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 review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CMS 209), the laboratory testing personnel competency assessment records, and interview with the office supervisor, the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for two of six testing personnel (TP) in 2023. The findings include: 1. Review of the CMS 209 revealed six testing personnel who perform complete blood count patient testing. 2. Review of testing personnel competency assessment records for 2023 revealed competency assessments completed on 03.03.2023 for TP #1 and #2 failed to include documentation of the six required criteria of competency that 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. 3. Interview with the office supervisor on September 11, 2023 at approximately 11:30 a.m. confirmed the laboratory's technical consultant failed to document the six required criteria for assessing personnel competency for two of six TP in 2023. 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 --