Wrong Site, Wrong Procedure, Wrong Person Surgery

Transcription

1 Back to Basics Seventh in a Series Patient Safety Wrong Site, Wrong Procedure, Wrong Person Surgery By Alecia Cooper, RN, BS, MBA, CNOR An alarming occurrence affecting perioperative patient safety: According to the Joint Commissionʼs Sentinel Event Statistics, as of December 31, 2007, wrong site surgery has been reported 625 times. It is now the number one most frequently reported sentinel event and represents 13 percent of all errors reported to the Joint Commission. 1 Sentinel events A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury. The Joint Commission tracks them through its voluntarily reported Sentinel Event Database. 2 Wrong site, wrong procedure, wrong person surgery is particularly alarming, with five to eight new cases reported per month. 2 We could attempt to rationalize this data by insisting that the healthcare industry is putting forth greater effort to report medical errors, as many states have mandated reporting systems for medical errors including wrong site surgery. Although, when we track the evolution of the Universal Protocol along with all of the supporting initiatives to prevent the occurrence, such as the AORN Correct Site Surgery Tool kit, one would expect that the incidence should be 100 on the decline. Universal Protocol The Joint Commissionʼs Universal Protocol (see Universal Protocol on Page 98) was launched in July 2004 and has been followed by a sustained increase (not decrease) in the number of Wrong-site surgeons reviewed by year S. E. Alert #24 December 2001 S. E. Alert # 6 August 1998 NPSGs January reported cases of wrong site surgery in the United States. Because of the persistent rise, The Joint Commission convened a second Wrong Site Surgery Summit in February 2007 to examine the data, review the experience, identify barriers and explore other potential strategies for eliminating wrong site surgery. 2 Included at this summit were the following organizations: American Academy of Orthopaedic Surgeons American College of Physicians American College of Surgeons American Dental Association American Hospital Association American Medical Association Association of perioperative Registered Nurses Partnership for Patient Safety In summary, it was determined that the Universal Protocol needed more directive and prescriptive terminology, that zero tolerance for failure to follow the Universal Protocol was the short-term goal and that the long-term goal should be zero W.S.S. Summit I May 2003 U.P. W.S.S. Summit II February 2007 tolerance for this sentinel event. In addition, opportunities for patient and family involvement at all points in the preoperative verification process were identified, as were measures to reconfirm understanding for the planned procedure with the procedural staff. This includes involving patients in the surgical site marking process whenever possible Aligning practice with policy to improve patient care 9

2 and confirmed discussions at the time of signature for consent. 2 The Universal Protocol is being revised to include additional implementation expectations. The revised Universal Protocol is available for review in the Joint Commissionʼs proposed 2009 Patient Safety Goals and has just completed comment phase. The revised Universal Protocol contains the same concepts as the previous version and additions have been made in an attempt to clarify the requirements. The proposed revisions can be found at: Safety/NationalPatientSafetyGoals/08_hap_npsgs.htm. Centers for Medicare & Medicaid Services (CMS) Not only has the Joint Commission identified the occurrence of wrong site, wrong procedure and wrong person surgery as preventable, the Centers for Medicare & Medicaid Services (CMS) determined the following: That wrong surgery (e.g., right patient, wrong surgery; right surgery, wrong patient) is not a reasonable and necessary service Services must be reasonable and necessary to bill for Medicare payment Wrong surgery is not a complication or comorbidity (CC) and does not meet the criteria of the statute CMS will use other appropriate mechanisms to ensure that payment is not made for wrong surgeries. 3 Bottom line, moving forward, if a wrong site, wrong procedure, wrong patient surgery occurs, there will be zero reimbursement for the facilities and zero tolerance in facilities accredited by the Joint Commission. Barriers to compliance One of the most frequently cited barriers to compliance in preventing wrong site, wrong procedure, wrong patient surgery is lack of physician agreement to a standardized approach, i.e., the Universal Protocol. The difficulty occurs because the protocol requires a change in culture and behavior that was not put into place until In an environment where time represents significant money, there is pressure to start, complete and turn over rooms with speed and efficiency. BOTTOM LINE, moving forward, if a wrong site, wrong procedure, wrong patient surgery occurs, there will be zero reimbursement for the facilities and zero tolerance in facilities accredited by the Joint Commission. Pressure leads to the omission of certain safety procedures because staff either forget to do it or do not recognize or accept the potential harm and research data that support the need to implement standardized protocols with evidencedbased support. 2 Another barrier is reluctance among nurses and other staff to question the surgeon when a possible error is identified. Failure to recognize the risks in procedural settings other than the operating room is cited as well. Inadequate human resources and knowledge for facilitating the processes is being challenged, along with the citing of automatic behavior during the time-out process ( going through the motions without meaningful communication) i.e., being on autopilot. Lessons from the Pa. Patient Safety Reporting System The Pennsylvania Patient Safety Reporting System, through analysis, has concluded that misinformation is the main source of errors and that it starts before the patient reaches the OR. Misperceptions typically initiate errors that start in the OR after the initial verification by the circulating nurse. To illustrate their findings, they developed two flow charts, one illustrating the awareness of information in the operating room and the other to illustrate the flow of information from before the operation until the site marking. 4 Their entire study and process improvement strategy can be found at Based upon their retrospective analyses, observations and preliminary, contemporary comparisons, they believe that opportunities for wrong site surgery are minimized when all information is in agreement, including the following: OR schedule Consent History and physical (H&P) Diagnostic studies They also believe that confusion is minimized when all members of the OR team assume a personal responsibility to have first-hand knowledge that the correct patient is getting the correct procedure at the correct location The OR Connection

3 Ensuring we get it right Despite a recent surge in patient safety awareness, preventable harm to surgical patients still occurs. Wrong site, wrong procedure and wrong person surgery can be catastrophic to patients, healthcare professionals and institutions. 5 WHAT ELSE can be done to prevent wrong site, wrong procedure and wrong person surgery? Assess for risk factors The most common risk factors are: 6 More than one surgeon involved in the case, either because multiple procedures are contemplated or because the care of the patient was transferred to another surgeon Multiple procedures are conducted on the same patient during a single trip to the operating room, especially when the procedures were on different sides of the patient Unusual time pressures related to an unusual start time or pressure to speed up the preoperative procedures Unusual patient characteristics such as physical deformity or massive obesity that might alter the usual process for equipment set-up or positioning of the patient Orthopedic surgery (between 41 percent and 68 percent of all wrong site surgery occurs in orthopedic surgical cases) Preoperative verification The first step in the Joint Commission protocol is the preoperative verification process. A hospital should create or adopt a checklist to define what documents are needed to appropriately complete a preoperative verification. (See Forms & Tools on Page 101 to find a sample preoperative checklist). 5 The Veteran's Health Administration (VHA) expanded on the Joint Commissionʼs protocol in their directive titled Ensuring Correct Surgery and Invasive Procedures. VHA explicitly directs the operative team to do the following during the preoperative verification and time-out: Compare the consent form and patient identification band Ask the patient to verbally state their name, social security number and the specific location on their body where the procedure should take place The staff member who carries out the active identification stays with the patient until they are inside the OR. 5 Second, the directive calls for appropriate execution/verification of the consent form. This verification empowers staff to halt the procedure if the patient's (or legally authorized designee's) signature, title of the procedure (including site/ laterality) and/or a brief description and rationale for the procedure are missing from the form. Finally, when imaging data are necessary to determine or confirm the operative site, this directive requires that two members of the OR team review pertinent radiologic images and agree on the operative site. In addition to the mandated directives, VHA offers suggestions to further safeguard patients, such as calling the patient 24 to 48 hours before the procedure to confirm the surgical site, auditing cases the evening prior or the morning of the operation to check the consent form against the OR schedule, asking patients to touch the site during the verification process and having teams write the patient's name, planned procedure and site and details regarding use of any implants on a dry-erase board in the OR. Each additional step provides a redundant and independent check to prevent errors. Site marking The second step is marking the correct site, which involves lateral (right/left) distinction, multiple structures (fingers, toes) or multiple levels (spine). Site marking will likely have a large impact in preventing wrong site operations because it is a well-defined behavior. It is also recommended that the surgeon and patient participate in marking the site and that the site is marked with a permanent marker. 5 Aligning practice with policy to improve patient care 11

4 In the Joint Commissionʼs proposed 2009 Patient Safety Goals, they propose that the site is marked before the patient is moved to the location where the procedure will be performed. In addition, the mark must be positioned to be visible after the patientʼs skin is prepped, the patient is positioned and sterile draping is complete. For cases in which it is technically or anatomically impossible or impractical to mark the site (mucosal surfaces, perineum, premature infants) an alternative method for visually identifying the correct side is used, such as a temporary unique wristband on the side of the procedure, which contains the patientʼs name, a second identifier, the intended procedure and site. Time-out The last step involves a time-out, which is an independent check to potentially identify and correct errors. This intentional pause before incision is a communication tool and final safety check between the surgical, nursing and anesthesia care teams. The time-out should occur immediately prior to initiating the procedure and must verify, at a minimum, the correct: Patient name and medical record number (or social security number, date of birth or other identifier) Procedure Site and laterality (including visual verification) Patient position Implants or any special equipment necessary for the operation The Joint Commission recommends that a time-out be conducted in a fail-safe mode, whereby no procedure is started until all questions and concerns from all individuals involved are addressed. In most sentinel events, someone knew something was wrong but either did not speak up or spoke up but was ignored The OR Connection At the Johns Hopkins Hospital, an OR briefing tool is used as part of an expanded time-out. In addition to confirming correct patient, procedure and operative site, this tool prompts for additional dialogue between the anesthesia care team, nursing staff and surgical team. The timing of a briefing is specialty-specific. For example, neurosurgery initiates a time-out after final positioning of the patient, but before drapes are placed. Team member names and roles are introduced and also written on a white board in each OR. The operative plan, required equipment and any contingency plans are reviewed with all participants. Recommended Interventions 1. Implement the Joint Commissionʼs Universal Protocol. 2. Continuously re-educate and train personnel in the perioperative setting. 3. Create a specific and detailed preoperative verification process and time-out that includes a checklist with explicit behaviors (model after Veterans Health Administration). 4. Implement OR briefings and debriefings. 5. Implement technology when efficiency and costs-benefits are in line. Recommended Measures 1. Evaluate the presence of a detailed policy or procedure for preoperative verification. 2. Evaluate staff knowledge of the process for preoperative verification and time-out. 3. Evaluate appropriate use of the time-out through direct observation using a compliance instrument The surgeon is encouraged to discuss estimated blood loss, the need for cultures or biopsies and any anticipated complications or risks. The nursing team confirms the availability of instrumentation and supplies and discusses any family issues. The anesthesiologist and/or certified registered nurse anesthetist (CRNA) review significant patient comorbidities, risks for complications and anesthetic management (e.g., antibiotic administration, patient allergies, vascular access, blood availability, etc). The briefing is concluded with open input to a question like, If something were to go wrong, what would it likely be? 5 Innovation and new technology Technology such as radiofrequency identification (RFID) may help reduce wrong site operations. In November 2004, the FDA approved an RFID temporary tag that can be placed close to the surgical site. Such tags can hold medical history, prescribed medications, allergies and other pertinent information. Data are read remotely using an RFID scanner (reading device). 5 Continued on page 14

5 A less invasive technology is a procedure-specific wristband with an embedded microchip that sets off a sensor if the chip remains activated. The sensor is typically placed in the hallway between the preoperative area and the OR suites. To deactivate the chip, the surgeon must sign the site with the marking pen packaged with the wristband, remove the label affixed to the pen and place it over the microchip. 5 Both the RFID scanner and the smart wristband are early in their development. The efficacy and cost-effectiveness of these technologies are in process of being determined. More simple reminders to activate the time-out process have been created that can be placed directly on the operative field. Skin markers and scalpels can be covered with a sleeve that must be removed to initiate the time-out process. One facility creatively developed stainless steel table tent signs that they sterilize within instrument sets and place strategically in the operative field to remind caregivers to perform a time-out. Also just introduced are surgical drapes with a time-out tag placed at the fenestration site that must be removed before the procedure can begin. These drapes are produced by Medline Industries, Inc. Continue your CE coursework at Medline University Courses you can attend at any time, from anywhere you have Internet access. Medline University offers more than 50 self-study nursing CE-credit courses. An affordable online resource. Visit Making surgery safer All healthcare organizations need a method to evaluate the effectiveness of interventions in reducing the probability that another patient will be harmed. Education and training, along with measuring performance, are vital to eliminating errors. Implementing technology where there is evidence-based information that supports the cause within a reasonable cost-benefit ratio will prove beneficial as testing data becomes available. Unfortunately, with wrong site surgery, the rates and occurrences are too low to measure as statistical run rates. About the author Alecia Cooper, RN, BS, MBA, CNOR, is the clinical editor of The OR Connection. She has also been a perioperative nurse for more than 20 years and director of surgical services for 12 years. References 1. The Joint Commission. Sentinel Event Statistics: As of December 31, Available at: Accessed March 3, The Joint Commission National Patient Safety Goals. Available at: 3. Valuck TB. CMSʼs progress toward implementing value-based purchasing. Available at: 4. Patient Safety Authority. Insight into Preventing Wrong-Site Surgery. Available at: # Clarke JR, Johnston J, Finley ED. Getting surgery right. Ann Surg. 2007;246: The Joint Commission. Facts about the Universal Protocol. Available at 14 The OR Connection