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Virginia Regulatory Town Hall

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Action:
Amend Regulations Following Periodic Review
Stage: Proposed
12VAC5-412-10

Part I
Definitions and Requirements for Licensure

12VAC5-412-10. Definitions.

The following words and terms when used in this regulation shall have the following meanings unless the context clearly indicates otherwise:

"Abortion" means the use of an instrument, medicine, drug, or other substance or device with the intent to terminate the pregnancy of a woman, known to be pregnant, for reasons other than a live birth or to remove a dead fetus. Spontaneous miscarriage is excluded from this definition.

"Abortion facility" means a facility in which five or more first trimester abortions per month are performed.

"Administrator" means the person appointed by the governing body as having responsibility for the overall management of the abortion facility. Job titles may include director, executive director, office manager, or business manager.

"Commissioner" means the State Health Commissioner.

"Department" means the Virginia Department of Health.

"First trimester" means the first 12 weeks from conception based on an appropriate clinical estimate by a licensed physician as determined in compliance with § 18.2-76 of the Code of Virginia.

"Informed written consent" means the knowing and voluntary written consent to abortion by a pregnant woman of any age in accordance with § 18.2-76 of the Code of Virginia.

"Licensee" means the person, partnership, corporation, association, organization, or professional entity who owns or on whom rests the ultimate responsibility and authority for the conduct of the abortion facility.

"Medication induced abortion" means any abortion caused solely by the administration of any medication or medications given to a woman in the first trimester of pregnancy with the intent to produce abortion.

"Minor" means a patient under the age of 18.

"Patient" means any person seeking or obtaining services at an abortion facility.

"Physician" means a person licensed to practice medicine in Virginia.

"Spontaneous miscarriage" means the expulsion or extraction of a product of human conception resulting in other than a live birth and which is not an abortion.

"Surgical abortion" means any abortion caused by any means other than solely by the administration of any medication or medications given to a woman in the first trimester of pregnancy with the intent to produce abortion.

"Trimester" means a 12-week period of pregnancy.

12VAC5-412-30

12VAC5-412-30. Classification. (Repealed.)

Abortion facilities shall be classified as a category of hospital.

12VAC5-412-130

12VAC5-412-130. Violation of this chapter or applicable law; denial, revocation, or suspension of license.

A. When the department determines that an abortion facility is (i) in violation of any provision of Article 1 (§ 32.1-123 et seq.) of Chapter 5 of Title 32.1 § 32.1-125.01, 32.1-125.4, 32.1-132, 32.1-135.2, or 32.1-137.01 of the Code of Virginia or of any applicable regulation, or (ii) is permitting, aiding, or abetting the commission of any illegal act in the abortion facility, the department may deny, suspend, or revoke the license to operate an abortion facility in accordance with § 32.1-135 of the Code of Virginia.

B. If a license or certification is revoked as herein provided, a new license or certification may be issued by the commissioner after satisfactory evidence is submitted to him that the conditions upon which revocation was based have been corrected and after proper inspection has been made and compliance with all provisions of Article 1 of Chapter 5 of Title 32.1 § 32.1-125.01, 32.1-125.4, 32.1-132, 32.1-135.2, or 32.1-137.01 of the Code of Virginia and applicable state and federal law and regulations hereunder has been obtained.

C. Suspension of a license shall in all cases be for an indefinite time. The commissioner may restore a suspended license when he determines that the conditions upon which suspension was based have been corrected and that the interests of the public will not be jeopardized by resumption of operation. No additional fee shall be required for restoring such license.

D. The abortion facility has the right to contest the denial, revocation, or suspension of a license in accordance with the provisions of the Administrative Process Act (§ 2.2-4000 et seq. of the Code of Virginia).

12VAC5-412-230

Part IV
Patient Care Management

12VAC5-412-230. Patient services; patient counseling.

A. Abortions performed in abortion facilities shall be performed only on patients who are within the first trimester of pregnancy based on an appropriate clinical estimate by a licensed physician as determined in compliance with § 18.2-76 of the Code of Virginia.

B. No person may perform an abortion upon an unemancipated minor unless informed written consent is obtained from the minor and the minor's parent, guardian, or other authorized person. The informed written consent shall be notarized as required by § 16.1-241 of the Code of Virginia. If the unemancipated minor elects not to seek the informed written consent of an authorized person, a copy of the court order authorizing the abortion entered pursuant to § 16.1-241 of the Code of Virginia shall be obtained prior to the performance of the abortion.

C. A physician shall not perform an abortion without first obtaining the informed written consent of the patient pursuant to the provisions of § 18.2-76 of the Code of Virginia.

D. When abortions are being performed, a staff member currently certified to perform cardiopulmonary resuscitation shall be available on site for emergency care.

E. The 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 and post-abortion counseling services to its patients.

F. There shall be an organized discharge planning process that includes an evaluation of the patient's capacity for self-care and an assessment of a patient's safety for discharge and discharge instructions for patients to include instructions to call or return if signs of infection develop.

12VAC5-412-240

12VAC5-412-240. Medical testing and laboratory services.

A. Prior to the initiation of any abortion, a medical history and physical examination, including a confirmation of pregnancy, and completion of all the requirements of informed written consent pursuant to § 18.2-76 of the Code of Virginia, shall be completed for each patient.

1. Use of any additional medical testing shall be based on an assessment of patient risk. The clinical criteria for such additional testing and the actions to be taken if abnormal results are found shall be documented. Medical testing shall include a recognized method to confirm pregnancy and determination or documentation of Rh factor.

2. Medical testing shall include a recognized method to confirm pregnancy and determination or documentation of Rh factor. Use of any additional medical testing shall be based on an assessment of patient risk.  

3. The abortion facility shall develop, implement, and maintain policies and procedures for screening of sexually transmitted diseases consistent with current guidelines issued by the U.S. Centers for Disease Control and Prevention. The policies and procedures shall address appropriate responses to a positive screening test.

4. 3. A written report of each laboratory test and examination shall be a part of the patient's record.

B. Laboratory services shall be provided on site or through arrangement with a laboratory certified to provide the required procedures under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) (42 CFR Part 493).

1. Facilities for collecting specimens shall be available on site.

2. If laboratory services are provided on site they shall be directed by a person who qualifies as a director under CLIA-88 and shall be performed in compliance with CLIA-88 standards.

3. All laboratory supplies shall be monitored for expiration dates, if applicable, and disposed of properly.

C. All tissues removed resulting from the abortion procedure shall be examined to verify that villi or fetal parts are present if;. If villi or fetal parts cannot be identified with certainty, the patient shall be notified that pregnancy tissue was not identified and the possibility of ectopic pregnancy shall be explained to the patient. In such cases, the patient shall be offered a pathologic examination of the tissue including a disclosure of the cost and should the patient desire, the tissue specimen shall be sent for further pathologic examination and the patient alerted to the possibility of an ectopic pregnancy, and referred appropriately. The facility shall track and log any specimens sent for further pathologic examination.

D. All tissues removed resulting from the abortion procedure shall be managed in accordance with requirements for medical waste pursuant to the Regulated Medical Waste Management Regulations (9VAC20-120).

12VAC5-412-250

12VAC5-412-250. Anesthesia service.

A. The anesthesia service shall comply with the office-based anesthesia provisions of the Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (18VAC85-20-310 et seq.).

B. The anesthesia service shall be directed by and under the supervision of a physician licensed in Virginia.

C. When moderate sedation or conscious sedation is administered, the licensed health care practitioner who administers the anesthesia shall routinely monitor the patient according to procedures consistent with such administration. The administration of sedation and monitoring of the patient shall be documented in the patient's medical record.

D. An abortion facility administering moderate sedation/conscious sedation shall maintain the following equipment, supplies, and pharmacological agents as required by 18VAC85-20-360 B:

1. Appropriate equipment to manage airways;

2. Drugs and equipment to treat shock and anaphylactic reactions;

3. Precordial stethoscope;

4. Pulse oximeter with appropriate alarms or an equivalent method of measuring oxygen saturation;

5. Continuous electrocardiograph;

6. Devices for measuring blood pressure, heart rate, and respiratory rate;

7. Defibrillator; and

8. Accepted method of identifying and preventing the interchangeability of gases.

E. Elective general anesthesia shall not be used.

F. If deep sedation or a major conductive block is administered or if general anesthesia is administered in an emergent situation, the licensed health care practitioner who administers the anesthesia service shall remain present and available in the facility to monitor the patient until the patient meets the discharge criteria.

G. In addition to the requirements of subsection D of this section, an abortion facility administering deep sedation or a major conductive block, or administering general anesthesia in an emergent situation, shall maintain the following equipment, supplies, and pharmacological agents as required by 18VAC85-20-360 C:

1. Drugs to treat malignant hyperthermia, when triggering agents are used;

2. Peripheral nerve stimulator, if a muscle relaxant is used; and

3. If using an anesthesia machine, the following shall be included:

a. End-tidal carbon dioxide monitor (capnograph);

b. In-circuit oxygen analyzer designed to monitor oxygen concentration within breathing circuit by displaying oxygen percent of the total respiratory mixture;

c. Oxygen failure-protection devices (fail-safe system) that have the capacity to announce a reduction in oxygen pressure and, at lower levels of oxygen pressure, to discontinue other gases when the pressure of the supply of oxygen is reduced;

d. Vaporizer exclusion (interlock) system, which ensures that only one vaporizer, and therefore only a single anesthetic agent can be actualized on any anesthesia machine at one time;

e. Pressure-compensated anesthesia vaporizers, designed to administer a constant nonpulsatile output, which shall not be placed in the circuit downstream of the oxygen flush valve;

f. Flow meters and controllers, which can accurately gauge concentration of oxygen relative to the anesthetic agent being administered and prevent oxygen mixtures of less than 21% from being administered;

g. Alarm systems for high (disconnect), low (subatmospheric), and minimum ventilatory pressures in the breathing circuit for each patient under general anesthesia; and

h. A gas evacuation system.

H. The abortion facility shall develop, implement, and maintain policies and procedures outlining criteria for discharge from anesthesia care. Such criteria shall include stable vital signs, responsiveness and orientation, ability to move voluntarily, controlled pain, and minimal nausea and vomiting. Discharge from anesthesia care is the responsibility of the health care practitioner providing the anesthesia care and shall occur only when the patient has met specific physician-defined criteria, and those criteria have been documented within the patient's medical record.

12VAC5-412-290

12VAC5-412-290. Emergency services.

A. An abortion facility shall provide ongoing urgent or emergent care and maintain on the premises adequate monitoring equipment, suction apparatus, oxygen, and related items for resuscitation and control of hemorrhage and other complications.

B. An abortion facility that performs abortions using intravenous sedation shall provide equipment and services to render emergency resuscitative and life-support procedures pending transfer of the patient to a hospital. Such medical equipment and services shall be consistent with the current edition of the American Heart Association's Guidelines for Advanced Cardiopulmonary Resuscitation and Emergency Cardiovascular Life Support Care.

C. A written agreement shall be executed with a licensed general hospital to ensure that any patient of the abortion facility shall receive needed emergency treatment. The agreement shall be with a licensed general hospital capable of providing full surgical, anesthesia, clinical laboratory, and diagnostic radiology service on 30 minutes notice and which has a physician in the hospital and available for emergency service at all times. When emergency transfer is necessary, the responsible physician at the abortion facility must provide direct communication to the emergency department staff appropriate receiving facility staff regarding the status of the patient, the procedure details, and the suspected complication. All patients must be provided with contact information for a representative of the abortion facility, so that an emergency department physician or treating provider may make contact with a provider of the facility if late complications arise.

12VAC5-412-370

Part VII
Design and Construction

12VAC5-412-370. Local and state codes and standards.

Abortion facilities A. All construction of new buildings and additions or major renovations to existing buildings for occupancy as an abortion facility shall comply with conform to state and local codes, and zoning, and building ordinances and the Virginia Uniform Statewide Building Code (13VAC5-63). In addition, abortion facilities All construction of new buildings and additions or major renovations to existing buildings for occupancy as an abortion facility that perform only surgical abortions or a combination of surgical and medication induced abortions shall comply be designed and constructed consistent with Part 1 and sections 3.1‑1 through 3.1‑8 and section 3.7 section 3.8 of Part 3 of the 2010 Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities of the, 2014 edition, The Facilities Guidelines Institute (2014 guidelines), which shall take precedence over the Virginia Uniform Statewide Building Code pursuant to § 32.1-127.001 of the Code of Virginia. Abortion facilities that perform only medication induced abortions shall be designed and constructed consistent with sections 1.1, 1.3, and 1.4 of Part 1 of the 2014 guidelines.

Entities operating as of the effective date of this chapter as identified by the department through submission of Reports of Induced Termination of Pregnancy pursuant to 12VAC5-550-120 or other means and that are now subject to licensure may be licensed in their current buildings if such entities submit a plan with the application for licensure that will bring them into full compliance with this provision within two years from the date of licensure.

Abortion procedures may take place in a procedure room, as detailed in section 3.8‑3.1 of Part 3 of the 2014 guidelines, except that minimum square footage requirements for procedure rooms used for the provision of surgical abortion do not need to be greater than 120 square feet, with a minimum room dimension of 10 feet and a minimum clear dimension of three feet at each side and at the foot of the bed. Rooms designed in accordance with section 3.8‑3.2 of Part 3 of the 2014 guidelines are not required for abortion facilities. Section 3.7‑3.6.13.1(2) of Part 3 of the 2014 guidelines shall not apply to facilities that do not have a room designed in accordance with section 3.8‑3.2.

Architectural drawings and specifications for all new construction or for additions, alterations, or renovations to any existing building shall be dated, stamped with professional seal, and signed by the architect. The architect shall certify that the drawings and specifications were prepared to conform to the Virginia Uniform Statewide Building Code (13VAC5-63) and be consistent with the applicable sections of the 2014 guidelines. The certification shall be forwarded to the Office of Licensure and Certification of the Virginia Department of Health.

B. In order to determine whether the abortion facility facility's design and construction is in compliance consistent with this provision the applicable sections of the 2014 guidelines, the commissioner may obtain additional information from the facility or its architect concerning the design and construction of the facility.

12VAC5-412-9999

DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-412)

Guidelines for Design and Construction of Health Care Hospitals and Outpatient Facilities, 2010 Edition 2014 edition, Part 1 and Sections 3.1-1 through 3.1-8 and 3.7 of Part 3, The Facilities Guidelines Institute (formerly of the American Institute of Architects), Washington, D.C. (http://www.fgiguidelines.org)

Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. November 2, 2010, Volume 122, Issue 18 Suppl 3, American Heart Association, 7272 Greenville Avenue, Dallas, TX 75231-4596 (http://circ.ahajournals.org/content/vol122/18_suppl_3/).

Sexually Transmitted Diseases Treatment Guidelines, 2010, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services

Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services (http://www.cdc.gov/HAI/prevent/prevent_pubs.html)

Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care, version 2.2, November 2015, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services (http://www.cdc.gov/HAI/settings/outpatient/outpatient-care-guidelines.html)

Standards for Ambulatory Care, Rights and Responsibilities of the Individual, 2011, 2015 Standards for Ambulatory Care, The Joint Commission, 1515 W. 22nd Street, Suite 1300W, Oak Brook, IL 60523, telephone 1-877-223-2866 1-770-238-0454, email jcrcustomerservice@pbd.com.

Bloodborne Pathogens - OSHA's Bloodborne Pathogens Standard, OSHA Fact Sheet and Quick Reference Guide, 2011 U.S. Occupational Safety and Health Administration.