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Hospitals' Adverse Event Reporting Systems Inadequate

 |  By cclark@healthleadersmedia.com  
   July 26, 2012

An Office of Inspector General's report last week again poked holes in the credibility of the nation's hospital patient harm reporting system. After analyzing clinical records for Medicare beneficiaries treated by 189 hospitals, the agency determined those hospitals had reported only 1% of adverse events.

Four sentences of this report are of particular interest:

1. "To date, no Federal standards require States to operate adverse event reporting systems."

2. Half the states do not operate adverse event reporting systems to monitor the occurrence of harmful events in hospitals.

3. The 25 states and the District of Columbia that do have reporting standards "varied as to whether they made reporting voluntary or mandatory, what types of events they specified should be reported, and what additional information they asked hospitals to report."

4. "Hospital administrators indicated that staff often did not report events because they identified them not as patient harm, but rather as expected side effects."

In other words, the systems by which the nation's hospitals detect and quantify patient harm within their facilities can be summarized with the Tower of Babel cliché:  It seems that everyone uses a different definition of what is a reportable adverse event.

David Classen, MD, an infectious disease expert at the University of Utah who developed the Institute for Healthcare Improvement's patient safety Global Trigger Tool and helped write the Institute of Medicine's report "Health IT and Patient Safety," agrees.


Validity of Tracking Questioned
"If you think you can go to your state and look at their adverse reporting events and have any clue what's going on in hospitals, you're smoking some very good stuff," Classen told me in an interview. "The first step is for us to admit that our whole system is tracking nothing valid."

His words may be harsh, but correct, even as they come after a November, 2010 OIG report that found that more than one in four Medicare beneficiaries endured hospital-caused harm. And for half of those, the harm was serious; some patients died. Nearly half of all these events, 44%, were preventable, the OIG said.

Variation in hospital adverse event reporting is a serious problem because it impedes our ability to learn if procedural changes and safeguards are working. But what's even worse is that none of these systems are actually capturing the bulk of adverse events that cause harm.

Even the very best state reporting systems, like Pennsylvania's, "only pick up a teeny, teeny fraction of all these adverse events," Classen says.   Instead, they are only picking up very serious events that are obvious, such as wrong-site surgery, or stolen newborns, or retained surgical objects. These are listed in the National Quality Forum's 28 "Serious Reportable Events."

Even the very best state reporting systems, like Pennsylvania's, "only pick up a teeny, teeny fraction of all these adverse events," Classen says.   Instead, they are only picking up very serious events that are obvious, such as wrong-site surgery, or stolen newborns, or retained surgical objects. These are listed in the National Quality Forum's 28 "Serious Reportable Events."

But, Classen explains, those 28 "are rare, orders-of-magnitude less-common than other adverse events that occur in hospitals, such as side effects of drugs, or complications from procedures or infections. That's where the money is. But unfortunately, these reporting systems don't address those."

To date, hospital reporting systems don't routinely pick up, for example, harmful urinary tract infections that can lead to sepsis and patient death, especially in a patient who is frail.

Adverse Event or 'Expected Complication'?

Classen explains: "the hospital administrator will say, 'Oh, that's not an adverse event; that's an expected complication.' Well, my comment back is, 'No. If you had used the catheter properly, you could have gotten it out quickly and this wouldn't have happened.' "

Apparently, many hospitals today just put these events into the category of "Sometimes Bad Stuff Just Happens,"or chalk it up to the natural deterioration of the patient's condition. There's no event report, internal or external.

Even though every hospital is required by its Medicare/Medicaid contract to have an internal adverse event reporting system—the existence of which is verified by accreditation agencies such as the Joint Commission—only 14% of adverse events experienced by beneficiaries were recognized as such internally, the OIG report said.  Instead, they were seen as expected complications.

Classen advocates a federal system in which all hospitals are required to be transparent about all patient harm in a uniform way. And only when all those events are quantified and examined can the healthcare system prioritize which should be targeted first. Electronic health records, he says, can not only sound an alert when a potentially harmful event is about to occur, but retrospectively provide clues as to what led to it.

He notes that the septic shock death of Rory Staunton, the 12-year-old boy who died after he was mistakenly sent home from the emergency room of NYU Langone Medical Center with dangerously high levels of white blood cells and a fever, might have been prevented with such a warning system.

He adds that today, many hospital leaders are stuck in a mindset of thinking that very few harmful events are preventable. "The problem with deciding rigidly what is preventable and what is not is that over time, we've seen how preventability is a moving target," Classen explains.

For example, "We used to say that only one-third of hospital infections were preventable, but now, most people would agree that 75% to 80% are preventable. Ultimately, as we get smarter about this, we'll see that a lot more of it will be preventable, and even if we can't prevent it, it helps to identify it early and mitigate it."

A Call for Standardization
The only realistic and practical way to start that process is to have a national system, Classen adds. "We have to move from measuring only those most serious events to measuring all-cause harm, and that will probably represent a paradigm shift from voluntary reporting to some sort of surveillance system."

If it's left up to individual state public health departments to design their own, he says, "you'll have 50 different solutions."

A major issue complicating the development of a reporting standard is the question of what makes an error a reportable adverse event. These four scenarios illustrate the confusion.

1. An expired, potentially harmful medication erroneously remains stored in the pharmacy and ready to be filled with a doctor's order. The expiration date is noticed before the drug leaves storage.

2. The expired medication is drawn for a patient and taken to the patient's bedside but is caught before it is administered.

3.  The expired medication is administered to the patient but does not cause harm, or provokes a very minor symptom that is promptly mitigated.

4. The expired medication is administered, prompting a severe reaction that exacerbates illness, prolongs hospitalization, and perhaps even leads to a patient death.

One method to standardize harm reporting, called "Common Formats," is under development by the federal Agency for Healthcare Research and Quality, mainly for use by Patient Safety Organizations (PSOs) working with hospitals. Programmed hospital event reporting systems would capture "anything that goes wrong with the patient as the result of the care process," explains William Munier, MD, Director of AHRQ's Center for Quality Improvement and Patient Safety. 

While that's a long way off from being widely implemented, what may evolve could achieve the same ends as the voluntary Centers for Disease Control and Prevention's National Healthcare Safety Network reporting system now in use for reporting certain types of hospital-acquired infections.

Common Formats is already in use by a number of PSOs, and I hope to write about it in the next few weeks.

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