Summary:
Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. 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 laboratory policy, personnel records, and confirmed in staff interview, the technical supervisor failed to evaluate and document annual competency assessments for 1 of 5 testing persons (TP-2) responsible for high complexity testing in 2019 and 2020. Findings: 1. Review of the laboratory's policy "Employee Competency" revealed: "Purpose All testing personnel and staff will be assessed and documented upon initial employment and periodically thereafter to assure their competency to perform test procedures and report test results promptly, accurately and proficiency. The required ways to ensure that competence of [sic] Procedure 1. All new employees will be directly observed for competency upon employment. 2. All employees will be directly observed for competency biannually in the first year and annually thereafter." 2. Review of personnel records revealed the 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 -- technical supervisor failed to evaluate and document annual competency assessment for TP-2 in 2019 and 2020. 3. During an interview on 06/10/2021 at 9:40 am, the Scientific Director confirmed the above findings. -- 2 of 2 --