Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 21, 2024. FRANCISCO FLORES MD LLC 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 random patient reports review and staff interview, the laboratory failed to ensure that the patient report listed the name of the laboratory that performed the testing for five out of five patient's reports reviewed. Findings include: Review of five final patient reports: P#1(dated 11/04/2022), P#2 (dated 03/31/2023), P#3 (dated 10/20 /2023), P#4 (dated 03/07/2024), and P#5 (dated 09/06/2024); revealed that the reports failed to list the name of the laboratory that performed the Hematoxylin and Eosin stain testing. During an interview on 10/21/2024 at 11:30 AM, with the laboratory consultant, he confirmed that the reports reviewed did not include the name of the laboratory that performed the Hematoxylin and Eosin stain testing. 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 --