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- Legal and Policy Approaches 8
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- Teamwork 1
- Technologic Approaches 3
- Transparency and Accountability 2
- Device-related Complications 11
- Discontinuities, Gaps, and Hand-Off Problems 1
- Medical Complications 7
- Medication Errors/Preventable Adverse Drug Events 9
- Nonsurgical Procedural Complications 1
- Surgical Complications 2
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- Health Care Executives and Administrators 29
Health Care Providers
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Non-Health Care Professionals
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- United States of America
Search results for "United States Federal Government"
- Governmental Reporting
- United States Federal Government
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.
Silver Spring, MD: US Food and Drug Administration; April 9, 2019.
Efforts to address the opioid epidemic range from regulation to changes in pain management. This safety announcement raises awareness of potential harms associated with rapidly decreasing the dose of or discontinuing opioids for patients who may be physically dependent on the medication. It also announces a requirement regarding changes to prescribing information for opioids to provide expanded guidance on how to safely taper doses. Health care providers should discuss tapering plans with patients and provide ongoing monitoring and support.
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.
AHRQ National Scorecard on Hospital-Acquired Conditions Updated Baseline Rates and Preliminary Results 2014–2017.
Rockville, MD: Agency for Healthcare Research and Quality; January 2019.
Hospital-acquired conditions (HACs) represent a significant source of preventable harm to patients. The Centers for Medicare and Medicaid Services financially penalizes hospitals with increased numbers of HACs through the Hospital-Acquired Condition Reduction Program. This policy of nonpayment has prompted hospitals to focus significant resources on preventing HACs. This AHRQ report found a reduction in HACs from 99 per 1000 acute care discharges to 86 per 1000 discharges between 2014 and 2017, representing a decrease in 910,000 HACs and savings of $7.7 billion. Declines in certain HACs such as adverse drug events and Clostridium difficile infections were noted to be more significant as compared to others. A past WebM&M commentary highlighted the clinical significance of HACs and described an incident involving a patient who developed a pressure ulcer while in the hospital.
FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
Defense Health Agency Should Improve Tracking of Serious Adverse Medical Events and Monitoring of Required Follow-up.
Washington, DC: United States Government Accountability Office; April 2018. Publication GAO-18-378.
Adverse event reporting is an important step toward failure reduction. However, weaknesses in feedback, follow-up, and action resulting from incident reports diminish their impact on safety. This publication analyzed reporting activity and action in the Defense Health Agency. The resulting recommendations suggest the need to improve tracking of incident reports and for clarifying reporting requirements.
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.
Improved Policies and Oversight Needed for Reviewing and Reporting Providers for Quality and Safety Concerns.
Washington, DC: United States Government Accountability Office; November 2017. Publication GAO-18-63.
Tracking concerns related to individual clinician performance has the potential to uncover opportunities for clinician skill and system safety enhancements. This report highlights weaknesses in the peer reporting processes of Veterans Affairs medical centers and offers recommendations to improve the quality and timeliness of reporting to ensure safety of patients in the VA system.
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.
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.
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.
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.
Federal Register. Rockville, MD: Agency for Healthcare Research and Quality. February 18, 2014;79:9214-9215.
Journal Article > Commentary
Public reporting of health care–associated surveillance data: recommendations from the Healthcare Infection Control Practices Advisory Committee.
Talbot TR, Bratzler DW, Carrico RM, et al; Healthcare Infection Control Practices Advisory Committee. Ann Intern Med. 2013;159:631-635.
Avery L, Bennett R, Brinsley-Rainisch K, et al. Atlanta, GA: Centers for Disease Control and Prevention; October 9, 2018.
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.