Laboratory workers at Maryland General Hospital warned top hospital administrators and state officials in writing nearly two years ago of serious and long-standing testing problems that put patients and employees at risk.
The letter of July 25, 2002, cites "documented cases of apparent neglect and compromised patient care" - and inaction by hospital managers.
"We went to laboratory management and Human Resources with our concerns and were literally told it was none of our business," said the letter, obtained by The Sun. "As lab workers, we have to live with ourselves at the end of the day. We know that there is a patient attached to every specimen."
The letter - sent to hospital president and chief executive officer Timothy D. Miller and other officials there - is fresh evidence that Maryland General and state regulators had early knowledge of serious problems.
But those problems weren't taken seriously until this year, when state inspectors investigated a similar warning letter in December from a former employee, Kristin Turner.
State officials have confirmed the existence of the 2002 letter and acknowledged that they investigated at the time. They said they took the allegations seriously but found them vague and did not discover the serious problems until this year.
The hospital announced Tuesday the resignations of Miller and the medical director of the lab. Another lab executive had resigned earlier, and hospital spokesman Lee Kennedy said yesterday that another lab worker had been let go. He declined to provide details.
Kennedy said yesterday in a statement that the lab of "two years ago is not the same laboratory today" and noted it has been under new management since March 18 by a Utah firm, Park City Solutions.
"We have already acknowledged that there were problems and we are addressing those problems appropriately," he said. "That effort began several weeks ago."
Kennedy also noted the recent resignations and said the lab has a new medical director, among other staffing changes.
One of the authors of the 2002 letter was former lab technician Teresa Williams, who wrote a follow-up letter last month to the state after the lab scandal had become public. In the recent letter, Williams compared what was going on at Maryland General, which serves a large minority population, to the infamous experiments on blacks who believed they were being treated for syphilis but in fact were being denied treatment.
"It felt like the Tuskegee Experiments but on a larger scale where the victims were poor Blacks, Latinos and Whites," Williams recounted in the 11-page, March 31 letter sent to state Health Secretary Nelson J. Sabatini.
'A cloud of fear'
Williams, who quit her job at Maryland General in August 2002, said she and other laboratory workers repeatedly complained about poor lab practices and inadequate patient care but were rebuffed and threatened with the loss of their jobs.
Employees were forced to work "beneath a cloud of fear," Williams wrote last month in the letter, also obtained by The Sun. "When we did come forward we were labeled as troublemakers and were targeted by our employer with threats of retaliation."
Williams, who lives out-of-state, was not available for an interview. Her letter was sent to Sabatini as well to attorneys for the hospital and Turner. Turner's letter to the state in December triggered successful investigations leading to the resignations of Miller and others and promised reforms by Maryland General.
Sabatini confirmed yesterday that the March letter was sent to his office and that a prior letter complaining about the hospital lab had been sent in mid-2002. He said state inspectors responded to the 2002 letter with an inspection and did find problems. But, Sabatini said, the items in the 2002 letter were too general to lead inspectors to the specific deficiencies that have since turned up.
"This time," he said, referring to the most recent complaint, "we had very specific information."
The July 2002 letter did cite the example of an untrained clerk "being ordered to perform high complexity testing and verify patient results." And it used strong language in describing an atmosphere of intimidation that discouraged reform.
"We have no recourse and feel as though we have been targeted as troublemakers for coming forward with our concerns. No one will listen," said the letter. "Many people would like to come forward to tell of the atrocities that they have witnessed, but the costs are too high and the threats to job loss and retaliation are ever present."
According to Williams, the lab workers were so intimidated that when state inspectors did show up in October 2002, they were too scared to talk.
"Out of fear they remained silent," she wrote to Sabatini last month. By the time the inspectors arrived, she had quit the hospital.
Sabatini said the delay in detecting problems at Maryland General resulted from a broken and cumbersome regulatory system that hampers the ability of state regulators to oversee hospitals. Generally, the state, which has fuller authority over nursing homes and some other health facilities, can inspect hospitals only in response to a specific complaint.
"If this were a nursing home," said Sabatini, "it would be on its way to de-licensure."
The letter and the disclosure of the 2002 warning are the latest developments in an unfolding story first publicized in March. In a series of inspections of the hospital's lab over the past four months, state and federal regulators have turned up dozens of deficiencies, including the fact that the hospital sent out HIV and hepatitis test results even though equipment readings showed those results might be inaccurate.
The hospital has offered free retests to those patients along with about 2,000 others who had tests conducted on the same equipment. The hospital is expected to file a corrective action plan within the next few days. So far, Kennedy says, all of the HIV tests have proved accurate, and only two of the hepatitis test results sent to patients were wrong.
In the latest report, state and federal inspectors said the problems went beyond the laboratory to the hospital's top administrators.
"Despite a pattern of poor performance in laboratory services," the report states, "the hospital leadership neglected to provide the oversight necessary to monitor lab activities and improve performance."
Williams' letter last month details a series of laboratory problems dating from Jan. 15, 2001, when she was hired as a lead technologist. She backed up her story by providing copies of e-mails, memos and other documents dating to 2001.
In one memo dated Aug. 9, 2002, lab administrator James Stewart admonished an employee who had complained about problems. Stating that the employee was "seen as a focal point of destructive criticism," Stewart - who resigned this month - warned the worker that she would face disciplinary action if she continued to voice complaints to others.
According to Williams' letter, problems were evident from the start of her employment.
Describing the situation as "total chaos," she said the department was "poorly staffed, poorly trained, overworked and morale was low. We were all totally overwhelmed."
Among the problems cited by Williams were the use of the wrong control samples with testing equipment - proper controls were deemed "too expensive" - and the repeated reporting to patients of suspect test results.
Technicians, she wrote, "were fearful of the accuracy of the test results that they were being required to report out."
"Everyone complained individually and in groups to management about the lack of monitoring and all the other problems, but nothing was done," the letter continues.
In May 2002, according to Williams' letter, a clerk was assigned to perform a series of complex tests even though she had no training. Though she at first refused, "she did as she was demanded" after being threatened with the loss of her job.
"Her being forced to do this testing was a blatant disregard for patient care," the letter states.
Williams also asserts in her letter that the hospital was charging more than it should have for a variety of tests, but when she questioned the excess charges, nothing was done.
"I told him [Stewart] this should be changed," Williams wrote. She added that when she and others complained to Stewart about "poor lab practices and inadequate patient care," the administrator responded, "What I do is none of your damn business."
Williams also cited recurrent problems with the Labotech, an analyzer used to test for HIV and hepatitis and the same machine that Turner has charged in a lawsuit caused her to become infected with HIV and hepatitis.
Corroborating statements by Turner, Williams cited three specific dates in August 2002 when Labotech test results were sent out even though the machine failed validation tests.
"If this doesn't clearly and unequivocally prove that patient welfare was not the primary concern at Maryland General Hospital, then I guess nothing will," Williams concluded.