dselection.ru

Quality control in laboratory orders. Quality control in the laboratory orders 45 order for quality control of laboratory research

QUALITY CONTROL OF LABORATORY STUDIES

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

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

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

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

Systematic measurement error part of the measurement error that remains constant or regularly changes during repeated measurements of the same measurand.

Random measurement error - part of the measurement error that varies randomly with repeated measurements of the same measurand.

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

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

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

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

General reproducibility – the quality of measurements, reflecting the proximity to each other of all measurements of the same material (determined by intra-series and inter-series reproducibility).

Set value - method-dependent value of the determined indicator, indicated by the manufacturer of the control material in the passport (instruction). Due to the fact that the true value of the measured value cannot be established absolutely accurately, in practice the term "set value" is used instead of the term "true value".

Quality assurance of laboratory researches in CDL is carried out by the system of intralaboratory quality control at which reproducibility and correctness of researches are systematically determined.

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



B = (1), where

is the average value of measurements of the controlled material;

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. The mathematical value of the random error is expressed by the standard deviation (S) and the coefficient of variation (CV).

ON THE APPROVAL OF SUPPLEMENT N 1 TO THE PROCEDURE FOR APPOINTING ON-SITE TAX CHECKS, APPROVED BY ORDER OF THE MINISTER OF THE RUSSIAN FEDERATION FOR TAXES AND FEES FROM 08.10.99 N AP-3-16/318

Minister
Russian Federation
on taxes and fees
A.P.POCHINOK

Application
to the order of the Ministry of Taxes of the Russian Federation
dated February 7, 2000 No. AP-3-16/34

APPENDIX No. 1
TO THE PROCEDURE FOR APPOINTING ON-SITE TAX CHECKS APPROVED BY ORDER OF THE MINISTER OF THE RUSSIAN FEDERATION ON TAXES AND DUTIES N AP-3-16/318 DATED 08.10.99 "ON APPROVAL OF THE PROCEDURE FOR APPOINTING ON-SITE TAX CHECKS"

Appendix No. 1
to Addendum No. 1

Appendix No. 4

tax audits

Place of the stamp of the tax authority Decision N ___ on making additions (changes) to the decision ________________________________________ (name of the tax authority) dated __________ N __ on conducting an on-site tax audit _________________________________ "__" ____________ (name of the settlement) (date) In connection with the need expansions (changes) in the composition of specialists conducting an on-site tax audit, ___________________ _________________________________________________________________________ (full name of the organization (full name of the individual entrepreneur), TIN); (full name of the organization, branch or representative office of the organization, TIN / code of the reason for registration) head (deputy head) _________________________________ (name of the tax authority) _______________________________________________________________________________ (class rank, surname, initials) Decided: Include in the decision on conducting an on-site tax audit dated _______ N ____________ the following (her) additions (s) (changes (s): _____________________________________________________________________________ (content of the additions (changes) introduced _______________________________________________________________________________ _______________________________________________________________________________ Head (deputy head) ______________________________________ (name of the tax authority) ______________________________________ ________ ____________ (class rank) (signature) (F. I.O.) (Place of printing) head of the organization (its branch or representative office) (full name of the individual entrepreneur) or full name her (his) representative) ______ _______________ (date) (signature)

Appendix No. 2
to Addendum No. 1

Appendix No. 5
to the procedure for appointing visiting
tax audits

Place of the stamp of the tax authority Resolution N ___ on making additions (changes) to the resolution ____________________________________ (name of the tax authority) dated __________ N __ on conducting a repeated field tax audit _________________________________ "__" ____________ (name of the settlement) (date) In connection with the need expansion (change) of the composition of specialists conducting a repeated field tax audit, _________ _______________________________________________________________________________ (full name of the organization (full name of the individual

  • dated February 16, 2009 N 45n (with amendments and additions)
  • ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION OF 07.02.2000 N 45 "ON THE SYSTEM OF MEASURES TO IMPROVE THE QUALITY OF CLINICAL LABORATORY STUDIES IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION" (TOGETHER WITH THE "REGULATION ON THE ORGANIZATION OF QUALITY MANAGEMENT OF LABORATORY STUDIES IN HEALTH CARE INSTITUTIONS, "RULES FOR INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE LABORATORY STUDIES" , "INTERIM STANDARDS FOR THE ACCURACY OF CLINICAL LABORATORY STUDIES")
  • ORDER of the Ministry of Health and Social Development of the Russian Federation dated February 16, 2009 N 45n (as amended on April 19, 2010) “ON APPROVAL OF THE NORMS AND CONDITIONS FOR THE FREE ISSUANCE OF MILK OR OTHER EQUIVALENT FOOD PRODUCTS TO WORKERS WORKING WITH HARMFUL CONDITIONS PRODUCTS, THE PROCEDURE FOR THE COMPENSATION PAYMENT IN THE AMOUNT EQUIVALENT THE COST OF MILK OR OTHER EQUIVALENT FOOD PRODUCTS, AND THE LIST OF HARMFUL PRODUCTION FACTORS UNDER THE INFLUENCE OF WHICH THE CONSUMPTION OF MILK OR OTHER EQUIVALENT FOOD PRODUCTS IS RECOMMENDED FOR PREVENTIVE PURPOSES"

Order of the Ministry of Health and Social Development of the Russian Federation of February 16, 2009 N 45n “On Approval of the Norms and Conditions for the Free Delivery of Milk or Other Equivalent Food Products to Employees Employed in Harmful Working Conditions, the Procedure for Making Compensatory Payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which, for preventive purposes, the use of milk or other equivalent food products is recommended” (with amendments and additions)

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

With changes and additions from:

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

1. The rules and conditions for the free distribution of milk or other equivalent food products to employees employed in jobs with harmful working conditions, which can be issued to employees instead of milk, in accordance with Appendix No. 1;

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

Registration N 13795

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

The rate of free milk distribution is still 0.5 liters per shift, regardless of the duration of the shift. The issued milk must comply with the requirements of the Technical Regulations for milk and dairy products. Employees who come into contact with inorganic compounds of non-ferrous metals (formerly lead) will be given 2 g of pectin in addition to milk as part of food products (drinks, jellies, jams, etc.). With constant contact with inorganic compounds of non-ferrous metals, sour-milk products or products for dietary (therapeutic and preventive) nutrition under harmful working conditions are relied on instead of milk.

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

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

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

Order of the Ministry of Health and Social Development of the Russian Federation of February 16, 2009 N 45n “On Approval of the Norms and Conditions for the Free Delivery of Milk or Other Equivalent Food Products to Employees Employed in Harmful Working Conditions, the Procedure for Making Compensatory Payments in an amount equivalent to the cost of milk or other equivalent food products, and the List of harmful production factors, under the influence of which, for preventive purposes, the use of milk or other equivalent food products is recommended.

This Order shall enter into force 10 days after the date of its official publication.

This document has been modified by the following documents:

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

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

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

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

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

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

1.3. Interim Accuracy Standards for Clinical Laboratory Tests (Appendix 3).

2. By January 1, 2001, the heads of the health authorities of the subjects of the Russian Federation should take measures to ensure the development in each clinical diagnostic laboratory of health care institutions of the "Guidelines for the Quality of Clinical Laboratory Tests" in accordance with the standard model (Appendix 1, Section 2) for the entire list research carried out in this laboratory.

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

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

4.1. Summarize during 2001 the results of the implementation in the country's clinical diagnostic laboratories of the "Temporary Accuracy Standards for Clinical Laboratory Research" with a view to the subsequent development of a "Clinical Laboratory Accuracy Standard".

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

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

5. To impose control over the implementation of this order on the First Deputy Minister A.I. Vyalkov.

Regulations

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

Federal Agency for Technical Regulation and Metrology GOST R 53133.2-2008 “Laboratory clinical technologies. Quality control of clinical laboratory research. Part 2. Rules for conducting intralaboratory quality control of quantitative methods of clinical laboratory research using control materials.

Federal Agency for Technical Regulation and Metrology GOST R 53133.3-2008 “Laboratory clinical technologies. Quality control of clinical laboratory research. Part 3. Description of materials for quality control of clinical laboratory studies.

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

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

Ministry of Health of the Russian Federation Order dated 07.02.2000. #45 "On the system of measures to improve the quality of clinical laboratory research in healthcare institutions of the Russian Federation."

Ministry of Health of the Russian Federation Order dated 30.03.2006. No. 224 " On approval of the Regulations on the organization of medical examinations for pregnant women and puerperas.

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

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

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

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

with changes and additions, included in the text,

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

1. The rules and conditions for the free distribution of milk or other equivalent food products to employees employed in jobs with harmful working conditions, which can be issued to employees instead of milk, in accordance with Appendix No. 1;

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

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

Application No. 1

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

Norms and conditions for the free distribution of milk or other equivalent food products to workers employed in jobs with harmful working conditions that may be given to workers instead of milk

according to the order of the Ministry of Health and Social Development of the Russian Federation of 19.04.2010. city ​​No. 245n and

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

It is allowed to replace the compensation payment with milk or other equivalent products at the written request of employees.

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

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

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

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

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

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

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

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

Norms for the free distribution of equivalent food products that can be given to employees instead of milk

ORDER OF THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION OF 07.02.2000 N 45 "ON THE SYSTEM OF MEASURES TO IMPROVE THE QUALITY OF CLINICAL LABORATORY STUDIES IN HEALTH CARE INSTITUTIONS OF THE RUSSIAN FEDERATION" (TOGETHER WITH THE "REGULATION ON THE ORGANIZATION OF QUALITY MANAGEMENT OF LABORATORY STUDIES IN HEALTH CARE INSTITUTIONS, "RULES FOR INTRALABORATORY QUALITY CONTROL OF QUANTITATIVE LABORATORY STUDIES" , "INTERIM STANDARDS FOR THE ACCURACY OF CLINICAL LABORATORY STUDIES")

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

Out-of-control method detected by the cusum method is not a reason to stop the analysis and re-examine patient samples. It serves only as a warning signal to draw attention to the presence of systematic errors in the analysis.

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

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

2.3. Rules for conducting quality control of quantitative methods of laboratory analysis using patient samples.

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

2.3.1. Method of control of correctness on daily averages.

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

Conditions necessary for the implementation of the method:

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

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

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

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

2.3.2. Method for controlling reproducibility by duplicates.

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

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

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

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

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

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

Appendix No. 1
to the Order of the Ministry
health and social
development of the Russian Federation
dated February 16, 2009 N 45n

Popular:

  • ORDER of the Ministry of Health and Social Development of the Russian Federation of April 23, 2008 N 188 "ON APPROVAL OF THE UNIFIED QUALIFICATION DIRECTORY OF POSITIONS OF MANAGERS, SPECIALISTS AND EMPLOYEES, SECTION "QUALIFICATION CHARACTERISTICS OF POSITIONS OF MANAGERS AND SPECIALISTS […]
  • Order of the Ministry of Health and Social Development of the Russian Federation of March 1, 2012 N 181n "On approval of the Model list of measures annually implemented by the employer to improve working conditions and […]
  • Examination of Applications for Inventions Approved by Rospatent Order No. 87 dated July 25, 2011 (as amended by Rospatent Order No. 1 dated January 10, 2013 and No. 2 dated January 14, 2014) CONTENTS USED ABBREVIATIONS 1 Paris […]
  • Order 759 In DEMO mode, the first few pages of paid and free documents are available to you. To view the full texts of free documents, you must log in or register. To get full access to […]
  • Order of the Ministry of Economic Development of the Russian Federation of November 14, 2006 N 376 "On approval of the administrative regulations of the Federal Agency for the Cadastre of Real Estate Objects for the provision of public service" Maintenance of the state […]
  • Order of the Federal Migration Service of February 29, 2008 N 41 "On approval of the Administrative Regulations for the provision by the Federal Migration Service of the state service for extradition to foreign citizens and persons without […]
  • Order of the Ministry of Health of the Russian Federation of December 20, 2012 N 1175n "On approval of the procedure for prescribing and prescribing medicines, as well as forms of prescription forms for medicines, the procedure for […]
  • MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION ORDER of September 8, 2006 N 654 ON AMENDING THE ORDER OF THE MINISTRY OF HEALTH AND SOCIAL DEVELOPMENT OF THE RUSSIAN FEDERATION OF NOVEMBER 30, 2004 N 29 4 "ABOUT […]
    Appendix 1. Regulations on the organization of quality management of clinical laboratory research in healthcare institutions Appendix 2. Rules for intralaboratory quality control of quantitative laboratory research Appendix 3. Interim standards for the accuracy of clinical laboratory research

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

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

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

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

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

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

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

4.1. Summarize during 2001 the results of the introduction in the country's clinical diagnostic laboratories of the "Interim Accuracy Standards for Clinical Laboratory Research" with a view to the subsequent development of a "Clinical Laboratory Accuracy Standard".

4.2. In 2000-2002, to ensure the development of normative documents on intralaboratory quality control of non-quantitative laboratory tests.

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

5. To impose control over the implementation of this order on the First Deputy Minister A.I. Vyalkov.

Table 1

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

Defined indicator +-V, %
10
CV, %
10
+-B,%
20
CV, %
20
Biochemical research
Blood serum
1. Alanine aminotransferase
2. Albumin
3. Alpha Amylase
4. Aspartate aminotransferase
5. Protein total
6. Bilirubin total
7. Gamma-Glutamyltransferase
8. Glucose
9. Iron
10. Potassium
11. Calcium
12. Cortisol
13. Creatinine
14. Creatine kinase
15. Lactate dehydrogenase
16. Magnesium
17. Uric acid
18. Urea
19. Sodium
20. Thyroxine general
21. Free thyroxine
22. Thyrotropin
23. Triglycerides
24. Triiodothyronine total
25. Triiodothyronine free
26. Phosphorus inorganic
27. Chlorides
28. Cholesterol
29. Alkaline phosphatase

17
5
16
11
5
17
16
6
12
5
3,4
18
11
23
11
7
11
11
1,8
11
13
23
17
11
13
8
3,4
9
16

18
5
12
12
4
18
12
6
19
5
3,6
12
8
24
12
7
8
12
2,4
12
12
24
18
12
12
8
3,6
8
12

15
4
15
10
5
15
15
5
10
4
3,0
17
10
20
10
6
10
10
1,5
10
12
20
15
10
12
7
3,0
8
15

15
4
10
10
3
15
10
5
16
4
3,0
10
7
20
10
6
7
10
2,0
10
10
20
15
10
10
7
3,0
7
10

Quantitative analysis of urine
1. Alpha Amylase
2. Protein
3. Glucose
4. Potassium
5. Calcium
6. Creatinine
7. Uric acid
8. Urea
9. Sodium
10. Chlorides
11. Phosphorus inorganic

26
23
22
18
21
23
18
17
17
16
24

54
30
18
24
24
24
24
18
18
6
36

20
20
20
15
18
20
15
15
15
15
20

45
25
15
20
20
20
20
15
15
5
30
Hematological research
1. Hemoglobin
2. Red blood cells

5
7

5
5

4
6

4
4

table 2

Biologically Based Standards for Analytical Accuracy of Clinical Laboratory Tests

N
p.p.
Defined indicator CV, %
I
CV, %
G
+-B,%
20
CV, %
20
1 Activated partial
thromboplastin time
4,4 8,9 3,4 3,0
2 Alanine aminotransferase, activity
in serum
23,0 41,1 16,8 15,8
3 Albumin, serum concentration 2,8 4,4 1,9 1,9
Albumin, concentration in the morning
urine
35,5 36,0 20,4 24,3
4 Aldosterone, plasma concentration 29,4 40,1 18,9 20,1
5 Alpha-amylase, activity in
serum
8,7 25,8 8,7 6,0
Alpha-amylase, activity in
morning urine
132,0 21,0 62,3 90,4
6
serum activity
9,3 31,7 10,3 6,4
Alpha amylase pancreatic,
activity in daily urine
96,3 50,8 48,3 66,0
7 Antigen CA-125, concentration in
serum
36,0 59,3 25,2 24,7
8 Antigen CA-15-3, concentration in
serum
5,7 43,9 12,3 3,9
9 An antigen associated with
mucin-like carcinoma,
serum concentration
5,2 39,3 11,1 3,6
10 Antistreptolysin O, concentration in
serum
7,7 15,4 6,0 5,3
11 Antibodies to Toxoplasma gondii,
serum concentration
4,0 8,0 3,1 2,7
12 Rubella virus antibodies
serum concentration
6,0 12,0 4,7 4,1
13 Antibodies to cytomegalovirus
serum concentration
6,0 12,0 4,7 4,1
14 Alpha-1 Antitrypsin, concentration
in serum
4,8 15,7 5,2 3,3
15 Antichymotrypsin, concentration in
serum
13,5 18,3 8,6 9,2
16 Apolipoprotein A-1, concentration in
serum
6,4 14,0 5,3 4,4
17 Apolipoprotein B, concentration in
serum
7,3 23,9 7,8 5,0
18 Ascorbic acid, concentration
in serum
19,7 39,4 15,3 13,5
19 aspartate aminotransferase,
serum activity
11,6 13,6 7,0 7,9
20 Basophils + eosinophils + monocytes,
blood count
14,9 33,2 12,4 10,2
21 Total protein, concentration in
daily urine
39,4 17,8 19,4 27,0
Total protein, concentration in
serum
2,6 4,8 1,9 1,8
Total protein, concentration in
morning urine
48,4 38,1 26,0 33,2
22 Bilirubin total, concentration in
serum
22,0 42,6 16,8 15,1
23 Bilirubin bound, concentration
in serum
36,8 41,0 21,8 25,2
24 Haptoglobin, concentration in
serum
23,3 36,2 15,9 16,0
25 Hemoglobin, blood concentration 3,4 6,2 2,5 2,3
Hemoglobin, concentration in
erythrocytes
1,8 1,5 1,0 1,2
26 Bicarbonate, concentration in
plasma
4,0 4,8 2,4 2,7
27 2-Hydroxybutyrate dehydrogenase,
serum activity
6,6 13,2 5,1 4,5
28 17-Hydroxyprogesterone,
serum concentration
14,6 52,4 16,8 10,0
29 glycated albumin,
serum concentration
5,2 10,3 4,0 3,6
30 Glycohemoglobin, molar percentage
in blood
8,8 17,6 6,8 6,0
31 Glycoproteins, concentration in
serum
0,9 11,9 3,2 0,6
32 Alpha-1-Globulin, concentration in
serum
10,0 22,6 8,4 6,9
33 Alpha-2-Globulin, concentration in
serum
10,2 12,7 6,3 7,0
34 Beta-Globulin, concentration in
serum
9,6 9,2 5,4 6,6
35 Gamma Globulin, concentration in
serum
11,2 12,3 6,6 7,7
36 sex-binding globulin
hormones,
serum concentration
8,7 42,7 12,8 6,0
37 Gamma-Glutamyltransferase,
serum activity
12,2 41,0 13,4 8,4
38 Glutathione, concentration in
serum
9,1 20,0 7,5 6,2
39 Glucose, serum concentration 6,1 7,8 3,8 4,2
40 Granulocytes, share in fraction
leukocytes
7,2 14,6 5,6 4,9
Granulocytes, blood count 18,3 28,0 12,4 12,5
41 Carbon dioxide, partial
blood gas pressure
4,8 5,3 2,8 3,3
42 Dehydroepiandrosterone sulfate,
serum concentration
3,4 30,0 8,3 2,3
43 11-Deoxycortisol, concentration in
serum
21,3 31,5 14,2 14,6
44 Iron, serum concentration 26,6 23,3 14,7 18,2
45 Immunoglobulin A, concentration in
serum
5,0 38,1 10,7 3,4
46 Immunoglobulin G, concentration in
serum
4,4 15,9 5,1 3,0
47 Immunoglobulin M, concentration in
serum
5,9 47,9 13,4 4,0
48 Insulin, serum concentration 21,1 58,2 20,1 14,5
49 Potassium, daily concentration
urine
28,6 23,2 15,5 19,6
Potassium, serum concentration 4,6 4,7 2,7 3,2
50 Calcium, daily concentration
urine
28,0 36,6 17,7 19,2
Calcium, serum concentration 1,8 1,9 1,0 1,2
51 Kappa chains of immunoglobulins
serum concentration
4,8 15,3 5,1 3,3
52 Acid phosphatase, activity in
serum
7,3 8,0 4,3 5,0
53 Bone acid phosphatase
serum activity
10,8 13,3 6,6 7,4
54 Complement component C3,
serum concentration
5,2 14,8 5,1 3,6
55 Complement component C4,
serum concentration
8,9 31,1 10,0 6,1
56 Cortisol, serum concentration 20,9 45,6 17,1 14,3
57 Creatinine, daily concentration
urine
24,2 24,5 13,9 16,6
Creatinine, concentration in
serum
4,3 10,4 3,8 2,9
58 Creatine kinase activity in
serum
28,2 49,3 20,4 19,3
59 Creatine kinase MB, activity in
serum
18,4 36,8 14,3 12,6
60 lactate, serum concentration 27,2 16,7 13,9 18,6
61 Lactate dehydrogenase, activity in
serum
7,3 14,4 5,6 5,0
62 Lactate dehydrogenase-1, activity
in serum
2,3 8,2 2,6 1,6
63 Lactate dehydrogenase-2, activity
in serum
3,3 2,4 1,7 2,3
64 Lactate dehydrogenase-3, activity
in serum
2,8 3,8 1,8 1,9
65 Lactate dehydrogenase-4, activity
in serum
5,9 5,4 3,3 4,0
66 Lactate dehydrogenase-5, activity
in serum
8,0 9,6 4,9 5,5
67 Leukocytes, blood count 11,2 19,7 8,1 7,7
68 Lymphocytes, share in fraction
leukocytes
10,6 18,7 7,7 7,3
69 Lipoprotein(a), concentration in
serum
10,8 85,8 24,0 7,4
70 luteinizing hormone,
serum concentration
24,0 29,6 14,8 16,4
71 Lambda chains of immunoglobulins,
serum concentration
4,8 17,3 5,5 3,3
72 Magnesium, daily concentration
urine
45,4 37,1 24,6 31,1
Magnesium, serum concentration 3,2 5,9 2,4 2,2
73 Alpha-2-Macroglobulin,
serum concentration
3,3 20,7 6,0 2,3
74 Copper, serum concentration 4,3 13,4 4,5 2,9
75 Alpha-1-Microglobulin,
concentration in morning urine
33,0 58,0 23,9 22,6
76 Alpha-2-Microglobulin,
concentration in morning urine
32,0 46,0 21,0 21,9
77 Beta-2-Microglobulin, concentration
in serum
4,4 15,5 5,0 3,0
78 Monocytes, shares in fractions
leukocytes
9,8 13,6 6,3 6,7
79
daily urine
25,1 17,4 13,1 17,2
Uric acid, concentration in
serum
7,3 18,8 6,6 5,0
80 Urea, daily concentration
urine
23,2 25,9 13,8 15,9
Urea, serum concentration 11,6 17,4 7,8 7,9
81 Sodium, daily concentration
urine
24,0 26,8 14,3 16,4
Sodium, serum concentration 0,6 0,6 0,3 0,4
82 Neutrophils, share in fraction
leukocytes
7,4 11,1 5,0 5,1
83 Oxalate, daily concentration
urine
44,0 18,0 21,5 30,1
84 Orosomucoid, concentration in
serum
11,1 30,7 10,6 7,6
85 Serum osmolality 1,9 1,4 1,0 1,3
86 Osteocalcin, concentration in
serum
7,3 25,7 8,3 5,0
87 Pyruvate, serum concentration 15,2 13,0 8,3 10,4
88 Prealbumin, concentration in
serum
4,4 8,8 3,4 3,0
89 progesterone concentration in
serum
31,3 62,6 24,4 21,4
90 Prolactin, concentration in
serum
23,7 52,1 19,5 16,2
91 Properdin, concentration in
serum
9,5 11,2 5,8 6,5
92 prothrombin time 1,7 6,8 2,1 1,2
93 cancer embryonic antigen,
serum concentration
10,6 69,8 20,0 7,3
94 Rheumatoid factors, concentration
in serum
11,4 24,2 9,2 7,8
95 Retinol, serum concentration 20,5 41,0 16,0 14,0
96 blood plasma pH 3,5 2,0 1,8 2,4
97 C-peptide, serum concentration 9,3 13,3 6,1 6,4
98 C-reactive protein, concentration in
serum
56,6 53,2 31,8 38,8
99 ESR 29,3 58,6 22,8 20,1
100 Superoxide dismutase, activity in
serum
16,3 0,0 7,6 11,2
101 Testosterone, concentration in
serum
9,6 21,3 7,9 6,6
102 Thyroglobulin, concentration in
serum
4,4 12,6 4,3 3,0
103 Thyroxine total, concentration in
serum
6,0 11,9 4,6 4,1
104 Free thyroxine, concentration in
serum
7,6 12,2 5,3 5,2
105 Thyrotropin, concentration in
serum
20,0 29,4 13,3 13,7
106 Alpha-Tocopherol, concentration in
serum
15,2 19,9 9,6 10,4
107 Transferrin, concentration in
serum
2,8 2,1 1,5 1,9
108 Triglycerides, concentration in
serum
22,0 46,4 17,7 15,1
109 Triiodothyronine total, concentration
in serum
7,8 17,2 6,4 5,3
110 free triiodothyronine,
serum concentration
7,9 22,5 7,7 5,4
111 Platelets, blood count 9,0 23,3 8,2 6,2
112 Ferritin, serum concentration 12,8 13,5 7,5 8,8
113 Follitropin, concentration in
serum
17,3 33,6 13,2 11,9
114 Phospholipids, concentration in
serum
6,9 11,1 4,8 4,7
115 Phosphorus, inorganic
serum concentration
7,6 11,2 5,0 5,2
Phosphorus, inorganic
concentration in morning urine
43,0 33,9 23,1 29,5
116 Fructosamine, concentration in
serum
3,7 7,6 2,9 2,5
117 Chlorides, serum concentration 1,3 1,3 0,7 0,9
118 HDL cholesterol, concentration in
serum
7,5 23,8 7,9 5,1
119 LDL cholesterol, concentration in
serum
8,6 19,7 7,3 5,9
120 VLDL cholesterol, concentration in
serum
22,5 45,0 17,5 15,4
121 Cholesterol total, concentration in
serum
5,3 15,2 5,2 3,6
122 Cholinesterase activity in
serum
5,4 17,8 5,8 3,7
123 Alkaline phosphatase, activity in
serum
5,9 22,3 7,1 4,0
124 Alkaline phosphatase, bone
serum activity
6,6 35,6 10,5 4,5
125 Alkaline phosphatase placental,
serum activity
11,9 52,9 16,2 8,2
126 Erythrocytes, hematocrit value 2,4 4,8 1,9 1,6
Erythrocytes, blood count 2,1 7,0 2,3 1,4
Erythrocytes, average cell volume 1,1 4,1 1,3 0,8
127 Estradiol, concentration in
serum
21,7 88,7 27,6 14,9

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

    Appendix N 1. Norms and conditions for the free distribution of milk or other equivalent food products to employees employed in jobs with harmful working conditions that can be given to employees instead of milk Appendix N 2. The procedure for making compensation payments in an amount equivalent to the cost of milk or other equivalent food products Appendix N 3. List of harmful production factors, under the influence of which, for preventive purposes, it is recommended to use milk or other equivalent food products

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

With changes and additions from:

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

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

Registration N 13795

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

The rate of free milk distribution is still 0.5 liters per shift, regardless of the duration of the shift. The issued milk must comply with the requirements of the Technical Regulations for milk and dairy products. Employees who come into contact with inorganic compounds of non-ferrous metals (previously lead) will be given 2 g of pectin as part of food products (drinks, jellies, jams, etc.) in addition to milk. With constant contact with inorganic compounds of non-ferrous metals, sour-milk products or products for dietary (therapeutic and preventive) nutrition under harmful working conditions are relied on instead of milk.

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

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

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



Loading...