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Laboratory quality regulations and accreditation standards in Iran
Available online at www.sciencedirect.com
Clinical Biochemistry 42 (2009) 316
Case Report
Laboratory quality regulations and accreditation standards in Iran Mir Majid Mossalaeie ⁎ Iranian Association of Clinical Laboratory Doctors, No. 9, Abadian Alley, Felestin St., Tehran, Iran Received 18 April 2008; accepted 11 September 2008
Keywords: Laboratory accreditation; Laboratory regulations; ISO 15189; Laboratory standards; Laboratory guidelines
Objectives The main purpose of establishing regulations and accreditation standards is maintaining high quality services and improving quality in clinical laboratories. Laboratory service providers can be collated with updated international professional standards by laboratory accreditation.
installationsq, Laboratory Documentationsq, qLaboratory staffsq, qLaboratory equipments and kitsq and qLaboratory safety and hygieneq. They sent these new standards as an official notice and guidelines to all governmental and private laboratories. Ministry of Health gave a two years of grace period to establish all mentioned requirements. By using the scientific potential of professional societies, we may be able to teach these guidelines to the end users and can both establish and inspect them.
Design and methods Results We found that the first step is educating all of our colleagues including laboratory doctors, pathologists, laboratory managers and laboratory staffs, so we propounded the laboratory accreditation and regulations in our annual scientific meeting called National Congress on Quality Improvement in Clinical Laboratories, which have been held since 2001. Each year, we discussed different aspects of accreditation and regulations, and compared CLIA, CLSI and ISO requirements. We also studied other countries' experiences. This way our Lab. Professionals could understand the necessity of accreditation. After five years of research and study and also the expanding culture of accreditation among the service providers, policy makers and scientific and professional associations, expert committees along with the cooperation of MOH, our association was organized. They found out that accreditation is not enforceable with uncompromising standards such as ISO 15189, so, they produced country standards by the inspiration of ISO 15189 and CLSI requirements. These new standards consisted of 5 parts, including qSpace and lab.
There were meaningful basic differences between volunteer laboratories in different laboratory sections such as reception and sampling, Hematology, Bacteriology, Clinical Chemistry and Serology labs. These differences can clearly be anticipated. The most important thing was the willingness of most private laboratories to learn and establish these guidelines as soon as possible. Conclusions Our experience showed that teaching accreditation contexts is a time consuming process, but it was necessary to start a new movement in the current stream. It is a good idea to use scientific events such as congresses and workshops to establish new guidelines and it is necessary to use the power of governmental authorities to enforce these guidelines when dealing with private laboratories (by using and setting official notice).
⁎ Fax: +98 21 88902968. E-mail address: [email protected]. URLs: http://www.iacld.org, http://www.iqicl.org. 0009-9120/$ - see front matter © 2008 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.clinbiochem.2008.09.030
Clinical Biochemistry 42 (2009) 316
Case Report
Laboratory quality regulations and accreditation standards in Iran Mir Majid Mossalaeie ⁎ Iranian Association of Clinical Laboratory Doctors, No. 9, Abadian Alley, Felestin St., Tehran, Iran Received 18 April 2008; accepted 11 September 2008
Keywords: Laboratory accreditation; Laboratory regulations; ISO 15189; Laboratory standards; Laboratory guidelines
Objectives The main purpose of establishing regulations and accreditation standards is maintaining high quality services and improving quality in clinical laboratories. Laboratory service providers can be collated with updated international professional standards by laboratory accreditation.
installationsq, Laboratory Documentationsq, qLaboratory staffsq, qLaboratory equipments and kitsq and qLaboratory safety and hygieneq. They sent these new standards as an official notice and guidelines to all governmental and private laboratories. Ministry of Health gave a two years of grace period to establish all mentioned requirements. By using the scientific potential of professional societies, we may be able to teach these guidelines to the end users and can both establish and inspect them.
Design and methods Results We found that the first step is educating all of our colleagues including laboratory doctors, pathologists, laboratory managers and laboratory staffs, so we propounded the laboratory accreditation and regulations in our annual scientific meeting called National Congress on Quality Improvement in Clinical Laboratories, which have been held since 2001. Each year, we discussed different aspects of accreditation and regulations, and compared CLIA, CLSI and ISO requirements. We also studied other countries' experiences. This way our Lab. Professionals could understand the necessity of accreditation. After five years of research and study and also the expanding culture of accreditation among the service providers, policy makers and scientific and professional associations, expert committees along with the cooperation of MOH, our association was organized. They found out that accreditation is not enforceable with uncompromising standards such as ISO 15189, so, they produced country standards by the inspiration of ISO 15189 and CLSI requirements. These new standards consisted of 5 parts, including qSpace and lab.
There were meaningful basic differences between volunteer laboratories in different laboratory sections such as reception and sampling, Hematology, Bacteriology, Clinical Chemistry and Serology labs. These differences can clearly be anticipated. The most important thing was the willingness of most private laboratories to learn and establish these guidelines as soon as possible. Conclusions Our experience showed that teaching accreditation contexts is a time consuming process, but it was necessary to start a new movement in the current stream. It is a good idea to use scientific events such as congresses and workshops to establish new guidelines and it is necessary to use the power of governmental authorities to enforce these guidelines when dealing with private laboratories (by using and setting official notice).
⁎ Fax: +98 21 88902968. E-mail address: [email protected]. URLs: http://www.iacld.org, http://www.iqicl.org. 0009-9120/$ - see front matter © 2008 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. doi:10.1016/j.clinbiochem.2008.09.030