CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Anupama K. Sharma, MD, MHA
May 2021—As COVID-19 restrictions ease, many laboratories are ramping up for biennial CAP inspections. Some of these inspections were delayed due to COVID restrictions and others were performed virtually and now must complete the statutory requirement of an on-site inspection. To add to the mix, the CAP published its 2020 checklist edition earlier than usual because of its impending reapplication with the CMS for deeming authority as an accrediting organization under CLIA. Together, these have made the 2021 inspection process appear unusually daunting. While no laboratory is immune to inspection anxiety, it does help to arm oneself with the knowledge gathered from the collective experiences of peers and colleagues across the country. Knowing what the common inspection pitfalls are can bring us a step closer to the “utopia” of a flawless inspection.
Based on the information gathered from inspection data in 2018, 2019, and 2020 (partial), establishing the workload policy for manual screening of cytology slides (CYP.08500) remained the most frequently cited phase two deficiency in the cytopathology laboratory. This individual maximum workload and its documentation addresses the final CLIA ’88 rule that requires personnel who evaluate cytologic samples by manual technique to examine no more than 100 slides (gynecologic or nongynecologic or both) in a 24-hour period.1 In cases where there are additional state regulations for cytology workload limits, the most stringent of these regulations must be followed to establish the said workload.
To clarify the count, gynecologic slides include new routine slides, 10 percent rescreen slides, and five-year look-back negative slides. Primary screening of nongynecologic liquid-based slide preparations requires each slide to be counted as one-half slide for the purpose of workload recording, provided that cells are dispersed over one-half or less of the total available slide area. For primary screening of all other slide types (including gynecologic liquid-based preparations, FNA, and others), each slide must be counted as a single slide for the purpose of workload recording. These guidelines are designed to optimize sensitivity and accuracy rather than numeric productivity.2,3
In situations where employees screen less than eight hours at an individual laboratory, the workload is prorated according to the following formula: number of hours spent screening × 100/8 (maximum workload being completed in no less than an eight-hour workday). This is particularly relevant to screening personnel, who assist in or perform adequacy assessment of fine-needle aspiration smears or rapid on-site evaluation (ROSE). While ROSE is not considered primary cytology screening as such, the time spent performing adequacy assessments is used to prorate the maximum number of slides an individual can screen in a 24-hour period. To be compliant, stringent records of a tally showing the total number of slides examined by everyone during each 24 hours must be maintained along with time spent on ROSE and other cytopreparatory activities.3
A pitfall in this regard is the workload assessment for pathologists who screen previously unscreened gynecologic slides and previously unscreened nongynecologic slides (including FNA slides). CLIA ’88 requires laboratories to adhere to and record the aforementioned workload limit similarly for pathologists. For pathologists, this limit does not include previously screened reactive/repair, atypical, premalignant, and malignant gynecologic slides, rescreened five-year look-back slides, 10 percent rescreen of negative gynecologic slides, and prior screened nongynecologic slides including FNA slides.3