The line on laboratory accreditation south of the border
June 2001 Originally published in CAP TODAY
Erlo Roth, MD
More than 70 laboratories in Brazil have ISO 9002 certification but fewer than 50 have laboratory accreditation certificates. Why this discrepancy? Developing countries, like Brazil, that must export to maintain their balance of trade need ISO 9000 certification to ship their products to Europe. Consequently, many unskilled laborers are familiar with ISO 9000. The word "accreditation," however, entered the official vocabulary of Spanish and Portuguese only within the last decade.
I introduced the concepts of quality control and accreditation to clinical laboratories in Brazil in 1974 through a four-day seminar at the annual meeting of the Brazilian Society of Clinical Pathology (SBPC) in Rio de Janeiro. Two years later, the SBPC helped create the firm Control-Lab, which manufactures lyophilized sera. Control-Lab offered an external and internal quality control program for clinical laboratories. The two programs were bundled to minimize the chances that laboratories would register for proficiency testing but omit daily quality control.
It was not until 1995 that the Brazilian government agency INMETRO, comparable to the United States' National Institute of Standards and Technology, declared that it would include all of the 12,000 or so clinical laboratories in Brazil in its National Testing and Calibration Laboratory Network through certification by ISO Guide 25 (now ISO 17025). At the suggestion of the SBPC, however, Galdino G. Bicho, then director of INMETRO's certification division, agreed instead to study U.S.-based laboratory accreditation.
Bicho and members of a committee appointed to develop accreditation standards came to the United States to visit the offices of the division of laboratories of the Health Care Financing Administration, the College, NCCLS, and the Commission on Office Laboratory Accreditation. The committee then spent nearly two years in open monthly meetings, adapting the applicable CAP checklists to its needs. It published its results in December 1997.
The SBPC then asked me to set up a laboratory accreditation program based on the standards. This meant developing procedures and specific software, training inspectors, writing manuals, and presenting to laboratorians seminars on how to prepare for accreditation.
The Sociedade Brasileira de Análises Clínicas (SBAC), which represents medical technologists, developed a parallel program with less stringent criteria. Both programs were implemented in three levels, or phases, and the first level was launched by both societies by the end of 1999. But political problems, including lack of recognition from the Ministry of Health and lack of recognition from payers for purposes of providing laboratory services, as well as controversy over whether accreditation or ISO 9002 certification is better, have hindered the growth of laboratory accreditation in Brazil. Only about 20 labs had been accredited by SBPC as of April, including two clinical laboratories that have also been accredited by the CAP.
While progress has been slow in Brazil, other Latin American nations are progressing at various rates with their laboratory accreditation efforts.
Leading accreditation efforts in Argentina is the Fundación Bioquímica Argentina (Biochemists' Foundation of Argentina), an organization that represents the "bioquímicos," professionals who have training equivalent to that of medical technologists and who direct most of the laboratories in Latin America. In 1994, the Fundación launched a laboratory accreditation program based on a few simple criteria. Within four years, the organization had accredited more than 1,000 laboratories. That same year, the Fundación implemented the second part of a three-level program, which had 52 criteria and was based on an early draft of the international standard ISO DIS 15189, "Quality management in a medical laboratory."
Proficiency testing, however, is not yet required in Argentina. Yet, in 1999, the CAPaccredited two laboratories in Buenos Aires. And by 2000, virtually all of the 1,200 clinical laboratories nationwide had been accredited by the Fundación.
In Mexico, the Secretary of Health published in 1999 the government rule Norma Oficial Mexicana No. 166, which established minimum accreditation criteria. It contains basic requirements for internal and external quality control, quality assurance, procedure manuals, specimen collection, reporting of results, instrument maintenance, installations, safety, reference laboratories, confidentiality, informed consent, and advertising. The government expects that Mexico's laboratory professions will set up a private accreditation program based on these criteria. In the meantime, three Mexican laboratories have obtained CAP accreditation, and several have received ISO 9002 certification.
The country's leading laboratory organizations-the Federación Mexicana de Patología Clínica and Asociación Mexicana de Bioquímica Clínica-are discussing plans to create an accrediting organization and establish a proficiency testing program. Interest in this area is high, as evidenced at the XXIV Mexican Congress of Clinical Chemistry, held in Veracruz in March. This congress included three half-day sessions devoted to accreditation and certification issues.
Other Latin American countries
Laboratory organizations in Uruguay, Chile, Peru, and a few other Latin American countries also have begun discussing the need for laboratory accreditation and are monitoring the activities of ISO/TC 212, the committee hosted by the NCCLS that develops international standards for medical laboratories. Yet none of the anatomic pathology societies in Latin America have shown significant interest in accreditation, a phenomenon similar to what has happened in the United States, where quality assurance practices in anatomic pathology historically have lagged behind those in clinical pathology.
common markets such as Mercosul-comprising Brazil, Argentina, Uruguay, and Paraguay -and the possibility of a free trade association among all American countries lead to renewed interest in standardization, efforts to set up laboratory accreditation programs in Latin America are likely to intensify in coming years.
Dr. Roth is president, Hinsdale Pathology Associates, Hinsdale, Ill. He is state commissioner for Illinois for the CAP Laboratory Accreditation Program.