Fitness of Public Health Laboratory in the Republic of Macedonia for the Application of Standards for Quality
Science Journal of Public Health
Volume 2, Issue 3, May 2014, Pages: 229-233
Received: Apr. 24, 2014;
Accepted: May 13, 2014;
Published: May 30, 2014
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Evgenija Kiroska-Petreska, Institute for Public Health of Republic of Macedonia, Skopje, Republic of Macedonia
Katja Popovska, Institute of Microbiology and parasitology, Faculty of Medicine, University “Ss Cyril and Methodius”, Skopje, Republic of Macedonia
Vesna Kostikj, Institute for Public Health of Republic of Macedonia, Skopje, Republic of Macedonia
Dragan Gjorgjev, Institute for Public Health of Republic of Macedonia, Skopje, Republic of Macedonia
Branka Petrovska, Institute for Public Health of Republic of Macedonia, Skopje, Republic of Macedonia
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The main goal of this master’s study is to determine preparedness of public health laboratories concerning the conditions (area, equipment, and staff) and in relation to quality standard application, with identification of the current condition of laboratories in relation to the area, equipment and staff as well as quality standard application in the Institute and the Public Health Centres in the Republic of Macedonia. This research was conducted through a Questionnaire, which was adapted from the ISO/IEC 17025:2005 standard and modified for the goals of the study. Total 144 employees completed the Questionnaire which they were given during the survey (face to face method), with the aim of reducing possible errors. Statistic processing was conducted through application of standard descriptive analyses of quality indicators and check of the hypotheses put forward. The study identified that globally, the preparedness of public health laboratories in the Republic of Macedonia in relation to conditions (area, equipment and staff), for quality standard application, is seen as PARTIAL. The current condition of laboratories in relation to the area, equipment and staff, as well as quality standard application in the Institute and the Public Health Centres in the Republic of Macedonia varies and differs significantly between accredited and non-accredited public health laboratories. In the accredited public health laboratories in the RM, interviewed employees in the Public Health Institute of the RM showed best knowledge and dedication for quality system maintenance in testing laboratories. One can distinguish essential differences in the management staff’s view and knowledge in relation to introducing quality systems between managers - health professionals and managers – economists. Testing laboratories in the Institute of Public Health of the RM and few Public Health Centres have adequate and modern equipment, in line with the testing methods, great inadequacy of space in relation to its distribution, non-permitted access, cleanliness and monitoring the ambiance conditions. Professional and competent staffs work in the Institute and in all Public Health Centres, in particular when it comes to testing activities. Motivation of staffs instigated by management teams is what is missing. Both internal and external trainings of staffs are necessary.
Accreditation, Standards, Testing laboratory, Quality Management System, Technical Requirements
To cite this article
Fitness of Public Health Laboratory in the Republic of Macedonia for the Application of Standards for Quality, Science Journal of Public Health.
Vol. 2, No. 3,
2014, pp. 229-233.
Drake G. Objectives and Roles of Accreditation and Certification of Laboratories, Accred Qual Assur 2003; 8: 441.
Barker R, Wichmann B. Guidance for Accredited Laboratories. Accred Qual Assur 1999; 4: 287-98;
International Organization for Standardization (ISO). ISO/IEC 17025:2005 General Requirements for the competence of testing an calibration laboratories.
International Organization for Standardization (ISO). Quality Management for Medical Laboratory. (ISO/FDIS 15189). ISO: Geneva.
Loeber JG Slagter S. Code of practice for implementation of a quality system in laboratories in the health care sector. 2nd rev. ed. Bilthoven: CCKL secretariat, 1995. PO box 392, 3720 AJ Bilthoven, The Netherlands.
Jansen RTP, Kenny D, Blaton V, Burnett D, Huisman W, Plebani M, Queralto JM, Zerah S, van Lieshout J. Usefulness of EC4 Essential Criteria for Quality Systems of Medical Laboratories as Guideline to the ISO 15189 and ISO 17025 Documents. Clin Chem Lab Med 2000; 38: 1057-64.
WHO Office for the Eastern Mediterranean, Series 3 ,,Principles of Management of Health Laboratories,,, Alexandria, Egyp, 1993
International Organization for Standardization (ISO). ISO 9001:2008 Quality Management Systems (Requirements).
Engelhard T, Feller E, Nizri Z. A Comparison of the Complimentary and Different Issues in ISO/IEC 17025 and OECD GLP. Accred Qual Assur 2003; 8: 208-12.
Jacobson S. Accreditation of Calibration Laboratories to Normative Documents: Diversity or Standardization. Accred Qual Assur 2004; 9: 427-8.
Visser R. Standardization News: NEN 7777 – Standardization of the Validation Process. Accred Qual Assur 2001; 6: 327-9.
Stuart M, Squirrell A, Basley L. Reference Material Requirements for Laboratories and the Role of Accreditation Bodies. Accred Qual Assur 2004; 9: 209-14.
Fishbach R. Metrological Demands of ISO 17025 on Testing Laboratiries. Accred Qual Assur 2001; 6: 41.