The Case of the Double-Edged Protector

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This article is part of an occasional series of patient safety cases, written by the American Board of Ophthalmol­ogy (ABO) and appearing in Morning Rounds.

Angela Lee* was tired of dabbing away her tears and looked forward to the dacryocystorhi­nostomy (DCR) that she hoped would allow her to put away the tissue box that was always by her side. Although she had more bleeding than usual, the procedure was otherwise uncom­plicated. Her eye was covered with a pressure dressing, and after routine observation in the surgery center, she was discharged home in the care of her husband.

The surgeon called Mrs. Lee on the evening of her procedure, but no one answered the phone. Because of the intraoperative epistaxis, the patient had been instructed to arrange an office appointment within 48 hours after surgery, so the surgeon was not highly concerned. However, no appointment was scheduled.

The ophthalmologist next heard about Mrs. Lee four days after surgery, when her husband called the office to report that his wife couldn’t see out of the eye and was experiencing mild discomfort. He described what he saw when he parted his wife’s eyelids: “Everything looks white.” This infor­mation was relayed to the surgeon, who asked the staff to arrange an office visit the following day. At the beginning of that exam, the technician who was screening Mrs. Lee quickly discovered that the metallic corneal protector used during surgery was still in place within the palpebral fissure.

When the protector was removed, Mrs. Lee’s visu­al acuity, which had been 20/20-1, was now decreased to counting fingers at 2 feet. The cornea was edematous, and keratom­etry showed 8 D of central corneal flattening. The surgeon immediately apologized and took full responsibility for the retained corneal protector. She referred Mrs. Lee to a cornea specialist and offered to pay the cost of the cor­nea specialty care. Over the next several months, Mrs. Lee’s cornea gradually regained a more normal shape, and her final visual acuity was 20/25.

Safety Event Investigation/Root Cause Analysis

An adverse event or near miss should automatically prompt a formal inves­tigation to determine the root cause of the incident, followed by intervention and changes in processes to reduce the risk for repeated events. Larger health care facilities have reporting systems and designated safety specialists to coordinate such an investigation. How­ever, these resources were not available at either the surgery center or in the practice of Mrs. Lee’s ophthalmologist.

A review of this case shows that several factors might have contributed to the retained corneal protector and subsequent corneal injury:

• There was no “counting” process during the DCR to ensure that the corneal protector had been removed from the patient’s eye at the end of the procedure.
• The surgeon might have been dis­tracted while managing the increased epistaxis during the DCR.
• The surgeon did not examine the eye at the completion of surgery.
• Someone other than the surgeon might have placed the eye patch at the end of the case, being unaware the protector had been used.
• There was no office protocol to ensure that the patient was examined shortly after surgery, as requested by the physician.
• Cultural and language barriers might have inhibited the patient or family from contacting the ophthal­mologist sooner after surgery. (See “Health Literacy” section, below.)
• The surgeon did not recognize the significance of the problem when the husband called four days after surgery.

Root cause. The root cause for this adverse event was determined to be inadequate intraoperative protocols to ensure that corneal protectors are always removed at the completion of a procedure. Inadequate office processes for appropriate scheduling of postop­erative appointments and handling of phone calls contributed to patient harm by prolonging the duration of the corneal injury.

Discussion of Patient Safety Principles

Failure to remove the corneal protector is considered a preventable medical error. The unintended retention of foreign objects (URFOs)—also called retained surgical items (RSIs)—is a well-recognized medical error in other surgical specialties. There are many reports of sponges, needles, and whole instruments or broken parts inadver­tently left in surgical fields. Most of these cases result in additional care and/or prolonged hospital stays for the patients; some are fatal. Lawsuits are common. Typical root causes for these mistakes include 1) inadequate policies or inconsistent adherence to those policies and 2) poor staff education or team communication.¹ Certain types of cases carry an increased risk of UR­FOs, including emergency procedures, operations involving multiple surgical teams, and situations in which the sur­gical plan changes unexpectedly.

Operating room protocols are used to ensure that any item at risk for being inadvertently retained is counted both when introduced to the case and at the end of the procedure. Counts are also advised whenever there is a change in the scrub nurse. Any inconsistency in these counts must be rectified prior to the completion of surgery.

Eye surgery safety procedures. The true incidence of URFOs in ophthal­mology is unknown. Although failure to remove a corneal-scleral protector might seem like a rare occurrence, the authors are aware of similar events having occurred at other institutions. It would be wise for all ophthalmology surgery centers to institute a counting policy for protectors and other tem­porary external or internal devices used during ophthalmic procedures. Examining the status of the globe at the completion of surgery should be part of every operation.

Communication. Poor communica­tion between providers, staff, patients, and families is a common cause of medical adverse events. Each medical office should have protocols to ensure that appointments are scheduled, documented, and communicated to the patient. Postoperative patients who miss appointments should be contact­ed in a timely fashion to reschedule or verify their status.

Additional office protocols must be implemented to manage phone calls from patients who are having unex­pected symptoms. When Mrs. Lee’s husband called to report her discom­fort and decreased vision, the “white appearance” was attributed to Bell’s phenomenon, and neither staff nor physician recognized the significance of the postoperative visual change.

Health literacy. Poor health literacy can make it difficult for patients both to communicate symptoms and to understand instructions, contributing to poor health care. Mrs. Lee and her husband might not have completely understood their postoperative instruc­tions, as English was not their primary language. In addition, cultural factors might have contributed to their delay in reporting visual loss after surgery. It is important to identify those patients who have educational or language barriers that may hinder their ability to understand and follow instructions or to communicate with providers.²

Culture of medical facility. All members of the health care team must be mindful of the potential for med­ical errors. Adverse medical events can occur in a variety of health care settings, including physician offices and freestanding surgery centers. Reliable and standardized processes of care, as well as communication and teamwork, can decrease the risk of dangerous mis­takes. Continual education, vigilance, and process improvement are needed to identify and reduce the risk of errors.

Investigation. Each entity should have a designated person to coordi­nate patient safety activities. In a small office, this person may be an office manager or lead technician who wears multiple hats, including compliance and safety. Adverse events, near misses, and at-risk behavior should be reported and investigated. Once the underlying root causes are identified, changes in protocol can then be instituted. Open, nonpunitive communication is essen­tial to create an atmosphere that fosters a team approach to reducing medical error and improving patient care.

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*Patient name is fictitious.

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1 The Joint Commission Sentinel Event Alert. Preventing unintended retained foreign objects. 2013;51:1-5. http://www.jointcommission.org/assets/1/6/SEA_51_URFOs_10_17_13_FINAL.pdf.

2 Dewalt DA et al. J Gen Intern Med. 2004;19(12):1228-1239.

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Dr. Fountain is professor of ophthalmology at Rush University Medical Center in Chicago, emeritus director of oculoplastic and recon­structive surgery; and board chair emeritus of OMIC. Dr. Custer is professor of ophthalmology at Washington University School of Medicine, St. Louis, Mo., and emeritus director of the ABO. Dr. Bailey is clinical assistant professor of ophthal­mology and visual sciences at the University of Iowa, Iowa City, and director of the ABO. Relevant financial disclosures: None.

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