Summary:
Summary Statement of Deficiencies D0000 A CLIA recertification survey was conducted for the South Shore Medical Center - Kingston 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, technical consultant, and laboratory manager the laboratory failed to ensure the test report indicated the name of the laboratory where the test was performed as evidenced by the following: The laboratoy transitioned electronic medical record (EMR) and laboratory information system (LIS) vendors to Epic on 7/1/17. The surveyor reviewed twenty (20) patient charts from 1/24/18 - 6/3/19. The review revealed the new EMR and LIS indicated "SSMC KIN LAB" as the name of the laboratory where the tests were performed. The name of the laboratory is "South Shore Medical Center - Kingston." The laboratory director, technical consultant, and laboratory manager confirmed in an interview on 6/12/19 at 2:30 PM that the laboratory report in the EMR and LIS did not indicate the name of the laboratory where the test was performed. The laboratory performs 10,027 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 --