Summary:
Summary Statement of Deficiencies D0000 An on-site announced CLIA initial survey was conducted at Lee Memorial Health System Pathology at Ameripath on 11/29/23. 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 review of patient test reports and staff interview, the laboratory failed to have the correct laboratory name where the histopathology reading (testing) location was performed for seven out of seven patient test reports reviewed. Findings Included: Review of seven patient test reports dated 05/22/2023 (x2), 07/25/2023, 07/26/2023 (x2), 07/28/2023, and 09/18/2023 revealed the patient reports had the incorrect laboratory name of the histopathology reading location. On 11/29/2023 at 03:15 PM, the Point of Care and Compliance Manager confirmed that the patient test reports did not have the correct laboratory name for the reading/testing location. 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 --