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 a lack of accuracy verification (comparison testing) documentation and staff interview and confirmation, the laboratory failed to twice annually verify the accuracy of potassium hydroxide (KOH) skin preparation fungal and yeast examinations. No records were provided to show any comparison activity was conducted for this test in the year 2020 and three of six providers (TP#1, TP #4 and TP #5) had documentation that one accuracy verification was performed in the year 2019. Approximately 200 patient specimens are tested annually. During the interview at approximately 9:30 am, staff confirmed that accuracy verification had not been performed by any of the providers for the year 2020. Based on lack of accuracy verification (comparison testing) documentation and staff interview and confirmation, the laboratory failed to twice annually verify the accuracy of Mohs Surgery slide examinations by TP#1, TP #2 and TP #3 where no records were provided to show any comparison activity was conducted for this test in 2020. During the interview at approximately 10:00 am, staff confirmed that accuracy verification was being performed but that no records had been kept and had only been noted in the patient's electronic medical record. 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 --