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Marie Brionne-François, Anne Bauters, Christine Mouton, Sophie Voisin, Claire Flaujac, Agnès Le Querrec, Dominique Lasne
Point of care testing (POCT) must comply with regulatory requirements according to standard EN ISO 22870, which identify biologists as responsible for POCT. INR for vitamin K antagonists (VKAs) monitoring is a test frequently performed in haemostasis laboratories. Bedside INR is useful in emergency room, in particular in case of VKAs overdosage but also for specific populations of patients like paediatrics or geriatrics. INR POCT devices are widely used at home by the patients for self-testing, but their use in the hospital by the clinical staff for bedside measurement is growing, with devices which now comply with standard for POCT accreditation for hospital use...
April 27, 2018: Annales de Biologie Clinique
Charlotte Oris, Yoan Clavel, Matthieu Jabaudon, Annick Pialat, Hadj Abdelkader Mohamed, Frédérique Lioret, Vincent Sapin, Damien Bouvier
Background: Blood gas analyzers are o0.ften integrated into point-of-care testing provisions. International standards (ISO 22870 and 15189) as adapted to French COFRAC regulations make accreditation of point-ofta-care testintag obligatory. We installed and assessed 12 GEM PREMIER 4000 analyzers for pH, p CO2 , p O2 , Na+ , K+ , Cl- , Ca2+ , lactate, hemoglobin and oxyhemoglobin (O2 Hb) at Clermont-Ferrand Hospital. These instruments were distributed across 11 care sites in the hospital...
March 2018: Practical Laboratory Medicine
Christopher Florkowski, Andrew Don-Wauchope, Nuria Gimenez, Karina Rodriguez-Capote, Julien Wils, Annalise Zemlin
Point-of-care testing (POCT) is the analysis of patient specimens outside the clinical laboratory, near or at the site of patient care, usually performed by clinical staff without laboratory training, although it also encompasses patient self-monitoring. It is able to provide a rapid result near the patient and which can be acted upon immediately. The key driver is the concept that clinical decision making may be delayed when samples are sent to the clinical laboratory. Balanced against this are considerations of increased costs for purchase and maintenance of equipment, staff training, connectivity to the laboratory information system (LIS), quality control (QC) and external quality assurance (EQA) procedures, all required for accreditation under ISO 22870...
November 2017: Critical Reviews in Clinical Laboratory Sciences
Guilaine Boursier, Ines Vukasovic, Pika Mesko Brguljan, Maria Lohmander, Irina Ghita, Francisco A Bernabeu Andreu, Edward Barrett, Duilio Brugnoni, Christos Kroupis, Ludek Sprongl, Marc H M Thelen, Florent Vanstapel, Tatjana Vodnik, Willem Huisman, Michel Vaubourdolle
BACKGROUND: Accreditation is a valuable resource for medical laboratories. The development of quality systems based on ISO 15189 has taken place in many laboratories in the European countries but data about accreditation remain scarce. The EFLM Working Group "Accreditation and ISO/CEN standards" conducted a survey that reviews the current state of the accreditation process in European countries. METHODS: An on-line questionnaire was addressed to delegates of 39 EFLM scientific societies in March 2014...
April 2016: Clinical Chemistry and Laboratory Medicine: CCLM
Katsuhiko Kuwa
The quality management (QM) of POCT summarizes its internal quality control (IQC) and external quality assessment (EQA). For QM requirements in POCT, ISO 22870-Point-of-care testing (POCT) -Requirements for quality and competence and ISO 15189-Medical laboratories-Requirements for quality and competence, it is performed under the guidance of the QM committee. The role of the POC coordinator and/or medical technologist of the clinical laboratory is important. On measurement performance of POCT devices, it is necessary to confirm data on measurement performance from the manufacturer other than those in the inserted document...
February 2015: Rinsho Byori. the Japanese Journal of Clinical Pathology
Helen Holt, Danielle B Freedman
ISO 22870 standards require protocols for performance of internal quality control for all point-of-care testing devices and training of users in its theory and practice. However, the unique setting of point-of-care testing (i.e. processes conducted by non-scientific users) means that laboratory internal quality control programmes do not easily translate to point-of-care testing. In addition, while the evidence base for internal quality control within the laboratory has been increasing, the equivalent literature surrounding point-of-care testing is very limited...
March 2016: Annals of Clinical Biochemistry
Dominique Lasne, Anne Bauters, Agnès Le Querrec, Carole Bourdin, Sophie Voisin
Point of care testing (POCT) must comply with regulatory requirements according to standard EN ISO 22870, which identify biologists as responsible for POCT. Activated clotting time (ACT) is mandatory to monitor on whole blood, anticoagulation achieved by unfractionated heparin during cardiopulmonary bypass (CPB) or cardiac catheterization. This test has no equivalent in the laboratory. With the aim to help the multidisciplinary groups for POCT supervision when they have to analyse the wish of medical departments to use ACT and to help the biologists to be in accordance with the standard, we present the guidelines of the GEHT (Groupe d'étude d'hémostase et thrombose) subcommittee "CEC et Biologie délocalisée" for the certification of ACT...
March 2015: Annales de Biologie Clinique
Jaray Tongtoyai, Panutsaya Tientadakul, Wimol Chinswangwatanakul, Nisarat Opartkiattikul
PURPOSE: The purpose of this pilot paper is to use on-site assessment to determine common non-compliance in point-of-care (POC) glucose testing, deficiencies that should be improved by the POC team or emphasized in further training. DESIGN/METHODOLOGY/APPROACH: Assessment forms for POC site and staff competency were developed and used for direct observation in four POC sites. Nurses were sampled in these sites. FINDINGS: The on-site assessment demonstrated that initial operator training was insufficient...
2014: International Journal of Health Care Quality Assurance
Marie Brionne-Francois, Agnès Le Querrec, Dominique Lasne
Monitoring of the anticoagulant effect with the International normalized ratio (INR) is essential for patients receiving vitamin K antagonists (VKAs). The majority of point of care (POC) devices for INR monitoring has shown a good precision and accuracy with results similar to those obtained in a laboratory. In many countries, INR POC devices are widely used at home by the patients for self-testing. Their use in the hospital by the clinical staff (doctor or nurses) for bedside measurement is also growing. The INR POC testing is performed using fully automated devices...
November 2013: Annales de Biologie Clinique
S Penet, I Vuillaume, T Nicolas, A Szymanowicz, C Houlbert, P Pernet
For point-of-care-testing (POCT), the French regulation on medical biology states allows a unique situation where a delayed validation of results is possible. This paper proposes guidelines to organize POCT post-analytical phase in agreement with the local regulation and ISO 22870 requirements. In the first part, organization of POCT validation is detailed (since analysis results reading by the physician until validation of results by the medical biologist and their integration into the patient record). In a second part, elements to include in POCT presentation of results are discussed and a model is proposed...
February 2012: Annales de Biologie Clinique
C Houlbert, V Annaix, A Szymanowicz, A Vassault, M C Guimont, P Pernet
In this paper, guidelines are proposed to fulfill the requirements of EN ISO 22870 standard regarding the management of point-of-care testing (POCT) nonconformities. In the first part, the main nonconformities that may affect POCT are given, the means for resolution and the control of adverse events are proposed. In the second part, we propose recommendations in case of unavailability of a point-of-care testing device from the occurring of the adverse event, to the restarting of the device.
February 2012: Annales de Biologie Clinique
A Vassault, V Annaix, C Houlbert, Z Berkane, M Vaubourdolle, J Goudable, M C Guimont, P Pernet
Quality of point-of-care examinations depends on the quality assurance system settled. This paper describes the different tools used to control the pre-examination, examination and post-examination procedures taking part in the quality of patient care according to the requirements of the standard EN ISO 22870 and EN ISO 15189 as well. They include mainly: For the pre-examination phase, the sample traceability and for the analytical phase, the practice of internal quality control and the participation in external quality assessment programme...
February 2012: Annales de Biologie Clinique
P Pernet, A Szymanowicz, J Goudable, M C Guimont
This article proposes to organize the documentation system of point-of-care testing (POCT) to meet the requirements of EN ISO 22870. In a first part, we propose provisions to improve the control of documents circulating outside the laboratory and aimed at non-laboratory staff. Then we review POCT-related records and we propose an organization facilitating their audit. In the last part, a model of POCT quality plan is proposed : in addition to the quality manual, this document defines the specific measures taken in order to ensure the control of POCT...
February 2012: Annales de Biologie Clinique
P Pernet, A Szymanowicz, C Oddoze, A Vassault, V Annaix, A Gruson, M Boisson
In this paper, we focus on the additional requirements of EN ISO 22870 compared to those described in Chapter 4: Quality Management of EN ISO 15189. They concern the quality policy, the management reviews and the audits. Thus, we propose a template of quality policy statement, and specific requirements for conducting management review of POCT are given. Finally, a questionnaire for performing an audit of POCT activities is proposed. The composition and activities of the multidisciplinary group for the supervision of POCT activities, which is also a specific requirement of EN ISO 22870, is discussed in another article of this volume...
February 2012: Annales de Biologie Clinique
P Pernet, M C Guimont, I Vuillaume, S Penet, A Szymanowicz, C Houlbert, V Annaix, M Vaubourdolle
Implementation is the main step of the point-of-care testing (POCT) device installation process to comply with EN ISO 22870. The multidisciplinary POCT management group is in charge to align that process with the standards but also with the French regulation (ordinance 2010-49 of 13 January 2010) which authorizes POCT only in case of urgent therapeutic decisions. This article defines two reports to be prepared during the deployment of a POCT device : a report that justifies the use of a POCT device, taking into account a risk-benefit analysis and a report that justifies the choice of the device including proofs of conformity of its installation...
February 2012: Annales de Biologie Clinique
P Pernet, J Goudable, V Annaix, M Vaubourdolle, A Szymanowicz
EN ISO 22870 requires the medical laboratory director to form a multidisciplinary group for the management of point-of-care testing activities and to appoint a person responsible for this group. This article proposes to define the composition (representatives of the medical laboratory, care units owning point-of-care devices, administration), missions (introduction, follow-up and evaluation of point-of-care devices) and the decision circuit of this group and to describe the profile of the head and the tasks assigned...
February 2012: Annales de Biologie Clinique
M Vaubourdolle, V Annaix, J Goudable, P Pernet
Compliance to EN ISO 22870 standard for point-of-care testing (POCT) accreditation is close to those of EN ISO 15189 in central laboratory. However, it is mandatory to master the elements which are specific to POCT. In this paper, we describe the two main processes involved to help medical biologists to achieve standard requirements, particularly in the risk assessment study. The first process concerns the deployment of a POCT device in a hospital outside laboratory and the second is the classical process of medical biology testing, outlining the steps which are different from the laboratory testing process...
February 2012: Annales de Biologie Clinique
Ismahen Jday-Daly, Christine Augereau-Vacher, Claire De Curraize, Michèle Fonfrède, Guillaume Lefevre, Bernard Lacour, Carole Hennequin-Le Meur
As part of a tender AP-HP Paris Hospitals, an assessment of the reliability record of five blood glucose monitoring systems (BGMSs) (Optium Xceed (Abbott), Contour TS (Bayer), One Touch Ultra (Lifescan), Stat Strip Xpress (Nova) and Accu Check (Roche) and an evaluation of their sensitivity to changes in hematocrit were conducted in 4 hospitals of Paris. In terms of inaccuracy, all BGMSs have submitted CV repetability under the limits of acceptability. One BGMS (Lifescan) presented a CV of reproducibility outside limit of acceptability (13...
January 2011: Annales de Biologie Clinique
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July 2009: Klinicheskaia Laboratornaia Diagnostika
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