CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs within TJC-inspected facilities have two years to switch their CLIA accreditation provider. The reasons behind The Joint Commission’s decision remain unclear.
INTERESTING THINGS ARE UNFOLDING IN THE COMPETITIVE MARKET FOR CLIA ACCREDITATION. As of Jan. 1, The Joint Commission (TJC) ceased recognizing COLA accreditation of clinical laboratories at TJC-accredited facilities.
This action may have no precedent in the 30 years since the regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA) took effect in 1992. Until now, a CLIA lab accreditation issued by any of the organizations granted deeming authority by the Centers for Medicare and Medicaid Services (CMS) has been generally recognized by the other deeming bodies.
This new development is the latest sign that a long-standing status quo in the competitive market for the CLIA accreditation business of complex laboratories is coming to an end. Emerging signs indicate that the major organizations with deeming status—dominated by the College of American Pathologists (CAP) and The Joint Commission—are interested in capturing a larger share of the CLIA accreditation business of larger labs.
This is particularly true of the accreditation business of hospital and health system laboratories. In the past 24 months, several very large health systems changed their choice of CLIA accreditor. Consistent with those developments, TJC’s policy change covers “TJC-accredited facilities.”
Many in healthcare would interpret this as describing primarily acute care hospitals, where core laboratories and satellite laboratories perform a substantial number of tests daily. On its website, TJC states, “Today, The Joint Commission accredits approximately 3,800 general, pediatric, long term acute, psychiatric, rehabilitation, and specialty hospitals.”
A spokesperson for TJC told The Dark Report last week that approximately 300 facilities would be affected that have a lab accredited by COLA.
An Interesting Question
TJC’s decision to no longer accept a COLA-accredited lab in a TJC-accredited facility raises a key question. Under the CLIA statute and associated federal regulations, can one deeming organization cease recognizing the CLIA accreditation status of a lab inspected by another deeming organization that is in good standing with CMS?
The Dark Report asked this question to several attorneys experienced in aspects of the CLIA statues and associated regulations. None of them had heard of this situation before and said they could not answer the question. At the same time, each attorney declaimed that TJC’s policy may not be in violation of the CLIA requirements.
COLA seems to be caught equally flat-footed by TJC’s new policy. “We were surprised and disappointed by this decision,” COLA CEO Nancy Stratton wrote in a letter to member laboratories on Dec. 5. “COLA did not elect to terminate the relationship or seek to change the terms of the agreement. TJC made this decision unilaterally and without prior discussion or consultation with COLA.” (See COLA’s full letter below.)
TJC sent a statement to The Dark Report that said, in part, “After thorough review and careful consideration of COLA’s laboratory accreditation program, in keeping with the terms of our cooperative agreement, The Joint Commission determined that continuing our recognition of COLA did not best support our mission for quality and safety within Joint Commission accredited facilities.”
Recognition of COLA accreditation by TJC stretches back to 1997. In an interview with The Dark Report, Stratton said she did not know—and would not speculate about—what precipitated TJC’s decision.
“The Joint Commission made a business decision, and it’s not a devastating thing to us in any way,” Stratton said. “We at COLA need to dig our heels in and just continue going as we’ve been going the last few years.”
She touted the organization’s successes, including re-entering the pathology accreditation market last year. (See TDR, “COLA Re-enters CLIA Accreditation for Pathology,” April 4, 2022.)
When asked, Stratton said that COLA and TJC had not discussed TJC’s authority under the Clinical Laboratory Improvement Amendments of 1988 to not recognize another deemed clinical laboratory accreditor.
(For more analysis about why The Joint Commission may have made this move, see this story.)
In a letter to healthcare organizations, Heather Hurley, Executive Director of Laboratory Accreditation and Health Systems Strategic Accounts at TJC, wrote that there is a two-year phaseout of COLA accreditation for affected labs. (See TJC’s full letter below.)
Hurley noted that if a COLA lab is part of a TJC-accredited organization, the laboratory has until Dec. 31, 2024, to gain accreditation from The Joint Commission or another partner. Though not specified, presumably the lab accredited by COLA would switch to any of the six remaining organizations that currently have deeming status, including TJC and the College of American Pathologists.
“If your healthcare organization currently utilizes COLA as its laboratory accreditor (for one or more CLIA certificates within your organization), and your organization is accredited under any Joint Commission accreditation program, transition of your laboratory accreditor will be required,” Hurley wrote. “We understand that this is an impactful change and are extending a two-year transition period to allow organizations ample time to make this change.”
TJC’s policy change will not involve any clinical laboratories accredited by COLA that are not part of a TJC-accredited healthcare facility. However, for labs that are part of a TJC-accredited healthcare facility, replacing the COLA lab accreditation by switching to The Joint Commission or another TJC-acceptable deeming organization will be a burdensome change to undertake within the two year timeline.
While TJC cannot force a lab in a TJC-accredited healthcare facility to drop COLA, by contract, it can go to that accredited organization, inspect the lab, and make the organization pay for that inspection, according to a source familiar with the situation.
Stratton said she did not know by number how many clinical laboratories would be affected by The Joint Commission’s decision, but she added that laboratories within TJC-accredited facilities are “not a large component” of COLA’s accreditation mix.
CMS Reviewing the Situation
The federal Centers for Medicare and Medicaid Services (CMS) grants certain organizations deemed authority to accredit labs and pathology practices on behalf of the Medicare program and CLIA. As noted earlier, both TJC and COLA have deemed authority from CMS.
The Dark Report believes this is the first time since CLIA’s inception that one deemed authority has elected to cease recognizing another deemed authority within the lab accreditation field.
Asked about TJC’s move, a CMS spokesperson told The Dark Report that the agency is looking into how such situations might comply or conflict with regulatory provisions of CLIA.
“While most aspects of the business agreements and arrangements involving healthcare entities and accrediting organizations (AOs) are internal to those organizations, we are reviewing all applicable statutory requirements, as well as CMS’ AO oversight regulations, to determine what authority, if any, CMS may have in these situations,” the CMS wrote.
COLA’s letter states clinical laboratories accredited by COLA that operate within organizations also accredited by TJC have three choices:
- Labs can remain with COLA if the hospital or system chooses to change its accreditation from TJC to another accrediting organization.
- Labs can remain with COLA and also enroll in TJC accreditation.
- Labs can withdraw from COLA.
“While this is an unanticipated change for many organizations, our goal is to work closely with [clinical laboratories] and provide support throughout the transition process,” Hurley wrote.
CMS Lists Seven CLIA Organizations
On the Centers for Medicare and Medicaid Services website, these seven organizations are approved accreditation organizations under the Clinical Laboratory Improvement Amendments (CLIA):
- AABB, Bethesda, Maryland
- American Association for Laboratory Accreditation, Frederick, Maryland
- Accreditation Commission for Health Care, Inc (ACHC), Cary, North Carolina
- American Society for Histocompat-ibility and Immunogenetics, Mt. Laurel, New Jersey
- COLA, Columbia, Maryland
- College of American Pathologists, Northfield, Illinois
- Joint Commission, Oakbrook Terrace, Illinois
Under The Joint Commission’s New Policy, Labs Accredited to CLIA by COLA in TJC-Accredited Facilities Have Two Years to Engage a Different CLIA Accreditation Body