Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Quincy Pediatric Associates Inc. laboratory pursuant to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and CLIA regulations at 42 CFR 493. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the laboratory director, the laboratory failed to ensure the test report indicated units of measure as evidenced by the following: The laboratory transitioned Electronic Medical Record (EMR) vendors from LMR to Epic in June 2017. Chart review of Complete Blood Count (CBC) results revealed the new EMR did not indicate units of measure for CBC analytes. The laboratory director confirmed in an interview on 3/20/18 at 11:00 AM that the laboratory report in the EMR did not indicate units of measure for CBC analytes. The laboratory performs 19,200 Hematology tests annually. 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 --