Granite County Medical Center

Summary Statement of Deficiencies D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on record review and interview with the Laboratory Director (LD) #1, the laboratory failed to enroll in an HHS-approved proficiency testing program for Clostridium difficile (C. difficile) antigen and toxin from January 8, 2023, to January 8, 2025. Findings: 1. A review of the Test Volume Report revealed 15 TechLab C. diff Quick Check Complete tests were performed from January 8, 2024, to January 8, 2025. (12 months). 2. A review of 2023 and 2024 American Proficiency Institute (API) testing program records lacked documentation of proficiency testing for C. difficile antigen and toxin. 3. An interview on January 8, 2023, at 10:22 AM with the LD#1 confirmed the laboratory failed to enroll in an HHS-approved proficiency testing program for C. difficile antigen and toxin from January 8, 2023, to January 8, 2025. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 calibration records for Siemens Dimension Xpand and Siemens Dimension EXL 200 chemistry analyzer for analytes Sodium, Potassium, Chloride and interview with the Testing Personnel (TP) #1, the laboratory failed to perform at least a three point (a minimal, mid-point, and maximum) calibration verification every six months for years 2019 and 2020. Findings: 1. Review of 2019 and 2020 calibration records for Siemens Dimension Xpand chemistry analyzer and for Siemens 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 -- Dimension EXL 200 chemistry analyzer for analytes Sodium, Potassium, Chloride, revealed the laboratory failed to perform a calibration verification including, at least, a minimal, midpoint, and maximum value for each analyte, every six months for years 2019 and 2020. 2. Interview with the TP #1 on June 29, 2021 at 10:30 AM, confirmed the laboratory failed to perform at least a three point calibration verification for analytes Sodium, Potassium, Chloride on the Siemens Dimension Xpand and Siemens Dimension EXL 200 chemistry analyzer every six months for years 2019 and 2020. -- 2 of 2 --