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 lack of documentation and confirmation by staff, the laboratory technical consultant failed to evaluate 1 of 1 gross analysis testing personnel annually in 2020 to evaluate and document their testing performance. The laboratory performed approximately 22105 gross analyses per year. Findings include: 1. The laboratory failed to document competency evaluations in 2020 for 1 testing person's ability to perform histopathology testing that includes: direct observation of routine patient test performance, monitoring the recording and reporting of test results; direct observation of performance of instrument maintenance and function checks; assessment of test performance through testing previously analyzed specimens; internal blind testing samples or external proficiency testing samples; and assessment of problem solving skills. 2. In an interview conducted on 01/08/2021 at approximately 10:55 A.M. staff confirmed the laboratory lacked documentation of the 2020 competency evaluation for the one person who performed specimen gross analysis. 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 --