The Pain of the Timeout

Reference as : Robbins RA. The pain of the timeout. Southwest J Pulm Crit Care 2011:2:102-5. (Click here for a PDF version)

An article in the Washington Post entitled “The Pain of Wrong Site Surgery” (1) caught my eye earlier this month. In 2004 the Joint Commission of Healthcare Organizations (Joint Commission or JCAHO), prompted by media reports of wrong site surgery, mandated the “universal protocol” or surgical timeout. These rules require preoperative verification of correct patient, correct site, marking of the surgical site and a timeout to confirm everything just before the procedure starts. In announcing the rules, Dr. Dennis O’Leary, then president of the Joint Commission, stated “This is not quite ‘Dick and Jane,’ but it’s pretty close,” and that the rules were “very simple stuff” to prevent events such as wrong site or patient surgery which are so egregious and avoidable that they should be “never events” because they should never happen. During the following years different components have been added to the timeout and the timeout has been extended to cover most procedures in the hospital.

However, the article goes on to state that “some researchers and patient safety experts say the problem of wrong-site surgery has not improved and may be getting worse, although spotty reporting makes conclusions difficult”. Last year 93 cases were reported to the Joint Commission in 2009 compared to 49 in 2004. Furthermore the article states that reporting data from Minnesota and Pennsylvania, two states that require reporting have not shown a decrease over the past few years.

The reason for the increasing incidence of wrong site or wrong patient operations is not totally clear. Dr. Mark Chassin, who replaced O’Leary as president of the Joint Commission in 2008, said he thinks such errors are growing in part because of increased time pressures. Preventing wrong-site surgery also “turns out to be more complicated to eradicate than anybody thought,” he said, because it involves changing the culture of hospitals and getting doctors — who typically prize their autonomy, resist checklists and underestimate their propensity for error — to follow standardized procedures and work in teams. Dr. Peter Pronovost, medical director of the Johns Hopkins Center for Innovation in Quality Patient Care, echoed those sentiments by suggesting that doctors only pay lip service to the rules. Studies of wrong-site errors have consistently revealed a failure by physicians to participate in a timeout. Dr. Ken Kizer, former Undersecretary at the Department of Veterans Affairs and President of the National Quality Forum, advocates reporting doctors to a federal agency so wrong site surgery or patient cases can be investigated and the results publicly reported.

Several points made in the article need to be clarified

1. The reason that it is unclear whether the present Joint Commission mandates actually prevents wrong site or patient surgery is that no data was systematically collected prior to implementation of the timeout to ensure that it works and no data has been collected since implementation. As with most bureaucracies, the Joint Commission emphasis has been more on ensuring compliance rather than studying the effectiveness of an intervention.
2. Although no one condones wrong site or patient surgery, it is fortunately relatively rare. Stahel et al. (2) reported 132 wrong-site and wrong-patient cases during a 6 and a half year period by over 5000 physicians. They found only one death which was attributed to a wrong-sided chest tube placement for respiratory failure (2). This is questionable because a wrong sided chest tube does  not necessarily result in a patient’s death (3). Another 43 patients had significant harm from their wrong site or patient procedure and are listed below (Table 1). 
3. Based on the above, occurrence of these wrong site or patient operations would appear to be mostly in the operating room. The surgeon often enters the operating room after the patient is under general anesthesia, prepped and draped. Unless the surgeon saw the patient in the operating room prior to anesthesia and marked the operative site, it would not be possible for the surgeon to know that the correct site and patient are present.  It is not stated in the article how many of the operations reported had a timeout or the surgeon labeled the operative site but it is implied in the article that it was few. The first author of the manuscript, Philip Stahel, an orthopedic surgeon from the University of Colorado, explained the results stating that “many doctors resent the rules, even though orthopedists have a 25 percent chance of making a wrong-site error during their career….” Dr. John R. Clarke, a professor of surgery at Drexel University College of Medicine and clinical director of the Pennsylvania Patient Safety Authority, agreed stating, “There’s a big difference between hospitals that take care of patients and those that take care of doctors…The staff needs to believe the hospital will back them against even the biggest surgeon.”
4. Dr. Peter Pronost extends this sentiment by stating “Health care has far too little accountability for results. . . . All the pressures are on the side of production; that’s how you get paid.” He adds that increased pressure to turn over operating rooms quickly has trumped patient safety, increasing the chance of error.

I would offer some suggestions:

1. Focus should be on the operating room since this is where most of the wrong site or wrong patient procedures occur. I’m frustrated by the unnecessary timeouts that occur during bronchoscopy. For example, where the patient is known to me, enters the bronchoscopy suite awake and alert, and the biopsies are done under direct vision, fluoroscopic or CT guidance there is no real chance of wrong site or patient surgery. Similar procedures do not need a timeout. The Joint Commission needs to recognize this and stop its “one size fits all” approach.
2. What is needed is data. Right now it is unclear whether a timeout makes any difference. A scientific valid study of the timeout procedure is needed but not observational studies, designed only to create political statistics that a timeout works. The Joint Commission and other regulatory health care organizations need to break the habit of mandating interventions based on no or little evidence.
3. The Joint Commission mandates have apparently had little impact on reducing wrong site or patient operations. Making further mandates would seem to offer little hope. If, as Dr. Chassin believes, that time is the issue, adding more items to a checklist will not likely improve the problem and probably make it worse.
4. If time is the culprit in the operating room then simplifying the process as much as possible might be useful. I have been told of one operating room in Phoenix where a timeout is so extensive that it can take up to 30 minutes. Marking the site by the surgeon should be mandatory and a simplified, standardized checklist read and confirmed by the nurse, anesthesiologist and/or surgeon will hopefully simplify the timeout and enhance data collection.
5. I would agree with both Provost and Kizer that accountability needs to be present. However, Kizer’s idea of a Federal repository may be ineffectual at improving outcomes. Witness the National Practioner Databank which has done nothing to improve health care and blames only physicians for lapses in healthccare. It would seem that many of the physicians quoted above do the same, i.e., blame only the doctors. Dr. Chassin suggests a team approach to medicine, i.e., an operating room team. I agree but it seems inconsistent to refer to a team approach and only hold the physicians accountable. Instead, I would suggest a mandatory reporting system with a free, transparent and searchable data base available to everyone. This data bank should report not only the surgeon(s) but everyone else in the operating room. Hospitals also need to be identified so that they cannot deflect their accountability by blaming surgeons while emphasizing operating room turn around over patient safety. This means not only the hospital but the CEO or administrator needs to accept some responsibility. The CEO or administrator controls the finances and often touts their “accountability”. It is time to put some teeth to that claim. Such a transparent data base will not only allow patients to check on surgeons but also hospitals, nurses, and anesthesiologists. Furthermore, it will allow the healthcare providers to check on each other as well as substandard hospitals and their administrators.

Richard A. Robbins, M.D.

Editor, Southwest Journal of Pulmonary and Critical Care

References

1. Boodman SG. The pain of wrong site surgery. Washington Post. Published June 20, 2011. Available at URL http://www.washingtonpost.com/national/the-pain-of-wrong-site-surgery/2011/06/07/AGK3uLdH_story.html (accessed 6-21-11).
2. Stahel PF, Sabel AL, Victoroff MS, Varnell J, Lembitz A, Boyle DJ, Clarke TJ, Smith WR, Mehler PS. Wrong-site and wrong-patient procedures in the universal protocol era: analysis of a prospective database of physician self-reported occurrences. Arch Surg.2010;145:978-84
3. Singarajah C, Park K. A case of mislabeled identity. Southwest J Pulm Crit Care 2010;1:22-27.

The opinions expressed in this editorial are the opinions of the author and not necessarily the opinions of the Southwest Journal of Pulmonary and Critical Care or the Arizona Thoracic Society.