Medical Laboratory Accreditation according to ISO 15189:2003. The Mexican Experience
Rosa Isabel Sierra-Amor
In 1990, the Mexican Federal Government started the project under the leadership of the Ministry of Economy to supervise the implementation of ISO standards related to metrology, standardization and other laboratory regulations.
In 1997, Mexico also followed recommendations of the European Commission of Laboratory Accreditation and the European Confederation of Clinical Laboratory Sciences, but there was a need to create a body that oversees these activities. Therefore, in 1999 the Mexican Accreditation Entity (EMA), a non-profit organization was created (1). This organization has been in charge of coordinating the implementation of policies and guidelines to consolidate the accreditation process at all levels, for calibration, testing and medical (clinical) laboratories, certification bodies and inspection units. That same year, ISO/IEC 17025:1999 was published and used by EMA to initiate this process. However, ISO 17025:1999 did not fulfill the needs and requirements of medical laboratories; and only a few laboratories in Mexico were accredited by this standard. In 2003, ISO 15189: Medical laboratories – Particular requirements for quality and competence was published (http://www.iso.org (2)), and EMA initiated the implementation of that standard nationwide.
ISO 15189:2003 covers the three steps of the process: pre-examination, examination and post-examination procedures. It is a complete and well designed standard that includes all aspects of the quality system, ISO 9001:2000 as well as ISO/ IEC 17025:1999, and other important aspects such as biosafety, ethics and laboratory information systems. It is a standard that provides medical information based on the analytical interpretation of results helping the clinician to diagnose the patient in a timely manner. ISO 15189:2003 also takes into account the need for acceptable turn-around times, as well as the contribution to medical laboratory to patient care, and assures that accurate results are provided, including point of care examination procedures.
The Mexican Institute of Standards and Certification (IMNC) (http://www.imnc.org.mx) has recruited public and private medical laboratory scientists to help as volunteers; these individuals were charged with assisting in obtaining a translation into Spanish and adapting this ISO standard for Mexico. The newly formed working group on medical /clinical laboratories at IMNC also worked with EMA on this project. Simultaneously, EMA also created a working group on medical laboratories composed of volunteers that worked using the translated document to establish policies and other useful tools needed to assess the laboratories according to this ISO standard. The translated document was ready in May 2005, and IMNC distributed the Spanish version to the public for comments. In July 2006, the Spanish version, NMX-EC-15189-IMNC-2006 was published in the Diario Oficial de la Federación (http://www.dof.gob.mx) as a Mexican standard for medical laboratories.
Working groups in medical laboratory
One important aspect of accreditation was to have a group of technical experts and assessors to evaluate laboratories according to this standard. Therefore, in Mexico it was necessary to educate clinical biochemistry experts in different fields of laboratory medicine about ISO 15189:2003; and to plan how to conduct laboratory assessments according to these international guidelines. The members of the working group in medical laboratories at EMA were required to take courses in ISO 15189:2003, to review how others conducted the accreditation process in foreign countries, to be observers of this process, as well as to take courses in other areas, such as uncertainty of measurement, traceability, etc. The Mexican Association of Clinical Biochemistry (AMBC) (3), was one of the members of this working group.
Since peers should do technical assessment, those interested in becoming technical experts have submitted their biographies and resumes to EMA for approval according to EMA´s international standards. A technical expert eventually could become an assessor and a leader to conduct local and regional assessments. The medical/clinical laboratory working group at EMA also examined laboratory organizations by disciplines, dividing them into 15 areas: microbiology (bacteriology and mycology), parasitology, virology, clinical chemistry, urinalysis, hematology and coagulation, immunochemistry, molecular diagnosis, cytology, anatomopathology, toxicology, flow cytometry, transfusion medicine and blood bank, histocompatibility and genetics, and point of care testing. As of today, there are 60 technical experts, 2 assessors, and 6 leaders in all disciplines present in a medical laboratory.
Agreement of collaboration
In January 2005, EMA published notice of the accreditation program for medical
laboratories in their journal SISTEMA (http://www.ema.org.mx), they also participated in conferences and meetings related to the medical field, as well as national meetings with other governmental organizations such as the Ministry of Transportation, the Ministry of Health, Universities, Inspection Bodies, Certification bodies, the National Council of Technology and Sciences (CONACYT), and other non-profit organizations, launching the medical accreditation program in March 2005. Immediately after, in June 2005, the Mexican Association of Clinical Biochemistry (AMBC) and the Mexican Accreditation Entity (EMA), signed the first collaboration agreement between these two non-profit organizations. The purpose was to reinforce the accreditation process and publish in the AMBC´s journal BIOQUIMIA all activities regarding accreditation, improving knowledge about this standard and its process in laboratories, conducting courses on ISO 15189:2003, and supporting AMBC members´ applications as technical experts at EMA´s national program, helping EMA in having qualifying assessors and leaders, as well as technical experts.
Committee on laboratory accreditation
One important part of this process was the creation of a Committee that reviewed laboratory applications for accreditation. In order to do this, it was necessary that their peers recognized EMA, and in October 2006, the Asian Pacific Laboratory Accreditation (APLAC) reviewed and approved EMA´s accreditation application, allowing EMA to promote the creation of a Committee that oversees the accreditation process in Mexico. This Committee awaits final approval of the Ministry of Economy. Recently, EMA held the first joint meeting of the International Accreditation Forum (IAF) and the International Laboratory Accreditation Committee (ILAC) signing the agreement of the Americas, where Mexico, Canada, Argentina, Chile and the United States of America could be peers of each other supporting the work done on accreditation by these countries, all full members of ISO.
Proficiency testing programs
Another important issue was to have proficiency testing programs available for medical laboratories. These programs require following ISO GUIDE 43-1/ILAC G13. AMBC has been a proficiency testing provider since 1986 (4,5) and in 2005 submitted an application to obtain this recognition by the Mexican Accreditation Entity (6). In December 2006, the AMBC External Quality Assurance Scheme program (EQASP) in clinical chemistry (http://www.ambc.org.mx; http://www.digitalpt.com) obtained EMA´s certificate of recognition, and it became the first proficiency-testing provider in Mexico to be in compliance with ILAC G13:2000 (7).
In August, 2005, the first application for laboratory accreditation ISO 15189:2003 was received, and in September of the same year, an assessment of the laboratory was conducted. The laboratory received accreditation according to ISO 15189:2003 in November 2005. Since then, four additional laboratories were accredited in the following year.
Mexico has approximately ten thousand medical laboratories, divided into public and private, distributed in 32 states along the 1.959.248 km of territory with a population of 103.263.388 (http://www.inegi.gob.mx). There is also a national standard (NOM 166 SSA 1997) (http://www.dof.org.mx) that is mandatory but it is not used for accreditation. Therefore, in order to be comparable to medical laboratories worldwide, Mexican laboratories must be accredited by ISO 15189:2003/NMX-EC-15189-IMNC-2006. At this moment, we have five accredited laboratories and one blood bank; while there are another 16 applications in process.
For medical laboratories, to be accredited by ISO 151890: 2003, the only international standard that comprises three phases of the process, is a challenge but it is achievable. Work is still needed in order for the majority laboratories to learn and implement ISO 15189: 2003 requirements. This international initiative to standardize laboratory work, serving the patient and providing medically useful results in a timely manner so that clinicians can make accurate diagnosis and provide treatment to the patient, should be mandatory for laboratories worldwide.
The Mexico national accreditation project at EMA is to obtain one thousand signatures in organizations from all fields involved in accreditation. AMBC is part of the group of organizations linked to this initiative hoping to improve laboratory services by accreditation according to ISO 15189:2003. It is important to mention that ISO TC 212/WG1 started revision of ISO 15189:2003 last year. Few changes are expected to be made to the actual standard published in 2003; nevertheless, these changes are certainly to provide a better understanding on how to apply and implement this standard in medical laboratories so that they may achieve accreditation according to ISO 15189:2003.
We thank Robert Rej, PhD, Wadsworth Center and New York Department of Health, Albany NY, USA, for reviewing this manuscript.
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