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  • Avera McKennan Laboratory is the First Hospital Lab in U.S. to Gain ISO15189 Accreditation

Published on January 20, 2009

Avera McKennan Laboratory is the First Hospital Lab in U.S. to Gain ISO 15189SM Accreditation

SIOUX FALLS, S.D. (Jan. 20, 2009) - The College of American Pathologists, a deemed accreditation authority, has awarded accreditation to the CAP ISO 15189 SM  Accreditation Program to the Avera McKennan Laboratory. 

Avera McKennan's Laboratory is the second in the nation to reach this achievement, and the first hospital laboratory in the United States. "This accreditation means the quality of our laboratory is the highest it can be," said Leo Serrano, laboratory director at Avera McKennan. "We are extremely honored to have received it."

The accreditation is based on the International Organizations for Standardization (ISO) for laboratory technical competence and continual quality management and focuses on improved patient safety and risk reduction, outlining standards for quality and competence particular to medical laboratories.


Lab group with Senator Johnson
  lab group with John Thune
Lab group with Senator Thune

CAP 15189 SM is a voluntary, non-regulated accreditation to the ISO 15189:2007 Standard as published by the International Organization of Standardization. This program does not replace the Clinical Laboratory Improvement Amendments (CLIA)-based Laboratory Accreditation Program, but complements CAP accreditation and other quality systems. This program optimizes processes to improve patient care, strengthen quality standards while reducing institutional errors and risks, and controls costs.

The Avera McKennan laboratory completed a written application process, as well as an on-site inspection. In 2004, the Avera McKennan laboratory underwent a process improvement process known as LEAN, an important step in the lab's journey toward excellence. Through LEAN, the lab has achieved a phenomenal accuracy rate of 99.99993 percent, or only about 70 errors per 1 million tests.

"Patients can be assured they are getting the best possible lab service possible," Serrano said. "In a patient's medical record, up to 70 percent of all objective clinical information that doctors base their decisions upon come from a laboratory." Serrano says this achievement is external validation that Avera McKennan's laboratory is among the top in the nation.

"Although the 15189:2007 Standard is not currently mandated in the United States, CAP believes that laboratories that strive to be in the top 10th percentile in quality will benefit from seeking this standard and the College is proud to make it available to American laboratories," said Dr. Cordelia Sever, head of the CAP ISO Program and Accreditation Committee.

In photographs: Sen. Tim Johnson, above, and Sen. John Thune, below, congratulate laboratory staff on this achievement.