Early Options: The Physical Facility

Early Options - A Provider's Guide to Medical Abortion

This page contains the following sections:

Office Layout
TRAP Laws

After reading this section, you should be able to answer the following question:
Facilities offering medical abortion services must have on-site space for which aspects of medical abortion service delivery?

Office Layout
The ideal office layout expedites patient flow through the steps of the medical abortion process by creating optimally efficient traffic patterns. The amount of space needed will vary depending on the size of the office, the number of staff involved, patient volume, and the nature of the services provided (e.g., on-site ultrasound, surgical backup).

Adequate space is needed for reception, private counseling, physical examination, and medication administration. If ultrasound examination is offered on-site, an area to perform sonography and to store this diagnostic equipment will be needed.

Facilities that already provide surgical abortion services can offer medical abortion concomitantly, since surgical procedure rooms are not required for medical abortion. Providers of surgical abortion may find it advantageous to offer both services simultaneously to capitalize on the availability of laboratory and ultrasound services.

Coordinating the services can also facilitate the delivery of care for the small percentage of patients who initially choose medical abortion and subsequently require a surgical abortion for completion, or for those patients who are scheduled for a medical abortion but are ineligible for it or who choose a surgical abortion.

The practice's protocol for misoprostol administration may also affect physical plant requirements for medical abortion. The FDA labeling for Mifeprex® specifies that women should return to their health care provider 2 days after mifepristone administration to receive misoprostol.¹ However, the labeling does not require patients to remain in the health care setting for monitoring after receiving misoprostol.

Many providers employ mifepristone/misoprostol regimens that involve women self-administering misoprostol at home. Studies confirm the safety, efficacy, and acceptability of home administration of misoprostol, and, when given the choice, most women opt to self-administer the misoprostol and pass the pregnancy tissue at home rather than in the clinic or medical office.^2-5 Likewise, both in study protocols and in clinical use, methotrexate/misoprostol medical abortion regimens routinely employ at-home self-administration of misoprostol.^6,7 In these cases, additional office space requirements are not an issue. (Note: Although numerous studies have established its safety and efficacy, the combination of methotrexate and misoprostol is not FDA-approved for medical abortion.)

However, if the office protocol either requires women to return to the office for misoprostol administration and remain for monitoring or offers this option to the few women who state a preference for office administration and monitoring, a separate area is needed to accommodate patient needs during the post-misoprostol observation period (typically 1 to 4 hours). Adequate personnel also must be available to staff this area and attend to patient needs.

During this observation period, patients will need access to bathroom facilities, and may appreciate the availability of hot water bottles, heating pads, books, magazines, music, or videos. Current providers of surgical abortion may use their recovery room for an observation period. Practices without a recovery room or other suitable space may decide to establish protocols that employ at-home self-administration of misoprostol.

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After reading this section, you should be able to answer the following questions:
What does "TRAP" stand for?
How can you characterize TRAP laws?

TRAP Laws
With regard to the physical facility, a sizeable number of states have targeted regulation of abortion providers ("TRAP") laws that single out abortion-related facilities by imposing regulations regarding the physical plant, staffing, or patient testing that do not apply to other physicians' offices or outpatient clinics. For example, a Missouri law requires a procedure room with a ceiling at least 9 feet high and a separate recovery room with a minimum of 3 feet of clearance around at least 4 recovery beds. It also requires abortion clinics to have a system for changing the air 6 times per hour in the procedure and recovery areas.

TRAP laws vary in the degree of burden that they impose, the facilities affected by the statute, and the stages of gestation to which they apply. The wording of most current state laws regulating abortion services does not acknowledge a distinction between medical and surgical abortion.

Because of the broad definition of the term "abortion," TRAP laws usually apply to all abortion procedures, medical and surgical. Whether providers planning to offer medical abortions must comply with TRAP laws often depends on other state-specific criteria. For instance, some TRAP laws are triggered by a threshold number of abortions provided during a given period; others apply only to "specialty" clinics and exempt physicians' offices. Medical abortion would thus be exempt from TRAP laws in these states so long as it is provided in a physician's office rather than in a facility targeted by the laws.

Practices that do not currently offer abortion care but wish to add medical abortion to their services should consult with knowledgeable legal counsel in their state to assess the applicability of any existing TRAP laws, and to ensure compliance where needed.

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Proceed to Staffing.

References for this module