Summary:
Summary Statement of Deficiencies D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. This STANDARD is not met as evidenced by: Based on review of laboratory records and interview with the laboratory director (LD); the laboratory failed to ensure ungraded 2017 event 1 proficiency testing (PT) samples for potassium hydroxide (KOH) preparations were evaluated. Findings Include: 1. Review of American Proficiency Institute (API) PT records for 2017 event 1 found API did not grade samples KOH-01 and KOH-02. 2. Review of API PT performance evaluation records for event 1 of 2017 failed to address the ungraded PT samples and the LD indicated no