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 personnel records, the 2018 and 2019 proficiency testing records and interview with the laboratory liaison, the laboratory failed to ensure the proficiency testing samples were examined by the personnel who routinely perform patient testing, in 2018 and 2019. The findings include: 1) Review of the personnel records revealed six testing personnel between June 2018 and December 2019 performing urine microscopic, wet prep, potassium hydroxide (KOH), and complete blood counts (CBC) on patient samples. 2) Review of the 2018 and 2019 PT records revealed all six testing personnel did not participate in PT sample performance. 3) Interview on February 12, 2020 at 10:00 a.m. with the laboratory liaison confirmed the six patient testing personnel did not participate in PT in 2018 and 2019. 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 --