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Consent, Foreign Bodies, Wrong Location, & Bad Outcomes: Surgery Safety Issues or a James Bond Movie?

blog_ConsentForeignBodiesSurgery_260x200px.jpgMost predicaments in which James Bond finds himself require clever improvisation to achieve a good outcome. Bond knows that every mission entails huge risks that are largely unpredictable. In contrast, the risks of surgery are recognized in advance, and the procedures go according to plan in the vast majority of cases. Despite proactive safety measures, claims against surgeons continue to occur regularly for bad outcomes. It has been estimated that approximately 80 surgical never events occurred each week between 1990 and 2010. Below are tips & tools to avoid the following four common issues in surgery safety:

  1. Informed consent
  2. Retained foreign bodies
  3. Wrong site/patient/procedure surgery
  4. Surgical complications

Surgery Safety Issues

Informed Consent Caveats

Practitioners should have the informed consent discussion at a reasonable time in advance of the procedure. While hospitals are required to ensure that consent was obtained, it is a non–delegable duty of the practitioner performing the procedure to obtain the consent. Informed consent should not be considered an obstacle to be overcome so that the procedure can be performed. Rather, it is strong protection for the practitioner in the event that a known complication occurs. If a risk comes to fruition and it was not discussed, the informed consent may not hold up in court.

  1. Practitioners need to explain the risks and benefits of, as well as alternatives to, the proposed intervention to obtain valid informed consent.
  2. The discussion of risks needs to be as specific as possible without unduly alarming the patient.
  3. Any “material” risk of harm should be disclosed.
  4. It is normally not necessary to disclose personal characteristics of the practitioner unless the patient specifically asks.

Retained Foreign Bodies: Tips to Avoid

Although retained foreign bodies after surgery are not a frequent problem, they occur regularly enough that every effort must be made to avoid them. A study published in the New England Journal of Medicine in 2003 analyzed 54 cases of retained foreign bodies. Most of the cases involved items left in the abdomen (54%), vagina (22%), thorax (7.4%) and elsewhere, including the spinal canal, face, brain and extremities (17%). The article noted that the risk factors for a retained foreign body included emergency surgery, an unanticipated change in procedure, and high body mass index (BMI). The article further indicated that the risk of a retained foreign body in intra-abdominal cases was between 1 in 1,000 and 1 in 1,500 cases.

  1. Counts of instruments & sponges are an integral process that should be conducted according to policy whenever possible.
  2. Emergency cases that do not allow for a count should have a post-procedure X-ray taken to ensure that nothing was inadvertently left behind.
  3. If the policy or protocol cannot be followed in a particular case, the rationale for not complying with the policy (including a risk/benefit analysis) should be carefully documented.

Wrong-Site Surgery: Prevention Guidelines

tom-syzekWrong-site surgery is not an uncommon occurrence. In Minnesota alone, there were 381 reports of wrong-site surgery between 2003 and 2013. The Pennsylvania Patient Safety Reporting System stated in its 2013 Annual Report that it had received 550 reports of wrong-site surgeries since 2003. While it is sometimes a relatively benign occurrence (e.g., the patient wanted his right cataract done first, but the left one was done in error), there is always potential for a catastrophic occurrence (e.g., the functional right kidney was removed and the non-functioning left kidney was left in). If the system for preventing these occurrences fails, it can have terrible consequences. The prevention of this adverse event lies in a systematic approach that includes the entire physician’s office staff and Operating Room (OR) team.

  1.  The policy on time-outs needs to be followed each and every time.
  2. Time-outs should be performed both in pre-op and in the OR.
  3. Any procedure involving laterality should have the site marked.
  4. All marks should survive the preparation for surgery.
  5. All documentation regarding the case should be consulted to confirm the patient, procedure and site.
  6. Participants in the time-out should include the surgeon(s), anesthesiologist(s), all staff members, and the patient.

Surgical Complications: Prevention & Detection

Many claims that arise from surgical procedures are brought because a complication occurred, either during or after surgery. Regardless of the cause of the complication, malpractice claims are often brought because the physician failed to appropriately address the complication or the possibility of a complication. Juries may be willing to accept that bad things can happen in surgery (unless the outcome was catastrophic), but they are not accepting of complications that are not addressed and managed appropriately.

  1. Surgery actually begins in the office or other setting for the pre-operative assessment; patients should not be scheduled for surgery if they are not appropriate candidates.
  2. The surgeon needs to have the requisite training and experience to perform the procedure or acquired surgical skills that are transferable to the case before agreeing to perform the procedure.
  3. The acquisition of appropriate privileges is a patient safety issue.
  4. The capability of the surgeon to perform the procedure needs to be matched with the facility’s ability to provide follow-up care and monitoring.

With his considerable skills and good judgment, James Bond may have made a good surgeon. My guess is that he might have been bored, since surgeons can use a systems approach to prevent errors, anticipate risks and complications, and eliminate the need for Bond’s type of dramatic improvisations.

Interested in Learning more for CME?

Review our course series: Risks in Surgery

 

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