Summary:
Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the laboratory's testing personnel policy, review of testing personnel records, Potassium Hydroxide (KOH) logs and staff interview, the laboratory director failed to ensure testing person eight had documentation of training and demonstration of accuracy before performing patient testing for KOH/fungal element detection in 2023, with 15 patient tests for KOH performed by testing person eight before competency was assessed on 12/20/23. The findings include: 1. A review of the laboratory's testing personnel policy revealed the following statement: All lab personnel are evaluated for competency at the end of their training period, six months after hire, and annually thereafter. 2. A review of testing personnel records revealed testing person eight was evaluated for KOH competency on 12/20/23. 3. Review of KOH logs revealed patient testing for KOH performed by testing person number eight beginning 10/12/23 on patient 214455, with 15 patient tests for KOH/fungal elements performed by testing person eight between 10/12/23 until the date competency was assessed on 12/20/23. 4. The laboratory liaison confirmed the survey findings during interview on 05/13/24 at 11:30 a.m. 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 --