Summary:
Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) (b)(2)(i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (b)(2)(ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on the surveyor's review of the laboratory's policy and procedure, preventive maintenance (PM) documentation, ten patient records, and interviews with the practice manager (PM), regional director (RG) and interim director of operations (IDO), it was determined that the laboratory failed to ensure performed tests and function checks were documented or maintained prior to patient testing. The findings include: 1. The laboratory performed Mohs micrographic skin cancer surgeries and used an external Mohs technician company for processing wherein both the doctor and technician were responsible for documenting all phases of testing. 2. The surveyor reviewed ten patient records and found the following discrepancies: a. 6/20/2023 surgery date was missing an entry on the cryostat temperature affecting Patient 23- 084. Further review of the patient log revealed that a total of seven patients including Patient 23-084 underwent surgeries on the same date. b. 6/11/2025 surgery date had no entry for the stain preventive maintenance affecting Patient 25-075 from reviewed records. 3. The PM, RG and IDO affirmed by interviews on January 7, 2026, at approximately 10:45 a.m. that the preventive maintenance entries were overlooked during the daily quality assessment check. 4. According to the testing declaration form submitted at the time of the survey, the laboratory performed and reported approximately 355 Dermatopathology cases annually, which included the period when errors in the preventive maintenance occurred as mentioned in this deficiency. 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 -- 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 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 practice manager (PM), regional director (RG) and interim director of operations (IDO), it was determined that the laboratory failed to address errors in patient records prior to finalizing reports. The findings include: 1. The surveyor reviewed ten randomly selected patient test records for Dermatopathology dated from June 20, 2023, to November 14, 2025 and one out of ten had a mismatch of patient information from several documentation checked such as the patient log, electronic chart notes, Mohs map, and slides. 2. There was a lack of