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 a review of patient test reports and an interview with the laboratory lead on 10/23/2024, the laboratory failed to clearly indicate the address of the performing laboratory for each reported test. The findings include: 1. A review of 18 laboratory patient reports for histopathology and cytology testing identified that the laboratory failed to clearly indicate the address of the performing laboratory for each component of testing for 18 of 18 test reports. 2. An interview with the laboratory lead on 10/23 /2024 at 2:30 pm confirmed that the patient testing report did not indicate the location where testing occurred. 3. The laboratory reports performing 2,624 tests annually. 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 --