Summary:
Summary Statement of Deficiencies D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of performance evaluation documentation and interview with the facility personnel, the Technical Consultant failed to evaluate and document the performance of twenty-eight (28) testing personnel, at least semiannually during the first year the individuals tested patient specimens. Findings include: 1. The laboratory began patient testing in October 2020 under the specialties of Chemistry and Hematology, with an approximate annual test volume of 5,103. 2. During the survey conducted on April 20, 2023, the semi-annual competency evaluations presented for review for 28 out of 28 testing personnel indicated the competency evaluations were performed and documented by two employees who are not listed as Technical Consultants on the CMS-209, Laboratory Personnel Form that was provided during the survey. 3. The facility personnel interviewed on April 20, 2023 at 10:10am confirmed that the Technical Consultant listed on the CMS-209, Laboratory Personnel Form failed to perform and document semiannual competency evaluations for the testing personnel indicated above. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 review of performance evaluation documentation and interview with the facility personnel, the Technical Consultant failed to evaluate and document the performance of twenty-eight (28) testing personnel, at least annually after the first year the individuals tested patient specimens. Findings include: 1. The laboratory began patient testing in October 2020 under the specialties of Chemistry and Hematology, with an approximate annual test volume of 5,103. 2. During the survey conducted on April 20, 2023, the annual competency evaluations presented for review from 2021 and 2022 for 28 out of 28 testing personnel indicated the competency evaluations were performed and documented by two employees who are not listed as Technical Consultants on the CMS-209, Laboratory Personnel Form that was provided during the survey. 3. The facility personnel interviewed on April 20, 2023 at 10:11am confirmed that the Technical Consultant listed on the CMS-209, Laboratory Personnel Form failed to perform and document annual competency evaluations for the testing personnel indicated above. -- 2 of 2 --