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Accreditation and Quality Assurance: Journal for Quality, Comparability and Reliability in Chemical Measurement (v.8, #6)
The 14th International Conference of the Israel Society for Quality, 18–21 November, 2002, Jerusalem, Israel
by Ilya Kuselman (pp. 261-262).
In-house reference materials of mometasone furoate with traceable assay certified values by Alexander Weisman; Yael Gafni; Mark Vernik; Ilya Kuselman (pp. 263-266).
Characterization of in-house reference materials (IHRMs) with traceable property values for the mometasone furoate assay is discussed. The traceability of the value carried by the IHRM has been established to the value carried by a higher metrological status United States Pharmacopoeia Reference Standard (USP RS). A comparative approach is used to overcome systematic errors in measurement results, specific to the measurement method and/or to the laboratory developing the IHRM. The traceability chain was realized by the simultaneous analysis of the IHRM and the USP RS test portions under the same conditions.
Keywords: Mometasone furoate; Assay; Reference materials; Traceability; Comparative approach
Quality management in hematology laboratory improved preanalytics variables by Galit Sarig; Bilha Albersheim; Tamar Stam; Ruth Beck; Naomi Lanir (pp. 267-271).
Clinical decisions based on laboratory test values are correctly made when a preanalytical stage is properly performed. In this study we demonstrated that introduction of quality management procedures to Hematology laboratory at Medical Center and Health Care Center have helped to solve problems in the preanalytic stage. Blood clotting is a highly complicated process, which begins during blood withdrawal from vessels. In order to minimize in-vitro changes during collection, transportation and storage, the following steps were followed: centralization of blood collection, strict keeping of time interval between blood withdrawal to testing or freezing and purchasing of adequate freezer for storage. As a result, fibrin clots in frozen plasma were reduced from 10.6% to zero within 13 months and thus, the number of rejected samples decreased. Cooperation with ex-hospital customer who had introduced quality management system and established center for blood collection, separation and distribution have encouraged the introduction of new procedures.
Keywords: Quality management; Fibrin clot; Coagulation assays; Hematology
The role of an independent laboratory association in the standards, metrology, quality assurance and accreditation environment by Steve Sidney (pp. 272-275).
Whilst there can be no doubt as to the benefit that an independent 3rd party conformity assessment accreditation body plays in ensuring the competency of results, personnel and processes, it is often at the expense of an adversarial relationship with the laboratory community it serves. A significant improvement in this relationship can be obtained by the formation and active participation by an independent laboratory association. This paper describes such an organisation, how it was formed, what role and the functions it currently performs and, most importantly, how it interacts with the national accreditation body and the stakeholders who are its members.
Keywords: Laboratory association; Metrology; Accreditation; Quality assurance
The contribution of the accreditation process to public administration: promotion of vital organizational changes by Haim Hacham; Rivka Sheinman (pp. 276-281).
Accumulative evidence suggests that the implementation of international standard operating procedures, induce, by their virtues, major organizational changes. These changes are both cultural and behavioral including changes in decision-making processes, organizational norms, and values. The decision of any organization to adopt quality assurance, specifically via accreditation, should be regarded as a strategic one. As such, it prerequisites top management commitment, budgeting the process and promoting active inter-collaboration of all organizational members. The accreditation process according to ISO/IEC 17025:1999 of the Haifa Public Health Laboratory, will be used as a case study. A number of practical benefits of such organizational changes will be demonstrated and discussed, among them improved quality customer service and handling customer's complaints, establishing multichannel communication, enhanced interlaboratory collaboration and coordination. It is important to note that the accreditation process was accompaniment by extensive training of both management and employees on-site and off-site.
Keywords: ISO/IEC 17025; Organizational change; Public administration; Quality management; Public laboratory
The effect of implementation of the ISO 9000 on customer complaints; a 5-year follow-up study in a regional laboratory. by Mira Barak; Hatam Younes; Paul Froom (pp. 282-285).
Although the importance of quality management in the medical laboratory has been emphasized, we are unaware of any interventional studies demonstrating benefits of implementation of recommendations of the International Standards Organization (ISO). In the following 5-year follow-up study, we implemented quality management as stipulated by the ISO, received a certificate of approval, and determined how the program affected customer complaints. From 1997 to 2001 there was only a slight decrease in the number of customer complaints, but a significant continuing downward trend in the proportion of justified complaints (chi-squared test, p<0.001). In fact in 2001 the proportion of justified complaints had decreased by nearly 80% (relative risk, 0.22; 95% confidence interval, 0.09–0.52)), to only 10.9% of the total complaints. We conclude that the use of the ISO 9000 along with good laboratory practice resulted in a significant decrease in the proportion of justified complaints.
Keywords: ISO 9000; Quality management; Good laboratory practice; Complaints; Medical laboratory
The benefits calibration and testing laboratories may gain from ISO/IEC 17025 accreditation by Avner Halevy (pp. 286-290).
By definition (effectiveness through efficiency), quality is a business interest, not a supreme value in its own right. Quality systems must be beneficial to the organization operating them. In this paper, the possible tangible advantages (both business- and operations-related) an accredited laboratory may draw from formal accreditation is viewed. Also, an attempt is made to roughly classify laboratories into those which are more likely, or less so, to benefit from accreditation.
Keywords: Accreditation; Quality; Improvement
Proficiency testing as a tool for assessing the medical and economic impact of laboratory results: The blood coagulation case by Orna Dreazen; Etty Feller; Moshe Leshno (pp. 291-295).
An international commercial proficiency testing scheme was used to evaluate the impact of laboratory results on clinical decisions. The affect on atrial fibrillation was chosen as a model with 16 Israeli laboratories participating in an international study. A Markov model was constructed to evaluate the impact of any inaccurate results on the clinical outcomes. From the proficiency test study and the Markov model, 13–21% of the results were inaccurate and would have yielded erroneous medical decisions.
Keywords: Proficiency testing; Atrial fibrillation; Accuracy; Variation; Markov model
A computer program for a general case evaluation of the expanded uncertainty by Alex Lepek (pp. 296-299).
The ISO Guide to the Expression of Uncertainty in Measurement provides a uniform method for the evaluation of combined standard uncertainty of a measurand whose expectation and standard deviation are stable over the measurement period. However, the method provided for the evaluation of the expanded uncertainty is not complete. Particularly, it does not include the case where the contributing components are correlated. Also, the probability distribution of the combined uncertainty must be close to a Normal distribution otherwise other methods must be used. The method presented here, which is implemented in a computer program, is based on a combination of the ISO guide method and Monte-Carlo simulation.The Monte-Carlo Simulation can obtain the data needed for the evaluation of the expanded and standard uncertainties directly from the measurement equation (that defines the measurand in terms of the contributing components) or from a spreadsheet-like format. Some sample results obtained by the computer program using both methods are compared and discussed.
Keywords: Expanded-Uncertainty; Monte-Carlo Simulation; Software
Burden of proof and the credibility of uncertainty statements
by Adriaan M. H. van der Veen (pp. 300-301).
EPTIS update by Johannes van de Kreeke (pp. 307-307).
An update on EPTIS, the European Proficiency Testing Information System is given. Two developments are discussed: the extension of EPTIS towards a world-wide database and the provision of additional, topical information on forthcoming PT rounds, workshops, training courses or surplus PT samples.
Keywords: EPTIS; Proficiency testing; Database; External quality assessment; Accreditation
The Division of Analytical Chemistry of the Federation of European Chemical Societies and Professional Institutions
by Miguel Valcárcel; Ernst-Heiner Korte (pp. 308-309).