Patient Suicide Is an Example of a Sentinel Event Subject to Review by the Joint Commission

Background

Surgery is one expanse of health care in which preventable medical errors and near misses can occur. However, until the 1999 Constitute of Medicine report, To Err Is Human,^one clinicians were unaware of the number of surgery-associated injuries, deaths, and near misses because in that location was no procedure for recognizing, reporting, and tracking these events.ⁱⁱ Of smashing business concern is wrong-site surgery (WSS), which encompasses surgery performed on the incorrect side or site of the body, wrong surgical procedure performed, and surgery performed on the wrong patient.³ This definition also includes "any invasive procedure that exposes patients to more than than minimal run a risk, including procedures performed in settings other than the OR [operating room], such as a special procedures unit, an endoscopy unit, and an interventional radiology suite"⁴ (p. 11). WSS is besides divers every bit a picket event (i.e., an unexpected occurrence involving expiry or serious physical or psychological injures, or the risk thereof) by the Joint Commission (formerly called the Joint Commission on Accreditation of Healthcare Organizations), which constitute WSSs to exist the third-highest-ranking event.⁵

Causes and Consequences of Wrong-Site Surgery

WSS tin exist a devastating experience for the patient and have a negative impact on the surgical team.⁶ ^, ^vii Land licensure boards are imposing penalties on surgeons for WSS,⁸ and some insurers have decided to no longer pay providers for WSS or wrong-person surgery, nor for leaving a foreign object in a patient'southward body later surgery.⁹ Surgery performed on the incorrect site or wrong person has also often been held compensable under malpractice claims. Indeed, 79 percentage of incorrect-site eye surgery and 84 percent of incorrect-site orthopedic claims resulted in malpractice awards.^x ^, ^xi

WSSs are rare events, but we are learning more than about their prevalence. Because reporting of sentinel events to the Joint Committee is voluntary, it could be that only 10 percent of actual WSSs are reported.¹² Researchers have confirmed that the Articulation Commission's numbers are low, finding wide variations in the number of WSSs: i out of 27,686 cases,⁶ or 1 out of every 112,994 surgeries,¹³ or ane in 5 hand surgeons during their career,⁷ or 1 out of 4 orthopedic surgeons with 25 years' experience.^fourteen Regardless of the exact number of WSSs, they are seen equally a preventable medical error if certain steps are taken and standardized procedures are implemented in the perioperative setting.¹⁵ ^, ¹⁶

The incidence of reported WSS has increased in recent years. From the inception of the Joint Committee's Picket Effect programme, the number of WSSs reported has increased from xv cases in 1998, to a total of 592 cases reported by June 30, 2007.¹⁷ Of these, WSSs most commonly occur in orthopedic or podiatric procedures,^v full general surgery, and urological and neurosurgical procedures.¹⁷ In response to the occurrence of these preventable errors, the Joint Committee issued two National Patient Condom Goals on January 1, 2003 to target incorrect-site surgery:

Goal ane—to ameliorate the accuracy of patient identification past using two patient identifiers and a "time-out" procedure before invasive procedures.

Goal four—to eliminate incorrect-site, wrong-patient, and wrong-procedure surgery using a preoperative verification process to confirm documents, and to implement a procedure to mark the surgical site and involve the patient/family.^xl

Both of these goals keep to be an ongoing priority for the Joint Committee. Yet with many surgical procedures traditionally performed only in acute care settings now beingness performed in freestanding surgical centers and physician offices—not necessarily all under the purview of the Articulation Commission—surgeons, surgical teams, and patients need to be vigilant with all surgeries, peculiarly when the level of oversight and scrutiny may not exist equally high equally in hospitals.

WSS is generally caused by a lack of a formal arrangement to verify the site of surgery or a breakup of the arrangement that verifies the right site of surgery.¹⁸ In using root-cause analysis, a process that determines the underlying organizational causes or factors that contributed to an event, the Articulation Commission found the acme root causes of WSS to be communication failure (70 per centum), procedural noncompliance (64 per centum), and leadership (46 percent).^xvi Other arrangement and process causes are listed in Table ane. Risk factors associated with WSS were identified as emergency cases, multiple surgeons, multiple procedures, obesity, deformities, time pressures, unusual equipment or setup, and room changes.¹⁷

Tabular array one

Causes of Wrong-Site Surgeries

Universal Protocol for Preventing Wrong-Site Surgery

Early attempts to address the occurrence of WSS started with the American Academy of Orthopedic Surgeons (AAOS) and the N American Spine Social club (NASS). After reviewing of 10 years of malpractice claims and polling its members,²¹ AAOS developed an awareness campaign to encourage the marker of the right surgical site, called "Sign Your Site."²² But in practise, adding an additional warning such equally "No" on the incorrect site and having the surgical team work together to verify the correct site helped the Sign Your Site programme to exist effective.²³ The NASS further refined the Sign Your Site procedure by calculation more than detail for the appropriate level and site of the spine in its "Sign, Marking, and X-ray" programme, calling for marking the exact site and side of the spine with a radiopaque indicator, and put forth a checklist for patient and procedure verification.²⁴

In 2003, the Joint Commission convened a summit, including the AAOS and leaders from 23 other organizations, to accost the continued escalation of reported WSS cases (i.eastward., lookout events reported to the Joint Commission); and the impact of WSS on patients, their families, and health care professionals; and associated wellness care costs. The top was specifically designed to bring health care professionals and others together to accost and develop strategies to lessen or eliminate WSS.¹⁴ A major outcome of the summit was creation of a protocol, The Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery ^TM (see Text Box 1).²⁰ This protocol was designed to exist used in all areas where invasive procedures are performed within health intendance organizations, including nonoperating-room settings. The goal was to drastically reduce or eliminate completely the incidence of WSS by using a standardized routine and acceptable preoperative process of verifying the patient and the correct site, as well as the medico marking the site with his or her initials earlier the patient is sedated.

Box

Wrong site, wrong process, wrong person surgery tin can exist prevented. This Universal Protocol is intended to achieve that goal. It is based on the consensus of experts from the relevant clinical specialties and professional disciplines and is endorsed by (more...)

The Universal Protocol for WSS is based on prevention theories that drive safe exercise in high-risk industries, such equally aviation and development of nuclear weapons. The operating room is complex with "tight coupling" of processes that happen very quickly and cannot be turned off once started; failed parts cannot be isolated from other parts—resulting in an unsafe process. A model most often used to demonstrate this is the ane described by Reason²⁵ as the Swiss cheese model, where error defenses breakdown or are not in identify, resulting in patient harm. (Run across the chapter on human factors for more information on Reason'due south model.)

Past implementing a systems alter required by the WSS protocol, the possibility of a WSS should be prevented. The iii primal elements of the Universal Protocol for WSS are (ane) preoperative verification process, (ii) marking the operative site, and (3) taking a time out. The Universal Protocol is to be used in ambulatory care, hospitals, critical admission hospitals, and office-based settings.²⁰ Implementing and adhering to this protocol should eliminate WSS errors that tin be attributable to interruptions, distractions, and also many forms or procedures. On July 1, 2004, the Joint Commission began to include these 3 key Universal Protocol elements in its accreditation process for wellness intendance organizations and also provided further guidance on its implementation (see Text Box 2).

Box

These guidelines provide detailed implementation requirements, exemptions, and adaptations for special situations. Preoperative verification procedure

The Association of periOperative Registered Nurses (AORN), realizing the importance of the Universal Protocol for WSS, worked collaboratively with the Joint Commission to develop a Correct Site Surgery Tool Kit. The tool kit, designed to help health care providers to implement the Universal Protocol for WSS in their facilities, was endorsed past the American Higher of Surgeons, American Club of Anesthesiologists, American Society for Healthcare Hazard Management, American Infirmary Association, and the American Clan of Ambulatory Surgery Centers.

The AORN Correct Site Surgery Tool Kit contains a diverseness of resources to educate wellness care providers about the Universal Protocol for WSS and to assist them with its implementation. The resources include (one) an educational program on CD-ROM; (2) a pocket reference bill of fare outlining the steps necessary to promote patient identification, site mark, and the time out; (3) a template to facilitate evolution of a facility policy to implement the Universal Protocol for WSS; (4) a re-create of the Universal Protocol for WSS and Guidelines for Implementing the Universal Protocol; (5) ofttimes asked questions of the Joint Committee and AORN; (6) letters to nurses, physicians, facility primary executive officers, and health care gamble managers encouraging standard implementation of the Universal Protocol across all facilities; and (7) information for patients about the Universal Protocol for WSS and wellness care safety. This tool kit is available from AORN at http://www.aorn.org/PracticeResources/ToolKits/CorrectSiteSurgeryToolKit. In improver, AORN Standards, Recommended Practices, and Guidelines has a position statement on Correct Site Surgery that has additional data on preventing wrong site surgery.³⁹

Several other organizations have set up forth tools and policies to prevent WSS. The Veterans Affairs National Heart for Patient Prophylactic put along the Ensuring Right Surgery and Invasive Procedures directive, based on root-cause analysis, that adds 2 steps to the Joint Commission's Universal Protocol: ensuring the consent form is administered and used properly, and having two members of the surgical squad review patient information and radiological images prior to the start of the surgery.²⁶ The OR briefing tool used at Johns Hopkins Hospital expands the fourth dimension-out office of the Universal Protocol past prompting additional dialogue betwixt the anesthesia care team, nursing, and the surgical team.²⁷ Additionally, the British National Patient Safety Agency has introduced a risk direction tool, setting along a process for double-checking and identifying who is accountable at each stage for ensuring surgical markings on the right site to avoid WSS.²⁸

Research Evidence

There is limited enquiry on wrong-site surgery. The majority of studies accept been retrospective, chart reviews, case studies, and surveys of various professional organizations. The prove table summarizes the most recent evidence related to WSS, specifically the three components of the Universal Protocol.

In two of the retrospective studies that investigated WSS broadly, Meinberg and Stern,^seven in a written report relating to the Universal Protocol, found that nearly half of surgeons changed their preoperative practices in response to the Sign Your Site campaign. Since the campaign targeted orthopedic surgeons, they were more knowledgeable most the campaign and were more likely to have changed their practices. Kwaan and colleagues^vi identified 62 per centum of WSS cases that could have been prevented had providers adhered to the Universal Protocol. In this written report, the authors ended that the Universal Protocol would not take prevented the remaining one-tertiary of WSS documented cases because of errors initiated in weeks earlier surgery (e.g., incorrect documentation, inaccurate labeling of radiological reports). In an analysis of quality improvement efforts, similar findings also indicated implementation challenges associated with staff nonadherence because the issue of laterality was not addressed in the policy and the process was vulnerable to communication failures during handoffs.²⁹

Preoperative Verification

In verifying that the right patient is to have the correct surgery in the correct location, 1 study constitute that when discrepancies occurred among clinicians, a review of the patient's information could resolve the discrepancy.³⁰ Published guidelines affirm the need for a checklist to itemize exactly what should be checked, merely do not specify what should happen if a discrepancy occurs.³¹

Mark the Site

Three different studies and 1 quality improvement projection assessed aspects of site marking, included two different approaches in who actually marks the right site. All found challenges in ensuring that each surgical patient had the right site marked, therefore exposing patients to possible WSS. 1 report that surveyed a small number of surgeons on their site-marker practices post-obit the institution of national guidelines, found that their practices ranged from no marker to mark every patient, with some relationship to the type of surgery.³² In approaching site marking from the indicate of view that it is the patient's responsibility, instead of the surgeon having complete responsibility, DiGiovanni and colleagues³³ sought to have patients mark the right site after being given a set of instructions. They found that when patients (instead of someone from the surgical team) were asked preoperatively to mark "no" on the wrong foot or ankle, 60 percentage of patients marked the site correctly.

The final report and quality improvement project assessed whether marking would cause other errors, considering of the permanence of the ink, thereby discouraging site marker. The written report establish that marking the surgical site with a pen marker did not affect sterility or place a patient at a higher hazard for infection.³⁴ The quality improvement project found that staff were not marking the right site because the ink upset breast cancer patients and was indelible on premature infants, and the policy did not accost laterality.²⁹

Time Out

Two studies found that the time out component can prevent the majority of WSS, but not all.⁶ ^, ¹³ ^, ³⁵ Another written report found that when surgeons, anesthesiologists, and nurses were trained in doing a standardized ii-minute briefing prior to surgery, there were specific improvements in communication on the surgical site and side operated on.³⁶

Evidence-Based Practice Implications

In response to continued WSS lookout event reports, one of the Joint Commission'southward National Patient Rubber Goals continues to be to eliminate incorrect-site, wrong-patient, and wrong-procedure surgery. Eliminating WSS errors requires a systems arroyo, institutionalizing robust systems to verify the right site that fairly addresses potential causes of breakdowns in the organisation. Infirmary and surgery center leaders and managers should evaluate their policies and procedures regarding WSS and marking the right site to ensure that no WSSs occur under any circumstances.

Adoption of the Universal Protocol standardizes preoperative preparations, improves function of the health care team, and should avert whatever potential for WSS. All health care personnel must be knowledgeable about the Universal Protocol and consistently adhere to the three key elements—patient identification, site mark, and time out—as outlined in the Universal Protocol to reduce the number of WSSs occurring in the United States.

The Universal Protocol for WSS should be adhered to on all applicative cases, every bit the operating room and procedural areas are highly coupled and complex areas that would be unlikely to be completely error proof. Measures should exist taken that require less reliance on memory. For case, a surgical site mark is a measure to prevent reliance on memory. Nevertheless, when involving patients in marking the surgical site, one needs to assess their concrete, cognitive, and emotional ability.³¹

All health care professionals have an obligation to comply with the Universal Protocol and to speak upward if they feel patient safety is being compromised in any way.³⁷ Nurses, specifically perianesthesia nurses, should function equally the patient's advocate and foster procedures that ensure right-site surgery.³⁸

Enquiry Implications

In that location is piddling empirical prove regarding prevention of WSS or quantitative evaluation of implementation of strategies to prevent WSS. Part of the problem with enquiry in this area has been that the medical-error data are non piece of cake to extract, and error data are oftentimes transferred to medical claims data and medical liability, further preventing the sharing of such information. Mandatory reporting of these data has simply recently been required in some States. Consequently, there are gaps in the current evidence on wrong-site surgery. For instance, at that place were no randomized controlled studies to evaluate the effect of the Universal Protocol on WSS. Inquiry is needed to decide whether the patient's run a risk for WSS is associated with the organization post-obit the Joint Committee's Universal Protocol or other standardized procedure, or with the effectiveness of the surgical squad in communicating with each other. It is unknown how effective surgical teams are in complying with the protocol on a daily basis, and it is unknown what factors or barriers exist to implementing the Universal Protocol for WSS in facilities across the country.

Conclusion

The reported number of WSS cases continues to increase equally health care organizations get more transparent to medical mistake. Many health intendance organizations, cartoon on error-prevention theories and the experience of the aviation industry, recognize that through such transparencies, systems tin can change and result in better patient outcomes. Withal, it is unlikely that WSS volition fully be reported because of industrywide study cards, fright of litigation, and difference of opinions. Although absolute numbers of WSS may not be striking, the consequences to the patient on whom it occurs are dire.

Search Strategy

Both PUBMED® and CINAHL® databases between 1990 and March 2007 were searched, using incorrect site surgery[keyword] OR incorrect site surgery[subject heading]. This identified 239 citations. Citations were excluded for the post-obit reasons: not-English, dealt only with disclosing errors or patient preferences, opinion/editorial pieces, news articles, or announcements. This left 68 articles for consideration in this review, 10 of which were considered as testify.

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Source: https://www.ncbi.nlm.nih.gov/books/NBK2678/