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Transparency in Clinical Laboratory Results

    • ISSUE-brief-3-Trans-Lab-ResultsIf you are like most physicians, then you were probably bewildered by the U.S. Department of Health and Human Services' (DHHS) recent changes to the Health Insurance Portability and Accountability Act (HIPAA) privacy rules.

      "Upon request of a patient (or the patient's personal representative), laboratories subject to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 may provide the patient, the patient's personal representative, or a person designated by the patient, as applicable, with copies of a completed test report that, using the laboratory's authentication process, can be identified as belonging to that patient."1

      While Illinois law cites that the laboratory results must be reported to the ordering practitioner, you should know that federal law supersedes state law on this matter.2

      Applying laboratory regulations to your practice

      Here's how the federal and state directives work. DHHS formulates the regulations involving HIPAA and CLIA, while the Illinois Department of Public Health (IDPH) issues CLIA certificates and monitors the local activities of laboratories. Physician practices, clinics, hospitals and a few other HIPAA-covered entities are allowed to own and operate laboratories, but they must first register and
      certify their facilities with the state in order to bill Medicare, Medicaid and third-party payers for payment.


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