Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Andover Obstetrics and Gynecological Associates laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. . D6051 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8)(v) The procedures for evaluation of the competency of the staff must include, but are not limited to assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples. This STANDARD is not met as evidenced by: Based on record review and interview, the technical consultant failed to ensure that the procedures for competency of the staff included assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for testing personnel as evidenced by the following: A review of employee competency evaluations for calendar years 2016 and 2017 revealed that the procedures for competency of the staff did not include assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples for one (1) of three (3) personnel performing microbiology testing. The technical consultant confirmed that all personnel performing microbiology testing had not been included in blind sample testing of some type in an interview on 2/16/18 at 9:15 AM. 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 --