AORN Journal
Volume 84, Issue 1, Supplement 1 , Pages S13-S29, July 2006

Best Practices for Preventing Wrong Site, Wrong Person, and Wrong Procedure Errors in Perioperative Settings

Article Outline

 

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Wrong Site 

Case Study 1 

As the circulating nurse, I did not go to see the patient immediately after a previous case. The anesthesiologist insisted that the patient must be seen immediately and brought into the OR. The charge nurse informed me that I must see the patient and bring the patient to the room immediately. I was now feeling upset and rushed. I verified the procedure, site, and side verbally with the OR team. The surgeon left the OR to scrub, and I started prepping the patient's left limb. When the surgeon came back into the OR for gowning, he reiterated that the procedure was on the right limb. I stopped the prep, reconfirmed the site, and prepped the correct limb.

Case Study 2 

I was preparing the OR for the next patient and had several pieces of equipment to set up, which was taking some time. In the meantime, the patient was brought into the OR. Before I could acknowledge the patient's presence or review the patient's chart, check the consent, and confirm the surgical site, the surgeon proceeded to prepare the patient for surgery by positioning and doing the skin prep. As the surgeon completed the prep, he removed the drapes that had been used to cover the nonoperative site. It was at this stage that I noticed the wrong area had been prepared. I pointed this out to the surgeon, and we reconfirmed the surgical site. The correct area was prepped, and the operation went ahead as planned.

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Wrong Person 

Case Study 3 

It was a very busy day in our OR. Our supervisor was pushing to get the rooms turned over quickly to get on with the next case. The nurses were very rushed; we were short-staffed, and many of the nurses on duty had worked full shifts on the previous day and had been called in again during the night. We did not have enough staff to relieve the nurses who had worked all night. The anesthesiologists were in a similar situation. Some staff members had worked more than 16 hours in the previous 24-hour period.

I was going to the preoperative holding area to get my next patient, who was scheduled to have surgery on her arm. When I got there, my patient was not in the space that had been assigned to her; the stretcher and patient were gone. I asked the nurse in the preoperative holding area if she had checked the patient in or if someone had moved her to another area. She said the patient had been checked in, but she did not know whether anyone had moved her to another area. Together we looked for the patient. When we determined that she was not in the holding area, I had a sinking feeling that someone might have taken the wrong patient to another OR.

The OR supervisor and I ran from room to room, frantically looking for my patient. The second room I entered had a patient in lithotomy position, already shaved and prepped. They were just gowning the surgeon when I asked, “Are you certain you have the correct patient?” The surgeon said the patient was already asleep and draped when he came in. He added that her face did not look like his patient, but he didn't think much about it. The anesthesiologist said that he did not check the armband; he had assumed the circulator had the correct patient. They were rushed because we were behind schedule, so he had gone ahead with the anesthesia before the surgeon came in. The anesthesiologist immediately checked the armband, and we found that it was indeed my patient, who was to have surgery on her arm. She was 28 years old, and they were about to do a total vaginal hysterectomy on her!

The circulator admitted that she had not checked the armband, but she had asked the patient, “Are you Mrs. X?” and the patient said, “Yes.” The circulator also asked, “Are you having a vaginal hysterectomy?” and again, the patient said, “Yes.” So the circulator had brought the patient back to the OR without checking her armband. The anesthesiologist had not checked her armband. The surgeon did not speak with the patient or check the armband before induction of anesthesia. The patient's family had stepped out of the holding area to go to their car when the nurse came to get her for surgery. It turned out the patient could not speak or understand English and had only said yes because it was the only word she knew.

We did prevent her from having the total vaginal hysterectomy, but I shudder to think what would have happened if I had been just two or three minutes later in going to get my patient. The patient did not have surgery on her arm that day. I cannot imagine how she felt when she was told what had happened and why her perineum had been shaved.

Case Study 4 

The schedule was especially busy. Two operating rooms in the same area of the OR suite had different orthopedic teams in each room. The RN circulator in OR One sent for the next patient for Surgeon One but made a mistake in the patient's name because she looked at the list of patients for OR Two. The patient scheduled for OR One was to have a total hip arthroplasty; however, the RN selected the name of a patient who was having the same procedure by Surgeon Two in OR Two. When the patient arrived in the OR, another nurse met the patient and proceeded to assist the anesthesia team with the spinal anesthetic procedure. As the patient was about to be draped for the surgery by the team for Surgeon One, the anesthesiologist spoke to the patient and called him by the name of the patient on Surgeon One's list. When the patient did not respond to his name, the nurse explained, “This is Mr. Y,” using the actual name of the patient. The anesthesiologist became suspicious because Surgeon One had only one patient left on his list, and his name was Mr. Z. When the mistake was realized, Surgeon One informed Surgeon Two, and Surgeon Two carried out the surgery on his patient in OR One.

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Wrong Procedure 

Case Study 5 

A patient from a local long-term care facility was admitted to the hospital. The patient was not competent to give personal consent. A week earlier, the preadmissions staff had obtained a consent form for a left arm thrombectomy, but the procedure for this patient had been cancelled. On the patient's second visit to the hospital, the vascular surgeon came to visit the patient and confirm the correct site and procedure with the RN in the OR holding area. The RN asked the surgeon why there was a discrepancy between the consent and the procedure listed on the surgical schedule. Upon investigation, the RN found that the surgeon's office had not faxed the surgeon's new orders for the appropriate procedure to the preadmissions area. Because they had not received any new information, the preadmissions staff had assumed the patient was coming back for the same surgery that had been cancelled during the previous week, which was not the case. The RN in the holding area contacted the person who was the authorized holder of the patient's health care power of attorney to obtain consent for the correct site and correct procedure.

Case Study 6 

Scheduling personnel in the operating room had listed the wrong procedure on the schedule. When the surgeon reviewed the schedule, he alerted the preoperative staff that the wrong procedure was listed. The OR scheduling personnel were not familiar with the abbreviations used or the difference between abbreviations when they scheduled the case.

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Improving Outcomes 

Wrong site surgery is a broad term that encompasses all surgical procedures performed on the wrong patient, wrong body part, wrong side of the body, or at the wrong level of the correctly identified anatomic site. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) considers all wrong site surgeries, regardless of the extent of the procedure or the outcome, to be reviewable sentinel events.1

Universal Protocol 

In 2003, the Joint Commission developed its Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery. AORN participated in the development of this Universal Protocol and has endorsed it. The Universal Protocol also has been endorsed by the organizations representing other members of the surgical team—the American College of Surgeons, the American Association of Nurse Anesthetists, the American Society of Anesthesiologists, the American Society of PeriAnesthesia Nurses, and the Association of Surgical Technologists—and more than 40 other professional groups. The American Association of Ambulatory Surgery Centers, the Federated Ambulatory Surgery Association, and the Medical Group Management Association have endorsed the Universal Protocol for the ambulatory surgery setting.2

The Joint Commission asserts that wrong site surgery can be prevented. The Universal Protocol is intended to achieve that goal.3 Effective July 1, 2004, compliance with the Universal Protocol is required for all JCAHO-accredited organizations.4

Wrong site surgery is a devastating error for all patients, health care providers, and facilities involved. Despite the advent of the Universal Protocol in 2004 and the best efforts of many health care providers to implement it in the perioperative setting, wrong site surgeries continue to occur. According to the most recent JCAHO statistics, reports of wrong site surgery have actually increased since the Universal Protocol took effect.5 (See Table 1.)

TABLE 1. TREND OF WRONG SITE SURGERIES REPORTED TO JCAHO

Source: “Sentinel event statistics: December 31, 2005,” Joint Commission on Accreditation of Healthcare Organizations, http://www.jointcommission.org/SentinelEvents/Statistics (accessed 22 May 2006).

Although an argument can be made that the increase may be the result of improved awareness and diligence in reporting, it is clear that the problem of wrong site surgery persists despite concerted efforts to reduce the incidence. In an article published in USA Today, JCAHO President Dennis O'Leary contends that the problem of wrong site surgery is getting worse. Speaking to the number of wrong site surgeries reported in 2005, O'Leary said, “I can assure you that this is just the tip of the iceberg.” O'Leary continued, “Some hospitals are reporting everything and some hospitals don't report anything at all.”6

The Universal Protocol is based on the consensus of experts from the relevant clinical specialties and professional disciplines. It is incorporated in its entirety into AORN's position statement on correct site surgery, which was adopted by the House of Delegates in its current form in April 2005.1 The Universal Protocol is supported by a set of implementation expectations developed by the Joint Commission to provide details for implementing the Universal Protocol and adapting it to special situations.7 The Universal Protocol and the implementation expectations together provide guidance to prevent wrong site surgery errors and are reprinted in their entirety at the end of this article (see EXHIBIT A, EXHIBIT B).

AORN supports the use of the Universal Protocol to minimize the human and system factors involved in medical errors. The Universal Protocol and its implementation expectations apply to all operative and other invasive procedures that expose patients to more than minimal risk, including procedures done in settings other than the operating room, such as a special procedures unit, endoscopy unit, or interventional radiology suite. “Certain routine ‘minor’; procedures such as venipuncture, peripheral IV line placement, insertion of NG tube, or Foley catheter insertion are not within the scope of the Universal Protocol. However, most other procedures that involve puncture or incision of the skin, or insertion of an instrument or foreign material into the body, including, but not limited to, percutaneous aspirations, biopsies, cardiac and vascular catheterizations, and endoscopies are within its scope.”4

The central elements of the Universal Protocol are

conducting a preoperative verification process;

marking the operative site; and

taking a “time out” immediately before starting the procedure.3

Each of these elements is included in the Universal Protocol for a specific purpose.

The purpose of the preoperative verification process is to ensure that all of the information relevant to the patient and procedure is available before the start of the procedure, that it has been reviewed by the perioperative team, and that missing information or discrepancies are addressed before starting the procedure.

The purpose of marking the operative site is to provide a clear, unambiguous mark indicating the intended incision or insertion site.

The purpose of the time out is to provide another safety check by conducting a final verification of the correct patient, procedure, and site; by actively involving all of the members of the perioperative team; and by requiring the full attention and participation of all team members.3

The Universal Protocol states that the person performing the procedure should do the site marking.3 The word should recognizes the need for flexibility to accommodate the logistical and procedural realities of the full range of surgical facilities. “When it is not feasible for the person performing the procedure to mark the site, another member of the surgical team who is fully informed about the patient and the intended procedure must do the marking. In this context, the preoperative registered nurse is considered a member of the surgical team.”4 Any delegation of responsibility for marking the surgical site must be consistent with applicable law and regulation, keeping in mind that regulations in some states may prohibit nurses from marking the surgical site. “The organization must ensure that whenever the responsibility for site marking is delegated to someone other than the person who will be doing the procedure, the safety of the patient will not be compromised.”4 Although the Universal Protocol requires the patient to be involved in the site marking process, it is not expected, or even recommended, that the patient will mark his or her own surgical site.4

The time out, or immediate preoperative pause, must occur in the location where the procedure will be performed (eg, when the patient is on the operating table). Given this restriction, the time out may precede induction of anesthesia or may occur after the patient is anesthetized but before starting the procedure. In addition, the time out must involve the entire surgical team, which includes, at a minimum, active participation by the surgeon, anesthesia care provider, and circulating nurse. Participation by other members of the surgical team is encouraged as appropriate to their involvement in the procedure. All members of the surgical team should be expected speak up if there is concern about a possible error. According to the Joint Commission, including some members of the surgical team but not others “sends the wrong message.”4

The Universal Protocol emphasizes that “active involvement” and “active communication” among all members of the surgical team are important for the verification process and the time out that takes place immediately before starting the procedure.3 The Joint Commission states that “active communication” does not necessarily mean that everyone has to repeat the same information; the members of the team may signal their agreement by a brief oral acknowledgement, a nod, or some other gesture. Absence of a response, however, should not be interpreted as agreement.4

The AORN Correct Site Surgery Tool Kit has several resources to assist the perioperative team with the implementation of the Universal Protocol. A pocket reference and a policy template for the development of a correct site universal protocol policy are just a few of the resources available in the tool kit to provide guidance to ensure compliance with the Universal Protocol.8

The Perioperative Nursing Data Set (PNDS) and the AORN “Competency statements in perioperative nursing” identify the following nursing interventions that relate to the Universal Protocol.

I138.Implements protective measures prior to operative or invasive procedure.

I26.Confirms identity before the operative or invasive procedure.

I143.Verifies operative procedure, surgical site, and laterality.9, 10

Risk Factors Related to Haste or Distractions 

Studies show that patient safety is threatened when interruptions and frequent interferences occur. When asked why they believe medical errors occur, health professionals often state that interruptions and distractions are contributing factors. Risks to patient safety also can be shown to increase when inefficient care processes and work space design features reduce the amount of time nurses have for monitoring patients and for providing therapeutic care. When considering an employee's ability to learn, studies show that there must be time built in for reflection and analysis. The ability to learn is disrupted by pressure to hurry or rush.11

The Universal Protocol alone is not sufficient to prevent errors in patient identification and marking the surgical site. It must be implemented in a perioperative environment where safety is a priority, and in which perioperative team members acknowledge the potential for error and take steps to reduce errors. Recognizing that development of a patient-centric safety culture will help create an environment in which the Universal Protocol and other safety measures can be successfully employed, the AORN Board of Directors approved a guidance statement on creating a patient safety culture in November 2005.12

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Analysis—Wrong Site 

Case Study Analysis 1 

Questions that could be explored to help understand the contributing factors for this near miss include the following.

What measures could the circulating nurse have implemented to prevent this near miss?

What factors contributed to the incorrect limb being prepped?

What coaching could be provided to perioperative registered nurses to assist them in preventing an outcome as described in this case study?

In case studies 1 and 2, the procedures involved laterality, and the limbs should have been marked according to the Universal Protocol. The mark should have been visible when the nurse or surgeon began the skin prep and would have alerted the caregiver to the error if the nurse or surgeon had consciously looked for the mark before starting the prep.

In case study 1, the circulating nurse states that verbal verification of the procedure, site, and side was done. However, it was not an effective verification because the error still occurred. The definition of the word verify is, “To prove the truth of by presentation of evidence or testimony; substantiate.” The word verification includes the following components in the definition:

a confirmation of truth or authority;

the evidence for such a confirmation; and

a formal assertion of validity.13

When rushed, distracted, or fatigued, clinicians may intend to “verify” information verbally, but in reality, they are only speaking out loud as if announcing or delivering a message. The terms speaking and talking can be used interchangeably, but talking and verifying are two different actions. Clinicians need to conscientiously verify information with the rest of the team and develop an internal awareness to alert themselves if they begin to communicate on a superficial level or “verify” information by rote.

Case Study Analysis 2 

Questions that could be explored to help understand the contributing factors for this near miss include the following.

What steps in the Universal Protocol were omitted in this situation?

How could the perioperative registered nurse have intervened to ensure that best practices for correct site surgery were executed?

In this case study, the surgeon had good intentions to save time by prepping the patient's limb while the circulating nurse was finishing the equipment setup. If all members of the team were consciously committed to verbal verification of the procedure, site, and side, a pause for verification would have taken place when the patient entered the OR, when the anesthesia was administered, when the patient was positioned, and again before the surgeon started the skin prep. The time the surgeon was trying to save was lost because of the need to do a second prep.

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Analysis—Wrong Person 

Case Study Analysis 3 

Questions that could be explored to help understand the contributing factors for this near miss include the following.

What failures in the patient identification and verification process were present in this case study?

What opportunities to improve hand-off communication did the surgical team overlook in this near miss?

What other contributing factors were at hand in this situation?

This case involves several breakdowns in the verification process that had the potential to create devastating results. When developing systems to prevent patient identification errors, one patient safety author states, “Perhaps the most important part of the identification verification process is that clinicians consistently need to check the patient's identification bracelet and verify that they are caring for and providing services and treatment to the correct patient. Any changes in clinical protocol will not be entirely effective unless clinicians at the point of care are conscientious in their efforts to ensure that the right patient is undergoing the right procedure at the right time.”14 Identifying the patient is one of the most basic precepts learned in nursing school and in orientation to perioperative nursing—so basic, in fact, that it may be taken for granted or done without full concentration.9

In this case, the RN circulator and the anesthesia care provider admitted they did not check the patient's identification bracelet. They also did not confirm that the informed consent matched the name and procedure that was listed on the OR schedule. When the patient entered in the OR, the perioperative team members missed another opportunity for verification before administering anesthesia. The surgeon admitted that the patient did not look familiar, missing yet another opportunity for verification by not taking the time to confirm the identification bracelet.

Case study 3 also presents an example of a breakdown in hand-off communication. The JCAHO National Patient Safety Goals includes hand-off communication under Goal 2, which address the effectiveness of communication among caregivers.15 The RN in the preoperative holding area should have been involved in reporting off to the nurse who was planning to provide nursing care for the hysterectomy patient. The risk for error would have been decreased if there had been a face-to-face report between the nurses, with time to ask questions and to discuss the patient's language barrier. The type of information to be communicated in a hand-off includes diagnoses and current condition of the patient, recent changes in condition or treatment, and anticipated changes as a result of the treatment or surgical procedure.16

If there had been such a discussion, one of the nurses might have questioned the patient's age, asked why she was having a hysterectomy at the age of 28, and double-checked the patient's lab work to be sure the patient had a negative pregnancy test. The patient's language barrier would likely have been included in the conversation if a psychosocial assessment had been done by either of the nurses to verify the patient's awareness that she would no longer be capable of having children. Rather than relying on “yes” and “no” answers from the patient, an interpreter should have been available to confirm the procedure with the patient and to relay pertinent information to her before proceeding to the OR.17

Sleep deprivation was likely an additional risk factor because the staffing patterns did not allow either nurses or anesthesia care providers to be sent home after being called in to work for their on-call shifts. It is likely that most perioperative settings have nurses who do not verbalize their need for relief and continue to try to meet the work demands of their department. When supervisors or charge nurses push their staff to maximize efficiency, this adds another risk component for the person who is already working in a potentially compromised state due to fatigue.18

Although there is no laterality involved for a vaginal hysterectomy, marking the site could have helped if the anesthesia care provider or nurse had noticed a mark on the patient's arm when positioning or applying the blood pressure cuff, potentially alerting them to check or ask about the procedure site.

Case Study Analysis 4 

Questions that could be explored to help understand the contributing factors for this near miss include the following.

What steps in the Universal Protocol and best practices for hand-off communication were not implemented in this case study?

What environmental controls could be implemented to improve performance in this facility with regard to preventing wrong procedure, wrong patient, and wrong site errors?

How did barriers in communication contribute to this near miss?

Patient verification and hand-off communication that resulted in a near miss were key points in this case study. It is not clear whether the anesthesia planned for Surgeon Two's patient (Mr. Y) was the same for Surgeon One's patient (Mr. Z), but it is fortunate that Mr. Y was having the same surgical procedure as Mr. Z. If the mistake had not been discovered in time, at least the correct procedure would have been performed. Note, however, the increased risk for the occurrence of a sentinel event. If Mr. Z had been scheduled for a different procedure, or if the procedure was to be performed on a different side, Mr. Y could have ended up with a total hip arthroplasty being done unnecessarily or on the wrong hip.

The RN circulator was careless in reading the surgery schedule when she sent for the patient. When the perioperative team looked back on this event, they noted that the lists of patients are placed separately on the doors of each OR. This nurse had to go out of her way to select a patient from the incorrect list, and yet the error still occurred.

According to the Universal Protocol, a time out should take place immediately before starting the procedure.3 In this case, the time out should have taken place at the time of the spinal anesthetic procedure. Frequently, the perioperative team focuses on the time of incision for the surgical procedure, but in this case administration of the spinal anesthetic was a procedure in itself. Therefore, the patient's name, procedure, and laterality should have been verified and compared with the OR schedule before the anesthetic was administered.

A standardized hand-off communication process would have increased the chance of catching the error before the patient received the anesthetic. The narrative states, “When the patient arrived in the OR, a different nurse met the patient and proceeded to assist the anesthesia team.” The fact that another nurse was involved could increase the risk for error. On the other hand, the receiving nurse might have caught the error if there had been appropriate hand-off communication in the preoperative holding area, including verification of the patient's name and procedure with the surgical schedule.

Because the narrative alludes to someone else having delivered the patient to the receiving RN in the OR, it appears that there was no hand-off communication at all from the nurse in the preoperative holding area directly to the RN in the OR. If the preoperative RN or charge nurse was the person who delivered the patient to the OR, there should have been hand-off communication upon arrival in the OR, with another opportunity to note that this patient was scheduled for OR Two.

Teamwork is another key issue in this narrative. Communication checks and balances are very important in complex environments like the OR. For example, there was an opportunity for the transport team or the front desk person to question the nurse in OR One when she notified them to bring OR Two's patient. Administrative assistants and charge nurses who are present at the front desk and orderlies who transport patients are important members of the perioperative team who need to be encouraged to actively participate in communicating concerns about patient safety.

The patient and his or her family members are important members of the perioperative team, as well. In this case, the patient did not answer when he was called by the wrong name. Before the spinal anesthetic was administered, however, it is unknown whether he had been called by the wrong name by the anesthesia care provider and had not spoken up. It also is unknown if the surgeon visited the patient in the preoperative holding area. If so, the patient or a family member would have had an opportunity to voice a concern that they did not recognize the surgeon. It is possible that the preoperative nurse and the OR nurse were calling the patient by his correct name, but if one of them had made a reference to the surgeon, the patient would have had an opportunity to question his caregivers.

Patients often trust their health care providers and do not want to be considered difficult if they question something they are observing. Operating rooms and surgery centers have an interesting challenge in implementing an environment where the patient is encouraged to play an active role in his or her care. Perioperative staff members must strike a balance between assuring patients that safe care will be provided and encouraging them to ask questions if something is different from what they expected.

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Analysis—Wrong Procedure 

Case Study Analysis 5 

Questions that could be explored to help understand the contributing factors for this near miss include the following.

How could hand-off communication be improved between the physician's office, preadmission staff, and perioperative team?

How could the preadmission staff have intervened to prevent this near miss?

The issue of read-back arises when the surgery scheduler is taking the name of the patient, procedure, and laterality from the surgeon's office.16 There would have been an increased risk for error if the surgery scheduler had not confirmed that the procedure being scheduled was different from the one scheduled the previous week. In this case, the RN in the preadmissions area had not compared the informed consent with the surgery schedule and thus had not noted the discrepancy. It was not until the day of surgery that the RN in the preoperative holding area identified the potential error and took the appropriate action to get the informed consent signed. The narrative does not specify whether the patient had the correct diagnostic tests for the scheduled procedure or if there were any other patient care issues, additional costs, or delays associated with the error.

In this scenario, the surgeon's office was in error; however, there was a weak link in the preadmissions verification process. The preadmissions staff should initiate a follow-up evaluation with the surgeon's office staff and examine their own systems to determine how to prevent this type of error in the future. The RN in the preadmissions area should have confirmed whether the patient was having the same procedure scheduled for the previous week or a different procedure to facilitate accurate hand-off communication when the patient went to surgery.16

Case Study Analysis 6 

Questions that could be explored to help understand the contributing factors for this near miss include the following.

How could the competency of the OR schedulers be assessed in relation to abbreviations?

What information could be included in the facility's policies and procedures to help promote clarity when scheduling procedures involving laterality?

How could the preadmission and physician's office staff be involved in promoting best practices for the scheduling of procedures?

In this scenario, it is not clear whether the schedulers used a wrong abbreviation when they entered the procedure into the surgery schedule, or whether they misinterpreted an abbreviation given to them by the office. Perioperative leaders should implement policies to eliminate abbreviations associated with laterality; problem-prone, high-risk, or high-volume abbreviations; and acronyms or symbols that are unique to the perioperative venue.15, 19

Surgery schedulers should confirm (ie, “read back”) the procedure with the office booking the case and/or initiate questions with OR leaders if they are scheduling something unusual or unfamiliar. In addition to drafting instructions and training for schedulers so they do not use abbreviations, perioperative leaders also should emphasize the importance of read-back when scheduling a procedure.16 Surgery schedulers should clarify the procedure before hanging up the call with the surgeon's office.

Perioperative leaders should implement a verification process to be sure OR schedulers have the training and knowledge base they need. When new surgeons, new procedures, or new specialty services are a part of the strategic plan, perioperative leaders should alert the schedulers and offer additional training about criteria for scheduling the new procedures involved. There also should be a verification check-and-balance system in place to allow perioperative leaders to review the schedule ahead of time and ask questions if there are abbreviations, misspellings, or unfamiliar terms used for the cases posted. Goal 2 of the JCAHO National Patient Safety Goals requires the development of a standardized list of abbreviations, acronyms, and symbols that are not to be used in the organization;15 the AORN guidance statement on “do use” abbreviations and symbols provides guidelines for meeting these requirements in the perioperative setting.19

The preadmissions staff also could have served a check-and-balance role in this scenario. In many facilities, the surgeon's office calls the OR to schedule the procedure, the OR schedulers produce a preliminary schedule for the preadmissions department, and the surgeon's office sends the orders to the preadmissions department. The preadmissions staff could have found the discrepancy earlier if they had compared the orders with the surgery schedule and asked questions if there were unfamiliar abbreviations or if the procedure listed on the surgery schedule did not match the orders.

The Case Studies Overall 

In several of the case studies presented here, the patients had progressed much too far along in the surgery process before the errors were found. All of the narratives provide key examples of breakdowns in communication and the verification process. Fortunately, each situation turned out to be a near miss rather than a sentinel event because alert members of the perioperative team posed questions when they were suspicious about the patient's safety. Whether the team member who raises the question is an RN, technician, anesthesia care provider, surgeon, surgery scheduler, orderly, or the patient, it is important to stop and investigate the patient safety risks for error.

Several of the cases also represent the increased risk for error that results when members of the perioperative team are rushed or distracted. Studies show that reflection and analysis are important components when an employee is trying to learn. Perioperative nurses are in a constant state of learning, whether it is applying new technology to specific patients or procedures, anticipating surgeon techniques and preferences, or relating information from the patient's chart to the anesthetic and equipment set up in the room. Supervisors, charge nurses, and administrators need to offer support to frontline caregivers who express the need for additional time to assimilate information.

None of the surgeries illustrated in these cases appeared to be a life-threatening emergency. There is a big difference between being inefficient or slow and having false expectations of what it takes to be ready for a procedure. In some instances, the complexity of the case can be a factor leading to potential error. Another underlying factor is that a nurse may not feel comfortable stopping the surgeon or anesthesia care provider from bringing the patient into the room before the nurse is prepared. In a culture of patient safety, the nurse would readily speak up to say the room was not ready to receive the patient because the nurse would not be available to give the patient his or her undivided attention. Pushing too hard for efficiency may lead to unsafe conditions.

Can clinicians at the point of care be conscientious if they are tired, distracted, or hurried? Perioperative leaders hold the key to any patient safety program because of their critical responsibility to develop teams that are willing to learn and work together. In a culture of safety, staff members feel valued and supported, and every staff member is encouraged to participate in activities that promote patient safety. Clinicians who believe they are working in conditions that compromise patient safety have an obligation to speak up. Safety must be the first priority for the perioperative team and must be the driving force for decision making.20

Each of these case studies provides specific examples of breakdowns in patient safety culture, but all are examples of how the situation turned out to be a near miss rather than a sentinel event. In several instances, the perioperative nurse was vigilant and took immediate action to acknowledge that something was wrong. This action allowed the error to be caught before the incision was made.

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LESSONS LEARNED 

Despite the advent of the JCAHO Universal Protocol, wrong site surgeries continue to occur.

The Universal Protocol, including a preoperative verification process, site marking, and a time out immediately before starting the procedure, must be followed in all applicable situations. All members of the perioperative team are responsible for ensuring that the Universal Protocol is followed.

Safety must be the first priority for the perioperative team and must be the driving force for decision making.

Frontline caregivers who believe they are working in conditions that compromise patient safety have an obligation to speak up.

Allied health care providers and support personnel are important members of the perioperative team and need to be encouraged to speak up if they have concerns.

Patients are important members of the perioperative team and need to be encouraged to speak up if they have concerns.

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EXHIBIT A. Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery™ 

Wrong site, wrong procedure, wrong person surgery can be 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 than 40 professional medical associations and organizations.

In developing this protocol, consensus was reached on the following principles:

Wrong site, wrong procedure, wrong person surgery can and must be prevented.

A robust approach—using multiple, complementary strategies—is necessary to achieve the goal of eliminating wrong site, wrong procedure, wrong person surgery.

Active involvement and effective communication among all members of the surgical team is important for success.

To the extent possible, the patient (or legally designated representative) should be involved in the process.

Consistent implementation of a standardized approach using a universal, consensus-based protocol will be most effective.

The protocol should be flexible enough to allow for implementation with appropriate adaptation when required to meet specific patient needs.

A requirement for site marking should focus on cases involving right/left distinction, multiple structures (fingers, toes), or levels (spine).

The Universal Protocol should be applicable or adaptable to all operative and other invasive procedures that expose patients to harm, including procedures done in settings other than the operating room.

In concert with these principles, the following steps, taken together, comprise the Universal Protocol for eliminating wrong site, wrong procedure, wrong person surgery:

Preoperative verification process
Purpose: To ensure that all of the relevant documents and studies are available prior to the start of the procedure and that they have been reviewed and are consistent with each other and with the patient's expectations and with the team's understanding of the intended patient, procedure, site, and, as applicable, any implants. Missing information or discrepancies must be addressed before starting the procedure.

Process: An ongoing process of information gathering and verification, beginning with the determination to do the procedure, continuing through all settings and interventions involved in the preoperative preparation of the patient, up to and including the “time out” just before the start of the procedure.


Marking the operative site
Purpose: To identify unambiguously the intended site of incision or insertion.

Process: For procedures involving right/left distinction, multiple structures (such as fingers and toes), or multiple levels (as in spinal procedures), the intended site must be marked such that the mark will be visible after the patient has been prepped and draped.


“Time out” immediately before starting the procedure
Purpose: To conduct a final verification of the correct patient, procedure, site and, as applicable, implants.1

Process: Active communication among all members of the surgical/procedure team, consistently initiated by a designated member of the team, conducted in a “fail-safe” mode, ie, the procedure is not started until any questions or concerns are resolved.


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EXHIBIT B. Implementation Expectations for the Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery™ 

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

Preoperative verification process 

Verification of the correct person, procedure, and site should occur (as applicable):
At the time the surgery/ procedure is scheduled.

At the time of admission or entry into the facility.

Anytime the responsibility for care of the patient is transferred to another caregiver.

With the patient involved, awake, and aware, if possible.

Before the patient leaves the preoperative area or enters the procedure/surgical room.


A preoperative verification checklist may be helpful to ensure availability and review of the following, prior to the start of the procedure:
Relevant documentation (eg, history and physical, consent).

Relevant images, properly labeled and displayed.

Any required implants and special equipment.


Marking the operative site 

Make the mark at or near the incision site. Do NOT mark any nonoperative site(s) unless necessary for some other aspect of care.

The mark must be unambiguous (eg, use initials or “YES” or a line representing the proposed incision; consider that “X” may be ambiguous).

The mark must be positioned to be visible after the patient is prepped and draped.

The mark must be made using a marker that is sufficiently permanent to remain visible after completion of the skin prep. Adhesive site markers should not be used as the sole means of marking the site.

The method of marking and type of mark should be consistent throughout the organization.

At a minimum, mark all cases involving laterality, multiple structures (fingers, toes, lesions), or multiple levels (spine). Note: In addition to preoperative skin marking of the general spinal region, special intraoperative radiographic techniques are used for marking the exact vertebral level.

The person performing the procedure should do the site marking.

Marking must take place with the patient involved, awake, and aware, if possible.

Final verification of the site mark must take place during the “time out.”

A defined procedure must be in place for patients who refuse site marking.

Exemptions 

Single organ cases (eg, Cesarean section, cardiac surgery).

Interventional cases for which the catheter/ instrument insertion site is not predetermined (eg, cardiac catheterization).

Teeth—but, indicate operative tooth name(s) on documentation or mark the operative tooth (teeth) on the dental radiographs or dental diagram.

Premature infants, for whom the mark may cause a permanent tattoo.

“Time out” immediately before starting the procedure 

Must be conducted in the location where the procedure will be done, just before starting the procedure. It must involve the entire operative team, use active communication, be briefly documented, such as in a checklist (the organization should determine the type and amount of documentation) and must, at the least, include:

Correct patient identity.

Correct side and site.

Agreement on the procedure to be done.

Correct patient position.1

Availability of correct implants and any special equipment or special requirements.

The organization should have processes and systems in place for reconciling differences in staff responses during the “time out.”

Procedures for non-OR settings including bedside procedures 

Site marking must be done for any procedure that involves laterality, multiple structures, or levels (even if the procedure takes place outside of an OR).

Verification, site marking, and “time out” procedures should be as consistent as possible throughout the organization, including the OR and other locations where invasive procedures are done.

Exception: Cases in which the individual doing the procedure is in continuous attendance with the patient from the time of decision to do the procedure and consent from the patient through to the conduct of the procedure may be exempted from the site marking requirement. The requirement for a “time out” final verification still applies.

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Notes 

  1. In: “AORN position statement on correct site surgery” in Standards, Recommended Practices, and Guidelines . Denver: AORN, Inc; 2006;p. 348; Also available at http://www.aorn.org/about/positions/pdf/Final%20PS%20on%20Correct%20Site%20Surgery.pdf (accessed 17 May 2006)
  2. “Help prevent errors in your care: For surgical patients” Joint Commission on Accreditation of Healthcare Organizations . http://www.jointcommission.org/NR/rdonlyres/2020EE90-CBD6-482D-8FE3-24593431A313/0/wrong_site_brochure.pdf (accessed 17 May 2006)
  3. “Universal protocol for preventing wrong site, wrong procedure, wrong person surgery” Joint Commission on Accreditation of Healthcare Organizations . http://www.jointcommission.org/NR/rdonlyres/E3C600EB-043B-4E86-B04E-CA4A89AD5433/0/universal_protocol.pdf (accessed 17 May 2006)
  4. “Frequently asked questions about the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” Joint Commission on Accreditation of Healthcare Organizations . http://www.jointcommission.org/PatientSafety/UniversalProtocol/up_faqs.htm (accessed 17 May 2006)
  5. Sentinel event trends  . Wrong site surgeries reported by year” Joint Commission on Accreditation of Healthcare Organizations . http://www.jointcommission.org/NR/rdonlyres/6F94288C-EC8E-4B95-91F6-0A1C96C09708/0/se_trends_wss_reported.gif (accessed 17 May 2006)
  6. Davis R . “‘Wrong site’ surgeries on the rise” USA Today, 17 April 2006, Health and Behavior . Also available at http://www.usatoday.com/news/health/2006-04-17-wrong-surgery_x.htm (accessed 17 May 2006)
  7. “Implementation expectations for the Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery” Joint Commission on Accreditation of Healthcare Organizations . http://www.jointcommission.org/NR/rdonlyres/E3C600EB-043B-4E86-B04E-CA4A89AD5433/0/universal_protocol.pdf (accessed 17 May 2006)
  8. Correct Site Surgery Tool Kit . Denver: AORN, Inc; 2004; Also available at http://www.aorn.org/toolkit/Default.asp (members only; accessed 22 May 2006)
  9. Beyea SC . Perioperative Nursing Data Set: The Perioperative Nursing Vocabulary . second ed.. Denver: AORN, Inc; 2002;
  10. In: “Competency statements in perioperative nursing” in Standards, Recommended Practices, and Guidelines . Denver: AORN, Inc; 2006;p. 21–95
  11. Institute of Medicine  . Keeping Patients Safe: Transforming the Work Environment of Nurses . Washington, DC: National Academies Press; 2004; Also available at http://fermat.nap.edu/books/0309090679/html (accessed 17 May 2006)
  12. In: “AORN guidance statement: Creating a patient safety culture” in Standards, Recommended Practices, and Guidelines . Denver: AORN, Inc; 2006;p. 289–294 Also available at http://www.aorn.org/about/positions/pdf/PatSafetyCulture-2006.pdf (accessed 17 May 2006)
  13. “Dictionary.com” http://dictionary.reference.com (accessed 17 May 2006)
  14. Beyea SC . “Systems that reduce the potential for patient identification errors” (Patient Safety First) . AORN Journal . September 2002;76:504–506
  15. 2006 critical access hospital and hospital national patient safety goals  . Joint Commission on Accreditation of Healthcare Organizations . http://www.jointcommission.org/PatientSafety/NationalPatientSafetyGoals/06_npsg_cah.htm (accessed 17 May 2006)
  16. “FAQs for the 2006 National Patient Safety Goals (updated 2/06),” Joint Commission on Accreditation of Healthcare Organizations . http://www.jointcommission.org/NR/rdonlyres/25E48E23-6946-43E4-916C-65E116960FD5/0/06_npsg_faq2.pdf (accessed 17 May 2006)
  17. “Guidance memorandum: Title VI prohibition against national origin discrimination—Persons with limited-English proficiency,” (Jan 29, 1998) Department of Health and Human Services, Office for Civil Rights . http://www.hhs.gov/ocr/lepfinal.htm (accessed 17 May 2006)
  18. Beyea SC . Too tired to work safely? . AORN Journal . September 2004;80:559–562
  19. In: “AORN guidance statement: “‘Do-not-use’ abbreviations, acronyms, dosage designations, and symbols” in Standards, Recommended Practices and Guidelines . Denver: AORN, Inc; 2006;p. 239–241
  20. Beyea SC . “Creating a culture of safety” (Patient Safety First) . AORN Journal . July 2002;76:163–166
  • 1 AORN has requested that JCAHO add “patient position” to the purpose statement of the “‘Time out’ immediately before starting the procedure.” Richard Croteau, MD, executive director for strategic initiatives at JCAHO, is bringing that request forward. In the meantime, Dr Croteau clarified that “the presence of this language in the implementation guidelines for the Universal Protocol following the statement ‘must, at the least, include’ makes this a firm requirement of the protocol. That is, the guidelines are part of the protocol, and wherever the word ‘must’ is used, what follows is held by the Joint Commission to be a requirement for purposes of accreditation.” In other words, the correct patient position must be verified during the time out immediately before the start of the procedure.

PII: S0001-2092(06)60082-3

doi:10.1016/S0001-2092(06)60082-3

AORN Journal
Volume 84, Issue 1, Supplement 1 , Pages S13-S29, July 2006