Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 17, 2018. The laboratory was not in compliance with all applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 personnel competency assessment records, review of the laboratory personnel report form (CMS 209), and staff interview, the technical consultant failed to perform semi-annual and annual competency assessment on 2 of 3 employees who started testing after the July 20, 2016 recertification survey. Finding include: 1. Review of the CMS 209 revealed three employees, testing personnel #4, #7 and #8 (see CMS 209) started testing patient samples after the July 20, 2016 survey. 2. Review of personnel competency assessment records revealed initial competency assessment records dated 3/20/17 for testing personnel # 7 and #8 but no documentation of semi- annual or annual assessment. 3. Interview with testing personnel # 6 (see CMS 209) on July 17, 2018 in the office area assigned to the surveyor confirmed semi-annual and annual competency assessment has not been performed for testing personnel # 7 and #8. 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 --