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 review of American Proficiency Institute (API) Proficiency Testing (PT) records and an interview with Testing Personnel #3, the laboratory failed two consecutive API PT events on Urine Sediment examinations, a non-regulated test. This affected two of eleven PT events reviewed in 2021-2022. The findings include: 1. A record review revealed the laboratory utilized API PT to verify the accuracy of Urine Sediment. However, the laboratory received a failing score of 50% for Urine Sediment on two consecutive PT events, 2021 Hematology 3rd event and 2022 Hematology 1st event. 2. During an interview on 09/21/22 at 10:30 AM, Testing Personnel #3 explained the failures were due to the testing personnel attempting to identify crystals on PT surveys, when the laboratory only reported presence or absence of crystals. 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 a review of personnel records and interviews with Testing Personnel #3, the Technical Consultant failed to ensure competency assessments included an evaluation 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 -- of competency to perform Urine Sediment examinations. This was noted for five out of five Testing Personnel from the date of the last survey (1/28/21) to the date of the current survey (09/21/2022). The findings include: 1. A review of personnel records revealed a lack of competency evaluations in the subspecialty of Urine Sediment examination for five out of five Testing Personnel. 2. The surveyor further noted the laboratory received a failing score of 50% for Urine Sediment on two consecutive American Proficiency Institute (API) Proficiency Testing events. (Refer to D5217.) 3. During an interview on 09/21/2022, Testing Personnel #3 confirmed Testing Personnel listed on the CMS-209 performed Urine Sediment examinations, however there was no documentation of competency assessment. -- 2 of 2 --