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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Clinical Pathology Laboratories Get a New CLIA Accreditation Choice as CMS Grants Deeming Status to A2LA

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…)

Adoption of Quality Management Systems Could Mean Competitive Advantage for Clinical Pathology Laboratories

ISO 15189 is a quality management system  specifically designed for the needs of medical laboratories

Use of quality management systems (QMS) by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.

Going the Extra Mile to Improve Quality Could Be Strategic Opportunity

On all fronts of laboratory medicine, requirements are becoming more stringent. Each year, labs find themselves held to higher standards for compliance with both Clinical Laboratory Improvement Act (CLIA) requirements and Medicare accreditation guidelines. This situation will become further complicated as clinical labs face the need to also meet the requirements of accountable care organizations (ACOs) and similar models of integrated clinical care. Early adopters are responding to these marketplace dynamics by making strategic use of a QMS to boost the performance of their clinical laboratory organizations. As they do, they often gain a competitive advantage. (more…)

Clinical Pathology Laboratory Industry’s Innovators in Lean, ISO 15189, and Process Improvement Gather in San Antonio

Speakers at Sixth Annual Lab Quality Confab told attendees that ACOs and integration of clinical care now make it important for medical laboratories to use Lean and QMS to deliver more value while substantially reducing costs

DATELINE: SAN ANTONIO, TEXAS—Here at the 6th annual Lab Quality Confab and Process Improvement Institute (LQC), an enthusiastic crowd of clinical laboratory industry “first movers” gathered to learn how leading medical laboratories, pathology groups, and hospitals are harnessing the power of process improvement to drive gains in quality, customer satisfaction, and financial performance.

Institute of Medicine Report RecommendsContinuous Learning

LQC’s founder and host, The Dark Report‘s (TDR) Editor-in-Chief, Robert Michel, opened the general session on day one with a look at a recent report by the Institute of Medicine (IOM). The report, titled “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America”, has significant implications for healthcare providers. Including clinical laboratories. (more…)

Clinical Laboratories in United States Show More Interest in ISO 15189 Accreditation

It may be a small number of 15189-accredited medical laboratories, but these are prominent lab organizations and their ranks are growing

One by one, a small number of innovative clinical laboratory organizations are taking steps to earn accreditation to either ISO 15189 or CAP 15189. This is a quiet trend and one that has yet to attract widespread notice across the world of medical laboratory and pathology testing.

It is a trend that touches clinical lab organizations of all sizes. For example, many lab executives may be surprised to learn that multibillion-dollar Laboratory Corporation of America (NYSE: LH) has five different clinical laboratory locations that have earned accreditation to CAP 15189. (more…)

Innovative Clinical Pathology Laboratories Use Quality Management Systems (QMS) to Deliver Added Value to Physicians

DATELINE: San Antonio, Texas—This week, a large and enthusiastic crowd of clinical laboratory managers and pathologists gathered here to participate in the fifth annual Lab Quality Confab, a conference devoted to Lean, Six Sigma, and process improvement in medical laboratories and hospitals.

It was an opportunity to judge the “state of the clinical laboratory testing industry” in regards to how quality management and the tools of Lean and continuous improvement are helping to transform the nation’s more innovative medical laboratory organizations. This is an important trend in laboratory medicine and it is still in its earliest stages.