Source: http://register.dls.virginia.gov/details.aspx?id=5660
Timestamp: 2020-07-11 16:59:14
Document Index: 172861291

Matched Legal Cases: ['§ 32', '§ 32', '§ 32', '§ 32', '§ 18', '§ 32', '§ 32', '§ 32', '§ 32', '§ 18', '§ 16', '§ 16', 'art 1', 'art 3', '§ 32', 'art 1', 'art 3', 'art 3', 'art 3', 'art 1', 'art 3']

Vol. 32 Iss. 18 (Proposed Regulation) 12VAC5-412, Regulations For Licensure Of Abortion Facilities May 02, 2016
Vol. 32 Iss. 18 - May 02, 2016
Title of Regulation: 12VAC5-412. Regulations for Licensure of Abortion Facilities (amending 12VAC5-412-10, 12VAC5-412-130, 12VAC5-412-230, 12VAC5-412-240, 12VAC5-412-250, 12VAC5-412-290, 12VAC5-412-370; repealing 12VAC5-412-30).
Statutory Authority: §§ 32.1-12, 32.1-127, and 32.1-127.001 of the Code of Virginia.
June 13, 2016 - 10 a.m. - Perimeter Center, Board Room 2, 2nd Floor, 9960 Mayland Drive, Henrico, VA 23233
Public Comment Deadline: July 1, 2016.
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.
Basis: The regulation is promulgated under the authority of § 32.1-127 of the Code of Virginia. Section 32.1-127 of the Code of Virginia requires the board to promulgate regulations including minimum standards for (i) the construction and maintenance of hospitals, nursing homes, and certified nursing facilities to ensure the environmental protection and the life safety of its patients, employees, and the public; (ii) the operation, staffing, and equipping of hospitals, nursing homes, and certified nursing facilities; (iii) qualifications and training of staff of hospitals, nursing homes, and certified nursing facilities, except those professionals licensed or certified by the Department of Health Professions; (iv) conditions under which a hospital or nursing home may provide medical and nursing services to patients in their places of residence; and (v) policies related to infection prevention, disaster preparedness, and facility security of hospitals, nursing homes, and certified nursing facilities. Facilities in which five or more first trimester abortions are performed per month are classified as a category of hospital for the purposes of this requirement. (§ 32.1-127 B 1).
Section 32.1-127.001 requires the State Board of Health to adopt minimum standards for design and construction that are consistent with the current edition of the Guidelines for Design and Construction of Hospital and Health Care Facilities, now the Guidelines for Design and Construction of Hospitals and Outpatient Facilities.
Purpose: On May 12, 2014, Governor McAuliffe issued Executive Directive 1 (2014), which directed the State Board of Health to conduct a periodic review of 12VAC5-412, Regulations for Licensure of Abortion Facilities. As a result of the review, the Department of Health determined it was necessary to use the regulatory process to amend the regulations. This regulatory action will amend the regulations to clarify the requirements for parental consent, insert additional best practices regarding medical testing and laboratory services, insert additional best practices regarding anesthesia service, align the requirements regarding emergency services more specifically with medical best practices, update the requirements for facility design and construction, and make minor technical amendments.
The regulations are mandated by § 32.1-127 of the Code of Virginia. The regulations ensure health and safety standards are maintained throughout licensed facilities within the Commonwealth. The review of the regulations was mandated by Executive Directive. Upon review, the Department of Health found areas of the regulations which could be improved, therefore protecting the health and safety of patients of these facilities to a higher degree.
Substance: No new regulatory sections are being proposed. The following amendments will be proposed:
Definitions - Technical change. Addition of the terms "medication induced abortion" and "surgical abortion" in order to tailor the facility design and construction guidelines more precisely to the requirements of each facility.
Classification - Repeal the section. Unnecessary due to Code of Virginia requirements.
Violation of this chapter or applicable law; denial, revocation, or suspension of license - Amend this section to include guidance issued by the Virginia Department of Health Office of Licensure and Certification.
Patient services; patient counseling - Remove an unnecessary restriction not required by the Code of Virginia. Clarify the requirements of parental consent. Ensure all requirements of parental consent are within the regulations. Make additional technical changes that are in line with medical best practices.
Medical testing and laboratory services - Remove an unnecessary documentation requirement. Incorporate additional best practice standards. Remove an unnecessary mandate, that will allow the patient and physician to work together to determine the best course of action. Insert a new requirement which will allow tracking of lab results.
Anesthesia Service - Incorporate additional best practice standards. Add a documentation requirement.
Emergency Services - Align these provisions more precisely with medical best practices. Remove an unnecessary provision that is not required due to federal requirements.
Facility Design and Construction - Update the design and construction requirements.
Documents Incorporated by Reference - Update those documents incorporated by reference to reflect the most current publications.
Issues: The primary advantages of the regulatory action to the public are increased health and safety protections at abortion facilities. The primary disadvantage to the public associated with the regulatory action is some abortion facilities may need to change some of their current operating policies and procedures, which may cause a financial impact on these facilities. The financial impact might be passed on to the facilities' patients. The Department of Health does not foresee any additional disadvantages to the public. The primary advantage to the agency and the Commonwealth is the promotion of public health and safety. There are no disadvantages associated with the proposed regulatory action in relation to the agency or the Commonwealth.
Summary of the Proposed Amendments to Regulation. In this action, the State Board of Health (Board) proposes to: 1) exempt existing abortion facilities from meeting the Facilities Guidelines Institute (FGI) Guidelines requirements, unless they build an addition or have a major renovation, 2) require that new buildings, additions, and major renovations meet the 2014 FGI Guidelines requirements (rather than the 2010 FGI Guidelines requirements), 3) specify that abortion facilities that perform only medication induced abortions meet general building requirements (instead of the special building requirements for office-based procedures and operating rooms), 4) amend requirements for when villi or fetal parts cannot be identified with certainty in the tissue removed in the abortion, 5) no longer require that abortion facilities have a written agreement with a licensed general hospital regarding emergency treatment as this requirement is duplicative of federal law and unnecessary, 6) no longer require abortion facilities to develop, implement, and maintain policies and procedures for the screening of sexually transmitted diseases as this service is not a part of abortion procedures, and 7) amend other language to be consistent with the Code or to make the regulation more clear.
Exempting Existing Facilities. The current regulation requires that abortion facilities, both existing and newly constructed, comply with state and local codes, zoning, and building ordinances, the Virginia Uniform Statewide Building Code, and specified sections of the 2010 Guidelines for Design and Construction of Health Care Facilities of the Facilities Guidelines Institute. In practice, 12 of the 16 abortion facilities operating in the Commonwealth have been licensed with variances from meeting the FGI Guidelines requirement. For the majority of facilities, complying with the requirement would have cost hundreds of thousands of dollars.
The Board proposes to amend the requirement to apply to "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." The amended language would exempt existing facilities from the requirement, unless an addition or major renovation is built. Abortion facilities would no longer need to apply for variances with this change. According to the Department of Health, applying for a variance merely consists of asking for a variance in writing (can be one paragraph or one sentence) when applying for the yearly license renewal. So no longer needing to apply for a variance saves only a negligible amount of time and effort for facilities. On the other hand, the proposal to exempt existing facilities from the requirement will likely reduce uncertainty for these facilities since the possibility of having to meet the Guidelines requirement for their existing buildings (without an addition or major renovation) due to the possibility of their variance application disapproved will no longer apply.
2014 vs 2010 FGI Guidelines. The Board proposes to require that new buildings, additions, and major renovations meet the 2014 FGI Guidelines1 requirements rather than the 2010 FGI Guidelines requirements. The Facility Guidelines Institute published a study2 that estimates the change in costs of applying the 2014 Guidelines rather than the 2010 Guidelines for hospitals and outpatient facilities. The study breaks up hospitals and outpatient facilities into five facility types, and lists the estimated percentage cost increases for each category, as well as other across-the-board changes that would reduce costs. Based upon the study's cost estimate for the category that best fits abortion facilities and other factors that likely reduce the estimated costs for abortion facilities,3 the proposal to require that new buildings, additions, and major renovations meet the 2014 FGI Guidelines requirements rather than the 2010 FGI Guidelines requirements would on average increase net cost by less than two percent. The Board and the architects and engineers associated with the Facility Guidelines Institute believe that adopting the 2014 edition will increase patient and staff health and safety. Thus, the proposed amendment will likely produce a net benefit.
Surgical vs Medication Induced. The Board proposes to specify that abortion facilities that perform only medication induced abortions need not be designed and constructed or renovated with the full requirements for office-based procedures and operating rooms, but instead need only meet general building requirements. The Board also proposes to add the following definition: "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." There is one current facility that falls into this category. If this facility were to undertake a major renovation or build an addition, this proposed change would potentially save the owners hundreds of thousands of dollars in construction costs. The proposed amendment would also produce commensurate savings for the construction of new facilities that perform only medication induced abortions, but no surgical abortions.
When Villi or Fetal Parts Cannot Be Identified. Under both the current regulation and the proposed regulation, all tissues removed resulting from the abortion procedure must be examined to verify that villi or fetal parts are present. Under the current regulation, if villi or fetal parts cannot be identified with certainty, the tissue specimen must be sent for further pathologic examination and the patient alerted to the possibility of an ectopic pregnancy. The Board proposes to instead require that when villi or fetal parts cannot be identified with certainty, the patient be notified that pregnancy tissue was not identified and the possibility of ectopic pregnancy be explained to the patient. In such cases, the patient is to be offered a pathologic examination of the tissue including a disclosure of the cost; and should the patient desire, the tissue specimen would be sent for further pathologic examination. In essence, the proposed language enables the patient to make an informed decision whether or not to order a pathologic examination of the tissue, and to incur its associated cost. The proposed amendment likely produces a net benefit since it allows the patient to make an informed decision, rather than requiring that a potentially unwanted test be conducted.
Emergency Services and Screening for Sexually Transmitted Diseases. The current regulation requires that "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 Board determined that a written agreement is not necessary to ensure that any patient of the abortion facility shall receive needed emergency treatment due to the federal Emergency Medical Treatment and Labor Act. According to the Department of Health, all facilities have thus far been able to obtain such written agreements. Thus this proposed amendment will not significantly affect existing abortion facilities. The proposed amendment would save the time involved for obtaining such agreements for any potential future facilities.
The current regulation requires that "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." Pursuant to the recommendation of the Board's physician's regulatory advisory panel, the Board proposes to eliminate this provision as it is unrelated to abortion procedures. The Department of Health has accepted a statement indicating that the facility does not have such procedures as fulfilling the requirement.4 Thus to the extent that abortion facilities have been aware of this, the proposed amendment would not have a large impact.
Businesses and Entities Affected. The proposed amendments pertain to the 16 licensed abortion facilities within the Commonwealth, as well as any potential future abortion facilities. Six of the facilities qualify as small businesses.5
Localities Particularly Affected. The 16 abortion facilities operating in the Commonwealth are located in the following localities: Alexandria (2), Blacksburg (1), Charlottesville (2), Fairfax (1), Falls Church (1), Henrico (1), Newport News (1), Norfolk (1), Richmond (2), Roanoke (2), and Virginia Beach (2).6
Projected Impact on Employment. The proposed amendments will likely not significantly affect total employment.
Effects on the Use and Value of Private Property. Due to significant reduction in associated cost, the proposal to specify that abortion facilities that perform only medication induced abortions need not be designed and constructed or renovated with the full requirements for office-based procedures and operating rooms, may increase the likelihood that such facilities are renovated or constructed.
Real Estate Development Costs. The proposal to require that new buildings, additions, and major renovations meet the 2014 FGI Guidelines requirements rather than the 2010 FGI Guidelines requirements would on average increase net cost for the construction of new buildings, additions, and major renovations of surgical abortion facilities by less than two percent.
The proposal to specify that abortion facilities that perform only medication induced abortions need not be designed and constructed or renovated with the full requirements for office-based procedures and operating rooms would potentially save the owners hundreds of thousands of dollars in construction costs.
Costs and Other Effects. The proposal to require that new buildings, additions, and major renovations meet the 2014 FGI Guidelines requirements rather than the 2010 FGI Guidelines requirements would on average moderately increase net costs for small surgical abortion facilities that undergo such construction projects.
The proposal to specify that abortion facilities that perform only medication induced abortions need not be designed and constructed or renovated with the full requirements for office-based procedures and operating rooms, but instead need only meet general building requirements, would reduce costs for small facilities that perform only medication induced abortions and undergo building construction.
The proposals to no longer require that abortion facilities: a) have a written agreement with a licensed general hospital to ensure that any patient of the abortion facility shall receive needed emergency treatment, and b) develop, implement, and maintain policies and procedures for screening of sexually transmitted diseases, will moderately reduce costs for small abortion facilities.
Alternative Method that Minimizes Adverse Impact. The proposal to require that new buildings, additions, and major renovations meet the 2014 FGI Guidelines requirements rather than the 2010 FGI Guidelines requirements will moderately increase costs in net for small abortion facilities that undergo such projects. Not amending the regulation to include the 2014 edition requirements would eliminate the moderate net cost increase, but would also eliminate the likely increase in potential patient and staff health and safety.
Businesses. The proposal to require that new buildings, additions, and major renovations meet the 2014 FGI Guidelines requirements rather than the 2010 FGI Guidelines requirements would on average moderately increase net costs for surgical abortion facilities that undergo such construction projects.
Localities. The proposed amendments are unlikely to adversely affect localities.
Other Entities. The proposed amendments are unlikely to adversely affect other entities.
1The applicable 2014 edition is called Guidelines for Design and Construction of Hospitals and Outpatient Facilities.
2Gormley T, Garland J, Jones W. "Estimated Cost of Applying the 2014 vs. the 2010 FGI Guidelines for Design and Construction Requirements to Hospitals and Outpatient Facilities."
3The facility type that best fits abortion facilities includes dialysis centers. One of the items listed as contributing to cost increases in this category is a new requirement for a soiled workroom in renal dialysis centers. Since this does not apply to abortion facilities, the listed estimate of a 2.68% cost increase for the category is likely too high for abortion facilities. Combined with the across-the-board changes and a Board proposal to exempt abortion facilities from a FGI Guideline procedure room size requirement, the likely average net cost change for abortion facilities is less than 2%
4Source: Virginia Department of Health
5Data source: Virginia Department of Health
Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the economic impact analysis conducted by the Department of Planning and Budget.
The proposed amendments (i) clarify the requirements for parental consent; (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) update the facility design and construction requirements; and (v) make minor technical amendments. The proposed amendments are a result of the periodic review conducted in accordance with Governor McAuliffe's Executive Directive 1 (2014).
"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.
"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.
"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.
12VAC5-412-30. Classification. (Repealed.)
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.
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.
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.
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 facility shall track and log any specimens sent for further pathologic examination.
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.
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 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.
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.
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)
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, 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.
VA.R. Doc. No. R15-4258; Filed April 12, 2016, 5:24 p.m.