| Action | Amend Regulations Following Periodic Review |
| Stage | NOIRA |
| Comment Period | Ended on 2/11/2015 |
 |
“The Office of Licensure and Certification works to ensure that the quality of healthcare delivered by providers is safe, cost effective and compliant with state and federal laws. In partnership with stakeholders, we work to increase appropriate access to health care services and to promote the quality of life for all patients in a professional manner.” OLC Statement of Purpose
As a result of a periodic review of 12 VAC 5 – 412, the Virginia Department of Health determined it was necessary to amend these regulations, and the Board of Health approved a NOIRA to begin the rulemaking process. As a stakeholder in 12-VAC-5-412 regulations, I am submitting some suggestions for needed amendments to 12-VAC-5-412 to the Office of Licensure and Certification, and I stand ready to offer my assistance in the process.
I serve as the “Governing Body” and Policy Director of Falls Church Healthcare Center (FCHC). Our Center 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. We are proud of our quality and caring patient service, our ACOG Fellows Board Certified doctors, and our community involvement which includes: serving as a VDH Pandemic facility, an approved H1N1 site, a sex education resource for church and school youth groups and a training site for many local medical schools. Falls Church Healthcare Center, a faith-based center, 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.
In 2011 Senate Bill 924 classified our doctors’ office as a category of hospitals for a limited purpose of licensure. The resulting emergency regulations followed by permanent regulations arbitrarily forced our medical practice to implement burdensome, medically unnecessary, and over-reaching regulations that diverted resources away from our ongoing focus on improvements to our traditional patient-centered care.
As members of ARHP and NAF, FCHC has always supported proven and medically sound regulations and guidelines which genuinely advance public health and patient care and safety. Regulations and guidelines that identify appropriate best practices can help to ensure women’s continued access to quality reproductive health and abortioncare in the Commonwealth as has been provided for over 40 years with no Public Health crisis.
Through amendments to the harmful regulations previously adopted, you and I have an opportunity to return to the true traditions of Virginia Department of Health. That tradition ensures public health of Virginians, preserves full access to healthcare, protects small businesses, involves a panel of stakeholders in regulation revision, ensures healthcare for minorities and truly, truly understands how full reproductive healthcare including the choice to end a pregnancy has a positive impact on the stability of the family – especially a family’s authority and rights, education, nurture and supervision.
I am hopeful that the amendments and resulting regulations will demonstrate a:
FCHC trusts that our suggestions from the perspective of a stakeholder and a provider will be useful to the OLC and the Commissioner as you develop amendments to improve the current 12-VAC-5-412 regulations and its nearly overwhelming citations by reference.
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.”
-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.
-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 abortioncare 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 doctors 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.
-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. Compliance is 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 abortioncare in the office-based out patient 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 abortioncare be outfitted like an inpatient hospital or ASC.
-There needs to be recognition that many facilities and most doctors' offices lease space and thus will not have options for many structural changes currently included through FGI.
Respectfully submitted