Quality regulations and accreditation standards for clinical chemistry in Turkey Fikriye Uras ⁎ Biochemistry Department, Marmara University Faculty of Pharmacy, Tibbiye Cad. No 49, Haydarpasa, Istanbul, Turkey International Hospital, Istanbul Cad. No. 82 Yesilkoy, Istanbul, Turkey Received 18 April 2008; accepted 11 September 2008 Abstract Objective: The purpose of this paper is to review the current status of laboratory quality regulations and accreditation standards in Turkey. Design and method: This paper is written based on the current regulations, information collected by available websites and congress proceedings, and personal communications. Results: A total of 14 private and one public laboratory have been accredited according to ISO 15189 voluntarily. The total number of the JCI accredited hospitals is 24. One hospital has been accredited by HQS. A few medical laboratories have been accredited according to ISO 17025, whereas a lot of them have ISO 9001 certification from Turkish Accreditation Agency, TURKAK. There are no comprehensive laboratory standards and/or regulations to maintain a mandatory minimum quality of laboratories. External QC is not mandatory and there is no national proficiency testing program. It is a requirement to get a license to open a laboratory. There are residency programs for clinical chemistry and clinical microbiology. The Association of Clinical Biochemists, KBUD, is the youngest society in the field of clinical chemistry and is a leader in quality and accreditation activities. KBUDEK is an external QC program of KBUD. KBUD has organized four national and an international symposiums on quality and accreditation in addition to annual congresses and courses. Conclusion: The new standard and regulation should be designed and applied to all laboratories to increase the quality of laboratory service in Turkey. It will be useful if the ISO 15189 standard can be incorporated into the national standards and regulations. © 2008 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. Keywords: Quality; Accreditation; Laboratory medicine; Standardization; Education; Training; Harmonization; Patient safety; Regulations; Clinical chemistry Introduction Clinical laboratories provide information and services that contribute to the maximization of the effective delivery of health care in today's complex system by assuring that the correct test is performed on the right person, at the right time, producing accurate test results that enable providers to make the right diagnostic and therapeutic decisions using the right level of health care resources. It is essential to give a good quality laboratory service to establish laboratory accreditation standards, quality regulations and licensure of clinical laboratory professionals as a means of assuring that only appropriately educated and qualified people perform laboratory tests. Turkey is trying to develop and implement national standards/regulations in laboratory medicine at an international level. Accreditation The accreditation efforts started during the 2000s in laboratory medicine in Turkey. A private hospital received Joint Commission International (JCI) accreditation for the first time in 2002. At this time, there are 20 private health care organizations that have received JCI accreditation [1]. One of them is a hospital group, which has 5 private hospitals; so the total number of the JCI accredited hospitals is 24. Another private hospital was accredited by Health Quality System Accreditation (HQS) from Great Britain for the first time in 2005. In the same year, a private laboratory chain, which now has 13 laboratories, received ISO 15189 accreditation for Available online at www.sciencedirect.com Clinical Biochemistry 42 (2009) 263 – 265 ⁎ Biochemistry Department, Marmara University Faculty of Pharmacy, Tibbiye Cad. No 49, Haydarpasa, Istanbul, Turkey. Fax: +90 216 449 23 03. E-mail addresses: furas@marmara.edu.tr , furas@internationalhospital.com.tr . 0009-9120/$ - see front matter © 2008 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.clinbiochem.2008.09.008