“Operation a Success… But the Wrong Organ Was Removed”

Mark J. Lema, MD, PhD

(Reprinted with permission from NYSSA SPHERE, April-June, 2001)

Dr. Freese and I recently completed service on the Preoperative Protocols Panel at the invitation of Dr. Antonia Novello, New York State Commission of Health. The tasks assigned to the 12 panel members were as follows:

  • To reduce negative procedural outcomes
  • To reduce delays in the start of surgery after anesthesia has been administered
  • To resolve miscommunication among surgical team members

Specifically, the Commissioner wanted the group to review and analyze adverse outcome data obtained from NYPORTS (New York Perioperative Reporting System) which included the following problems in 1999 throughout the 260 surgical hospitals in New York State which conduct 1,000,000 procedures annually:

20 cases – Wrong Patient, Wrong Site – Surgical

103 cases – Incorrect Procedure – Invasive

90 cases – Retained Foreign Body

As a result of these findings the specific changes were:

  • Develop a means to reduce or prevent wrong site/side surgery, wrong procedures and procedures conducted on the wrong patients
  • Address surgical team communications and disagreements

The panel was comprised of 6 surgeons, 2 anesthesiologists, 2 OR nurses, 1 radiologist, and 1 nurse anesthetist. We convened on several occasions between July and December 2000. As a result of our deliberations, we submitted a recommendation which was accepted by the Commissioner and circulated to hospital administrators. Key points addressed in this short document include:

  • These are guidelines intended to assist medical personnel in providing a standardized high quality of safe care and serve as a baseline.
  • These guidelines apply to office-based surgery, ambulatory surgery centers, interventional radiology settings, as well as hospital facilities.
  • These guidelines apply primarily for elective surgery or urgent surgeries where there is adequate time for implementation.
  • Surgeons, anesthesia personnel and circulating nurses should discuss any patient issues prior to the commencement of the procedure.
  • Each institution must have a policy on dispute resolution. If discrepancies or disagreements regarding the procedure/equipment/supplies occur, surgery must be delayed until all issues are resolved.
  • If these guidelines do not lower the incidences cited using NYPORTS, stronger means to encourage compliance will be recommended.

The panel made specific recommendations:

  • Hospital should develop and implement policies and procedures to assure there are at least three independent verifications of surgical site, location, and correct patient identification.
  • The attending of record will sign the consent form prior to the induction of anesthesia, confirming its accuracy including the description of the procedure.
  • As one of the three independent verifications, the surgeon of record should mark or unequivocally identify the site and/or side prior to surgery.
  • Whenever possible, the surgeon of record (or designee) should physically see and talk to the patient in the perioperative area on the day of surgery.
  • When laterality (specific side) is at issue, the words ‘right’ or ‘left’ should be spelled out on the operative schedule and the consent form.
  • The anticipated level(s) for spinal surgery should be indicated on the operative schedule and the consent form.
  • For operating/procedure room settings, the circulating nurse or appropriate personnel will:
    • ensure that the correct patient is present.
    • the consent has been signed by the surgeon of record on the day of surgery.
    • the appropriate surgical site/side has been identified and marked.
    • relevant x-rays are present in the OR (as selected by the surgeon).
    • ensure agreement as to the planned procedure and document in the medical record.

Since these procedures are new to many (but not all) facilities implementation is a major concern. In my opinion, modifying the surgical consent form to provide statements and signature sites for all parties is the easiest solution. This concept of multiple verification is commonly performed when blood products are administered. Those preparing the product, sign off and those administering the product also sign off. When the patient is informed of the procedure and laterality is paramount a statement such as:

"I understand that I am having surgery on my [right/left] [name of body part]."

On the day of the procedure there should be a place on the same consent form for the surgeon to verify, sign, and date. In addition, any two members of the perioperative team can also verify patient, site, side, and sign off. A suggested statement could read:

"I attest that [patient name/number] is having surgery on his/her [right/left][name of body part]."

Signature/date ___________________ Signature/date ____________________________

In this case, the holding area nurse, circulating or supervising OR nurse, nurse anesthetist, anesthesiology resident/attending and/or surgical resident could sign. In essence, we are only formalizing what everyone does when a patient is undergoing limb, breast, or eye surgery.

Finally, identifying the side of the body without specifically marking the site with a pen can be accomplished by using a brightly colored arm/foot band stating "correct side" or "this side." In this way, sensitive body areas do not need to be exposed and internal organs can be easily identified (lung, kidney, ovary, testicle, etc.).

It is important to remember that in 1999, twenty New Yorkers had the wrong body part violated or removed, including brain and kidney! The goal is zero.