Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted from 10/16/2023 to 10/19/2023 found the DERMATOLOGY GROUP OF FLORIDA, PA clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3041 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(6) Test reports. Retain or be able to retrieve a copy of the original report (including final, preliminary, and corrected reports) at least 2 years after the date of reporting. (i) In addition, retain immunohematology reports as specified in 21 CFR 606.160(d) (ii) and pathology test reports for at least 10 years after the date of reporting. This STANDARD is not met as evidenced by: Based on record review and interview with risk office manager, the laboratory failed to provide onsite final report for one out of five patients reviewed for 2022 and 2023. Findings included: Review of patient log and patient slides for 2022 and 2023 for patients (I, II, III, IV and V) revealed that the laboratory failed to provide final report for patient V. During a phone conversation on 10/19/2023 at 12:35 PM, the risk office manager confirmed that she cannot provide the copy for the final report for the patient of reference. 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 --