Report Details Uptick in Cataract-surgery Errors, Recommends Changes

BOSTON — Cataract surgery is among the safest procedures in medicine. Serious, permanent complications are rare, and most patients report a significant increase in their quality of life following surgery.

This combination of low risk and high benefit — and the fact that about half of all Americans develop cataracts that affect their vision by the age of 75 — have helped make cataract surgery the single most common operation in the U.S. Almost 4 million cataract surgeries were performed in 2015 nationally — more than 60,000 in Massachusetts alone — and these numbers are expected to grow in future years as the population ages.

Yet, like most surgery, cataract removal involves complex processes prone to occasional systems failures that can result in serious harm to patients. While the risk to any individual patient is low, the large volume of procedures means that even a minuscule error rate can add up to many patients harmed.

In early 2015, the Mass. Department of Public Health alerted the Betsy Lehman Center to an uptick in reports of serious reportable events (SREs) associated with cataract surgery. These ‘never events’ involved preventable errors that should not have resulted in harm to patients. The center’s review of the data for the previous five years revealed that the most frequent type of SRE associated with cataract surgery was implantation of the wrong intraocular lens — that is, a lens not intended for the patient. There were also multiple mistakes in the administration of anesthesia, in some cases resulting in permanent loss of vision. Other errors included surgeries performed on the wrong eye and, in one case, on the wrong patient.

What can be learned from these events? Over the course of seven months, an expert panel of respected ophthalmologists, anesthesiologists, nurse managers, and patient representatives convened by the Betsy Lehman Center examined the issues. The panel relied on a unique collection of national and local data, including confidential conversations with several of the facilities that reported the SREs, surveys of Massachusetts cataract surgeons and facilities, key informant interviews, guidelines from professional organizations, and queries of other databases, including data on malpractice-insurance claims, to develop findings and recommendations.

Many of the reported events stemmed from breakdowns in communication, failure to conduct an effective timeout, lack of standardization within facilities (from lens order forms to surgical site markings), and issues related to safety culture. The anesthesia-related incidents prompted deliberation over the choice of anesthesia technique and credentialing and orientation of new anesthesiology staff.

In addition to the more general principles for advancing safe and reliable cataract surgery noted above, the panel developed the following recommendations:

• To prevent wrong-lens, wrong-eye, and wrong-patient errors, institute a formal lens-management policy that defines uniform processes for ordering, storing, selecting, and verifying intraocular lenses;

• Adopt a uniform, facility-wide policy for marking the operative eye, and perform a separate timeout prior to a nerve block;

• Use multiple patient identifiers and engage patients using active verification; and

• Perform robust timeouts before every key step in the procedure.

To prevent injuries related to anesthesia:

• Use the least invasive form of anesthesia appropriate to the case;

• Stay current on evidence-based practices for minimizing the risk of patient harm from anesthesia;

• Engage patients in decisions about anesthesia and sedation; and

• Strengthen ‘onboarding’ of new and contracted anesthesia staff including thorough credentialing, formalized orientations, and observed eye-block assessments.

The panel’s recommendations encourage providers to promote a culture of safety and to implement patient-safety programs and evidence-based best practices to prevent events like the ones reported in Massachusetts from happening again.