CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hundreds of hospital laboratories. Such a shift in the market for CLIA accreditation services has not happened since the Clinical Laboratory Amendments Act was enacted in 1988.
WITH LITTLE FANFARE OR NOTICE to the clinical laboratory profession, three large health systems—representing hundreds of hospitals—recently decided to use a different accrediting body to certify their laboratories to the requirements of the Clinical Laboratory Improvement Amendments (CLIA) of 1988.
In September, The Joint Commission (TJC) issued a press release announcing that the U.S. Department of Veterans Affairs (VA) had selected the accrediting agency in Oakbrook Terrace, Ill., to provide laboratory accreditation services for the hospital laboratories of the Veterans Health Administration.
The Joint Commission is considered to be the nation’s largest standards-setting and accrediting body in healthcare and has evaluated and accredited hospital-based laboratory services since 1979 and freestanding clinical laboratories since 1995.
Since that announcement on Sept. 14, The Dark Report has learned that at least two other large health systems have decided to switch to The Joint Commission for CLIA laboratory accreditation services. One is Ascension Health, in St. Louis, and the other is Providence Health and Services, in Renton, Wash.
In the market for CLIA laboratory certification, this development is significant for two reasons. First, the College of American Pathologists (CAP) has enjoyed the largest share of the market for clinical laboratory accreditation services for decades.
Second, the shift in CLIA accreditation business away from CAP and to TJC involves at least 372 hospitals: the VA has 170 hospitals, Ascension Health has 151, and Providence Health has 51.
Under the CLIA accreditors’ two-year inspection cycle, it will take several years to determine how many hospital labs actually have completed the move to have TJC do the next CLIA assessment at these clinical labs.
As the largest integrated healthcare system in the United States, the Veterans Health Administration serves more than nine million veterans annually at 1,243 healthcare facilities, including 170 VA Medical Centers and 1,063 outpatient sites of care of varying complexity.
In its Sept. 14 announcement, TJC said that, effective Sept. 15, it would provide laboratory accreditation services for the VA’s moderate- and high-complexity clinical laboratories at VA Medical Centers and community-based outpatient clinics. Those accreditation services would include education on the process, on-site and post-survey reviews, monitoring, and data and measurement activities. Left out of the announcement was the fact that CAP was the losing accrediting body after accrediting VA hospitals for many years.
The VA never issued a statement about the change and did not respond to repeated phone and email requests from The Dark Report for comment on why the agency shifted from CAP to TJC. When asked for its comments, CAP officials provided a statement that is reproduced in full on the sidebar below.
Changes in Lab Accreditation
While the VA’s decision was announced publicly, other hospitals that have switched from CAP to TJC did not make such announcements. Despite that, The Dark Report has learned that at least two other large health systems decided to make similar changes in how their laboratories are accredited.
Ascension Health will stop using CAP for accreditation and instead is contracting with The Joint Commission to accredit its laboratories.
Although no start date has been announced by Ascension, The Dark Report has learned that this change was discussed at the highest levels of management and could be announced publicly at any time. Ascension did not respond to requests for comment.
Ascension Health operates 145 hospitals and more than 40 senior-care facilities and provides healthcare services in 19 states and the District of Columbia.
Providence Health and Services (PHS) is the third large health system to switch its accreditation services from CAP to TJC. PHS operates 51 hospitals in six states: Alaska, California, Montana, Oregon, Texas, and Washington. Before this change, CAP was the primary organization providing accreditation services to Providence Health’s laboratories.
Using Both Accreditors
Under a new arrangement, CAP and TJC will provide accreditation services to PHS laboratories, sources said. The addition of The Joint Commission as a lab-accrediting body for PHS was not announced but was referenced on the website of the Providence Portland Hospital in recent weeks.
In a comment to The Dark Report, a spokesperson for Providence St. Joseph Health said, “Our labs across the six states we serve have different accreditations. Many are Joint Commission accredited. Others are maintaining CAP or COLA, and still others are CMS inspected. This isn’t new. In Oregon, for example, many of our labs transitioned to The Joint Commission five years ago, while one maintained CAP. Our lab operations in our different states are at different stages and have various reasons for the decisions they have made or are contemplating.”
The Providence healthcare network includes:
• St. Joseph Health in Northern Calif.,
• Covenant Health in West Texas,
• Facey Medical Foundation, Los Angeles,
• Hoag Memorial Hospital Presbyterian, Orange County, Calif.,
• Kadlec in Southeast Washington,
• Pacific Medical Centers in Seattle,
• Swedish Health Services in Seattle.
In addition to these three health systems—for which there is public information about their decisions to move hospital laboratory CLIA accreditation services away from CAP and to TJC—several parties have told The Dark Report that one of the nation’s largest for-profit hospital operators is considering switching from CAP and could contract with The Joint Commission.
When contacted by The Dark Report, none of the parties involved (the for-profit hospital operator, CAP, and The Joint Commission) would confirm this change or provide a comment.
Implications for Other Labs
It is unusual for any large, multihospital health system to decide to change its long-standing CLIA accreditation relations with its existing accrediting body. The fact that—during a period of just 18 to 24 months—three large health systems made a similar decision to switch away from CAP to begin using TJC is significant.
As noted earlier, these three large health systems operate 362 hospitals, which represents a large shift in accreditation business away from an existing accrediting body, and all three health systems decided to use the same accrediting body as their new provider.
Questions lab directors are likely to ask is whether these decisions were based, all or in part, on:
• obtaining a better price from the new accrediting body?
• because of poor service by one accrediting body?
• the perception that another accrediting body would provide better service?
• hospital owner’s desire to use one accrediting body for the entire hospital?
The answers to these questions are important to the clinical laboratory profession, because meeting the requirements of CLIA 1988 is integral to the ability of each laboratory to continue operating and to bill federal healthcare programs. The intelligence briefing that follows takes up these questions. It is in turn followed by an interview with a lab administrator about the reasons why his parent health system decided to use a new new organization to meet its CLIA accreditation requirements.
College of American Pathologists Provides Statement on Changes in CLIA Accreditation
IN RESPONSE TO THE DECISIONS BY SEVERAL LARGE HEALTH SYSTEMS to have their CLIA laboratory accreditation services provided by The Joint Commission (TJC), The Dark Reportasked the College of American Pathologists to comment. CAP provided the following statement from Richard M. Scanlan, MD, Chair of the CAP Council on Accreditation. Scanlan’s statement is reproduced in its entirety.
For nearly 60 years, the College of American Pathologists (CAP) has maintained its market-leading position as the most comprehensive provider of laboratory improvement and accreditation programs. In strong partnership with our laboratories and member pathologists, we continue to lead and define laboratory quality standards, bolstering patient care and safety.
During the last year, two health systems have indicated their decision to move their CLIA laboratory accreditation services. While it might be tempting to evaluate alternative accreditors, we know that those providers lack the CAP’s specialization to meet the needs of today’s high complexity laboratories.
Our accreditation program is unlike any other. Beginning with our annually updated checklists infused with best practices, offering a blueprint for running a high-quality laboratory coupled with our peer-to-peer review and strong collaboration in the field, we provide laboratories with a more thorough and up-to-date review process.
Many top-ranked hospitals prefer the CAP’s program because of its rigor and because we continually help them manage the changes in laboratory medicine, technology, and the evolving regulatory environment.
Through discipline-specific requirements, year-round education, and an adaptable peer inspection process, CAP-accredited laboratories keep current with the changes on the front lines of laboratory medicine.
Our priority is always to ensure seamless laboratory support and continuing access to the CAP’s broad range of resources. Chief among these are proficiency testing, education, cancer protocols, clinical guidelines, as well as advocacy for essential regulatory relief during this pandemic.
In a year when COVID-19 has underscored the critical importance of high-quality laboratory performance for global public health, the CAP’s commitment to our laboratories has never been more vital. Again, while some health systems may be enticed to evaluate alternate accreditation providers, the CAP continues to support them in many areas, and we stand ready to renew their accreditation when they wish to return.
VA’s Accreditation Decision Was Appealed
PATHOLOGISTS FAMILIAR WITH THE STEPS the Veterans Administration (VA) took to review CLIA lab accreditation services and to engage The Joint Commission (TJC) have told The Dark Report that the deliberations over this decision were lengthy.
These sources told The Dark Report that the VA had conducted a first review in 2018 that continued into 2019. Based on that review, the VA awarded its CLIA accreditation services to TJC. At that point, the College of American Pathologists (CAP) successfully appealed that decision, allowing CAP to retain the accreditation business with the VA hospitals until recently, sources said.
In 2019, the VA issued a new request for proposal (RFP) for CLIA hospital lab accreditation services. Following its review of the RFPs, it selected TJC to be its CLIA-accreditation provider.
When the VA awarded the accreditation contract to TJC, the decision was made at the highest levels of VA management, sources said. In making these decisions, the VA’s top executives did not seek the opinions of staff in the clinical laboratories—including pathologists who direct the operations of these labs—the sources added.
Other sources stated that the Veterans Administration decided to let individual hospital labs in the VA system continue to use CAP for its accreditation services, with one caveat: If a VA hospital lab chose to stay with CAP for its CLIA accreditation, that hospital would need to pay for those services from its own budget, sources said.
Some VA hospitals in New England are considering paying CAP under this arrangement, sources added.