Summary:
Summary Statement of Deficiencies 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 an interview with the lab manager, the laboratory's technical consultant failed to document the six required criteria for competency assessment for 3 or 3 testing persons (6,7 and 8) who perform throat cultures and urine microscopy from July 2017 to June 2019. Findings include: 1. There was no competency assessment available for review for testing persons 6,7 and 8 who perform throat cultures and urine microscopy to include: direct observation of routine patient test performance; monitoring the recording and reporting of test results; review of intermediate test results or worksheets, quality control records, proficiency testing results and preventative maintenance records; direct observation of performance of instrument maintenance and function checks; assessment of test performance through previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, assessment of problem solving skills from July 2017 to June 2019. 2. Interview with the lab manager on June 18, 2019 at 1:30 pm confirmed the technical consultant failed to perform competency assessments to include the six competency assessment criteria for testing persons 6, 7 and 8 who perform throat cultures and urine microscopy from July 2017 to June 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 --