River's Edge Hospital

Summary Statement of Deficiencies D0000 . The River's Edge Hospital 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 on December 5, 2024. The following standard-level deficiencies were cited: 493.1105 Retention requirements 493.1235 Personnel Competency Assessment Policies 493.1236 Evaluation of proficiency testing performance (a), (b)(2) 493.1251 Procedure Manual 493.1291 Test report 493.1451 Technical supervisor responsibilities (b)(7), (b)(8) . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to retain proficiency testing (PT) records for at least 2 years in 2022 and 2023. Findings are as follows: 1. The laboratory performed Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:45 a. m. on 12/04/2024. 2. The laboratory performed Hematology PT using the American Proficiency Institute (API) provider. 3. The following API PT documentation was not present in laboratory records on dates of survey. The laboratory was unable to provide these documents upon request. 2022 - 3rd Hematology/Coagulation event 2023 - 2nd Hematology/Coagulation 2nd event 4. In an interview at 10:10 a.m. on 12/05/2024, the GS confirmed the above finding. . D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- consultant competency. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to ensure the Technical Supervisor (TS), Technical Consultant (TC), and General Supervisor (GS) received a competency assessment in 2023 which included the specific TS, TC, and GS position responsibilities listed in Subpart M. Findings are as follows: 1. The laboratory performed Microbiology, Immunology, Chemistry, Hematology, and Immunohematology testing as confirmed by the GS during a tour of the laboratory at 10:45 a.m. on 12/04/2024. 2. The following analyzers, devices, and test systems were observed as present and available for use during the tour: Microscan Autoscan-4 - organism identification and sensitivity Bactec 0950 - blood culture Cepheid GeneXpert - molecular diagnostics Ortho Diagnostics Vitros 5600 - routine chemistry and immunology Radiometer ABL80 - blood gas analysis Sysmex XN-550 - complete blood count and automated differential ACL Top 300 - coagulation analysis Ortho Diagnostics Gel Test System - Immunohematology test system Microscopes for microscopic examination and manual differential Quidel Quickvue Serum HCG test kit Biorad Tox/See toxicology screening test kit 3. A TS, TC, and GS competency assessment was not found during review of 2023 laboratory personnel records. The laboratory was unable to provide the missing competency assessments upon request. 4. A TS, TC, and GS competency assessment procedure was not found in PolicyStat, the laboratory's policy management software. 5. In an interview at 12:40 p.m. on 12/04/2024, the GS confirmed the above finding. . D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to investigate one unacceptable Chemistry proficiency testing (PT) result out of fifteen challenges completed in 2023. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 10:45 a.m. on 12/04/24. 2. The laboratory performed PT using the American Proficiency Institute (API) proficiency testing provider. 3. The laboratory received one unacceptable PT result of fifteen CO2 testing challenges completed in 2023 as indicated in API reports. See below. 2023 - 2nd Chemistry core event Test: CO2 Sample: CH-09 Laboratory result: 17 API expected result: 24-37 4. Unacceptable result investigation and evaluation was required as established in the laboratory's Evaluating Proficiency Testing Results procedure found in PolicyStat, the laboratory's policy management software. 5. Investigation documentation for the unsuccessful CO2 score was not found in laboratory records. The laboratory was unable to provide evidence of PT result investigation and

Summary Statement of Deficiencies 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 verify 57 of 57 reference intervals (normal ranges) were appropriate for the laboratory's patient population during two of two new analyzer performance verification (PV) activities completed in 2021. Findings are as follows: 1. The laboratory performed Chemistry and Virology testing as confirmed by General Supervisor 2 (GS2) during a tour of the laboratory at 9:40 a.m. on 11/17/22. 2. Two Ortho Clinical DiagnosticsVitros 5600 analyzers were observed as present and available for use during the tour of the laboratory. The laboratory began testing on the two Vitros 5600 analyzers on 1/05/22 as confirmed by an email received by GS2 at 2: 08 p.m., on 11/18/22. 3. PV activities on the Vitros 5600 analyzers were performed in June 2021 as indicated on laboratory records found in the Vitros 5600 System Verification manuals. The normal range verification documentation for 57 analytes tested on the Vitros 5600 analyzers was not found in laboratory records. The laboratory was unable to provide this documentation upon request. 4. In an interview at 3:05 p.m. on 11/17/22, GS2 confirmed the above finding and stated the normal range verification has been in progress since 1/05/22 and the verification has not been completed. 5. In an email received at 12:09 p.m. on 11/23/22, GS2 indicated approximately 50,600 tests were performed annually on the Vitros analyzers. 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 -- D5805 TEST REPORT CFR(s): 493.1291(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: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure Histopathology test result reports included the name and address of the laboratory location in 2022. Findings are as follows: 1. The laboratory performed frozen sections under the subspecialty of Histopathology as confirmed by General Supervisor 2 (GS2) during a tour of the laboratory at 9:40 a.m., on 11/17/22. 2. The laboratory began performing frozen sections on 10/24/22, as indicated in laboratory records. 3. The name and address of the laboratory location, Rivers Edge Hospital, 1900 N. Sunrise Dr., St. Peter, MN 56082, was not included on the frozen section interoperative consultation test report dated 10/24/22, reviewed on the day of survey 11/17/22. 4. The laboratory performed one frozen section annually as indicated on the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification, Form CMS-116, provided by the laboratory on the date of survey. 5. In an interview at 4:30 p.m. on 11/17/22, GS2 confirmed the above finding. . -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: . Based on observation, document review and interview with laboratory personnel, the laboratory failed to retain calibration records for a Chemistry analyzer. Findings are as follows: A. Calcium 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/27/18 at 10:05 a. m. 2. An Abbott Architect ci4100 Chemistry analyzer was observed as present and available for use during the tour. 3. The Architect Serum / Urine Calcium Instruction for Use, and the Chemistry Department Calcium procedure, indicated that calibration of the Calcium assay is required by the manufacturer to be performed every 30 days. 4. Review of the Calcium Cal Curve Summary Report revealed that documentation of calibrations performed between 9/14/2017 (with reagent lot = 82307UN16) and 5/7 /2018 (with reagent lot = 80658UN17) were missing. The laboratory was unable to provide the missing records upon request. 5. In an interview on 11/28/2018 at 11:00 a. m., GS1 indicated that the calibrations had been performed, but that the instrument database had not properly retained entries of such. B. Total PSA 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/27/18 at 10:05 a.m. 2. An Abbott Architect ci4100 Chemistry analyzer was observed as present and available for use during the tour. 3. The Architect Total PSA Instruction for Use, and the Chemistry Department Total PSA procedure, did not provide a requirement for the frequency of PSA calibrations. 4. Review of the Total PSA Cal Curve Summary Report revealed that documentation of calibrations performed between 6/27/2017 (with reagent lot = 7003FN00) and 7/5 /2018 (with reagent lot = 82044FN00) were missing. The laboratory was unable to 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 -- provide the missing records upon request. 5. In an interview on 11/28/2018 at 11:00 a. m., GS1 indicated that the calibrations had been performed, but that the instrument database had not properly retained entries of such. . D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-graded proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/27/18 at 10:05 a.m. 2. The laboratory performed PT using the American Association of Bioanalysts (AAB) as PT provider. 3. The laboratory received non-graded results from AAB due to no consensus for the events and tests listed below. Event = 2017 - Chemistry - Quarter 2 Sample ID = Specimen #5 Test = Troponin Event = 2017 - Chemistry - Quarter 3 Sample ID = Specimens #1 & #2 Test = Urine Amylase Event = 2018 - Chemistry - Quarter 2 Sample ID = Specimen #1 Test = Urine Total Protein Event = 2018 - Non Chemistry - Quarter 1 Sample ID = Specimens #4 & #5 Test = Anti Hepatitis B Surface Antigen 4. An evaluation of the non-graded PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 11/27/18 at 12:30 p.m., GS1 confirmed the above findings. . D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of non-graded proficiency testing (PT) results. Findings are as follows: 1. The laboratory performed Chemistry testing as confirmed by the General Supervisor 1 (GS1) during a tour of the laboratory on 11/27/18 at 10:05 a.m. 2. The laboratory performed PT using the American Association of Bioanalysts (AAB) as PT provider. 3. The laboratory received non-graded results from AAB due to no consensus for the event and test listed below. Event = 2017 - Non Chemistry - Quarter 1 Sample ID = Specimens #2 & #5 Test = Rheumatoid Factor 4. An evaluation of the non-graded PT results was not found during review of laboratory records. The laboratory was unable to provide evaluations upon request. 5. In an interview on 11/27/18 at 12:30 p.m., GS1 confirmed the above findings. -- 2 of 2 --