Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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." 2. A review of the laboratory's submitted CMS 209 form (signed by the laboratory director on 9/7/21) 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: a) Testing person #4 Hire date: 6/24/19 Competency assessment: 12/18/19 and 12/30/20 Based on the 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 -- hire date, testing person #4 should have had at least 2 competency assessments performed prior to 6/2020. 4. An interview with the technical consultant on 9/7/21 at 2:05 p.m. in the office, after review of the records, confirmed the above findings. -- 2 of 2 --