Maryland may soon require hospitals to report all medical errors that seriously harm patients - a measure that regulators hope will curb mistakes like the chemotherapy overdoses recently given to two patients at the Johns Hopkins Children's Center.
The state health department has been drafting the mandatory-reporting regulations for several months and hopes to have them in place by early next year, an official said yesterday.
Carol Benner, director of the state's Office of Health Care Quality, said she expects the rules will require hospitals to report all mistakes that cause serious injury or death or require corrective treatment.
In each case, hospitals would have to analyze what went wrong and indicate what they were doing to prevent similar mistakes from occurring.
Additionally, the rules would require hospitals to tell families about mistakes, including medication and surgical errors, that result in a bad outcome.
"This will encourage hospitals to really take a look at their systems, at problems that cause these errors," Benner said yesterday. "It's what other states are doing. It is the right thing."
About 15 states have enacted such requirements in recent years, according to patient-safety organizations.
Benner said the rules, if they had been in effect, would have required Hopkins to report the two chemotherapy overdoses soon after they occurred.
The hospital did submit a full accounting after the health department launched an investigation and requested information, Benner said.
In one of the Hopkins cases, a 2 1/2 -year-old boy with neuroblastoma became deaf after receiving chemotherapy overdoses on three successive days. He was receiving the drug, carboplatin, in preparation for a bone marrow transplant.
In the other, a 3 1/2 -year-old girl received an overdose of the same drug, but the dosage was corrected after the first treatment and the girl was not harmed, the hospital said.
Hopkins officials discovered the girl's overdose during a routine review of chemotherapy doses, and that led doctors to find the error in the boy's treatment, hospital officials said yesterday.
The two incidents occurred in May, according to the health department.
Newspaper inquiry
Under current regulations, the state Department of Health and Mental Hygiene investigates hospital errors that are reported by patients or other parties.
In June, it looked into the Hopkins cases after receiving an inquiry from The Sun.
In a 1999 report on medical errors, the National Academy of Science's Institute on Medicine urged mandatory reporting of serious medical errors to state agencies.
The panel argued that such reporting is needed before hospitals and health agencies can devise ways to curb what it called a national epidemic of errors that kills 44,000 to 98,000 patients annually.
Benner said the department has drafted the rules and has begun to discuss them with hospital officials, insurers, regulators and physicians.
"They are definitely on a fast track, and I think we have consensus throughout the state that this is the right thing to do," Benner said. "There really has not been too much controversy about it."
Before the regulations could take effect, the department would have to solicit public comment. Though the rules would not require legislative approval, lawmakers could ask to review them in a hearing.
Benner did acknowledge that the hospitals are concerned that public disclosure of medical errors could expose them to liability and unwanted media attention.
Public disclosure
In their current form, the proposed rules would not make the hospital reports open for public inspection, though state officials would share key features with people who asked about particular incidents, she said.
"The department would give out factual information like I did in this case," she said, noting that she discussed key findings of the department's investigation of Hopkins without releasing documents.
"But we would not automatically do any kind of public disclosure every time something happened."
Beverly Miller, vice president of the Maryland Hospital Association, said the group wants to make sure that reports are confidential.
She favors the release of "aggregate, non-identifiable information" that shows trends in errors statewide rather than reports of specific cases.
Though the group supports measures that will improve patient safety, Miller said, she could not comment on the proposal because she has not yet seen anything in writing.
Miller is a member of a coalition of health care professionals that is working with state government to enact reforms.
Barbara McLean, director of the Maryland Health Care Commission, which rates nursing homes, hospitals and HMOs, said yesterday that her group is seeking grant money to start a center for patient safety that would study medical errors and work with hospitals to devise systems to prevent them.
The center would study examine reports of medical errors, but would be a nongovernmental agency.
"We're all horrified when we see something like the events reported in the paper," she said of the Hopkins overdoses. "But we have to step back and really look at what we are doing to improve the health care system."
Dosage miscalculation
Yesterday, Hopkins doctors in charge of the pediatrics department and its cancer program declined to discuss the overdoses.
But in a statement, a spokesman said doctors miscalculated the dosages because they incorrectly accounted for the patients' kidney function.
To calculate dosage, doctors use a formula that factors a patient's body surface area along with the kidney's ability to flush the drugs from the body.
The Children's Center has been evaluating computer systems that help doctors calculate chemotherapy doses and flag potential errors and hopes to have one installed in the coming year, the spokesman said.
"Hopkins is acutely aware of the need to continually update and upgrade its dosing processes to reflect the increasing complexity of therapies in both children and adults," said the spokesman, Gary Stephenson.
"Nothing has a higher priority than patient safety."