Source: http://register.dls.virginia.gov/details.aspx?id=3083
Timestamp: 2019-05-24 19:42:06
Document Index: 78240334

Matched Legal Cases: ['§ 18', '§ 32', '§ 32', '§ 32', '§ 32', '§ 32', '§ 32', '§ 32', '§ 2', '§ 18', '§ 16', '§ 54', '§ 54', '§ 54', '§ 1320', '§ 27', 'art 1', 'art 3', '§ 32']

Vol. 28 Iss. 10 (Emergency Regulation) 12VAC5-412, Regulations For Licensure Of Abortion Facilities January 16, 2012
12VAC5-412. Regulations for Licensure of Abortion Facilities (adding 12VAC5-412-10 through 12VAC5-412-380).
Effective Dates: December 29, 2011, through December 28, 2012.
Agency Contact: Joe Hilbert, Director of Governmental and Regulatory Affairs, Department of Health, 109 Governor Street, Richmond, VA 23219, telephone (804) 864-7006, FAX (804) 864-7022, or email joe.hilbert@vdh.virginia.gov.
Chapter 670 of the 2011 Acts of Assembly (Senate Bill 924) mandates that the State Board of Health promulgate regulations for facilities performing five or more first trimester abortions per month (http://lis.virginia.gov/cgi-bin/legp604.exe?111+ful+CHAP0670+pdf). Senate Bill 924 specified that, for purposes of licensure, those facilities were to be classified as a category of hospital. The bill further specified that the regulations have to be effective within 280 days of enactment. For that reason, the board is utilizing the emergency rulemaking process authorized by the Administrative Process Act.
The regulations contain provisions pertaining to definitions, procedures for licensure or license renewal, organization and management, infection prevention, patient care, quality assurance, medical records and reports, disaster preparedness, facility security, functional safety and maintenance, and design and construction.
"Staff privileges" means authority to render medical care in the granting institution within well-defined limits, based on the individual's professional license and the individual's experience, competence, ability and judgment.
"First trimester" means the first twelve weeks from conception based on an appropriate clinical estimate by a licensed physician.
"Informed written consent" means the knowing and voluntary written consent to abortion by a pregnant woman of any age in accordance with Virginia Code § 18.2-76.
"Ownership/person" means any individual, partnership, association, trust, corporation, municipality, county, governmental agency, or any other legal or commercial entity that owns and/or manages or operates an abortion facility.
A license to establish or operate an abortion facility shall be issued only when the abortion facility is in compliance with all applicable federal, state and local statutes and regulations, the provisions of this chapter, and when the application fee has been received by the department.
No ownership/person, as defined in 12VAC5-412-10, shall establish, conduct, maintain, or operate in this state, any abortion facility as defined and included within provisions of this chapter without having obtained a license. Any person establishing, conducting, maintaining, or operating an abortion facility without a license shall be subject to penalties and other actions pursuant to § 32.1-27 of the Code of Virginia.
Abortion facilities which have separate organized sections, units or buildings to provide services of a classification covered by provisions of other state statutes or regulations shall be required to have any additional applicable license required for that type or classification of service.
Facilities licensed as either a general hospital or an outpatient surgical hospital by the department are not subject to the provisions of these regulations.
A. Abortion facility licenses shall be issued by the commissioner. All applications for licensure shall be submitted initially to Department's Office of Licensure and Certification (OLC).
C. Application for initial licensure of an abortion facility shall be accompanied by a copy of the facility's certificate of use and occupancy.
D. The OLC shall consider an application complete when all requested information and the appropriate nonrefundable application fee is submitted.
A. Licenses shall expire at midnight April 30th following the date of issue, and shall be renewable annually, upon filing of a renewal application and payment of the appropriate nonrefundable renewal application fee. Renewal applications shall only be granted after a determination by the OLC that the applicant is in substantial compliance with this chapter.
C. Any abortion facility failing to submit an acceptable plan of correction as required in 12VAC5-412-120 shall not be eligible for license renewal.
D. Any license issued before April 30, 2012 shall not expire until April 30, 2013. No additional fee will be required for the period from May 1, 2012 until April 30, 2013.
12VAC5-412-70. Posting of license.
The abortion facility license issued by the commissioner shall at all times be posted in a place readily visible and accessible to the public.
12VAC5-412-80. Return of license.
A. It is the responsibility of the facility's governing body to maintain a current and accurate license.
B. The license issued by the commissioner shall be returned to the OLC when any of the following changes occur which may require reissuance of a license during the licensing year:
1. Revocation or suspension.
2. Change of location.
5. Voluntary closure.
C. The facility shall give written notification 30 working days in advance of any proposed changes that may require the reissuance of a license. Notices shall be sent to the attention of the director of the OLC.
D. The OLC will evaluate written information about any planned changes in operation that affect the terms of the license or the continuing eligibility for a license. A licensing representative may inspect the facility during the process of evaluating a proposed change.
E. The facility will be notified in writing whether a new application is needed.
12VAC5-412-90. Allowable variances.
Upon finding that the enforcement of a specific regulation would be an impractical hardship unique to the abortion facility, the commissioner may grant a variance temporarily waiving the enforcement of the specific regulation, provided patient safety, patient care, and services are not adversely affected.
12VAC5-412-100. Right of entry.
Pursuant to § 32.1-25 of the Code of Virginia, any duly designated employee of the Virginia Department of Health shall have the right to enter upon and into the premises of any licensed abortion facility, or any entity the department has reason to believe is operated, or maintained as an abortion facility without a license, in order to determine the state of compliance with the provisions of this chapter and applicable laws. Any such employee shall properly identify himself or herself as an inspector designated by OLC; the facility may verify the identity of the inspector prior to his or her admission. Such entries and inspections shall be made with the permission of the owner or person in charge, unless an inspection warrant is obtained after denial of entry from an appropriate circuit court. If the owner, or person in charge, refuses entry, this shall be sufficient cause for immediate revocation or suspension of the license. If the entity is unlicensed, the owner or person in charge shall be subject to penalties and other actions pursuant to § 32.1-27 of the Code of Virginia.
12VAC5-412-110. On-site inspection.
A. An OLC representative shall make periodic unannounced on-site inspections of each abortion facility as necessary, but not less often than biennially. If the department finds, after inspection, non-compliance with any provision of this chapter, the abortion facility shall receive a written licensing report of such findings. The abortion facility shall submit a written plan of correction in accordance with provisions of 12VAC5-412-120.
B. The abortion facility shall make available to the OLC's representative any requested records and shall allow access to interview the agents, employees, contractors, and any person under the facility's control, direction or supervision. If copies of records are removed from the premises, patient names and addresses contained in such records shall be redacted by the facility before removal.
C. If the OLC's representative arrives on the premises to conduct a survey and the administrator, the nursing director, or a person authorized to give access to patient records, is not available on the premises, such person or the designated alternate, shall be available on the premises within 1 hour of the surveyor's arrival. A list of current patients shall be provided to the surveyor within 2 hours of arrival if requested. Failure to be available or to respond shall be grounds for penalties in accordance with Virginia Code § 32.1-27 and denial, suspension or revocation of the facility's license in accordance with 12VAC5-412-130.
12VAC5-412-120. Plan of correction.
A. Upon receipt of a written licensing report each abortion facility shall prepare a written plan of correction addressing each licensing violation cited at the time of inspection.
C. The administrator shall be notified whenever any item in the plan of correction is determined to be unacceptable. Failure to submit an acceptable plan of correction may result in a penalty in accordance with Virginia Code § 32.1-27 or in denial, revocation or suspension of a license in accordance with 12VAC5-412-130.
12VAC5-412-130. 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 of Chapter 5 of Title 32.1 of the Code of Virginia (§ 32.1-123 et seq.) 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.
D. The facility has the right to contest the denial, revocation or suspension of a license in accordance with the provisions of the Administrative Process Act (Virginia Code § 2.2-4000 et seq.).
12VAC5-412-140. Governing body.
A. Each abortion facility shall have a governing body responsible for the management and control of the operation of the facility.
B. There shall be disclosure of facility ownership. Ownership interest shall be reported to the OLC and in the case of corporations, all individuals or entities holding 5.0% or more of total ownership shall be identified by name and address. The OLC shall be notified of any changes in ownership.
2. Description of the functions and duties of the governing body, or other legal authority;
12VAC5-412-150. Policy and procedures manual.
Each abortion facility shall develop, implement and maintain an appropriate policy and procedures manual. The manual shall be reviewed annually and updated as necessary by the licensee. The manual shall include provisions covering, at a minimum, the following topics:
2. Types of elective and emergency procedures that may be performed in the facility;
5. Obtaining written informed consent of the patient prior to the initiation of any procedures;
6. When to use ultrasound to determine gestational age and when indicated to assess patient risk;
8. Risk and quality management;
12. Facility security;
15. Functional safety and facility maintenance; and
16. Identification of the person to whom responsibility for operation and maintenance of the facility is delegated and methods established by the licensee for holding such individual responsible and accountable.
These policies and procedures shall be based on recognized standards and guidelines.
A copy of the approved policies and procedures and revisions thereto shall be made available to the OLC upon request.
12VAC5-412-160. Administrator.
A. The governing body shall select an administrator whose qualifications, authority and duties shall be defined in a written statement adopted by the governing body.
B. Any change in the position of the administrator shall be reported immediately by the licensee to the department in writing.
12VAC5-412-170. Personnel.
A. Each abortion facility shall have a staff that is adequately trained and capable of providing appropriate service and supervision to patients. The facility shall develop, implement and maintain policies and procedures to ensure and document appropriate staffing by licensed clinicians based on the level, intensity, and scope of services provided.
B. The licensee shall obtain written applications for employment from all staff. The licensee shall obtain and verify information on the application as to education, training, experience, appropriate professional licensure, if applicable, and the health and personal background of each staff member.
E. The facility shall develop, implement and maintain policies and procedures to document that its staff participate in initial and ongoing training and education that is directly related to staff duties, and appropriate to the level, intensity and scope of services provided. This shall include documentation of annual participation in fire safety and infection prevention in-service training.
F. Job Descriptions.
2. Each job description shall include: position title, authority, specific responsibilities and minimum qualifications.
3. Job descriptions shall be reviewed at least annually, kept current and given to each employee and volunteer when assigned to the position and when revised.
G. A personnel file shall be maintained for each staff member. The records shall be completely and accurately documented, readily available, and systematically organized to facilitate the compilation and retrieval of information. The file shall contain a current job description that reflects the individual's responsibilities and work assignments, and documentation of the person's in-service education, and professional licensure, if applicable.
H. Personnel policies and procedures shall include, but not be limited to:
4. Process for verifying that contractors and their employees meet the personnel qualifications of the facility; and
I. 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.
12VAC5-412-180. Clinical staff.
A. Physicians and non-physician health care practitioners shall constitute the clinical staff. Clinical privileges of physician and non-physician health care practitioners shall be clearly defined.
B. Abortions shall be performed by physicians who are licensed to practice medicine in Virginia and who are qualified by training and experience to perform abortions. The facility shall develop, implement and maintain policies and procedures to ensure and document that abortions that occur in the facility are only performed by physicians who are qualified by training and experience.
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 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 trained health care practitioners remain with the patient until she is discharged from the facility.
12VAC5-412-190. Consent of the patient.
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.
12VAC5-412-200. Minors.
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. 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.
12VAC5-412-210. Patients' rights.
B. The facility shall establish and maintain complaint handling procedures which specify the:
C. The facility shall designate staff responsible for complaint resolution, including:
D. The patient shall be given a copy of the complaint procedures, in a language or manner she understands, at the time of admission to service.
E. The facility shall provide each patient or her designee with the name, mailing address, and telephone number of the:
1. Facility contact person; and
2. The OLC Complaint Unit, including the toll-free complaint hotline number. Patients may submit complaints anonymously to the OLC. The facility shall display a copy of this information in a conspicuous place.
F. The facility shall maintain documentation of all complaints received and the status of each complaint from date of receipt through its final resolution. Records shall be maintained for no less than three years.
A. The abortion facility shall have an infection prevention plan that encompasses the entire facility and all services provided, and which is consistent with the provisions of the current edition of "Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care," published by the U.S. Centers for Disease Control and Prevention. An individual with training and expertise in infection prevention shall participate in the development of infection prevention policies and procedures and shall review them to assure they comply with applicable regulations and standards.
1. The process for development, implementation and maintenance of infection prevention policies and procedures and the regulations or guidance documents on which they are based shall be documented.
3. A designated person in the facility shall have received training in basic infection prevention, and shall also be involved in the annual review.
1. Procedures for screening incoming patients and visitors for acute infectious illnesses and applying appropriate measures to prevent transmission of community-acquired infection within the facility;
5. Compliance with blood-borne pathogen requirements of the U.S. Occupational Safety & Health Administration;
C. Written policies and procedures for the management of the facility, equipment and supplies shall address the following:
2, Availability of utility sinks, cleaning supplies and other materials for cleaning, disposal, storage and transport of equipment and supplies;
4. Procedures for handling, storing and transporting clean linens, clean/sterile supplies and equipment;
6. Procedures for handling, storing, processing and transporting regulated medical waste in accordance with applicable regulations;
8. Procedures for appropriate disposal of non-reusable equipment;
12. Other infection prevention procedures necessary to prevent/control transmission of an infectious agent in the facility as recommended or required by the department.
D. The facility shall have an employee health program that includes:
4. Documentation of screening and immunizations offered/received by employees in accordance with statute, regulation or recommendations of public health authorities, including documentation of screening for tuberculosis and access to hepatitis B vaccine;
5. Compliance with requirements of the U.S. Occupational Safety & Health Administration for reporting of workplace-associated injuries or exposure to infection.
E. The facility shall develop, implement and maintain policies and procedures for the following patient education, follow up, and reporting activities:
1. Discharge instructions for patients, to include instructions to call or return if signs of infection develop;
2. A procedure for surveillance, documentation and tracking of reported infections; and
3. Policies and procedures for reporting conditions to the local health department in accordance with the Regulations for Disease Reporting and Control (12VAC5-90), including outbreaks of disease.
12VAC5-412-230. Limitation of services offered by abortion facilities.
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.
12VAC5-412-240. Medical testing, patient counseling and laboratory services.
A. Prior to the initiation of any abortion, a medical history and physical examination, to include confirmation of pregnancy, shall be completed for each patient.
1. Use of any additional medical testing, including but not limited to ultrasonagraphy, 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.
2. Medical testing shall include a recognized pregnancy test and determination or documentation of Rh factor.
3. The 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.
B. The abortion facility shall offer each patient, in a language or manner they understand, appropriate counseling and instruction in the abortion procedure and shall develop, implement and maintain policies and procedures for the provision of family planning and post-abortion counseling to its patients.
C. 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).
D. All tissues removed resulting from the abortion procedure shall be examined to verify that villi or fetal parts are present; if villi or fetal parts cannot be identified with certainty, the tissue specimen shall be sent for further pathologic examination and the patient alerted to the possibility of an ectopic pregnancy, and referred appropriately.
E. 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 (9 VAC20-120).
A. The anesthesia service shall be managed in accordance with the Office-Based Anesthesia provisions of the Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic (18VAC85-20-310 et seq.).
C. The 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.
D. 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.
E. An abortion facility administering moderate sedation/conscious sedation shall maintain the following equipment, supplies and pharmacological agents, as required by 18VAC85-20-360 B:
6. Devices for measuring blood pressure, heart rate and respiratory rate;
F. When deep sedation, general anesthesia or a major conductive block is administered, 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 E of this section, an abortion facility administering general anesthesia, deep sedation or major conductive blocks shall maintain the following equipment, supplies and pharmacological agents, as required by 18VAC85-20-360 C:
e. Pressure-compensated anesthesia vaporizers, designed to administer a constant non-pulsatile output, which shall not be placed in the circuit downstream of the oxygen flush valve;
g. Alarm systems for high (disconnect), low (subatmospheric) and minimum ventilatory pressures in the breathing circuit for each patient under general anesthesia; and
H. 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.
I. Elective general anesthesia shall not be used.
A. Controlled substances, as defined in § 54.1-3401 of the Drug Control Act of the Code of Virginia, shall be stored, administered and dispensed in accordance with federal and state laws. The dispensing of drugs, excluding manufacturers' samples, shall be in accordance with Chapter 33 of Title 54.1 of the Code of Virginia, Regulations Governing the Practice of Pharmacy (18VAC110-20), and Regulations for Practitioners of the Healing Arts to Sell Controlled Substances (18VAC110-30).
B. Drugs, as defined in § 54.1-3401 of the Drug Control Act of the Code of Virginia, whose intended use is to induce a termination of pregnancy shall only be prescribed, dispensed or administered by a physician.
C. Drugs maintained in the facility for daily administration shall not be expired and shall be properly stored in enclosures of sufficient size with restricted access to authorized personnel only. Drugs shall be maintained at appropriate temperatures in accordance with definitions in 18VAC110-20-10.
D. The mixing, diluting or reconstituting of drugs for administration shall be in accordance with regulations of the Board of Medicine (18VAC85-20-400 et seq.).
E. Records of all drugs in Schedules I-V received, sold, administered, dispensed or otherwise disposed of shall be maintained in accordance with federal and state laws, to include the inventory and reporting requirements of a theft or loss of drugs found in § 54.1-3404 of the Drug Control Act of the Code of Virginia.
An abortion facility shall maintain medical equipment and supplies appropriate and adequate to care for patients based on the level, scope and intensity of services provided, to include:
An abortion facility shall maintain medical equipment, supplies and drugs appropriate and adequate to manage potential emergencies based on the level, scope and intensity of services provided. Such medical equipment, supplies and drugs shall be determined by the physician and shall be consistent with the current edition of American Heart Association's Guidelines for Advanced Cardiovascular Life Support. Drugs shall include, at a minimum, those to treat the following conditions:
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 American Heart Association's Guidelines for Advanced Cardiovascular Life Support.
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.
12VAC5-412-300. Quality assurance.
6. Infections, complications and other adverse events; and
2. A non-physician health care practitioner;
12VAC5-412-310. Medical records.
g. Physician and nurses' progress notes;
i. Patient instructions, preoperative and postoperative; and
j. Names of referral physicians or agencies.
12VAC5-412-320. Records storage.
Provisions shall be made for the safe storage of medical records or accurate and eligible reproductions thereof according to applicable federal and state law, including the Health Insurance Portability and Accountability Act (42 USC § 1320d et seq.). In the event of closure of the facility, the facility shall notify OLC concerning the location where patient medical records are stored.
12VAC5-412-330. Reports.
B. Abortion facilities shall report all patient, staff or visitor deaths to the OLC within 24 hours of occurrence.
12VAC5-412-340. Policies and procedures.
The abortion facility shall develop, implement and maintain policies and procedures to ensure safety within the facility and on its grounds and to minimize hazards to all occupants. The policies and procedures shall include, but not be limited to:
1. Facility security;
2. Safety rules and practices pertaining to personnel, equipment, gases, liquids, drugs, supplies and services; and
3. Provisions for disseminating safety-related information to employees and users of the facility.
12VAC5-412-350. Disaster preparedness.
A. Each abortion facility shall develop, implement and maintain policies and procedures to ensure reasonable precautions are taken to protect all occupants from hazards of fire and other disasters. The policies and procedures shall include provisions for evacuation of all occupants in the event of a fire or other disaster.
B. A facility that participates in a community disaster plan shall establish plans, based on its capabilities, to meet its responsibilities for providing emergency care.
12VAC5-412-360. Maintenance.
A. The facility's structure, its component parts, and all equipment such as elevators, heating, cooling, ventilation and emergency lighting, shall be kept in good repair and operating condition. Areas used by patients shall be maintained in good repair and kept free of hazards. All wooden surfaces shall be sealed with non-lead-based paint, lacquer, varnish, or shellac that will allow sanitization.
12VAC5-412-370. Fire-fighting equipment and systems.
C. Corridor Obstructions. All corridors and other means of egress or exit from the building shall be maintained clear and free of obstructions in accordance with the current edition of the Virginia Statewide Fire Prevention Code (§ 27-94 et seq. of the Code of Virginia).
12VAC5-412-380. Local and state codes and standards.
Abortion facilities shall comply with state and local codes, zoning and building ordinances, and the Uniform Statewide Building Code. In addition, abortion facilities shall comply with Part 1 and sections 3.1-1 through 3.1-8 and section 3.7 of Part 3 of the 2010 Guidelines for Design and Construction of Health Care Facilities of the Facilities Guidelines Institute, which shall take precedence over the Uniform Statewide Building Code pursuant to Virginia Code § 32.1-127.001.
Entities operating as of the effective date of these regulations 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.
VA.R. Doc. No. R12-2970; Filed December 29, 2011, 4:36 p.m.