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Book/Report
Adverse Health Events in Minnesota: 13th Annual Public Report.
St. Paul, MN: Minnesota Department of Health; February 2017.
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 2016 report summarizes information about 336 adverse events that were reported and found that while deaths due to medical error rose, the number of falls and fall-related deaths reached the lowest point since 2011. There were no reported incidence of patient suicide for the first time since 2011. Reports from previous years are also available.
Newspaper/Magazine Article
Health literacy and patient safety events.
Gardner LA. PA-PSRS Patient Saf Advis. June 2016;13:58-65.
Insufficient health literacy is a known patient safety hazard. This article reviews incidents submitted to a state reporting initiative where insufficient patient understanding may have played a role in delayed or missed care and describes a program to encourage adoption of teach-back and other strategies to help patients better comprehend their health care instructions. A past PSNet perspective discussed the role of health literacy in patient safety.
Journal Article > Study
Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.
Moore TJ, Furberg CD, Mattison DR, Cohen MR. Pharmacoepidemiol Drug Saf. 2016;25:713-718.
According to this study, many adverse drug event reports submitted by drug manufacturers to the Food and Drug Administration were incomplete. The authors advocate for the FDA to update their reporting requirements and compliance policies.
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
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
Investigating Clinical Incidents in the NHS.
Sixth Report of Session 2014–15. House of Commons Public Administration Select Committee. London, England: The Stationery Office; March 27, 2015. Publication HC 886.
Applying evidence generated from complaints submitted to health care services has been promoted as a way to inform improvement. As a follow up to a previous inquiry, this report explores the process of clinical incident investigations at the National Health Service. The authors draw from accident analysis practices in the aviation industry to provide guidance on developing an independent program to investigate health care incidents in the United Kingdom.
Book/Report
Culture Change in the NHS: Applying the Lessons of the Francis Inquiries.
Department of Health. London, England: Crown Publishing; February 2015. ISBN: 9781474112116.
The Francis inquiry uncovered numerous problems in the National Health Service and led to many commentaries about improvement strategies. Summarizing achievements in applying recommendations following the inquiry, this report outlines where further work is needed to ensure that advances in safe care delivery are sustained. Companion materials available include an analysis exploring equality considerations and a table revealing the government response and progress for each of the 290 recommendations put forth in the original inquiry.
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.
Newspaper/Magazine Article
The US has a drug shortage—and people are dying.
Koba M. Fortune. January 6, 2015.
National drug shortages are a persisting and serious patient safety issue in the United States. Reporting on the drug shortage problem, this magazine article explores underlying causes, economic factors involved, and how shortages threaten the safety and timeliness of patients receiving treatment.
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.
Journal Article > Study
Partnering with VA stakeholders to develop a comprehensive patient safety data display: lessons learned from the field.
Chen Q, Shin MH, Chan JA, et al. Am J Med Qual. 2016;31:178-186.
This study reports the development of a comprehensive patient safety tool for Veterans Administration medical centers, with input from frontline stakeholders, to integrate data sources including incident reports, AHRQ Patient Safety Indicators, and other quality measures related to safety in a single location in order to facilitate collaboration at local sites.
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.
Web Resource > Government Resource
Serious Reportable Events.
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.
Newspaper/Magazine Article
Feds stop public disclosure of many serious hospital errors.
O'Donnell J. USA Today. August 6, 2014.
This newspaper article reports on changes to publicly reported data on the Hospital Compare Web site. Several avoidable hospital-acquired conditions, such as air embolism or retained foreign objects, are no longer included. Working with the National Quality Forum, the Centers for Medicare and Medicaid Services (CMS) decided to modify the list to make it easier for consumers to use and understand.
Newspaper/Magazine Article
Maryland hospitals aren't reporting all errors and complications, experts say.
Cohn M. Baltimore Sun. July 26, 2014.
This news article reports weaknesses in a Maryland reporting program, including poor understanding about which errors should be reported and lack of regulations regarding disclosure. Limited public access to comprehensive incident reports and insufficient performance measurement hinder consumers' ability to select hospitals based on safety.
Book/Report
CPS Annual Reports.
Jefferson City, MO: Center for Patient Safety; April 12, 2016.
Patient Safety Organizations (PSOs) provide local evidence to inform learning at the state level. This annual report describes a Missouri PSO's activities in 2015 broken down by environments: long-term care; emergency medical services; home health and hospice; and hospitals, ambulatory surgical centers, and medical offices. The publication also summarizes breakdowns of data collected over 5 years.
Journal Article > Study
Multistate point-prevalence survey of health care–associated infections.
- Classic
Magill SS, Edwards JR, Bamberg W, et al; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. N Engl J Med. 2014;370:1198-1208.
Health care–associated infections (HAIs) are a serious and common cause of patient harm. The Centers for Disease Control and Prevention (CDC) created the National Healthcare Safety Network to provide information on incidence rates of infections, but most hospitals limit reporting to only certain complications. This multistate prevalence study found that approximately 4% of sampled patients had HAIs. Using a model to extrapolate these findings, nearly 650,000 patients in United States hospitals are estimated to have had an HAI in 2011. Infections associated with devices—including central lines, urinary catheters, and ventilators—have been a major focus of strategies to decrease HAIs, but together they accounted for only about a quarter of all HAIs. Clostridium difficile was responsible for more than 12% of infections, highlighting the importance of efforts to mitigate this life-threatening disease. A recent CDC report suggested the potential promise of antibiotic stewardship programs to decrease C. difficile rates.