Literature Review

2 Literature Review

2.1 Introduction

This review of literature explores various resources in regard to preventing wrong site surgery using Universal Protocol.

2.2 Search Strategy

A systematic search and review of various resources relating to the prevention of wrong site surgery using Universal Protocol, including the Joint Commission on Accreditation of Health care Organizations (JCAHO) website, scholarly articles and electronic databases. The search strategy entitled studies published between 2004 and 2016, and employed a number of medical keywords and subheadings relates to Universal Protocol, time out, wrong site surgery and patient safety, checklist, and site marking. Additionally, Google scholar was used to validate references cited in the underlying important articles. Consequentially, 45 seminal articles were used to explicate the key themes of the review. The key themes in this review of literature were identified through preliminary review by the researcher. From the preliminary review, the key themes explored in details include wrong site surgery, the universal Protocol and Checklist.


2.3 Wrong Site Surgery and Patient Safety

Surgery is one of the key areas in healthcare where preventable medical errors as well as near misses still occur. Despite the improvement in the safety of the patient secondary to the advancement in surgical processes and procedures, there are still several reports pointing cases of wrong site surgeries. With over 200 million surgeries carried out annually, the rate of wrong site surgeries remain inadmissibly high. As the term suggests, wrong site surgery (WSS) refers to a surgical procedure performed on wrong body party, wrong patient or wrong side of the patients body. In addition, the term refers to also covers surgical procedures that have been wrong conducted at the wrong level of an anatomic site that was correctly identified. WSS also include invasive procedures that expose patients beyond minimal risks. In the same line, WSS is viewed as a sentinel event an unexpected incidence involving serious psychological or physical injuries, or death. Undeniably, WSS represents some of the medical errors experienced by surgeon and patients. Besides having detrimental experience for patients, WSS can have a negative effect on the surgical team. For example, a patients right side part of her vulva was removed yet the cancerous lesion was on her left side of her vulva. This is a classic case of a WSS involving operation on the wrong side or incorrect body part. Another apt example of wrong-site surgery involves operating on the wrong level of a patients spine. Surprisingly, this is a common problem for neurosurgeons. In regards to wrong patient surgery, a classic case entailed a patient who wrongly underwent a cardiac procedure meant for another patient because they had similar names. Figure 1 illustrates the frequency of wrong site surgeries, with wrong side surgeries leading (59%) followed by another wrong site (correct side, wrong site), wrong procedure and wrong patient.


Figure 1 Types of Wrong-Site Surgery (AHRQ, 2016a)

Despite the fact that publicity has been given to high-profile cased of wrong-site surgery errors, WSPEs are relatively rare to an extent that an hospital can experience one error in a span of 5 -10 years . However, this estimate covers only incidences in the operating room environment, implying that the rate may be higher if the incidences of WPSEs in other non-surgical settings are included. These include WPSEs in interventional radiology and ambulatory surgery. WSS are rare, but physician are increasingly learning about their causes and consequences. In Florida, the states licensure board for imposed stiff penalties on surgeons linked to WSS, and some insurers deliberately failed to pay providers for WSPEs. Legally, wrong site or wrong person surgeries are compensable under malpractice claims. For this reason, the surgical teams strive to prevent risk of WSS. Given that reporting WSS to the Joint Commission is voluntary, their occurrence might be slightly higher than the reported cases. Regardless of the incidence rate of WSSs, they are preventable of certain predefined and formalized steps are taken into account. In addition, these medical errors are preventable if standardized procedures are adopted in the preoperative environment.

Consistent with Figure 1, wrong patient and wrong site procedure are never-events that are preventable and should not be occurring in the modern surgical environment. Despite the widespread adoption of the Universal Protocol to prevent WSS, there has been a number of reports documenting wrong-site, wrong-procedure and wrong patient errors (WSPEs) in the United States. For instance, Clarke, Johnston, Martindell and Blanco analyzed hospital reports on WSPEs in Pennsylvania between 2004 and 2006. During this 30 months study duration, 427 reports of WSS occurrences were noted. In these cases 56% were near miss incidences. In the same analysis, a formal Time-out was noted to have failed to prevent WSS in 31 cases. Jhawar, Mitsis and Duggal conducted a nationwide survey estimation the incidence of wrong level and wring side spinal and craniocerebral surgery among surgeons in the United States. In their survey, 25% of the 138 participating neurosurgeons admitted to have performed wrong-side incisions at some point of their practice. After reviewing the National Practitioner Data Bank and other closed claims databases, Seiden and Barach concluded that WSS occurred approximately between 1,300 and 2,700 times each year in the United States. Table 1 presents a summary never-events reported in the above studies

Table 1 Never-events

Preventable Surgical never-events in the United States

1. Surgical procedure performed on wrong patients

2. Surgical procedure performed on the wrong part of the patients body

3. Incorrect surgical procedure (wrong patient)

4. Accidental retention of foreign object inside a patient

5. Intraoperative death due to wrong procedure

An analysis of the wrong surgical procedure in the United States Veterans Affairs (VA) system reported a decline in the number of WPSEs compared with prior studies . Similar to prior studies, 50% of the incorrect procedures were noted outside the operating room. According to Neily, et al., the root cause analysis of errors showed that human factors and lack of standardization were the main contributing factors. During the study, the VA adopted a teamwork training program, which has led to a significant drop in surgical mortality. Efforts to prevent, detect and eliminate WSPEs originally centered on operating room procedures and procedural disciplines. However, a recent analysis of WSPEs showed that a significant number of WSPEs committed by physicians outside the surgical field, including internal medicine. The primary culprits identified by the root cause analysis in the same study were communication errors and diagnostic errors. Using the root cause analysis a method of determining the underlying organizational causes or factor that contributes to an event three root causes are evident across various studies: leadership, procedural non-compliance and communication failures. Interestingly, most of the injured patients did not file lawsuits linking the physicians to malpractice. The study by Stahel, Clarke, Smith and Victoroff confirmed and extended existing research demonstrating that many wrong site surgery errors occur outside the OR. Based on this observation, the authors strongly recommends that members of surgical teams should strictly adhere to the Universal Protocol enacted by the Joint Commission in order to prevent these adverse errors. With most surgical procedures conventionally performed under acute care settings currently being performed in physician offices and freestanding surgical centers, patients, surgical teams and surgeons need to be cautious in all surgeries, especially when the level of scrutiny and oversight are lower than in as in hospitals.

2.4 Universal Protocol

Prior attempts to address wrong site surgeries are traced to the North American Spine Society (NASS) and the American Academy of Orthopedic Surgeons (AAOS). After reviewing cases of malpractice claims, AAOS initiated an awareness campaign to prevent wrong site surgeries by ensuring that the right surgical site was marked appropriately. In the same efforts, the NASS improve on the surgical site marking requirement by adding details for the appropriate site and level of the spine, calling surgeons to make the exact side and site of the spine. Besides these radiopaque indicator markings, NASS required that surgeons to verify the surgical procedure and patient using a predefined checklist. To advance these developments as well as to address the escalating cases of WSS, associated healthcare costs, and the impact of WSSs on patients, the Joint Commission organized a summit in 2003, including AAOS and key leaders from various healthcare organizations. The main outcome of the summit was the development of a protocol for preventing WSSs.

The Universal Protocol is a Joint Commission standard designed to reduce the incidence rate of wrong patient and wrong site surgery. This standardized protocol was mandated on 1 July, 2004 by the Joint Commission following the growing need to address never-events occurring in the surgical environment. The term never-events refers to wrong-site, wrong-procedure and wrong patient errors that should never occur because they present grave underlying patient safety problems. The Protocol was developed through an expert-based consensus on steps for and principle of preventing wring procedure, wrong site and wrong-person surgery. It applies to ambulatory care, as well as accredited hospitals and other surgery facilities. The Protocol for WSS anchors on prevention theories that propel safety proactive in industries that are marked by high risks, including nuclear energy and aviation industry. Similarly to operational environments of these industries, the operating room is extraordinarily complex with a number of intertwined processes that run quickly and often irreversible once initiated. In fact, the failed parts of the entire surgical processes cannot be separated from the main process, leading to unsafe procedures. In simple terms, there are no error defenses in place, leading to patient harm. By implementing a system-based change required by the wrong site surgery protocol, the risks of WSS should be prevented. The Universal Protocol entails three steps, including verification, site marking and Time Out. Both surgical site marking and pre-procedure verification process are performed within the perioperative holding unit, whereas the Time out procedure is performed inside the operating room as a final review before the surgery.

2.4.1 Verification

According to Stahel, Mehler, Clarke and Varnell, 20-30% of wrong patient procedures or wrong site surgeries are linked to error made before patient are admitted to the hospital. For instance, inaccurate clinic note information related to a wrong side as in the case of a mislabeled radiograph or a mix-up of the referred patient with identical or similar names can results in WSS. The underlying reason for carrying out a pre-procedure verification process is to confirm: the patients identity, the exact surgical site and nature of the planned surgical procedure. To that end, the process will be reducing the risk of WSS. Typically, each patient is identified by an identification bracelet indication the patients name, medical record number and date of birth. During this process, the patient is given a surgical consent form, indication the planned procedure and the name of the surgeon responsible for the procedure. Patients are required to sign the consent form only when the provided information is correct. Additionally the surgeon responsible for site marking verifies the surgical site with the patients before the actual marking . According to JCAHO, the pre-procedure verification process should engage members of the surgical team responsible for the patient. This increases awareness of the surgical site and other pertinent things including allergies, antibiotics and relevant instruments. Normally, a standardized list is used to verify the availability of items pertinent to the procedure and matched to the patient. Items that are available for in the procedure area are also matched to the planned procedure and the patient.

2.4.2 Site Marking

Inaccurate or inadequate surgical site marking is a major contributor or risk factor for WSS. This risk factor include imprecise marking of the correct surgical site, erroneous marking of the wrong site or side and inadequate marking. Since the marked site is often cleaned during surgical preparation, it is important to use a permanent marker to avoid the marking being washed off . In addition, large and legible letters should be used in singing the surgeons initials. In reference to the available standards and recommendations, as well as from the experience gained from complications and failures, Stahel, Mehler, Clarke and Varnell recommended that several parameter be considered to improve the safety and accuracy of surgical site marking. The first measure entails involving the patient in site marking process if possible. This would serve as the source of patient knowledge or awareness of the surgical site that will be verified during the surgical time-out process. Secondly, site marking should be performed by only licensed practitioners who are part of the procedure team. The practitioners must also be present not only during the time out, but also during the planned procedure. Ideally, site marking should be done by the lead surgeon. Site markings should also be performed in the preoperative holding area before the patient is move to the operating room or the surgical facility where the operation will be performed. To avoid ambiguity, site marks must use predefined terminology, which should also be consistent with the institutions site marking terminology. Given that the use of temporary markers such as stickers or placing markers on dressing or cast is not feasible, indelible ink should be used. Normally, the markers used does not affect the sterility of the surgical site . In the same context, site markings should be resistant to any surgical preparation process to ensure that the marking remain visible until the time of incision . In areas where site marking is impossible, awareness should be increased to ensure that there are no misunderstanding during the procedure. To note, the verification process takes place when the surgical procedure is scheduled. It follows that it is done at the time of entry or admission to the holding unit before a patient in moved to the operating room.

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2.4.3 Time Out

The Universal Protocol demands that a Time Out is performed prior to commencing a surgery . As the last step of the Universal Protocol, it is performed in the OR, just before the planned surgical procedure is performed . It presents the final review and reassurance of accurate surgical site, patient identity and planned surgical procedure. Additionally, the presence of allergies, need for perioperative antibiotics, patient positioning, equipment settings and positioning, as well as availability of relevant implants, document and other pertinent instrument is confirmed during the time-out . Stahel  stresses the importance of this practice subject to the fact that it has been proven to not only decrease the risk of WSS, but also improve teamwork. According to Stahel, Mehler, Clarke and Varnell , the success of time-out in surgical processes depends on a number of parameters. The first parameter requires that the time-out process be standardized all levels of an institution. Secondly, the time-out should be called by a specifically designated member of the surgical team, for example, a circulation nurse. The logic is that a clear role distribution reduced communication failures and increased attentiveness as opposed to a scenario where the time-out is called by any member of the surgical team. In line with checklist, time-outs helps the surgical team to clarify each personnels role during the procedure. In ideal conditions, the patient should be awake during time-out to take part in the verification process of surgical site, patient identity and planned procedure. Evidently, the participation of the patient reduces the risks of wrong-patient and wrong-site surgeries. The latter is reasonable, especially where the patient is informed of the exact site for the planned procedure. Fourthly, the immediate members of the surgical team, that is, circulating nurse, anesthesia provider, operating team technician and the surgeon must participate in the time-out actively. According to Makary, et al., WSS can be catastrophic to the not only the care giver and the patient, but to also the healthcare institution. Despite the fact that communication failures have been documented as the leading cause of WSPEs, of operating room briefings improve collaboration among surgical personnel and significantly reduces the perceived risk of WSS. Through this participation, teamwork cohesion is improved. Additionally, active participation increases the attentiveness of all members of the procedure team; thus, reducing the possibility of WSS. Lastly, during time-out, all other activities must be suspended to improve awareness, but the patients safety must not be compromised.

2.5 Checklists

Consistent with Wang and Serak , surgical procedures are complex tasks that demands not only attentiveness to detail, but also situational awareness by all members of the surgical team. In a recent study on the efficacy of surgical safety checklist in the overall effort of improving patient safety, Ragusa, Bitterman, Auerbach and Healy  noted that similarly to Time Out, checklists are strategy for improving teamwork and preventing WSPEs. Surgical safety checklists can be viewed as algorithmic listings of key actions to be performed within a surgical setting. The main goal of using these checklists is to ensure that all steps are performed. Despite seeming to be a simple surgery safety tool, checklists have a deep theoretical foundation in the principle of human factors engineering. In that regard, they play a critical role in the successes achieved in the efforts towards ensuring patient safety in clinical setting . Checklist are effective tools that reduce mortality and morbidity. Haynes, et al.  also demonstrated that the effective adoption of the World Health Organization (WHO) checklist improves the safety of surgery in both developing and developed economies. Ethnographic studies reporting either effective or ineffective implementation of checklists have been pivotal in improving understanding of the hurdles that can limit the use of checklists. For example, Verdaasdonk, Stassen, Hoffmann, Elst and Dankelman  demonstrated that the use of structured checklist can reduce the number of incidents linked to the use of technical laparoscopic equipment. In their study, they noted the number of incidents per procedure were 53% lower in the checklist group (23/30) than in the control group (49/30). Additionally the use of checklists resulted in fewer incidents or wrong connections, positioning and settings of equipment. Congruent with prior studies that assessed the effect of structured checklist, Verdaasdonk, Stassen, Hoffmann, Elst and Dankelman  confirmed that checklist improved safety climate, improved team cohesion and personal satisfaction; and reduced wrong site surgery. Figure 2 illustrates the effect of using a structured checklist with laparoscopic procedure equipment. Evidently the use of checklists reduced positioning errors by 50%.


Figure 2 Surgeon's experience with structured checklists with laparoscopic procedure equipment (Verdaasdonk, Stassen, Hoffmann, Elst, & Dankelman, 2008)

The Universal Protocol in its self consists instruction that guide a pre-operative verification process, marking of appropriate anatomic site and time-out prior to the actual surgical procedure. The application of checklists is recommended, especially in the time-out period. The benefits of checklists seems logical but critics still doubt their advantages and point out their disadvantages, including extra work; extra time need to meet all the items in the list; and the rigidity of meeting following all the items in the list. Undeniably, the benefits of checklist outweigh the stated disadvantages because patient safety is given the highest priority.

Congruent with cognitive psychology, most tasks can be classified as entailing either attentional behavior or schematic behavior. In the former classification, active planning and problem-solving are needed. In the latter, tasks are performed on autopilot or reflexively. Errors associated with these behaviors are different. For instance, failures in schematic behavior are termed to as slips and are caused by distractions, lapsed in concentration and fatigue. On the other hand, failures tied to attentional behavior are referred to as a mistakes and are often due to insufficient training or lack of experience. In the surgical setting, most of the MSPEs are as a result of slips rather than mistakes. Checklists represent an elegant strategy to minimize the risks of slips. An apt example and analogy of the application of checklist is flight preparation, whereby air traffic controllers and pilots must follow a pre-takeoff checklist irrespective of the number of times they have performed the same tasks. The logic is that, by standardizing the list of actions to be taken or steps to be followed, and ratifying that every step must be followed for all patients, checklist presents the best method to significantly reduce surgical errors due to slips.

Despite the remarkability as a tool for improving patient safety in the surgical setting, AHRQ  stresses that checklists are not a panacea. As they gain popularity and widespread usage, it is increasingly becoming apparent that their effectiveness largely depends on appropriately targeting checklists and utilizing a cautiously implemented checklist . Errors in surgical procedures that involve chiefly attentional behavior including handoff errors and diagnostic errors require solutions based on supervision, decision support and training rather than standardizing activities; thus inappropriate for checklist. In the clinical setting, an effective checklist demands an expert consensus about the mandatory safety behavior. According to AHRQ, the effectiveness of checklists in improving surgical safety and preventing central line infections was due to the strong evidence-based support for each step in the checklist. Therefore, checklists may not be effective in scenarios where universal standard safety practices are yet to be established.

Where surgical safety checklists are appropriate, the surgical team must ensure that relevant checklists are implemented . The most important to note is that implementing checklists is a complex social and technical effort, requiring surgeons to change their conventional approaches to tasks and engage in change meant to enhance patient safety. Consistent with Wang and Serak, AHRQ  points that the successful implementation of any checklist requires preparatory work to optimize safety culture in the context where this intervention is used. Additionally, there is a need for leaders within the clinical setting to emphasize the significance of checklists and linked clinical outcomes. The reported poor use of checklists in real world settings and the resultant disappointing surgical results can be attributed to failure to engage in adequate preparatory and monitoring during design and implementation of checklists. This implies that the effectiveness of checklists can be improved and result in even over 50 % reduction in the incidents of WSS errors. In a retrospective study by Kwaan, Studdert, Zinner and Gawande , over 60% of the WSSs (8/13) could be prevented by the correct implementation of the Universal Protocol. Determining the effect of the Universal Protocol solely is always tasking because the incidences of wrong site surgeries are rare. In line with this reasoning, it is important to note that checklists alone do not prevent the incidents of WSPEs. Studies on the use of checklist for anesthesia also show that this intervention has the potential to detect and eliminate some faults. For this reasons, the surgical team must be more cautious with the idea that checklists do not detect or eliminate all risks of wrong patient and wrong site surgery. Another important factor that must be taken into account to improve the effectiveness of checklists in the operating room (OR) is the engagement of the surgeon . The cooperation of the surgeon is considered to be vital because the chief surgeon is obliged to ensure that the all items in the checklist are executed. This strategy is effective and it is recommended that enthusiastic leaders be assigned to checklists to initiation the protocol .

2.6 Chapter Summary

The Universal Protocol was enacted by the Joint Commission in 2004 with then objective on improving patient safety by avoiding wrong surgical procedures on the wrong patient or at wrong site. As highlighted in the review above, this standardized three-step process has implemented widely and considerably prevented the occurrence of such erroneous never-events. Despite its wide implementation, several reports point out some cases of wrong site surgeries. It follows that potential loopholes and technical pitfalls should be addressed in current and future researches. Reviewing literature and evidence on the application of checklists in the surgery environment, this review of literature shows that the tool reduces never-events and helps the surgical team to effectively manage the hierarchy in the operating environment. However, the use of surgical safety checklists does not guarantee the safety of the patient or desirable outcomes. Furthermore, the impact of checklists surpasses any directly quantifiable reduction in the never-events. In the busy operating room environment, marked by independent priorities and constraints, a standardized checklist would provide an effective structure for performance and communication. In addition, checklists enhances consciousness regarding patient safety issues, as well as awareness of the significance of preventing slips.

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