Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 31st, 2024. Taslimi & Mirza Md Pa clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on record review and interview, the Laboratory Director failed to sign the attestation form for the Proficiency Testing (PT) for 5 events of the following specialties: Bacteriology, Chemistry and Hematology for 2023 and 2024. Findings included: 1-Review of the American Proficiency Institute (API) I PT instructions revealed the following "SIGNATURE REQUIRED- for all PT results, an attestation must be signed by the testing personnel and the laboratory director." 2-Review of the attestation forms for the 3 events of 2023 and 2 events of 2024 for the specialties of Bacteriology, Chemistry and Hematology, revealed that the signature for the Laboratory Director or designee was done by the laboratory consultant who is not included in the 209 form and did not have a designee letter. 3-During the interview on October 31st, 2024, at 03:00 PM, the laboratory consultant confirmed the Laboratory Director failed to sign the attestations 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 --