Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5805 TEST REPORT CFR(s): 493.1291(c) (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 review of patient Mohs maps and confirmed in interview, the laboratory failed to include the testing facility address on the patient Moh's maps for six of six patients in 2024 (random review December) and seven of seven patients in 2025 (random review March). Findings included: 1. A random review of patient Mohs maps from December 2024 and March 2025 revealed the following 13 patient Mohs maps which did not include the testing facility address: 12/16/2024 Mohs Case #s: JFP-009, JFP-010 12/23/24 Mohs Case #s: JFP-011, JFP-012 12/30/24 Mohs Case #s: JFP-013, JFP-014 03/24/2025 Mohs Case #s: JFP-024, JFP-025, JFP-026 03/31/2025 Mohs Case #s: JFP-027, JFP-028, JFP-029, JFP-030 2. During an interview on 04/07 /2025 at 11:03 a.m., the laboratory representatives, after a review of records, confirmed the laboratory failed to include the testing facility address on the patient Moh's maps. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --