WITH THE ONSET OF THE COVID-19 PANDEMIC IN MARCH, three of the major organizations deemed to have CLIA status suspended inspections of clinical laboratories for several months. Inspections and assessments of laboratories have restarted, but with significant changes because of the SARS-CoV-2 outbreak.
These changes to the CLIA lab assessment and accreditation process were the subject of an important virtual session at the Executive War College last month. The panel chair was Nora Hess, a senior consultant with Accumen, a healthcare consulting firm. The panelists represented:
• College of American Pathologists,
• COLA, and,
• The Joint Commission.
One key message shared by all the panelists is that, because of the ongoing pandemic, clinical laboratory managers should prepare themselves for more virtual inspections and a slow return to business as usual.
Hess opened the panel by noting that travel restrictions and stay-at-home orders across the country disrupted clinical lab inspections and changed the way the accrediting agencies operate while complying with the requirements of CLIA.
Following is an overview of the comments from each of the three panelists representing the three major laboratory accrediting agencies. They provide insights and information about how the pandemic affected their ability to conduct surveys of clinical labs and pathology labs.
The Joint Commission: TJC ISCATCHING UP ON CLIA LAB SURVEYS
The Joint Commission (TJC) paused surveys in March but resumed in June, offering both virtual and on-site surveys, stated Heather Hurley, Executive Director.
When determining where to travel for surveys, The Joint Commission considers COVID-19 positivity rates in communities where clinical laboratories are located, as well as the number of COVID-19 patients currently being treated in a particular hospital.
“We are in communication with each healthcare organization due for a CLIA lab survey to understand how it has been impacted by the pandemic and whether the facility is able to sustain a survey in its current condition,” said Hurley. “These factors determine whether or not we will complete an on-site survey. Based on our system, we determine ‘no go’ zones which indicate the surveys in those areas will be done virtually.”
The organization has expanded its driving radius, though surveyors do continue to fly to clinical laboratories for inspections. All surveyors are employed by The Joint Commission.
“For clinical laboratory organizations that are past due, CLIA has put out a requirement that surveyors need to catch up by the end of the year. So if your laboratory is past due, you can expect that we will be reaching out to you soon,” she stated.
To limit contact, Joint Commission surveyors typically travel alone or in small groups, noted Hurley. TJC surveyors are not entering areas where there are COVID-19 positive patients.
“Our surveyors practice social distancing, wear personal protective equipment, and limit the number of staff in the room with our surveyors,” continued Hurley. “In regions designated ‘no go’ zones—and that changes daily and weekly—we expect virtual CLIA laboratory surveys to continue.”
College of American Pathologists: CAP CUSTOMIZING CLIA INSPECTIONS
The College of American Pathologists (CAP) also stopped performing inspections in mid-March and resumed them in June, explained Denise Driscoll, CAP’s Senior Director of Laboratory Accreditation and Regulatory Affairs. Initially upon resuming inspections, the CAP performed a limited number, primarily in response to complaints, to investigate immediate jeopardy concerns, or to follow up instances of noncompliance.
CAP’s next priority was completing initial CLIA inspections for laboratories, followed by addressing overdue routine inspections in regions where the community spread of COVID-19 allowed such activity. Routine inspections were next on the priority list, Driscoll explains.
“We’re trying to optimize the process for the future,” said Driscoll. “The scope of the inspection has not really changed. We will conduct a complete inspection of all disciplines and subdisciplines prior to an accreditation decision, with a slight change in how we go about doing that.”
Specifically, CAP inspectors are being encouraged to perform online document review prior to the on-site inspection, thus allowing for a smaller group of inspectors to go onsite at a clinical laboratory. The goal is to reduce potential exposure to the virus.
The federal Centers for Medicare and Medicaid Services (CMS) does require an on-site component of CLIA inspections, but currently allows remote document review.
“We are working to manage this balance as best fits the laboratory being examined,” explained Driscoll. “Some clinical labs are not comfortable providing online access to the inspectors ahead of time, or they may want only a few documents to be shared with the team ahead of time. There’s a lot of customization of inspections based on the laboratory’s needs.”
Another change is that the CAP team is not personally observing testing performed in patient care areas because of potential exposure of inspection team members and patients, noted Driscoll. CAP also has reduced inspection team size. In many cases, both CAP staff surveyors and local peer inspectors—who can drive rather than fly to the sites—are conducting inspections. “We continue to make modifications as needed,” she added.
CAP suspended international inspections. It has plans underway to begin virtual options for non-CLIA laboratories and to follow domestic plans for CLIA-licensed labs outside the United States; however, travel restrictions will impede on-site visits for all international laboratories in CAP accreditation programs.
COLA: COLA OFFERS THREE-STEP CLIA SURVEY PROCESS
COLA suspended routine CLIA clinical lab surveys in mid-March, but has since resumed surveys in areas deemed safe, stated Kathy Nucifora, Chief Operating Officer.
“We do that by looking at the incidence of new COVID-19 cases in a given area, as well as the positivity rate,” she said. “Each week, we go into several credible websites and maps and drill down to the state and county level and make a decision as to whether or not we will go into that area the following week. And then the next week, we do it again. We have had areas where we have paused CLIA lab surveys, maybe resumed a few, and then paused again. We do this in near-real time to protect our surveyors, the clinical laboratories being assessed, and their staffs.”
Currently, COLA surveyors only drive to sites and do not fly. Initially, surveyors would do day trips, but now they may do extended trips, coming home at the end of the week. “COLA is assessing the safety of air travel and hopes to be able to have surveyors fly to sites in the not-too-distant future,” she said. “COLA surveyors practice social distancing, wear PPE, and follow other guidelines recommended by the federal Centers for Disease Control and Prevention.”
Remote CLIA Surveys
CMS announced in May that accrediting organizations would be given the flexibility to define a process for remote surveys. COLA received approval for its remote process in July and has since implemented virtual CLIA surveys for clinical laboratories that are due or overdue for surveys and are located in areas that surveyors cannot get to by driving, or that have not been deemed to be safe.
The process is not 100% virtual, explains Nucifora. There are three components to COLA’s virtual surveys:
1. Documentation Review. Clinical laboratories are asked to upload documents to COLA’s customer portal, including current CLIA certificate, qualifications for any personnel that have not yet been reviewed, competency assessments, all proficiency testing records, as well as a representative sampling of quality assurance and quality control records.
2. Video Conference. Once documents are reviewed, surveyors hold a video conference with the clinical laboratory director and staff to follow up on document reviews and do spot checks to ensure ongoing compliance. The date of the video conference is recorded as the official survey date.
3. On-site Visit. Once the clinical laboratory is deemed safe, surveyors perform an on-site visit. This serves as a confirmation of lab operations and allows additional follow-up on issues identified during the first two components of the inspection.
Not all COLA clinical labs are eligible for remote surveys. New labs and large labs are prioritized for on-site surveys. Laboratories are encouraged to contact COLA to discuss the possibility of a virtual survey.
“When surveyors are onsite, they practice physical distancing,” stated Nucifora. “We ask that laboratories give our surveyors the space to work so they can maintain six feet of distance from others. This has been a significant challenge. Our surveyors report that it’s hard to break habits that have been solidified over years and years.”
COLA surveyors will not observe certain processes in patient care areas, such as transfusions. Surveyors will comply with all facility requirements in place to protect patients and staff, such as taking temperatures, answering questionnaires, and limiting the areas of the hospital or clinical lab where they are working.
Though COLA is not yet caught up on surveys, it is trying to get back to a regular biennial schedule, explained Nucifora. For example, if a clinical laboratory was due for its CLIA survey in March 2020, but because of the pandemic it was not surveyed until July 2020, the next biennial survey will be in March 2022.
Future Impact on Inspections
All the representatives from the accrediting agencies believe the changes to the CLIA survey process made due to COVID-19 will continue to impact inspections. Nucifora believes virtual surveys will likely continue to some extent for the foreseeable future.
Surveyors also will be enforcing a relatively new CLIA requirement that all clinical laboratories report results of SARS-CoV-2 to their state health agency. TDR
Contact Kathy Nucifora at firstname.lastname@example.org; Heather Hurley at email@example.com; Denise Driscoll at firstname.lastname@example.org.