Methods of clinical laboratory research. N

Methods for biochemical, coagulological, serological, immunological, morphological, mycological, and cytological studies of human body fluids are described, adapted to automated equipment. The book provides modern information about the structure and function of vital organs, clinical and laboratory tests reflecting the characteristics of their condition, methods of laboratory diagnostic research, the peculiarities of changes in the biochemical and morphological composition of blood, urine, gastric contents, cerebrospinal fluid, sputum, genital secretions and other biological material for common diseases, as well as quality control of laboratory tests and interpretation of the results obtained. The description of each method includes information about the principle, the course of the study and the clinical and diagnostic significance of the test. The book can be successfully used in training and practical activities of clinical laboratory diagnostics specialists with secondary and higher medical education.

Publisher: "MEDpress-inform" (2016)

Format: 216.00mm x 145.00mm x 38.00mm, 736 pages.

ISBN: 978-5-00030-273-6

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State budgetary educational institution

higher professional education

"Pacific State Medical University"

Ministry of Health of the Russian Federation

Faculty of Residency and Postgraduate Studies

Department of Clinical Laboratory Diagnostics, General and Clinical Immunology

Structure of the laboratory service of the Russian Federation. Basic legislative, regulatory, methodological documents. Principles and forms of centralization of laboratory research

Completed by: intern of the KLD department,

general and clinical immunology

Kunst D. A.

Teacher: Associate Professor, Ph.D.

Zabelina N.R.

Vladivostok 2014

Abstract plan

1. Introduction

Laboratory service structure

Principles and forms of centralization of laboratory research

Regulatory documents regulating diagnostic laboratories

Conclusion

Bibliography

1. Introduction

Clinical laboratory diagnostics is a medical specialty whose specialists focus on clinical laboratory research, i.e. studying the composition of samples of biomaterials from patients with the task of detecting/measuring their endogenous or exogenous components, structurally or functionally reflecting the state and activity of organs, tissues, body systems, damage to which is possible due to the suspected pathology. Specialists with higher medical education and training in clinical laboratory diagnostics are qualified as clinical laboratory diagnostic doctors. Specialists with secondary medical education receive qualifications in the specialty “laboratory diagnostics” or “laboratory science”. The term “clinical laboratory diagnostics” officially denotes a scientific medical specialty (code 14.00.46).

The field of practical activity of clinical laboratory diagnostics specialists is the divisions of medical institutions called CDL or clinical laboratory diagnostic departments, in which various types of laboratory tests can be performed depending on the size and profile of health care facilities.

The main types of research conducted at KDL:

Purpose of the study

· assessment of a person’s health status during a preventive examination;

· detection of signs of diseases (diagnosis and differential diagnosis);

· determination of the nature and activity of the pathological process;

· assessment of functional systems and their compensatory capabilities;

· determining the effectiveness of the treatment;

· drug monitoring

· determining the prognosis of the disease;

· determining the achievement of treatment results.

The information ultimately obtained is used in up to 70% of medical decisions in virtually all clinical disciplines. Laboratory tests are included in the medical examination program and in the standards of medical care for most forms of pathology. The high demand for laboratory research is demonstrated by the annual increase in their number throughout the country. According to statistics from the Ministry of Health and Social Development of the Russian Federation, only the laboratories of healthcare institutions under ministerial subordination (without departmental, private ones) perform over 3 billion tests during the year. Laboratory tests account for 89.3% of the total number of objective diagnostic tests. Analysis of reports by region clearly indicates an increase in the number of studies and an increase in technological research. In departmental health care institutions, the provision of patient tests is noticeably higher than the national average. This, as well as the rapid growth in the volume of research performed in commercial laboratories, suggests that the real need for this type of medical services, both specialized and mass routine, is not fully satisfied.

2. Laboratory service structure

diagnostic laboratory clinical

Currently, there are almost 13 thousand clinical diagnostic laboratories of various directions and specializations operating on the territory of the Russian Federation, which allows solving a wide range of problems.

Main tasks of the KDL

Conducting clinical laboratory tests in accordance with the profile of health care facilities (general clinical, hematological, immunological, cytological, biochemical, microbiological and others with high analytical and diagnostic reliability) in the volume according to the declared nomenclature of studies when accredited by the CDL in accordance with the license of the health care facility;

introduction of progressive forms of work, new research methods with high analytical accuracy and diagnostic reliability;

improving the quality of laboratory research through systematically conducting intra-laboratory quality control of laboratory research and participation in the program of the Federal System of External Quality Assessment (FSVOK);

providing advisory assistance to doctors of medical departments in choosing the most diagnostically informative laboratory tests and interpreting data from laboratory examinations of patients;

providing clinical personnel involved in the collection of biological material with detailed instructions on the rules for collecting, storing and transporting biomaterial, ensuring the stability of samples and the reliability of results. Responsibility for the strict adherence to these rules by clinical staff lies with the heads of clinical departments;

advanced training of laboratory personnel;

carrying out measures for labor protection of personnel, compliance with safety regulations, industrial sanitation, anti-epidemic regime in the KDL;

maintaining accounting and reporting documentation in accordance with approved forms.

The main goalThe activity of a clinical diagnostic laboratory when performing analytical procedures is the high-quality performance of laboratory tests, with a high level of service for the patient, his safety and the safety of laboratory personnel. To achieve this goal, diagnostic laboratories must meet a number of requirements:

· perform a set of modern informative laboratory diagnostic methods that satisfy the patient;

· have a material and technical base that is adequate to the assigned tasks and complies with the regulatory documents of the Russian Ministry of Health;

· control the quality of research conducted in accordance with the documents regulating the activities of the CDL (orders of the Russian Ministry of Health and relevant national standards);

· have highly professional laboratory personnel;

· have a high level of organization and management of laboratory activities based on the latest information technologies (availability of a laboratory information system (LIS));

· guarantee a high service level (strive to reduce time (TAT) - from the English Turn-Around-Time).

The laboratory service of the Russian Federation has its own management structure:

.Chief (freelance) specialist in clinical laboratory diagnostics (chief laboratory assistant) of the Ministry of Health of the Russian Federation. Kochetov Mikhail Glebovich

.Coordinating Council for Clinical Laboratory Diagnostics

.Chief (freelance) specialist in clinical laboratory diagnostics of the healthcare management body of a constituent entity of the Russian Federation. Zhupanskaya Tatyana Vladimirovna - PC specialist

.Organizational and methodological department of the healthcare management body of a constituent entity of the Russian Federation.

.Chief district (city) specialists in clinical laboratory diagnostics.

.Head of the laboratory (department) of clinical laboratory diagnostics.

Depending on the location and tasks assigned to the laboratory, DL can be divided into 3 large groups:

· general laboratories

· specialized

· centralized

It should be noted that recently such a form of research as mobile research has been actively developing. This variety is distinguished by the fact that all processes occur outside the CDL using portable analyzers and express diagnostic methods. It does not require specially trained personnel and can be performed even by patients themselves. Most often it is used directly in medical departments and at the pre-hospital stage of providing medical care.

General laboratories.

CDLs of this type are usually a diagnostic unit of a specific medical and preventive institution and are created as a department. Their main goal is to meet the needs of a given healthcare facility for reliable and timely diagnostic information, therefore the volume and types of studies performed must correspond to the specifics and capacity of the healthcare facility. Depending on the type of research carried out, the following departments are distinguished in the structure of the laboratory:

· clinical

· express diagnostics

· biochemical

· cytological

· immunological, etc.

This division is determined by the characteristics of the analyzed biomaterial, research methods, equipment used, and the professional specialization of clinical laboratory diagnostic doctors. One of the most important tasks of laboratory diagnostics is the diagnosis of emergency conditions. Its task is to carry out research, the results of which are necessary to make a diagnosis in an emergency situation, to assess the severity of the patient’s condition, and to adjust replacement or drug therapy. The solution to this problem in most healthcare facilities is assigned to the express diagnostic laboratory, which performs a limited list of diagnostic tests approved by the head of the healthcare facility.

The clinical department performs hematological and general clinical tests. Hematology testing is used to diagnose and monitor diseases in which the number, size or structure of blood cells changes. General clinical studies include analysis of the physicochemical characteristics and cellular composition of other (except blood) biological fluids of the patient’s body - urine, sputum, fluid of serous spaces (for example, pleural fluid), cerebrospinal fluid (CSF) (CSF), feces, discharge of the genitourinary organs, etc. .d.

The cytological department aims to study the morphological characteristics of individual cells.

The laboratory of clinical biochemistry (biochemical) performs a wide range of tests necessary for diagnosis and evaluation of the effectiveness of treatment of many diseases and conditions, such as ELISA, RIF, etc.

Specialized laboratories

These laboratories usually focus on a specific type of research, which requires special equipment and personnel qualifications. Often created at specialized healthcare institutions - dispensaries, diagnostic centers, consultations, etc.

Types of specialized CDLs:

· bacteriological

· toxicological

· molecular genetic

· mycological

· coagulological

· virological, etc.

Centralized laboratories

Currently, there is a tendency towards the formation of large centralized laboratories engaged in high-tech, expensive and rare types of research. Their creation allows us to solve a number of problems that arose during the development of the diagnostic service. As a rule, such institutions are organized on the basis of large regional medical centers, as this minimizes the risk of errors at the preanalytical stage and reduces logistics costs, and also partially solves the issue of shortage of qualified personnel.

Let us consider the issue of centralization in more detail, since it is important in shaping the appearance of the modern laboratory service of the Russian Federation.

3. Principles and forms of centralization of laboratory research

Recently, there has been a rapid development of methods and technologies for clinical laboratory diagnostics. This development is driven by overall healthcare trends and technological factors.

Main directions of development

· Improving clinical laboratory diagnostic methods and improving the quality of laboratory research based on the introduction of new laboratory equipment and technologies.

· Replacement of labor-intensive manual methods with automated ones, performed on biochemical, hematological, immunological, coagulological, bacteriological and other types of analyzers, comprehensive informatization and integration based on the development of computer technologies.

· Transition of medical diagnostic technologies to objective quantitative research methods, implementation of treatment protocols and diagnostic standards. Development of a set of measures to manage the quality of laboratory research

· Treatment monitoring using laboratory data, implementation of drug monitoring technologies and laboratory screening programs.

· The use of molecular genetic methods in therapy that require constant laboratory monitoring.

· Integration of laboratory diagnostics with other medical disciplines

· Improving the knowledge of clinical doctors in the field of clinical laboratory diagnostics

· The use of a laboratory report as a final medical diagnosis for an increasing number of nosological forms (cytological report in oncology, hematological report in oncohematology, enzyme immunoassay for HIV and other viral and bacterial infections, etc.)

Obtaining highly informative, reliable and timely information is ensured through the use of modern high-tech and automated laboratory equipment.

Since it is impossible to equip all existing CDLs with modern automated and high-performance equipment, it is advisable to organize a small number of large centralized laboratories.

Centralization of laboratory research is a way of organizing the provision of laboratory services for various health care facilities by concentrating resources and creating large-scale production of analyzes based on a centralized laboratory.

A centralized laboratory allows us to provide:

· improving quality as a result of using modern equipment and technologies;

· expanding the range of laboratory services, including high-tech and rare types of research;

· reducing the time required to complete laboratory tests;

· strengthening quality control;

· systematic replacement of equipment and improvement of technological processes for analysis;

· personnel safety.

Creating a centralized laboratory is an extremely complex and costly process, so it is necessary to be guided by the following principles, without which the enterprise will become ineffective.

Principles of centralization

. Medical appropriatenesslaboratory tests - compliance of prescribed laboratory tests with the clinical condition of the patient or the diagnostic task. Medical expediency is uniform throughout the Russian Federation, has the character of a standard and is the same for all medical and preventive institutions (HCI) of state subordination and for those providing medical care under Compulsory Medical Insurance (CHI) programs.

Medical expediency implies conducting an adequate (sufficient, complete) and timely examination of the patient in accordance with the assigned (existing) clinical or diagnostic task. Adequacy is assessed by the depth of the survey (set of necessary parameters) and the regulated duration of its implementation.

The regulated duration (the period from the appointment to the moment of obtaining the result) of the study is the time for conducting a specific type of study, specified in the algorithm for performing laboratory tests of a given health care facility, and sufficient for the full cycle of its implementation (pre-analytical, analytical and post-analytical stages). The regulated duration of the study is determined by the clinical or a diagnostic task, technological features of the diagnostic method used, organizational capabilities, financial efficiency of the applied algorithm for performing this type of research. If there are several options for the regulated duration of the study (Cito!, express analysis, planned, etc.), the timing of diagnostic procedures is determined by the attending physician (authorized medical professional) based on the patient’s clinical condition and in accordance with the diagnostic task. The criteria for prescribing studies of a particular urgency are described in the algorithm for performing laboratory tests of a given health care facility

. Organizational capabilities- are determined taking into account the geographical characteristics of the territorial administrative unit (TAU), population density, compactness of its residence, the location of healthcare facilities of one capacity or another in the TAO, the distance of lower-level healthcare facilities (FAP, clinics, district hospitals, etc.) from large multidisciplinary hospitals and diagnostic centers. When assessing the organizational capabilities of centralizing laboratory research, one should take into account the transport features of the TAO (the presence of a network of highways, water and/or air transport), the influence of seasonality on the possibility of transporting material, the development of computer technologies in the region, etc. The degree of distance from the patient of any service affects timing of medical care. At the same time, the effectiveness of medical care should also presuppose the possibility of sustainable and high-quality performance of basic professional tasks.

. Economic efficiencydetermined by calculation and identified by comparing the costs associated with conducting laboratory tests “on site” or when transporting them to a centralized laboratory. Medical effectiveness is based on the financial situation that has developed in a particular TAO, is individual in nature and is assessed specifically for each health facility. Economic efficiency is determined by the financial capabilities of the healthcare facility and is determined by the managers of the healthcare facility. The economic efficiency of diagnostic work at health care facilities is based on the introduction of full financial security for laboratory services.

Full financial security includes:

· Full accounting of all laboratory tests performed by the structural units of health care institutions, medical institutions attached to the laboratory (divisions of health care institutions), as well as third-party organizations collaborating on a commercial basis (outsourcers). Progress reports are completed monthly.

· Establishing the price of each type of research (it is possible to establish several price categories for the same type of research: budgetary, preferential, urgent, commercial, etc.). The price of the research cannot be lower than the cost of the work performed.

· Determination of financial sources (in full) of all ongoing research without exception.

· Full payment (internal and external accounting) for work performed with the transfer of funds earned by the laboratory to the laboratory’s virtual account or a specially designated special account.

· Funds received for diagnostic work performed must fully cover all costs of health care facilities for laboratory diagnostics, including wages, costs for the purchase of reagents, consumables, payment for quality control systems, utility bills, overhead costs, advertising activities, and a development fund.

As the experience of successful centralized laboratories shows, the cost of research is inversely proportional to their number. The more research a laboratory conducts per unit of time, the lower its cost.

In the process of organizing centralized laboratories, the following options can be considered:

. By status: independent or as part of large treatment and preventive institutions (including interhospital ones).

Treatment and preventive institutions on the basis of which it is planned to create centralized diagnostic laboratories must have the necessary conditions:

· experience of personnel working with modern analytical equipment;

· availability of trained specialists for equipment repair and maintenance;

· experience in using information systems;

· experience in implementing educational programs for clinicians;

· knowledge of modern approaches to quality management;

· established connections with the medical network;

· experience in implementing large medical projects.

But when creating a centralized laboratory, you should take into account a number of problems that will inevitably arise during the organization process:

Deadlines for obtaining laboratory information. There are critical care facilities and departments that deal with patients whose clinical decision times range from minutes to hours, which is not comparable to the turnaround time of most centralized services.

Logistics problem. There remains a group of studies that are not subject to centralization, most often due to the strict conditions for the duration of the preanalytical stage, in particular in studies such as a general clinical analysis of urine, pH/blood gases, etc. Sometimes the conditions for the delivery of biological material to the site become critical analysis (measurement of parathyroid hormone, ACTH concentration).

Based on the above, total centralization is meaningless, therefore, along with organizing a system of centralized laboratory diagnostics, it is necessary to provide for the possibility of creating a system for providing express services within the framework and volumes sufficient for the operation of hospitals. Taking this into account, it should be assumed that large hospitals have a developed in-house routine and emergency laboratory service.

The activities of all types of laboratories, regardless of their size, location and tasks performed, are strictly regulated by certain regulatory documents, which ensures the unification of the laboratory process and high reliability of the information received.

4. Regulatory documents regulating diagnostic laboratories

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

· Orders

· Standards (GOSTs)

· Recommendations

Order- a subordinate regulatory legal act issued individually by the head of an executive body or department and containing legal norms.

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

List of main documents

1. Federal laws of the Russian Federation.

1. Federal Law No. 323 dated October 21. 2011 “On the basics of protecting the health of citizens of the Russian Federation”;

2. Federal Law No. 94 of July 21. 2005 “On placing orders for the supply of goods, performance of work, provision of services for state and municipal needs”;

3. Federal Law No. 326 of October 29, 2010." On compulsory health insurance in the Russian Federation.

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

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

2. Ave. Ministry of Health and Social Protection of the Russian Federation No. 415N dated 07 . 07. 2009 “On approval of qualification requirements for specialists with higher and postgraduate medical and pharmaceutical education in the field of healthcare”

3. PR. Ministry of Health and Social Development of the Russian Federation No. 705N dated December 9, 2009. “On approval of the procedure for improving the professional knowledge of medical and pharmaceutical workers”;

4. Explanatory note to Pr. Ministry of Health and Social Development of the Russian Federation No. 705N dated December 9, 2009;

5. Ave. Ministry of Health and Social Development of the Russian Federation No. 869 dated October 6, 2009. “On approval of a unified qualification reference book for positions of managers, specialists and employees, section 2 Qualification characteristics of positions of employees in the field of healthcare”;

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

7. Ave. Ministry of Health and Social Protection of the Russian Federation No. 808N dated July 25, 2011. “On the procedure for obtaining qualification categories by medical and pharmaceutical workers.”

3. Quality control at KDL.

1. Ave. Ministry of Health of the Russian Federation No. 45 dated 02/07/2000. “On the system of measures to improve the quality of clinical laboratory research in healthcare institutions of the Russian Federation”;

2. Ave. Ministry of Health of the Russian Federation No. 220 dated May 26, 2003 “On approval of the industry standard “Rules for conducting in-laboratory quality control of quantitative methods of clinical laboratory research using control materials.”

4. Specifics of CDL.

1. Ave. Ministry of Health of the Russian Federation No. 380 dated December 25, 1997. “On the state and measures to improve laboratory support for the diagnosis and treatment of patients in healthcare institutions of the Russian Federation”;

2. Ave. Ministry of Health of the USSR No. 1030 dated 10/04/1980. “Medical records of laboratories within medical institutions”;

3. Ave. Ministry of Health of the Russian Federation No. 109 dated March 21, 2003. “On improving anti-tuberculosis measures in the Russian Federation”;

4. Ave. Ministry of Health of the Russian Federation No. 87 dated March 26, 2001. “On improving the serological diagnosis of syphilis”;

5. Ave. Ministry of Health of the Russian Federation No. 64 dated February 21, 2000. “On approval of the nomenclature of clinical laboratory tests”;

6. Ave. Ministry of Health of the Russian Federation No. 2 45 dated 08/30/1991 “On alcohol consumption standards for healthcare, education and social security institutions”;

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

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

2. SanPiN 2.1.3.2630-10 dated May 18, 2010. “Sanitary and epidemiological requirements for organizations engaged in medical activities”;

6. Standardization in KDL.

6.1. Standards of medical care.

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

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

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

1.4. Etc. Ministry of Health and Social Development of the Russian Federation No. 723 dated December 1, 2005. “On approval of the standard of medical care for patients with Nelson syndrome”;

1.5. Etc. Ministry of Health and Social Development of the Russian Federation No. 71 dated 03/09/2006. “On approval of the standard of medical care for patients with hypoparothyroidism”;

1.6. Etc. Ministry of Health and Social Development of the Russian Federation No. 761 dated December 6, 2005. “On approval of the standard of medical care for patients with premature puberty”;

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

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

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

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

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

1.12. Etc. Ministry of Health and Social Protection of the Russian Federation, 2009. “On additional medical examination of working citizens.

6.2. National standards in KLD

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

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

) Rules for quality management of clinical laboratory research.

) Assessing the analytical reliability of research methods.

) Rules for assessing the clinical informativeness of laboratory tests.

) Rules for developing requirements for the timeliness of provision of laboratory information.

) Rules for describing research methods.

) Guide to quality management in the diagnostic laboratory.

) Uniform rules for the interaction of clinical staff

divisions and CDL.

) Rules for conducting the preanalytical stage

2.4. GOST R 53.133.(1-4)-2008; “Quality control of clinical laboratory research”:

) Limits of permissible errors in the results of measuring analytes in CDL.

) Rules for conducting intra-laboratory quality control of quantitative methods of clinical laboratory research using control materials.

) Description of materials for quality control of clinical laboratory tests.

) Rules for conducting a clinical audit.

2.5. GOST R ISO 15189-2009; “Medical laboratories. Special requirements for quality and competence. Standards for methods of control, testing, measurements and analysis" establish requirements for the equipment used, conditions and procedures for carrying out all operations, processing and presentation of the results obtained, and personnel qualifications. This standard is identical to the international standard ISO 15189:2007 “Medical laboratories. Particular requirements for quality and competence" (ISO 15189:2007 "Medical laboratories - Particular requirements for quality and competence").

2.6. GOST R ISO 22870; Requirements for quality and competence

Conclusion

Currently, medical care to the population is impossible without high-quality laboratory tests. The information provided by laboratories about the patient’s condition plays a huge role for the clinician, so its demand increases every year.

The rapid development of medical technologies has led to a rapid increase in the quantity and quality of laboratory tests. Every year, new diagnostic methods appear and old ones are improved, and accordingly, the requirements for the qualifications of laboratory personnel - clinical diagnostic doctors and paramedics - laboratory assistants - increase. There is a gradual reform of the structure of the laboratory service - a gradual shift away from the old, economically ineffective model (1 health care facility - 1 clinical hospital) to a new, more effective one (1 centralized laboratory - several health care facilities). This process is called centralization, and it is possible thanks to the automation of many laboratory processes, the introduction of information systems (LIS) into daily activities, and the improvement of quality control systems, both external and internal. The private sector is actively developing; many Russian commercial laboratories have quality certificates from the foreign ISO system, which indicates their high level of material and technical equipment and the professionalism of their personnel. At the same time, the laboratory service still faces a number of problems, such as the problem of personnel, low material and technical equipment, characteristic of laboratories remote from administrative centers.

Also acute is the problem of rejection by many clinical specialists, especially the “old school”, of new information about laboratory research methods, which leads to irrational use of the existing technical base of health care facilities and affects primarily the patient, as well as the economic efficiency of the laboratory.

Solving these issues and further carrying out the above processes will allow the Russian laboratory service to reach a qualitatively new level, which will make laboratory information more reliable and accessible to all segments of the population.

Bibliography

1.Basic literature.

)Clinical laboratory diagnostics: manual. In 2 volumes. Volume 1. / Ed. V.V. Dolgova. 2012. - 928 p. (National Guidelines Series)

)Clinical laboratory diagnostics: textbook. - M.: GEOTAR-Media, 2010. - 976 p. : ill.

)Lecture "Modern approaches to organizing a clinical diagnostic laboratory." Skvortsova R.G. Siberian Medical Journal, 2013, No. 6

4)"Assessment of personnel performance in clinical diagnostic laboratories." M.G. Morozova, V.S. Berestovskaya., G.A. Ivanov, k, E.S. Laricheva Article on the website www.remedium.ru dated 04/15/2014

)Centralization of clinical laboratory research. Guidelines. Kishkun A.A.; Godkov M.A.; M.: 2013

)Guidelines. "Documents regulating the activities of a clinical diagnostic laboratory." R.G. Skvortsova, O.B. Ogarkov, V.V. Kuzmenko. Irkutsk: RIO IGIUVA, 2009

)Article "Centralization of laboratory services requires a systemic solution" Shibanov A.N. Journal "Laboratory Medicine" No. 10.2009

)Article "Centralization of research as a stage in the development of laboratory services" Berestovskaya V.S.; Kozlov A.V. Journal "Medical Alphabet" No. 2.2012

Supporting literature

Lecture No. 1 Laboratory research methods. Organization of laboratory services.

Introduction

Modern medicine is impossible without laboratory diagnostics. This is an indicator of the patient's health status. High-quality diagnostics helps the doctor in making the correct diagnosis and prescribing effective treatment. Modern laboratory diagnostics allows us to solve questions for doctors of different specialties and areas of medicine. At the same time, timely and high-quality performance of medical tests allows not only to make the diagnosis as accurately as possible, but also to monitor the effectiveness of the treatment. At the same time, laboratory diagnostics is one of the fastest growing branches of medical science - the creation and implementation of new equipment, the development of new research methods, the range of possible tests - all this is progressing every day.

The rapid development of biology and the revolutionary transformation of scientific instrumentation at the beginning of the 21st century radically changed the arsenal of diagnostic capabilities in medicine.

The analytical progress of a scientific discipline aimed at studying the composition and properties of biological materials from the human body - in vitro diagnostics - has essentially provided it with a breakthrough to the forefront in the diagnostic and treatment process, which has changed the level of responsibility of this area of clinical medicine

The effectiveness of laboratory activities is determined by the quality of interaction between the laboratory and the clinic.

Despite the implementation of national programs with significant financial investments in medicine and the implementation of measures aimed at modernizing laboratory services, to date a number of issues relating to the activities of a modern laboratory remain without due attention or require administrative decisions at the federal level. The following problems reduce the efficiency of medical institutions and hinder the diagnostic potential of the laboratory.

Despite the fact that the number of CDLs in our country is decreasing, their number nevertheless exceeds that in developed countries of the world. Thus, in the United States, whose population exceeds the population of the Russian Federation by more than 2 times, there are 8,560 hospital laboratories, 4,936 commercial laboratories, and 105,089 laboratories in doctors’ offices. In Germany there are only 2150 CDLs, of which 82% are hospital laboratories and 18% are private laboratories. In the Russian Federation, CDL performed 3.2 billion tests in 2008, in the USA - more than 8 billion, in Germany - about 2 billion. According to statistics, it seems that in our country, CDL perform quite a lot of tests. However, if we use a pan-European approach to counting the number of studies, then in reality we will have not 3.2 billion laboratory tests in our country, but at best about 1 billion. This is due to the fact that almost every indicator that is obtained using hematological or urinary analyzers are considered a separate analysis. ( Kishkun A.A. Journal of Laboratory Medicine No. 11, year of publication: 2011, Relevance of the problem of centralization of clinical laboratory research for the country's healthcare system).

One of the key problems in the institution is quality of medical care, which is regulated by regulations: from the fundamentals of the legislation of the Russian Federation on protecting the health of citizens to departmental and interdepartmental regulations. The new SanPiN 2.1.3.2630-10 “Sanitary and epidemiological requirements for organizations engaged in medical activities” also came into force. However, to date there are no uniform requirements and a rationally operating quality system, the purpose of which is to ensure the rights of patients to receive care of the required volume and proper quality based on the use of advanced medical (laboratory) technologies. This problem entails a second problem - the problem control over its provision, implying a system of criteria to determine timeliness, adequacy, completeness And efficiency of medical care.

*In the system of the Ministry of Health of Russia, according to data for 2012, there are 15.5 thousand diagnostic laboratories, of which about 13 thousand are clinical diagnostic laboratories (CDL), bacteriological 1012, serological 616, biochemical 730, cytological 329, coagulological 48, of which centralized 1125 laboratories. Over the past 5 years, there has been a slight reduction in the number of general medical clinics, mainly due to the closure of rural healthcare facilities. At the same time, the number of specialized bacteriological, serological, and biochemical laboratories tended to increase. More or less large laboratories have hospitals with a capacity of over 400 beds. In total, there are more than 900 such institutions in the country. General diagnostic centers and diagnostic centers for AIDS and viral hepatitis have large laboratory units.

*At the same time, 28% of independent outpatient clinics, 12.9% of tuberculosis sanatoriums, 14.2% of district hospitals do not have clinical diagnostic laboratories at all. In addition, 3,570 hospitals and other institutions, which is 26.7% of their total number, according to the staffing table, cannot have clinical laboratory diagnostics doctors on their staff. They are content with a small laboratory with a medical laboratory assistant (medical laboratory technician).

*The Laboratory Diagnostics Service has significant human resources. In the system of the Russian Ministry of Health, about 18 thousand specialists with higher education work in the KDL, the vast majority of them are clinical laboratory diagnostic doctors. Of these, approximately half have a medical education, and the other half have a university biology education. About 45% of clinical laboratory diagnostic doctors have this category.

The position of biologist has been introduced into the staffing table of the KDL, for which specialists who have graduated from universities and have a diploma with the qualification “biologist” are accepted, but this position has not yet become widespread.

*KDL employs 75.5 thousand specialists with secondary medical education in the positions of laboratory assistant, medical technician (paramedic laboratory assistant), and medical laboratory technologist. The ratio of doctors/workers with secondary specialized education is on average 1: 4.3, the norm is 1: 2.8 (explained by the fact that in many small departments, average specialists work independently).

*The human and material resources of the clinical laboratory service allow us to annually perform 2.6-2.7 billion laboratory tests. In outpatient health care:

About 120 laboratory tests are performed per 100 visits,

There are about 42 tests per inpatient.

Every year there is an increase in research by 2-3%. (For comparison, 7 other services performing objective diagnostic studies together performed 238.3 million studies in 2012, i.e., 11.1 times less research volume).

*Per 1 KDL employee (based on the number of individuals with higher and secondary education), an average of 130-140 tests are performed per 1 working day.

The difference in labor productivity between laboratories with automated equipment and laboratories using manual methods can reach 10-15 times.

Despite the significant quantitative indicators of the scale of the structure and volume of work, the clinical laboratory diagnostic service does not operate effectively enough, experiencing significant difficulties due to the presence of a number of serious unresolved problems.

Examples of the organization of diagnostic laboratories in the Stavropol region and the city of Togliatti.

*The history of the development of healthcare in the Stavropol region has its roots in past centuries. The first mention of qualified medical care was at the beginning of the 19th century. In Stavropol and the district there was one hospital with 15 beds. The doctor traveled around the villages once every two months, but he did not have a permanent place to receive patients. (you can see more details in the work).

*The municipal district of Stavropol is located on an area of 3697.5 sq. km. The district includes 24 rural settlements, uniting 51 settlements.

The population of the region has a steady tendency to increase from year to year. So, as of 01/01/2013 the number was 63,360 people, which is 5.3% more than in 2010 (54,545 people). The population density in the area is 17 people per 1 sq. km. area (in general for the Samara region this figure is 60 people per 1 sq. km. area). The age composition of the population is characterized by a predominance of older age groups. The proportion of persons over 18 years of age is 83% of the total population, persons over working age - 1/4 of the total population (24%).

The state budgetary healthcare institution of the Samara region “Stavropol Central District Hospital” (GBUZ SO “Stavropol Central District Hospital”) is a huge network of treatment and preventive institutions in the region, uniting all the settlements of the region.

At the moment, it is a multidisciplinary medical budgetary healthcare institution, which has structural divisions, financed from compulsory medical insurance funds and partially from the municipal budget.

The main laboratory is located in the Central District Hospital; in addition, laboratory diagnostics are carried out in 13 departments of general medical (family) practice.

Laboratory diagnostics are carried out in 8 main areas, more than 70 types of tests.

The CDL of the Central District Hospital includes 3 therapeutic departments, 12 offices and 6 outpatient clinics, which are located in villages adjacent to the Stavropol region, in which one laboratory assistant works.

The very first office was opened in the village. Zelenovka in 2010.

It consists of one general clinical room. The office receives patients from 8:00 to 10:00. The number of patients per day is approximately 20 people. There is one laboratory technician on staff. The laboratory technician takes all tests based on the doctor’s direction, which indicates the name, age, and presumed diagnosis.

His work includes: taking blood for OBC (stating ESR, preparing a blood smear), taking blood for sugar, OAM. The laboratory technician takes unstained blood smears every day to the Central District Hospital, where they are then fixed and stained, and then examined by a doctor.

The office is equipped with: statfax, microscope, centrifuge, thermostat, refrigerator, glucometer.

The cabinet area is divided into three honors. In the first zone there is a table for urine for OAM, on which a laboratory assistant does an analysis (determines the amount of urine, color, turbidity, relative density, formed elements: protein and glucose, prepares urine sediment for microcopying. A centrifuge and thermostat are also located here.

In the second zone there is a refrigerator for solutions and preparations, a table at which blood is taken for the OAC, on the same table there is a microscope, sterile instruments, sterile cotton wool, sterile tweezers; disposable scarifiers; sterile glass slides; sterile Panchenkov capillaries; 5% solution of sodium citrate (citrate); latex gloves; 70% ethyl alcohol solution; stand with test tubes for collecting blood for ESR, microvets for collecting blood for erythrocytes, hemoglobin, leukocytes; blood collection plate; Petri dish with ground glass for making a blood smear; container for prepared blood smears.

The third zone contains disinfectant solutions for surface treatment (6% hydrogen peroxide solution, 0.6% calcium hypochloride solution, etc.), a container with cotton swabs for gloves, storage containers - containers for waste: used cotton wool, scarifiers , capillaries, container for used gloves. Biomaterial is recycled in this zone.

The post-analytical stage is divided into intra-laboratory and extra-laboratory parts. The main element of the in-laboratory part is checking the analysis result by a qualified laboratory technician for its analytical reliability, biological probability, as well as comparison of each result with reference intervals. After this stage, the laboratory technician confirms the results and transmits them to the clinician or patient.

The extra-laboratory part is the attending physician’s assessment of the clinical significance of information about the patient’s condition obtained as a result of laboratory testing and interpretation of the laboratory information obtained. The main form of quality control of the post-analytical stage is regular external and internal audits.

For preanalytical stage accounts for up to 60% of the time spent on laboratory research. Errors at this stage inevitably lead to distorted analysis results. In addition to the fact that laboratory errors are fraught with loss of time and money for repeated tests, their more serious consequence can be incorrect diagnosis and incorrect treatment.

The results of laboratory tests may be influenced by factors related to the individual characteristics and physiological state of the patient’s body, such as: age; race; floor; diet and fasting; smoking and drinking alcoholic beverages; menstrual cycle, pregnancy, menopausal status; physical exercise; emotional state and mental stress; circadian and seasonal rhythms; climatic and meteorological conditions; position of the patient at the time of blood collection; taking pharmacological drugs, etc.

The accuracy and correctness of the results is also influenced by the technique of taking blood, the instruments used (needles, scarifiers, etc.), the tubes in which the blood is taken, and subsequently stored and transported, as well as the conditions for storing and preparing the sample for analysis.

There are basically two ways to collect venous blood for analysis. Open systems (hollow needle, glass tube) have been used since time immemorial. This method involves contact of blood with air; in the case of a closed method, there is no contact with air, and blood collection is carried out in a closed mode.

Currently, in 65% of cases, blood is taken from a vein using an open method, i.e. either with a syringe or using a hollow needle into a test tube - by gravity. When collecting blood in this way, a number of difficulties often occur: blood thrombosis in the needle, and hemolysis caused by blood passing through the needle twice, since during the syringe collection, blood cells are twice injured due to squeezing through the narrow needle of the syringe, cell walls are torn, which greatly reduces the accuracy of the results due to mixing with cellular contents. If it is necessary to fill several tubes with blood, the duration of blood sampling increases. Various difficulties also occur when delivering glass tubes with blood to the laboratory: the tubes break, blood samples can spill, some of the blood is absorbed into the cotton swab that covers the tube, etc.

These and many other problems are easily solved by using so-called “closed” or vacuum blood collection systems.

The first “closed” system (Vacutainer) was invented in 1947 by Joseph Kleiner and released to the market in 1949. In its modern form (plastic unbreakable tube), the Vacutainer system experienced a second “birth” in 1991. The system works on this principle: a vacuum of a certain strength is created in a test tube; when the test tube is filled, it allows blood to flow into the test tube until it is filled to the required volume. In addition to more accurate dosing of blood volume, modern test tubes make it possible to increase the accuracy of the content of the required reagent in the test tube, in comparison with glass reusable tubes, into which the reagent is added not in production, but manually. Also, modern closed vacuum systems completely eliminate the risk of blood splashing and accidental needle sticks, making them a safer solution. (we will talk in more detail about fences with closed systems in practical classes). Source: Pr-consulta.ru

General clinical studies:

Complete blood count and ESR
Blood type and Rh factor
General urine analysis and Nechiporenko test
Feces for detection of helminth eggs
Scraping for enterobiasis

General blood analysis

Almost any visit to a therapist ends with him sending us for a finger prick blood test. Why do we take this test so often? What can he tell the attending physician?

Blood is a highly variable tissue of the body. (Yes, blood is a tissue, albeit a liquid one.) So, its composition subtly reflects the state of the entire organism and reacts to any deviations in health. That is why the doctor sends you for a blood test. This way he manages to quickly collect a huge amount of valuable information about what is happening to your body.

The clinical minimum includes examination of a patient admitted to the clinic. The analysis determines blood components (red blood cells, leukocytes, lymphocytes), ESR (erythrocyte sedimentation rate), hemoglobin and other blood characteristics

The analysis procedure is known to everyone: in the laboratory, a puncture is made in the fingertip with a scarifying needle. A drop of blood appears at this place. Usually its size does not satisfy the laboratory technician and she massages her finger so that enough blood is collected to fill a special pipette.

GENERAL BLOOD ANALYSIS AND ESR

The material for the study is venous blood, which is taken from the ulnar vein.
For a general analysis, blood is taken into a vacuum tube with a purple cap (with K 3 EDTA). For an accurate blood-anticoagulant ratio it is necessary to fill the entire test tube to the mark or specified blood volume!
Blood on ESR is also taken from the cubital vein using a vacuum system, but in a thin test tube with black lid! When prescribing both CBC and ESR, both tubes of one patient (purple and black) are signed by one and the same the same number! And this number is fixed in the direction.
Test tubes must clearly indicate patient identification number and name of the medical institution. The identification number must be kept in the institution's register.
The patient's blood must be stored in the refrigerator before being transferred to the courier. (+2 - +4°С) or in a container with refrigerant.
The blood tubes are given to the courier along with the directions. The numbers of the tubes must match the numbers on the directions.
The blood is sent to the laboratory on the day of collection. Blood cannot be stored until the next day!

What happens next is not known to everyone. The analysis can be done either using old laboratory methods, using a microscope and chemical reagents, or a pipette will be loaded into a contraption that will print out the answer in a minute.

In any case, the results of the analysis are abbreviations for various parameters and their numerical values. So, let's look at these parameters:

Hemoglobin - Hb. The norm for men is 120–160 g/l, the norm for women is 120–140 g/l. Hemoglobin is a protein substance concentrated in red blood cells - erythrocytes and is responsible for the transfer of oxygen and carbon dioxide between the lungs and body tissues. With a lack of hemoglobin, difficulties arise in providing cells with oxygen. A person may experience a feeling of suffocation despite intense breathing. A decrease in hemoglobin levels occurs with anemia, after blood loss, and also due to a number of hereditary diseases.

Hematocrit - Ht. The norm for men is 40–45%, the norm for women is 36–42%. This is an indicator of the percentage of blood cellular elements (erythrocytes, leukocytes and platelets) of the total blood volume. A drop in hematocrit (a decrease in the number of cells per liter of blood) may indicate blood loss (including internal) or inhibition of hematopoietic function (severe infections, autoimmune diseases, exposure to radiation). A high hematocrit is also bad. Thick blood passes through blood vessels more poorly, increasing the risk of blood clots.

Red blood cells - RBC, the norm for men is 4–5*10^12 per liter, for women – 3–4*10^12 per liter. Red blood cells are precisely those cells in which hemoglobin is concentrated. The change in their number is closely related to the concentration of hemoglobin and accompanies similar diseases.

Color Index - CPU, normally is 0.85–1.05. It is the ratio of hemoglobin concentration to the number of red blood cells. Its change indicates the development of various forms of anemia. It increases in B12-, folate-deficiency, aplastic and autoimmune anemia. A decrease in color index occurs with iron deficiency anemia.

Leukocytes - WBC. The leukocyte norm is 3–8*10^9 per liter. Leukocytes are our body's protectors from infection. When pathogenic microorganisms penetrate, their number should increase. In severe infections, cancer and autoimmune pathologies, the number of leukocytes decreases.

Neutrophils - NEU. This is the most numerous group of leukocytes (up to 70% of their total number). They are cells of a nonspecific immune response. Their main function is phagocytosis (ingestion) of everything foreign that has entered the body. That is why there are so many of them in the mucous membranes. An increase in the number of neutrophils indicates purulent inflammatory processes. But it’s even worse if the purulent process is, as they say, “on the face”, but there are no neutrophils.

Lymphocytes - LYM make up 19–30% of leukocytes. Lymphocytes are responsible for specific (targeting certain microorganisms) immunity. If, against the background of an inflammatory process, the percentage of lymphocytes drops to 15% or lower, then their number per 1 μl of blood should be assessed. You need to sound the alarm if it turns out to be less than 1200 - 1500 cells.

Platelets - PLT. The normal platelet count is 170–320*10^9 per liter. Platelets are the cells that stop bleeding. In addition, they select the weapons of immune cells that they used in the fight against microorganisms - the remnants of immune complexes circulating in the blood. Therefore, a decrease in platelet count indicates immunological diseases or severe inflammation.

Erythrocyte sedimentation rate - ESR (ROE). The ESR norm for men is up to 10 mm/h, for women - up to 15 mm/h. An increase in ESR cannot be ignored. This may indicate inflammation of certain organs, or it may also be a pleasant signal informing a woman about pregnancy.

Preparing the patient for the blood donation procedure and the main preanalytical factors that can affect the result

Ø Medicines (the influence of drugs on the results of laboratory tests is varied and not always predictable).

Ø Eating (possible both a direct effect due to the absorption of food components, and an indirect effect - shifts in hormone levels in response to food intake, the influence of sample turbidity associated with an increased content of fat particles).

Ø Physical and emotional overload (cause hormonal and biochemical changes).

Ø Alcohol (has acute and chronic effects on many metabolic processes).

Ø Smoking (changes the secretion of some biologically active substances).

Ø Physiotherapy, instrumental examinations (may cause temporary changes in some laboratory parameters).

Ø Phase of the menstrual cycle in women (significant for a number of hormonal studies; before the study, you should check with your doctor about the optimal days for taking a sample to determine the level of FSH, LH, prolactin, progesterone, estradiol, 17-OH-progesterone, androstenedione).

Ø Time of day when blood is drawn (there are daily rhythms of human activity and, accordingly, daily fluctuations in many hormonal and biochemical parameters, expressed to a greater or lesser extent for different indicators; reference values - the boundaries of the “norm” - usually reflect statistical data obtained under standard conditions, when taking blood in morning time).

A large number of existing diseases, individual degrees in different people complicate the diagnostic process. Often in practice, the use of the doctor’s knowledge and skills alone is not enough. In this case, clinical laboratory diagnostics helps to make the correct diagnosis. With its help, pathologies are identified at an early stage, the development of the disease is monitored, its possible course is assessed, and the effectiveness of the prescribed treatment is determined. Today, medical laboratory diagnostics is one of the most rapidly developing areas of medicine.

Concept

Laboratory diagnostics is a medical discipline that applies in practice standard methods for identifying and monitoring diseases, as well as searching for and studying new methods.

Clinical laboratory diagnostics greatly facilitates and allows you to select the most effective treatment regimen.

Sub-sectors of laboratory diagnostics are:

Information obtained using various methods of clinical laboratory diagnostics reflects the course of the disease at the organ, cellular and molecular levels. Due to this, the doctor has the opportunity to timely diagnose the pathology or evaluate the result after treatment.

Tasks

Laboratory diagnostics is designed to solve the following problems:

continuous search and study of new methods for analyzing biomaterials;
analysis of the functioning of all human organs and systems using existing methods;
detection of the pathological process at all its stages;
control over the development of pathology;
assessment of the outcome of therapy;
accurate diagnosis.

The main function of a clinical laboratory is to provide the doctor with information about the analysis of biomaterial and compare the results obtained with normal values.

Today, 80% of all information important for making a diagnosis and monitoring treatment is provided by the clinical laboratory.

Types of material studied

Laboratory diagnostics is a way of obtaining reliable information by examining one or more types of human biological material:

Venous blood is taken from a large vein (mainly in the bend of the elbow).
Arterial blood is most often taken to assess CBS from large veins (mainly from the thigh or the area under the collarbone).
Capillary blood - taken from a finger for many studies.
Plasma - it is obtained by centrifugation of blood (i.e., dividing it into components).
Serum is blood plasma after the separation of fibrinogen (a component that is an indicator of blood clotting).
Morning urine - collected immediately after waking up, intended for general analysis.
Daily diuresis is urine that is collected in one container during the day.

Stages

Laboratory diagnostics includes the following steps:

preanalytical;
analytical;
post-analytical.

The preanalytical stage involves:

Compliance by a person with the necessary rules for preparing for analysis.
Documentary registration of the patient upon arrival at the medical institution.
Signing test tubes and other containers (for example, urine) in the presence of the patient. The name and type of analysis are written on them by the hand of a medical worker - he must pronounce these data out loud to confirm their accuracy by the patient.
Subsequent processing of the taken biomaterial.
Storage.
Transportation.

The analytical stage is the process of direct examination of the obtained biological material in the laboratory.

The post-analytical stage includes:

Documentary recording of results.
Interpretation of results.
Generation of a report containing: data of the patient, the person who conducted the study, medical institution, laboratory, date and time of collection of biomaterial, normal clinical limits, results with corresponding conclusions and comments.

Methods

The main methods of laboratory diagnostics are physical and chemical. Their essence is to study the taken material for the relationship of its various properties.

Physico-chemical methods are divided into:

optical;
electrochemical;
chromatographic;
kinetic.

The optical method is most often used in clinical practice. It consists of recording changes in a beam of light passing through a biomaterial prepared for research.

In second place in terms of the number of analyzes performed is the chromatographic method.

Probability of errors

It is important to understand that clinical laboratory diagnostics is a type of research during which errors can be made.

Each laboratory must be equipped with high-quality instruments, and analyzes must be performed by highly qualified specialists.

According to statistics, the main share of errors occurs at the preanalytical stage - 50-75%, at the analytical stage - 13-23%, at the post-analytical stage - 9-30%. Measures should be taken regularly to reduce the likelihood of errors at each stage of laboratory research.

Clinical laboratory diagnostics is one of the most informative and reliable ways to obtain information about the state of health of the body. With its help, it is possible to identify any pathologies at an early stage and take timely measures to eliminate them.