Summary:
Summary Statement of Deficiencies 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 observation of the laboratory, review of final patient test reports and staff interview, the final patient test report failed to include the name and address of the laboratory where the final diagnosis was rendered for three of three reports reviewed for gynecologic cytology in 2023. The findings include: 1. Observation of the laboratory area on 09.11.23 at 8:15 am revealed microscopes in use for reading slides for cytopathology. 2. Review of patient test reports revealed that the name of the laboratory where the final diagnosis for gynecologic cytology was rendered was not included on the final patient test report for three of three reports reviewed (accession #s CP23-000174, CP23-000176, CP23-000172). 3. Interview with the lab director on 09/11/23 at 10:45 am confirmed the survey findings. 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 --