The nation's primary laboratory accreditation agency gave its highest rating to Maryland General Hospital's lab in July, failing to detect serious, long-term problems that went unaddressed until a whistleblower's complaint brought in state inspectors this year.
"Accredited with Distinction," the College of American Pathologists reported July 16, based on a review conducted in April last year.
Yet state officials have concluded there were widespread, serious deficiencies in the Baltimore hospital's lab operation dating at least to August 2002. The lab generated hundreds of suspect test results for HIV and hepatitis, and botched tests for Legionella bacteria and sexually transmitted diseases.
This month, the state health department ordered the hospital to make immediate improvements or face fines of up to $10,000 a day. Hospital officials say they are taking necessary steps, including trying to contact 2,169 patients who might have received incorrect results.
State Health Secretary Nelson J. Sabatini says the Maryland General case "shows the inadequacy of the whole process" of hospital accreditation, which is done by private organizations with strong links to the health care industry. "We have a totally ineffective process to make sure problems are corrected or people are put out of business."
The system undermines state regulators by barring them from doing their own hospital inspections until there is a specific complaint, according to Sabatini. And, he said, when problems are found, they're seldom cured. "They'll draft a plan of correction," he said. "Then they'll have a meeting and rework it. Then there will be a few more meetings."
State and federal law requires that routine inspections and accreditation of hospitals be done by the Joint Commission on Accreditation of Healthcare Organizations, a nonprofit association originally established to inspect hospitals but which now examines a wide array of health care facilities. If a hospital is accredited by the commission, Sabatini said, it is deemed to be in compliance with state and federal requirements.
The commission, in turn, has an agreement sanctioned by the federal government under which the College of American Pathologists inspects hospital laboratories. The college is a nonprofit association representing board-certified pathologists.
Officials of the college provided two statements in response to questions about how an accreditation team missed serious problems during what it described as a routine, regularly scheduled inspection of Maryland General's lab. Such inspections are done every two years.
College spokesman Anthony Phipps said the inspection April 22 showed "no indication of a problem" with the lab equipment that the state later said performed poorly. In fact, said Executive Vice President Nicki Norris, the college didn't learn of the problem until it was informed March 17.
"The nature of the problem ... is such that a routine accreditation inspection would not have readily identified the problem without a prior complaint having been filed," said Phipps.
"We now understand that sometime after the college conducted its regularly scheduled inspection in April of 2003, the state of Maryland received a complaint report from a former laboratory employee," he said. "The complainant not only pinpointed the specific piece of equipment, but also the specific tests where the problem was occurring, as well as the specific manipulations of the data. This information was not given to the college at the time of its inspection of the lab."
The college spells out in a 112-page manual the requirements for obtaining accreditation, encompassing areas such as staffing, training and quality-control standards. The manual includes checklists for inspectors, and describes deficiencies they're expected to look for.
Phipps said the college is now conducting its own investigation of the laboratory.
The vice president of the joint commission, Margaret Van Amringe, said the Maryland General case had raised questions about the relationship between her organization and the college.
"We are concerned that the relationship needs to be reviewed," she said, adding that the matter will be discussed during an annual meeting.
Van Amringe termed the Maryland General case as the first of its kind. "We've not really run into this before," she said. She did not directly address Sabatini's concerns about hospital accreditation, saying that he needs to speak to the college about the lab issue. "We do not go into accredited labs on a routine basis," she said.
Van Amringe noted that state inspectors had visited Maryland General's lab in November and sounded no alarms. State inspectors had visited the laboratory at that time, apparently in response to a complaint.
In December, one-time lab worker Kristin S. Turner wrote to her ex-boss at the hospital reminding him he had known for many months of equipment defects undermining accurate testing. She is suing the hospital, contending a defective machine caused her to become infected with HIV and hepatitis C.
After receiving a copy of her letter, state inspectors visited the hospital in January and concluded April 2: "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."
Van Amringe's group, as well as federal inspectors, participated in the inspection of Maryland General. She said her organization has had "a long-term relationship with the state. We are very amenable to working with the state."
But Dr. Peter Lurie of Public Citizen, a Washington-based advocacy group, said he believes the conflict between regulators and the provider-run associations is fundamental.
"The problem is these hospitals should be regulated by the federal government. Instead, you have people with a massive conflict doing the inspections. It's the very definition of the fox guarding the hen house," said Lurie. "All their instincts are toward accreditation or very loose regulation, and no accountability."
"I just don't buy that," Van Amringe responded. She said the criticism is outdated.
"I heard that 20 years ago," she said, adding that accreditation surveyors are full-time professionals and the organization has regularly updated and improved its inspection methods.