In July, authorities discovered that a
In September, the Maryland health department shut down a
And last fall, hundreds of patients in 20 states became infected with fungal
What the three cases have in common is that each exposed loopholes in our health care regulatory structure, with deadly consequences. The Maryland Department of Health and Mental Hygiene is proposing legislation in response to all three incidents, and while none of the bills may offer a perfect solution, each would make Marylanders safer.
On Thursday, the
The health care staffing agencies in Maryland and other states that employed the radiology technician, David Kwiatkowski, weren't solely to blame, a new report from the state health department found. Hospital workers who suspected something was amiss were also reluctant to report him. He failed to disclose a DWI arrest and other possibly disqualifying infractions when he sought a radiographer license from the Maryland Board of Physicians, and a national registry that should have enabled the state to catch those omissions failed to list all of his faults. The report also suggests that the Board of Physicians conduct background checks as part of its licensure process. Nonetheless, the staffing agency legislation is an important part of the effort to prevent something like this from happening again.
In the case of the cosmetic surgery death, state and local inspectors found inadequate infection control procedures. A loophole in state law explains why they weren't discovered earlier. The state is authorized to regulate ambulatory surgery centers, but the definition of those centers under state law has to do not only with what procedures they perform but also with how they bill for their services. This legislation would base the requirement for state regulation solely on what invasive procedures a facility performs. The legislation also allows the health department to add to the list of procedures that trigger a registration requirement if it determines that they pose a potential risk.
Perhaps the trickiest of the three proposed regulations deals with compounding pharmacies. The term originally referred to facilities where pharmacists could reconstitute drugs on an individual basis — for example, turning a pill into a liquid medicine for a child. But in cases like the New England Compounding Center, they have become de facto drug manufacturers operating outside of federal
This bill would create a new kind of license for sterile compounding facilities in Maryland and would require out-of-state facilities to receive a permit from the Maryland Board of Pharmacy before selling drugs here. The licensing requirements include adherence to proper sanitary procedures and staff training. The health department and legislators are working on an amendment to the bill that would allow some kind of waiver process for facilities that have not received Maryland permits but which supply drugs for which there is a demonstrated need, though the details have not been finalized.