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 the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory's records, employee files, and an interview with the testing personnel (TP); the technical consultant (TC) failed to evaluate the competency of all TP and assure that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently in the specialty of Microbiology, affecting 4 out of 4 TP. Findings: 1. The CMS 209 lists 4 TP performing the BD Affirm test for Candida species (Yeast), Gardnerella vaginalis and Trichomonas vaginalis in the laboratory. 2. The personnel files revealed that 4 out of 4 TP received training for the BD Affirm test on 01/28/2016. No documentation was provided as evidence that the TP had been assessed as competent to perform the test after being trained, prior to testing patients. 3. The laboratory's patients' test logs, quality control sheets and patients' result reports revealed that 4 out of 4 TP were performing patient testing during the period of 2016 through to 2018. 4. On a Recertification survey conducted on 03/15/2018 at 12:30 PM, the TP confirmed the above findings. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. 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 STANDARD is not met as evidenced by: Based on the surveyor's review of the Laboratory Personnel Report (CMS 209), the laboratory's records, employee files, and an interview with the testing personnel (TP); the technical consultant (TC) failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens, affecting 4 out of 4 TP. Findings: 1. The CMS 209 lists 4 TP performing the BD Affirm test for Candida species (Yeast), Gardnerella vaginalis and Trichomonas vaginalis (a moderately complex test) in the laboratory. 2. The personnel files revealed that 4 out of 4 TP received training for the BD Affirm test on 01/28/2016. No documentation was provided as evidence that the TP had been assessed for competent to perform the test since being trained in January of 2016. 3. The six month evaluation requirement for TP is not included in the laboratory's competency policy. 4. On a Recertification survey conducted on 03/15 /2018 at 12:30 PM, the TP confirmed the above findings. -- 2 of 2 --