Singular views of the year ahead: continued pressure and P4P.
The implications of GAO findings from its in-depth review of CLIA could have far-reaching consequences for labs of all sizes. Recent highly publicized lab failures have focused attention on inspections and CLIA enforcement. As a result, a number of labs can look forward to unannounced inspections. Regulators, however, must be wary of the unintended outcomes and potential disruptions to patient care--especially in smaller lab settings.
In 2006, lab managers must demonstrate laboratory quality every day in order to succeed in an evolving payment system. With heightened Congressional concern over patient safety, quality indicators become even more important to P4P. Held increasingly accountable for overall operations in light of waived testing, lab directors need to devote more attention to competency and training for testing personnel. Regulators investigating government fraud and abuse will broaden their scope to include quality-of-care issues. For all these reasons, savvy directors would do well to embrace robust quality-management systems as a path to demonstrating quality each and every day.
--Maxfield L. Williams
Director, Policy and External Affairs
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|Title Annotation:||Clinical Laboratory Improvement Amendments|
|Author:||Williams, Maxfield L.|
|Publication:||Medical Laboratory Observer|
|Article Type:||Brief Article|
|Date:||Dec 1, 2005|
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