Generally Hospitals take time out to verify the right procedure and right patient as part of multidisciplinary

 

 

The Application of Three R’s

 

“Generally, hospitals take time out to verify the right site, right procedure and right patient as part of multidisciplinary safety campaigns and accordingly, last July, the surgical teams in JCAHO-accredited hospitals, ambulatory care and office-based surgery facilities are required to take moment before the first cut and make sure that the team is operating on the correct patient and doing the correct surgery on the correct body part. The preoperative verification, marking of the site, and the time-out, which immediately precedes the first incision, are required elements of the Universal Protocol. The protocol also is intended for any invasive procedure, whether it’s in surgical suite, emergency department, as wrong site surgery is basically unforgivable and Universal Protocol will prevent these surgeries from happening and that one of the biggest challenges is getting beyond the concept of regulation and compliance and really driving patient safety agendas that are unique and specific to individual organizations” (cited in, Karla Knight, August 2, 2004 from: http://www.nurseweek.com/news/features/04-08/safety.asp). The surgical team has successfully incorporated this process into the operating room work flow. Development of a process has increased awareness of these measures and has helped achieve standardization across multiple campuses and surgical areas. There is then, a systematic approach toward safety measures can improve compliance. Incorporating additional measures into the Time Out to identify correct operative site has allowed our facility to improve application and timing of the procedure.

 

AORN’s Evaluation

 

AORN is evaluating the Universal Protocol to establish what factors promote the use of the protocol, as well as which factors serve as obstacles to its execution. There will be a second summit on wrong-site surgery held later this year, during which the results of the evaluation will be offered for discussion. The reason for the evaluation is that these sentinel events may still occur, and not all medical professionals are instituting the time out as is recommended. , MSN, CNOR, of Massachusetts General Hospital, and a preoperative education consultant for AORN, will be performing a dissertation study on the results of the Universal Protocol, and will also evaluate the effect of the AORN Correct Site Surgery Tool Kit on implementation of the protocol. “With any new protocol, it is critical to evaluate its effectiveness and how well it supports practice,” Mulloy observes. “The Universal Protocol is supported on the intellectual basis. However, in practice, distractions can occur, and there is only one recent study (Kwaan et al 2006) about it, which suggests that the Universal Protocol is effective in approximately two-thirds of the cases of wrong-site surgery. Since the protocol is not always being followed, AORN wants to ascertain how to get physicians, nurses, and other healthcare workers to fully observe the Universal Protocol. The association is not in a position to enforce compliance, Mulloy points out, “They can recommend practices based on research and standards and encourage members to follow them. In addition, they can provide supportive materials to members, as in this case — the Correct Site Surgery Tool Kit. Professionals have an obligation to read and follow the best practices every day.”

 

 

 

Site marking should be done by the person performing the procedure, and must take place with the patient awake, aware, and involved. There must still be a final verification of the site mark during the time out. In addition, the healthcare facility should have a defined procedure in place in case a patient refuses site marking. The time out must take place in specific locations and at multiple times, according to the protocol. It must be conducted in the procedure area just before the surgery begins, and must involve the entire operative team. At a minimum, it must be documented, involve active communication, and must include a correct recognition of patient identity, side and site of surgery, and procedure type, as well as correct patient position and availability of required implants and special equipment or requirements for the procedure.

There should also be a system in place for resolving differences in staff responses during the time out.

If there is a non-OR setting being used for the procedure, then the following procedures apply:

-          Site marking for any procedure with laterality, multiple structures or levels 

-          Verification, site marking, and time out procedures that are consistent throughout the facility 

 

Wrong-site surgeries – still happening

 

The majority of mistakes occurred in orthopedics and involved surgeons operating on the body part, such as in the highly publicized Willie King case that quickly became the national poster-story for wrong-site surgery. In 1995, King went into a Florida hospital to have a foot amputated for gangrene, but surgeons amputated the wrong foot. In another mishap, a Rhode Island surgeon cut into the wrong side of a patient’s head after a CT scan was placed backward on the X-ray viewing box. According to JCAHO, the growing numbers of surgery mistakes are most often caused by a breakdown in communication among surgical team members and the patient and family. Many of the mistakes are made in emergency cases, or where there is an unusual time pressure or set-up in the operating facility. Lack of hospital policy safeguards such as requiring the marking of operative sites and verification checklists have also played a key role. Most experts believe the new rules will help to make operating rooms safer for patients, but that there is no way to completely eliminate human error.

 

The American Society for Aesthetic Plastic Surgery Takes Time Out for Patient Safety

The American Society for Aesthetic Plastic Surgery (ASAPS) is taking a Time Out to offer some suggestions to patients to help prevent wrong-site surgery and other preventable surgical mistakes for people having aesthetic plastic surgery.  For ASAPS, honoring Time Out Day is part of the Aesthetic Society's Campaign for Patient Safety, an ongoing initiative to raise awareness of the steps that plastic surgeons and their patients can take to make cosmetic surgery safer. The Society's first campaign issue was focused on the prevention of venous thromboembolism; the second initiative was about prevention of hypothermia during surgery.  The surgical time out, including active communication among the surgical team, final verification of the correct patient, and marking of the operative site, help your board certified plastic surgeon make your surgery as safe as possible.  

Wrong-site surgery is a devastating problem that affects both the patient and surgeon and results from poor preoperative planning, lack of institutional controls, failure of the surgeon to exercise due care, or a simple mistake in communication between the patient and the surgeon.

Patient Safety in Surgery – Current Issues

Complications due to individual surgeons' errors and system failures are inherent in surgical practice and represent important preventable causes of morbidity and mortality. In spite of the increasing public attention to medical errors in general, a new level of transparency for consumers, and the current trend to process preventable adverse events systematically, surgical complications appear to represent a persistent taboo throughout different countries and institutions. One would assume that a patient scheduled for a surgical procedure would expect to be better off after the intervention than before. However, while physicians strive to achieve excellent results and favorable patient outcomes in daily practice, this noble task has failed more often than one expects.

 

Preoperative communication breakdown

A recent analysis of the American College of Surgeons' closed claims study revealed that most events leading to iatrogenic patient injuries involved a delay in diagnosis, a failure to diagnose. Thus, patient safety in surgery appears to be challenged more by the mistakes and failures that occur before and after surgical procedures than by the operative intervention itself. Interestingly, technical intra-operative errors resulting in surgical complications represent less than half of all events leading to a claim. Indeed, about 25 per cent of all medico-legal surgical claims related to errors leading to an adverse patient outcome are attributed to a preoperative breakdown in communication. Thus, the surgical patient appears to be more at risk of sustaining an adverse outcome from hidden system errors than from an individual surgeon's human failure. A detailed analysis of communication breakdown patterns revealed an equal distribution of occurrence during the pre-, intra-, and postoperative phases of surgery. More than 90 per cent of communication breakdowns appeared to occur verbally. Of these, information was either transmitted in an inaccurate fashion (about 40 per cent of cases) or it was never transmitted at all (about 50 per cent of cases). Similarly, the Malpractice Insurers Medical Error Prevention Study recently provided information related to trainee involvement in medical errors. Teamwork breakdowns in the form of (1) a lack of adequate supervision and (2) "handoff" problems were causative in 70 per cent of all errors leading to malpractice claims (Source: Archives of Internal Medicine 2007).

An adequate approach for improving "communication safety" in the operating room should include the implementation of standardized "read backs" of received information, and the unambiguous assignment and transfer of responsibilities. These strategies have long been implemented in other high-risk domains, such as nuclear reactor control rooms, submarine services and commercial aviation safety protocols. In clinical practice, clear-cut algorithms should define triggers which mandate the communication with an attending surgeon (Journal of Patient Safety & Quality 2007). Furthermore, standardized protocols for patient handoffs and transfers should be defined at the institutional level. Written orders and checklists should support inter-individual verbal communication, including the count of lap sponges and surgical instruments, in order to reduce the incidence of adverse events related to communication breakdowns in surgery. Currently, the development of specific communication skills is underemphasized in residency programmers and may contribute to the missing system factors, which beget poor results of patient care.

 

 

 

 

The concept of a surgical "time-out"

Any intervention involving a wrong site (wrong side / wrong level / wrong anatomic structure), a wrong procedure, or a wrong patient, represents an unacceptable surgical complication "never-events" (Table 1). A lesson learned from aviation safety is that a "culture of blame" approach for dealing with individual surgical errors is not helpful in improving patient safety or reducing the incidence of severe complications. On the contrary, wrong site surgery represents a "classical" system error rather than pure human failure by an individual surgeon. Ten years ago, this notion led to the implementation of a standardized surgical "time-out" in North America as an improved method of verifying patient identity, correct procedure and intended-site operations. Since then, the concept of a surgical time-out has been widely implemented in operating rooms throughout the US and represents a standard recommendation by the Joint Commission on Accreditation of Healthcare Organizations . A culture of zero tolerance for "never events" is a key to keeping patients safe. From a patient safety perspective, the fact that this surgical time-out paradigm has not yet been implemented as a standard of care in most parts of the world appears incomprehensible and ethically unacceptable.  Of note, the time-out concept can never be 100 per cent protective from wrong site interventions. Potential loopholes in this system include relegating the time-out to a robotic hackneyed type ritual or the continuing "dilution" of the time-out by expanding to secondary safety issues, such as antibiotic and venous thromboembolism prophylaxis, as implemented in the so-called "expanded surgical time-out" or "universal protocol". The (abuse of the formal time-out as a quality control tool for secondary parameters may deflect from its original purpose of ensuring correct site, correct procedure and correct patient surgery. Another risk factor for wrong site surgery is represented by the situation of multiple simultaneous procedures performed during the same surgical session. This is exemplified by the case of a patient undergoing multiple surgical interventions for different injuries, thereby obscuring the focus of the time-out on a particular operation. In addition, some specific anatomic locations may represent "black boxes" during the time-out, and thus represent a particular risk for wrong site interventions. These include orthopedic procedures at the torso (spine, pelvis), dental surgeries, neurosurgical interventions, and intra-abdominal or intra-thoracic operations. For example, an orthopedic surgeon may perform a sacroiliac screw fixation on the wrong side or fuse a wrong intervertebral segment of the spine.

 

Recently published studies indicate that wrong-site / wrong-procedure / wrong-patient surgeries surprisingly continue to occur in North America. For example, adverse event data from the state of Florida, US, reported 178 wrong site, 82 wrong procedure and 34 wrong patient cases for the years 2000-2003 (Archives of Surgery 2006). A detailed analysis of an extensive database at the Colorado Physician Insurance Company (COPIC) on 20,775 physician self-reported complications, we detected 99 cases of wrong-site surgery and 20 cases of wrong-patient procedure in the years 2002-2007 (Stahel et al., unpublished results). The persistent occurrence of these "never-events" in the era of a surgical time-out may be explained by individual surgeons' non-compliance and by numerous pitfalls related to accurate surgical site determination, as outlined above. Also, the time-out should not absolve the individual surgeon from taking full responsibility in ensuring by all available means that the correct procedure is performed at the correct site on the correct patient. All institutions have to now consider adapting a formal time-out concept as a standardized quality assurance tool. Patients must be educated to inquire their surgeons whether a formal time-out procedure will occur in the elective surgical suite.

 

Reporting of medical errors in surgery

Systematic medical errors represent an essential "information problem". While the intellectual argument for reporting medical errors in surgery is compelling beyond a doubt, surgeons remain inherently reluctant to disclose surgical failures and complications in public. The main barriers for reporting surgical errors are based on the fear of medico-legal lawsuits, potential loss of professional prestige among peers, and the well-engrained tenet of non-admission of guilt and fallibility among surgeons ("blame and shame culture"). In this regard, the major ethical concern is that the suppression of data on surgical errors will deprive other surgeons of adequate scientific knowledge, which may help prevent identical errors in the future. In contrast to aviation safety, where the implementation of systematic error reduction policies has led to an irrefutable, impressive drop in fatal accident rates in the past decades, surgeons remain reluctant to recognize, analyse, and officially report their own errors. The "human factor" which may help explain the discrepancy between the situations in aviation versus surgery is based on the fact that a pilot is usually killed with a crashed plane, whereas a surgeon suffers no personal physical harm from a patient's complication. Thorough reporting and peer-review of surgical errors creates a new dilemma for the surgeon in practice: an increased quality of reporting leads to an increased official number of complications and adverse events, thus affecting the individual surgeon's professional track record and the respective institution's ranking among peers. Until legislation provides legal protection for medical error disclosure and analysis, we continue to rely on the inadequate reporting of errors and complications in the peer-reviewed biomedical literature. A recently launched open-access online journal, Patient Safety in Surgery , was designed to complement traditional journals in surgery by filling this essential void, through providing a forum for discussion, review, and "root cause" analysis of failures in the management of surgical patients. This scientific forum should create a focal point for critical discussion of surgical errors and lower the threshold for reporting adverse events in all fields of surgery. As a result, the long-term goal of increasing safety and quality of care for patients undergoing surgical procedures will be effectuated.