College of American Pathologists
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  Maryland lab case little to
  learn, lots to remember

  cap today

February 2005
Feature Story

Anne Paxton

When standards are allowed to slip, the human cost can be incalculable. That’s a truism that was starkly brought home last year when the Baltimore Sun published the story of Maryland General Hospital’s laboratory.

Operating with faulty equipment despite repeated complaints from staff, the laboratory had continued to release HIV and HCV test results—numbers that turned out to be unreliable.

Results of tests on controls were edited to be brought within acceptable ranges, while confirmatory tests that conflicted with the hospital’s test results were ignored. At least 460 people were given potentially inaccurate HIV or HCV test results, hospital officials estimate.

All of this came to light because of a staff member who alerted Maryland state health officials.

"We heard about it right in the middle of a meeting on March 11, the day the story first appeared," says Ronald B. Lepoff, MD, chair of the CAP Commission on Laboratory Accreditation. There followed months of meetings, conference calls, policy changes, Maryland Senate hearings, and even testimony before Congress.

Now, CAP officials and other leading figures in the laboratory field look back on what most agree was a preventable tragedy—one that must serve as a wakeup call to laboratories and hospitals.

"Everybody has feared the cuts made in the infrastructure of some hospital laboratories would start to show up, and that an MGH would occur," says Pennell C. Painter, PhD, professor emeritus of pathology and director of laboratory operations for LabCorp/Dynacare Tennessee Laboratory, Knoxville. History explains much of it, he says.

Between 1966 when Medicare began and 1983 when DRGs came in, "that was essentially the heyday of medicine from a financial perspective. Many hospitals were built in that period, and actually if you look at laboratory personnel and nurses, about 70 percent of all the people who have ever been trained were trained in those years."

It was after 1983, he says, that the money gradually started going out of health care. And in 1992 the government "cracked down severely on utilization and used the judicial and enforcement branches to penalize for overuse of laboratory tests. That further drew down the income for laboratories," Dr. Painter says.

"Now we’re over 20 years out since DRGs came into effect, and laboratories have seen a gradual erosion of funds so that the vast majority of labs have moved from being profit centers to cost centers for hospitals."

Some laboratories have faced progressive cuts in their resources, to the point that "the whole infrastructure of quality started to fall out from under them."

"What we’ve been existing off is essentially that ’bank account’ of trained people," Dr. Painter says. "People are what keep the laboratories’ quality systems from collapsing—not just bodies, but people who know what they’re doing and have the time to oversee and foster all that goes into making a quality-focused laboratory."

The hospital administrative leadership is the first tier in the hospital charged with ensuring that the laboratory has what it needs to do quality work, he says. "That’s something very few people in the laboratory are aware of. It’s part of the hospital Medicare Conditions of Participation."

What tends to be forgotten, he says, is that the medical director and owner of the laboratory are the only two names that appear on the CLIA certificates, so they are held directly responsible for everything that happens in that laboratory.

If they don’t know what’s going on, they can be in for a "big surprise," he says, when something goes awry. "Some of the top people in both lab and hospital administration lost their jobs at Maryland General, and a lot of this was because they did not follow through on some of their responsibilities."

Dr. Painter recalls a case reported several years ago involving erroneous PT INR results because someone forgot to change the ISI factor used to calculate the INR, resulting in patient deaths. "But that was literally a single tech making a clerical mistake."

"The situation at MGH was very different. It was a quality systems failure, with one or more instrumental analyzers turning out incorrect results over a protracted period, the staff notifying management that something was wrong with the testing equipment, and management not effectively correcting the problem while permitting patient result reporting to continue."

If equipment is not working properly, "the remedy in lab sciences is to cease testing immediately, stop testing until the testing equipment begins working properly, and if there’s not enough money to fix it, then it stays out of service. If management decides to continue testing even though the testing systems are not working reliably, then that’s a serious problem."

Dr. Painter is not comfortable with the term "whistleblower" in this context. "The techs doing the testing have always been our first-line guardians of laboratory quality. You cannot reasonably expect to uncover the kinds of things we’re talking about here during a typical laboratory inspection, so our safeguard for quality goes back to the personnel doing the testing who, under CLIA, are required to report such problems to management."

But that big "savings account" of formally trained medical technologists is drying up now as technologists retire, he says, and that looming laboratory testing personnel shortage sets the stage for potential quality lapses. "Some places bring people in off the street and train them, which you can do under CLIA for anything moderately complex." That includes almost any automated analyzer, "so the most complicated system on the market that can do hundreds of chemistry tests at high speed is considered moderate complexity."

"The people trained to be operators often don’t understand what the results mean, and don’t know when they don’t make sense," he says. That doesn’t mean they can’t turn out reliable lab work, but it does put an additional burden on the lab’s quality system.

Autoverification systems are starting to gain the power to make some of the same informed decisions a technologist would, however, and just like a good technologist, Dr. Painter says, the better systems are able to look across all other test results in a panel and determine whether they appear reasonable before they are reported. "So as those techs who ’understand’ laboratory tests and laboratory science leave the profession," he says, "even better quality surveillance and more intelligent instrumental systems will be needed."

In the Maryland General case, there were signs that some employees were not aware that the CAP is open to hearing complaints from employees, Dr. Lepoff says.

Since 1992, when the government granted deeming authority to the CAP’s Laboratory Accreditation Program, the CAP has had in place a person dedicated just to complaints. "Complainants are a very important source of information, since no accrediting organization can be there all the time and know what happens every day to every sample," Dr. Lepoff says.

To re-emphasize that message, beginning Oct. 1 all 6,000 CAP-accredited laboratories were required to post a sign asking employees with concerns about the quality of patient testing or laboratory employee safety to call a toll-free number, and promising that their identity will be kept confidential.

Since then, the College has received about 20 calls a month, with perhaps 10 percent of them indicating potentially serious problems.

Gerald Hoeltge, MD, is the CAP’s special commissioner for non-routine processes, also known as the "complaints commissioner." The lessons that emerged from the Maryland General situation apply to all laboratories, he says.

"No. 1 is that leadership is essential to laboratory quality. The most senior people in the organization have to be committed to quality, and every laboratory has to have indicators that are meaningful and monitored by those at the top."

No. 2 is that technical staff need to take pride in excellence. "They do need clear direction regarding quality, but they also need to be involved in discussions about quality, and they need feedback on their own performance and that of the laboratory as a whole."

The third lesson is that it’s essential to pay attention to the details of every step in the analytic process, he says.

The CAP’s move to make it easier to lodge complaints has eliminated the "threshold of inconvenience," Dr. Hoeltge says. The College employs trained technologists who have a structured interview form to follow when receiving these calls.

"Sometimes I’ll call back, or it will be one of the senior people in CAP accreditation, if we need more information, because we want our followup to the laboratory to be as efficient and helpful as possible.

"The whole thing is about laboratory improvement. We’re not out to get on people’s cases; we’re here to help people find opportunities to improve."

In Dr. Lepoff’s view, the biggest lesson of the Maryland General situation is that the responsibility of the laboratory director for quality cannot be abrogated.

"Of course the situation was not simple, and I don’t pretend we’ll ever fully understand what happened. But this was a typical, inner-city urban safety-net hospital under financial pressure, as a lot of hospitals are. It has a lot of indigent patients, a lot of homeless patients."

"There were cutbacks, and at one point apparently they placed an administrative director into the laboratory who basically took administrative control from the laboratory director."

"So the laboratory director, who is a pathologist, either ceded or was forced to cede administrative control to a person who reported, as nearly as we can tell, directly to the hospital."

"The hospital was very cost-conscious, and clearly in the process of cutting back staff they went too far, and employees were hurt and patients were exponentially hurt because of poor decisions made in terms of quality."

That became very clear when the government, the Joint Commission on Accreditation of Healthcare Organizations, the state, and the CAP went in to look at the laboratory, he says. "As long as the laboratory director’s name is on the CLIA certificate, he or she has ultimate responsibility for everything that happens in the laboratory. The argument that the administration has control just doesn’t hold water."

It may sound trite, Dr. Lepoff adds, but a second lesson is that quality improvement is important. "It is so easy to pay lip service to quality assurance and not actually close the loop and fix things. And that is not going to fly. The quality assurance practices of the laboratory are the key to maintaining a quality product."

He acknowledges there’s no way to prevent hospitals from making poor management decisions, but says, "What we can do is make sure the laboratories we accredit function at a higher level than is required by law by doing a thorough and a fair inspection that represents the state of the art in how laboratories should practice laboratory medicine."

"The way to fix medical errors is not to have them happen—and the way to do that is to make sure the system works right."

Because people in the laboratory and the hospital are busy, sometimes oversight is not what it should be and followups don’t occur, says Kent Lewandrowski, MD, associate chief of pathology at Massachusetts General Hospital and associate professor at Harvard Medical School. "It reflects more of an organizational disease whereby bad practices or complaints from employees don’t necessarily get the attention they should."

The CAP and JCAHO inspections are equally vulnerable to missing these lapses, in his view. "No inspection is going to ensure uniformly across the U.S. that every laboratory is functioning optimally in all situations."

"The regulations are not built around a system designed to detect and eliminate fraud, and I think that’s a key idea here," Dr. Lewandrowski contends. "People can be engaged in good, bad, or indifferent medicine, but those engaged in fraud are entering into a potentially more criminal realm."

Is a new regulatory approach needed? One Maryland congressman thinks so: He has introduced a bill to require unannounced inspections for laboratories under Medicare and federal whistleblower protections for laboratory personnel.

But Dr. Lewandrowski says the reflex response should not be to install a raft of new regulations, conduct a public witch-hunt, or panic and overhaul the inspection process.

"You have to put it in perspective. You recognize acetaminophen toxicity kills people every day. Should it be pulled off the market because it’s a hazard to public health? Do we have to change the basic system of laboratory oversight? In my opinion, the answer is probably no.

"No amount of system and regulation, short of one that consumes the entire gross domestic product of the U.S., can prevent a similar incident happening somewhere sometime," Dr. Lewandrowski says. As long as patients are sleeping on the street outside the hospital who may have HIV and don’t know it, and tens of millions of patients are uninsured, he says, he thinks "health care dollars could be better spent."

"Was this a local problem with people clearly not doing the job they were supposed to? Or is this a widespread problem with the system coming apart and breaking down? My feeling is it’s the former. Every debacle should not result in billions of dollars in new regulations that rob productive funding from the system for little yield."

Nevertheless, says Dr. Hoeltge, who is head of the section of transfusion medicine at the Cleveland Clinic Foundation, Maryland General is not unique. "This is a hospital just like the one in your own neighborhood. It happens to be urban, but it’s a community-based primary-care hospital. It has family practitioners. People come for treatment for diabetes and high blood pressure. It’s as typical as can be. The only difference is it happens to be located in an old part of Baltimore."

It’s critical to remember that bad things can happen and the probability is they will happen, Dr. Painter says, if a lab does not have a good quality system that is fully supported. "Laboratory instrumental and noninstrumental testing systems are inherently unstable, meaning laboratory testing systems will go wrong. Not ’might,’ but ’will,’" he says.

"Laboratory testing is very complex and some institutions don’t give adequate credence to just how likely a bad result is to occur," he adds. But the quality systems on which high-quality labs operate have long been in place, and they work. "There is no magic bullet that can allow you to skip steps and still maintain consistent quality."

That’s why Dr. Painter says the Maryland General experience should perhaps not be thought of in terms of the lessons learned there but in terms of the "lessons we should have remembered."

Anne Paxton is a writer in Seattle.