The Truth Opaque
Surgical-Instruments

The retained surgical sponge case is probably the most classic example of clear-cut medical malpractice.  When a surgeon or nurse leaves a surgical sponge or instrument inside a patient’s body during surgery, Pennsylvania law recognizes that this is an error so obviously beneath accepted standards of care that the usual rules requiring a Plaintiff to have a medical expert are relaxed.

We would all like to think that these kinds of medical mistakes are uncommon.  The Pennsylvania Patient Safety Authority (PSA), in a startling report issued recently, tells us otherwise.  Here is a link to the report:

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Sep;9(3)/Pages/106.aspx.

In 2011, there were a shocking 452 reported cases involving a retained sponge, medical instrument, surgical needle or other item, according to the PSA’s September 2012 advisory, “Update on the Prevention of Retained Surgical Items.”  The Advisory also reports on various measures different organizations have recommended to suggest clearer hospital guidelines.  The hope is that more coherent hospital policies will reduce this incidence of retained surgical items.

For a number of reasons, I don’t believe guidelines and policies alone are sufficient to address this problem.

First, one has to wonder how this kind of error could ever occur in our modern health care system.  The idea that you could have abdominal surgery, even a routine procedure with a low risk of post-operative complication, and end up with a debilitating and costly infection because someone left a surgical sponge or a piece of an instrument inside your abdominal cavity?  There is just no excuse for this kind of mistake.

Second, there are already powerful incentives in place for surgeons and operating room staff to avoid these kinds of errors.  Retained surgical item cases lead to legal claims and those claims are costly.  Most of the time, hospitals have no liability defense in these cases.  This means that retained sponge cases almost always lead to claims pay-outs on top of litigation defense costs.  Still, the threat of litigation itself apparently has not limited the careless behavior that leads to retained surgical items.

Third, the Pennsylvania experience provides empirical evidence that hospital policies and professional association guidelines are not sufficient to address this problem.  The PSA’s just-released Advisory is an “Update,” but the report conspicuously leaves out the very data it is updating.  That’s alright, because even though the PSA didn’t see fit to mention the findings of its previous report, “Beyond the Count: Preventing Retention of Foreign Objects,” which was issued in June 2009, one can find it easily enough.  Here is the link:

http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2009/Jun6(2)/Pages/39.aspx.

The numbers tell a significant part of the story:  In 2008, there were 194 reports of retained foreign objects (RFOs), including such items as retained surgical packing, surgical sponges, surgical drains and other surgical devices and equipment.  In 2011, the number of incidents (now called retained surgical items, or RSIs) had more than doubled, to 452 events.  The 2011 incident reports are broken down as follows:  30.2 percent are surgical sponges; 16.3 percent are medical instruments; 13 percent are needles; and 40.5 percent are “other,” which includes implements such as guidewires.

It is admirable, then, that between the first and second PSA Advisories, the National Quality Forum changed its definition of when surgery technically ends – from the closing of the surgical incision to the time the patient leaves the OR – as a way of emphasizing the roles and responsibilities of the perioperative staff.  It is fine and well that the Association of periOperative Registered Nurses has issued revised guidelines for the prevention of RSIs.

But the numbers are going up.

I have represented victims of this kind of surgical malpractice.  Sometimes, a retained surgical item sounds worse than it is and results in relatively little harm to the patient.  Sometimes, however, the consequences are very significant indeed and result in pain and suffering, additional medical care costs, lost time from work and other damages.

What then is the rest of the story (as famed radio newsman Paul Harvey used to ask)?  Or, if guidelines and hospital policies are not enough to reduce retained surgical item events, then what?  An approach well worth trying is set forth in a new book by Marty Makary, M.D., an oncologic surgeon at Johns Hopkins Hospital and an associate professor of health policy at Johns Hopkins School of Public Health.  In Dr. Makary’s new work, Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, he argues that hospitals must make patient safety data available to the public.

The fact is, transparency works.  Dr. Makary relates the experience in New York, where in 1989 the state’s health commissioner required hospitals to disclose death rates from coronary artery bypass graft (CABG) procedures.  In the modern era of anesthesia and advanced surgical techniques, the thinking was, post-operative complications from CABG should be relatively low.

Once hospitals made public their CABG mortality rates, there was immediate and profound change.  Initially, reported death rates at New York hospitals varied from one percent to as high as 18 percent.  As Dr. Makary recounts, those hospitals with higher death rates leaped quickly into action.  Hospital executives held meetings with surgical and nursing staff to focus on finding ways to improve patient safety and reduce their hospital’s poor mortality figures.  There was actual competition, not for profits, but for the best record on patient outcomes.

Dr. Makary singles out Erie County Medical Center, once one of New York’s worst-performing hospitals, as a shining example.  When death rates were first published over the internet, the hospital posted CABG mortality rates at 18 percent.  “With its awful numbers now out in the open, on the Internet, the hospital’s administrators acted swiftly to resuscitate its heart program.  Hospital management listened to its frontline personnel, hired a new chief and some new dedicated staff, and instituted internal review conferences.  Remarkably, within three years the mortality rate was cut to 7 percent, and in the years since, it has fallen to 1.7 percent.”

Could this same approach reduce medical errors and improve patient safety in other areas?  There may be challenges to comparing outcomes when it comes to some procedures, for a number of reasons.  Some physicians and some hospitals may tend to attract patients who are more ill or whose disease is more advanced because they develop a reputation for skillful handling of these more difficult cases.  Should these practitioners then be penalized if they have a higher death rate among their patients?

There are differences among hospitals and among physicians practicing in the same specialty.  Hospital size, patient mix, urban versus suburban location and other factors may well complicate efforts to measure patient outcomes.  Then again, certain outcomes are easier to measure than others.

Hospitals already track post-operative infection rates and publish this data on a voluntary basis.  The question then is whether the public should have access to this kind of data for all hospitals?  What is the excuse for a hospital not voluntarily disclosing this information, where other hospitals already do?  Is the reason that some hospitals refuse to participate in the voluntary disclosure of outcome data that these are the hospitals with the more dismal records?  Should poor-performing hospitals be allowed to shield this information from the public?  Isn’t poor performance all the more reason for mandatory disclosure?

The problem of retained surgical items is one area that seems clearly to lend itself to public disclosure.  If a hospital has a good, clean record when it comes to the incidence of retained surgical items, then there should be nothing to hide.  There should be no reason not to have that information available to the public.  If a hospital has a poor record, has more than a reasonable number of lost needles and retained sponges, then patients surely have a right to that information.

Pennsylvania already tracks this data.  There is now a basis for comparing 2008 to 2011 numbers, even if the latest Advisory failed to be explicit in making the comparison.  We know the problem is getting worse.  What we don’t know is which hospitals are experiencing this problem and in what numbers.

As Dr. Makary notes in his new book, “Transparency can empower consumers to make their hospitals accountable and make the practice of medicine more honest.”

What is Pennsylvania waiting for then?  In the interest of improving patient safety – and everything good that goes along with that  — hospitals should be required to disclose the truth about retained surgical item cases.