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 review of Proficiency Testing (PT) scores from 2019 and interview with lead laboratory testing personnel, the laboratory failed to prove accuracy of potassium hydroxide(KOH) and wet prep (WP) screening slides on two events in 2019 through PT or twice a year accuracy verification. The findings include: 1. A review of PT scores for 2019 show unacceptable scores of zero percent for first event 2019 and fifty percent for second event 2019 for KOH/WP. 2. An interview with the lead laboratory testing personnel at approximately 1:00p.m. on October 21,2019 confirms the KOH/WP PT failed to prove their accuracy during 2019 through either PT or twice a year accuracy verification. =================================== D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: ================================== Based on lack of documented initial training and competency for 1 of 2 providers performing KOH (potassium hydroxide testing), Wet Preps and urine sediment microscopics and upon interview with the lead Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory testing personnel, determined the technical consultant failed to ensure documented initial training and annual competencies for 1 of 2 providers in 2018 and 2019. The findings include: 1. There were no initial training or competencies documented for 1 of 2 providers performing KOH, Wet Preps and urine sediment microscopics for 2018 and 2019. 2. An interview with the lead laboratory testing personnel at approximately 1:00 p.m. October 21, 2019, confirmed the Technical Consultant failed to document initial training and annual competencies for 1 of 2 providers in 2018 and 2019 performing KOH, Wet Preps and urine sediment microscopics. ================================== -- 2 of 2 --