Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at Leavitt Medical Associates of Florida Inc. dba Advanced Dermatology & Cosmetic Surgery on 03/03/2022. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the location manager, the laboratory failed to include the name of the laboratory where the testing was performed for 4 out of 4 operative (op) reports reviewed. Findings Included: Review of patient reports pulled on 07/09/2021, 09/24/2021, 11/10/21, and 01/31/2022 revealed none of the reports included the name of the laboratory where the testing was performed. The corresponding micrographically oriented histographic surgery (Mohs) map for each patient included the name of the laboratory but did not contain an address. Record review of the laboratory's policy "Mohs Laboratory Quality Assessment" revealed: "On a quarterly basis, the Histotechnician or Director of Laboratory Operations will review ten (10) percent of cases during the previous quarter. This process will include pulling the patient charts, the Mohs log, and slides. They will be checked to make sure that the op-report, map, Mohs log and slides are accurate. If there are any 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 -- discrepancies, it will be noted on the Quarterly QA form and