CAP Introduces Features to Aid CLIA Inspections

Today’s multi-site laboratory organizations have new needs when undergoing a CLIA inspection

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CEO SUMMARY: Clinical labs are changing in multiple ways and the College of American Pathologists regularly revises its CLIA accreditation processes in response to these changes. One such change is the growth in the number of integrated delivery networks that operate multiple hospitals and multiple medical clinics, creating a multi-site clinical lab service. To meet the evolving needs of these labs, the CAP introduced several services and features designed to expedite the CLIA inspection process.

INTERESTING CHANGES ARE HAPPENING TO THE PROCESS OF INSPECTING LABS for compliance with the federal Clinical Laboratory Improvement Amendments (CLIA) of 1988. Organizations with deeming authority from the federal Centers for Medicare and Medicaid Services to conduct CLIA inspections are introducing new services to help clinical laboratories comply with CLIA requirements. 

New Ways of Operating 

These new services are needed because market forces have caused clinical laboratories to evolve in response to new technologies, the ongoing regionalization of hospitals and providers, and the new capabilities offered by more fully-automated lab testing instruments. 

To assist labs as they change, the College of American Pathologists (CAP) has launched several new features designed to help its lab clients manage the CLIA inspection process more efficiently and with less effort. 

The CAP introduced these new features in response to the fundamentally different way that labs are organized, how they operate, and the more complex menu of tests they perform today—particularly compared with how labs operated in 1992, when federal officials published the final CLIA 88 rule. 

To learn more about what’s changing with CLIA lab inspections at the CAP, the editors of The Dark Report interviewed members of the CAP’s accreditation and marketing teams during a Zoom call last month. On the call were:

• Mary de Sousa, Senior Vice President, Sales and Marketing; 

• William Groskopf, Vice President, Laboratory Quality Solutions, which include the proficiency testing and laboratory accreditation programs among others; and 

• Denise K. Driscoll, MS, MT(ASCP)SBB, Senior Director for Laboratory Accreditation and Regulatory Affairs.

Three Factors Driving Change

As a starting point for the discussion, the CAP’s accreditation team identified three significant factors driving change in the clinical laboratory profession that have affected how laboratory managers and pathologists approach compliance with CLIA requirements. 

“One factor is the growing number of multi-hospital, multi-provider health systems,” Groskopf noted. “Within a single health system, clinical laboratory testing is performed at different hospitals and in different provider settings. Consequently, compliance with CLIA becomes a multi-site challenge.

Consolidation of Hospitals 

“Over the years we’ve continued to see consolidation of hospitals and medical offices into integrated delivery networks (IDNs) which created a new type of customer—if you will—for CLIA accreditation,” he continued. “Pathologists and lab leaders in these settings need to oversee regulatory compliance across many lab testing sites and sometimes across a large geographic region.”

“Another factor involves advances in information technology and the integration of different sources of data,” de Sousa commented. “These new IT capabilities make it possible to eliminate paper, a factor that makes it easier to share data and documentation digitally. This trend is the basis for several new assessment tools that the CAP brought to market in recent years.”

Driscoll added a third factor. “We have also noticed another trend across the clinical laboratory industry, and that is the increased challenge of managing all the different lab sites within a health system,” she said.

Uniformity Across All Sites 

“When a system has multiple sites, most often they find a need to standardize operations at each site,” Driscoll explained. “Pathologists and lab leaders want uniformity across all testing sites. That starts with standardizing analyzers and assays. But there is also the need to standardize other activities across all lab sites. For example, labs must document lab staff competency and keep those records updated. When they do that, they can have the flexibility to move staff to different lab facilities within the system.”

CAP’s accreditation program is continually working to adapt to these developments, Groskopf commented. “One of the most popular innovations we launched in recent years is a performance analytics dashboard,” he stated. “This dashboard gives the laboratory system a holistic and an individual view of many quality metrics that feed into their system.

“One dashboard feature proving to be of high value involves previous deficiencies,” Groskopf observed. “We load several years’ worth of data on prior deficiencies at a client’s laboratory sites into the dashboard. This feature has a hierarchy of access. The health system’s leadership can view prior deficiencies across the entire organization. Other managers can view only prior deficiencies at their lab facility.” 

Access to Past Deficiencies

Having the ability to look back at earlier inspections has significant value for lab managers and directors, Driscoll commented. “A lab director can see if the same deficiency was identified within several of their laboratories,” she explained. “This information is useful when labs within the same IDN are not on the same two-year inspection cycle. 

“If lab managers detect that there were similar issues cited at different lab sites, the dashboard data helps them achieve uniformity across the integrated delivery network,” she said. “We see labs grab this data from the dashboard and use it to come up with simple solutions. That avoids having, say, 50 different solutions in the same network.”

“Clinical lab directors and managers also find it useful that the dashboard data are not limited to information only about accreditation,” Groskopf added. “The dashboard includes data on proficiency testing (PT), for example. We can now show PT data at the system level and the individual lab level.

“In addition, we added a specific system report to spotlight successful, unsuccessful, and repeat unsuccessful PT analyte performance for laboratories, as well as PT analytes that are at risk of potentially becoming unsuccessful,” he explained. 

“Our customers value having the ability to look at proficiency testing performance by site,” he added. “These proficiency testing metrics allow laboratory managers to identify how consistently their lab sites are meeting specifications.” 

Dashboard Can Flag Issues

Another popular feature of the dashboard is the ability to identify potential problem areas, Driscoll noted. “The dashboard has triggers that will flag specific activities or metrics that are worth a closer look for the lab team,” she said. “These flags appear on the landing page. This feature includes testing.

“For clinical laboratories that want to evaluate themselves against similar labs, the dashboard tool can run a comparison of the client’s lab against a broader group of similar accredited laboratories,” she added. “Now the laboratory can benchmark itself against peer labs.”

Advance Document Upload

Another feature of CAP’s accreditation services is designed to make inspections easier and simpler for lab staff and for inspectors. “It is now possible for labs to upload documentation in advance of an inspection,” de Sousa said. 

“Labs come to our website and upload documentation—such as the quality management plan—so that the inspection team can review those documents before they arrive on-site. This feature gives laboratories the option to make certain documents and records available to the inspection team before the video conference portion of the inspection. 

“This pre-review process optimizes the time spent while the inspection team is on-site and streamlines the work being completed virtually,” she explained. “It also allows the inspectors and the lab staff almost instant access to any relevant documents during the inspection.” 

Mix of New Features

This mix of new features that the CAP has introduced demonstrate how this deeming organization is working to streamline the laboratory accreditation process. These new features are also consistent with a trend for deeming organizations to introduce new capabilities that add value to the clinical laboratory organizations undergoing the CLIA accreditation process. 

Today’s generation of clinical laboratories are much more complex organizations than clinical labs were in 1992, when the CLIA 88 regulations became effective. At that time, hospitals, clinical laboratories, and other healthcare providers were heavily reliant on paper to document many work processes and activities. 

Fast forward 30 years and a host of new technologies and informatics solutions now make it possible for clinical laboratories and anatomic pathology groups to eliminate paper across the entire enterprise. This is not yet widespread across the clinical laboratory profession, but there are examples of labs that have successfully eliminated paper in nearly all of their activities. 

“This pre-review process optimizes the time spent while the inspection team is on-site and streamlines the work being completed virtually. It also allows the inspectors and the lab staff almost instant access to any relevant documents during the inspection.”

Mary-de-Sousa

Mary de Sousa

The CAP saw this opportunity to move paper-based CLIA accreditation processes to a digital platform. This raises the bar in the competitive marketplace while also giving its lab clients a feature that helps them to be more productive while streamlining a CLIA accreditation process introduced in 1992. 

Another market factor is that both government and private payers have been slashing what they spend on clinical lab tests in recent years. When lab revenue is reduced, managers are motivated to find new ways to improve productivity and reduce costs. That naturally motivates clinical lab managers to study the CLIA accreditation process and its cost to identify how to meet those federal requirements at less cost and with fewer disruptions to normal lab testing activities.

Contact Mary de Sousa at 847-832-7578 or mdesous@cap.org.

SARS-CoV-2 Pandemic Created Need for Virtual CLIA Laboratory Assessments

WHEN THE CORONAVIRUS PANDEMIC BEGAN RAGING NATIONWIDE LAST YEAR, CLIA inspectors from the College of American Pathologists (CAP), were like inspectors from all organizations with deeming authority from the federal Centers for Medicare and Medicaid Services in that they needed to move away from doing as many on-site inspections as they had done in previous years. 

In place of on-site work, CAP inspectors turned to virtual inspections for about 20% of the inspections they did last year, said Denise K. Driscoll, MS, MT(ASCP)SBB, the CAP’s Senior Director for Laboratory Accreditation and Regulatory Affairs.

“We’ve always had what we call our traditional model for doing inspections of labs,” said William Groskopf, the CAP’s Vice President, Laboratory Improvement Programs. “The traditional model is the standard on-site inspection. We continued to do those inspections, but when there’s a big spike in COVID-19 infections, we can also turn to our virtual inspections.

“When the inspection will be virtual, we offer the labs a chance to send us the documentation before the inspection begins,” he explained. “For that, we’ve launched a new system for laboratories so that they can upload documentation to our website so the inspection team can do a pre-review of those documents.

“Doing a pre-review means the inspectors can stay in their offices to begin the inspection,” he noted. “That process improves the efficiency of the inspector and streamlines the time onsite while maintaining the quality of the inspection.”

Driscoll added that the CAP inspectors can supplement the document pre-review with a virtual tour of the lab.

Virtual Laboratory Tour 

“That virtual tour happens when someone from the lab staff uses a device with a video camera and walks around the lab,” she added. “When I’m on an inspection team, I might say, ‘Oh, let’s stop here,’ or I’ll ask, ‘What was that?’ Or I might ask to get a closer look at test tubes to see how they’re labeled, for example.

“For a safety walk-through as part of a virtual inspection, the camera view from the lab being inspected is very important,” Driscoll noted. “I might want to see the exits, for instance, or I might want to see where the fire extinguishers are located. We also do some of the virtual walk-throughs with a smartphone.

“When we combine the virtual walk through with the advanced document pre-review, we get a good idea of what’s happening in each lab,” she added.

 

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