ANNAPOLIS — Maryland’s health department has drafted new regulations for clinics where surgical abortions are performed, after a woman required emergency surgery following an abortion performed by an unlicensed doctor at an Elkton clinic last year.
The regulations, which were submitted for public comment Friday, were developed in response to abortions performed in Elkton by a doctor whose license has since been suspended in New Jersey. Regulators found that Dr. Steven Brigham was starting late-term abortions in New Jersey and sending patients to Maryland to complete the procedures.
“These draft regulations are strictly aimed at patient safety, and rely on professional judgment,” the Maryland Department of Health and Mental Hygiene said. “We believe that these draft regulations reflect the right balance of preserving both safety and access.”
The draft regulations would require clinics to have a license from the state. A clinic staff member would have to be available 24 hours a day for emergencies. Anesthetics would have to be administered by appropriately trained staff and licensed health care providers. A surgical abortion facility also would have to have a procedure to transfer patients to a hospital when care is needed beyond the capabilities of the facility.
Abortion procedures have been regulated in the state in the same way as other medical procedures, the department said. Abortions have had to be performed by a licensed physician. The draft regulations will supplement the standards.
“The department is moving forward to strengthen oversight in light of rare cases of physicians who violated the standard of care with surgical abortions,” the department said.
The public comment period on the regulations runs through Aug. 18. The department will then review the comments and make any needed changes before the regulations are formally published in the Maryland Register. The public will have 30 days to comment after the regulations are published.
Brigham’s practices first caught the attention of Maryland regulators last year after a patient was hospitalized with a ruptured uterus and small intestine. He was ordered to stop practicing without a license in the state. The later suspension of his New Jersey license left him without a valid medical license in any state.
The draft regulations were developed after the state researched laws in other states, as well as public records of the Maryland Board of Physicians.
“We also spoke with advocacy groups, and interviewed clinical experts in the fields of gynecology, anesthesiology, obstetrics, and outpatient surgery,” the department said.
A review of the board’s public orders from 1991 found that five physicians had been disciplined for violating the standards of care for surgical abortions, the department said. Women died or were seriously injured in each case, according to the disciplinary records. Women were harmed by improper administration or monitoring of general anesthesia under the care of three of the five physicians, the department said.
The department also noted that the board directed charging documents to three additional physicians in August and September of last year at the Elkton site.
“Among other problems identified was lack of an appropriate transfer procedure for a patient needing emergency care,” the department said. “The draft standards aim to address some of the deficiencies identified in these cases.”