PATIENT PARTICIPATION Wrong events are often the result of an error made upstream in the surgical process, such as the wrong IOL being ordered and not double-checked with the patient for a cataract procedure.

From October 2009 to October 2010, 31 wrong-site surgical events were reported in Minnesota. More than 60% of those wrong-site procedures occurred on the wrong side — left rather than right, or vice versa — and nearly all could be attributed to breakdowns in basic best practices. The site mark wasn't visualized. Source documents weren't referenced. The surgeon said, "I agree," rather than independently verifying the procedure and site. And, in a surprisingly high number of cases, no process was in place for site-marking and conducting a time out.

These sorts of oversights — most of them seemingly insignificant at the time — happen every day in ORs nationwide, despite years of the Universal Protocol and sentinel event status for wrong events. We know because wrong events are still happening. Here's a look at a few from our database (for legal reasons, they're composites, but the elements are all real) and what could have been done to prevent them.

THE MINNESOTA TIME OUT
Every Patient, Every Procedure, Every Time

POSITIVE RESULT Minnesota's push to get ORs to stop for time outs before all procedures resulted in a 20% drop in wrong events.

Hospitals and ASCs have made progress on implementing robust time-out processes, but room for improvement remains: Many wrong site events in 2011 were related to inconsistencies or lack of verification at various points in the scheduling process, or to a lack of policy for site-marking or time out in certain areas of facilities.

To that end, in early 2011, the Minnesota Department of Health, Minnesota Medical Association, Minnesota Hospital Association, MMIC (a state malpractice carrier) and the state's Medical Group Management Association joined to form the Minnesota Safety Surgery Coalition. Its first goal is to hardwire the time-out process anywhere procedures are being performed, statewide. Called the Minnesota Time Out, it focuses on independent verification by the surgeon and the conducting of effective site marking — every time, for every patient and every procedure or surgery.

Results from 2011 data show that the Minnesota Safe Surgery Coalition's work may be starting to come to fruition. First, more facilities report they're following the steps of the Minnesota Time Out both in and outside of the operating room. Second, in the last reporting year, which ended in October 2011, there were 24 wrong events — a 20+% drop from the reporting year that ended in October 2010, and the lowest point since 2007.

— Diane Rydrych, MA, and Rachel Jokela

Case No. 1: Wrong implant
The patient was seen in the surgeon's clinic for removal of a cataract and replacement of the lens in the right eye. The patient and surgeon agreed that the patient's vision wouldn't be corrected to 20/20 because the patient never had 20/20 vision and didn't want this change. The patient consented to correction to less than 20/20, and the surgery was scheduled. The physician ticked the wrong box on the documentation, though, and the surgery center ordered the wrong implant. The physician ended up implanting a lens in the right eye that corrected vision to 20/20.

This isn't a case where the OR time out could have helped — the documentation matched the expected procedure and the supplies in the room — but asking the right questions would have. The pre-op phone call should have verified the implant type in addition to the procedure type. No one asked about the implant type once the patient was in the surgery center, either. This information is as important as the site, side and procedure type.

Even if the patient isn't unhappy with the result, and doesn't want to undergo a second procedure to correct the initial one, it's a wrong-implant surgery and needs to be reported. For procedures with implants, include active questions for patients ("What kind of lens are we implanting, one with 20/20 correction or one without?") to corroborate the documentation.

Case No. 2: Block on wrong body part
The patient entered the hospital as an outpatient for a dialysis fistula graft de-clotting procedure. The patient had a fistula graft in each arm, but the right arm was the one set to be operated on that day. With the fistulae immediately visible on both sides, the radiologist injected the local anesthetic into the left arm before the procedure. It wasn't until the patient questioned the injection that the radiologist realized that the local anesthetic had been injected in the incorrect side. He proceeded to do a local injection on the right, and the procedure continued as planned.

In the last year or two, we've seen an increase in the number of wrong-block procedures reported. They happen the same way most other events do. It's all too common that the care team focuses on the procedure to be done and not on the block as a separate procedure. The dynamics for the block needed be the same as those in the OR, with site-marking and a robust time out before injection, just as you do before incision.

DATA SAMPLING
Where and on Whom Wrong Events Are Happening

HIGH RISK Anesthesia blocks are in great danger of being performed on the wrong side and require a time out.

In "Quarterly Update: What Body Parts and Procedures Are Associated with Wrong-Site Surgery?" recently published in the Pennsylvania Patient Safety Advisory, which is issued by ECRI Institute and the Institute for Safe Medication Practices under contract to the Pennsylvania Patient Safety Authority, author John R. Clarke, MD, breaks down some of the common occurrences of wrong surgeries, using data from recent cases.

Wrong-Patient Events

• 4 involved patients with the same or similar names
• 2 involved another patient's information entered in the chart
• 1 involved using another patient's chart
• 1 involved operating on patients out of the scheduled order

Wrong-Procedure Events

• 14 hand procedures
• 12 insertions of an incorrect device, including 1 incorrect type of ear tubes
• 10 ENT procedures, including the previously noted ear tube event
• 5 eye procedures

Wrong-Location

• 307 total reported
• 104 wrong-side anesthesia blocks
• 41 wrong-side pain procedures
• 1 procedure started on the wrong side and at the wrong spinal level (counted as half for each)
• 64 other procedures started at the wrong level of the spine (63) or rib cage (1)
• 59 procedures started at a wrong location near the correct location
• Knees, spine, eyes, legs and ureters most common locations for wrong-side surgical procedures

On the Web
"Quarterly Update: What Body Parts and Procedures Are Associated with Wrong-Site Surgery?" tinyurl.com/d6q84n7

— Stephanie Wasek

Case No. 3: Wrong procedure
A caesarean section was planned for delivery of twins at 39 weeks. At the same time, a tubal ligation. The patient consented on the day of surgery, during admit, to the caesarean section and tubal ligation. The twins were successfully delivered; however, the tubal ligation wasn't completed. This wasn't noticed until the patient was in recovery and the surgeon was reviewing the chart.

When we talk about a robust time out, we mean one that comprises a consistent, evidence-based, human-factors-driven approach. In this case, a good time out could have prevented the wrong surgery.

Every time you do an invasive procedure, there should be a time out that doesn't let team members answer by rote. That is, the time out's questions shouldn't yield such answers as "Yes" or "I agree." The questions should be based on validated source documents, with answers that involve cognitive engagement. For example, "Mrs. Smith is having both caesarean and tubal ligation," or "The knee arthroscopy will be done on the right side."

Recordkeeping in the OR is important, too, to document that the steps were done every time, and as a reminder for the team. If possible, it should be done concurrently, on a form that includes each time-out step, rather than after the fact or using a form with a single check box for "time out completed."

NO DIFFERENT Nerve blocks should come with their own, separate time outs.

Give safety a voice
In an age in which surgeons might practice in their offices, at ASCs and in hospitals, a consistent time out is needed, ideally statewide or nationally (see "Every Patient, Every Procedure, Every Time" on page 57). In our work to implement the Minnesota Time Out, we know it must be done every time, for every invasive procedure. We have to be fully engaged, and hold surgeons or other team members accountable by regularly observing the ORs.

But we also know that those who are responsible for implementing the process may not understand the rationale behind each step in the process. So ensuring they have a firm grounding in the evidence or rationale, and can explain it to any skeptical team members, is paramount.

Wrong events are nearly always preventable. But your facility's culture must support staff who speak up for their patients — and patients who speak up for themselves. We often see in reports that someone on the care team knew something was wrong or had questioned something, but was afraid to speak up for fear of the consequences. Protect your employees, whether in the business office or the OR, to ensure everyone speaks more readily.