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- Quality Improvement Strategies 5
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- Device-related Complications 4
- Discontinuities, Gaps, and Hand-Off Problems 1
- Identification Errors 2
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Search results for "Web Resource"
US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.
Silver Spring, MD: US Food and Drug Administration; April 2018.
Reliable use of medical devices is an important contributor to safe health care delivery. This report describes the US Food and Drug Administration's plan to raise awareness of problems with devices in the field, develop new devices with better safety and cybersecurity protections, and enhance innovation and the product life cycle through regulation.
Washington, DC: Department of Veterans Affairs, Office of Inspector General. March 7, 2018. Report No. 17-02644-130.
Systemic weaknesses in the Veterans Affairs health system have resulted in high-profile failures. Highlighting concerns at one medical center that were found to contribute to opportunities for waste, fraud, and poor health care delivery, this report by the Office of Inspector General outlines 40 recommendations to address deficiencies.
St. Paul, MN: Minnesota Department of Health; March 2019.
The National Quality Forum has defined 29 never events—patient safety problems that should never occur, such as wrong-site surgery and patient falls. Since 2003, Minnesota hospitals have been required to report such incidents. The 2018 report summarizes information about 384 adverse events that were reported and found pressure ulcers and invasive procedure events increased, while fall-related deaths decreased. Reports from previous years are also available.
Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients.
US Senate Health, Education, Labor, and Pensions Committee. January 13, 2016.
Insufficient sterilization of duodenoscopes and other medical equipment has been linked to health care–associated infection outbreaks. This report summarizes findings from a government investigation into existing methods for monitoring and reporting device problems and provides recommendations for Congress, hospitals, and the Food and Drug Administration to augment identification and prevention of safety issues associated with medical devices.
Technical Evaluation, Testing, and Validation of the Usability of Electronic Health Records: Empirically Based Use Cases for Validating Safety-Enhanced Usability and Guidelines for Standardization.
Lowry SZ, Ramaiah M, Taylor S, et al. Gaithersburg, MD: US Department of Commerce, National Institute of Standards and Technology; October 2015. NISTIR 7804-1.
Unintended consequences associated with usability of electronic health record (EHR) systems have the potential to negatively affect patient safety. This report outlines standards to enhance safety-related usability of EHRs by identifying root causes of use errors and addressing these weaknesses through human factors design.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 2015. Report No. OEI-01-13-00400.
A widely-reported meningitis outbreak in the United States uncovered quality and safety issues associated with the use of compounded sterile preparations. This publication describes an analysis of five accreditation organizations and their ability to provide oversight and inspection of Medicare hospitals that contract with compounding entities. The authors offer recommendations to help hospitals determine if their compounded sterile preparations contracts ensure products are prepared safely for use, including targeted training for surveyors related to compounding and improved contracting processes.
Fourth Report of Session 2014–15. House of Commons Health Committee. London, England: The Stationery Office; January 13, 2015. Publication HC 350.
Complaints are a proactive way to monitor and address recurring problems that may result in adverse events and system failures. This report discusses progress achieved through complaint response efforts in the United Kingdom and provides recommendations to augment how complaints are managed to develop further improvements.
Healthcare Inspection: Evaluation of the Veterans Health Administration's National Consult Delay Review and Associated Fact Sheet.
Daigh JD Jr. Washington, DC: VA Office of the Inspector General; December 15, 2014. Report No. 14-04705-62.
Misrepresentation of findings, either by accident or design, can result in ineffective use of resources and poor decision-making. This investigation found inconsistencies in the information reported by the Veterans Health Administration in the widely-publicized analysis discussing weaknesses in the organization that resulted in delayed care. The author calls for the assessment to be revisited to ensure conclusions and work toward improvement are verifiable to augment the safety and timeliness of care provided to veterans.
Pino R, Furniss WH, Mueller L, Olson JC. Hartford, CT: Connecticut Department of Public Health; October 2016.
This annual publication provides data on adverse events reported to the Connecticut Department of Public Health. The most recent report discusses an analysis of the 456 incidents submitted in 2015, which represents a slight decrease. The most common adverse events reported were pressure ulcers and fall-related injuries or deaths. Past reports are also available.
Web Resource > Government Resource
Nova Scotia Department of Health and Wellness.
Incident reporting systems are an important method for capturing, analyzing, and learning about a broad range of potential safety issues. This Web site provides access to information about serious adverse events reported to the Department of Health and Wellness in Nova Scotia related to surgical procedures, product or device use, patient harm, care management, and hospital environment.
Federal Register. Rockville, MD: Agency for Healthcare Research and Quality. February 18, 2014;79:9214-9215.
Web Resource > Government Resource
Division of Licensing and Regulatory Services, Maine Department of Health and Human Services.
This Web site provides information about Maine's statewide incident reporting initiative and includes annual sentinel event reports.
Web Resource > Government Resource
National Patient Safety Agency.
This Web site provides data on safety incidents from the United Kingdom in the form of workbooks sorted by either organization or region.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; July 2012. Report No. OEI-06-09-00092.
This report built on earlier research to examine rates of adverse events reported to state-level reporting systems compared with hospital data. It found that, even in states with required hospital reporting of adverse events, only about one in nine events is reported to the state. Because few of the events were found in each hospital's incident reporting system, the investigators concluded that the low rate of reporting was likely due to hospital failure to identify events rather than hospitals failing to report known events.
Lucado J, Paez K, Elixhauser A. HCUP Statistical Brief #109. Rockville, MD: Agency for Healthcare Research and Quality; April 2011.
Salt Lake City, UT: Utah Department of Health, Utah Hospitals & Health Systems Association, and HealthInsight; March 10, 2010.
This brief provides information on 101 sentinel events reported to the state of Utah in 2009. The report also includes background on efforts to address such incidents.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 5, 2010. Report No. OEI-06-09-00360.
Tools/Toolkit > Multi-use Website
Portland, ME: National Academy for State Health Policy.
This online toolkit provides sample documents, policies, and Web site links related to the 27 states that have implemented adverse event reporting initiatives.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; December 2008. Report No. OEI-06-07-00471.
The Tax Relief and Health Care Act of 2006 mandated that the Office of Inspector General (OIG) report to Congress a series of analyses with the first related to understanding the issues around hospital-based adverse events. This related and simultaneously released report identifies and describes state reporting systems and how they utilize the captured information. The report concludes that as of January 2008, 26 states had reporting systems in place, 23 states used the data to hold individual hospitals accountable, and 18 states reported using the data to promote learning and develop prevention strategies. A past AHRQ WebM&M perspective discusses the role of state reporting systems in advancing patient safety.