Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on 01/26/2023 and the facility was found not to be in substantial compliance with the laboratory requirements at 42 CFR Part 493, with deficiencies cited. 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 interview, and record review, it was determined the laboratory performed potassium hydroxide (KOH) preparations for yeast but failed to perform twice annual accuracy assessments for two (2) of two (2) years reviewed (2021 and 2022). The findings include: Review of the laboratory's policy titled, "Potassium Hydroxide (KOH) Examination of Skin, Hair or Nails," signed by the Laboratory Director on 01 /04/2010, and a "KOH Log," revealed KOH examinations were performed as recently as 10/14/2022. During an interview with the Laboratory Director (LD), on 01/26/2023 at 4:45 PM, he stated the laboratory failed to perform the twice annual accuracy assessments for KOH examinations. The LD was asked to provide documentation for the twice annual accuracy assessments for KOH examinations but no documentation was provided. 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 --