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 record review and staff interview, the laboratory failed to verify, twice annually, the accuracy of test procedures used for Histopathology and Mycology testing in 2021. Findings include: 1) Review on 9/19/2022 of verification of accuracy records in 2021 and 2022 revealed the laboratory sent Histopathology slides out to another laboratory for blind assessment in April 2022. Further review revealed assessment of test performance had been performed for KOH September 2022. There were no records of blind assessments or other method(s) to verify accuracy of procedures conducted in 2021 for Histopathology slides or for KOH testing. 2) Interview on 9/19/2022 at 10:15 a.m. with the Laboratory Director confirmed no assessments had been performed in 2021 for the Histopathology slides and KOH testing. 3) The laboratory performed 21 KOH tests and approximately 775 Histopathology slide examinations in 2021. 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 --