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 interview with the Medical Assistant, the laboratory failed to ensure verification of accuracy procedures were performed for its Potassium Hydroxide (KOH) and Scabies preparations at least twice annually for 1 (2021) of 2 years reviewed. Findings include: 1. A review of the laboratory's "SYSTEM FOR VERIFYING ACCURACY AND RELIABILITY OF LABORATORY TESTS ASSURING VALIDITY OF TEST RESULTS QUALITY CONTROL PROCEDURES" on 6/16/22 revealed a section stating, "The tests done in this laboratory, which do not have HCFA approved proficiency testing available, include reading of pathology slides, reading of positive or negative fungus cultures for dermatophytes or yeast, and KOH microscopic examinations. Any or all of the dermatologists who read laboratory tests in our office will take the examination on those tests, provided twice per year by the Michigan Dermatological Society." 2. A review of the laboratory's Michigan Dermatological Society documentation revealed the examination for Fall 2020 Physician Performed Microscopy procedures was performed on 2/1/21. There was a lack of documentation of the second examination for 2021. 3. An interview on 6/16/22 at 2:16 pm with the Medical Assistant confirmed the laboratory had not completed the examinations twice annually in 2021 as required by its policy. 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 --