Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on surveyor observation, review of laboratory environmental logs, Centers for Medicare and Medicaid Services (CMS)-116 form, and confirmed in interview with staff, the laboratory failed to have a system in place to ensure Mohs patient slides were maintained under proper preservation conditions for 337 of 337 days in 2023 and 2024 (05/08/2023-04/09/2024). Findings included: 1. During a tour of the facility on 04/09/2024 at 1:15 PM, two boxes of previous patient slides were observed stored in an employee office. There was no mechanism observed to monitor patient slide storage conditions in the office. The surveyor requested documentation of environmental monitoring in the employee office to ensure preservation of patient slides, and none was provided. 2. Review of laboratory environmental logs from 2023 and 2024 revealed no documentation of the employee office environment in which patient slides were stored. 3. Review of CMS-116 form submitted at time of survey, 04 /09/2024, revealed the laboratory began patient testing on 05/08/2023 and performed 800 Mohs patient tests annually. 4. During an interview on 04/09/2024 at 1:16 PM, the laboratory regulatory compliance director confirmed the laboratory failed to have a system in place to ensure Mohs patient slides were maintained under proper preservation conditions for 337 of 337 days in 2023 and 2024 (05/08/2023-04/09 /2024). D5781