COLA Re-enters CLIA Accreditation for Pathology

COLA announced that CMS granted it deeming authority for pathology specialty, effective March 7

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Nancy-Stratton

CEO SUMMARY: COLA again has deemed authority by the Centers for Medicare and Medicaid Services to accredit clinical labs and pathology groups for the pathology specialty. The organization’s CEO says the move will help meet current and future lab customer needs. It’s a reversal from 12 years earlier when COLA bowed out of pathology accreditation due to low lab enrollment in the program. 

CLINICAL LABORATORIES SEEKING ACCREDITATION FOR PATHOLOGY HAVE A NEW OPTION, as COLA recently received deeming authority for that specialty. 

The change became official on March 7, when the U.S. Centers for Medicare and Medicaid Services (CMS) awarded COLA deemed status for the specialty of pathology. 

The deemed status, which falls under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), lasts through March 7, 2024. Clearly, COLA sees new business opportunities in today’s pathology market. 

“We knew that the addition of pathology to COLA’s laboratory accreditation program would allow us to support a wider variety of laboratories,” CEO Nancy Stratton, MBA, told The Dark Report in a written response to questions. “The bottom line is that we are now better positioned to meet the needs of our current and prospective customers,” Stratton added. 

Veteran lab administrators and pathologists will recall that COLA previously had deemed status for accreditation for pathology from 2007 to 2010. In June 2010, COLA informed its members and CMS that it was voluntarily dropping its pathology accreditation program. 

At that time, COLA noted that the decision was financially motivated. Only 3% of the organization’s labs were accredited for pathology back then, and it was too expensive to maintain the program given the low number of labs being accredited for the specialty. 

“The cost to maintain the highest levels of quality and patient care for this small number of laboratories has become prohibitive,” then CEO Douglas Beigel wrote to COLA’s members. 

Rare Move from CMS 

It is rare for CMS to grant new deemed status to an accrediting organization. The last similar decision by CMS occurred in 2014 when it approved deeming authority to the American Association for Laboratory Accreditation (A2LA). (See TDR, “CMS Gives Deemed Status to A2LA Under CLIA Law,” April 7, 2014.) 

Prior to that announcement, it had been seven years since COLA had deemed status for pathology, as noted earlier. 

CMS can grant authority to approved third-party organizations to conduct CLIA inspections on the federal agency’s behalf. Those organizations’ laboratory surveys must meet or exceed CLIA requirements.

COLA joins other well-known groups in inspecting for pathology under deeming authority, including The Joint Commission, College of American Pathologists, and A2LA. 

The addition of COLA as a deeming authority for pathology gives laboratory directors a new choice when it comes time for their lab to meet pathology-related CLIA requirements.

In-house Influence?

COLA’s move comes as many office-based physicians continue to offer their own pathology services rather than referring patients elsewhere for those activities. Doing so brings additional revenue into the physicians’ practice and offers patients convenient options for testing. 

As far back as 2004, The Dark Report noted a shift by physician groups to offer in-house anatomic pathology. (See TDR, “Pathology Consultants See In-House AP Trend Unfolding,” Aug. 9, 2004.)

An example of this arrangement would be a gastroenterology physician group practice establishing an in-house histology laboratory and employing a pathologist to handle the professional component of diagnosing the tissue.

Pathology Accreditation

For its part, COLA said its move to pathology accreditation was not in response to this scenario. “COLA recognizes that in-house histology laboratories established by physician groups is one type of pathology laboratory setting,” said the organization’s new Chief Medical Officer, David Chhieng, MD. “We do not have any information about the percentage of pathology laboratories that fall into this category or any ongoing trend.”

As noted, earlier, since the early 2000s, one major trend in the urology and gastroenterology specialties has been for physician groups to set up an in-house histology laboratory to perform and bill for the technical component (TC). The groups would then either hire a pathologists or contract with a pathology group for the professional component (PC). 

Because it is known that COLA provides CLIA accreditation services to many physician office laboratories (POLs), regaining its CLIA deeming authority for pathology positions COLA to serve these types of laboratories as well.

Contact Nancy Stratton at nstratton@cola.org; David Chhieng at dchhieng@cola.org.

COLA Adds Pathology Muscle To Its CLIA Team

IN GRANTING COLA DEEMED STATUS FOR PATHOLOGY ACCREDITATION, the U.S. Centers for Medicare and Medicaid Services (CMS) said COLA’s pathology specialty includes histopathology, cytology, and oral pathology. 

In preparation for the added status, COLA assembled a pathology team, including new Chief Medical Officer, David Chhieng, MD. He will lead the organization’s pathology accreditation program.

Chhieng joined COLA in November 2021 after more than four years as Director of Anatomic Pathology, Vice Chair of Clinical Affairs, and Professor in the Department of Pathology at the University of Washington’s School of Medicine in Seattle. 

Prior to that, he had stints at Mt. Sinai Health System in New York, Yale University School of Medicine in New Haven, Conn., and the University of Alabama at Birmingham.

He has more than 20 years’ experience participating in accreditation services.

Also as of March, COLA named Kathy Wilson, HT(ASCP)QLS, as Director of Pathology Accreditation. Wilson was hired by COLA as an executive in December 2021 and previously served as Operations Manager of Anatomic Pathology at Clinical Pathology Laboratories in Austin, Texas.

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