Ortonville Area Health Services

Summary Statement of Deficiencies D0000 The Ortonville Area Health Services laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the recertification survey completed on February 6, 2025. The following standard-level deficiencies were cited: 493.1253 Establishment and verification of performance specifications . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) (b) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (b)(1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (b)(1)(i) (A) Accuracy. (b)(1)(i)(B) Precision. (b)(1)(i)(C) Reportable range of test results for the test system. (b)(1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to complete required performance verification (PV) activities for 1 of 45 analytes implemented in the laboratory in 2023. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the Technical Consultant 1 (TC1) during a tour of the laboratory at 1:07 PM on 2/5/25. 2. An Ortho Vitros 7600XT Chemistry analyzer was observed as present and available for use during the tour. The laboratory performed Procalcitonin (PCT) testing using this analyzer beginning on 9/19/2023. 3. PV documentation for Chemistry testing on the Ortho Vitros 7600XT analyzer found in the System Verification manual included accuracy, precision, and reportable range verification for PCT. Reference range verification documentation for PCT was not found. The laboratory was unable to provide the missing documentation upon request. The Laboratory Director approved PV activities 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 -- on 9/18/2023. 4. The laboratory was required to verify reference ranges for new analytes during PV activities as established in the New Test Requirements procedure found in the Lab Standard Operating Procedures and Policies manual. 5. In an interview at 9:31 AM on 2/6/2025, TC1 confirmed the above findings. 6. In an email received at 8:32 AM on 2/13/2025, TC1 indicated 389 PCT tests were performed on patient samples since 9/19/2023. . -- 2 of 2 --

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: . Based on observation, record review, and an interview with laboratory personnel, the laboratory failed to evaluate and document the relationship between two Chemistry testing methods at least twice annually in 2022. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by General Supervisor (GS) during a tour of the laboratory at 1:45 p.m. on 01/26/2023. 2. The following Chemistry methods for Basic Metabolic Panel (BMP) testing were observed as present and available for use during the tour: Siemens Dimension EXL- primary method iSTAT Chem-8+ - back up method 3. A twice annual process for comparison of test results obtained from multiple non-waived methods was found in the laboratory's procedure: Comparison of Test Results - Ortonville, signed by the Laboratory Director 12/15/2022. 4. Comparison of test results obtained from the two Chemistry methods was not found in laboratory records for 2022. The laboratory was unable to provide documentation of test comparisons upon request. 5. In an interview at 12:01 p.m. on 01/27/23, the GS confirmed the above finding. The GS indicated it was not done due to the fact they did not test any patients on the back-up method, however it was available for use as the laboratory's back-up chemistry analyzer during the 2022 year. . 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 --