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 record review and an interview with the Laboratory Operations Manager (LOM), the Technical Supervisor (TS) failed to evaluate and document the performance of one out of six new Testing Personnel (TP), who was responsible for high complexity testing procedures at least semiannually during the first year the individual tested patient specimens. All patients tested by TP#3 had the potential to be affected by this deficient practice. Findings Include: 1. The LOM stated TP#3 had begun testing in September 19, 2018 after initial training was completed. 2. Review of policy titled "GEN.2.02" found the following statement: "...D. Competency Plan...All employees will be assessed for competency at six months, again at 12 months after hire and then annually." 3. Review of the laboratory's 2018-2019 training and competency assessment documentation, provided on the date of the inspection, found TP#3 did not have a semi-annual competency assessment record. 4. The LOM confirmed TP#3 did not have a semiannual competency assessment within the first year of testing. The interview occurred on 12/02/2019 at 11:00 AM. 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 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 -- to include the use of the new test methodology or instrumentation. This STANDARD is not met as evidenced by: Based on record review and an interview with the Laboratory Operations Manager (LOM), the Technical Supervisor (TS) failed to evaluate and document the competency of two out of 16 Testing Personnel (TP) responsible for high complexity testing, at least annually after the first year of testing patient specimens. All patients tested at this laboratory by TP#3 and TP#13 had the potential to be affected. Findings Include: 1. Review of initial training records revealed a hire date of 7/9/2018 for TP#3 and a hire date of 9/19/2016 for TP#13. 2. Review of the policy titled "GEN.2.02" found the following statement: "...D. Competency Plan...All employees will be assessed for competency at six months, again at 12 months after hire and then annually." 3. Review of the laboratory's 2018-2019 training and competency assessment documentation, provided on the date of the inspection, found no annual hematology competency assessment, due 7/2019, for TP#3 and no annual hematology competency assessment, due 9/2018, for TP#13. 4. An interview with the LOM confirmed the TS failed to evaluate and document the annual 2018 and 2019 competency for TP#3 and TP#13. -- 2 of 2 --