Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5805 TEST REPORT CFR(s): 493.1291(c) (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 final reports and confirmed in interview, the laboratory failed to include the testing facility address on the laboratory report for 12 of 12 patients in 2025 (random review January-May). Findings included: 1. A random review of patient histopathology and cytology final reports from January through May 2025 revealed the following 12 patient final reports which did not include the testing facility address: 01/28/2025 Patient case#: BN25-44 03/06/2025 Patient case#: BN25- 115 04/17/2025 Patient case#: BR25-601 04/08/2025 Patient case#: BR25-615 05/01 /2025 Patient case #s: BN25-246, BR25-679 05/07/2025 Patient case#: BR25-727 05 /12/2025 Patient case#: BR25-757 05/16/2025 Patient case#: BR25-783 05/19/2025 Patient case#: BR25-795 05/20/2025 Patient case#: BR25-800 05/21/2025 Patient case#: BR25-809 2. During an interview on 06/06/2025 at 10:45 a.m., the laboratory representatives after a review of records, confirmed the above findings. 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 --