Laboratory Operations

Understanding ISO 15189 for Laboratory Accreditation and Global Convergence

One important trend in the laboratory profession is the global convergence of laboratory operations. This trend is reinforced by the acceptance of ISO 15189 as a standard for laboratory accreditation. ISO 15189 is finding its way into the laboratory accreditation requirements of such countries as the United Kingdom, Germany, France, Canada, and Australia, to name a few.

“In the United States, there are a number of statutory regulations and requirements that cover clinical laboratories. That is why ISO 15189 has not found ready acceptance in our country,” said Lucia Berte, Founder of Laboratories Made Better  of Broomfield, Colorado. Berte was speaking to the general session of the Lab Quality Confab in Atlanta yesterday.

Berte explained why laboratories in countries across the world are increasingly evolving toward common organizational models and operations. “Accreditation plays a role in encouraging convergence,” declared Berte, who is part of the committee that is responsible for updating ISO 15189 standards. “ISO 15189 is becoming a framework around which many countries are choosing to design their laboratory 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.”

Because the United States already has an existing arrangement for laboratory regulation and accreditation, it is not likely to incorporate much of ISO 15189 into licensure and accreditation requirements. “The acronyms are familiar,” noted Berte. “Depending on its mix of clinical laboratory testing, a single laboratory in the United States may need to comply with, or accredit through, CMS, JC, CAP, OSHA, CLIA, COLA, FDA, and A2LA.

“ISO 15189 is gaining favor outside the United States as the foundation for laboratory licensing and accreditation because it is a quality system that is developed from ISO 9001, and is being tailored to reflect the specific characteristics of a medical laboratory,” explained Berte. “The key elements of a quality system are: 1) quality infrastructure; and 2) quality system essentials. ISO also addresses the two elements of how the application of the quality system applies to the work performed. These are: 1) process model; and, 2) path of workflow.”

In answer to a question from the audience, Berte stated that, to her knowledge, no laboratory in the United States has yet to earn certification under ISO 15189. “Because of existing statutory requirements and accreditation programs, laboratories in the United States have not wanted to devote the time and resources needed to earn certification as ISO 15198 complaint,” she explained.

Berte’s presentation capped a general session that included important presentations by Kara Gelb of General Electric Healthcare Performance Solutions, Barton Gill of Premier, Inc.’s Consulting, Solutions, and Richard J. Zarbo, M.D. of Henry Ford Health System. The theme of the session was how the healthcare system and the laboratory profession have steadily increased the use of quality management methods.

Lab Quality Confab concludes today. The support for the conference is a demonstration of laboratories and hospitals have succeeded with Lean, Six Sigma, and similar improvement principles. The 270 attendees included people from Argentina, Australia, Brazil, Canada, Sweden, and the United Kingdom. At the exhibition, the 15 exhibitors were swamped with interest. Dark Daily plans to share details of some of the most important innovations and successes in e-briefings coming your way in the next few weeks.

From Lab Quality Confab in Atlanta, your Dark Daily Editor,
Robert Michel