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Book/Report
Legislative Report to the General Assembly: Adverse Event Reporting.
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.
Book/Report
Few Adverse Events in Hospitals Were Reported to State Adverse Event Reporting Systems.
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.
Web Resource > Multi-use Website
Hospital Safety Grade.
Leapfrog Group.
Drawing from data reported by the Leapfrog Hospital Survey, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), and the Centers for Medicare and Medicaid Services (CMS), this website provides grades for hospitals in the United States based on their safety. The 2017 results are the fifth generation of the scores. A related report from the Armstrong Institute examines avoidable death associated with grading hospitals.
Book/Report
Medication-Related Adverse Outcomes in U.S. Hospitals and Emergency Departments, 2008.
Lucado J, Paez K, Elixhauser A. HCUP Statistical Brief #109. Rockville, MD: Agency for Healthcare Research and Quality; April 2011.
Using data from the Healthcare Cost and Utilization Project, this report updates a 2004 analysis of medication-related adverse events and includes incidents in emergency departments.
Tools/Toolkit > Multi-use Website
Patient Safety Toolbox.
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.
Tools/Toolkit > Fact Sheet/FAQs
FDA 101: How to Use the Consumer Complaint System and MedWatch.
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; February 27, 2009.
This fact sheet provides information for consumers about how to report adverse drug events and product complaints to the US Food and Drug Administration (FDA) through the Consumer Complaint Reporting system and MedWatch.
Book/Report
Adverse Events in Hospitals: State Reporting Systems.
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.
Web Resource > Government Resource
Indiana Medical Error Reporting System.
Indiana State Department of Health.
This Web site provides background and information on Indiana's statewide incident reporting initiative.
Book/Report
VA Health Care: Selected Credentialing Requirements at Seven Medical Facilities Met, but an Aspect of Privileging Process Needs Improvement.
Washington, DC: United States Government Accountability Office; May 2006. Publication GAO-06-648.
This report reviews findings from a federal inspection indicating that Veterans Affairs (VA) facilities, while complying with basic credentialing policies, are not routinely submitting malpractice data as required to be used by the VA to inform privileging determinations.
Web Resource > Government Resource
Patient Safety Reporting Initiative.
New Jersey Department of Health and Senior Services.
This Web site supports the data collection and educational initiatives associated with New Jersey's incident reporting program. The site includes reporting forms, instructions, and a patient safety newsletter.
Web Resource > Government Resource
MedWatch.
US Food and Drug Administration.
MedWatch, the Food and Drug Administration (FDA) Safety Information and Adverse Event Reporting Program, serves both health care professionals and consumers of health care products. The site shares safety information about medications and medical products that are regulated by the FDA.
Book/Report
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.
Book/Report
NHS Safety Thermometer Report: Patient Harms and Harm Free Care, November 2014–November 2015.
Leeds, UK: Clinical Support Audit Unit, Health and Social Care Information Centre. December 9, 2015. ISBN: 9781783865697.
The NHS Safety Thermometer is a tool developed by the National Health Service to facilitate staff participation in measuring patient harm in various care environments. This report explores the data collected on four types of health care–acquired conditions (pressure ulcers, falls, catheter–associated urinary tract infections, and venous thromboembolisms) in NHS patients over a 1-year period.
Book/Report
Indiana Medical Error Reporting System: Final Report for 2014.
Whitson T, Garten B, Ordway GV. Indianapolis, IN: Indiana State Department of Health; 2015.
This annual report provides information on never events reported to the Indiana Medical Error Reporting System. The most common problems in the 114 incidents reported in 2014 were advanced pressure ulcers, retained foreign objects, and wrong-site surgery. Past reports are also available.
Book/Report
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.
Press Release/Announcement
Infections associated with reprocessed flexible bronchoscopes.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; September 17, 2015.
Use of incompletely cleaned medical devices has been linked to health care–associated infections. Drawing from reports submitted to the FDA regarding infections related to reprocessed flexible bronchoscopes, this announcement offers recommendations to enhance the reliability of scope sterilization methods.
Book/Report
Complaints and Raising Concerns.
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.
Book/Report
Medicare’s Oversight of Compounded Pharmaceuticals Used in Hospitals.
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.
Book/Report
National and State Healthcare-Associated Infections Progress Report.
Avery L, Bennett R, Brinsley-Rainisch K, et al. Atlanta, GA: Centers for Disease Control and Prevention; January 2015.
This annual analysis explores rates of health care–associated infections reported in the United States. Data from 2013 revealed significant reductions central line–associated bloodstream infections and surgical site infections, while rates of catheter-associated urinary tract infections increased, raising awareness of the need for enhanced prevention efforts nationwide.
Book/Report
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.
