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.