Going into a hospital or surgical center for a needed surgical procedure, and waking up to find you’ve had the wrong operation, or surgery on the wrong site, is a patient’s nightmare. And while “wrong person, wrong procedure, wrong site” surgery is relatively uncommon, it is a type of medical mistake that should never happen. When it does, it is medical malpractice.
Just how often these errors happen is a matter of some debate, but some estimates range as high as 40 per week throughout the United States. Because wrong site surgery is always avoidable, the Joint Commission which oversees accreditation for healthcare organizations, established the Universal Protocol in healthcare to prevent wrong site surgeries.
The Universal Protocol consists of three components which, used together, are designed to prevent doctors from operating on the wrong person, performing the wrong procedure, or operating on the wrong site.
The first step in the Universal Protocol is a pre-procedure verification, which involves verifying the patient’s identity, confirming the procedure they are having performed, and exactly where on the body it is being performed. During this step, medical staff also review documentation such as the patient’s informed consent form, imaging studies, and other medical records.
If you have ever gone to a surgical center for a procedure and had every medical provider who appeared at your bedside ask your name, birthdate, and what procedure you were having done, you may have wondered, “Can’t they just check my chart for that information?” They could, but that’s not why they were asking. They were performing pre-procedure verification, and needed to make sure they were operating on the right person, for the right reason, on the right site. By confirming your identity and medical issue, you assisted in that process.
The second step in the Universal Protocol is site marking. As the name indicates, this step is intended to clearly mark and identify the correct surgical site on the patient’s body. While some types of surgery (e.g. gallbladder removal) have only one possible surgical site, there are many others that involve laterality (e.g. left vs. right), more than one possible structure (e.g. fingers and toes), or multiple levels (e.g. vertebrae in the spine). Site marking should, if possible, be done while the patient is still conscious so that they can confirm, for example, that it is their left foot, not their right, being amputated.
Marking of a surgical site should be done with a permanent marker that will not easily smudge or be washed away, and it should be clear and unambiguous. For example, writing “YES” or the surgeon’s initials on the skin at the surgical site, rather than something like an “X” which could be interpreted as either “don’t cut here” or “do cut here.”
The final step in the process is to take a “time out:” a break from the urgency of the preop and surgical process to pause and once again confirm the identity of the patient, the procedure they are to have performed, and the site and side of the body on which the procedure will take place. The time-out takes place in the room where the surgery or procedure will happen.
During the time-out, the team also confirms that the patient is correctly positioned, and that everything needed for the procedure, such as required equipment, blood products, and imaging is present and in the correct place for use. If there are special considerations, such as a latex allergy or bleeding risk, these should be noted as well. The time-out involves the entire team participating in the procedure, all of whom must agree for the procedure to move forward.
The goal of the Universal Protocol is to promote active communication between all members of the surgical team and to prevent procedures being performed on the wrong patient or at the wrong site, or for the wrong procedure to be performed on a patient who presented for a different procedure. Using the Universal Protocol is a requirement of facility accreditation by the Joint Commission.
While the Universal Protocol’s components may seem like commonsense measures that should be universally followed, not all providers fully agree. Some feel that the imposition of the Universal Protocol is needless bureaucracy and box-checking, and that it fails to actually promote meaningful communication between team members. Some doctors may even feel that the Universal Protocol reflects a lack of trust in their professional judgment. Providers with such a view may not take the requirements of the Universal Protocol seriously, leading to catastrophic results for patients.
If you have suffered a wrong-site injury, or if a surgeon performed the wrong surgery on you, including a procedure intended for another patient, you may have a claim for medical malpractice. Failure to follow the Universal Protocol is evidence of a breach of the standard of care for medical treatment. While there are few “smoking guns” in medical malpractice cases, operating on the wrong patient or the wrong site are among them.
These medical errors are 100% preventable when the proper care is exercised, and the Universal Protocol is a way of exercising that care. To learn more about the Universal Protocol or to discuss a medical or surgical injury you have suffered, contact the Fraser Law Firm to schedule a consultation.