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 surveyor review of four patient reports signed out by a Micrographic Surgeon (Staff A) and the CMS (Centers for Medicare and Medicaid Services) ASPEN (Automated Survey Process Environment) database, and interview with the Laboratory Director, four of the four reports showed Staff A performed the testing under CLIA certificate number 52D1040623, a terminated certificate. Findings include: 1. Review of four random patient test reports for micrographic surgeries Staff A performed between November 1, 2023, and March 20, 2024, showed the CLIA certificate number shown on the reports was 52D1040623. 2. Review of records in the ASPEN system showed the termination of CLIA certificate 52D1040623 was effective April 15, 2022 after a request for termination was received from the laboratory. 3. Interview with the Laboratory Director on March 27, 2024, at 10:00 AM confirmed the reports showed an incorrect CLIA number for testing performed by Staff A. 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 --