Summary:
Summary Statement of Deficiencies D5813 TEST REPORT CFR(s): 493.1291(g) (g) The laboratory must immediately alert the individual or entity requesting the test and, if applicable, the individual responsible for using the test results when any test result indicates an imminently life-threatening condition, or panic or alert values. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, review of patient test records from August 2025 and September 2025, and staff interview, the laboratory failed to have documentation of the notification of 7 of 7 critical values. The findings included: 1. A review of the laboratory's policy titled "Critical Values" (signed by the laboratory director on 11/21/2020)determined: "The laboratory Personnel will immediately notify the requester or user about lab results in the 'Critical Value' or 'Panic Range'." The policy defined 'Critical Value' as: WBC: less than 2.0 or greater than 20.0 HGB: less than 7.5 or greater than 18 HCT: less than 25 or greater than 55 PLT: less than 50 or greater than 800. 2. A review of the laboratory's policy titled "Reporting Critical Values" (signed by the laboratory director on 12/21/2020) determined: "It is the policy of this laboratory to document the reporting of critical values. Document: - who was notified - when the person was notified - by who was the person notified." 3. A review of patient test records from August 2025 and December 2025 identified 7 patient results which met the laboratory's criteria as a 'Panic Value'. The test date, patient identification numbers, and results were: August 20, 2025 ID: 39830 WBC: 40.7 August 29, 2025 ID: 45352 HCT: 23.5 August 29, 2025 ID: 39830 WBC: 25.8 August 31, 2025 ID: 44607 PLT: 31 September 8, 2025 ID: 39690 HCT: 23.6 September 10, 2025 ID: 41110 HCT: 24.4 September 30, 2025 ID: 9678 HCT: 55.1 3. The technical consultant confirmed the findings in an interview conducted on 01/13/2026 at 11:30 hours in the break room. Key WBC - white blood cell HCT- hematocrit HGB - hemoglobin PLT - platelet 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 --