Organization of the work of the medical laboratory service in accordance with the requirements of the standard GOST ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence»

2020 ◽  
pp. 15-22
Author(s):  
Elena Vitalievna Perminova
Keyword(s):  
Clinical Laboratory ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Iso 15189 ◽  
Laboratory Service ◽  
Medical Laboratories

Clinical laboratory diagnostics is a medical specialty, which is based on in vitro diagnostic studies of biomaterial obtained from an individual. At the present stage, there are three main types of organization of the laboratory research process — a laboratory service as part of a medical and preventive institution, a centralized laboratory where biomaterials are delivered for research from various healthcare institutions, as well as mobile laboratories that allow conducting the research directly at the patient’s bedside. This discipline involves the use of a wide variety of diagnostic research methods and the use of a huge number of specific techniques. Their list should include carrying out hematological, microbiological, virological, immunological, serological, parasitic, and biochemical studies. Also, when organizing laboratory diagnostic activities, a number of other studies (cytological, histological, toxicological, genetic, molecular biological, etc.) are provided. A laboratory report is formulated after obtaining clinical data and comparing them with the obtained test results. The quality of laboratory tests is ensured through the systematic implementation of internal laboratory control, as well as participation in a national program for external quality assessment. The activities of the clinical diagnostic laboratory should be organized in accordance with the requirements of the standard GOST R ISO 15189–2015 «Medical laboratories. Particular requirements for quality and competence», which is based on the provisions of two more fundamental standards — ISO 9001 and ISO 17025, and adds a number of special requirements related to medical laboratories.

scholarly journals THE PROFESSIONAL STANDARD OF A SPECIALIST IN CLINICAL LABORATORY MEDICINE AND ITS EVALUATION BY MEDICAL LABORATORY STAFF

2017 ◽  
Vol 25 (3) ◽  
pp. 63-68
Author(s):  
P. N. Zolotaryov
Keyword(s):  
Higher Education ◽  
Clinical Laboratory ◽  
Laboratory Medicine ◽  
Study Data ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Professional Standard ◽  
Laboratory Staff ◽  
Wide Range

The issue of improving the personnel service in clinical laboratory diagnostics is topical, since specialists, having modern knowledge in laboratory research, can not stay aside from active participation during their appointment and interpretation. Training of specialists of this level requires revision of the regulatory framework, namely, the development of professional standards for specialists in clinical laboratory medicine. The survey involved 83 specialists with higher education working in clinical diagnostic laboratories of various forms of ownership in the Samara Region (Russia). In the course of the study, data were obtained reflecting the readiness to perform a number of generalized labor functions of the professional standard. Prior to the evaluation of the criterion of attention paid to the labor function in each group of respondents, we expected to obtain values of 9-10 units. However, in the course of the study, we found that this indicator in various groups of respondents fluctuated in a wide range. We believe that the training of professional stuff with higher education in laboratory medicine should be implemented in parallel with the introduction of the professional standard.

scholarly journals The new ISO and CEN standards for quality and accreditation of medical laboratories

2004 ◽  
Vol 23 (3) ◽  
pp. 305-310 ◽  
Author(s):  
Kenny Desmond
Keyword(s):  
Point Of Care ◽  
Medical Laboratory ◽  
Iso 15189 ◽  
International Standard ◽  
Laboratory Service ◽  
Medical Laboratories ◽  
Medical Environment ◽  
Common Basis ◽  
The World ◽  
Almost All

The new international standard EN ISO 15189:2003 ?Medical laboratories - particular requirements for quality and competence?, after many delays, was finally published in February 2003. This standard has been developed specifically to address requirements for accreditation of medical laboratories. It takes into account the special constraints imposed by the medical environment and the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories provide not only testing of patient samples, but also advisory, interpretative and educational services. It also acknowledges the role of diagnostics manufacturers in maintaining the quality of medical laboratory services. The international standard ISO/IEC 17025 ?General requirements for the competence of testing and calibration laboratories? is already used in some countries for accreditation of medical laboratories. This is a standard which was developed mainly for use in industrial testing laboratories, and has serious deficiencies when used in the medical environment. While still in draft form, 15189 was already approved by ILAC (International Laboratory Accreditation Co-operation) as a suitable basis for accrediting medical laboratories. It is expected that this document will be used widely in Europe and throughout the world as the preferred standard for this purpose. An informal survey of FESCC member societies shows that 15189, alone or in combination with other standards, will be used in almost all European countries for accreditation of medical laboratories. A further complementary standard, ISO 15190 ?Medical laboratories - requirements for safety? has now been published. A standard for quality and competence in Point Of Care Testing (POCT) is under development, and will be published as a new Annex to EN ISO 15189. These standards will for the first time provide a common basis for the development of quality systems and requirements for competence in medical laboratories throughout the world.

scholarly journals Stability Testing, Shelf Life and Product Expiration Dating

1998 ◽  
Vol 6 (10) ◽  
pp. 20-21
Author(s):  
Peter A. Takes
Keyword(s):  
Shelf Life ◽  
Laboratory Research ◽  
Stability Testing ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
In Vitro Diagnostic ◽  
Expiration Dating ◽  
Intended Use ◽  
Specific Reagent

Reagents available for laboratory, research, and clinical use are often acquired with a specified expiration date. Yet, many are not, depending on the manufacturer and reagent type. What a manufacturer does is frequency determined by how they label the product.The U.S. Ricd and Drug Administration [FDA] has defined categories by which reagents can he labeled based on their “intended use”. individual reagents (e.g., antibodies) intended for clinical diagnostic laboratory use will be labeled as an in Vitro Diagnostic [IVD] or Analyte Specific Reagent [ASR]. Under these categories, specified expiration dates must be supported by stability testing which establishes the product shelf life.

scholarly journals Laboratory and patient of kyiv city clinical emergency hospital

2021 ◽  
Vol 11 (5) ◽  
pp. 158-165
Author(s):  
O. B. Kryatchenko ◽  
V. P. Pechyborsch ◽  
V. M. Yakimets ◽  
S. I. Mazii ◽  
O. V. Pechyborsch ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Absolute Number ◽  
Laboratory Research ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Systematic Analysis ◽  
Emergency Hospital ◽  
Treatment And Prevention ◽  
Clinical Diagnostic ◽  
Clinical Emergency

The aim of the work is to analyze the activities of the clinical diagnostic laboratory of the Kyiv City Clinical Emergency Hospital (hereinafter – KCCEH) in comparison with the hospitals of Kyiv for 2017-2018 and determine the role of existing mechanisms to optimize the activities of this laboratory.The article uses the materials of statistical reports of KCCEH and treatment and prevention facilities of Kyiv for 2017-2018 using the method of systematic analysis of statistical materials, as well as systemic and structural-functional approaches.Analysis of the main performance indicators of the clinical diagnostic laboratory of the Kyiv City Clinical Emergency Hospital shows that in 2018 compared to 2017 there is an increase of 2.9% in the absolute number of laboratory tests due to increased highly informative research and introduction of innovative technologies in diagnosis.In the context of reforming the health care system under the conditions of social and economic crisis and our country's hybrid war, the only most appropriate way to optimize the laboratory department of the Kyiv City Clinical Emergency Hospital and similar hospitals in Ukraine is the centralization of clinical laboratory research and laboratory services.

scholarly journals Considerations from the College of American Pathologists for implementation of an assay for SARS-CoV-2 testing after a change in regulatory status

2021 ◽  
Author(s):  
David R. Peaper ◽  
Daniel D. Rhoads ◽  
Kaede V. Sullivan ◽  
Marc R. Couturier ◽  
Romney M. Humphries ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Clinical Laboratory ◽  
Clinical Diagnostic Laboratory ◽  
Diagnostic Laboratory ◽  
Regulatory Status ◽  
Pass Through ◽  
Clinical Laboratory Improvement Amendments ◽  
Regulatory Landscape ◽  
The U.S

The U.S. Food & Drug Administration FDA regulates the marketing of manufacturers’ in vitro diagnostic tests IVDs including assays for the detection of SARS-CoV-2. The U.S. government’s Clinical Laboratory Improvement Amendments CLIA of 1988 regulate the studies that a clinical diagnostic laboratory needs to perform for an IVD before placing it into use. Until recently, the FDA has authorized the marketing of SARS-CoV-2 IVDs exclusively through the Emergency Use Authorization EUA pathway. The regulatory landscape continues to evolve, and IVDs will eventually be required to pass through conventional non-EUA FDA review pathways once the emergency declaration is terminated in order to continue to be marketed as an IVD in the U.S. When FDA regulatory status of an IVD changes or is anticipated to change, the laboratory should review manufacturer information and previously performed internal verification studies to determine what, if any, additional studies are needed before implementing the non-EUA version of the IVD in accordance with CLIA regulations. Herein, the College of American Pathologists’ Microbiology Committee provides guidance for how to approach regulatory considerations when an IVD is converted from EUA to non-EUA status.

Quality management in medical laboratories

2010 ◽  
Vol 30 (02) ◽  
pp. 55-62
Author(s):  
M. Fritzer-Szekeres
Keyword(s):  
Quality Management ◽  
Medical Laboratory ◽  
Management Systems ◽  
The European Union ◽  
Quality Management Systems ◽  
Iso 17025 ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Systems Quality ◽  
Standard Iso 15189

SummaryDuring the 20th century understanding for quality has changed and international and national requirements for quality have been published. Therefore also medical branches started to establish quality management systems. Quality assurance has always been important for medical laboratories. Certification according to the standard ISO 9001 and accreditation according to the standard ISO 17025 have been the proof of fulfilling quality requirements. The relatively new standard ISO 15189 is the first standard for medical laboratories. This standard includes technical and management requirements for the medical laboratory. The main focus is the proof of competence within the personnel. As this standard is accepted throughout the European Union an increase in accreditations of medical laboratories is predictable.

scholarly journals The antinuclear antibody HEp-2 indirect immunofluorescence assay: a survey of laboratory performance, pattern recognition and interpretation

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Anne E. Tebo ◽  
Robert L. Schmidt ◽  
Kamran Kadkhoda ◽  
Lisa K. Peterson ◽  
Edward K. L. Chan ◽  
...  
Keyword(s):  
Indirect Immunofluorescence ◽  
Clinical Laboratory ◽  
Immunofluorescence Assay ◽  
Indirect Immunofluorescence Assay ◽  
Medical Laboratory ◽  
Nuclear Staining ◽  
International Consensus ◽  
In Vitro Diagnostic ◽  
Traditional Pattern

Abstract Background To evaluate the interpretation and reporting of antinuclear antibodies (ANA) by indirect immunofluorescence assay (IFA) using HEp-2 substrates based on common practice and guidance by the International Consensus on ANA patterns (ICAP). Method Participants included two groups [16 clinical laboratories (CL) and 8 in vitro diagnostic manufacturers (IVD)] recruited via an email sent to the Association of Medical Laboratory Immunologists (AMLI) membership. Twelve (n = 12) pre-qualified specimens were distributed to participants for testing, interpretation and reporting HEp-2 IFA. Results obtained were analyzed for accuracy with the intended and consensus response for three main categorical patterns (nuclear, cytoplasmic and mitotic), common patterns and ICAP report nomenclatures. The distributions of antibody titers of specimens were also compared. Results Laboratories differed in the categorical patterns reported; 8 reporting all patterns, 3 reporting only nuclear patterns and 5 reporting nuclear patterns with various combinations of other patterns. For all participants, accuracy with the intended response for the categorical nuclear pattern was excellent at 99% [95% confidence interval (CI): 97–100%] compared to 78% [95% CI 67–88%] for the cytoplasmic, and 93% [95% CI 86%–100%] for mitotic patterns. The accuracy was 13% greater for the common nomenclature [87%, 95% CI 82–90%] compared to the ICAP nomenclature [74%, 95% CI 68–79%] for all participants. Participants reporting all three main categories demonstrated better performances compared to those reporting 2 or less categorical patterns. The average accuracies varied between participant groups, however, with the lowest and most variable performances for cytoplasmic pattern specimens. The reported titers for all specimens varied, with the least variability for nuclear patterns and most titer variability associated with cytoplasmic patterns. Conclusions Our study demonstrated significant accuracy for all participants in identifying the categorical nuclear staining as well as traditional pattern assignments for nuclear patterns. However, there was less consistency in reporting cytoplasmic and mitotic patterns, with implications for assigning competencies and training for clinical laboratory personnel.

scholarly journals Documenting metrological traceability as intended by ISO 15189:2012: A consensus statement about the practice of the implementation and auditing of this norm element

2019 ◽  
Vol 57 (4) ◽  
pp. 459-464 ◽  
Author(s):  
Marc Thelen ◽  
Florent Vanstapel ◽  
Pika Meško Brguljan ◽  
Bernard Gouget ◽  
Guilaine Boursier ◽  
...  
Keyword(s):  
Metrological Traceability ◽  
Measurement Procedure ◽  
Medical Laboratory ◽  
Clinical Samples ◽  
End User ◽  
Worst Case ◽  
Iso 15189 ◽  
Value Assignment ◽  
Traceability Chain ◽  
Medical Laboratories

Abstract ISO15189:2012 requires medical laboratories to document metrological traceability of their results. While the ISO17511:2003 standard on metrological traceability in laboratory medicine requires the use of the highest available level in the traceability chain, it recognizes that for many measurands there is no reference above the manufacturer’s selected measurement procedure and the manufacturer’s working calibrator. Some immunoassays, although they intend to measure the same quantity and may even refer to the same reference material, unfortunately produce different results because of differences in analytical selectivity as manufacturers select different epitopes and antibodies for the same analyte. In other cases, the cause is the use of reference materials, which are not commutable. The uncertainty associated with the result is another important aspect in metrological traceability implementation. As the measurement uncertainty on the clinical samples is influenced by the uncertainty of all steps higher in the traceability chain, laboratories should be provided with adequate and appropriate information on the uncertainty of the value assignment to the commercial calibrators that they use. Although the between-lot variation in value assignment will manifest itself as part of the long-term imprecision as estimated by the end-user, information on worst-case to be expected lot-lot variation has to be communicated to the end-user by the IVD provider. When laboratories use ancillary equipment that potentially could have a critical contribution to the reported results, such equipment needs verification of its proper calibration and criticality to the result uncertainty could be assessed by an approach based on risk analysis, which is a key element of ISO15189:2012 anyway. This paper discusses how the requirement for metrological traceability as stated in ISO15189 should be met by the medical laboratory and how this should be assessed by accreditation bodies.

Combined international external quality assessment results of medical laboratory performance and reporting of samples with known antimicrobial resistance

Diagnosis ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. 161-166
Author(s):  
Michael A. Noble ◽  
Robert Rennie
Keyword(s):  
Antimicrobial Resistance ◽  
Quality Assessment ◽  
Clinical Laboratory ◽  
External Quality Assessment ◽  
Medical Laboratory ◽  
External Quality ◽  
Laboratory Performance ◽  
Reporting Practices ◽  
Medical Laboratories ◽  
Poor Treatment

Abstract Background Reporting on the presence of antimicrobial resistance is of considerable concern both for individual patient care and for understanding the underlying health status within the community at large. Antimicrobial resistance is solely dependent upon clinical laboratory detection and thus can be impacted upon by the quality and competence of medical laboratories. Proficiency testing or external quality assessment (PT/EQA) is the international standard for the direct measurement of medical laboratory performance on critical testing. Methods An international, intercontinental collaborative retrospective study of medical laboratory performance in antibiotic resistance was performed by the Microbiology Working Group (MWG) of the European Organisation for External Quality Assurance for Laboratory Medicine (EQALM) with particular examination of laboratory performance on the testing and reporting of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE) and carbapenem-resistant Enterobacteriaceae (CRE). Results The results of 1880 medical laboratories were compiled. Strictly accurate reporting of isolates as resistant occurred with MRSA 96.9%, with VRE 91.3% and with CRE 93.1% of the time. On the other hand, very major errors (reporting of false susceptibility) were observed with 2.2% of MRSA and 2.4% of VRE and 0.8% of CRE. Major errors (false resistance) were reported for vancomycin susceptibility testing for MRSA at a rate of 0.6%. Conclusions Depending on how clinical physicians read and understand microbiology susceptibility reports, proficient acceptable results were reported either between 91% and 94% of the time, or between 97% and 100%. While very major errors are infrequently reported, they were found in all regions and could potentially cause poor treatment decisions by clinicians. A collective analysis of multi-program PT/EQA information can provide valuable insights into the testing and reporting practices of medical laboratories.

scholarly journals Status of Development and Implementation of Medical Laboratories Accreditation in Serbia

2008 ◽  
Vol 27 (2) ◽  
pp. 144-147
Author(s):  
Ljubinka Gligić
Keyword(s):  
Accreditation Process ◽  
Laboratory Accreditation ◽  
European Countries ◽  
Medical Laboratory ◽  
External Quality Assessment Scheme ◽  
Iso 15189 ◽  
Medical Laboratories ◽  
Laboratory Services ◽  
Set Up ◽  
Definition Of

Status of Development and Implementation of Medical Laboratories Accreditation in SerbiaThrough the release of the SRPS ISO 15189:2008 standard entitled >>Medicinske laboratorije: posebni zahtevi za kvalitet i kompetentnost<< conditions have been created for medical laboratory accreditation in Serbia. The application of the ISO 15189:2007 standard is an accepted mechanism for improvement of the quality of medical laboratory services throughout EU today. In that way, different approaches to the quality improvement of medical laboratories have been harmonized. Functional organisation of the accreditation process of medical laboratories in most European countries is mainly carried out in cooperation with national accreditation bodies, medical experts appointed by scientist associations and health departments. This type of collaboration has proven successful in the United Kingdom, Germany, Hungary, France, Finland, Croatia, etc. The experiences of the Accreditation Board of Serbia (ABS) in medical laboratory accreditation according to the SRPS ISO/IEC 17025:2006 standard (5 laboratories have been accredited) and the positive experiences of European countries in accreditation process constitute the basis for the development of the program for medical laboratory accreditation in Serbia. The first step in this direction is the set-up of the Committee consisting of experts from different medical fields, ABS experts and representatives of the competent Ministry, as well as the definition of their tasks, such as: preparation of the necessary documentation, set-up and preparation of qualification criteria and training programs for assessors, participation in the development of the external quality assessment scheme through interlaboratory testing, liaison with the European organisations for accreditation, organisation of mutual assessments with national and international assessors, participation in decision making on accreditation and accreditation maintenance.

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