News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Despite Passage of New Law on CLIA enforcement, Ohio State University Settles with CMS Agrees to Pay $268,000, and Names New Clinical Laboratory Medical Director

Medical laboratory continues to operate, retains its CLIA certificate, and maintains that the PT violations at heart of CMS case were inadvertent

One nationally prominent clinical laboratory organization closed its chapter in the ongoing story of CLIA enforcement of the regulations governing the inadvertent referral of proficiency testing specimens. But this chapter ended with an unexpected twist for the Ohio State University Wexner Medical Center (OSUWMC), which was given severe sanctions by officials of the Centers for Medicare & Medicaid Services (CMS), despite recent enactment of a new federal law on the subject of enforcement of CLIA proficiency testing errors.

The settlement between OSUWMC and CMS was announced on January 16. It calls for OSUWMC to:

  • Appoint a new medical director for the clinical laboratory,
  • Pay $268,000, and
  • Provide additional training to the medical laboratory staff in proficiency testing (PT).

New Medical Director Named at OSUWMC’s Clinical Laboratory

OSU named Daniel Sedmak, M.D., to the position of medical director of the clinical laboratory, as part of this resolution with federal officials who administer the Clinical Laboratory Improvement Amendments (CLIA). Sedmak is currently the Chair of the OSU College of Medicine, Department of Pathology and a professor of pathology.


Last month, Ohio State University Wexner Medical Center issued a press release stating that it had resolved pending sanctions assessed against its clinical laboratory by the Centers for Medicare & Medicaid Services for violations of CLIA requirements, including the inadvertent referral of proficiency testing specimens. (Photo by


TEST Act Signed By President Obama, Provides Regulators Discretion When Clinical Laboratories Mistakenly Violate CLIA PT Requirements

Pathologists will welcome this law, which provides more latitude for federal regulators should a medical laboratory inadvertently refer a proficiency testing specimen

Last Tuesday, the clinical laboratory testing industry gained an important measure of regulatory relief after President Obama signed into law the Taking Essential Steps for Testing (TEST) Act of 2012. This law removes severe penalties for medical laboratories that inadvertently violate proficiency testing (PT)  requirements.

More specifically, the language of the TEST Act provides guidance to federal regulators to resolve an issue concerning the inadvertent referral of PT specimens as defined by the Clinical Laboratory Improvement Amendments (CLIA) statute of 1988. (See The Dark ReportCongress May Respond to Tough CLIA PT Penalties,” August 6, 2012.) (more…)

Bill to Fix CLIA Proficiency Testing Language for Clinical Laboratories Passes in the House, Awaits Senate’s Return in November

New law would lessen penalties for medical laboratories from violations of CLIA regulations if they made inadvertent referrals of  proficiency tests to other clinical labs

Clinical laboratories may have to wait at least another month before the U.S. Senate returns from recess to vote on a bill to remove severe penalties for labs that inadvertently violate certain CLIA proficiency testing (PT) requirements. A similar bill was passed in the House in September.

The bill, S. 3391: Taking Essential Steps for Testing Act, was ready for a Senate vote in mid-October. It was set aside so that senators could return home while the campaign season entered its final weeks. (more…)

Proactive Healthcare Emphasized as United Kingdom Works to Reform Healthcare System and Clinical Pathology Laboratory Testing

Speakers at Frontiers in Laboratory Medicine See Increased Role for Pathology

DATELINE: BIRMINGHAM, ENGLAND—As our North American readers of Dark Daily arrive for work this morning, it will be late afternoon here in the United Kingdom and the last presentations on the second day of the 10th annual Frontiers in Laboratory Medicine (FiLM) will be wrapping up.

It was a packed auditorium this year at FiLM, as clinical biochemists, pathologists, and medical laboratory scientists gathered to learn about achieving best practices in pathology management and clinical laboratory operations. One reason for this heightened interest is the major reforms already cascading throughout the United Kingdom’s National Health Service (NHS).


Training America’s Next Generation of Clinical Pathology Laboratory Managers

Demand for Capable Medical Laboratory Managers Will Skyrocket In Coming Years

Much is written about the acute—and soon to worsen—shortage of medical technologists (MT) and other skilled positions in America’s clinical laboratories and pathology groups. But what gets constantly overlooked is the equally critical need to have capable clinical laboratory managers, supervisors, directors, and administrators at every level in the medical laboratory organization.

This situation creates an unprecedented opportunity for those up-and-coming med techs and laboratory professionals who aspire to a management career in their clinical laboratory. Demand for their services is assured. But before they can step into management positions that come with increased responsibility and higher salaries, they must have the training, the experience, and the maturity required to be an effective manager. (more…)