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 observation of new Covid-19 testing, lack of Covid-19 training documents and interview with general supervisor #2, the technical supervisor failed to identify and to document training needs for six of six testing personnel in 2021. Findings: 1. Review of the laboratory developed testing Covid-19 Method: Yale School of Public Health, Department of Epidemiology of Microbial Diseases, SalivaDirect (Trademark) showed no training documents for testing personnel #1, #2, #3, #4, #5 and #6. Laboratory started patient testing on March 17, 2021. 2. Interview with the general supervisor #2 on February 15, 2022 at 2:00 P.M. confirmed the technical supervisor failed to identify and to document training needs for six of six testing personnel in 2021. D6127 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 semiannually during the first year the individual tests patient specimens. 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 -- This STANDARD is not met as evidenced by: Based on observation of new Covid-19 testing, lack of semiannual records for Covid competencies, and interview with general supervisor #2, the technical supervisor failed to evaluate and to document semiannual competencies for six of six testing personnel in 2021. Findings: 1. Review of the laboratory developed testing Covid-19 Method: Yale School of Public Health, Department of Epidemiology of Microbial Diseases, SalivaDirect (Trademark) showed no records of semiannual competencies for testing personnel #1, #2, #3, #4, #5 and #6. Laboratory started patient testing for Covid-19 method on March 17, 2021. 2. Interview with the general supervisor #2 on February 15, 2022 at 2:00 P.M. confirmed the technical supervisor failed to evaluate and to document semiannual competencies for six of six testing personnel in 2021. -- 2 of 2 --