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The Food Safety Modernization Act
(Sparta Systems: Holmdel, NJ) – On Jan. 4, President Obama signed into law one of the most comprehensive changes to U.S. food safety since the 1938 Food, Drug, and Cosmetic Act. The Food Safety Modernization Act gives the Food and Drug Administration (FDA) and related government agencies the…
Corkscrewing Electrons: Like Rotini, But Smaller
Electron microscopes are among the most widely used scientific and medical tools for studying and understanding a wide range of materials, from biological tissue to miniature magnetic devices, at tiny levels of detail. Now, researchers at the National Institute of Standards and Technology (NIST)…
Health Care IT: Concepts in Clinical Measurement
(National Quality Forum: Washington) -- Two new studies by the National Quality Forum (NQF) are designed to promote future work in clinical decision support (CDS) and expand the understanding of the benefits of health information technology (HIT) tools on care delivery. The reports “lay the…
Expert Examines Main Points of New Food Safety Measure
On Dec. 21, 2010, the U.S. Congress passed the FDA Food Safety Modernization Act, the first major food safety measure in the United States in more than 60 years. Given the recent and frequent deadly food-borne illness outbreaks, this is welcome news to many Americans. A food safety expert with the…
ACSI: Customers Not Impressed with Health Insurance
(ACSI: Ann Arbor, MI) -- Steady or improving customer satisfaction with several types of financial services is not enough to overcome the customer satisfaction challenges of the health insurance industry, according to a recent report released by the American Customer Satisfaction Index (ACSI). The…
FDA’s Transparency Initiative Revealed at New Website
(FDA: Silver Spring, MD) — The U.S. Food and Drug Administration (FDA) has introduced a new web resource called FDA Basics for Industry to help companies and others save time and resources in their interactions with the agency. The website includes basic information about the regulatory process,…
New Year, New Food Law
(InfinityQS: Chantilly, VA) -- With the Jan. 4 signing of the Food Safety Modernization Act, the most significant update in American food safety was passed into law since the Federal Food, Drug and Cosmetic Act of 1938. This new law authorizes the Food and Drug Administration (FDA) to increase…
Not Just Another Management Tool
U.S. health care organizations, from multihospital systems to rural community health centers, are gearing up for the challenge of their times: the effect of health care reform on how they care for patients and how they run their operations. Future health care organizations will need to find a way…
Event: Pharmaceutical Inspections and Compliance
(ISPE: Tampa, FL) -- As part of its 2011 conference, “Applying Solutions to Emerging Industry Challenges,” the International Society for Pharmaceutical Engineering (ISPE), a global, nonprofit association of more than 22,000 professionals, will feature eight educational sessions designed to help…
Study: Mortality Rates Unreliable for Assessing Hospital Quality
(Harvard Medical School: Boston) -- Researchers at Harvard Medical School (HMA) and Massachusetts General Hospital have found wide disparities among four common measures of hospitalwide mortality rates, with competing methods yielding both higher and lower-than-expected rates for the same…
Standards Revised for Pharmacy Quality Management Accreditation Programs
(URAC: Washington) -- URAC, a leading health care accreditation and education organization, has released revisions to three products within its suite of Pharmacy Quality Management Accreditation programs. These revisions are part of organization’s commitment to regular comprehensive review of its…
Massachusetts Physician Groups Improving Patient Experience
Most Massachusetts physician groups are using results from a statewide patient survey to help improve patient experiences, but a significant number are not making use of the information or are making relatively limited efforts, according to a new RAND Corp. study. Although physician…
Book: Safer Hospital Care: Strategies for Continuous Innovation
(CRC Press: Boca Raton, FL) -- From newborns switched in the nursery to medication mix-ups and hospital-acquired infections, we are all familiar with the horror stories about hospital safety. The safety issue in U.S. hospitals has become so profound and embedded, that we cannot hope to fix it…
Free ISO 22000 Gap Analysis Audit Tool
(Vinca LLC: Eden Prairie, MN) -- Quality systems professionals at Vinca LLC have outlined the steps to use in developing quality management systems with clients. The first step they recommend is to complete a thorough project plan. An effective plan must begin with solid information about what…
EAGLE Food Registrations Offers Certification to SQF Ethical Sourcing Standard
(EAGLE Food Registrations: Dayton, OH) -- EAGLE Food Registrations Inc., specializing in third-party certification to international management system standards, announced it will begin certifying companies to the Safe Quality Food (SQF) Ethical Sourcing Standard on Jan. 3. SQF Ethical Sourcing…
Audio Program: “The Patient Activist”
(Institute for Healthcare Improvement: Cambridge, MA) -- During Dec. 9–12, some 50 patient activist leaders travelled to the Institute for Healthcare Improvement’s (IHI) National Forum on Quality Improvement in Orlando, Florida, to share experiences and consider ways to combine forces to be that…
Book: <i>Leading the Lean Healthcare Journey</i>
(CRC Press: Boca Raton, FL) -- In the book Leading the Lean Healthcare Journey: Driving Culture Change to Increase Value (CRC Press, 2010), by Joan Wellman, Patrick Hagan, and Dr. Howard Jeffries, every health care organization can learn from Seattle Children’s Hospital’s continuous improvement…
Book: <i>Transforming Health Care</i>
(Productivity Press: Boca Raton, FL) -- What does the production line at a car manufacturer have to do with a doctor scrubbing in for brain surgery? A lot, as it turns out. For almost 10 years, Virginia Mason Medical Center in Seattle has adopted the essential principles of the Toyota…
Book: Essentials for the Improvement of Healthcare Using Lean & Six Sigma
I n his new book, Essentials for the Improvement of Healthcare Using Lean & Six Sigma (CRC Press, 2010), author Diomidis H. Stamatis (aka Dean) presents solutions to the problems that plague the health care industry by providing case studies and explaining a multitude of quality tools and…
Get Quick Answers on Conformity to IEC 60601 Third Edition
(UL: Northbrook, IL) --  Underwriters Laboratories (UL), a world provider of product safety testing and certification, has released an extensive resource, “UL’s Comprehensive 60601 3rd edition Q&A” that addresses more than 70 frequently asked questions (FAQ) regarding IEC 60601 third edition,…
Most Drug and Biological Product Makers Meet Postmarketing Requirements
Despite recent headlines targeting Johnson & Johnson’s uncorrected manufacturing problems and deficiencies, most makers of approved drug and biological products are meeting their regulatory obligations and targets for postmarketing studies and clinical trials in a timely manner, according to a…
Webinar: “Vision Solutions for Food & Beverage Production and Packaging”
(Cognex Corp.: Natick, MA) -- Tough competition means food and beverage manufacturers and packagers cannot afford production errors. This is why they must increasingly rely on machine vision systems and image-based ID readers to help achieve quality, improve productivity, and comply with product…
New Dissolution Apparatus for Pharmaceutical Quality Control
(Agilent Technologies: Santa Clara, CA) -- Agilent Technologies Inc. has introduced the 708-DS Dissolution Apparatus, a quality control instrument that can be configured for manual and automated applications. The new device includes an improved design that minimizes variability and improves…
SmartSolve’s Update Includes New SmartStudio Platform
(Pilgrim Software Inc.: Tampa, FL) --  Pilgrim Software Inc., a  global provider of enterprise risk, compliance, and quality management (ERCQM) software solutions, has announced the availability of SmartSolve 9, the latest and most enhanced version of its integrated process automation platform…
QualiPedia: Never Events
The term “never events” refers to particularly shocking medical errors that should never occur (e.g., wrong-site, wrong-patient, wrong-procedure surgeries). There are other terms used in official capacities for such errors, but none have captured the nation’s attention or perhaps done more toward…

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