Quality Improvement Guidelines for Preventing Wrong Site, Wrong Procedure, and Wrong Person Errors: Application of the Joint Commission “Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery” to the Practice of Interventional Radiology

Marking the Operative Site 

“Marking the site is required for procedures involving right/left distinction, multiple structures (such as fingers and toes), or levels (as in spinal procedures). Site marking is not required (nor is it prohibited) for other procedures. These may include mid-line sternotomy, Cesarean section, laparotomy and laparoscopy, cardiac catheterization and other interventional procedures for which the site of insertion is not predetermined. For those procedures in which site marking is not required, the other requirements for preventing wrong site, wrong procedure, wrong person surgery still apply” (4).

Time Out 

“To conduct a final verification of the correct patient, procedure, site and, as applicable, implants. 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, that is, the procedure is not started until any questions or concerns are resolved” (3).

Invasive Procedure 

“The universal protocol should be applicable or adaptable to . . . invasive procedures that expose patients to harm, including procedures done in settings other than the operating room” (3). “Certain routine ‘minor' procedures such as venipuncture, peripheral [intravenous catheter] placement, insertion of [nasogastric] tube, or Foley catheter insertion are not within the scope of the protocol” (4).

Sentinel Event 

“A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, ‘or the risk thereof' includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called ‘sentinel' because they signal the need for immediate investigation and response” (3).

Implementing the Universal Protocol 

The application of the Universal Protocol for patient identification is indicated for all invasive procedures. (The Joint Commission's specific expectations for implementation of the Universal Protocol are available on their Web site [6].) Within the group of procedures subject to the Universal Protocol are a subset of procedures for which skin marking is required and a subset of procedures for which skin marking is not necessary. This portion of the guideline attempts to clarify certain issues that may arise during implementation of the Universal Protocol. All quotations in this section are taken from the Joint Commission Web site.

Time Out Process 

The purpose of the time out is “to conduct a final verification of the correct patient, procedure, site and, as applicable, implants” (3). “The ‘time out,' or immediate preoperative pause, must occur in the location where the procedure is to be done (for example, 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 (participation by the patient is not expected) but just before starting the procedure” (4). “The ‘time out' must involve the entire surgical team. At a minimum, this includes active participation by the surgeon, anesthesia provider, and circulating nurse. Participation by the other members of the team, as appropriate to their involvement in the procedure, is also encouraged. In particular, there should be no barrier to anyone speaking up if there is concern about a possible error. To include some members of the team but not others sends the wrong message” (4).

For interventional radiology, this means that the time out should be performed after the patient is placed on the procedure table, regardless of whether this is in the interventional fluoroscopy suite, the computed tomography (CT) scanner, an ultra-sound (US) room, or at the bedside. All personnel involved in the procedure should also be involved in the time out. The time out must be performed before the invasive procedure is started.

Procedures for which the Site/Side Must Be Marked on the Skin 

The correct site must be marked for all invasive procedures involving “(i) right/left distinction based on external landmarks, history, or prior studies; or (ii) multiple structures (fingers, toes) or levels (spine)” (3). If both the left and right side will be sites for intervention, both must be marked. For spine procedures, the general region may be marked, but the exact level should be determined with intraprocedural imaging (3).

For interventional radiology, the side or individual structure may be known, in which case it should be marked on the skin. Alternatively, the lesion may be identified during intra-procedural imaging, in which case it cannot be marked on the skin. This situation would normally be exempted based on the continuous presence exemption (as described later).

There are situations in which site marking is required by the Joint Commission, but implementation of this requirement is difficult or impossible. For example, if angioplasty of the right renal artery is planned, theoretically the skin over the right kidney should be marked. However, after the patient is draped, this mark will not be visible. In these situations, the Joint Commission recommends “marking the skin at or near the proposed incision/insertion site to indicate the correct side of the proposed procedure, even when the proposed incision/insertion site is in the midline or through a natural body orifice. This mark, as for other site marks, must be positioned to be visible after the patient is prepped and draped unless it is technically or anatomically impossible or impractical to do so” (4). This would require a skin mark on the groin indicating which renal artery is to undergo angioplasty. This is a potential source of confusion because it may be seen as an indication of which common femoral artery should be punctured. The Joint Commission advises that, “in such technically difficult cases, an alternative method for visually identifying the correct side should be used (eg, a temporary unique wrist band or other similar device)” (4). Unfortunately, such an alternative method is unlikely to be visible through the sterile drapes. In these cases, the Society of Interventional Radiology recommends that the side of intervention be confirmed in the manner traditionally used by interventional radiologists: appropriate intraprocedural imaging. This is consistent with the Joint Commission's requirement that spinal levels be confirmed with imaging at the time of the intervention.

Situations Excluded from the Skin Marking Requirement 

Site marking is not required (nor is it prohibited) for procedures other than those described earlier in this report. “These may include mid-line sternotomy, Cesarean section, laparotomy and laparoscopy, cardiac catheterization and other interventional procedures for which the site of insertion is not predetermined. For those procedures in which site marking is not required, the other requirements for preventing wrong site, wrong procedure, wrong person surgery still apply” (4).

Situations with right/left distinction in which intraprocedural imaging is used to provide confirmation of the correct side may also be exempt from the marking requirement. The Joint Commission requires site marking when there is “right/left distinction based on external landmarks, history, or prior studies” (emphasis added) (4). Situations in which right/left distinction is determined or confirmed with intraprocedural imaging before the intervention (the case in virtually all interventional procedures) do not fall within this requirement. This interpretation is consistent with New York State Surgical and Invasive Procedure Protocol (exception E7) (7). When both left- and right-sided structures are known to be abnormal (eg, bilateral hydronephrosis), the Society of Interventional Radiology recommends that skin marking be performed even if intraprocedural imaging is employed.

It is the opinion of the Society of Interventional Radiology that, in procedures in which vascular access is simply a means to provide a route of access to perform a procedure or to provide central venous access, skin marking at the vascular access site is not needed. This is consistent with the Joint Commission guidance cited earlier in this report regarding cardiac catheterization. Placement of central venous catheters is a special clinical situation in which side marking is not required, but in which it is good clinical practice to investigate if there is a preferred side.

In addition to the exemptions noted earlier, the Joint Commission specifically notes that “skin marking is not mandatory if the practitioner performing the procedure remains with the patient continuously from the time the decision is made to do the procedure and consent is obtained from the patient up to the time of the procedure itself” (3). Finally, the patient always has the right to refuse skin marking (4).

Method for Performing Skin Marking 

The Protocol states, “The person performing the procedure should do the site marking.” The word “should” is in contrast to the more definitive term “must,” which is used elsewhere in the Protocol. It 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. Any delegation of responsibility for marking the surgical site must be consistent with applicable law and regulations (we are advised that 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. Note that while the Protocol requires that the patient be involved in the process, it is not expected, or even recommended, that the patient mark his/her own surgical site (4).

“The [Universal] Protocol does not specify the type of mark—that is left to the organization to decide— but whatever the decision on this, the mark must be unambiguous and the process should be consistent throughout the organization. Consideration should be given to aligning the site marking procedures with those of other surgical facilities in the same geographic area, since surgeons are frequently on multiple medical staffs. Use of 'X' is discouraged since this may be ambiguous: does 'X' mean ‘operate here' or ‘do not operate here'? A line indicating the intended site of incision, the surgeon's initials, or the word ‘yes' are all preferable ways to mark the site” (4). “A marker that is sufficiently permanent to remain visible and will not wash off when the site is prepped may be used for marking the site” (4). “Under the Universal Protocol, adhesive site markers are permitted as an adjunct to directly marking the skin. While the Protocol does not explicitly prohibit the use of adhesive markers, it does state, ‘Adhesive site markers should not be used as the sole means of marking the site.” This means that when site marking is required, it must be done by directly marking the skin” (4). “Site marking should be done prior to moving the patient into the room where the procedure will be done. Part of the requirement is that the site marking be done ‘with the involvement of the patient.' For this to be done in a meaningful way, it should happen before the patient is significantly sedated. Participation may be precluded by a disease state or heavy sedation. However, sedation by itself does not necessarily prevent the patient from participating in the site marking process. The patient's capacity to participate must be based on an individual assessment” (4).

“In cases of non-speaking, comatose, or incompetent patients, or children, the ‘patient involvement' in the site marking process should be handled in the same way that you handle the informed consent process. Whoever has authority to provide informed consent for the patient to undergo the procedure would, as appropriate, participate in the site marking process” (4).

Clinical Emergency 

“None of these precautions should interfere with the timely care of the patient in an emergency situation. In most of these cases, when invasive procedures are performed under emergency or urgent conditions, the practitioner performing the procedure will be in continuous attendance of the patient from the point of decision to do the procedure. Under those circumstances, marking the site would not be necessary, although the ‘time-out' to verify the correct patient, procedure, and site would still be appropriate (unless it was such an emergency that even the time out would add more risk than benefit)” (4).

Planning/Evaluation 

Errors can be caused by omission or commission. Controlling WS errors at this stage should focus on preventing scheduling errors because these can easily be perpetuated in subsequent stages (eg, patient is scheduled for a right nephrostomy when they really need a left nephrostomy). This plan-ning/evaluation stage is also important in avoiding a missed opportunity to order outside radiologic studies or copies of operative reports that may be helpful in preventing WS errors in later stages (see “3” below). Informed consent is often done in advance, which adds another opportunity for the patient to participate in the planning of the procedure. There is substantial evidence that active early involvement of patients in the planning of their procedures prevents many WS errors (8). During the consent process, the patient and the patient's family should understand that the site of skin entry and the site of treatment may be different.

If possible, indicate the side and site at the time of procedure scheduling (often indicated by a referring physician) or preprocedural evaluation in the interventional radiology clinic. Scheduling should be performed by a health care professional familiar with interventional radiology procedures whenever possible.

Make sure all potentially necessary images and/or reports are requested so they are available at the time of procedure. If beneficial, mark or annotate the region of interest on the films/images. Appropriate physician-to-physician communication should be the norm.

Preprocedural Marking 

Preprocedural marking is only rarely required in interventional radiology procedures. More importantly, in the immediate preprocedural period, information from many different sources should be collected. The interventional radiologist or designee are responsible for insuring that the correct structure and side are identified on previous studies. This identification process may require marking a film (or Picture Archiving and Communication System image) with the intended site of treatment.

Patient marking is necessary only when direct puncture into the area of interest is done based on external landmarks (rather than intraprocedural imaging) and there is a possibility for left/right or level errors (see Indications section).

Time Out 

The time out is fully described on the Joint Commission Web site (3), but errors unique to interventional radiology can occur when preprocedural information is not conveyed to the staff and physicians performing the procedure. For example, a patient with multiple lesions on a planning magnetic resonance (MR) angiogram or CT angiogram could undergo a different procedure in the absence of appropriate communication.

Intraprocedural errors can also occur as a result of patient positioning (prone versus supine) and patient orientation in the room. These errors may not be immediately recognized by the interventional radiologist because of patient draping that masks the anatomy. Site marking will prevent this error, but the time out should include a review of the patient's orientation.

Imaging equipment (eg, fluoros-copy, US, CT, MR, or other) that does not insure correct orientation or labeling of the images could potentially lead to errors. The interventional radiologist should be aware of this issue, and use the time out to confirm correspondence between the image guidance system image and the patient orientation (eg, the apparent left side of the patient in the image on the screen corresponds to the patient's left side).

Manual entry of patient information into the imaging equipment may lead to misidentification of the images as belonging to the wrong patient. The time out process should include a step to confirm that the correct patient's information is displayed on the image monitor before the procedure is started.

Postprocedure 

Make certain that all permanent images are correctly labeled regarding patient and side before archiving. A regular program of equipment maintenance and quality assurance is recommended.

Success Rates 

There is no literature evidence to determine an acceptable success rate in executing these steps. Success rates should approach 100%, but will have to be locally determined and monitored.

Complications 

In 1998, the Joint Commission received 15 reports of wrong site, wrong person, or wrong procedure surgery. In a Sentinel Event Alert issued in December 2001, 150 such instances were reported, 41% of which were related to orthopedic or podiatric surgery (9). The Joint Commission identified emergency procedures, unusual physical characteristics of the patient, time pressures, multiple surgeons, and multiple procedures on the same patient as risk factors. In a survey of orthopedic surgeons, of an estimated 6,700,000 surgical procedures, 242 were performed at the wrong site, for an incidence of one in 27,686 procedures (10). An analysis of insurance claims and malpractice claims suggest that the incidence appears to be one in 112,994 for surgery in general (11). It is recommended that there be a zero threshold for this type of error and a quality improvement initiative with peer review be undertaken when one of these events is identified (8).

Estimating the frequency of WS errors in interventional radiology is essentially impossible. Published rates for individual types of complications are highly dependent on patient selection and are based on series comprising thousand of patients, and for procedures far removed from an interventional radiology practice. No reliable data exist for interventional radiology procedures.