Archive for the ‘Never Events’ Category

Reducing Bloodstream Infections

Monday, February 22nd, 2010

Emperor_Clothes_01There’s this light on my way to work that is just a royal pain. It’s set up so that you have to wait for the arrow to make a left hand turn. The intersection is busy, especially in the mornings, and the arrow only stays lit for about 13 seconds. So you end up waiting five minutes or more – through several light cycles – to make the turn.
OR … you can go straight through the intersection, turn left into McDonald’s parking lot, pull out of the parking lot, come back to the intersection from the other direction, and make a right turn, saving yourself 4 minutes and 30 seconds.
Now mind you that drivers who choose the latter route are, in effect, going through a red turn arrow – they’re just taking a bunch of extra steps to make sure that they are complying with all of the traffic laws in the process.

You’re probably wondering what a traffic light has to do with bloodstream infections. I’ll get to that later.

This month, Consumer Reports published a well-written article about reducing hospital infections, and a lot of the take-home messages are good ones. The Consumer Reports article focuses on blood stream infections – also known as “septicemia“. Consumer Reports compared central line infection data for intensive care units at 926 hospitals in 43 states. Hospitals voluntarily submit such information to the Leapfrog Group, a nonprofit organization based in Washington, D.C. and Consumer Reports obtained the data from Leapfrog.

As many people realize, septicemia and sepsis can lead to significant mortality in patients. Approximately 20–35% of patients with severe sepsis and 40–60% of patients with septic shock die within 30 days. Anything that we can do to prevent bloodstream infections will be a net positive for patient care.

So it was interesting to read the data Consumer Reports collected regarding central line-related bloodstream infections. In every state, hospitals significantly decreased the number of central line infections that occurred. In fact, many hospitals – several with more than 6,000 central line days – reported ZERO central line-related blood infections. You read that right. ZERO. Zilch. Nada. Absolutely no incidents of central line-related bloodstream infections.

The prevention in central line-related infections is credited to a simple five step checklist that was developed by Peter Pronovost, a Johns Hopkins critical care specialist. He felt that public disclosure of infection rates was a powerful motivator for hospitals to reduce the incidence of infections.

I agree, to a point, but there is a bigger motivator out there, though. Cold hard cash.

Under Section 5001(c) of the Deficit Reduction Act, the Centers for Medicare and Medicaid Services was required to select diagnosis codes that “have a high cost or high volume”, results in higher payment, and “could reasonably be prevented using evidence-based guidelines.” Bloodstream infections related to catheters was chosen as one of these codes and eventually became known as a “never event” – at least alluding to the notion that such infections should “never” happen and making a firm statement that the government would “never” pay for care related to such infections. In law, the concept of incurring liability for the occurrence of an event, regardless of whether that event is within one’s control is called strict liability. Here are come comments I previously made about strict liability in medicine.
Faced with public scrutiny and the possibility of being held liable for providing significant amounts of uncompensated care to sepsis patients, hospitals needed to make changes … and they did.

So first I’d like to start by congratulating the hospitals in Pennsylvania that made the Consumer Reports list for ZERO central line-related bloodstream infections.
At the top of the list was UPMC Presbyterian – Shadyside. Shadyside was not only tops in the state, it was tops in the NATION. Shadyside had 13,596 patient “central line days” without a single central line-related infection. Amazing.
Also included in Pennsylvania’s list were UPMC St. Margaret in Pittsburgh with 2,902 infection-free central line days, UPMC Magee Women’s Hospital in Pittsburgh with 1,600 infection-free central line days, and Southwest Regional Medical Center in Waynesburg with 1,040 infection-free central line days.

Congratulations to these hospitals on jobs well done.

You’re probably wondering why I chose to look at the hospitals in Pennsylvania, aren’t you?

As part of the public shame er, um, disclosure efforts required under Pennsylvania law, Pennsylvania created a web site to compare various costs of treatment and efficiency of health care for multiple different medical problems. Pennsylvania collects information on more than 4.5 million patient visits each year and then summarizes that information on its Health Care Cost Containment Council web site (which it calls “PHC4″).
It just so happens that one of the metrics on the PHC4 web site is “septicemia” – those same “blood infections” that Consumer Reports wrote about.

Now if all four hospitals dropped their cathether-related blood infections to ZERO, then the incidence of blood infections should also decrease at least a little, right?

Let’s look at UPMC Shadyside. Even though the number of catheter-related blood infections was ZERO, the cases of septicemia increased each year between 2002 and 2008, and they increased a lot. As in 145 cases in 2002 up to 881 cases in 2008. The costs to treat those cases also increased – from $30,000 to more than $69,000 per event. AND their “outlier” numbers for prolonged length of hospital stay in patients with sepsis were worse than expected between 2006 and 2008.

UPMC St. Margaret’s data also showed an upward trend, from 152 cases of septicemia in 2002 to 250 cases of septicemia in 2006 and then down to 209 cases by 2008. Costs also more than doubled during that time period, reaching $37,228 per case by 2008.

Southwest Regional was the only hospital that had a downward trend of septicemia cases, but even that data was haphazard. 32 cases of septicemia in 2002, 40 cases in 2004, 14 cases in 2006, and 23 cases in 2008. The costs for treating septicemia at Southwest Regional also doubled, but in 2008, its charges were $16,253 – less than one quarter of UPMC Shadyside charges for treatment of the same medical problem.

Magee-Women’s Hospital also had strange data. The number of septicemia cases it reported remained between 5 and 9 per year from 2002 to 2005. Suddenly in 2006, the number of cases at Magee-Women’s jumped to 28 and remained between 23 and 28 per year from 2006 to 2008. Its costs increased by almost double from 2004 to 2008, reaching $41,288.

You’re probably thinking that other variables can affect this data, and I’d agree with you. Perhaps more people in Pennsylvania just happened to develop non-catheter related bloodstream infections during those years. Maybe all the other hospitals except for those above are getting contaminated central line kits delivered to them. Maybe some hospitals focus so much on preventing catheter associated bloodstream infections that they drop the ball in other areas. Who knows what other facts may explain the precipitous fall in catheter related bloodstream infections despite a significant increase in bloodstream infections as a whole. It just puts a question in my mind. Are things really getting better or are hospitals all over the country just telling us … and CMS … what we want to hear?

Think about it. For the sake of example, I’m going to use UPMC Shadyside because of their high volume of patients. Assume in 2008, that 10% of the patients with septicemia at UPMC Shadyside were Medicare patients with catheter-related bloodstream infections (this article from Great Britain cites catheter related bloodstream infections as 10%-20% of all hospital acquired infections in the UK, so I’m staying on the low side of the cited statistics). If all those infections were considered “never events,” Shadyside would have lost more than $6 million dollars in 2008 on the care of those patients. Every patient with a catheter-related bloodstream infection at Shadyside can translate into more than $69,000 in lost revenue for the hospital.

With reimbursements being cut and many hospitals bleeding red ink, you think that every hospital out there doesn’t have an incentive to selectively interpret bloodstream infection data?

Here are some examples of how that selective interpretation might occur.

All of the data that I could find relates to catheter associated bloodstream infections in the Intensive Care Unit. If a patient develops signs of an infection and is then moved out of the ICU before official culture results come back, does that patient get dropped as a data source? Don’t know. I couldn’t find any guidelines on what to do in that situation.

How is a “catheter associated bloodstream infection” even defined? There’s no universal definition. Even the CDC admits that “the rate of all catheter-related infections (including local infections and systemic infections) is difficult to determine. Although CRBSI [“catheter related blood stream infections”] is an ideal parameter because it represents the most serious form of catheter-related infection, the rate of such infection depends on how CRBSI is defined.”

We can use the definition from the National Nosocomial Infections Surveillance System requiring “presence of recognized pathogen” in blood cultures not “related to” infection at another site. What if the pathogen was not specified? Perhaps only gram positive cocci but subtyping not performed. Does that data get thrown out? What if the patient has a pimple at another site? Is that “related to” the blood stream infection? Does that data get thrown out? What if there is a bedsore anywhere on the patient’s body? No longer a catheter-related bloodstream infection?

Appendix A of this MMWR report (.pdf download) has other definitions. One definition requires that the same organism be cultured from the blood and the tip of the catheter that has been removed. What if the catheter tip wasn’t cultured? Another definition requires that two blood cultures at different times show the same organism. What if only one blood culture was done?

The definitions don’t say anything about antibiotics, either. If a patient receives antibiotics prior to blood cultures being drawn, it is likely that the antibiotics in the bloodstream will inhibit bacterial growth and will falsely decrease the numbers of positive blood cultures. If the patients get antibiotics through their central lines, how do you think that will affect the results of the cultures of the tips of the central lines? Is that reportable?

Leapfrog Group and the federal government make a big deal about paying for performance. “Tie payment to outcomes” the Leapfrog Group advocates. When you start tying payments to outcomes without a well-thought out plan on how to reliably measure the outcomes, you’re going to get exactly what you pay for. Garbage in, garbage out. Just like  drivers trying to avoid waiting five minutes to turn a corner when they’re late for work, hospitals have an incentive to avoid undesirable situations by taking advantage of loopholes in the rules and definitions.

The thing that bothers me most about data like this is that it tends to make people both complacent and angry.
People become complacent when they go to hospitals with “zero” catheter related bloodstream infections. What a great place this must be! I’m safe here! Maybe that’s true, but maybe it isn’t true. How is their data interpreted?
People become angry when they’re affected by one of these highly-publicized negative outcomes.  Hospitals that still “allow” patients to develop such infections are viewed as negligent and get a bad reputation.

Does this mean that hospitals shouldn’t follow the Dr. Pronovost’s five step checklist? Absolutely not. But if those checklists work sooooo well, then why doesn’t the government just say “we’re not going to pay you if you don’t use the checklist”? Focus on the process, not the outcome. You’ll get everyone following the checklist overnight. Then you’ll see how effective it really is.

Nah. There’s more political capital in making the agencies look good and making the hospitals look bad.

What’s the point of this protracted post? There are a few.
1. You get what you pay for. If you pay for statistics showing a decrease in some measured outcome, you’ll get statistics showing a decrease in some measured outcome.
2. You don’t get what you don’t pay for. When you stop paying for an outcome, those providing the services might find a way to avoid the outcome, they might find a way to make it look like the outcome never happened, they might find a way to make someone else pay for the outcome, or they just might stop providing the services altogether.
3. The devil is in the details.

Now, what’s all this about CMS representatives marching in some parade … with an Emperor?

P.S. Did anyone see any government run hospitals in Consumer Reports’ list? I didn’t.

How to get rid of C. diff?

Thursday, May 7th, 2009

According to this Medscape article, trying to get rid of Clostridium difficile spores by using traditional hand sanitizers won’t cut it.

C. difficile spores are everywhere, including tables, curtains, lab coats, scrubs, plants and cut flowers, computer keyboards, bedpans, furniture, toilet seats, linens, telephones, stethoscopes, jewelry, diaper pails, fingernails and physician’s neck ties.

The spores themselves aren’t harmful, but when they are ingested, they can transform and cause colitis. C. difficile spores are difficult to eradicate because they secrete a sticky substance allowing them to adhere to surfaces which, in turn, makes them difficult to remove. Think of little beads with a honey coating.

In the Medscape article none of the cleansing products – even the soaps – removed more than 90% of C. difficile spores.

According to this study, C. difficile can be cultured from the stool of 3% of healthy adults and 80% of healthy infants.
This MSNBC article shows that C. difficile is present in 40% of grocery meats.
According to this commentary, more than a third of patients in a North Carolina study had community-acquired C. difficile infections (i.e. not the hospital’s fault) and more than half of patients with C. difficile recently used antibiotics.
And … one of the quality measures forced upon us by CMS and Hospital Compare requires us to use antibiotics on ALL known or suspected cases of pneumonia within 6 hours of the patient’s arrival. These “quality measures” significantly increase antibiotic use without any improvement in mortality or hospital length of stay. At the same time, they increase the likelihood of C. difficile infections.

C. difficile is present in up to 40% of the meat we eat.
C. difficile is commonly present in the stool of healthy infants and adults.
We can’t completely get rid of C. difficile spores no matter how much we wash.
And … for the sake of “quality care,” the government forces us to give many patients unnecessary antibiotics that actually increase the chances that a C. difficile infection will occur.
But if C. difficile infections occur in a hospitalized patient, the government won’t pay to treat them because the infections are “never events” and should “never” happen.

Go figure.

VA Never Events

Tuesday, February 17th, 2009

Here’s a conundrum for a VA Hospital.

According to this article in the Oregonian, the widow of a patient who fell to his death from the roof of a Veterans Affairs Medical Center is suing the hospital and the doctors for $4.5 million.

The federal government has already stated that a patient death associated with a fall while being cared for in a healthcare facility is a “never event.”

I wonder whether the widow’s attorney will use the federal government’s new classifications of never events as proof that the government hospital was negligent. After all, if the government states, in effect, that such events should “never” happen, shouldn’t the occurrence of such an event be used as prima facie evidence of the government hospital’s negligence in this matter?

Strict liability.

Hello, summary judgment.

United “FraudCare”

Wednesday, January 14th, 2009

According to MSNBC, United HealthCare just paid $50 million to settle New York Attorney General Andrew Cuomo’s claims that United HealthCare manipulated its own proprietary pricing database to set an unreasonably low “fair market value” for medical care. By doing so, it is alleged that UHC forced its insureds to pay more out of pocket costs when using “out of network” providers – to the tune of tens of millions of dollars.

No criminal actions have been filed, but class action lawsuits are reportedly already in the works.

Other insurers are in the sights of several state Attorneys General.

A New York Times article about the suit and the basis behind the suit is here.

Also some interesting discussion going on at Newsvine.com.

The question I have is … with a company that has revenues of $45 billion, is a $50 million settlement enough to dissuade similar actions in the future?

That’s like a person who makes $100,000 per year agreeing to pay a fine of $100 – not exactly a big hit in the pocketbook.

Instead, why not disgorge all of UHC’s revenues for a couple of years? How about a fine of $50 billion instead of $50 million?

I can’t think of a better example of a corporate “never event” – can you?

If providers shouldn’t be paid for things that should “never” occur, neither should the insurers.

Medical Tourism

Friday, November 14th, 2008

sas_airplane_1The Chicago Tribune has an AP story about how WellPoint is going to start a pilot program of medical tourism where it will send some non-emergent patients to India for surgeries in order to save money. A knee or hip replacement costs between $65,000 and $80,000 in the U.S., but only costs between $8,000 and $10,0000 in India. As a carrot to get patients interested, insurers will pay for travel, lodging, and the medical procedure for a patient AND will pay travel costs and lodging for a companion.

I think medical tourism is a good idea. I especially like the concept because it cuts out the middle man. Patient pays for care, doctor and hospital provide care. Maybe patient and provider haggle over price. Maybe patient calls around to different hospitals and comparison shops – not unlike reading through the Sunday paper and comparing grocery ads.

It concerns me that now a “middle man” wants to get involved.

I also foresee all kinds of new issues popping up once American insurance companies actively engage in sending people to other countries to have medical procedures performed.
Right now (and this is pure conjecture on my part), unless there is a catastrophic injury I believe that medical tourists effectively give up their right to sue a foreign doctor for malpractice. The patient will have to submit to another country’s malpractice laws. Doubt that the payouts would be anywhere near as big as they are in the US (although the docs might get jail time and 1500 lashes with a whip). To get started, the patient would have to retain an attorney (or attorneys) experienced in both malpractice and in international law.  Think you’ll be able to get some of those on contingency?
Will the insurance company be liable in the US if there is malpractice in another country and the insurance company “brokered the deal”? Maybe you can’t sue the insurer for medical malpractice, but can you sue the insurer for negligent contracting? Will the ERISA shield apply to these types of lawsuits against insurers?
What happens if there are surgical complications? In the US, the price for surgery includes a certain amount of follow-up care (30-90 days?). With foreign surgeries, does the patient stay in India until the complications are resolved? Will the insurance company pay for that care as well? What if there is a complication and family wants to visit? Who picks up the travel and lodging tab?
What if the patient is OK when leaving India, then returns and develops a surgical complication? Surgeons in the US are often hesitant to “become involved in someone else’s screw up” (as I have heard more than one surgeon put it). A “screw up” is already more likely to end up in court. If a US surgeon tries to fix an Indian surgeon’s screw up and the patient doesn’t get better, then the US surgeon may be stuck holding the bag in the event of a lawsuit. If there is a “screw up” do the patient and a companion get shipped back to India to make good on the care?
What happens if, during the trip, the patient has another medical problem?
What happens if the surgery has to be canceled? Free trip for two to India?
Aaaaack! What happens if there is a “never event”? Free care?? Or do those never event thingees only happen in American hospitals?
The most pressing question of all is: Who gets to keep the frequent flyer miles?

The Chief Medical Officer interviewed for the article hinted that insurers are trying to use medical tourism to put the squeeze on doctors to lower their prices for non-emergent procedures like joint replacements. “It may change the game in terms of local contracting conversations,” the CMO said.

Here come those unintended consequences. If doctors get pinched on performing non-emergent surgeries, how are they going to make up for that monetary loss? You got it. Guess what’s going to happen to prices for surgeries that can’t be sent overseas.
That acute cholecystectomy just got more expensive. Don’t want to pay it? Fine. Get on an airplane with your companion and go register in one of those insurer-approved New Dehli “ERs”. Just hope your gall bladder doesn’t explode somewhere over the Bay of Bengal.
Have a hip fracture? Hope your travel companion is someone qualified to administer narcotic pain medications because sitting in an economy class seat with a busted hip for 20 hours is going to hurt. Then again, maybe a hand full of Vicodins will be part of the insurance travel package.

These are all issues that can occur regardless of whether the trips are brokered by an insurance company.

The problem occurs when a third party tries to squeeze in the middle of the doctor/patient relationship – making the consumer pay more and making the provider accept less – so that the third party can make a profit. Some aspects of insurer-brokered medical tourism may work. Ultimately I think that issues like those above will become the tail that wags the dog.

I have a bad feeling about this.

CNN published an article on medical tourism echoing several of the points above.

Clostridium difficile Not A Medical Error?

Thursday, October 30th, 2008

According to this article in American Medical News, researchers at McGill University in Montreal discovered that less than half of 836 patients with Clostridium difficile infections had been exposed to antibiotics in the 45 days prior to their hospitalizations. The study is in CMAJ, but the link isn’t working at the time of this post. The study also showed that, just like MRSA, the rate of community-acquired Clostridium difficile is rising. The rate per 100,000 person-years among people 65 and older in Quebec rose from 0.5 in 1997 to 57.2 in 2004.

If Clostridium difficile infections occur more than half the time without any preceding antibiotic therapy, what exactly is the “error” that needs to be corrected to cease the occurrence of this “never event”?

“Never events” aren’t about patient safety. Never events aren’t about evidence-based medicine.

Never events are all about the Benjamins.

The joke’s on CMS, though. Now we’re going to spend so much money testing hospitalized patients for “C. diff” that the money CMS saves by not paying for the few positive instances of this “never event” will pale in comparison.

The link to the CMAJ article is here. Commentary about the article is here.
Factiods from these two articles include:

  • C. difficile can be “cultured from the stool of 3% of healthy adults and up to 80% of healthy newborns and infants.” Is the birth of a health child with C. difficile in its colon the next “never event”? Will all healthy newborns be given Flagyl and Vancomycin to eradicate these organisms?
  • Admitted patients may have C. difficile, but will not all have symptoms of C. difficile-associated diarrhea during their hospital stay. In other words, people might have C. diff prior to admission, but might not develop symptoms until after they’re hospitalized. Hospital gets dinged for an “error” that wasn’t its fault.
  • In addition to antibiotic use, C. difficile is also associated with use of a proton pump inhibitor, presence of inflammatory bowel disease, presence of irritable bowel syndrome, and presence of renal failure. What are we going to do with people who take Prilosec and have Crohn’s disease? Refuse to admit them to avoid the “never event”?

We’re All Dead …

Thursday, October 23rd, 2008

If you believe Michael Cannon’s article “Universal Coverage Kills” at the National Review Online.

It amuses me when people possessing little knowledge of the inner workings of the practice of medicine write articles as if they are “in the know.” Mr. Cannon’s article is one such work.

I’m not going to pick apart the whole article, but there are several statements Mr. Cannon makes that are either purposely inflammatory or that show a fundamental lack of insight. Contrary to its title, the article talks very little about “universal coverage” but instead tries to incite the public about “never events.” I’m glad he links to a few statistics, but the conclusions he comes up with are flat out wrong.

Mr. Cannon states that

“For more than 40 years, Medicare has provided financial rewards to providers when a patient requires follow-up care following a medical error.”

This is a partial truth, but he’s sensationalizing the whole concept. There are errors such as wrong medications, wrong site surgeries, and wrong type blood transfusions. I’ve stated before that I can’t think of a legitimate reason for some of those things happening. Should practitioners be compensated if they commit those errors? Maybe, maybe not. Errors are a part of any profession. If your mechanic doesn’t fix the rattle in your car, you still have to pay him for his “error” in trying to diagnose the problem. If the restaurant messes up your order, maybe you get comped the meal, but you don’t walk out of the restaurant without paying the check. If your attorney can’t get case filings done on time and requests a continuance, you’re paying him for going to court to get the judge’s permission and your paying for the letter/phone call telling you the status of your case.

The other side of the coin, as I’ve also stated before, is that if people like Mr. Cannon and our beloved government are so sure that all of these “errors” are preventable, then provide all of us overpaid brain dead doctors with a way to prevent the errors, then. Give me some links to those articles, there, Hippocrates. Put up or shut up.

Mr. Cannon also makes the statement that

“Medicare will still reward hospitals for many medical errors, including infections and medication errors ….”

Since when did living organisms that cause infections become a “medical error”? If you get a strep throat are you going to pay the doctors double for your “error”? How about that painful little drip coming from the tip of your woo-hoo? OK, I guess that the clap results from an error in judgment. So you’ll have to pay us triple for that one – once for the medical error and once for the judgment error. How about pneumonia? How about paronychia from chewing your fingernails? For that matter, how about the cavities from the organisms in your mouth? What about influenza? Are all of these infectious processes “medical errors”? I’d like to see how you rationally differentiate post-op infections, c difficile, and UTIs from other compensible “infections.”

Mr. Cannon’s article does propose a solution to all of medicine’s ills, though. Actually, the idea was created by Group Health Cooperative and Kaiser Permanente “more than 60 years ago.” According to Mr. Cannon’s article,

“Doctors and patients who choose those plans tend to like them, and the plans receive high marks for quality, which suggests the financial incentives they use serve patients better.”

He doesn’t really explain what he’s talking about, so I did a little searching.

Mr. Cannon wrote another article here that expounded more on this process.

Drumroll, please … he’s advocating a national HMO.

Yes, HMOs are Michael Cannon’s answer to the healthcare crisis. Pay a flat monthly fee for every patient a physician sees and the physicians are responsible for paying for all of the care that the patient requires. If the patients require more care than the monthly fees, the doctor has to pay for the care out of pocket.


Do I even need to link to articles on what a colossal failure HMOs have been? Try finding a physician who even takes HMO patients in many parts of the country. Doctors are less happy and see fewer patients. You think it’s tough to get an MRI now? Try getting an expensive test with an HMO. HMOs reward minimalist medicine. The less you do, the more money you make. That’s great if you’re a healthy patient with few medical problems. I have neither the time nor the desire to track them down, but I would like to see some studies on how many chronically ill people are happy with their HMO care.

As I sat here shaking my head at another person perpetuating misinformation to the public, I started thinking about how to explain the concept of a “never event” to a journalist.

If you’re a journalist whose articles don’t follow the rules of proper English, a never event woul mean that you don’t get paid for writing the article. Any article you write in which your editor has to make any correction is uncompensated. You don’t like that idea? Why you miserable incompetent money-grubbing wretch. Taking money from a publisher when you’ve made a mistake?!?!? That borders on unethical. You churl!

Of course, your editor, as a representative of the employer that is paying you money, has an incentive to find errors so that the employer doesn’t have to pay you. Even so, that type of system shouldn’t bother you so much. After all, how hard can it be to follow the rules of English? Those are at least written out in Strunk and White.

Yeah. I can go with that concept.

Mr. Cannon’s article uses the “naked this” like it’s going out of style and has dangling modifiers and sentence fragments galore. Maybe we can start a petition to the National Review and request that they withhold Mr. Cannon’s paycheck this week for all of those literary “never events.”

I propose that they send his paycheck to their local hospital to help it avoid more “medical errors.”

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