A near miss
Dermatologists discuss patient safety issues in procedural dermatology.
Feature
By Allison Evans, Assistant Managing Editor, December 1, 2024
The 2000 landmark report by the Institute of Medicine, To Err Is Human: Building a Safer Health System ushered in the patient safety movement in the modern era, bringing much needed notoriety to the issue. The report highlighted nearly 98,000 hospital deaths per year due to medical errors. Faulty processes and systems in the care environment accounted for over half of the deaths. Patient safety and quality improvement are now regular activities of residency training programs where a systems-based team approach in the prevention of errors is emphasized rather than the blame-and-shame culture of the past.
The first and most fundamental step in quality improvement is acknowledging that errors do occur and creating a culture and system for effective reporting. Individual errors do not always lead to harm but can function as an early warning system to prevent more serious occurrences in the future.
Rita Khodosh, MD, FAAD, chair of the AAD’s Patient Safety and Quality Committee, became interested in the issue of patient safety after reading Atul Gawande’s writing in The New Yorker called “When doctors make mistakes,” and later, his book The Checklist Manifesto. “I was really surprised that in medicine, we didn’t have these simple safeguards, like checklists, to prevent errors from reaching the patient. It was unsettling how many physicians were resistant to introducing these safeguards. There was a pervasive mentality that only bad doctors make mistakes,” she said.
“Often people rightfully focus on safety but forget to consider how complicated the process becomes.”
“We are a procedural field, and we do plenty of small procedures every day. Maybe these are not going to lead to a patient dying, but there are plenty of serious adverse events that can happen,” she added.
Dr. Khodosh recommends that dermatologists pay attention to two things: Are the processes safe and reliable to avoid errors, and does the process avoid being overly burdensome. “Often people rightfully focus on safety but forget to consider how complicated the process becomes. They may ask physicians or staff to follow a procedure so burdensome and complicated that people either get burnt out trying to do it or they find workarounds and don’t do it anyway.”
Studies indicate that wrong-site surgery and errors in the skin biopsy pathway are common in dermatology practice, with potential patient care and legal ramifications.
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Key takeaways from this article:
Studies indicate that skin biopsy pathway errors and wrong-site surgery are common in dermatology practice, with potential patient care and legal ramifications.
Studies have shown that misidentification of the biopsy site is the main cause of wrong-site surgery.
A clearly labeled preoperative photograph is the gold standard for identifying biopsy sites, with a process often used called “mark, map, and magnify.”
A pre-procedure verification process often includes reviewing digital photographs, verifying the patient’s name, date of birth, and the procedure being done.
According to a JAAD study, dermatologists reported that 50% of their most recent errors and 40% of their most serious errors were specimen errors.
There are approximately 20 handoffs in the biopsy pathway process. In any one of these steps, errors can occur. Visual and verbal confirmation should be done to ensure the specimen is in the cup.
Resources are limited, so it is important to prioritize which steps would be most important to improve.
Having a system for reporting mistakes and analyzing them is important to continue quality and patient safety efforts.
Wrong-site surgery
Wrong-site surgery is more of a risk in dermatology than in some other fields because of anatomic and technical difficulties inherent in identifying skin biopsy sites. Kimberly Ken, MD, FAAD, assistant professor of dermatology and director of Quality Improvement for Procedural Dermatology at Penn State Health, Milton S. Hershey Medical Center, and her colleagues reviewed wrong-site surgery in their department. “While there isn’t much literature published about wrong-site surgery in dermatology, we found in our department that it was less than 0.00009% — very low for wrong-site surgery, but the goal is zero.”
Most of the specific wrong-site surgery literature originates from Mohs surgery data. A survey of 300 Mohs surgeons revealed that 14% of their malpractice lawsuits were a result of wrong-site surgery (doi:10.1111/1524-4725.2006.32009). Improper performance of procedures often occupies the top spots for malpractice claims against dermatologists.
“Wrong-site surgeries are considered a ‘never event,’ which is a term coined in 2001 to describe a medical error that should never occur, and we took this to heart in our department,” Dr. Ken said. Over time, the term’s use has expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable. Additionally, Medicare does not pay for repeat surgery if the first one is on the wrong body part, with a number of private insurance companies following suit.
What factors may contribute to wrong-site surgery? Studies have shown that misidentification of the biopsy site is the main cause of wrong-site surgery. According to Dr. Ken, when patients have had multiple skin cancers, you’re navigating skin topography with multiple scars from multiple prior procedures. “Biopsy sites can be challenging to identify if it has been more than six weeks between the biopsy and the surgery as biopsy sites can heal quickly depending on the anatomic area. If the patient had multiple biopsies done and you’re only treating one of the sites, that can lead to confusion.” Also complicating things is that sometimes the surgeon doing the definitive procedure is different from the physician who performed the biopsy, Dr. Ken added.
Biopsy site identification is challenging, Dr. Khodosh said. “You think that if you ask the patient and surgeon to identify the site, we could do pretty well, but that’s not actually the case.” Indeed, a study involving 271 surgical sites revealed that 16.6% of sites were misidentified by patients and 5.9% of sites were misidentified by physicians without photography, even when clinical notes and diagrams were included in the assessment (doi: 10.1111/j.1524-4725.2009.01426.x).
Physician and medical staff safety
Dr. Wisco executed a study at Brown that looked at safety mishaps within their department. They found that wrong-site surgery, errors in specimen processing, and injuries to the health care team were the top safety issues. “Out of non-needle stick injuries and needle-stick injuries, the latter was the biggest issue.”
“Physicians and medical staff surrounded by sharps are more prone to injury, whether it be lidocaine needles or skin hooks on the field. People don’t recognize their significant injury potential,” Dr. Wisco said.
To avoid needle injuries, there are best practices that can be adopted. “One way in which to protect health care staff is to ensure the surgical tray is set up in a standardized way so that everybody knows where the needles should live, which includes suture needles, anesthesia needles, and keeping sharps like the surgical blades and skin hooks in a certain area on the tray.”
Dr. Wisco added that communicating with staff is also an important safety protocol. “If a needle goes down into the field, let people know where it is — and it has to be closed communication: ‘I’ve put the needle here’ and the staff have to respond, ‘I understand the needle is there.’
Most injuries in surgery occur, much like everything in medicine, in the transition to the next stage, Dr. Wisco said. “Even in just thinking about the surgical environment that includes setting up the tray, using the tray, taking down the tray. You have to think about those very specific steps and what mishaps might happen in the process.”
Photography
There have been many proposed solutions to avoid uncertainty about biopsy location, the most prevalent being photography at time of biopsy. A clearly labeled preoperative photograph is the gold standard for identifying biopsy sites.
“In our department, we’ve implemented a universal standard operating procedure for biopsy site photographs because through root cause analyses, we found that often errors were due to inadequate photographs,” Dr. Ken explained. “We start off with marking the biopsy site with the skin marker, and then we take two photographs. One is a mapping photograph, which is a faraway photograph that shows at least two anatomic landmarks. If you’re doing a biopsy of the cheek, you might include the nose and the ear so you can identify the site in relation to other anatomic landmarks.”
“The second photograph is the magnification photo, which is a zoomed-in photo of the site itself. Each biopsy done in our department has two photographs which are utilized for site identification when a definitive procedure is indicated,” Dr. Ken said.
Oliver Wisco, DO, FAAD, FACMS, director of the Brown Dermatology Cutaneous Oncology Program and the chair of the department’s Quality and Safety Committee, recommends having a close-up image with at least one landmark that can be identified, preferably with a ruler in the area to provide a direct measurement of where the lesion is in relation to that landmark.
“It’s also really important to be specific when labeling the biopsy site. Instead of ‘scalp,’ what we really need is ‘right occipital scalp’ or ‘right frontal scalp.’ You need to provide more direction to the person who may be doing that surgery down the road, including yourself. We see a lot of patients and sometimes it can be hard to remember every single one, especially when the patient has had multiple biopsies,” Dr. Wisco added.
Since Dr. Ken’s department completed the final rollout of their biopsy photo standard operating procedure in June 2023, they’ve performed regular audits of their biopsy site photos. “We have had zero wrong-site surgeries since the implementation of our protocol which is the goal. We’re over 95% compliant with our biopsy photo SOP with a department of more than 30 clinicians which is amazing.”
Pre-procedure verification
At Penn State, Dr. Ken and her colleagues have a procedural safety checklist that they review with every procedure. “We have our pre-procedure, our timeout, and our post-procedure checklists. In our pre-procedure process, we utilize the biopsy photographs by bringing the digital photographs into the room and showing them to the patient and care team. We then mark the site needing treatment and have the patient confirm the correct site is marked either with a mirror or an additional photo with reference to the biopsy site photographs.”
At Brown, Dr. Wisco says that “if anyone during the process, whether it be the patient, a family member, or someone on the care team, doesn’t agree on the correct site, we don’t proceed with surgery.”
Dr. Wisco explains the importance of verifying before the patient is draped. “A lot of times what happens is if the patient is already draped and you see that there was a biopsy there, you’ve missed the image opportunity to verify. I’ve seen wrong-site surgeries occur because the patient is already draped and you operate on a biopsy site, but it was a previous biopsy that wasn’t cancer, it was misidentified earlier and assumed to be correct.”
A procedural timeout is important for any procedure done in dermatology, Dr. Ken said. “Our timeout involves everyone in the procedure, including the physician, the advanced practice providers, residents, nursing staff, and the patient. It can be challenging for patients to identify their biopsy site, especially if it’s in an area they can’t see well themselves. This is when the pre-operative referral paperwork with the photos is critical.”
In addition to the right site, Dr. Wisco emphasizes verifying it’s the correct patient. “I’ve seen a one-time mishap where two patients came to the same practice location with a cancer on their right temples. The patients had similar skin, same age demographic, and the same last name. The right procedure was being done on the wrong patient.” Patient verification becomes particularly important for institutions that move patients between rooms, he added.
Quality and patient safety
Biopsy pathway
According to a JAAD study, dermatologists reported that 50% of their most recent errors and 40% of their most serious errors were specimen errors (doi: 10.1016/j.jaad.2012.10.058). Obtaining a skin biopsy specimen is a common procedure in dermatology, and more than 2.2 million skin biopsy specimens are obtained annually in dermatology offices in the United States. There is some literature on specimen loss in dermatology, ranging from 0.3% to 0.7%, Dr. Ken said. “While these rates are low, that doesn’t negate the fact that when these events occur, there can be serious consequences for the patient. Specimen loss is also considered a ‘never event.’”
“Efforts to address errors within the biopsy pathway should be a priority for dermatologists. From the first decision to obtain a biopsy specimen until the integration of those results into the patient’s care plan, it has been estimated that there are approximately 20 handoffs. In any one of these steps, errors can occur,” Dr. Khodosh said.
Best practices for avoiding site identification error
At the time of biopsy:
Take a high-quality photograph with ≥1 visible anatomic landmarks
Before and during consultation:
Confirm with referring physician receipt of documentation used to identify site
Have patient point to biopsy site while looking in a mirror
Review available documentation
Perform a physical examination of the area
Surgeon circles/marks biopsy site
Have patient reconfirm site after consultation and marking
Take a photograph of marked biopsy site for medical record
If surgeon unsure of site after consultation, ask referring physician for clarification
Day of surgery:
Identify site based on documentation
Ask patient for verbal confirmation of site
Ask patient to point to site
Recircle/mark the biopsy site
Nursing/medical assistants to confirm procedure with patient
Source: doi: 10.1111/dsu.12297
Holes in the process
As an attending and as the director for Safety and Quality in Dermatology at UCSF, Dr. Khodosh supervised a team of residents and fellows on a project in which they investigated the holes in their biopsy pathway process. They identified two critical steps in the process where if errors occurred in those steps, you were likely to lose the specimen. “Those steps are confirming that the specimen is in the jar and making sure that the container itself doesn’t go missing before it makes it to pathology. Out of the 20 or so steps, we focused on those two to ensure the process we were proposing wasn’t too burdensome.”
One change Dr. Khodosh and her colleagues introduced is that they asked staff when they were setting up a biopsy to place a sticker in a log where they kept track of all their pathology specimens. “This would take place before the biopsy was completed; it was a setup step indicating that a biopsy is going to be done.”
Once the biopsy was completed, they had to check off a box and say that it was completed. “Before these processes existed, if the specimen was collected but never made it to the pathology bin, you wouldn’t know about it. Now, if the specimen never materialized by the end of the shift, people would start asking questions,” Dr. Khodosh said. “It’s much easier to find the specimen within a few hours of loss,” she added.
The second step Dr. Khodosh’s team implemented was even simpler than the first. “We asked the physician and the nurse collecting the specimen from the room to look in the container and verify they could see the specimen in each container.”
One mistake that could occur in specimen collection is that it might get stuck to the blade or the tray and not make it into the jar. “If you were checking on this right in the room, it’s much easier to recover,” Dr. Khodosh said.
Once you have your specimen, you must ensure that all the bottles make it into the specimen processing area, Dr. Wisco said. “I’ve seen bottles accidentally put back into the cabinet because of a mislabeling in the process. You have a set number of bottles that leave, bottles that you then have to verify, and then you have to track those bottles.”
A multistep pathway
Ensuring reliability of a multistep pathway requires a low error rate at each individual step. For example, in a 25-step pathway if each step is 95% reliable then the overall reliability of the pathway is only 28%; this increases to only 78% if each step is 99% reliable. Optimizing the reliability of this pathway requires implementing a biopsy tracking system, staff training, and processes or tools designed to detect error in the pathway (doi: 10.1016/j.jaad.2012.10.058).
There are multiple ways that specimen loss can occur. “Sometimes we’re doing a two- or three-millimeter shave biopsy for cosmetically sensitive areas on the face. Maybe the specimen stuck to the blade used to remove it, and you think it went into the container, but it didn’t,” Dr. Ken said. “Sometimes smaller specimens can get stuck to the cap.”
There’s always a risk of mislabeling the specimen or not confirming that the correct specimen was placed in the container with the correct patient’s name.
Dr. Ken and her colleagues have recently revised some of their protocols. When a biopsy is done, there are always two people in the room. “Once the specimen is in the cup, we look at the cup and each person will verbally say, ‘specimen in the cup.’ Once the verbal confirmation occurs, a bright red sticker, that says ‘specimen’ with a check box is then checked. There is both the verbal confirmation and the visual reminder to do that verbal confirmation.”
Even when you make process changes, things will inevitably arise that you don’t anticipate, Dr. Khodosh said. “One of my patients walked off with the specimen container, which you think would never happen. What we ended up focusing on in that situation was the fact that it wasn’t noticed that the specimen was missing until much later in the day — actually, until the patient’s wife called to inform us that she found the specimen in his pocket.”
When these types of one-off events occur, it’s important to carefully analyze what happened. “If you jump to conclusions and decide you have to get the specimen out of the room before a patient could grab it, that might be really cumbersome, and it might even create more problems than it would solve,” she said.
Changing habits
Reporting mistakes is really important, emphasized Dr. Khodosh. “At UMass, we have a really easy system to report right from the patient’s medical record. You can click a button and report a near miss or an adverse event.”
Being perfect is unrealistic, noted Dr. Wisco. “It’s possible to strive for perfection, but in order to strive for perfection we have to understand our gaps.”
Dr. Khodosh emphasized that institutional culture plays a critical role in people’s willingness to report. “You have to have a culture that recognizes that errors happen and that we’re not going to look at the reports and figure out who’s at fault. We’re going to look at the reports to better understand how we can improve and do better next time. Errors are not the problem of a bad physician, but usually a problem of a bad system.”
With the implementation of any new procedures and protocols, it’s critical to have buy-in from the entire team. “You’re changing the workflow and habits of some individuals that have been practicing a certain way for many years, so it did take a few months for us to modify our processes,” Dr. Ken said.
“When I was first doing this work,” Dr. Khodosh said, “I used to think that all I needed to do is just come up with a really good idea of how to make things better and then tell everyone. People would often be caught off guard and not be bought-in to what I was asking them to do. Really engage everybody from the start so you can hear everybody’s ideas and find out where the pain points are.”
While creating new patient safety protocols is important, it’s just as important to have a plan to monitor, Dr. Ken said. “It’s one thing to implement a process, but you have to know how effective it is.”
