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 confirmation, the laboratory failed to twice annually verify the accuracy of potassium hydroxide (KOH) fungal and yeast examinations where no records were provided to show any comparison activity was conducted for this test in 2017 and 2018 and approximately 200 patient specimens are tested annually. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on the review of the quality assessment (QA) plan for the general laboratory systems and staff interview, the laboratory failed to establish written policies and procedures for staff to follow in 2017 and 2018 for an ongoing mechanism to monitor, assess, and take