Summary:
Summary Statement of Deficiencies D0000 An announced validation survey of the laboratory was completed on 04/27/2026. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. 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 patient final reports, and confirmed in interview, the laboratory failed to include the address of the testing laboratory for ten of ten patient reports randomly reviewed in April 2026. Findings include: 1. Review of the final reports determined the laboratory failed to include the address of the testing laboratory for ten of ten patient reports randomly reviewed in April 2026: a. Patient ID: 2714677 b. Patient ID: 4316649 c. Patient ID: 5101844 d. Patient ID: 5130099 e. Patient ID: 5486624 f. Patient ID: 5961884 g. Patient ID: 6216434 h. Patient ID: 6228026 i. Patient ID: 6327888 j. Patient ID: 6354826 2. Technical consultant-2 (as listed on the CMS-209 form) confirmed the findings in an interview conducted on 04/27/2026 at 1158 hours in the conference room. Key: CMS - Centers for Medicare and Medicaid Services Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, review of patient final reports, and confirmed in interview, the laboratory failed to have reference ranges for nine of nine patient reports randomly reviewed in April 2026. Findings include: 1. Review of the laboratory's policy titled "Vaginal Wet Prep" stated: "INTERPRETATION OF TEST RESULTS: ...REFERENCE RANGES: A non-pathological vaginal discharge may contain a few bacteria, normal epithelial cells, WBC's and RBC's. The "Whiff" test for amine odor is negative." 2. Review of patient final reports determined the laboratory failed to include reference ranges for ten of ten patients randomly reviewed in April 2026: a. Patient ID: 5486624 Collected: 04/21/2026 1400 hours b. Patient ID: 6354826 Collected: 04/21/2026 1434 hours c. Patient ID: 5961884 Collected: 04/21 /2026 1437 hours d. Patient ID: 6228026 Collected: 04/21/2026 1615 hours e. Patient ID: 6327888 Collected: 04/22/2026 0940 hours f. Patient ID: 2714677 Collected: 04 /22/2026 1107 hours g. Patient ID: 6216434 Collected: 04/22/2026 1133 hours h. Patient ID: 4316649 Collected: 04/22/2026 1152 hours i. Patient ID: 5130099 Collected: 04/22/2026 1515 hours 3. Technical consultant-2 (as listed on the CMS- 209 form) confirmed the findings in an interview conducted on 04/27/2026 at 1158 hours in the conference room. Key: CMS - Centers for Medicare and Medicaid Services -- 2 of 2 --