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Wrong-Site, Wrong-Procedure, and Wrong-Patient Surgery

Author: M. Aroon Kamath, M.D. | Submitted: September 17, 2010. Updated: October 07, 2010.

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The operating room is where, without doubt, many lives are saved and a multitude of destinies are altered. However, in today’s rapidly changing world, the number and complexity of surgical procedures are increasing dramatically. So is the number of surgical sub-specialties. The operating lists in general are getting longer by the day. Improved operating room (OR) efficiency often demands ‘impressive’ reductions in OR ‘turnover times’ leading to inevitable parallel increases in the flow of patients both into and out of the OR suite. In the midst of this ‘organized’ chaos, the potential for an unintended mishap is dangerously very real.

“Wrong-side/wrong-site & wrong-procedure/wrong-patient” adverse events (WSPEs), often simply called “wrong site surgery”, are increasingly being recognized as preventable serious (often under-reported) medical errors.

Up until about the last decade, information on incidence of wrong site surgery was either non-existent or best not talked about. Medical errors are estimated to be one of the top ten leading causes of death in the United States; and wrong-site surgery is frequently one of the top ten most reported medical errors that cause patient injury. Some estimates indicate that there are 1300 to 2700 WSPEs annually in the United States [1]. A study supported by the Agency for Healthcare Research and Quality (AHRQ) analyzed information from nearly 3 million operations between 1985 and 2004, discovering a rate of 1 in 112,994 cases of wrong-site surgery [2]. It is suggested that the average large hospital may be involved in such an event every 5 to 10 years, a rate 10 times less frequent than for instance, retained foreign bodies. ‘Near misses’ generally go unreported & unanalyzed. Thus, WSPEs, although ‘rare’, are perhaps more common than generally assumed.

National Quality Forum (NQF) has listed wrong-site surgery as one of its serious, largely preventable events, which it calls “never events”. This requires the reporting of wrong-site surgery as a “sentinel event” implying that they signal the need for urgent investigation and response [3].

Wrong-site surgery involves all surgical procedures performed
- On a wrong patient,
- On a wrong body part,
- On the wrong side of the body, or
- At a wrong level (of an otherwise correctly identified anatomic site).

Wrong-patient surgery may also include
- Patients who were never scheduled for a procedure, but operated upon,
- Procedures scheduled correctly but in which a different procedure was performed, and
- Procedures performed that were not scheduled.

Wrong Site Surgery; Contributing Factors
- Inadequate patient assessment,
- Incomplete medical record review,
- Poor handwriting,
- Reliance on surgeon alone to identify site,
- Poor communication among OR team,
- Multiple procedures performed on same patient,
- Time pressure, and
- Lack of clear policies.

The Impact of wrong site cases
- Leads to loss of faith in the healthcare system and providers,
- Surgeon litigation and licensure penalties,
- Hospital litigation and accreditation penalties,
- Indefensible public image risk,
- Undermines the cohesion of the surgical team.

Where can it occur?
- In the regular OR setup,
- In day care surgery, and
- In the out-patient setup.

Which specialties are prone?
WSPEs can occur in the context of almost all types of surgery. Orthopedic surgeons and dental surgeons seem to be at a higher risk.

Institutional strategies for identifying the correct surgical site

A retrospective 10 year joint review by the American Academy of Orthopedic Surgeons (AAOS) and the North American Spine Society (NASS) resulted in an awareness campaign to encourage the marking of the right surgical site, called “Sign Your Site” initiative [4]. The Universal Protocol for Preventing Wrong Site, Wrong Procedure, and Wrong Person Surgery came into existence following a summit convened by the Joint Commission in association with the AAOS and leaders from 23 other organizations [5]. The three key elements—patient identification, site mark, and time out, are incorporated in the following discussion. The Association of periOperative Registered Nurses (AORN), working in collaboration with the Joint Commission, developed a “Correct Site Surgery Tool Kit”, designed to assist health care providers to implement the Universal Protocol for WSS in their facilities [6].

Marking the Surgical Site
Individual institutions must formulate and specify policy and procedure as to how, when, and by whom the surgical site is to be marked. The site is marked as early as possible but always prior to entering the OR. The surgeon or designee is responsible for the marking the site. Each operative/procedural sites involving laterality, multiple structures or levels should be marked. Surgeon/designee actively engages the patient in the marking of the site. Never mark any non-operative site. Avoid writing “Left” or “Right”.  In English the word “right” can mean the opposite of “wrong” or the opposite of “left”. One may write “Yes” but better to avoid the word ‘No”. “No” upside down looks like “oN”. Do not write “X”. It may be misunderstood to mean “do not operate”. Further confusion results from a common inability to identify the right and left side of a rotated or mirrored object (for example, a patient in one of the lateral positions or jack-knife position). It may be best to write one’s initials at the operative site (‘Sign Your Site’). The site is best marked with the marker’s initials (familiar to the team) using persistent marker that remains visible once patient is prepped and draped. Mark the site at or near proposed incision. By “Near” it is meant that it remains visible following prepping and draping. Mark a visually sensitive site (e.g. face) with a dot or small visible mark with persistent marking. If patient refuses marking, always this fact must be documented.

Exceptions
- Where the procedure site cannot be marked - (e.g. teeth) relevant x-rays or other imaging studies must, if possible, be available to indicate the site (a diagram is the ideal way of demonstrating the site and side of surgery in these cases).
- In the case of severe burns, and some Ear, Nose and Throat surgery, such as tonsillectomy.
- Where the urgency of surgery precludes marking.
- When intra-procedure imaging for localization (e.g. radiological, MRI, stereo taxis) will be used.
- If the site is a traumatic site (an obvious surgical site).
- Interventional cases for which the catheter/instrument site is not predetermined (cardiac catheterization, epidural/spinal analgesia /anesthesia).
- Premature infants, where marking may lead to permanent tattooing.
- In the case of upper and lower gastro-intestinal endoscopic procedures.
- Caesarian sections.
- Laparotomies

Use a verification checklist immediately before surgery
- Verbal communication with the patient and/or family members and significant others to re-confirm the site,
- A thorough medical record review,
- Review of the informed consent (which should include specific mention of the surgical site).

Verification at the OR
The surgeon first calls a “timeout” period immediately prior to the incision or start of the procedure for final confirmation of the surgical site. This is a pause for safety.

During this pause, the following things should be done:
- Review of all available imaging studies,
- Direct observation of the marked surgical site,
- Verbal verification of the correct site & side with each member of the surgical team. The site is verbally confirmed by the surgeon, nurse and the anesthesiologist, collectively agreed upon, and then recorded in the theatre log.
- Agreement on procedure to be performed,
- Correct patient position, and
- Checking availability of correct implants, special equipment or requirements.
The surgeon then calls “time-in.” Nothing should proceed further until “time-in” follows the “time-out.”

Is there anything to learn from others?
Statistics from non-medical (industrial) studies indicate that for every 300 “near misses” there is one serious injury. A continuum of cascade effects exists from apparently trivial incidents to near misses and full blown adverse events.

Reporting of errors and near misses has been successfully used in several industries over the last 40 years [7] including,
- Aviation,
- Nuclear power technology,
- Petrochemical processing,
- Mining,
- Avalanche research,
- Steel production, and
- Military operations.

Significant differences in attitude between surgeons and airline pilots,
was observed in one study [8]. Ninety four percent of cockpit crews disagreed with the statement that junior team members should not question decisions made by senior members, only 55% of surgeons disagreed with the same statement. While 64% of surgeons surveyed felt that high levels of teamwork occurred in their operating room, their optimistic view was shared by only 28% of surgical nurses and 39% of anesthesiologists, underscoring a strong disconnect between the different members whose functions are critical to successful surgery.

Conclusions
The odds are greater that a person will be injured or die as a result of medical error than as a consequence of driving or flying [9]. Has it changed since 1991? Perhaps, only time will show.

In conclusion, wrong-site surgery is a rare but, an indefensible error for a surgeon and a shocking experience for the public. A unified and continued effort among surgeons, hospitals and other health care providers are urgently needed. No protocol will be able to prevent all cases, but efforts should continue. In the end, it is the surgeon who must make sure that each patient he or she operates on is the right patient; the procedure is the one that has been scheduled; the side and site of the operation are correct.

CITE THIS ARTICLE:
M. Aroon Kamath, M.D.. Wrong-Site, Wrong-Procedure, and Wrong-Patient Surgery. Doctors Lounge Website. Available at: http://www.doctorslounge.com/index.php/blogs/page/14123. Accessed August 27 2014.

References



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October 08, 2010 09:37 PM

John Kenyon, CNA's avatar

Dear Dr. Aroon,
I found your article to be extremely interesting and informative. I have worked in the pre-op link of the surgery chain, but we were all included in traiing regarding implementation of the Mark/List/Pause strategy as well as being impressed with the statistics (1991 study figures) since we were all in part responsible for the outcome. From assembly of the chart to discharge there is room for errors. That the system is in place is comforting, even if we won’t know for some time to come just how effective it has been. It is interesting that nursing and anesthesiology staff statistically felt much less reassured than surgeons about the improvement. My own personal take on this (and as you know I favor a very liberal-yet-cautious approach to most things) was that it almost certainly must be making a difference for the good and of course concur with your opinion that it is only sensible to make use of any protocol which might reduce the chance for error. Hopefully studies will soon tell us how effectie it has been.

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October 09, 2010 04:35 AM

M. Aroon Kamath, M.D.'s avatar

Dear Mr. John,
Thank you for the very valid points that you have made. Personally, i tend to think that more than the undoubtedly useful protocols which are in place, what finally would determine the success or otherwise of this initiative would be the rate of reporting of such adverse incidents and more specifically, the “near misses”. 

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