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 review of proficiency testing for all events for 2017 and 2018 microscopy, urine sediment, and interview with testing personnel at 3:00 PM on 5/7/2019 proficiency testing samples were tested by testing personnel who do not routinely perform the testing in the laboratory. 1. Review of proficiency testing all 3 events for 2017 & 2018 for microscopy, urine sediment, revealed failures on 2017 1st event (50%), 2017 3rd event (50%), 2018 1st event (0%), and 2018 2rd event (50%). 2. Interview with testing personnel confirmed the laboratory's proficiency testing samples for 2017 & 2018 microscopy, urine sediment, were tested by testing personnel who do not routinely perform the testing in the laboratory. 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 the list of tests performed, review of proficiency testing, and interview with the testing personnel at 3:00 PM on 5/7/2019, the laboratory failed to verify the accuracy of microscopy, urine sediment, for 2018. Findings are: 1. Review of the list of tests performed provided by the laboratory revealed urine microscopy performed at 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 -- this laboratory with an annual volume of 1 test for 2018. 2. Review of proficiency testing all 3 events for 2018 for microscopy, urine sediment, revealed failures on 2018 1st event (0%) and 2018 2rd event (50%). 3. Interview with the testing personnel confirmed the laboratory had failed to have proficiency testing samples for 2018 microscopy, urine sediment, tested by personnel who routinely perform the testing in the laboratory. (See D2007) D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on interview with testing personnel it was confirmed the laboratory had failed to have proficiency testing samples for 2017 & 2018 microscopy, urine sediment, tested by personnel who routinely perform the testing in the laboratory. (See D2007) -- 2 of 2 --