Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the South Shore Skin Center laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . 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 personnel competency record review and interview with the National Director of Laboratory Operations (NDLO) on 6/28/2023, the Technical Consultant (TC) failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the 2022 personnel competency records for review. The review revealed that a semiannual competency evaluation was not performed and documented for the only new testing person (TP) hired in 2021 performing provider performed microcopy procedures (PPMP) potassium hydroxide (KOH) preps. The NDLO confirmed in an interview on 6/28/2023 at 1:00 PM that the TC failed to perform and document a semiannual competency evaluation for the only new TP hired in 2021 in their first year of performing moderate complexity testing. The laboratory performs 38 mycology (KOH Preps) tests annually. . D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting 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 -- performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: . Based on personnel competency record review and interview with the National Director of Laboratory Operations (NDLO) on 6/28/2023, the Technical Consultant (TC) failed to evaluate and document the performance of individuals responsible for moderate complexity testing at least annually, after the first year the individual tested patient specimens as evidenced by the following: The surveyor asked for the 2022 personnel competency records for review. The review revealed that annual competency evaluations were not performed and documented at least annually for eight (8) out of eight (8) Testing Persons (TP) performing provider performed microcopy procedures (PPMP) potassium hydroxide (KOH) preps. The NDLO confirmed in an interview on 6/28/2023 at 1:00 PM that the TC failed to perform and document annual competency evaluations for eight (8) out of eight (8) TP's in 2022 after their first year of performing moderate complexity testing. The laboratory performs 38 mycology (KOH Preps) tests annually. -- 2 of 2 --