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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FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label

Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs.

UDIs also will apply to certain combinations of products that contain devices licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)

Medical Laboratories at Hospitals Urged to Improve Newborn Screening Procedures After Wisconsin Report Uncovers Shocking Testing Delays

Analysis of almost 3 million newborn blood samples found that tens of thousands of specimens were not screened promptly for rare but deadly disorders, leading to patient harm in some cases

State-mandated newborn testing has come under increased media scrutiny following the discovery that delays in reporting the clinical laboratory test results had resulted in harm to some children with genetic diseases. One source of problems is some hospitals fail to promptly submit specimens from babies to their state’s newborn testing laboratory.

In Wisconsin, pathologists and medical laboratory and laboratory managers probably know the story of Colton Hidde because of news stories about his case. When Karen and Mike Hidde brought their newborn baby Colton home from the hospital after his birth in October 2012, they had no idea that he would soon be close to death. He appeared to be a normal newborn. But he was not, and the Hiddes didn’t find out that he had a rare and life-threatening genetic defect until they rushed him back to the hospital less than 24 hours after bringing him home. (more…)

Medical Device Companies May Pass New 2.3% Federal Excise Tax Along to Healthcare Providers, Including Clinical Pathology Laboratories

Lots of controversy is associated with this new tax levy that was mandated by the Affordable Care Act

Will it be medical device manufacturers or their customers—including medical laboratories—who pay the new 2.3% medical device tax that became effective on January 1, 2013? That question is being asked by healthcare policymakers and experts, as well as pathologists and clinical laboratory administrators.

This new tax is mandated by the Affordable Care Act on medical device sales to healthcare providers. It taxes gross receipts of more than $5 million for manufacturers and importers of medical devices and is unpopular within the medical device industry, including in vitro diagnostics (IVD) manufacturers. (more…)

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…)