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In Texas, a cancer patient died after a surgeon mistakenly removed his healthy right lung rather than the diseased left lung. In Florida, an orthopedic surgeon has been sued twice for operating on the wrong leg. And in Germany, a woman went into the hospital for leg surgery, and had her anal sphincter replaced instead, because she had been mixed up with another patient. These are examples of wrong side, wrong site, wrong procedure, or wrong patient adverse events (WSPEs). Currently, the frequency of WSPEs cannot be accurately determined, since many incidents remain undocumented. A 2006 study states that WSPEs are "likely more common than realized"; although, their overall incidence remains low. The study reviewed National Practitioner Data Bank (NPDB) records over a 13-year period and found 5,940 reports of WSPEs. Based on data from the NPDB and other sources, the authors estimate that 1,300 to 2,700 WSPEs occur in the United States each year. WSPEs can have a devastating effect on the patient and surgical staff. They could leave patients in pain, scarred, disfigured, impaired, or dead. Surgeons responsible for a WSPE may face malpractice lawsuits, lose their job and/or license, and suffer irreparable damage to their professional reputation. What Causes WSPEs?A variety of factors contribute to WSPEs: Human factors such as fatigue and haste; patient factors such as confusing two people with the same or similar names; and procedure factors such as changing operating rooms, or draping and prepping the wrong side of the body. Poor communication among surgeons, surgical team members, and patients is the root cause of many WSPEs. A 1996 article from the American Society of Anesthesiologists newsletter cites several examples. In one case, the surgeon planned to perform a left craniotomy and requested that the patient be positioned "supine, head turned, left side." The surgical staff positioned the patient with the head turned to the patient's left side, causing a right craniotomy to be performed. In another case, an aphasic stroke patient responded to staff when they addressed him by the wrong name, which led to him receiving a bilateral orchiectomy rather than the intended circumcision. Preventing WSPEsIn 2003, The Joint Commission published the Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery, along with implementation expectations. The Universal Protocol is endorsed by more than 40 professional medical associations and organizations, and has been implemented at many surgical facilities. It consists of three main steps: Pre-operative Verification Process • Ensure that all of
the relevant documents (e.g., consent forms, charts)
and images (e.g., MRIs, x-rays) are available.
• Review all documents
and images to ensure that they are correct and
consistent with each other.
• Verify that all members
of the surgical team and, whenever possible, the
patient agree on the identity of the patient, the
procedure to be performed, and the operating site.
• Any missing information
or discrepancies must be addressed before starting
the procedure. Marking the Operative Site • Have the surgeon clearly
mark the operative site, at or near the intended
point of incision. Whenever possible, the patient
should be awake and aware during the marking.
• At a minimum, all surgeries
involving laterality (left and right limbs and
organs), multiple structures (fingers, toes, lesions),
or multiple levels (the spine) should be marked.
• Non-operative sites
should not be marked unless it's necessary for
some other reason. (In one
WSPE incident, the non-operative site was
marked with the word "NO," which looked like the
word "ON" when seen upside down. This ambiguity
led to the surgeon performing a hypobaric spinal
block on the wrong side.)
• The mark must be unambiguous.
Examples of unambiguous marks include initials,
the word "YES," or a line at the proposed incision
site. "X" is an example of an ambiguous mark, since
it could be interpreted as "no" or as "X marks
the spot."
• The surgical facility
should have a standard type of mark for all patients
and a consistent method for marking.
• The mark must remain
visible after skin prep and draping. "Time Out" Immediately Before Starting the Procedure • The time out is used
to conduct a final verification just before the
operation. One member of the surgical team should
be the designated leader for the time out, and
all members must actively participate in the process.
• Use a checklist or
other form of documentation to verity the correct
patient identity, patient position, operative side
and site, and the procedure to be performed. Also
verify that all necessary equipment, images, and
supplies are available.
• Do not start the procedure
until all questions and concerns have been resolved.
Additional Efforts Are Still NeededThe Universal Protocol is a good way to reduce WSPEs, but additional efforts are required to eliminate them. The 2006 study reports that 14 cases of WSPEs occurred in one healthcare system over an 18-month period, even though the Universal Protocol was part of the system's institutional policy. Mandatory reporting of all WSPEs and near misses is the first step towards eliminating them. This is the only way of determining the true prevalence of WSPEs and their causes, and will enable healthcare staff to develop better prevention strategies. The authors stress that WSPEs will only be reported when healthcare workers feel safe to do so, and the stigma and shame that surrounds WSPEs need to be removed through increased awareness. Medical personnel must accept responsibility for causing adverse events and make the appropriate reparations. However, regulatory bodies should not adopt overly strict penalties, especially for near misses, since they discourage reporting, and further jeopardize patient safety. For example, Florida doctors risk being fined and assigned community service for reporting a near miss, and this has negatively impacted adverse event reporting and patient safety programs. The study also recommends making WSPE prevention strategies part of healthcare curricula and on-the-job training. Surgical team members, patients, healthcare facilities, and regulatory bodies all need to take part in eliminating WSPEs.
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