Source: http://register.dls.virginia.gov/details.aspx?id=6232
Timestamp: 2019-04-19 12:45:37+00:00

Document:
Title of Regulation: 12VAC5-412. Regulations for Licensure of Abortion Facilities (amending 12VAC5-412-10, 12VAC5-412-80, 12VAC5-412-100, 12VAC5-412-130, 12VAC5-412-180, 12VAC5-412-190, 12VAC5-412-200, 12VAC5-412-220, 12VAC5-412-230, 12VAC5-412-240, 12VAC5-412-250, 12VAC5-412-280, 12VAC5-412-290, 12VAC5-412-300, 12VAC5-412-320, 12VAC5-412-330, 12VAC5-412-350, 12VAC5-412-370; repealing 12VAC5-412-30, 12VAC5-412-360).
Statutory Authority: § 32.1-127 of the Code of Virginia.
Agency Contact: Erik Bodin, Director, Office of Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite 401, Richmond, VA 23233, telephone (804) 367-2109, FAX (804) 527-4502, or email erik.bodin@vdh.virginia.gov.
The amendments (i) modify defined terms; (ii) add best practices for medical testing, laboratory services, and anesthesia services; (iii) align the emergency services requirements more specifically with medical best practices; (iv) modify the facility design and construction requirements; (v) make minor technical amendments; (vi) modify onsite inspection provisions; (vii) remove the reference to the Joint Commission Standards of Ambulatory Care for patient rights and responsibility protocols; (viii) remove the reference to certain federal guidelines for infection prevention plans; (ix) remove maintenance and firefighting equipment and systems requirements that are already addressed by existing legal requirements; (x) specify that all construction of new buildings and additions or major renovations to existing buildings for occupancy as an abortion facility shall conform to state and local codes and ordinances; (xi) conform allowable variance provisions to the hospital licensure regulations; (xii) prohibit removal of copies of personnel records from the facility unless redacted; (xiii) remove the requirement that a physician remain on the premises until the last patient is discharged and the requirement that the physician give a discharge order; (xiv) amend the definition of first trimester of pregnancy; (xv) require facilities to offer screening for sexually transmitted diseases or at a minimum refer patients to clinics that provide such testing as well as requiring that facilities have policies and procedures for patient reevaluation in the event that tissue examination is insufficient to confirm termination of the pregnancy; (xvi) remove specific conditions for which emergency drugs must be available; (xvii) require health information records to include certain information if medically indicated; (xviii) remove the requirement to report incidents that are reported to malpractice insurance carriers or reported in compliance with the federal Safe Medical Devices Act; and (xix) remove the requirement that facilities have policies and procedures related to facility security and the dissemination of safety information.
A. 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.
B. Modification of any individual standard herein for any purpose shall require advance written approval from the OLC.
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, or ] 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, and ] 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.
H. A personnel file shall be maintained for each staff member. Personnel record information shall be safeguarded against loss and unauthorized use. Employee health related information shall be maintained separately within the employee's personnel file. Unless redacted, copies of personnel files shall not be removed from the premises.
C. A physician shall remain on the premises until all patients are medically stable, sign the discharge order, and be readily available and accessible until the last patient is discharged. Licensed health care practitioners trained in post-procedure assessment shall remain on the premises until the last patient has been discharged. The physician shall give a discharge order after assessing a patient or receiving a report from such trained health care practitioner indicating that a patient is safe for discharge. The abortion facility shall develop, implement, and maintain policies and procedures that ensure there is an appropriate evaluation of medical stability prior to discharge of the patient and that adequate adequately trained health care practitioners remain with the patient until she is discharged from the abortion facility.
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 meaning 13 weeks and 6 days after last menstrual period or based on an appropriate clinical estimate by a licensed health care provider ].
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.
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.
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 offering screening of sexually transmitted diseases consistent with current guidelines issued by the U.S. Centers for Disease Control and Prevention or at a minimum referring patients to clinics that provide such testing. ] 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.
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 abortion facility shall have policies and procedures for evaluation of all tissues removed during the abortion and for reevaluation of the patient in the event the evaluation of tissue is insufficient to confirm termination of the pregnancy. ] The facility shall track and log any specimens sent for further pathologic examination.
B. The anesthesia service shall be directed by and under the supervision of a physician licensed in Virginia [ who is certified in advanced resuscitative techniques and has met the continuing education requirements ].
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.
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.
[ 12VAC5-412-280. Emergency equipment and supplies.
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.
[ 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.
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).
VA.R. Doc. No. R15-4258; Filed January 25, 2017, 8:41 a.m.

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