Summary:
Summary Statement of Deficiencies D0000 Cancer Specialists Llc was found not to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a initial survey on 12/12/2024. 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 staff interview, the laboratory failed to ensure the patient's final test report included the name of the laboratory for 3 of 3 patient test reports reviewed. Findings include: Review of 3 sampled patient test reports showed the name of the laboratory as "Cancer Specialists of North Florida". The CLIA certificate laboratory name is documented as "Cancer Specialists Llc". During the interview with the laboratory manager on 12/12/24 at 12:30pm, it was stated that Cancer Specialists Llc is doing business as (DBA) Cancer Specialists of North Florida. She confirmed the test report had the name of the DBA and not what was on the CLIA certificate. 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 --