Summary:
Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (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 upon review of calibration verification records and review of the laboratory's policies and procedures, the laboratory failed to perform calibration verification activities that included a minimal value near the lower limit of the laboratory's reportable range as well as a maximum value near the upper limit of the laboratory's reportable range for 2 of the 16 analytes performed on the ACE Axcel Chemistry 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 -- analyzer. Findings: Review of the September 2023 calibration verification records for alkaline phosphatase and sodium performed on the ACE Axcel Chemistry analyzer revealed the following: 1. Five concentrations of linearity material were used to assess the reportable range of alkaline phosphatase - Levels A, B, C, D and E. Replicates of these samples exhibited the following approximate means respectively: 7.3 IU/L, 315.7 IU/L, 611.3 IU/L, 846.3 IU/L, 1005.3 IU/L. 2. Five concentrations of linearity material were used to assess the reportable range of sodium - Levels A, B, C, D and E. Replicates of these samples exhibited the following approximate means respectively: 81.1 mmol/L, 105.8 mmol/L, 131.5 mmol/L, 162.7 mmol/ L, 190.0 mmol/L. Review of the laboratory's "ACE Axcel Chemistry Analyzer" policy reveals a chart in section "VI. Documentation." The chart includes a linear range for each analyte performed on the analyzer. A review of the chart revealed the following: 1. The chart listed a linear range of 9-1400 IU/L for alkaline phosphatase. When calibration verification is performed, Level E is approximately 1005.3 IU/L. The laboratory is not using a value near its upper limit for alkaline phosphatase. 2. The chart listed a linear range of 40- 205 mmol/L for sodium. When calibration verification is performed, Level A is approximately 81.1 mmol/L. The laboratory is not using a value near its lower limit for sodium. -- 2 of 2 --