The rules announced Friday are meant to increase oversight of surgical abortion clinics, which are not currently held to the same standards as other outpatient surgery facilities.
Under the current law, surgical abortion providers in Maryland can be disciplined by the state's Board of Physicians for violating rules, but the facilities where abortions are provided are subject to little supervision. The proposed rules aim to give the department authority to inspect a facility and intervene if problems arise.
"I think the department has done an outstanding job at putting the health and safety of women first in these regulations," said Nancy E. Paltell, associate director of Respect for Life, a division of the Maryland Catholic Conference, which lobbies in Annapolis on behalf of the Catholic Church. "They really did a good job of including stakeholders in the process."
The rule-making process was inclusive, and the state took recommendations from interested organizations seriously, said Jodi Finkelstein, executive director of NARAL Pro-Choice Maryland. She declined to comment further until she'd had the opportunity to discuss the regulations with the state's abortion providers.
"We are supportive of [the department's] evidence-based approach," said Ann Rasenberger, interim head of Planned Parenthood of Maryland, who had not had a chance to read the proposed regulations Friday evening.
The new regulations mirror the rules that govern ambulatory surgery centers, which are equipped to safely perform surgeries outside of hospitals, Phillips said. Experts, other states' laws and interest organizations — including the Maryland Catholic Conference and Planned Parenthood of Maryland — were all considered during the rule-making process, she said.
The regulations require facilities providing surgical abortions "as a regular service" to apply for a license every three years at a cost of $1,500, open their facilities and records for inspection by department officials and designate an administrator responsible for everyday operations.
In addition, anesthetics must be administered by a qualified doctor or a nurse anesthetist, and personnel must be present who are certified in "basic life support." Life support equipment, such as defibrillators and oxygen, must also be present. The facility must be prepared to provide appropriate transportation to a hospital if an emergency occurs, among other rules.
The state health department began exploring the possibility of imposing new restrictions in August 2010, after a New Jersey doctor was found to be illegally providing abortions at the American Women's Services clinic in Elkton, and a young woman suffered a ruptured uterus and other internal injuries during a procedure. As a result of that case, two doctors' licenses were revoked and a third, who was never licensed to practice in Maryland, was ordered to stop working in the state.
"We decided with the Elkton situation, now was the time to push," said Paltell, whose organization originally hoped a law grouping surgical abortion providers with other outpatient surgery centers would be passed by the General Assembly during the last session. "I mean, these injuries just have to stop. … We realized, 'Wow. There's no oversight.'"
Maryland's abortion law — passed by the General Assembly in 1991 and approved by referendum a year later — gives the state health department the authority to craft regulations that restrict how abortions are offered as long as they are the "least intrusive method" of ensuring women's health and are consistent with established medical practice.
The department produced draft regulations at the end of July and considered more than 60 sets of comments before releasing the revised version. The most significant changes bolstered privacy protections for patients and added restrictions on who can administer not only general anesthesia but also sedation.
Abortion-rights advocates are concerned that some of the new regulations — including the requirement that anesthesia be administrated by a qualified doctor or nurse — will create financial and administrative burdens on providers, thereby limiting women's access to abortions in Maryland.
Other than a separate recovery room and waiting area, no building codes have been placed on facilities under the regulations. Building requirements in a Virginia rule approved in September were considered by some as a way of forcing abortion providers to close if they couldn't afford to move or renovate.
American Women's Services — the provider that ran the clinic in Elkton and has facilities in Baltimore, Cheverly and Frederick, according to its website — declined to address the rules' potentially burdensome requirements.
"We believe that we are already largely compliant with these newly proposed regulations," said spokeswoman Bridget Wilson in a statement Friday. "We welcome proper regulatory oversight of our services, provided that such oversight is carried out in manner that is nondiscriminatory and fair to abortion providers, while also protecting the confidentiality and safety of women."
Public comments will be accepted again after the proposed regulations are published in the Maryland Register in January.
For the Maryland Catholic Conference, the main sticking point is the definition of a surgical abortion facility, which excludes clinics that perform abortions infrequently in cases of medical emergencies, said Paltell.
"Aren't you more likely to make a mistake if you haven't done one for a couple of months?" Paltell asked. Women who have abortions by doctors who do not perform them regularly deserve the same protections as women who undergo the procedure elsewhere, she said.
The anesthesia administration requirements will be the main rule scrutinized by Planned Parenthood as the process moves forward, Rasenberger said.