ANNAPOLIS – New regulations will take effect in the state’s hospitals today, as procedures designed to reduce error through increased communication roll into place.
“Right now, the only time we know if something occurs is if the hospital decides to report it voluntarily or if we get a complaint from the patient or the family,” said Carol Benner, director of the Office of Health Care Quality in the Department of Health and Mental Hygiene.
That will change under the new regulations, said Benner, because hospitals will have to report events resulting in death or serious injury to the department. All hospitals must have a patient safety section and separate errors into categories.
Hospitals have been gearing up for months for the deadline, and should be ready to take on the new regulations, said Nancy Fiedler, spokeswoman for the Maryland Hospital Association.
Under the new system, an incident that results in death or serious disability must be reported to the health department along with a “root cause analysis,” or an investigation that looks at human, mechanical and environmental factors that may have contributed to the error.
Root cause analysis isn’t new: It’s already done by hospitals to get accreditation. But from now on, each one will be reviewed by the health department to determine if it is acceptable.
The analysis won’t be public knowledge, but patients will benefit from revamped hospital procedures.
Hospitals will also need to start talking to one another. If doctors at one hospital treat a patient for injuries sustained at another hospital, it’s their responsibility to relay the information back. The first hospital then would open an investigation.
The regulations strengthen requirements regarding patient-hospital communication. Hospitals must tell patients who submit complaints that if the hospital investigation is unsatisfactory, the patient may ask for a follow-up by the health department. Hospitals also have to notify patients about any unanticipated outcome.
“When something goes wrong in the hospital, we see very frequently a wall go up,” said Benner. Communication breaks off because of potential lawsuits, she said.
The goal of the regulation, said Benner, is to get good investigations and to get families talking with hospitals.
The Department of Health and Mental Hygiene, which put out the regulations after an investigation prompted by the Legislature in 2001, expects the new procedures will have only a minimal financial impact on the regulated entities.
At the end of this year, the state will also have a way to deal with less severe medical events.
The soon-to-be-created Maryland Patient Safety Center, a privately run non-profit, will amass information from hospitals and determine best practices.
Reporting on these less-severe events will be anonymous and voluntary, but patients will be able to find out if a hospital participates.
The center is designed to get to the cause of events before they happen, said Barbara McLean, executive director of the Maryland Health Care Commission, in a briefing to lawmakers.
The Maryland Health Care Commission is still reviewing proposals from contractors to run the Patient Safety Center, and hopes to select one after mid-April.
Unlike the Board of Physicians, which disciplines errant physicians, the Patient Safety Center will play a role that is more academic than regulative. The goal is to encourage hospitals to report potential problems and identify systemic problems without consequences, thus avoiding attempts to cover-up practices that keep patients at risk.
“The thing we will find most useful . . . is the sharing of information so that other hospitals can learn from information . . . about what has resulted in adverse events,” said Fiedler. Negligent doctors will still be regulated by the Board of Physicians and the Department of Health.