G2 Industry Buzz: Asian Laboratory Receives CAP 15189 Certification

The College of American Pathologists (CAP) has accredited an Asian laboratory, its second such certification overseas, but the organization appears to be on the fence regarding any expansion of its growing 15189 accreditation program outside of the United States. The accreditation was given to the Indian pharmaceutical giant Quintiles’ central laboratory in Mumbai, India, and was announced in January. CAP had previously certified a Quintiles facility in Edinburgh, Scotland, in the United Kingdom. CAP’s 15189 certification program guarantees a laboratory undergoing it complies with the International Standard of Organizations’ measurements for quality in processes and error avoidance in medical laboratories. It takes about three years to obtain a certification. The process includes an on-site assessment, including interviews with management, a report of nonconformities, and a couple of years of surveillance prior to the issuance of an accreditation. “The accreditation focuses on the continuum of care directly connected with improved patient safety and risk reduction,” said Anil Raghavan, managing director of Quintiles’ India division. Since it launched the certification process in 2008, CAP has certified 20 laboratories, which includes a mix of laboratories operated by national players such as LabCorp and Quest Diagnostics, as well as several hospital-operated facilities. As opposed to medical testing, Quintiles uses its laboratory facilities for testing associated with its pharmaceutical products. Based on data supplied by CAP, the number of certified labs is expected to grow swiftly in the coming years. CAP spokesperson Joe Schramm said that 40 laboratories both in the United States and overseas are currently in the middle of the certification process. Although Schramm said that there are no plans to make its certification program one with global scope, CAP Chief Executive Officer Charles Roussel noted in a brief interview at the recent G2 Intelligence Pathology Summit, held in Fort Lauderdale, Fla., Feb. 28-March 1, that the demand for accreditation from overseas labs indicates some promise for the program outside of the United States. However, Roussel added that CAP’s certification program could be in conflict with accreditations from other bodies, such as the one in Australia.