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 histopathology reports and an interview with laboratory director (LD) #1, the histopathology patient reports failed to list the name and address of the laboratory that performed the microscopic examination of the slide(s) with evaluation and diagnostic interpretation and diagnostic findings from August 1, 2022, to August 1, 2024. Findings: 1. A review of histopathology reports lacked the name and address of the laboratory that conducted the microscopic examination of the slide(s) with histopathology interpretation and diagnostic findings. 2. A review of the test menu revealed that 9431 histopathology tests were performed from August 1, 2023, to August 1, 2024. 3. An interview on August 1, 2024, at 11:30 AM with LD #1 confirmed the histopathology reports failed to include the name and location of the laboratory responsible for the microscopic examination and diagnostic interpretation from August 1, 2022, to August 1, 2024. 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 --