Sanford Jackson Medical Center

Summary Statement of Deficiencies D0000 The Sanford Jackson Medical Center 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 performed on October 24, 2024. The following standard-level deficiency were cited: 493.1253 Establishment and verification of performance specifications . D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (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 ensure three of four reviewed Chemistry reportable ranges obtained during twenty measured analyte performance verifications (PV) were adopted by the laboratory in 2024. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 10/24/24. 2. An Abbott i-STAT blood analysis system and an Abbott Architect ci41000 chemistry analyzer were observed as present and available for use during the tour of the laboratory. A. Abbott i-STAT 1. PV activities for i-STAT CG4+ (3 measured analytes), Chem8+ (9 measured analytes), and Troponin (1 measured analyte)cartridges were completed in August 2024 for a replacement i-STAT system as indicted in records found in the New i-STAT 2024 folder. The Laboratory Director approved the PV's on 08/22/24. The CG4+ data for 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 -- measured analytes pH, pCO2, and pO2 was reviewed in depth during the survey. 2. The upper and/or lower reportable range limits adopted by the laboratory for 2 of 3 measured analytes in the CG4+ cartridge did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in PV records and the Laboratory Test List . See below. Analyte Obtained Adopted pCO2 18.50-94.20 15- 110 pO2 46.00-404.00 15-450 3. The laboratory's New Method Verification Procedure for FDA Approved Non-Waived Assays found in the policy and procedure manager PolicyTech did not provide guidance on the adoption of the manufacturer's analytical measurement range (AM) when obtained values did not meet or exceed the AMR. 4. In an interview at 2:15 p.m. on 10/24/24., the GS confirmed the above finding and indicated the manufacturer's AMR for the analytes had been adopted. B. Abbott Architect ci41000 1. PV activities for the following analytes were completed in 2024 as indicted in individual folders for each analyte: Acetaminophen (ACE) Alanine Transaminase Aspartate Aminotransferase Lactic Acid Total Protein Uric Acid Phosphorus The Acetaminophen data was reviewed in depth during the survey. The Laboratory Director approved this PV on 05/16/24. 2. The upper and/or lower reportable range limits adopted by the laboratory for ACE did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in PV records and the Laboratory Test List . See below. Analyte Obtained Adopted ACE 11- 354 3-377 3. In an interview at 4:45 p.m. on 10/24/24., the GS confirmed the above finding and indicated the manufacturer's AMR for Acetaminophen had been adopted. -- 2 of 2 --

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure Chemistry and Coagulation reference intervals were consistent between procedures, reference range tables, and patient test reports. Findings are as follows: A. Chemistry - Arterial Blood Gases 1. The laboratory performed Chemistry testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory at 7:05 a.m. on 12/08/22. 2. An Abbott i-STAT chemistry system was observed as present and available for use during the tour of the laboratory. The laboratory included the following analytes in the arterial blood gas test performed on this analyzer: pCO2 - Partial pressure of Carbon Dioxide pO2 - Partial pressure of Oxygen HCO3 - Bicarbonate BE - Base Excess sO2 - Oxygen Saturation pH - Potential of Hydrogen 3. Reference intervals listed in the i-STAT Procedure Manual procedure and the Sanford Jackson Medical Center Laboratory Test List spreadsheet, both located in the laboratory's electronic chemistry procedures folder, were not consistent with each other and/or those included on a patient test report (Female - 71 yrs) from 04/21/22 reviewed on date of survey as indicated below. Analyte Procedure Spreadsheet Report pH 7.35-7.45 7.37-7.44 7.37-7.44 pO2 80-100 85-100 85-100 HCO3 24-28 21-28 24-28 4. In an interview at 11:20 a.m. on 12/08/22, the TS confirmed the above finding. B. Chemistry - Basic Metabolic Panel 1. The laboratory performed Chemistry testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory at 7:05 a.m. on 12/08/22. 2. An Abbott i-STAT chemistry system was observed as present and available for use during the tour of the laboratory. The laboratory included the following analytes in the Basic Metabolic Panel 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 -- performed on this analyzer: Na - Sodium K - Potassium Cl - Chloride BUN - Blood Urea Nitrogen Glu - Glucose Crea - Creatinine TCO2 - Total Carbon Dioxide 3. Reference intervals listed in the i-STAT Chem 8+ Basic Panel - Jackson procedure and the Sanford Jackson Medical Center Laboratory Test List spreadsheet, both located in the laboratory's electronic chemistry procedures folder, were not consistent with each other and/or those included on a patient test report (Female - 75 years) from 05/03/22 reviewed on date of survey as indicated below. Analyte Procedure Spreadsheet Report Na 135-145 136-148 136-148 K 3.5-5.3 3.6-5.0 3.6-5.0 Cl 99-110 98-106 98-106 BUN 6-22 8-23 8-23 Glu 70-100 70-105 70-105 Creat Age &Sex* 0.8- 1.2 0.8-1.2 TCO2 23-32 23-33 23-33 * Age & Sex Creatinine reference intervals values table not found 4. In an interview at 11:20 a.m. on 12/08/22, the TS confirmed the above finding. C. Coagulation - Pro Time / INR 1. The laboratory performed Coagulation testing as confirmed by the Technical Supervisor (TS) during a tour of the laboratory at 7:05 a.m. on 12/08/22. 2. A Stago Satellite system was observed as present and available for use during the tour of the laboratory. 3. Reference intervals listed in the Sanford Jackson Medical Center Laboratory Test List spreadsheet, located in the laboratory's electronic procedures folder, were not consistent with those on a patient test report (Male - 76 yrs) from 09/15/22 reviewed on date of survey as indicated below. ProTime / INR - Prothrombin Time / International Normalized Ratio Analyte Procedure Spreadsheet Report ProTime Not given 8.8-12.9 12.0-14.5 INR Not given 0.89-1.29 0.9-1.1 4. In an interview at 12:40 p.m. on 12/08/22, the TS confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D2010 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(2) The laboratory must test samples the same number of times that it routinely tests patient samples. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure Hematology proficiency testing (PT) samples from 1 of 6 Hematology PT events completed in 2019 and 2020 were tested consistent with the number of times the laboratory routinely tested patient specimens. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:10 a.m. on 03/23/21. 2. The laboratory performed PT in 2019 and 2020 using the American Proficiency Institute (API) proficiency provider. 3. The Proficiency Testing procedure located in the General Lab Procedure Manual indicated PT samples would be tested in the same manner as patient specimens. 4. Hematology PT samples were tested on multiple days prior to the 2019 3rd event submission deadline as indicated on documents found in the API PT manual. See below. 2019 - Hematology 3rd event Submission deadline 11/25/19 Samples ABT-11 through ABT-15 Sample ID Test date Test date ABT-11 11/20/19 11 /22/19 ABT-12 11/18/19 11/22/19 ABT-13 11/14/19 11/22/19 ABT-14 11/20/19 11/22 /19 ABT-15 11/18/19 11/22/19 5. The test results submitted to API were those obtained on 11/22/19 as manually documented on the PT test result records found in the 2019 API PT manual and confirmed with the API 2019 Hematology 3rd event report. 6. In an interview at 11:10 a.m. on 03/23/21, the GS confirmed the above finding and indicated patient samples would not be handled in this manner. 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 --