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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.
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.
Journal Article > Study
Quality improvement in ambulatory surgery centers: a major national effort aimed at reducing infections and other surgical complications.
Davis KK, Mahishi V, Singal R, et al. J Clin Med Res. 2019;11:7-14.
Ambulatory surgery centers are increasingly utilized to provide surgical care to patients. Quality improvement approaches utilized in the inpatient setting may need to be modified or adapted to be applicable in the ambulatory surgery environment. Researchers describe efforts to implement a surgical safety checklist and infection control techniques across 665 ambulatory surgery centers recruited for the study. They identified several barriers and conclude that the unique aspects of ambulatory surgery centers must be taken into account when implementing quality improvement initiatives.
Journal Article > Study
Assessment of incorrect surgical procedures within and outside the operating room. A follow-up study from US Veterans Health Administration medical centers.
Neily J, Soncrant C, Mills PD, et al. JAMA Network Open. 2018;1:e185147.
The Joint Commission and National Quality Forum both consider wrong-site, wrong-procedure, and wrong-patient surgeries to be never events. Despite improvement approaches ranging from the Universal Protocol to nonpayment for the procedures themselves and any consequent care, these serious surgical errors continue to occur. This study measured the incidence of incorrect surgeries in Veterans Health Administration medical centers from 2010 to 2017. Surgical patient safety events resulting in harm were rare and declined by more than two-thirds from 2000 to 2017. Dentistry, ophthalmology, and neurosurgery had the highest incidence of in–operating room adverse events. Root cause analysis revealed that 29% of events could have been prevented with a correctly performed time-out. A WebM&M commentary examined an incident involving a wrong-side 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.
Journal Article > Commentary
Soncrant CM, Warner LJ, Neily J, et al. AORN J. 2018;108:386-397.
Root cause analysis has been widely promoted as a failure analysis tool for use in a variety of settings. This quality improvement project applied the method to patient falls in Veterans Health Administration operating rooms and developed recommendations to guide improvement. Areas of focus included team communication, restraint use, and staff education. An Annual Perspective provides insights regarding how to enhance root cause analysis to help investigate incidents and improve care.
AHRQ National Scorecard on Hospital-Acquired Conditions Updated Baseline Rates and Preliminary Results 2014–2016.
Rockville, MD: Agency for Healthcare Research and Quality; June 2018.
Reducing hospital-acquired conditions (HACs) such as health care-associated infections has been a major focus of quality improvement efforts, motivated in part by Medicare nonpayment and reporting. According to the Agency for Healthcare Research and Quality (AHRQ), HAC rates decreased by just over 20% between 2010 and 2015. In this report, AHRQ estimates that between 2014 and 2016, HAC reduction efforts resulted in an 8% decrease in events, $2.9 billion dollars in savings, and the prevention of about 8,000 deaths. While infections and adverse drug events decreased, pressure ulcers increased and represent an opportunity for further improvement. Overall, this report suggests that HAC reduction efforts continue to be successful.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration. May 29, 2018.
Surgical fires can result in patient harm. This announcement provides information about causes of surgical fires and reviews FDA recommendations to prevent them, such as presurgery fire risk assessment, promoting team communication, and fire management planning. A WebM&M commentary discussed common sources of operating room fires and how to reduce risks.
Journal Article > Study
Factors associated with hospital admission after outpatient surgery in the Veterans Health Administration.
Mull HJ, Rosen AK, O'Brien WJ, et al. Health Serv Res. 2018;53:3855-3880.
The Veterans Affairs Surgical Quality Improvement Program (VASQIP) and the private sector National Surgical Quality Improvement Program have transformed both safety measurement and quality in surgery. Historically, VASQIP has placed comparatively little emphasis on outpatient surgical safety. This study examined trends in hospital admission within 7 days of all outpatient surgeries performed among veterans age 65 and older in the United States. Researchers found that 16% of these procedures were associated with 7-day admission, higher than what has been observed in younger, healthier patients. Common reasons for admission included surgical, medical, or device complications and inability to secure safe aftercare at home. The authors posit that, while not every admission represents a preventable adverse event, measurement is a critical step toward improving outpatient surgical safety. A recent PSNet interview and perspective explored the evolution of surgical patient safety.
Rockville, MD: Agency for Healthcare Research and Quality. December 2017. AHRQ Publication No. 16(18)-0004-1-EF.
Large-scale collaboratives have achieved success in implementing patient safety improvements. This report describes the work and outcomes of a 3-year surgical safety program funded by AHRQ that involved more than 200 hospitals in the United States. The project employed models and tools to implement surgical site infection prevention strategies. Participants reported substantial reductions of surgical site infections in their facilities.
Rockville, MD: Agency for Healthcare Research and Quality; November 2017.
Preventing surgical complications including surgical site infections are a worldwide target for improvement. This toolkit builds on the success of the Comprehensive Unit-based Safety Program to initiate change. The tools represent practical strategies that helped members of a large-scale collaborative to identify areas of weakness, design improvements, and track the impact of the interventions.
Hoyt DB, Ko CY, eds. Chicago, IL: American College of Surgeons; 2017. ISBN: 9780996826242.
Surgery is complex and involves a wide range of possibilities for error that can result in patient harm. This textbook explores both technical and organizational contributors to those factors. The authors provide context for how leaders can address weaknesses across all phases of surgical care to help improve safety. Topics covered include high reliability, teamwork, communication, and patient-centered culture.
Web Resource > Multi-use Website
Rockville, MD: Agency for Healthcare Research and Quality.
Patients are vulnerable to harm after surgery. This program used methods from the Comprehensive Unit-based Safety Program to help hospitals integrate best practices into all stages of surgery to ensure safe recovery. Targeted areas of improvement include safety culture, teamwork skills, and partnering with patients. The program is currently accepting enrollees.
Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017.
Berríos-Torres SI, Umscheid CA, Bratzler DW, et al. JAMA Surg. 2017;152:784-791.
Surgical site infections are a common hospital-acquired condition. This clinical guideline reviews the literature and gathers expert opinion to identify generalizable evidence-based strategies to reduce surgical site infections. The authors highlight antimicrobial, preoperative hygiene, glycemic control, and skin preparation procedures to prevent infection.
Tools/Toolkit > Government Resource
Agency for Healthcare Research and Quality: Rockville, MD.
Journal Article > Study
Improving surgical complications and patient safety at the nation's largest military hospital: an analysis of National Surgical Quality Improvement Program data.
Maturo S, Hughes C, Kallingal G, et al. Mil Med. 2017;182:e1752-e1755.
This retrospective record review study compared surgical complication rates at a military medical center to National Surgical Quality Improvement Program data and found that complication rates were comparable to civilian hospitals, with the exception of catheter-associated urinary tract infections, which occurred at higher rates.
US Senate Finance Committee. December 6, 2016.
The practice of scheduling concurrent surgeries has raised concerns about increased risks of surgeon distraction, procedure delay, and insufficient expertise available in the operating room. This United States Senate report summarizes findings of an inquiry that assessed insights from 17 hospitals regarding concurrent and overlapping surgical policies. Areas of concern identified by the investigation include a lack of available data on the patient outcomes associated with the practice and need for specific billing requirements.
Famolaro T, Yount ND, Hare R, Thornton S, Sorra J. Rockville, MD: Agency for Healthcare Research and Quality; May 2016. AHRQ Publication No. 16-0028-EF.
For more than a decade, the Hospital Survey on Patient Safety Culture has been used in hospitals to evaluate aspects of local organizational culture that affect patient safety. Improved patient safety culture scores have been associated with reduced adverse events and better patient outcomes. The Medical Office Survey on Patient Safety Culture expands this widely used tool for application in the medical office setting. The 2016 User Comparative Database includes data from more than 25,000 respondents across 1,528 medical offices that completed the survey between 2013 and 2015. As with similar databases for hospitals and pharmacies, this resource serves as a tool for benchmarking performance and identifying potential areas for improvement. Teamwork and patient care tracking received the strongest positive scores, whereas work pressure and pace was identified as the area with the most potential for improvement. A prior PSNet perspective discussed establishing a safety culture.
Improving Patient Safety in Ambulatory Surgery Centers: A Resource List for Users of the AHRQ Ambulatory Surgery Center Survey on Patient Safety Culture.
Rockville, MD; Agency for Healthcare Quality and Research; March 2016.
Audiovisual > Audiovisual Presentation
Agency for Healthcare Research and Quality. July 15, 2015.
Ambulatory surgery centers have been the focus of patient safety concerns due to high-profile incidents of harm. This webinar highlighted the AHRQ Ambulatory Surgery Center Survey on Patient Safety Culture, results of its pilot test, and insights from hospitals using the survey.