External evaluation of examinations performed at clinical diagnostic laboratories (CDLs) is among most important elements of a quality-assuring system in clinical laboratory diagnostics. Since 1995, these activities are performed in frames of Federal System for external quality control in clinical laboratory examinations which now encompasses all the kinds of clinical laboratory examinations.

The main purpose of FSEQC is lending aid to CDLs in assuring quality of the studies performed, by means of providing information about correct results of analyzing control samples, recommendations for avoiding the sources of errors revealed, as well as improvement of the techniques used. Moreover, FSEQC encourages development of intralaboratory systems for QC management, providing the laboratories with appropriate control samples, computer software and manuals.

FSEQC activities are carried out under the auspices of Federal Service for Inspection in Health Care and Social Development (RosZdravNadzor), while interacting with its regional branches, managing bodies in health care etc. Functioning of the System is provided through the Center of External Quality Control in clinical laboratory examinations, acting together with regional control management centers for clinical laboratory diagnostics, Research Center for clinical and laboratory diagnostics and FSEQC expert groups, involving leading experts in appropriate research and clinical institutions.

An important task of FSEQC is to provide Health Care administrative bodies with data about quality of laboratory examinations for different regions of the country, as well as reagents and equipment that are applied in CDLs. Enrolling a lot of CDLs (over 6,000 a year), FSEQC is able to retrieve reliable information which may be effectively used at various levels of administrative decision making.

1. The laboratories participating in FSEQC are supplied with valid data an the quality of examinations performed, thus justifying their decisions concerning revisions of the methods, reagent kits and measurement tools applied, improvement of intra-laboratory quality management system.

2. A bulk of data is accumulated in FSEQC, concerning the equipment and techniques in CDLs, thus enabling estimation of laboratory services, delineation of the most urgent issues and the means of its perfection.

3. Comparisons of results for examinations performed by different methods, reagent kits and measuring tools permits to get the data about their quality that may be used by appropriate surveillance authorities.

Since 2005, the maintenance of Certification System for the Processes of Laboratory Examinations (arranged by RosZdravNadzor) has become an important aspect of activities performed at the Centre of External Quality Control in clinical laboratory examinations. The Certification System is the most significant tool of the quality management at clinical laboratories. Co-ordinated activities of Certification System and FSEQC are aimed for real maintenance of quality in the CDL network of Russian health care system.

Сooperation between St. Petersburg Branch of RAACI and FSEQC

Since 2002, St. Petersburg Branch of RAACI performs successful cooperation with FSEQC in developing specialized programs for external quality control and standardization in laboratory immunological parameters.

In 2002, an appropriate Immunoglobulin E program was launched (FSEQC-2007, Cat.# 82)
In 2002, two other programs, Rheumatoid Factor and Antinuclear Antibodies, were introduced (FSEQC-2007, Cat.##, resp., 83 and 84).

Since 2007, four new programs are included into FSEQC Catalogue, i.e.:

Antibodies to double-stranded DNA (FSEQC-2007, Cat # 85)
Anti-phospholipid antibodies (FSEQC-2007, Cat # 86)
Antibodies to thyroid peroxidase and thyroglobulin (FSEQC-2007, Cat # 87)
IgG antibodies to Helicobacter Pylori (FSEQC-2007,Cat # 88)

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