NEWS UPDATE: American Association of Laboratory Accreditation (A2LA) is given four-year authority to accredit clinical laboratories to CLIA requirements for all specialty and subspecialty lab test areas

There’s a new Centers for Medicare and Medicaid Services-approved (CMS) accrediting organization for clinical laboratories. Medicare officials granted deeming status for Clinical Laboratory Improvement Amendments (CLIA) to the American Association for Laboratory Accreditation (A2LA). The approval marks the first time in two decades that CMS has added a new organization to accredit medical laboratories under CLIA.

CMS announced the approval in a notice published March 25 in the Federal Register. CMS approved A2LA’s application as an accreditation organization for clinical laboratories under CLIA for all specialty and subspecialty areas for four years. “We have determined that the A2LA meets or exceeds the applicable CLIA requirements,” stated the CMS announcement.

Accreditation by A2LA Means a Laboratory Meets CLIA Rules

The approval means that any clinical laboratory accredited by A2LA will be deemed to meet the CLIA requirements and, therefore, will generally not be subject to routine inspections by state survey agencies to determine compliance with CLIA requirements. Laboratories accredited by A2LA will still be subject to CMS’ validation and complaint investigation surveys, according to CMS.

“The A2LA policies and procedures for oversight of laboratories performing laboratory testing for all CLIA specialties and subspecialties are equivalent to those of CLIA in the matters of inspection, monitoring proficiency testing (PT) performance, investigating complaints, and making PT information available,” the CMS wrote.

A2LA logo

In a notice published in the Federal Register on March 25, Medicare officials announced the approval of the American Association for Laboratory Accreditation (A2LA) as an organization with deemed status for CLIA accreditation. This approval gives clinical laboratories another option when seeking CLIA accreditation.

“In its application, A2LA demonstrated that its requirements for monitoring and inspecting laboratories, data management, the inspection process, procedures for removal or withdrawal of accreditation, notification requirements, and accreditation organization resources were equal to or more stringent than the requirements of the CLIA regulations,” the CMS added.

Medical Directors and Lab Managers Have a New Accreditor Choice

This development gives medical directors, pathologists and lab managers a new choice of an accrediting organization to meet CLIA requirements. Roxanne Robinson, A2LA’s Vice President and Chief Operating Officer, said A2LA expects to start receiving applications from clinical laboratories within about a month and will do its first assessment within about 90 days. “We already have a list of labs that have been waiting for us to get deemed status and they will be pleased to hear this news,” she said.

A2LA’s clinical laboratory program offers three options for accreditation:

  • Accreditation to CLIA standards,
  • Accreditation to ISO 15189:2012, or
  • A2LA’s Platinum Choice—Accreditation to CLIA and ISO 15189 through one assessment with one team of assessors.

A2LA submitted its application to CMS in January 2012, Robinson explained. “The review process involved answering numerous questions about how A2LA conducted accreditations,” she said. “During the review process, we provided documents and other materials to support the application and answered questions from CMS about our operations.”

A2LA Has Accredited Testing Labs Since 1978

“CMS was diligent in considering our application because A2LA is different from other accreditation organizations, perhaps because we are not focused solely on clinical testing,” explained Robinson. “But A2LA has been an accrediting body since 1978 and heavily involved in accrediting to ISO standards. This approval benefits our accredited labs because the testing has been performed, but is accepted everywhere. That’s our goal: for the services offered by our accredited organizations to be accepted globally.”

A2LA has spent decades accrediting organizations across a wide range of industries and businesses. It accredits testing labs, calibration labs, proficiency testing providers, reference material producers, inspection bodies, and product certifiers. All of these organizations are using the ISO standards.

 

Peter Unger, pictured above, is the President and CEO of the American Association for Laboratory Accreditation (A2LA). His organization was just granted deemed status by the Centers for Medicare and Medicaid Services to provide accreditation services to clinical laboratories seeking to meet CLIA requirements. (Photo copyright A2LA.)

Peter Unger, pictured above, is the President and CEO of the American Association for Laboratory Accreditation (A2LA). His organization was just granted deemed status by the Centers for Medicare and Medicaid Services to provide accreditation services to clinical laboratories seeking to meet CLIA requirements. (Photo copyright A2LA.)

 

“In addition to doing accreditations in clinical laboratory testing area, we also accredit in 14 other disciplines,” added Robinson. “These include chemical, biological, construction materials, electrical, mechanical, and information systems.”

A2LA Is Recognized to ISO 17011

The association is distinguished by another fact. “A2LA is internationally recognized as being in compliance with ISO 17011, the standard by which accrediting bodies operate,” stated Larnell C. Simpson, A2LA’s Director of Marketing and Medical Affairs. “At the same time, ISO 17011 assures that our assessors are qualified to assess a lab rigorously, knowledgeably, and independently. Each of our assessors is thoroughly vetted and trained to demonstrate that they are competent and qualified for the assessments they perform.”

In November 2000 A2LA was one of 36 laboratory accreditation bodies (representing 28 countries) to become full members of ILAC.

“In addition to being in the first class of signatories to ILAC (International Laboratory Accreditation Cooperative), we already had bilateral agreements with many other countries to ensure that accredited laboratories could be recognized in all those other countries,” Robinson added.

A2LA Will Present Session at Executive War College on April 29

Pathologists and clinical lab executives interested in knowing more details about A2LA’s CLIA accreditation services, as well as its ISO 15189 accreditation program, can hear Larnell Simpson speak at the upcoming 19th Annual Executive War College on Lab and Pathology Management, April 29-30, 2014. His presentation is titled: “CMS Announces A2LA as the Newest CLIA Accreditation Body: Introduction to A2LA as Source for Simultaneous CLIA and ISO 15189 Accreditation.”

Readers can view the full program and agenda at http://www.executivewarcollege.com/agenda/ and register at http://www.executivewarcollege.com/register/. To view the entire Executive War College website, visit http://www.executivewarcollege.com.

In conclusion, the decision by CMS to grant deeming status to A2LA for accrediting labs to the requirements of CLIA may have some interesting long-term consequences. Because of A2LA’s extensive relationships with ILAC and the global ISO community, it will bring fresh perspectives and insights to those labs it helps with the CLIA accreditation process. In particular, its familiarity with the ISO quality management system may give its lab clients an added edge as they establish the structure necessary to meet and exceed the requirements of CLIA.

—by Joseph Burns

Related Information:

Medicare Program; Announcement of the Approval of the American Association for Laboratory Accreditation (A2LA) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

“CMS Announces A2LA as the Newest CLIA Accreditation Body: Introduction to A2LA as Source for Simultaneous CLIA and ISO 15189 Accreditation

19th Annual Executive War College on Laboratory and Pathology Management