Froedtert & Mcw Moorland Reserve Laboratory

Summary Statement of Deficiencies D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with a technical consultant, the laboratory had not developed a system that evaluated and defined the relationship between test results using the iSTAT test system and the Roche chemistry analyzers for six of six analytes the laboratory reported from the two test systems. Findings include: 1. Review of the 'Laboratory Test Methodology Report' showed the laboratory performed creatinine, sodium, potassium, blood urea nitrogen, glucose and chloride testing using the iSTAT and the Roche chemistry analyzers. 2. Review of laboratory records showed no evidence of comparisons between the iSTAT test system and the Roche analyzers or other evaluation of the relationship between the results from the two test systems. 3. Interview with a technical consultant (staff A) on August 31, 2023, at 1:30 PM confirmed the laboratory had not developed a system to evaluate the relationship between the test results from the two test systems. This is a repeat deficiency previously cited on September 18, 2017. 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 D2005 ENROLLMENT CFR(s): 493.801(a)(4) Authorize the proficiency testing program to release to HHS all data required to-- (i) Determine the laboratory's compliance with this subpart; and (ii) Make PT results available to the public as required in section 353(f)(3)(F) of the Public Health Service Act. This STANDARD is not met as evidenced by: Based on surveyor review of Certification and Surveyor Provider Enhanced Reporting (CASPER) records and American Proficiency Institute (API) forms, and interview with the general supervisor, the laboratory did not report proficiency test results to Health and Human Services (HHS) for the core chemistry regulated analytes in 2020 and 2021. Findings include: 1. Review of the CASPER report 0155D (Individualized Laboratory Profile) for the laboratory on October 31, 2021 shows no proficiency testing data available for review for the following analytes: Albumin, alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, total bilirubin, calcium, chloride, creatine kinase, creatinine, glucose, lactate dehydrogenase, magnesium, potassium, sodium, total protein, urea nitrogen and uric acid. 2. Review of the API "CMS Reporting Selections" form showed "DO NOT SEND SCORE" for the core chemistry regulated analytes. 3. Interview with the general supervisor, at 9:30 AM, confirmed the laboratory did not report proficiency test results to HHS for the core chemistry regulated analytes in 2020 and 2021. 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 D5503 BACTERIOLOGY CFR(s): 493.1261(a)(2) (a) The laboratory must check the following for positive and negative reactivity using control organisms: (a)(2) Each week of use for gram stains. This STANDARD is not met as evidenced by: Based on surveyor review of gram stain records and interview with the general supervisor, the laboratory has not documented the performance of gram stain quality control. Findings include: 1. Review of gram stain records shows no documented evidence of quality control performance. 2. Interview with the general supervisor on September 4, 2019 at 4:00 PM confirmed the laboratory did not document gram stain quality control. 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 --