Sanford Worthington Medical Center

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 ensure two of two Chemistry reportable ranges obtained during performance verification (PV) activities completed 2022 were adopted by the laboratory. In addition, the laboratory failed to verify reference intervals for one of one Hematology (Coagulation) analytes during PV activities completed in 2021. Findings are as follows: The laboratory performed Chemistry and Hematology testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a. m. on 12/14/22. A. Chemistry 1. An Abbott Architect ci4100 chemistry analyzer was observed as present and available for use during the tour of the laboratory. The laboratory implemented Enzymatic Creatinine (CrEnz) testing on this analyzer in March 2022 as indicated by the GS during the tour. 2. PV activities were completed in March 2022 as indicated in laboratory records found in the March 2022 Enz. Creat. manilla folder. The Laboratory Director approved the PV on 03/29/22. 3. Verification of reportable range was required as established in the Laboratory Test Validation procedure found in the PolicyTech electronic procedure program. 4. The upper and/or lower reportable range limits adopted by the laboratory for CrEnz did not reflect the actual reportable range values obtained by the laboratory during the PV as indicated in the PV documents and Architect analyzer reporting limits for the analyte. See below. 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 -- Analyte PV Adopted CrEnz urine 6.35-762.91 0.0-40.0 CrEnz serum 0.2-36.19 0.0- 40.0 5. In an interview at 2:40 p.m. on 12/14/22, the GS confirmed the above finding. B. Hematology 1. A Stago Compact Max coagulation analyzer was observed as present and available for use during the tour of the laboratory. The laboratory implemented Heparin Xa testing on this analyzer in July 2021 as indicated by the GS during the tour. 2. PV activities for Heparin Xa accuracy, precision, and reportable range were completed on the Compact Max analyzer as indicated in laboratory records found in the Stago Compact Max Install manual. The Laboratory Director approved the PV with no date documented. 3. Verification of reference range was required as established in the Laboratory Test Validation procedure found in the PolicyTech electronic procedure program. 4. PV documentation did not include verification of Heparin Xa reference ranges (normal values). The laboratory was unable to provide this documentation upon request. 5. In an interview at 3:00 p.m. on 12/14/22, the GS confirmed the above finding. . D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the Technical Consultant failed to ensure comprehensive initial training, semi-annual competency assessments and annual competency assessment were performed for all testing personnel in 2021 and 2022. Findings are as follows: 1. The laboratory performed Immunology and Chemistry testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 12/14/22. 2. The following test systems or test kits were observed as present and available for use during the tour. i-STAT Troponin (back-up) Hologic TLiQ Fetal Fibronectin Amnisure ROM 3. Personnel competency evaluation encompassing all duties performed was required as established in the Competency Assessment procedure found in the PolicyTech electronic procedure program. 4. The i-STAT Troponin, Fetal Fibronectin, and Amnisure ROM tests were not included in the Self Assessment and Orientation Skills Checklist forms or Annual Competency forms completed between March 2021 and date of survey, 12 /14/22. Testing personnel (TP) were not assessed for competency on these tests. See below. 2021 - 5 of 5 tenured TP were not assessed annually 2022 - 6 of 6 new TP were not assessed initially 2022 - 1 of 1 new TP was not assessed semi-annually 5. The laboratory was unable to provide the missing training records and missing competency assessment documents upon request. 6. In an interview at 11:25 a.m. on 12/14/22, the GS 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 1 of 2 2020 calibration verification records for a Hematology (Coagulation) analyzer for at least 2 years. Findings are as follows: 1. The laboratory performed Coagulation testing as confirmed by the General Supervisor (GS) during a tour of the laboratory at 8:05 a.m. on 03/24/21. 2. A Stago STA Compact Max coagulation analyzer was observed as present and available for use during the tour of the laboratory. The laboratory began using this analyzer in June 2020 as indicated by the GS during the tour and confirmed by laboratory records. 3. Calibration verification was required every 6 months as established in the D-Dimer Worthington procedure located in the Coagulation Manual. 4. The calibration verification documents from December 2020 were not found during review of laboratory records. The laboratory was unable to provide the missing documents upon request as the original documents had not been retained and calibration records were not retrievable from the analyzer software on date of survey. 5. In an interview at 4:50 p.m. on 03/24/21, the GS confirmed the above finding. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: . Based on a review of Center for Medicare and Medicaid Services (CMS) reports, the American Proficiency Institute (API) proficiency testing reports, and the College of American Pathologists (CAP) proficiency testing reports, the laboratory failed to successfully participate in proficiency testing for pO2* testing, under the specialty of Chemistry. Findings are as follows: D2087 - the laboratory failed to obtain a PT score of at least 80 percent for pO2 testing. D2096 - the laboratory failed to achieve satisfactory analyte PT performance for pO2 testing in two out of three consecutive events. *Note pO2 - Partial pressure of Oxygen . 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 -- D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API) and the College of American Pathologists (CAP), the laboratory failed to obtain a PT score for pO2 testing of at least 80 percent which resulted in unsatisfactory performance for the analyte. Unsatisfactory PT performance of pO2 testing was obtained in the following events: - 2018 API 3rd Event: 60% - 2019 CAP 2nd Event: 60% . D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: . Based on a review of proficiency testing (PT) reports from the American Proficiency Institute (API) and the College of American Pathologists (CAP), the laboratory failed to achieve successful performance for pO2 testing in two out of three consecutive PT events. Findings are as follows: The laboratory failed pO2 testing in two out of three consecutive PT events. Two out of three consecutive PT failures for the same analyte constitutes unsuccessful performance. PT reports from API and CAP listed the following unsatisfactory pO2 scores. - 2018 API 3rd Event: 60% - 2019 CAP 2nd Event: 60% . -- 2 of 2 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)