Spooner Health System

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 surveyor review of calibration verification records, quality control (QC) records and interview with the technical consultant, the laboratory did not perform calibration verification every six months for two of two analytes on the Biomerieux Vidas 3 chemistry analyzer in 2022. Finding include: 1. Review of calibration verification records showed calibration verification performed on the Vidas 3 analyzer November 11, 2021, and November 4, 2022. Further review showed no evidence of 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 -- additional calibration verification performed for D-dimer and procalcitonin on the analyzer in 2022 when calibration verification was due on May 11, 2022. 2. Review of the "DAILY QC LOG" for the Vidas 3 showed one hundred seventeen patient testing days for D-dimer and one hundred twenty-seven patient testing days for procalcitonin between May 11, 2022, and November 4, 2022. 3. Interview with the technical consultant on January 17, 2024, at 3:34 PM confirmed the laboratory performed the laboratory did not perform calibration verification every six months on the Biomerieux Vidas 3 chemistry analyzer in 2022. D5545 HEMATOLOGY CFR(s): 493.1269(b)(d) (b) For all nonmanual coagulation test systems, the laboratory must include two levels of control material each 8 hours of operation and each time a reagent is changed. (d) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on surveyor review quality control (QC) records, U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) classification database and Individualized Quality Control Plans (IQCP) and interview with the technical consultant and testing personnel, staff A, the laboratory did not perform QC each eight hours of patient testing on the Vidas 3 D-dimer test for forty- four of one hundred fifty patient tests between October 1, 2024 and January 17, 2024, and had not developed an IQCP. Findings include: 1. Interview with staff A on January 17, 2024, at 2:20 PM stated QC was performed on the Vidas 3 D-dimer test once per 24 hours of patient testing. 2. Review of QC records for D-dimer testing on the Vidas 3 chemistry analyzer showed QC was run one time every 24 hours of patient testing from October 1, 2023 and January 17, 2024. 3. Review of the FDA CLIA classification database showed D-dimer testing on the Vidas 3 chemistry analyzer is classified as a hematology test. 4. Review of the laboratory's IQCPs showed no evidence of an IQCP for the Vidas 3 D-dimer test. 5. Interview with the technical consultant on January 17, 2024, at 2:30 AM confirmed the laboratory did not perform QC each eight hours of patient testing on the Vidas 3 D-dimer test and had not developed an IQCP. -- 2 of 2 --

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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) reports and Wisconsin State Laboratory of Hygiene (WSLH) PT records, and interview with the administrative laboratory director, the laboratory failed to successfully participate in four of six events for the Compatibility Testing subspecialty in the Immunohematology specialty in 2021 and 2020. Findings include: 1. Review of PT records in the federal CASPER reporting system as of January 20, 2022 showed the laboratory had unsatisfactory performance for compatibility testing on events one and two in 2020 and events two and three in 2021. A score of 100% is required for satisfactory performance for compatibility Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- testing. Event 2020-1, score 80% Event 2020-2, score 80% Event 2021-2, score 0% Event 2021-3, score 80% 2. Surveyor review of the WSLH PT evaluation report confirmed the unsatisfactory scores for compatibility testing for two consecutive PT events in 2021 which results in unsuccessful participation in PT for compatibility testing. 3. Surveyor review of the federal CASPER reporting system shows this is a subsequent unsuccessful PT performance and a repeat deficiency which was cited September 30, 2020. See D 2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) reports and Wisconsin State Laboratory of Hygiene (WSLH) PT records, and interview with the administrative laboratory director, the laboratory failed to successfully participate in PT for the Compatibility Testing subspecialty in the Immunohematology specialty in four of six events in 2020 and 2021. Findings include: 1. Review of PT records in the federal CASPER reporting system as of January 20, 2022 shows the laboratory had unsatisfactory performance for compatibility testing on events one and two in 2020 and events two and three in 2021. A score of 100% is required for satisfactory performance for compatibility testing. Event 2020-1, score 80% Event 2020-2, score 80% Event 2021-2, score 0% Event 2021-3, score 80% 2. Surveyor review of the WSLH PT evaluation reports confirmed the unsatisfactory scores for compatibility testing for two consecutive PT events in 2021 which results in unsuccessful participation in PT for compatibility testing. 3. Surveyor review of the federal CASPER reporting system shows this is a subsequent unsuccessful PT performance and a repeat deficiency which was cited September 30, 2020. 4. Interview with the administrative laboratory director (staff A) on January 25, 2022 at 8:45 AM confirmed the laboratory failed to successfully participate in PT for the Compatibility Testing subspecialty in the Immunohematology specialty in two events in 2021 and two events in 2020. 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)

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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) reports and American Proficiency Institute (API) PT records, the laboratory failed to successfully participate in PT for the Compatibility Testing subspecialty in the Immunohematology specialty for PT events 2020-1 and 2020-2. Findings include: 1. Review of PT records in the federal CASPER reporting system as of September 30, 2020 shows the laboratory had unsatisfactory performance for compatibility testing on events 2020-1 and 2020-2. A score of 100% is required for satisfactory performance for compatibility testing. Event 2020-1, score 80% Event 2020-2, score 80% 2. Surveyor review of the API PT 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 -- evaluation reports confirmed the unsatisfactory scores for compatibility testing for two consecutive PT events which results in unsuccessful participation in PT for compatibility testing. See D 2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 surveyor review of the federal Certification and Survey Provider Enhanced Reports (CASPER) Proficiency Testing (PT) reports and American Proficiency Institute(API) PT records, the laboratory failed to successfully participate in PT for the Compatibility Testing subspecialty in the Immunohematology specialty in events 2020-1 and 2020-2. Findings include: 1. Review of PT records in the federal CASPER reporting system on September 30, 2020 shows that the laboratory had unsatisfactory performance for compatibility testing on events 2020-1 and 2020-2. A score of 100% is required for satisfactory performance for compatibility testing. Event 2020-1, score 80% Event 2020-2, score 80% 2. Surveyor review of the API PT evaluation reports on September 30, 2020 confirmed the unsatisfactory scores for compatibility testing for two consecutive PT events which results in unsuccessful participation in PT for compatibility testing. -- 2 of 2 --

Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency test (PT) records and interview with the general supervisor, the laboratory director or a qualified designee did not attest to the routine integration of the samples into the patient workload using the laboratory's routine methods for six of six immunohematology events in 2018 and 2019. Findings include: 1. Review of American Proficiency Institute (API) immunohematology PT records showed the laboratory director, who is the immunohematology technical supervisor, did not sign six of six attestation statements in 2018 and 2019. 2. Interview with the general supervisor on February 5, 2020 at 11:22 AM confirmed the laboratory director or a qualified designee did not sign immunohematology events in 2018 and 2019. 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 surveyor review of proficiency testing (PT) records from four events in 2018 and 2019, laboratory procedures, and interview with the general supervisor, testing personnel repeated the antibody screen for six of twelve samples with negative 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 -- antibody screen results while patient samples with negative antibody screen results were not repeated. Findings include: 1. Review of immunohematology PT records for all events in 2018 and event one of 2019 revealed twelve samples had negative antibody screens. Further review showed the antibody screen on the following six samples was repeated by a second testing person: a. 2018-1: Ser-02 and Ser-05 b. 2018-2: Ser-09 c. 2018-3: Ser-14 d. 2019-1: Ser-01 and Ser-04 The testing records do not indicate a reason for the repeated analysis. 2. Review of the "MTS Antibody Screen" procedure under "Interpretation of Results" revealed testing personnel do not repeat negative antibody screen testing. 3. Interview with the general supervisor on February 5, 2020 at 11:35 AM confirmed testing personnel repeated negative antibody screens for proficiency testing when patient negative antibody screens are only tested once. 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: Item 1: Based on surveyor review of performance verification records for the STAT Site M beta-hydroxybutyrate analyzer and interview with the general supervisor, the laboratory did not verify the precision or reference intervals for this test system prior to performing patient testing. Findings include: 1. Review of performance verification records for the STAT Site M showed no evidence the precision and reference intervals were evaluated prior to testing patient samples. 2. Interview with the general supervisor on February 5, 2020 at 3:28 PM confirmed the laboratory did not evaluate precision and reference intervals prior to testing patient samples. Item 2 Based on surveyor review of performance verification records for the STAT Site M beta- hydroxybutyrate analyzer and interview with the general supervisor, the laboratory did not document review and evaluation of the verification data prior to performing patient testing. Findings include: 1. Review of the performance verification records for the STAT Site M showed no evidence the laboratory reviewed and evaluated the data prior to testing patient samples. 2. Interview with the general supervisor on February 5, 2020 at 3:28 PM confirmed the laboratory did not have documentation the performance verification was reviewed and evaluated prior to testing patient samples. -- 2 of 2 --