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 policy and procedures, and interviews with the team lead (TL); it was determined that the laboratory failed to have and follow written safety procedures for the laboratory to ensure protection from physical, chemical, biochemical, and biohazardous materials. The findings include: 1. The laboratory failed to provide at the time of the survey May 12, 2026, safety policy and procedure to provide protection from physical, chemical, biochemical, and biohazardous materials as needed based on a laboratory's risk assessment. 2. The TL affirmed by interviews on May 12, 2026, at approximately 12: 30 p.m., that the laboratory did not have a written and approved safety plan for the laboratory. 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 3,200 samples were processed and reported for Dermatopathology laboratory tests, including the time when the laboratory failed to follow safety procedures. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on the surveyor's review of ten (10) patients' Mohs procedure testing records including log-in documents, Mohs notes, mapping, final reports, slides, and an interview with the office manager (OM) and team lead (TL); the laboratory failed to follow established policies and procedures to ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. The findings include: 1. The surveyor reviewed ten (10) patient records for the Mohs procedure and Histopathology reports. For three (3) out of ten (10) patient reports reviewed discrepancies were found as follows: a. For a patient Mohs performed on 09/16/2025 the slides show a state II, mapping also indicated Sate II. However, notes only describe Stage I in the final report. b. Two (2) patients samples processed for Mohs on two different dates 7/25/ 2025 and 10/31/2025, slides reviewed indicate Toluidine Blue stain was used for the diagnosis. The Mohs notes description of the stages of Basal Cell Carcinoma describe Hematoxylin and Eosin (H&E) stain as used for the diagnosis. No H&E-stained slides were found. 3. The OM and TL affirmed by interviews on May 12, 2026, at approximately 12:45 p.m. that records were discrepant as described in 1.a. and b. and were missed from performing