| Action | Amend Regulations Following Periodic Review |
| Stage | Proposed |
| Comment Period | Ended on 7/1/2016 |
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Falls Church Healthcare Center (“FCHC”) supports the Board of Health’s proposed amendments to the Final Regulations for the Licensure of Abortion Facilities and commends the Governor for his recommendations to return to science-based rulemaking to ensure that medical care is between a patient and her or his doctor. We know firsthand what happens when rule making and regulations run contrary to this important standard.
At FCHC we know firsthand what protecting the health and safety of our patients means. FCHC was established in 2002 to offer our patients opportunities to live productive and healthy lives with integrated full spectrum reproductive health services.
FCHC is a medical practice dedicated to pro-choice gynecology and wellness. As a faith-based center, FCHC is proud of its high-quality and caring patient service, its ACOG Fellows Board Certified doctors, and its community involvement which includes: serving as a VDH Pandemic facility, a sex education resource for church and school youth groups, and a training site for prestigious medical schools. FCHC has provided quality reproductive healthcare in Virginia for over a decade with a distinguished record of excellent medicine and compassionate support for women and families.
We know firsthand that the abortion services provided by FCHC – and indeed provided by the vast majority of independent abortion care providers in Virginia and across the country – are among the safest of all in-office medical procedures. This was recognized by the Supreme Court of the United States in its June 27, 2016, opinion in Whole Woman’s Health v. Hellerstedt, whereby the Court invalidated TRAP (Targeted Regulations Against Abortion Providers) regulations in the State of Texas.
First hand we know the ability for FCHC to continue to provide our reproductive health services in a safe, cost-effective manner has been threatened in recent years by the many TRAP regulations in Virginia imposing a heavily prescriptive regulatory regime meant to price abortion facilities out of existence and to delay and deny access to patients.
We know firsthand the burden to patients and doctors alike created by the waiting periods, mandatory 24 hour sonograms and bureaucratic administrative requirements only appropriate to hospitals put in place in Virginia.
These problems were exacerbated by the General Assembly’s efforts to impose its views on the practice of medicine through House of Delegates amendments to S. 924 accepted by the Senate on a tie breaking vote by then Lt. Gov. Bolling.
And yes we know firsthand that 12VA5-412 has virtually nothing to do with patient safety or quality of care. Indeed, FCHC has never had a medical issue arise that would have been avoided if the physical and administrative changes necessitated by the 12VA5-412 had been put in place. We know firsthand the items that would have been required of FCHC under the TRAP regulations were not grounded in evidence-based medicine and its onerous burdens were wholly disproportionate to the very low risks involved in reproductive healthcare. As with the Texas TRAP regulations invalidated by the Supreme Court, Virginia’s TRAP regulations would serve only to deprive women of safe, legal, high-quality care that they need at a time in their lives that are already full of challenges.
Moreover we know firsthand that the expenditures required pursuant to the promulgated regulations would have no relation to quality of care, patient safety or patient satisfaction. FCHC could not cover the enormous costs of such remodeling through increases in fees charged to patients because many of FCHC’s patients could not afford such cost increases. Money spent on regulations that have no scientific or medical basis would also reduce the amount of money available to FCHC to make improvements to its facilities that do promote patient safety, care and service.
For these reasons, we know that the regulations must be amended.
Accordingly, FCHC generally supports the Board of Health’s proposed amendments to the regulations for the licensure of abortion facilities in the Commonwealth because they would substantially ease medically unnecessary burdens. Moreover, FCHC strongly supports the Governor’s recommendations for the regulations because such recommendations address the concerns expressed by the Governor in his May 11, 2014, Executive Directive – “that the extreme and punitive regulations adopted [in 2013] jeopardize the ability of most women’s health centers to keep their doors open and place in jeopardy the health and reproductive rights of Virginia women.”
FCHC believes that approval of the final regulations and the Governor’s recommendations at the Board of Health’s next meeting is of vital importance. FCHC believes that the Board of Health should ensure in adopting final regulations that the only regulations left in place are those based on sound medical evidence.
FCHC also requests that the Board can adopt at its next meeting additional amendments and improvements such as those advanced by FCHC in comments earlier in this proceeding without requiring further rulemaking procedures. Those amendments and improvements are reflected in Appendix A below.
More broadly, it will be important for the Commonwealth to engage in a constitutional review of its entire scheme of abortion regulations to eliminate provisions inconsistent with the United States Supreme Court’s Whole Woman’s Health v. Hellerstedt decision and the Supreme Court’s reaffirmation that women have the right to make their own decisions about abortion and that the right to make those decisions may not be infringed by medically unnecessary burdens imposed by the government.
The Court’s decision calls into question both regulations adopted previously by the Board of Health, which the Board of Health can propose to amend, and Virginia statutes that must be amended by the General Assembly or struck down by the courts.
But first things first. At the very minimum as a positive step forward, FCHC urges the Board to adopt the Board’s proposed amendments, as well as the Governor’s recommendations, to protect the health, safety, access, ensure confidentiality of women seeking abortion services in the Commonwealth of Virginia, and to ensure the availability of safe, high-quality reproductive healthcare for the women of Virginia. Then we will know firsthand that Virginia’s rulemaking ensures and reflects real care for women and their families as has been VDH Public Health practice for decades.
Respectfully submitted,,Rose Codding, Director,Falls Church Healthcare Center
Appendix A
Recommendations Submitted in this Proceeding by Falls Church Healthcare Center
RECOMMENDED AMENDMENTS / ADMINISTRATIVE ISSUES
Define the class of hospital as such: “Class 4 –Office-based Out-Patient Medical Practices and non ASC, non Hospital-Based Abortion Facilities.”
12VAC5-412-70. Return and/or Reissuance of License
-Remove the requirement that a change in administrators or ownership triggers an automatic need for re-licensure. (Notification is appropriate but with reasonable timing of 30 days after change.) The current requirement interferes with best business practices and discourages investors who want to improve licensed facilities.
-Subsection E of 412-70 is too broad and needs to be clarified. For example, in this section, and in section 412-140, there is no definition of “operator”. Also, changes in ownership should be relevant to health and safety only if they change the functional program or operation of the facility.
12VAC5-100. On-site Inspections
-The regulations should further differentiate between complaint driven inspections and routine inspections.
-For routine inspections, the regulations should implement an inspection system on a scheduled basis, as done with the CLIA system used by OLC, so that the inspection system is based on a commitment to support and improve a practice rather than be punitive.
-Though not specific to a needed amendment I want to voice my support for VDH’s proposed “rating” so to categorize major, minor, administrative etc. deficiencies that may be cited during inspection. OLC Director presented this idea to the Board of Health in December. I also support including a “grading” system for medical facilities similar to what is used for restaurant inspections.
Section 170 is far too onerous in dictating how a smaller facility accomplishes Section 170’s objectives. Health centers should have greater flexibility in assigning the tasks set out in Section 170 to appropriate staff in a way that assures compliance without requiring the hiring of a single administrator responsible for all such tasks. To hire and retain a single person to do all of the tasks required in Section 170 on an ongoing basis would require paying a hospital administrator’s salary. That is simply beyond the reach of small health centers.
-Quality assurance programs and review systems should be designed relative to the business size and functional program. Right now the regulations don’t recognize that there may be a need for different programs between small and large women’s health centers as well as where different types of abortion care are provided.
-Medication abortions should be facilitated in a gynecology practice and not discouraged.
-This regulation should be amended to better reflect the realities of a small health center. It is overbearing and counterproductive to the effective operation of the smaller facility to require governing bodies, quality assurance committees of four or more staff members, and administrators in smaller doctor’s offices or medical practices.
-This section needs to be amended so that the requirements for smaller abortion facilities are consistent with the regulations affecting other doctors’ offices and health care facilities of similar size.
-Do not make broad citations to sections of related regulations without specifying what that regulation is supposed to ensure. For example reference to the NFP’s or the FGI (which should not even be included as part of the regulation) should specify which provisions and for what purpose(s) reference (s) are made. e.g. Is the regulation cited for the purpose of insuring that fire extinguishers are on site? For training staff how to handle fire emergencies? For other purposes? The references should be specific so that compliance is more realistic and not to apply a shot-gun effect of blasting well-meaning facilities that want to comply.
-A licensed facility should be advised directly of changes to the regulations, similar to what advisories are given for CLIA changes.
-Provision of Medication Abortion should be regulated as any other general medical service provided in a doctor’s office setting.
RECOMMENDED AMENDMENTS / CLINICAL ISSUES
Delineate appropriate regulations for Medication Abortion and D & C abortions. Provision of Medication Abortion should be regulated as any other general medical service provided in a doctor’s office setting.
-Though the regulations currently include in Section B mandatory reporting within 24 hours of a catastrophic event, adding to this section a system of self-reporting of adverse events (as we now do for morbidity reporting), and apply this to all health care facilities would facilitate VDH/OLC’s monitoring safety of medical services throughout Virginia. Attached for reference see NAF”s current reporting system of quality indicators.
-Amend to clarify the events listed in 12VAC5-412-320 2 and 5
-Amend so the applicability of local building and fire codes have precedence. Any Medical facility should be guided by and comply with state and local codes, zoning, and building ordinances and the Uniform Statewide Building Code as will be demonstrated by issuance of occupancy permits and fire marshals’ inspections.
-Reference to and applicability of FGI included in this section is unwarranted for doctors’ office providing office-based, non-invasive procedures. ACOG and CMS guidelines even specify the suitability for abortion care in the office-based outpatient setting. These FGI guidelines are not medically appropriate and are not applied to other office-based healthcare facilities. It is detrimental to patients and wastes healthcare resources to require that a medical office providing abortion care be outfitted like an inpatient hospital or ASC.