Imagine you’re about to undergo a minor medical procedure. You’ve already read and signed an informed consent form that describes unfortunate things that could happen in the course of the procedure. Now a member of the medical team pauses, and announces your name and the nature of what’s going to happen next to everyone gathered. Unnerving? Perhaps, but you should be reassured. “It’s not that we’re suddenly wondering who you are and why you’re here,” explains Karen Blankenship, MA, Ambulatory Project Manager at Seattle’s 336-bed Virginia Mason Medical Center
(VMMC). “We’re simply ensuring that before we begin the procedure, you are who we think you are, and that we are, in fact, doing what you think we are doing.”
The protocol’s three major elements include:
- Initial verification of the intended patient, procedure, and site of the procedure;
- Marking the intended site with a sterile pen, where applicable; and
- A final “time-out” immediately before beginning the procedure in which medical team members actively verify each element listed above.
During this process, caregivers also make sure that the patient is in the correct position and that all relevant medical records and documents related to the procedure are on hand.
With exclusions for procedures that already have their own “pause protocols,” such as blood transfusions and chemotherapy, the new protocol applies to invasive procedures that expose a patient to “more than minimal risk.” Anything that punctures or cuts into a patient’s skin falls into this category, including biopsy, cardiac catheterization, and epidural; so does the insertion of an instrument or foreign material into the patient’s body, as for an endoscopy or to place an intra-uterine device. Whenever a patient needs to be sedated, the protocol goes into effect, since sedation itself affects a patient’s bodily functions and constitutes an added risk. Routine procedures, such as inserting a nasal-gastric tube or a urinary catheter, are not included.
However, many procedures can fall into a grey area, especially in the outpatient setting where most lower-risk procedures that don’t involve sedation occur. VMMC’s Karen Blankenship sums up the problem this way: “If a dermatologist removes a mole from a patient’s arm, he might have a different view of the amount of risk involved than an internist who removes the same mole. We didn’t think the decision about level of risk ought to be subjective.”
To make sure that nothing was left to individual interpretation, the hospital asked the Procedural Pause Leadership Team, of which Blankenship is a member, to interpret the JCAHO protocol for the outpatient setting. “We felt the protocol needed more rigor around determining when it was applicable,” she says. At first, Blankenship and her team tried to come up with a list of covered procedures, because they were concerned that evaluating all of the outpatient procedures performed at VMMC’s 18 specialty clinics, including eight satellite centers, could take months, if not years. Then came a breakthrough: the team realized that a good equivalent standard for JCAHO’S “more than minimal risk” was the requirement for a written informed consent. “Now if a procedure requires the patient to sign an informed consent,” says Blankenship, “we’ve decided that, at VMMC, it’s covered by the JCAHO protocol.”
To help formulate a strategy for implementing the new protocol, Blankenship enlisted John Buckmiller, MD, a hand surgeon who has performed more than 7,500 procedures in his 20-year career at VMMC. The protocol was rolled out in May 2005. Buckmiller, who has always insisted on marking the site of his surgeries in advance, has never operated on the wrong site, but he acknowledges that it’s a real problem. He cites a survey of hand surgeons published in the February 2003 Journal of Bone and Joint Surgery
in which 21 percent of surgeons admitted that they had operated on the wrong site — generally the wrong finger — at least once. Another 16 percent reported that they had nearly done so. “I’ve had two close calls myself,” says Buckmiller, “where I marked the wrong site but did not cut. This was before we implemented the pause.”
Under the JCAHO protocol, even an accidentally mismarked site is almost certain to be noticed and properly identified during the required “time-out” — which VMMC calls a “procedural pause” — immediately before the procedure begins. As with the JCAHO time-out, the VMMC pause requires the entire medical team to agree on the patient’s identity and all of the required elements of the impending procedure by using verbal communication — no nods or hand signals — and consulting supporting documents, such as test results, if applicable. If any member of the team does not agree on the relevant information, the procedure does not go forward.
To ease the process, VMMC developed an optional documentation form, called “Procedure Without Sedation,” in which the procedural pause elements are listed in large black letters. The nurse manager on each case can fill out the form, showing that all the steps in the procedural pause have been completed, or the MD can dictate into the procedural record that the procedural pause was completed. “As we switch to electronic record-keeping, we’ll document the pause that way,” says Blankenship.
To check compliance with the new standard, VMMC conducts monthly audits of departments every time they perform ten procedures or more. Since the protocol was phased in, ambulatory compliance has been excellent, Blankenship says. “We did our first audit in August and it was 90 percent. In December, it was 99 percent.” Patients, too, have quickly caught on that all the extra checking is a good sign, not a bad one, and VMMC is contemplating publicly posting a “Safe Patient Encounter Bundle” — a list of all the precautions the hospital takes to ensure safety such as patient identification, hand washing, and proper labeling of drugs. “We want to advance patient education so that patients know what to expect from us,” says Blankenship
Marie Schall, a Director at the Institute for Healthcare Improvement (IHI), praises the VMMC initiative as a model of how to achieve improvement. “They identified an area that needed attention and they figured out how to spread the required changes across a large health care system consistently and reliably.”