Summary:
Summary Statement of Deficiencies D5813 TEST REPORT CFR(s): 493.1291(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: Through a review of the laboratory panic value policy, a review of the hematology instrument datalog and patient medical records, lack of documentation, and interviews with laboratory staff, it was determined the laboratory failed to document that the healthcare provider was notified of panic values. Survey findings include: A. The laboratory panic value policy states that a White Blood Cell count (WBC) less than 4.0 and greater than 20.0 should be treated as panic values. The policy further states "for all above panic values contact doctor immediately and follow doctor's orders." B. Three of three panic value results, observed on the instrument datalog, failed to document that the policy was followed. The medical record of Patient #48704 does not document that the provider was immediately notified of the patient's WBC result of 3.12 on 10/18/2023. The medical record of Patient #58019 does not document that the provider was immediately notified of the patient's WBC result of 3.25 on 10/25 /2023. The medical record of Patient #95182 does not document that the provider was immediately notified of the patient's WBC result of 21.87 on 02/29/2024. C. In an interview at 12:24pm on 5/9/2024, the technical consultant confirmed the lack of documentation that the panic value policy had been followed and the patients healthcare provider had been notified in three of three patients with panic values reported. 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 --