Volume 36 Number 5 | October 2022
Andrea Prinzi PhD, MPH, SM(ASCP)
I had the pleasure of interviewing Dr. Carol Rauch, MD, PhD, adjunct associate professor of pathology, microbiology, and immunology at Vanderbilt University School of Medicine, and an active College of American Pathologists (CAP) committee member, about the CAP process for inspecting and accrediting clinical labs. For those who have undergone the inspection process, preparations can feel daunting. Additionally, inspection-associated anxiety might be higher for clinical microbiology labs since CAP has implemented new checklist items requiring microbiology labs to be aware of the antimicrobial susceptibility testing (AST) breakpoints they are using and to get obsolete breakpoints updated within three years of their publication date. The clinical and regulatory processes around AST breakpoints can be complex. As a result, clinical microbiologists may be confused about what is needed or required for managing breakpoint updates to pass a CAP inspection successfully.
Although it can feel overwhelming, the CAP inspection process and the requirement for labs to update their AST breakpoints are essential public health measures that ensure optimal quality, safety, and patient care. With the right resources and support, clinical labs can successfully perform the tasks necessary to pass a CAP inspection and support better patient care. In this interview, Dr. Rauch explains the CAP inspection process and provides information on what labs will expect as they update AST breakpoints.
Dr. Prinzi: Dr. Rauch, can you explain the process CAP undertakes for updating inspection checklist items? What inspires these changes? Who is typically involved in this process?
Dr. Rauch: The CAP Laboratory Accreditation Program benefits from feedback from inspection team members, team leaders, and the labs that have undergone inspection. A team of technical specialists manages questions that arise during an inspection or at any other time, whenever a concern arises that needs clarification. This team communicates with other staff members at CAP who are affiliated with accreditation, as well as with subject matter experts who are on the scientific committees. Ideas for revision, retirement, or the creation of checklist items can come from any of these sources. Changes in requirements are based on active issues in the field, such as new methods and technology, the regulatory environment, and the experiences of committee members and colleagues. A lot goes into gathering and updating resources for participant labs as well. New or revised items are fed into a process of review and editing that involves vetting by the Checklist Committee (of which I am a current member), request for comment by members of other committees and the user community, different stages of review, and ultimately CMS approval (Centers for Medicare and Medicaid Services).
Dr. Prinzi: Is there formal training offered by CAP to laboratorians who are chosen to perform CAP inspections?
Dr. Rauch: Yes, there is formal training for inspection team members and inspection team leaders. I have taken both training courses multiple times over the years, and I always learn something new. These courses are well-prepared, updated annually, and offer CME/CE credit. Inspections are typically very busy days, so anything that helps focus attention and makes an inspector more prepared and efficient helps the process go smoothly. It is a wonderful overview for those new to this process, and the information benefits an inspector’s home laboratory.
“I firmly believe in the value of peer inspections for protecting patient safety and improving quality by having someone with similar experience and qualifications come to your laboratory.”
Dr. Prinzi: AST breakpoint updates are a hot topic right now! This can be quite challenging for labs, and many people are looking for guidance. Can you speak about what CAP expects to see from labs that are updating their AST breakpoints? Let’s start with documentation. Is there a preferred structure for documentation of validation or verifications (i.e., any templates or guidance documents out there that are preferable for review)?
Dr. Rauch: There is a lot of discretion afforded to the medical director of the laboratory regarding the number of isolates to test, how to go about the study, and how to format data presentation; these elements are not directly addressed in CLIA regulations. CAP inspectors do not require any specific format as long as the documentation is clear on what was done and what was found. That said, however, guidance is available for labs struggling with how to proceed. One resource that I find particularly useful is from the APHL-ASM Antimicrobial Resistance Laboratory Workgroup, which provides a step-by-step guide for doing these studies on carbapenems for Enterobacterales.1 This resource reviews how to obtain isolates from the CDC/FDA AR Isolate Bank, and it has templates for data collection and analysis. I think this evolved from prior efforts of the California Department of Public Health, which was the work of Janet Hindler and her colleagues. Other resources from CLSI, CAP, and more are on the way. The lab first needs to see whether a panel they are using has the correct dilutions to address a breakpoint that has been revised (usually by lowering it) and whether the manufacturer has issued a software update to accommodate this change. If so, the lab can proceed to implement those changes. If not, they may have to consider a panel, manufacturer, or method change for that drug, or consider sending it out for testing at a reference laboratory. Remember that these results typically cross several interfaces and seeing the final patient report is a part of the process that leads to the right outcome. Testing the organisms is just a piece of making the changes to impact patient care and infection prevention.
Dr. Prinzi: How will inspectors determine if a lab uses obsolete or updated breakpoints?
Dr. Rauch: Inspectors generally review the lab’s documentation and occasionally cross-reference with outside sources of information. For labs to achieve compliance with the revised checklist item MIC.11380 (knowing what breakpoints are being applied), they will be going through their systems to identify what breakpoints they are using for testing particular organisms and drugs, documenting that review, and using it to assess whether these breakpoints have any current validity according to FDA, CLSI, EUCAST, or in rare instances a locally determined breakpoint. To do this review, labs will often have to contact the manufacturer of a commercially available AST system. When documenting the source of a breakpoint, it is essential to include the year or version of a document such as CLSI M100-S31 (2021). After this work, a lab may have found one or more breakpoints that are not currently recognized, and they may have to prioritize what they need to do about it. These choices are best made with input from pharmacy and infectious disease clinical partners. Additional options besides validation/verification include:
- Suppressing the result.
- Using an alternative test method.
- Sending the isolate to a reference laboratory.
Dr. Prinzi: Should labs be able to demonstrate that they have a process in place for a yearly review of breakpoints?
Dr. Rauch: Yes, there should be records of annual review by the laboratory and their relevant stewardship partners (if applicable). As always, patient reports, protocol, and proficiency testing results must match. As part of bringing up to date some of the lab’s testing, these partners will need to understand the anticipated impact on patient care and antibiograms. With lowered breakpoints, the laboratory may have higher rates of resistance found in its results, and it would be good not to have everyone surprised by changes. Annual review and discussion will help to manage change.
Dr. Prinzi: In general, how are inspection teams chosen?
Dr. Rauch: Peer labs are chosen to be relatively matched for the size and scope of services offered, so there is some variety for team and lab pairings regarding inspection assignments. Sometimes an inspecting team needs a specialty inspector and can find one from a database maintained by the CAP. The team is usually mostly from one facility, and the team will include section directors, supervisors, bench techs, pathology/laboratory medicine residents, and fellows. It is ideal to pair seasoned, experienced inspectors with those who have never done it before so they can have some mentoring about the process. The team size is monitored by CAP staff so that a reasonable number of “inspector days” can cover what is needed without overburdening the laboratory being inspected.
Dr. Prinzi: Is there anything else you think is essential for laboratorians to know about the CAP inspection process?
Dr. Rauch: It is great to remember that we are all in this together. An inspector is just another set of eyes on your processes, someone who has taken time away from their work and families to observe the alignment of your systems, practice, and documentation with the intent of the inspection checklist items. They can only observe what is available for review, and there is a fair amount of follow-up to address whatever needs attention. I firmly believe in the value of peer inspections for protecting patient safety and improving quality by having someone with similar experience and qualifications come to your laboratory. Overall, this is an amazingly effective system and a positive experience with shared learning.
Rarely, someone takes a citation of a deficiency as an affront to their ego, and they can over-react. Also, sometimes a lab manager’s performance incentives are tied to inspection outcomes and receiving a citation can affect their pay. While this is well-intentioned by laboratory leadership, it can lead to missing the point of an opportunity to think differently and improve patient care with a different approach. We all need to remember that it’s not judgment being rendered at a summation conference; it is just an inspection stage that proceeds to further evaluation (including perhaps challenges to deficiencies). Labs must balance a sincere intent to perform well with being open to new ideas and receiving feedback that comes with this process. The purpose, according to CAP, is “to improve laboratory performance through objective evaluation and constructive criticism.” No matter the outcome for any participant, they can count on this being an opportunity for improvement, and our patients need us to focus on that.
- Association of Public Health Laboratories. CRO Implementation Toolkit. https://www.aphl.org/programs/infectious_disease/Pages/CRO-Breakpoint-Implementation-Toolkit.aspx
Andrea Prinzi works as a Medical Science Liaison for bioMérieux, Inc.