The Centers for Medicare and Medicaid Services (CMS) recently granted approval to A2LA—a large multi-discipline accreditation body in the United States—to accredit clinical laboratories across the world using Clinical Laboratory Improvement Amendment (CLIA) requirements. The CMS approval makes A2LA the only accreditation body in the U.S. that has achieved “dual recognitions in the clinical testing arena: Recognition by the International Laboratory Accreditation Cooperation for the accreditation of clinical laboratories to ISO 15189:2012 and recognition by CMS for the accreditation of clinical laboratories to the CLIA requirements,” according to a press release announcing the approval.
“We are the first accreditation organization to be approved by CMS in 20 years,” says Amanda McDonald, A2LA accreditation officer II. “Laboratories around the world now have an option for not only meeting their U.S. regulatory needs, but also achieving internationally recognized ISO 15189:2012 accreditation.”
The single accreditation A2LA now offers provides accredited clinical laboratories “increased international business opportunities and a clear competitive advantage,” according to the press release. McDonald added that “a clinical laboratory seeking accreditation through A2LA is sending a clear message that they are dedicated to laboratory quality, to assuring the accuracy of test results and, ultimately, to ensuring patient health and welfare.”
Accreditation takes an average of 6 months, although some laboratories may complete the process sooner, and others may need more time. “It depends greatly on the readiness and response time of the laboratory,” McDonald explains. “It is also important to note that, for the dual accreditation program, while the two standards are examined during a single on-site assessment, they are considered to be two separate accreditations, meaning that accreditation of the laboratory to CLIA requirements will not be delayed while issues related to ISO 15189:2012 compliance are being addressed by the laboratory, and vice versa.”
At the end of the process, the laboratory receives two certificates, one for each standard in the dual program. A2LA also offers an extended 4-year contract to potential applicants in either of these programs, which allows laboratories to better manage the costs associated with accreditation.
A2LA is a 501(c)(3) nonprofit educational institution, and it offers public training courses to help organizations prepare for, achieve, and maintain accreditation. Training is available on the ISO 15189:2012 standard, as well as training specifically for accreditation to both ISO 15189:2012 and CLIA requirements. Details about A2LA’s training courses are on the organization’s website.
Read the press release announcing A2LA’s CMS approval.