Summary:
Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for 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; (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 review of competency assessment records, CMS Form 209, and interview, the technical supervisor failed to ensure that all six required elements for competency assessment were performed for seven of seven testing personnel (TP). Findings: 1. Competency assessments in 2023 and to date of survey for TP #1, 2, 3, 4, 5, 6, and 7 did not contain the following required elements: a. Direct observations of routine patient test performance, including patient preparation, if applicable, specimen handling,processing and testing; b. Monitoring the recording and reporting of test results; c. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventative maintenance records; d. Direct observation of performance of instrument maintenance and function checks; e. Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or externalproficiency testing samples; and f. Assessment of problem solving skills. 2. All seven TP have performed mycology (KOH) testing. 3. Interview with the Business Manager on 8/12/24 at 10:25 a.m. confirmed, the technical supervisor failed to ensure that all six required elements for competency assessment were performed for seven of seven testing personnel (TP). 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 --