Summary:
Summary Statement of Deficiencies D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least annually after the first year, unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individual's performance must be reevaluated to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, the laboratory failed to have documentation of the technical supervisor performing annual competency assessments on 12 of 12 testing personnel in 2022. The findings included: 1. A review of the laboratory's submitted Form CMS 209 determined the laboratory identified 12 testing personnel. 2. A review of the laboratory's personnel records determined the laboratory failed to have documentation of the technical supervisor performing 12 of 12 competency assessments in 2022. 3. The laboratory was asked to provide documentation of the missing competency assessments. No documentation was provided. 4. The clinical service manager confirmed the findings in an interview conducted 05/08/2024 at 1030 hours in the office. 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 --