Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was generated as a result of the onsite CLIA recertification survey conducted at your facility on April 8, 2025. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state or local laws. 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 a review of patient reports and electronic health records, patient result data, a review of the director approved laboratory policies, and an interview with the director of nursing and technical consultant, the laboratory failed to ensure that critical values were identified and reported appropriately. Findings include: 1. A random review of patient reports and result data from October 2023 through March 2025, found that the laboratory failed to document that critical values were correctly identified, the physician was notified, and that the physician acknowledged the critical values for two of nine patients reviewed. 2. Patient #1 with a date of service of January 16, 2024 had a pO2 of 27 mmHg. The critical value for pO2 as documented on the report form is less than 43 mmHg. There was no documentation completed in the area of the of the report stating, "**Panic value was read-back by physician or receiver for verification purposes: (Document first and last name of physician or receiver of panic value time/date called)." There were no additional notes in the patient's electronic health record to indicate notification and acknowledgement of the critical value. 3. Patient #2 with a date of service of February 6, 2025 had a pO2 of 34 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 -- mmHg. The critical value for pO2 as documented on the report form is less than 43 mmHg. There was no documentation completed in the area of the of the report stating, "**Panic value was read-back by physician or receiver for verification purposes: (Document first and last name of physician or receiver of panic value time/date called)." There were no additional notes in the patient's electronic health record to indicate notification and acknowledgement of the critical value. 4. A review of the director approved policy titled "Quality Assessment" found that the policy stated, "All critical values are immediately reported to the ordering physician. The notification date, time, and readback, must be documented, including who was notified and who notified the physician." 5. An interview with the director of nursing and the technical consultant at approximately 3:30 PM on April 8, 2025, confirmed these findings. The laboratory performs approximately 163 routine chemistry tests annually. -- 2 of 2 --