Wrong-site, wrong-procedure, wrong-patient errors—also known as WSPEs—are “never events.” These errors can be devastating to patients and suggest fundamental flaws in safety procedures.1 

The incidence of wrong-site surgery in the operating room across all surgical specialties is estimated to be one event per 100,000 to 112,994 procedures, but is likely higher due to underreporting.2,3 This doesn’t include procedures performed in other settings, such as ambulatory surgery centers or interventional radiology services.4 In fact, a retrospective review of all surgical events over three years in the Veterans Health Administration system found that up to half of procedure-related adverse events occur in settings outside the OR.5 In that study, ophthalmology had the second highest rate of adverse events.

Given the high volume and frequency of procedures performed outside the OR in office-based retina practices, the prevention of clinic-based WSPEs should be a high-priority focus in the specialty, with every effort made to implement standards and processes to prevent such errors. Here, we review patient safety challenges in office settings and describe steps for reducing and eliminating WSPEs.

 

Challenges in the clinic

Estimates of WSPEs in clinic-based settings aren’t readily available. Certain key differences between the OR and clinic setting may make the clinic an even higher risk environment for procedural errors. Most ORs have strict, established guidelines and protocols with institutional and, often, national oversight. 

Subsequent checks and verifications help minimize the incidence of adverse events. For instance, nurses preoperatively typically verify the patient’s information, type of surgery and laterality with the patient, and corroborate this information with the consent form. The surgeon typically marks the surgical site, while simultaneously verbally confirming with the patient and checking the consent form.  

This often occurs again in the OR prior to draping and is finally verified in the standard “time-out” before starting the procedure. While some of these checks and verifications can be mirrored in the clinic for most in-office procedures, certain differences render clinic procedures more vulnerable to adverse events. 

 


Retina clinic vs. OR

A standard retina practice in the United States is often a busy, fluid and evolving environment that may predispose retina specialists or their staff to committing errors. As opposed to the OR, where the focus of the care team is typically on only one patient in one room at a time, a provider in a retina clinic may see in excess of 50 patients on an average day spread over multiple rooms that are in constant turnover. Furthermore, the physician in the clinic also faces a multitude of distractions—phone calls, texts and staff interruptions.

Medical practices face unique challenges in managing and training employees. They require a management infrastructure with proper oversight to promote standardized training methods, define employee responsibilities and maintain retention of experienced staff. Office-based care may also involve a larger care team concomitantly managing multiple patients, potentially from multiple providers, at the same time. It’s essential the care team communicate and maintain a healthy teamwork climate to ensure safety.


The nature of the procedures performed in the retina clinic, specifically intravitreal injections, can lead to potential error and WSPEs. The physician’s treatment algorithm for injections can depend on the disease being treated, type of medication and patient factors, as well as insurance guidelines. These factors may result in a multitude of treatment plans involving simultaneous treatment of both eyes or sequential treatment at different times. A large quantity of injectable medications are often stocked and freely accessed in a fast-paced environment.  

In OR-based settings, especially in hospitals, medications are often taken from a centralized, controlled system (i.e., BD Pyxis MedStation). In such systems, the  patient name and medication must be verified and entered into the electronic system in order to obtain the medication. Subsequent barcode scanning of patient bracelets and medications are required before administering the medication. Such automated systems are generally not available in the clinic. 

 

EHR and the potential for WSPEs 

Medical records can become a source of WSPEs starting with the initial clinic encounter. A recent study found that “upstream” errors in the form of erroneous lens specifications or calculations originating in the clinic may be responsible for up to a quarter of WSPEs in ORs. These errors would not have been necessarily prevented by conducting a time-out in the OR.6 Many electronic health record systems use drop-down windows or checkbox functions that can inadvertently lead the user to select the wrong eye or medication in clinic notes. 

Many EHRs have a carry-forward function that allows the provider to transfer previously documented exam notes to notate a current patient encounter. This can be useful to expedite vast amounts of required documentation, but it can cause problems if the information being carried forward is dated or inaccurate. 

Upon entering the room, the physician or staff member must closely confirm on the computer monitor that the medical record and images are for the correct patient. Following the exam, the doctor needs to diligently review the notes for accuracy before finalizing them.  

 


Tools for reducing preventable errors

Procedural checklists have evolved over the years in an attempt to reduce the risk of potential wrong site surgery. The Joint Commission introduced the well-known Universal Protocol in 2004, which has been adopted and implemented in ORs across the United States. In 2012, the Ophthalmic Mutual Insurance Company invited the American Academy of Ophthalmology and other key organizations to help develop an ophthalmic-specific surgical checklist (available at https://www.omic.com/ophthalmic-surgical-checklist/). 

In 2014, the AAO subsequently developed additional recommendations to minimize preventable surgical site and procedure errors.7 Many of these recommendations are specifically focused on inpatient or ambulatory surgical centers. However, limited consensus or guidelines on clinic-specific protocols exist for office-based retina procedures. Standardized safety protocols used in the OR should be modified and implemented in office-based settings, keeping in mind the key differences already noted.

 


Our office protocol

In our practice, we have developed a standardized clinical protocol for in-office procedures to address safety concerns and potentially reduce the risk of WSPEs (box). Our protocol begins when the physician and patient agree on a treatment plan. Before each procedure, the informed consent is either obtained or reviewed. This provides an opportunity to confirm the eye (or eyes in the case of a bilateral treatment plan) and medication. With the scribe present, the physician will then place a sticker over the eye or eyes. The sticker has a large capital letter indicating the name of the medication (A for Avastin, E for Eylea, etc., Figure, page 29).  

Before prepping the eye, the technician again confirms the treatment with the patient as they review the consent form together. The physician, who may have evaluated or treated other patients in the meantime, will then re-enter the room and once again confirm the patient, site and medication before proceeding with the treatment.  

We use this general protocol for other office procedures, such as lasers and pneumatic retinopexy. These repeat checks and confirmations at multiple stages of the process reduce the risk of error with in-office procedures without adding significant time to the process. Having the patient and other team members participate in the site and medication confirmation reduces reliance on memory and helps the retina specialist better deal with the workload, complexity and stressors of a busy retina practice. The medication-specific sticker serves as a visual reminder that creates shared situational awareness amongst all team members. 

 

Bottom line

We don’t fully know the true scope of preventable WSPEs in the office setting, because significant underreporting may exist. These errors have the potential to cause harm to the patient’s ocular health. Even if no concrete harm occurs, these situations can be deleterious to the physician-patient relationship. 

Errors still occur amongst high-functioning, conscientious and efficient teams due to the numerous factors that can negatively impactindividual and team situational awareness in fast-paced clinics. Instituting a clear and established protocol for in-office procedures can help minimize the risk of harm. RS

 

Anne M. Menke, RN, PhD, patient safety manager for the Ophthalmic Mutual Insurance Company, provided input in the preparation of this article.

 

REFERENCES

1. U.S. Department of Health and Human Services; Agency for Healthcare Research and Quality Patient Safety Network. Wrong-site, wrong-procedure, and wrong-patient surgery. https://psnet.ahrq.gov/primers/primer/18/wrong-site-wrong-procedure-and-wrong-patient-surgery. Updated January 2019. Accessed September 11, 2019.

2. Ambe PC, Sommer B, Zirngibl H. Wrong site surgery: Incidence, risk factors and prevention. Chirurg. 2015;86:1034-1040. 

3. Hempel S, Maggard-Gibbons M, Nguyen DK, et al. Wrong-site surgery, retained surgical items, and surgical fires: A systematic review of Surgical never events. JAMA Surg. 2015;150:796-805.

4. Seiden SC, Barach P. Wrong-side/wrong-site, wrong-procedure, and wrong-patient adverse events: Are they preventable? Arch Surg. 2006;141:931-939.

5. Neily J, Mills PD, Eldridge N, et al. Incorrect surgical procedures within and outside of the operating room: A follow-up report. Arch Surg. 2011;146:1235-1239.

6. Parikh R, Palmer V, Kumar A, Simon JW. Surgical confusions in ophthalmology: Description, analysis and prevention of errors from 2006-2017. Ophthalmology. Article in Press. https://doi.org/10.1016/j.ophtha.2019.07.013 Accessed August 15, 2019.

7. American Academy of Ophthalmology. Recommendations of AAO Wrong-Site Task Force–2014. https://www.aao.org/patient-safety-statement/recommendations-of-american-academy-ophthalmology- Updated August 2014. Accessed August 13, 2019.