APPROVED BY
By order of the Federal
agencies for technical
regulation and metrology
dated December 4, 2008 N 355-st

NATIONAL STANDARD OF THE RUSSIAN FEDERATION
Foreword

The goals and principles of standardization in the Russian Federation are established Federal law of December 27, 2002 N 184-FZ "On technical regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions".

Information about the standard

1. Developed by the Laboratory of Problems of Clinical and Laboratory Diagnostics of the Moscow Medical Academy. IM Sechenov, Roszdrav, the Department of Clinical Laboratory Diagnostics of the Russian Medical Academy of Postgraduate Education, Roszdrav, the Department of Certification and Quality Control of Clinical Laboratory Research of the State Research Center for Preventive Medicine of Rosmedtechnologies, the Department of Clinical Laboratory Diagnostics of the Russian State Medical University of Roszdrav.

2. Introduced by the Technical Committee for Standardization TC 466 "Medical Technologies".

3. Approved and put into effect by the Order of the Federal Agency for Technical Regulation and Metrology of December 4, 2008 N 355-st.

4. Introduced for the first time.

Information about changes to this standard is published in the annually published information index "National standards", and the text of changes and amendments - in the monthly published information indexes "National standards". In case of revision (replacement) or cancellation of this standard, the corresponding notice will be published in the monthly published information index "National standards". Relevant information, notice and texts are also posted in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet.

1 area of ​​use

This standard establishes general provisions, principles and uniform rules for the activities of health authorities at all levels for planning, ensuring, monitoring and improving the quality of laboratory research performed in clinical diagnostic laboratories of medical organizations of all forms of ownership. This International Standard is intended for use by all organizations, institutions and enterprises, as well as individual entrepreneurs whose activities are related to the provision of medical care.

2. Normative references

This standard uses normative references to the following standards:

GOST R ISO 5725-2-2002. Accuracy (correctness and precision) of measurement methods and results. Part 2. Basic method for determination of repeatability and reproducibility of a standard measurement method

GOST R ISO 9001-2008. Quality management systems. Requirements

GOST R ISO 15189-2006. Medical laboratories. Special requirements for quality and competence

GOST R ISO 15193-2007. Medical devices for in vitro diagnostics. Measurement of quantities in samples of biological origin. Description of reference measurement techniques

GOST R ISO 15194-2007. Medical devices for in vitro diagnostics. Measurement of quantities in samples of biological origin. Description of reference materials

GOST R ISO 15195-2006. Laboratory medicine. Requirements for reference measurement laboratories.

Note - When using this standard, it is advisable to check the validity of reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or according to the annually published information index "National Standards", which was published as of January 1 of the current year , and according to the relevant monthly information signs published in the current year. If the reference standard is replaced (changed), then when using this standard, the replacing (modified) standard should be followed. If the reference standard is canceled without replacement, then the provision in which the reference to it is given applies to the extent not affecting this reference.

3. Clinical laboratory research in the system of measures for the provision of medical care
3.1. The purpose and objectives of the development of the standard

The purpose of the development of this standard is to form a regulatory framework for bringing into a system based on uniform principles and criteria, measures taken by health authorities at all levels, for quality management of laboratory tests performed in clinical diagnostic laboratories of medical organizations, in order to achieve a single objectively substantiated the level of analytical reliability and clinical information content of research results, unconditional provision and continuous improvement of their quality.

The main tasks of the development and implementation of this standard are:

Determination of significant objects, processes, procedures related to different levels of the health care system and capable of directly or indirectly influencing the conditions and results of laboratory tests;

Establishing principles for the development and rules for the application of criteria for assessing the compliance of the characteristics of these objects, processes, procedures with the requirements for achieving the quality of laboratory research that meet the needs of effective clinical management of patients;

Formation of a system of mutually agreed normative documents that ensure the creation of optimal conditions for reliable laboratory support for treatment and diagnostic activities of medical organizations.

3.2. Medical relevance of clinical laboratory research

Clinical laboratory studies are one of the forms of an objective assessment of the state of human health and clinical diagnosis of human diseases, based on the study, using laboratory analytical procedures, of the composition of samples of biological materials taken from the examined patients. The purpose of clinical laboratory studies is to obtain objective information about the state of the internal environment of the patient's body, to establish the presence or absence of changes in the composition of biological materials characteristic of the deviation of the activity of organs and systems of the patient's body from the state of health and characteristic of certain forms of pathology.

The process of clinical diagnostics is a sequential accumulation of information to reduce (up to elimination) uncertainty in the understanding of the patient's condition, the presence and form of pathology in him. The role of clinical laboratory research performed by:

During the clinical examination of the patient;

In the order of a dispensary or medical and genetic examination;

During a preventive examination,

consists in reducing the uncertainty in assessing the patient's condition by detecting and / or measuring in samples of biomaterials taken from the patient, certain analytes, functionally or structurally linked by a causal relationship with the impaired function or the affected organ, and reflecting the presence of a pathological process, characterizing its cause, mechanisms occurrence and development, severity and individual clinical picture. The clinical information content of laboratory studies is the higher, the closer to the true idea of ​​the presence and nature of pathology in a patient is formed on the basis of the results of these studies.

Correct laboratory information about the condition of the patient being examined, the presence of pathology and the dynamics of the disease is essential for establishing the diagnosis, deciding on the application of the necessary treatment measures, assessing and predicting the severity of the disease and the effectiveness of the treatment.

3.3. Conditions for performing clinical laboratory tests

Clinical laboratory tests are performed by the staff of clinical diagnostic laboratories - departments of medical organizations, in some situations - by the staff of clinical departments of medical organizations ("research at the point of treatment"), in some cases on the recommendation of the attending physicians - by the patients themselves in the order of self-control. The totality of clinical diagnostic laboratories forms the clinical laboratory service of the health care system. The modern nomenclature of studies includes several thousand laboratory tests, which, provided that they are justified, performed correctly, and interpreted correctly, provide analytically reliable and clinically highly informative answers to the doctor's questions about diagnosis and patient management within an acceptable time frame. With inaccurate laboratory data, the risk of clinical difficulties reaches 26% - 30%, and the risk of unjustified actions of the doctor is 7% - 12%. The measure of compliance of laboratory test results with the true content of the analyzed analytes in the patient's body and the expected clinical informativeness of laboratory results depend on the influence of a number of both intralaboratory and extralaboratory factors at the preanalytical, analytical and postanalytical stages of research.

The combination of various types of variation caused by the action of these factors: biological, iatrogenic, preanalytical, analytical, along with pathological itself, leads to uncertainty and the possibility of obtaining erroneous results of laboratory tests. Limiting the action of these factors by taking a set of measures to different levels healthcare management - from the level of the federal executive body in the field of healthcare to individual medical organizations and clinical diagnostic laboratories - aimed at creating optimal conditions for analytical and diagnostic work of clinical diagnostic laboratories, can significantly increase the accuracy of laboratory results and thereby contribute to an increase in the efficiency of diagnostics and treatment of patients.

4. Quality management of clinical laboratory research. General requirements
4.1. Clinical laboratory research as a special type of medical service

Laboratory studies of biomaterials samples from patients are specific services that clinical diagnostic laboratories of healthcare institutions (or staff of clinical departments) provide to patients on behalf of the attending physicians, in the order of clinical examination, medical genetic examination, and preventive examination.

The essence of clinical laboratory research consists in the use of precisely characterized and interconnected in the form of laboratory tests (analytical technologies, research methods) analytical procedures to study the composition of the patient's biological materials (biological fluid, excreta, tissue samples) in order to detect changes in them reflecting the deviation of organ activity and the systems of the body being examined from the state of health and indicating the presence of certain forms of pathology.

Clinical and laboratory analytical procedures are effects of a physical, chemical or biological nature on a sample of biological material obtained from a patient, so that, as a result of a specific interaction aimed at changing the structure and properties and generating an appropriate signal, detect and / or measure a certain component<*>(analyte) functionally or structurally related to an organ or physiological system the patient's body affected by the alleged pathological process.

<*>A component is a delineated part of a system. In analytics, the components of a system are subdivided into "analytes", "concomitants" and "solvents"; the last two are referred to as "matrix". Matrix - all components of the material system, excluding the analyte. Analyte is a sample component specified in the name of the investigated property or measured value.

Analytes can represent different properties of interest and different measurable quantities, including:

Physical properties;

Chemical elements, ions, inorganic molecules;

Low molecular weight organic structures;

Macromolecules of known or approximately established structure and specific biological properties;

Cells, their structural elements or cellular systems;

Microorganisms, their structural characteristics and biological properties;

In the process of clinical laboratory research, three stages are distinguished:

Preanalytical (preanalytical);

Analytical;

Post-analytical (post-analytical).

The preanalytical stage includes:

a) the out-of-laboratory phase, including: selection and appointment of a study by a clinician, preparing a patient for analysis, taking a biomaterial sample, most often by clinical staff; labeling the sample to identify it with the patient; in some cases, the necessary primary processing, short-term storage and transportation of the biomaterial sample to the laboratory;

B) intra-laboratory phase, including registration of a biomaterial sample, identification of a sample with a patient, distribution of biological samples or their portions according to the assigned types of research; necessary further processing of samples to prepare them for analysis.

The analytical stage includes a set of analytical procedures necessary for performing the research, combined by the research methodology and ending with the receipt of the research result in numerical or descriptive form, depending on the type and method of research. The main procedures of clinical laboratory research methods are to create conditions for the isolation of the analyte from the variety of other components of the biomaterial, identification of the analyte based on the detection of its specific properties and (in some cases) in the quantitative assessment of its content. In the process of laboratory research, chemical or biological reagents are used that selectively interact with the analyte, converting it into the form that generates the corresponding signal and allows its identification, detection or measurement. The principle of research and the details of analytical procedures depend on the characteristics of the composition, structure and properties of the desired analyte. The registration of the analysis result is carried out on the basis of subjective (visual) or objective (instrumental) assessment.

The post-analytical stage includes:

a) the intralaboratory phase, in which the result of the study is assessed by a laboratory specialist for its analytical reliability (according to the data of intralaboratory quality control), its biological likelihood (likelihood), as well as by comparison with previously conducted similar studies or other parallel studies conducted in the same the patient (in case of cytological studies, the laboratory report may contain the wording of the probable diagnosis);

b) the out-of-laboratory phase, when the clinician assesses the clinical significance of information about the state of a certain area of ​​the patient's internal environment, obtained as a result of laboratory research, and compares it with the data of his own observation of the patient and the results of other types of objective research.

The performance of research by clinical personnel outside the laboratory requires systematic monitoring by competent laboratory personnel of the quality of out-of-laboratory research: by training clinical personnel in the rules for performing research at the point of treatment using portable analytical devices and quality control methods, comparing the results of research performed outside the laboratory with laboratory results.

4.2. The quality of clinical laboratory tests and factors affecting it

4.2.1. The quality of a medical device or service is seen as the degree to which it meets the patient's needs for an accurate assessment of his condition, diagnosis of a disease, and effective treatment. The main characteristics of the quality of clinical laboratory tests are analytical reliability, clinical information content and the timeliness of providing the results of the analysis of analytes (to the doctor or directly to the patient), corresponding to the needs of clinical diagnostics and monitoring of treatment results.

During the implementation of each of the stages and each of the phases of a clinical laboratory study, various objective and subjective factors that can reduce the quality of the study can manifest their effect and have a deviating effect on the final result. Sources of some degree of uncertainty in the values ​​of research results are:

The multicomponent composition of human biological materials;

Variety of characteristics of structure, properties and stability of components;

Variability of the content of components in biomaterials before and during analysis under the influence of pathogenic and non-pathogenic factors;

The dependence of the research results on the preparation of the patient for the laboratory test, on the conditions for taking, storing and transporting the biomaterial sample to the laboratory;

Properties of methods and means of analysis (measuring instruments and equipment, sample preparation, etc.);

Application in the analysis process of various types of physical, chemical and biological effects on a sample of biomaterial to determine the individual required components.

4.2.2. The following factors of the preanalytical stage can affect the results of laboratory tests:

a) errors in the identification of the patient and the biomaterial sample;

B) biological factors: gender, age, ethnicity, physiological state (physical fitness, pregnancy), biological rhythms, environmental influences;

C) removable factors: food intake, fasting, body position, physical activity, smoking, alcohol consumption;

d) iatrogenic factors:

Diagnostic procedures (palpation, punctures, biopsies, functional tests, physical stress during exertion, ergometry; endoscopy; introduction of contrast media; immunoscintigraphy);

Operational interventions;

Various medical procedures (infusions and transfusions; dialysis; ionizing radiation);

Medicines (including those taken without a doctor's prescription);

E) conditions for taking, temporary storage and transportation of biomaterial:

Pick-up time, pick-up time;

Preparation of a body site for taking material;

Procedures for taking blood, urine, and other biomaterials;

Containers for collecting samples of biomaterials (purity, material);

Impact of environmental factors (temperature, air composition);

Preservatives, anticoagulants;

Primary processing procedures (mixing, centrifugation, cooling, freezing);

f) properties of the analyte:

Biological half-life of the analyte;

Stability in biological material at different temperatures;

In vitro metabolism, including sensitivity to light and the like.

4.2.3. As part of the analytical stage of a clinical laboratory study, its result is influenced by the conditions for performing the analysis and the components of the analytical system:

Composition and properties of the studied sample of the patient's biomaterial;

Accuracy characteristics of research methods;

Properties of various types of equipment and consumables used for taking a sample of biomaterial and its primary processing and influencing it;

Metrological characteristics of measuring instruments;

Properties of additives that provide temporary stability of a biomaterial sample or analyte under study;

The composition and properties of reagents (analyte converters) specifically reacting with the analyte due to their chemical or biological properties, generating the corresponding signal and thereby making it possible to detect and / or measure it;

Composition and metrological characteristics of calibration materials (working standard samples of the composition or properties of the analyzed analytes) used for the quantitative (indirect) assessment of the analyte content in the biological sample;

Accuracy of adherence to the sequence of individual analytical procedures, their duration and intervals between them, temperature conditions and other analysis conditions provided for by the established research methodology;

The composition and properties of control materials, which are varieties of a working standard sample of an analyte or a reference sample, intended for carrying out procedures for internal laboratory control or external assessment of the quality of studies;

Educational training, the level of professional qualifications and discipline of the implementation of methods by laboratory specialists involved in the implementation of research.

4.2.4. At the post-analytical stage, the following can have a negative impact on the use of laboratory results for clinical purposes:

Failure to take into account the discrepancy between the results of studies conducted in parallel with similar biological bases in the same patient;

Underreporting of the results of internal laboratory quality control and delivery of results to the clinic with unacceptable errors;

Mixing up the test results of different patients;

Use of general population reference intervals for evaluating the results without taking into account the age or other characteristics of the patient;

Unaccounted for causes of interference;

Late delivery of test results to the attending physician;

Distrust or ignorance of laboratory results by the doctor.

4.3. Quality Management Principles for Clinical Laboratory Research

Achievement required quality clinical laboratory research is possible as a result of the implementation of its management functions, which consist of:

In establishing quality indicators, that is, acceptable limits of variation, characteristic properties of clinical laboratory tests, and determining measures to ensure that the results of the work process meet these criteria (quality planning function);

In the implementation of the planned measures to ensure the required quality, including the standardization of conditions and stages of research (quality assurance function);

Tracking the compliance of the research results of the components with the established framework of their variation and making a decision on the degree of such compliance and, if necessary, on measures to eliminate the nonconformity (quality control function);

In identifying and eliminating the causes of non-compliance of the results with the established criteria and in improving the work process (quality improvement function).

The most complete provision and continuous improvement of the quality of laboratory results is achieved with a systematic approach to its management, which allows consistently and timely elimination of heterogeneous causes of laboratory errors using measures taken at different levels of healthcare management.

The quality system in accordance with the standards GOST R ISO 9001 and GOST R ISO 15189 includes the organizational structure, procedures, processes and resources necessary for the implementation of quality management.

To prevent deviating influences various factors at the stages of clinical laboratory research, quality management of clinical laboratory research provides for the establishment of a system of general requirements and rules for their application to all components of the quality of clinical laboratory research:

Technologies used (methods of taking biomaterials, research methods, measurement techniques, laboratory tests);

Resources used for their implementation (reagents, calibration materials, equipment);

Criteria and methods for assessing analytical reliability, clinical efficacy and compliance of the results with the needs of patient management.

The quality of clinical laboratory tests in each clinical diagnostic laboratory reflects the end result of quality management measures. Assessment of the compliance of research quality with the needs of clinical diagnostics and monitoring and analysis of the causes and sources of laboratory errors in clinical diagnostic laboratories is (in the feedback order) the basis for improving the activities of organs and structures at those levels and stages of quality management where sources of laboratory errors have arisen (resolution use of technology, calibration materials, reagents, devices that do not meet the established requirements; insufficient professional training of personnel; purchase of analysis tools that are not recommended for use in clinical diagnostic laboratories; lack of funding, which prevented the acquisition of analysis tools that meet quality requirements, etc. ).

4.4. Means and methods of quality management of clinical laboratory research

Medical needs are prioritized in setting research quality criteria. The clinical diagnostic laboratory is obliged to provide in a timely manner analytically reliable results of clinical laboratory tests that correspond to those clinical needs that have caused the need to perform a specific test.

Comparison of the results obtained with the results of reference measurement procedures, traceability of the properties of the calibrators used to the properties of certified reference materials in accordance with GOST R ISO 15193, GOST R ISO 15194, GOST R ISO 15195, GOST R ISO 17511, GOST R ISO 18153, in relation to analytes studied in clinical diagnostic laboratories.

The establishment of specific requirements for individual technologies of an integral process for the provision and implementation of clinical laboratory research and the use of these technologies in the activities of clinical diagnostic laboratories of medical organizations is provided for in a set of interrelated regulatory documents that constitute the normative basis for the implementation of the main functions of quality management of clinical laboratory research:

a) the function "Planning the quality of clinical laboratory research":

Rules for assessing the analytical reliability of research methods (accuracy, sensitivity, specificity);

Rules and methods for assessing the clinical information content of laboratory tests;

Rules for the development of requirements for the timeliness of the provision of laboratory information;

B) function "Quality assurance of clinical laboratory research":

Rules for describing methods of clinical laboratory research;

Description of calibrators and control materials;

Rules for the selection of measuring and test equipment;

Principles and rules for technical equipment of clinical diagnostic laboratories;

Principles and rules for assessing the level of professional competence (qualifications, knowledge and skills) of the personnel of clinical diagnostic laboratories;

Rules for conducting the preanalytical stage of clinical laboratory research;

Standard model of "Guidelines for the quality of research in a clinical diagnostic laboratory";

Rules of interaction between the personnel of clinical departments and clinical diagnostic laboratories of medical organizations;

c) the function "Quality control of clinical laboratory research":

Rules for assessing the margin of error for quantitative clinical laboratory tests;

Rules for conducting internal laboratory quality control of quantitative methods using control materials;

Rules for conducting internal laboratory quality control of evaluative (semi-quantitative) methods of clinical laboratory research;

Rules for conducting internal laboratory quality control of qualitative (non-quantitative) methods of laboratory research;

Rules for conducting an external quality assessment of the results of clinical laboratory tests;

Rules for conducting a clinical audit of the effectiveness of laboratory support for the activities of medical organizations;

Principles and criteria for evaluating the medico-economic efficiency of clinical laboratory research.

Normative documents for individual components of quality management of clinical laboratory research establish principles for the development and rules for the application of criteria in the field of application of each individual normative document. Specific forms of assessing compliance with regulatory requirements should be defined for each component of clinical laboratory research quality management. Laboratory clinical laboratory testing quality control metrics serve as the resulting indices of regulatory compliance across the entire research quality management system and provide a basis for analysis of the causes and sources of deficiencies at the appropriate management levels.

4.5. Organizational and legal structure of quality management of clinical laboratory research

The legal basis for measures to manage the quality of clinical laboratory research is the laws and regulations of the Russian Federation.

Quality management measures for clinical laboratory studies are carried out in accordance with technical regulations, national standards and guidelines of the federal executive body in the field of health care:

At the federal level - by the federal executive body in the field of health care; independent organizations for external assessment of the quality of clinical laboratory research; National Metrology Institute; reference (expert) laboratories;

At the level of the constituent entities of the Russian Federation - by local healthcare authorities, their functional divisions, authorities for licensing medical activities;

At the level of medical organizations - by the heads of medical organizations, heads of clinical diagnostic laboratories.

With regard to medical organizations operating on the basis of contracts with the Mandatory Health Insurance Fund, the bodies of this fund and the experts appointed by them may participate in the quality management of clinical laboratory research. Professional organizations of specialists in clinical laboratory diagnostics have the right to take part in the development of proposals for improving the quality of laboratory research and submit them at any level of healthcare management in accordance with the legislation of the Russian Federation on the protection of public health.

4.6. Measures to bring the practice of work in clinical diagnostic laboratories in line with regulatory requirements

The principles and rules established by the normative documents of the quality management system for clinical laboratory research reflect the objective needs to ensure an accurate assessment of the health status of patients, clinical diagnosis of diseases and monitoring the effectiveness of treatment measures. Compliance with regulatory requirements is a prerequisite for the accreditation of clinical diagnostic laboratories and licensing of the activities of medical organizations. Responsibility for compliance with regulatory requirements lies with the heads of the relevant structures and organizations of the health care system. In case of non-compliance with regulatory requirements, healthcare management bodies have the right to:

Require the responsible persons to take effective measures to bring the practice of clinical diagnostic laboratories in accordance with the requirements of regulatory documents;

Carry out an inspection check of execution and, if necessary, apply administrative sanctions in accordance with the current legislation of the Russian Federation and within the powers provided for by the provisions on these bodies.

BIBLIOGRAPHY

ISO 22870: 2006 Medical facility-based biological examination of a patient (ROST).

Requirements for the quality and competence of laboratories

ISO 22870: 2006 Point-of-Care Testing (GROWTH) - Requirements for quality and competence

This standard establishes uniform rules for the development of their own quality management systems, including a system of administrative management, technical activities, based on the preparation and maintenance of documentation that regulates the activities of clinical diagnostic laboratories of medical organizations of all forms of ownership.
This International Standard has been created to ensure the quality of clinical diagnostic research and can be used by laboratory accreditation bodies in the recognition or confirmation of the competence of laboratories.
This standard can be used by all organizations, institutions and enterprises, as well as individual entrepreneurs whose activities are related to the provision of medical care.

Title of the document:	GOST R 53079.2-2008
Document type:	standard
Document status:	acting
Russian name:	Laboratory clinical technologies. Quality assurance of clinical laboratory research. Part 2. Guidelines for quality management in a clinical diagnostic laboratory. Typical model
English name:	Medical laboratory technologies. Quality assurance of clinical laboratory tests. Part 2. Guidelines for improvements of quality in clinical-diagnostic laboratory. Typical model
Date of text update:	01.08.2013
Date of introduction:	01.01.2010
Description update date:	01.08.2013
Number of pages in the main text of the document:	18 pcs.
Date of issue:	30.07.2009
Reissue:
Last modified date:	22.05.2013
Located in:	OKS All-Russian classifier of standards 11 HEALTHCARE 11.020 Medical sciences and health care in general (Including quality management and environment in health technologies; Application of information technologies in health care see: 35.240.80)

Approved. By order of the Federal Agency for Technical Regulation and Metrology of December 18, 2008 N 554-st

National standard of the Russian Federation GOST R 53079.4-2008

"TECHNOLOGIES LABORATORY CLINICAL. QUALITY ASSURANCE OF CLINICAL LABORATORY STUDIES. Part 4. RULES FOR CONDUCTING THE PREANALYTIC STAGE"

Clinical laboratory technologies. Quality assurance of clinical laboratory tests. Part 4. Rules for conducting of preanalytical stage

Introduced for the first time

Foreword

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On technical regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions"

1 area of ​​use

This standard establishes requirements for the conditions and procedures for conducting the preanalytical stage of clinical laboratory research in order to exclude or limit the influence of endogenous, exogenous, iatrogenic and other factors that interfere with the correct reflection of the state of the internal environment of the examined patients in the results of clinical laboratory studies.

This standard can be used by all organizations, institutions and enterprises, as well as individual entrepreneurs whose activities are related to the provision of medical care.

2. Normative references

This standard uses normative references to the following national standards:

GOST R ISO 15189-2006 Medical laboratories. Special requirements for quality and competence

GOST R ISO 15190-2007 Medical laboratories. Safety requirements

Note - When using this standard, it is advisable to check the validity of the reference standards in the public information system - on the official website of the Federal Agency for Technical Regulation and Metrology on the Internet or according to the annually published information index "National Standards", which was published as of January 1 of the current year and according to the relevant monthly information signs published in the current year. If the reference standard is replaced (changed), then when using this standard, the replacing (modified) standard should be followed. If the reference standard is canceled without replacement, then the provision in which the reference to it is given applies to the extent not affecting this reference.

3. Rules for conducting the preanalytical stage of clinical laboratory research

3.1. General Provisions

The reliability of the reflection in the results of laboratory studies of the state of the patient's internal environment, the content of the desired components of biological materials largely depends on the conditions in which the patient was in the period preceding the taking of the biomaterial sample from him, on the conditions and procedures for taking the sample, its primary processing and transportation to laboratory, that is, from the factors of the preanalytical stage of clinical laboratory research.

In order to exclude or limit the influence of preanalytical out-of-laboratory factors on the laboratory results, this standard regulates:

a) the conditions of the period preceding the taking of a sample of biological material from the patient (Appendix A);

b) conditions and procedures for taking a sample of biological material from a patient;

c) procedures for primary processing of a sample of biological material;

d) conditions of storage and transportation of biomaterial samples to clinical diagnostic laboratories.

The requirements of the standard are based on:

a) scientific data on constant and variable factors of a physical, chemical and biological nature that can affect the content of substances and cells in biological materials of patients;

b) generalized data on the stability of components in samples of biological materials after taking them at different conditions storage (Appendices B, C, D);

c) generalized data on the effect of medicinal products taken by the patient on the results of laboratory tests (Appendix D);

d) the requirements of GOST R ISO 15189 (section 5.4).

The rules are intended to ensure such quality of conducting the preanalytical stage of clinical laboratory research, which is necessary to obtain their results, which reliably reflect the state of the internal environment of the examined patients at the time of examination, by:

Correct preparation patients for laboratory tests;

Informing patients about the required dietary restrictions, physical activity, smoking, about the rules for collecting biological materials, which are usually collected by the patient himself (urine, feces);

Instructing the personnel involved in taking samples of biological materials from patients about the peculiarities of the procedures for taking various types of these materials;

Rational organization of the process of taking samples of biomaterials;

Full provision of procedures for taking samples of biomaterials with the necessary tools, utensils, means of primary processing and transportation.

Taking into account the potential biohazards of samples of biological material obtained from patients, personnel performing these functions should be informed and trained in the rules of safe sampling and should have protective equipment (gloves, devices for the safe collection of used needles, etc.) in accordance with with the requirements of GOST R ISO 15190.

These rules contain general provisions that in relation to individual biological materials and individual analytes studied in them, biological objects may require special conditions and procedures, which should be reflected in regulatory documents on technologies for the provision of appropriate simple or complex medical services, in relation to the functions of various categories of clinical personnel.

Based on these general rules, each medical organization should develop and introduce for mandatory implementation internal rules for conducting the preanalytical stage in relation to each type of research performed in the laboratory, taking into account the peculiarities of the medical profile and organizational form of the institution. If studies are performed in a laboratory of another institution, the rules for conducting the preanalytical stage, including the conditions for transporting samples, in relation to these studies should be agreed with the head of the laboratory performing these studies. The presence and implementation of the rules for conducting the preanalytical stage of laboratory research by the personnel is one of the prerequisites for certification of the processes of performing research in a clinical diagnostic laboratory.

3.2. Requirements for the conditions and procedures for taking a sample of biological material

Taking a sample or sample is the process of taking or forming samples, characterized by the procedure for taking them, that is, operational requirements and / or instructions for the selection, withdrawal and preparation of one or more samples from an inspected lot to determine the characteristics of this lot (in laboratory medicine, an inspected lot is this is the patient being examined, and samples or samples are portions of a particular biological material).

3.2.1 Biological material - blood

Most clinical laboratory tests are performed on blood samples: venous, arterial, or capillary. Venous blood is the best material for determining hematological, biochemical, hormonal, serological and immunological parameters.

To test analytes in whole blood, serum, or plasma, a blood sample is most often taken from the cubital vein. Indications for taking blood from a finger for a clinical blood test:

In case of burns that occupy a large surface area of ​​the patient's body;

If the patient has very small veins or when they are difficult to access;

With severe obesity of the patient;

With an established tendency to venous thrombosis;

In newborns.

When taking a blood sample from a venous or arterial catheter through which the infusion solution was infused, the catheter should be pre-flushed with isotonic saline in a volume corresponding to the volume of the catheter, and discard the first 5 ml (milliliters) of blood taken from the catheter. Insufficient flushing of the catheter can lead to contamination of the blood sample with drugs given through the catheter. Do not take blood samples from heparin-treated catheters for coagulation studies.

Depending on the type of examination, a blood sample should be collected with strictly defined supplements. To obtain plasma, blood is collected with the addition of anticoagulants: ethylenediaminetetra acetic acid, citrate, oxalate, heparin. For studies of the blood coagulation system, only citrated plasma is used (in the exact ratio of one part of 3.8% (0, 129 mol / l) sodium citrate solution and nine parts of blood). In most hematological studies, venous blood is used with salts of ethylenediaminetetraacetic acid (EDTA, K 2 or K 3 -EDTA). To obtain serum, blood is collected without anticoagulants. For glucose testing, blood is collected with the addition of glycolysis inhibitors (sodium fluoride or iodoacetate).

The inhibitor aprotinin is used to study a number of unstable hormones (osteocalcin, calcitonin, adrenocorticotropic hormone).

To obtain sample variants for various types of studies from blood samples, the following sequence of filling the tubes is recommended:

Blood without additives - for obtaining blood cultures used in microbiological studies;

Blood without anticoagulants - to obtain serum used in clinical, chemical and serological studies;

Blood with citrate - to obtain plasma used in coagulation studies;

Blood with heparin - to obtain plasma used in biochemical studies;

Blood with EDTA - for obtaining whole blood, used for hematological studies, and plasma used for some clinical and chemical studies.

In order to preserve red blood cells in the blood sample, a mixture of anticoagulants with additives, for example, ACD (anticoagulant-citrate-dextrose or acid-citrate-dextrose), is used.

In order to avoid iatrogenic anemization of patients, the volume of blood taken for research should be rationally calculated on the assumption that, in the end, only half of the originally taken volume is consumed directly for analysis (taking into account the use of serum or plasma at a hematocrit of 0.5).

When using modern analyzers, the following sample volumes are sufficient:

For biochemical research: 4 - 5 ml; when using heparinized plasma: 3 - 4 ml;

For hematological studies: 2 - 3 ml of blood with EDTA;

For studies of the coagulation system: 2 - 3 ml of citrated blood;

For immunoassays, including protein studies, etc.: 1 ml of whole blood for 3 - 4 immunoassays;

To study the erythrocyte sedimentation rate: 2 - 3 ml of citrated blood;

For the study of blood gases: capillary blood - 50 μl (microliters); arterial or venous blood with heparin - 1 ml.

It is rational to use test tubes for taking blood of a small volume (4 - 5 ml) with a ratio of tube diameter and height of 13 to 75 mm. Using plasma instead of serum gives an increase of 15% - 20% in the yield of the analyzed material with the same volume of blood taken from the patient. The collection of venous blood is facilitated by the use of vacuum tubes. Under the influence of a vacuum, blood from a vein quickly enters the test tube, which simplifies the collection procedure and shortens the time it takes to apply the tourniquet.

To indicate the contents of tubes with various additional components, color coding of the caps that close them is used. So, for test tubes with anticoagulants, the lilac color of the cork means the presence of EDTA, the green color means heparin, and the blue color means citrate. Addition of glycolysis inhibitors (fluoride, iodoacetate) to the tube, either alone or in combination with anticoagulants (heparin, EDTA), coded by a stopper gray(see table 1).

Table 1

Additives in tubes with color codes

Tube contents	Application	Code color
Empty, no additives, for whey	Biochemistry, serology	Red White
Heparin (12-30 U / ml)	Plasma for biochemistry	Green / orange
K 2 or K 3 -EDTA (1, 2 - 2, 0 mg / ml)	Hematology and Selected Plasma Chemistry	Purple / red
Sodium citrate (0, 105-0, 129 mol / L)	Coagulation tests	Blue / green
Sodium fluoride (2 - 4 mg / ml) / potassium oxalate (1 - 3 mg / ml)	Glucose, lactate
K 3 -EDTA and aprotinin	Unstable hormones
NOTE Tubes containing acid-citrate-dextrose (ACD, formulas A and B) are used for cell preservation and are coded in yellow.

3.2.2 Biological material - cerebrospinal fluid

Cerebrospinal fluid sampling is carried out in strict accordance with the established procedure and, if possible, soon after taking blood for studies in serum, with the results of which the data in the cerebrospinal fluid are compared.

The first 0.5 ml and all cerebrospinal fluid (hereinafter - CSF) mixed with blood should be removed. Recommended CSF sample volumes - according to Table 2.

table 2

The sample is placed in compliance with the aseptic rules in tubes with stoppers (for microbiological studies - in sterile ones, for cytological and clinical-chemical studies - in free of dust particles, without EDTA and fluoride).

3.2.3 Biological material - urine

Depending on the purpose of the study, urine samples are collected either in separate portions or over a certain period of time. The first morning urine sample (on an empty stomach, immediately after sleep) is used to general analysis, the second morning urine portion - for quantitative studies in relation to the release of creatinine and for bacteriological research, a random portion - for qualitative or quantitative clinical and chemical studies, daily urine - for the quantitative determination of the excretion of analytes.

It is advisable to use a vessel with a wide neck and a lid; if possible, it is necessary to collect the urine directly into the vessel in which it will be delivered to the laboratory. You cannot take urine from a vessel, duck, or a pot, since even after rinsing these vessels, a phosphate sediment may remain, which contributes to the decomposition of fresh urine. If not all of the collected urine is delivered to the laboratory, then thorough shaking is necessary before draining its part, so that the sediment containing shaped elements and crystals is not lost.

When taking morning urine (for example, for a general analysis), collect the entire portion of morning urine (preferably, the previous urination was no later than two in the morning) in a dry, clean, but not sterile container, with free urination. When collecting daily urine, the patient collects it for 24 hours on a regular drinking regime. In the morning at 6-8 o'clock, he empties the bladder (this portion of urine is poured out), and then, during the day, collects all the urine in a clean vessel with a wide neck and a tightly closing lid, with a capacity of at least 2 liters. The last portion is taken exactly at the same time when the collection was started the day before (the start and end times of the collection are noted). If not all urine is sent to the laboratory, then the amount of daily urine is measured with a graduated cylinder, a part is poured into a clean vessel in which it is delivered to the laboratory, and the volume of daily urine must be indicated.

If for the analysis it is required to collect urine for 10-12 hours, the collection is usually carried out at night: before bedtime, the patient empties the bladder and marks the time (this portion of urine is discarded), then the patient urinates after 10-12 hours into the prepared dish, this portion of urine delivered to the laboratory for research. If it is impossible to keep urination for 10 - 12 hours, the patient urinates into the prepared dishes in several steps and marks the time of the last urination.

If it is necessary to collect urine in two or three hours, the patient empties the bladder (this portion is discarded), marks the time and exactly 2 or 3 hours later collects urine for examination.

When conducting a sample of three vessels (glasses), the morning portion of urine is collected as follows: in the morning on an empty stomach, after waking up and thoroughly using the external genitalia, the patient begins to urinate into the first vessel, continues in the second and ends in the third. The second portion should be predominant in volume. When diagnosing urological diseases in women, a sample of two vessels is more often used, that is, when urinating, urine is divided into two parts, it is important that the first part in this case is small in volume. When conducting a sample of three vessels in men, the last third portion of urine is collected after massage of the prostate gland. All vessels are prepared in advance, each must indicate the number of the portion.

Various preservatives are added to the first portion of urine collected per day, depending on the type of study assigned: for most components - thymol (several crystals of thymol per 100 ml of urine), for glucose, urea, uric acid, potassium, calcium, oxalate, citrate - sodium azide (0, 5 or 1, 0 g) for the entire amount of daily urine, for catecholamines and their metabolites, 5-hydroxyacetic acid, calcium, magnesium, phosphates - hydrochloric acid (25 ml, which corresponds to 6 mol / L for the volume of daily urine) , for porphyrins, urobilinogen - sodium carbonate, 2 g per liter of urine. It is also possible to use Muller's liquid (10 g of sodium sulfate, 25 g of potassium dichromate, 100 ml of water), 5 ml per 100 ml of urine, boric acid, 3 - 4 granules per 100 ml of urine, glacial acetic acid, 5 ml for the entire amount of daily urine, benzoate or sodium fluoride 5 g for the entire amount of daily urine. A few milliliters of toluene is added to the urine vessel so that it covers the entire surface of the urine in a thin layer; this gives a good bacteriostatic effect and does not interfere with chemical analyzes, but causes slight turbidity. Formalin, added at the rate of approximately 3-4 drops per 100 ml of urine, inhibits the growth of bacteria, preserves cellular elements well, but interferes with some chemical determinations (sugar, indican). Chloroform, added at the rate of 2 - 3 ml of chloroform water (5 ml of chloroform per 1 l of water) per 100 ml of urine, shows an insufficient preservation effect, and also adversely affects the results of the study of urine sediment (cell changes) and the results of some chemical studies.

3.2.4 Biological material - saliva

Saliva, which is either a product of only one gland, or a mixture of secretions from several glands, can be used to study a number of hormones and medicinal substances, including for drug monitoring. Saliva collection can be carried out using devices (tampons, balls), consisting of various absorbent materials (cotton, viscose, polymers).

3.2.5 Biological material - feces

Feces for research should be collected in a clean, dry dish with a wide neck, preferably glass (you should not collect feces in jars and bottles with a narrow neck, as well as in boxes, matchboxes, paper, etc.). Avoid the impurity of urine, discharge from the genitals and other substances, including drugs, to the feces. If for any chemical determination (for example, urobilinogen) it is necessary to know exactly the amount of excreted feces, then the dishes into which the feces are collected must be weighed first.

3.3. Features of the conditions for taking samples of biomaterials for special types of research

When taking samples for bacteriological research special attention must be paid to the prevention of contamination. The contents of the abscess should be aspirated through the skin, if possible, as it is easier to disinfect than mucous membranes. Liquid material is preferred over swab specimens. The secret containing interfering secondary microorganisms must be removed from the surface of the open wound, then the sample is collected with a bacteriological swab with circular rotational movements from the center to the periphery of the wound. The sample volume should be as large as possible. Blood culture specimens should, if possible, be collected during periods of increased body temperature. If infective endocarditis is suspected, at least ten blood cultures should be taken.

Samples for virus isolation and identification are usually collected immediately after symptom onset (if possible, in the first three days). For analysis, samples are used on tampons (from the nose, larynx, eyes), lavage from the pharynx, fluid from the vesicles for skin lesions, feces, urine and cerebrospinal fluid.

When taking skin samples for mycological studies, scrapings from areas of active lesion are taken with a scalpel after thorough disinfection of the skin area. In case of deposits on the hair, samples are taken with an epilation pipette or cut. When the nails are damaged, they are taken from their cuts and scrapings from the lower part of the nails. A random urine sample is used to detect yeast in urine, and a morning urine sample is preferable to detect yeast or fungi in sputum.

3.4.1 Rules for issuing a referral for laboratory research

Requests for tests must be agreed with all specialist doctors involved in the patient's treatment in order to take material for all necessary studies during venipuncture and not to repeat the procedure. The nurse must collect all the applications of this patient and give a summary request for tests (applicable only to the hospital). If the patient is transferred to another department, then she must also notify the laboratory about this, so that the results of the tests are sent to the right department and are not lost.

In the direction for laboratory research (application), the following data should be displayed:

Date and time of appointment;

Date and time of blood sampling (collection of biological material);

Surname and initials of the patient;

Department, medical history number, ward number; - age, gender;

Diagnosis;

The time of taking the last dose of drugs that can affect the test result;

Surname and initials of the attending physician who ordered the study;

List of required studies;

Signature of the specialist who took the blood or other biological material.

3.4.2 Rules for primary processing of a biomaterial sample

The most important procedure for the primary processing of biomaterial samples after taking them from patients is their coding for the purpose of their subsequent reliable identification. The coding of the types of samples by the nature of the additives introduced into them is fixed with the help of different colors of the caps of the tubes containing the corresponding additives: red / white - without additives, for serum, clinical and chemical research, serology; green - heparin, for plasma, clinical and chemical studies; violet - EDTA, for plasma, hematological studies; blue - sodium citrate, for coagulation studies; gray - sodium fluoride, for the study of glucose, lactate. Identification of samples from certain patients is most rational with the help of barcodes, which reflect the identification of patients: surname, clinical department, surname of the attending physician, etc. Barcodes are made at the place of sampling (when delivering samples from another laboratory, marking is allowed carried out in the laboratory performing the analysis) and read using a special device in the clinical laboratory. In small institutions, it is possible to manually code test tubes by drawing on them with a pencil on the glass or with a felt-tip pen conventional symbols and numbers.

Other procedures for the primary processing of biomaterial samples at the place of their collection depend on the general organization of laboratory support in a given institution. If the treatment rooms are located in the same building as the laboratory, then the containers with the samples should be brought to the laboratory as soon as possible, where all further actions will be carried out.

3.4.2.1 Biological material - blood

If a longer transportation to the laboratory is required, blood clotted samples (usually clotting occurs within 30 minutes) intended to obtain serum must be centrifuged on site no later than 1 hour after the sample is taken. Blood for serum or plasma is centrifuged in for 10 - 15 minutes at an acceleration of 1000 - 1200 g (revolutions per minute) .Citrate plasma for studies of the blood coagulation system is centrifuged for 15 minutes at 2000 d; to obtain plasma free of platelets, centrifugation lasts 15 - 30 minutes at 2000 - 3000 d. Centrifugation of tubes with capillary blood is performed at 6000 - 15000 d for 90 s. Usually centrifugation is carried out at a temperature of 20 ° C - 22 ° C. For individual analytes centrifugation at a temperature of 4 ° C, 6 ° C may be required. Blood smears for differential counting of leukocytes should be prepared no later than 3 hours after sampling.

Since nucleic acids degrade rapidly, samples for molecular biological studies should be quickly stabilized by inactivating DNases and RNases using chaotropic substances (guanidine isothiocyanate - GITC) and an organic solvent such as phenol. The final concentration of HITC in the stabilized sample should not be less than 4 mol / L. The material stabilized in this way should not be cooled in order to avoid crystallization of the GITZ. Blood with EDTA does not require stabilization for DNA extraction from leukocytes.

3.4.2.2 Biological material - feces

3.5. Requirements for the conditions of storage and transportation of biomaterial samples to the clinical laboratory

The storage conditions of biomaterial samples taken from patients are determined by the stability of the desired analytes under these conditions. The maximum permissible instability, expressed as the percentage deviation of the result after storage from the initial level, should not exceed half the size of the total determination error, calculated from the sum of the biological and analytical variation of a given analyte. The maximum allowable storage time is measured by the period of time during which 95% of samples retain the analyte content at baseline.

The stability of analytes in various types of samples (blood, urine, cerebrospinal fluid) and samples (serum, plasma, sediment, blood smear) is not the same (see Appendices B, C, D). Stability data for samples should also be taken into account during storage after arrival at the laboratory. For analytes unstable to light, appropriate precautions should be taken (collecting material in a dark container, protecting the sample from direct light).

3.5.1 Biological material - blood

The content of electrolytes, substrates, and some enzymes may not change when serum samples are stored at a refrigerator temperature of 4 ° C for up to four days. Hemoglobin, erythrocytes are stable for one day when stored in a closed tube. Storage of blood plasma samples intended for studies of the coagulation system at room temperature for more than 4 hours is not recommended.

Blood gas testing should be performed immediately; if urgent research is impossible, samples in closed glass containers can be stored in a bath with ice water for up to 2 hours.

When transported to the laboratory, containers with blood samples should be protected from shaking to avoid the development of hemolysis. Temperatures below 4 ° C and above 30 ° C can significantly change the content of many analytes in a sample. Whole blood samples cannot be shipped.

3.5.2 Biological material - urine

The collected urine is transported to the laboratory as soon as possible. Long-term storage of urine at room temperature leads to a change physical properties, destruction of cells and multiplication of bacteria. Urine collected for general analysis can be stored no more than 1, 5 - 2, 0 hours in the refrigerator, the use of preservatives is undesirable, but it is allowed if more than 2 hours pass between urination and the study. The most acceptable way to preserve urine is refrigeration (you can store in the refrigerator, but do not freeze). During cooling, the shaped elements are not destroyed, but it is possible to influence the results of determining the relative density.

3.5.3 Biological material - cerebrospinal fluid

When examining within 1 hour, the sample is not cooled. Closed tubes are used to transport CSF samples. When researching within three hours, store on ice, do not freeze, do not fix, do not add preservatives. Transport should be carried out as soon as possible due to cell instability. For cytological studies, you should send the preparations obtained by cytocentrifugation of the CSF sample (20 min at 180 d), which are stable for 4 to 6 days at room temperature. For long-term storage, after separation of cells by centrifugation, the sample should be quickly frozen to minus 70 ° C in a carefully sealed polypropylene vessel.

3.5.4 Delivery to the laboratory of biomaterials for microbiological research

Delivery to the laboratory of any sample of biomaterial intended for microbiological research should last no more than two hours after taking the material. Even the most advanced transport system cannot serve as a substitute for rapid transport and immediate sample examination. Requirements for the transportation and storage of bacteriological samples are given in Table 3. If these conditions cannot be met, inoculation into a blood culture vial or hemoflask is recommended, or, for example, for urine samples, the use of immersion slides.

Table 3

Conditions for transportation and storage of samples of various biomaterials for bacteriological research

	Transportation	Storage temperature
	Blood culture bottle
CSF abscess material Pleural, pericardial, peritoneal, synovial fluid Secrets of the sinuses	Fast transport: leave the sample in a syringe (sealed) under anaerobic conditions.	Room temperature, do not incubate, protect from refrigeration
Cerebrospinal fluid (when tested for N. meningitidis)		37 ° С in a thermostat or thermos
Bronchoalveolar lavage (BAL) fluid		Room temperature
		Cool
	Fast transportation (2 hours)	Room temperature
	Delayed transportation (up to 24 hours)	Cool
	Immersion slides	Room temperature or 37 ° C
	Fast transportation (2 hours)	Room temperature
	Delayed transportation	Cool
	Fast transportation (1h)	Room temperature
	Delayed transportation (use transport medium)	Cool
Sample swab: from eyes, ears, mouth, larynx, nose, urethra, cervix, rectum, wounds	Swab in a transport environment (transportation time more than 4 hours)	Room temperature
Biopsy material	Rapid transport in sterile isotonic saline	Cool
	Delayed transportation (use transport medium)	Temperature from 4 ° С to 30 ° С - depending on the expected type of microorganism

Samples for the detection and identification of viruses should be delivered to the laboratory quickly at 4 ° C in a separate container. Under these conditions, viruses usually remain stable for 2 to 3 days.

Samples of skin, hair and nail sections for mycological examination are sent to the laboratory dry in sterile containers. A random urine sample for yeast detection is immediately sent to the laboratory in a sterile container. Do the same with a morning sputum sample to detect yeast-like and mold fungi in it. Tissue samples for mycological research, placed in isotonic solution, are immediately sent to the laboratory. It is recommended that specimens from the vagina, upper respiratory tract or stool for mycological examination (two swabs with each specimen) be shipped in sterile containers. With a short period of transportation of samples for mycological studies, room temperature does not negatively affect the results. When transporting over long distances, cooling of the samples is recommended (this is not necessary for samples on swabs) to prevent bacterial suppression of slowly growing fungi. If a phycomycete infection (eg Mucor) is suspected, the specimen should be transported quickly without refrigeration.

Sample material

Sample type and transportation

For example, Ascaris, proglottides

For example fleas, lice

Feces for transportation

Stool tube

For Lawless coloring, fix in alcohol sublimate (alcohol / HgCl 2)

Eggs or larvae of intestinal nematodes, cestodes, intestinal flukes, hepatic flukes, pulmonary flukes. Cysts of protozoa: amoebae, flagellate, ciliary, coccidia, microsporidia. Vegetative forms of protozoa (especially amoeba, lamblia)

Feces for immediate examination

Vegetative forms of protozoa (especially amoeba, lamblia)

Duodenal fluid

At room temperature for immediate examination

Vegetative forms, lamblia

Daily urine

Schistosoma haematobium

Thin smear, thick smear, heparinized blood

Plasmodia, trypanosomes, microfilariae

Bone marrow

Smear, sterile bone marrow

Leishmania

Sputum tube

Paragonimus eggs, intestinal hookworm larvae, sometimes Echinococcus hooklets

Skin sections in isotonic NaCI (H)

Onchocerca (microfilaria)

Sterile skin biopsies

Leishmania

Detection of eggs or adults on the perianal skin

The selection of material is carried out on a tampon or adhesive tape

During shipment of samples, their integrity must be ensured in order for the analysis result to be correct and to comply with the biological safety requirements: there should be no risk either to people or to the environment.

The rules governing transportation by mail are determined by the relevant documents. Samples sent by mail must "resist leaks, shocks, pressure changes and other influences that may occur during normal transport." It is not allowed to use glass as a packing material when transporting samples in order to avoid breakage and possible harm to persons involved in transportation.

Inner packaging for sample material,

Absorbent material,

Outer packaging, with information about the sample and laboratory forms of prescribing analyzes: box, bag.

Multiple sample containers up to 500 ml can be packed in a single box made of cardboard, wood, suitable plastic or metal in accordance with the regulations for the transport of biohazardous materials. Diagnostic samples, if they do not evaporate through the packaging, can be sent in parcels. Packages with infectious substances must be labeled with the following inscription: DIAGNOSTIC SAMPLE / INFECTIOUS HAZARD. The sender is responsible for mailing infectious materials. The optimal delivery times for biomaterial samples to the laboratory are shown in Table 5.

Note - In any case, if there is an infectious material in the transport package, an additional secondary container is required to prevent any leakage of the material in the event of any mechanical damage.

Table 5

Optimal delivery times for samples to the laboratory

The name of the parameters under study	Maximum allowable time from the moment of taking the material, min
Urine microscopy
feces for amebiasis	Immediately
Clinical blood test
Biochemistry:
enzymes
K, Na, CI, HCO 3
Coagulology
Microbiology:
routine bacteriological culture
swabs (smear) with medium
swabs (swab) without medium
liquid samples (blood, urine, etc.)

3.5.5 Criteria for refusal to accept a biomaterial for research by a laboratory:

Discrepancy between the data of the application and the label (initials, date, time, etc.);

The absence of a label on the container for sampling (container or test tube);

Inability to read the patient's passport data on the application and / or label;

The absence of the name of the department, the number of the medical history, the name of the attending physician, the signature of the procedural nurse, a clear list of necessary studies;

Hemolysis (except for studies that are not affected by the presence of hemolysis);

The taken material is in an inappropriate container (that is, the material was taken with the wrong anticoagulant, preservative, etc.);

The presence of clots in samples with an anticoagulant;

The material was taken into vacuum containers with an expired shelf life.

Requirements
to the conditions of the period preceding the taking from the patient of the sample (s) of biological material (s)

Requirements for the conditions of the period preceding the taking of samples of biological material from a patient for laboratory research mainly relate to the actions of clinical personnel (doctors, nurses), whose representatives directly serve and supervise patients. However, due to the significant effect of non-compliance with these requirements on laboratory results, the following requirements are included in this International Standard.

A.1. Requirements for taking into account the influence of iatrogenic factors on the results of laboratory tests

The conditions of the period preceding the taking of a sample of biological material from a patient for a laboratory test can have a significant impact on the results of a laboratory study. Factors that should be taken into account include treatment and diagnostic measures carried out in relation to the patient:

Medicines taken by the patient;

Operational interventions;

Injections, infusions, transfusions;

Puncture, biopsy;

Ergometry

Introduction of X-ray contrast agents, immunoscintigraphy;

Ionizing radiation;

Endoscopic examination;

Special diets.

The taking of material for performing a laboratory test should be carried out before the implementation of a therapeutic or diagnostic measure or postponed for a particular period of time, depending on the duration of the aftereffect of the therapeutic or diagnostic measure.

Note - After surgery, depending on its volume and nature, changes various indicators can last from several days to three weeks. After infusion of solutions, blood sampling should be delayed by at least 1 hour, and after infusion of fat emulsion - by at least 8 hours.After cystoscopy, urine analysis can be prescribed no earlier than 5-7 days after X-ray examination of the stomach and bowel examination of feces is carried out no earlier than 2 days later.

Medicines that could affect the results of the prescribed test in vivo or in vitro, should be canceled 2 - 3 days before the test, if possible due to the patient's condition. If drug withdrawal is undesirable, they should be possible influence take into account when interpreting research results. The prescribing form should indicate the medications the patient is taking if they may interfere with laboratory results. Information on the effect of drugs on the results of laboratory tests - in accordance with Appendix D. If the laboratory has a test that is similar in informational content, the results of which are not influenced by the drugs taken by the patient, such a test should be prescribed.

If a laboratory test is needed against the background of drug therapy, a blood sample should be taken before taking the next dose of the drug. When conducting therapeutic drug monitoring, the time of taking a sample of a biomaterial is selected depending on the nature of the treatment. For long-term treatment, a blood sample should be taken when the drug concentration has reached equilibrium, after about five half-lives of the drug. After intravenous administration, wait until the end of the distribution phase - approximately 1-2 hours. In the case of the administration of digoxin and digitoxin, wait 6-8 hours. The time after taking the last dose of this medication must be indicated on the test prescription form.

When conducting a study against the background of a special diet, its nature should be indicated when prescribing an analysis.

A.2. Requirements for taking into account the influence of biological factors

A.2.1 Biological material - blood

With the planned appointment of a laboratory test with a blood test, the material for its implementation should be taken on an empty stomach (after about 12 hours of fasting and abstaining from alcohol and smoking), immediately after the subject wakes up (between 7 and 9 a.m.), with minimal physical activity immediately before taking (within 20 - 30 minutes), with the patient lying or sitting. When taking a sample of the material at a different time of the day, the period of time that has passed since the last meal should be indicated (after a meal, the content of glucose, cholesterol, triglycerides, iron, inorganic phosphates, amino acids rises in the blood), and fluctuations in the content of a number of analytes in during the day (see Table A.1).

Table A.1

Daily fluctuations in the content of some analytes in the blood

			Swing range
Adrenalin
Aldosterone
Hemoglobin
Cortisol
Norepinephrine
Prolactin
Somatotropin
Testosterone
Eosinophils
Note - ACTH - adrenocorticotropic hormone, T 4 - thyroxine, TSH - thyroxine-binding globulin.

A.2.2 Biological material - urine

When a laboratory test with urine analysis is scheduled, the material should be collected from the morning portion. To avoid contamination of urine by various external impurities, a thorough toilet of the external genital organs should be performed before collecting the sample. Bedridden patients are preliminarily washed with a weak solution of potassium permanganate, then the perineum is wiped with a dry sterile cotton swab in the direction from the genitals to the anus. In bedridden patients, when collecting urine, it is necessary to ensure that the vessel is located above the perineum to avoid contamination from the anus.

When prescribing a test with a study of the daily amount of urine, the 24-hour collection period should be strictly observed. When examining analytes in random portions of urine, daily fluctuations in their excretion should be borne in mind (see Table A.2).

Table A.2

Diurnal fluctuations in urinary excretion of some analytes

	Maximum excretion (time of day in hours)	Minimum excretion (time of day in hours)	Swing range (as a percentage of the average per day)
Cortisol
Norepinephrine

Note - Do not examine urine during menstruation.

A.2.3 Biological material - feces

Discontinue taking before stool examination. drugs affecting the secretory processes in the stomach, the peristalsis of the stomach and intestines, as well as changing its color. Before examining feces for occult blood, medications containing metals should be canceled, meat, fish, tomatoes, green vegetables should be excluded from the diet. The study of feces to assess the functional ability of the digestive tract should be preceded by the patient's adherence to a certain diet: sparing or stressful.

A.3 Informing patients about the conditions for preparing for laboratory tests

Preparing a patient for research should include:

Verbal instructing the patient and issuing him a reminder about the specifics of the prescribed study (see examples of reminders below);

Compliance by the patient with the prescribed regimen and rules for collecting material (urine, sputum) (especially in out-of-hospital settings).

Example 1 - Patient Memo (When Prescribing a Glucose Tolerance Test) The glucose tolerance test has been prescribed by your doctor. The purpose of the test is to determine the effectiveness of the insulin-secreting mechanism of your pancreas and the glucose-distribution system of the body. You must prepare yourself for this test by changing your diet and medication at least 3 days before the test. It is very important that you follow the instructions below exactly, as only then will valuable test results be obtained.

There are three main guidelines to follow:

The amount of carbohydrates in food must be at least 125 g per day for 3 days before the test;

You can not eat anything for 12 hours prior to the start of the test, but in no case should fasting be more than 16 hours;

Do not exercise for 12 hours before starting the test.

It is very important that you follow these recommendations exactly, as only in this case reliable blood test results will be obtained.

Example 2 - Patient Memo (when prescribing a general clinical urine test) A general clinical urine test is prescribed by your doctor. The purpose of the study is to objectively assess your condition.

To obtain reliable results, you need to prepare yourself for this study: refrain from physical activity, drinking alcohol, go to bed the day before at your usual time. You should collect your first morning urine sample. Therefore, in the morning after getting up, you should get a container for collecting urine from the ward nurse. Make sure that the urine container contains your details: surname, initials, department, ward. Before collecting urine, you need to conduct a thorough toilet of the external genital organs, rinsing them in the shower with soap, so that the discharge from them does not get into the urine. After this preparation, you go to the toilet and completely collect all the urine in a container. Screw on the lid and deliver the urine to the location indicated by the ward nurse. It is very important that you strictly follow the indicated recommendations, as only in this case reliable results will be obtained.

Appendix B
(reference)

Appendix A (reference). Working hours of the medical staff of the clinical diagnostic laboratory for research. Appendix B (reference). Forms of organizing laboratory support in medical institutions of various capacities Appendix B (recommended). Recommended timing of studies, the results of which are vital for patients in critical situations

National standard of the Russian Federation GOST R 53022.4-2008
"Clinical laboratory technologies. Requirements for the quality of clinical laboratory research. Part 4. Rules for the development of requirements for the timeliness of the provision of laboratory information"
(approved by order of the Federal Agency for Technical Regulation and Metrology of December 18, 2008 N 556-st)

Medical laboratory technologies. Requirement for quality of clinical laboratory tests. Part 4. Rules for development of requirements for timeliness of laboratory information submitting

Introduced for the first time

Foreword

The goals and principles of standardization in the Russian Federation are established by the Federal Law of December 27, 2002 N 184-FZ "On technical regulation", and the rules for the application of national standards of the Russian Federation - GOST R 1.0-2004 "Standardization in the Russian Federation. Basic provisions"

1 area of ​​use

This standard establishes uniform rules for the development of requirements for the timing of clinical laboratory tests in clinical diagnostic laboratories and the procedure for their application in the organization of laboratory support for the activities of medical organizations. This International Standard is intended for use by all organizations, institutions and enterprises, as well as individual entrepreneurs whose activities are related to the provision of medical care.

This standard uses normative references to the following standards:

b) from the general organization of laboratory support for treatment and diagnostic activities in a medical organization (Appendix B), including depending on the following conditions that determine the preanalytical and postanalytical time:

Place of performance of laboratory tests;

The order and timing of the procedures for preparing a patient for a laboratory test;

The duration of the procedures for taking a sample of biomaterial and its primary processing;

The procedure and method for delivering a biomaterial sample to the laboratory;

The procedure and method for delivering the test result from the laboratory to the doctor who ordered the test.

Based on the general provisions and taking into account the factors affecting the timing of obtaining the result of laboratory research, in accordance with Appendices A and, the medical institution develops requirements for the timing of laboratory tests, the results of which are of vital importance for patients in critical conditions. Such requirements should contain:

A list of studies that should be performed urgently, with an indication of the deadline allotted to the analytical procedure itself,

Application form for such studies,

Form for recording compliance with these requirements.

Application forms and accounting forms must be described in the Quality Manual GOST R 53079.2 or in a separate document of the quality management system in a medical institution.

Recommended timing of studies that are of vital importance in some pathological conditions are given in Appendix B. Compliance with the timing of urgent studies is subject to strict control by the management of a medical organization, if necessary, it can be considered as an urgent clinical audit GOST R 53133.4. The procedure and terms for performing studies, the need for the results of which is systematic and planned, are determined by the management of the medical organization and are fixed by the corresponding internal administrative document.

Open the current version of the document right now or get full access to the GARANT system for 3 days for free!

If you are a user of the Internet version of the GARANT system, you can open this document right now or request a Hotline in system.