Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Holliston Pediatric Group, Inc. 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 record review interview and interview, the technical consultant 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: a) Review of the CMS 209 Laboratory Personnel Report on 8/16/18 showed that there were two (2) new personnel hired and performing testing since the last CLIA recertification survey on 8 /25/16. b) Review of personnel competencies for calendar year 2018 revealed that there was no documentation of semiannual competency evaluation for one (1) of the two (2) new testing personnel (testing personnel number 6). c) The laboratory director confirmed in an interview on 8/16/18 at 2:55 PM that no semiannual competency evaluation had been performed on the one new testing person. 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 --