Saunders Medical Center

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor tour of the laboratory, lack of documentation, and interview with the laboratory supervisor, the laboratory failed to have maintenance documentation from 2024 and 2025 on five out of five centrifuges in use. Findings are: 1. Tour of the laboratory on 11/6/2025 at 11:26 AM revealed the laboratory had five centrifuges in use. 2. The laboratory did not have documentation of maintenance from 2024 and 2024 on the five centrifuges in use. 3. Interview with the laboratory supervisor on 11/6 /2025 at 11:26 AM, confirmed the laboratory did not have documentation of centrifuge maintenance at time of survey. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: 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 -- Based on review of patient's laboratory test reports and interview with the laboratory supervisor the laboratory failed to have the test report date on two out of two patient's laboratory test reports reviewed. Findings are: 1. Review of the two patient's laboratory test reports from 10/30/2025 and 11/14/2025 revealed the report did not include the test report date. 2. Interview with the laboratory supervisor on 11/6/2025 at 12:10 PM, confirmed the patient's laboratory test reports did not include the test report date. -- 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 review of laboratory's procedure, review of calibration records, lack of calibration verification records, and an interview with the general supervisor the laboratory failed to perform calibration verification every six months for the electrolytes tested on the chemistry instrument. Findings are: 1. The laboratory's procedure for Dimension EXL 200 indicates "A 3-point cal verification is required every 6 months for Na/K/Cl." 2. Review of calibration records for the 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 -- instrument in use revealed only two point calibrations for sodium, potassium and chloride. 3. The laboratory failed to provide documentation of calibration verification performed on the electrolytes tested on the chemistry instrument for 2020 and 2021. 4. Interview with the general supervisor on 10/12/2021 at 12:17 PM, confirmed the required calibration verifications for these analytes had not been performed every six months for 2020 and 2021. -- 2 of 2 --