National standard quality assurance clinical part 4. Technologies laboratory clinical

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FEDERAL AGENCY FOR TECHNICAL REGULATION AND METROLOGY

NATIONAL

STANDARD

RUSSIAN

FEDERATIONS

Laboratory clinical technologies

QUALITY ASSURANCE OF CLINICAL LABORATORY STUDIES

Official edition

Standardinform

Foreword

Objectives and principles of standardization in Russian Federation installed Federal law of December 27, 2002 No. 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 for the Problems of Clinical and Laboratory Diagnostics of the Moscow Medical Academy. THEM. Sechenov, Roszdrav, Department of Biochemistry, Russian Medical Academy of Postgraduate Education, 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 dated December 18, 2008. No. 554-st

4 INTRODUCED FOR THE FIRST TIME

Information on changes to this standard is published in the annually published information index "National Standards", and the text of changes and amendments is published 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

This standard may not be reproduced in whole or in part, replicated and distributed as an official publication without the permission of the Federal Agency for Technical Regulation and Metrology.

1 Scope ........................................ 1

3 Rules for conducting the preanalytical stage of clinical laboratory research ....... 1

3.1 General ....................................... 1

3.2 Requirements for the conditions and procedures for taking a sample of biological material ........ 2

3.3 Features of the conditions for taking samples of biomaterials for special types of research 6

3.4 Procedures for primary (pre-laboratory) processing of samples of biological materials ... 6

3.5 Requirements for storage and transportation of biomaterial samples to clinics

which laboratory ....................................... 7

patient sample (s) of biological material (s) ................. 12

Appendix B (informative) Stability of analytes in blood samples ................. 15

Annex B (informative) Stability of analytes in urine samples ................. 42

Appendix D (informative) Stability of analytes in cerebrospinal fluid samples ....... 45

Appendix D (informative) Nature of influence medicines on the results of clinical

laboratory research ............................. 46

Bibliography ............................................ 64

NATIONAL STANDARD OF THE RUSSIAN FEDERATION

Clinical laboratory technologies QUALITY ASSURANCE OF CLINICAL LABORATORY STUDIES

Rules for conducting the preanalytical stage

Clinical laboratory technologies. Quality assurance of dinical laboratory tests.

Part 4. Rules for conducting of preanalytical stage

Date of introduction - 2010-01-01

1 area of use

This International 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 ones. 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:

GOSTRISO 15189-2006 Medical laboratories. Special requirements for quality and competence

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 in each medical organization, it is necessary to 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 Sampling or sampling is the process of taking or forming samples, characterized by the procedure for taking them, that is, operational requirements and / or instructions for the collection, withdrawal and preparation of one or more samples from the inspected lot for clarification characteristics of this lot (in laboratory medicine, the inspected lot is the patient being examined, and samples or samples are portions of one or another biological material).

3.2.1 Biological material - blood

Most clinical laboratory tests are performed on blood samples: venous, arterial, or capillary. Deoxygenated blood - best material to determine 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 first be flushed with isotonic saline in a volume corresponding to the volume of the catheter, and the first 5 ml (milliliters) of blood taken from the catheter should be discarded. 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.