Summary:
Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a lack of documentation and an interview with the general supervisor (GS) on June 11, 2025 the laboratory failed to document the initial training and evaluate the competency of two (2) of two (2) testing personnel (TP) for urine sediment, and one (1) of two (2) TP for automated urine chemistry prior to performing patient testing and reporting beginning on April 21, 2025. Findings include: 1. A request was made to review initial training and competency evaluation documentation specific for this laboratory and documentation could not be provided for two (2) of two (2) TP for Urine Sediment, and one (1) of two (2) TP for automated Urine Chemistry Testing. 2. An onsite interview conducted on June 11, 2025 at approximately 12:30 PM with the GS, confirmed the laboratory did not have written documentation of initial training or competency assessments for two (2) of two (2) TP for Urine Sediment, and one (1) of two (2) TP for automated Urine Chemistry Testing specific for this laboratory. 3. The laboratory reports performing approximately 10,000 Urine Chemistry patient tests annually. 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 --