By Andrea K. Walker, The Baltimore Sun
8:23 PM EDT, May 24, 2013
State health regulators suspended the licenses of several abortion clinics owned by Associates in OB/GYN Care for the second time after an employee with no health care license or certification gave a patient a drug to induce an abortion at the Baltimore facility.
The same employee also performed an ultrasound on the woman, although the employee wasn't trained in the procedure, according to records released Friday by the Department of Health and Mental Hygiene. There also was no physician at the clinic, even though the woman had scheduled an appointment for a May 4 procedure.
The doctor who arrived at the clinic later that day refused to perform the abortion, saying that "this facility is not equipped to do this procedure safely," according to the state records.
The woman was 13 to 14 weeks pregnant with triplets and had an enlarged uterus, said Bridget Wilson, an OB/GYN Care spokeswoman.
The state's Office of Health Care Quality investigated the clinic and suspended its license after receiving an anonymous complaint about the patient's treatment on May 7. The agency also examined operations at clinics owned by OB/GYN Care in Cheverly, Frederick and Silver Spring and suspended the licenses of those clinics as well.
The investigation found that it was standard protocol at the clinics to administer the drug Misoprostol to induce an abortion in patients in the 11th week of pregnancy or later, even if the patient had not been seen by a doctor and there was no physician at the clinic.
"The abortion procedure is a medical process that requires appropriate supervision, and OHCQ felt that was not the case in this situation," said Health Secretary Joshua M. Sharfstein in an interview Friday.
In a hearing earlier this month, OB/GYN Care admitted that its Baltimore facility's treatment of the patient was improper, as was having unlicensed staff administer Misoprostol, the state documents said. However, the firm blamed the problem on one physician and contested the license suspensions, which prohibit the clinics from performing surgical abortions.
Wilson said Friday that the contract physician worked at all four facilities but did not inform the firm's medical director that he was allowing unlicensed staff to administer drugs to patients.
"This was the policy of this physician," Wilson said. "This is not a policy of OB/GYN Care. It is not something that any of our other physicians do. Once it was found out, we told our staff it was no longer allowed. … We were unaware of it until the suspension."
During a hearing at which it contested the suspension, OB/GYN Care told the state it had corrected the problem, Wilson said.
"It seems as though they want to penalize all of our facilities for the actions of one physician, and this is unfair selective enforcement," she said. "If all health care facilities in the state of Maryland were to be shut down based on the action of one physician who worked there, there would be no open health care facilities in the state, yet this seems to be the standard they are holding us to."
The state declined to lift the suspensions because OB/GYN Care did not provide "compelling evidence" to do so, according to state documents. OB/GYN Care plans to request an additional hearing to ask that the licenses be reinstated.
The firm's clinics in Baltimore, Cheverly and Silver Spring had their licenses suspended in March after a woman suffered complications after an abortion at the Baltimore facility and died at a local hospital. The woman had trouble breathing after the procedure, and the state said she suffered cardiac arrest at the clinic. OB/GYN Care disputes that account.
The patient suffered from a fatal heart condition, may have had defective heart valves and was probably in heart failure, wrote Melissa Shachnovitz, an OB/GYN administrator, in a letter to state officials in March.
Although the woman's death was caused by underlying conditions and not the abortion, state investigators found that the incident raised questions about whether doctors at the clinic could handle an abortion that goes wrong. Health officials also cited other problems at the three facilities at the time.
The licenses were reinstated about two weeks later after OB/GYN Care submitted a "plan of correction."
The suspensions were among the first actions the state took after adopting regulations for abortion clinics last year. Created in part because of a botched procedure at an Elkton clinic in 2010, the regulations allow the state to fine or shut down a clinic for violations related to anesthesia, emergency services, lab work and other areas.
Several delegates complained earlier this year that the state was not inspecting clinics quickly enough after a New York teacher died at a Germantown facility in February.
The state health department sent letters to the chairs of the powerful Senate Finance and House Health and Government Operations committees Friday detailing their progress. The state inspected 16 facilities, and all but the four OB/GYN Care facilities met standards, many after correcting some violations.
The violations found by state investigators didn't present "an immediate and serious threat to the health and safety of patients," the letter to the committee chairs said. Common deficiencies were failures to document the professional credentials of doctors and to include the condition of patients at discharge in medical records.
In one example from state records, inspectors found that a staff member at Planned Parenthood of Maryland's Baltimore clinic was not trained on transferring a patient to a hospital in an emergency. The inspection found medical records for five patients that did not include their condition at discharge.
The facility has since added discharge information to medical records, including check boxes that indicate a completed or incomplete abortion, state records show. Random chart audits now look for discharge diagnosis.
In a statement Friday, Planned Parenthood said a patient's discharge diagnosis had been included previously but wasn't clearly labeled. As for the improperly trained staff member, it said she was on medical leave and her file was not updated at the time of the inspection. Documentation of all of training was entered into her personnel file, including her training on emergency transfer of a patient to the hospital, before she returned to work.
"Planned Parenthood of Maryland welcomes appropriate regulatory steps that help ensure patient safety in medical facilities across the state," the group said in a statement.
Planned Parenthood said its staff reported the incident that led to the state investigation of OB/GYN Care. Because of privacy laws, the group could not say if the woman ultimately got an abortion at its facility.
According to the state account, the doctor at OB/GYN Care gave the patient three options after refusing to perform the procedure.
He told the patient she could be taken to a OB/GYN Care facility in New Jersey to have an abortion performed under general anesthesia or go to a local hospital to have the procedure completed, state documents said. He also said gave her the option of traveling two days later to the clinic in Frederick to get additional Misoprostol and a type of seaweed to dilate the cervix. The woman could then have a procedure the following day in Baltimore and a second one if needed a day later in Cheverly or Silver Spring.
The woman ultimately underwent an abortion with no complications, according to the state report, which didn't say where.
While there were no "serious and adverse" effects, state investigators said the actions by OB/GYN Care posed "a serious and immediate danger to patients."
Sen. Thomas M. "Mac" Middleton, chair of the Senate Finance Committee, said he was pleased with how the new regulations were working.
"When you are talking about abortion procedures, you are talking about a very, very serious procedure," the Charles County Democrat said. "A lot of complications could arise, and there has to be the proper medical oversight and it has to be done safely."
Del. Nic Kipke, an Anne Arundel County Republican, said that the state has made some strides with the new regulations but that weaknesses remain in the system.
He said there are abortion clinics that advertise on the Internet but are not licensed by the state.
"The Office of Health Care Quality is moving in the right direction to protect women, but the state can do more," Kipke said.
Sharfstein said state investigators are working to find facilities that should have licenses.
"We are actively investigating whether there are clinics that aren't licensed and should be," Sharfstein said.
Copyright © 2013, The Baltimore Sun