Wrong Site Surgery Performed by ENT

In 2010, an ENT performed a tongue tie release on a 5 years old child who was supposed to undergo a tongue lesion biopsy (apparently 1cm in size over the central dorsal tongue). Tongue tie release was NOT consented for nor discussed with the parents who expected a tongue biopsy to be performed instead. In the investigative report performed by the Department of Public Health:

"When the surgeon was asked whether he examined the patient in the preop area prior to the surgery, he stated, "Usually, I don't examine anybody. I sometimes visit... In this case, there was no time to do a pre-operative visit. From now on, I need to see the patient prior to the surgery." [link]

According to the record, time-out WAS performed. Consent WAS in the chart for a tongue lesion biopsy. Records indicated that all mandated check-lists and time-outs were performed.

So what happened?

1) Surgeon Error: Let's face it... the surgeon made a mistake. Ultimately, it is his responsibility to ensure that the procedure goes smoothly which by definition means doing the correct procedure.

Seeing patients before surgery probably would have prevented this error. Not seeing the patient prior to surgery is not good practice.

Even if a surgeon employs a nurse practitioner or a physician assistant to see patients for him in the office or in the hospital, before any surgery, he personally should examine and discuss the upcoming surgery with all patients.

As an aside, at least once per week, I have patients calling who desire to schedule surgery without wanting to see me first for a consultation appointment. There are many reasons why I mandate that a patient MUST first be personally seen by me in the office PRIOR to any surgery scheduling. Preventing this scenario is one good reason why.

2) Nursing Error??? If the nurses knew what procedure was supposed to be done (according to the report, they did)... they should have spoken up! If they were too afraid to speak up, they should have contacted management to speak up for them... or ask the anesthesiologist to say something.

After all, patient welfare supersedes all else. Having wrong site surgery is the exact opposite.

However, to be fair in this particular situation, I do not believe the nurses knew what the surgeon was doing. Why???

The procedure was being done inside the mouth and a small child's mouth at that... honestly, nobody except the surgeon and possibly the anesthesiologist can really see what the surgeon is doing. The instruments used for tongue tie release is very similar to what would be used for tongue lesion biopsy.

3) Time-Out and Check-List Error: In a typical day, there are so many time-outs and check-lists being performed that it starts to get muted into background noise. It's just like the alarms and blinking lights that I imagine an instrument panel of a sophisticated machine would be for somebody who stares at it all day, everyday. You hear/see it... but than you don't hear/see it.

What people notice are sounds that are unusual for a given situation.

For example, cars make all sorts of noises when being turned on and moving somewhere. However, most people don't actually "hear" the sounds being produced by the car because of our lack of attention to it, because it is repetitive and continuous.

However, if one day, the engine starts knocking, that certainly gets a driver's attention and remembered.

Time-outs and check-lists suffer from inattention... even if performed.

They are a wonderful tool, but utterly undependable for long-term use.

So what would work given it must be done per regulations??? My suggestion would be to mix it up to prevent it from becoming "background" noise.

Have the time-out performed by different members of the surgical staff on every case rather than the same person. Ring a bell before doing time-out one time. On another time, have everyone dance a short jig before doing it. Whatever is done, do NOT make it repetitive which otherwise risks being inadvertently ignored.

The key is to make it different and notable each and every time in order to focus attention and prevent the task from becoming muted into the background.

Source:
CA Fines 14 Hospitals for Medical Errors. Health Leaders Media 8/31/12

Reference:
California Human and Health Resources Department of Public Health Report. 5/18/11

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Surgical Time-Out, circa Year 2050

In the year 2050, surgical time-outs have reached a new level of safety to ensure the utmost care and risk reduction for patients.

Unlike the primitive time-outs performed in the the first decade of the 21st century (2000-2012) which involved one designated individual to confirm prior to incision (Basic9), the patient name, surgical site, performing surgeon, allergies, antibiotic administration, positioning, x-ray name confirmation, fire hazards, and fall risk, significant additional safety checklists have been implemented to create a new state-of-the-art culture of safety both in and out of the operating room.

In 2015, surgical time-outs extended to also include electrical and air quality checks (Environ2) along with separate mandatory time-outs of the Basic9 before, during, and at conclusion of surgery.  To ensure minimal air contaminants as well as maintain the highest performance of all electrical equipment in the operating room, the Environ2 requires a separate electrical and environmental engineer to certify all equipment and confirm air quality at a level of no more than one contaminant part per trillion to the 10th power in 35 separate locations within the operating theater. The Environ2 checks are double-confirmed by the circulating nurse who has been granted broad powers to cancel surgery for any reason without consequence if there are any concerns with the operating room environment that may increase infection risk for the patient as well as sub-optimal performance of any and all equipment used to perform the surgery.

In 2020, the Total5 was added to Basic9 and Environ2 which truly heralded the onset of state-of-the-art surgical time-outs. Total5, developed jointly by the Harvard School of Public Health and National Institute of Medicine, involves a comprehensive time-out of any and all individuals entering into the operating room in the knowledge that surgical outcomes are affected by personnel movement into and out of the operating room whether from contaminants on the skin or clothing of staff to infections that they may or may not be harboring. In rare cases, given the recent terrorist attacks both biological as well as chemical, the Total5 would additionally eliminate such threats.

As such, Total5 involves for each and every staff member that enters the operating room to undergo "individual time-outs":

1) Geiger counter check

2) Body pat-down by TSA (whose duties have tremendously expanded from initial airport security)

3) Metal detector check

4) Chemical check (specifically looking for arsenic, mercury, formaldehyde, etc as well as drug screen)

5) Biohazard check (routine organisms include MRSA, VRSA, C dif, HIV, hepatitis, etc as well as more exotic organisms like Ebola, Swine Flu, Anthrax, etc).

A separate consent must be in the chart for each and every individual who is present for the patient's surgery with their Total5 report.

The Basic9, Environ2, and Total5 surgical time-outs collectively have ensured a 360 degree safety net for the patient.

But... it is not until now in the year 2050 that the surgical time-out has reached a penultimate state with the expansion of the Total5 to Total10. In addition to the original Total5 for surgical staff, 5 additional time-out checks of surgical staff is now required. Continuing with #6...

6) Retina scan (to confirm staff identity)

7) Fingerprint scan (to double-check staff identity)

8) Malpractice insurance check (if positive, consent must be in chart to ensure patient was aware of any malpractice committed by any surgical personnel doctor or nurse)

9) EKG to ensure peak cardiac health of staff member

10) EEG to ensure a rested mind at peak performance of staff member

As with the Total5, Total10 report for each staff member must be included in the patient consent in the patient's chart.

There was some confusion whether each staff member can undergo just one Total10 per day, but with new regulation acknowledging possibility of patient infection contaminating personnel as well as staff member fatigue that may progress throughout the day, a Total10 MUST be performed before each and every surgical case.

For any further questions on surgical time-outs, please contact your local hospital JCAHO executive liaison.

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