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…)
DATELINE—BIRMINGHAM, ENGLAND: Workforce issues in medical laboratories received special attention here at the 10th Annual Frontiers in Laboratory Medicine (FiLM) conference that ended last week. Probably the major concern going forward is how to attract, train, and sustain adequate numbers in the medical laboratory workforce.
Two speakers addressed medical laboratory workforce issues at a strategic level, with an overview about developments in the United Kingdom and the United States. Speaking about the United Kingdom was Professor Sue Hill, OBE, Ph.D., Chief Science Officer for the National Health Service. Speaking about the United States was Elissa Passiment, Ed.M., CLS (NCA), Executive Vice President, American Society of Clinical Laboratory Science (ASCLS). (more…)
Federal and state laboratory regulators tighten down during inspections of nation’s medical laboratories
Across the United States, medical laboratory accreditation and CLIA compliance is quietly getting tougher. This is a trend which affects every clinical laboratory and anatomic pathology medical group that must comply with CLIA and meet the accreditation requirements of the Medicare program.
One sign that laboratory accreditation and compliance is getting tougher is the increased number of hospital laboratories willing to publicly acknowledge that a recent assessment, survey, or inspection resulted in serious deficiencies.
Federal and state clinical laboratory regulators are backing up tough talk about tighter enforcement of the requirements of the Clinical Laboratory Improvement Act (CLIA) requirements. Over the past 18 months, Dark Daily is aware that two nationally-prominent medical laboratory companies—following CLIA inspections of certain lab facilities—were required to cease certain types of clinical testing until serious deficiencies were corrected. These consequences demonstrate that it is not just hospital laboratories feeling the brunt of more rigorous CLIA inspections.