Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on October 14, 2024. PERFECTFEETCARE INC clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 staff interview, the laboratory report failed to list the laboratory name and address for the Mycology test listed in the report since the laboratory started testing in June 2024 Findings Include: -Review of test menu listed in the Form CMS-116 signed bby the laboratory director on 10/11/2024, revealed that the laboratory performed tests in the Histology specialty, interpretation of the following stains: Hematoxylin and Eosin, Periodic Acid & Schiff (PAS) and Grocott - Gomori's-methenamine silver (GMS). -Review of 3 patient reports revealed that 2 out of 3 reports have a result for Mycology added in an addendum, the addendum failed to list the name and address of the laboratory that performed the Mycology test. -The laboratory has performed 700 tests since testing started in June. During an interview on 10/14/2024 at 10:30 AM, the laboratory consultant confirmed that the reports of the laboratory failed to include the name and address of the laboratory that performed the Mycology tests 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 --