June 25, 2012 “Intelligence: Late Breaking Lab News”

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Earlier this month, the clinical laboratory at Ohio State University Wexner Medical Center (OSUWMC) was sent a letter by federal CLIA (Clinical Laboratory Improvement Act) officials declaring that the laboratory was in violation of proficiency testing (PT) regulations. The OSUWMC laboratory faces two sanctions. One is revocation of its CLIA license. The second is cancellation of the lab’s approval to receive Medicare payments. The OSUWMC laboratory has 60 days from the June 11 imposition to appeal the determination to revoke the laboratory’s CLIA certificate.


Officials at OSUWMC released the following statement: “This letter from CMS constitutes only a notification of a potential action against The Ohio State Wexner Medical Center’s laboratory. The Ohio State Wexner Medical Center intends to provide additional information to CMS as part of the process of appealing against the potential action. Once CMS reviews this additional information, Ohio State is confident that the government’s concerns will be addressed.” Clients and regular readers of THE DARK REPORT will recall that a growing number of clinical laboratories are finding themselves ensnared in the conflicting language of CLIA requirements as they pertain to proficiency testing. Moreover, federal officials in different regions of the country are handling issues involving PT violations in a different manner. Reports are that the Midwest Region has taken the toughest enforcement actions concerning proficiency testing violations.


Boston Children’s Hospital has announced plans to develop and create an “optimized laboratory infrastructure and lab protocols” for next generation gene sequencing that will meet both CLIA and CAP certification standards. The 395-bed hospital will collaborate with Life Technologies Corporation on this project and will use the company’s Ion Proton Sequencer. Boston Children’s Hospital bills itself as “the world’s largest pediatric research enterprise” and describes its agreement with Life Technologies as a “research and development collaboration to develop an end-to-end genetic sequencing lab workflow.”

Dark Daily Update

dark_daily_logoHave you caught the latest e-briefings from DARK Daily? If so, then you’d know about…

…how 32% of the nation’s 690,000 physicians are now enrolled in the federal program to encourage use of electronic health records (EHR). Smaller groups and rural doctors are lagging in EHR use compared to urban physicians.

You can get the free DARK Daily e-briefings by signing up at www.darkdaily.com.



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