Summary:
Summary Statement of Deficiencies D6127 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 semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on a review of Testing Personnel records, the Policy and Procedure manual, and an interview with the Technical Supervisor, the Technical Supervisor failed to evaluate the performance of personnel at least semiannually during the first year of performing testing on the BD FACSCanto II (Flow Cytometry) analyzer. This was noted for one of four Testing Personnel. The findings include: 1. A review of the competency records for Testing Personnel #3 revealed only the initial training for the BD FACSCanto II, dated 05/13/2021. 2. A review of the Policy and Procedure manual revealed the following under a section titled "Quality Assurance", "...Personnel are evaluated semiannually during the first year of employment or when new methodologies are incorporated...". 3. During an interview on 09/07/2022 at 10:30 AM, the Technical Supervisor stated, "[Testing Personnel #3] told me the previous Technical Supervisor never signed off on her six month or yearly competency". 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. 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 -- This STANDARD is not met as evidenced by: Based on a review of Testing Personnel records, the Policy and Procedure manual, and an interview with the Technical Supervisor, the Technical Supervisor failed to evaluate the performance of personnel at least annually after the first year of performing testing on the BD FACSCanto II (Flow Cytometry) analyzer. This was noted for one of four Testing Personnel. The findings include: 1. A review of the competency records for Testing Personnel #3 revealed only the initial training for the BD FACSCanto II, dated 05/13/2021. 2. A review of the Policy and Procedure manual revealed the following under a section titled "Quality Assurance", "...Personnel are evaluated semiannually during the first year of employment or when new methodologies are incorporated. Thereafter, evaluations are performed yearly...". 3. During an interview on 09/07/2022 at 10:30 AM, the Technical Supervisor stated, "[Testing Personnel #3] told me the previous Technical Supervisor never signed off on her six month or yearly competency". -- 2 of 2 --