Aspirus Kronenwetter Clinic

Summary Statement of Deficiencies D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of Individualized Quality Control Plans (IQCP) and interview with the Laboratory Director, three of four current IQCPs did not specify the number and or type of external quality control required. Findings include: 1. Review of four current IQCP procedures showed references to the laboratory's required external quality controls for three IQCP were as follows: KOH (Potassium Hydroxide) IQCP: "The target level for one of the external quality control is near the medical decision cutoff point. (Positive KOH)." "This lab will perform external QC on this assay monthly; with each new lot; for each new shipment; for each newly trained testing staff." Troponin IQCP: "Level 1 control has a defined mean around 0.5 which is near the 0.3 medical decision cutoff level." "We verify the integrity of cartridges included in every shipment, upon receipt, by analyzing two levels of external controls. We also run two levels of external controls monthly." INR (International Normalized Ratio) IQCP: "The target level for one of the external quality control is near the medical decision cutoff point. Level 2 routinely runs at an INR of 2.8 - 3.2 which is the top of the normal therapeutic range." "We will run QC 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 -- monthly and with each new lot to ensure accuracy. QC results must be within the Roche established QC range before testing can proceed." The fourth IQCP identified the number and type of controls required. 2. Interview with the laboratory director on March 6, 2024, at 1:00 PM confirmed the KOH, Troponin, and INR IQCP procedures did not specify the number and or type of external controls required. -- 2 of 2 --

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 on surveyor review of calibration verification records and interview with the laboratory director, the laboratory did not perform calibration verification every six months on the Roche Cobas Integra 400 plus chemistry analyzer in 2021 and 2022. Finding include: 1. Review of calibration verification records showed calibration verification performed on the Roche Cobas Integra 400 plus chemistry analyzer on: August 6, 2020 and March 1, 2021. Calibration verification was due February 6, 2021. 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 -- July 26, 2021, and February 15, 2022. Calibration verification was due January 26, 2022. 2. Interview with the laboratory director on March 22, 2022 at 1:30 PM confirmed the laboratory did not perform calibration verification every six months on the Roche Cobas Integra 400 plus chemistry analyzer in 2021 and 2022. -- 2 of 2 --