Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the Mass General Brigham Community Physicians 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 General Supervisor (GS) on 9/15/21, the laboratory failed to indicate on the patient final report the correct name of the laboratory where the test was performed as evidenced by the following: The surveyors reviewed nine (9) patient final test reports dated January 2021 through September 2021. The reviewed revealed: The laboratory failed to indicate the correct name of the laboratory location where the test was performed for nine (9) out of nine (9) patient final test reports. The name on the patient final test reports is Partners Community Physicians Org - One Parkway. The laboratory's name on the CLIA certificate is Mass General Brigham Community Physicians Inc. The GS confirmed in an interview on 9 /15/21 at 1:55 P.M. that the patient final test reports did not indicate the correct name of the laboratory where the test was performed. The laboratory performs approximately 8,071 Microbiology, 18,485 Immunology, 927,690 Chemistry, and 264, 390 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 --