In the late 1990s, says William Robb, M.D., co-chair of the recent National Surgical Patient Safety Summit (NSPSS), the Institute of Medicine released information regarding the safety of healthcare in the U.S. “They estimated that there were nearly 100, 000 deaths annually from preventable medical errors. Most recent estimates indicate that errors now contribute to as many as 400, 000 deaths in the U.S. each year.”
Apparently, the number of annual deaths from preventable medical errors has increased roughly four-fold. What is going on? Preventable medical errors are, in and of themselves, troubling. But could they be the canary in the coal mine with respect to the many changes now sweeping the U.S. healthcare system?
Here’s is what one of the leading experts on preventable medical errors is saying.
“Adverse medical events remain a challenge in our country, ” says Dr. Robb. “Despite efforts made by many of the organizations participating in the Summit sponsored by the American Academy of Orthopaedic Surgeons (AAOS) and the American College of Surgeons (ACS), adverse events have actually increased in the last 10 years.”
The NSPSS welcomed 150 participants from the surgical community including surgical professional, peri-operative nursing, anesthesia, government, payer and credentialing/certification organizations in an effort to develop consensus needed to support new surgical care and surgical education curricula standards.
Dr. Robb, a past-chair of the AAOS Patient Safety Committee, told OTW, “In the late 1990s AAOS inaugurated the ‘Sign Your Site’ program for all surgeons and ORs in the country, designed to reduce wrong site surgery.
“When we looked back 10 years later, we were alarmed to find that the incidence of wrong site surgery had actually increased!
“Many organizations have tried to address these safety concerns by improving safety processes driven by improved reporting. Minnesota and Pennsylvania implemented mandatory reporting of certain adverse events such as wrong site surgery 15 years ago and have demonstrated some improvements when safety protocols are followed.
“Over 30 states now have mandatory adverse event reporting programs, however the standards of reporting differ from state to state and there is no national database. The bottom line is that although surgical safety there has been identified as a national concern, there little good evidence that we are improving the safety of preoperative, operative, and postoperative surgical care
“Over the past two years four workgroups from the AAOS, ACS, nursing and anesthesia developed surgical safety recommendations for the Summit.
- Workgroup 1 proposed standardized surgical safety definitions, terminology and key surgical safety processes for each episode of surgical care.
- Workgroup 2 focused on the evaluation of human factors and safety culture that support safe behaviors among surgical professionals and by surgical facilities.
- Workgroup 3 evaluated surgical safety data and technology supported adverse event reporting.
- Workgroup 4 evaluated surgical safety education programs and proposed expanded surgical safety education programs for medical students, nurses, surgical residents and fellows, anesthesia as well as practicing surgeons.
“Surgical safety is undermined by the reluctance of all surgical professionals to report adverse events based upon the fear of attribution for the event. The culture of most current health care organizations places blame on individuals rather than the systems in which they provide care. An organization with a ‘Just’ safety culture permits individuals to feel comfortable disclosing these adverse events, including their own, while maintaining accountability for both their care givers and systems.
“To improve safety we need to increase voluntary reporting by all professionals invested in surgical care and standardize the categories and types of adverse events. Based upon improved reporting, a national surgical safety data base is needed to better understand of the scope of the problem and design targeted programs which can improve the safety of surgical care.”
Detailing the issues surrounding preoperative safety, Dr. Robb told OTW, “Surgical credentialing organizations have recommended use of standardized safety processes such as surgical checklists. While there is no doubt that use of checklists has increased, it is less clear that surgical professionals understand how best to use them. Use of a checklist in and of itself does not ensure safety; there are safe behaviors needed by surgical team members using the checklist to maximize its effectiveness.
“The Minnesota ‘Time-Out’ program, looked at eight years of data and found that the number of wrong site surgeries had tripled since the initiation of mandatory event reporting despite wide spread adoption of the surgical checklist in Minnesota during that period.
“Concerned about this significant increase in surgical patient harm increase, human factors and team behavior researchers studied how the checklist was used in Minnesota. Based upon their observations they recommended that in addition to universal adoption of the surgical checklist prior to surgery, that:
- The surgeon should announce the ‘Time-Out’;
- All activity in the OR must cease (full stop) when the checklist is in use;
- All team members introduce themselves to the team using first and casual name and specifying their role;
- All team members must participate in the checklist process fulfilling their individual safety roles of the checklist elements;
- The surgeon should conclude the checklist process by inviting any team member to announce any safety concern observed or sensed during the surgery.”
A state wide education program was initiated educate surgical teams and adopt use of these behaviors and three years later the numbers of wrong site surgeries was reduced by 50% in Minnesota. “This is great evidence that surgical safety can be improved but that solely mandating safety processes is not enough”, Dr. Robb said.
At the summit participants identified five key safety process recommendations for the surgical community to consider as standards for surgical care:
- Adoption of standardized surgical discussion among the surgeon, team members and patient prior to surgery; shared decision making using the AHRQ universal health literacy guidelines.
- Standardization of informed surgical patient consent processes including improved documentation and patient-centered communication so patients better understand potential adverse events as well as realistic surgical outcomes.
- Adoption of uniform surgical site marking processes by the surgeon before the surgery and as part of the consent review and patient/surgical site/procedure confirmation process with a legible mark to remain visible in the surgical field during the ‘Time-Out’.
- Universal adoption of the WHO Safe Surgery Checklist prior to beginning the surgery and use of standardized OR team communication tools—brief, time-out and debrief.
- Consistent team member use of validated standardized communication tools (such as SBAR and I-PASS) to support improved information transfer during the many transitions of surgical care.
Each of these recommendations support improved safety throughout the five phases of surgical care:
- Preoperative phase (shared-decision making and informed consent);
- Immediate preoperative phase (surgical consent, patient/site/procedure confirmation, surgical site marking);
- The OR (surgical checklist);
- Immediate postoperative
- Recovery phases (standardized communication tools).
“Supporting a safe continuum of care for surgical patients is complex but possible when safety processes are used regularly and supported by all team members with safe behaviors. Both the entire team and the surgical facility must be committed to safety and consistently use safe processes and behaviors supported by safe systems”, said Dr. Robb.
“Doing the pre-surgical brief creates a common shared vision for all surgical team members—anesthesia, nursing and surgical team members. The brief is a verbal review of, ‘patient specific needs, what are we going to do, what equipment we need, are there any anticipated possible contingencies needed, are we ready?.’ The Time-Out is completed just before the incision. Following the surgery—and before the patient has left the OR—the OR team needs to ‘debrief’, where everyone reviews what happened during case. Questions asked are: Can we improve? Does any equipment need to be replaced before the next case? Are all the specimens labeled properly? Is the OR documentation accurate?
“Communication, as well as honest, attentive engagement is key. Many healthcare professionals don’t necessarily know how to communicate or understand what behaviors create a safety culture—with patients and their peers, ” said Dr. Robb.
“The surgical community has traditionally focused on technical skills education. The thinking goes, ‘If we just become better and better surgical technicians we will provide safer and better care.’ But this implies that safety is contained within those skills! Safety is largely contained in many non-technical skills that we have failed to understand and use consistently throughout surgical care.
“The recommendations emanating from the NSPSS will be used to finalize National Surgical Patient Safety Standards and recommendations, develop surgical safety education curriculum proposals, and determine how to best to proceed to create an improved ‘culture of safety’ in our nation’s operating rooms. Patients deserve no less.”
