Double check, pause...and proceed

By Emily Margosian, content specialist, October 3, 2016

As the culture of health care and developing regulatory trends continue to move in an increasingly quality-focused direction, dermatologists may soon find themselves under more scrutiny. Wrong-site surgery is one of the leading causes of adverse events, and on the legal end for dermatologists, wrong-site surgeries can lead to litigation. “Although in-office cutaneous surgery has relatively low rates of adverse eventswrong-site surgery accounts for an estimated 14 percent of malpractice claims” (Dermatol Surg 2016; 42:477484).

While the specialty enjoys a relatively low number of errors in proportion to other branches of medicine, dermatologists’ occasional mistakes can produce serious consequences such as wrong-site, wrong-procedure, or even wrong-patient surgery. In response to these hurdles, valuable guidelines for improved quality outcomes have emerged for dermatologists’ use during surgery, as well as their general dermatologic practice. In this piece Dermatology World takes a look at the benefits of:

• Pre and post-procedure verification
• Methods for marking surgical sites
• Biopsy site photography
• Timeouts
• Surgical tray safety
• Solutions for reducing labeling errors

Resources at the ready

In order to understand how dermatology adopted the quality efforts described below, a short trip back in time is necessary. “The history behind it is that the Joint Commission did a study beginning in 1995 analyzing things that go wrong during surgery. They found that 13 percent of reported adverse events were from wrong-site surgery in general,” explains Bruce Brod, MD, clinical professor of dermatology at the University of Pennsylvania, and member of the AAD Patient Safety and Quality Committee. As the issue of wrong-site surgery flared into the public’s attention, particularly in the orthopedic domain, Dr. Brod notes that “the ball really got rolling on this whole thing,” culminating in the release of the Joint Commission’s Universal Protocol in 2004 (www.jointcommission.org/standards_information/up.aspx).

Cited by many dermatologists as the basis for their own surgical quality efforts, the Universal Protocol is a suggested national quality standard specifically designed to ensure physicians operate on the correct patient, using the correct procedure, on the correct surgical site. The Protocol’s primary recommendations are:

1. Conduct a pre-procedure verification process
2. Mark the procedure site
3. Perform a time-out prior to starting any procedure

While not specifically tailor-made for dermatology, “I think this has transferred over to the dermatology world because there’s a lot of potential for error and room for improvement when we’re trying to accurately do surgery on the area of the skin pertaining to a biopsy,” says Dr. Brod. “In dermatology it can be very confusing because quite often, of course we’re operating on patients who have lots of different spots on their skin; sun-damaged skin has lots of freckles and moles. So we’ve sort of adopted some of those same principles.”

Pre-procedure verification

Making sure you have the right patient can be as simple as remembering to ask for their name. A successful pre-procedure verification should use at least two identifiers, commonly the patient’s name and their date of birth. Additional verifications can also include a signed consent form with the correct procedure verified. Repetition of these questions is key according to James Taylor, MD, past AAD vice president and an advisor to the AAD Patient Safety and Quality Committee. “If you’re roomed, before you see the doctor, they’ll ask you those questions. If they do a procedure, they’ll review, and ask you those questions again to make sure you’re the right person,” Dr. Taylor explains. “It’s well documented if for instance the nurse goes into the waiting room and calls Jones’ and doesn’t use a full name, there could be three Jones. If the wrong one comes up and they don’t double check the identification, then there will be problems.”

Identifying surgical sites

Wrong-site identification remains one of the leading causes of medical errors in the field and a significant challenge for dermatologists. However there are several methods for successfully identifying a prior surgical site available to physicians. Some options include:

1. Skin marking
2. Anatomic description
3. Diagrams
4. Biopsy site photography

Although some of these methods vary in convenience and popularity, are all strengthened when used in tandem with each other as part of clinical and surgical practice.

Skin marking

Skin marking can come in a variety of forms with varying levels of efficacy. Problems can arise if physicians or staff use the wrong modality to mark the correct biopsy site, and even the use of an indelible marker can transfer over time, or obscure the site due to “stamping” if the location is smudged due to contact with another object, thus increasing risk of a wrong-site procedure. Some alternative methods of skin marking include ultraviolet tattoos, which although fairly accurate are not considered mainstream in clinical practice. “I don’t think ultraviolet tattoos are commonly employed. Certain practitioners may not be comfortable with them, and parents might also take issue with that type of marking. They’re probably not ideal for children or pregnant women, but they are a method that’s talked about,” says Dr. Brod.

Sutures are a more reliable and less controversial means of marking biopsy sites, although they also have their limitations. “That’s a pretty harmless thing to do, but is more amenable when using a suture to repair the site, which of course is not the case with all biopsies. Dermatologists also perform a lot of shave biopsies,” Dr. Brod explains.

Anatomic description

Written anatomic descriptions are one potential method of tracking surgical sites without the use of photography. However, the success of this method is dependent on the specificity and anatomical proficiency of the clinician providing the description.

Vague indications can cause site misidentification in patients with multiple skin irregularities within a specific region, and can also result in instances of wrong-patient surgery if the description of the site and patient is too unspecific. “You typically run into problems if you have a patient with multiple biopsies,” explains Oliver Wisco, DO, deputy chair of the AAD’s Patient Safety and Quality Committee. “If you see five biopsy scars in a region, which one is it? So a lot of times when we list the site on our biopsy report, or our biopsy order, we’ll say left temple, or right forehead. That’s a large area. There should be some standard nomenclature,” he suggests.

However, written anatomic descriptions can still be implemented successfully as a means of correctly identifying operative sites. By clearly noting specific measurements from fixed anatomic landmarks, and incorporating the “triangulation method,” which utilizes three nearby landmarks to identify the location of a site or lesion, accuracy greatly improves. “For folks who aren’t taking photos, using measurements to triangulate biopsy sites is an easy way to ensure that the biopsy site is found. There are anatomic sites that are fixed on the face. If you take a biopsy on a patient’s right cheek, and you are able to measure the distance from that biopsy site to the patient’s tragus, and you can put coordinates in that the biopsy is six centimeters at three o’clock from the patient’s right tragus, that’s something that could replicate the precision of a photo,” says Joseph Sobanko, MD, director of dermatologic surgery education, assistant professor of dermatology at the Hospital of the University of Pennsylvania, and a member of the AAD Patient Safety and Quality Committee.

An additional benefit for those squeamish about the potential patient privacy issues stemming from biopsy site photography is that utilizing anatomic descriptions can eliminate any potential infractions regarding the storage and transfer of photos between providers. In further comparison, this method is also notably less expensive and non invasive, as photography can incur additional technological costs and potential patient discomfort.

Diagrams

Body diagrams are another possible method for successfully reducing errors in biopsy site identification without the use of photography – provided that they are likewise sufficiently detailed with clear measurements from recognizable landmarks. “If a physician doesn’t have a secure way to store the photographs, they’re in a rural area, or they’re not hooked up to an EHR, they can use diagrams to measure the distance of the biopsy from several different anatomical sites to make like a triangle,” said Dr. Brod.

Biopsy site photography

The general consensus in dermatology is that photographs incorporating anatomic landmarks are the best method in the standard documentation of biopsy sites. “If you have a photo, you just need the region, and the photo can tell you everything from there,” says Dr. Wisco. Although dermatology has no official consensus requiring photo documentation of biopsies, a survey of Mohs surgeons indicated that 89 percent believe that a photograph is the best form of documentation, although troublingly 88 percent also reported not receiving photographs for the majority of their referrals (Dermatol Surg2016; 42:477484). “There’s nothing mandated to do it. It’s part of the education process in graduate training and postgraduate training, but I don’t know what percentage of dermatologists do photography or not,” said Dr. Taylor. “Our derm surgeons actually provided a camera to a couple of the practices that send us a lot of patients because they weren’t routinely taking photographs.”

Additionally, while a poor memory is purportedly one of the keys to happiness, it’s also a leading cause of medical error. Due to dermatology’s propensity for patients with multiple wound sites and other irregularities in skin condition, patients are not always reliable in their ability to identify biopsy sites on their own bodies, failing to correctly identify surgical sites 16 - 29 percent of the time. In the same studies dermatologists incorrectly identified patients’ biopsy sites in 5.9 percent of cases, with 4 - 12 percent of sites incorrectly identified by both patient and physician (Dermatol Surg 2016; 42:477484). “That doesn’t inspire a lot of confidence,” notes Dr. Brod. “The use of biopsy site photography can be very, very helpful. Performing a biopsy at the time the procedure is performed, storing it within the electronic record, or sending it in a secure way to a referring surgeon can help reduce a lot of errors.”

“It’s been shown that if you rely on patients’ assertions, and patient identification of the site, it’s not always reliable or even on a relative site. Especially on somebody with Florida-fried skin who has multiple areas of dark spots and scars, they may say it’s a certain place, but it could be three or four millimeters away, or three or four inches away,” adds Dr. Taylor. “Sometimes it’s the wrong side. Laterality is a huge issue in terms of right versus left. If I look at a patient head on, and the site is on the left side, it’s on my right side so I might record it as being on the right side without a photo for reference.”

Some different photographic site identification techniques include:

• Preoperative photography

Methods for taking good pre-biopsy photos include making sure images are in focus, not too close or far from the targeted lesion, and have the site marked. Physicians are also advised to take two photographs of each site: one from a distance capturing notable landmarks on the body, and one zoomed in to the targeted area in order to capture nearby cutaneous lesions or identifiers.

High image quality is also crucial, as low-quality images can essentially be worthless if the image is too blurry or indistinct for proper identification. “You have to have a camera that preferably has 10x optical zoom capability. Then you want at least 1 megabyte per photo. But any iPhone or Apple product these days will take pictures of acceptable quality,” recommends Dr. Wisco.

“You don’t necessarily need a fancy camera to take quality photos. I know that there are a lot of electronic database interfaces that will allow you to take photos with an iPad or digital device, and you can electronically transfer that photo directly into the chart,” Dr. Sobanko adds.

• Cell phone pictures

In the event that in-office photography by trained staff is unavailable due to financial or logistical constraints, cell phone images can be a viable alternative, as high-res cameras on most modern smartphones become a more ubiquitous part of everyday life. “Patient-owned cell phone pictures avoid many patient privacy concerns, are easily transported, and serve as a reliable method of communicating among several providers, particularly if providers have different EMRs,” according to a Dermatologic Surgery article (2016; 42:477–484). Most current records systems will allow physicians to upload images directly from mobile devices, although it’s important to note that these devices must be appropriately encrypted, with images taken and stored through a HIPAA-compliant app.

From the dermatologist perspective, “My opinion about a procedure I do is that it’s my responsibility. From that perspective, I think that the care coordination efforts need to be driven by me,” says Dr. Wisco. “That being said, it’s ok if the patient takes a picture on their phone and stores their own photo. I think that’s a great way to go for empowering the patient, but in the end, you should still have your own photo documented in your chart, or your log or system.”

“It’s another way to do it,” says Dr. Brod. “Having patients double check the site by at the time of the biopsy taking a photograph of their lesion on their own mobile phone. There’s no security issue, as patients are allowed to photograph themselves. There isn’t as much standardization in place, and of course the photo could be lost, however.”

However, while photography is considered the gold standard in terms of site identification in dermatology, it does have some potential drawbacks. Dermatologists who opt for photo documentation are responsible for any financial, technical, and logistical challenges associated with introducing new tech. Practitioners are also responsible for meeting secure storage requirements, and ensuring that digital photos are compatible with their EHR systems. “There can be filing issues. We take 80,000 photographs a year in our department, so we’re talking about huge numbers of photographs. You have to have a filing system and an auditing system to make sure that it’s accurate,” acknowledges Dr. Taylor.

Despite these challenges, Dr. Wisco maintains that incorporating photography will soon be a hallmark of a modern, responsible physician. “The simplest, most reasonable thing to do is biopsy site photography, and biopsy tracking. So in other words, there should be no reason why in today’s world we can’t have photos of patients. There are multiple secure server options. Just saving photos on your own secure network and creating a biopsy log that tracks what biopsies you do and how they were treated it would make an enormous impact if everybody did those two things. No patient should ever have to go to another clinician and say I have a skin cancer, I don’t know where it is, and they don’t have a photo, what do you think we should do?’”

Dr. Sobanko agrees. “Taking photos of operative sites or biopsy sites is crucial. It’s something we’ve published on where patients have much more confidence when definitive removal of a lesion happens when you have a photo of the initial biopsy site. And that gives the practitioner confidence too because a fair percentage of patients don’t know where their biopsy was done.”

Beyond their effectiveness as a quality surgical effort, biopsy site photography is taking steps toward more formal recognition as a measurable degree of quality under MACRA. “The AAD actually has a quality measure on the use of biopsy site photos or diagrams before surgery with the intent to have those adopted as a valid quality measure that would be used under the upcoming MIPS program,” says Dr. Brod. “That measure is really designed to assess what portion of biopsies that end up being non-melanoma skin cancer, basal or squamous cells, have had a photograph taken at the time of the biopsy procedure.”

Take a timeout

Formally established as part of the Joint Commission’s release of their Universal Protocol, timeouts are intended to prevent errors in surgery caused by not obtaining final verifications of patient identity, procedure type, or site location before beginning any type of clinical or surgical procedure. As per the Joint Commission’s recommendations, timeouts should occur immediately prior to a surgical procedure.

Recommendations for timeouts include:

• Physicians and their teams should complete final verifications of patient identity, surgical site, and planned procedure
• If the patient is awake, they should be included in the verification process
• The completion of the timeout should be documented
• The timeout process should be repeated for every additional procedure performed on the same patient within a visit, not beginning a new step until all questions and concerns are resolved

Timeouts are most effective at reducing error when they are not altered from patient to patient. “If one of your criteria for final timeout is that you have to have agreement from both the patient and physician, don’t make an exception to that. That’s where you’re going to run into errors, such as if they’re adamant that it’s the correct spot, but you feel it’s someplace else. Don’t veer from protocol; always make sure that your protocol is sound,” recommends Dr. Wisco.

Although originally designed as a quality measure for surgery, use of a timeout can be applied to virtually any administering of treatment during a dermatology patient’s visit. “This became standard practice in the operating room years ago when studies indicated that timeouts and checklists eliminate significant errors in surgery. Fortunately, that’s now been transferred to the clinic setting,” explains Dr. Sobanko. “If you perform biopsies and other procedures with local anesthesia, although the patient is awake, it still is helpful to reconfirm so that all members of the team and the patient are aware and in agreement of what’s going on.”

Patient safety: more than just a buzzword

Why should the average dermatologist take note of these quality measures? “With the advent of the Patient Protection and Affordable Care Act, the Physician Quality Reporting System, and increasing regulatory oversight, tracking and improving patient safety has been brought to the forefront of health care delivery,” reports a recent JAAD article (2015;73:1-12).

Dr. Wisco agrees that changes in the health care landscape have put increased pressure on dermatologists to eliminate practice errors that compromise patient safety as legislation and regulatory oversight has begun to crack down. “If you just look at health care reform, and where we’re losing the most amount of money, it’s from unnecessary procedures and medical errors. Most of the data for wrong-site surgery comes from the orthopedic and the neurosurgical community, not dermatology, but because of the awareness, everybody is becoming much more scrutinized. It’s becoming a much more important topic within what we do, particularly because in dermatology we’re very procedurally based,” he explains.

Overall, by using a variety of quality tactics from surgery’s wheelhouse, dermatologists can increase their level of accuracy in site identification. While no one method or technique is right for every situation and individual, regardless of what techniques physicians choose to employ, “the bottom line is, it’s better than nothing,” says Dr. Brod. “It’s better than not having a system in place. The goal is ideally we’d like to have an error rate of zero percent in terms of wrong-site surgery. Unfortunately, that’s probably not a reality, but if we can improve those numbers, then we’ve made a difference.” 

Additional DermWorld Resources