Order 220 on quality control. Quality control of laboratory tests. Rules for conducting internal laboratory quality control of quantitative methods using control materials
"On the approval of the industry standard" Rules for conducting internal laboratory quality control of quantitative methods of clinical laboratory research using control materials "
Edition of 05/26/2003 - Valid
MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION
ORDER
dated May 26, 2003 N 220
ON APPROVAL OF THE INDUSTRIAL STANDARD "RULES FOR CONDUCTING IN-LABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS"
In order to develop the system of standardization in the health care of the Russian Federation and manage the quality of medical care, I order:
To approve the industry standard "Rules for conducting internal laboratory quality control of quantitative methods of clinical laboratory research using control materials" OST 91500.13.0001-2003 (appendix).
The minister
Yu.L. SHEVCHENKO
Appendix
APPROVED BY
By order of the Ministry of Health of Russia
dated May 26, 2003 N 220
INDUSTRY STANDARD
SYSTEM OF STANDARDIZATION IN HEALTHCARE OF THE RUSSIAN FEDERATION
REGULATIONS
IN-LABORATORY 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 internal laboratory quality control of quantitative methods of clinical laboratory research using control materials" establishes a unified procedure for internal laboratory quality control of quantitative tests performed in clinical diagnostic laboratories, medical organizations that include these laboratories.
2. MAINTENANCE OF OST
OST is maintained by the Moscow Medical Academy. THEM. Sechenov, 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" (Collected Legislation of the Russian Federation, 1997, N 46, Art. 5312).
Resolution 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" (Collected Legislation of the Russian Federation, 1999, N 44, Art. 5322).
Decree of the Government of the Russian Federation of 04.07.2002 N 499 "On approval of the Regulation on licensing of medical activities" (Collected Legislation of the Russian Federation, 2002, N 27, Art. 2710; N 41, Art. 3983).
4. ABBREVIATIONS
The following abbreviations are used in the text of the industry standard: OST - Industry standard
5. IN-LABORATORY 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 tests.
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 of researching 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 daily intralaboratory quality control procedures aimed at identifying unacceptable random and systematic errors at the analytical stage of clinical laboratory studies performed by quantitative methods. The random measurement error is the component of the measurement result error that changes randomly (in sign and value) during repeated measurements, carried out with the same care, of the same physical quantity. The systematic measurement error is the component of the measurement result error that remains constant or regularly changes during repeated measurements of the same physical quantity.
5.2. Internal laboratory control in the quality management system of medical care
Quality control of clinical laboratory tests is an integral part of a system of interrelated measures for managing the quality of medical care, including quality planning by setting accuracy standards, quality assurance through examination of research methods, laboratory equipment and consumables allowed for use in clinical diagnostic laboratories of medical organizations and establishment of rules for the receipt, storage and transportation of biomaterial samples 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 tests in medical organizations of the Russian Federation is regulated by the relevant regulatory documents. Intralaboratory quality control of clinical laboratory tests 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 specifies the tolerance limits for the error characteristics. Uniform requirements for the analytical quality of quantitative methods have been developed for measuring blood, serum and urine parameters. The maximum permissible values are established by expert judgment based on information on biological variation of 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 organizing and conducting internal quality control in CDL
The organization and provision of internal laboratory 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 carrying out internal laboratory quality control of measurements of laboratory parameters should be carried out according to the rules of this OST.
It is allowed to use the clinical diagnostic laboratory of 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.
The reporting forms of the internal laboratory quality control are drawn up in the form of control charts (in accordance with clause 6.3), tables, journals or on electronic media and are archived for a period of at least 3 years.
The results of internal laboratory quality control should be reflected in the reporting forms, which 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 "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 internal laboratory quality control" (Appendix 4 to this industry standard).
The presence of a system of internal laboratory quality control is one of the criteria for laboratory accreditation and is taken into account when licensing medical activities.
Verification of the presence of a system of intralaboratory quality control in clinical diagnostic laboratories is carried out by territorial health authorities.
6. RULES FOR CONDUCTING IN-LABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS
These rules establish the means, methods and procedure for carrying out in-laboratory quality control of quantitative methods of clinical laboratory research, providing for the use of control materials and aimed at identifying unacceptable random and systematic errors at the analytical stage of laboratory research.
The analytical stage of laboratory research includes: storage and preparation of the sample for measurement, calibration of the analytical system, measurement of the laboratory parameter in the analytical series, in patient samples and control materials, assessment of the acceptability of the results. 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 readjustment and calibration of the analytical system, in which the characteristics of the analytical system remain stable.
The purpose of internal laboratory quality control is to achieve 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 evaluate the measurement error of the laboratory indicator in patient samples.
Control materials used in clinical diagnostic laboratories for carrying out in-laboratory quality control of quantitative methods of clinical laboratory research should be recommended for use by the Ministry of Health of the Russian Federation.
During internal laboratory 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 (concentration of the substance, 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 can be 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 uncertified values - only for control of 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:
- 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; control material of animal or mixed origin is allowed, except for certain analytical methods (limitations are indicated in the manufacturer's instructions).
- Test Component Levels in the control material must correspond to the values of the indicators in the normal and pathological ranges; the range of values of the laboratory indicator corresponding to the state of health of the subject is taken as normal, and 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 parameters studied in the laboratory.
Methods for determining indicators in the control material should correspond to the methods used in the particular laboratory.
after making 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 bottle or reconstructing lyophilized forms:
4 - 8 hours at 20 - 25 ° C; the reconstruction time of lyophilized forms is no more than 30 minutes at 20 - 25 ° C.
6.3. Use of control materials
The quantity of purchased control material of one batch should be sufficient for conducting 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 required control material is carried out based on the number of studies to be controlled in a given laboratory.
The preparation of the control material for the study is carried out in accordance with the manufacturer's instructions. Control materials should be tested in the same way as patient samples, i.e. in the same analytical series and conditions.
When reconstructing lyophilized forms, to reduce the size of the dosing error, it is necessary to use the same verified dosing device.
One-time freezing and thawing of the reconstructed control material is allowed. A single thawing of frozen control material should be carried out at room temperature in an aqueous medium at 20-25 ° C. The method of freezing and thawing should be standardized for all studied parameters in accordance with the manufacturer's instructions.
For economical use of the reconstructed control material, it is possible to dispense the contents of the vial into aliquots. The volume of aliquots (not less than 0.5 ml) should be placed in tubes or vials of the corresponding volume with sealed caps, which are stored at -20 ° C and lower temperatures for later use.
The material from which the tubes are made should not adsorb 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 bases for assessing the errors of quantitative research methods using control materials
The statistical basis for assessing errors in intralaboratory quality control of quantitative laboratory research methods is the assumption that the frequency distributions of the results of multiple 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 assess random and systematic measurement errors:
- arithmetic mean(average):
where the sum of the squares of the deviations of the measurement results x1, x2, ..., xn from the mean
arithmetic
- the coefficient of variation(CV):
| (3) |
These statistical characteristics are used to assess the repeatability, reproducibility and accuracy of laboratory measurements in control material and patient samples.
The standard deviation (S) and the coefficient of variation (CV) characterize random errors and are used to assess the repeatability and reproducibility of measurements. The convergence of the 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. Reproducibility of measurement results is the proximity 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 displacement (B), which characterizes the correctness of the measurements. The accuracy of measurements reflects the closeness to zero of systematic errors in their results. The bias (B) is determined by the closeness of the arithmetic mean of the results of repeated measurements of the control material () to the certified value (AZ) of the measured quantity (see paragraph 6.1.1) and can be expressed in absolute and / or relative values. The relative systematic error or bias (B) is calculated by the formula:
| (4) |
The resulting result must contain a number sign (+ or -).
Appendix 1 shows the PDZ of the error characteristics: the relative bias (V) and the coefficient of variation (CV) for the determination of laboratory parameters in the control material.
6.5. The procedure for conducting internal laboratory quality control
The procedure for conducting internal laboratory quality control consists of three sequential stages:
Stage 1. Evaluation of the convergence of measurement results.
Stage 2: first, second and third stages. Evaluation of reproducibility and accuracy of measurement results (installation series), construction of control charts.
Stage 3. Conducting operational quality control of laboratory research results in each analytical series.
A preliminary assessment of the repeatability, reproducibility and accuracy of measurements of the laboratory indicator (stages 1 and 2 of internal laboratory quality control) is carried out when each new technique is introduced into the laboratory. If significant changes are made to the analytical system, namely, when the analytical principles of measurement (instruments, reagents, calibration means, control materials, technological procedure, etc.) change, stages 1 and 2 of internal laboratory quality control should be repeated. Performing 20 measurements of a laboratory indicator in control materials in 2 stages is called a setting 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 the laboratory indicator, obtained in the laboratory, are assessed by the values of the coefficient of variation and relative displacement, 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: evaluating the convergence of the measurement results
Purpose: to verify that the convergence of the measurement results meets the established standards.
Test material: control material or patient sample with the value of the determined indicator in the normal range.
Carry out 10 measurements in the same material in one analytical series.
The measurement results should be entered into the registration form "Assessment of the convergence of measurement results" (Appendix 2 to this industry standard).
Check that the obtained 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 carry out work to eliminate them. Then repeat stage 1.
If the convergence is consistent with the established standards, they proceed to the next stage.
6.5.2. Stage 2: assessment of reproducibility and accuracy of measurement results (installation series), construction of control charts
FIRST STAGE
Purpose: preliminary assessment of the compliance of the values of the coefficient of variation and relative displacement with the established norms.
Test material: measurement of the determined indicator is carried out in two certified control materials<*>- to assess the values of the coefficient of variation and the relative bias of the method. The values of the determined parameters 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 operational quality control.
<*>It is possible to use two certified and two non-certified control materials as a test material in the 2nd stage. Two certified control materials - to assess the values of the relative displacement and; two uncertified control materials - for carrying out the installation series of measurements and for evaluating the values of the coefficient of variation and.
Sequence of execution:
Measure the indicator in 10 analytical series; in each series, one measurement simultaneously in two control materials;
The results should be entered into the registration form "Results of the installation series of measurements of the indicator in control materials" (Appendix 3 to this industry standard);
Perform the indicated series one per day (if necessary, it is allowed to carry out 2-3 series per day, 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 displacement;
Check that the obtained values and do not exceed the maximum permissible 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 carry out work to eliminate them. Then the first stage is performed again.
If the values of the coefficient of variation () and relative displacement () 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
displacement () to the established norms.
Materials under study: the same as in the first stage.
Sequence of execution:
Measure 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 permissible measurement values and (Appendix 1 to this industry standard).
If one of the obtained values or exceed the values of the corresponding and, identify the sources of unacceptably large random and systematic errors and carry out work to eliminate them. Then the second stage is performed again.
If the values of the coefficient of variation and the relative displacement do not exceed the established norms, a final conclusion is made about the possibility of using the considered technique for the purposes of laboratory diagnostics and proceeds to the next stage - the construction of control charts.
THIRD STAGE
Purpose: building control charts.
Sequence of execution:
From the results of measurements of the determined indicator obtained in the installation series for each control material according to formulas 1-2, the following is calculated: the arithmetic mean, standard deviation S, control limits:, and.
If in a 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 and S.
The control chart, built on the basis of the installation 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).
A line corresponding to the arithmetic mean is drawn through the middle of the ordinate axis, and lines corresponding to the control limits are marked parallel to this line:
Control limit "1 standard deviation";
Control limit "2 standard deviations";
3 standard deviations control limit.
Control charts are constructed for each laboratory parameter 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 likelihood of detecting errors in daily operational quality control. Narrow control limits increase the likelihood of false rejection of an analytical batch.
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 internal quality control
Conducting operational quality control of quantitative laboratory research methods involves the serial measurement of the indicator in control materials and an 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: confirmation of the stability of the analytical system based on the results of the study of control materials in each analytical batch.
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 uncertified control materials in two ranges of determined indicators.
Sequence of execution:
Calibrate the analytical system in accordance with the procedure.
Distribute samples of control materials evenly among the analyzed samples of patients.
Carry out a single measurement of the indicator in control materials and patient samples in each analytical batch (the number of measurements in an analytical batch is not limited)
Mark 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 by 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 batch. Control rules are indicated by type symbols, where A- the number of control results, L- control limit.
Check the presence of the rule on both control cards;
If one of the results of the analysis of control materials is outside the limits, sequentially check for the presence of control rules,,,, and; an analytical series is recognized as 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 considered 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 corresponding line.
If, in addition to a sign, at least one of the indicated signs is found:,,,, 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 signs,, should be checked on one control chart and / or on both control charts (Figure 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 re-examined.
The results of measurements of control materials in a batch found to be unacceptable should not be used in the assessment according to the control rules of repeated and subsequent batches.
If none of the above signs are found on any control card, the research should be continued.
The decision on the acceptability of the results of measuring the laboratory indicator in the biological material of patients is made by the employee responsible for the quality of the research. If the results of the analytical batch are found unacceptable, an appropriate entry is made in the "Recording of rejected results of internal laboratory quality control" (Appendix 4 to this industry standard).
The control sign is a warning sign, its appearance should not lead to discarding the results of the analytical batch and re-examination of 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 method.
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 constructed.
In the laboratory, it is allowed to select other algorithms for the application of control rules that are allowed for use in clinical diagnostic laboratories, in the manner prescribed by the relevant regulatory documents. The detection of control signs in the daily work of a 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 control material
To maintain the continuity of the internal laboratory control during the period when the used control material remains only for 20 analytical series, it is necessary to switch to a new control material by carrying out the so-called "overlap".
Overlapping consists in the fact that during 20 series (overlapping period) the clinical diagnostic laboratory examines the simultaneously ending material ("used"), for which the current control continues, and the material that replaces it ("introduced"). In this case, the samples of the introduced control material are placed in positions spaced two or more positions from the positions in which the samples of the used control material are located. For example, if samples of the used control material are at positions 07, 36, then samples of the injected control material can be placed at positions 4, 33.
Based on the results obtained for the introduced control material, the arithmetic mean and standard deviation are calculated, according to which a new control chart is constructed.
Appendix N 1
to the industry standard
THE LIMITING PERMISSIBLE VALUES OF THE DISPLACEMENT (B) AND THE VARIATION COEFFICIENT (CV) FOR DETERMINING LABORATORY INDICATORS IN THE CONTROL MATERIAL
| Study of biological fluids | OK-PMU code | , % | , % | , % | , % | |
| 1 | Study of the level of alanine transaminase<*>in blood | 09.05.042 | ± 17 | 16 | ± 15 | 15 |
| 2. | Study of the level of albumin in the blood | 09.05.011 | +5 | 4 | ± 4 | 4 |
| 3. | Study of the level of amylase<*>in blood | 09.05.045 | ± 16 | 11 | ± 15 | 10 |
| 4. | Study of the level of aspartate transaminase<*>in blood | 09.05.041 | ± 11 | AND | ± 10 | 10 |
| 5. | Study of the level of total protein in the blood | 09.05.010 | ± 5 | 3 | ± 5 | 3 |
| 6. | Study of the level of total bilirubin in the blood | 09.05.021 | ± 17 | 16 | ± 15 | 15 |
| 7. | Study of the level of gamma glutamine transferase<*>in blood | 09.05.044 | ± 16 | 11 | ± 15 | 10 |
| 8. | Blood glucose test | 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. | Study of the level of creatinine in the blood | 09.05.020 | ± 11 | 8 | ± 10 | 7 |
| 13. | Study of the level of creatine kinase<*>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 of blood plasma | 09.05.025 | ± 17 | 16 | +15 | 15 |
| 20. | 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. | Study of the level of cholesterol in the blood | 09.05.026 | ± 9 | 8 | ± 8 | 7 |
| 23. | Study of the level of alkaline phosphatase<*>in blood | 09.05.046 | ± 16 | 11 | ± 15 | 10 |
| 24. | Determination of protein in urine | 09.28.003 | ± 24 | 27 | ± 20 | 25 |
| 25. | Study of the level of glucose in urine | 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 red blood cells 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 N 2
to the industry standard
"Rules for conducting an intralaboratory
quality control quantitative methods
clinical laboratory research
using control materials "
REGISTRATION FORM "EVALUATION OF CONVERGENCE OF MEASUREMENT RESULTS"
| Laboratory: | Indicator: | |||
| The Department: | ||||
| Measurement date: | Test material (underline as required): patient sample, control material | |||
| Measurement technique: | Control material (name, range of values): | |||
| Executor: | Control material manufacturer: | Control lot #: | Shelf life of the control material: | |
| Measurement serial number | Indicator measurement result | |||
| 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 is entered into the registration form and compared with the value 0,5 (Appendix 1 to this industry standard).
Head of the Clinical Diagnostic Laboratory .................... signature
Appendix N 3
to the industry standard
"Rules for conducting an intralaboratory
quality control quantitative methods
clinical laboratory research
using control materials "
REGISTRATION FORM "RESULTS OF INSTALLATION SERIES OF MEASUREMENT OF INDICATOR IN CONTROL MATERIALS"
| Laboratory: The Department: | Indicator: | Measurement date from to Executor: |
|||||||||
| Control materials:(names) | Best before date: | Manufacturers: | N batch | Passport values (value range): | |||||||
| 1. | 1. | 1. | 1. | 1. | |||||||
| 2 | 2. | 2. | 2. | 2. | |||||||
| Instrument: | 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 | |||||||||||
| = = | = = | = = |
|||||||||
In almost all articles on the organization and planning of the quality control process for clinical laboratory research, there are similar pictures:
The meaning of this picture is that the three systems - intralaboratory quality control, external assessment of research quality and interlaboratory quality control - do not oppose, do not replace, but are designed to complement each other. Only by putting three pieces of the puzzle together, participating in all three quality control systems, can you get a reliable picture. We offer you the simultaneous solution of two of the three tasks, moreover, for the same cost. How? Read on ...
Quality control of CDL work is understood as a system of measures aimed at quantifying closeness of results to true
measured value "> accuracy,
measurements made
under different conditions "> reproducibility,
close to zero systematic
errors in their results,
those. matching average
results values
true value measurements
measured component "> correct and proximity to each other of results
measurements carried out
under the same conditions "> convergence laboratory research. Quality control should be objective, daily, covering all areas of measurement - normal and pathological results. Quality control activities are aimed both at assessing whether the results obtained are reliable enough for the laboratory to issue them, and at eliminating the causes of unsatisfactory characteristics of these results.
- Internal laboratory quality control(VKK) - a system of measures carried out directly in the laboratory in each analytical series. The VKK is intended for self-assessment of the quality of the analysis results obtained in the laboratory by using the accepted algorithms for assessing measurements of the analyte content in control materials. Its main purpose: assessment and continuous monitoring proximity to each other of results
measurements made
in different conditions "> reproducibility measurement results.Some experts do not view internal quality control as a complete assessment tool. correctness analyte measurements and recommend using clinical laboratory diagnostics, M., 2004 "> passport values of the certified control material only as indicative... To obtain a reliable picture, the laboratory must participate in any of the external quality assessment programs.
- External quality assessment(EQA) - an objective verification of laboratory results, carried out periodically by an external organization. The purpose of external assessment of the quality of research is to assess the compliance of research results with the established standards of analytical accuracy, that is, periodic validation measurements. External assessment of the quality of clinical laboratory tests in clinical diagnostic laboratories is carried out in accordance with the regulatory documents of the Ministry of Health of Russia. Participation in the Federal System of External Quality Assessment is recommended for laboratories of all forms of ownership and is taken into account during their accreditation and licensing, but is not mandatory. At the same time, it is possible for laboratories to participate in other external quality assessment programs: international, commercial, regional.
Until recently, it was believed that the participation of laboratories in the FSVOK was mandatory. However, on December 30, 2014, the Federal Antimonopoly Service of Russia published a report on the conduct of an unscheduled on-site inspection of Roszdravnadzor. There were quite a few results of this check, and it is best to read about the part of them that concerns FSVOK in an article from the magazine Vademecum [Come with me]. In short: discrimination against laboratories and clinics that do not participate in the FSVOK is unacceptable. Laboratories are free to use any external quality assessment program of their choice.
- Interlaboratory quality control(IQC) is a kind of external quality control. This method allows you to identify systematic and random errors by monitoring proximity to each other of results
measurements carried out
under the same conditions "> convergence results obtained in several laboratories on the same control material using the same method. The method of interlaboratory comparisons can replace external quality assessment in cases where the required types of research are not covered by the available EQA systems, or their application is not economically feasible.
To approve the industry standard "Rules for conducting internal laboratory quality control of quantitative methods of clinical laboratory research using control materials" OST 91500.13.0001-2003 (Appendix).
The industry standard "Rules for conducting internal laboratory quality control of quantitative methods of clinical laboratory research using control materials" establishes a unified procedure for internal laboratory quality control of quantitative tests performed in clinical diagnostic laboratories, medical organizations that include these laboratories.
Resolution 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" (Collected Legislation of the Russian Federation, 1997, N 46, Art. 5312).
Decree of the Government of the Russian Federation of 10.26.1999 N 1194 "On the Program of State Guarantees for Providing Citizens of the Russian Federation with Free Medical Care" (Collected Legislation of the Russian Federation, 1999, N 44, Art. 5322).
Decree of the Government of the Russian Federation of 04.07.2002 N 499 "On approval of the Regulation on licensing of medical activities" (Collected Legislation of the Russian Federation, 2002, N 27, Art. 2710; N 41, Art. 3983).
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 tests.
An integrated system of regulatory support - the development of industry standards governing the preanalytical, analytical and postanalytical stages of quantitative, qualitative and other methods of researching 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 daily intralaboratory quality control procedures aimed at identifying unacceptable random and systematic errors at the analytical stage of clinical laboratory studies performed by quantitative methods. The random measurement error is the component of the measurement result error that changes randomly (in sign and value) during repeated measurements, carried out with the same care, of the same physical quantity. The systematic measurement error is the 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 research is an integral part of a system of interrelated measures for managing the quality of medical care, including quality planning by setting accuracy standards, quality assurance through examination of research methods, laboratory equipment and consumables allowed for use in clinical diagnostic laboratories of medical organizations. and the establishment of rules for the receipt, storage and transportation of biomaterial samples 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 tests in medical organizations of the Russian Federation is regulated by the relevant regulatory documents. Intralaboratory quality control of clinical laboratory tests 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 specifies the tolerance limits for the error characteristics. Uniform requirements for the analytical quality of quantitative methods have been developed for measuring blood, serum and urine parameters. The limit values are established by expert judgment based on 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).
The organization and provision of internal laboratory 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.
It is allowed to use the clinical diagnostic laboratory of 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.
The reporting forms of the internal laboratory quality control are drawn up in the form of control charts (in accordance with clause 6.3), tables, journals or on electronic media and are archived for a period of at least 3 years.
6. RULES FOR CONDUCTING IN-LABORATORY QUALITY CONTROL OF QUANTITATIVE METHODS OF CLINICAL LABORATORY STUDIES USING CONTROL MATERIALS
These rules establish the means, methods and procedure for carrying out in-laboratory quality control of quantitative methods of clinical laboratory research, providing for the use of control materials and aimed at identifying unacceptable random and systematic errors at the analytical stage of laboratory research.
The analytical stage of laboratory research includes: storage and preparation of the sample for measurement, calibration of the analytical system, measurement of the laboratory parameter in the analytical series, in patient samples and control materials, assessment of the acceptability of the results. 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 readjustment and calibration of the analytical system, in which the characteristics of the analytical system remain stable.
4.1. General principles organization and conduct of intralaboratory quality control in CDL
In accordance with the Regulations on the CDL of health care facilities and the centralized clinical diagnostic laboratory (Appendix 1 to the order of the Ministry of Health of the Russian Federation dated December 25, 1997 N 380), one of the most important tasks of the laboratory is to improve the quality of laboratory research through systematic internal laboratory quality control of laboratory research and participation in the program of the federal system of external quality assessment (hereinafter - FSVOK).Quality control consists in the development and implementation of control measures to detect and track unacceptable random and systematic errors that may appear during the analysis of biomaterial samples and distort information about the state of the internal environment of the examined patients.
Quality control of clinical laboratory tests at the level of the clinical diagnostic laboratory (intralaboratory quality control) consists in constant, that is, everyday, in each analytical series, monitoring activities, including the examination of samples of control materials and the application of control measures using patient samples.
The goal of internal quality control is to achieve the stability of the analytical system. In this case, the following tasks are solved - detecting an unacceptable error in the results of analyzes performed by the laboratory, assessing the compliance of the research results with the 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.
Internal laboratory quality control is mandatory for all types of research carried out in the laboratory. The procedure for internal laboratory quality control should be reflected in the "Guidelines for the quality of clinical laboratory research" of this particular laboratory. The organization of internal laboratory quality control of research in accordance with the regulatory documents of the Ministry of Health of Russia is the responsibility of the head of the laboratory and the laboratory staff authorized by him, while the direct performance of control studies is carried out by the laboratory doctor during the analysis of biological indicators. The presence of a system of internal laboratory quality control is one of the grounds for accreditation and licensing of laboratories.
What should be done in laboratories for so that your analyzes give more accurate results? For this, along with the identification and timely elimination of possible errors; it is necessary daily, in parallel with the material from patients, to conduct studies of the concentration of indicators and in the control material. The indicators obtained as a result of the analysis of the control material are plotted on a graph on the so-called. control chart and compared with the true (established or target) value given in the passport to the control material. Based on the results of this comparison, a conclusion is drawn - whether the study was carried out correctly, whether errors were made in the methodology, and, finally, whether it is possible to believe those results analysis of patients' samples, which were obtained in parallel with the analysis of the control material.
Thus, the laboratory assistant, receiving the results of the study of the control material, can himself assess the quality of the determination of any indicator and either transfer the results of the patients' analyzes to the doctor, or repeat the study. 4.2. Rules for conducting internal laboratory quality control of quantitative methods using control materials
4.2.1. General Provisions
The procedure and technology for conducting in-laboratory quality control of measurements of laboratory parameters must comply with the industry standard "Rules for conducting in-laboratory quality control of quantitative methods of clinical laboratory research using control materials" OST 91500.13.0001-2003 (Order of the Ministry of Health of the Russian Federation of May 26, 2003, N 220) ...The results of internal laboratory quality control should be reflected in the reporting forms, which are given in Annexes to the specified industry standard:
form "Assessment of the convergence of measurement results" (Appendix 2 to OST);
form "Results of the setting series of measurements of the indicator in control materials" (Appendix 3 to OST);
journal "Registration of rejected results of internal laboratory quality control" (Appendix 4 to OST).
Verification of the presence of a system of intralaboratory quality control in clinical diagnostic laboratories is carried out by territorial health authorities.
Reporting forms for internal laboratory quality control are drawn up in the form of control charts, tables, journals or on electronic media and archived for a period of at least 3 years. 4.2.2. Control materials and their use
The control material is a natural or artificial homogeneous material containing the same components as the studied patient samples. The measurement result of the control material is used to evaluate the measurement error of the laboratory indicator in patient samples. The control material cannot be used simultaneously as a calibration material.
For intralaboratory control, control materials with certified and non-certified values of controlled indicators can be used. The certified value is the value of the measured characteristic of the control material (concentration of the substance, enzymatic activity, etc.), established during its certification and given in the passport for the control material. Control materials with certified values indicators are used to control the correctness and reproducibility of laboratory analysis results, and with uncertified values - only to control reproducibility.
For the same indicator in the documents for the control material, several values can be indicated separately for each measurement method. These values can vary significantly from each other. Therefore, it should be borne in mind that it is possible to control the correctness of the analysis only if the certified values for your research method are given in the passport to the control material.
From the requirements for control materials and work with them, it is necessary to highlight the following:
The levels of the investigated components in the control material must correspond to the values of the indicators in the normal and pathological ranges; the range of values of the laboratory indicator corresponding to the state of health of the subject is taken as normal, and the range corresponding to the state of the patient's illness is taken as pathological.
Control charts are drawn up and archived: in the form of graphs, tables, including on electronic media.
Stage 3: Conducting operational internal quality control
Conducting operational quality control of quantitative laboratory research methods involves the serial measurement of the indicator in control materials and an 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: confirmation of the stability of the analytical system based on the results of the study of control materials in each analytical batch.
Test material: For operational quality control, the laboratory must use two CRMs in two ranges defined indicators, however, it is possible to use two non-certified control materials in two ranges of determined indicators. In the latter case, in the course of daily studies, it is possible to control only the reproducibility of the analyzes performed.
Evaluation of the acceptability of the results of patient samples in a given analytical series is carried out according to the results of measuring control materials using control rules.
Sequence of execution:
Calibrate the analytical system in accordance with the procedure.
Distribute samples of control materials evenly among the analyzed samples of patients.
Carry out a single measurement of the indicator in control materials and patient samples in each analytical series (the number of measurements in an analytical series is not limited).
Mark 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 rules, use the algorithm shown in Figure 21.
The sequence of application of the algorithm:
Check for the presence of rule 1 2s on both control cards;
If one of the results of the analysis of control materials is outside the range (X ± 2S), sequentially check for the presence of the following control rules 1 3s, 2 2s, R 4s, 4 1s, and 10 X. An analytical series is considered unsatisfactory if at least one of them is present :
1 3s - one of control measurements goes beyond limits (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 considered analytical series are located on opposite sides of the X ± 2S corridor;
4 1s - the last four control measurements are above (X + 1S) or below the limit (X - 1S).
10 X - the last ten control measurements are located on one side of the line corresponding to X.
Rice. 21. Scheme of sequential application of control rules
If, in addition to the 1 2s feature, at least one of the specified features is found: 1 3s, 2 2s, R 4s, 4 1s, or 10 X, all the results obtained in this analytical series should be considered unacceptable.
Control signs should be checked first on each control chart separately and then simultaneously on both control charts. An example of control charts for two control materials showing batches that are unsatisfactory due to violation of different control rules is shown in Fig. 22.
If the batch is found unacceptable, the analysis must be suspended, the causes of the increased errors must be identified and eliminated. All samples analyzed in this series (both patients and controls) should be re-examined.
The results of measurements of control materials in a batch found to be unacceptable should not be used in the assessment according to the control rules of repeated and subsequent batches.
If none of the above signs is found on any control card, the research should be continued, and the results obtained should be entered on the forms (authorized).
Solution on the acceptability of the measurement results laboratory indicator in the biological material of patients is taken by the employee responsible for the quality of research. If the results of the analytical batch are recognized as unacceptable, an appropriate entry is made in the journal "Registration of rejected results of internal laboratory quality control" (Appendix 4 to the OST).
Rice. 22. Examples of violation of control rules in the case of two control materials. The numbers of the unsatisfactory series are circled and the rules violated in them are indicated.
Pool A - control material with normal values: X = 100, S = 4.
Pool B - control material with pathological values: X = 150, S = 5.
Control feature 1 2s is a warning, its appearance should not lead to discarding the results of the analytical series and re-examination of samples. The appearance of control signs: 1 3s - indicates the presence of a gross error, R 4s - an increase in random errors, and signs 2 2s, 4 1s and 10 X - an increase in the systematic error of the method.
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 constructed. Moreover, if the laboratory works with certified control materials, it can assess not only the reproducibility, but also the correctness of measurements of the laboratory indicator (2nd stage of internal laboratory quality control), compare the obtained values with the maximum permissible and, if necessary, correct the parameters of the analytical system.
In the laboratory, it is allowed to select other algorithms for applying control rules that are approved for use in clinical diagnostic laboratories, in the manner prescribed by the relevant regulatory documents. The detection of control signs in the daily work of a clinical diagnostic laboratory can be performed "manually" or with the help of special computer programs. 4.2.5. Change control material
To maintain the continuity of the internal laboratory control when changing the control material, the transition to a new control material is carried out using the so-called "overlap" in the period when the used control material remains only for 20 analytical series.
Overlapping consists in the fact that during 20 series (overlapping period) the clinical diagnostic laboratory examines the simultaneously ending material ("used"), for which the current control continues, and the material that replaces it ("introduced"). In this case, the samples of the introduced control material are placed in positions spaced two or more positions from the positions in which the samples of the used control material are located. For example, if the samples of the used control material are in positions 7, 36, then the samples of the injected control material can be placed in positions 4, 33.
Based on the results obtained for the introduced control material, the arithmetic mean and standard deviation are calculated, according to which a new control chart is constructed.