Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of proficiency and laboratory correlation records for 2016, 2017 to date and interview with the office staff revealed, the laboratory failed to establish a means to verify the accuracy of KOH testing twice a year. Findings: 1. Review of proficiency records for 2016 and 2017 to present date revealed the laboratory failed to enroll to prove accuracy on the nonregulated analyte for KOH microscopic exams. 2. Review of correlation records for 2016 and 2017 to present date revealed a lack of documentation to prove accuracy 2 times a year for KOH microscopic exams. 3. Interview with the office staff on August 15, 2018 at 6:45 AM confirmed the laboratory failed to verify the accuracy of the nonregulated KOH microscopic testing twice annually for 2016, 2017 and to date August 15, 2018. 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 --