Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of troponin procedure, troponin quality control (QC) and interview with testing personnel #1 the laboratory failed to follow written QC procedure for troponin QC for three of seventeen months. Findings: 1. Review of troponin procedure states "QC must be completed monthly". 2. Review of troponin QC showed no QC completed in April 2018, January 2019 and February 2019. 3. Interview with testing personnel #1 on May 23, 2019 at 11:30 AM confirmed the laboratory failed to follow procedure and complete troponin QC monthly. 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 testing personnel #1 the technical consultant failed to evaluate competency for nine of twelve testing personnel in 2017, 2018 and to date May 23, 2019. Findings: 1. Review of initial competencies showed testing personnel #1, #4, #7 and #9 failed to have an initial competency. 2. 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 -- Review of 2018 annual competencies showed testing personnel #1, #2, #8, #11 and #12 failed to have an annual competency in 2018. 3. Review of 2017 annual competencies showed testing personnel #3 failed to have an annual competency in 2017. 4. Interview with testing personnel #1 on May 23, 2019 at 11:30 AM confirmed the technical consultant failed to evaluate competency. -- 2 of 2 --