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 review of the laboratory's personnel records, and staff interview, it was revealed the laboratory failed to have documentation of the technical consultant performing semiannual competency assessments on 1 of 1 testing personnel within the first year of testing. The findings include: 1. A review of the laboratory's personnel records revealed testing personnel number 9 was hired by the facility in April 2021. Thus, two competency assessments were required by April 2022. 2. The laboratory was asked to provide documentation of the two competency assessments being performed within the first year of testing. No documentation was provided. 3. An interview with the medical assistant supervisor on 05/11/2022 at 1000 hours in her office revealed competency assessments had not been performed for testing personnel number 9. This confirmed the findings. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on review of the laboratory's personnel records, and staff interview, it was 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 -- revealed the laboratory failed to have documentation of the technical consultant performing annual competency assessments on 5 of 5 testing personnel requiring them in 2021. The findings include: 1. A review of the laboratory's personnel records revealed 5 testing personnel required annual competency assessments for 2021. 2. The laboratory was asked to provide documentation of the competency assessments being performed in 2021. No documentation was provided. 3. An interview with the medical assistant supervisor on 05/11/2022 at 1000 hours in her office revealed competency assessments had not been performed in 2021. This confirmed the findings. 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 personnel records, and staff interview, it was revealed the laboratory failed to have documentation of the technical supervisor performing annual competency assessments on 2 of 2 testing personnel requiring them in 2021. The findings include: 1. A review of the laboratory's personnel records revealed 2 testing personnel required annual competency assessments for 2021. 2. The laboratory was asked to provide documentation of the competency assessments being performed in 2021. No documentation was provided. 3. An interview with the medical assistant supervisor on 05/11/2022 at 1000 hours in her office revealed competency assessments had not been performed in 2021. This confirmed the findings. -- 2 of 2 --