Maryland General

July 2004

There are two questions that all laboratory professionals are asking (or should be) about the scandal at Maryland General Hospital: How could it get this bad? and How could it take so long to discover the problem? Dr. Westgard and Sten Westgard try to answer those questions, and pose an even more important question: Are there more Maryland Generals out there?

Hear, Hear, Hear! Hearings on untruth and unquality!
Part III. Broken Windows at Maryland General Hospital

• "Broken Windows" Theory
• Broken Windows in the Hospital and Laboratory Administration
• Broken Windows in the Regulatory Process
• Does Broken Windows apply to Healthcare Laboratories?
• One Final Question

with Sten Westgard, MS

In the wake of the Maryland General Hospital laboratory scandal, at least two important questions remain unanswered for the laboratory community: How could this happen? And why did it take so long to discover?

The list of problems at the Maryland General Hospital laboratory has been summarized in a previous discussion on this website. Let is suffice to say that the basic workings of a laboratory broke down – to the point where control data was being faked, the staff was hiding problems from inspectors, and warnings about conditions in the laboratory were being ignored outright by the laboratory and hospital administration.

But why? While little is known about the individual workers in the lab, it's safe to assume that this wasn't an exceptional group of bad apples. Quite the contrary, it was two of the workers, Kristin Turner and Theresa Williams, who blew the whistle on conditions in the lab and brought media attention to the problem. These two technologists both indicated that many workers at the lab were concerned about the quality of testing, but were pressured to produce results regardless of quality by laboratory administration. In fact, the consequent inspections and judgments have laid the blame on poor management of the lab -- the administrative lab director, medical director of the laboratory, and President and Chief Executive of Maryland General Hospital have all resigned.

“Broken Windows” Theory

One way to understand what happened is the “broken windows” theory, which was originally described by James Q. Wilson and George L. Kelling in the March 1982 issue of the Atlantic Monthly in an article titled “Broken Windows: The police and neighborhood safety.” This article has had profound effects on police work and law enforcement ever since, but the core theory has applications in healthcare as well.

“Broken Windows” theory is a metaphor for attitudes about tolerance for deviant behavior and disorder. The name of the theory and its central premise is based on an observation made by both social psychologists and police officers: if “a window in a building is broken and is left unrepaired, all the rest of the windows will soon be broken. This is as true in nice neighborhoods as in rundown ones.”

“Philip Zimbardo, a Stanford psychologist, reported in 1969 on some experiments testing the broken-window theory. He arranged to have an automobile without license plates parked with its hood up on a street...in Palo Alto, California....The car in Palo Alto sat untouched for more than a week. Then Zimbardo smashed part of it with a sledgehammer. Soon, passersby were joining in. Within a few hours, the car had been turned upside down and utterly destroyed.”
http://www.theatlantic.com/politics/crime/windows.htm

A “Broken Window” is a sign that disorder is tolerated and order will not be enforced. It sends a message that another window can be broken without consequence, and another, and another, until all the windows are broken.

In law enforcement, Broken Windows was taken to mean that there should be no tolerance for disorder, even minor crimes like vandalism and pan-handling. New York City's dramatic reduction in crime was credited to policing based on Broken Windows theory.

Maryland General is a case where the laboratory tolerated the disorder of a few broken windows, then a few more, then more and more until there was a very serious problem with the reliability of HIV and hepatitis tests. How could it get this bad?

Broken Windows in the Laboratory and Hospital Administration

Through the Congressional testimony, it is clear that the laboratory administration at Maryland General was a Broken Window. The message that was sent to staff and was reinforced forcefully was that quality didn't matter, but getting test results out the door did. Furthermore, management not only ignored staff concerns about quality, but threatened and intimidated those staff who raised the issue.

As far back as 2002, workers were complaining about conditions in the laboratory. In a letter sent on July 25, 2002, several workers sent a letter to the hospital president and state health officials:

“We have no recourse and feel as though we have been targeted as troublemakers for coming forward with our concerns. No one will listen. Many people would like to come forward to tell of the atrocities that they have witnessed, but the costs are high and the threats to job loss and retaliation are ever present.”

One of those workers was Theresa Williams. In a followup letter in March 2004, she said that lab employees at Maryland General were working “under a cloud of fear.” As proof of her claim, she provided memos, emails and other documents dating back to 2001.

One memo dated August 9, 2002, reveals that the lab administrator retaliated against a worker who had voiced concerns about the quality of laboratory testing. The memo stated the employee was “seen as a focal point of destructive criticism,” and the worker was warned that she would be disciplined if she continued to complain.

Williams also said that the staff was “poorly trained, overworked and morale was low. We were all totally overwhelmed...Everyone complained individually and in groups to management about the lack of monitoring and all the other problems, but nothing was done.” According to her, the technicians “were fearful of the accuracy of the test results that they were being required to report out.” [Walter F. Roche, Jr., Lab Workers warned Maryland General 2 years ago, April 22, 2004, Baltimore Sun]

Kristin Turner's congressional testimony corroborates this:

“The problems at Maryland General stemmed from a lack of accountability at every level in administration, and a grave disregard for the health and safety of people in that community. In the laboratory, one man was allowed to choose profit over patient safety and his actions were never questioned by his superiors; making them just as responsible for the multitude of problems that resulted from his decision. Patients were provided less than optimal care, and were provided results from a machine that he knew was unreliable and unable to be validated. He demanded that the results be run in house instead of sent out, even with the equipment problems, because the Labotech was the 'money-maker' for the laboratory and to send out tests would have cost the hospital money. In my view his conduct was a betrayal of the community’s trust which the administration allowed to continue.”

“....What is particularly disappointing is Maryland General Hospital's response to this public health catastrophe. When its laboratory practices were first called into question, the hospital circled the wagons around [laboratory] and other administrators who failed to do their jobs. They denied responsibility and awareness of the serious problems their lack of action caused.”

[Kristin Turner, Statement to Congress, May 18, 2004]

This isn't so much a case of management tolerating broken windows as the managers themselves throwing rocks through the windows. When executives value producing numbers over producing quality, it's only a matter of time before the lower levels of management reflect that. Everything at Maryland General seems to have been done to produce results fast and cheap. Producing the right results was no longer a priority.

Broken Windows in the Regulatory Process

Why did it take so long for this to be discovered and become public? The hospital was fully accredited by JCAHO and the laboratory was inspected by CAP. The April 2003 CAP inspection identified nine laboratory deficiencies, but Maryland General provided documentation that the deficiencies were corrected and the laboratory received accreditation “with distinction”.

In her Congressional testimony, Kristin Turner neatly summarizes the paradox:

“...following my complaint, the state found many more problems in the laboratory than those I cited, yet Maryland General's lab had passed all the accreditation and certification inspections that had recently been conducted. This flies in the face of all common sense and seriously calls into question the validity of the inspections and accreditation process established to ensure public safety....I fear the problem of lack of proper oversight is not a problem limited to Maryland General Hospital.”

[Kristin Turner, Statement to Congress, May 18, 2004]

The Maryland State Secretary of Health and Mental Hygiene, Nelson J. Sabatini, characterizes the inspections process as flawed:

“Accreditation surveys are generally announced in advance – and even if unannounced they are fairly predictable. The surveys are collegial in nature and leisurely in execution, and the focus almost entirely on process instead of outcome. This is like saying a business is doing fine as long as its books appear to be in order.” [Nelson J. Sabatini, Statement to Congress, May 18, 2004] He also believed that, because inspections are performed by peers who are often local to the region, those inspectors are reluctant to uncover the errors and problems of their colleagues.

Furthermore, as a rule, inspections are infrequent. If inspections are rare events, it's possible to obscure the problems for a short period of time. During the 2003 CAP inspection occurred, the laboratory administration warned the staff not to disclose any problems to the inspectors.

Even when an inspection uncovered a problem, the other accrediting agencies were not informed. So when complaints were sent to the State of Maryland, CAP and JCAHO were not informed. At the Congressional Hearing, the head of CAP stated that, if they had known about the earlier complaints, that would have affected their decision on accreditation. But the agencies didn't communicate.

Finally, any failures and deficiencies that were found were never going to be made public. CAP kept its report private even from Maryland State officials and only disclosed the report under pressure from Nelson Sabatini and the glare of media scrutiny. If laboratory failures are kept secret, there is even less incentive to assure the proper quality.

The net result of these factors is that there were no consequences for bad quality. If an inspection took place, staff could be silenced. Even if inspectors managed to find a problem, “we'll do better” documents would satisfy any issues they raised. And the fact that those problems were documented didn't matter, since the public would never see those inspection reports.

Does the Broken Windows Theory apply to Healthcare Laboratories?

When one looks at the CLIA requirements and the minimums for quality control today, one might think that most laboratories would operate far above the minimum of 2 levels of control per day. And the latest CMS proposal for equivalent QC procedures allow the reduction of daily QC to weekly or even monthly QC. These absurd minimums serve notice that quality is not very important today and that minimum levels of performance will be tolerated. The regulations themselves are a broken window.

The collorary to the Broken Windows theory is that where failures are tolerated, failures will accumulate. If there is no action taken when a failure occurs, more failures will occur and they will gather. Eventually, the errors can compound and multiply each other, and reach a sort of critical mass that causes a catastrophic chain reaction.

Isn’t this what happened at Maryland General? Failures of quality were tolerated and they accumulated. More and more failures were tolerated – even as the bench level analysts protested vigorously – until a critical mass of failures had built up and the problem could no longer remain hidden.

One Final Question

There is one final question that should strike fear in the hearts of laboratory and healthcare professionals. Are there other Maryland Generals out there? Given the flaws exposed in the inspection and regulatory processes, the only way to judge laboratories is to rely on the workers themselves. Inspections may or may not catch these problems. But the bench level workers know whether or not quality is supported by their bosses.

So ask the bench level analysts in your laboratory. Does our laboratory tolerate failures like those that occurred at Maryland General? Does the hospital and laboratory administration promote practices that short-change quality?

Do you even dare find out the answers to these questions?

James O. Westgard, PhD, is a professor of pathology and laboratory medicine at the University of Wisconsin Medical School, Madison. He also is president of Westgard QC, Inc., (Madison, Wis.) which provides tools, technology, and training for laboratory quality management.