ANNAPOLIS – Maryland lawmakers promised to clean up the state’s medical laboratories last year, after reports of negligence that may have tainted hundreds of HIV and hepatitis-C tests at Maryland General Hospital.
They think they are on track with a bill that swept through the Senate this week, requiring unannounced inspections of the state’s nearly 4,400 licensed medical labs and establishing protections for lab workers who blow the whistle on wrongdoing.
But critics say the measure that passed the Senate on a 45-0 vote Wednesday is just “a small step in the right direction.”
The bill is “a needed part of the substantial effort to reduce medical errors and consistently deliver a higher quality of medical care,” said Robert Michel, who edits the medical-lab industry newsletter, the Dark Report.
But the bill would “not at all” reform accreditation, he said.
Sen. Paula Hollinger, D-Baltimore County, said her bill will significantly alter the medical lab accreditation process, which has been blamed for the problems at Maryland General.
Maryland labs are inspected and accredited at regularly scheduled times by private firms such as the College of American Pathologists (CAP), which accredits most of the labs in Maryland. But in news reports last year, and in testimony by a former Maryland General Hospital lab worker, those inspections were criticized as inconsistent and too easy for lab workers to circumvent.
Since the story broke last year, CAP promised to revoke lab accreditations if complaints are ignored and it established a toll-free number for whistle-blowers.
The Joint Commission on Accreditation of Healthcare Organizations has also said it will require its members make unannounced inspections starting next year.
Hollinger’s bill would add another level of inspection, requiring the state health department to conduct unannounced inspections and to report any violations to the private accreditation agencies. It would also prohibit retaliatory action against whistleblowers.
The state health department supported the bill, saying in a written statement that it “needs the authority to better hold an accreditation organization accountably.”
But the chairman of lab accreditation for CAP said unannounced inspections are not necessarily more effective than scheduled ones, and he sees no need for state reforms.
“I don’t think the fundamental accreditation process for clinical laboratories in this country is broken,” said Ronald Lepoff of CAP.
Other industry officials disagreed, saying Maryland lawmakers have not gone far enough.
Hollinger’s bill does not clearly mandate the amount or type of information that the state must share with private accreditation agencies, said Mark Crafton of the joint accreditation commission.
Michel added that the performance of labs should be measured and reported. While protecting whistleblowers works in theory, it may not improve testing procedures in reality.
The Maryland Hospital Association said it would like to see the bill amended to require that employees first take concerns to supervisors before becoming whistleblowers.
Delegate John Donoghue, D-Washington, has introduced a House bill similar to Hollinger’s, whose Education, Health and Environmental Affairs Committee is scheduled to take up a separate measure this week that would let the state require that medical labs do certain retests and publicly report testing errors.
No matter what happens to the measures, Hollinger said she is confident lawmakers will make Maryland medical labs conduct more accurate, safer tests.
“We think we have the framework” to do so, she said. The bills are “more than a starting point. Hopefully they’ll be a finishing point.”
Gov. Robert Ehrlich has not yet taken a position on Hollinger’s bill, a spokeswoman said. But Hollinger said she remains confident.
“Realistically this bill will pass” and become law, she said. “We know how necessary it is now.”
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