The Future of the Profession

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Options for ordering and utilizing diagnostic laboratory testing are burgeoning. It is estimated that more than 10,000 diagnostic laboratory tests are available to providers to aid in diagnosis and treatment. Further, spending for in vitro diagnostics represents 2-3% of the U.S. gross domestic product.¹ With the emergence of testing capability in the genome, and the promise of personalized, designer laboratory medicine, numbers of tests and their costs are increasing daily. Unfortunately, the services delivery gap between analytic accuracy (laboratorians' providing valid, actionable test results) and medical meaningfulness (providers' understanding of what to do with them) is growing larger, too. Issues related to re-interpretation of diagnostic laboratory information produced by older generations of technology in light of information from new, more sensitive and specific generations are increasing, also, because of the rapid advancement of technology and computerization. With the Health and Human Services (HHS) Department announcement, September 12, 2011, https://www.cms.gov/apps/media/fact_sheets.asp, that HHS, Center for Medicare and Medicaid Services (CMS), and Centers for Disease Control and Prevention (CDC) intend to amend the Clinical Laboratory Improvement Act of 1988 to allow patients direct access to their test results, the stakes have become even higher in the challenge to provide quality laboratory information at reasonable costs.²

As discussed extensively in the professional literature, a new practice role is needed to address this gap in services delivery in laboratory medicine (LM).^3.4,5 While other members of the LM team, i.e., pathologists and specialty Ph.D. scientists, focus on medical and analytic issues, respectively, this new practice role…