Cincinnati Children's Hospital: Shots in the Dark
Near Baby J's bedside at Cincinnati Children's Hospital Medical Center sat a slim computer terminal that allowed the staff to consult the hospital's Integrating Clinical Information System (ICIS) for instructions. The system was designed to track a patient's vital signs and medication histories on a Web page, around the clock. It also allows clinicians to order simple things such as blood tests, but also morphine, X-raysand potassium chloride.
To make sure that the right amounts of medicine are applied, the clinicians are presented with standardized lists of treatments and medications known as "order sets.''
Baby J got the wrong order.
The infant was supposed to get a solution that contained a small amount of potassium chlorideabout 5 cubic centimeters (cc), equivalent to a sixth of an ounceper liter. But the underlying data written into the order set for this procedure was wrong. The code, entered somewhere along the line from a team of programmers and physicians, called for 5 cc for every 250 milliliters, a concentration four times higher than intended.
An overdose of potassium chloride can short-circuit the body's "electronic" partsbrain waves and the heart, for instance. Just a half-ounce, or 15 cc, of that chemical compound is used to still the heartbeat of a prisoner on Death Row in a capital-punishment state such as Missouri.
The doctor who clicked on the order set was unaware he was administering an overdose. Only the sharp eye of a critical-care nurse, who looked at the solution brought into the intensive care unit, stopped the more concentrated mix from entering Baby J's veins.
Incidents such as this are forcing Cincinnati Children's and other hospitals to confront the dark side of computerization: It's not a panacea for patient care.
Patient care information systems, which place drug orders and keep track of patient records and images, promise to cut medication order and dispensing errors, especially those that result from the mislabeling of lab tests or from a doctor's illegible handwritten prescription. Cincinnati Children's system has eliminated the potential for hundreds of such errors. But what goes unsaid is that these systems require significant customization, are difficult to network, and are costly, at a time when one of three health-care institutions is losing money. An order entry system alone can cost up to $15 million. And, once installed, there still are unanticipated errors and adversities, like the one confronted by Baby J.
Hospitals have the added burden of building record-keeping and order entry systems that never lose or corrupt files, nor send out inaccurate or incomplete orders. When something goes wrong in a financial or manufacturing system, says Dr. Neil Johnson, who has led many of Cincinnati Children's systems projects, "There's not a human being who's directly affected. They can have a small rate of mistakes or a small rate of bad outcomes. When we make one of those mistakes, there's not just a lawsuit on the other end, but a human suffering. Our product is a human being."
But despite the best intentions, computer systems have not eliminated mistakes at Cincinnati Children's or other health-care facilities. The problems include:
There is no indisputable data on the number of errors caused by information technology, or for that matter on how many total medical errors existeven though the National Academy of Sciences' Institute of Medicine estimated in 2003 that "tens, if not hundreds of thousands" of mistakes occur daily.
In an academic paper published in March, a team led by Joan Ash, an associate professor at Oregon Health & Science University, detailed problems caused by patient care information systems at several hospitals in the U.S., Australia and the Netherlands. Ash said she was able to trace many of the troubles with patient care information systems to two main problems: errors in communications and coordinating processes, and errors in entering and retrieving data. A Price to Pay
The first set of errors, in communications or coordination, can result if the system overwhelms a clinician with information. At Cincinnati Children's, a doctor examining a patient picked up an abnormal heart rhythm. One way to get the heart back to normal is to use a medication called Adenosine, a drug that if not administered carefully could stop a patient's heart. The doctor, who wanted a tiny dosea fraction of a cubic centimetermistakenly wrote into the system a prescription for a dose 10 times stronger than what he had intended. The computer system has alert messages that flash on the screen when an overdose is suspected, but this doctor ignored the warnings.
The drug was administered, but luckily that patient's body flushed the drug without suffering any harm. Dr. Craig Hallstrom, a physician at the hospital who tracked the unintended consequences of the patient care system, said one of the problems in this instance was that the system had too many alerts. Physicians were coming across warnings for allergies, drug interactions and other potential problems almost every time they ordered a drug. Before long, doctors become desensitized to the alerts.
Data entry and retrieval problems can result from something as simple as a poor screen design, such as those with "pick and click" interfaces that allow doctors to check boxes to order medications and tests.
These screens often cram too many options into too little space, making it easy for time-harried physicians to pick the wrong medicine or dosage. For instance, another Cincinnati Children's doctor, when ordering a mild pain reliever, was given the choice to order the medication in pill or liquid form. The physician mistakenly hit "tablets" instead of "milliliters" when clicking off dosage options, ignored subsequent warnings to reconsider, and ended up prescribing 325 tablets of Tylenol to be administered to a child. The amount of Tylenol ordered was a potentially harmful dose, but was so out-of-bounds that a pharmacist easily caught the error.
"The only people who think [this is] easy are the people who haven't done it," Johnson says.
The difficulties of electronic record-keeping and order-processing are so substantial that, to date, only 159 of 5,794 U.S. hospitalsaround 2.7%have live order entry systems that doctors use, according to KLAS Enterprises, a research company specializing in health-care information technology.
Yet early this year, ignoring the odds, President Bush won support from both Democrats and Republicans in Congress when he launched his own "moon shot" program: a call to create a national electronic health-records system within 10 years that would allow patients to own and share their medical information with hospitals and other health-care providers. He appointed a coordinator, Dr. David Brailer, and budgeted $150 million for research and development to get the job done.
So far, the various health-care constituenciesinsurers, hospitals, doctors, policy makershave agreed on what technical issues to address. Standards for recording and exchanging data, as well as federal certification of technologies and products, are on the list. But few, if any, details on what is specifically needed or how results will be achieved have been worked out. There have not even been any noticeable discussions during this initiative, which is led by the U.S. Department of Health and Human Services, of using technology to track and report medical errors. The project to unify record-keeping and exchange could cost as much as $1 trillion to install.
Yet it could promote a greater "culture of safety'' in the health-care industry. Advocates of increasing patient safety, such as David M. Lawrence, chairman emeritus of the Kaiser Foundation Health Plan, say the airline industry can be a model. From 1950 to 1990, fatalities in commercial aviation fell 80% after the industry began meticulously analyzing accidents and near-misses.
But while hospitals have leaped at the chance to invest in new technologies that they can charge for, such as whole-body scanners, they have been slow to invest in or fund the development of computer software and hardware that improve patient care and safety. In May, Forrester Research found that while organizations across the country plan to increase their information-system spending this year by 2.4%, hospitals will increase tech spending by only 1.9%. And last month, the Medical Records Institute, a group pushing for the adoption of electronic health-care records, found that 55% of the 800 health-care managers it surveyed cited a lack of funds as the biggest barrier to the adoption of electronic health records. As a result, it may indeed take 10 yearsor morefor a common method of keeping track of patient care instructions and history to emerge and be adopted.
So why would any health-care institution want to go through the pain of converting to electronic records? If they want to see why it's worth it, administrators and physicians need only look at Cincinnati Children's Hospital.
Despite the difficulties, Cincinnati Children's, through hard work and force of will, built a system that, in the two years it's been installed, has cut medication order and dispensing errors to fewer than 90 a month from almost 120 a month in 2003; virtually eliminated mislabeled lab reports, such as putting the wrong patient's name on a blood test, to 0.02% from about 0.08% in 2002; and cut the time it takes to deliver drugs from the pharmacy to the bedside from almost two hours in 2002 to one hour.
The result: the 423-bed, not-for-profit medical center, which specializes in pediatric medicine, research and teaching, last year was the first children's hospital to win the Nicholas E. Davies Award of Excellence, given by the Health Information Management Systems Society for progress in computerizing patient records.
"Their drive to become better, and their willingness to pay the price, is unique," says Jerome Dykstra, a systems consultant in Chicago who has worked with Cincinnati Children's since 1997.
Parents from around the world bring their children babies in strollers, toddlers walking the halls with stuffed animals in handto Cincinnati Children's. And for good reason: The pediatric medical center is consistently placed among the top 10 children's hospitals in an annual U.S. News & World Report ranking.
Among similarly sized U.S. pediatric hospitals, the National Association of Children's Hospitals has ranked Cincinnati Children's second in the number of surgical procedures performed (24,000 inpatient and outpatient procedures in fiscal 2003) and fourth in the number of emergency visits (84,486 in fiscal 2003). In all, the hospital last year saw 700,000 kids for traumas, liver ailments, and heart and bone marrow transplants.
Dr. Johnson, a slim, 51-year-old radiologist who was born in Australia, glides quickly across the facility's finely polished floors, offering a friendly "G'day" to the doctors and nurses he recognizes. A typical day for Johnson, who coordinates the hospital's medical services with its information-systems initiatives, might be a morning meeting in his office to explain a plan to install a new medical-imaging management system, and an afternoon over an operating table where he'll take a biopsy of a 16-year-old boy with a strange growth in his hip.
After a doctor recruited him to the States, Johnson found himself in Cincinnati in the late 1990s just as radiology digital-imaging systems, known as Picture Archiving and Communication Systems (PACS), were coming onto the market. Soon, Johnson was helping get one of the systems installed in Cincinnati Children's radiology department.
Between 85% and 90% of patients at Cincinnati Children's have an X-ray, CT scan or other medical image taken. But, Johnson says, when he arrived, the department was awash in pictures and paper files: "It was obvious what had to happen."
The imaging archive Johnson put in place was the hospital's first big deployment of an information system for a clinical service. Today, Cincinnati Children's uses no film. The system captures X-ray, Magnetic Resonance Imaging and other medical images in digits and then zaps them around the hospital. Images are put up as dots on screens, not sheets of film in folders, speeding analysis and reporting.
Now it takes just 7 hours for a doctor to examine X-rays and CT scans and prepare a report on a patient's condition. In 2000, it took more than 28.
In the use of computers, Johnson says, "Radiology was way ahead of the hospital."
But some doctors, such as orthopedic surgeons, resisted. They wanted to hold a picture in their hand, or didn't want to take the time to log in to a computer to see medical images, or both. User complaints are something Johnson has gotten accustomed to over the years, and they are commemorated by decals of bullet holes on his office door. "We got shot at a lot," he says. But the archiving team slowly brought dissenters along.
Johnson personally spent time with the doctors, showing them the ropes, and even took some of them on field trips to other hospitals that had adopted the system to show skeptics how the system helped save hours in figuring out the problems a patient was experiencing.
"It was a standoff for a while," he says. "But I knew it was the right thing to do."
About the time Johnson was completing the PACS system, the Institute of Medicine issued a sobering report asserting that errors in medical treatment killed as many as 98,000 people per year. The report shocked the public, while the medical community debated fiercely whether the institute's death rates were accurate. There was, however, no debate on the central thesis: Everyday errors in prescribing and executing care for patients were a big problem. And just recently, on July 27, a Colorado health-care consulting firm, HealthGrades, released a study that doubled the estimate of deaths each year due to medical errors, to 195,000.
The 1999 Institute of Medicine study and an internal report that found its own staff making medication errors forced Cincinnati Children's to concentrate on how to protect its patients from human mistakes. By 2000, a committee of doctors, nurses and staff were looking into the benefits of computerized medication order entry. The group found several studies indicating that computer systems for ordering drugs did in fact reduce errors from bad handwriting, could warn physicians about potential overdoses, and tracked procedures and medications better than paper-based systems.
A 1999 study by a group of physicians, including Dr. David Bates of Brigham and Women's Hospital and Harvard Medical School, and Dr. Jonathan Teich of the Harvard School of Public Health, found that medication errors fell more than 80% when a hospital installed an electronic order system, although the paper also warned of the potential for "causing new errors."
The committee recommended that the hospital move to computerized order entry. Hospital managers were also realizing that what the hospital really needed was to automate and integrate all of its patient care processes. The paper-based process that had long been in place, says chief executive officer James Anderson, was "inefficient, shabby."
At that point, however, the hospital managers had little inkling of the challenges ahead.System Operations
Today, the hospital has ICIS in place. The system is based on a software bundle from Siemens Medical called Invision that helps Cincinnati Children's and scores of other health-care providers with everything from record-keeping to billing to order entry to tracking patients' medications.
In the mid-1990s, the hospital was using Invision for billing and other financial functions. But it wasn't until 2000 that it tried to computerize the way doctors entered orders for medication and other clinical treatment of young patients, and to keep a digital record of vital signs, weights and assessments of a patient's condition.
That didn't mean the Siemens system could do all that. The Siemens software, for instance, couldn't check the accuracy of doses of medicine prescribed for young patients, couldn't fully process critical-care nursing documents, and didn't easily integrate with other systems the hospital decided to use. In addition, the hospital's information-technology staff had to come up with a way within the system to, for instance, capture and program the order sets that would standardize repeatable medical treatments.
The icis software, and the hardware needed to run it, cost about $14 millionno small amount for a hospital with an annual budget of about $20 million for information technology. The hospital would also find that its new software would overload its mainframe system, necessitating the $1.8 million purchase of new computer and storage equipment.
"We ran into our share of implementation issues," Johnson says.
There were people challenges as well. Doctors, long accustomed to simply telling nurses how they wanted patients cared for and scratching a few lines on a prescription pad to order medication, now would be required to fill out specific fields on screen to say how a patient's care should proceed. Even a simple request for aspirin would have to be typed in before it could be sent to an on-site pharmacy.
The time taken to order treatment can be as time-consuming as the treatment itself. Ear, nose and throat specialists, for instance, can often perform a simple ear-tube insertion procedure, which helps kids drain fluids from their ears, in about 5 minutes. In the past, when they were done, they could just tell a nurse how they wanted their patients to be looked after.
The system requires these doctors to sit at a computer terminal, log in, fill out an ordersay, for an antibioticand log back out. That could take 5 minutes each time. With 20 or more procedures a day, that can add hours to their schedules.
To overcome this problem, Johnson says the team honed the ENT order set. Since ENT doctors rarely deviate from common after-care orders, they weren't presented with multiple choices on which drugs to order or the amount of time the child should be watched by a nurse before discharge. The system instead presents a complete screen the physician can simply OK with a few clicks. Additional choices are presented only if the care deviates from standard procedure.
Other problems weren't as easy to solve. One of the biggest hurdles was adding a dosage-checker for kids and newborns such as Baby J.
Many systems for adults, including one from Siemens, come with a program that checks medications against a list of characteristics and requirements, such as how the drugs interact with other pharmaceuticals and a patient's maximum allowable daily dose. When there are potential problems, such software may flash a red "Dose Check Warning" message on the screen when a single order exceeds the recommended daily dose.
But few if any vendors on the market offer a product to check for errors in pediatric prescriptions. Part of the problem is that dosing children is a major challenge, says Marianne James, the hospital's vice president of information services.
"In an adult hospital, you dose based on a vial of this or a capsule of that," says Dr. Brian Jacobs, the hospital's director of technology and patient safety. "We take care of children who range in size from 500 grams [about 1.1 pounds] all the way to 150 kilograms [about 330 pounds]. In children, we always dose per kilo. So a dose of morphine is 0.1 milligrams per kilo. That's a very different dose for a premature infant than it is for an obese adolescent."
Cincinnati Children's team used a database from a company called First Databank that contains information on the properties of all drugs approved by the U.S. Food and Drug Administration, plus information on the characteristics of herbal and dietary supplements. Then it tied the database into an electronic list of the drugs the hospital uses, and added a homegrown program to make sure the doses doctors ordered were in line with their pediatric patient's weight and age.
That was the easy part.
What took time and effort was setting the error warnings. Cincinnati Children's recruited a team of doctors to figure out the trigger points for the alarms.
The hospital has some 3,800 drugs listed in its system, with 470 considered potentially toxic. While a doctor might prescribe 20 milligrams of morphine to a terminal cancer patient in severe pain, a 20-milligram dose of the drug could be fatal to an infant. It took the hospital three to four months to check all of the drug possibilities.
"It's quite onerous," says Johnson.
Considering the effort, it's somewhat ironic that the alerts were partly responsible for the incidents in which doctors mistakenly ordered the 325 tablets of Tylenol and the overdose of Adenosine.
Granted, that's just two incidents out of 4.2 million drugs ordered since the system went live in 2002, but they forced the hospital to confront such unintended consequences head-on. For instance, Jacobs, who was the ICIS project leader, says it became clear early on that the system generated too many alerts. A poll of physicians found about 75% of the alerts were useless. Oncologists, for instance, didn't need to see a warning every time they ordered 20 milligrams of morphine.
Since then, Jacobs and his team have been going through the program and simply suppressing those alerts they think extraneous. But in a follow-up poll, doctors said they still found 50% of the alerts useless.
"It's well known that if you have too many alerts, people just dismiss them without reading," Johnson says.
With that in mind, he explains, the team realized it needed to build "blocks" into the system that would not allow doctors to prescribe excessive doses of dangerous drugs. The hospital put blocks on 105 of its 470 toxic drugs.
Today, if a doctor mistakenly tries to order a harmful dosagesay, 2 milligrams of the anesthetic Lidocaine for each kilogram of the patient's weightthe system will not let the order go through. If the doctor really wants the drug, he has to call down to the pharmacy and explain why the dose is necessary.
The measures appear to be working, but the hospital had to come up with its own metric for determining that. The reporting of errors and near-misses is voluntary in most hospitals. So Jacobs says Cincinnati Children's began to track the use of drug antidotes as a measure of the system's success. By looking at the number of orders for Narcan, a morphine overdose medication, for instance, the hospital can back into a count of morphine medication errors. The hospital says there were eight Narcan orders in the six months leading to the launch of the system, but only one in the six months after it was deployed.
Meanwhile, the team working on the ICIS computer interface redesigned the screen for ordering a drug. Where once a doctor had a pull-down menu to choose between administering a drug as a liquid or tablet, the physician now has to type in his preference. This eliminates "form errors.''
"We've eliminated a lot of those form options because mistakes were made," says Gayle Lykowski, a registered nurse now working as a systems analyst in the information-systems department.
But as hard as the staff worked to fill the gaps and get the system right, the hospital in some ways is just scratching the surface, Johnson believes.
For instance, after a doctor prescribes a medication, the system sends the request to a printer in the pharmacy. The druggist takes the printout and rekeys the order into the pharmacy's own inventory control system, called Worx.
According to John Hingle, operations specialist in the department of pharmacy at Cincinnati Children's, Siemens owns the proprietary code needed to integrate ICIS with outside pharmacy systems and does not share it. Siemens says it often shares code, but has not yet created software that will connect its application to the hospital's pharmacy system.
Tying its systems together, especially as it tries to create a holistic view of patients in its care, is a challenge for Cincinnati Children's. According to James, the hospital has a dozen systems. One system tracks cardiology patients, another tracks psychiatric patients, and yet another tracks cancer outpatients. In one case, the struggle to tie the Siemens-based ICIS to a GE critical-care notation system has delayed a long-standing plan to electronically document the care of critically ill patients.
"It's tough sometimes to get [the vendors' products] to work together," says James.
In the critical-care units of Cincinnati Children's, doctors and nurses use a large piece of paper called a flow sheet to track their patients' progress. The document includes vital signs, readings of ventilator settings and details on the medications and liquids delivered to the patient. The single sheet allows clinicians to quickly determine the next course of treatment.
A digital version of this would allow clinicians to view data in side-by-side graphs and also automatically chart data, so they can more quickly spot changes in patients' health.
Cincinnati Children's chose to bring in GE's Centricity Acute Care package to keep track of vitals, medications and treatment because it felt the GE package could clearly present data such as the relationships between factors like medications and vital signs. Siemens was working to bolster its critical-care product, but Donald Rucker, a medical doctor and Siemens' chief medical officer, admits the software had its "limits" when Cincinnati Children's was making its decision in 2002.
The challenge now is that while doctors will be planning care with the GE package, they'll still need access to the ICIS system to order painkillers, antibiotics and other medications.
The hospital decided to go with a third-party software package from Sentillion, an Andover, Mass., company that helps health-care organizations link different computer systems. James thought Sentillion would best meet the hospital's needs. The Sentillion product, Vergence, is designed to let doctors sign on once and access both the GE and ICIS systems. In this setup, Sentillion sits between the two systems. When a user logs in to ICIS, Sentillion will connect to Centricity and tap into it on request, allowing the GE program to appear as a selection on the ICIS screen.
But the pilots have resulted in some "flippy" exchanges, says James. Sometimes when a nurse or doctor picks a patient from one system, they get an "Other Patient Not Found" notice when they look for a file in the other system. "It doesn't work half the time," James laments.
"It's a question of working out the bugs," she says. "It's part of being on the edge of trying to do things that are different."
The cultural challenges, however, proved to be just as tough as the technical travails, Johnson says.
Cincinnati Children's knew from the beginning that if it was to have any chance of success, it needed to get its medical department directors, doctors and nurses to use the system consistently and happily. But the hospital did have an edge. Unlike a community hospital, in which private practitioners treat patients in the facility, the doctors who work in Cincinnati Children's are hired hands. Being the boss gave the hospital's managers the ability to mandate usage of the system.
"I don't know how [one] puts these systems into a hospital where all the physicians are independent, private practitioners," Johnson says.
Throughout the process, both Johnson and Jacobs said they wanted to be sure there were no revolts like the one that led to systems suspension at Cedars-Sinai in Los Angeles.
The plan: provide extensive training tailored to doctors' schedules. Also, offer one-on-one sessions and plenty of 24/7 support when the systems went live in the units.
Nurses, though, took the brunt of the implementation headaches. Installation of the computer terminals disrupted the daily flow, as new machines were put on the floors and both the paper and electronic systems had to run in parallel during installation so no orders were missed. Plus, while doctors come in and out of the units, a large part of a nurse's day is taking vitals and administering meds, which had to be done electronically.
Yet some of the nurses had never touched a computer. For the "newbies," the hospital provided basic computer training. And the hospital's nursing managers held some hands and held others' feet to the fire, to get the staff using the system. "Nursing leadership was big," Johnson says.
The project team also rolled out the system in stages. Johnson and the ICIS leaders came up with a plan called Radiology Lite, a pilot system that allowed one group, intensive care, to perform one task, radiology orders, on the system.
The pilot introduced doctors and nurses to the system, promoted its acceptance, and allowed the ICIS team to test the system in the real world. After its success, the full order entry and clinical documentation system was piloted in two medical surgical units in the spring of 2002, with rollouts to the hospital's other units through the end of that year.
Today, ICIS is widely used throughout the hospital, although some pieces are still not up. In the hematology/ oncology unit, an order set for chemotherapy treatments has yet to be built. Chemotherapy is based on a number of factors, including how well a treatment works and how a patient responds to a dose. Because of the variables, the staff has had to spend additional time checking order sets.
And Johnson is working on a PACS upgrade. He's leading a team implementing an image and record-keeping system that will feature voice-recognition dictation. That way, radiologists could sit at a terminal, look over results and dictate the findings, all in one sitting. The goal is compiling radiology reports in as little as an hour, Johnson says. His department and GE are trying to work this through. But much of the code the vendor is writing is new. For GE, he says, "It's like starting over."
Perhaps a more strategic initiative is getting single, complete records for every patient the hospital treats.
The outpatient department is testing GE's Logician software, which is tailored for handling one-day visits. The outpatient staff is just beginning to make decisions on how the system should collect and send admissions, orders and test results to inpatient and other patient care systems. For now, inpatient and outpatient electronic medical records are not unified.
But Johnson isn't sure the hospital should even call the end result an electronic medical records system.
"I hate that term," he says. He doesn't feel it accurately describes what happens in the hospital, as the systems are more than just a electronic copy of a patient's chart. What Cincinnati Children's is using, he says, is a clinical information system: "The chart doesn't say, 'Doc, it's the wrong dose.'"
The Bush administration's electronic health records push is also looking at more than just electronic charting. The aim is to create an information infrastructure that can be used not just to record what's happening to current patients, but to improve care of all patients in the future.
But Johnson wonders whether Washington understands the challenges. "It's good that the national political scene is paying attention. But I'm personally concerned," he says. "Just as the expectation of the doctors hereeven a few years agowas that if we picked the right vendor, got the right technology and installed it, everything would work perfectly. That is no longer the myth it used to be in this institution."
Johnson says he's worried that people outside health care don't realize the technical and cultural challenges involved. And they may not be ready for the unanticipated consequences.
"Throwing money and technology alone at hospitals will not [give] them integrated, beautiful electronic medical records anytime soon," Johnson says. As Cincinnati Children's has found out, "It's a long slog."