Summary:
Summary Statement of Deficiencies D0000 This Statement of Deficiencies was created as a result of an on-site initial CLIA certification survey conducted at your facility on February 23, 2026. The findings and conclusions of any investigation by the Division of Healthcare Purchasing and Compliance 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. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratorys and, as applicable, the manufacturers test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a random patient audit of four patients tested between the dates of August 25, 2025 and January 23, 2026, a review of the i-STAT Chem 8+ quality control records, and an interview with the office manager and the technical consultant, the laboratory failed to ensure that