A Powerful Message on Lean and Healthcare

Why I Work In Healthcare | DailyKaizen

Here's a great one to end the day on... Lee Fried has a powerful post over on the DailyKaizen blog. Some unfortunately heartache for him and his family, but an important reminder of why this stuff is so important (and why Lean is so powerful in helping).

Go to his site to read the whole post and the story behind it, but he's spot on about this (and everything he wrote, actually). Lee said:

I often find myself debating with people within my industry whether standard work can be applied to patient care. I often hear back that it does not apply because ”no two patients are the same” or “healthcare is far too complex for standard work” to work. This argument is frustrating and we need to find ways to put to rest. I am sure that every industry has heard the same exact argument about why standard processes can not be applied in their field. I was telling my neighbor about what happened and he confirmed that in his industry (aerospace) twenty years ago it was the same story. “Airplanes are far to complex to be built by standard processes.”

Yes, let's put the argument to rest. Lean *does* work in healthcare. Standardized Work is saving lives in many ways, including "checklists." We need more of this in healthcare and fewer obstacles.

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Tom Peters on Healthcare

From Modern Healthcare, Tom Peters throws a few verbal bombs at the healthcare industry:

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Quality gains needn’t be costly, Peters tells HFMA

Financial executives can do more to improve healthcare quality and it won’t cost more money to do so, said management guru Tom Peters, speaking at the Healthcare Financial Management Association’s yearly meeting.

In a keynote speech, Peters told attendees of the gathering that “despite our good work in some areas, like patient safety, we still haven’t reached up to the awful level.” The high number of hospital-caused drug errors and infections is a “disgrace,” Peters said.

Peters is absolutely right that better quality CAN cost less - and it should. Improving processes saves money -- Lean is one way to get there. I guess Peters has earned the right to throw rocks... is it helpful? In his talk, Peters said we need to train more in "people skills" not in numbers. To me, Lean definitely falls into the "people" side as opposed to being really mathematically rigorous like, say, Six Sigma.

Managing the right process will bring the right results -- that Lean truism certainly holds in healthcare. Managing processes means getting out there and seeing how work is done, working with and coaching people. I think the path to improvement can't rely exclusively on measurement, quotas, and incentives. You have to manage the people and the process. I'm hoping Peters would agree with that.

The HFMA website also has an interview with Peters.

Peters often speaks in terms that might remind you of Lean:

My revolution is a revolution of simplicity that gets us focused back on delivering health care and realizing that a lot of our operational problems that are involved with healthcare delivery itself are problems that can be fixed with some straightforward solutions. Just throwing money at these problems is not the answer.

You could think of Lean as a "revolution of simplicity" (he *is* good with turning a phrase). With Lean, we simplify procedures to get the waste out of people's day -- eliminating unnecessary steps and activities so people can focus on caring for patients. That's the brilliance of Lean -- not "working harder" or "being more careful." Lean solutions are straightforward - they seem like common sense, in hindsight -- but yet we're not always adopting these ideas on our own, without Lean training and coaching.

Part of his advice for CFO's:

I don’t want you to sign off on a $3.5 million investment to make patient safety things happen in your hospital. I do want you to sign off on 14 little experiments that go after bits and pieces of it where we can see what works and what doesn’t work.

That's also Lean thinking!! Great stuff from Peters...

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Let the Process Experts Decide

Leading article: Infected by political calculation

This isn't a "Lean" story, per se, but it still caught my eye. Hospital-acquired infections are a major problem throughout the world. As this commentary from The Independent points out:

Britain has the worst record of hospital infections in Europe, and patient surveys reveal that superbugs have overtaken waiting times as their prime source of concern. The situation could not go unchallenged.

Fair enough -- it's a serious problem and it demands attention. The "solution" reminded me a of a recent rant from a specialist physician I saw back in the U.S. a month ago or so. He started complaining about all of the government interference in healthcare and he said "Every time there's legislation about medicine, they make it worse. They need to let doctors make the decisions, not the politicians."

To be a cynic, a politician's job is to get re-elected. Are they always making decisions that are right for the community or for patients? Back to the article, where the Prime Minister got involved:

But as so often with this administration, new rules have been accompanied with a heavy dose of politically-motivated and unhelpful meddling. Last September, Gordon Brown announced that the 1,500 NHS hospitals in England would be subjected to a "deep clean". It sounded good. This would involve clearing wards, washing walls and scrubbing behind radiators.

But there was a problem. There was no clinical evidence to suggest this was where effort ought to be directed. According to infection control experts, superbugs were being spread not by bacteria multiplying in neglected corners of wards, but by sloppy daily cleaning procedures and the failure of many medical staff to wash their hands properly. Yet the Prime Minister ploughed on anyway because the idea of a deep clean was deemed a way of communicating to the typical voter how seriously he was taking the problem of superbug infections. Most hospitals finished their deep clean three months ago and, as we can see from these latest figures, it has made very little difference to the standards of cleanliness in our wards.

Millions are being spent on efforts that "sound good" or "feel good" instead of doing what really works. Pretty lousy, huh? How do we get local hospitals to manage their "Standardized Work?" -- That's the challenge. It's not a great revelation that hand hygiene is critical. How do we get people to follow good daily processes (for hand hygiene and room/equipment cleaning) instead of taking big splashy efforts that might not make a difference. Did the politicians ASK hospitals, executives or physicians, how to solve this problem or did they mandate a "solution?" Sounds like they should have done more asking.

The column concluded:

This is a lesson on how little is achieved and how much is wasted when politicians put the chase for favourable headlines above expert advice. It is not only our hospitals that urgently need to clean up their act.

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What Do You Think of This Sign?

A reader sent this picture from a hospital restroom. I'm not sure if the reader is a patient parent or a hospital employee. They asked, "Why are we putting it on the parents to remind doctors to wash their hands? We have enough to worry about, our kid is sick. Who really does this??"

I'd absolutely agree. I've seen tons of signs in hospitals about handwashing and proper hand hygiene. Some are serious, some are cute. If hanging signs worked, we wouldn't have such low hand hygiene adherence. Different studies put the number at roughly 50%, as I've blogged about before. This isn't in the context of before surgery, rather this is about hand hygiene between patient encounters.

As we discussed before (and also here), signs and admonishment don't work. You need to ask "why?" Are people too busy to wash their hands? Are managers not observing the process to see if standard work is being followed? Are managers not holding people accountable? Are co-workers not holding each other accountable?

There are many many root causes for which we can develop countermeasures. I'd argue it IS wholly unfair to ask parents to nag the caregivers. Honestly, I'd be embarrassed to put up a sign like this... it's an abdication of the hospital's responsibility for safety patient care. That's my opinion. What's yours?

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Dennis Quaid on 60 Minutes

Dennis Quaid Recounts Twins' Drug Ordeal, Actor Tells 60 Minutes' Steve Kroft Medical Errors Kill Thousands - CBS News

Did you see the actor Dennis Quaid on 60 Minutes last week? He talked about the sad case where his twin babies were mistakenly overdosed TWICE at Cedar-Sinai Hospital in Los Angeles.

His babies are recovered now, thankfully. The silver lining on the sad case is that Quaid, as an actor and celebrity can become a powerful voice and advocate for patient safety and preventing systemic errors - highlighting the problem AND suggesting countermeasures and systemic fixes.

As Quaid recounted the story, he first seemed to blame the nurse: "The nurse didn't bother to look" at the dose (the correct dose, on the right, and the incorrect dose are both pictured here). Later, he mentioned, correctly, that a series of errors had occurred. As I've said before, it's too simplistic to just blame or punish a single person when an error like this occurs. That approach certainly doesn't help prevent other such errors.

He said the babies had been given TWO massive overdoses in an 8-hour period "that we know of," he said -- again, the signs that there's suspicion of a cover-up. It also highlights what a systemic error this is, that it could happen twice in the same hospital. It was a chain of errors that occurred. First, someone in the pharmacy picked the wrong dose. Secondly, a pharmacist is supposed to double-check any medications that leave the pharmacy (an inspection step). That's two people who are supposed to "bother" to look at the label. Then, there's the person who delivers the medication to the ICU. Finally, the nurse is the last in that chain. But, the nurse isn't expecting that the adult dose of Heparin is even there in a neonatal unit. So, pretty easy to let your guard down, right? I don't think that's an excuse, that's just reality.

Quaid was right to say the errors were "avoidable" -- pointing out it was the same avoidable errors as the case where three babies died at Methodist in Indianapolis.

Quaid has become pretty obsessed with researching the topic (he was shown on the computer, maybe he's been on this blog?) and discovered the errors happen "everywhere." He cited the "100,000 deaths a year" number (which comes from the late 90's study from the Institute of Medicine. Quaid said, "This is bigger than AIDS, bigger than breast cancer... yet nobody seems to be really aware of the problem." I'm glad Quaid is trying to spread the word and to help others.

There was a lot of talking about the old labeling being too similar across the two bottles. The new label (pictured on the right) is better because it's not just a different shade of blue and it requires a different motion (tearing off a paper cover) that is not required for the smaller Hep-Lock dose that is intended for babies.

The old stock (the old, more mistakable labels) was NOT recalled. Cedar-Sinai was using up their old stock first (sure, it was "FIFO" or First-In-First-Out, something Lean folks generally like), but that shouldn't have been the case when safety was at risk. What responsibility does hospital administration take for this materials decision?

The maker of the drugs, Baxter, had a spokesperson on 60 Minutes who reminded us that people were supposed to read the label (again, casting blame), even though the labels had been mistaken many times before by other nurses in other hospitals. But they redesigned the labels after earlier incidents. It was not necessary to recall, 60 Minutes asked? The Baxter spokesperson said "No, the drugs were safe" and that it was due to preventable errors in the hospital's system.

The CEO of Cedar-Sinai admits it was human error, preventable error. The CEO said "you need backup systems" and CBS's Steve Kroft asked, "but you had backup systems, you had three people." How many more backups can you add? More inspections and more backups isn't necessarily more effective due to, here it is again, "human error" in inspection. When many people are checking something, it's human nature to let your guard down because the "other person" will get it.

So what is my advice? Hospitals need to bee proactive, with this and other known risks. Leaders need to manage the process, not just reacting after bad results. If you're in a similar hospital setting, are YOUR people double-checking the medications? Are you spot checking this to see if it's really the case? There was "standardized work" (the Lean term, the hospital probably called it "policy") in place to double check the medications, but administration took their eye off the ball (if it was ever on there). We need to move from "policies" (which are never "policed") to a "standardized work system" where supervisors and leaders are working WITH their employees, checking to see if key processes are being followed, BEFORE harm occurs.

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"Patient Safety Week" Starts Today

Patient Safety Focus Blog

Patient Safety Awareness Week Site

Today is the start of the annual "Patient Safety Awareness Week" in hospital world, running March 2 to March 8.

I have mixed feelings about this. Not mixed feelings about "patient safety." That's obviously a good thing and I'm all in favor of patient safety and any steps that can be taken to protect it.

But the idea of a "week" -- that's what I have mixed feelings about. Building awareness is good, but having a week makes patient safety seem like an add-on, rather than a core issue. Patient safety should be a priority every week and every day. Education and support for patient safety issues should be ongoing.

I don't remember factories ever having "Quality and Customer Focus Week." Do any? If they don't have a week like that, it doesn't mean that quality and customer focus aren't important. Now, sometimes factories will send a message that quality isn't a core function by having a "quality department" that is somehow responsible. The best factories integrate quality into everybody's job, every day. I'd assume the best hospitals would incorporate patient safety into everything, every day, as well.

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The Feds Reverse Their Decision on Checklists!

Wachter's World : The Checklist Saga: Victory!

This is great news for patients and is probably great news for those of you who have been following the "checklists" saga. The federal government has reversed its earlier decision to shutdown the Michigan hospital checklist usage, recognizing that quality improvement protocols are NOT the same as experimenting with a new drug.

For those of you catching up on this story, here's my original blog post about the use of checklists at Johns Hopkins and the follow up about the government putting a stop to the program.

“We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects,” said Dr. Ivor Pritchard, acting director of OHRP. “HHS regulations provide great flexibility and should not have inhibited this activity. The regulations are designed to protect human subjects.”

The Johns Hopkins study demonstrated that a comprehensive five-step program can dramatically reduce the incidence of catheter-borne infections in ICUs. HHS strongly encourages hospitals nationwide to adopt the program, which can save thousands of lives and millions of dollars each year.

OHRP noted that the Johns Hopkins project has evolved to the point where the intervention, including the checklist, is now being used at certain Michigan hospitals solely for clinical purposes, not medical research or experimentation. Consequently, the regulations that govern human subjects research no longer apply and neither Johns Hopkins nor the Michigan hospitals need the approval of an institutional review board (IRB) to conduct the current phase of the project.

Bob Wachter, in his blog post (hat tip to him for breaking this update to the story and kudos to him for writing such informative and passionate posts on the subject), wrote:

The prior OHRP decision, if left standing, could have mandated regulatory approval and the need to obtain patient and provider consent every time one wanted to improve a process and measure its impact.

The one thing that bugged me about the prior OHRP ruling... the hospitals were measuring the impact of the checklists (an important part of the Plan-Do-Check-Act cycle), therefore it became research? So it would have been OK if the hospital were just using the checklist without measuring the impact? Seems a bit irresponsible. But what is really more irresponsible is a hospital NOT using checklists (or standardized work) to ensure consistent care and patient safety.

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Another Pathology Mishap

L.I. Hospital Scrutinized After Deaths of Patients - New York Times

It wasn't the same laboratory this time, but it's more than likely a similar root cause. I wrote before about pathology specimen labeling errors, how they're preventable human error. Labs need to get away from batching multiple specimens (working with multiple patient specimens at the same time) and they need to stop blaming individuals when errors happen. We have to look at the system. We have to be proactive. We have to try to prevent errors from occurring.

You might recall an incident from last year, where a private NY pathology lab mixed up two patient specimens ("This Will Happen Again, Unless...")

In this most recent case (at a hospital):

"Last spring, doctors at Mercy Medical Center on Long Island gave a patient the news she had feared: Cancer had been detected in her left breast. She was only in her 30s, but she decided to act swiftly because breast cancer ran in her family. On May 25, she had a double mastectomy. The next day, she died of complications from the surgery. As it turned out, the woman did not have cancer. According to the State Department of Health, the pathology report from the woman’s surgery had found no tumors in her breasts. The hospital’s lab had mixed up her test with another woman’s."

Why the woman died after the surgery is a altogether different story and there aren't many details about that. The lab error was more clearly preventable.

Every pathology lab should be using Lean methods to identify "standardized work" methods that allow work to be done in a single-piece flow manner, reducing the opportunity for error. This should be done pro-actively, before an error occurs in your lab. I heard a lab manager say once, after being asked about error proofing that process, "But my people are careful." I'm sure they were generally "careful" in Long Island also, but being careful is not enough.

How many times does something like this need to occur? For all of the truly complicated things in a hospital, this is NOT one of them. These processes are all pretty manual -- put the right patient specimen onto the correct, properly labeled "cassette" or slide. These errors can be prevented.

In this article, a doctor who is speaking out very publicly about the problems at the hospital says:

"That mix-up was a simple procedure," Dr. Anthony Colantonio said. "The simple thing of placing a label on a specimen container. That sort of mistake should not happen."

Thinking about this more, I might not be completely accurate in calling it a "pathology error." It *is* possible that the specimen container was improperly labeled in the operating room, before it ever got to the lab.

Update: Here' s an overview of the anatomic pathology and "histology" process steps, including a photo of the cassettes and slides that get labeled.

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Yes, Standardized Work Saves Lives

'Bundling' hospital processes may help prevent infections - USATODAY.com

"Bundling hospital processes" = Standardized Work

Why isn't every hospital doing this? Why isn't every hospital administrator making sure this is happening?

The IHI [Institute for Healthcare Improvement] defines bundling as a group of processes needed by patients undergoing certain risky treatments. The idea is to join scientifically grounded elements that reduce the risk of serious complications, such as pneumonia or central-line infections.

Ventilator-associated pneumonia is one of the most common hospital-acquired infections. The related bundle requires that the head of the bed be elevated, the patient be woken daily for assessment, and preventative steps be taken to prevent blood clots and ulcers.

The medical/surgical intensive care unit at BryanLGH Medical Center in Lincoln, Neb., put this bundle into effect and went 27 months without a case of the targeted infection. "Bundles aren't rocket science, but they're effective and they work," says Mona Reynolds, a clinical nurse manager at BryanLGH.

Yes, standardized work and checklists aren't glamorous... process work isn't necessarily glamorous, but it works and it can save lives.

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Why Do Patients Have to Do This?

The Informed Patient - WSJ.com

Good column in the WSJ today, as always, from Laura Landro. She writes about the need for patients to take an active role in their care and their own safety.

I'll try to keep with the Toyota philosophy of asking "why?" We could go through each of these in "the 5 Whys" problem solving method.

• Why do patients have to ask their surgeons if they are following proper surgical safety protocols?

• Related question, why do patients have to ask nurses and physicians if they have properly cleaned their hands?

The focus of my question is on the patients, why is it necessary to ask patients to take such an active role in the quality of care delivery, not "why is it important to properly clean your hands?"

Do we ever hear food safety advocates suggest, "You should ask your restaurant to confirm that the meat was cooked to the proper temperature"?? Are car buyers encouraged to nag Toyota or GM about whether the car is safe to drive off of the lot?

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Updated: Glenn Beck's Surgery Gone "Horribly Awry"

This is compelling video (scroll down), radio and TV talk show host Glenn Beck, talking about his surgery gone "horribly awry" and how "phenomenally bad" his hospital care was (not sure what the procedure was, but it was planned and scheduled).

Update: His version of the story from his website, 1/7/08. Will comment more on it later, the story has less to do with the surgery itself, but the after care and problems with his return visit to the Emergency Deparment.

Beck says he hopes his story will serve as a "wake up call" to the hospital CEO about what sorts of things are happening at his facility. He says the stories he will tell on Monday will "melt your brain." Of course he's teasing his Monday radio and Headline News shows, but I'll tune in to see if he shares more details. He was pretty cryptic about what happened, but claimed the pain drove him to the point of being suicidal. His website says:

"Well it all started out fine. How it all ended with me in the hospital for 5 days and sent home with patches they give people (I found out later) who are at 'end of life' for pain is a journey I would like to forget, but know I won't anytime soon."

Take a look at the first minute or two at least... I wonder what happened to him? Something more process oriented than normal surgical complications? A preventable medical error or errors? Beck mentions he had some great physicians and great nurses -- that's not at all inconsistent with most medical errors, as most errors are caused by bad processes and systems. Deming stated that and respected research on patient safety has shown the same thing.

If you want to learn more about the "Lean" concept and how it's helping in healthcare, check out the links below the post or my "What is Lean?" page... it's not just for Toyota and for cars.

Anyway, best wishes for a speedy recovery, Glenn.

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Quaid Case Update: Whose Responsibility is Standardized Work?

If you're a regular reader, you might recall the Cedar-Sinai medical error that harmed Dennis Quad's twins (and others).

Quaid and his wife are now suing the maker of the drug, Baxter, claiming the company is negligent for not designing packaging with good visual distinctions between the two doses (photo there on the linked TMZ.com page).

This week, Baxter announced an initiative to redesign the packaging of their "high risk" medications.

Considering this problem has happened before, I'm sure that effort isn't just a direct response to the Cedar-Sinai incident. It sounds like Baxter tried to get some "voice of the customer" input:

Baxter conducted multiple interviews with more than 100 pharmacists, physicians and nurses to identify areas for improvement . The feedback received from health care professionals guided the design of the new vial packaging.

In research conducted after the three-phase development program, clinicians indicated that the new packaging design enhancements addressed the current clinical needs for safer injectable drug administration and could help reduce medication errors.

“Health care professionals played a vital role in the design of the new label and we look forward to their continued input to gain key insights that will help in the development of future design enhancements, ” said Bonderud.

Baxter had already done some redesign, but Cedar-Sinai may have tried to save a few bucks by using up the old medication (in the old packaging) first. Normally "FIFO" would be a good thing, but not if the old product leads to a greater patient safety risk. In hindsight, would have been cheaper to throw the old stuff out, right?

I'm also not impressed that Cedar-Sinai leadership is apparently throwing their employees under the bus. In a statement, they said:

The medical center's investigation found that preventable errors made by pharmacy and nursing staff caused the wrong concentration of heparin to be used.

A pharmacy technician failed to follow hospital policy of having another pharmacy technician verify the medication and concentration prior to removing it from main pharmacy inventory. As a result, the technician mistakenly retrieved a higher concentration of heparin (10,000 units per milliliter) instead of the lower-concentration heparin (10 units per milliliter) used for flushing IV catheters.

The higher concentration heparin was delivered to the satellite pharmacy that serves the pediatrics unit. A second pharmacy technician, working in the satellite pharmacy, did not verify the concentration of the delivery from the main pharmacy, as required by hospital policy.

As a result, the higher-concentration heparin was placed in a location in the pediatrics unit where the lower-concentration heparin is kept. The nurses who subsequently administered the heparin to the patients also did not follow hospital policy of verifying the correct medication and dose prior to flushing the intravenous site.

The error was identified later that day by Cedars-Sinai staff, who immediately performed blood tests on the patients to measure blood clotting function. In one of the three patients, the clotting tests returned quickly to normal. The other two patients were given protamine sulfate, a drug that reverses the effects of heparin and helps restore blood clotting function to normal. Additional medical tests and clinical evaluation conducted on the two patients found no adverse effects from the heparin or from the temporary abnormal clotting function.

"Although this was a rare event, and attributable to human error, it is also an important opportunity for the entire institution to explore any and all ways we can further improve medication safety," said Michael L. Langberg, M.D., chief medical officer at Cedars-Sinai Medical Center.

"On behalf of the medical center, I extend my deepest apologies to the families who were affected by this situation, and we will continue to work with them on any concerns or questions they may have. This was a preventable error, involving a failure to follow our standard policies and procedures, and there is no excuse for that to occur at Cedars-Sinai," Langberg said.

Whose responsibility is it for the Standardized Work to be followed? Doesn't management have a responsibility to be proactively checking and looking to see if policies and procedures are being followed? It's not enough to wait and react when an incident occurs. I'd guess those same policy violations were happening every day and it finally caught up to them. Are employees responsible for following processes? Sure, but it's also management's responsibility to manage the process and the people. Does Toyota say, "well, our policy says people don't build defective vehicles"? Of course not.

Does management taking responsibility mean that we constantly hound and watch employees? No, but we have a responsibility to check to see if there are violations of policies BEFORE an injury or death occurs. Proper training and re-training should happen BEFORE problems occur. The employees directly involved in the Quaid incident are suspended. What about the managers and leaders?

To be fair, Cedar-Sinai is making a number of systemic changes (including moving from using heparin to saline, which is much safer, they say). But, they've also added MORE double checks (adding more of a method, relying on inspection and "be careful," that didn't work 100%).

I hope other hospitals, where the same risk factors exists, will be more proactive. We need to make "preventable" errors into "prevented" errors.

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Follow Ups to BIDMC

If you've been following any of the posts about healthcare, here are a few interesting follow ups.

Following up on this post about Boston's Beth Israel Deaconess Medical Center, CEO Paul Levy posted many interesting employee responses to his email about the systemic waste that people have to fight every day in your typical hospital (and there).

After the medical mistake with Dennis Quaid's twins in L.A., I had asked Paul what BIDMC was doing to proactively protect against that same error from happening at their hospital. Paul asked some of staff and posted a lengthy response here.

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The Need for Clean Hospitals

Our Unsanitary Hospitals - WSJ.com

That's "Clean", not a typo of "Lean." Good column in the WSJ today by Betsy McCaughey, head of the Committee to Reduce Infection Deaths organization (link).

She asks why restaurants and meat packing plants get inspected more than our nation's operating rooms.

"Restaurants in New York are inspected, without prior notice, once a year. In Los Angeles, inspections are done three times a year, and restaurants must display their grade near the front door. After L.A. instituted this inspection system in 1998, the number of people sickened by food-borne illnesses fell 13%, according to the Journal of Environmental Health. Other cities are now following L.A.'s lead.

Why aren't hospitals held to the same rigorous standard? The consequences of inadequate hygiene are far deadlier in hospitals than in restaurants. The Centers for Disease Control and Prevention estimate that 2,500 people die each year after picking up a food-borne illness in a restaurant or prepared food store. Forty times that number -- 100,000 people -- die each year, according to the CDC, from infections contracted in health-care facilities."

What leads to infections? Some of it is a classic Lean "standardized work" issue:

These infections are caused largely by unclean hands, inadequately cleaned equipment and contaminated clothing that allow bacteria to spread from patient to patient. In a study released in April, Boston University researchers examining 49 operating rooms at four New England hospitals found that more than half the objects that should have been disinfected were overlooked by cleaners.

Why is this? Lack of training? Lack of clear standardized work? Lack of time to do their job properly?

She then writes:

"Hospitals used to routinely test surfaces for bacteria, but in 1970 the CDC and the American Hospital Association advised them to stop, saying testing was unnecessary. The CDC still adheres to that position despite a 32-fold increase in MRSA infections. CDC officials say that lab capacity should be reserved for tests on patients.

Testing surfaces is so simple and inexpensive that it's used routinely in the food industry. Is it more important to test for bacteria in meat processing plants than in operating rooms?"

If we have lab capacity issues (that testing is done in a hospital lab), there is another opportunity for Lean, to improve flow and to free up capacity. The healthcare industry has smart people and the tools to fix all of these problems, we just need the leadership and the attention to be paid to these issues. The public needs to start standing up and demanding better.

It's not just hospitals, either, it's doctor's offices, which get no inspection at all. McCaughey tells a story of a physician who was REUSING NEEDLES (yes, you read that right) with patients. Who in their right mind does that?

The New York State Department of Health called Dr. Finkelstein's reuse of syringes
a "correctable error," and is allowing him to continue to practice under observation.

I know I often write about not blaming people, but this is not an "error," it's a "violation," which involves choices that doctor is knowingly making. How can he not be held more accountable? The state "regulators" knew, in 2005, the doctor was doing this, but they wouldn't suspend his license. Yeah, the state sure is looking out for you in New York. (another article) It's mindboggling that we'll fire and punish people who make an inadvertant error, but we'll look the other way when a doctor is purposefully and intentionally doing something unsafe. They're having to test patients of his for Hep C and HIV because of his stupidity. Ok, enough of that tangent.

Anyway, the WSJ piece is a good article if you have access to check it out. Rupert Murdoch is most likely going to make the WSJ a free ad supported website in the future, rather than relying on paid subscriptions.

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My At-Home Medical Mistake

I'm a bit mad at myself for inflicting some preventable human error on myself last night. It's OK, I didn't harm myself, but let me tell the story.

I've been battling what's either severe allergies or a mild cold for three or four days. I've alternated a bit between the daytime and nighttime formulas of a major branded OTC cold/congestion pill. Last night, I was in bed and couldn't sleep, I was wired. I thought, uh-oh, got up to check and, sure enough, I had given myself non-drowsy daytime formula.

The upside is that I went out to the home office and got a lot of work done, but I'm dragging this morning.

What has me kicking myself... I didn't practice what I preach in the Lean methodology!!

I had a "near miss" the night before. I had made the exact same mistake the night before. I had caught the error right after popping the pills in my mouth, I spit them out and took the nighttime formula. I'm mad at myself for not fixing the root cause of the problem. I didn't move the daytime formula off the bathroom counter, making it harder to mistakenly grab the wrong on while getting ready for bed. I did what so many people do in healthcare, because of time pressures, fatigue, or because of just human fallibility. I didn't take the time to really prevent the problem from occurring again. Obviously, the stakes aren't very high in the case of OTC cold medicine.

I'm doubly human. 1) I took the wrong pill and 2) I didn't think to take preventative measures!!

That said, looking at the packaging of the two formulas, there's some room for confusion (again, the "severity" score for the FMEA calculation of the RPN would be low for this one). The outer box of the daytime formula used to be primarily yellow (somewhat indicating "day") and the nighttime formula used to be primarily blue (indicating "night"). But the packaging changed to be more consistent, and that color coding is less prominent in the corner of the box. The backs of the blister packs are all white, being basically identical, except for some small text.

There *was* some color coding of the pills themselves, which should have been a tip off. The daytime pills are white, the night time cold/head congestion pills are blue. But, the color coding is NOT consistent among different products in that brand family. The "sinus congestion/pain" formula is green for day, white for night, when they come in the dual-boxed pack that includes day and night formulas. Strangely, when you buy daytime "sinus congestion/pain" on its own (without night), the pill is a green/white caplet. Why would they manufacture two different forms of the same pill?" The "sinus congestion/pain SEVERE" formula has white pills for daytime.

Seems like an opportunity for some standardization. Or time for me to quit obsessing about it, time to get to work!

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Putting the Burden on Patients?

I saw this ad (click on the photo for a larger, readable view) in the Wall Street Journal Monday. It's an ad run by a patient advocacy organization called "RID" (Reduce Infection Deaths).

The headline is "15 Steps You Can Take to Reduce Your Risk of Getting an Hospital Infection."

It's good to make patients aware about safety risks and reasonable precautions they can take to look out for their own safety. However, it's a crying shame that it comes to this... why aren't hospitals being more responsible?

The tips basically put the burden on the shoulders of patients to "inspect" their doctor's work or to tell them what to do, including:

1) Ask that hospital staff clean their hands before treating you

2) Before your doctor uses a stethoscope, ask that the diaphragm (the flat surface) be wiped with alcohol.

9) Ask your doctor about keeping you warm during surgery.

14) If you must have an IV, make sure that it's inserted and removed under clean conditions and changed every 3 to 4 days.

This is ridiculous. Maybe the burden for cleaning the "thingy "on the "doohickey" around the doctor's neck that checks your ticker should be placed on someone who knows what the diaphragm is on the stethoscope without parenthetical explanations.

Do we see this need in other industries? The need to put the burden of safety on the customer?

I can just see it now:

15 Steps You Can Take to Reduce Your Risk of Your Plane Crashing, including:

1. Carry a handheld Breathalyzer and ask your pilot to blow into it before takeoff.
2. Ask to see your airline's maintenance records

15 Steps You Can Take to Reduce Your Risk of Your New Car Having Defects, including:

1. Have the dealer triple check that the wheels' lug nuts have been tightened properly
2. Ask to see the Statistical Process Control charts that verify that your engine's cylinder bore diameters are within design tolerances.
   

15 Steps You Can Take to Reduce Your Risk of Your New PC Failing, including:

1. Make an unannounced trip to the factory and ask that PC assembly operators are wearing proper static-protection wrist bands.
2. Ensure that the bands and their grounding are properly grounded (press the button labeled "test" on the workstation)
   

Asking patients to track such details, expecting THEM to know how often an IV should be changed is an outrage. Hospitals and physicians, please quit abdicating your patient safety responsibilities onto the patients. If hospitals were following "standardized work" practices, we wouldn't have to make patients worry about and track issues like this themselves.

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Relying on Memory Leads to Errors

Patient Safety Blog - Telling Our Stories

Here is an unfortunate story about a surgeon operating on the wrong side of an 86 year-old man, who died sooner after. There's no clear cause-and-effect between that error and death:

The surgeon didn’t confirm his memory by checking the CT scan, health inspectors found. He wrote down the wrong side on the form, and then cut open the wrong side. When he realized his error, he operated on the correct side.

The patient 86-died Saturday, and the medical examiner's office is still trying to determine whether the surgical error contributed to his death.

Procedures were clearly not followed, even given that this was an emergency surgery.

The hospital's chief quality officer said that the staff's sense of urgency about caring for the patient had superseded the rules.

Of course, as the quality officer added, emergencies are "exactly where policies and procedures need to be as tight as possible."

Exactly. Policies and procedures are in place to protect patients and I can't imagine it would have taken much longer for things to be done properly.

The book "To Err Is Human: Building a Safer Health System", about 7 years old at this point, pointed out that relying on memory was a major cause of errors. Standardized Work was not followed in this case -- how do we prevent that error from happening again? There were many people involved in this error, I'm not trying to point fingers just at the surgeon. We need to ask "why?" Why did this happen? Follow through the "5 Whys." If a response is "it was an emergency and we were busy," what is the "why?" for that? Was staffing too low? Not enough training? Not enough leadership oversight of the Standardized Work?

You might wonder if the recommended "time out" process was in place, a recommended practice where any participant can "pull the andon cord" to "stop the line" (stopping the procedure, really).

Cooper said that she believed someone in the operating room had questioned whether the correct side was being cut, but the surgeon was confident he was right.

There's yet another element of Standardized Work that was not followed. Overconfidence and over-reliance on memory sure seem to be contributing factors.

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We Must Follow Standardized Work, Right?

The Informed Patient - WSJ.com

Here's an article ($$) about hospitals working to prevent bedsores or "pressure ulcers" as they are called. I didn't get around to blogging about this more fully, but it was in the news recently that the federal government is going to stop paying hospitals for "reasonably preventable" errors, such as bed sores, items left inside patients after surgery and some others. On the one hand, this is good and "Lean" -- it's a form of waste to pay for things twice, things that should have been done right the first time. There's plenty of argument over what's preventable and what's provable -- did the patient have that condition before entering the hospital or not. I'll try to write more about that again in that delayed post on those issues.

There are certain preventive measures that hospitals and their employees can follow to help reduce or eliminate bed sores. Those measures could be considered a form of "Standardized Work," as we would call it in the Lean world. But are those measures followed?

Owensboro Medical Health System in Kentucky began a program in 2000 that included putting pictures of clouds on the doors of at-risk patients to remind nurses to reposition them in their beds every two hours. But a study in 2003 found it hadn't made a dent in reducing pressure ulcers. Joni Sims, a nurse and director of medical/surgical services, says nurses weren't all adhering to the turn schedules, and some patients who were at risk didn't get the cloud symbols. The hospital switched to turn clocks in each patient's room with a clearly marked schedule for turning patients every two hours; it also provided nurses' assistants with pagers to remind them of turn times.

Byron Morris, a nurse at Owensboro, says that the assistants help by repositioning patients if the nurse is busy. The paging system "can be unnerving, but it's all worth it in the end," he adds. "A little prevention goes a long way."

So in the first attempt, 2000, the hospital basically relied on "be careful" reminders -- reminders that weren't always put on the doors when needed (a different weakness in the standardized work). "Be careful" is a very weak form of error proofing, as we're human, we get busy, we get frazzled, we can't always "be careful." The second attempt, in 2003, seemed a bit better, going with the clocks and the pagers, but what happened if the clocks or pagers are ignored? These technology solutions don't ENFORCE the standardized work. Who is overseeing the process to make sure the standardized work is followed properly? Nobody?

Even with apparent flaws in the system, progress was made:

Owensboro has reduced the incidence of skin breakdown at the hospital to 3% of patients from 24% in 2000, preventing an estimated 474 pressure ulcers from March 2003 to March 2007. That comes to a savings of as much as $1.9 million on treatment costs, and $97,457 in supply costs, "not to mention the harm to patients we've prevented," says Ms. Sims.

But there's still room for improvement!

This isn't about terrorizing the employees -- it's about making sure the patients are taken care of. It's about saving money for the hospital by preventing bedsores and the legal liability that can come along with it. I'm not blaming the individual employees. We have to look at the system. As administrators and leaders, there is an obligation to make sure that people CAN follow the standardized work. If it's important to do something every two hours, do you have the proper staffing levels required to ENSURE that can happen? People being too busy is NOT a good excuse. You have two options -- reduce waste to free up time or add people. We all know what the preferred option would be.

We could also challenge, as the hospital above did, why highly skilled nurses have to be repositioning patients. Why not have lower-paid assistants do that kind of more menial work? Seems like repositioning patients wouldn't be the best use of nurse time. That's a system design issue that management is responsible for -- are the right people doing the right kind of work? Lean manufacturers solved this a long time ago -- highly skilled machinists aren't responsible for chasing down their own parts, lower paid assistants bring the parts to them. Why don't we treat nurses and their time (and skill) with the same kind of respect?

So, my final thought comes back to the enforcement of standardized work. We can't turn managers into police, running around making sure people are doing the right thing constantly. But, we have to recognize standardized work doesn't implement itself. It requires oversight -- make sure people have the time required to follow the standardized work, make sure they know WHY the standardized work is important (to rely on intrinsic motivation), and make sure those who are not following the standard work aren't just blamed. Rather, they should be involved in the problem solving process to figure out how we can ensure the standardized work is really followed, every patient, every hour, every day. Too much is at stake to do otherwise, right?

I got a blurb on the Marketplace website

APM Marketplace (Business/Economy radio)

As you've read here, I'm trying to help get the word out that we should be not just focusing on access to care, but also focusing on quality of care -- preventable medical mistakes. I think it's much more realistic to solve the medical mistakes problem, with Lean, than it is to solve the access problem.

I submitted a blurb to the "rants" section of the Marketplace website and they printed it (without name, but I'm sure you'll believe it's me).

The webpage changes every day, so here's the text of it:

[Michael] Moore cites statistics that say 18,000 Americans a year die because they lack access to good healthcare. That's a tragedy. The bigger killer that's being ignored by Moore and the media are the patients who are killed when they do have access. The Institute of Medicine estimates that 98,000 Americans per year die because of preventable medical errors — wrong drugs given, hospital acquired infections, errors in surgery, etc. This problem does not go away even with universal coverage. Canada has a per-capital error rate that's as bad (if not slightly worse) than the U.S. The UK has major medical error problems as well. So, it's not the payment system that's the factor there. These are problems that hospitals are struggling with worldwide.

I'm also going to try submitting a 400 word essay on the topic to try to help get more exposure for the issue and the role Lean can play.

The Growing Patient Safety Movement

The Informed Patient - WSJ.com

This article from the WSJ talks about a trend where patients (or, more often, family members of patients) who were injured or killed by medical mistakes are dedicating their lives to improving patient safety for others, instead of just suing the pants off of everybody. In many cases, people are taking their settlements and are turning that money into a useful and productive outlet, patient safety advocacy organizations.

For one, this speaks to the importances and meaning of healthcare.... rarely (if ever) does a person say "I got a defective engine, I need to make sure that never happens to another customer."

When her 18-month-old daughter Josie died after a series of medical mistakes at Johns Hopkins Children's Center in Baltimore six years ago, Sorrel King was consumed by grief and anger, wanting to destroy the hospital and even end her own life. But with three other children to live for, she and her husband Tony decided they had to help fix a broken system.

"We had to do something good that would prevent this from ever happening to a child again," Ms. King says. When the hospital offered a financial settlement, Ms. King, a former fashion designer who had become a stay-at-home mom, asked Johns Hopkins to take some of the money back to start a children's safety program. She also created the Josie King Foundation to fund safety initiatives at other hospitals.

Now, to take the message to a broader audience of both consumers and medical professionals, she is launching a new Web site, josieking.org, with her own blog on patient safety; an online community where families can post their medical-error experiences and provide emotional support; advice from medical and legal experts on how to avoid error and deal with it when occurs; and resources for hospitals seeking to improve safety.

Here is a collection of websites on patient safety and other grass roots, patient-driven efforts. In what other industry are the CUSTOMERS having to work so hard to drag their suppliers (the hospitals, health systems, and caregivers) into proactive and preventative quality improvement and error prevention? Amazing.

Josie King Foundation

PULSE - Persons United Limiting Substandards and Errors in Health Care

MITSS - Medically Induced Trauma Support Services

SurgicalFire.org - Preventing Surgical Fires

CAPS - Consumers Advocating Patient Safety

Mothers Against Medical Error