Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 07/15/2025. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with chief executive officer, chief nursing officer, director of quality managerment, and the respiratory/laboratory manager during an exit conference performed at the conclusion of the survey. D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3)-- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on a review of records and interview with the respiratory/laboratory manager, the laboratory failed to perform calibration verification procedures at least once every six months for the Gem Premier 3500 Blood Gas test system during the review period 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 -- of January 2024 through the current date. Findings include: (1) On 07/15/2025 at 09: 30 am, the respiratory/laboratory manager stated the laboratory performed Blood Gas (pH, pCO2, pO2) testing using the Gem Premier 3500 analyzer; (2) A review of records from 01/01/2024 through the current date identified no evidence the calibration verification procedures had been performed for each analyte prior to 10/15 /2024; (3) The findings were reviewed with the respiratory/laboratory manager, who stated on 07/15/2025 at 10:15 am, the calibration verification procedures had not been performed every six months as stated above. -- 2 of 2 --