Baltimore Hospital Lab Problems Put Spotlight On CAP Inspections

Plenty of "not-to-do" lessons for lab managers

CEO SUMMARY: Here’s an exclusive peek into a three-year battle between medical technologists wanting to do the right thing and a laboratory manager—backed by hospital administration—who aggressively stifled well-justified dissent. It is an inside look at one of the most grievous failures of a hospital-based laboratory in several decades. By knowingly reporting unreliable test results, the laboratory at Maryland General Hospital put patients at risk. But that’s just one aspect of this sordid tale.

PUBLIC SCRUTINY of the laboratory at Maryland General Hospital in Baltimore continues to trigger remarkable disclosures and embarrass any number of healthcare organizations.

Not the least of these is the College of American Pathology (CAP). In April 2003, its inspectors visited the laboratory at Maryland General Hospital (MGH). In the report based upon this inspection, the MGH laboratory was given CAP’s highest performance rating: “accredited with distinction.” It is now known that, for at least several years, the problem-plagued MGH laboratory was reporting questionable test results to physicians and patients.

But CAP is not the only embarrassed party. Several inspections by the Maryland Department of Health (DOH) during that same year failed to identify operational failings at the MGH laboratory. Even as his own agency’s inspections came under scrutiny, Nelson J. Sabatini, Maryland’s State Health Secretary, was particularly critical of the CAP laboratory inspection process.

Failure Of “The System”

This sensitivity is understandable. It took a medical technologist-turned-whistleblower to blow the lid off the failings at MGH’s laboratory. Kristin Turner’s letters to the Maryland DOH in December 2003 triggered a series of laboratory inspections over the next 60 days. It wasn’t until March 2004 that government agencies finally told the public about the true scope and scale of problems at the MGH laboratory.

The hospital was forced to make a public announcement that HIV and HCV testing done on more than 2,000 patients over an 18-month period had produced unreliable results. It launched a program to publicize this fact, locate the individuals, and get them in for retesting. As a result of this lab scandal, resignations were accepted from the hospital’s CEO, from Laboratory Director James Stewart, and from Medical Director Philip Whalen, M.D. (See TDRs, April 5, 2004 and April 26, 2004.)

The problems at Maryland General Hospital’s laboratory story are highly significant. This may be the worst failure of laboratory operations in a hospital in the past decade, possibly longer. It also demonstrates how public intolerance is increasing for institutional failures within healthcare that affect patient outcomes. This change in public attitude raises the stakes for any laboratory that delivers laboratory testing services of unacceptable quality.

THE DARK REPORT is closely tracking ongoing public disclosures about the problems and failings at the Maryland General Hospital Laboratory. It is in possession of a range of internal documents, dating back as far as 2002. It also has copies of recent inspections of the laboratory by the Maryland DOH.

With this information, it is possible to do a preliminary forensic management analysis of the MGH laboratory. The result is useful insights, conclusions, and recommendations for clients and readers of THE DARK REPORT.

Major Failures In The Lab

The basic list of operational breakdowns runs a wide gamut: 1) failure of laboratory management, at the level of both the laboratory administrator and the laboratory medical director; 2) failure of both government and non-government laboratory inspectors to uncover ongoing operational problems with the potential to negatively affect patient care; 3) failure of middle managers and technical staff in the laboratory to successfully attract the attention of lab management, hospital administration, and various inspecting agencies to the lab’s operational deficiencies and problems; 4) failure of hospital administration to respond to the warnings provided by concerned laboratory staff; 5) failure of internal laboratory systems to identify, respond, and correct fundamental flaws with diagnostic instruments, reagents, and operational protocols; 6) allegations of wrongful coding and billing for certain laboratory tests; and, 7) failure of the hospital’s organization culture to support people attempting to “do the right thing.”

To give context to these failures, a brief history of events at Maryland General Hospital’s lab will be helpful. The following outline builds on coverage provided by THE DARK REPORT in previous issues.

Rundown Of The Facts

Maryland General Hospital is a 245-bed community hospital which serves a poorer neighborhood of Baltimore. In the past three years, it became a part of the University of Maryland Health System (UMHS).

Internal lab memos dating back to 2001 indicate problems with inadequate laboratory staffing, due to budget constraints. This was particularly true in the chemistry department. During this period, a new laboratory administrator, James Stewart, was hired.

The laboratory’s technical staff could see a range of operational problems. Individuals were quite vocal about bringing these issues to the attention of both laboratory management and hospital administration. Memos and letters document repeated meetings on these topics and reveal that, for various reasons, senior laboratory management was able to refute such claims and satisfy hospital administration that no serious problems existed in the laboratory.

Problems Of Short-Staffing

That belies the facts presented by the vocal component of the laboratory staff. Some examples from these memos and letters illustrate the serious nature of their concerns. “On the day that was short-staffed with no one educated or trained to work the Olympus [chemistry instrument], which performs high complexity testing, he [James Stewart] demanded that [name deleted], a high school graduate with no formal training or education in laboratory testing, run the Olympus and verify patient results. When she protested, she was told that her evaluation would be in jeopardy if she did not comply. He logged her on the computer and had her verify patient results under his log-on. He is also not trained on the instrument. There was no one in the Chemistry I lab that day trained to operate the instrument or verify patient results from the instrument.”

That quote is from a memo sent by lab staff to hospital administration on July 25, 2002. Another example from the same document: “Please refer to the recent CAP survey C-B 2002 which failed not only Lithiums, but the entire survey failed. Twelve CAP survey specimens that failed were outside of three standard deviations [SD] and one was outside of 10 SD. All of the Lithium controls fell outside 5 SD or above. Considering anything outside of 2 SD is a concern and the farther away from 2 SD the more serious, you can see how troubling this is. It further supports the argument that [name withheld] was not monitoring the controls. …all of this suggests that patients’ results that were verified and used to diagnose and treat patients are unquestionably suspect.”

LABOTECH’s Failures

In April, THE DARK REPORT detailed the laboratory’s problems with an instrument used to run infectious disease tests. It was the Adaltis LABOTECH. Acquired as a refurbished instrument, it was in clinical service from June 2002 through August 2003. Maryland DOH officials have determined that HIV and HCV test results produced during this time were released, despite the fact that the laboratory knew this instrument was producing unreliable results.

Some comments about the LABOTECH problems illustrate the deeper flaws in the operational structure of this laboratory The next group of comments come from a letter written by the former Chemistry II Lead Tech at MGH to the hospital, government health officials, and the local Congressman. It is dated March 31, 2004. “June 17 2002 thru July, 2002…Reagent validation studies [on the LABOTECH] continued to fail. The instrument continued to malfunction. All kinds of errors, mis-pipetting, mis-steps, probe crashes, arm errors and many more. the machine was a lemon and once [it was] on site, we found that it really did not accommodate our testing platform. It took longer from start to finish to complete a test than performing the test using the manual method.”

Failed Validation Studies

Another example: “August 12, 2002…a directive was given to the Techs to do the Hepatitis B testing on the LABOTECH even though the LABOTECH had failed the validation studies. …Patient results went out on the failed validation studies on the LABOTECH August 8, 14, 15, 2002….these patient results were intentionally tested and reported out on a failed instrument with full knowledge by Jim Stewart that they were unacceptable.”

The next quote illustrates how med techs were specifically directed not to disclose these types of problems to state health inspectors (coming on site in response to complaints by the lab staff). This is also from the March 31, 2004 letter. “August 12, 2002: After the hospital and the state received the letters of complaint, everyone was scared. After that, I heard that the State would be coming in to investigate and that the problems would finally be addressed, corrected and all the information would be provided them to make the necessary changes. We all knew that once the State saw all the evidence, the hospital would be made to contact the patients and doctors and correct all the problems.”

But the state’s inspection of the lab did not uncover these problems. The writer continues “October 31, 2002. I received a panic call from several employees that the State had made a surprise visit and that Stewart told everyone ‘do not say anything that would jeopardize the hospital.’ What does that mean? If anyone were to tell the truth about what was going on at Maryland General Hospital, that would in fact jeopardize the hospital? So what were they supposed to say when questioned? Out of fear, they remained silent.”

Lab Techs Publicly Blamed

Earlier in this same March 31, 2004 letter, the writer references recent newspaper stories on the lab’s problems and states that “only one side of the situation [is] being revealed to the public [and that] is frightening. …Maryland General Hospital has its own Watergate, here and now. …What we have here is a flood of cover-ups. The hospital has decided to blame it on the folks at the bottom of the food chain, the technologists. The technologists work under the direct supervision of the Lab Director. We were all under the total and complete dictatorship of Jim Stewart. We were told what to do and how to do it. When we voiced our concerns we were told by Jim Stewart it was ‘none of our damn business’.”

She continues “…this country encourages whistleblowers to come forward… But when we did come for- ward, we were labeled as troublemakers and were targeted by our employer with threats of retaliation. …As employees with little influence, we sought help through the hospital chain of command. They too failed us.”

THE DARK REPORT provides these quotes for two reasons. First, they graphically illustrate the range of problems in the laboratory, as told by the laboratory staff in their own words. Second, these quotes aptly describe the fundamental problem found within the walls of the laboratory at Maryland General Hospital. That was the failure of lab management and of the hospital management to acknowledge and fix the problems identified by the laboratory staff.

As reported in the Baltimore Sun, government lab regulators and hospital administration repeatedly identified the LABOTECH instrument as the “primary source” of the inaccurate test results reported to several thousand patients. Experienced laboratorians know this is a misrepresentation to whitewash the real reasons behind this sordid affair.

This lab’s failures are directly attributable to the unwillingness of administrators to do the right thing. Thus reticence to act was reinforced by the corporate culture within Maryland General Hospital. Obviously hospital administrators and managers did not feel they would be supported if they tried to “do the right thing.”

Techs Publicly Blamed

Quotes from memos and letters reproduced on these pages demonstrate these facts. Med techs in the laboratory complained that it was understaffed. Moreover, understaffing was significant enough that the laboratory director was willing to order an employee—who had no technical laboratory training—to operate a chemistry instrument and report the results using his (the lab director’s) log-on ID.

Not only is this laboratory director willing to accommodate the corporate culture by operating an understaffed (as well as improperly staffed) laboratory, but he is willing to order a non-technical employee to perform clinical testing duties that violate every tenet of laboratory operations.

Maryland General Hospital Lab Accreditation For Chemistry and POCT is Pulled by CAP

CRITICISM OF THE LABORATORY INSPECTION process as it took place at the laboratory of Maryland General Hospital brings unwelcome attention to the accreditation program operated by the College of American Pathology (CAP).

Late in April, the Maryland Department of Health (DOH) squeezed CAP. It requested to see the inspection and accreditation report of the MGH laboratory filed by CAP inspectors after their April 2003 site visit, when they had rated the troubled laboratory as “Accredited with Distinction.” Initially CAP refused, stating that the College did not have a relationship with the state of Maryland.

Surprised by CAP’s response, Maryland Health Secretary Nelson J. Sabatini responded, “So we told them, if they won’t release their report, then we won’t accept their certification.” He then went on to say that state inspectors would assume responsibility for laboratory inspections. Sabatini then sent a letter to CAP stating that the Maryland Department of Health (DOH) would revoke the current accreditation of all Maryland laboratories inspected by the College of American Pathology. That would involve more than 120 labs in the state.

Faced with Maryland’s challenge, CAP quickly backtracked on its position. It made the accreditation report available to DOH. It then conducted a re-inspection of the MGH laboratory on April 26, 2004. In a press release issued May 3, the College stated that “after thorough investigation of the issues, the College has determined that what caused the errors [in the accreditation process at MGH] appears to be the deliberate data manipulation by laboratory employees. The employees edited the quality control reports of the testing instrument used. This action caused unreliable patient results to be released and concealed MGH’s problem from the CAP and the state of Maryland laboratory inspectors.”

Based on the April 26 re-inspection and based on a “review of pertinent information regarding this laboratory and its compliance with the Colleges Standard for Laboratory Accreditation, the College has decided to suspend accreditation of the laboratory’s chemistry and point-of-care testing services for a 30-day period beginning April 26, 2004.”

Another failing was in quality control/quality assurance. The MGH corporate culture would not allow the laboratory to acknowledge that the purchase of the refurbished LABOTECH instrument was a mistake. But more significantly, lab administration was willing to put that instrument into clinical use before it was validated and begin to report patient results from that unvalidated instrument.

This lab director’s actions speak volumes about the corporate culture and the willingness of clinical administrators in the hospital to bend established procedures for quality control. This, despite the fact that they knew, from their training and experience, that such violations could negatively affect patient care.

Moreover, the operation of this malfunctioning LABOTECH instrument led to a lab accident that exposed the med tech operating it to HIV and HCV. Months later she tested positive for both diseases, was the whistleblower who finally got the state to pay closer attention to this lab’s problems, and is suing the hospital, the lab director, and Adaltis for causing her exposure to both life-threatening diseases.

What is most troubling is the failure of laboratory administration and hospital administration to place patient safety first. After 14 months of use, the decision was made to unplug the LABOTECH because it was delivering unreliable results. Yet no individual at either level of administration was willing to go back and address these failings with the patients who would be affected by inaccurate lab test results.

Unreliable Test Results

Here is a case of knowingly generating unreliable test results—for diseases that would negatively impact not only the patient, but other family members and people with whom they come in contact. There are plenty of court cases where a patient, knowing he/she was infected with HIV or AIDS, deliberately infected others by hiding this fact. If that was a criminal act in such instances, is it any less criminal for a laboratory administrator—and its hospital administration—to knowingly allow individuals who might be positive for serious disease to continue in society, acting on the basis of a laboratory test result that is known to be unreliable?

This is an ethical and legal question few lab managers and pathologists have to answer. That’s because their laboratory performs to a high level of accuracy. Everyone has a high level of confidence in the accuracy of the test results they report to physicians and patients. Moreover, most laboratories have a working environment that encourages laboratory staff at all levels to come forward if problems are suspected.

That’s what makes the serious problems inside the laboratory at Baltimore’s Maryland General Hospital such a rare event. As a lab management case study, it demonstrates how quickly an unsound management culture can corrupt an entire institution.

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