results interfaces are not specifically mandated in the Stage 1 meaningful use criterion). Because many of the CQMs that are options for clinicians to report involvelaboratory tests [Tables 5 and 6], laboratories may find opportunities to facilitate their clients’ ability to meet these meaningful use reporting requirements. Atminimum, eligible providers will likely want to receive test result data in a way that will automatically populate information into their EHRs and in turn facilitate CQMreporting to meet meaningful use criteria.Challenges for LaboratoriesFor laboratories, more widespread and time-sensitive expectations for LIS-EHR interfaces present substantialchallenges and bring with them considerations that go beyond the specific requirements mentioned in the FinalRules. Implementing interfaces between LISs and EHRsis not “plug and play,” and requires considerable attentionto technical as well as organizational/administrative factors. In addition, there may be considerable expensesinvolved in implementing interfaces and maintaining interfaces. There may be lack of control or involvement available to the laboratory for EHR management at physician sites. Poor process design resulting in problemswith laboratory testing may be blamed inappropriately on the laboratory.
J Pathol Inform 2011, 2:7 Primary among the challenges is that the laboratory hasthe responsibility for the accuracy of test result data that are transmitted from the laboratory to receiving systems. The CLIA (Clinical Laboratory ImprovementAmendments) regulation states this responsibility specifically (42 CFR 493.1291(a)):“Thelaboratorymusthaveadequatemanualorelectronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following:…(2) Results and patient-specific data electronically reported to network or interfaced systems.”As part of its stated goal to promote the electronic exchange of health information and in recognition of the fact that laboratory information is an integral part of EHRs, CMS recently issued a revised guidance related to interpretation and compliance with CLIA requirementsfor laboratory result reporting and laboratory information exchange. This guidance was issued in March 2010 in the form of the document entitled “Issuance of RevisedSurveyProceduresandInterpretiveGuidelinesforLaboratories and Laboratory Services in Appendix C of the State Operations Manual.” Generally, such interpretiveguidance in the State Operations Manual is the guidancefor surveyors for interpretation and application of CLIArequirements when surveying or inspecting laboratories.