Order 363 of the Ministry of Health blood transfusion. What you need to know about the rules of blood transfusion? Executive Director of the Federal Compulsory Medical Insurance Fund V.V. Grishin

Valid Editorial from 25.11.2002

ORDER of the Ministry of Health of the Russian Federation dated November 25, 2002 N 363 "ON APPROVAL OF INSTRUCTIONS FOR THE USE OF BLOOD COMPONENTS"

11. Post-transfusion complications

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.

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, years after the transfusion (long-term complications). The main types of complications are presented in Table 3.

Table 3

COMPLICATIONS OF BLOOD 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 ABO 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 to 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 are prescribed to stimulate diuresis and reduce the deposition of hemolysis products in the distal tubules of the nephrons. body weight. 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 in 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 to 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 express 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, it is necessary to use slow administration in transfusion practice: the transfusion rate is 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 ranges from 6 to 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.

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 phosphate. 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 to 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, to 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 the 1st day of storage has a pH of 7.1 (on average, the pH of circulating blood is 7.4), and on the 21st day 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 for 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;

Prescribing pharmacological drugs aimed at treating massive transfusion syndrome without taking into account pathogenetic processes can 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 - a 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.

RESULTS OF DETERMINING BLOOD GROUP AB0

12) Order of the Ministry of Health of the Russian Federation of November 25, 2002 N 363 “On approval of the Instructions for the use of blood components” (registered by the Ministry of Justice of the Russian Federation on December 20, 2002 N 4062);

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:

1. Regulations on the system of departmental quality control of medical care in healthcare institutions of the Russian Federation (Appendix 1).
2. Regulations on the system of non-departmental quality control of medical care in the Russian Federation (Appendix 2).
3. Regulations on a freelance medical expert (Appendix 3).
4. 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 Directorate of Educational Institutions of the Ministry of Health of Russia (N.N. Volodin) and the Directorate of Scientific and Methodological Support and Personnel Training of the Federal Compulsory Medical Insurance Fund should develop and, in accordance with the established procedure, 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 ability 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

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. 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

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 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 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.

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 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.

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 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.

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:

• 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.

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.

ABOUT APPROVAL OF INSTRUCTIONS

ON 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:

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. Vyalkov.

Minister Yu.L.SHEVCHENKO

Appendix No. 1

APPROVED

by order of the Ministry of Health

Russian Federation

dated November 25, 2002 N 363

INSTRUCTIONS FOR USE OF BLOOD COMPONENTS

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 for plasma coagulation hemostasis (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 A0 system (with the exception of children), transfusion is allowed 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. Rhesus negative red blood cells or a 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 affiliation. 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 Rhesus affiliation 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 having alloimmune antibodies, make 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 specialist - transfusiologist.

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. If transportation lasts more than half an hour, blood components must be kept in an insulated container (refrigerator 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.

Doctor, transfusion of blood components, must, regardless of previous studies and existing records, personally carry out the following control studies directly at the recipient's bedside:

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

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

1.3. Compare the blood type and Rhesus affiliation 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 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 07.22.93 N 5487-1 (Gazette of the SND and the Armed Forces of the Russian Federation 08.19.93, N 33, Art. 1318). In cases when 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 consultation - the attending (duty) doctor directly, with subsequent notification of officials of the medical and preventive 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.

Biological sample.

Before transfusion, the container with the transfusion medium (packed red blood cells 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 phenotypic 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 ABO 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 preserved in within 48 hours in a 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 ABO 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 ABO and Rh;

The result of a control check of the group affiliation of blood or red blood cells taken from the container, according to ABO 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.

During outpatient blood transfusion the recipient must be under the supervision of a physician after the end of the transfusion 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.

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