Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the New England Women's Healthcare laboratory on 02/01/2024 pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D6045 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(7) (b) The technical consultant is responsible for-- (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; This STANDARD is not met as evidenced by: . Based on personnel training record review and interview with Technical Consultant (TC) on 2/01/24, the TC failed to identify training needs and assuring each testing person (TP) receives appropriate training and education prior to patient testing as evidenced by the following: The surveyor asked for the personnel training records for review. The review revealed that the TC failed to document that nine (9) out of nine (9) TPs performing the Fern test on amniotic fluid received training before reporting patient results. The TC confirmed in an interview on 2/01/24 at 10:37 AM that the 9 TPs did not have any training documentation on file for performing the Fern test on amniotic fluid. The laboratory performs 25 Fern tests annually. . 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. 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 personnel competency record review and interview with Technical Consultant (TC) on 2/01/24, the 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 personnel competency records for review. The review revealed that a semiannual competency evaluation was not performed and documented for nine (9) out of nine (9) testing personnel performing the Fern test on amniotic fluid in the first year (2022) of testing. The TC confirmed in an interview on 2/01/24 at 10:37 AM that TC failed to perform and document semiannual competency evaluations for the 9 TPs performing the Fern test on amniotic fluid. The laboratory performs 25 Fern tests annually. . 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. This STANDARD is not met as evidenced by: . Based on personnel competency record review and interview with Technical Consultant (TC) on 2/01/24, the 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 personnel competency records for review. The review revealed that annual competency evaluations were not performed and documented at least annually for nine (9) out of nine (9) testing personnel performing the Fern test on amniotic fluid after the first year of testing. The TC confirmed in an interview on 2/01 /24 at 10:37 AM that TC failed to perform and document annual competency evaluations for the 9 TPs after the first year of performing the Fern test on amniotic fluid. The laboratory performs 25 Fern tests annually. . -- 2 of 2 --