Summary:
Summary Statement of Deficiencies 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 record review and interview with Clinical Supervisor (CS), the laboratory failed to include laboratory name and address on the patient test report for 6 (#1- #6) of 6 patient test reports reviewed: 1. A record review of 6 patient test reports revealed that the laboratory name and address was not listed for the following patients: a. Patient 1 received histopathology testing on 10/04/2024. b. Patient 2 received histopathology testing on 11/01/2024. c. Patient 3 received histopathology testing on 12/06/2024. d. Patient 4 received histopathology testing on 01/03/2025. e. Patient 5 received histopathology testing on 02/07/2025. f. Patient 6 received histopathology testing on 03/07/2025. 2. An interview with CS on 03/19/2025 at 11:45 am confirmed the laboratory name and address was missing from the patient test reports. 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 --