating the reasons that caused the provision of medical care to patients of inadequate quality;
prepare an appropriate conclusion based on the results of the examination, document the results of the inspection in an act of the established form and provide a copy of the act to the management of the healthcare institution upon completion of the inspection;
report to the head of the sending organization on the results of the work by submitting an expert control report.

The expert, in accordance with the established procedure, bears responsibility, within the limits of his powers and competence, for the quality and objectivity of the examination performed.

If the expert’s activities do not comply with professional requirements, the organization that has entered into an agreement with the expert is obliged to report this to the body that forms the register of experts and the body that issues a license for the right to carry out expert activities, in order to resolve the issue of the possibility of continuing this activity.

Head of Department
medical organization
assistance to the population
Ministry of Health of Russia
A.A. Karpeev

Head of Department
organization of compulsory
health insurance
Federal Compulsory Medical Insurance Fund
N.D. Tegay

Appendix 4
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund
dated October 24, 1996 N 363/77

Position
about the expert of the Insurance Medical Organization<*>

(as amended by Order of the Ministry of Health of the Russian Federation No. 20, FFOMS No. 13 dated January 21, 1997)

1. General Provisions

An expert can be a specialist with a higher medical education, who has at least 5 years of experience in a medical specialty, specialization in healthcare organization and social hygiene, and who has undergone special training in examination.

The expert is a full-time employee of the medical insurance organization and reports to its head.

The expert in his work is guided by the current legislative acts of the Russian Federation, other regulatory documents regulating legal relations in the system of examination of the quality of medical care, the Regulations on the system of non-departmental quality control of medical care in the Russian Federation and these Regulations.

The appointment and dismissal of an expert is carried out in accordance with the established procedure.

To confirm his authority, the expert has a document confirming his relationship to the medical insurance organization.

The expert’s actions should not contradict professional ethics and medical deontology.

The main task of the expert is to organize control and assess the volume, timing and quality of medical care in the event of an expert case in accordance with the terms of the health insurance contract.

2. Organization of the expert’s work

In accordance with the objectives and procedure for conducting non-departmental quality control of medical care on the territory of a constituent entity of the Russian Federation, the main functions of the expert are:

2.1. Identification of defects in the process of providing medical care to the insured, including:

unfavorable disease outcomes associated with deficiencies in medical interventions;
complaints from patients or insurers about the low quality and culture of medical care;
inconsistency of submitted invoices for payment of medical services with territorial medical and economic standards or inclusion in the invoice of medical services that are not included in the territorial compulsory medical insurance program;
the presence of numerous defects in the provision of medical care to the insured by individual specialists, departments, and institutions.

2.2. Justification of the need for an expert assessment in accordance with the identified defects, a clear formulation of the goals and objectives of the upcoming examination and its coordination with the management of treatment and prophylaxis

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

On approval of instructions for the use of blood components

In order to improve medical care to the population of the Russian Federation and ensure quality in the use of blood components, I order:

Approve the Instructions for the use of blood components.
Control over the implementation of this Order is assigned to First Deputy Minister A.I. Vyalkova.

Minister Yu.L. Shevchenko

Appendix No. 1

Approved by Order of the Ministry

healthcare of the Russian Federation

dated November 25, 2002 N 363

INSTRUCTIONS FOR USE OF BLOOD COMPONENTS

General provisions

The operation of transfusion of blood components is accompanied by consequences for the recipient, both positive (an increase in the number of circulating red blood cells, an increase in the level of hemoglobin during the transfusion of red blood cells, relief of acute disseminated intravascular coagulation during the transfusion of fresh frozen plasma, cessation of spontaneous thrombocytopenic bleeding, an increase in the number of platelets during the transfusion of platelet concentrate), and negative (rejection of cellular and plasma elements of the donor’s blood, risk of viral and bacterial infection, development of hemosiderosis, inhibition of hematopoiesis, increased thrombogenicity, allosensitization, immunological reactions). In patients with immunosuppression, transfusion of cellular blood components can lead to the development of graft-versus-host disease.

When transfusing whole canned blood, especially for long periods (more than 7 days)

storage, the recipient receives, along with the components he needs, functionally defective platelets, leukocyte breakdown products, antibodies and antigens, which can cause post-transfusion reactions and complications.

Currently, the principle of replacing specific blood components missing in the patient’s body in various pathological conditions has been established. There are no indications for transfusion of whole canned donor blood, except in cases of acute massive blood loss, when there are no blood substitutes or fresh frozen plasma, red blood cells or suspension. Whole canned donor blood is used for exchange transfusion in the treatment of hemolytic disease of newborns.

The blood of donors at blood transfusion stations (BTS) or in blood transfusion departments in the coming hours (depending on the preservative used and the procurement conditions - on-site or in-patient) after receipt must be divided into components. It is advisable to use blood components collected from one or a minimum number of donors in the treatment of one patient.

In order to prevent post-transfusion complications caused by the Kell antigen, departments and blood transfusion stations issue red blood cell suspension or mass that does not contain this factor for transfusion into the clinic. Kell positive recipients can be transfused with Kell positive red blood cells. When transfusing plasma-coagulation hemostasis correctors (all types of plasma), platelet concentrate, and leukocyte concentrate, the Kell antigen is not taken into account.

Blood components should be transfused only from the AB0 group and the Rh group that the recipient has.

For health reasons and in the absence of blood components of the same group according to the ABO system (with the exception of children), transfusion of Rh-negative blood gas carriers of group 0(1) to the recipient with any other blood group in an amount of up to 500 ml is allowed. Rh-negative erythrocyte mass or suspension from donors of group A(I) or B(lII) according to vital indications can be transfused to a recipient with group AB(IV), regardless of his Rhesus status. In the absence of single-group plasma, the recipient can be transfused with group AB(IV) plasma.

In all cases without exception of transfusion of erythrocyte-containing blood components, it is absolutely mandatory to conduct individual compatibility tests before the start of transfusion and at the beginning of transfusion - a biological test.

When a patient is routinely admitted to the hospital, the blood group A0 and Rh are determined by a doctor or other specialist trained in immunoserology. The form with the results of the study is pasted into the medical history. The attending physician rewrites the data of the study result on the front side of the title page of the medical history in the upper right corner and affixes it with his signature. It is prohibited to transfer data on blood group and Rh status to the title page of the medical history from other documents.

Patients with a history of post-transfusion complications, pregnancies resulting in the birth of children with hemolytic disease of the newborn, as well as patients with alloimmune antibodies, undergo an individual selection of blood components in a specialized laboratory. If multiple transfusions are necessary in patients with myelodepression or aplastic syndrome, the patient's phenotype is examined in order to select an appropriate donor.

The transfusion of blood components has the right to be carried out by the attending or duty doctor who has special training; during the operation - by a surgeon or anesthesiologist who is not directly involved in the operation or anesthesia, as well as by a doctor in the blood transfusion department or room, a transfusiologist.

Before proceeding with the transfusion of blood components, it is necessary to ensure their suitability for transfusion, the identity of the group affiliation of the donor and recipient according to the AB0 and Rh systems. Visually, directly by the doctor transfusion of the transfusion medium, the tightness of the packaging, the correctness of certification are checked, and the quality of the blood transfusion medium is assessed macroscopically. It is necessary to determine the suitability of the blood transfusion medium with sufficient lighting directly at the storage site, avoiding shaking. The criteria for suitability for transfusion are: for whole blood - plasma transparency, uniformity of the upper layer of red blood cells, the presence of a clear boundary between red blood cells and plasma; for fresh frozen plasma – transparency at room temperature. If there is possible bacterial contamination of whole blood, the color of the plasma will be dull, with a gray-brown tint, it loses transparency, and suspended particles appear in it in the form of flakes or films. Such blood transfusion media are not subject to transfusion.

Transfusion of blood components that have not previously been tested for HIV, hepatitis B and C, and syphilis is prohibited.

Transportation of blood components is carried out only by medical personnel responsible for compliance with transportation rules. To avoid hemolysis, blood components should not be subjected to hypothermia or overheating during transportation. With transport time less than 30 minutes. it can be produced using any containers that provide sufficient isothermality. When transportation lasts more than half an hour, blood components must be kept in an insulated container (cooler bag). For even longer transportation (several hours) or at high ambient temperatures (above 20 degrees C), it is necessary to use dry ice or cold accumulators that provide isothermal conditions in the transport container. It is necessary to protect blood components from shaking, shock, turning over and overheating, and cellular components from freezing.

The doctor performing the transfusion of blood components is obliged, regardless of previous studies and existing records, to personally conduct the following control studies directly at the recipient’s bedside:

1.1. Recheck the recipient's blood group using the AB0 system, and compare the result with the data in the medical history.

1.2. Recheck the blood group according to the AB0 system of the donor container and compare the result with the data on the container label.

1.3. Compare the blood type and Rh status indicated on the container with the results of the study previously entered into the medical history and just received.

1.4. Conduct tests for individual compatibility according to the AB0 and Rh systems of donor erythrocytes and recipient serum.

1.5. Check with the recipient the last name, first name, patronymic, year of birth and compare them with those indicated on the title page of the medical history. The data must match, and the recipient must confirm them whenever possible (except in cases where the transfusion is carried out under anesthesia or the patient is unconscious).

1.6. Conduct a biological test (see point 6).

1.7. A necessary precondition for medical intervention is the informed voluntary consent of the citizen in accordance with Article 20 of the Federal Law of November 21, 2011 N 323-FZ.

In cases where a citizen’s condition does not allow him to express his will, and medical intervention is urgent, the question of its implementation in the interests of the citizen is decided by a council, and if it is impossible to assemble a council, by the attending (duty) doctor directly, with subsequent notification of officials of the medical institution.

The plan for performing the operation of transfusion of blood components is discussed and agreed upon with the patient in writing, and, if necessary, with his relatives. The patient's consent is drawn up in accordance with the sample given in the appendix and is filed with the inpatient card or outpatient card.

Transfusion of blood transfusion media is carried out by medical personnel in compliance with the rules of asepsis and antisepsis using disposable devices for intravenous administration with a filter.

In order to prevent immunological reactions in a certain group of patients (children, pregnant women, people with immunosuppression), transfusion of red blood cells and suspension, platelet concentrate should be carried out using special leukocyte filters approved for clinical use by the Ministry of Health of the Russian Federation.

The procedure for immunoserological studies during transfusion of blood components

2.1. Immunoserological studies of blood gas carrier transfusions

When transfusing red blood cells (planned, emergency), the doctor performing the transfusion is obliged to:

2.1.1. Determine the blood group AB0 and Rhesus status of the recipient and donor (by red blood cells in the container).

2.1.2. Conduct a test for individual compatibility of the blood of the recipient and the donor (see below) in one of two ways:

first method: two-stage test in test tubes with antiglobulin;
second method: on a plane at room temperature and one of three tests (indirect Coombs reaction, conglutination reaction with 10% gelatin or conglutination reaction with 33% polyglucin).

For health reasons, if the blood type and Rh affiliation of the recipient are unknown, the doctor performing the transfusion can transfuse the recipient with blood gas carriers (erythrocyte mass, suspension) of group 0 (1) Rh-negative, subject to mandatory tests for individual compatibility and biological samples.

If the recipient has anti-erythrocyte, anti-leukocyte or anti-platelet antibodies, the selection of blood components is carried out in a specialized laboratory. If the red blood cell mass or suspension is selected individually for the recipient in a specialized laboratory, the doctor performing the transfusion determines the blood group of the recipient and donor before the transfusion and conducts only one test for individual compatibility - on a plane at room temperature.

2.2. Immunoserological studies during transfusion of hemostasis and fibrinolysis correctors, immunity correction agents

When transfusion of hemostasis and fibrinolysis correctors, immunity correction agents, the doctor performing the transfusion is obliged to:

2.2.1. Determine the ABO blood group and Rhesus status of the recipient.

The doctor performing the transfusion determines the group and Rh affiliation of the donor according to the label on the container with the transfusion medium; he does not conduct an individual compatibility test.

Immunoserological research technique

Determination of blood type, Rh status, and a test for individual compatibility of the blood of the donor and recipient are carried out in accordance with the instructions for immunoserology. They are also guided by the attached instructions that are attached to the reagent kit by the manufacturer. Red blood cells and blood serum of the recipient are used for no more than a two-day storage period at a temperature of +2 - 8 degrees. WITH.

For the plane agglutination method and the conglutination method, a sediment of unwashed red blood cells is taken in test tubes with 10% gelatin or 33% polyglucin.

For a two-stage test in tubes with immunoglobulin and an indirect Coombs test, red blood cells are washed three times with saline. Erythrocytes are washed in the usual manner.

3.1. AB0 blood group determination

2 drops (0.1 ml) of the reagent are placed on the plate at three points under the designations anti-A, anti-B, anti-AB and next to one drop of erythrocyte sediment (0.01 - 0.02 ml when using hemagglutinating sera; 0.02 – 0.03 ml when using cyclones). The serum and red blood cells are mixed with a glass rod. The plate is shaken periodically, observing the progress of the reaction for 3 minutes. when using zoliclones; 5 minutes. when using hemagglutinating serums. After 5 min. 1 - 2 drops (0.05 - 0.1 ml) of physiological solution can be added to the reaction mixture to remove possible nonspecific aggregation of erythrocytes.

The results are interpreted according to Table 1.

Table 1

Note. The sign (+) indicates agglutination, the sign (-) indicates the absence of agglutination.

In the presence of agglutination with all three reagents, it is necessary to exclude nonspecific agglutination of the red blood cells being tested. To do this, a drop of physiological solution is added to a drop of erythrocytes instead of coliclones, and group AB(IV) serum is added instead of hemagglutinating sera. Blood can be classified as AB(IV) only if there is no agglutination of red blood cells in saline or AB(IV) serum.

3.2. Determination of Rh status

3.2.1. Agglutination reaction on a plane using anti-D super cyclones:

Apply a large drop (about 0.1 ml) of the reagent to the plate or tablet. A small drop (0.02 - 0.03 ml) of the red blood cells being tested is placed nearby. Mix the reagent with red blood cells thoroughly using a glass rod.

After 10–20 s, gently rock the plate. Despite the fact that clear agglutination occurs in the first 30 s, the results of the reaction are taken into account after 3 min. after mixing.

If agglutination is present, the blood being tested is marked as Rh-positive; if not, it is marked as Rh-negative.

To determine Rh status by an accelerated method on a plane at room temperature, polyclonal anti-D sera with incomplete antibodies, prepared in combination with colloids (albumin, polyglucin), can be used.

3.2.2. Conglutination method with 10% gelatin:

Reagents containing incomplete polyclonal antibodies (anti-D sera) or incomplete monoclonal antibodies (anti-D coliclones) are used.

Add 0.02 - 0.03 ml of red blood cell sediment into 2 test tubes, for which a small drop of red blood cells is squeezed out of a pipette and touches the bottom of the test tube with it. Then add 2 drops (0.1 ml) of gelatin and 2 drops (0.1 ml) of the reagent to the first test tube, add 2 drops (0.1 ml) of gelatin and 2 drops (0.1 ml) to the second (control) test tube. physiological solution.

The contents of the tubes are mixed by shaking, after which they are placed in a water bath for 15 minutes. or thermostat for 30 minutes. at a temperature of +46 – 48 degrees. C. After the specified time, add 5–8 ml of physiological solution to the test tubes and mix the contents by inverting the test tubes 1–2 times.

The result is taken into account by viewing the test tubes with the naked eye or through a magnifying glass. Agglutination of red blood cells indicates that the blood sample being tested is Rh-positive, and the absence of agglutination indicates that the blood being tested is Rh-negative. There should be no agglutination of red blood cells in the control tube.

To determine Rh status by an accelerated method in a test tube at room temperature, a universal reagent can be used, which is anti-D serum with incomplete antibodies diluted with 33% polyglucin.

Tests for individual compatibility of donor and recipient blood

An individual compatibility test allows you to ensure that the recipient does not have antibodies directed against the donor's red blood cells, and thus prevents the transfusion of red blood cells that are incompatible with the patient's blood.

The compatibility test, performed on a plane at room temperature, is intended to identify complete group agglutinins of the ABO, MNSs, Lewis, etc. systems in the recipient. The compatibility test using 10% gelatin, 33% polyglucin, an indirect Coombs test is intended to identify incomplete group antibodies. A two-stage test in test tubes with antiglobulin involves the detection of both antibodies, including group hemolysins.

The most sensitive and recommended is a two-stage test in tubes with antiglobulin, then a combination of two tests - a flat test at room temperature and an indirect Coombs test. Instead of the indirect Coombs test, a conglutination reaction with 10% gelatin or a conglutination reaction with 33% polyglucin can be used. The last test is inferior in sensitivity to the first two, but takes less time.

4.1. Two-stage test in test tubes with antiglobulin

First stage. Add 2 volumes (200 µl) of the recipient's serum and 1 volume (100 µl) of a 2% suspension of thrice-washed donor erythrocytes suspended in saline or LISS (low ionic strength solution) into a labeled tube. The contents of the tube are mixed and centrifuged at 2500 rpm. (about 600 d) for 30 s. The presence of hemolysis in the supernatant is then assessed, after which the erythrocyte pellet is resuspended by lightly tapping the bottom of the tube with a fingertip, and the presence of erythrocyte agglutination is determined. In the absence of pronounced hemolysis and/or agglutination, proceed to the second stage of the test using antiglobulin serum.

Second phase. The test tube is placed in a thermostat at a temperature of 37 degrees. C for 30 minutes, after which the presence of hemolysis and/or red blood cell agglutination is again assessed. Then the red blood cells are washed three times with saline, 2 volumes (200 μl) of antiglobulin serum for the Coombs test are added and mixed. The tubes are centrifuged for 30 s, the red blood cell sediment is resuspended and the presence of agglutination is assessed.

The results are recorded with the naked eye or through a magnifying glass. Severe hemolysis and/or agglutination of erythrocytes indicates the presence in the recipient's serum of group hemolysins and/or agglutinins directed against the donor's erythrocytes and indicates the incompatibility of the blood of the recipient and the donor. The absence of hemolysis and/or agglutination of red blood cells indicates the compatibility of the blood of the recipient and the donor.

4.2. Compatibility test on a plane at room temperature

Apply 2-3 drops of the recipient's serum to the plate and add a small amount of red blood cells so that the ratio of red blood cells to serum is 1:10 (for convenience, it is recommended to first release a few drops of red blood cells from the container through a needle onto the edge of the plate, then from there transfer a small a drop of red blood cells into the serum). Next, the red blood cells are mixed with the serum, the plate is gently rocked for 5 minutes, observing the progress of the reaction. After the specified time, 1–2 drops of physiological solution can be added to the reaction mixture to remove possible nonspecific aggregation of red blood cells.

Accounting for results. The presence of red blood cell agglutination means that the donor's blood is incompatible with the recipient's blood and should not be transfused. If after 5 min. There is no agglutination of red blood cells, this means that the donor’s blood is compatible with the recipient’s blood for group agglutinogens.

4.3. Indirect Coombs test

One drop (0.02 ml) of the sediment of thrice washed donor erythrocytes is added to the test tube, for which a small drop of erythrocytes is squeezed out of the pipette and touched to the bottom of the test tube, and 4 drops (0.2 ml) of the recipient's serum are added. The contents of the tubes are mixed by shaking, after which they are placed for 45 minutes. into the thermostat at a temperature of +37 degrees. C. After the specified time, the red blood cells are washed again three times and a 5% suspension is prepared in physiological solution. Next, add 1 drop (0.05 ml) of red blood cell suspension onto a porcelain plate, add 1 drop (0.05 ml) of antiglobulin serum and mix with a glass rod. The plate is rocked periodically for 5 minutes.

The results are recorded with the naked eye or through a magnifying glass. Agglutination of red blood cells indicates that the blood of the recipient and the donor are incompatible; the absence of agglutination is an indicator of the compatibility of the blood of the donor and recipient.

4.4. Compatibility test using 10% gelatin

Add 1 small drop (0.02 - 0.03 ml) of donor erythrocytes into the test tube, for which squeeze out a small drop of erythrocytes from a pipette and touch the bottom of the test tube with it, add 2 drops (0.1 ml) of gelatin and 2 drops (0.1 ml) recipient serum. The contents of the tubes are mixed by shaking, after which they are placed in a water bath for 15 minutes. or thermostat for 30 minutes. at a temperature of +46 – 48 degrees. C. After the specified time, add 5–8 ml of physiological solution to the test tubes and mix the contents by inverting the test tubes 1–2 times.

4.5. Compatibility test using 33% polyglucin

2 drops (0.1 ml) of recipient serum, 1 drop (0.05 ml) of donor erythrocytes are added to the test tube and 1 drop (0.1 ml) of 33% polyglucin is added. The test tube is tilted to a horizontal position, shaking slightly, then slowly rotated so that its contents spread over the walls in a thin layer. This spreading of the contents of the test tube along the walls makes the reaction more pronounced. Contact of erythrocytes with the patient’s serum while rotating the tube should continue for at least 3 minutes. After 3 – 5 minutes. add 2–3 ml of physiological solution to the test tube and mix the contents by inverting the test tube 2–3 times without shaking.

The result is taken into account by viewing the test tubes with the naked eye or through a magnifying glass. Agglutination of red blood cells indicates that the blood of the recipient and the donor are incompatible; the absence of agglutination is an indicator of the compatibility of the blood of the donor and recipient.

Causes of errors when determining blood type, Rh-accessory and conducting tests for individual compatibility and measures to prevent them

Errors in determining the blood group, Rh affiliation and conducting tests for individual compatibility occur when the technique of performing the study is violated or in cases of difficult-to-determine blood groups.

5.1. Technical errors

5.1.1. Incorrect order of reagents. With a correct assessment of the result in each individual reagent, an incorrect conclusion can be made about the blood group and Rh status if the order of the reagents in the stand or on the plate is not correct. Therefore, each time when determining a blood group, you should check the location of the reagents, as well as visually assess their quality, and exclude the use of cloudy, partially dried reagents, or expired reagents.

5.1.2. Temperature conditions. Blood group determination is carried out at a temperature not lower than 15 degrees. C, since the blood being tested may contain polyvalent cold agglutinins, which cause nonspecific adhesion of red blood cells at low temperatures. The appearance of agglutination can create the formation of “coin columns”. Nonspecific aggregation of red blood cells, as a rule, disintegrates after adding 1 - 2 drops of saline solution and shaking the plate.

At elevated temperatures, anti-A, anti-B, anti-AB antibodies lose activity, so blood group determination is carried out at a temperature no higher than 25 degrees. WITH.

5.1.3. The ratio of reagents and tested red blood cells. The optimal ratio of erythrocytes and test reagents for the agglutination reaction is 1:10 when using hemagglutinating sera, 2 - 3:10 when using monoclonal reagents (coliclones) and reagents prepared in combination with colloids.

With a significant excess of red blood cells, agglutination may not be noticed, especially in cases where the agglutination properties of red blood cells are reduced - subgroup A2. If there is an insufficient number of red blood cells, agglutination appears slowly, which can also lead to incorrect interpretation of the results in the case of studying red blood cells with weak agglutinability.

5.1.4. Duration of observation. Agglutination of erythrocytes appears within the first 10 s, however, monitoring the progress of the reaction should be carried out for at least 5 minutes, especially carefully observing those drops in which agglutination did not appear. This makes it possible to identify a weak agglutinogen A2, characterized by delayed agglutination.

5.2. Difficult to determine blood types

5.2.1. Blood subgroups. Antigen A, contained in red blood cells of groups A(I) and AB(IV), can be represented by two variants (subgroups) - A1 and A2. Antigen B has no such differences. A2 erythrocytes differ from A1 erythrocytes in their low agglutination ability against anti-A antibodies. Blood subgroups are not important in clinical transfusiology, therefore they are not taken into account when transfusing red blood cells. Persons who have the A2 antigen can be transfused with A1 red blood cells; persons with A1 antigen can be transfused with A2 red blood cells. The exception is recipients who have extraagglutinins alpha1 and alpha2. These antibodies do not cause post-transfusion complications, but they manifest themselves in an individual compatibility test. In particular, the serum of the A2alpha1 recipient agglutinates A1 erythrocytes on a plane or in test tubes at room temperature, therefore A2alpha1(M) recipients are transfused with 0(1) erythrocytes, and A2Valfa1(1U) recipients are transfused with B(lII) or 0(1) erythrocytes.

5.2.2. Nonspecific agglutination of erythrocytes. It is judged on the basis of the ability of erythrocytes to agglutinate with sera of all groups, including AB(IV). Nonspecific agglutination is observed in autoimmune hemolytic anemia and other autoimmune diseases accompanied by the adsorption of autoantibodies on erythrocytes, in hemolytic disease of newborns, whose erythrocytes are loaded with maternal alloantibodies.

Nonspecific agglutination is difficult to distinguish from specific agglutination. Therefore, if there is agglutination of erythrocytes with anti-A, anti-B, anti-AB, anti-D reagents, it is necessary to conduct a test with standard AB(IV) serum and saline solution. Otherwise, the recipient may be mistakenly assigned to the AB(IV) Rh-positive group, which will entail an incorrect choice of donor.

If, due to nonspecific agglutination of erythrocytes, the patient’s blood group cannot be established, a conclusion on the blood group is not issued, and the blood sample is sent to a specialized laboratory. If there are vital indications, the patient is transfused with red blood cells of group 0(1).

5.2.3. Blood chimeras. Blood chimeras are the simultaneous presence in the bloodstream of two populations of red blood cells that differ in blood type and other antigens. Transfusion chimeras arise as a result of repeated transfusion of red blood cells or suspension of group 0(1) to recipients of another group. True chimeras occur in heterozygous twins, as well as after allogeneic bone marrow transplantation.

Establishing the blood type in blood chimeras is difficult because in some cases half of the red blood cells circulating in the bloodstream have one blood type, and the other half have another.

A recipient who has a blood chimera is transfused with red blood cells or a suspension that does not contain antigens to which the recipient may have antibodies.

5.2.4. Other features. Determining blood group A0 and Rh status can be difficult in patients due to changes in the properties of red blood cells in various pathological conditions. This can be reflected in increased agglutinability of erythrocytes, observed in patients with liver cirrhosis, burns, and sepsis. Agglutinability can be so high that red blood cells stick together in their own serum and saline. In leukemia, there is a decrease in the agglutinability of erythrocytes, as a result of which a significant number of them remain not involved in agglutination even when using highly active standard reagents (false blood chimera).

In some newborns, unlike adults, antigens A and B on red blood cells are weakly expressed, and the corresponding agglutinins are absent in the blood serum.

In all cases of unclear or questionable results, it is necessary to repeat the study using additional standard reagents of a different series. If the results remain unclear, the blood sample is sent to a specialized laboratory for testing.

Biological sample

Before transfusion, the container with transfusion medium (erythrocyte mass or suspension, fresh frozen plasma, whole blood) is removed from the refrigerator and kept at room temperature for 30 minutes. It is permissible to warm transfusion media in a water bath at a temperature of 37 degrees. With thermometer control.

The biological test is carried out regardless of the volume of the blood transfusion medium and the speed of its administration. If it is necessary to transfuse several doses of blood components, a biological test is carried out before the start of the transfusion of each new dose.

The technique for conducting a biological test is as follows: 10 ml of blood transfusion medium is transfused once at a rate of 2 - 3 ml (40 - 60 drops) per minute, then the transfusion is stopped for 3 minutes. They monitor the recipient, monitoring his pulse, breathing, blood pressure, general condition, skin color, and measure his body temperature. This procedure is repeated twice more. The appearance during this period of even one of the clinical symptoms such as chills, lower back pain, a feeling of heat and tightness in the chest, headache, nausea or vomiting requires immediate cessation of the transfusion and refusal to transfuse this transfusion medium.

The urgency of transfusion of blood components does not exempt from performing a biological test. During this procedure, it is possible to continue transfusion of saline solutions.

When transfusing blood components under anesthesia, the reaction or incipient complications are judged by an unmotivated increase in bleeding in the surgical wound, a decrease in blood pressure and an increase in heart rate, a change in the color of urine during bladder catheterization, as well as by the results of a test to detect early hemolysis. In such cases, the transfusion of this hemotransfusion medium is stopped, the surgeon and anesthesiologist, together with the transfusiologist, are obliged to find out the cause of the hemodynamic disturbances. If nothing other than transfusion could cause them, then this blood transfusion medium is not transfused; the issue of further transfusion therapy is decided by them depending on clinical and laboratory data.

A biological test, as well as a test for individual compatibility, is necessarily carried out in cases where an individually selected in the laboratory or phenotyped red blood cell mass or suspension is transfused.

It should be noted once again that a control check of the group affiliation of the recipient and donor according to the AB0 and Rh systems, as well as a test for individual compatibility, are carried out by a transfusiologist directly at the recipient’s bedside or in the operating room. Only the doctor who administers the transfusion performs these control checks (and he is also responsible for the transfusions performed).

It is prohibited to introduce any other medications or solutions into the container with the blood component other than 0.9% sterile isotonic sodium chloride solution.

After the end of the transfusion, the donor container with a small amount of the remaining blood transfusion medium and the test tube with the recipient’s blood used for individual compatibility tests must be stored for 48 hours in the refrigerator.

For each transfusion, the doctor performing the transfusion of blood components is obliged to register in the patient’s medical record:

indications for blood component transfusion;
before the start of the transfusion - passport data from the label of the donor container, containing information about the donor code, blood group according to the AB0 and Rh systems, container number, date of procurement, name of the blood service institution (after the end of the transfusion, the label is detached from the container with the blood component and pasted into the medical patient card);
the result of a control check of the recipient’s blood group according to A0 and Rh;
the result of a control check of the group affiliation of blood or red blood cells taken from the container, according to A0 and Rh;
the result of tests for individual compatibility of the blood of the donor and recipient;
result of a biological test.

It is recommended for each recipient, especially if multiple transfusions of blood components are necessary, in addition to the patient’s medical record, to have a transfusion card (diary), which records all transfusions performed on the patient, their volume and tolerability.

After the transfusion, the recipient remains in bed for two hours and is observed by the attending physician or the doctor on duty. His body temperature and blood pressure are measured hourly, recording these indicators in the patient’s medical record. The presence and hourly volume of urine output and the preservation of normal urine color are monitored. The appearance of red coloration of urine while maintaining transparency indicates acute hemolysis. The next day after the transfusion, a clinical blood and urine test must be performed.

When performing an outpatient blood transfusion, the recipient after the end of the transfusion must be under the supervision of a physician for at least three hours. Only in the absence of any reactions, stable blood pressure and pulse, and normal urination can he be released from the hospital.

Transfusion of blood gas carriers

7.1. Indications for blood gas carrier transfusions

The introduction of donor blood gas carriers is aimed at replenishing the volume of circulating red blood cells and maintaining normal oxygen transport function of the blood in anemia. The effectiveness of transfusion of blood gas carriers, which can be judged by a decrease in shortness of breath, tachycardia, and an increase in hemoglobin levels, depends on the initial condition of the patient, the hemoglobin level, as well as on the hematocrit level of the transfusion medium and its shelf life. Transfusion of one unit of red blood cells (i.e., the number of red blood cells from one blood supply of 450 +/- 45 ml) generally increases the hemoglobin level by approximately 10 g/L and the hematocrit level by 3% (in the absence of ongoing active bleeding).

Patients with blood loss between 1000 and 1200 ml (up to 20% of circulating blood volume) very rarely require blood gas carrier transfusions. Transfusion of saline solutions and colloids completely ensures their replenishment and maintenance of normovolemia, especially since the inevitable decrease in muscle activity is accompanied by a decrease in the body's need for oxygen. An excessive desire for a “normal” hemoglobin level can lead, on the one hand, to the development of heart failure due to hypervolemia, and on the other hand, it can contribute to increased thrombogenicity. The desire to completely replace the volume of lost red blood cells is especially dangerous if the bleeding is accompanied by the development of hemorrhagic shock, which is always accompanied by the development of disseminated intravascular coagulation (DIC), which intensifies with transfusion of red blood cells or whole blood.

The indication for transfusion of blood gas carriers in acute anemia due to massive blood loss is a loss of 25–30% of circulating blood volume, accompanied by a decrease in hemoglobin levels below 70–80 g/l and hematocrit below 25% and the occurrence of circulatory disorders. In the first hours, acute blood loss is usually not accompanied by a drop in hemoglobin concentration; a decrease in circulating blood volume is manifested by pallor of the skin, mucous membranes, especially the conjunctiva, desolation of the veins, the appearance of shortness of breath and tachycardia. Shortness of breath can be judged by the participation of the muscles of the neck and wings of the nose in the act of inhalation.

In these cases, the goal of transfusion therapy is to rapidly restore intravascular volume to ensure normal organ perfusion, which is more important at this time than increasing the number of circulating red blood cells. It is necessary to immediately administer saline solutions, colloidal plasma substitutes or albumin, fresh frozen plasma, followed by the connection of a transfusion of blood gas carriers.

The indications for blood gas carrier transfusions in chronic anemia are even more stringent. For such patients with a reduced amount of circulating hemoglobin, the most important thing is to eliminate the cause of the anemia, and not to restore the hemoglobin level using transfusions of red blood cell-containing blood transfusion media. In these patients, the development of compensatory mechanisms is observed: an increase in cardiac output, a shift to the right of the oxyhemoglobin dissociation curve, resulting in an increase in oxygen delivery to the tissues, a decrease in physical activity, and an increase in respiratory rate.

As a result, the clinical manifestations of a reduced number of red blood cells and hemoglobin in the circulation are neutralized to some extent. Transfusions of blood gas carriers are prescribed only to correct the most important symptoms caused by anemia and not amenable to basic pathogenetic therapy. In addition, since it has been proven that the introduction of donor red blood cells can suppress the recipient's own erythropoiesis, transfusion of blood gas carriers in chronic anemia should be regarded as the “last frontier” of therapy.

In general, when prescribing transfusions of blood gas carriers in patients with chronic anemia, the following points should be taken into account:

establish clinical symptoms caused by anemia, which can be a criterion for the effectiveness of transfusion;
do not prescribe transfusions of blood gas carriers, focusing only on the hemoglobin level, because it fluctuates depending on the volume of transfused saline solutions, diuresis, and the degree of cardiac compensation;
when heart failure and anemia are combined, transfusions should be cautious (transfusion rate 1–2 ml of red blood cells or suspension/kg body weight per hour) with the possible administration of diuretics before transfusion (risk of hypervolemia due to the increased volume of circulating plasma).

7.2. Characteristics of blood gas carriers and features of their use

Red blood cell mass is the main blood transfusion medium, the hematocrit of which is not higher than 80%. Red blood cells are obtained from preserved blood by separating the plasma. Transfusion of red blood cells is the method of choice to restore the oxygen transport function of the blood. Compared to whole blood, red blood cells contain a smaller volume of the same number of red blood cells, but significantly less citrate, cell breakdown products, cellular and protein antigens and antibodies. Patients with chronic anemia, heart failure, and elderly people do not tolerate a sharp increase in blood volume, so transfusion of red blood cells with a reduced oxygen capacity of the blood is most appropriate for them, because with a minimal increase in blood volume due to an increase in the number of circulating red blood cells, oxygen delivery to tissues is significantly improved. In addition, non-hemolytic transfusion reactions with red blood cell transfusion are observed much less frequently than with whole blood transfusion. At the same time, the risk of transmitting viral infections is reduced.

In medical practice, several types of red blood cells can be used, depending on the method of preparation and indications for use. In addition to the standard red blood cell mass with a hematocrit not higher than 80%, which is used most often, a phenotypic red blood cell mass is prescribed - a transfusion medium in which at least 5 antigens are identified in addition to the A, B and D antigens of the Rh system. Prescribed to prevent alloimmunization to erythrocyte antigens. Transfusion of phenotypic red blood cells is indicated for multiple transfusions in patients with aplastic syndrome and thalassemia. In such cases, phenotyping of the recipient is necessary before the first transfusion.

Along with the erythrocyte mass, an erythrocyte suspension is used in a resuspending, preservative solution (the ratio of erythrocytes and solution is determined by its hematocrit, and the composition of the solution is determined by the duration of storage), as well as erythrocyte mass depleted of leukocytes and platelets, and erythrocyte mass thawed and washed. These transfusion media are necessary when carrying out replacement therapy in women who have given birth many times, in persons with a burdened transfusion history, who may have antibodies to leukocytes and/or platelets. Such recipients may have febrile nonhemolytic reactions after transfusion of transfusion media containing incompatible leukocytes. The frequency and severity of temperature reactions are proportional to the number of leukocytes transfused with red blood cells. Transfusion of red blood cells depleted of leukocytes and platelets is indicated to prevent alloimmunization with histoleukocyte antigens and refractoriness to repeated platelet transfusions. The use of red blood cells depleted of leukocytes and platelets reduces the risk of transmission of viral infections (human immunodeficiency virus, cytomegalovirus). Currently existing special leukocyte filters make it possible to effectively remove plasma proteins, microaggregates, platelets and leukocytes from the red blood cell mass (filtered red blood cell mass).

An erythrocyte suspension is practically a deplasmated concentrate of erythrocytes, the protein level in which does not exceed 1.5 g/l. Transfusion of red blood cell suspension is indicated for persons with a history of severe allergies in order to prevent anaphylactic reactions, as well as for patients with IgA deficiency or when antibodies to IgA are detected in the recipient. It can be recommended to use erythrocyte suspension in patients with paroxysmal nocturnal hemoglobinuria, since the erythrocytes of these patients are highly sensitized to lysis by complement, which is activated by transfusion of standard erythrocyte mass.

The erythrocyte mass, thawed and washed, contains a smaller amount of leukocytes, platelets and plasma compared to other erythrocyte-containing transfusion media. It is an ideal form for storing rare blood groups, for long-term (years) storage of blood components for the purpose of autotransfusion. Red blood cell mass, thawed and washed, must be used within 24 hours after thawing. Transfusion of thawed, washed erythrocytes is especially indicated for patients with a burdened transfusion history when anti-leukocyte and anti-platelet antibodies are detected.

An erythrocyte suspension with physiological solution is obtained from whole blood after removal of plasma or from erythrocyte mass by washing three times in an isotonic solution or in special washing media. During the washing process, plasma proteins, leukocytes, platelets, microaggregates of cells and stroma of cellular components destroyed during storage are removed. An erythrocyte suspension with physiological solution is an areactogenic transfusion medium, the transfusion of which is indicated for patients with a history of post-transfusion reactions of the non-hemolytic type, as well as for persons sensitized to leukocyte and platelet antigens, and plasma proteins. The shelf life of erythrocyte suspension with physiological solution at a temperature of +4 degrees C is 24 hours from the moment of their preparation.

Standard red blood cell mass is stored at a temperature of +4 – +2 degrees. C. Storage periods are determined by the composition of the blood preservative solution or resuspension solution. Red blood cell mass obtained from blood collected in a solution of Glugitsir or Citroglucophosphate is stored for 21 days, from blood collected in a solution of Tsiglyufad, CPDI - up to 35 days. Red blood cell mass resuspended in Erythronaf solution can be stored for up to 35 days, Adsol and SIGM for up to 41 days.

7.3. Criteria for the effectiveness of transfusion of blood gas carriers

The effectiveness of transfusion therapy with blood gas carriers can and should be assessed in almost every transfusion. Clinical data, oxygen transport indicators, quantitative increases in hemoglobin levels and circulating blood volume can be used as criteria.

In the absence of ongoing active bleeding, an effective transfusion of 250 ml of red blood cells an hour after its completion leads to an increase in the volume of circulating blood by the same amount. However, after 24 hours, the circulating blood volume returns to its original level. A slower return to the pretransfusion blood volume is observed in patients with chronic renal failure, hepatomegaly of various origins, chronic anemia and congestive heart failure.

A lower than expected increase in hemoglobin after transfusion can be observed with severe splenomegaly, ongoing bleeding, immunological incompatibility and prolonged hyperthermia.

When conducting transfusion red blood cell replacement therapy, the reasons for effectiveness or ineffectiveness should be analyzed. It is known that in healthy individuals the normal daily production of red blood cells is approximately 0.25 ml/kg body weight. Therefore, in persons with myelosuppression, it is sufficient to transfuse 200–250 ml of red blood cells once or twice a week to maintain adequate hemoglobin levels. The need for more frequent transfusions is often due to their ineffectiveness, the reason for which should be clarified and, if possible, eliminated.

In general, when prescribing a red blood cell-containing transfusion medium, the physician should take into account the following circumstances:

with single transfusions, the possibility of transmission of infectious diseases (HIV, hepatitis, cytomegalovirus infection) and the development of alloimmunization in women of childbearing age;
with multiple transfusions, in addition to the above circumstances, there is the possibility of iron overload, exacerbation of chronic disseminated intravascular coagulation, especially in cancer and chronic renal failure, and the development of allosensitization.

7.4. Features of transfusion of blood gas carriers in pediatrics

The strategy and tactics of transfusions of blood gas carriers in pediatrics are not fundamentally different from those in adult patients, except for the neonatal period. Newborns differ not only from adults, but also from young children in the following features:

high sensitivity to hypovolemia, increased risk of developing tissue anoxia and hypothermia;
special physiological parameters of the blood formula: BCC = 85 ml/kg; hematocrit – 45 – 60%; red blood cell count – 4.0 – 5.6 x 1E12 /l;
the presence of fetal hemoglobin (60 - 80%), which causes a high affinity for oxygen and a decrease in its release in tissues.

Some plasma coagulation factors, due to physiological reasons, are at low levels at birth (II, VII, X), while other factors (I, V, VIII, XIII), as well as platelet levels, are determined at the same level as in adults.

It should also be noted that immunosuppression is typical for young children.

The criteria for prescribing transfusions of blood gas carriers during the neonatal period (i.e., children under four months of age) are: the need to maintain a hematocrit above 40% during the surgical treatment of children with severe cardiopulmonary pathology; in case of moderately severe cardiopulmonary pathology, the hematocrit level should be above 30%; during minor elective operations in stable newborns, the hematocrit level should be maintained at least 25%.

For children older than four months, transfusions of blood gas carriers are indicated in the presence of preoperative anemia (hemoglobin level less than 130 g/l) and intraoperative blood loss of more than 15% of the bcc, with a postoperative hemoglobin level below 80 g/l and clinically pronounced signs of anemic syndrome. In addition, transfusion of blood gas carriers is indicated for acute blood loss that is not corrected by transfusions of saline solutions or colloids, i.e. with ongoing manifestations of hypovolemic syndrome. It is possible to transfuse blood gas carriers in patients with a hemoglobin level of less than 130 g/l in the presence of concomitant severe lung diseases requiring artificial ventilation. In chronic anemia caused by any underlying disease, transfusion of blood gas carriers is indicated when the hemoglobin level is less than 80 g/l, not corrected by pathogenetic drug therapy, or when the hemoglobin level is less than 100 g/l and clinical manifestations of anemia.

The distinctive features of the physiology of newborns dictate special rules for transfusions:

All transfusions to newborns are considered massive, given their high sensitivity to hypothermia, sharp fluctuations in acid-base balance and ionic composition of the blood. Therefore, transfusions to newborns should be carried out under the strictest control of both the volume of transfused erythrocyte-containing transfusion media and the volume of blood taken for tests.
The least reactogenic and preferred blood component containing erythrocytes for transfusion to newborns should be considered an erythrocyte suspension that has been thawed and washed.
The rate of red blood cell transfusion is 2–5 ml/kg body weight per hour under mandatory monitoring of hemodynamics and respiration.
Pre-warming of erythrocyte-containing media is necessary for rapid transfusions (0.5 ml/kg body weight per minute). However, their overheating is fraught with complications, as well as hypothermia due to the transfusion of cold red blood cells or suspension.
In the presence of acute bleeding with a deficiency of blood volume of more than 15%, transfusion of blood gas carriers is preceded by correction of hypovolemia by transfusion of a 5% albumin solution at a dose of 20 ml/kg body weight.
The type of anticoagulant used to preserve the transfused donor red blood cells must be taken into account. The immature neonatal liver has a low ability to metabolize citrate. Citrate intoxication, which manifests itself as alkalosis with an increase in plasma carbonate concentrations, is a common post-transfusion complication in newborns, especially premature infants. The best blood preservative for premature babies and newborns is heparin.
When selecting a donor of blood components, it should be remembered that the mother is an undesirable donor of plasma for the newborn, since the mother’s plasma may contain alloimmune antibodies against the newborn’s red blood cells, and the father is an undesirable donor of red blood cells, against the antigens of which the newborn’s blood may contain antibodies that have penetrated from the mother’s bloodstream through placenta.
For a premature newborn or fetus during intrauterine transfusion, it is advisable to transfuse only cytomegalovirus-negative, leukocyte-free, radiation-irradiated red blood cells or suspension.

Before transfusion of blood gas carriers, as well as platelet concentrate, newborns must:

Determine blood group according to the AB0 system. ABO testing is performed only on the recipient's red blood cells, using anti-A and anti-B reagents, since natural agglutinins are usually not detected at an early age. Below is table 2 of the selection of blood or red blood cells for transfusion to children under four months of age according to the AB0 system. If there are difficulties in determining the blood group in the ABO system of the recipient, then 0(1) red blood cells compatible with the serum of the newborn and mother should be transfused. In the absence of the mother, red blood cells 0(1), compatible with the child's serum, are transfused.
Determine the Rh factor of the newborn's blood. For hemolytic disease caused by anti-D antibodies, only Rh-negative blood is transfused. If the pathogenic antibodies are not anti-D antibodies, the newborn can be transfused with Rh-positive blood.

The search for immune antibodies and individual compatibility testing are carried out with both the serum of the newborn and his mother. If it is not possible to obtain newborn blood for testing (especially in premature infants, since the sample required for analysis is 1–2% of the bcc), testing is performed with maternal serum. For intrauterine transfusion, only red blood cells and suspension or whole canned donor blood 0(1), compatible with maternal serum, are used.

table 2

7.5. Autodonation of blood components and autohemotransfusion

The advantages of a treatment intervention that includes receiving from patients who are both donors and recipients blood or its components (autoerythrocyte mass or suspension, fresh frozen plasma, platelet concentrate), and the subsequent return (transfusion) of what was taken (autodonation), are the absence alloimmunization, eliminating the risk of transmission of infections, significantly reducing the risk of transfusion reactions, less need for allogeneic blood components, stimulation of erythropoiesis, which ensures greater safety of replacement transfusion therapy with blood components. That is why autodonation as a therapeutic transfusiological measure is being used more and more often.

7.5.1. Indications for autodonation. The main indications for the use of autotransfusions of blood or plasma gas carriers are:

Complex and extensive planned surgical operations with estimated blood loss of more than 20% of the circulating blood volume (orthopedics, cardiac surgery, urology). In pregnant women in the third trimester, if there are indications for a planned caesarean section, it is possible to carry out autodonor plasma procurement in a volume of up to 500 ml.
Patients with a rare blood group and the impossibility of selecting an adequate number of donor blood components.
Refusal of patients from transfusion of allogeneic blood components for religious reasons if there are indications for transfusion of blood components during planned surgical treatment.

The following methods of performing autologous transfusions exist:

preoperative collection of autologous blood or autoerythrocyte mass or suspension, which allows collecting 3–4 doses (up to 1000–1200 ml of preserved autologous blood or 600–700 ml of autoerythrocyte mass) 3–4 weeks before planned surgery;
preoperative normovolemic or hypervolemic hemodilution, which involves the preparation of 1 - 2 units of blood (600 - 800 ml) immediately before surgery or the start of anesthesia with mandatory replenishment of temporary blood loss with saline solutions and plasma substitutes with the maintenance of normovolemia or hypervolemia;
intraoperative blood reinfusion - collection during surgery from the surgical wound and cavities of spilled blood with mandatory subsequent washing and return to the recipient's bloodstream of autologous cavity blood, canned, filtered for reinfusion. The same procedure is possible when using drainage blood obtained under sterile conditions during postoperative drainage of body cavities.

Each of these methods can be used separately or in various combinations. It is possible to use simultaneous or sequential transfusions of autologous blood components with allogeneic ones.

7.5.2. Conditions for exfusion of blood components from an autodonor. Autodonation improves the safety of transfusions for an individual patient. Autologous donation of blood components is used to reduce the risk of post-transfusion complications. The patient must give written consent to the collection of autologous blood or its components, which is recorded in the medical history. The patient's attending physician must inform him about the features of donating blood components and possible reactions (Section 1 of these Instructions). Testing of autologous blood and its components is similar to that for allogeneic blood components. When labeling autologous blood or its components, the label must include the phrase “for autologous transfusion.”

The criteria for admission to donation of autologous blood components are generally the same as for regular donors. There is no upper age limit for autodonors; in each specific case, the decision on the possibility of autodonation is decided jointly by the attending physician and the transfusiologist, taking into account the opinion of the patient or his legal representatives. The lower age limit is determined by the physical development and somatic condition of the child, as well as the severity of peripheral veins. As a rule, autotransfusions of blood components are used in persons from 5 to 70 years of age.

7.5.3. Preoperative collection of autologous blood components. The volume of a single blood donation for persons weighing more than 50 kg should not exceed 450 ml. With a body weight of less than 50 kg, the volume of blood donation is no more than 8 ml/kg of body weight. Persons weighing less than 10 kg are not allowed to undergo therapeutic autodonation. The amount of anticoagulant solution decreases in proportion to the amount of blood exfused.

The hemoglobin level of the autodonor before each blood donation should not be lower than 110 g/l, the hematocrit should not be lower than 33%.

The frequency of autologous blood donations is determined by the attending physician and transfusiologist. It should be taken into account that the plasma volume and the level of total protein and albumin are restored after 72 hours, i.e. The last blood donation before a planned operation should be performed 3 days before.

Most autodonors, especially when collecting more than one unit of blood, should receive iron tablets. It is known that the rate of erythropoiesis is limited by the adequate amount of iron in the body, which is approximately 2 g for women and 3 g for men. Each donation of 1 unit of blood reduces iron stores by 200 mg (approximately 1 mg per 1 ml of red blood cells). Iron supplementation begins before the first blood donation. In some cases, to accelerate the formation of red blood cells, it is advisable to simultaneously administer erythropoietin. The prescription of iron and erythropoietin supplements to an autodonor should be agreed with the attending physician.

Storage of autologous blood or its components is carried out according to the same rules as for homologous blood components.

Persons with an established source of infection (any source of infection, preliminary sanitation is required) or bacteremia, upon verification of unstable angina, aortic stenosis, sickle cell anemia, are not allowed to donate. Detected thrombocytopenia (platelet count below 180 x 1E9/l) also serves as a basis for withdrawal from autodonation.

Positive serological testing of the autorecipient for HIV, hepatitis and syphilis is a contraindication to the use of autodonation.

The frequency of adverse reactions during the procurement of autologous blood components is similar to general donor practice and ranges from 2 to 5% of all donations. The most common are vasovagal reactions to temporary blood loss (fainting, dizziness, cardiac arrhythmia, mild decrease in systolic blood pressure). The room where blood exfusion from autodonors is carried out must be equipped to carry out possible intensive care measures, and the staff must be suitably trained.

Pre-transfusion monitoring of autologous blood gas carriers, testing for its compatibility with the recipient and biological tests must be performed by the doctor who directly transfused this transfusion medium, as in the case of using allogeneic blood components, especially if both donor and autodonor blood components are used.

In general, preoperative collection of autologous blood or its components should not worsen the patient’s condition before surgery.

In most cases, the autodonation program involves the collection, short-term storage and transfusion of canned whole autologous blood and autoerythrocyte mass or suspension. However, autodonation of plasma and platelets is possible.

Fresh frozen autoplasma, obtained from autologous blood, can be prepared in therapeutically significant quantities (500 - 1000 ml) under planned conditions and has been successfully used during complicated caesarean sections in obstetrics, cardiovascular surgery and orthopedics.

Autologous platelet concentrate and fresh frozen autoplasma can be used in operations with artificial circulation in cardiovascular surgery, where thrombocytopenia is often observed in the postoperative period. The autoplatelet concentrate prepared 3–5 days before surgery is stored at room temperature (20–24 degrees C) under constant stirring and transfused during or immediately after surgery, which significantly reduces the amount of postoperative blood loss.

7.5.4. Preoperative hemodilution. The advantage of this method of autodonation is that during the operation the patient loses blood with a lower content of red blood cells than he had before hemodilution. Subsequent transfusion of preserved whole autologous blood several hours earlier, mainly after the end of the main surgical blood loss, allows you to quickly increase the concentration of hemoglobin, coagulation factors, platelet levels and blood volume.

Hemodilution can be isovolemic, in which the original (normal) volume of circulating blood is preserved and maintained, in which the volume and concentration of blood cells only temporarily decreases. Hypervolemic hemodilution is also possible, in which the doctor, before the upcoming massive blood loss, increases the intravascular circulating blood volume above normal due to excessive transfusion of plasma substitutes under the control of hemodynamics and central venous pressure, thereby also reducing the loss of red blood cells during surgery.

Preoperative hypervolemic hemodilution is not indicated for patients with severe coronary insufficiency, severe cardiac arrhythmias, hypertension (systolic blood pressure more than 180 mm Hg), severe damage to the lungs with respiratory failure, kidneys, liver, disorders of the coagulation system, and in the presence of foci of infection.

The patient must be informed in advance about the preoperative hemodilution, to which he gives his consent, recorded in the medical history (Section 1 of these Instructions). The attending physician and transfusiologist use the medical history to justify the need for hemodilution. Preoperative hemodilution is performed by a transfusiologist or a specially trained physician. Immediately before the start of the procedure, blood pressure, pulse, hemoglobin and hematocrit levels are measured and recorded. Two veins are punctured - one for exfusion, the other for replenishment. If it is impossible to puncture the second vein, exfusion and replenishment alternate.

The exfused blood volume is replenished with saline solutions (3 ml for each ml of collected blood) or colloids (1 ml for each ml of collected blood). The amount of blood taken varies, but the post-hemodilution hemoglobin level should not be lower than 90-100 g/l, and the hematocrit level should not be less than 28%. Blood is collected in standard plastic blood containers containing a hemopreservative. A hemodilution protocol is maintained, which records the patient’s condition, the volume of blood exfused, the volume of replenishment, the state of hemodynamics, and the start and end time of the procedure.

The container with whole preserved autologous blood is carefully labeled: day, hour, patient’s name, name of the environment; if there are several containers, then their serial number. The interval between exfusion and reinfusion should not be more than 6 hours, otherwise containers with blood should be placed in a refrigerator at a temperature of 4 degrees. C. Containers with whole preserved autologous blood are not removed from the operating room during preoperative hemodilution.

Transfusion of whole preserved autologous blood begins, as a rule, after the end of the stage of the operation associated with the greatest blood loss. The dose of autologous blood collected last is transfused first. Autologous blood is transfused through standard transfusion systems with a filter.

Normovolemic hemodilution is carried out either before the patient is put under anesthesia or after induction of anesthesia, but before the start of the operation. In the latter case, autogenous blood is taken oxygenated, since artificial ventilation, carried out during anesthesia in the mode of moderate hyperventilation, helps to increase the oxygen content in the venous blood. During basic anesthesia and surgery, it is necessary to monitor hemodynamic parameters, hourly diuresis, and blood gases in order to maintain normal tissue oxygenation and normovolemia, ensuring adequate organ perfusion.

Hypervolemic hemodilution is carried out according to the same principles as normovolemic, but at the same time the hematocrit level is maintained within 23–25%, using solutions of hydroxyethyl starch or 5–10% albumin to replace exfused autologous blood.

7.5.5. Intraoperative blood reinfusion. Reinfusion of blood lost during surgery involves aspiration of such blood from the surgical wound or body cavities using sterile suction into a sterile container, followed by washing, and then return to the recipient during surgery or within a period not exceeding 6 hours after the start of collection. The use of intraoperative blood reinfusion is indicated only in circumstances where the estimated blood loss exceeds 20% of the circulating blood volume, which is observed in cardiovascular surgery, rupture of an ectopic pregnancy, orthopedic surgery, and traumatology.

Intraoperative reinfusion of blood is contraindicated if it is bacterially contaminated, if there is ingress of amniotic fluid, or if there is no possibility of washing off the blood that was spilled during the operation.

The blood poured into the body cavity differs in composition from the circulating blood. It has a reduced content of platelets, fibrinogen, 2,3-diphosphoglycerate, a high level of free hemoglobin, and there are products of fibrinogen degradation. To some extent, these shortcomings are leveled out in the process of mandatory washing of red blood cells before reinfusion.

Filtering spilled blood through several layers of gauze is currently unacceptable.

Special devices have been created for intraoperative collection and washing of blood lost during surgery.

Transfusion of plasma-coagulation hemostasis correctors

Plasma is the liquid part of the blood, devoid of cellular elements. Normal plasma volume is about 4% of total body weight (40 – 45 ml/kg). Plasma components maintain normal circulating blood volume and its fluid state. Plasma proteins determine its colloid-oncotic pressure and balance with hydrostatic pressure; They also maintain a balanced state of the blood coagulation and fibrinolysis systems. In addition, plasma ensures the balance of electrolytes and the acid-base balance of the blood.

In medical practice, fresh frozen plasma, native plasma, cryoprecipitate and plasma preparations are used: albumin, gamma globulins, blood coagulation factors, physiological anticoagulants (antithrombin III, protein C and S), components of the fibrinolytic system.

8.1. Characteristics of plasma-coagulation hemostasis correctors

Fresh frozen plasma means plasma that is separated from red blood cells by centrifugation or apheresis within 4 to 6 hours after blood exfusion and placed in a low-temperature refrigerator that ensures complete freezing to a temperature of -30 degrees. C per hour. This mode of plasma procurement ensures its long-term (up to a year) storage. In fresh frozen plasma, labile (V and VIII) and stable (I, II, VII, IX) coagulation factors are preserved in an optimal ratio.

If cryoprecipitate is removed from plasma during fractionation, the remaining part of the plasma is the supernatant fraction of plasma (cryosupernatant), which has its own indications for use.

After separation of water from plasma, the concentration of total protein and plasma coagulation factors, in particular IX, increases significantly - such plasma is called “native concentrated plasma”.

The transfused fresh frozen plasma must be of the same group as the recipient according to the AB0 system. Compatibility according to the Rh system is not mandatory, since fresh frozen plasma is a cell-free medium, however, with volume transfusions of fresh frozen plasma (more than 1 liter), Rh compatibility is required. Compatibility for minor erythrocyte antigens is not required.

It is desirable that fresh frozen plasma meets the following standard quality criteria: the amount of protein is not less than 60 g/l, the amount of hemoglobin is less than 0.05 g/l, the potassium level is less than 5 mmol/l. Transaminase levels should be within normal limits. The results of tests for markers of syphilis, hepatitis B and C, and HIV are negative.

After thawing, plasma must be used within an hour; plasma cannot be re-frozen. In emergency cases, in the absence of single-group fresh frozen plasma, transfusion of group AB(IV) plasma is allowed to a recipient with any blood group.

The volume of fresh frozen plasma obtained by centrifugation from one dose of blood is 200 – 250 ml. When performing double donor plasmapheresis, the plasma yield can be 400–500 ml, while hardware plasmapheresis can be no more than 600 ml.

8.2. Indications and contraindications for transfusion of fresh frozen plasma

Indications for prescribing fresh frozen plasma transfusions are:

acute syndrome of disseminated intravascular coagulation (DIC), complicating the course of shocks of various origins (septic, hemorrhagic, hemolytic) or caused by other reasons (amniotic fluid embolism, crash syndrome, severe injuries with crushing tissue, extensive surgical operations, especially on the lungs, blood vessels, brain brain, prostate), massive transfusion syndrome;
acute massive blood loss (more than 30% of circulating blood volume) with the development of hemorrhagic shock and disseminated intravascular coagulation syndrome;
liver diseases accompanied by a decrease in the production of plasma coagulation factors and, accordingly, their deficiency in the circulation (acute fulminant hepatitis, cirrhosis of the liver);
overdose of indirect anticoagulants (dicoumarin and others);
when performing therapeutic plasmapheresis in patients with thrombotic thrombocytopenic purpura (Moschkowitz disease), severe poisoning, sepsis, acute disseminated intravascular coagulation syndrome;
coagulopathies caused by a deficiency of plasma physiological anticoagulants.

It is not recommended to transfuse fresh frozen plasma for the purpose of replenishing circulating blood volume (there are safer and more economical means for this) or for parenteral nutrition purposes. Caution should be exercised in prescribing fresh frozen plasma transfusions in persons with a significant transfusion history or in the presence of congestive heart failure.

8.3. Features of fresh frozen plasma transfusion

Fresh frozen plasma transfusion is carried out through a standard blood transfusion system with a filter, depending on clinical indications - in a stream or drip; in acute DIC with severe hemorrhagic syndrome - in a stream. It is prohibited to transfuse fresh frozen plasma to several patients from the same container or bottle.

When transfusing fresh frozen plasma, it is necessary to perform a biological test (similar to transfusion of blood gas carriers). The first few minutes after the start of the infusion of fresh frozen plasma, when a small amount of the transfused volume has entered the recipient's circulation, are decisive for the occurrence of possible anaphylactic, allergic and other reactions.

The volume of fresh frozen plasma transfused depends on clinical indications. For bleeding associated with DIC, administration of at least 1000 ml of fresh frozen plasma at a time under the control of hemodynamic parameters and central venous pressure is indicated. It is often necessary to re-administer the same volumes of fresh frozen plasma under dynamic monitoring of the coagulogram and clinical picture. In this condition, the administration of small amounts (300 - 400 ml) of plasma is ineffective.

In case of acute massive blood loss (more than 30% of the circulating blood volume, for adults - more than 1500 ml), accompanied by the development of acute disseminated intravascular coagulation syndrome, the amount of transfused fresh frozen plasma should be at least 25 - 30% of the total volume of transfusion media prescribed to replenish blood loss, t .e. at least 800 – 1000 ml.

In chronic disseminated intravascular coagulation syndrome, as a rule, a transfusion of fresh frozen plasma is combined with the prescription of direct anticoagulants and antiplatelet agents (coagulological monitoring is required, which is a criterion for the adequacy of the therapy). In this clinical situation, the volume of fresh frozen plasma transfused once is at least 600 ml.

In severe liver diseases, accompanied by a sharp decrease in the level of plasma coagulation factors and the development of bleeding or the threat of bleeding during surgery, transfusion of fresh frozen plasma at the rate of 15 ml/kg of body weight is indicated, followed, after 4 - 8 hours, by repeated transfusion of plasma in a smaller volume ( 5-10 ml/kg).

Immediately before transfusion, fresh frozen plasma is thawed in a water bath at a temperature of 37 degrees. C. Thawed plasma may contain fibrin flakes, but this does not prevent its use using standard intravenous transfusion devices with a filter.

The possibility of long-term storage of fresh frozen plasma allows it to be accumulated from one donor in order to implement the “one donor – one recipient” principle, which allows to sharply reduce the antigenic load on the recipient.

8.4. Reactions during transfusion of fresh frozen plasma

The most serious risk when transfusing fresh frozen plasma is the possibility of transmission of viral and bacterial infections. That is why today much attention is paid to methods of viral inactivation of fresh frozen plasma (plasma quarantine for 3–6 months, detergent treatment, etc.).

In addition, immunological reactions associated with the presence of antibodies in the plasma of the donor and recipient are potentially possible. The most severe of them is anaphylactic shock, clinically manifested by chills, hypotension, bronchospasm, and chest pain. As a rule, such a reaction is caused by IgA deficiency in the recipient. In these cases, it is necessary to stop the plasma transfusion and administer adrenaline and prednisolone. If there is a vital need to continue therapy using fresh frozen plasma transfusion, it is possible to prescribe antihistamines and corticosteroids 1 hour before the start of the infusion and re-administer them during the transfusion.

8.5. Cryoprecipitate transfusion

Recently, cryoprecipitate, which is a drug obtained from donor blood, is considered not so much as a transfusion medium for the treatment of patients with hemophilia A and von Willebrand disease, but as a starting material for further fractionation in order to obtain purified factor VIII concentrates.

For hemostasis, it is necessary to maintain the level of factor VIII up to 50% during operations and up to 30% in the postoperative period. One unit of factor VIII corresponds to 1 ml of fresh frozen plasma. Cryoprecipitate obtained from one unit of blood must contain at least 100 units of factor VIII.

The need for cryoprecipitate transfusion is calculated as follows:

Body weight (kg) x 70 ml/kg = blood volume (ml).

Blood volume (ml) x (1.0 – hematocrit) = plasma volume (ml).

Plasma volume (ml) x (required factor VIII level – available factor VIII level) = required amount of factor VIII for transfusion (units).

Required amount of factor VIII (units): 100 units. = number of doses of cryoprecipitate required for a single transfusion.

The half-life of transfused factor VIII in the recipient's circulation is 8 to 12 hours, so repeat cryoprecipitate transfusions are usually necessary to maintain therapeutic levels.

In general, the amount of cryoprecipitate transfused depends on the severity of hemophilia A and the severity of bleeding. Hemophilia is regarded as severe when the level of factor VIII is less than 1%, moderate – when the level is in the range of 1 – 5%, mild – when the level is 6 – 30%.

The therapeutic effect of cryoprecipitate transfusions depends on the degree of distribution of the factor between the intravascular and extravascular spaces. On average, one fourth of the transfused factor VIII contained in the cryoprecipitate passes into the extravascular space during therapy.

The duration of therapy with cryoprecipitate transfusions depends on the severity and location of bleeding and the patient's clinical response. For major surgeries or dental extractions, it is necessary to maintain factor VIII levels of at least 30% for 10-14 days.

If, due to some circumstances, it is not possible to determine the level of factor VIII in the recipient, then the adequacy of therapy can be indirectly judged by the activated partial thromboplastin time. If it is within the normal range (30 - 40 s), then factor VIII is usually above 10%.

Another indication for the use of cryoprecipitate is hypofibrinogenemia, which is extremely rarely observed in isolation, more often as a sign of acute disseminated intravascular coagulation. One dose of cryoprecipitate contains an average of 250 mg of fibrinogen. However, large doses of cryoprecipitate can cause hyperfibrinogenemia, which is fraught with thrombotic complications and increased erythrocyte sedimentation.

The cryoprecipitate must be AB0 compatible. The volume of each dose is small, but transfusion of many doses at once is fraught with volemic disorders, which is especially important to consider in children who have a smaller blood volume than adults. Anaphylaxis, allergic reactions to plasma proteins, and volume overload may occur with cryoprecipitate transfusion. The transfusiologist must constantly remember the risk of their development and, if they appear, carry out appropriate therapy (stop transfusion, prescribe prednisolone, antihistamines, adrenaline).

Transfusion of platelet concentrates

Transfusion of platelet concentrate has in recent years become a mandatory condition for the program therapy of tumors of the blood system, aplastic anemia, and bone marrow transplantation. Under the “protection” of transfusions of platelet concentrate, courses of intensive chemotherapy are carried out with a pre-planned period of prolonged agranulocytosis and thrombocytopenia, and abdominal operations (laparotomy, splenectomy) that were previously impossible are performed.

9.1. Characteristics of platelet concentrate

A standard platelet concentrate, prepared from one 450 ml unit of banked blood, contains at least 55 x 1E9 platelets. This amount is considered one unit of platelet concentrate, the transfusion of which should increase the number of platelets in the circulation of a recipient with a body surface area of 1.8 m2 by approximately 5 - 10 x 1E9/l in the absence of signs of bleeding. However, such a transfusion will not be therapeutically effective in cases of deep thrombocytopenia in patients with myelosuppression complicated by bleeding. It has been established that the therapeutic dose of platelet concentrate is the transfusion of at least 50 - 70 x 1E9 platelets for every 10 kg of body weight or 200 - 250 x 1E9 per 1 m2 of body surface.

Therefore, for adult recipients, the required therapeutic platelet count should be 300 – 500 x 1E9. This number of platelets can be obtained by transfusing platelet concentrate obtained from 6 to 10 donors into one recipient (multi-donor platelet concentrate). An alternative to this technique is the method of obtaining platelet concentrate from one donor using 4-fold plateletpheresis using refrigerated centrifuges and built-in plastic closed containers. In this case, you can get up to 300 x 1E9 platelets from one donor.

The use of the Optisystem method (automatic plasma extractors and special containers) makes it possible to obtain a pooled (polydonor) platelet concentrate of more than 300 x 1E9 with a minimal admixture of leukocytes.

The largest number of platelets (800 - 900 x 1E9) can be obtained when performing plateletpheresis from one donor using blood cell separators operating automatically in a constant blood flow.

In a platelet concentrate obtained by any of the above methods, there is always an admixture of erythrocytes and leukocytes, and therefore, if recipients experience severe transfusion reactions to the administration of platelet concentrate or refractoriness, it is necessary to remove erythrocytes and especially leukocytes. For this purpose, the monodonor platelet concentrate is subjected to gentle centrifugation (178 d) for 3 minutes. This technique allows you to “wash” almost 96% of the leukocytes present in the platelet concentrate, but, unfortunately, about 20% of the platelets are lost. Currently, there are special filters that remove leukocytes from platelet concentrate directly during transfusion to the recipient, which significantly increases the effectiveness of platelet replacement therapy.

9.2. Indications and contraindications for transfusion of platelet concentrate

The causes of thrombocytopenia and resulting bleeding may be:

insufficient formation of platelets in the bone marrow - amegakaryocytic thrombocytopenia (leukemia, hematosarcomas and other oncological diseases with bone marrow damage, aplastic anemia, myelodepression as a result of radiation or cytostatic therapy, acute radiation sickness, bone marrow transplantation);
increased consumption of platelets (acute disseminated intravascular coagulation syndrome, massive blood loss, dilution thrombocytopenia with massive transfusion syndrome, surgical interventions using a heart-lung machine). Often under these circumstances, not only the number of platelets decreases, but their functional ability is also impaired, which increases the severity of bleeding;
increased destruction of platelets (immune and other thrombocytolytic diseases, in which, as a rule, the number of megakaryocytes in the bone marrow may be normal or even increased).

Pathological bleeding can also be observed with qualitative platelet deficiency, i.e. with hereditary or acquired thrombocytopathies, in which the number of platelets is usually within normal limits or moderately reduced as a result of a shortened life of defective cells.

A platelet level of 50 x 1E9/L is usually sufficient for hemostasis, provided they are in normal functional capacity. In these cases, the bleeding time is within the normal range (2 - 8 minutes according to Jvy), there is no need for transfusion of platelet concentrate even when performing abdominal operations.

When the platelet level decreases to 20 x 10 x 9/l, in most cases, clinical manifestations of spontaneous thrombocytopenic hemorrhagic syndrome are observed: petechial rashes and bruising on the skin of the lower extremities, spontaneous bleeding on the mucous membranes of the mouth and nose. Transfusion of platelet concentrate in such conditions is necessary, and in the event of pinpoint hemorrhages on the upper half of the body, hemorrhages in the conjunctiva and fundus of the eye, local bleeding (gastrointestinal tract, uterus, kidneys, bladder) - transfusion of platelet concentrate is an emergency, vitally indicated procedure.

Transfusion of platelet concentrate in case of increased destruction of platelets of immune origin is not indicated, because Antiplatelet antibodies circulating in the recipient quickly (within minutes) lyse donor platelets.

In case of thrombocytopathies, transfusion of platelet concentrate is indicated only in urgent situations - during massive bleeding, operations, and childbirth. Transfusion of platelet concentrate for prophylactic purposes in this category of patients is not recommended due to the possible rapid development of alloimmunization with subsequent refractoriness to platelet transfusion in critical situations.

Specific indications for prescribing platelet concentrate are established by the attending physician based on an analysis of the clinical picture and causes of thrombocytopenia, its severity and location of bleeding, the volume and severity of the upcoming operation.

9.3. Criteria for the effectiveness of platelet concentrate transfusions

Clinical criteria for the effectiveness of transfusion of platelet concentrate are the cessation of spontaneous bleeding and the absence of fresh hemorrhages on the skin and visible mucous membranes. Clinically observed hemostasis is the most important criterion for the effectiveness and adequacy of the dose of transfused donor platelets, although the calculated and expected increase in the number of platelets in the circulation often does not occur.

Laboratory signs of the effectiveness of replacement therapy of platelet concentrate transfusion are an increase in the number of circulating platelets in the recipient’s bloodstream an hour after the transfusion (with effective transfusion, their number reaches 50 - 60 x 10x9 / l). After 24 hours, if the result is positive, their amount should exceed the critical level of 20 x 10x9 / l or, in any case, be higher than the initial pre-transfusion amount. Normalization or reduction of bleeding time can also be a criterion for the effectiveness of platelet concentrate transfusions.

Another criterion for the effectiveness of platelet concentrate transfusions may be the time it takes for the recipient's platelet count to return to its original level - usually after 1 to 2 days. This indicator makes it possible to evaluate not only the effectiveness of platelet therapy, but also to predict the frequency of transfusions and their immunological compatibility.

In reality, 100% of the expected increase in platelet count is never observed. A decrease in post-transfusion levels is influenced by the presence in recipients of splenomegaly, infectious complications accompanied by hyperthermia, disseminated intravascular coagulation syndrome, massive local bleeding (especially gastrointestinal or uterine), alloimmunization with immunologically caused destruction of donor platelets caused by antibodies to platelet and/or leukocyte antigens.

In these not-so-rare clinical situations, the need for transfusion of a therapeutically effective amount of platelets increases. In case of splenomegaly, the number of transfused platelets should be increased compared to the usual by 40 - 60%, in case of infectious complications - by an average of 20%, in case of severe DIC syndrome, massive blood loss, alloimmunization phenomena - by 60 - 80%. In this case, the required therapeutic dose can be given in two doses, for example, in the morning and in the evening.

The optimal regimen for transfusion of platelet concentrate is one in which the bleeding time is within the normal range, and the number of platelets in the peripheral blood is maintained at a level above 40 x 10 x 9/L.

9.4. Prophylactic transfusion of platelet concentrate

When prescribing platelet concentrate transfusions prophylactically, i.e. when there is relatively deep thrombocytopenia (20 - 30 x 10x9/l) of amegakaryocytic nature without signs of spontaneous bleeding, the transfusiologist is always obliged to correlate the risk of possible hemorrhagic complications with the risk of early alloimmunization of patients, especially when using multi-donor platelet concentrate. Preventive transfusions of platelet concentrate are indicated in the presence of sepsis in patients with agranulocytosis and disseminated intravascular coagulation syndrome. Transfusion of platelet concentrate is indicated in patients with acute leukemia for the prevention of hemorrhages. For such patients, it is advisable to carry out preliminary selection of donors with typing according to the HLA system, because It is the class 1 HLA antigens present on the platelets themselves that most often cause sensitization and refractoriness that develop with multiple transfusions of platelet concentrate.

In general, the prophylactic administration of platelet concentrate transfusions requires an even stricter attitude than the therapeutic administration of replacement transfusions of donor platelets with minimal bleeding.

9.5. Conditions for transfusion of platelet concentrate

The platelet donor is subject to the same mandatory pre-transfusion control as when donating whole blood, red blood cells or plasma in accordance with current regulatory documentation. In addition, platelet donors are not allowed to take aspirin and other salicylic acid preparations for three days prior to plateletpheresis, because aspirin inhibits platelet aggregation.

When transfusing platelet concentrate, the donor-recipient pair must be compatible for ABO and Rh antigens. ABO incompatibility reduces the effectiveness of donor platelets. However, in everyday clinical practice, especially when there are a large number of recipients requiring platelet concentrate transfusions and a limited number of donors, it is acceptable to transfuse type 0(1) platelets to recipients of other blood groups without delaying the transfusion in search of compatible platelet concentrates.

Immediately before transfusion of platelet concentrate, the doctor carefully checks the labeling of the container, its tightness, and verifies the identity of the donor and recipient groups. Compatibility according to the Rh system is also necessary; if platelets of different Rh groups are transfused, then possible reactions can be prevented by the administration of immunoglobulin containing anti-D antibodies.

With multiple transfusions of platelet concentrate (sometimes after 6–8 transfusions), some patients may experience refractoriness (lack of both an increase in platelets in the blood and a hemostatic effect), associated with the development of a state of alloimmunization. Alloimmunization is caused by sensitization of the recipient by alloantigens of platelets of the donor (donors) and is characterized by the appearance of immune antiplatelet and anti-HLA antibodies in the recipient. In these cases, transfusion of platelet concentrate is accompanied by a temperature reaction, chills, lack of increase in the number of platelets in the circulation and lack of hemostatic effect.

Therefore, in recipients who will obviously need long-term repeated transfusions of platelet concentrate (aplastic anemia, bone marrow transplantation), it is better to use platelet concentrate obtained by automatic apheresis from relative donors or from a bone marrow donor. In order to remove leukocyte impurities, in addition to additional “soft” centrifugation, special filters should be used to reduce the number of leukocytes in the platelet concentrate.

The platelet concentrate also contains an admixture of stem cells, therefore, to prevent graft-versus-host disease in patients with immunosuppression during bone marrow transplantation, the platelet concentrate must be irradiated at a dose of 1500 rads before transfusion.

In general, when using platelet concentrate in routine (uncomplicated) practice, the following tactics are recommended: patients who do not have a burdened transfusion history receive transfusions of platelet concentrate of the same erythrocyte antigen groups A0 and Rh. When clinical and immunological data on refractoriness appear, subsequent transfusions of platelet concentrate require special selection of a donor-recipient pair based on platelet antigens and antigens of the HLA system, knowledge of the phenotype of the recipient's platelets, testing for the compatibility of the patient's plasma with the donor's platelets, and transfusion of platelets through special leukocyte filters .

Transfusion of leukocyte concentrate

10.1. Characteristics of leukocyte concentrate

The standard therapeutic dose of leukocyte concentrate is considered to be 10 x 10 x 9 cells, of which at least 60% are granulocytes. This number of cells can be obtained using leukapheresis, carried out in a constant blood flow on automatic blood separators.

When labeling a leukocyte concentrate, the manufacturer indicates the volume in ml, the total number of leukocytes and the percentage of granulocytes, AB0 and Rh status (since the admixture of red blood cells in the leukocyte concentrate is often significant). Before starting donor leukapheresis, when selecting a donor-recipient pair, it is mandatory to perform the following tests: AB0 and Rh compatibility, leukoagglutination reaction, tests for HBsAg and anti-HCV antibodies, anti-HIV antibodies, syphilis.

High requirements for the immunological compatibility of the donor-recipient pair when using leukocyte transfusions make it absolutely necessary to obtain therapeutically significant quantities of leukocytes from only one donor. Transfusions of leukocytes obtained from one unit of blood (no more than 1 x 10 x 9 cells) are useless and often harmful.

Leukocyte concentrate is stored at a temperature of 20 - 24 degrees. With no more than 24 hours after the end of receipt. However, recent studies have shown that after only 8 hours of storage, granulocytes reduce their ability to circulate and migrate to the site of inflammation. Therefore, it is advisable to transfuse leukocytes as soon as possible after receiving them.

10.2. Indications and contraindications for transfusion of leukocyte concentrate

The main indication for transfusion of leukocyte concentrate is a decrease in the absolute number of granulocytes in the recipient to less than 0.5 x 10 x 9 / l (0.5 x 10 x 3 / ml) in the presence of an infection uncontrolled by antibacterial therapy. The use of leukocyte concentrate transfusions for neonatal sepsis is effective.

Recipients of leukocyte concentrate are most often individuals who have a chance of restoring granulocytopoiesis, because transfusion of leukocytes has only a temporary effect. Leukocyte transfusions quickly become ineffective due to the development of alloimmunization. Leukocyte concentrate transfusions are ineffective for local bacterial, fungal or viral infections. Patients scheduled for bone marrow transplantation cannot receive white blood cells from a potential bone marrow donor.

10.3. Features of leukocyte concentrate transfusion

Leukocytes are transfused, if possible, immediately, but no later than 24 hours after receipt. To achieve a therapeutic effect, leukocyte transfusions must be daily, for at least 4–6 days in a row, provided there is no restoration of granulocytopoiesis or adverse reactions. The leukocyte concentrate is transfused through a conventional device for intravenous transfusion of blood and its components with a filter. Pre-transfusion testing of leukocyte concentrate is similar to that for blood gas carrier transfusions. Compatibility with AB0 and Rh systems is required. Histoleukocyte antigen (HLA) matching provides a better response to transfusion, especially in patients with identified HLA antibodies. The volume of leukocyte concentrate is usually in the range of 200–400 ml; in pediatric practice it should be reduced in order to avoid volume overload.

10.4. Criteria for the effectiveness of leukocyte concentrate transfusion

Post-transfusion increase, which is a traditional method for assessing the effectiveness of transfusion of blood components, is not adequate for transfusion of leukocytes, because transfused leukocytes quickly leave the vascular bed and migrate to the site of inflammation. Therefore, the best indicator of the therapeutic effectiveness of transfused leukocytes is the dynamics of the clinical picture: a decrease in body temperature, a decrease in intoxication and physical manifestations of inflammation, an improvement in the X-ray picture in the lungs in the presence of pneumonia, stabilization of previously impaired organ functions.

10.5. Prophylactic transfusions of leukocyte concentrate

Transfusion of leukocytes for prophylactic purposes to recipients with granulocytopenia without signs of infection is not used, because side effects exceed the expected positive outcome.

10.6. Adverse reactions during transfusion of leukocyte concentrate

Transfusion of leukocytes may be accompanied by the development of pathological phenomena in the lungs or a severe febrile reaction.

The temperature reaction, often with chills, usually of moderate severity, is caused by the binding of donor leukocytes by recipient antibodies, followed by degranulation of granulocytes and activation of complement. These phenomena can be prevented by prescribing corticosteroids, slowing down the infusion rate, and administering promedol to relieve chills. If these therapeutic measures do not achieve an effect, further use of leukocyte concentrate is contraindicated. Sometimes hyperthermia is accompanied by the development of shortness of breath and hypotension, which requires immediate cessation of transfusion, administration of large doses of prednisolone, or, if it is ineffective, vasopressors.

Symptoms of adverse reactions from the lungs during leukocyte transfusion are coughing paroxysms, inspiratory shortness of breath, and hyperthermia. More often, such reactions are observed in patients with infectious pathology in the lungs. The reasons for these reactions may be:

1) volume overload in severe heart failure (diuretics are effective in therapy);

2) compaction of the alveolar membrane with donor granulocytes, which are localized in the pneumonic focus;

3) endotoxemia observed in septicemia can cause degranulation of donor leukocytes, complement activation and pulmonary disorders.

Transfusion of blood components is a potentially dangerous way to correct and replace their deficiency in the recipient. Complications after transfusion, previously united by the term “transfusion reactions,” can be caused by a variety of reasons and observed at different times after transfusion. Some of them can be prevented, others cannot, but in any case, medical personnel conducting transfusion therapy with blood components must know possible complications, notify the patient about the possibility of their development, and be able to prevent and treat them.

11.1. Immediate and long-term complications of blood component transfusion

Complications from the transfusion of blood components can develop both during and shortly after the transfusion (immediate complications), and after a long period of time - several months, and with repeated transfusions, even years after the transfusion (long-term complications). The main types of complications are presented in Table 3.

Table 3

Complications of blood component transfusion

11.1.1. Acute hemolysis. The time between suspicion of a hemolytic post-transfusion complication, its diagnosis and the start of therapeutic measures should be as short as possible, since the severity of subsequent manifestations of hemolysis depends on this. Acute immune hemolysis is one of the main complications of erythrocyte-containing blood transfusion media, often severe.

Acute post-transfusion hemolysis is based on the interaction of recipient antibodies with donor antigens, which results in activation of the complement system, coagulation system and humoral immunity. Clinical manifestations of hemolysis are caused by developing acute disseminated intravascular coagulation, circulatory shock and acute renal failure.

The most severe acute hemolysis occurs with incompatibility of the AB0 and Rh systems. Incompatibility for other groups of antigens can also cause hemolysis in the recipient, especially if stimulation of alloantibodies occurs due to repeated pregnancies or previous transfusions. Therefore, the selection of donors using the Coombs test is important.

Initial clinical signs of acute hemolysis may appear immediately during the transfusion or shortly after it. These include pain in the chest, abdomen or lower back, a feeling of heat, and short-term agitation. Subsequently, signs of circulatory disorders appear (tachycardia, arterial hypotension). Multidirectional changes in the hemostatic system are detected in the blood (increased levels of paracoagulation products, thrombocytopenia, decreased anticoagulant potential and fibrinolysis), signs of intravascular hemolysis - hemoglobinemia, bilirubinemia, in the urine - hemoglobinuria, later - signs of impaired renal and liver function - increased levels of creatinine and urea in the blood, hyperkalemia, decreased hourly diuresis up to anuria. If acute hemolysis develops during an operation performed under general anesthesia, then its clinical signs may be unmotivated bleeding of the surgical wound, accompanied by persistent hypotension, and in the presence of a catheter in the bladder, the appearance of dark cherry or black urine.

The severity of the clinical course of acute hemolysis depends on the volume of incompatible red blood cells transfused, the nature of the underlying disease and the condition of the recipient before transfusion. At the same time, it can be reduced by targeted therapy, ensuring normalization of blood pressure and good renal blood flow. The adequacy of renal perfusion can be indirectly judged by the amount of hourly diuresis, which should reach at least 100 ml/hour in adults within 18-24 hours after the onset of acute hemolysis.

Therapy for acute hemolysis involves the immediate cessation of transfusion of red blood cell-containing medium (with the obligatory preservation of this transfusion medium) and the simultaneous initiation of intensive infusion therapy (sometimes in two veins) under the control of central venous pressure. Transfusion of saline solutions and colloids (optimally albumin) is carried out in order to prevent hypovolemia and hypoperfusion of the kidneys, fresh frozen plasma - to correct disseminated intravascular coagulation. In the absence of anuria and the restored volume of circulating blood, osmodiuretics (20% mannitol solution at the rate of 0.5 g/kg body weight) or furosemide at a dose of 4–6 mg/kg body weight are prescribed to stimulate diuresis and reduce the deposition of hemolysis products in the distal tubules of the nephrons . If the response to the prescription of diuretins is positive, the tactics of forced diuresis continue. At the same time, emergency plasmapheresis in a volume of at least 1.5 liters is indicated in order to remove free hemoglobin and fibrinogen degradation products from the circulation with mandatory replacement of the removed plasma by transfusion of fresh frozen plasma. In parallel with these therapeutic measures, it is necessary to prescribe heparin under the control of aPTT and coagulogram parameters. The optimal solution is intravenous administration of heparin at a dose of 1000 units per hour using a drug dispenser (infusion pump).

The immune nature of acute hemolysis of post-transfusion shock requires the administration of intravenous prednisolone at a dose of 3–5 mg/kg body weight in the first hours of treatment for this condition. If there is a need to correct severe anemia (hemoglobin less than 60 g/l), transfusion of an individually selected red blood cell suspension with saline is carried out. The administration of dopamine in small doses (up to 5 mcg/kg body weight per minute) increases renal blood flow and contributes to more successful treatment of acute transfusion hemolytic shock.

In cases where complex conservative therapy does not prevent the onset of acute renal failure and the patient's anuria continues for more than a day or uremia and hyperkalemia are detected, the use of emergency hemodialysis (hemodiafiltration) is indicated.

11.1.2. Delayed hemolytic reactions. Delayed hemolytic reactions may occur several days after transfusion of blood gas carriers as a result of immunization of the recipient by previous transfusions. Antibodies formed de novo appear in the recipient’s bloodstream 10–14 days after transfusion. If the next transfusion of blood gas carriers coincides with the beginning of antibody formation, then the emerging antibodies can react with donor red blood cells circulating in the recipient’s bloodstream. Hemolysis of erythrocytes in this case is not pronounced; it can be suspected by a decrease in hemoglobin levels and the appearance of anti-erythrocyte antibodies. In general, delayed hemolytic reactions are rare and therefore relatively little studied. Specific treatment is usually not required, but monitoring of renal function is necessary.

11.1.3. Bacterial shock. The main cause of pyrogenic reactions, including the development of bacterial shock, is the entry of bacterial endotoxin into the transfusion medium, which can occur during venipuncture, preparation of blood for transfusion, or during the storage of canned blood if the rules of preservation and temperature conditions are not observed. The risk of bacterial contamination increases as the shelf life of blood components increases.

The clinical picture of transfusion of a bacterially contaminated transfusion medium resembles that of septic shock. There is a sharp increase in body temperature, pronounced hyperemia of the upper half of the body, rapid development of hypotension, the appearance of chills, nausea, vomiting, diarrhea, and muscle pain.

If clinical signs suspicious for bacterial contamination are detected, the transfusion must be stopped immediately. The recipient's blood, the suspected transfusion medium, as well as all other intravenously transfused solutions are subject to testing for the presence of bacteria. The study must be carried out for both aerobic and anaerobic infections, preferably using equipment that provides rapid diagnostics.

Therapy includes the immediate prescription of broad-spectrum antibiotics, anti-shock measures with the mandatory use of vasopressors and / or inotropes in order to quickly normalize blood pressure, and correction of hemostasis disorders (DIC).

Prevention of bacterial contamination during transfusions of blood components involves the use of disposable equipment, careful adherence to the rules of asepsis when puncturing a vein and a plastic container, constant monitoring of the temperature and shelf life of blood components, and visual inspection of blood components before transfusion.

11.1.4. Reactions caused by anti-leukocyte antibodies. Non-hemolytic febrile reactions observed during a transfusion or immediately after its completion are characterized by an increase in the recipient's body temperature by 1 degree. C or more. Such febrile reactions are a consequence of the presence in the recipient’s blood plasma of cytotoxic or agglutinating antibodies that react with antigens located on the membrane of transfused lymphocytes, granulocytes or platelets. Transfusion of red blood cells depleted of leukocytes and platelets significantly reduces the incidence of febrile non-hemolytic reactions. The use of leukocyte filters significantly increases the safety of transfusion therapy.

Non-hemolytic febrile reactions are more common with repeated transfusions or in women who have had multiple pregnancies. The administration of antipyretic drugs usually stops the febrile reaction.

However, it should be noted that transfusion-associated fever may often be the first sign of more dangerous complications such as acute hemolysis or bacterial contamination. The diagnosis of a febrile non-hemolytic reaction should be made by exclusion, having previously excluded other possible causes of increased body temperature in response to transfusion of blood or its components.

11.1.5. Anaphylactic shock. The characteristic distinguishing features of anaphylactic shock caused by transfusion of blood or its components are its development immediately after the administration of several milliliters of blood or its components and the absence of an increase in body temperature. In the future, symptoms such as non-productive cough, bronchospasm, shortness of breath, a tendency to hypotension, spasmodic abdominal pain, nausea and vomiting, stool disorder, and loss of consciousness may be observed. The cause of anaphylactic shock in these circumstances is IgA deficiency in recipients and the formation of anti-IgA antibodies in them after previous transfusions or pregnancies, but often the immunizing agent cannot be clearly verified. Although IgA deficiency occurs with a frequency of 1 in 700 people, the incidence of anaphylactic shock for this reason is much less common, due to the presence of antibodies of different specificities.

Treatment of anaphylactic transfusion reactions in adult recipients includes discontinuation of the transfusion, immediate subcutaneous injection of epinephrine, intravenous saline infusion, and administration of 100 mg prednisone or hydrocortisone intravenously.

In the presence of a complicated transfusion history and suspected IgA deficiency, it is possible to use preoperatively prepared autologous blood components. If this is not possible, only thawed, washed red blood cells are used.

11.1.6. Acute volume overload. A rapid increase in systolic blood pressure, shortness of breath, severe headache, cough, cyanosis, orthopnea, difficulty breathing or pulmonary edema during or immediately after transfusion may indicate hypervolemia caused by a sharp increase in circulating blood volume due to transfusion of blood components or colloids such as albumin. A rapid increase in the volume of blood in the circulation is poorly tolerated by patients with heart disease, lung disease, and in the presence of chronic anemia, when there is an increase in the volume of circulating plasma. Transfusions of even small volumes, but at a high rate, can cause vascular overload in newborns.

Stopping the transfusion, placing the patient in a sitting position, and giving oxygen and diuretics quickly stop these phenomena. If the signs of hypervolemia do not go away, indications for emergency plasmapheresis arise. If patients are prone to volume overload, in transfusion practice it is necessary to use slow administration: transfusion rate -1 ml/kg body weight per hour. If transfusion of large volumes of plasma is necessary, the administration of diuretics before transfusion is indicated.

11.1.7. Vector-borne infections transmitted through transfusion of blood components. The most common infectious disease complicating the transfusion of blood components is hepatitis. Transmission of hepatitis A is extremely rare, because with this disease the period of viremia is very short. The risk of transmission of hepatitis B and C remains high, with a tendency to decrease due to testing of donors for HBsAg carriage, determination of the level of ALT and anti-HBs antibodies. Donor self-questioning also helps improve transfusion safety.

All blood components that are not subject to viral inactivation carry a risk of hepatitis transmission. The current lack of reliable guaranteed tests for carriage of hepatitis B and C antigens makes it necessary to constantly screen all donors of blood components using the above tests, as well as introduce quarantine of plasma. It should be noted that unpaid donors carry a lower risk of transfusion transmission of viral infections compared to paid donors.

Cytomegalovirus infection caused by transfusion of blood components is most often observed in patients who have undergone immunosuppression, primarily in patients after bone marrow transplantation or in patients receiving cytotoxic therapy. It is known that cytomegalovirus is transmitted with peripheral blood leukocytes, therefore, in this case, the use of leukocyte filters when transfusing red blood cells and platelets will help to significantly reduce the risk of developing cytomegalovirus infection in recipients. Currently, there are no reliable tests to determine the carriage of cytomegalovirus, but it has been established that in the general population its carriage is 6-12%.

Transfusion transmission of human immunodeficiency virus accounts for about 2% of all cases of acquired immunodeficiency syndrome. Screening donors for antibodies to the human immunodeficiency virus significantly reduces the risk of transmitting this viral infection. However, the presence of a long period of formation of specific antibodies after infection (6-12 weeks) makes it almost impossible to completely eliminate the risk of HIV transmission. Therefore, to prevent viral infections transmitted by transfusion, the following rules must be observed:

transfusions of blood and its components should be performed only for health reasons;
total laboratory screening of donors and their selection, removal of donors from risk groups, preferential use of gratuitous donation, self-questioning of donors reduce the risk of transmission of viral infections;
the wider use of autodonation, plasma quarantine, and blood reinfusion also increases the viral safety of transfusion therapy.

11.2. Massive transfusion syndrome

Canned donated blood is not the same as the blood circulating in the patient. The need to preserve blood in a liquid state outside the vascular bed requires the addition of solutions of anticoagulants and preservatives. Non-clotting (anticoagulation) is achieved by adding sodium citrate (citrate) in an amount sufficient to bind ionized calcium. The viability of preserved red blood cells is maintained by a decrease in pH and excess glucose. During storage, potassium constantly leaves red blood cells and, accordingly, its level in plasma increases. The result of plasma amino acid metabolism is the formation of ammonia. Ultimately, banked blood differs from normal blood in the presence of hyperkalemia, varying degrees of hyperglycemia, increased acidity, increased levels of ammonia and phosphates. When severe massive bleeding occurs and a fairly rapid and large-volume transfusion of preserved blood or red blood cells is required, then in these circumstances the differences between circulating and preserved blood become clinically significant.

Some of the dangers of massive transfusions depend solely on the number of blood components transfused (for example, the risk of transmission of viral infections and immune conflicts increases when more donors are used). A number of complications, such as citrate and potassium overload, are largely dependent on the rate of transfusion. Other manifestations of massive transfusions depend on both the volume and rate of transfusion (eg, hypothermia).

Massive transfusion of one volume of circulating blood (3.5 - 5.0 liters for adults) within 24 hours can be accompanied by metabolic disorders that are relatively easy to treat. However, the same volume administered over 4–5 hours can cause significant metabolic disturbances that are difficult to correct. Clinically, the most significant manifestations of massive transfusion syndrome are:

11.2.1. Citrate intoxication. After transfusion to the recipient, citrate levels drop sharply as a result of dilution, with excess citrate being rapidly metabolized. The duration of circulation of citrate transfused with donor red blood cells is only a few minutes. Excess

citrate is immediately bound by ionized calcium mobilized from the body's skeletal reserves. Consequently, the manifestations of citrate intoxication are more related to the rate of transfusion than to the absolute amount of blood transfusion medium. Predisposing factors such as hypovolemia with hypotension, previous hyperkalemia and metabolic alkalosis, as well as hypothermia and previous steroid hormone therapy are also important.

Severe citrate intoxication extremely rarely develops in the absence of these factors and blood loss, requiring transfusion at a rate of up to 100 ml/min. a patient weighing 70 kg. If it is necessary to transfuse canned blood, red blood cells, or fresh frozen plasma at a higher rate, citrate intoxication can be prevented by prophylactic administration of intravenous calcium supplements, warming the patient and maintaining normal blood circulation, ensuring adequate organ perfusion.

11.2.2. Hemostasis disorders. In patients who have suffered massive blood loss and received large volumes of blood transfusion, in 20–25% of cases various hemostatic disorders are recorded, the genesis of which is due to the “dilution” of plasma coagulation factors, dilution thrombocytopenia, the development of disseminated intravascular coagulation syndrome and, much less frequently, hypocalcemia.

DIC syndrome plays a decisive role in the development of true posthemorrhagic and posttraumatic coagulopathy.

Plasma unstable coagulation factors have a short half-life; their pronounced deficiency is detected after 48 hours of storage of donor blood. The hemostatic activity of platelets in preserved blood decreases sharply after several hours of storage. Such platelets very quickly become functionally inactive. Transfusion of large quantities of canned blood with similar hemostatic characteristics in combination with one’s own blood loss leads to the development of disseminated intravascular coagulation syndrome. Transfusion of one volume of circulating blood reduces the concentration of plasma coagulation factors in the presence of blood loss of more than 30% of the initial volume to 18–37% of the initial level. Patients with disseminated intravascular coagulation syndrome due to massive transfusions are characterized by diffuse bleeding from surgical wounds and skin puncture sites with needles. The severity of the manifestations depends on the amount of blood loss and the volume of transfusion required, correlated with the volume of blood in the recipient.

The therapeutic approach to patients diagnosed with DIC due to massive transfusions is based on the replacement principle. Fresh frozen plasma and platelet concentrate are the best transfusion media for replenishing the components of the hemostatic system. Fresh frozen plasma is preferable to cryoprecipitate because it contains the optimal range of plasma coagulation factors and anticoagulants. Cryoprecipitate may be used if a marked decrease in fibrinogen levels is suspected as the main cause of impaired hemostasis. Transfusion of platelet concentrate in this situation is absolutely indicated when their level in patients decreases below 50 x 1E9/l. Successful stopping of bleeding is observed when the platelet level increases to 100 x 1E9/l.

It is of utmost importance to predict the development of massive transfusion syndrome if massive transfusion is necessary. If the severity of blood loss and the required amount of red blood cells, saline solutions and colloids for replenishment are large, then platelet concentrate and fresh frozen plasma should be prescribed before the development of hypocoagulation. It is possible to recommend transfusion of 200 - 300 x 1E9 platelets (4 - 5 units of platelet concentrate) and 500 ml of fresh frozen plasma for each transfused 1.0 liter of red blood cells or suspension in conditions of replenishment of acute massive blood loss.

11.2.3. Acidosis. Preserved blood using a glucose citrate solution already on day 1 of storage has a pH of 7.1 (on average, the pH of circulating blood is 7.4), and on day 21 of storage the pH is 6.9. By the same day of storage, the red blood cell mass has a pH of 6.7. Such a pronounced increase in acidosis during storage is due to the formation of lactate and other acidic products of blood cell metabolism, as well as the addition of sodium citrate and phosphates. Along with this, patients who are most often recipients of transfusion media often have pronounced metabolic acidosis due to injury, significant blood loss and, accordingly, hypovolemia even before the start of transfusion therapy. These circumstances contributed to the creation of the concept of “transfusion acidosis” and the mandatory prescription of alkalis for the purpose of its correction. However, a subsequent thorough study of the acid-base balance in this category of patients revealed that the majority of recipients, especially those who had recovered, had alkalosis, despite massive transfusions, and only a few had acidosis. The alkalization carried out led to negative results - a high pH level shifts the dissociation curve of oxyhemoglobin, impedes the release of oxygen to tissues, reduces ventilation, and reduces the mobilization of ionized calcium. In addition, acids found in stored whole blood or packed red blood cells, primarily sodium citrate, are rapidly metabolized after transfusion to an alkaline residue—about 15 mEq per unit of blood.

Restoration of normal blood flow and hemodynamics contributes to the rapid reduction of acidosis caused by both hypovolemia, organ hypoperfusion, and transfusion of large quantities of blood components.

11.2.4. Hyperkalemia. During storage of whole blood or red blood cells, the level of potassium in the extracellular fluid increases by the 21st day of storage, respectively, from 4.0 mmol/L to 22 mmol/L and 79 mmol/L with a simultaneous decrease in sodium. Such movement of electrolytes during rapid and volumetric transfusion should be taken into account, because It may play a role in some circumstances in critically ill patients. Laboratory monitoring of the level of potassium in the recipient's blood plasma and ECG monitoring (the appearance of arrhythmia, prolongation of the QRS complex, acute T wave, bradycardia) are necessary in order to timely prescribe glucose, calcium and insulin drugs to correct possible hyperkalemia.

11.2.5. Hypothermia. Patients in a state of hemorrhagic shock who require transfusion of large volumes of red blood cells or preserved blood often have a reduced body temperature even before the start of transfusion therapy, which is due to a decrease in the rate of metabolic processes in the body in order to conserve energy. However, with severe hypothermia, the body's ability to metabolically inactivate citrate, lactate, adenine and phosphate is reduced. Hypothermia slows the rate of 2,3-diphosphoglycerate reduction, which impairs oxygen delivery. Transfusion of “cold” canned blood and its components stored at a temperature of 4 degrees. C, aimed at restoring normal perfusion, may aggravate hypothermia and associated pathological manifestations. At the same time, warming the transfusion medium itself is fraught with the development of hemolysis of erythrocytes. A decrease in the transfusion rate is accompanied by slow warming of the transfused medium, but often does not suit the doctor due to the need for rapid correction of hemodynamic parameters. Of greater importance is the warming of the operating table, the temperature in the operating rooms, and the rapid restoration of normal hemodynamics.

Thus, the following approaches to preventing the development of massive transfusion syndrome may be applicable in medical practice:

the best protection of the recipient from metabolic disorders associated with the transfusion of large quantities of preserved blood or its components is to warm him and maintain stable normal hemodynamics, which will ensure good organ perfusion;
the prescription of pharmacological drugs aimed at treating massive transfusion syndrome, without taking into account pathogenetic processes, may cause harm rather than benefit;
laboratory monitoring of homeostasis indicators (coagulogram, acid-base balance, ECG, electrolytes) allows timely detection and treatment of manifestations of massive transfusion syndrome.

In conclusion, it must be emphasized that massive transfusion syndrome is practically not observed where whole blood is completely replaced by its components. The syndrome of massive transfusions with severe consequences and high mortality is often observed in obstetrics during acute disseminated intravascular coagulation syndrome, when whole blood is transfused instead of fresh frozen plasma.

The knowledge of doctors and nurses plays a decisive role in preventing post-transfusion complications and improving the safety of transfusion therapy. In this regard, the medical institution needs to organize annual training, retraining and testing of the knowledge and skills of all medical personnel involved in transfusion of blood components. When assessing the quality of medical care in a medical institution, it is necessary to take into account the ratio of the number of complications registered in it and the number of blood component transfusions.

Application

to Instructions for Use

blood components

dated November 25, 2002 N 363

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ABOUT APPROVAL OF INSTRUCTIONS

In order to improve medical care to the population of the Russian Federation and ensure quality in the use of blood components, I order:
1. Approve the Instructions for the use of blood components.
2. Entrust control over the implementation of this Order to First Deputy Minister A.I. Vyalkova.

Minister
Y.L.SHEVCHENKO

Appendix No. 1

Approved
By order of the Ministry
health
Russian Federation
dated November 25, 2002 N 363

INSTRUCTIONS
ON THE USE OF BLOOD COMPONENTS

1. General Provisions

Transfusion (transfusion) of blood components (erythrocyte-containing blood gas carriers, platelet-containing and plasma correctors of hemostasis and fibrinolysis, leukocyte-containing and plasma correction agents of immunity) is a therapeutic method that consists of introducing into the bloodstream of the patient (recipient) the specified components prepared from the donor or the recipient himself (autodonation), as well as blood and its components poured into the body cavity during injuries and operations (reinfusion).
The operation of transfusion of blood components is accompanied by consequences for the recipient, both positive (an increase in the number of circulating red blood cells, an increase in the level of hemoglobin during the transfusion of red blood cells, relief of acute disseminated intravascular coagulation during the transfusion of fresh frozen plasma, cessation of spontaneous thrombocytopenic bleeding, an increase in the number of platelets during the transfusion of platelet concentrate), and negative (rejection of cellular and plasma elements of the donor’s blood, risk of viral and bacterial infection, development of hemosiderosis, inhibition of hematopoiesis, increased thrombogenicity, allosensitization, immunological reactions). In immunosuppressed patients, transfusion of cellular blood components can lead to the development of graft-versus-host disease.
When transfusing whole canned blood, especially with long (more than 7 days) storage periods, the recipient receives, along with the components he needs, functionally defective platelets, leukocyte breakdown products, antibodies and antigens, which can cause post-transfusion reactions and complications.
Currently, the principle of replacing specific blood components missing in the patient’s body in various pathological conditions has been established. There are no indications for transfusion of whole canned donor blood, except in cases of acute massive blood loss, when there are no blood substitutes or fresh frozen plasma, red blood cells or suspension. Whole canned donor blood is used for exchange transfusion in the treatment of hemolytic disease of newborns.
The blood of donors at blood transfusion stations (BTS) or in blood transfusion departments in the next few hours (depending on the preservative used and the procurement conditions - on-site or in-patient) after receipt must be divided into components. It is advisable to use blood components collected from one or a minimum number of donors in the treatment of one patient.
In order to prevent post-transfusion complications caused by the Kell antigen, departments and blood transfusion stations issue red blood cell suspension or mass that does not contain this factor for transfusion into the clinic. Kell positive recipients can be transfused with Kell positive red blood cells. When transfusing correctors, plasma-coagul

Pages: 1 ...

Registration N 29362

In accordance with paragraph 7 of part 2 of article 9 of the Federal Law of July 20, 2012 N 125-FZ “On the donation of blood and its components” (Collected Legislation of the Russian Federation, 2012, N 30, Art. 4176) I order:

Approve the attached Rules for the clinical use of donor blood and (or) its components.

Minister V. Skvortsova

Rules for the clinical use of donor blood and (or) its components

I. General provisions

1. These Rules establish requirements for the conduct, documentation and control of the clinical use of donor blood and (or) its components in order to ensure the effectiveness, quality and safety of transfusion (transfusion) and the formation of reserves of donor blood and (or) its components.

2. These Rules are subject to application by all organizations engaged in the clinical use of donor blood and (or) its components in accordance with Federal Law of July 20, 2012 N 125-FZ “On the donation of blood and its components” (hereinafter referred to as organizations).

II. Organization of activities for transfusion (transfusion) of donor blood and (or) its components

3. Organizations create a transfusiology commission, which includes heads of clinical departments, heads of the transfusiology department or transfusiology room, and if they are not on the organization’s staff, doctors responsible for organizing the transfusion (transfusion) of donor blood and (or) its components in the organization and other specialists.

The transfusion commission is created on the basis of a decision (order) of the head of the organization in which it was created.

The activities of the transfusiology commission are carried out on the basis of the regulations on the transfusiology commission, approved by the head of the organization.

4. The functions of the transfusion commission are:

a) control over the organization of transfusion (transfusion) of donor blood and (or) its components in the organization;

b) analysis of the results of clinical use of donor blood and (or) its components;

c) development of optimal programs for transfusion (transfusion) of donor blood and (or) its components;

d) organization, planning and control of increasing the level of professional training of doctors and other medical workers on the issues of transfusion (transfusion) of donor blood and (or) its components;

e) analysis of cases of reactions and complications that arose in connection with transfusion (transfusion) of donor blood and (or) its components, and development of measures for their prevention.

5. In order to ensure the safety of transfusion (transfusion) of donor blood and (or) its components:

a) transfusion (transfusion) of donor blood and (or) its components to several recipients from one container is prohibited;

b) transfusion (transfusion) of donor blood and (or) its components that has not been examined for markers of human immunodeficiency viruses, hepatitis B and C, the causative agent of syphilis, ABO blood group and Rh status is prohibited;

c) when transfusion (transfusion) of donor blood and (or) its components that have not been subjected to leukoreduction, disposable devices with a built-in microfilter are used, ensuring the removal of microaggregates with a diameter of more than 30 microns;

d) in case of multiple transfusions in persons with a burdened transfusion history, transfusion (transfusion) of erythrocyte-containing components, fresh frozen plasma and platelets is carried out using leukocyte filters.

6. After each transfusion (transfusion) of donor blood and (or) its components, its effectiveness is assessed. The criteria for the effectiveness of transfusion (transfusion) of donor blood and (or) its components are clinical data and laboratory results.

III. Rules for transfusion (transfusion) of donor blood and (or) its components

7. Upon admission of a recipient in need of a transfusion (transfusion) of donor blood and (or) its components, an initial study of the group and Rh affiliation of the recipient’s blood is carried out by a doctor from the clinical department of the organization who has been trained in transfusiology.

8. Confirmatory determination of blood group according to the ABO system and Rh, as well as phenotyping for antigens C, c, E, e, Cw, K, k and determination of anti-erythrocyte antibodies in the recipient is carried out in a clinical diagnostic laboratory.

The results of confirmatory determination of the ABO blood group and Rh, as well as phenotyping for antigens C, c, E, e, Cw, K, k and determination of anti-erythrocyte antibodies in the recipient are included in the medical documentation reflecting the recipient’s health status.

It is prohibited to transfer data on blood group and Rh status to medical documentation reflecting the health status of the recipient, the organization in which it is planned to carry out a transfusion (transfusion) of donor blood and (or) its components to the recipient, from medical documentation reflecting the health status of the recipient, other organizations , where the recipient previously received medical care, including including transfusion (transfusion) of donor blood and (or) its components, or a medical examination was carried out.

9. Recipients with a history of post-transfusion complications, pregnancy, the birth of children with hemolytic disease of the newborn, as well as recipients with alloimmune antibodies, undergo an individual selection of blood components in a clinical diagnostic laboratory.

10. On the day of transfusion (transfusion) of donor blood and (or) its components (no earlier than 24 hours before the transfusion (transfusion) of donor blood and (or) its components), blood is taken from the recipient’s vein: 2-3 ml per a test tube with an anticoagulant and 3-5 ml into a test tube without an anticoagulant for mandatory control studies and compatibility tests. The tubes must be labeled indicating the surname and initials of the recipient, the number of medical documentation reflecting the health status of the recipient, the name of the department where the transfusion (transfusion) of donor blood and (or) its components is carried out, group and Rh affiliation, the date of taking the blood sample.

11. Before starting a transfusion (transfusion) of donor blood and (or) its components, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components must ensure their suitability for transfusion, taking into account the results of laboratory control, check the tightness of the container and the correctness certification, conduct a macroscopic examination of the container with blood and (or) its components.

12. When transfusing erythrocyte-containing components of donor blood, the doctor conducting the transfusion (transfusion) of erythrocyte-containing components conducts a control check of the blood group of the donor and recipient according to the ABO system, as well as tests for individual compatibility.

If the results of the primary and confirmatory determination of the blood group according to the ABO system, Rhesus, the phenotype of the donor and recipient coincide, as well as information about the absence of anti-erythrocyte antibodies in the recipient, the doctor conducting the transfusion (transfusion) of erythrocyte-containing components, before the transfusion, during a control check, determines the recipient's group and blood donor according to the ABO system and performs only one test for individual compatibility - on a plane at room temperature.

13. After conducting a control check of the blood group of the recipient and the donor according to the ABO system, as well as tests for individual compatibility, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components performs a biological test.

14. A biological test is carried out regardless of the type and volume of donor blood and (or) its components and the rate of their administration, as well as in the case of individually selected erythrocyte-containing components in a clinical diagnostic laboratory or phenotyped ones. If it is necessary to transfuse several doses of donor blood components, a biological test is performed before the start of transfusion of each new dose of a donor blood component.

15. A biological test is carried out through a single transfusion of 10 ml of donor blood and (or) its components at a rate of 2-3 ml (40-60 drops) per minute for 3-3.5 minutes. After this, the transfusion stops and the recipient’s condition is monitored for 3 minutes, his pulse, number of respiratory movements, blood pressure, general condition, skin color are monitored, and body temperature is measured. This procedure is repeated twice. If clinical symptoms appear during this period: chills, lower back pain, feelings of heat and tightness in the chest, headache, nausea or vomiting, the doctor performing the transfusion (transfusion) of donor blood and (or) its components immediately stops the transfusion (transfusion). donated blood and (or) its components.

16. A biological test is performed, including during emergency transfusion (transfusion) of donor blood and (or) its components. During transfusion (transfusion) of donor blood and (or) its components, continued transfusion of saline solutions is urgently allowed.

17. When transfusion (transfusion) of donor blood and (or) its components under anesthesia, signs of a reaction or complication include increased bleeding in the surgical wound for no apparent reason, a decrease in blood pressure, increased heart rate, and a change in the color of urine during bladder catheterization. If any of the above cases occurs, transfusion (transfusion) of donor blood and (or) its components is stopped.

A surgeon and an anesthesiologist-resuscitator, together with a transfusiologist, determine the cause of the reaction or complication. If a connection between a reaction or complication and a transfusion (transfusion) of donor blood and (or) its components is established, the transfusion (transfusion) of donor blood and (or) its components is stopped.

The issue of further transfusion (transfusion) of donor blood and (or) its components is decided by a council of doctors specified in this paragraph, taking into account clinical and laboratory data.

18. A doctor performing a transfusion (transfusion) of donor blood and (or) its components is obliged to register the transfusion in the register of blood transfusion and its components, as well as make an entry in the medical documentation of the recipient, reflecting the state of his health, with the obligatory indication of:

a) medical indications for transfusion (transfusion) of donor blood and (or) its components;

b) passport data from the label of the donor container, containing information about the donor code, blood group according to the ABO system and Rhesus, donor phenotype, as well as the container number, date of procurement, name of the organization (after the end of the transfusion (transfusion) of donor blood and (or ) its components label or a copy of the label from the container with the blood component, obtained using photographic or office equipment, is pasted into the medical documentation reflecting the health status of the recipient);

c) the result of a control check of the recipient’s blood group according to the ABO system, indicating information (name, manufacturer, series, expiration date) about the reagents (reagents) used;

d) the result of a control check of the donor blood group or its erythrocyte-containing components taken from the container according to the ABO system;

e) the result of tests for individual compatibility of the blood of the donor and recipient;

f) the result of a biological test.

An entry in the medical documentation reflecting the health status of the recipient is drawn up with a protocol for the transfusion (transfusion) of donor blood and (or) its components according to the recommended sample given in Appendix No. 1 to these Rules.

19. After a transfusion (transfusion) of donor blood and (or) its components, the recipient must remain in bed for 2 hours. The attending or duty doctor monitors his body temperature, blood pressure, pulse, diuresis, urine color and records these indicators in the recipient’s medical record. The next day after transfusion (transfusion) of donor blood and (or) its components, a clinical analysis of blood and urine is performed.

20. When carrying out a transfusion (transfusion) of donor blood and (or) its components in an outpatient setting, the recipient after the end of the transfusion (transfusion) of donor blood and (or) its components must be under the supervision of a doctor conducting the transfusion (transfusion) of donor blood and (or) ) of its components, at least three hours. Only in the absence of any reactions, stable blood pressure and pulse, and normal diuresis can the recipient be released from the organization.

21. After the end of the transfusion (transfusion) of donor blood and (or) its components, the donor container with the remaining donor blood and (or) its components (5 ml), as well as the test tube with the recipient’s blood used for individual compatibility tests, are subject to mandatory preserved for 48 hours at a temperature of 2-6 C in refrigeration equipment.

IV. Rules for research during transfusion (transfusion) of donor blood and (or) its components

22. The following studies are carried out in adult recipients:

a) primary and confirmatory determination of blood group according to the ABO system and Rh (antigen D) (carried out using reagents containing anti-A, anti-B and anti-D antibodies, respectively);

b) upon receipt of results that raise doubts (weak reactions) during a confirmatory study, determination of the blood group according to the ABO system is carried out using reagents containing anti-A and anti-B antibodies, and standard red blood cells O(I), A(II) ) and B(III) except for the cases provided for in subparagraph “a” of paragraph 68 of these Rules, and determination of Rh (antigen D) - using reagents containing anti-D antibodies of a different series;

c) determination of erythrocyte antigens C, c, E, e, Cw, K and k using reagents containing appropriate antibodies (in children under 18 years of age, women of childbearing age and pregnant women, recipients with a history of transfusion, having antibodies to erythrocyte antigens , recipients in need of multiple (including repeated) transfusions (transfusions) of donor blood and (or) its components (cardiac surgery, transplantology, orthopedics, oncology, oncohematology, traumatology, hematology);

d) screening of anti-erythrocyte antibodies using at least three samples of erythrocytes, which together contain antigens C, c, E, e, Cw, K, k, Fy a, Fy b, Lu a, Lu b, Jk a and Jk b .

23. If anti-erythrocyte antibodies are detected in the recipient, the following is carried out:

a) typing of erythrocytes according to antigens of the Rhesus, Kell and other systems using antibodies of appropriate specificity;

b) identification of anti-erythrocyte antibodies with a panel of typed erythrocytes containing at least 10 cell samples;

c) individual selection of blood and red blood cell donors with an indirect antiglobulin test or its modification with similar sensitivity.

24. When conducting immunoserological studies, only equipment, reagents and research methods approved for use on the territory of the Russian Federation are used.

V. Rules and methods of research for transfusion (transfusion) of canned donor blood and erythrocyte-containing components

25. During a planned transfusion (transfusion) of canned donor blood and erythrocyte-containing components, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components is obliged to:

a) according to the medical documentation reflecting the health status of the recipient and the data on the label of the container of preserved donor blood or erythrocyte-containing components, make sure that the phenotypes of the recipient and the donor are compatible. For heterozygous recipients (Cc, Ee, Kk), both hetero- and homozygous donors are considered compatible: Cc, CC and CC; Her, HER and hers; Kk, КК and кk respectively. For homozygous recipients (CC, EE, KK), only homozygous donors are compatible. The selection of blood donors and (or) its components compatible with the recipient for Rh-Hr and Kk, during transfusion (transfusion) of erythrocyte-containing components, is carried out in accordance with the table given in Appendix No. 2 to these Rules;

b) recheck the recipient’s blood group according to the ABO system;

c) determine the donor’s blood group in the container using the ABO system (the donor’s Rh status is determined by the designation on the container);

d) conduct a test for individual compatibility of the blood of the recipient and the donor using the following methods:

26. In case of emergency transfusion (transfusion) of canned donor blood and erythrocyte-containing components, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components is obliged to:

a) determine the recipient’s blood group according to the ABO system and its Rh status;

b) determine the donor’s blood group in the container using the ABO system (the donor’s Rh status is determined by the designation on the container);

c) conduct a test for individual compatibility of the blood of the recipient and the donor using the following methods:

on a plane at room temperature;

one of three tests (indirect Coombs reaction or its analogues, conglutination reaction with 10% gelatin or conglutination reaction with 33% polyglucin);

27. If the recipient has anti-erythrocyte antibodies, the selection of donor blood components is carried out in a clinical diagnostic laboratory. If the red blood cell mass or suspension is selected individually for the recipient in a clinical diagnostic laboratory, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components, before the transfusion, determines the blood group of the recipient and the donor and conducts only one test for individual compatibility on a plane at room room. temperature and biological sample.

VI. Rules and methods of research for transfusion (transfusion) of fresh frozen plasma and platelet concentrate (platelet)

28. When transfusing fresh frozen plasma, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components is obliged to determine the recipient’s blood group according to the ABO system; when transfusing platelets - the blood group according to the ABO system and the Rhesus status of the recipient.

The doctor performing the transfusion (transfusion) of platelets determines the group and Rh affiliation of the donor according to the markings on the container with the blood component, while tests for individual compatibility are not carried out.

29. When transfusing fresh frozen plasma and platelets, erythrocyte antigens C, c, E, e, Cw, K and k are not taken into account.

VII. Rules for transfusion of canned donor blood and erythrocyte-containing components

30. The medical indication for transfusion (transfusion) of donor blood and erythrocyte-containing components in acute anemia due to massive blood loss is a loss of 25-30% of the circulating blood volume, accompanied by a decrease in hemoglobin levels below 70-80 g/l and hematocrit below 25% and the occurrence of circulatory disorders .

31. In case of chronic anemia, transfusion (transfusion) of donor blood or erythrocyte-containing components is prescribed only to correct the most important symptoms caused by anemia and not amenable to basic pathogenetic therapy.

32. Donor blood and erythrocyte-containing components are transfused only from the ABO group and the Rh and Kell affiliation that the recipient has. If there are medical indications, the selection of a donor-recipient pair is carried out taking into account antigens C, c, E, e, Cw, K and k.

During planned transfusion (transfusion) of preserved blood and erythrocyte-containing components, to prevent reactions and complications, as well as alloimmunization of recipients, compatible transfusions (transfusions) are carried out using donor erythrocytes phenotyped for 10 antigens (A, B, D, C, c, E, e , C w , K and k) for the groups of recipients specified in subparagraph “c” of paragraph 22 of these Rules.

33. According to vital indications, in emergency cases, recipients with blood group A(II) or B(III) in the absence of single blood or erythrocyte-containing components can be transfused with Rh-negative erythrocyte-containing components O(I), and AB(IV) recipients can be transfused Rh-negative erythrocyte-containing B(III) components, regardless of the Rh status of the recipients.

In emergency cases, if it is impossible to determine the blood group according to vital indications, the recipient is transfused with erythrocyte-containing components of the O(I) group Rh-negative in an amount of no more than 500 ml, regardless of the group and Rh affiliation of the recipient.

If it is impossible to determine antigens C, c, E, e, Cw, K and k, the recipient is transfused with erythrocyte-containing components compatible with the ABO blood group and Rh antigen D.

34. Transfusion (transfusion) of red blood cells depleted of leukocytes and platelets is carried out to prevent alloimmunization with leukocyte antigens and refractoriness to repeated platelet transfusions.

35. When transfusion (transfusion) of donor blood and erythrocyte-containing components, the criteria for the effectiveness of their transfusion are: clinical data, indicators of oxygen transport, quantitative increase in hemoglobin level.

36. Transfusion (transfusion) of donor blood and (or) erythrocyte-containing components should be started no later than two hours after removing the donor blood and (or) erythrocyte-containing components from refrigeration equipment and warming to 37 C.

Transfusion (transfusion) of erythrocyte-containing components of donor blood is carried out taking into account the group properties of the donor and recipient according to the ABO, Rh and Kell systems. It is prohibited to introduce any medications or solutions into the container with red blood cells other than 0.9% sterile sodium chloride solution.

37. For the prevention of graft-versus-host disease in recipients receiving immunosuppressive therapy, children with severe immune deficiency syndrome, newborns with low body weight, with intrauterine transfusions, as well as with related (father, mother, siblings) transfusion of components Before transfusion, donor blood erythrocyte-containing components are subjected to X-ray or gamma irradiation in a dose of 25 to 50 Gray (no later than 14 days from the date of receipt).

38. Storage of irradiated erythrocyte-containing components, with the exception of erythrocyte suspension (mass) depleted of leukocytes, before transfusion to newborns and young children should not exceed 48 hours.

39. Storage of irradiated erythrocyte-containing components (erythrocyte suspension, erythrocyte mass, washed erythrocytes) before transfusion to an adult recipient should not exceed 28 days from the date of procurement of erythrocyte-containing components.

40. To carry out transfusion (transfusion) of donor blood and erythrocyte-containing components to alloimmunized recipients, the following is carried out:

a) if a recipient has extra-agglutinins anti-A1, he is transfused with erythrocyte-containing components that do not contain the A1 antigen, recipient A2(II) is transfused with erythrocyte-containing components A2(II) or O(I), and recipient A2B(IV) is transfused with erythrocyte-containing components B(III);

b) recipients with identified anti-erythrocyte antibodies or those recipients in whom antibodies were detected during a previous study are transfused with erythrocyte-containing components that do not contain antigens of the corresponding specificity;

c) if the recipient has nonspecifically reacting anti-erythrocyte antibodies (panagglutinins) or antibodies with unknown specificity, he is transfused with individually selected erythrocyte-containing components that do not react in serological reactions with the recipient’s serum;

d) for alloimmunized recipients, individual selection of blood and erythrocyte-containing blood components is carried out in a clinical diagnostic laboratory;

e) for recipients immunized with leukocyte system antigens (HLA), donors are selected according to the HLA system.

VIII. Rules for transfusion (transfusion) of fresh frozen plasma

41. The transfused fresh frozen plasma of the donor must be of the same ABO group as that of the recipient. Diversity according to the Rh system is not taken into account. When transfusing large volumes of fresh frozen plasma (more than 1 liter), the matching of the donor and recipient for antigen D must be taken into account.

42. In emergency cases, in the absence of single-group fresh frozen plasma, transfusion of fresh frozen plasma of group AB(IV) to a recipient with any blood group is allowed.

43. Medical indications for prescribing transfusions of fresh frozen plasma are:

a) acute disseminated intravascular coagulation syndrome, complicating the course of shocks of various origins (septic, hemorrhagic, hemolytic) or caused by other causes (amniotic fluid embolism, crash syndrome, severe trauma with crushing tissue, extensive surgical operations, especially on the lungs, blood vessels, brain , prostate), massive transfusion syndrome;

b) acute massive blood loss (more than 30% of the circulating blood volume) with the development of hemorrhagic shock and disseminated intravascular coagulation syndrome;

c) liver diseases, accompanied by a decrease in the production of plasma coagulation factors and, accordingly, their deficiency in the circulation (acute fulminant hepatitis, cirrhosis of the liver);

d) overdose of indirect anticoagulants (dicoumarin and others);

e) therapeutic plasmapheresis in patients with thrombotic thrombocytopenic purpura (Moschkowitz disease), severe poisoning, sepsis, acute disseminated intravascular coagulation syndrome;

f) coagulopathy caused by a deficiency of plasma physiological anticoagulants.

44. Transfusion (transfusion) of fresh frozen plasma is performed by stream or drip. In acute DIC with severe hemorrhagic syndrome, transfusion (transfusion) of fresh frozen plasma is performed only as a stream. When transfusion (transfusion) of fresh frozen plasma, it is necessary to perform a biological test (similar to that carried out during transfusion (transfusion) of donor blood and erythrocyte-containing components).

45. For bleeding associated with DIC, at least 1000 ml of fresh frozen plasma is administered, while hemodynamic parameters and central venous pressure are monitored.

In case of acute massive blood loss (more than 30% of the circulating blood volume, for adults - more than 1500 ml), accompanied by the development of acute disseminated intravascular coagulation syndrome, the amount of transfused fresh frozen plasma should be at least 25-30% of the total volume of transfused blood and (or) its components, prescribed to replenish blood loss (at least 800-1000 ml).

In severe liver diseases, accompanied by a sharp decrease in the level of plasma coagulation factors and bleeding or bleeding during surgery, transfusion of fresh frozen plasma is carried out at the rate of 15 ml/kg of body weight of the recipient, followed (after 4-8 hours by repeated transfusion of fresh frozen plasma into smaller volume (5-10 ml/kg).

46. Immediately before transfusion (transfusion), fresh frozen plasma is thawed at a temperature of 37 C using specially designed thawing equipment.

47. Transfusion (transfusion) of fresh frozen plasma should begin within 1 hour after it is thawed and last no more than 4 hours. If there is no need to use thawed plasma, it is stored in refrigeration equipment at a temperature of 2-6 C for 24 hours.

48. To increase the safety of blood transfusions, reduce the risk of transferring viruses that cause infectious diseases, prevent the development of reactions and complications arising in connection with the transfusion (transfusion) of donor blood and (or) its components, use fresh frozen plasma, quarantined (or) fresh frozen plasma virus ( pathogen) inactivated.

IX. Rules for transfusion (transfusion) of cryoprecipitate

49. The main medical indications for transfusion (transfusion) of cryoprecipitate are hemophilia A and hypofibrinogenemia.

50. The need for transfusion (transfusion) of cryoprecipitate is calculated according to the following rules:

Body weight (kg) x 70 ml = circulating blood volume bcc (ml).

BCC (ml) x (1.0 - hematocrit) = volume of circulating plasma BCC (ml).

VCP (ml) x (required level of factor VIII - available level of factor VIII) = required amount of factor VIII for transfusion (in units).

Required amount of factor VIII (in units): 100 units. = number of doses of cryoprecipitate required for a single transfusion. For hemostasis, the level of factor VIII is maintained up to 50% during operations and up to 30% in the postoperative period. One unit of factor VIII corresponds to 1 ml of fresh frozen plasma.

51. Cryoprecipitate obtained from one unit of blood must contain at least 70 units. factor VIII. The donor's cryoprecipitate must be of the same ABO group as that of the recipient.

X. Rules for transfusion (transfusion) of platelet concentrate (platelets)

52. The therapeutic dose of platelets is calculated according to the following rules:

50-70 x 10 9 platelets for every 10 kg of the recipient’s body weight or 200-250 x 10 9 platelets per 1 m 2 of the recipient’s body surface.

53. Specific indications for platelet transfusion are determined by the attending physician based on an analysis of the clinical picture and causes of thrombocytopenia, the degree of its severity and the location of bleeding, the volume and severity of the upcoming operation.

54. Platelet transfusion is not performed in case of thrombocytopenia of immune origin, except in cases of vital indications in case of developed bleeding.

55. In case of thrombocytopathies, transfusion of platelets is carried out in urgent situations - during massive bleeding, operations, childbirth.

56. Clinical criteria for the effectiveness of platelet transfusion are the cessation of spontaneous bleeding, the absence of fresh hemorrhages on the skin and visible mucous membranes. Laboratory signs of the effectiveness of platelet transfusion are an increase in the number of circulating platelets 1 hour after the end of the transfusion (transfusion) and exceeding their initial number after 18-24 hours.

57. In case of splenomegaly, the number of transfused platelets should be increased compared to the usual by 40-60%, in case of infectious complications - by an average of 20%, in case of severe DIC syndrome, massive blood loss, alloimmunization phenomena - by 60-80%. The required therapeutic dose of platelets is transfused in two doses with an interval of 10-12 hours.

58. Preventive platelet transfusions are mandatory if recipients have agranulocytosis and disseminated intravascular coagulation syndrome complicated by sepsis.

59. In emergency cases, in the absence of platelets of the same group, transfusion of platelets of O(I) group to recipients of other blood groups is allowed.

60. To prevent graft-versus-host disease, platelets are irradiated before transfusion at a dose of 25 to 50 Gray.

61. To increase the safety of platelet transfusions, platelets that are depleted of leukocytes, virus (pathogen), and inactivated are transfused.

XI. Rules for transfusion (transfusion) of granulocyte concentrate (granulocytes) obtained by apheresis

62. An adult therapeutic dose of apheresis granulocytes contains 1.5-3.0 x 10 8 granulocytes per 1 kg of recipient body weight.

63. Apheresis granulocytes are irradiated with a dose of 25 to 50 Gray before transfusion.

64. Apheresis granulocytes are transfused immediately after they are received.

65. The main medical indications for prescribing granulocyte transfusion are:

a) a decrease in the absolute number of granulocytes in the recipient to less than 0.5 x 10 9 /l in the presence of an infection uncontrolled by antibacterial therapy;

b) sepsis of newborns, uncontrolled by antibacterial therapy.

Granulocytes must be compatible with ABO and Rh antigens.

66. The criteria for assessing the effectiveness of transfusion (transfusion) of granulocytes is the positive dynamics of the clinical picture of the disease: decrease in body temperature, decrease in intoxication, stabilization of previously impaired organ functions.

XII. Rules for transfusion (transfusion) of donor blood and (or) its components to children

67. Upon admission to the organization of a child in need of transfusion (transfusion) of donor blood and (or) its components, an initial study of the group and Rh affiliation of the child’s blood is carried out by a medical worker in accordance with the requirements of paragraph 7 of these Rules.

68. It is mandatory for a child in need of transfusion (transfusion) of components of donor blood and (or) its components (after the initial determination of group and Rh affiliation) to be carried out in a clinical diagnostic laboratory: confirming determination of the ABO blood group and Rh affiliation , phenotyping for other erythrocyte antigens C, c, E, e, Cw, K and k, as well as detection of anti-erythrocyte antibodies.

These studies are carried out in accordance with the following requirements:

a) blood group determination according to the ABO system is carried out using reagents containing anti-A and anti-B antibodies. In children over 4 months of age, the blood type is determined, including by the cross method, using anti-A, anti-B reagents and standard erythrocytes O(I), A(II) and B(III);

b) determination of Rh (D antigen) is carried out using reagents containing anti-D antibodies;

c) determination of erythrocyte antigens C, c, E, e, Cw, K and k is carried out using reagents containing the corresponding antibodies;

d) screening of anti-erythrocyte antibodies is carried out by an indirect antiglobulin test, which detects clinically significant antibodies, using a panel of standard erythrocytes consisting of at least 3 cell samples containing in total clinically significant antigens in accordance with subparagraph “d” of paragraph 22 of these Rules. The use of a mixture (pool) of red blood cell samples for screening of anti-erythrocyte alloantibodies is not permitted.

69. If anti-erythrocyte antibodies are detected in a child, individual selection of donors of erythrocyte-containing components is carried out with an indirect antiglobulin test or its modification with similar sensitivity.

70. If there is a need for emergency transfusion (transfusion) of donor blood and (or) its components in the inpatient setting of an organization in the absence of round-the-clock immunoserological support, the doctor conducting the transfusion (transfusion) of donor blood is responsible for determining the blood group according to the ABO system and the child’s Rh status. and (or) its components.

71. The studies specified in paragraph 68 of these Rules are carried out using immunoserological methods: manually (applying reagents and blood samples to a flat surface or in a test tube) and using laboratory equipment (adding reagents and blood samples to microplates, columns with gel or glass microspheres and other research methods approved for use for these purposes on the territory of the Russian Federation).

72. To carry out transfusion (transfusion) of donor blood of erythrocyte-containing components to alloimmunized recipients of childhood, the following rules apply:

a) if anti-A1 extraagglutinins are detected in a pediatric recipient, he is transfused with erythrocyte-containing components that do not contain the A1 antigen, fresh frozen plasma - one group. A pediatric recipient with A2(II) is transfused with washed red blood cells O(I) and fresh frozen plasma A(II), a pediatric recipient with A2B(IV) is transfused with washed red blood cells O(I) or B(III) and fresh frozen plasma AB(IV) ;

b) if a child recipient has nonspecifically reacting anti-erythrocyte antibodies (panagglutinins), he is transfused with erythrocyte-containing components O(I) Rh-negative, which do not react in serological reactions with the recipient’s serum;

c) for alloimmunized pediatric recipients, individual selection of donor blood and erythrocyte-containing components is carried out in a clinical diagnostic laboratory;

d) for HLA-immunized pediatric recipients, platelet donors are selected according to the HLA system.

73. In newborns, on the day of transfusion (transfusion) of donor blood and (or) its components (not earlier than 24 hours before the transfusion (transfusion), no more than 1.5 ml of blood is taken from a vein; in infants and older children, from a vein 1.5-3.0 ml of blood is taken into a test tube without an anticoagulant for mandatory control studies and compatibility tests. The tube must be labeled with the surname and initials of the recipient of childhood (in the case of newborns in the first hours of life, the surname and initials of the mother are indicated) , number of medical documentation reflecting the health status of the pediatric recipient, name of the department, group and Rh affiliation, date of blood sample collection.

74. During a planned transfusion of erythrocyte-containing components, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components is obliged to:

a) according to the medical documentation reflecting the health status of the recipient in childhood, and the data on the container label, compare the phenotype of the donor and recipient by erythrocyte antigens in order to establish their compatibility. It is prohibited to administer to a patient an erythrocyte antigen that is not present in his phenotype;

b) recheck the blood group of the pediatric recipient using the ABO system;

c) determine the donor’s blood group according to the ABO system (the donor’s Rh status is determined by the designation on the container);

d) conduct a test for individual compatibility of the blood of a child recipient and a donor using the following methods: on a plane at room temperature, one of three tests (indirect Coombs reaction or its analogues, conglutination reaction with 10% gelatin or conglutination reaction with 33% polyglucin). If donor blood or an erythrocyte-containing component is individually selected in a clinical diagnostic laboratory, this test is not performed;

d) conduct a biological test.

75. In case of emergency transfusion (transfusion) of erythrocyte-containing components to a pediatric recipient, the doctor conducting the transfusion (transfusion) of donor blood and (or) its components is obliged to:

a) determine the blood group of a child recipient according to the ABO system and his Rh status;

b) determine the donor’s blood group according to the ABO system (the donor’s Rh status is determined by the designation on the container);

c) conduct a test for the individual compatibility of the blood of a donor and a pediatric recipient using the following methods: on a plane at room temperature, one of three tests (indirect Coombs reaction or its analogues, conglutination reaction with 10% gelatin or conglutination reaction with 33% polyglucin);

d) conduct a biological test.

If it is impossible to determine the phenotype of a childhood recipient based on erythrocyte antigens C, c, E, e, Cw, K and k, it is allowed to ignore these antigens when transfusing erythrocyte-containing components.

76. A biological test during transfusion (transfusion) of donor blood and (or) its components into a pediatric recipient is mandatory.

The procedure for conducting a biological test:

a) a biological test consists of a three-time administration of donor blood and (or) its components, followed by monitoring the condition of a child recipient for 3-5 minutes with the blood transfusion system clamped;

b) the volume of administered donor blood and (or) its components for children under 1 year is 1-2 ml, from 1 year to 10 years - 3-5 ml, after 10 years - 5-10 ml;

c) in the absence of reactions and complications, transfusion (transfusion) of donor blood and (or) its components continues under constant supervision of the doctor conducting the transfusion (transfusion) of donor blood and (or) its components.

Emergency transfusion (transfusion) of donor blood and (or) its components to a pediatric recipient is also carried out using a biological sample.

A biological test, as well as a test for individual compatibility, is mandatory in cases where a child recipient is transfused with donor blood or erythrocyte-containing components individually selected in the laboratory or phenotyped.

77. The criterion for assessing transfusion (transfusion) of donor blood and erythrocyte-containing components in children is a comprehensive assessment of the child’s clinical condition and laboratory test data.

For children under 1 year of age in critical condition, transfusion (transfusion) of donor blood and (or) erythrocyte-containing components is carried out when the hemoglobin level is less than 85 g/l. For older children, transfusion (transfusion) of donor blood and (or) erythrocyte-containing components - with a hemoglobin level of less than 70 g/l.

78. When transfusion (transfusion) of donor blood and (or) erythrocyte-containing components to newborns:

a) erythrocyte-containing components depleted of leukocytes are transfused (erythrocyte suspension, erythrocyte mass, washed erythrocytes, thawed and washed erythrocytes);

b) transfusion (transfusion) to newborns is carried out under the control of the volume of transfused components of donor blood and the volume of blood taken for testing;

c) the volume of transfusion (transfusion) is determined at the rate of 10-15 ml per 1 kg of body weight;

d) for transfusion (transfusion), erythrocyte-containing components are used with a shelf life of no more than 10 days from the date of procurement;

e) the rate of transfusion (transfusion) of donor blood and (or) erythrocyte-containing components is 5 ml per 1 kg of body weight per hour under mandatory monitoring of hemodynamics, respiration and renal function;

f) components of donor blood are pre-warmed to a temperature of 36-37 C;

g) when selecting donor blood components for transfusion, it is taken into account that the mother is an undesirable donor of fresh frozen plasma for the newborn, since the mother’s plasma may contain alloimmune antibodies against the newborn’s erythrocytes, and the father is an undesirable donor of erythrocyte-containing components, since it is against the father’s antigens in the newborn’s blood there may be antibodies that have penetrated from the mother’s bloodstream through the placenta;

h) the most preferable is to transfuse children with a cytomegalovirus-negative erythrocyte-containing component.

79. The selection of donor blood and (or) its components for transfusion (transfusion) to children under four months of age with hemolytic disease of newborns according to the ABO system or suspected hemolytic disease of newborns is carried out in accordance with the table given in Appendix No. 3 to these Rules.

In the case of transfusion (transfusion) of erythrocyte-containing components that differ in the ABO system from the child’s blood group, washed or thawed erythrocytes are used that do not contain plasma with agglutinins and, taking into account the recipient’s phenotype.

80. For intrauterine transfusion (transfusion) of donor blood and (or) its components, erythrocyte-containing components O(I) of the Rhesus D-negative group are used with a shelf life of no more than 5 days from the moment of procurement of the component.

81.3 Blood transfusions are carried out to correct anemia and hyperbilirubinemia in severe forms of hemolytic disease of the newborn or in hyperbilirubinemia of any etiology: disseminated intravascular coagulation syndrome, sepsis and other life-threatening diseases of the child.

82. For replacement blood transfusion, erythrocyte-containing components are used with a shelf life of no more than 5 days from the moment the component is prepared.

83. Donor blood and (or) its components are transfused at the rate of 160-170 ml/kg body weight for a full-term baby and 170-180 ml/kg for a premature baby.

84. The selection of donor blood components depending on the specificity of alloantibodies is carried out as follows:

a) for hemolytic disease of newborns caused by alloimmunization to the D antigen of the Rh system, single-group Rh-negative erythrocyte-containing components and single-group Rh-negative fresh frozen plasma are used;

b) in case of incompatibility with ABO system antigens, washed erythrocytes or erythrocyte suspension and fresh frozen plasma are transfused in accordance with the table given in Appendix No. 3 to these Rules, corresponding to the Rh affiliation and phenotype of the child;

c) in case of simultaneous incompatibility of antigens of the ABO and Rhesus systems, washed erythrocytes or an erythrocyte suspension of O(I) group Rh-negative and fresh frozen AB(IV) Rh-negative plasma are transfused;

d) in case of hemolytic disease of newborns caused by alloimmunization to other rare erythrocyte antigens, individual selection of donor blood is carried out.

85. Fresh frozen plasma is transfused into a pediatric recipient in order to eliminate the deficiency of plasma coagulation factors, in case of coagulopathies, in case of acute massive blood loss (more than 20% of the circulating blood volume) and when performing therapeutic plasmapheresis.

Transfusion of virus (pathogen) inactivated fresh frozen plasma to pediatric recipients undergoing phototherapy is not permitted.

XIII. Autodonation of blood components and autohemotransfusion

86. When carrying out autodonation, the following methods are used:

a) preoperative procurement of autologous blood components (autoplasma and autoerythrocytes) from a dose of preserved autologous blood or by apheresis;

b) preoperative normovolemic or hypervolemic hemodilution, which involves collecting 1-2 units of blood (600-800 ml) immediately before surgery or the start of anesthesia with mandatory replenishment of temporary blood loss with saline and colloid solutions while maintaining normovolemia or hypervolemia;

c) intraoperative hardware reinfusion of blood, which involves the collection of spilled blood from the surgical wound and cavities during surgery with the release of erythrocytes from it, followed by washing, concentration and subsequent return of autoerythrocytes to the recipient’s blood stream;

d) transfusion (transfusion) of drainage blood obtained under sterile conditions during postoperative drainage of body cavities, using specialized equipment and (or) materials.

Each of these methods can be used separately or in various combinations. Simultaneous or sequential transfusion (transfusion) of autologous blood components with allogeneic ones is allowed.

87. When performing autotransfusion of blood and its components:

a) the patient gives informed consent to the collection of autologous blood or its components, which is recorded in medical documentation reflecting the health status of the recipient;

b) preoperative collection of autologous blood or its components is carried out at a hemoglobin level of not lower than 110 g/l, hematocrit - not lower than 33%;

c) the frequency of autologous donations of blood and (or) its components before surgery is determined by the attending physician together with the transfusiologist. The last autodonation is carried out no less than 3 days before the start of surgery;

d) with normovolemic hemodilution, the post-hemodilution hemoglobin level should not be lower than 90-100 g/l, and the hematocrit level should not be less than 28%; with hypervolemic hemodilution, the hematocrit level is maintained within 23-25%;

e) the interval between exfusion and reinfusion during hemodilution should not be more than 6 hours. Otherwise, containers with blood are placed in refrigeration equipment at a temperature of 4-6 C;

f) intraoperative reinfusion of blood collected during surgery from the surgical wound and cavities of shed blood, and reinfusion of drainage blood is not carried out if it is bacterially contaminated;

g) before transfusion (transfusion) of autologous blood and its components, the doctor conducting the transfusion (transfusion) of autologous blood and (or) its components performs a test for their compatibility with the recipient and a biological test, as in the case of using allogeneic blood components.

XIV. Post-transfusion reactions and complications

88. Identification and recording of reactions and complications that arose in recipients in connection with the transfusion (transfusion) of donor blood and (or) its components are carried out both in the current period of time after the transfusion (transfusion) of donor blood and (or) its components, and and after an indefinite period of time - several months, and with repeated transfusion - years after it was carried out.

The main types of reactions and complications that arise in recipients in connection with the transfusion (transfusion) of donor blood and (or) its components are indicated in the table given in Appendix No. 4 to these Rules.

89. When identifying reactions and complications that have arisen in recipients in connection with the transfusion (transfusion) of donor blood and (or) its components, the head of the transfusion department or transfusiology room of the organization, or a transfusiologist appointed by order of the head of the organization:

a) organizes and ensures the provision of emergency medical care to the recipient;

b) immediately sends to the head of the organization that procured and supplied the donor blood and (or) its components, a notification of reactions and complications that have arisen in recipients in connection with the transfusion (transfusion) of donor blood and (or) its components, according to the recommended sample given in Appendix No. 5 to these Rules;

c) transfers the remaining part of the transfused donor blood and (or) its components, as well as samples of the recipient’s blood taken before and after the transfusion (transfusion) of donor blood and (or) its components, to the organization that prepared and supplied the donor blood and (or) ) its Rh affiliation of donor blood and (or) its components, as well as for testing for the presence of anti-erythrocyte antibodies and markers of blood-borne infections;

d) analyzes the actions of medical workers of the organization in which the transfusion (transfusion) of donor blood and (or) its components was carried out, as a result of which a reaction or complication occurred.

XV. Formation of a supply of donor blood and (or) its components

90. The formation of a supply of donor blood and (or) its components is carried out in accordance with the procedure established in accordance with Part 6 of Article 16 of the Federal Law of July 20, 2012 N 125-FZ “On the Donation of Blood and Its Components”.

In order to improve medical care to the population of the Russian Federation and ensure quality in the use of blood components, I order:

Approve the Instructions for the use of blood components.
Control over the implementation of this order is entrusted to the First Deputy Minister A.I. Vyalkov

Minister
Yu.L. Shevchenko

Appendix No. 1

Instructions
on the use of blood components
(approved by order of the Ministry of Health of the Russian Federation dated November 25, 2002 N 363)

1. General Provisions

The operation of transfusion of blood components is accompanied by consequences for the recipient, both positive (an increase in the number of circulating red blood cells, an increase in the level of hemoglobin during the transfusion of red blood cells, relief of acute disseminated intravascular coagulation during the transfusion of fresh frozen plasma, cessation of spontaneous thrombocytopenic bleeding, an increase in the number of platelets during the transfusion of platelet concentrate), and negative (rejection of cellular and plasma elements of the donor’s blood, risk of viral and bacterial infection, development of hemosiderosis, inhibition of hematopoiesis, increased thrombogenicity, allosensitization, immunological reactions). In immunosuppressed patients, transfusion of cellular blood components can lead to the development of graft-versus-host disease.

When transfusing whole canned blood, especially with long (more than 7 days) storage periods, the recipient receives, along with the components he needs, functionally defective platelets, leukocyte breakdown products, antibodies and antigens, which can cause post-transfusion reactions and complications.

The blood of donors at blood transfusion stations (BTS) or in blood transfusion departments in the next few hours (depending on the preservative used and the procurement conditions - on-site or in-patient) after receipt must be divided into components. It is advisable to use blood components collected from one or a minimum number of donors in the treatment of one patient.

Blood components should be transfused only from the AB0 system group and the Rh group that the recipient has.

For health reasons and in the absence of blood components of the same group according to the ABO system (with the exception of children), transfusion of Rh-negative blood gas carriers of group 0 (I) to the recipient with any other blood group in an amount of up to 500 ml is allowed. Rh-negative erythrocyte mass or suspension from donors of group A(II) or B(III), according to vital indications, can be transfused to a recipient with group AB(IV), regardless of his Rhesus status. In the absence of single-group plasma, the recipient can be transfused with group AB(IV) plasma.

When a patient is routinely admitted to a hospital, the ABO blood group and Rh status are determined by a doctor or other specialist trained in immunoserology. The form with the results of the study is pasted into the medical history. The attending physician rewrites the data of the study result on the front side of the title page of the medical history in the upper right corner and affixes it with his signature. It is prohibited to transfer data on blood group and Rh status to the title page of the medical history from other documents.

Before proceeding with the transfusion of blood components, it is necessary to ensure their suitability for transfusion and the identity of the group affiliation of the donor and recipient according to the ABO and Rh systems. Visually, directly by the doctor transfusion of the transfusion medium, the tightness of the packaging, the correctness of certification are checked, and the quality of the blood transfusion medium is assessed macroscopically. It is necessary to determine the suitability of the blood transfusion medium with sufficient lighting directly at the storage site, avoiding shaking. The criteria for suitability for transfusion are: for whole blood - plasma transparency, uniformity of the upper layer of red blood cells, the presence of a clear boundary between red blood cells and plasma; for fresh frozen plasma - transparency at room temperature. If there is possible bacterial contamination of whole blood, the color of the plasma will be dull, with a gray-brown tint, it loses transparency, and suspended particles appear in it in the form of flakes or films. Such blood transfusion media are not subject to transfusion.

Transfusion of blood components that have not previously been tested for HIV, hepatitis B and C, and syphilis is prohibited.

Transportation of blood components is carried out only by medical personnel responsible for compliance with transportation rules. To avoid hemolysis, blood components should not be subjected to hypothermia or overheating during transportation. With transport time less than 30 minutes. it can be produced using any containers that provide sufficient isothermality. When transportation lasts more than half an hour, blood components must be kept in an insulated container (cooler bag). For even longer transportation (several hours) or at high ambient temperatures (above 20°C), it is necessary to use dry ice or cold accumulators that ensure isothermal conditions in the transport container. It is necessary to protect blood components from shaking, shock, turning over and overheating, and cellular components from freezing.

Recheck the recipient's blood group according to the AB0 system, compare the result with the data in the medical history;
Recheck the blood group according to the AB0 system of the donor container and compare the result with the data on the container label;
Compare the blood type and Rh status indicated on the container with the results of the study previously entered into the medical history and just received.
Conduct tests for individual compatibility according to the AB0 and Rh systems of donor erythrocytes and recipient serum;
Check with the recipient the last name, first name, patronymic, year of birth and compare them with those indicated on the title page of the medical history. The data must match, and the recipient must confirm them whenever possible (except in cases where the transfusion is carried out under anesthesia or the patient is unconscious).
Conduct a biological test (see point 6).
A necessary precondition for medical intervention is the informed voluntary consent of the citizen in accordance with Article 32 of the “Fundamentals of the Legislation of the Russian Federation on the Protection of Citizens” dated July 22, 1993 N 5487-1 (Gazette of the SND and the Armed Forces of the Russian Federation 08/19/93, N 33, Art. 1318).

In cases where a citizen’s condition does not allow him to express his will, and medical intervention is urgent, the issue of its implementation in the interests of the citizen is decided by a council, and if it is impossible to assemble a council, by the attending (duty) doctor directly, with subsequent notification of officials of the medical institution.

The plan for performing the operation of transfusion of blood components is discussed and agreed upon with the patient in writing, and, if necessary, with his relatives. The patient's consent is drawn up in accordance with the sample given in the Appendix and is filed with the inpatient card or outpatient card.

Legislative framework of the Russian Federation. What you need to know about the rules of blood transfusion? Organization of the expert’s work

Minister of Health Russian Federation T.B. Dmitrieva

Executive Director Federal Mandatory Fund health insurance V.V. Grishin

Annex 1 to the Order of the Ministry of Health of the Russian Federation and the Federal Compulsory Medical Insurance Fund

Regulations on the system of departmental quality control of medical care in healthcare institutions of the Russian Federation

1. General Provisions

2. Organization and procedure for departmental quality control of medical care

3. Conclusion

Head of Organization Department medical assistance to the population Ministry of Health of Russia A.A. Karpeev

Appendix 2 to the Order of the Ministry of Health of the Russian Federation and the Federal Compulsory Medical Insurance Fund dated October 24, 1996 N 363/77

Regulations on the system of non-departmental quality control of medical care in the Russian Federation

1. General Provisions

2. Subjects of the system of non-departmental quality control of medical care and their competence

3. Organization of interaction between subjects of non-departmental quality control and healthcare institutions to carry out examination of the quality of medical care

4. Organization and procedure for non-departmental quality control of medical care

Head of Department medical organization assistance to the population Ministry of Health of Russia A.A. Karpeev

Head of Department organization of compulsory health insurance Federal Compulsory Medical Insurance Fund N.D. Tegay

Appendix 3 to the Order of the Ministry of Health of the Russian Federation and the Federal Compulsory Medical Insurance Fund dated October 24, 1996 N 363/77

Position about a freelance medical expert<*>

1. General Provisions

3. Rights, duties and responsibilities of an expert

Head of Department medical organization assistance to the population Ministry of Health of Russia A.A. Karpeev

Head of Department organization of compulsory health insurance Federal Compulsory Medical Insurance Fund N.D. Tegay

Appendix 4 to the Order of the Ministry of Health of the Russian Federation and the Federal Compulsory Medical Insurance Fund dated October 24, 1996 N 363/77

Position about the expert of the Insurance Medical Organization<*>

1. General Provisions

2. Organization of the expert’s work

On approval of instructions for the use of blood components

INSTRUCTIONS FOR USE OF BLOOD COMPONENTS

General provisions

The procedure for immunoserological studies during transfusion of blood components

Immunoserological research technique

Tests for individual compatibility of donor and recipient blood

Causes of errors when determining blood type, Rh-accessory and conducting tests for individual compatibility and measures to prevent them

Biological sample

Transfusion of blood gas carriers

Transfusion of plasma-coagulation hemostasis correctors

Transfusion of platelet concentrates

Transfusion of leukocyte concentrate

Rules for the clinical use of donor blood and (or) its components

Minister of Health
Russian Federation
T.B. Dmitrieva

Executive Director
Federal Mandatory Fund
health insurance
V.V. Grishin

Annex 1
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund

Head of Organization Department
medical assistance to the population
Ministry of Health of Russia
A.A. Karpeev

Appendix 2
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund
dated October 24, 1996 N 363/77

Head of Department
medical organization
assistance to the population
Ministry of Health of Russia
A.A. Karpeev

Head of Department
organization of compulsory
health insurance
Federal Compulsory Medical Insurance Fund
N.D. Tegay

Appendix 3
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund
dated October 24, 1996 N 363/77

Position
about a freelance medical expert<*>

Head of Department
medical organization
assistance to the population
Ministry of Health of Russia
A.A. Karpeev

Head of Department
organization of compulsory
health insurance
Federal Compulsory Medical Insurance Fund
N.D. Tegay

Appendix 4
to the Order of the Ministry of Health of the Russian Federation
and the Federal Compulsory Medical Insurance Fund
dated October 24, 1996 N 363/77

Position
about the expert of the Insurance Medical Organization<*>