The Use of Static Telecytological Applications for Proficiency Testing Purposes in the Field of Diagnostic Cytopathology

In recent years, informatics and computer sciences have changed dramatically the practice of clinical cytopathology. New types of cameras and microscopes, connected to computers made possible image capture and transmission (telecytology). The wide implementation of telemedical systems in the field of cytopathology became a necessity dictated by the need of real-time results for therapeutic decisions. A telemedical application is a valuable tool for cytopathologists in order to manage and promote interlaboratory collaboration. The result is better cytological data management and sharing. ISO 15189:2007 for medical laboratories requires successful participation in proficiency testing programs. This chapter emphasizes on the necessity of developing a proficiency test for cytopathology labs wishing to be accredited according to ISO 15189:2007, and examines the feasibility of using low cost telemedical applications and solutions for this purpose. Furthermore, this chapter gives clear and comprehensive guidance concerning various financial, legal, professional, and ethical problems in this field.

Download Full-text

Static Telecytological Applications for Proficiency Testing

Telehealth Networks for Hospital Services ◽

10.4018/978-1-4666-2979-0.ch015 ◽

2013 ◽

pp. 228-239

Author(s):

Stavros Archondakis

Keyword(s):

Data Management ◽

Real Time ◽

Proficiency Testing ◽

Low Cost ◽

Image Capture ◽

Ethical Problems ◽

Iso 15189 ◽

Medical Laboratories ◽

Cytological Data ◽

Therapeutic Decisions

In recent years, informatics and computer sciences have changed dramatically the practice of clinical cytopathology. New types of cameras and microscopes, connected to computers made possible image capture and transmission (telecytology). The wide implementation of telemedical systems in the field of cytopathology became a necessity dictated by the need of real-time results for therapeutic decisions. A telemedical application is a valuable tool for cytopathologists in order to manage and promote interlaboratory collaboration. The result is better cytological data management and sharing. ISO 15189:2007 for medical laboratories requires successful participation in proficiency testing programs. This chapter emphasizes on the necessity of developing a proficiency test for cytopathology labs wishing to be accredited according to ISO 15189:2007, and examines the feasibility of using low cost telemedical applications and solutions for this purpose. Furthermore, this chapter gives clear and comprehensive guidance concerning various financial, legal, professional, and ethical problems in this field.

Download Full-text

Implementation of Precaptured Videos of Thyroid Fine-Needle Aspiration Cytology Specimens for External Quality Control Purposes

Austin Journal of Pathology & Laboratory Medicine ◽

10.26420/austinjpathollabmed.2021.1029 ◽

2021 ◽

Vol 8 (1) ◽

Author(s):

Archondakis S ◽

Keyword(s):

Proficiency Testing ◽

Video Quality ◽

Surgical Excision ◽

Needle Aspiration ◽

Cytological Diagnosis ◽

File Transfer ◽

Iso 15189 ◽

Significant Difference ◽

Thyroid Fine Needle Aspiration ◽

Needle Aspiration Cytology

Objective: The objective of this study was examine the feasibility of developing a proficiency testing scheme for cytology labs wishing to be accredited according to ISO 15189:2012, by using videos captured by static telecytological applications. Methods: The current study was carried out on 252 adequate specimens of 157 patients, retrospectively selected from the department’s registry. In all cases, surgical excision followed the initial cytological diagnosis. Three diagnostic categories of cytological reports were used. All cases were confirmed by histological diagnosis of surgical specimens. One representative video from each case was transferred via file transfer protocol to password-protected accounts for remote review by 3 independent cytopathologists. In addition to diagnosis, reviewers commented on overall digital video quality. Contributor’s and reviewer’s diagnoses were collected, recorded and statistically evaluated. Results: Statistical evaluation of cytological diagnoses detected no significant difference in diagnostic accuracy between the diagnoses proffered on the basis of precaptured videos and conventional slides. The overall interobserver agreement was ranging from substantial to almost perfect. Conclusions: Videos production by static telecytology applications can be used as an alternative method for cytological diagnosis validation. It is a prompt and valid method for quality assessment and proficiency testing and can be integrated into daily workflow. Pre-captured videos can improve significantly small cytology departments’ quality indices. Precaptured videos can also be used for teleconsultation and second opinion purposes and improve the performance of the already existing static telecytology stations.

Download Full-text

Quality management in medical laboratories

Hämostaseologie ◽

10.1055/s-0037-1617044 ◽

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.

Download Full-text

Assessment of laboratory errors and best laboratory practices

International Journal of Bioassays ◽

10.21746/ijbio.2016.07.008 ◽

2016 ◽

Vol 5 (07) ◽

pp. 4704

Author(s):

Syed Riaz Mehdi* ◽

Sharique Ahmad ◽

Noorin Zaidi

Keyword(s):

External Quality Control ◽

External Quality ◽

Iso 15189 ◽

Laboratory Errors ◽

Control Programs ◽

Medical Laboratories ◽

Laboratory Error ◽

Active Communication ◽

Total Testing Process ◽

Five Phases

Laboratory error is defined by ISO 22367 as “Failure of planned actions to be completed as intended or use a wrong plan to achieve an aim”. Lundeberg in 1981 outlined the concept of Total Testing Process (TTP) and Plebani elaborated it further and classified the whole testing process into five phases of Pre-Pre Analytic, Pre Analytic, Analytic, Post Analytic and Post - Post Analytic. The errors have to be identified and resolved in each phase of the process. The medical laboratories have to run Internal and External Quality Control programs and abide by the guidelines of ISO 15189 in order to be accredited by bodies like JCI, CAP or NABL. Active communication and regular interaction between the clinicians and the laboratory is recommended during Pre Analytic and Post Analytic phases of TTP in order to achieve the target of Best Laboratory Practices.

Download Full-text

Flexible scope for ISO 15189 accreditation: a guidance prepared by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group Accreditation and ISO/CEN standards (WG-A/ISO)

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2015-0257 ◽

2015 ◽

Vol 53 (8) ◽

Cited By ~ 8

Author(s):

Marc H.M. Thelen ◽

Florent J.L.A. Vanstapel ◽

Christos Kroupis ◽

Ines Vukasovic ◽

Guilaime Boursier ◽

...

Keyword(s):

Working Group ◽

Clinical Chemistry ◽

Laboratory Medicine ◽

Position Paper ◽

European Federation ◽

Medical Field ◽

Iso 15189 ◽

Medical Laboratories ◽

Flexible Scope ◽

Scientific Disciplines

AbstractThe recent revision of ISO15189 has further strengthened its position as the standard for accreditation for medical laboratories. Both for laboratories and their customers it is important that the scope of such accreditation is clear. Therefore the European co-operation for accreditation (EA) demands that the national bodies responsible for accreditation describe the scope of every laboratory accreditation in a way that leaves no room for doubt about the range of competence of the particular laboratories. According to EA recommendations scopes may be fixed, mentioning every single test that is part of the accreditation, or flexible, mentioning all combinations of medical field, examination type and materials for which the laboratory is competent. Up to now national accreditation bodies perpetuate use of fixed scopes, partly by inertia, partly out of fear that a too flexible scope may lead to over-valuation of the competence of laboratories, most countries only use fixed scopes. The EA however promotes use of flexible scopes, since this allows for more readily innovation, which contributes to quality in laboratory medicine. In this position paper, the Working Group Accreditation and ISO/CEN Standards belonging to the Quality and Regulation Committee of the EFLM recommends using an approach that has led to successful introduction of the flexible scope for ISO15189 accreditation as intended in EA-4/17 in The Netherlands. The approach is risk-based, discipline and competence-based, and focuses on defining a uniform terminology transferable across the borders of scientific disciplines, laboratories and countries.

Download Full-text

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»

Spravočnik vrača obŝej praktiki (Journal of Family Medicine) ◽

10.33920/med-10-2012-02 ◽

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.

Download Full-text

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

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2018-1212 ◽

2019 ◽

Vol 57 (4) ◽

pp. 459-464 ◽

Cited By ~ 4

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.

Download Full-text