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 histology final patient reports and interview with the testing person (TP), the laboratory did not ensure that the final test report listed the name and address of the laboratory performing the grossing of the tissue that was collected for slide preparation at another location. Findings: 1. The laboratory that was being surveyed is a satellite office that used the same laboratory information system (LIS) as the main hospital. 2. According to the TP, certain specimens were collected and grossed at the satellite office and then sent to the main laboratory for slide preparation and interpretation. At 10:15 AM, the TP pulled patient reports from the computer system for review. Patient reports from the grossing laboratory were reviewed and it was determined that the final reports included only the name and address of the main laboratory and not the grossing laboratory. 3. During the survey on 05/06/22 at 12:45 PM, the quality assurance staff confirmed that the LIS did not ensure that the correct address of the grossing laboratory was included on the final report. 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 --