Summary:
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 laboratory's policies and procedures, and interviews with the office manager (OM) and laboratory assistant (LA); the laboratory failed to have and follow written and approved laboratory safety procedures to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to have a written Safety plan and procedures based on the laboratory's risk assessment to provide protection from physical, chemical, biochemical, and biohazardous materials as needed. 2. Surveyor observed during the laboratory tour that no eye wash station or eye wash portable bottle kit was found in the testing area. The fire extinguisher was located in an area not readily accesible to the laboratory. 3. The laboratory did not have a biological or chemical spill kit in the laboratory area where the Mohs procedure is performed. 4. The OM and LA. affirmed by interview on July 15, 2026, at approximately 1:30 p.m that the laboratory did not have a written and laboratory director approved, signed, and dated Safety Plan based on a risk assessment and lacked an eye washing station and a chemical spill kit in the laboratory area. 5. The safety of laboratory testing personnel could not be assured at this time. 6. The annual testing declaration form submitted at the time of the survey stated 100 samples were processed and reported for Dermatopathology during the time when safety concern for all testing personnel could not be assured. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- 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 review of the laboratory's proficiency testing (PT) peer review documentation from the year 2023 through 2026, six (6) patients test results, and interviews with the office manager (OM) and laboratory assistant (LA) on July 15, 2026; the laboratory failed to verify the accuracy of tests not included in Subpart I at least twice annually, as required by 42 CFR 493.1236(c). The findings included: 1. The laboratory failed to perform PT (peer review) for both the dermatopathologist performing histopathology slide reading and diagnosis and the Mohs surgeon diagnosis for half of the year 2023, and the years 2024, 2025, and for the past 6 months of the year 2026. 2. The OM and LA confirmed by interview on July 15, 2026, had no accuracy verification (peer review) was performed as stated in statement 1. 3. There was no