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 review of patient test reports and interview with the laboratory director, the laboratory failed to include on the test report the laboratory address where the testing was performed. Findings include: 1. The laboratory began patient testing in the subspecialty of histopathology in September 2020, with an approximate annual test volume of 1,000. 2. The test reports reviewed during the survey (TN22-172645, TN21- 178105 and TN20-157153) were missing the laboratory address where the testing was performed. 3. The laboratory director confirmed that the laboratory address where the diagnosis was made was not indicated on the patient test reports issued by the laboratory. 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 --