Summary:
Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies, a review of the laboratory's submitted CMS 209 form, a review of the laboratory's personnel records, and staff interview, it was revealed that the laboratory failed to have documentation of the technical consultant performing a competency assessment, at least semiannually during the first year of testing, for 1 of 5 testing personnel. Findings include: 1. A review of the laboratory's policy titled 'Quality Assessment Program' revealed the following: "Personnel are evaluated semiannually during the first year of employment and when new methodologies are incorporated."(medtox EZ cup) 2. A review of the laboratory's submitted CMS 209 form (signed by the laboratory director on 9/15/21) revealed the laboratory identified 5 testing personnel performing moderate complexity testing. 3. A review of the laboratory's personnel records revealed the following 1 testing person, their hire date, and documentation of the competency assessments performed: 4. An interview with the technical consultant on 9/15/21 at 2:30 p.m. in the office, after review of the records, confirmed the above findings. 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 --