Apr 2, 2014 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
NEWS UPDATE: American Association of Laboratory Accreditation (A2LA) is given four-year authority to accredit clinical laboratories to CLIA requirements for all specialty and subspecialty lab test areas
There’s a new Centers for Medicare and Medicaid Services-approved (CMS) accrediting organization for clinical laboratories. Medicare officials granted deeming status for Clinical Laboratory Improvement Amendments (CLIA) to the American Association for Laboratory Accreditation (A2LA). The approval marks the first time in two decades that CMS has added a new organization to accredit medical laboratories under CLIA.
CMS announced the approval in a notice published March 25 in the Federal Register. CMS approved A2LA’s application as an accreditation organization for clinical laboratories under CLIA for all specialty and subspecialty areas for four years. “We have determined that the A2LA meets or exceeds the applicable CLIA requirements,” stated the CMS announcement. (more…)
Sep 4, 2013 | Coding, Billing, and Collections, Digital Pathology, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
As medical laboratories struggle to reduce costs and squeeze their budgets, it is essential that the lab’s quality assurance/quality control program is run properly to protect and enhance the analytical integrity of lab test results
When does budget cutting in a clinical laboratory begin to undermine the accuracy and analytical integrity of the medical laboratory test results produced by the laboratory?
This question is apparently a subject of much discussion within some lab organizations where aggressive cost reduction programs are shrinking lab staff and reducing funds spent on controls and similar QA/QC resources.
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Feb 20, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology
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 Wikipedia.com.)
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Dec 10, 2012 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
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 Report “Congress May Respond to Tough CLIA PT Penalties,” August 6, 2012.) (more…)
Oct 19, 2012 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Pathology
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…)
