Wrong-site surgery and checklist (non)compliance


At one hospital, a skin incision was made in the right groin of a patient who was to have had a left orchiectomy. Fortunately the error was discovered, and the skin was closed. The correct testicle was removed. To his credit, the surgeon told the patient and his wife what happened immediately after the operation.

An investigation found that the patient’s groin had not been marked. The time out did not prevent the error because the OR team did not verify the operative site as the protocol mandates. In other words, they had gone through the motions.

The hospital was fined $75,000.

The other California case did not turn out as well. Instead of removing a cancerous left kidney, surgeons did a right nephrectomy. The error was not discovered until the pathology report was reviewed. A number of assumptions and misunderstandings contributed to this error for which the hospital was fined $100,000.

Both hospitals made the usual system and protocol corrections that are precipitated by any state investigation. But these were human errors and will likely happen again. The existing policies were adequate. They simply were not followed.

Another case that occurred in July but recently just surfaced is from Florida. A surgeon performed a vascular procedure on the wrong leg. Apparently, a nurse anesthetist noticed the error during the case and spoke up, but the surgeon didn’t stop. He finished the wrong leg and then did the correct leg too.

When the patient awoke, the surgeon asked her to sign a consent form for the wrong leg and told her that she had needed that surgery anyway.

The hospital failed to report the error for two weeks.

In the Orlando Sentinel article, a hospital spokesman said, “We have policies in place, and training in place, but the system broke down because of the human element.” I think he was admitting that the incorrect procedure was the result of a human error, but I’m not sure.

A state inspection found many issues, and the hospital has been threatened with termination of its Medicare and Medicaid provider agreement.

 

It appears that operating room checklists, for all their promise, are not working out as well as they should.

Two recent papers looking at three distinct hospital settings, have found that checklist use and completeness are less than ideal.

At Scott and White Memorial Hospital in Texas, researchers found that OR checklists were used 94% of the time, but 54% contained inaccurate data and 15% were not fully completed. Compliance with the “time out” portion of the checklist was found in 77.8% of cases.

The paper appeared on line in the Journal of the American College of Surgeons.

In a Medscape report on the study, the senior author was interviewed and said that some of the hospital’s surgeons did not “buy in” to the concept.

Dr. Atul Gawande, commenting on the paper, wondered if scrubbing 94% of the time would be acceptable and speculated that using the checklist was not the norm in that institution. Gawande also suggested that one-on-one contact with every surgeon might be the way to improve checklist use.

A paper from the UK published in BMJ Open looked at OR checklists in two hospitals in the UK and one in sub-Saharan Africa. Staff from all three were interviewed extensively.

The authors found that the rate of checklist use was better in the UK hospitals than the one in Africa, but like the Texas study, checklists were not used 100% of the time. Accuracy was also inconsistent. Completeness was noted to be variable especially in Africa, and there were many lapses in performance of checklist components.

An OR nurse in the African hospital said, “Even though training on the checklist was given for surgeons, they don’t use it, they don’t believe in this bit of paper, because mostly they said, ‘we don’t mistake the identity of the patient, it doesn’t happen that we get the wrong patient.'”

An anesthetist in the UK said, “We’re trying to prevent what are usually rare errors, rare mistakes, you know, the majority of the things on that checklist are done most of the time without the checklist, but every now and then […] you forget to check if you’re operating on the right leg and not the left leg, and that’s rare, but on very rare occasions it then leads to a disaster.”

What have we learned here?

We have a long way to go until the checklist becomes a real factor in preventing errors.

Surgeons should reflect and admit that this sort of mistake should never occur. Until we accept this and lead the way, these stories will continue to make us all look bad.

Interventions for reducing wrong-site surgery and invasive clinical procedures .


Background

Specific clinical interventions are needed to reduce wrong-site surgery, which is a rare but potentially disastrous clinical error. Risk factors contributing to wrong-site surgery are variable and complex. The introduction of organisational and professional clinical strategies have a role in minimising wrong-site surgery.

Objectives

To evaluate the effectiveness of organisational and professional interventions for reducing wrong-site surgery (including wrong-side, wrong-procedure and wrong-patient surgery), including non-surgical invasive clinical procedures such as regional blocks, dermatological, obstetric and dental procedures and emergency surgical procedures not undertaken within the operating theatre.

Search methods

For this update, we searched the following electronic databases: the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register (January 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014), MEDLINE (June 2011 to January 2014), EMBASE (June 2011 to January 2014), CINAHL (June 2011 to January 2014), Dissertations and Theses (June 2011 to January 2014), African Index Medicus, Latin American and Caribbean Health Sciences database, Virtual Health Library, Pan American Health Organization Database and the World Health Organization Library Information System. Database searches were conducted in January 2014.

Selection criteria

We searched for randomised controlled trials (RCTs), non-randomised controlled trials, controlled before-after studies (CBAs) with at least two intervention and control sites, and interrupted-time-series (ITS) studies where the intervention time was clearly defined and there were at least three data points before and three after the intervention. We included two ITS studies that evaluated the effectiveness of organisational and professional interventions for reducing wrong-site surgery, including wrong-side and wrong-procedure surgery. Participants included all healthcare professionals providing care to surgical patients; studies where patients were involved to avoid the incorrect procedures or studies with interventions addressed to healthcare managers, administrators, stakeholders or health insurers.

Data collection and analysis

Two review authors independently assesses the quality and abstracted data of all eligible studies using a standardised data extraction form, modified from the Cochrane EPOC checklists. We contacted study authors for additional information.

Main results

In the initial review, we included one ITS study that evaluated a targeted educational intervention aimed at reducing the incidence of wrong-site tooth extractions. The intervention included examination of previous cases of wrong-site tooth extractions, educational intervention including a presentation of cases of erroneous extractions, explanation of relevant clinical guidelines and feedback by an instructor. Data were reported from all patients on the surveillance system of a University Medical centre in Taiwan with a total of 24,406 tooth extractions before the intervention and 28,084 tooth extractions after the intervention. We re-analysed the data using the Prais-Winsten time series and the change in level for annual number of mishaps was statistically significant at -4.52 (95% confidence interval (CI) -6.83 to -2.217) (standard error (SE) 0.5380). The change in slope was statistically significant at -1.16 (95% CI -2.22 to -0.10) (SE 0.2472; P < 0.05).

This update includes an additional study reporting on the incidence of neurological WSS at a university hospital both before and after the Universal Protocol’s implementation. A total of 22,743 patients undergoing neurosurgical procedures at the University of Illionois College of Medicine at Peoria, Illinois, United States of America were reported. Of these, 7286 patients were reported before the intervention and 15,456 patients were reported after the intervention. The authors found a significant difference (P < 0.001) in the incidence of WSS between the before period, 1999 to 2004, and the after period, 2005 to 2011.  Similarly, data were re-analysed using Prais-Winsten regression to correct for autocorrelation. As the incidences were reported by year only and the intervention occurred in July 2004, the intervention year 2004 was excluded from the analysis. The change in level at the point the intervention was introduced was not statistically significant at -0.078 percentage points (pp) (95% CI -0.176 pp to 0.02 pp; SE 0.042; P = 0.103). The change in slope was statistically significant at 0.031 (95% CI 0.004 to 0.058; SE 0.012; P < 0.05).

 

Plain language summary

Interventions for reducing wrong-site surgery

Wrong-site surgery is a rare, but serious event that can have substantial consequences for patients and healthcare providers. It occurs when a surgical or invasive procedure is undertaken on the wrong body part, wrong patient, or the wrong procedure is performed. A number of interventions to reduce surgical error or prevent WSS, mainly involving pre-operative verification, such as the development of Universal Protocol, site marking and ‘time-out’ procedures have been proposed over recent years. This updated review contains two interrupted-time-series (ITS) studies (studies in which data are collected at multiple time points before and after an intervention), one from the original review, which evaluated a targeted educational intervention aimed at reducing the incidence of wrong-site surgery, and which was found to reduce its incidence. An additional study evaluated the incidence of wrong-site surgery before and after the introduction of the Universal Protocol, however the relevance of these findings regarding the impact of the intervention is unclear given that prior to its introduction, the incidence was decreasing due to other unclear factors. Overall, this review now contains two studies, of relatively low quality evidence, on very specific populations and their generalisability to a larger audience is low.