CMS: 30-day preview period for corrected inpatient quality data begins Friday   08/12/2013
Beginning Aug. 16, hospitals participating in the inpatient quality reporting program will have 30 days to preview corrected data for five readmission measures and one complication measure currently suppressed on the Hospital Compare website, the Centers for Medicare & Medicaid Services announced Friday. CMS suppressed the measure data for heart attack, heart failure, pneumonia, hip and knee replacement, and hospital-wide readmissions, and for hip and knee replacement complications in July due to an issue with how hospitals were categorized as better, worse and no different than the national average. The issue does not affect the calculation of excess readmissions for the hospital readmission payment penalty program. CMS plans to report the corrected measures on the website in October. Hospitals can access their facility-specific preview reports at QualityNet.org.
FDA alerts providers to recall by Specialty Compounding   08/12/2013
The Food and Drug Administration is alerting health care providers and patients to a voluntary recall of all sterile-use products made and distributed by Specialty Compounding LLC of Cedar Park, TX, after 15 patients at two Texas hospitals who received infusions of calcium gluconate supplied by the company developed bacterial bloodstream infections. Any sterile-use products received from the company since May 9 should not be used but quarantined and returned, FDA said. According to information the company provided to FDA, the recalled products were distributed directly to patients in all states but North Carolina, and to hospitals and physicians’ offices in Texas. Cultures from a sample of calcium gluconate compounded by the company showed growth of bacteria, said FDA, which is working with the Centers for Disease Control and Prevention and Texas officials to determine the scope of the contamination. Adverse reactions experienced with any Specialty Compounding products may be reported to FDA's MedWatch program.
FDA awards contract for new way to test radiation countermeasures   08/12/2013
The Food and Drug Administration today awarded Harvard University’s Wyss Institute for Biologically Inspired Engineering a $5.6 million contract to apply its organs-on-chips technology to assessing medical countermeasures for treating acute radiation syndrome, also known as radiation sickness. The technology mimics the functions and tissue structures of living organs on chips the size of a thumb drive. Luciana Borio, M.D., the FDA’s assistant commissioner for counterterrorism policy, said the technology “holds enormous promise for improving our understanding of new medical countermeasures, particularly when it is unethical or unfeasible to conduct efficacy studies in humans; and when available animal models have limited use in accurately predicting human response.”