Normative documents regulating diagnostic laboratories. Quality control of laboratory research Order 220 on quality control

28.06.2020

"On approval of the industry standard "Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials"

Edition dated 05/26/2003 - Valid

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER
dated May 26, 2003 N 220

ON APPROVAL OF THE INDUSTRY STANDARD "RULES FOR INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS"

In order to develop a system of standardization in healthcare Russian Federation and quality management medical care I order:

Approve the industry standard "Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials" OST 91500.13.0001-2003 (appendix).

Minister
Yu.L. SHEVCHENKO

Appendix

APPROVED
Order of the Ministry of Health of Russia
dated May 26, 2003 N 220

INDUSTRY STANDARD

SYSTEM OF STANDARDIZATION IN HEALTH CARE OF THE RUSSIAN FEDERATION

REGULATIONS
INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS
OST 91500.13.0001-2003

1 AREA OF USE

The industry standard "Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials" establishes a unified procedure for intralaboratory quality control of quantitative studies performed in clinical diagnostic laboratories, medical organizations that include these laboratories.

2. MAINTENANCE OST

The OST is maintained by the Moscow medical academy them. THEM. Sechenov of the Ministry of Health of Russia.

3. REGULATORY REFERENCES

dated 05.11.97 N 1387 "On measures to stabilize and develop health care and medical science in the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1997, N 46, art. 5312).

Decree of the Government of the Russian Federation of October 26, 1999 N 1194 "On the Program of State Guarantees for Providing Citizens of the Russian Federation with Free Medical Care" (Sobraniye Zakonodatelstva Rossiyskoy Federatsii, 1999, N 44, Art. 5322).

Decree of the Government of the Russian Federation of 04.07.2002 N 499 "On approval of the Regulations on the licensing of medical activities" (Collected Legislation of the Russian Federation, 2002, N 27, article 2710; N 41, article 3983).

4. ABBREVIATIONS

The following abbreviations are used in the text of the industry standard: OST - Industry Standard

5. INTRALABORATORY QUALITY CONTROL OF CLINICAL LABORATORY STUDIES

5.1. Introduction

One of the important directions in improving the quality management of medical care for the population of the Russian Federation is the development of a system of measures to improve the reliability of the results of clinical laboratory studies.

An integrated system of regulatory support - the development of industry standards that regulate the pre-analytical, analytical and post-analytical stages of quantitative, qualitative and other methods for studying laboratory indicators - will significantly increase the reliability of laboratory research results.

The industry standard "Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials" was created to provide normative support for everyday intralaboratory quality control procedures aimed at identifying unacceptable random and systematic errors at the analytical stage of clinical laboratory research performed by quantitative methods. Random measurement error is a component of the error of the measurement result, which changes randomly (in sign and value) during repeated measurements carried out with the same care, the same physical quantity. A systematic measurement error is a component of the measurement result error that remains constant or regularly changes during repeated measurements of the same physical quantity.

5.2. Intralaboratory control in the quality management system of medical care

Quality control of clinical laboratory studies is an integral part of the system of interrelated measures for managing the quality of medical care, including quality planning by establishing accuracy standards, quality assurance by examining research methods, laboratory equipment and consumables allowed for use in clinical diagnostic laboratories of medical organizations and establishing rules for obtaining, storing and transporting samples of biomaterials from a patient in clinical diagnostic laboratories.

Quality control of clinical laboratory research exists in two interrelated forms: intralaboratory quality control and external quality assessment. External assessment of the quality of laboratory research in medical organizations of the Russian Federation is regulated by the relevant normative documents. Intralaboratory quality control of clinical laboratory studies is carried out by employees of each clinical diagnostic laboratory in order to maintain the stability of the analytical system and is regulated by the regulatory documents of the medical organization.

This industry standard introduces limit values for error characteristics. Uniform requirements for the analytical quality of quantitative methods have been developed for measuring blood, blood serum and urine. The limit values are set by peer review based on information on biological variation of the components of biological fluids and data on analytical variation obtained as a result of activities (Appendix 1 to this industry standard).

5.3. General principles of organization and conduct of intralaboratory quality control in CDL

The organization and provision of intralaboratory quality control of quantitative methods of clinical laboratory research is the responsibility of the employee authorized to ensure the quality of the research.

Intralaboratory quality control is mandatory for all types of quantitative studies performed in a clinical diagnostic laboratory for which control materials have been developed.

The procedure and technology for conducting intralaboratory quality control of measurements of laboratory parameters must be carried out according to the rules of this OST.

It is allowed to use by the clinical diagnostic laboratory computer programs for performing intralaboratory quality control, certified and approved for use in clinical diagnostic laboratories by the Ministry of Health of the Russian Federation.

Reporting forms for conducting intralaboratory quality control are drawn up in the form of control charts (according to clause 6.3), tables, journals or on electronic media and archived for a period of at least 3 years.

The results of intralaboratory quality control should be reflected in the reporting forms that are given in the annexes to this industry standard:

registration form "Assessment of the convergence of measurement results" (Appendix 2 to this industry standard);

registration form "The results of the installation series of measurements of the indicator in control materials"(Appendix 3 to this -; industry standard);

journal "Registration of rejected results of intralaboratory quality control" (Appendix 4 to this industry standard).

The presence of an internal laboratory quality control system is one of the criteria for laboratory accreditation and is taken into account when licensing medical activities.

Checking the availability of a system of intralaboratory quality control in clinical diagnostic laboratories is carried out by territorial health authorities.

6. RULES FOR INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS

These rules establish the means, methods and procedure for conducting intralaboratory quality control of quantitative methods of clinical laboratory research, involving the use of control materials and aimed at identifying unacceptable random and systematic errors at the analytical stage of a laboratory study.

The analytical stage of a laboratory study includes: storage and preparation of a sample for measurement, calibration of the analytical system, measurement of a laboratory indicator in an analytical series, in patient samples and control materials, and assessment of the acceptability of the results obtained. An analytical system is a complete set of measuring instruments and other equipment combined to perform special measurements, which also includes chemical and biological substances and other materials. An analytical series is a set of measurements of a laboratory indicator performed under the same conditions without reconfiguration and calibration of the analytical system, in which the characteristics of the analytical system remain stable.

The purpose of intralaboratory quality control is to achieve the stability of the analytical system.

6.1. Control materials

The control material is a natural or artificial homogeneous material containing the same components as the patient samples. The measurement result of the control material is used to estimate the measurement error of the laboratory parameter in patient samples.

Control materials used in clinical diagnostic laboratories for intralaboratory quality control of quantitative methods of clinical laboratory research should be recommended for use by the Ministry of Health of the Russian Federation.

During intralaboratory control, control materials with certified and non-certified values of controlled indicators are used. The certified value is the value of the measured characteristic of the control material (substance concentration, enzymatic activity, etc.), established during its certification and given in the passport and other documents for the control material. For the same indicator in the documents for the control material, several values \u200b\u200bare indicated separately for each measurement method.

Control materials with certified values of indicators are used to control the correctness and reproducibility of laboratory analysis results, with non-certified values - only to control reproducibility.

The control material cannot be used simultaneously as a calibration material.

6.2. Requirements for control materials

Control materials must meet the following requirements:

- The matrix, i.e. the composition and properties of the biological material in which the measured component is located (blood serum, plasma, whole blood, urine or other biological material), preferably of human origin; the use of control material of animal or mixed origin is allowed, with the exception of certain analytical methods (limitations are indicated in the manufacturer's instructions).

- Component Levels in the control material should correspond to the values of indicators in the normal and pathological range; the range of values of the laboratory indicator corresponding to the state of health of the subject is taken as normal, the range corresponding to the state of the patient's illness is taken as pathological.

- List of components in the passport of the purchased control material must correspond to the indicators studied in the laboratory.

Methods for determining indicators in the control material should correspond to the methods used in a particular laboratory

after the production of the control material:

When storing lyophilized forms (at 2 - 8 ° C) for more than 1 year - for certified, more than 2 years - for non-certified control materials;

For liquid control materials (ready-to-use) at 2 - 8°C - at least 3 months;

after opening the vial or reconstitution of lyophilized forms:

4 - 8 hours at 20 - 25°C; reconstruction time of lyophilized forms - no more than 30 minutes at 20 - 25°C.

6.3. Use of control materials

The amount of purchased control material of one batch should be sufficient to conduct operational quality control for a long time (from 3 months to 3 years, depending on the stability of the control material); the calculation of the amount of necessary control material is based on the number of studies to be controlled in a given laboratory.

Preparation of the control material for the study is carried out in accordance with the manufacturer's instructions. Control materials should be analyzed in the same way as patient samples, i.e. in the same analytical series and conditions.

When reconstructing lyophilized forms, in order to reduce the dosing error, it is necessary to use the same verified dosing device.

Single freezing and thawing of the reconstructed control material is allowed. A single thaw of the frozen control material should be carried out at room temperature in an aqueous medium at 20 - 25°C. The freezing and thawing procedure should be standardized for all parameters studied in accordance with the manufacturer's instructions.

For economical use of reconstituted control material, the contents of the vial may be aliquoted. The volume of aliquots (not less than 0.5 ml) should be placed in test tubes or vials of the appropriate volume with sealed lids, which are stored at -20°C and lower temperatures for further use.

The material from which the test tubes are made must not adsorb the components of the control material (calcium, albumin, etc.).

When using reagents and calibrators from one manufacturer, it is recommended to use certified control materials from another manufacturer.

6.4. Statistical basis for assessing the errors of quantitative research methods using control materials

The statistical basis for assessing errors in intralaboratory quality control of quantitative methods of laboratory research is the assumption that the frequency distributions of the results of repeated measurements of the same control material by the same analytical method have the form of a normal distribution. The following statistical characteristics are used to evaluate random and systematic measurement errors:

- arithmetic mean(average):

where the sum of the squared deviations of the measurement results x1,x2,...,xn from the mean

arithmetic

- the coefficient of variation(CV):

(3)

The given statistical characteristics are used to assess the convergence, reproducibility and correctness of measurements of laboratory parameters in the control material and patient samples.

The standard deviation (S) and the coefficient of variation (CV) characterize random errors and are used to evaluate the convergence and reproducibility of measurements. The convergence of measurement results is the closeness to each other of the results of measurements of the same quantity, performed repeatedly by the same means, by the same method under the same conditions and with the same care. The reproducibility of measurement results is the closeness of measurement results of the same quantity obtained in different places, by different methods, by different means, by different operators, at different times, but

The arithmetic mean () is used to calculate the relative offset (B), which characterizes the correctness of the measurements. The correctness of measurements reflects the closeness to zero of systematic errors in their results. Bias (B) is determined by the proximity of the arithmetic mean of the results of repeated measurements of the control material () to the certified value (AZ) of the measured quantity (see clause 6.1.1) and can be expressed in absolute and / or relative values. The relative systematic error or bias (B) is calculated using the formula:

(4)

In the result obtained, the sign of the number (+ or -) must be indicated.

Annex 1 shows the ELVs for the error characteristics: relative bias (B) and coefficient of variation (CV) for determining laboratory parameters in the control material.

6.5. The procedure for conducting intralaboratory quality control

The procedure for conducting intralaboratory quality control consists of three successive stages:

Stage 1. Evaluation of the convergence of the measurement results.

Stage 2: the first, second and third stages. Evaluation of reproducibility and correctness of measurement results (setting series), construction of control charts.

Stage 3. Conducting operational quality control of the results of laboratory studies in each analytical series.

A preliminary assessment of the convergence, reproducibility and accuracy of measurements of a laboratory indicator (stages 1 and 2 of intralaboratory quality control) is performed when each new technique is introduced into the work of the laboratory. If significant changes are made to the analytical system, namely, when changing the analytical principles of measurement (instruments, reagents, calibration tools, control materials, technological procedure, etc.), stages 1 and 2 of the intralaboratory quality control should be repeated. Performing in stage 2 20 measurements of a laboratory indicator in control materials are called the installation series of measurements, from the results of which the standard deviation (S) and control limits are calculated.

Accepted designations in the text. The results of measurements of a laboratory indicator obtained in the laboratory are evaluated by the values of the coefficient of variation and relative bias, in the text of the OST are indicated by the following symbols:

convergence();

Reproducibility (, - respectively in 10 and 20 analytical series);

Correctness (, - respectively 10 and 20 analytical series).

Calculation formulas (1-4) are given above.

6.5.1. Stage 1: Evaluation of the convergence of the measurement results

Purpose: to check the conformity of the measurement results to the established standards.

Test material: A control material or patient sample with an analyte value in the normal range.

Perform 10 measurements on the same material in one analytical series.

Enter the measurement results into registration form"Assessment of the convergence of measurement results" (Appendix 2 to this industry standard).

Check that the received value does not exceed half of the value (Appendix 1):

(5)

If the value exceeds , it is necessary to find out the sources of unacceptably large random errors and work to eliminate them. Then, stage 1 should be repeated.

If the convergence meets the established standards, they proceed to the next stage.

6.5.2. Stage 2: assessment of the reproducibility and correctness of the measurement results (setup series), construction of control charts

FIRST STEP

Purpose: preliminary assessment of the compliance of the values of the coefficient of variation and the relative bias with the established standards.

Test material: the measurement of the determined indicator is carried out in two certified control materials<*>- to estimate the values of the coefficient of variation and the relative bias of the methodology . The values of the determined indicators in the selected certified control materials must correspond to the "normal" and "pathological" ranges. The same control materials are used in the third stage for online quality control.

<*>It is possible to use two certified and two non-certified control materials as the test material in the 2nd stage. Two certified control materials - to evaluate the values of the relative displacement and ; two non-certified control materials - for carrying out the installation series of measurements and for estimating the values of the coefficient of variation and .

Execution sequence:

To measure the indicator in 10 analytical series; in each series, one measurement simultaneously in two control materials;

Enter the results into the registration form "Results of the initial series of measurements of the indicator in control materials" (Appendix 3 to this industry standard);

Perform the indicated series one at a time (if necessary, 2-3 series per day are allowed, for example, due to the limited shelf life of the reagents);

From the 10 results obtained for each of the control materials, using formulas 1-4, calculate the values of the coefficient of variation and the value of the relative bias ;

Check that the obtained values and do not exceed the maximum allowable values for this indicator and (Appendix 1).

If one of the obtained values or exceed the values of the corresponding ones, identify the sources of unacceptably large random and systematic errors and work to eliminate them. After that, the first stage is performed again.

If the values of the coefficient of variation () and relative bias () do not exceed the established norms, proceed to the second stage.

SECOND PHASE

Purpose: the final assessment of the correspondence between the values of the coefficient of variation () and the relative

offset () established norms.

Materials to be tested: the same as in the first stage.

Execution sequence:

Carry out the measurement of the indicator in 10 additional analytical series (see stage 2, first stage).

Enter the results in the second part of the registration form (Appendix 3).

Check that the obtained values and do not exceed the maximum allowable measurement values and (Appendix 1 to this industry standard).

If one of the obtained values or exceeds the values of the corresponding and , identify the sources of unacceptably large random and systematic errors and work to eliminate them. After that, the second stage is performed again.

If the values of the coefficient of variation and relative bias do not exceed the established norms, the final conclusion is made about the possibility of using the technique under consideration for the purposes of laboratory diagnostics and proceed to the next stage - the construction of control charts.

THIRD STAGE

Purpose: construction of control charts.

Execution sequence:

From the results of measurements of the determined indicator for each control material obtained in the installation series 20, according to formulas 1-2, the following are calculated: arithmetic mean value , standard deviation S, control limits: , and .

If in the series of results obtained for one of the control materials there is a value that is outside the limits, then it is discarded; for this material, another analytical series of measurements is carried out, after which the values of and S are calculated again.

The control chart, built according to the initial series of measurements, 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 (Fig. 1).

Through the middle of the y-axis, a line is drawn corresponding to the arithmetic mean, and lines corresponding to the control limits are marked parallel to this line:

Control limit "1 standard deviation";

Control limit "2 standard deviations";

Control limit "3 standard deviations".

Control charts are built for each laboratory indicator and for each control material intended for operational quality control.

The width of the control limits is determined by the value of the standard deviation (S). The wider the control limits, the lower the probability of detecting errors in daily online quality control. Narrow control limits increase the likelihood of false rejection of an analytical run.

Control charts are drawn up and archived: in the form of graphs, tables, including on electronic media.

Rice. 1. An example of a control chart.

6.5.3. Stage 3: conducting operational intralaboratory quality control

Conducting operational quality control of quantitative methods of laboratory research involves serial measurement of the indicator in control materials and assessment of the acceptability of the results of the study of patient samples. The acceptability of the results of measurements of patient samples of each analytical series is assessed by the results of the study of control materials, using control rules.

Purpose: To confirm the stability of the analytical system from the results of the study of control materials in each analytical series.

Test material: for operational quality control, the laboratory must use two certified control materials in two ranges of determined indicators, it is possible to use two non-certified control materials in two ranges of determined indicators.

Execution sequence:

Calibrate the analytical system in accordance with the procedure.

Distribute the control material samples evenly among the analyzed patient samples.

Carry out a single measurement of the indicator in control materials and patient samples in each analytical series (the number of measurements in the analytical series is not limited)

Put the points corresponding to the results of control measurements on the corresponding control charts.

If the results of control measurements deviate beyond the control limit limited by the control rule, evaluate the acceptability of the results of patient samples in this analytical series according to the results of measurement of control materials using control rules<*>:

<*>The control rule includes the control limit (, , ) and the number of control measurements in the analytical series. Control rules are denoted by symbols like , where BUT- number of control results, L- control limit.

Check the presence on both control cards of the rule;

If one of the results of the analysis of control materials is outside the limits, check successively for the presence of control rules , , , , and ; An analytical series is considered unsatisfactory if one of them is present:

One of the control measurements is out of range.

The last two control measurements are above or below the limit.

Two control measurements in the analyzed analytical series are located on opposite sides of the corridor;

The last four control measurements are above or below the limit.

The last ten control measurements are located on one side of the line corresponding to .

If, in addition to the feature, at least one of the indicated features is detected: , , , , or , all the results obtained in this analytical series should be considered unacceptable (Fig. 2).

Rice. 2. Scheme of sequential application of control rules

Control features , , should be checked on one control chart and/or on both control charts (Fig. 3).

Rice. 3. Examples of violation of control rules in the case of two control materials.

Suspend the analysis, identify and eliminate the causes of increased errors. All samples analyzed in this series (both patients and controls) should be retested.

The results of the measurement of control materials in a lot that is considered unacceptable should not be used in the evaluation of the control rules of the second and subsequent lots.

If none of the above signs is found on any control card, the research should be continued.

The decision on the acceptability of the results of measuring a laboratory indicator in the biological material of patients is made by the employee responsible for the quality of studies. If the results of the analytical series are considered unacceptable, an appropriate entry is made in the journal "Registration of rejected results of intralaboratory quality control" (Appendix 4 to this industry standard).

The control sign is a warning, its appearance should not lead to the rejection of the results of the analytical series and the re-examination of the samples. The appearance of control signs: - indicates the presence of a gross error, - an increase in random errors, and signs , , and - an increase in the systematic error of the technique.

To assess the stability of the analytical system, it is necessary to periodically recalculate the control limits every 30 measurements, including previous measurements, except for the values of the control material of those batches that were discarded. After that, new control limits are calculated and a new control chart is built.

In the laboratory, it is allowed to select other algorithms for applying control rules that are allowed for use in clinical diagnostic laboratories, in the manner prescribed by the relevant regulatory documents. Identification of control signs in the daily work of the clinical diagnostic laboratory can be performed "manually" or with the help of special computer programs. An example of control charts for two control materials, which show batches that are unsatisfactory due to violation of different control rules, is shown in fig. 3.

6.5.4. Change of control material

In order to maintain the continuity of intralaboratory control during the period when the used control material remains for only 20 analytical runs, it is necessary to switch to a new control material by carrying out the so-called "overlapping".

The overlapping consists in the fact that during the 20 series (overlapping period) the clinical diagnostic laboratory examines both the ending material ("used"), which continues to be monitored, and the material that replaces it ("introduced"). In this case, the samples of the input control material are placed in positions separated by two or more positions from the positions in which the samples of the control material used are located. For example, if the control material being used is at positions 07, 36, then the control material being injected can be placed at positions 4, 33.

Based on the results obtained for the input control material, the arithmetic mean and standard deviation are calculated, from which a new control chart is built.

Appendix No. 1
to the industry standard

LIMIT PERMISSIBLE VALUES OF OFFSET (B) AND COEFFICIENT OF VARIATION (CV) FOR DETERMINATION OF LABORATORY INDICATORS IN THE CONTROL MATERIAL

	Study of biological fluids	Code OK-PMU	, %	, %	, %	, %
1	Study of the level of alanine transaminase<*>in blood	09.05.042	±17	16	±15	15
2.	The study of the level of albumin in the blood	09.05.011	+5	4	±4	4
3.	Amylase test<*>in blood	09.05.045	±16	11	±15	10
4.	The study of the level of aspartate transaminase<*>in blood	09.05.041	±11	AND	±10	10
5.	The study of the level of total protein in the blood	09.05.010	±5	3	±5	3
6.	The study of the level of total bilirubin in the blood	09.05.021	±17	16	±15	15
7.	Investigation of the level of gamma-glutamine transferase<*>in blood	09.05.044	±16	11	±15	10
8.	Blood glucose testing	09.05.023	±6	5	±5	5
9.	Study of the level of iron in the blood	09.05.007	±12	17	±10	16
10.	Study of the level of potassium in the blood	09.05.031	±5	4	±4	4
11.	Study of the level of calcium in the blood	09.05.032	±3.4	3,3	±3.0	3,0
12.	The study of the level of creatinine in the blood	09.05.020	±11	8	±10	7
13.	Creatine kinase test<*>in blood	09.05.043	+23	22	±20	20
14.	Study of the level of lactate dehydrogenase<*>and its isoenzymes in the blood	09.05.039	±11	11	±10	10
15.	Study of the level of magnesium in the blood	09.05.132	±7	7	±6	6
16.	Study of the level of uric acid in the blood	09.05.018	±11	8	±10	7
17.	Study of the level of urea in the blood	09.05.017	±11	11	±10	10
18.	Study of the level of sodium in the blood	09.05.030	±1.8	2,2	±1.5	2,0
19.	Study of the level of neutral fats and triglycerides in blood plasma	09.05.025	±17	16	+15	15
20.	The study of the level of phosphates (inorganic) in the blood	09.05.033	±8	8	±7	7
21.	Study of the level of chlorides in the blood	09.05.034	±3.4	3,3	±3.0	3,0
22.	Blood cholesterol test	09.05.026	±9	8	±8	7
23.	Alkaline Phosphatase Test<*>in blood	09.05.046	±16	11	±15	10
24.	Determination of protein in urine	09.28.003	±24	27	±20	25
25.	Urinary glucose testing	09.28.011	±22	16	±20	15
26.	Study of the level of total hemoglobin in the blood	09.05.003	±5	4	±4	4
27.	Study of the level of erythrocytes in the blood	08.05.003	±1	4	±6	4

Note.<*>- for these indicators, the study of the level means the measurement of enzyme activity.

Appendix No. 2
to the industry standard
"Rules for conducting intralaboratory
quality control of quantitative methods
clinical laboratory research
using control materials"

REGISTRATION FORM "ASSESSMENT OF CONVERGENCE OF MEASUREMENT RESULTS"

Laboratory:			Indicator:
The Department:
Date of measurement:	Test material (underline as appropriate): patient sample, control material
Measurement technique:	Control material (name, range of values):
Executor:	Control material manufacturer:	N batch of control material:		Expiry date of control material:


Sequence number of the measurement	The result of the indicator measurement
1
2
3
4
5
6
7
8
9
10
number of results (n)=10	10 measurements =
=	0,5 =	Convergence Acceptable: Yes No

The sign of the sum of the results.

According to formulas 1-2, the standard deviation and the value of the coefficient of variation are calculated, which are entered into the registration form and compared with the value 0,5 (Appendix 1 to this industry standard).

Head of Clinical Diagnostic Laboratory ................................. Signature

Appendix No. 3
to the industry standard
"Rules for conducting intralaboratory
quality control of quantitative methods
clinical laboratory research
using control materials"

REGISTRATION FORM "RESULTS OF INSTALLATION SERIES OF MEASUREMENTS OF THE INDICATOR IN CONTROL MATERIALS"

Laboratory: The Department:			Indicator:			Date of measurement from to Executor:
Control materials:(names)		Best before date:		Manufacturers:	Party N			Passport values (range of values):
1.		1.		1.	1.			1.
2		2.		2.	2.			2.
Device:			Measurement technique:				Reagents:
Number of episodes	Control material 1					Control material 2
	Measurement result					Measurement result
1
2
3
4
5
6
7
8
9
10
n=10
= =			= =					= =

A diagnostic laboratory can be both a diagnostic unit of a medical institution and is created as a department, or a separate legal entity. DL, regardless of subordination and form of ownership, must have a certificate for the chosen type of activity. All documents regulating its activities can be divided into 3 groups:

· Orders

Order- a by-law normative legal act issued solely by the head of an executive authority or department and containing legal norms.

Standards- lists of diagnostic and treatment services (including laboratory services) recognized by leading experts of the relevant branch of medicine as minimally necessary and sufficient to provide medical care to a patient with a certain form of pathology in its typical variants. The standards of medical care are given the importance of official documents.

List of main documents

1. federal laws RF.

1.1. Federal Law No. 323 dated 21.10. 2011 "On the basics of protecting the health of citizens of the Russian Federation";

1.2. Federal Law No. 94 dated 21.07. 2005 "On placing orders for the supply of goods, performance of work, provision of services for state and municipal needs";

1.3. Federal Law No. 326 dated October 29, 2010” On compulsory health insurance in the Russian Federation.

2. On admission to work in the CDL of the Russian Federation.

2.1. Etc. Ministry of Health of the Russian Federation No. 210N dated March 23, 2009. “On the nomenclature of specialties for specialists with higher and postgraduate medical and pharmaceutical education in the healthcare sector of the Russian Federation”;

2.2. Etc. Ministry of Health and Social Development of the Russian Federation No. 415N dated 07.07. 2009 "On approval of qualification requirements for specialists with higher and postgraduate medical and pharmaceutical education in the field of healthcare"

2.3. ETC. Ministry of Health and Social Development of the Russian Federation No. 705N dated 09.12.2009 "On approval of the procedure for improving the professional knowledge of medical and pharmaceutical workers";

2.4. Explanatory note to Ave. Ministry of Health and Social Development of the Russian Federation No. 705N dated 09.12.2009;

2.5. Etc. Ministry of Health and Social Development of the Russian Federation No. 869 of 06.10.2009. "On approval of the unified qualification directory of positions of managers, specialists and employees, section 2 Qualification characteristics of positions of workers in the field of healthcare";

2.6. Etc. Ministry of Health and Social Development of the Russian Federation No. 176N dated April 16, 2008. “On the nomenclature of specialists with secondary medical and pharmaceutical education in the healthcare sector of the Russian Federation”;

2.7. Etc. Ministry of Health and Social Development of the Russian Federation No. 808N dated July 25, 2011. "On the procedure for obtaining qualification categories by medical and pharmaceutical workers."

3. Quality control in KDL.

3.1. Etc. 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 research in healthcare institutions of the Russian Federation";

3.2. Etc. Ministry of Health of the Russian Federation No. 220 dated May 26, 2003 “On approval of the industry standard “Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory studies using control materials”.

4. Specificity of CDL.

4.1. Etc. Ministry of Health of the Russian Federation No. 380 of December 25, 1997. "On the state and measures to improve laboratory support for the diagnosis and treatment of patients in healthcare institutions of the Russian Federation";

4.2. Etc. Ministry of Health of the USSR No. 1030 dated 04.10.1980. "Medical records of laboratories as part of medical institutions";

4.3. Etc. Ministry of Health of the Russian Federation No. 109 dated March 21, 2003. "On the improvement of anti-tuberculosis measures in the Russian Federation";

4.4. Etc. Ministry of Health of the Russian Federation No. 87 dated March 26, 2001. "On improving the serological diagnosis of syphilis";

4.5. Etc. Ministry of Health of the Russian Federation No. 64 dated February 21, 2000. "On approval of the nomenclature of clinical laboratory tests";

4.6. Etc. Ministry of Health of the Russian Federation No. 2 45 of 08/30/1991. "On the norms of alcohol consumption for healthcare, education and social security institutions";

4.7. Etc. Ministry of Health and Social Development of the Russian Federation No. 690 dated October 2, 2006. “On approval of accounting documentation for the detection of tuberculosis by microscopy”;

4.8. Reporting form No. 30 was approved by the Decree of the State Statistics Committee of Russia No. 175 dated September 10, 2002.

5. Sanitary and epidemiological regime in KDL.

5.2. SanPiN 2.1.3.2630-10 dated 18.05.2010 "Sanitary and epidemiological requirements for organizations engaged in medical activities";

6. Standardization in KDL.

6.1. Standards for the provision of medical care.

6.1.1. Etc. Ministry of Health and Social Development of the Russian Federation No. 148 dated March 13, 2006. "Standard for the provision of medical care to patients with bacterial sepsis of the newborn";

6.1.2. Etc. Ministry of Health and Social Development of the Russian Federation No. 82 dated February 15, 2006. "On approval of the standard of medical care for patients with Itsenko-Cushing's syndrome";

6.1.3. Etc. Ministry of Health and Social Development of the Russian Federation No. 68 dated February 9, 2006. "On approval of the standard of medical care for patients with polyglandular dysfunction";

6.1.4. Etc. Ministry of Health and Social Development of the Russian Federation No. 723 dated 01.12.2005. "On approval of the standard of medical care for patients with Nelson's syndrome";

6.1.5. Etc. Ministry of Health and Social Development of the Russian Federation No. 71 dated 09.03.2006. "On approval of the standard of medical care for patients with hypoparothyroidism";

6.1.6. Etc. Ministry of Health and Social Development of the Russian Federation No. 761 dated 06.12.2005. "On approval of the standard of medical care for patients with precocious puberty";

6.1.7. Etc. Ministry of Health and Social Development of the Russian Federation No. 150 dated March 13, 2006. "On approval of the standard of medical care for patients with chronic renal failure";

6.1.8. Etc. Ministry of Health and Social Development of the Russian Federation No. 122 dated March 28, 2006. "On approval of the standard of medical care for patients with other and unspecified cirrhosis of the liver";

6.1.9. Etc. Ministry of Health and Social Development of the Russian Federation No. 168 dated March 28, 2005. "On approval of the standard of medical care for patients with chronic adrenal insufficiency";

6.1.10. Etc. Ministry of Health and Social Development of the Russian Federation No. 889 of December 29, 2006. “On approval of the standard of medical care for patients with chronic adrenal insufficiency (in the provision of specialized care);

6.1.11. Etc. Ministry of Health and Social Development of the Russian Federation No. 662 dated September 14, 2006. “On approval of the standard of medical care for women with normal pregnancy;

6.1.12. Etc. Ministry of Health and Social Development of the Russian Federation.2009 “On additional medical examination of working citizens.

6.2. National standards in KLD

6.2.1. GOST R 52905-2007 (ISO 15190:2003); Medical laboratories. Safety requirements. This International Standard specifies requirements for establishing and maintaining a safe working environment in medical laboratories.

6.2.2. GOST R 53022.(1-4)-2008; "Requirements for the quality of clinical laboratory research"

1) Rules for the quality management of clinical laboratory research.

2) Evaluation of the analytical reliability of research methods.

3) Rules for assessing the clinical information content of laboratory tests.

4) Rules for the development of requirements for the timeliness of the provision of laboratory information.

6.2.3. GOST R 53079.(1-4)-2008; "Quality assurance of clinical laboratory research"

1) Rules for describing research methods.

2) Guidelines for quality management in the diagnostic laboratory.

3) Uniform rules for the interaction of personnel of clinical sub-

divisions and KDL.

4) Rules for conducting the preanalytical stage

6.2.4. GOST R 53.133.(1-4)-2008; "Quality control of clinical laboratory studies":

1) Limits of permissible errors in the results of measurement of analytes in CDL.

2) Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials.

3) Description of materials for quality control of clinical laboratory studies.

4) Rules for conducting clinical audit.

6.2.5. GOST R ISO 15189-2009; "Medical Laboratories. Special requirements for quality and competence. Standards for Methods of Control, Testing, Measurement and Analysis” establish requirements for the equipment used, conditions and procedures for the implementation of all operations, processing and presentation of the results, and personnel qualifications. This standard is identical to the international standard ISO 15189:2007 “Medical laboratories. Particular requirements for quality and competence" (ISO 15189:2007 "Medical laboratories - Particular requirements for quality and competence").

In almost all articles on the organization and planning of the quality control process of clinical laboratory studies, there are similar pictures:

The meaning of this picture is that three systems - intralaboratory quality control, external assessment of the quality of research and interlaboratory quality control - do not oppose, do not replace, but are designed to complement each other. It is only by putting the three pieces of the puzzle together, by participating in all three quality control systems, that a true picture can be obtained. We offer you simultaneous solution two out of three tasks, moreover, for the same cost. How? Read more…

Quality control of CDL work is understood as a system of measures aimed at quantifying closeness of the results to the true
measured value">accuracy,
measurements taken
under various conditions"> reproducibility, close to zero systematic
errors in their results,
those. compliance with the average
results values
measurements true value
measured component">correctness And closeness of results
measurements performed
under the same conditions"> convergence laboratory research. Quality control should be objective, daily, covering all areas of measurement - normal and pathological results. Quality control measures are aimed both at assessing whether the results obtained are reliable enough for the laboratory to issue them, and at eliminating the reasons for the unsatisfactory performance of these results.

Intralaboratory quality control(VKK) - a system of measures carried out directly in the laboratory in each analytical series. The VQC is designed to self-assess the quality of laboratory test results by using accepted algorithms for evaluating analyte measurements in control materials. Its main purpose: evaluation and continuous monitoring closeness of results
measurements taken
in various conditions"> reproducibility measurement results.
Some experts do not consider intralaboratory quality control as a complete tool for assessing correctness analyte measurements and recommend using clinical laboratory diagnostics, M., 2004 "> passport values of certified control material only as indicative. To obtain a reliable picture, participation of the laboratory in any of the external quality assessment programs is required.
External quality assessment(EQA) - objective verification of laboratory results, carried out periodically external organization. The purpose of external evaluation of research quality is to assess the compliance of research results with established standards of analytical accuracy, that is, periodic validation measurements. External assessment of the quality of clinical laboratory research in clinical diagnostic laboratories is carried out in accordance with the regulations of the Russian Ministry of Health. Participation in the Federal system of external quality assessment is recommended for laboratories of all forms of ownership and is taken into account in their accreditation and licensing, but is not mandatory. At the same time, it is possible for laboratories to participate in other programs of external quality assessment: international, commercial, regional.
Until recently it was believed that the participation of laboratories in the FSQA is mandatory. However, on December 30, 2014, the Federal Antimonopoly Service of Russia published a report on an unscheduled on-site inspection of Roszdravnadzor. There were quite a lot of results of this check, and about the part of them that concerns the FSVOK, it is best to read in an article from the magazine Vademecum [Come with me]. In short: there is no discrimination against laboratories and clinics that do not participate in the SFQA. Laboratories are free to use any external quality assessment program they choose.
Interlaboratory quality control(MKK) - a kind of external quality control. This method allows you to identify systematic and random errors by monitoring closeness of results
measurements performed
under the same conditions convergence results obtained in several laboratories on the same control material, by the same method. The method of interlaboratory comparisons can replace external quality assessment in cases where the required types of studies are not covered by available EQA systems, or their use is not economically feasible.

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

Organization of intralaboratory quality control

The main tasks of the CDL are to conduct the necessary clinical laboratory tests and improve their quality. The quality of laboratory studies must meet the requirements for analytical accuracy established by the regulations 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 intralaboratory quality control, which consists in the constant (everyday in each analytical series) control measures: the study of samples of control materials or the application of control measures using patient samples. The purpose of intralaboratory control is to assess the compliance of the 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 intralaboratory quality control of quantitative studies are contained in 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 studies in healthcare institutions of the Russian Federation”. When conducting quality control of laboratory studies, the following terms are used:
Measurement accuracy - the quality of measurements, reflecting the proximity of their results to the true value of the measured quantity. High measurement accuracy corresponds to small errors of all kinds, 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 during repeated measurements of the same value.
The correctness 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 with repeated measurements of the same value.
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 - the quality of measurements, reflecting the closeness to each other of the results of measurements performed in the same analytical series.
Inter-run reproducibility - the quality of measurements, reflecting the closeness to each other of the results of measurements performed in different analytical series.
Overall reproducibility - the quality of measurements, reflecting the proximity to each other of the results of all measurements.
The set value is the method-dependent value of the determined indicator, indicated by the manufacturer of the control material in the passport or instructions.
Sources of errors detected by the intralaboratory 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. To internal - non-compliance with the conditions established by the methodology for conducting an analytical study: time, temperature, volumes, rules for the preparation and storage of reagents.

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

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 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: control card method; method "Sizit"; Westgard control rule method. Methods using patient data:
Method of parallel trials.
The method of average normal values ("average norm").
Study of a random sample.
Study of repeated samples.
Study of a mixed sample.

Control chart method. Every day, a laboratory worker, when conducting all types of analysis, examines the control material along with experimental samples. The 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, control material is taken in the same amount. Control materials can be prepared in the laboratory yourself (drain sera) or purchased from firms - commercial control materials. In turn, commercial sera can be certified (with a known content of components) and non-certified (with an unknown content of components). Non-certified control sera are primarily used for reproducibility control, and certified ones for correctness.

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

If non-certified material or confluent sera are used, X, S and CV are calculated from the results obtained. Verify that the obtained B and CV values do not exceed their limit values. If this condition is met, they make a conclusion about the possibility of using the technique under consideration for the purposes of laboratory diagnostics and proceed to the construction of control charts. If one of the obtained values B or CV exceeds the corresponding limit values, extra work to eliminate sources of increased bias or variation, or choose a different method for determining this indicator.

The control chart is a graph, on the abscissa axis of which the number of the analytical series (or the date of its completion) is plotted, and on the ordinate axis - the values of the determined indicator in the control material. A line is drawn through the middle of the y-axis, corresponding to the arithmetic mean value X, 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 studied indicator is carried out. To this end, in each analytical series, one measurement is carried out in each of the two control materials (N and P); or two measurements on the same control material if a single material is used (in the latter case, two points per series are applied to the control card).

The evaluation of the results of the study of control materials is carried out using the Westgard control rules:
1 2S - if one of the results of the analysis of control materials is outside 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 goes beyond (x±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 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 the signs 2 2S , 4 1S , I0 X indicate an increase in the systematic error of the technique. 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 CDL. However, these methods do not detect the error in general.

Control by daily averages. For many studies, a daily average control that uses samples or results from a study of patient samples can be recommended as an additional option. Conditions necessary for the implementation of the method: the number of patient samples examined daily should 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 fairly homogeneous (by pathology, sex, age); the number of results to be averaged should be approximately the same, and it depends on the analyzed component.

Sequence of procedures:
Every day, from the results obtained during the day, the calculation of the daily arithmetic mean value (x) is carried out, and this procedure is repeated for 20 days.
Even from 20 daily averages, a total average x total is calculated. and standard deviation (S).
Control limits (XTOV ± 1S, XTOV ± 2S, XTOV ± 3S) are calculated and a control chart is generated.
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 point.

Control chart analysis is carried out according to Westgard rules.

Method for controlling reproducibility by duplicates. The principle of this method of intralaboratory quality control is to conduct two parallel studies of the indicator being determined in a randomly selected patient sample, finding 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 outside. Sequence of procedures:
determine the level of the indicator being determined in a randomly selected patient sample twice during one analytical series;
calculate the relative range between the two definitions using the formula:
R i \u003d ((2 x (X 1 - X 2)) / (X 1 + X 2)) x 100%, where (X 1 -X 2) is the difference between the results of the 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 R:

Next, control limits are calculated by multiplying the obtained R value by coefficients corresponding to 95% and 99% quantiles of the range distribution: for a 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 a zero range), on which the number of the analytical series is marked, and lines corresponding to R and the control limits of 95% and 99% are drawn parallel to it in a convenient scale . On the y-axis, the level of the indicator being determined is marked. Further, in each analytical series, a parallel study of the determined indicator in a randomly selected patient sample is carried out. Samples intended for parallel testing should be randomly distributed 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 limit "95% (control feature "2 R9S"), then such an analytical series is considered unsuitable, the study is carried out again.

Study of a mixed sample. When assessing reproducibility by the method of parallel samples, closer values are obtained than usually obtained in the presence of random errors. In the mixed sample method, this is excluded. The method is as follows: two samples (A and B) are randomly selected from a group of samples; from each sample A and B take equal volumes and mix (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, a study should be carried out for 40 days. The mean deviation (dav) 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: a 50% straight line 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 two samples and the actual value obtained from 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 specifics of hematological studies, their quality control implies the presence of certain controls and materials that are not used in other types of laboratory research. To control the quality of determining the hemoglobin content, standard solutions of hemiglobin cyanide with a known content of Hb and special control solutions (donor blood, lysed blood and canned blood) are used. The hemiglobincyanide standard solution is used to control the correct operation of photometers and to build a calibration curve in the hemiglobincyanide method for determining Hb in blood. To control the reproducibility of the determination of Hb, a solution of lysed blood (hemolysate) is used. For the preparation of hemolysates use: canned human citrated blood, possibly expired; canned horse blood; donor human blood, fresh, collected in a vessel with a 0.6 mol/l solution of sodium citrate at a rate of 1:5.

200 ml of the obtained citrated blood is centrifuged at 3000 rpm for 30 minutes. The plasma is drained, 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 thoroughly mixed again for 30 minutes.

The solution is then 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°C. Stable for 1 year. To assess the reproducibility of determining the concentration of Hb, 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 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, i.e. in the same cases and under the same conditions. The results of the study of Hb 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%.

The following control materials are used to control the quality of blood cell counting: 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 cards. 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 the 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. environment. The calculation of the leuco formula is considered correct if the results of the cell count 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 results of urine tests obtained mainly depends on the qualifications of the laboratory assistant, the equipment used, the reagents and the research method. To obtain correct and reproducible test results chemical composition Swords use controls that are as close as possible to patient urine samples and control swabs to control the quality of microscopic examinations of urine sediment. As control materials for monitoring the chemical composition of urine, the following are used: aqueous solutions of substances; drained urine with preservatives; artificial solutions of urine with additives of substances studied in urine.

Control materials are used to check the methods commonly used in the laboratory for qualitative and quantitative study of the chemical composition of urine. Aqueous solutions substances with a known content are used for quality control 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, corresponding to GOST 6709-72, and chemically pure and analytical grade reagents.

Aqueous solutions are stored in the refrigerator for 1 month. For quality control of urine chemistry studies, drained urine prepared in the laboratory can be used. 2 g of EDTA are added to 1 liter of fresh human urine, and 5 ml of thymol solution are poured with vigorous shaking and stirring of the vial. After 2 weeks, the urine is centrifuged to remove mucus and a small amount of uric acid. After this treatment, the urine becomes transparent and almost odorless.

The control material is stored at room temperature. Shelf life - several years. Drained urine is used to control reproducibility.

Control solutions imitating urine are used to control the quality of diagnostic strips. Method of preparation: in a 500 ml volumetric flask with 200 ml of distilled water, add 5 ml of glucose (for intravenous injections), 2 ml of acetone (pure, 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 to lyse the erythrocytes). Mix thoroughly and dilute to volume with saline. Using 0.1 M HCl, the pH was adjusted to 6.0. The control solution can be stored in the refrigerator for up to one month.

Quality control of coagulation studies

The quality control of coagulation 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 end point of fibrin formation, as well as the type of reagents used. To control coagulological studies, apply:
Mixed fresh plasma from a large number of donors (at least 20 people).
Standard human lyophilized plasma (pool) for calibration.
Control human plasma with the exact content of coagulation factors (normal and pathological).
Control plasma deficient in individual coagulation factors.
Control plasma to control the upper and lower boundaries of the therapeutic area when taking anticoagulants.

As the main control material, fused, citrate-only plasma with normal and prolonged clotting time is used. Method for preparing fused plasma: fresh plasma taken from a 3.8% sodium citrate solution is collected from several donors, mixed and bottled. Freeze quickly. The main requirement for plasma is the absence of traces of hemolysis and red blood cells in it.

Control plasma is thawed daily and used at the start 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 tested in parallel. If the difference between parallels is greater 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 results of urine tests obtained mainly depends on the qualifications of the laboratory assistant, the equipment used, the reagents and the research method. To obtain correct and reproducible results of the study of the chemical composition of urine, control materials are used, as close as possible to the urine samples of patients, and control smears are used to control the quality of microscopic examinations of the urine sediment. As control materials for monitoring the chemical composition of urine, the following are used: aqueous solutions of substances; drained urine with preservatives; artificial solutions of urine with additives of substances studied in urine.

Control materials are used to check the methods commonly used in the laboratory for qualitative and quantitative study of the chemical composition of urine. Aqueous solutions of substances with a known content are used for quality control 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 complies with GOST 6709–72, and chemically pure and analytical grade reagents. Aqueous solutions are stored in the refrigerator for 1 month. For quality control of urine chemistry studies, drained urine prepared in the laboratory can be used.

2 g of EDTA are added to 1 liter of fresh human urine, and 5 ml of thymol solution are poured with vigorous shaking and stirring of the vial. After 2 weeks, the urine is centrifuged to remove mucus and a small amount of uric acid. After this treatment, the urine becomes transparent and almost odorless.

The control material is stored at room temperature. Shelf life - several years. Drained urine is used to control reproducibility. Control solutions imitating urine are used to control the quality of diagnostic strips.

Method of preparation: in a 500 ml volumetric flask with 200 ml of distilled water, add 5 ml of glucose (for intravenous injections), 2 ml of acetone (pure, analytical grade), 25 ml of drained human serum and 0.1 ml of lysed blood (to 0 1 ml of whole blood, add 0.1 ml of distilled water to lyse the erythrocytes). Mix thoroughly and dilute to volume with saline. Using 0.1 M HCl, the pH was adjusted to 6.0. The control solution can be stored in the refrigerator for up to one month.

Evaluation of the quality of the work of a laboratory assistant

The evaluation of the quality of the work of the laboratory assistant should be part of the internal laboratory quality control program. The technique of laboratory technicians can be assessed using the following methods:
A method that uses the results of an external quality assessment.
random sampling method.
Sample dilution method.
The method of duplication of analyzes.
A method that uses the results of in-house quality control.

If a laboratory assistant has performed 20 or more tests, then it is easy to evaluate his work if the true size of the samples is known. The standard deviation of a laboratory can be thought of as a measure of the ability to perform correct analyzes by each laboratory assistant by calculating the average of all standard deviations for all tests. This average can be called the combined standard deviation (KS).

The value of KS is calculated for a certain period of time (half a year, a year) for each laboratory assistant and gives a rough estimate analytical ability everyone. 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 due date Evaluation sheets are prepared for each laboratory assistant. On the score sheet, the name of the test, the result obtained by the laboratory assistant, the true value and the standard deviation are recorded. From these values, the difference between the true value and that obtained by the laboratory assistant is calculated, and divided by the standard deviation, for example: when examining blood hemoglobin, the laboratory assistant obtained a value of 163 g/l, X cf.=162 g/l; S=2, so KS = (163-162)/2 = 0.5.

The lower the KS, the better job laboratory assistant. This value can be used to rank laboratory assistants 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 - very bad.

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

Automation of intralaboratory quality control

Conducting internal laboratory quality control in in full for all research carried out in the CDL requires a significant investment of labor, time and money. The reduction of these costs is possible only with the automation of quality control using 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 personnel of the CDL as a routine work is to enter into the program the results of measurements of the control material or patient samples.

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

The currently used wide range of laboratory studies 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 allow monitoring 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 the metrological support of measuring instruments, the procedure and terms for verifying measuring instruments in the CDL are determined. Measuring instruments are verified by departmental metrological authorities 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 forbidden to work on an untested device. The error of the instrument is included in the total error of the analysis. The error of the analysis includes the errors of the laboratory assistant, sampling, dosing, measurement.

Due to the fact that CDL verification tools are not available, some characteristics of photometric absorptiometers can be checked using control filters included 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 CDL and allow checking 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, the lipid content of this instrument can be tested. The 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, quantitatively transfer 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 ammonium cobalt 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 at room temperature to the mark 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, bring the volume to the mark with 0.05 N KOH solution.

The total component of the laboratory error includes dosing error. Therefore, it is a very special problem to check the used dosing and measuring means for the accuracy of the readings. It is known from practice that about 30-40% of all volumetric utensils are rejected due to its measured volume error according to the following formula: ((initial volume - volume obtained) / 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 lab is of good quality. The assessment of accuracy is carried out on an analytical balance by the gravimetric method: the mass of water, which is the volume of the dosing object, is repeatedly (at least 10 times) weighed 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 monitoring the quality of distilled water (purity, pH value).

Approve the industry standard "Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials" OST 91500.13.0001-2003 (Appendix).

Decree of the Government of the Russian Federation of 05.11.1997 N 1387 "On measures to stabilize and develop health care and medical science in the Russian Federation" (Sobraniye zakonodatelstva Rossiyskoy Federatsii, 1997, N 46, art. 5312).

An integrated system of regulatory support - the development of industry standards governing the pre-analytical, analytical and post-analytical stages of quantitative, qualitative and other methods for studying laboratory indicators will significantly increase the reliability of laboratory research results.

The industry standard "Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials" was created to provide normative support for everyday intralaboratory quality control procedures aimed at identifying unacceptable random and systematic errors at the analytical stage of clinical laboratory research performed by quantitative methods. A random measurement error is a component of the error of the measurement result, which changes randomly (in sign and value) during repeated measurements carried out with the same care, of the same physical quantity. A systematic measurement error is a component of the measurement result error that remains constant or regularly changes during repeated measurements of the same physical quantity.

Quality control of clinical laboratory studies is an integral part of the system of interrelated measures for managing the quality of medical care, including quality planning by establishing accuracy standards, quality assurance by examining research methods, laboratory equipment and consumables that are allowed for use in clinical diagnostic laboratories of medical organizations, and establishing rules for obtaining, storing and transporting samples of biomaterials from a patient in clinical diagnostic laboratories.

Quality control of clinical laboratory research exists in two interrelated forms: intralaboratory quality control and external quality assessment. External assessment of the quality of laboratory research in medical organizations of the Russian Federation is regulated by the relevant regulatory documents. Intralaboratory quality control of clinical laboratory studies is carried out by employees of each clinical diagnostic laboratory in order to maintain the stability of the analytical system and is regulated by the regulatory documents of the medical organization.

This industry standard introduces limit values for error characteristics. Uniform requirements for the analytical quality of quantitative methods have been developed for measuring blood, blood serum and urine. The limit values are set by peer review based on information about the biological variation of the components of biological fluids and data on analytical variation obtained as a result of activities (Appendix 1 to this industry standard).

Intralaboratory quality control is mandatory for all types of quantitative studies performed in a clinical diagnostic laboratory for which control materials have been developed.

Normative documents regulating diagnostic laboratories. Quality control of laboratory research Order 220 on quality control

MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION

ORDER dated May 26, 2003 N 220

ON APPROVAL OF THE INDUSTRY STANDARD "RULES FOR INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS"

INDUSTRY STANDARD

SYSTEM OF STANDARDIZATION IN HEALTH CARE OF THE RUSSIAN FEDERATION

REGULATIONS INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS OST 91500.13.0001-2003

1 AREA OF USE

2. MAINTENANCE OST

3. REGULATORY REFERENCES

4. ABBREVIATIONS

5. INTRALABORATORY QUALITY CONTROL OF CLINICAL LABORATORY STUDIES

5.1. Introduction

5.2. Intralaboratory control in the quality management system of medical care

5.3. General principles of organization and conduct of intralaboratory quality control in CDL

6. RULES FOR INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS

6.1. Control materials

6.2. Requirements for control materials

6.3. Use of control materials

6.4. Statistical basis for assessing the errors of quantitative research methods using control materials

6.5. The procedure for conducting intralaboratory quality control

6.5.1. Stage 1: Evaluation of the convergence of the measurement results

6.5.2. Stage 2: assessment of the reproducibility and correctness of the measurement results (setup series), construction of control charts

6.5.3. Stage 3: conducting operational intralaboratory quality control

6.5.4. Change of control material

LIMIT PERMISSIBLE VALUES OF OFFSET (B) AND COEFFICIENT OF VARIATION (CV) FOR DETERMINATION OF LABORATORY INDICATORS IN THE CONTROL MATERIAL

REGISTRATION FORM "ASSESSMENT OF CONVERGENCE OF MEASUREMENT RESULTS"

REGISTRATION FORM "RESULTS OF INSTALLATION SERIES OF MEASUREMENTS OF THE INDICATOR IN CONTROL MATERIALS"

List of main documents

6. RULES FOR INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS

ORDER
dated May 26, 2003 N 220

REGULATIONS
INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS
OST 91500.13.0001-2003