We are writing on behalf of Richmond Medical Center for Women to urge the Board of Health to draft permanent regulations that are medically appropriate for physicians’ offices that provide abortion care.  We operate four women’s health care centers under the name Richmond Medical Center for Women, with locations in Richmond, Charlottesville, Peninsula, and Roanoke.  Dr. William G. Fitzhugh, a board-certified obstetrician-gynecologist, started Richmond Medical Center for Women in 1973 out of concern for the safety and well-being of women in the Richmond area who were seeking abortions.  At that time, there were no health care facilities providing abortion in the central Virginia area, forcing women from that area to travel for hours to get to Washington, D.C.  Travelling for medical care creates unnecessary risks for patients, so Dr. Fitzhugh opened Richmond Medical Center for Women to offer safe, high-quality abortion care to women locally. The next year, Dr. Fitzhugh opened the Roanoke and Peninsula centers for the same reason, feeling that it was safer for patients if he travelled to them than if they had to travel to Richmond for care.  Patient safety is at the core of our medical practice.

We have serious concerns about our ability to continue meeting our patients’ needs if the Board decides to make the emergency regulations permanent.   Many of the requirements in the emergency regulations are inappropriate, medically unnecessary, and inconsistent with medical standards of care. 

I.          Patient and Provider Confidentiality and Safety

The emergency regulation 12 VAC 5-412-110(C) permits the Office of Licensure and Certification (OLC) to make “periodic unannounced on-site inspections of each abortion facility” at least once annually, and requires the facility to “make available to the OLC’s representative any requested records,” including patient records, and to provide the inspector with “a list of current patients” if requested. 

This regulation endangers patient privacy and confidentiality, particularly since it is in the context of reproductive health services.  Patients expect total confidentiality and privacy in their medical records, and are entitled to that confidentiality in the context of the doctor-patient relationship.  Allowing inspectors to review unredacted patient records, and to request a list of current patients, violates patients’ confidentiality, and does so for no reason. Patients have a right to expect that their private, medical information, particularly their identifying information, will remain confidential – in fact, a federal court has held that “giving [a state department of health] unbounded access to unredacted patient records violates the informational privacy rights of patients.”  Tucson Woman's Clinic v. Eden, 379 F.3d 531, 553 (9th Cir. 2004).   

The regulations also require health care facilities that provide abortion care to provide a range of personnel and facility information, with absolutely no protection for the confidentiality of that information.  Reproductive health care facilities, as well as their staff and volunteers, have long been the targets of violence and protest.  As a result, our clinic and others are extremely attentive to security in all of our procedures. Over the many years we have provided abortion services, our clinics have faced weekly protests and harassment.  Furthermore, in 1992, we were targeted for arson at our Richmond facility, and a smaller fire at our facility in Newport News.   Dr. Fitzhugh and Jill Abbey have also had protesters at their homes.  We are very concerned that the absence of confidentiality protections for personnel files and facility information, including protections against releasing this information pursuant to Freedom of Information Act requests from the public, could endanger the safety of our staff and patients. 

Recommendation:  We urge you to ensure that the permanent regulations provide the highest levels of protection for patient records, personnel files and facility information.  In particular, the regulations should:  allow OLC representatives to inspect patient records only after they have been redacted of any potentially identifying information, giving health care facilities a reasonable time to redact the records; eliminate the requirement that health care facilities produce a list of current patients; and require any information about personnel or the facility to be kept strictly confidential within the OLC.

II.        Denial, revocation or suspension of license for violations of the Va. Code § 32.1-123 (et seq.), 12 VAC 5-412-130

Under 12 VAC 5-412-130, if the Department “determines that an abortion facility is (i) in violation of any provision of Article 1 of Chapter 5 of Title 32.1 of the Code of Virginia . . . or of any applicable regulation . . . the department may deny, suspend, or revoke the license to operate an abortion facility.”  In addition, if the Department revokes a facility’s license, the facility must show its ability to comply with that Article in order to receive a new license.

There are two significant problems with this regulation.  First, it requires abortion facilities to comply with the entire statutory code relating to hospitals in order to become and stay licensed.  However, Senate Bill 924, the bill that authorizes the Department to promulgate abortion clinic regulations, gave the Board the authority to regulate facilities that provide five or more first trimester abortions only for the purposes of Va. Code § 32.1-127(B), one paragraph of the referenced Article.  Senate Bill 924 explicitly requires the Board only to promulgate regulations for abortion facilities relating to “construction and maintenance . . . operation, staffing, and equip[ment] . . . qualifications and training of staff . . . conditions under which a hospital or nursing home may provide medical and nursing services to patients in their places of residence; and policies related to infection prevention disaster preparedness and facility security[.]”  Applying the entire Article 1 of Chapter 5 of Title 32.1 of the Code of Virginia threatens abortion facilities with the denial or loss of license for violation of provisions of the statutory code that should not apply to them at all.

Recommendation:  We urge you to omit the reference to “any provision of Article 1 of Chapter 5 of Title 32.1 of the Code of Virginia” from the permanent regulations.

III.       Transfer Agreement - 12 VAC 5-412-29

Under 12 VAC 5-412-290(C), health care facilities that provide abortion care must execute a written agreement with a licensed general hospital “to ensure that any patient of the abortion facility shall receive needed emergency treatment.”  However, it is unnecessary to obtain a documented transfer agreement with a nearby hospital, because the Emergency Medical Treatment and Labor Act (EMTALA) requires them to treat and stabilize or transfer any patient presenting with an emergency medical condition.  (42 U.S.C. § 1395(dd) (2003).)  It is an unnecessary administrative burden on both clinics and hospitals to require documentation, as all local hospitals are already bound by federal law to accept patients in emergency cases. 

Recommendation:  We urge you to eliminate this requirement from the permanent regulations.

IV.       Physical Facility Requirements - 12 VAC 5-412-380

Richmond Medical Center for Women has been providing safe, essential reproductive health care for almost forty years.  First-trimester abortion procedures are regularly provided safely in office-based practices like ours.  It is neither necessary nor consistent with medical standards of care to provide them in hospital-type settings.  Instead, abortion should be regulated in a manner that is appropriate to the type of surgery involved.  Physical plant requirements for facilities providing first trimester abortion should not incorporate burdensome requirements that are not related to the needs or safety of the procedure and that will only have the effect of reducing or eliminating patients’ access to care.  However, this is exactly what the emergency regulations impose on health care facilities that provide abortion care.

Whenever Virginia has regulated facilities in the past, it has differentiated between existing facilities and new construction.  However, the emergency regulations do not:  they require health care facilities that provide abortion care to satisfy the standards found in three chapters of the 2010 Guidelines for Design and Construction of Health Care Facilities (“the Guidelines”) within the next two years, and to propose a plan for compliance in order to become licensed.  But the Guidelines are “intended as minimum standards for designing and constructing new health care facility projects.”  Facility Guidelines Institute, Guidelines for Design and Construction of Health Care Facilities 4 (2010) (emphasis added).  They are not intended to apply to existing facilities, except when those facilities engage in significant renovation.  Even then, the Guidelines provide that they should only apply to renovations and not the entire facility.  To be consistent with the Guidelines, the permanent regulations should not apply new construction standards to existing facilities.

Recommendation: The permanent regulations must distinguish between existing facilities and new construction or renovation of existing facilities to be consistent with medical standards of care as well as current Virginia law.  The Board should not subject existing physicians’ offices, like ours, to standards for new construction.

V.        Allowable Variances -- 12 VAC 5-412-90

This regulation allows the Commissioner to grant a temporary variance to an abortion facility “[u]pon finding that the enforcement of a specific regulation would be an impractical hardship unique to the abortion facility” and “provided patient safety, patient care and services are not affected.”  This regulation applies a much more restrictive set of standards to abortion facilities than are applied to any other type of health facility in Virginia.  In all other cases, the Commissioner may grant a permanent or temporary variance if “the enforcement of one or more of these regulations would be clearly impractical” and “safety and patient care and services are not adversely affected.”  12 VAC 5-410-30 (hospitals); see also 12 VAC 5-371-80 (applying the same standard to nursing homes); 12 VAC 5-381-120 (applying the same standard to home care organizations); 12 VAC 5-391-130 (applying the same standard to hospice care organizations). 

These heightened standards are unnecessary and unreasonable.  There is no medical need to have more restrictive standards for variances for health care facilities that provide abortion care than health care facilities that provide every other kind of health care.  There is also no justification for allowing abortion facilities only temporary variances, while all other health care facilities may request permanent variances.

Recommendation:  The permanent regulation should provide for variances according to the standards imposed on all other health care facilities: “Upon the finding that the enforcement of one or more of these regulations would be clearly impractical, the commissioner shall have the authority to waive, either temporarily or permanently, the enforcement of one or more of these regulations, provided safety and patient care and services are not adversely affected” (quoting 12 VAC 5-410-30 (regulating hospitals)).

            VI.       Conclusion

We believe that the emergency regulations, if made permanent, will impose unnecessary harms on our patients and their families.  Among other things, if we are forced to close our doors because of the incredible expense and burden of trying to comply with the physical plant requirements—which, again, are medically inappropriate—this will create the very scenario that Dr. Fitzhugh opened Richmond Medical Center for Women to avoid, where women have reduced access to essential health care. Furthermore, many facilities that provide reproductive health care provide a range of services, including STI testing and contraception.  If those facilities are forced to close, the impact of the closure is even greater.  We urge you to consider these impacts on women and their families in determining the content of the permanent regulations. 

We are also requesting a public hearing later in the regulatory process, after proposed regulations have been published.

Sincerely,

Dr. William Fitzhugh

Jill Abbey, Administrator

Richmond Medical Center for Women