Summary:
Summary Statement of Deficiencies D0000 An onsite survey conducted 06/16/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 laboratory test records and confirmed in an interview the laboratory failed to include the laboratory address on patient final reports for 15 of 15 reports that were verified for accuracy from September 2022 to November 2022. The findings included: 1. In an interview on 6/16/2023 at 10:10 hours, in the record review room, the laboratory director stated that they received histopathology slides and reports from offsite to review for interpretation accuracy. The LD would review the slides and provide an electronic signature on the patient's final report verifying the histopathology results. A review of the following laboratory test reports did not include the laboratory address where histopathology slide interpretation was verified for accuracy: Received for verification September 26, 2022: ADG22-20202 ADGS22- 83424 ADG22-21306 ADG22-20201 ADG22-20922 Received for verification October 20, 2022: ADG22-22113 ADG22-23524 ADG22-23104 ADG22-23702 ADG22-23694 Received for verification November 7, 2022: ADG22-25225 ADG22- 26774 ADG22-26410 ADG22-26406 ADG22-26761 2. In an interview on 6/16/2023 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- at 10:14 hours, in the record review room, the laboratory director confirmed that the address of the laboratory, where patient results were reviewed and verified for accuracy, was not included in the patient's final report. -- 2 of 2 --