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 requested for documentation and interview with laboratory representatives, the laboratory failed to twice annually verify the accuracy of their KOH preps and Wet Mounts. Findings include: a. The surveyor requested (at August 2, 2019, 9:55 A. M.) to see 2018 documentation of verifications of accuracy for the laboratory's KOH preps and Wet Mounts. The laboratory representatives could not produce documentation of the bi-annual verification of these tests. b. For 2018, the laboratory performed approximately a total of 100 patient KOH preps and Wet Mounts without verifying and documenting the accuracy of these tests. 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 --