Summary:
Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the Vaginal Fungal (KOH) and Parasitology (Wet Prep) Proficiency Testing (PT) records for 2017 and 2018 and upon interview with the Laboratory Director (LD), determined the laboratory PT samples were not being tested by two of three testing personnel (as listed on the Laboratory Personnel Report Form 209) in the same manner as the regular patient workload for KOH/Wet Prep specimens in 2017-18. The findings include: 1. A review of the KOH/Wet Prep PT records for 2017 and 2018 revealed only 3 of 3 testing personnel's signature on the attestation sheets. 2. An interview with the lab director at approximately 9:30 a.m. on May 7, 2019 confirmed he was the only person of three, listed on the Laboratory Personnel Report Form, reviewing all KOH/Wet Prep PT results before submission to the PT agency during 2017 and 2018. 3. An interview with the Laboratory Director at approximately 9:45 a.m. on May 7, 2019, confirmed the laboratory was not performing KOH/Wet Prep PT specimens with the regular patient workload and the LD was taking the best result of 3 of 3 to submit to the PT agency in 2017-18. 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 --