45 order for quality control of laboratory research. With changes and additions from

Intralaboratory quality control in a clinical diagnostic laboratory is a set of measures aimed at ensuring the quality of clinical laboratory research.

Organization of internal laboratory quality control

The main tasks of the CDL are to carry out the necessary clinical laboratory tests and improve their quality. The quality of laboratory tests must meet the requirements for analytical accuracy established by the regulatory documents of the Ministry of Health of Russia, which is a prerequisite for reliable analytical work of the CDL. An important element of quality assurance is internal laboratory quality control, which consists in continuous (daily in each analytical series) control activities: examination of samples of control materials or application of control measures using patient samples. The purpose of internal laboratory control is to assess the compliance of research results with the established criteria for their acceptability with the maximum probability of error and the minimum probability of false rejection of the results of analytical series performed by the laboratory.

Internal laboratory quality control is mandatory for all types of research carried out in the laboratory. The rules for internal laboratory quality control of quantitative studies are contained in the Order of the Ministry of Health of the Russian Federation No. 45 dated 02/07/2000 "On the system of measures to improve the quality of clinical laboratory research in healthcare institutions of the Russian Federation." When conducting quality control of laboratory tests, the following terms are used:
Accuracy of measurements - the quality of measurements, reflecting the proximity of their results to the true value of the measured value. High measurement accuracy corresponds to small errors of all types, both systematic and random.
Measurement error - deviation of the measurement result from the true value of the measured value.
Systematic measurement error - a component of the measurement error that remains constant or regularly changes with repeated measurements of the same value.
Accuracy of measurements is the quality of measurements, reflecting the closeness to zero of systematic errors in their results.
Random measurement error - a component of the measurement error that changes randomly when repeated measurements of the same quantity.
Analytical series - a set of measurements of a laboratory indicator performed at a time in the same conditions without reconfiguring and calibrating the analytical system.
Intra-batch reproducibility is the quality of measurements reflecting the closeness to each other of measurement results performed in the same analytical batch.
Inter-batch reproducibility is the quality of measurements that reflects the closeness of measurement results performed in different analytical series.
Overall reproducibility is the quality of measurements that reflects the closeness of all measurements to each other.
Established value - method-dependent value of the determined indicator, indicated by the manufacturer of the control material in the passport or instructions.
Internal (laboratory) and external factors can be sources of errors detected by the internal laboratory quality control system. External factors include the principle of the analytical method, the quality of instruments and reagents, and calibration tools. Internal - non-observance of the conditions established by the analytical research methodology: time, temperature, volumes, rules for the preparation and storage of reagents.

Depending on the nature of the influence on the results of the analytical study, systematic and random errors are distinguished, which are revealed by repeated examination of the control material in analytical series. The systematic error characterizes the accuracy of measurements, which is determined by the degree of coincidence of the average result of repeated measurements of the control material (X) and the specified value of the measured quantity. The difference between them is called displacement and can be expressed in absolute or relative values ​​and is calculated as a percentage using the formula:
B = ((X - US) / US) x 100%, where X is the average value of measurements of the control material, Y3 is the set value.

The random error reflects the scatter of measurements and manifests itself in the difference between the results of repeated measurements of the determined indicator in the same sample. Mathematically, the magnitude of the random error is expressed by the standard deviation (S) and the coefficient of variation (CV).

Internal laboratory quality control includes control of reproducibility and accuracy (correctness) and can be carried out using methods using special control materials or means of a number of methods that do not require control materials. Methods using control materials: method of control charts; method "Sisit"; Westgard control rule method. Methods using patient data:
Parallel sample method.
Method of average normal values ​​("average norm").
Investigation of a random sample.
Investigation of repeated samples.
Study of a mixed sample.

Control chart method. Every day, a laboratory worker, when carrying out all types of analysis, along with experimental samples, examines the control material. Determination of the content of components in the control material is carried out simultaneously with the study of experimental samples, while instead of serum or blood plasma, the control material is taken in the same amount. Control materials can be prepared in the laboratory on their own (drained sera) or purchased from companies - commercial control materials. In turn, commercial sera can be certified (with a known content of components) and uncertified (with an unknown content of components). Uncertified control sera are primarily used for reproducibility control, and certified control sera are used primarily for accuracy.

The determination of each component in the control material is carried out by the method used in this laboratory. The results are recorded daily. For certified control materials for 20 results obtained in 20 completed series, calculate:
arithmetic mean X;
standard deviation S;
coefficient of variation CV;
the value of the relative displacement B.

If uncertified material or drained sera are used, X, S and CV are calculated from the results obtained. Check that the obtained values ​​of B and CV do not exceed their maximum permissible values. If this condition is met, a conclusion is made about the possibility of using the considered technique for the purposes of laboratory diagnostics and proceeds to the construction of control charts. If one of the obtained values ​​of B or CV exceeds the corresponding maximum permissible values, additional work is carried out to eliminate sources of increased displacement or variation, or another method for determining this indicator is selected.

The control chart is a graph, on the abscissa axis of which the number of the analytical series (or the date of its execution) is plotted, and on the ordinate axis - the values ​​of the determined indicator in the control material. Through the middle of the ordinate, draw a line corresponding to the arithmetic mean X, and parallel to this line mark the lines corresponding to the control limits:
X ± 1S
X ± 2S
X ± 3S

Using the constructed control charts, operational ("current") quality control of the results of determining the investigated indicator is carried out. For this purpose, in each analytical series, one measurement is carried out in each of the two control materials (N and P); or two measurements in the same control material if a single material is used (in the latter case, two points per series are plotted on the control card).

Evaluation of the test results of control materials is carried out using the Westgard control rules:
1 2S - if one of the results of the analysis of control materials goes beyond (x ± 2S), then the presence of all the following signs is checked sequentially, and the analytical series is considered unsatisfactory if at least one of them is present;
1 3S - one of the control measurements is out of range (х ± 3S);
2 2S - the last two control measurements exceed the limit (x + 2S) or lie below the limit (X-2S);
R 4S - two control measurements in the considered analytical series are located on different sides of the corridor х ± 2S (does not apply to one measurement in a series of a single control material);
4 1S - the last four control measurements exceed (x + 1S) or lie below (x-1S);
10 X - the last ten control measurements are located on one side of the line corresponding to X.

The appearance of control signs 1 3S and R 4S indicates an increase in random errors, while signs 2 2S, 4 1S, I0 X - an increase in the systematic error of the method. After eliminating the causes of increased errors, all samples analyzed in this series (both patients and controls) are re-examined. Methods using control materials are the most widely used for quality control in CDLs. However, these methods do not catch the error altogether.

Control by daily averages. For many studies, a daily average control that uses samples or results from patient samples may be recommended as an additional option. Conditions necessary for the implementation of the method: the number of patient samples examined daily must be sufficient for the statistical reliability of the data (30 or more, the value of this number depends on the analyzed component); the contingent of patients examined by the laboratory should be sufficiently homogeneous (by pathology, gender, age); the number of averaged results should be approximately the same, and it depends on the analyzed component.

The sequence of procedures:
Every day, from the results obtained during the day, the daily arithmetic mean (x) is calculated, and this procedure is repeated for 20 days.
Even from 20 daily averages, the total average x total is calculated. and standard deviation (S).
Control limits are calculated (X TOTAL ± 1S, X TOTAL ± 2S, X TOTAL ± 3S) and a control chart is constructed.
After building a control chart in the laboratory, x is calculated daily from all the results of each analyzed indicator, and the resulting value is plotted on the map as a dot.

The control chart is analyzed according to Westgard guidelines.

Reproducibility control method for duplicates. The principle of this method of intralaboratory quality control consists in conducting two parallel studies of the determined indicator in a randomly selected patient sample, finding the value of the relative range (R i,%) between the first value of the indicator (X 1) and the second (X 2) and comparing it with the established control values. outside. The sequence of procedures:
determine the level of the determined indicator in a randomly selected patient sample twice during one analytical series;
calculate the value of the relative swing between the two definitions using the formula:
R i = ((2 x (X 1 - X 2)) / (X 1 + X 2)) x 100%, where (X 1 –X 2) is the difference between the results of determination by the absolute value;
repeat the described procedure in 20 analytical series;
from the obtained 20 values ​​(R 1, 2, 3. 20) calculate the arithmetic mean value of R:

Next, the control limits are calculated by multiplying the obtained value of R by the coefficients corresponding to the 95% and 99% quantiles of the range distribution: for the 95% control border - 2.46; for the 99% control limit - 3.23. Based on the obtained control limits, a control chart is built, where a zero line is plotted on the abscissa axis (it will correspond to a zero range), on which the number of the analytical series is marked, and lines corresponding to R and control boundaries of 95% and 99% are drawn parallel to it on a convenient scale. ... The level of the indicator being determined is marked on the ordinate axis. Further, in each analytical series, a parallel study of the determined indicator is carried out in a randomly selected patient sample. Samples to be analyzed in parallel should be randomly spaced along the length of the analytical run. The obtained value of the relative range is compared with the control limits. If at least one obtained value goes beyond the control limit corresponding to 99% (control feature "1 R99", or if two consecutive values ​​go beyond the control line "95% (control feature" 2 R9S "), then such an analytical series is considered unsuitable, the study repeated.

Study of a mixed sample. Reproducibility evaluations by parallel sampling give closer values ​​than would normally be obtained in the presence of random errors. This is excluded in the mixed sample method. The method is as follows: from a group of samples, two are randomly selected (A and B); equal volumes are taken from each sample A and B and mixed (sample C); examine all three samples, calculate the theoretical content of the component in the sample C ((A + B) / 2) and the difference between the theoretical and investigated content ((A + B) / 2 – C). To build a control chart using this method, the study should be carried out within 40 days. Then calculate the mean deviation (d avg.) For single analyzes by adding all the differences (omitting the signs) and dividing by 40. Then prepare a control chart on which three straight lines are drawn: 50% straight is 0.845 dCP; 95% straight is 2.5 dCP; 99.5% straight is 3.5 dCP.

In the future, a mixed sample is prepared daily and the result is noted on the map. Each point represents the difference between the theoretical value calculated as the average of the two samples and the actual value obtained by examining the mixed sample. If many points are located above the straight lines 95% and 99.5%, it is necessary to take appropriate measures to identify possible sources of errors.

Features of quality control of hematological studies

Due to the specifics of hematological studies, their quality control presupposes the presence of certain control means and materials that are not used in other types of laboratory studies. To control the quality of determining the hemoglobin content, standard solutions of hemiglobin cyanide with a known Hb content and special control solutions (donor blood, lysed blood and preserved blood) are used. Hemiglobin cyanide standard solution is used to control the correct operation of photometers and to construct a calibration curve in the hemiglobin cyanide method for determining Hb in blood. To control the reproducibility of Hb determination, a solution of lysed blood (hemolysate) is used. For the preparation of hemolysates use: canned human citrated blood, it is possible with an expired shelf life; canned horse blood; donor human blood, fresh, collected in a vessel with 0.6 mol / l sodium citrate solution at a rate of 1: 5.

200 ml of the obtained citrated blood is centrifuged at 3000 rpm for 30 minutes. The plasma is decanted, 100 ml of sterile distilled water is added to the erythrocytes and thoroughly mixed on a magnetic stirrer for 30 minutes. The solution is placed in a refrigerator at -20 degrees for 24 hours. The next day, the solution is thawed and again thoroughly mixed for 30 minutes.

Then the solution is filtered under aseptic conditions through a Millipore glass filter (corresponds to No. 4 - with a pore size of 4–10 µm) and poured into sterile 1 ml vials. Store the solution in a refrigerator, optimal t = –20 ° С. Stable for 1 year. To assess the reproducibility of determining the Hb concentration, the hemolysate is examined for 20 days, the XCP, S, CV, control limits (X ± 2S) are calculated from the data obtained and a control card is built. The coefficient of variation should not exceed 5%.

To control the correctness, control blood with a known hemoglobin content is used. Control blood is examined in the same way as normal patient samples, that is, in the same cases and under the same conditions. The results of the Hb study in the control blood are compared with the passport values ​​specified in the manufacturer's instructions, and the B bias is calculated. It should not be more than 4%.

The following control materials are used to control the quality of counting blood cells: preserved or stabilized blood; fixed blood cells (suspensions); control blood smears. The quality control of the determination of erythrocytes is carried out according to the principle of indirect control by the method of control charts. Within 2 days, 20 determinations of the number of erythrocytes in canned blood are carried out, control limits are calculated and a control chart is built. The coefficient of variation when counting erythrocytes in the control material should not exceed 5%.

To control the quality of counting the leukocyte formula in blood smears, control smears are used. They are prepared from the capillary blood of donors and patients in the usual way. Then control smears are repeatedly counted (at least 20 times) by 200 cells by qualified specialists (at least 5 people). From the data obtained, the criteria for determining the correctness of the smear count by calculating X and S are statistically calculated. To increase the shelf life of the smear, BF-6 glue is used, which forms a thin transparent film that hermetically adheres to the surface of the smear and glass and protects the smear from environmental influences. The calculation of the leukoformula is considered correct if the results of the cell count are within the calculated control limits (X ± 2S) for each type of blood cells.

Quality control of blood tests

The degree of accuracy of the obtained results of urine tests mainly depends on the qualifications of the laboratory assistant, the equipment used, reagents and the research method. To obtain correct and reproducible test results chemical composition swords use control materials as close as possible to patients' urine samples and control swabs to control the quality of microscopic examinations of urine sediment. The following are used as control materials to control the chemical composition of urine: aqueous solutions of substances; drained urine with preservatives; artificial urine solutions with additives of substances investigated in urine.

Control materials are used to check the methods usually used in the laboratory for the qualitative and quantitative study of the chemical composition of urine. Aqueous solutions of substances with a known content are used to control the quality of studies of the chemical composition of urine (for example, a solution of glucose, acetone, albumin). For the preparation of aqueous solutions, distilled water is used that corresponds to GOST 6709-72, and reagents of reagent grade and analytical grade.

Aqueous solutions are stored in a refrigerator for 1 month. To control the quality of studies of the chemical composition of urine, you can use drained urine prepared in the laboratory. To 1 liter of fresh human urine add 2 g of EDTA, and with vigorous shaking and stirring the bottle, add 5 ml of thymol solution. After 2 weeks, the urine is centrifuged to remove mucus and trace amounts of uric acid. After this treatment, the urine becomes transparent and almost odorless.

The control material is stored at room temperature... The shelf life is several years. Drained urine is used for reproducibility control.

Control solutions that simulate urine are used to control the quality of the test strips. Method of preparation: 5 ml of glucose (for intravenous injection), 2 ml of acetone (h, analytical grade), 25 ml of drained human serum and 0.1 ml of lysed blood (to 0.1 ml whole blood add 01 ml of distilled water for lysis of erythrocytes). Mix thoroughly and make up the volume to the mark with physiological saline. Using 0.1 M HC1, the pH is adjusted to 6.0. The control solution should be kept in the refrigerator for up to one month.

Quality control of coagulation studies

Quality control of coagulological studies has its own characteristics, primarily related to the nature of the methodological principles that are used to study the parameters of the coagulation system and fibrinolysis and are based mainly on determining the endpoint of fibrin formation, as well as with the type of reagents used. To control coagulological studies, use:
Mixed fresh plasma from a large number of donors (at least 20 people).
Standard human lyophilized plasma (pool) for calibration.
Control human plasma with accurate clotting factors (normal and abnormal).
Control plasma with a deficiency of individual coagulation factors.
Control plasma to control the upper and lower boundaries of the therapeutic area when taking anticoagulants.

As the main control material, a fusion, only citrate plasma with normal and prolonged clotting times is used. Method of preparation of drained plasma: fresh plasma taken with a 3.8% sodium citrate solution is collected from several donors, mixed and poured into vials. Freeze quickly. The main requirement for plasma is the absence of traces of hemolysis and erythrocytes in it.

The control plasma is thawed every day and used at the beginning of work and every 20 samples. It is recommended to use at least one portion of plasma with a prolonged clotting time. Each sample and control plasma are analyzed in parallel. If the difference between the parallels is more than 3 seconds, then the test should be repeated with a fresh sample from the patient.

Quality control of urine tests

The degree of accuracy of the obtained results of urine tests mainly depends on the qualifications of the laboratory assistant, the equipment used, reagents and the research method. To obtain correct and reproducible results of the study of the chemical composition of urine, control materials are used, which are close, if possible, to urine samples of patients, and control smears to control the quality of microscopic studies of urine sediment. The following are used as control materials to control the chemical composition of urine: aqueous solutions of substances; drained urine with preservatives; artificial urine solutions with additives of substances investigated in urine.

Control materials are used to check the methods usually used in the laboratory for the qualitative and quantitative study of the chemical composition of urine. Aqueous solutions of substances with a known content are used to control the quality of studies of the chemical composition of urine (for example, a solution of glucose, acetone, albumin). For the preparation of aqueous solutions, distilled water corresponding to GOST 6709–72 and reagents of chemically pure and analytical grade are used. Aqueous solutions are stored in a refrigerator for 1 month. To control the quality of studies of the chemical composition of urine, you can use drained urine prepared in the laboratory.

To 1 liter of fresh human urine add 2 g of EDTA, and with vigorous shaking and stirring the bottle, add 5 ml of thymol solution. After 2 weeks, the urine is centrifuged to remove mucus and trace amounts of uric acid. After this treatment, the urine becomes transparent and almost odorless.

The control material is stored at room temperature. The shelf life is several years. Drained urine is used for reproducibility control. Control solutions that simulate urine are used to control the quality of the test strips.

Method of preparation: 5 ml of glucose (for intravenous injection), 2 ml of acetone (h, analytical grade), 25 ml of drained human serum and 0.1 ml of lysed blood (to 0 , 1 ml of whole blood is added with 0.1 ml of distilled water for lysis of erythrocytes). Mix thoroughly and make up the volume to the mark with physiological saline. Using 0.1 M HCl, the pH is adjusted to 6.0. The control solution should be kept in the refrigerator for up to one month.

Assessment of the quality of the laboratory assistant's work

Assessment of the laboratory technician's performance should be part of an internal laboratory quality control program. You can evaluate the technique of laboratory technicians using the following methods:
A method using the results of an external quality assessment.
Random sampling method.
Sample dilution method.
Duplicate analysis method.
A method using the results of internal laboratory quality control.

If a laboratory technician has performed 20 or more analyzes, then his work is easy to evaluate if the true value of the samples is known. The standard deviation of a laboratory can be thought of as an estimate of each laboratory technician's ability to perform correct analyzes when calculating the average of all standard deviations for all tests. This mean can be called the combined standard deviation (KS).

The KS value is calculated for a certain period of time (six months, a year) for each laboratory assistant and a rough estimate of the analytical ability of each is given. First, the results of analyzes of control materials for a certain period of time are postponed, each test is identified with the name of the laboratory assistant who performed it. After the expiration of the specified period, assessment sheets are prepared for each laboratory assistant. The name of the test, the result obtained by the laboratory assistant, the true value and the standard deviation are recorded on the score sheet. From these values, the difference between the true value and that obtained by the laboratory assistant is calculated, and it is divided by the standard deviation, for example: when examining blood hemoglobin by the laboratory assistant, a value of 163 g / l was obtained, X cf. = 162 g / l; S = 2, so KS = (163-162) / 2 = 0.5.

The lower the KS, the better the work of the laboratory assistant. This value can be used to rank laboratory technicians according to the quality of work: for example, with KS:
0-0.5 - excellent;
0.5-1.0 - good;
1.0–1.5 - satisfactory;
1.5–2.0 - bad;
above 2.0 is very bad.

This method is difficult to apply in fully automated laboratories. To compare the quality of the work of laboratory technicians, you can use the results of the method of duplicating samples, the method of dilution. Their disadvantage is that they can only be used to assess the quality of laboratory technicians, but not for ranking.

Automation of internal laboratory quality control

Conducting in-house quality control in full for all studies performed in the CDL requires significant expenditures of labor, time and money. Reducing these costs is possible only with the automation of quality control using a personal computer and software. It is also important that the results obtained with the help of the program are highly reliable, since the number of errors made during manual control is reduced. The only thing that is required from the CDL personnel as routine work is to enter the results of measurements of control material or patient samples into the program.

Control of the operation of devices, equipment and the quality of dishes

The wide range of laboratory research used at present requires the use of a wide variety of technical means, and their list includes dozens of items. The complex of organizational and technical measures allowing to control the technical and metrological characteristics of manufactured products is carried out on the basis of the Regulation of the State System for Ensuring the Uniformity of Measurements (GSI).

Measuring instruments are subject to verification in accordance with GOST 8002–71. In accordance with the guidelines for metrological support of measuring instruments, the procedure and timing of calibration of measuring instruments in the CDL are determined. Measuring devices are verified by departmental metrological bodies in accordance with the instructions, which indicate the operations performed and the means of verification. All technical and metrological indicators recorded in the passport attached to the device are subject to verification. It is prohibited to work on an untested device. The instrument error is included in the total analysis error. The analysis error includes the errors of the laboratory assistant, sampling, dosing, measurement.

Due to the fact that the KDL does not have verification means, some characteristics of the photometric absorptiometers can be checked using the control light filters supplied with the device. Verification can also be carried out using specially prepared solutions - liquid indicators, which in a certain region of the spectrum have constant spectral characteristics. Liquid indicators can be prepared directly in the QDL and allow checking the measurement accuracy in various spectral regions (from 300 to 550 nm). The absorbance peak of the filter should be close to the absorbance peak of the liquid indicators. In addition, by preparing appropriate dilutions of these solutions, you can check the lipidity of this device. Measurements are carried out in a cuvette with an optical path length of 10 mm.

Preparation of solutions for checking the spectral characteristics of photometers

Dissolve copper sulfate in an amount of 20 g in 10 ml of concentrated sulfuric acid, transfer quantitatively to a 100 ml volumetric flask, after reaching room temperature, bring the volume to the mark with distilled water. Store in a dark container. Dissolve cobalt ammonium sulfate in an amount of 14.481 g in 10 ml of concentrated sulfuric acid, transfer to a 100 ml volumetric flask, bring the volume up to the mark with distilled water at room temperature. Store tightly closed in a dark container. Dissolve potassium chromate in an amount of 40 mg in 600 ml of 0.05 N KOH solution in a 100 ml volumetric flask, bring the volume to the mark with 0.05 N KOH solution.

The common component of the laboratory error includes the dosing error. Therefore, it is a very special problem to check the used dosing and metering means for the accuracy of the readings. It is known from practice that about 30-40% of all volumetric glassware is rejected due to its inaccuracy in the measured volume according to the following formula: ((initial volume - received volume) / initial volume) x 100%.

The result, expressed in%, should not exceed: for 20 µl - 3%, for 100-200 µl - 1%, for 1000-2000 µl - 0.3%. Every laboratory is of the right quality. Accuracy is assessed using an analytical balance gravimetrically: the mass of water that makes up the volume of the dosing object is weighed many times (at least 10 times) on an analytical balance. Converting mass units to volumetric ones, they expect to develop and implement a quality control program for the equipment used, which includes checking and recording the state of refrigerators, water baths, thermostats, pipettes, timers, as well as monitoring the quality of distilled water (purity, pH value).

ABOUT THE SYSTEM OF MEASURES TO IMPROVE THE QUALITY OF CLINICAL LABORATORY STUDIES IN HEALTHCARE INSTITUTIONS OF THE RUSSIAN FEDERATION

REGULATION ON THE ORGANIZATION OF QUALITY MANAGEMENT OF CLINICAL LABORATORY STUDIES IN HEALTHCARE INSTITUTIONS

1. System of measures for quality management
clinical laboratory research

1.1. The quality of laboratory tests must meet the requirements for analytical accuracy established by the regulatory documents of the Ministry of Health of Russia, which is a prerequisite for reliable analytical work of clinical diagnostic laboratories of health care institutions (regardless of the form of ownership) to provide laboratory diagnostic information to health care institutions in the country. Implementation of a system of measures for managing the quality of clinical laboratory research is the basis for achieving and universal compliance with the required level of quality of these studies.
1.2. Quality management of clinical laboratory research consists of planning, ensuring and controlling the quality of research.
1.3. Planning the quality of clinical laboratory research consists in determining the accuracy standards that are actually feasible using the technical means, chemical and biological reagents and consumables at the disposal of laboratories with a minimum cost of working time and laboratory materials, taking into account medically justified requirements.
1.3.1. The accuracy standards for various types of clinical laboratory tests are established by the regulatory documents of the Ministry of Health of Russia and serve as industry standards for the analytical accuracy of these studies. When developing accuracy standards, both information about the intra- and interindividual biological variation of the determined indicators of biological materials of healthy people and the resulting requirements for the maximum permissible values ​​of analytical variation, and the technical capabilities of the equipment with which clinical laboratories are equipped are taken into account. The revision of the standards for the accuracy of clinical laboratory research should take place as the methodological and technical equipment of clinical diagnostic laboratories improves.
1.3.2. The planning of measures to ensure the quality of clinical laboratory tests in accordance with the current regulatory documents of the Ministry of Health of Russia and the list of tests performed in the laboratory is the responsibility of the head of the clinical diagnostic laboratory. When performing laboratory tests outside the laboratory by non-laboratory personnel, planning the quality of research should be carried out by the head of the relevant clinical unit, a private medical institution or a family doctor with the advice and methodological assistance of the clinical diagnostic laboratory of this or the nearest medical institution.
1.3.3. An important element of quality assurance in clinical diagnostic laboratories is intra-laboratory quality control. When planning and implementing intralaboratory quality control, the provisions of the "Rules for intralaboratory quality control of quantitative laboratory studies" are used. The accuracy of laboratory tests performed on a daily basis achieved in the laboratory should be reflected in the “Guidelines for the quality of clinical laboratory tests” of the given laboratory.
1.4. Quality assurance of clinical laboratory research consists in the implementation of measures that create the necessary conditions to obtain laboratory information that adequately reflects the state of the internal environment in patients. Quality assurance measures are carried out:
- at the level of the healthcare system in Russia,
- at the level of an individual health care institution,
- at the level of a separate clinical diagnostic laboratory.
1.4.1. Ensuring the quality of clinical laboratory research at the level of the Russian healthcare system consists in the examination of the quality of devices, reagents, standard samples (calibration and control materials), laboratory equipment and other equipment intended for use in clinical diagnostic laboratories in the country. After carrying out technical and medical tests of samples of technical, chemical and biological equipment of laboratories in the most qualified institutions, the relevant commissions of the Committee on New Medical Equipment of the Ministry of Health of Russia issue permits for the use in clinical diagnostic laboratories of healthcare institutions of Russia serially produced by Russian enterprises or supplied from abroad products. The activities of the commissions of the Ministry of Health of Russia are regulated by the current legislation of the Russian Federation and regulatory documents of the Ministry of Health of Russia.
1.4.2. Analytical characteristics of research methods (sensitivity, specificity, accuracy, reproducibility, measurement range) and laboratory diagnostic tools recommended for use in clinical diagnostic laboratories of healthcare institutions are evaluated in expert laboratories accredited in accordance with the Order of the Ministry of Health of Russia dated 05.06.1996 N 233 ...
1.4.3. Ensuring the quality of research at the level of an individual healthcare institution consists in the development and implementation of measures by the staff of clinical departments to prevent the negative impact on the quality of laboratory test results of the factors of the preanalytical stage (diagnostic and treatment procedures that interfere with the correct reflection in the results of studies of the state of the internal environment of the examined patients, violation of the rules taking, labeling, primary processing, storage conditions and transportation to the laboratory of biomaterial samples taken from patients) and the post-analytical stage (inadequate interpretation of the research results). The development and implementation of quality assurance measures for clinical laboratory research at the level of an individual health care institution is the responsibility of the head of that institution.
1.4.4. Ensuring the quality of clinical laboratory studies at the level of a clinical diagnostic laboratory consists in the development and implementation of measures to prevent the negative influence of preanalytical factors (violation of the rules for labeling, storage, primary processing), analytical (violation of the rules for conducting an analytical procedure, errors in the calibration of the method and setting the measuring device, the acquisition and use of reagents and other consumables that are not approved for use) and post-analytical (assessment of the plausibility and reliability of the research results, their preliminary interpretation) stages that can interfere with obtaining a reliable laboratory test result. The development and implementation of measures to ensure the quality of clinical laboratory research at the level of the clinical diagnostic laboratory and their reflection in the "Guidelines for the quality of clinical laboratory research" of this laboratory is the responsibility of the head of the laboratory.
1.5. Quality control of clinical laboratory studies consists in the development and implementation at the level of the healthcare system of Russia, at the level of the constituent entities of the Russian Federation and at the level of clinical diagnostic laboratories of a system of control measures for the detection and tracking of errors that may appear in the process of performing clinical laboratory studies of samples of biomaterials of patients and distort clinical and laboratory information about the state of the internal environment of the examined patients of healthcare institutions.
1.5 1. Quality control of clinical laboratory studies at the level of the healthcare system of Russia and at the level of the constituent entities of the Russian Federation (interlaboratory quality control) is carried out by the Federal System for External Quality Assessment (FSVOK) based on the processing of the results of clinical and diagnostic laboratories examinations of samples of control materials sent by the Center for External quality control of clinical laboratory research and its regional departments. The purpose of external assessment of the quality of research is to assess the degree of comparability of research results carried out in different health care institutions, and their compliance with the established standards of analytical accuracy. External assessment of the quality of clinical laboratory tests in clinical diagnostic laboratories of health care institutions is carried out in accordance with the regulatory documents of the Ministry of Health of Russia. Participation in FSVOK events is mandatory for laboratories of health care institutions of all forms of ownership and is taken into account during their accreditation and licensing. Along with this, laboratories are allowed to participate in other external quality assessment programs (international, commercial and regional), in particular, for indicators that are absent in the FSVOK.
1.5.2 Quality control of clinical laboratory studies at the level of the clinical diagnostic laboratory (intralaboratory quality control) consists in continuous (daily, in each analytical series) carrying out control measures: examining samples of control materials or applying control measures using patient samples. The purpose of internal laboratory quality control is to assess the compliance of research results with the established acceptance criteria with the maximum probability of detecting an unacceptable error and the minimum probability of false rejection of the results of analytical series performed by the laboratory. Internal laboratory quality control is mandatory for all types of research carried out in the laboratory. The procedure for carrying out internal laboratory quality control should be reflected in the "Guidelines for the quality of clinical laboratory research" of this laboratory. The organization of internal laboratory quality control of research in accordance with the regulatory documents of the Ministry of Health of Russia is the responsibility of the head of the laboratory and the laboratory staff authorized by him. The presence of a system of internal laboratory quality control is one of the grounds for accreditation and licensing of laboratories.
1.5.3 Regularly conducted external quality assessment and routine internal laboratory quality control complement but do not replace each other: external quality assessment is aimed primarily at identifying systematic errors in laboratory methods and ensuring the uniformity of measurements throughout the country, and internal laboratory quality control is intended to maintain stability of the analytical system, identification and elimination of unacceptable random and systematic errors.
1.6. Chief specialists in clinical laboratory diagnostics of health authorities at all levels should promote the implementation of measures to manage the quality of clinical laboratory research in health care institutions of all forms of ownership; support and organize educational activities aimed at introducing internal laboratory control and regular participation in external quality assessment in the daily work of laboratories.

2. Typical model of "Guidelines for the quality of research
in the clinical diagnostic laboratory ".

"Guidelines for the quality of research in the clinical diagnostic laboratory" (hereinafter referred to as the "Quality Guidelines") is a set of documents of the clinical diagnostic laboratory (CDL), which includes: regulatory documents of the Ministry of Health of Russia, territorial health authorities and the laboratory's own documents regulating its structure, equipment and activities and is a system for ensuring the quality of research carried out by the CDL. Each laboratory prepares its own "Quality Manual" based on this generic model, taking into account its specific features.
Laboratory activities should be carried out in strict accordance with the requirements, procedures and regulations set out in the "Quality Manual". Any changes to the quality assurance system for laboratory analysis should be immediately documented. The laboratory manager is responsible for compliance with the rules and requirements of the Quality Manual. The document must be available to all laboratory staff. The "Quality Manual" is the main document required for the accreditation of CDLs of any profile and subordination, therefore, among other provisions, it includes the Laboratory Passport, provided for by the CDL accreditation procedure, carried out in accordance with the order of the Ministry of Health of Russia dated December 21, 1993 N 295. List of documents referred to in the "Quality Manual" should be changed in accordance with the cancellation of old and the approval of new ones. The main regulatory documents of the Ministry of Health of Russia governing the activities of the CDL (June 1999) are given in section 2.4. of this document. In the text of the Quality Manual, references to the relevant documents are provided for each section.

2.1. a common part
The documents included in the general part of the "Quality Manual" provide information on the organizational structure of the CDL, staffing and conditions of its activities.
2.1.1. Information data about the CDL (form N 1 to the Laboratory Passport):
- the name of the institution, which includes the CDL,
- Full name of the head of the medical and preventive institution and his phone number,
- name of the CDL,
- the legal address of the laboratory,
- Full name of the head of the KDL and his phone number,
- Full name of the official responsible for quality control in the KDL.
2.1.2. Information about the accreditation of the CDL and the results of inspection control.
The registration number, date of issue and validity of the certificate of accreditation of the KDL are given. The types of activities included in the scope of accreditation of the CDL are listed. The dates of signing the acts of inspection control and the content of the conclusions of the inspection control commissions for the period after the issuance of the current certificate of accreditation of the CDL are given.
2.1.3. Organizational structure of the laboratory.
This section provides a structural diagram of laboratory divisions with an indication of the types of research performed and their number (according to the report for the previous year in form N 30), including the centralized execution of research for other institutions.
2.1.4. Staffing of the KDL.
The section provides data on the laboratory personnel in form No. 3 to the Laboratory Passport: composition, qualifications, staffing (number of occupied positions, individuals). Attached are job descriptions for each employee, indicating the methods that he owns.
2.1.5. Operating conditions of the CDL - laboratory premises.
The authorization reports of the territorial bodies of the sanitary and epidemiological service, fire safety and safety inspection about the laboratory premises are given. The data on the main production facilities of the CDL in form No. 6 to the Laboratory Passport are indicated: the total area of ​​the laboratory with an indication of the premises for performing analyzes, storage of reagents and equipment, premises for the needs of personnel, the availability of heating, water supply, ventilation, sewerage and the degree of compliance with the current standards ( 10, 18).
2.1.6. Normative and technical documentation (NTD), regulating the activities of the CDL.
This section provides a list of regulatory documents available in the laboratory. NTDs include: orders of the Ministry of Health of Russia and territorial health authorities, industry standards, guidelines and instructions for the use of unified clinical laboratory research methods approved by the USSR Ministry of Health and the Ministry of Health of Russia, pharmacopoeial articles, passports, technical descriptions and instructions for the operation of devices and the use of kits reagents.

2.2. Quality assurance system for the activities of the CDL.
The quality assurance system of the CDL is built in accordance with the following documents regulating its equipment and activities.
2.2.1. The list of the studied indicators (form N 2 to the Laboratory Passport).
The section provides a complete list of the analyzed indicators with an indication of research methods, calibration materials.
2.2.2. Description of the preanalytical pre-laboratory stage of the analysis.
The section contains instructions approved by the chief physician of a medical and preventive institution and agreed with the head of the laboratory, containing the rules for preparing subjects and taking biological material in compliance with the rules of asepsis and antiseptics, methods and timing of its transportation, ensuring the safety of samples and epidemiological safety (14).
2.2.3. Regulatory and methodological support of preanalytical intralaboratory and analytical stages.
The section provides a description of all the research methods used by the laboratory: instructions for the use of reagent kits approved by the Ministry of Health of Russia for use in CDL, unified methods (approved by orders of the USSR Ministry of Health or the Ministry of Health of Russia) or non-standardized methods approved by the management of a medical and preventive institution. The description of the method (instructions) should indicate: the principle of the analytical method and the characteristic of its reliability, the method for preparing reagents, the time and temperature of storage of the biological material before the study, the specifics of preparing the sample for the study (time and speed of centrifugation, mixing of samples immediately before analysis, etc.). ), equipment, precautions for working with reagents, analyzed samples, ranges of normal values ​​of the determined indicator, procedure and duration of analysis, method of calculating research results, conditions and shelf life of reagents (reagent kits).
2.2.4. List of CDL equipment.
The section contains a list of the main and auxiliary equipment, indicating the factories and manufacturers, the time of manufacture and purchase according to Forms N 4 and N 5 to the Laboratory Passport. Attached is a log of metrological verification and service maintenance of devices, which indicates the timing of verification and repair. For each device, it is necessary to have operating instructions and safety instructions and a logbook for recording the operating time of the devices, certified by the signature of the head of the laboratory (13).
2.2.5. List of reagents used.
The list contains manufacturers, date of manufacture, purchase, expiration date, storage conditions of substances. For reagents manufactured in the laboratory, the dates of preparation, shelf life and the name of the person responsible for the preparation are indicated. Storage, accounting and use of reagents should be carried out in accordance with the regulatory documents of the Ministry of Health of Russia (10).
The list of reagents used must correspond to the current state, all new acquisitions are entered into it and records are made on the expenditure of previously purchased ones. All records are certified by the signature of the laboratory director or other responsible person.
2.2.6. Quality control of laboratory analysis results.
The section describes the internal and external quality control of laboratory analysis results in accordance with Form No. 7 of the Laboratory Passport and Appendix No. 3 to the Regulations on the Accreditation of Clinical Diagnostic Laboratories.
When characterizing the internal laboratory quality control, the following are indicated: the controlled indicators and the corresponding control materials, the frequency of control measurements, the presence of control charts. Data on intra-batch and inter-batch variation based on the results of examining the control material or patient samples and on the bias (systematic error) obtained in the analysis of certified control materials are indicated. It is noted that control procedures are carried out when introducing new techniques, when studying new components of biological fluids, when changing equipment or leaving it from repair.
The internal laboratory quality control system in the CDL should operate in accordance with the regulatory documents of the Ministry of Health of Russia (4), methodological recommendations (5) and the "Rules for conducting internal laboratory quality control of quantitative methods of clinical laboratory research".
Provides information on the laboratory's participation in the Federal System for External Quality Assessment (FSVOK) and the results of quality assessment. The list of controlled parameters and the number of cycles in which the laboratory took part, in accordance with Form No. 7 (column 5) to the Laboratory Passport, is indicated. If, in addition to FSVOK, the laboratory participates in other systems of external quality assessment (international, commercial), information on participation in these systems is also provided.
The activities of the CDL to participate in the external quality assessment of laboratory research results must comply with the regulatory documents of the Ministry of Health of Russia (6, 7, 8, 9).
2.2.7. Destruction of residues of biomaterials, reagents and consumables.
The section provides instructions containing a description of environmentally friendly methods for neutralizing and destroying residues of biological materials, reagents, consumables, which is signed by the chief physician of the medical and preventive institution and the head of the laboratory. The instruction must comply with the rules and requirements specified in the regulatory documents of the Ministry of Health of Russia (10, 19).
2.2.8. Post-analytical control.
The section provides the procedure for conducting post-analytical control of laboratory analysis results: viewing research results, assessing their analytical reliability according to the study of control materials, comparing the results obtained with reference values, assessing possible interference of medicinal substances, signing forms.

2.3. Accounting and reporting documentation.
Unified forms of accounting and reporting documentation must comply with the regulatory documents of the Ministry of Health of Russia (17).
2.3.1. The section provides forms for registering the results of laboratory research: computer or using registration journals. Responsible for the safety of the laboratory archive, confidentiality of information are indicated.
2.3.2. The forms for issuing the results of laboratory analysis (forms, e-mail), the procedure and time for issuing the results to patients and clinicians are indicated.
2.3.3. The forms of monthly, quarterly, annual reports on the results of laboratory research are given.

2.4. The list of the main departmental normative documents used in the development of the "Quality Manual" in the CDL.
1. Order of the Ministry of Health of Russia of 25.12.1997 N 380 "On the state and measures to improve laboratory support for diagnostics and treatment of patients in healthcare institutions of the Russian Federation."
2. Order of the Ministry of Health of Russia dated 12.21.1993 N 295 "On approval of the regulation on the accreditation of clinical diagnostic laboratories."
3. Order of the Ministry of Health of Russia dated 05.06.1996 N 233 "On the accreditation of clinical diagnostic laboratories as expert".
4. Order of the Ministry of Health of the USSR of 04/23/1985 N 545 "On the further improvement of quality control of clinical laboratory tests."
5. Methodical recommendations "Quality control of coagulological studies", approved by the Ministry of Health of Russia in 1993.
6. Order of the Ministry of Health of the USSR of 24.12.1990 N 505 "On further improvement and development of the system of interlaboratory quality control of clinical laboratory research."
7. Order of the Ministry of Health of Russia dated January 26, 1994 N 9 "On improving the work on external quality control of clinical laboratory research."
8. Order of the Ministry of Health and the Ministry of Health of the Russian Federation of 05/03/1995 N 117 "On the participation of clinical and diagnostic laboratories of medical and preventive institutions of Russia in the Federal system of external quality assessment of clinical laboratory research."
9. Order of the Ministry of Health and the Ministry of Health of the Russian Federation of 02.19.1996 N 60 "On measures to further improve the Federal system for external quality assessment of clinical laboratory research."
10. "Rules for the device, safety precautions and industrial sanitation in clinical diagnostic laboratories of medical and preventive institutions of the system of the Ministry of Health of the USSR", 1971
11. "Rules for the device, safety and industrial sanitation, anti-epidemic regime and personal hygiene when working in laboratories (departments, departments) of sanitary and epidemiological institutions of the system of the Ministry of Health of the USSR", 1981
12. "Regulations on the procedure for recording, storing, handling, dispensing and shipping cultures of bacteria, viruses, rickettsia, fungi, protozoa, mycoplasmas, bacterial toxins, poisons of biological origin", Ministry of Health of the USSR dated 05/18/1979.
13. "Safety rules for the operation of medical equipment in health care institutions", Ministry of Health of the USSR, 1985
14. "Instructions on measures to prevent the spread of infectious diseases when working in clinical diagnostic laboratories of medical and preventive institutions", approved on 17.01.1991 by the USSR Ministry of Health.
15. "Instruction on anti-epidemic regimen in AIDS diagnostic laboratories", N 42-28 / 39-90 of 05.06.1990
16. "Rules for operation and safety when working on autoclaves", from 30.03.1991
17. Order of the Ministry of Health of the USSR of 04.10.1980 N 1030 "On the approval of the forms of primary documentation of health care institutions."
18. Order of the Ministry of Health of Russia dated 04.29.1997 N 126 "On the organization of work on labor protection in management bodies, institutions, organizations and enterprises of the system of the Ministry of Health of the Russian Federation."
19. Sanitary rules and norms. 2.1.7.728-99. "Rules for the collection, storage and disposal of waste in medical and preventive institutions."

Question: In accordance with the Decree of the Government of the Russian Federation No. 584 of June 27, 2016, all state-owned enterprises must apply professional standards in terms of the requirements for the qualifications of an employee. In SE "Pharmacy" pharmaceutical workers (pharmacists, specialists in the management of pharmaceutical activities) comply with the requirements of professional standards - orders of the Ministry of Labor and Social Protection No. 428n of May 22, 2017 and No. 91n of March 9, 2016. How can a company carry out an independent assessment qualifications of compliance with professional standards for the specified positions. Are there qualification assessment centers? Can an enterprise independently assess the qualifications of compliance with professional standards for the specified positions?

The question is related to the topic:

Question: The pharmacy received from the wholesale warehouse the drug Chymotrypsin in the amount of 5 vials (factory packaging of 10 vials). Does the pharmacy have the right to take this drug without secondary (consumer) packaging? Does the wholesale warehouse have the right to violate the integrity of the secondary packaging, or does the pharmacy only have this right when dispensing to the buyer?

The question is related to the topic:

Question: Can a pharmacist (more than 6 years of experience in the position of head of a pharmacy) with a certificate "Economics and Management in Pharmacy" occupy the position of head of a pharmacy, as well as dispense drugs in the trading floor?

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• dated February 16, 2009 N 45n (with amendments and additions)
• Order of the RF Ministry of Health 07.02.2000 N 45 "On the system of measures to improve the quality of clinical laboratory tests in the Health Care of the Russian Federation" (with the "Regulations on the Organization QUALITY CONTROL OF CLINICAL LABORATORY Health Care," RULES OF QUANTITATIVE INTRA QUALITY CONTROL LABORATORY " , "TIME STANDARDS FOR ACCURACY OF CLINICAL LABORATORY STUDIES")
• ORDER of the Ministry of Health and Social Development of the Russian Federation of 16.02.2009 N 45n (as amended on 19.04.2010) “ON APPROVAL OF THE STANDARDS AND CONDITIONS OF FREE ISSUANCE TO WORKERS EMPLOYED IN WORK WITH HARMFUL WORKING CONDITIONS, MILK OR OTHER WALKERS THE COST OF MILK OR OTHER EQUAL VALUABLE FOOD PRODUCTS, AND THE LIST OF HARMFUL PRODUCTION FACTORS WHEN EXPOSED TO WHICH FOR PREVENTIVE PURPOSES, THE USE OF MILK OR OTHER FOOD PRODUCTS IS RECOMMENDED

Order of the Ministry of Health and Social Development of the Russian Federation of February 16, 2009 N 45n "On the approval of the norms and conditions for free distribution of milk or other equivalent food products, The procedure for the implementation of compensation payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which it is recommended to consume milk or other equivalent food products for preventive purposes "(with amendments and additions)

Order of the Ministry of Health and Social Development of the Russian Federation
dated February 16, 2009 N 45n
"On the approval of the norms and conditions for the free distribution of milk or other equivalent food products to workers employed in hazardous working conditions, the Procedure for the implementation of compensation payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which for prophylactic purposes, the use of milk or other equivalent food products is recommended "

With changes and additions from:

In accordance with clauses 5.2.75 and 5.2.77 of the Regulation on the Ministry of Health and Social Development of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 2004 N 321 (Collected Legislation of the Russian Federation, 2004, N 28, Art.2898; 2005 , N 2, Art. 162; 2006, N 19, Art. 2080; 2008, N 11, Art. 1036; 2008, N 15, Art. 1555; 2008, N 23, Art. 2713; N 42, Art. 4825 ; N 46, Art.5337; N 48, Art.5618; 2009, N 2, Art.244; N 3, Art.378; N 6, Art.738) I order:

1. Norms and conditions of free issuance of milk or other equivalent food products to workers employed in hazardous working conditions, which can be issued to workers instead of milk, in accordance with Appendix No. 1;

3. The list of harmful production factors, under the influence of which, for preventive purposes, it is recommended to use milk or other equivalent food products, in accordance with Appendix No. 3.

Registration N 13795

New norms have been approved for the free distribution of milk or other equivalent food products to workers employed in hazardous working conditions.

The free milk dispensing rate is still 0.5 liters per shift, regardless of the length of the shift. The milk dispensed must comply with the requirements of the Technical Regulations for milk and dairy products. Workers who come into contact with inorganic compounds of non-ferrous metals (formerly lead), in addition to milk, will be given 2 g of pectin in food (drinks, jelly, jams, etc.). In case of constant contact with inorganic compounds of non-ferrous metals, fermented milk products or products for dietary (therapeutic and prophylactic) nutrition under harmful working conditions are relied on instead of milk.

The list of equivalent products that can be dispensed instead of milk has been reduced. It includes fermented milk liquid products, cottage cheese, cheese, products for dietary (therapeutic and prophylactic) nutrition under harmful working conditions. Previously, the list also included beef, fish low-fat varieties, eggs, condensed milk. It is not allowed to replace milk with sour cream, butter, other products (except for equivalent ones). To replace milk with such products, the consent of the employee must be obtained and the opinion of the trade union must be taken into account.

From now on, the dispensing of milk or other equivalent products can be replaced at the request of workers by a compensation payment in an amount equivalent to the cost of milk or other equivalent food products, if this is provided for by the collective and (or) labor agreement. The rules for calculating the amount of this payment, its frequency (at least once a month) and the indexation procedure have been established.

A list of harmful production factors, under the influence of which, for prophylactic purposes, the use of milk or other equivalent food products is recommended. This list includes chemical, biological and physical factors.

Order of the Ministry of Health and Social Development of the Russian Federation of February 16, 2009 N 45n "On the approval of the norms and conditions for the free distribution of milk or other equivalent food products to workers employed in hazardous working conditions, the Procedure for the implementation of compensation payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which the use of milk or other equivalent food products is recommended for prophylactic purposes "

This order comes into force 10 days after the day of its official publication.

This document is amended by the following documents:

The changes take effect 10 days after the day of the official publication of the said order.

Order of the Ministry of Health of the Russian Federation of February 7, 2000 N 45 "On the system of measures to improve the quality of clinical laboratory research in healthcare institutions of the Russian Federation"

Order of the Ministry of Health of the Russian Federation of February 7, 2000 N 45
"On the system of measures to improve the quality of clinical laboratory research in healthcare institutions of the Russian Federation"

In order to increase the analytical reliability of the results of clinical laboratory tests performed in healthcare institutions of the Russian Federation, to improve the activities of clinical diagnostic laboratories for internal laboratory quality control, I order:

1.1. Regulation on the organization of quality management of clinical laboratory research in health care institutions (Appendix 1).

1.2. Rules for internal laboratory quality control of quantitative laboratory tests (Appendix 2).

1.3. Time limits for the accuracy of clinical laboratory studies (Appendix 3).

2. Before January 1, 2001, the heads of the healthcare authorities of the constituent entities of the Russian Federation take measures to ensure the development in each clinical diagnostic laboratory of healthcare institutions "Guidelines for the quality of clinical laboratory research" in accordance with the standard model (Appendix 1, Section 2) for the entire list research carried out in this laboratory.

3. The Department of Educational Medical Institutions and Personnel Policy (Volodin N.N.) to provide for the inclusion in the programs of cycles at the departments of laboratory diagnostics of educational institutions of postgraduate training the study of regulatory documents on quality control of laboratory research in accordance with Appendices 1 - 3.

4. Department of the organization of medical care to the population (Karpeev A.A.):

4.1. To summarize, during 2001, the results of the implementation of the "Temporary Accuracy Standards for Clinical Laboratory Research" in the country's clinical diagnostic laboratories with the aim of further developing the "Accuracy Standard for Clinical Laboratory Research".

4.2. To provide in 2000-2002 the development of normative documents on the internal laboratory quality control of non-quantitative laboratory tests.

4.3. Bring the accuracy standards of laboratory tests used in the Federal System for External Quality Assessment of Clinical Laboratory Research in accordance with Appendix 3.

5. Control over the implementation of this order shall be entrusted to the First Deputy Minister AI Vyalkov.

Regulations

Federal Agency for Technical Regulation and Metrology GOST R 53133.1-2008 “Technologies are laboratory clinical. Quality control of clinical laboratory tests. Part 1. Limits of permissible errors. "

Federal Agency for Technical Regulation and Metrology GOST R 53133.2-2008 “Technologies are laboratory clinical. Quality control of clinical laboratory tests. Part 2. Rules for conducting internal laboratory quality control of quantitative methods of clinical laboratory research using control materials. "

Federal Agency for Technical Regulation and Metrology GOST R 53133.3-2008 “Technologies are laboratory clinical. Quality control of clinical laboratory tests. Part 3. Description of materials for quality control of clinical laboratory research. "

Federal Agency for Technical Regulation and Metrology GOST R 53133.4-2008 “Technologies are laboratory clinical. Quality control of clinical laboratory tests. Part 4. Rules for conducting a clinical audit of the effectiveness of laboratory support for the activities of medical organizations. "

Ministry of Health of the Russian Federation Order of May 26, 2003. No. 220 "Rules for conducting internal laboratory quality control of quantitative methods of clinical laboratory research."

Ministry of Health of the Russian Federation Order of 07.02.2000. No. 45 "On the system of measures to improve the quality of clinical laboratory research in healthcare institutions of the Russian Federation."

Ministry of Health of the Russian Federation Order of 30.03.2006. No. 224 " On the approval of the Regulations on the organization of medical examination of pregnant women and parturient women. "

Ministry of Health of the Russian Federation Order of February 10, 2003 N 50 "On the improvement of obstetric and gynecological care in outpatient clinics."

On the approval of the professional standard "Worker for quality management of production assets of hydropower facilities (hydroelectric power plants / pumped storage power plants)"

Free delivery of milk or other equivalent food products is made to employees on the days of actual employment at work with harmful working conditions due to the presence of harmful production factors at the workplace provided for by the List of harmful production factors, under the influence of which it is recommended to consume milk or other equivalent food products for preventive purposes , and the levels of which exceed the established standards.

Order of the Ministry of Health and Social Development of the Russian Federation
dated February 16, 2009 No. 45n
"On the approval of the norms and conditions for the free distribution of milk or other equivalent food products to workers employed in hazardous working conditions, the Procedure for the implementation of compensation payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which for prophylactic purposes, the use of milk or other equivalent food products is recommended "

with changes and additions, incorporated into the text,

In accordance with clauses 5.2.75 and 5.2.77 of the Regulation on the Ministry of Health and Social Development of the Russian Federation, approved by Decree of the Government of the Russian Federation No. 321 dated June 30, 2004 (Collected Legislation of the Russian Federation, 2004, No. 28, Art. 2898; 2005 , No. 2, Art. 162; 2006, No. 19, Art. 2080; 2008, No. 11, Art. 1036; 2008, No. 15, Art. 1555; 2008, No. 23, Art. 2713; No. 42, Art. 4825 ; No. 46, Art. 5337; No. 48, Art. 5618; 2009, No. 2, Art. 244; No. 3, Art. 378; No. 6, Art. 738) I order:

1. Norms and conditions of free issuance of milk or other equivalent food products to workers employed in hazardous working conditions, which can be issued to workers instead of milk, in accordance with Appendix No. 1;

2. The procedure for making compensation payments in an amount equivalent to the cost of milk or other equivalent food products, in accordance with Appendix No. 2;

3. The list of harmful production factors, under the influence of which the use of milk or other equivalent food products is recommended for prophylactic purposes, in accordance with Appendix No. 3.

Appendix No. 1

to the order of the Ministry of Health and
social development of the Russian Federation
dated February 16, 2009 No. 45n

Norms and Conditions of Free Issuance of Milk or Other Equivalent Food Products to Employees Working in Hazardous Working Conditions, Which Can Be Issued to Employees instead of Milk

according to the order of the Ministry of Health and Social Development of the Russian Federation of 04/19/2010. No. 245n and

Order of the Ministry of Labor of Russia dated February 20, 2014 No. 103n)

1. In accordance with article 222 of the Labor Code of the Russian Federation (Collected Legislation of the Russian Federation, 2002, No. 1, Part I, Art. 3; 2006, No. 27, Art. 2878; 2007, No. 41, Art. 4844) at work employees with harmful working conditions are provided with milk * or other equivalent food products free of charge in accordance with the established norms.

* Hereinafter, the term "milk" means milk, drinking milk, defined by the Federal Law of June 12, 2008 No. 88-FZ "Technical Regulations for Milk and Dairy Products" (Collected Legislation of the Russian Federation, 2008, No. 24, Art. 2801).

2. Free delivery of milk or other equivalent food products is made to employees on the days of actual employment at work with harmful working conditions due to the presence of harmful production factors at the workplace provided for by the List of harmful production factors, under the influence of which, for preventive purposes, it is recommended to consume milk or other equivalent food products (hereinafter - the List), given in Appendix No. 3, and the levels of which exceed the established standards.

3. The dispensing and consumption of milk or other equivalent food products must be carried out in canteens, canteens or in rooms specially equipped in accordance with the established sanitary and hygienic requirements.

4. The free milk dispensing rate is 0.5 liters per shift, regardless of the duration of the shift. If the time of work in hazardous working conditions is less than the established duration of the work shift, milk is issued when work is performed under these conditions for at least half of the work shift.

5. Workers in contact with inorganic compounds of non-ferrous metals (except for compounds of aluminum, calcium and magnesium), in addition to milk, are given 2 g of pectin as part of food products enriched with it: drinks, jelly, jams, marmalades, fruit juice products and (or) vegetables and canned food (the actual pectin content is indicated by the manufacturer).

It is allowed to replace these products with natural fruit and (or) vegetable juices with pulp in the amount of 300 ml.

In case of constant contact with inorganic compounds of non-ferrous metals (except for compounds of aluminum, calcium and magnesium), instead of milk, fermented milk products or products for dietary (therapeutic and prophylactic) nutrition are issued under harmful working conditions.

The distribution of pectin-enriched food products, drinks, jellies, jams, marmalades, juice products from fruits and (or) vegetables and canned food should be organized before starting work, and fermented milk products - during the working day.

6. Workers involved in the production or processing of antibiotics instead of fresh milk fermented milk products enriched with probiotics (bifidobacteria, lactic acid bacteria), or colibacterin prepared on the basis of whole milk are dispensed.

7. It is not allowed to replace milk with sour cream, butter, other products (except for those of equal value provided for by the norms of free distribution of equivalent food products that can be issued to workers instead of milk), as well as the issuance of milk or other equivalent food products for one or several shifts in advance, equal as well as for the past shifts.

The norms for the free distribution of equivalent food products that can be issued to workers instead of milk are shown in Table 1.

8. Replacement of milk with equivalent food products is allowed with the consent of employees and taking into account the opinion of the primary trade union organization or other representative body of employees.

9. Replacing milk with products for dietary (therapeutic and prophylactic) nutrition under harmful working conditions is allowed only with a positive conclusion on their use by the federal executive body exercising control and supervision functions in the field of ensuring the sanitary and epidemiological well-being of the population, protecting consumer rights and consumer market.

10. The issuance of milk or other equivalent food products to employees according to the established norms may be replaced, upon written applications of the employees, by a compensation payment in an amount equivalent to the cost of milk or other equivalent food products, which is made in accordance with the Procedure for the implementation of compensation payments in an amount equivalent to the cost of milk or other equivalent food products listed in Appendix No. 2.

Substitution of compensation payments for milk or other equivalent products is allowed upon written applications from employees.

11. Employees who receive free medical and prophylactic nutrition due to particularly harmful working conditions are not provided with milk or other equivalent food products.

12. The employer is responsible for ensuring the free distribution of milk and equivalent food products to employees, as well as for compliance with these standards and the conditions for their issuance.

13. In case of ensuring safe (permissible) working conditions, confirmed by the results of a special assessment of working conditions, the employer decides to stop the free distribution of milk or other equivalent food products, taking into account the opinion of the primary trade union organization or other representative body of employees.

The grounds for the employer to make a decision to stop the free distribution of milk or other equivalent food products to employees are:

availability of the results of a special assessment of working conditions;

the consent of the primary trade union organization or other representative body of employees (if available to the employer) to stop the free distribution of milk or other equivalent food products to employees based on the results of a special assessment of working conditions at their workplaces.

If the employer does not have data on the results of a special assessment of working conditions or if he does not fulfill the above requirements, the procedure for the free distribution of milk or other equivalent food products, which was in force before the entry into force of this order, remains.

14. Other issues related to the free distribution of milk or other equivalent food products are resolved by the employer independently, taking into account the provisions of the collective agreement.

Norms of Free Issuance of Equivalent Food Products That May Be Issued to Workers in Place of Milk

Order of the RF Ministry of Health 07.02.2000 N 45 "On the system of measures to improve the quality of clinical laboratory tests in the Health Care of the Russian Federation" (with the "Regulations on the Organization QUALITY CONTROL OF CLINICAL LABORATORY Health Care," RULES OF QUANTITATIVE INTRA QUALITY CONTROL LABORATORY " , "TIME STANDARDS FOR ACCURACY OF CLINICAL LABORATORY STUDIES")

This control method does not provide for the mandatory construction of a control chart. As a rule, it is sufficient to calculate and estimate the cusum using a table.

The method out of control, revealed by the cusum method, is not a reason for stopping the analysis and re-examining patient samples. It serves only as a warning signal to draw attention to the presence of systematic errors in the analysis.

In some cases (if appropriate computer programs are available), it is recommended to start calculating the cumulative amount if

0.5S, which makes it possible to detect systematic errors of a smaller size than in the given example. In this case, the method is considered "out of control" when the cusum in absolute value exceeds 5.1S.

2.3. Quality control rules for quantitative laboratory analysis methods using patient samples.

These methods are used as additional methods of quality control of laboratory research results, and as independent methods - only in exceptional cases, for example, in the absence of control materials.

2.3.1. The method of checking the correctness by daily averages.

This method is used to control the correctness of laboratory analysis results and allows you to identify systematic errors not only at the analytical, but also at the preanalytical stage. The principle of the method consists in the daily calculation of the arithmetic average of all the results of determining this indicator, obtained in the laboratory per day.

Conditions required for the implementation of the method:

- the number of patient samples examined daily by the laboratory should be large enough (30 or more, the value of this number depends on the analyzed component);

- the contingent of patients examined by the laboratory should be sufficiently homogeneous (by pathology, gender, age),

- the number of averaged results should be approximately the same.

- For components with tightly controlled homeostatic mechanisms (potassium, sodium, chlorine, total protein), which change in a narrow range of values, the number of averaged results can be small, and for anabolic products (glucose, cholesterol) and even more so for substances secreted by cells organs (enzymes), and catabolic products (urea, uric acid, creatinine), their number should be greater.

2.3.2. Reproducibility control method for duplicates.

The principle of this method of intralaboratory quality control consists in conducting two parallel studies of the determined indicator in a randomly selected patient sample (duplicates), finding the value of the relative range (Ri) between the first value of the indicator (X2) and the second (X2) and comparing it with the established control limits.

- to determine the level of the determined indicator in the patient's sample selected at random twice during one analytical series;

ORDER of the Ministry of Health and Social Development of the Russian Federation of 16.02.2009 N 45n (as amended on 19.04.2010) “ON APPROVAL OF THE STANDARDS AND CONDITIONS OF FREE ISSUANCE TO WORKERS EMPLOYED IN WORK WITH HARMFUL WORKING CONDITIONS, MILK OR OTHER WALKERS THE COST OF MILK OR OTHER EQUAL VALUABLE FOOD PRODUCTS, AND THE LIST OF HARMFUL PRODUCTION FACTORS WHEN EXPOSED TO WHICH FOR PREVENTIVE PURPOSES, THE USE OF MILK OR OTHER FOOD PRODUCTS IS RECOMMENDED

(as amended by the Order of the Ministry of Health and Social Development of the Russian Federation of 19.04.2010 N 245n)

In accordance with clauses 5.2.75 and 5.2.77 of the Regulation on the Ministry of Health and Social Development of the Russian Federation, approved by Decree of the Government of the Russian Federation of June 30, 2004 N 321 (Collected Legislation of the Russian Federation, 2004, N 28, Art.2898; 2005 , N 2, Art. 162; 2006, N 19, Art. 2080; 2008, N 11, Art. 1036; 2008, N 15, Art. 1555; 2008, N 23, Art. 2713; N 42, Art. 4825 ; No 46, Art.5337; No 48, Art 5618; 2009, No 2, Art 244; No 3, Art 378; No 6, Art 738), I order:

2. The procedure for making compensation payments in an amount equivalent to the cost of milk or other equivalent food products, in accordance with Appendix No. 2;

Appendix N 1
to the Order of the Ministry
health and social
development of the Russian Federation
dated February 16, 2009 N 45n

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Order of the Ministry of Health and Social Development of the Russian Federation of February 16, 2009 N 45n "On the approval of the norms and conditions for the free distribution of milk or other equivalent food products to workers employed in hazardous working conditions, the Procedure for the implementation of compensation payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which the use of milk or other equivalent food products is recommended for prophylactic purposes "(with amendments and additions)

Appendix N 1. Norms and conditions of free distribution of milk or other equivalent food products to workers employed in hazardous working conditions, which can be given to workers instead of milk Appendix N 2. Procedure for compensation payments in an amount equivalent to the cost of milk or other equivalent food products Appendix N 3. The list of harmful production factors, under the influence of which, for prophylactic purposes, it is recommended to use milk or other equivalent food products

Order of the Ministry of Health and Social Development of the Russian Federation
dated February 16, 2009 N 45n
"On the approval of the norms and conditions for the free distribution of milk or other equivalent food products to workers employed in hazardous working conditions, the Procedure for the implementation of compensation payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which for prophylactic purposes, the use of milk or other equivalent food products is recommended "

With changes and additions from:

2. The procedure for making compensation payments in an amount equivalent to the cost of milk or other equivalent food products, in accordance with Appendix No. 2;

3. The list of harmful production factors, under the influence of which, for preventive purposes, it is recommended to use milk or other equivalent food products, in accordance with Appendix No. 3.

Registration N 13795

New norms have been approved for the free distribution of milk or other equivalent food products to workers employed in hazardous working conditions.

The free milk dispensing rate is still 0.5 liters per shift, regardless of the length of the shift. The milk dispensed must comply with the requirements of the Technical Regulations for milk and dairy products. Workers who come into contact with inorganic compounds of non-ferrous metals (formerly lead), in addition to milk, will be given 2 g of pectin in food (drinks, jelly, jams, etc.). In case of constant contact with inorganic compounds of non-ferrous metals, fermented milk products or products for dietary (therapeutic and prophylactic) nutrition under harmful working conditions are relied on instead of milk.

The list of equivalent products that can be dispensed instead of milk has been reduced. It includes fermented milk liquid products, cottage cheese, cheese, products for dietary (therapeutic and prophylactic) nutrition under harmful working conditions. Previously, the list also included beef, low-fat fish, eggs, condensed milk. It is not allowed to replace milk with sour cream, butter, or other products (except for those of equal value). To replace milk with such products, the consent of the employee must be obtained and the opinion of the trade union must be taken into account.

From now on, the dispensing of milk or other equivalent products can be replaced at the request of workers by a compensation payment in an amount equivalent to the cost of milk or other equivalent food products, if this is provided for by the collective and (or) labor agreement. The rules for calculating the amount of this payment, its frequency (at least once a month) and the indexation procedure have been established.

A list of harmful production factors, under the influence of which, for prophylactic purposes, the use of milk or other equivalent food products is recommended. This list includes chemical, biological and physical factors.

QUALITY CONTROL OF LABORATORY STUDIES

Quality control of laboratory tests in the CDL is carried out in accordance with the order of the Ministry of Health of the Russian Federation No. 45 of February 7, 2000 "On the system of measures to improve the quality of clinical laboratory research in healthcare institutions of the Russian Federation." The quality of laboratory tests must meet the requirements for analytical accuracy established by the Ministry of Health of the Russian Federation and performing the function of industry standards.

A number of concepts are used to assess the quality of research.

Accuracy of measurements - the quality of measurements, reflecting the proximity of their results to the true value of the measured quantity.

Measurement error – deviation of the measurement result from the true value of the measured value.

Systematic measurement error – the part of the measurement error that remains constant or regularly changes with repeated measurements of the same measured value.

Random measurement error - part of the measurement error that changes randomly when repeated measurements of the same measured value.

Correctness of measurements - the quality of measurements, reflecting the proximity to zero of systematic errors.

Analytical series - a set of measurements of a laboratory indicator performed simultaneously under the same conditions without reconfiguring and calibrating the analytical system.

Intra-batch reproducibility (convergence) of measurements - the quality of measurements, reflecting the proximity to each other of the results of measurements of the same material, performed in the same analytical series.

Inter-batch reproducibility is the quality of measurements that reflects the closeness to each other of measurements of the same material performed in different analytical series.

Overall reproducibility - the quality of measurements, reflecting the closeness to each other of all measurements of the same material (determined by intra-batch and inter-batch reproducibility).

Set value - method-dependent value of the indicator being determined, indicated by the manufacturer of the control material in the passport (instructions). Due to the fact that the true value of the measured value cannot be established with absolute certainty, in practice the term “set value” is used instead of the term “true value”.

Quality assurance of laboratory research in CDL is carried out by a system of internal laboratory quality control, in which the reproducibility and accuracy of research are systematically determined.

The systematic measurement error characterizes right measurements, which is determined by the degree of coincidence of the average result of repeated measurements of the control material () and the set value of the measured quantity. The difference between them is called the magnitude of the systematic error or bias, shift and can be expressed in absolute and relative values. The systematic error, expressed in relative values, or the relative systematic error, is calculated as a percentage using the formula 1:

B = (1), where

- the average value of measurements of the controlled material;

Set value.

The random error reflects the scatter of measurements and manifests itself in the difference between the results of repeated measurements of the determined indicator in the same sample. The mathematical value of the random error is expressed by the standard deviation (S) and the coefficient of variation (CV).