As Maryland General Hospital moved to correct flaws that led to 460 possibly incorrect HIV and hepatitis test results, the inquiry has begun to focus on how to fix the accreditation process to ensure a similar scenario won't be repeated.
In late April the Baltimore hospital handed state officials a 400-page plan of corrective action to address problems and prevent future missteps. By doing so, the hospital avoided fines of $10,000 a day.
But even as Maryland's top health official expressed optimism that things were on the mend at 216-bed Maryland General, he said he remained troubled by how inspectors not only missed problems at the hospital's laboratory but actually gave the facility its highest rating, "Accredited with Distinction." "Maryland General is going to fix their problems," state Health Secretary Nelson Sabatini said. "Now we need to look at how to create a systemic approach to prevent ... these issues."
The state is reviewing the report the College of American Pathologists completed on Maryland General last summer. While the Joint Commission on Accreditation of Healthcare Organizations accredits a broad spectrum of healthcare facilities including about 4,500 laboratories, the college performs many hospital lab inspections under an agreement between the two organizations that is sanctioned by the federal government. The college accredits 6,300 laboratories. Accreditation is voluntary, and a laboratory's pathologists do not have to be members of the college for it to accredit the facility. Lab inspections by the college cost an average of $2,200, compared with an average of $5,500 for a JCAHO inspection. The college reaps no profit from the work, a spokeswoman said.
The college inspected Maryland General in April 2003. Three months later it gave the laboratory its "Accredited with Distinction" honor. Later, a former employee alerted health officials that thousands of patients may have received incorrect test results. During subsequent inspections, federal, state and JCAHO inspectors found widespread problems including equipment failures, staff communication problems and lost or mishandled specimens. After those inspections, the hospital retested more than 2,000 patients who may have received invalid results from June 2002 to August 2003. Three hospital officials, including Timothy Miller, president and chief executive officer, resigned in the wake of the scandal.
What troubles state officials is that before the college's inspection there were indications that problems existed with the lab dating back to August 2002. Former employees have also more recently publicly disclosed a series of internal complaints dating back to 2001.
"Something doesn't add up," Sabatini said. "How do you get a meritorious rating (in light of all the problems that existed)? Something is wrong."
Hospital officials said a Labotech blood analyzer that malfunctioned was the root of the problem. In an interview with Modern Healthcare, Ron Lepoff, chair of the college's commission on laboratory accreditation, said that for inspectors to have discovered the problem, they would have had to be led to it specifically.
Indeed, last November, in response to a complaint, state inspectors found no pressing issues after visiting Maryland General's lab.
Sabatini wouldn't go so far as to say that he wants the state to take over inspections, but Peter Lurie, deputy director of Public Citizen's Health Research Group, said that inspection oversights such as the one at Maryland General happen because the system relies on provider-run associations doing the inspecting. "It is a fox guarding the henhouse problem," he said. Public Citizen is a consumer advocacy group.
A 112-page manual that laboratories receive from the college also maps out staffing and training requirements for accreditation and includes checklists for inspectors and describes deficiencies inspectors are looking for.
"It's like taking an exam and being told what the questions will be beforehand," Lurie said.
"I don't believe (Lurie's criticism) applies in this case," Lepoff said. "The people doing the inspections are not regulators. ... They are people who work in laboratories voluntarily." Inspections are done by peers from other facilities and are conducted on-site every two years.
According to those in the hospital industry, the college's accreditation is considered the gold standard of laboratory accreditation.
"It's a very detailed inspection process," said Mary Harrington, lab director at Medical Center East, a 282-bed hospital in Birmingham, Ala., whose lab is accredited by the college. "It's not regarded as a rubber stamp kind of thing."
Despite the problems at Maryland General, Charles Mowll, executive vice president of business development and external relations for the JCAHO, said the commission will continue to honor the agreement it has had with the college since 1965. "The ultimate goal is to make sure that laboratories undergo a rigorous and credible review," he said.
Public Citizen's Lurie said he would like to see the accreditation process taken away from associations. "Even if you improved the details of the inspection," he said, "it will not be improved until you have a government entity step in."