The Joint Commission has urged action in US hospitals to ensure objects are not left in patients’ bodies after surgery. HRMR examines the problem of retained surgical items and asks whether they can become a ‘never’ event.
Late in 2013 The Joint Commission issued a Sentinel Event Alert urging hospitals and ambulatory surgery centers to take a new look at how to avoid mistakenly leaving items such as sponges, towels and instruments in patients’ bodies after surgery.
Known in medical terminology as the unintended retention of a foreign object (URFO), or retained surgical items (RSIs), this is a serious patient safety issue that can cause death or harm patients physically and emotionally.
The Joint Commission has received more than 770 voluntary reports of URFOs in the past seven years. These cases resulted in 16 deaths, and about 95 percent of the incidents resulted in additional care and/or an extended hospital stay. Beyond the human toll, studies have shown that objects remaining after surgery may cost as much as $200,000 per case in medical and liability payments.
“Leaving a foreign object behind after surgery is a well-known problem, but one that can be prevented,” says Dr Ana Pujols McKee, executive vice president and chief medical officer for The Joint Commission. “It’s essential to establish and comply with policies and procedures to make sure all surgical items are identified and accounted for, as well to ensure that there is open communication by all members of the surgical team about any concerns.”
It’s a point that Dr Verna Gibbs has been making for 10 years. A professor of surgery at the University of California, San Francisco, she set up the national surgical patient safety project NoThing Left Behind in 2004 after realising that little was being done to tackle to problem of RSIs.
In particular Gibbs was struck by the fact that in 80 percent of cases where a sponge was left in a patient, the nurses mistakenly believed they had accounted for all the sponges—a problem that stems from poor counting procedures.
“An outgrowth of my quality improvement efforts led me to have a query about this problem: why does it happen and why has it been so hard to make it go away? This should be a ‘never’ event,” she says.
NoThing Left Behind began as an effort to find best practices relating to RSIs and disseminate this information to hospitals.
“When I started I thought there was going to be lots of information already out there and that we would be finding it and putting it together in one place,” she says. “What we found instead was that there were no best practices, there hadn’t been a lot of good research and there wasn’t a clearing house or central entity that was engaged or involved in prevention of RSIs.”
NoThing Left Behind has striven to fill that gap, drawing on “unbelievable support” from hundreds of hospitals, big systems and individuals across the country.
“The data has come from hospitals raising their hands to say, ‘we have a problem, come and help us,’ and being willing to share some of the information that has been developed and the work that has been done in those institutions,” says Gibbs.
A key discovery has been that when reporting RSI cases, risk managers frequently leave out vital pieces of information that could help drive future quality improvements.
RSIs can be divided into four classes: sponges, sharps from needles, instruments and small miscellaneous items. The last category includes unretrieved device fragments—UDFs—which are pieces of instruments that break or fall off during a procedure.
When reporting RSIs risk managers rarely use these subdivisions to pinpoint exactly what the object was; instead they simply report a ‘retained foreign object’ (RFO).
“Reporting risk managers should never use ‘RFO’ because it’s a worthless term,” says Gibbs. “We need to know, for instance, if it was a sponge, a needle or a device fragment. Technically an RFO could be a bullet. That’s why we prefer the term ‘retained surgical item’ and we want to know what the item is—that is valuable information.”
Knowing what the RSI is can help risk managers, providers and the wider medical community understand what needs to be done to prevent that particular problem from occurring again. However, risk managers are sometimes reluctant to get to the bottom of an RSI incident.
“A device fragment may break off because there was a problem with the device, or it may be that the provider didn’t use the device in the way that was intended. Yet the doctor will always say she or he doesn’t know why it broke. Risk managers accept that and report it as a device malfunction. They rarely ask whether the provider knew what she or he was doing, because that pushes too many buttons.
“They must strive to have the intellectual honesty to pursue the causes of those errors. Instead of backing off the risk manager can ask questions such as, ‘how did that break off?’”
Preventing the problem
The ideal, of course, is that the problem should never occur in the first place. Dr Ronald Wyatt, medical director for The Joint Commission’s division of healthcare improvement, says that it is important to create an environment where a potential RSI can be pointed out.
“A big part of this is culture: do team members feel that they can speak up? Do they feel they can point out a possible problem in a way that will be received appropriately?” he says.
“With a surgeon who is a strong personality you can find that the team does not feel empowered to speak up. We’ve seen cases where there were staff in the OR who knew there was an RSI but they did not speak up because of fear.”
However, the biggest issue—especially when it comes to retained sponges—is poor counting practices, whereby nurses make a mistake when counting the sponges back in at the end of the procedure, so that the wound is closed with a sponge still in place.
“The biggest problem is that the nurses’ counting methodology is not reliable,” says Gibbs. “In over 80 percent of cases where there has been a retained sponge, the counts have been called correct.”
She says that a clear, reliable set of procedures is a key factor in eliminating the problem of RSIs.
“If you have no sponge management practice—that is, you don’t know how many you started with, you don’t know where they were when you started the procedure and you don’t know if you got them all at the end of it, why would you be surprised that you can leave sponges in patients?
“Whatever we are doing to patients we must have a practice to make sure that the tools are accounted for at the end of the procedure.”
Wyatt agrees, stressing that OR teams need to be properly prepared to carry out procedures and fully understand the policies and procedures around RSI prevention.
“There needs to be some type of team training around procedures, which would include a briefing of each procedure and then a debrief following the procedure,” he says.
At present there is no standardized practice for how sponges are managed in ORs. NoThing Left Behind offers a solution, in the form of its own sponge accounting system, on its website, www.nothingleftbehind.org. It also has downloadable posters that can be displayed in ORs to remind staff of the correct procedure.
This procedure includes the imperative that surgeons should always perform a methodical wound exam before they close a wound.
“They often don’t have that hard-wired into their practice and they wait for the nurses to tell them they’re missing something. That’s not the same as looking first,” says Gibbs.
Wyatt adds that using sponges that are radio frequency identified or radio opaque (so that they can be detected using an X-ray at the end of the operation) can be a helpful preventive measure. It is also advisable to be especially mindful that certain situations—such as operating on an obese patient or carrying out an emergency procedure—carry a much higher risk of RSIs.
If the worst happens and a patient leaves hospital with an RSI, they can go years—a lifetime even—without symptoms. In other cases—especially if the RSI is a sponge—a potentially fatal infection can develop. On other occasions the body tries to create a protective wall around the sponge and it takes on the appearance of a tumour. If an item such as a guide wire is left in a vein or artery, it can cause various problems, including thrombosis.
Even if the RSI causes no problems and is impossible to retrieve, it can be important for the patient to know it is there. Retained metallic items, for instance, can heat up dangerously if the patient undergoes an MRI. It is always desirable, therefore, to tell a patient as soon as an RSI is discovered.
“The most important thing is that you must identify what the object is, where it is, and tell the patient, because going forward there may be tests they shouldn’t have, or tests they should have to make sure this thing hasn’t moved,” says Gibbs.
Wyatt agrees that disclosure is vital and adds that it can benefit the hospital as well as the patient.
“We are increasingly seeing organizations putting more emphasis on disclosure and training risk managers how to handle disclosure, which includes apology,” he says. “There’s ample literature supporting the positive impact of apology and disclosure in terms of decreasing cost and also improving the organization’s reputation with the patient and the community.
“It has been demonstrated by Richard Boothman and the team at the University of Michigan Health System that with a strategic approach to apology and disclosure there are fewer claims paid, fewer lawsuits and less money paid out if it was handled in an appropriate way.”
Of course, with a robust, organization-wide approach to RSI prevention, the problem should either cease to occur or become extremely rare. Thanks to NoThing Left Behind and The Joint Commission, ample facts and figures, advice and resources are available to any hospital seeking to make RSIs a ‘never’ event.
“I believe that near zero is attainable,” says Wyatt. “There’s still a way to go but I remain hopeful that we can get really close to that.”
Actions recommended in The Joint Commission Alert include:
• Creating a highly reliable and standardized counting system to prevent URFOs—making sure all surgical items are identified and accounted for.
• Developing and implementing effective evidence-based organization-wide standardized policies and procedures for the prevention of URFOs through a collaborative process promoting consistency in practice to achieve zero defects.
• Specific recommendations for counting procedures, wound opening and closing procedures and when intra-operative radiographs should be performed.
• Organizations should research the potential of using assistive technologies to supplement manual counting procedures and methodical wound exploration.
• Effective communication should be a standard part of the surgical procedure, including team briefings and debriefings, to allow the opportunity for team members to express concerns they have regarding the safety of the patient, including the potential for a URFO.
• Appropriate documentation should include the results of counts of surgical items, instruments, or items intentionally left inside a patient (such as needle or device fragments deemed safer to remain than remove), and actions taken if count discrepancies occur. Tracking discrepant counts is important to understanding practical problems.
Risk factors for RSIs
Although RSIs can occur in previously healthy patients during elective operations, one study shows common risk factors include overweight patients, urgent procedures, more than one surgical procedure and multiple surgical teams or multiple staff turnovers during the procedure. Occurrence of a URFO was nine times more likely when an operation was performed on an emergency basis and four times more likely when the procedure changed unexpectedly.
The Joint Commission Alert warns that objects most commonly left behind after a procedure are soft goods such as sponges and towels, small miscellaneous items such as broken parts of instruments and stapler components and needles or other sharps. The cases studied by The Joint Commission showed the most common causes of RSIs are the absence of policies and procedures, failure to comply with existing policies and procedures, problems with hierarchy and intimidation in the surgical team, failure of communication with physicians, failure of staff to communicate relevant patient information and inadequate or incomplete staff education.
The Joint Commission, US, Retained Surgical Items, Dr Ana Pujols McKee, Dr Verna Gibbs, NoThing Left Behind