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 record review and an interview with the Laboratory Director and the Office Manager (OM), the laboratory failed to indicate the address of the laboratory location where the tissue biopsy grossing procedures were performed on the final test report. Findings include: 1. Review of three out of three of laboratory's 2018 final patient test reports did not find the correct laboratory address of the location where the tissue biopsy grossing procedures were performed, beginning 01/22/2018. The final test reports indicated the address of the previous laboratory location where tissue biopsy grossing procedures were performed. 2. The Laboratory Director and OM confirmed the laboratory did not indicate the correct address of the laboratory location where the tissue biopsy grossing procedures were performed on the final test report. The OM stated the supply of new letterhead printer paper had not been received as of the date of the inspection and no other amendments (manual or electronic) were made to the final test reports. The interview occurred on 04/10/2018 8:55 AM. 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 --