Froedtert Community Hospital - Oak Creek

Summary Statement of Deficiencies 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 surveyor review of American Proficiency Institute (API) proficiency testing (PT) records and interview with the laboratory director, the laboratory did not evaluate the accuracy for five of five "Not Graded" PT results for the Pathfast D- dimer assay in 2022 and 2023 Findings include: 1. Review of API PT records showed API entered "Not Graded" for two of five D-dimer results in event 3 in 2022, two of five D-dimer results in event 1 in 2023 and one of five results in event 3 in 2023. Further review showed no documentation the laboratory evaluated the accuracy of the D-Dimer PT for the five "Not Graded' results. 2. Interview with the laboratory director on December 19, 2023, at 10:15 AM confirmed the laboratory did not evaluate the accuracy of "Not Graded" PT results for the Pathfast D-dimer assay in 2022 and 2023. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Item 1 Based on surveyor observation of the Abbott I-Stat reagent cartridges and interview with the technical consultant, testing personnel did not label ten of ten I-Stat cartridges with the shortened room temperature expiration date. Findings include: 1. Observation of the Abbott I-Stat cartridges bin on December 19, 2023, at 11;55 AM revealed ten cartridges, Lot# H23291, original expiration date of April 15, 2024, were being stored at room temperature. Further observation showed the cartridges were acceptable for use for two weeks after being placed at room temperature and the stamp on one cartridge stated the new expiration date was January 2, 2023, while the stamp on the rest of the cartridges was illegible. 2. Interview with the technical consultant on December 19, 2023, at 11:58 AM, confirmed testing personnel did not label the I-Stat cartridges with the shortened expiration date after being placed at room temperature. Item 2 Based on surveyor observation of the chemistry quality control (QC) material and interview with the technical consultant, testing personnel did not label four of four opened QC vials with the shortened open expiration date. Findings include: 1. Observation of the BioRad chemistry QC in the laboratory refrigerator on December 19, 2023, at 12:00 PM revealed four vials of quality control, two levels of BioRad D-Dimer QC and two levels of Cardiac Marker QC, in a bin available for use. The vials showed an opened date of 12/19 without a year and showed no revised expiration date. Further observation of the bin showed the D- Dimer QC was acceptable for use for fifteen days after open and no indication how long the Cardiac Marker QC was acceptable for use after being opened. 2. Interview with the technical consultant on December 19, 2023, at 12: 05 PM confirmed the Cardiac Marker QC is acceptable for use for five days after open. Further interview confirmed testing personnel did not label the QC vials with the shortened expiration date after they were opened. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Item 1 Based on surveyor review of maintenance records and interview with the laboratory director, testing personnel did not document daily maintenance on the Abbott i-Stat chemistry analyzer for thirty of one hundred eighty-four days from March 1, 2023 through August 31, 2023. Findings include: 1. Review of the maintenance logs for the Abbott i-Stat chemistry analyzer showed no documentation of daily maintenance on the following days in 2023: March: 1, 2, 3, 4, 15, 18, 23, 30 April: 19, 26, 27, 29 May: 15, 23, 24, 28 June: 6, 7, 8, 10, 20, 21, 22, 24 July: 5, 19, 20, 22, 24 August: 1 2. Interview with the laboratory director on December 19, 2023, at 11:35 AM, confirmed testing personnel did not document daily maintenance on the Abbott i-Stat chemistry analyzer for each day of use. Item 2 Based on surveyor review of maintenance records and interview with the laboratory director, testing personnel did not document daily maintenance on the Sysmex XN330 hematology analyzer for seven of one-hundred twenty days from January 2023 through April 2023. Findings include: 1. Review of the maintenance logs for the Sysmex XN330 hematology analyzer showed no documentation of daily maintenance on the following days in 2023: January: 1, 3, 4 March: 2, 3, 23 April: 22 2. Interview with the laboratory director on December 19, 2023, at 11:35 AM, confirmed testing personnel did not -- 2 of 3 -- document daily maintenance on the Sysmex XN330 hematology analyzer for each day of use. This is a repeat deficiency from June 8, 2022. -- 3 of 3 --

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations (42 CFR Part 493, effective April 24, 2003). No deficiencies were cited. 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 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on surveyor observation of test systems, review of testing records and records in the WEDSS (Wisconsin Electronic Disease Surveillance System) database, and interview with the laboratory director, the laboratory did not report SARS CoV-2 test results for 155 patient tests performed between March 24 and June 17, 2022 using the Lucira Check It test system. Findings include: 1. Observation of the laboratory on June 8, 2022 at 9:00 AM revealed the laboratory performs SARS CoV-2 tests using the Lucira Check It test system which uses a molecular amplification technology for the detection of SARS-CoV-2 viral RNA. 2. A search of the WEDSS database on June 13, 2022 for two randomly identified patients (Patient 1 and 2) revealed no record of the SARS CoV-2 tests performed on these two patients in April 2022. 3. Email from the laboratory director on June 17, 2022 at 12:23 PM confirmed the laboratory started testing for SARS CoV-2 on March 24, 2022 and performed 155 SARS CoV-2 tests between March 24 and June 17, 2022. Email from the laboratory director on June 20, 2022 at 5:32 PM confirmed the laboratory did not report SARS CoV-2 test results to the Wisconsin health department. 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 D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on surveyor review of maintenance records and interview with the technical consultant, testing personnel did not document completing the monthly maintenance on the PathFast analyzer during four of four months from February to May 2022. Findings include: 1. Review of maintenance logs for the PathFast analyzer showed the routine monthly maintenance included: *Wipe the outside of the instrument with a damp towel, *Wipe the piercing nozzle edges with ethanol, *Clean the tip holder surface and wells with ethanol, *Power down and self-check. Review of the logs from February to May 2022 showed testing personnel documented wiping the outside of the instrument with a damp towel on March 30, 2022. No other documentation of monthly maintenance is present on the logs. The technical consultant initialed and dated the maintenance logs documenting their review but included no