Summary:
Summary Statement of Deficiencies D6042 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(4) (b) The technical consultant is responsible for-- (b)(4) Establishing a quality control program appropriate for the testing performed and establishing the parameters for acceptable levels of analytic performance and ensuring that these levels are maintained throughout the entire testing process from the initial receipt of the specimen, through sample analysis and reporting of test results; This STANDARD is not met as evidenced by: Based on review of quality control (QC) and interview with testing personnel #6, the technical consultant failed to review QC and ensure that acceptable levels of analytic performance was maintained for eight of twelve months in 2019. Findings: 1. Review of Troponin QC showed no documentation of technical consultant review for May, June, July, August, September, October, November and December 2019. 2. Interview with testing personnel #6 on February 11, 2020 at 10:30 AM confirmed the technical consultant failed to review Troponin QC and ensure acceptable levels of analytic performance was maintained. 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 competencies and interview with the testing personnel #6, the technical consultant failed to evaluate competency of five of five testing personnel 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 -- annual competencies in 2018 and 2019. Findings: 1. Review of competencies showed no technical consultant evaluation and documentation of annual competency for testing personal #1, #3, #4, #5 and #6 in 2018 or 2019. 2. Interview with testing personnel #6 on February 11, 2020 at 10:00 AM confirmed the technical consultant failed to evaluate and document annual competencies in 2018 and 2019. -- 2 of 2 --