Summary:
Summary Statement of Deficiencies D0000 An initial certification survey was conducted on August 9, 2022. Advanced Gastroenterology of Central Florida 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 record review and interview, the laboratory failed to include name and address of the laboratory where the professional component was performed for four (#2, #3, #4, #5) of five patients' gastrointestinal (GI) pathology reports, (#1, #2, #3, #4, #5). Findings: Review of patients' "GI Histology Report" showed the name and address of the laboratory where the professional component was performed was not listed on four (#2, #3, #4, #5) of five patient reports reviewed, (#1, #2, #3, #4, #5). According to the Clinical Laboratory Improvement Amendment (CLIA) Application for Certification, signed and dated by the Laboratory Director on 08/09/2022, the laboratory had an annual test volume of 1,500 tests. On 08/09/2022 at 11:32 AM, the Laboratory Director stated he did not know why the name and address of the laboratory where the professional component was performed disappeared from the reports. 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 --