45 order on quality control of laboratory research. With changes and additions from. Regulations on the organization of quality management of clinical laboratory research in healthcare institutions

Appendix 1. Regulations on the organization of quality management of clinical laboratory tests in healthcare institutions Appendix 2. Rules for intra-laboratory quality control of quantitative laboratory tests Appendix 3. Temporary standards for the accuracy of clinical laboratory tests

Order of the Ministry of Health of the Russian Federation dated 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 in intra-laboratory quality control, I order:

1.1. Regulations on the organization of quality management of clinical laboratory research in healthcare institutions (Appendix 1).

1.2. Rules for intra-laboratory quality control of quantitative laboratory studies (Appendix 2).

2. Heads of healthcare authorities of the constituent entities of the Russian Federation, before January 1, 2001, take measures to ensure the development in each clinical diagnostic laboratory of healthcare institutions of the “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.) should include 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 tests in accordance with Appendices 1 - 3.

4. Department for organizing medical care to the population (Karpeev A.A.):

4.1. To summarize during 2001 the results of the implementation in clinical diagnostic laboratories of the country of the “Temporary Standards for the Accuracy of Clinical Laboratory Tests” with a view to the subsequent development of a “Standard of Accuracy for Clinical Laboratory Tests.”

4.2. To ensure in 2000 - 2002 the development of regulatory documents on intra-laboratory quality control of non-quantitative laboratory research.

4.3. Bring the laboratory test accuracy standards used in the Federal System of External Quality Assessment of Clinical Laboratory Tests into compliance with Appendix 3.

5. Control over the implementation of this order is entrusted to the First Deputy Minister A.I. Vyalkov.

Table 1

Maximum permissible values ​​of bias (B) and coefficient of total analytical variation (CV), calculated from the results of 10 or 20 measurements of the determined indicator in the control material

table 2

Biologically based standards for analytical accuracy of clinical laboratory tests

• dated February 16, 2009 N 45n (with amendments and additions)
• ORDER OF THE MINISTRY OF HEALTH OF THE RF DATED 02/07/2000 N 45 “ON THE SYSTEM OF MEASURES TO IMPROVE THE QUALITY OF CLINICAL LABORATORY STUDIES IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION” (TOGETHER WITH THE “REGULATIONS ON THE ORGANIZATION OF QUALITY MANAGEMENT CLINICAL LABORATORY STUDIES IN HEALTHCARE INSTITUTIONS, “RULES OF IN-LABORATORY QUALITY CONTROL OF QUANTITATIVE LABORATORY STUDIES” , "TEMPORAL STANDARDS FOR ACCURACY OF CLINICAL LABORATORY STUDIES")
• ORDER of the Ministry of Health and Social Development of the Russian Federation dated 02/16/2009 N 45n (as amended on 04/19/2010) “ON APPROVAL OF THE STANDARDS AND CONDITIONS OF FREE ISSUANCE TO WORKERS WORKING IN WORK WITH HARMFUL WORKING CONDITIONS, MILK OR OTHER EQUIVALUE P FOOD PRODUCTS, PROCEDURE FOR IMPLEMENTING COMPENSATION PAYMENT IN AN AMOUNT EQUIVALENT THE COST OF MILK OR OTHER EQUILIBLE FOOD PRODUCTS, AND THE LIST OF HARMFUL PRODUCTION FACTORS UNDER WHICH THE CONSUMPTION OF MILK OR OTHER EQUILIBLE FOOD PRODUCTS IS RECOMMENDED FOR PREVENTIVE PURPOSES"

Order of the Ministry of Health and Social Development of the Russian Federation dated February 16, 2009 N 45n “On approval of the norms and conditions for the free issuance of milk or other equivalent food products to employees engaged in work with hazardous working conditions, the Procedure for making 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 approval of the norms and conditions for the free issuance of milk or other equivalent food products to employees engaged in work with hazardous working conditions, the Procedure for making 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 preventive purposes, it is recommended to consume milk or other equivalent food products."

With changes and additions from:

In accordance with paragraphs 5.2.75 and 5.2.77 of the Regulations 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 for the free provision to employees engaged in work with hazardous working conditions, milk or other equivalent food products that can be issued to employees instead of milk, in accordance with Appendix No. 1;

3. List of harmful production factors, under the influence of which, for preventive purposes, it is recommended to consume milk or other equivalent food products, according to Appendix No. 3.

Registration No. 13795

New standards have been approved for the free distribution of milk or other equivalent food products to employees engaged in work with hazardous working conditions.

The rate of free milk is still 0.5 liters per shift, regardless of the length of the shift. The milk supplied 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) will be given 2 g of pectin in food products (drinks, jellies, jams, etc.) in addition to milk. With constant contact with inorganic compounds of non-ferrous metals, instead of milk, fermented milk products or products for dietary (therapeutic and preventive) nutrition under hazardous working conditions are used.

The list of equivalent products that can be issued instead of milk has been reduced. It includes fermented milk products, cottage cheese, cheese, products for dietary (therapeutic and preventive) nutrition under hazardous working conditions. Previously, the list also included beef, low-fat fish, eggs, and condensed milk. It is not allowed to replace milk with sour cream, butter, or other products (except equivalent ones). To replace milk with such products, it is necessary to obtain the consent of the employee and take into account the opinion of the trade union.

Now, the provision of milk or other equivalent products can be replaced, at the request of employees, with a compensation payment in an amount equivalent to the cost of milk or other equivalent food products, if this is provided for in the collective and (or) labor agreement. Rules have been established for calculating the amount of this payment, its frequency (at least once a month) and the indexation procedure.

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

Order of the Ministry of Health and Social Development of the Russian Federation dated February 16, 2009 N 45n “On approval of the norms and conditions for the free issuance of milk or other equivalent food products to employees engaged in work with hazardous working conditions, the Procedure for making 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"

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

This document is amended by the following documents:

The changes come into force 10 days after the official publication of the said order.

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

Order of the Ministry of Health of the Russian Federation dated 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 in intra-laboratory quality control, I order:

1.1. Regulations on the organization of quality management of clinical laboratory research in healthcare institutions (Appendix 1).

1.2. Rules for intra-laboratory quality control of quantitative laboratory studies (Appendix 2).

1.3. Temporary standards for the accuracy of clinical laboratory tests (Appendix 3).

2. Heads of healthcare authorities of the constituent entities of the Russian Federation, before January 1, 2001, take measures to ensure the development in each clinical diagnostic laboratory of healthcare institutions of the “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 (N.N. Volodin) should include 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 tests in accordance with Appendices 1 - 3.

4. Department for organizing medical care to the population (Karpeev A.A.):

4.1. To summarize during 2001 the results of the implementation in clinical diagnostic laboratories of the country of the “Temporary Standards for the Accuracy of Clinical Laboratory Tests” with a view to the subsequent development of a “Standard of Accuracy for Clinical Laboratory Tests.”

4.2. To ensure in 2000-2002 the development of regulatory documents on intra-laboratory quality control of non-quantitative laboratory research.

4.3. Bring the laboratory test accuracy standards used in the Federal System of External Quality Assessment of Clinical Laboratory Tests into compliance with Appendix 3.

5. Control over the implementation of this order is entrusted to the First Deputy Minister A.I. Vyalkov.

Regulations

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

Federal Agency for Technical Regulation and Metrology GOST R 53133.2-2008 “Laboratory and clinical technologies. Quality control of clinical laboratory tests. Part 2. Rules for conducting intra-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 “Laboratory and clinical technologies. 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 “Laboratory and clinical technologies. 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 dated May 26, 2003 No. 220 “Rules for conducting intra-laboratory quality control of quantitative methods of clinical laboratory research.”

Ministry of Health of the Russian Federation Order dated 02/07/2000 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 dated March 30, 2006 No. 224 " On approval of the Regulations on the organization of medical examination of pregnant women and postpartum women.”

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

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

Free distribution of milk or other equivalent food products is provided to employees on days of actual employment in jobs with hazardous working conditions due to the presence in the workplace of harmful production factors provided for in 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 whose levels exceed established standards.

Order of the Ministry of Health and Social Development of the Russian Federation
dated February 16, 2009 No. 45n
“On approval of the norms and conditions for the free issuance of milk or other equivalent food products to employees engaged in work with hazardous working conditions, the Procedure for making 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 preventive purposes, it is recommended to consume milk or other equivalent food products."

with changes and additions, included in the text,

In accordance with paragraphs 5.2.75 and 5.2.77 of the Regulations 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 No. 321 (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 for the free provision to employees engaged in work with hazardous working conditions, milk or other equivalent food products that can be issued to employees 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. List of harmful production factors, under the influence of which, for preventive purposes, it is recommended to consume milk or other equivalent food products, according to 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 for the free provision to employees engaged in work with hazardous working conditions of milk or other equivalent food products that can be issued to employees instead of milk

according to the order of the Ministry of Health and Social Development of the Russian Federation dated April 19, 2010. city ​​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 (Collection of Legislation of the Russian Federation, 2002, No. 1, Part I, Art. 3; 2006, No. 27, Art. 2878; 2007, No. 41, Art. 4844) at work workers with hazardous working conditions are given milk* or other equivalent food products free of charge according to established standards.

* Further in the text, the term “milk” refers to milk, drinking milk, as 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 distribution of milk or other equivalent food products is carried out to employees on days of actual employment in jobs with hazardous working conditions due to the presence in the workplace of harmful production factors provided for in 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. food products (hereinafter referred to as the List) given in Appendix No. 3, and the levels of which exceed the established standards.

3. The distribution and consumption of milk or other equivalent food products must be carried out in buffets, canteens or in premises specially equipped in accordance with duly approved sanitary and hygienic requirements.

4. The rate of free milk distribution is 0.5 liters per shift, regardless of the duration of the shift. If the time spent working in hazardous working conditions is less than the established duration of a work shift, milk is provided when work is performed in the specified conditions for at least half of the work shift.

5. Workers who come into contact with inorganic compounds of non-ferrous metals (except for compounds of aluminum, calcium and magnesium) are given 2 g of pectin in addition to milk as part of food products enriched with it: drinks, jellies, 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 an amount of 300 ml.

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

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

6. Instead of fresh milk, workers involved in the production or processing of antibiotics are given fermented milk products enriched with probiotics (bifidobacteria, lactic acid bacteria), or colibacterin prepared from whole milk.

7. It is not allowed to replace milk with sour cream, butter, or other products (except for equivalent ones provided for by the standards for the free distribution of equivalent food products that can be issued to employees instead of milk), as well as the distribution of milk or other equivalent food products one or more shifts in advance, equally as for previous shifts.

The standards for the free issuance of equivalent food products that can be given to employees instead of milk are given in Table 1.

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

9. Replacing milk with products for dietary (therapeutic and preventive) nutrition under hazardous 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 established standards may be replaced, upon written statements from 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 making a compensation payment in an amount equivalent to the cost of milk or other equivalent food products given in Appendix No. 2.

It is allowed to replace the compensation payment with milk or other equivalent products upon written statements from employees.

11. Employees receiving free therapeutic and preventive nutrition due to particularly harmful working conditions are not given milk or other equivalent food products.

12. Responsibility for ensuring free provision of milk and equivalent food products to employees, as well as for compliance with these standards and conditions for their distribution rests with the employer.

13. If safe (acceptable) working conditions are ensured, confirmed by the results of a special assessment of working conditions, the employer makes a decision to terminate 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 workers.

The grounds for an employer to decide to stop providing free milk or other equivalent food products to employees are:

availability of results of a special assessment of working conditions;

consent of the primary trade union organization or other representative body of employees (if the employer has one) to terminate 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 fails to comply with the above requirements, the procedure for the free distribution of milk or other equivalent food products that was in force before this order came into force is retained.

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

Standards for the free issuance of equivalent food products that can be given to employees instead of milk

ORDER OF THE MINISTRY OF HEALTH OF THE RF DATED 02/07/2000 N 45 “ON THE SYSTEM OF MEASURES TO IMPROVE THE QUALITY OF CLINICAL LABORATORY STUDIES IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION” (TOGETHER WITH THE “REGULATIONS ON THE ORGANIZATION OF QUALITY MANAGEMENT CLINICAL LABORATORY STUDIES IN HEALTHCARE INSTITUTIONS, “RULES OF IN-LABORATORY QUALITY CONTROL OF QUANTITATIVE LABORATORY STUDIES” , "TEMPORAL STANDARDS FOR ACCURACY OF CLINICAL LABORATORY STUDIES")

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

A method out of control detected by the cusum method is not a reason to stop the analysis and retest 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 identify systematic errors of a smaller size than in the example given. In this case, the method is considered “out of control” when cusum in absolute value exceeds 5.1S.

2.3. Rules for quality control of quantitative methods of laboratory analysis 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. Method for checking accuracy using daily averages.

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

Conditions required to implement the method:

— the number of patient samples examined daily by the laboratory must be quite large (30 or more, the value of this number depends on the component being analyzed);

— the population of patients examined by the laboratory should be fairly 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 proteins), 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. Method for monitoring reproducibility using duplicates.

The principle of this method of intra-laboratory quality control is to conduct two parallel studies of the determined indicator in a randomly selected patient sample (duplicates), find the value of the relative range (Ri) between the first value of the indicator (X2) and the second (X2) and compare it with established control limits.

— determine the level of the determined indicator in a randomly selected patient sample twice during one analytical series;

ORDER of the Ministry of Health and Social Development of the Russian Federation dated 02/16/2009 N 45n (as amended on 04/19/2010) “ON APPROVAL OF THE STANDARDS AND CONDITIONS OF FREE ISSUANCE TO WORKERS WORKING IN WORK WITH HARMFUL WORKING CONDITIONS, MILK OR OTHER EQUIVALUE P FOOD PRODUCTS, PROCEDURE FOR IMPLEMENTING COMPENSATION PAYMENT IN AN AMOUNT EQUIVALENT THE COST OF MILK OR OTHER EQUILIBLE FOOD PRODUCTS, AND THE LIST OF HARMFUL PRODUCTION FACTORS UNDER WHICH THE CONSUMPTION OF MILK OR OTHER EQUILIBLE FOOD PRODUCTS IS RECOMMENDED FOR PREVENTIVE PURPOSES"

(as amended by Order of the Ministry of Health and Social Development of the Russian Federation dated April 19, 2010 N 245n)

In accordance with paragraphs 5.2.75 and 5.2.77 of the Regulations 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:

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 No. 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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QUALITY CONTROL OF LABORATORY RESEARCH

Quality control of laboratory tests in the clinical laboratory is carried out in accordance with the order of the Ministry of Health of the Russian Federation No. 45 dated February 7, 2000 “On the system of measures to improve the quality of clinical laboratory tests 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 serving as industry standards.

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

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

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

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

Random measurement error - part of the measurement error that changes randomly with repeated measurements of the same measured quantity.

Correct measurements - quality of measurements, reflecting closeness to zero 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 closeness to each other of the results of measurements of the same material, performed in the same analytical series.

Inter-run reproducibility is the quality of measurements, reflecting the closeness to each other of the results of measurements of the same material carried out in different analytical series.

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

Set value – method-dependent value of the determined indicator, 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 absolutely accurately, in practice, instead of the term “true value”, the term “established value” is used.

Ensuring the quality of laboratory research in KDL is carried out by a system of in-laboratory quality control, in which the reproducibility and accuracy of research is 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 established value of the measured value. The difference between them is called the magnitude of the systematic error or displacement, shift and can be expressed in absolute and relative values. Systematic error, expressed in relative values, or relative systematic error, is calculated as a percentage using formula 1:

B = (1), where

– average value of measurements of the controlled material;

Set value.

Random error reflects the scatter of measurements and is manifested 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).

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 objectives of the CDL are to conduct 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 Russian Ministry of Health, which is a prerequisite for reliable analytical work of CDL. An important element of quality assurance is in-laboratory quality control, which consists of constant (routine in each analytical series) control activities: examination of samples of control materials or application of control measures using patient samples. The purpose of intra-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.

Intralaboratory quality control is mandatory for all types of research performed in the laboratory. The rules for intra-laboratory quality control of quantitative studies are contained in Order No. 45 of the Ministry of Health of the Russian Federation dated 02/07/2000 “On the system of measures to improve the quality of clinical laboratory tests in healthcare institutions of the Russian Federation.” When conducting quality control of laboratory tests, the following terms are used:
Measurement accuracy is the quality of measurements, reflecting the closeness 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 is the deviation of the measurement result from the true value of the measured value.
Systematic measurement error is a component of measurement error that remains constant or changes naturally with repeated measurements of the same quantity.
The accuracy of measurements is the quality of measurements, reflecting the closeness to zero of systematic errors in their results.
Random measurement error is a component of measurement error that changes randomly with repeated measurements of the same quantity.
An analytical series is a set of measurements of a laboratory indicator performed simultaneously under 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 the measurement results performed in the same analytical series.
Inter-run reproducibility is the quality of measurements, reflecting the closeness to each other of the measurement results performed in different analytical series.
Overall reproducibility is the quality of measurements, reflecting the closeness to each other of the results of all measurements.
Established value is a method-dependent value of the indicator being determined, indicated by the manufacturer of the control material in the passport or instructions.
The sources of errors detected by the internal laboratory quality control system can be internal (laboratory) and external factors. External factors include the principle of the analytical method, the quality of instruments and reagents, and calibration tools. Internal - non-compliance with 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 identified through repeated examination of the control material in analytical series. Systematic error characterizes the accuracy of measurements, which is determined by the degree of agreement between the average result of repeated measurements of the control material (X) and the established value of the measured value. The difference between them is called the offset 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 measurement value of the control material, Y3 is the set value.

Random error reflects the scatter of measurements and is manifested 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).

Intralaboratory quality control includes control of reproducibility and accuracy (correctness) and can be carried out using methods that use special control materials or means of a number of methods that do not require control materials. Methods using control materials: control card method; Sizit method; Westgard control rules method. Methods using patient data:
Parallel sampling method.
Method of average normal values ​​(“average norm”).
Random sample study.
Repeated sample study.
Mixed sample study.

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

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

If non-certified material or drain serums 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 drawn about the possibility of using the method in question for laboratory diagnostic purposes and proceed to the construction of control charts. If one of the obtained B or CV values ​​exceeds the corresponding maximum permissible values, additional work is carried out to eliminate sources of increased bias or variation or a different method for determining this indicator is chosen.

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

Using the constructed control charts, operational (“current”) quality control of the results of determining the indicator under study 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 test results of control materials is carried out using Westgard control rules:
1 2S - if one of the results of the analysis of control materials goes beyond the limits (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 outside the limits (x±3S);
2 2S - the last two control measurements exceed the limit (x+2S) or are below the limit (X-2S);
R 4S - two control measurements in the analytical series under consideration are located on opposite sides of the x±2S corridor (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 indicate 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 most widely used for quality control in CDL. However, these methods do not detect the error as a whole.

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

Sequence of procedures:
Every day, from the results obtained during the day, the daily arithmetic average (x) is calculated, and this procedure is repeated for 20 days.
Even from 20 daily averages, the overall 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 constructing 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 point.

The control chart analysis is carried out according to Westgard rules.

Method for monitoring reproducibility using duplicates. The principle of this method of intra-laboratory quality control is to conduct two parallel studies of the determined indicator in a randomly selected patient sample, find the relative range (Ri, %) between the first value of the indicator (X 1) and the second (X 2) and compare it with established control values outside. Sequence of procedures:
determine the level of the determined indicator in a randomly selected patient sample twice during one analytical series;
calculate the relative range 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 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 R:

Next, control limits are calculated by multiplying the resulting R value by coefficients corresponding to the 95% and 99% quantiles of the range distribution: for the 95% control limit - 2.46; for the 99% control limit - 3.23. Based on the obtained control limits, a control chart is constructed, where a zero line is plotted on the abscissa axis (it will correspond to the zero range), on which the number of the analytical series is noted, and lines corresponding to R and the control limits 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. Next, in each analytical series, a parallel study of the determined indicator is carried out in a patient sample selected at random. Samples intended for parallel testing should be distributed randomly along the length of the analytical run. The resulting relative range value is compared with the control limits. If at least one obtained value is outside the control limit corresponding to 99% (control point “1 R99", or if two consecutive values ​​are outside the control limit “95%” (control point “2 R9S”), then such an analytical series is considered unsuitable, the study is repeated.

Mixed sample study. When assessing reproducibility using the parallel sampling method, closer values ​​are obtained than would normally be obtained in the presence of random errors. This is excluded in the mixed sample method. The method is as follows: two samples (A and B) are randomly selected from a group of samples; equal volumes are taken from each sample A and B and mixed (sample C); All three samples are examined, the theoretical content of the component in the sample C((A+B)/2) and the difference between the theoretical and studied content ((A+B)/2–C) are calculated. To construct a control chart using this method, the study should be carried out within 40 days. The mean deviation (d av.) for single analyzes is then calculated by adding all differences (omitting signs) and dividing by 40. A control chart is then prepared on which three straight lines are drawn: the 50% straight line is 0.845 dCP; 95% straight is 2.5 dCP; 99.5% direct is 3.5 dCP.

Subsequently, 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 95% and 99.5% lines, appropriate measures must be taken to identify possible sources of error.

Features of quality control of hematological studies

Due to the specific nature of hematological research, their quality control requires the presence of certain control tools and materials that are not used in other types of laboratory research. To control the quality of determination of hemoglobin content, standard solutions of hemiglobin cyanide with a known Hb content and special control solutions (donor blood, lysed blood and canned blood) are used. A standard solution of hemiglobin cyanide is used to monitor the correct operation of photometers and to construct a calibration curve in the hemiglobin cyanide method for determining Hb in the blood. To control the reproducibility of Hb determination, a solution of lysed blood (hemolysate) is used. To prepare hemolysates, use: canned human citrated blood, possibly expired; preserved horse blood; donor human blood, fresh, collected in a vessel with 0.6 mol/l sodium citrate solution at a ratio of 1:5.

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

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

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

To control the quality of blood cell counting, the following control materials are used: canned or stabilized blood; fixed blood cells (suspensions); control blood smears. Quality control of red blood cell determination is carried out according to the principle of indirect control using the control chart method. Over the course of 2 days, 20 determinations of the number of erythrocytes in preserved blood are carried out, control limits are calculated and a control chart is built. The coefficient of variation when counting red blood cells 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 capillary blood of donors and patients in the usual way. Then the control smears are repeatedly counted (at least 20 times) for 200 cells by qualified specialists (at least 5 people). From the data obtained, the criteria for determining the correctness of the smear count are statistically calculated by calculating X and S. 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 leukoformula count is considered correct if the cell count results are within the calculated control limits (X ± 2S) for each type of blood cell.

Quality control of blood tests

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

Control materials are used to test methods usually used in the laboratory for qualitative and quantitative studies of the chemical composition of urine. Aqueous solutions of substances with known contents are used to control the quality of studies of the chemical composition of urine (for example, a solution of glucose, acetone, albumin). To prepare aqueous solutions, use distilled water that complies with GOST 6709-72 and chemically pure and analytical grade reagents.

Aqueous solutions are stored in the 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. Add 2 g of EDTA to 1 liter of fresh human urine and add 5 ml of thymol solution while vigorously shaking and stirring the bottle. After 2 weeks, the urine is centrifuged to remove mucus and a small amount of uric acid. After this treatment, the urine becomes clear and almost odorless.

Control material is stored at room temperature. Shelf life - several years. The drained urine is used to monitor reproducibility.

To control the quality of diagnostic strips, control solutions that simulate urine are used. Method of preparation: add 5 ml of glucose (for intravenous injection), 2 ml of acetone (pure grade), 25 ml of drained human serum and 0.1 ml of lysed blood (to 0.1 ml) into a 500 ml volumetric flask with 200 ml of distilled water. whole blood add 01 ml of distilled water to lyse red blood cells). Mix thoroughly and adjust the volume to the mark with saline solution. Using 0.1 M HC1, the pH value is adjusted to 6.0. The control solution can be stored in the refrigerator for no more than one month.

Quality control of coagulological studies

Quality control of coagulation studies has its own characteristics, associated primarily with 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 end point of fibrin formation, as well as 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 precise levels of coagulation factors (normal and pathological).
Control plasma deficient in individual coagulation factors.
Control plasma to monitor the upper and lower limits of the therapeutic area when taking anticoagulants.

As the main control material, pooled, only citrated plasma with normal and prolonged clotting time is used. Method for Preparation of Confluent Plasma: Fresh plasma taken with 3.8% sodium citrate solution is collected from several donors, mixed and filled into vials. Freezes quickly. The main requirement for plasma is the absence of traces of hemolysis and red blood cells.

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 prolonged clotting time. Each sample and control plasma are examined in parallel. If the difference between parallels is more than 3 seconds, then the test must be repeated with a fresh sample from the patient.

Quality control of urine tests

The degree of accuracy of the obtained urine test results mainly depends on the qualifications of the laboratory assistant, the equipment used, reagents and the research method. To obtain correct and reproducible results from studying the chemical composition of urine, control materials are used that are close, if possible, to patient urine samples, and control smears are used to control the quality of microscopic examinations of urine sediment. The following are used as control materials for monitoring the chemical composition of urine: aqueous solutions of substances; drained urine with preservatives; artificial urine solutions with additives of substances tested in urine.

Control materials are used to test methods usually used in the laboratory for qualitative and quantitative studies of the chemical composition of urine. Aqueous solutions of substances with known contents are used to control the quality of studies of the chemical composition of urine (for example, a solution of glucose, acetone, albumin). To prepare aqueous solutions, use distilled water that complies with GOST 6709–72 and chemically pure and analytical grade reagents. Aqueous solutions are stored in the 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.

Add 2 g of EDTA to 1 liter of fresh human urine and add 5 ml of thymol solution while vigorously shaking and stirring the bottle. After 2 weeks, the urine is centrifuged to remove mucus and a small amount of uric acid. After this treatment, the urine becomes clear and almost odorless.

Control material is stored at room temperature. Shelf life - several years. The drained urine is used to monitor reproducibility. To control the quality of diagnostic strips, control solutions that simulate urine are used.

Method of preparation: add 5 ml of glucose (for IV injection), 2 ml of acetone (pure grade), 25 ml of drained human serum and 0.1 ml of lysed blood (to 0) into a 500 ml volumetric flask with 200 ml of distilled water. .1 ml of whole blood add 0.1 ml of distilled water to lyse red blood cells). Mix thoroughly and adjust the volume to the mark with saline solution. Using 0.1 M HCl, the pH value is adjusted to 6.0. The control solution can be stored in the refrigerator for no more than one month.

Assessing the quality of a laboratory assistant's work

Assessing the quality of the laboratory technician's work should be part of the laboratory's quality control program. The technique of laboratory technicians can be assessed using the following methods:
A method that uses the results of external quality assessment.
Random sampling method.
Sample dilution method.
Method of duplicating analyses.
A method that uses the results of in-laboratory quality control.

If a laboratory technician has performed 20 or more tests, then his work can be easily assessed if the true sample size is known. The standard deviation of a laboratory can be thought of as an estimate of each laboratory technician's ability to perform correct tests when calculating the average of all standard deviations for all tests. This average 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 gives a rough assessment of the analytical ability of each. First, the results of analyzes of control materials for a certain period of time are set aside, each test is identified with the name of the laboratory technician who performed it. After the expiration of the established period, evaluation 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 evaluation sheet. From these values, calculate the difference between the true value and that obtained by the laboratory assistant, and divide it by the standard deviation, for example: when examining blood hemoglobin, the laboratory assistant obtained a value of 163 g/l, X av.=162 g/l; S=2, so KS = (163-162)/2 = 0.5.

The lower the KS, the better the laboratory assistant's performance. This value can be used to rank laboratory assistants according to the quality of their 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 - very bad.

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

Automation of in-laboratory quality control

Conducting full intra-laboratory quality control for all studies performed at the KDL requires a significant investment of labor, time and money. Reducing these costs is only possible by automating quality control using a personal computer and software. It is also important that the results obtained using the program are highly reliable, since the number of errors made during manual control is reduced. The only routine work required of the CDL staff is to enter the measurement results of control material or patient samples into the program.

Monitoring the operation of devices, equipment and the quality of utensils

The wide range of laboratory tests currently used requires the use of a wide variety of technical means, and their list includes dozens of items. A set of organizational and technical measures that make it possible to control the technical and metrological characteristics of manufactured products is carried out on the basis of the Regulations 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 for verification of measuring instruments in the CDL are determined. Measuring instruments are verified by departmental metrological bodies in accordance with the instructions, which indicate the operations performed and verification means. 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 overall analysis error. The analysis error includes errors of the laboratory technician, sampling, dosing, and measurement.

Due to the fact that there are no CDL verification means available, some characteristics of photometric absorptiometers can be checked using control filters included with the device. Testing can also be carried out using specially prepared solutions - liquid indicators, which have constant spectral characteristics in a certain region of the spectrum. Liquid indicators can be prepared directly in the CDL and make it possible to check the accuracy of measurements in various regions of the spectrum (from 300 to 550 nm). The absorption peak of the filter should be close to the absorption peak of the liquid indicators. In addition, by preparing appropriate dilutions of these solutions, you can check the lipid content 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, and after reaching room temperature, bring the volume to the mark with distilled water. Store in a dark container. Dissolve ammonium cobalt sulfate in an amount of 14.481 g in 10 ml of concentrated sulfuric acid, transfer to a 100 ml volumetric flask, and bring the volume to the mark at room temperature with distilled water. 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, adjust the volume to the mark with 0.05 N KOH solution.

The general component of laboratory error includes dosing error. Therefore, a very special problem is checking the dosing and measuring equipment used for the accuracy of the readings. It is known from practice that about 30-40% of all measuring utensils are rejected due to their measurement volume error according to the following formula: ((initial volume - obtained volume) / original volume) x 100%.

The result, expressed in %, should not exceed: for 20 µl - 3%, for 100–200 µl - 1%, for 1,000–2,000 µl - 0.3%. Each laboratory requires good quality. Accuracy assessment is carried out on an analytical balance using a gravimetric method: the mass of water that makes up the volume of the dosing object is weighed repeatedly (at least 10 times) on an analytical balance. Having converted mass units into volume units, they expect to develop and implement a quality control program for the equipment used, which includes checking and recording the condition of refrigerators, water baths, thermostats, pipettes, timers, as well as quality control of distilled water (purity, pH value).

ABOUT THE SYSTEM OF MEASURES TO IMPROVE THE QUALITY OF CLINICAL LABORATORY RESEARCH IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION

REGULATIONS ON THE ORGANIZATION OF QUALITY MANAGEMENT OF CLINICAL LABORATORY RESEARCH IN HEALTHCARE INSTITUTIONS

1. System of quality management measures
clinical laboratory tests

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 and diagnostic laboratories of healthcare institutions (regardless of the form of ownership) to provide laboratory diagnostic information to the country's healthcare institutions. Implementation of a system of measures to manage the quality of clinical laboratory research is the basis for achieving and universally complying with the required level of quality of these studies
1.2. Quality management of clinical laboratory research consists of planning, ensuring and monitoring the quality of research.
1.3. Planning the quality of clinical laboratory research consists of determining standards of accuracy that are realistically feasible using the technical means, chemical and biological reagents and consumables available to laboratories with minimal expenditure of working time and laboratory materials, taking into account medically reasonable requirements.
1.3.1. Accuracy standards for various types of clinical laboratory tests are established by regulatory documents of the Russian Ministry of Health and serve as industry standards for the analytical accuracy of these studies. When developing accuracy standards, both information about intra- and inter-individual biological variation of the determined parameters of biological materials of healthy people and the resulting requirements for maximum permissible values ​​of analytical variation, as well as the technical capabilities of the equipment that clinical laboratories are equipped with, are taken into account. A revision of the standards for the accuracy of clinical laboratory tests should occur as the methodological and technical equipment of clinical and diagnostic laboratories improves.
1.3.2. Planning activities 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 studies performed in the laboratory is the responsibility of the head of the clinical and diagnostic laboratory. When performing laboratory tests outside the laboratory by non-laboratory personnel, planning the quality of the studies should be carried out by the head of the relevant clinical unit, private medical institution or family doctor with advisory and methodological assistance from the clinical diagnostic laboratory of this or a nearby medical institution.
1.3.3. An important element of quality assurance in clinical diagnostic laboratories is intralaboratory quality control. When planning and implementing intra-laboratory quality control, the provisions of the “Rules for In-Laboratory Quality Control of Quantitative Laboratory Research” are used. The accuracy of routine laboratory tests achieved by the laboratory should be reflected in the laboratory's Clinical Laboratory Test Quality Manual.
1.4. Ensuring the quality of clinical laboratory research consists of implementing measures that create the necessary conditions for obtaining laboratory information that adequately reflects the state of the internal environment of patients. Quality assurance measures are carried out:
— at the level of the Russian healthcare system,
- at the level of an individual healthcare institution,
- at the level of a separate clinical and diagnostic laboratory.
1.4.1. Ensuring the quality of clinical laboratory research at the level of the Russian healthcare system consists of examining the quality of instruments, reagents, standard samples (calibration and control materials), laboratory equipment and other equipment intended for use in clinical and diagnostic laboratories of 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 and diagnostic laboratories of healthcare institutions in Russia, mass-produced by Russian enterprises or supplied from abroad products. The activities of the commissions of the Russian Ministry of Health are regulated by the current legislation of the Russian Federation and regulatory documents of the Russian Ministry of Health.
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 assessed in expert laboratories accredited in accordance with Order of the Ministry of Health of Russia dated 06/05/1996 N 233 .
1.4.3. Ensuring the quality of research at the level of an individual healthcare institution consists of the development and implementation by staff of clinical departments of measures to prevent the negative impact on the quality of laboratory research results from factors of the preanalytical stage (diagnostic and treatment procedures that interfere with the correct reflection in the research results of the state of the internal environment of the patients being examined, violations of rules collection, labeling, primary processing, storage conditions and transportation to the laboratory of samples of biomaterials taken from patients) and the post-analytical stage (inadequate interpretation of research results). The development and implementation of measures to ensure the quality of clinical laboratory research at the level of an individual healthcare institution is the responsibility of the head of this institution.
1.4.4. Ensuring the quality of clinical laboratory research at the level of a clinical diagnostic laboratory consists of developing and implementing measures to prevent the negative influence of preanalytical factors (violation of the rules of labeling, storage, primary processing), analytical (violation of the rules of the analytical procedure, errors in calibrating the method and setting up the measuring device, acquisition and use of reagents and other consumables not approved for use) and post-analytical (assessment of the credibility and reliability of the research results obtained, their preliminary interpretation) stages that can interfere with obtaining a reliable result of a laboratory study. The development and implementation of measures to ensure the quality of clinical laboratory research at the level of a clinical diagnostic laboratory and their reflection in the “Quality Guide for Clinical Laboratory Research” of this laboratory is the responsibility of the head of the laboratory.
1.5. Quality control of clinical laboratory research consists of the development and implementation at the level of the Russian healthcare system, at the level of the constituent entities of the Russian Federation and at the level of clinical and diagnostic laboratories of a system of control measures for detecting and tracking errors that may appear in the process of performing clinical laboratory tests of samples of biomaterials from patients and distort clinical and laboratory information about the state of the internal environment of examined patients in healthcare institutions.
1.5 1. Quality control of clinical laboratory tests at the level of the Russian healthcare system and at the level of the constituent entities of the Russian Federation (interlaboratory quality control) is carried out by the Federal System of External Quality Assessment (FSVOK) based on processing the results of studies of samples of control materials carried out by clinical and diagnostic laboratories, sent by the Center for External quality control of clinical laboratory tests and its regional departments. The purpose of external research quality assessment is to assess the degree to which the results of studies performed in different health care institutions are comparable and meet established standards of analytical accuracy. External assessment of the quality of clinical laboratory tests in clinical diagnostic laboratories of healthcare institutions is carried out in accordance with the regulatory documents of the Russian Ministry of Health. Participation in FSVOC events is mandatory for laboratories of healthcare 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 not included in the FSVOK.
1.5.2 Quality control of clinical laboratory tests at the level of clinical diagnostic laboratory (in-laboratory quality control) consists of constant (everyday, in each analytical series) control activities: examination of samples of control materials or application of control measures using patient samples. The purpose of intra-laboratory quality control is to assess the compliance of research results with established criteria for their acceptability 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. Intralaboratory quality control is mandatory for all types of research performed in the laboratory. The procedure for conducting intra-laboratory quality control should be reflected in the “Quality Guide for Clinical Laboratory Research” of the given laboratory. The organization of intra-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 employees authorized by him. The presence of an internal laboratory quality control system 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 care authorities at all levels should promote activities to manage the quality of clinical laboratory tests 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 into the daily work of laboratories.

2. Standard model of the “Research Quality Guidelines”
in the clinical diagnostic laboratory."

“Guide to the quality of research in a clinical diagnostic laboratory” (hereinafter referred to as the “Quality Guide”) is a set of documents of a 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 representing a system for ensuring the quality of research performed by the CDL. Each laboratory draws up its own “Quality Manual” based on this standard model, taking into account its features.
The laboratory's activities must be carried out in strict accordance with the requirements, procedures and regulatory documents set out in the Quality Manual. Any changes in the quality assurance system for laboratory analysis should be immediately recorded in the appropriate documents. The head of the laboratory 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 presented for accreditation of CDL 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 Order of the Ministry of Health of Russia dated December 21, 1993 N 295. List of documents mentioned in the Quality Manual must change in accordance with the cancellation of old ones and the approval of new ones. The main regulatory documents of the Russian Ministry of Health regulating the activities of CDL (June 1999) are given in section 2.4. of this document. The text of the Quality Manual contains links to relevant documents for each section.

2.1. a common part
The documents included in the general part of the Quality Manual provide information about the organizational structure of the KDL, staffing and conditions of its activities.
2.1.1. Information data on CDL (Form No. 1 to the Laboratory Passport):
— name of the institution that includes the CDL,
- Full name of the head of the medical and preventive institution and his telephone number,
— name of the KDL,
— legal address of the laboratory,
- Full name of the head of the KDL and his telephone number,
— Full name of the official responsible for quality control at KDL.
2.1.2. Information about KDL accreditation and the results of inspection control.
The registration number, date of issue and validity period of the KDL accreditation certificate are provided. The types of activities included in the scope of KDL accreditation are listed. The dates of signing the inspection control certificates and the content of the inspection control commissions’ conclusions for the period after the issuance of the current KDL accreditation certificate are given.
2.1.3. Organizational structure of the laboratory.
This section provides a structural diagram of the laboratory's divisions, indicating the types of research performed and their quantity (according to the report for the previous year in Form N 30), including the centralized implementation of research for other institutions.
2.1.4. Staffing of 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 he/she knows.
2.1.5. Conditions of operation of the KDL - laboratory premises.
Permissive conclusions of the territorial authorities of the sanitary and epidemiological service, fire safety and safety inspections on the laboratory premises are provided. Data on the main production premises of the KDL are indicated in Form No. 6 to the Laboratory Passport: the total area of ​​the laboratory indicating the premises for performing analyses, storing reagents and equipment, premises for personnel needs, the presence of heating, water supply, ventilation, sewerage and reflects the degree of compliance with current standards ( 10, 18).
2.1.6. Regulatory - technical documentation (NTD) regulating the activities of CDL.
The section provides a list of regulatory documents available in the laboratory. NTD 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 Ministry of Health of the USSR and the Ministry of Health of Russia, pharmacopoeial articles, passports, technical descriptions and instructions for the use of devices and the use of kits reagents.

2.2. Quality assurance system for KDL activities.
The KDL quality assurance system is built in accordance with the following documents regulating its equipment and activities.
2.2.1. List of studied indicators (Form No. 2 to the Laboratory Passport).
The section provides a complete list of analyzed indicators, indicating research methods and calibration materials.
2.2.2. Description of the preanalytical pre-laboratory stage of analysis.
The section contains instructions, approved by the chief physician of the 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 antisepsis, methods and timing of its transportation, ensuring the safety of samples and epidemiological safety (14).
2.2.3. Regulatory and methodological support for preanalytical in-laboratory and analytical stages.
The section provides a description of all research methods used by the laboratory: instructions for the use of reagent kits approved by the Russian Ministry of Health for use in clinical laboratory tests, unified methods (approved by orders of the USSR Ministry of Health or the Russian Ministry of Health) or non-unified methods approved by the management of a medical and preventive institution. The description of the method (instructions) must indicate: the principle of the analytical method and the characteristics of its reliability, the method of preparing reagents, the time and temperature of storage of biological material before the study, the features of preparing the sample for the study (time and speed of centrifugation, mixing 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 sets).
2.2.4. List of KDL equipment.
The section provides a list of main and auxiliary equipment, indicating the factories and manufacturing companies, the time of manufacture and purchase according to forms No. 4 and No. 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 and safety instructions and a journal 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 indicates the manufacturers, date of manufacture, purchase, expiration date, storage conditions of the substances. For reagents manufactured in the laboratory, the dates of preparation, shelf life and the name of the person responsible for preparation are indicated. Storage, accounting and use of reagents must be carried out in accordance with the regulatory documents of the Russian Ministry of Health (10).
The list of reagents used must correspond to the current state; all new acquisitions are included in it and records are made about the consumption of previously acquired ones. All records are certified by the signature of the head of the laboratory or other responsible person
2.2.6. Quality control of laboratory analysis results.
The section describes 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 intra-laboratory quality control, the following are indicated: controlled indicators and corresponding control materials, frequency of control measurements, and the presence of control cards. Data are provided on intra- and inter-assay variation based on the results of the study of control material or patient samples and on the bias (systematic error) obtained from the analysis of certified control materials. It is noted that control procedures are carried out when introducing new methods, when studying new components of biological fluids, when changing equipment or when it is out of repair.
The system of intra-laboratory quality control in the CDL must operate in accordance with the regulatory documents of the Ministry of Health of Russia (4), methodological recommendations (5) and the “Rules for conducting intra-laboratory quality control of quantitative methods of clinical laboratory research”.
Information is provided on the laboratory's participation in the Federal System of External Quality Assessment (FSVOK) and the results of quality assessment. A list of controlled parameters and the number of cycles in which the laboratory took part are indicated in accordance with Form No. 7 (column 5) to the Laboratory Passport. If, in addition to FSVOK, the laboratory participates in other external quality assessment systems (international, commercial), information about participation in these systems is also provided.
The activities of the clinical laboratory to participate in external assessment of the quality of laboratory test results must comply with the regulatory documents of the Russian Ministry of Health (6, 7, 8, 9).
2.2.7. Destruction of residues of biomaterials, reagents and consumables.
The section contains instructions containing a description of environmentally friendly methods for neutralizing and destroying residues of biological materials, reagents, and consumables, which is signed by the chief physician of the medical and preventive institution and the head of the laboratory. The instructions must comply with the rules and requirements specified in the regulatory documents of the Russian Ministry of Health (10, 19).
2.2.8. Post-analytical control.
The section provides the procedure for conducting post-analytical control of the results of laboratory analysis: reviewing research results, assessing their analytical reliability based on data from 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 Russian Ministry of Health (17).
2.3.1. The section provides forms for recording the results of laboratory tests: computer or using log books. Those responsible for the safety of the laboratory archive and confidentiality of information are indicated.
2.3.2. The forms for issuing laboratory test results (forms, e-mail), the procedure and time for issuing results to patients and clinicians are indicated.
2.3.3. Forms for monthly, quarterly, and annual reports on the results of laboratory tests are provided.

2.4. List of main departmental regulatory documents used in the development of the “Quality Manual” in KDL.
1. Order of the Ministry of Health of Russia dated December 25, 1997 N 380 “On the status and measures to improve laboratory support for the diagnosis and treatment of patients in healthcare institutions of the Russian Federation.”
2. Order of the Ministry of Health of Russia dated December 21, 1993 N 295 “On approval of the regulations on the accreditation of clinical and diagnostic laboratories.”
3. Order of the Ministry of Health of Russia dated June 5, 1996 N 233 “On the accreditation of clinical and diagnostic laboratories as expert laboratories.”
4. Order of the USSR Ministry of Health dated April 23, 1985 N 545 “On further improvement of quality control of clinical laboratory research.”
5. Methodological recommendations “Quality control of coagulological studies”, approved by the Russian Ministry of Health in 1993.
6. Order of the USSR Ministry of Health dated December 24, 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 dated 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 assessment of the quality of clinical laboratory research.”
9. Order of the Ministry of Health and the Ministry of Health of the Russian Federation dated February 19, 1996 N 60 “On measures to further improve the Federal system of external assessment of the quality of clinical laboratory tests.”
10. “Rules for the design, safety and industrial sanitation in clinical and diagnostic laboratories of medical and preventive institutions of the USSR Ministry of Health system,” 1971.
11. “Rules for the design, safety and industrial sanitation, anti-epidemic regime and personal hygiene when working in laboratories (departments, departments) of sanitary and epidemiological institutions of the USSR Ministry of Health system,” 1981.
12. “Regulations on the procedure for accounting, storage, handling, release and shipment of cultures of bacteria, viruses, rickettsia, fungi, protozoa, mycoplasmas, bacterial toxins, poisons of biological origin,” USSR Ministry of Health dated 05/18/1979.
13. “Safety rules for the operation of medical equipment in healthcare institutions,” USSR Ministry of Health, 1985.
14. “Instructions on measures to prevent the spread of infectious diseases when working in clinical and diagnostic laboratories of medical and preventive institutions,” approved on January 17, 1991 by the USSR Ministry of Health.
15. “Instructions for the anti-epidemic regime in AIDS diagnostic laboratories”, N 42-28/39-90 dated 06/05/1990.
16. “Rules for operation and safety precautions when working in autoclaves,” dated March 30, 1991.
17. Order of the Ministry of Health of the USSR dated October 4, 1980 N 1030 “On approval of forms of primary documentation of healthcare institutions.”
18. Order of the Ministry of Health of Russia dated April 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 regulations. 2.1.7.728-99. “Rules for the collection, storage and disposal of waste in medical and preventive institutions.”

Question: In accordance with 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 employee qualification requirements. In the State Enterprise “Pharmacia”, pharmaceutical workers (pharmacists, specialists in the field of pharmaceutical activity management) meet 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 an enterprise 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 the drug Chymotrypsin in the amount of 5 bottles from a wholesale warehouse (factory packaging of 10 bottles). Does the pharmacy have the right to accept this drug without secondary (consumer) packaging? Does a wholesale warehouse have the right to violate the integrity of secondary packaging or does only a pharmacy organization have this right when dispensing it to a buyer?

The question is related to the topic:

Question: Can a pharmacist (more than 6 years of experience as a pharmacy manager) with a certificate in “Economics and Management in Pharmacy” hold the position of a pharmacy manager, as well as dispense medications on the sales floor?

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