Summary:
Summary Statement of Deficiencies 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 proficiency testing records, lack of documentation, and staff interview, the laboratory failed to evaluate proficiency testing results for 1 of 12 testing events reviewed from January 2019 to January 2021. The findings were: 1. Review of the American Proficiency Institute proficiency testing report showed it failed to include documentation the laboratory had evaluated test scores of less than 100% for the 2020 Microbiology Event 2 proficiency testing evaluation. Results showed the laboratory scored a 50% for KOH (potassium hydroxide) preparation (glass slide). There was no documentation the laboratory had evaluated the test result. 2. Interview with the laboratory manager on 5/17/21 at 2:30 PM revealed the proficiency testing event included a photograph of a KOH preparation. Further, after the results of the proficiency test event had been received she and the laboratory director had reviewed the photograph and determined the photograph was of poor quality and no further action was needed. The laboratory manager confirmed the laboratory did not have any documentation the test results had been addressed. 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 --