Vera Dermatology

Summary Statement of Deficiencies D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on the surveyor's observations during the laboratory tour, review of the policy and procedures, and interviews with the staff; it was determined that the laboratory failed to follow safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to follow their safety policy and procedure to provide protection from physical, chemical, biochemical, and biohazardous materials as needed based on the laboratory's risk assessment. 2. The surveyor observed during the laboratory tour that no eye wash station nor eye wash portable bottle kit was found in the testing area. 3. The staff affirmed by interviews on September 11, 2025, at approximately 11:40 a.m., that the laboratory lacked an eye washing station. 4. The safety of laboratory personnel cannot be assured at this time. 5. The annual testing declaration form submitted at the time of the survey stated 200 samples were processed and reported for Dermatopathology including the time when the laboratory failed to follow safety procedures. D5821 TEST REPORT CFR(s): 493.1291(k) (k)When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's quality assessment (QA) policy and procedure, randomly chosen patient test records, and interviews with the laboratory staff (LS); it was determined that the laboratory failed to maintain duplicates of original report. The findings include: 1. The surveyor reviewed five patient test records for Dermatopathology dated from November 23, 2023, to August 21, 2025. One record was missing, specifically for LW06091943, examined on September 30, 2024, where the Mohs map record could not be found. 2. It was the practice of the laboratory to scan and upload the Mohs map in the electronic medical charting system and original files are not retained. 3. A review of the QA policy and related documentation showed that there was no

Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on the lack of the laboratory's Mohs reports peer review, review of six (6) randomly chosen histopathology patient's reports, review of submitted laboratory forms, and interviews with the laboratory's office staff (OS) on AUGIST 16, 2023; it was determined that the laboratory failed to verify, at least twice annually, the accuracy of its histopathology tests for the years 2022 and 2023. The findings included: 1. The laboratory could not provide documentation showing that it had verified its histopathology Mohs tests' accuracy for the years 2022 and 2023 for the dermatopathologist performing slide reading and providing patients' diagnosis. Therefore, the accuracy of the laboratory's test results for patients' histopathology procedures, cannot be assured. 2.