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 test report review and interview with staff, the laboratory test report failed to include the location of the laboratory performing gross analysis testing for 12 of 12 test reports reviewed. Findings include: 1. The laboratory test report included a gross analysis test result for tissue specimens received for OSW17-2848, OSW17-2854, OSW17-2981, OSW17-2984, OSW18-0058, OSW18-0057, OSW18-0390, OSW18- 0392, OSW18-0614, OSW18-0620, OSW18-0781, and OSW18-0782. 2. In an interview conducted with laboratory staff on 04/02/2018 at approximately 5:00 P.M. staff stated gross analysis testing was performed off-site at the same laboratory that processed the specimens and made the slide for histopathology interpretation. 3. The test report did not include the location of the laboratory that performed gross analysis testing. 4. In an interview conducted on 04/02/2018 at approximately 5:45 P.M., laboratory staff confirmed the final test report did not state the gross analysis test location. 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 --