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Hospitals Treating Y2K Bug as Serious Ill

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TIMES STAFF WRITER

A cardiac monitor stalls. An ultrasound device miscalculates the age of a fetus. A radiation-therapy machine deals a deadly overdose to a cancer patient.

These dire scenarios present real concerns for hospitals scrambling to prepare for the year 2000 and, with it, the threat of malfunctioning computer technology.

Many types of medical equipment that are used to diagnose, treat or prevent disease rely on calendar dates to run properly or stamp the time on a patient’s chart. When the clock passes midnight on Dec. 31, 1999, experts predict, a significant, though unknown, number of systems could succumb to an internal flaw: They won’t recognize the programmer’s two-digit shorthand “00” for the year 2000 and, as a result, could make wrong calculations or shut down entirely.

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Medical experts say most of the medical technology in hospitals here and elsewhere should work safely and that hazards to patients will be rare. But the thought of even a few incidents is enough to cause anxiety.

“You have to look at the numbers, and this makes me worry,” says Dr. Kenneth W. Kizer, undersecretary of health for the Veterans Health Administration, which annually cares for about 3 million veterans at more than 1,100 hospitals, clinics and other facilities nationwide.

“How many patients are treated in America every day? About 3.8 million in a hospital or outpatient setting,” Kizer says. “Those in intensive care, for example, are having hundreds to thousands of interactions with technology a day. Say there’s just a tiny fraction of the devices or systems that don’t work that could cause harm--the numbers are still bothersome.”

Hospitals across the country are bracing for millennial problems of a scope and complexity that no one fully understands. Anything from a small $800 medication pump to a $1.6-million nuclear accelerator that kills tumors may be suspect. Two-digit dating errors may arise in the software or in an embedded chip.

Threats to patient safety raise the prospect of potentially huge hospital liabilities. Malpractice insurers are mulling over whether to cover any patient-related mishaps. And some hospitals have only a few months to make corrections because some date-related snafus will start showing up in January.

Hospital officials say they’re focusing first on ventilators, heart-lung machines, cardiac monitors and other life-support equipment. They’re also concerned about anything that’s technically complex, such as CT scan machines, nuclear accelerators, ultrasound equipment, lab equipment and computerized linkups between equipment.

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Unless the technology is debugged or replaced beforehand, some of this equipment will stall. Other items will keep working, with some possibly jeopardizing future care by stamping incorrect dates on patient records throughout the hospital.

Costs of Resolving Problem Are Huge

Ken Kleinberg of GartnerGroup, a Stamford, Conn., technology consulting firm, predicts the cost of trouble-shooting millennial software problems across all industries worldwide could total $300 billion to $600 billion.

He figures that the U.S. health-care system’s tribulations could account for $10 billion to $20 billion. That excludes the costs associated with medical equipment. “Nobody [knows] those numbers,” Kleinberg says.

For individual hospitals, the millennial challenge is enormous. For large hospital systems, equipped with tens of thousands of various machine makes and models, the job of locating a weak link is a mind-numbing task.

“It’s an enormous project--much bigger than I expected,” says Marc Beauchesne, a movie industry software developer hired last year to run Cedars-Sinai Health System’s Y2K project.

Cedars’ 1,000-bed hospital, research center and outpatient offices house as many as 20,000 pieces of equipment, he says. His handpicked team of a dozen technical specialists--including six biomedical engineers--has made its way through about 70% of the inventory. Thus far, they’ve turned up 1,700 pieces of clinical equipment with date-related problems.

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Among them: Fifty-two defibrillators, which modulate irregular heart rhythms, won’t work come Jan. 1, 1999. These defibrillators, worth a total of $350,000, could be fooled into working if they were reset using a bogus date, Beauchesne says. But Cedars-Sinai will replace them rather than run the risk of having an erroneous date on a patient’s record lead to errors in medical care and potential legal liability.

“If you take an X-ray of someone’s heart, for example, it must be dated appropriately so doctors can take the necessary action,” Beauchesne says.

Beauchesne estimates that the cost of resolving Cedars’ millennial problems in medical equipment will be $5 million.

For any hospital, recent changes in health care render the job difficult. Rising cost-cutting pressures by managed care have forced patients with less serious problems out of the hospital and into outpatient care. As a result, the typical hospital patient today is sicker than a decade ago.

Increasingly, hospitals are relying on electronic patient monitoring, linkups with automated laboratories and other advancing technologies to help manage care for the seriously ill. Emergency and operating rooms; intensive care units; and wards for labor, delivery and neonatal care are typically wired to the gills.

Experts guess that a small percentage of the medical equipment in use--some say 10% to 20%--faces millennial problems. Only about 2% or 3% of those could harm somebody directly. But the cost of rooting out and replacing culprits can run into the tens of millions of dollars for large hospital systems.

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Consider Catholic Healthcare West, a 40-hospital network based in San Francisco that’s been unusually aggressive in tackling the problem. Engineers have tested 92% of the organization’s 80,000 pieces of medical equipment so far. They’ve found only 3.3% with millennial glitches. Of these, only nine machines--including a cardiac monitor, a CT scan machine and a blood analyzer--shut down.

Still, Dr. Kevin Fickenscher, the network’s chief medical officer, says: “We’ve got to test all of our equipment. We don’t think it’s acceptable for one patient to have a problem as a result of this issue.”

Fickenscher estimates that the cost of analyzing the network’s medical equipment, fixing what can be fixed and replacing what can’t be will cost about $15 million.

Manufacturers Slow to Assist

Experts predict hospitals will face lawsuits that question whether they did everything possible to protect patients from millennial snafus.

“I believe there will be unnecessary deaths. But I don’t know how many or where,” consultant Joel Ackerman said at a recent conference on millennial planning for hospital managers in Orange. “Everybody is going to sue and be sued,” Ackerman told his audience.

Medical technology itself isn’t the only problem. Like other industries, hospitals could face power outages, disruptions in food, water, drugs or medical supplies and troubles in billing and other information systems.

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“I’m starting to wake up in the middle of the night,” says LeeAnn Wrenn, a director in Kaiser Permanente’s millennial project.

She estimates that 15% of the organization’s 135,000 pieces of medical equipment have year 2000 issues, most of them minor. Kaiser Permanente expects to spend more than $100 million nationally to trouble-shoot millennial problems that include equipment issues, says one official.

Hospital officials complain that many, but not all, manufacturers have been slow to help them pinpoint problem equipment.

Last year, the Veterans Health Administration queried 1,600 manufacturers of medical equipment and devices. As of August, less than half, or 728, had assured the agency that their products would work fine or that problems had been fixed. Sixty-five others admitted problems in obsolete equipment that they refuse to fix, and 46 more were still analyzing their products.

Another 130 promised to repair faulty equipment, though most didn’t divulge the nature of the problem. What’s more, 222 inquiries came back marked “Return to Sender.” An additional 102 manufacturers failed to respond, despite multiple inquiries. Another 111 have gone out of business or quit making medical equipment, and 196 have merged with other companies.

In recent months, many manufacturers have responded to regulators’ demands for more information. The Health Industry Manufacturers Assn., representing 800 companies that make 90% of the medical equipment sold in the U.S., is encouraging the industry to post information on a Web site sponsored by the Food and Drug Administration.

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Many of the larger manufacturers have established their own Web sites as well. Yet some remain reluctant to divulge protocols for testing their equipment.

“We are trying to find a way to address that issue in the FDA database. I hope we succeed,” says Bernie Liebler, the association’s director of technology and regulatory affairs. Liebler acknowledged that manufacturers, like hospitals, are loath to do anything that will affect their legal liability for equipment screw-ups: “Nobody wants to be at the wrong end of a lawsuit.”

Still, hospital managers say that not all medical equipment deemed Y2K-compliant by manufacturers passes their tests.

“We must test them all,” says Dan Forrester, a manager at Orange-based St. Joseph Health System. He says the only manufacturer he believes is one who guarantees there’s a problem.

Some hospitals may not have all their questions about every piece of equipment answered by the end of next year. James Kalyvas, a Los Angeles lawyer, recommends that they have their patients sign a waiver, much like someone involved in a medical experiment.

Necessarily, hospitals are brainstorming ways to handle the unexpected once the millennium arrives. Next spring, Hoag Memorial Hospital Presbyterian in Newport Beach will start drills for hospital employees on how to do their jobs, with or without technology.

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“Much of patient care can be provided by personnel. Technology allows us to do our job more efficiently or in a more timely way; but care in most instances can be provided without the latest and greatest in technology,” says Mary Kay Payne, a vice president in charge of Hoag’s millennial project.

Come New Year’s Eve 1999, it’s clear that many hospital managers across Southern California won’t be partying. Gordon P. Hosoda, for one, says he’ll be patrolling the emergency room and three intensive-care wards at the VA medical center in Loma Linda.

Hosoda, the hospital’s chief of clinical engineering, will focus on ventilators, heart monitors and other life-support equipment. He plans to test all the equipment in advance. But he’ll have doubles for backup, if necessary, because nobody really knows what to expect.

“It may be a mouse, it may be a lion,” Hosoda says. “We’ll hope for the mouse but prepare for the lion.”

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Times staff writer Barbara Marsh can be reached via e-mail at barbara.marsh@latimes.com.

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