MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation requirements of the federal Clinical Laboratory Improvement Amendment (CLIA) statute.
Such a movement of hospital labs from one CLIA-accrediting body to another has not happened since the CLIA regulations became effective in 1992. To learn more about the differences in how CAP accredits labs versus how TJC conducts lab accreditations, The Dark Report interviewed William Remillard, MT (ASCP), Laboratory Director of the Providence Health Care (PHC) hospital labs in Eastern Washington.
Remillard has extensive lab management experience at TriCore Reference Laboratories; PAML of Spokane, Wash.; and ARUP Laboratories, and has worked with CLIA lab accreditors from CAP, TJC, COLA, AABB, and others over more than three decades in the clinical laboratory industry.
In an interview with The Dark Report, he said, “I feel strongly that CAP needs to re-evaluate how they do their CLIA inspections. There are fundamental differences in how the two larger organizations handle the inspection process.
“Lab professionals perform CAP’s inspections and work as volunteers when they visit peer labs. While CAP requires their volunteer inspectors to complete CAP online training modules, the process can result in variability among inspectors,” explained Remillard. “By comparison, The Joint Commission’s processes generally require fewer on-site inspectors who follow a checklist and serve as employed professional inspectors.”
Since Providence St. Joseph Health System engaged The Joint Commission for CLIA accreditation of some of its hospital labs at the beginning of last year, two of the system’s hospital labs in Remillard’s area have had a TJC assessment. TJC inspects labs on a two-year cycle.
“The Providence St. Joseph’s Hospital System operates 51 hospitals in six states: Alaska, California, Montana, Oregon, Texas, and Washington,” he noted. “We’re split into six regions, and PHC is the Washington-Montana region.
“Since my return here in 2018, we’ve continued with many system-driven standardization initiatives in our hospitals and in our labs,” he added. “Not all of our hospital labs are accredited through The Joint Commission because we are a large complex system and local decisions may steer each lab in a different direction. That said, some of them have already moved to TJC and some are just considering the move.”
In a comment to The Dark Report, a spokesperson for Providence St. Joseph Health said, “Our labs in 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 TJC 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.”
In the Washington-Montana region, Remillard is responsible for lab operations at four hospitals. Previously, two of those hospitals were with CAP before switching to The Joint Commission last year. The other two are smaller critical access hospitals that the Washington State Department of Health inspects. “We’re sticking with that for now,” he noted.
Seeking improvements in efficiency and lower costs, the two larger hospitals switched from CAP to The Joint Commission, Remillard explained.
“One important factor was that The Joint Commission accredits the entire hospital, which gives it oversight over just about everything,” he noted. “That means we now have complete alignment with one regulatory body for much of the hospital, including the laboratory.
“In many hospitals, the laboratory is a bit of an outlier,” he explained. “It’s almost as if we speak a different language, and in many ways we do. To get alignment within our hospitals, it made a lot of sense to go with The Joint Commission because CAP doesn’t inspect hospitals. It does laboratory CLIA inspections.
“Previously, when we would talk about being inspected by CAP, hospital leaders would sometimes say, ‘Remind me again of what CAP does,’” he recounted. “That doesn’t happen anymore.
“Now that we’re with The Joint Commission, we’re working with one regulatory body, which levels the playing field by simplifying the language everyone speaks when talking about accreditation,” Remillard said.
“In that way it improves communication within the hospital,” he added.
“The Joint Commission uses different assessors who inspect the laboratory from those who inspect the hospital itself,” he said. “But the process is smooth and more efficient for all concerned.
“Another way that TJC inspection is different is that it has fewer people do the inspections,” he reported. “CAP sends a team to inspect your lab and that team is sized in a way that’s appropriate to your operation. Generally, that’s more than one person, and it could be as many as 25 people inspecting your facility.
“In my experience, the CAP inspectors try to get their inspections done in one to three days,” he said. “For most of my career, I’ve worked with larger labs, and I’ve found CAP will generally bring an entire army of people into those laboratories.
“Basically, that army is comprised of colleagues and peers from within the lab industry,” Remillard explained. “CAP has said that having peers doing inspections is a big advantage, and in some cases this is true. Unfortunately, CAP has gone in a direction in which its process can be a burden on the laboratory that’s being inspected—in part because they bring this small army of people to your lab.
“Many times, CAP inspectors in one department request the same documentation that other CAP inspectors are requesting in another department,” he warned. “That kind of overlap is redundant and stressful for the staff, supervisors, and the management team.
Reciprocal CLIA Inspections
“To execute its inspection strategy, CAP expects your medical director to assemble and send a team to do a reciprocal CLIA inspection at another facility of a similar size,” he noted. “While this is often an exciting process to do, it’s also a burden because it’s a big commitment for your lab to fulfill. You must assemble a team and send them on the road to do a CLIA inspection in another city or another state for multiple days.
“CAP has said that sending out peers to inspect other labs is an advantage because your team sees how other labs operate and potentially your team can learn best practices,” he noted. “But my experience from a number of CAP inspections is that it can be hit or miss as to how much peer inspectors learn or share best practices when they assess your lab.
“There are times when a team of peers has extensive experience and does a thorough inspection. But then you might get the opposite too,” he cautioned. “The team may be confused about the questions they’re asking, or they may not fully understand the intent of the questions in the inspection process. Also, the team might interpret what your staff says about your lab operations in a way that’s different from the way your staff interprets those same operations. When that happens, there’s a potential for a difference of interpretation.
“To be fair, CAP has a way to resolve those issues, but that process often creates more work, and if those questions are not resolved, then the process can go off in a wrong direction quickly,” he noted. “At least that’s been my experience.”
Remillard’s experience with TJC is much different. “The Joint Commission’s professional inspectors use a checklist and have a lot of experience using that checklist,” he noted. “They know exactly what they’re looking for, and there’s not much interpretation in how they use the checklist.
“When we had our TJC inspection at one hospital in this region, it was thorough and went smoothly,” he added. “This was one of our larger hospitals with 750 beds. In that facility, we had one inspector who stayed for about four days total. With a single inspector we could quickly establish a good, professional rapport and we found this inspector to be quite knowledgeable.
“Preparation for the change to the Joint Commission was extensive,” he reported. “In July 2019, we presented the idea for the change to key lab stakeholders. Once we had their buy-in, we sent two content experts to an off-site TJC training in November. Preparation then continued with significant effort to update our standard operating procedures and to train to TJC checklist. Our on-site inspection was in February 2020, which was just prior to the pandemic travel freeze.
kFeedback from Staff
“The feedback from our staff was that if they had known what The Joint Commission CLIA inspection would be like, they would have moved to TJC many years ago,” he recalled. “I say that because the lab team considered it, overall, to be a great experience. Not only was it a more efficient inspection, but we were not required to send out a team of inspectors to go to another lab.
“CAP might say that with The Joint Commission, we would not get the peer-to-peer experience or learn best practices,” he added. “I would challenge that thinking because the inspectors from TJC have been in many dozens of labs over the years. That experience means they can guide us to meet regulatory requirements using their wealth of knowledge. In that way, we don’t lose out on the opportunity for TJC’s CLIA assessor to share best practices with us.”
In closing, Remillard added that having one accrediting body for the hospital and lab is an important point that lab directors and hospital administrators should not overlook. “Being aligned with the rest of the hospital is very important for labs,” he said. “As laboratorians, we’re separated enough as it is from the rest of the hospital staff. Having one accrediting organization both for the hospital and the lab helps to bring both entities into more of an alliance than they would be otherwise.”
Contact William Remillard at William.firstname.lastname@example.org.
NOTE: The Dark Report invites those who would like to explain the pros and cons of CAP vs. TJC accreditations to respond to: email@example.com.