Virginia Regulatory Town Hall
Agency
Virginia Department of Health
 
Board
State Board of Health
 
chapter
Regulations for Licensure of Abortion Facilities [12 VAC 5 ‑ 412]
Action Amend Regulations Following Periodic Review
Stage Proposed
Comment Period Ended on 7/1/2016
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6/23/16  6:15 pm
Commenter: Heather Shumaker, National Abortion Federation

Medical Professionals Support Amended Regulations
 

NAF supports the amendment of the current regulations for licensure of abortion facilities to reflect evidence-based, medically-appropriate practices.

The National Abortion Federation (NAF) is the professional association of abortion providers. Our mission is to ensure safe, legal, and accessible abortion care, which promotes health and justice for women. Our member facilities care for half of the women who choose abortion in the United States and Canada each year, including Virginia women. NAF is the leading organization offering accredited continuing medical education to health care professionals in all aspects of abortion care. NAF member facilities, including our Virginia members, adhere to our evidence-based Clinical Policy Guidelines (CPGs), which set the standards for quality abortion care in North America. See National Abortion Federation, Clinical Policy Guidelines (2016) [hereinafter NAF CPGs], available at https://prochoice.org/wp-content/uploads/2016-CPGs-web.pdf. Our experience and expertise includes developing evidence-based standards, drafting medically-appropriate regulations for abortion facilities with state health departments, and assisting health care providers in the delivery of high-quality abortion care.

NAF is committed to patient health and safety, and evidence-based regulations, but the current regulations do not reflect the safety of abortion care, the needs of patients, or the expertise of providers. As such, we generally support the Board of Health’s proposed amendments – and strongly support Governor Terry McAuliffe’s recommendations. We offer the following specific comments below:

1. NAF supports the governor’s recommendation for Section 12VAC5-412-230(A) regarding the definition of “first trimester” and opposes the Board of Health’s recommended amendments to Sections 12VAC5-412-10 and 12VAC5-412-230(A) regarding the same.

NAF supports the governor’s medically-appropriate recommendation that “first trimester” of pregnancy in Section 12VAC5-412-230(A) be defined as “13 weeks and 6 days after the last menstrual period or based on an appropriate clinical estimate by a licensed health care provider.” NAF opposes the Board of Health’s recommended amendments, including the definition of “first trimester” in Section 12VAC5-412-10 as “the first 12 weeks from conception as determined in compliance with § 18.2-76 of the Code of Virginia” and the requirement in Section 12VAC5-412-230(A) that “[a]bortions performed in abortion facilities shall be performed only on patients who are within the first trimester of pregnancy as determined in compliance with § 18.2-76 of the Code of Virginia.”

Medical professionals measure pregnancy using trimesters from the first day of a woman’s last menstrual period (LMP), totaling 40 weeks. And while the definition of first and second trimester can vary, it is generally accepted that the first trimester goes to 14 weeks LMP. NAF CPGs do not directly define trimesters, but reference the premise that the second trimester begins after 14 weeks LMP. See NAF CPGs, page 29. “[Twelve] weeks from conception,” on the other hand, is a less technically accurate measure of the first trimester of pregnancy.

Additionally, NAF supports the inclusion of health care providers broadly in the definition of “first trimester,” and the medically-appropriate recommendation states “13 weeks and 6 days after the last menstrual period or based on an appropriate clinical estimate by a licensed health care provider” (emphasis added). It is widely accepted within the medical community that health care providers other than physicians can accurately date a pregnancy.

Additionally, Virginia Code § 18-2-76 is not relevant for defining “first trimester.” Code § 18-2-76 does not define “first trimester” and instead discusses informed consent, and should not be referenced in regard to dating a pregnancy.

2. NAF supports the Board of Health’s recommended amendments, and in particular, the governor’s additional recommended amendments to Section 12VAC5-412-370, regarding design and construction standards for abortion facilities.

Any physical plant requirements for health care facilities should be based on the medical needs for the services provided as well as the safety record of services provided. Abortion care is a simple procedure that is typically provided in office-based settings. Abortion care is one of the safest and most commonly provided medical procedures in the United States. Serious complications are extremely rare. See Facts on Induced Abortion in the United States, Guttmacher Institute, https://www.guttmacher.org/fact-sheet/induced-abortion-united-states#9 (last updated May 2016).  Credit for the outstanding safety record of abortion care is attributed to the specialized care given and received in outpatient facilities, which currently provide 95% of the abortion care in the United States. See Rachel K. Jones and Kathryn Kooistra, Guttmacher Institute, Abortion Incidence and Access to Services in the United States, 2008, 43 Perspectives on Sexual and Reproductive Health, no. 1, at 42 (March 2011).

As a result, the standard of care for abortion procedures does not require an ambulatory surgical center setting – which is the setting for a variety of complicated and invasive surgical procedures. NAF CPGs do not discuss the setting for first trimester abortion care, but state that second trimester abortion care can safely be provided in medical offices and freestanding clinics. See page 29. Requiring first trimester abortion care to be provided in a hospital-like setting is extraordinarily burdensome, medically unnecessary and inappropriate – and does nothing to advance patient health and safety.

Because first trimester abortion care can safely be provided in an office-based setting, abortion providers should not have to adhere to any portion of the hospital design and construction standards outlined by the Facilities Guidelines Institute (FGI). So while we would like to see the amendments go further, the Board and Governor’s recommendations for design and construction are an important first step, given the limitations of the Virginia statutes, to bring the regulations for the licensure of abortion facilities in line with the medical reality of first trimester abortion care.

3. NAF supports the Board of Health’s recommended amendments to Section 12VAC5-412-230(E) regarding counseling.

NAF supports the removal of the requirement of “post-abortion counseling” in Section 12VAC5-412-230(E) of the Board of Health’s recommendations, which would provide that, “[t]he abortion facility shall offer each patient seeking an abortion, in a language or manner she understands, appropriate counseling and instruction in the abortion procedure and shall develop, implement, and maintain policies and procedures for the provision of or referral for family planning services to its patients.” NAF fully supports medically-accurate and appropriate informed consent, patient education, and counseling. NAF CPGs state “[o]btaining informed consent and assessing that the decision to have an abortion is made freely by the patient are essential parts of the abortion process.” See page 2. However, requirements for so-called “post-abortion counseling” originate from false anti-choice claims that women face long-term distress following an abortion procedure. Counseling requirements for health care should be grounded in medicine and evidence-based practices, and as such, the removal of this language is appropriate.

4. NAF supports the Board of Health’s recommended amendments to Section 12VAC5-412-230(F) regarding discharge planning.

The Board of Health’s recommended amendment to Section 12VAC5-412-230(F) edits the language related to “an organized discharge planning process.” NAF supports the deletion of the requirement that the organized discharge planning process include “an evaluation of the patient’s capacity for self-care,” and instead require “an assessment of a patient’s safety for discharge.” NAF CPGs reflect the importance of an assessment of a patient’s safety for discharge. See pages 46-47. For example, NAF CPGs require a provider to document that a patient is stable and require that a patient be given post-procedure instructions regarding self-care, what to expect, and emergency contacts. See page 46. The Board of Health’s recommended amendment replaces the existing TRAP regulation with a more medically-appropriate requirement.

5. NAF supports the Board of Health’s recommended amendments to Section 12VAC5-412-240 regarding medical testing, laboratory services, and ectopic pregnancy.

The Board of Health’s recommended amendments to Section 12VAC5-412-240 are consistent with NAF CPGs related to laboratory practice and Rh status, management of pregnancy of uncertain location, and evaluation of evacuated uterine contents. See pages 6, 9, 25-26, and 49-50.

6. NAF supports the Board of Health’s recommended amendments to Section 12VAC5-412-250 regarding documentation of anesthesia services.

The Board of Health’s recommended amendments to Section 12VAC5-412-250 add the requirement that “[t]he administration of sedation and monitoring of the patient shall be documented in the patient's medical record.” This requirement is consistent with NAF CPGs, Standard 11.9, which requires monitoring to be documented. See page 40.

7. NAF supports the Board of Health’s recommended amendments to Section 12VAC5-412-290 regarding emergency services.

NAF supports the Board of Health’s recommended amendments to Section 12VAC5-412-290, which eliminate the requirement for a written transfer agreement with a hospital for emergency treatment. NAF CPGs do not require our members to have transfer agreements with local hospitals. There are many reasons why a facility providing abortion care would not routinely have a transfer agreement, none of which have to do with the standard of care. Requirements for transfer agreements vary from hospital to hospital. As such, hospitals may refuse to grant facilities these agreements because of outside pressure.

More so, women can obtain emergency care in hospitals in the rare cases they need it without their facility having a transfer agreement. In the unusual instance when a woman must seek emergency care, she would likely visit the hospital nearest to her, which in any case is not necessarily the hospital with which her facility has a transfer agreement, particularly given the significant distances many women travel to access abortion care.

In conclusion, NAF thanks you for your time in reviewing our comments and in amending the regulations to reflect the reality of abortion care. We urge you to adopt medically-appropriate amendments, including the governor’s recommendations. 

CommentID: 50283