Summary:
Summary Statement of Deficiencies D0000 The recertification survey was performed on 07/12/2022. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the general supervisor and senior tech at the conclusion of the survey. 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 a review of patient reports and interview with the general supervisor and senior tech, the laboratory failed to ensure patient test reports included the name and address of each laboratory location performing interpretations for 2 of 2 patient reports. Findings include: (1) On 07/12/2022 at 10:45 am, the general supervisor and senior tech stated the following: (a) Chromosome analysis was performed using the ASI Imaging software in the Oklahoma City location; (b) The Oklahoma City laboratory counted and documented the interpretation of ten cells per patient case and Integrated Genetics, the main laboratory in North Carolina, counted and documented the interpretation of ten cells. The case was then signed out from the North Carolina location. (2) A review of patient reports revealed they did not include the name and address to reflect the portion of the interpretation that had been performed at the Oklahoma City location for two of two reports: (a) Peripheral Blood Karyotype reported on 07/05/2022 (b) Peripheral Blood Karyotype reported on 07/08/2022 (3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- The reports were discussed with the general supervisor and senior tech. Both stated on 07/12/2022 at 11:10 am, the Oklahoma City location performed a portion of the interpretations and the reports did not include the name and address of this location. -- 2 of 2 --