ISO 15189 Gains Favor For Lab Accreditation

CLSI works with government in Tanzania to accredit five regional labs in African nation

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CEO SUMMARY: Volunteers for the Clinical and Laboratory Standards Institute (CLSI) are in the midst of an 18-month project to help five state-run medical labs in Tanzania gain ISO 15189 accreditation. The project shows how labs in Africa and other countries are moving to adopt international accreditation standards. A growing number of countries, including Australia, Germany, France, and Canada, already use ISO 15189 in their accreditation requirements.

IN VARIOUS NATIONS across the world, laboratories are pursuing accreditation based on ISO 15189. That’s because a growing number of countries are adopting ISO 15189 as the basis for their
national accreditation standard.

Use of ISO 15189 for laboratory accreditation is an important example of the convergence of laboratory operations now occurring across the globe. A number of laboratory professionals from the United States and Canada are actively involved in this trend.

“Volunteers from the Clinical and Laboratory Standards Institute (CLSI) in Wayne, Pennsylvania, have been working since August 2005 to help five of the largest state-run medical labs in the United Republic of Tanzania gain ISO 15189 accreditation,” said Sheila Woodcock, President and Principal Consultant for QSE Consulting, Inc., in Rose Bay, Nova Scotia.

Woodcock traveled to Tanzania twice this year to help officials from these five zonal labs as they work to earn accreditation by 2010. “Zonal labs are operated by the Ministry of Health and Social Welfare in Tanzania, which initiated the ISO 15189 accreditation program,” explained Woodcock. “In Tanzania, the zones are regional districts with a number of hospitals offering different levels of service and centered around a main hospital.

Strong and Growing Trend

Acceptance of ISO 15189 in laboratory accreditation internationally is a trend not well known to American laboratory professionals. That’s because laboratories here have different accreditation and licensing requirements which pre-date the creation of ISO 15189, which is a quality management system customized to medical laboratories.

Since its creation in 2003, however, ISO 15189 has found growing acceptance as the basis for laboratory accreditation and licensure in industrialized countries and developing nations across the globe. For example, ISO 15189 is used as a standard for laboratory accreditation in Australia, Canada, France, and Germany, among other large industrialized nations.

“The world is moving toward ISO 15189,” said Glen Fine, Executive Vice President at CLSI. Last month, Fine traveled to the African nation of Namibia month to advise the government there on ISO 15189 accreditation. CLSI is also working with Nigeria and Côte d’Ivoire.

“The rest of the world doesn’t have the same laboratory licensure and accreditation requirements as currently exist in the United States,” Woodcock added. “So, one by one, the nations of the world are adopting international standards. In many cases, they are working toward the ISO 15189 standard. ISO 15189, of course, was developed specifically for medical laboratories. Across Canada, this standard is being implemented province by province.

“Within the United States, there are a couple of organizations using ISO 15189 as the basis for medical laboratory accreditation,” Woodcock said. “One is COLA (Commission on Laboratory Assessment), in Columbia, Maryland, which is using ISO 15189 accreditation with medical laboratories in Taiwan, and the other is the American Association for Laboratory Accreditation (A2LA), in Frederick, Maryland. A2LA has just launched a new international accreditation program for clinical laboratories using ISO 15189.

“Globalization of the lab industry is a trend which is reinforced by the common technology used in laboratories around the world,” Woodcock continued. “No matter where you go in the world, you see the same equipment in all these different labs. By using ISO 15189 as an accreditation standard, these labs are demonstrating that they meet the same standards as other labs around the world. That was the reason the Tanzania government choose ISO 15189 for its state run labs.”

Working in Tanzania

In recent years, THE DARK REPORT has pointed out that laboratories across the world are evolving toward common organizational models and operations. “Accreditation plays a role in encouraging convergence,” said Lucia Berte, Founder of Laboratories Made Better! of Broomfield, Colorado. Berte spoke last month at the Lab Quality Confab in Atlanta and is a member of the international committee responsible for updating ISO 15189 standard. “ISO 15189 is becoming a framework around which many countries are choosing to design their lab accreditation programs. Thus, a common standard for accreditation from one country to the next plays a role in encouraging common forms of laboratory organization and operation.”

Resident Lab Mentors Wanted in Tanzania

TO SERVE AS RESIDENT VOLUNTEERS in Tanzania, the Clinical Laboratory Standards Institute (CLSI) in Wayne, Pennsylvania, is seeking five qualified and dedicated laboratory professionals.

Each resident mentor will reside in Tanzania for two to three months to coordinate, support, monitor, and continuously assess the development of a quality assurance system in each assigned medical laboratory facility. This is the next phase of the project to advise five zonal labs in the West African nation on ISO 15189 accreditation.

The zonal laboratories involved in this effort are: 1) Kilimanjaro Christian Medical Centre, in Moshi; 2) Bugando Medical Centre in Mwanza; 3) Muhimbili National Medical Centre in Dar es Salaam; 4) Mnazi Mmoja Hospital, in Zanzibar; and, 5) Mbeya Referral Hospital in Mbeya.

Candidates selected as resident volunteers will receive formal training in specific quality management systems, the ISO 15189 standard, and how to introduce and establish a quality management system for the Tanzanian laboratories. More information can be found on the CLSI’s Web site. (


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