Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on October 22, 2019. South Florida Urology Center Inc clinical laboratory was found 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 interview, the laboratory's patient reports failed to list the name and address of the laboratory where the technical component was performed for 5 out of 5 patients (1, 2, 3, 4, and 5). Findings: Review of the "FISH and Non-GYN Cytology Report" for patient 1, 2, 3, 4, and 5 showed that the laboratory's name and address where the technical component was performed was not listed on the reports. During an interview on 10/22/19 at 3:57 PM, the Laboratory Consultant acknowledged that the patient reports did not have the name and address of where the technical component was performed. 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 --