Summary:
Summary Statement of Deficiencies D6125 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(8)(v) (b)(8)(v) Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and This STANDARD is not met as evidenced by: Based on record review and staff interview, competency assessments performed in 2024 for 1 of 3 testing personnel records reviewed failed to include assessment of hematology test performance. Findings include: 1. Review on 7/23/2025 of 3 testing personnel competency assessment records for 2024 revealed the competency assessment for 1 of 3 testing personnel (TP1) performed in August 2024 failed to include an assessment of test performance for semen analysis. 2. Interview on 7/23 /2025 at 11:00 a.m. with the Laboratory Director and Testing Personnel confirmed the above finding. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) 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 staff interview, the Technical Supervisor failed to perform competency assessments on 1 new testing personnel semiannually in the first year of hematology testing in 2024 and 2025. Findings include: 1. Review on 7/23 /2025 of 3 personnel records revealed 1 new testing personnel (TP1). Further review of TP1's records revealed training was completed in May 2024 and a competency 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 -- assessment was conducted in August 2024. There was no record of a second competency assessment in the first year of performing semen analysis. 2. Interview on 7/23/2025 at 11:00 a.m. with the Laboratory Director and Testing Personnel confirmed a second competency assessment for TP1 had not been performed within the first year of testing patient specimens. -- 2 of 2 --