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- Study 2
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- Students 1
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United States of America
United States Federal Government
- Department of Health and Human Services (HHS) 50
- United States Federal Government 59
Search results for "Government Resource"
- Government Resource
- Error Reporting
National Quality Forum.
Patient safety organizations collect data across various systems and states. This announcement calls for review of the current beta version of the common formats developed to provide a standardized method to collect and report incident data to patient safety organizations. The current comment period is of open duration.
Legislation/Regulation > Colorado Legislation
Pettersen B, Tate J, Tipper K, McKean H. Colorado Senate Bill 19-201.
Communication-and-resolution mechanisms are seen as important approaches to improving transparency and healing after an adverse event. This state bill, referred to as the "Colorado Candor Act," protects conversations between organizations, clinicians, patient, and families from legal discoverability and outlines criteria to guarantee that protection.
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.
Tools/Toolkit > Fact Sheet/FAQs
London, England: NHS Resolution; 2018.
Although victims of adverse events have clearly expressed their preferences for full error disclosure, most physicians remain uncomfortable with disclosing and apologizing for errors. This leaflet offers information to help clinicians understand the value of effective apologies along with tips for organizations to support open disclosure efforts.
Williams N. Department of Health and Social Care. London, England: Crown Copyright; 2018.
Accountability for errors and organizational assessment of failures affect incident reporting. This policy review explores how potential legal ramifications stemming from investigations of negligence can hinder improvement efforts and outlines recommendations to support safety culture in health care.
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.
NHS Improvement. London, UK: National Health Service.
Organizational processes to investigate adverse care incidents play an important part in generating the learning needed for improvements. This announcement sought multidisciplinary insights regarding how to revise the Serious Incident Framework (2015), currently used by the National Health Service, to enhance reporting and investigation processes.
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.
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.
Washington, DC: United States Government Accountability Office; October 2017. Publication GAO-18-15.
Opioid prescribing is under increased scrutiny in an effort to address opioid misuse. Examining Medicare Part D prescription trends, this report recommends that the Centers for Medicare and Medicaid Services collect more data on beneficiaries receiving high doses of opioids and the clinicians who prescribe them and advocates for increased reporting of clinicians who inappropriately prescribe opioids. An Annual Perspective discussed the opioid epidemic as a patient safety problem.
Web Resource > Government Resource
Centers for Disease Control and Prevention.
Whitson T, Garten B. Indianapolis, IN: Indiana State Department of Health; 2017.
Learning, Candour and Accountability. A Review of the Way NHS Trusts Review and Investigate the Deaths of Patients in England.
Newcastle Upon Tyne, UK: Care Quality Commission; December 2016. CQC-356-122016.
Patients and families can contribute to improvement when they are treated with respect and openness. This report explored the extent to which those characteristics are present in National Health Service (NHS) investigations regarding patient deaths and found them to be lacking, particularly in cases involving patients with mental health conditions or learning disabilities. The authors recommend a framework to guide behaviors consistently across the NHS to improve the timeliness and quality of investigations and ensure system-level learning.