Tools, Technologies and Training for Healthcare Laboratories

Part II. Facts of the Maryland General Healthcare Scandal

June 2004

For those of you who weren't able to follow the scandal at Maryland General Hospital, or have never heard of it - here's a recap of the laboratory deficiencies, errors, and catastrophes - plus details on the congressional hearings on this issue.

Hear, Hear, Hear! Hearings on untruth and unquality!
Part II. What Happened

June 2004

with Sten Westgard, MS

Over the past several months, there has been an unfolding scandal about laboratory testing failures at the Maryland General Hospital, an affiliate of the University of Maryland Health System, in Baltimore. Given the mass of other crises gripping the US this year, the news has fallen under the radar for most people. Even within the circle of healthcare professionals, not many are following the developments. But it is a critically important story, so we feel the need to draw your attention to it here on this website.

The Facts about Lab Errors at Maryland General Hospital

The spark that started this firestorm is the revelation that for 14 months(!), the laboratory at Maryland General Hospital released up to 460 questionable HIV and hepatitis test results. These results were released to the doctors and patients even though the instrument QC indicators showed the patient results might NOT be accurate. The laboratory analysts who worked with the instrument, a robotic analyzer, apparently altered quality control values to make them fall within acceptable ranges, so the test results could be reported.

What drew media attention to this issue was the case of a medical analyst at Maryland General, Kristen Turner, who was splashed with blood while using the robotic analyzer on December 12, 2003. She later contracted by HIV and hepatitis. That same month, she sent a letter to Baltimore city health officials, which was forwarded to state regulators, who initiated a limited inspection in January. That in turn led to the wider investigation and media coverage.

According to Turner's interview with the Baltimore Sun (March 19, 2004), she noticed problems with their HIV testing instrument almost as soon as she started working at the laboratory in the fall of 2002:

“Every run had different errors. Three of every five tests were wrong. The machine failed its own self test.” She also stated that the machine would sometimes skip over required steps in the testing process. Complaints about the machine grew to the point that the manufacturer sent another machine to act as a backup.

The widening investigation revealed that Turner's complaint was not the only one. Back in 2002, Theresa Williams, who worked at Maryland General, had also complained to to both the hospital leadership and state health officials. The letter stated that problems in the laboratory went back as far as January of 2001. Her complaints, in 2002 and reiterated again in March 2004, documented the following problems:

  • When laboratory analysts warned Maryland General supervisors of problems in testing, they were admonished for their complaints.
  • Lab workers were threatened with the loss of their jobs if they reported these problems to state inspectors. “Many people would like to come forward to tell of the atrocities they have witnessed, but the costs are too high and the threats to job loss and retaliation are ever present.”
  • An untrained clerk was “being ordered to perform high complexity testing and verify patient results.”
  • The laboratory department was “poorly staffed, poorly trained, overworked and morale was low. We were all totally overwhelmed.”
  • The wrong control samples were used when the proper controls were deemed “too expensive.”
  • Technicians were required to report out test results even though they were “fearful of the accuracy.”
  • The hospital was charging more than it should for some tests.

[Walter F. Roche, Jr., Lab workers warned Maryland General 2 years ago, April 22, 2004, Baltimore Sun]

Finally, William's statements corroborate the claim that the robotics instrument was problematic, noting three separate dates in August 2002 when results were sent out even though the machine failed validation tests. She also stated that the machine required frequent service and repair visits by the instrument distributor. At numerous times, Williams said that lab workers requested that the instruments be replaced by a different analytic system, but their concerns were ignored by laboratory administrators.

On March 16-24, 2004, the laboratory was inspected by a combined team of Maryland state inspectors from the Office of Health Care Quality, officials from Joint Commission for Accreditation of Healthcare Organizations (JCAHO), and representatives of the Centers for Medicare and Medicaid Services (CMS). They found the following additional problems:

  • Questionable test results for HIV, hepatitis B and C, sexually transmitted diseases such as chlamydia and gonorrhea.
  • The laboratory used chemical reagents for a variety of routine tests after they had passed their expiration date.
  • Lack of sufficient staffing.
  • Failure to adequately train lab personnel.
  • A specific failure: when two tests on the same sample provided opposite results, the laboratory failed to investigate the cause.
  • Mishandling tests conducted for Legionella bacteria on five patients at a Northwest Baltimore nursing home - test results were issued despite being invalid.
  • Basic testing procedure manuals contained incomplete and sometimes inaccurate instructions.
  • “From at least August of 2002 to February of 2004 the laboratory was rife with equipment failure and malfunctions, training and communication problems with staff, and lost or mishandled specimens....Despite a pattern of poor performance in laboratory services as documented by the state Office of Health Care Quality survey of 2002, the hospital leadership neglected to provide the oversight necessary to monitor lab activities and improve performance.” [From the report.]

[Walter F. Roche Jr., State orders Maryland General to fix its lab, April 3, 2004, Baltimore Sun]

Failure of Inspection and Accreditation?

What makes the Maryland General situation especially puzzling is that while the failures were occurring, during the same time the laboratory passed its inspections and the hospital maintained its accreditation.

In October 2002, the state of Maryland had cited the laboratory director with a specific deficiency related to quality assurance. But as recently as April 2003, the laboratory at Maryland General was “accredited with distinction.” That is, it was recognized for complying with government CLIA regulations as well as additional CAP requirements. This is not to say that the April 2003 CAP inspection gave high marks to the laboratory. In fact, the 13-member CAP inspection team found nine deficiencies in the laboratory, including a “failure to carry out its quality improvement plan as designed and failure of the laboratory's medical director to monitor standards of performance and quality control.” [May 18, 2004, Statement of Ronald B. Lepoff, MD, FCAP, Chair, Commission on Laboratory Accreditation College of American Pathologists to US House of Representatives]. It also noted that the laboratory had gone for an entire year without adhering to its quality-assurance plan.[Walter F. Roche, Jr, Action taken against hospital, May 11, 2004, Baltimore Sun] The laboratory was given thirty days to remedy these deficiencies – and the laboratory responded by providing documentation to CAP that it had remedied the errors. After receiving this document, the CAP re-accredited the laboratory.

It should also be noted that during inspections, the lab personnel were instructed to remain silent. “It is now clear that workers in this laboratory worked beneath a cloud of fear, intimidated into silence by hospital and laboratory administrators. It was this fear that prevented laboratory workers from communicating their concerns during the CAP accreditation process” [Statement on Ronald B. Lepoff, ibid.]

Furthermore, it appears that complaints to the state officials of Maryland were not passed on to CAP. Nor did CAP initially share its 2003 inspection report with Maryland officials. Only after the Maryland Health Secretary Nelson J. Sabatini threatened to revoke accreditation of all CAP-inspected laboratories in Maryland did the CAP turn over the document.

Congressional Hearings

The failings of the laboratory at Maryland General are so severe and so shocking that Congress is now investigating what went wrong. Representative Elijah E. Cumming of Maryland, in whose district Maryland General Hospital is located, organized an initial hearing for testimony from representatives from CAP, JCAHO, CMS, Maryland General Hospital, and various industry and state health officials.

Health Secretary Nelson J. Sabatini provided the most striking testimony. “It would be a terrible mistake to categorize this as an isolated incident. I believe that the Maryland General experience is merely a symptom of a system failure.”[Walter F. Roche, Jr., Inspectors are called too close to hospitals, May 19, 2004, Baltimore Sun]

Mr. Sabatini was blunt in assessing the failures of the healthcare regulatory system in the Maryland General case:

“When it comes to hospital laboratories, though, there are at least four different agencies or organizations involved in quality oversight – the state and federal governments and at least two accrediting organizations – which means among other things that when something goes wrong, accountability is spread so thin as to be meaningless. Today you will hear lots of people explain how someone else dropped the ball. Let me say this as plainly as I can: we all dropped the ball. We all are responsible. We all should be held to account for this.”[Nelson J. Sabatini, Statement to Congress, May 18, 2004]

Mr. Sabatini also expressed skepticism about the accreditation process by 'deemed providers' like CAP and JCAHO. “Patient safety is ultimately a government regulatory responsibility, but we have subcontracted it out.” He suggested that inspections, when carried out by local peers, are often too friendly and are unlikely to uncover problems. He further believes that inspectors “have uncomfortably close ties to the industry they survey.” [Walter F. Roche, Jr.,Baltimore Sun, Inspectors are called too close to hospitals, May 19, 2004]

Representative Cummings summed up it up this way: “I just want to say this is a mess and, sadly, it is the poor patients who suffer. It's a situation where the right hand doesn't know what the left is doing and the head doesn't know either.” [Walter F. Roche, Jr., Inspectors are called too close to hospitals, May 19, 2004, Baltimore Sun]

Representative Cummings believes that changes may be needed in how hospital labs are monitored. “The Maryland General Hospital situation is just the tip of the iceberg that has national implications” [Stephen Manning, Hospital errors focus of congressional testimony, May 18, 2004, Associated Press]

More to come?

In the wake of the scandal, Maryland General has offered to retest over 2,000 patients and over 1,000 of them have actually been retested. Edmond F. Notebaert, University of Maryland Health System president, stated that 2 patients who originally tested negative for HIV have since tested positive. Three people who had tested negative for hepatitis have since tested positive. [Walter F. Roche, Jr., Inspectors are called too close to hospitals, May 19, 2004, Baltimore Sun ]

Of these retesting efforts and their apparently low number of diagnostically serious errors, Representative Cummings said, “They were very lucky. But we cannot base public policy on luck. That's not good enough when it comes to life-and-death issues....Our main concern is to find out what happened here. It may be necessary to tighten federal standards.” [Walter F. Roche, Jr., Hearing to probe hospital errors, May 17, 2004, Baltimore Sun]

Representative Cummings was particularly concerned that a laboratory with major deficiencies could nevertheless pass the highest accreditation standards. “We've got to follow up. I'm very concerned about with the process of accreditation.” [Walter F. Roche, Jr., 2nd Congressional hearing set on Maryland General, May 22, 2004, Baltimore Sun]

At the time of this writing, a second congressional hearing has been scheduled but then delayed. All of the witnesses from the first hearing have yet to be questioned.

That's the story so far. Westgard Web will provide continuing coverage and analysis in the months to come. In the meantime, if you have comments, questions, etc., please contact us.

A List of Sources:

The Baltimore Sun has provided 21 stories on the Maryland General scandal, which are listed below and provide the information for this compilation. Credits and kudos to the Baltimore Sun staff and Walter F. Roche Jr. in particular for covering this most important story. The following list is from the Baltimore Sun website: and can be accessed directly at,0,7736886.storygallery?coll=bal-local-headlines

  • 2nd congressional hearing set on Maryland General
    Accreditation among chief concerns, Cummings says (May 22, 2004)
  • Inspectors are called too close to hospitals
    State health chief tells Congress flaws found at Md. General are systemic (May 19, 2004)
  • Hearing to probe hospital errors
    Congressional panel to assess lab oversight; 'Our main goal is patient safety'; Maryland General facility had gotten highest rating (May 17, 2004)
  • Action taken against hospital
    Parts of Md. General lose accreditation for month (May 11, 2004)
  • Hospital report notes troubles
    Inspectors found faulty quality assurance plan; Md. General still got high marks (Apr 30, 2004)
  • Accreditation group releases Md. General inspection report
    State wants to know how troubled lab got top rating (Apr 29, 2004)
  • Md. General faces probe over billing for lab tests
    Also, ex-top doctor sues over anesthesia expenses (Apr 28, 2004)
  • State insists on lab reports
    Md.'s health secretary warns accrediting group refusing to release records; Facts on Md. General sought; Sabatini might revoke automatic approval for about 120 medical labs (Apr 27, 2004)
  • Md. General faces review of operations
    State health officials to look beyond faulty tests; 'A top to bottom review'; Three major deficiencies found at city hospital (Apr 23, 2004)
  • Lab workers warned Md. General 2 years ago
    Hospital's managers ignored them, letter says (Apr 22, 2004)
  • Hospital chief quits in shakeup
    Medical director of lab at Md. General also resigns amid criticism; Faulty test results were issued; Errors 'not acceptable,' says head of UM medical system, blames leaders (Apr 21, 2004)
  • Maryland General lab chief on paid leave, won't return
    He supervised facility where HIV, hepatitis test results questioned (Apr 13, 2004)
  • Hospital lab had received highest rating
    Accreditation agency for Maryland General failed to detect problems; Inspection process faulted; Suspect test results, botched exams occurred (Apr 10, 2004)
  • State orders Md. General to fix its lab
    Baltimore hospital faces $10,000-a-day fines if it fails to correct problems; Test results issued despite errors; Equipment malfunctions, inadequate training, sample mishandling noted (Apr 3, 2004)
  • More dubious test results discovered at hospital
    Complaint exposes errors at Maryland General's lab (Mar 26, 2004)
  • Maryland General offers free retesting
    Tool used in HIV, hepatitis tests may be unreliable (Mar 23, 2004)
  • Hospital seeks FDA review of equipment
    Maryland General Hospital officials say they will ask the U.S. Food and Drug Administration to investigate the reliability of blood testing equipment used in generating 460 suspect HIV and hepatitis tests for patients at the 245-bed facility. (Mar 20, 2004)
  • Ill ex-hospital worker cites lab troubles, fearing worst
    Inquiry: kristin s. turner, suing maryland general after contracting hiv, recalls faulty equipment and fears thousands of questionable tests. (Mar 19, 2004)
  • HIV tests spur joint inspection at Md. General
    Federal, state agencies, accreditation panel send 9; Suspect results were sent to 400; Hospital cooperating fully with probe, official says (Apr 23, 2004)
  • Hospital was told of faulty HIV tests
    Ex-Md. General worker sent letter in December; Former employee files suit; Woman says flawed gear infected her with diseases (Mar 12, 2004)
  • City hospital's HIV testing manipulated
    Evidence of false results ignored by lab workers at Md. General, state says; More than 400 people affected; Hospital president says patients will be notified to return for free re-tests (Mar 11, 2004)


July 25, 2002:
Theresa Williams, lead technologist at Maryland General Hospital, files a formal letter of complaint with the state of Maryland as well as hospital leadership. This letter from lab workers warns of serious and long-standing testing problems that put patients and employees at risk. Many of the allegations are ignored by state inspectors because allegations are “too vague.” CAP was not notified by the state. Theresa Williams eventually quits.

November 8, 2002:
The State of Maryland completes a focused CLIA complaint survey/inspection at Maryland General from an unrelated issue that resulted in two CLIA condition level deficiencies, laboratory director responsibilities and quality assurance.

March 12, 2003:
Kristin S. Turner has an accident while working with the LaboTech instrument. She later contracts HIV and hepatitis.

April 2003:
The College of American Pathologists (CAP) conducts an accreditation survey/inspection, finding nine deficiencies related to laboratory management and quality assurance, including failure to carry out a quality improvement plan (the lab had gone for a year without adhering to a plan), and failure of the medical director to monitor standards of performance and quality control. CAP gives the lab 30 days to remedy the deficiencies. The lab subsequently provides documentation that it has corrected the deficiencies. After that, CAP re-accredits the laboratory.

August 2003:
Hospital discontinues HIV/hepatitis testing.

December 2003:
The state receives a written complaint specifically addressing problemswith HIV and Hepatitis C testing, from Kristin Turner, stating that there was improper alteration of quality control results.

January 23, 2004:
The state completes a complaint survey under their state licensure law that results in condition level deficiencies specific to quality control testing for HIV and Hepatitis C well as general quality assurance. The laboratory sends a plan of correction to the state.

March 8, 2004:
The state notifies the Philadelphia Regional Office (RO) of press interest in problems at Maryland General. The RO gave the state agency authorization to conduct a CLIA laboratory survey and a hospital Medicare investigation.

March 12, 2004:
The state provides a copy of the state laboratory licensure survey performed on January 23, 2004 to the RO.

March 16-24, 2004:
A joint federal CLIA and state licensure survey is conducted. The CLIA survey team, consisting of state and RO representatives, identifies 6 CLIA condition level deficiencies: bacteriology, general immunology, analytic systems, technical consultant, laboratory director and technical supervisor. The state survey agency conducting the hospital Medicare investigation and a simultaneous state licensure investigation finds non-compliance with the Hospital Conditions of Participation for Governing Body, Laboratory Services and Quality Assessment and Performance Improvement Program.

April 2, 2004:
The state (under their state licensure law) sends the laboratory survey findings to the laboratory.

April 5, 2004:
The RO sends the survey findings and a letter to the hospital removing its hospital deemed status, placing it under state agency monitoring and requiring the hospital to submit a plan of correction for the deficiencies cited. Administrative Director of the Maryland General Laboratory, James Stewart, is placed on paid leave. He later resigns.

April 6, 2004:
The Philadelphia RO sends the CLIA laboratory survey findings to the laboratory. The State and RO prepared the survey findings together, but sent separate reports. The state report was sent in response to Maryland’s laboratory licensure requirements and the RO report was sent in response to the CLIA requirements. The RO report included a notice that the laboratory’s accreditation deemed status had been removed and the laboratory must report directly to the state until the condition level deficiencies were removed.

April 20, 2004:
Maryland General sends a plan of correction to the state. President and Chief Executive of Maryland General, Timothy D. Miller resigns. Medical Director of the Laboratory, Dr. Philip Whelan, also resigns.

April 22, 2004:
Maryland General sends a plan of correction to the RO.

April 26, 2004:
CAP conducts an inspection of the laboratory and has findings similar to CMS and the State. CAP removes accreditation of the laboratory in the affected areas (chemistry and point-of-care) until May 25th (at which time another inspection was to be performed).

May 18, 2004:
Congressional Hearing by the Subcommittee on Criminal Justice (of the Committee on Government Reform) about “Ensuring accuracy and accountability in laboratory testing: Does the experience of Maryland General Hospital expose cracks in the system?”

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.