Accreditation and regulatory implications of electronic health records for laboratory reporting.
The Clinical Laboratory Improvement Amendments of 1988 include strict regulations for reporting content, and it falls on the named director to ensure that this content is available to the caregiver. With the electronic health record serving as the conduit to the end user of the laboratory data, the laboratory generally, and the director specifically, must verify accurate transmission of these content components. An understanding of regulatory and accreditation requirements is essential both to allow the proper discharge of these mandated responsibilities and to enforce the role and authority that the pathologist must have to ensure that these requirements are satisfied by the reporting system. The regulatory requirements will be discussed in the context of the Clinical Laboratory Improvement Amendments of 1988 standards; however, interpretation and expansion on these regulations exist both in Clinical Laboratory Improvement Amendments of 1988 inspection guidelines from the Centers for Medicare and Medicaid Services and in accreditation program requirements. This regulatory expectation both places the laboratory director in a position of risk and provides leverage to ensure meaningful and accurate communication of laboratory information.
From the Department of Pathology and Laboratory Medicine, Penn State Hershey Medical Center, Hershey, Pennsylvania (Dr Castellani); the Informatics Program, Department of Pathology, Yale University School of Medicine, New Haven, Connecticut (Dr Sinard); the Division of Laboratory Medicine, Geisinger Medical Laboratories, Danville, Pennsylvania (Dr Wilkerson); the Diagnostic Intelligence and Health Information Technology Committee, College of American Pathologists, Northfield, Illinois (Dr Whitsitt); and the Center for Pathology Informatics, Cleveland Clinic Foundation, Cleveland, Ohio (Dr Henricks).
William J
WJ
Castellani
John H
JH
Sinard
Myra L
ML
Wilkerson
Mark S
MS
Whitsitt
Walter H
WH
Henricks
D000068:Accreditation; D014487:Centers for Medicare and Medicaid Services, U.S.; D057286:Electronic Health Records / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D010338:Pathology, Clinical / Q000592:standards*; D014481:United States