Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 6/6/24 at Michael J Freeman, a clinical laboratory in Ocala, Florida. Michael J Freeman was found not in compliance with Code of Federal Regulations (CFR), Part 493, requirements for clinical laboratories D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and staff interview, the laboratory failed to maintain documentation to verify accuracy of the reading and interpretation of the Hematoxylin and Eosin (H&E) stain at least twice annually in 2023. The findings include: Review of the document titled "Moh's Microscopic Surgery (MMS) Consultation/Peer Review Record" showed peer review was documented 8/2023. There was no other documentation indicating the review was performed twice annually. On 6/6/24 at 11: 10 AM, the Practice Manager confirmed the second peer review documentation was missing. 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 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 -- 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 address where the histopathology reading (testing) was performed in 2023 and 2024. Findings Included: Review of the document titled "Mohs Flowsheet/Operative Report" showed the patient reports had the incorrect laboratory address. On 6/6/24 at 10:45 am., the Practice Manager confirmed the patient test reports did not have the correct laboratory address for the reading/testing location. -- 2 of 2 --