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 a review of two patient test reports and staff interview, the laboratory failed to include on the patient report the facility name and address of the laboratory where the testing was performed. Findings include: a. For biopsy slide #S18ML304 (specimen collected 10-9-18), the laboratory's final patient report contained the facility name but did not indicate the address of the laboratory location where the testing had been performed. b. For Mohs surgery performed on 12-27-18 and chart #4960, the laboratory's final patient report contained neither the facility name nor the address of the laboratory location where the testing had been performed. c. On 3-5-19 at about 2 p.m., staff stated they were unaware of these regulatory requirements, and confirmed the laboratory name and address was not included on the final patient report as required by the federal CLIA regulations. 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 --