Summary:
Summary Statement of Deficiencies D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to obtain an event score of 80% for gram stain proficiency testing (PT), event 3 of 2017, resulting in unsatisfactory analyte performance. Findings Include: 1. Review of Wisconsin State Laboratory of Hygiene (WSLH) PT records found the laboratory failed PT event 3 for gram stain testing in 2017. a. Gram Stain Score - 60% 2. On survey date 8-30-2018, at 11:20 am, the LD confirmed the unsatisfactory score of 60% for gram stain testing in event 3 of 2017. 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 review of laboratory records and interview with the laboratory director (LD); the laboratory failed to ensure 1 of 6 proficiency testing (PT) events were reviewed for gram stain testing. Findings Include: 1. Review of Wisconsin State Laboratory of Hygiene (WSLH) PT records from 2016 through 2018 revealed the laboratory failed review gram stain PT results for event 2 of 2017. 2017 WSLH Event 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 -- 2 Gram Stain Score - 80% 2. On survey date 8-30-2018, at 11:20 am, the LD confirmed WSLH PT records from event 2 of 2017 were not reviewed for gram staining and no