TITLE 12. HEALTH
Titles of Regulations: 12VAC5-410. Regulations for
the Licensure of Hospitals in Virginia (amending 12VAC5-410-10, 12VAC5-410-60).
12VAC5-412. Regulations for Licensure of Abortion Facilities (adding 12VAC5-412-10 through 12VAC5-412-370).
Statutory Authority: §§ 32.1-12 and 32.1-127 of the
Code of Virginia.
Effective Date: June 20, 2013.
Agency Contact: Erik Bodin, Director, Office of
Licensure and Certification, Department of Health, 9960 Mayland Drive, Suite
401, Richmond, VA 23233, telephone (804) 367-2102, FAX (804) 527-4502, or email
The regulations are necessary to support the implementation
of the amendments to § 32.1-127 of the Code of Virginia enacted by
Chapter 670 of the 2011 Acts of Assembly. The regulations establish licensure
requirements for facilities performing five or more first trimester abortions
per month. For purposes of licensure, these facilities are classified as a category
of hospital. 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.
Summary of Public Comments and Agency's Response: A
summary of comments made by the public and the agency's response may be
obtained from the promulgating agency or viewed at the office of the Registrar
Definitions and General Information and Procedures
As used in this chapter, the following words and terms shall
have the following meanings unless the context clearly indicates otherwise:
"Board" means the State Board of Health.
"Chief executive officer" means a job descriptive
term used to identify the individual appointed by the governing body to act in
its behalf in the overall management of the hospital. Job titles may include
administrator, superintendent, director, executive director, president,
vice-president, and executive vice-president.
"Commissioner" means the State Health Commissioner.
"Consultant" means one who provides services or
advice upon request.
"Department" means an organized section of the
"Direction" means authoritative policy or
procedural guidance for the accomplishment of a function or activity.
"Facilities" means building(s), equipment, and
supplies necessary for implementation of services by personnel.
"Full-time" means a 37-1/2 to 40 hour work week.
"General hospital" means institutions as defined by
§ 32.1-123 of the Code of Virginia with an organized medical staff; with
permanent facilities that include inpatient beds; and with medical services,
including physician services, dentist services and continuous nursing services,
to provide diagnosis and treatment for patients who have a variety of medical
and dental conditions that may require various types of care, such as medical,
surgical, and maternity.
"Home health care department/service/program" means
a formally structured organizational unit of the hospital that is designed to
provide health services to patients in their place of residence and meets Part
II (12VAC5-381-150 et seq.) of the regulations adopted by the board for the
licensure of home care organizations in Virginia.
"Medical" means pertaining to or dealing with the
healing art and the science of medicine.
"Nursing care unit" means an organized jurisdiction
of nursing service in which nursing services are provided on a continuous
"Nursing home" means an institution or any
identifiable component of any institution as defined by § 32.1-123 of the Code
of Virginia with permanent facilities that include inpatient beds and whose
primary function is the provision, on a continuing basis, of nursing and health
related services for the treatment of patients who may require various types of
long term care, such as skilled care and intermediate care.
"Nursing services" means patient care services
pertaining to the curative, palliative, restorative, or preventive aspects of
nursing that are prepared or supervised by a registered nurse.
"Office of Licensure and Certification" or
"OLC" means the Office of Licensure and Certification of the Virginia
Department of Health.
"Organized" means administratively and functionally
"Organized medical staff" means a formal organization
of physicians and dentists with the delegated responsibility and authority to
maintain proper standards of medical care and to plan for continued betterment
of that care.
"Outpatient hospital" means institutions as defined
by § 32.1-123 of the Code of Virginia that primarily provide facilities
for the performance of surgical procedures on outpatients. Such patients may
require treatment in a medical environment exceeding the normal capability
found in a physician's office, but do not require inpatient hospitalization.
abortion clinics are deemed a category of outpatient hospitals.
"Ownership/person" means any individual,
partnership, association, trust, corporation, municipality, county,
governmental agency, or any other legal or commercial entity that owns or
controls the physical facilities and/or manages or operates a hospital.
"Rural hospital" means any general hospital in a
county classified by the federal Office of Management and Budget (OMB) as
rural, any hospital designated as a critical access hospital, any general
hospital that is eligible to receive funds under the federal Small Rural
Hospital Improvement Grant Program, or any general hospital that notifies the
commissioner of its desire to retain its rural status when that hospital is in
a county reclassified by the OMB as a metropolitan statistical area as of June
"Service" means a functional division of the
hospital. Also used to indicate the delivery of care.
"Special hospital" means institutions as defined by
§ 32.1-123 of the Code of Virginia that provide care for a specialized
group of patients or limit admissions to provide diagnosis and treatment for
patients who have specific conditions (e.g., tuberculosis, orthopedic,
"Special care unit" means an appropriately equipped
area of the hospital where there is a concentration of physicians, nurses, and
others who have special skills and experience to provide optimal medical care
for patients assigned to the unit.
"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.
"Unit" means a functional division or facility of
12VAC5-410-60. Separate license.
A. A separate license shall be required by hospitals
maintained on separate premises even though they are operated under the same
management. Separate license is not required for separate buildings on the same
grounds or within the same complex of buildings.
B. Hospitals which have separate organized sections, units,
or buildings to provide services of a classification covered by provisions of
other state statutes or regulations may be required to have an additional
applicable license for that type or classification of service (e.g.,
psychiatric, nursing home, home health services, and outpatient
outpatient abortions) surgery).
REGULATIONS FOR LICENSURE OF ABORTION FACILITIES
Definitions and Requirements for Licensure
The following words and terms when used in this regulation
shall have the following meanings unless the context clearly indicates
"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
"Department" means the Virginia Department of
"First trimester" means the first 12 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 § 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
"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.
"Trimester" means a 12-week period of pregnancy.
A license to establish or operate an abortion facility
shall be issued only (i) when the abortion facility is in compliance with all
applicable federal, state, and local statutes and regulations and the
provisions of this chapter and (ii) when the application fee has been received
by the department.
No person or entity shall establish, conduct, maintain, or
operate in this state, any abortion facility 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 shall be classified as a category of
12VAC5-412-40. Separate license.
An abortion facility operating at more than one location
shall be required to obtain separate licenses for each location in which
abortion services are provided.
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
Facilities licensed as either a general hospital or an
outpatient surgical hospital by the department are not subject to the
provisions of this chapter.
12VAC5-412-50. Request for issuance.
A. Abortion facility licenses shall be issued by the
commissioner. All applications for licensure shall be submitted initially to
the department's Office of Licensure and Certification (OLC).
B. Each abortion facility shall be designated by a
distinct identifying name which shall appear on the application for licensure.
Any change of name shall be reported to the OLC within 30 days.
C. Application for initial licensure of an abortion
facility shall be accompanied by a copy of the abortion facility's certificate
of use and occupancy or a statement from the facility’s certified architect or
engineer that the facility is substantially complete and eligible for a
certificate of occupancy.
D. The OLC shall consider an application complete when all
requested information and the appropriate nonrefundable application fee are
E. Written notification from the applicant to OLC that it
is ready for the on-site survey must be received 30 days prior to OLC
scheduling of the initial licensure survey. Applicants for initial licensure
shall be notified of the time and date of the initial licensure survey, after
the notice of readiness is received by the OLC.
F. A license shall not be assigned or transferred. A new
application for licensure shall be made at least 30 days in advance of a change
of ownership or location.
12VAC5-412-60. License expiration and renewal.
A. Licenses shall expire at midnight April 30 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.
B. The annual license renewal application shall be
submitted to the OLC at least 60 days prior to the expiration date of the
current license. A renewal application submitted more than 60 days past the
expiration of the current license shall not be accepted.
C. Any abortion facility failing to submit an acceptable
plan of correction as required in 12VAC5-412-110 shall not be eligible for
12VAC5-412-70. Return and/or reissuance of license.
A. It is the responsibility of the abortion facility's
governing body to maintain a current and accurate license at all times.
B. An abortion facility shall give written notification 30
calendar days in advance of implementing any of the following planned changes:
1. Change of location.
2. Change of ownership.
3. Change of name.
4. Voluntary closure.
5. Change of administrator.
6. Change of operator.
Notices shall be sent to the attention of the director of
C. The license issued by the commissioner shall be
returned to the OLC when any of the changes listed in subsection B of this
section occur. In addition, if the abortion facility is no longer operational,
or the license has been suspended or revoked, the license shall be returned to
the OLC within five calendar days of the abortion facility closing. The
abortion facility's patients and the OLC shall be notified where all patient
records will be located.
D. The OLC shall determine if any changes affect the terms
of the license or the continuing eligibility for a license. A licensing
representative may inspect the abortion facility during the process of
evaluating a change.
E. The abortion facility will be notified in writing by
the OLC whether a license can be reissued or a new application is needed.
12VAC5-412-80. Allowable variances.
A. The commissioner may authorize a temporary variance
only to a specific provision of this chapter. In no event shall a temporary
variance exceed the term of the license. An abortion facility may request a
temporary variance to a particular standard or requirement contained in a
particular provision of this chapter when the standard or requirement poses an
impractical hardship unique to the abortion facility and when a temporary
variance to it would not endanger the safety or well-being of patients. The
request for a temporary variance shall describe how compliance with the current
standard or requirement constitutes an impractical hardship unique to the
abortion facility. The request should include proposed alternatives, if any, to
meet the purpose of the standard or requirement that will ensure the protection
and well-being of patients. At no time shall a temporary variance be extended
to general applicability. The abortion facility may withdraw a request for a
temporary variance at any time.
B. The commissioner may rescind or modify a temporary
variance if: (i) conditions change; (ii) additional information becomes known
that alters the basis for the original decision; (iii) the abortion facility
fails to meet any conditions attached to the temporary variance; or (iv)
results of the temporary variance jeopardize the safety or well-being of
C. Consideration of a temporary variance is initiated when
a written request is submitted to the commissioner. The commissioner shall
notify the abortion facility in writing of the receipt of the request for a
temporary variance. The licensee shall be notified in writing of the
commissioner's decision on the temporary variance request. If granted, the
commissioner may attach conditions to a temporary variance to protect the
safety and well-being of patients.
D. If a temporary variance is denied, expires, or is
rescinded, routine enforcement of the standard or requirement to which the
temporary variance was granted shall be resumed.
12VAC5-412-90. 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 as an inspector designated by OLC; the
abortion facility may verify the identity of the inspector prior to his 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.
12VAC5-412-100. 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, noncompliance 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 12VAC5-412-110.
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 abortion 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 abortion 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 one hour of the surveyor's arrival. A list of patients receiving
services on the day of the survey as well as a list of all of the abortion
facility's patients for the previous 12 months shall be provided to the
surveyor within two hours of arrival if requested. Failure to be available or
to respond shall be grounds for penalties in accordance with § 32.1-27 of the
Code of Virginia and denial, suspension, or revocation of the facility's
license in accordance with 12VAC5-412-130.
12VAC5-412-110. 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.
B. The administrator shall submit, within 15 working days
of receipt of the inspection report, an acceptable plan of correction as
determined by the OLC. The plan of correction shall contain for each violation
1. A description of the corrective action or actions to be
taken and the personnel to implement the corrective action;
2. The expected correction date, not to exceed 30 working
days from the exit date of the survey;
3. A description of the measures implemented to prevent a
recurrence of the violation; and
4. The signature of the person responsible for the validity
of the report.
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
§ 32.1-27 of the Code of Virginia or in denial, revocation, or suspension
of a license in accordance with 12VAC5-412-130.
D. The administrator shall be responsible for assuring the
plan of correction is implemented and monitored so that compliance is
12VAC5-412-120. OLC complaint investigations.
A. The OLC shall investigate any complaints regarding
alleged violations of this chapter and applicable law. When the investigation
is complete, the abortion facility and the complainant, if known, will be
notified of the findings of the investigation.
B. As required by the OLC, the administrator shall submit
a plan of correction for any deficiencies found during a complaint
investigation in accordance with 12VAC5-412-110 and shall be responsible for
assuring the plan of correction is implemented and monitored so that compliance
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 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
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
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).
Organization and Management
12VAC5-412-140. Management and administration.
A. The abortion facility shall comply with:
1. This chapter (12VAC5-412);
2. Other applicable federal, state, or local laws and
3. The abortion facility's policies and procedures.
B. The abortion facility shall submit or make available
reports and information necessary to establish compliance with this chapter and
C. The abortion facility shall permit OLC inspectors to
conduct inspections to:
1. Verify application information;
2. Determine compliance with this chapter and applicable
3. Review necessary records and documents; and
4. Investigate complaints.
D. An abortion facility shall give written notification 30
calendar days in advance of implementing any of the following planned changes:
1. Change of location.
2. Change of ownership.
3. Change of name.
4. Voluntary closure.
5. Change of administrator.
6. Change of operator.
Notices shall be sent to the attention of the director of
E. The current license from the department shall be posted
at all times in a place readily visible and accessible to the public.
12VAC5-412-150. Governing body.
A. Each abortion facility shall have a governing body
responsible for the management and control of the operation of the abortion
B. There shall be disclosure of abortion 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.
C. The governing body shall provide facilities, personnel,
and other resources necessary to meet patient and program needs.
D. The governing body shall have a formal organizational
plan with written bylaws. These shall clearly set forth organization, duties
and responsibilities, accountability, and relationships of professional staff
and other personnel. The bylaws shall identify the person or organizational
body responsible for formulating policies.
E. The bylaws shall include at a minimum the following:
1. A statement of purpose;
2. Description of the functions and duties of the governing
body or other legal authority;
3. A statement of authority and responsibility delegated to
the administrator and to the clinical staff;
4. Provision for selection and appointment of clinical
staff and granting of clinical privileges; and
5. Provision of guidelines for relationships among the
governing body, the administrator, and the clinical staff.
12VAC5-412-160. Policies and procedures.
A. Each abortion facility shall develop, implement, and
maintain documented policies and procedures, which shall be readily available
on the premises and shall be reviewed annually and updated as necessary by the
governing body. The policies and procedures shall include but shall not be
limited to the following topics:
2. Types of elective services performed in the abortion
3. Types of anesthesia that may be used;
4. Admissions and discharges, including criteria for
evaluating the patient before admission and before discharge;
5. Obtaining informed written consent of the patient
pursuant to § 18.2-76 of the Code of Virginia prior to the initiation of
6. When to use sonography to assess patient risk;
7. Infection prevention;
8. Quality and risk management;
9. Management and effective response to medical and/or
10. Management and effective response to fire;
11. Ensuring compliance with all applicable federal, state,
and local laws;
12. Abortion facility security;
13. Disaster preparedness;
14. Patient rights;
15. Functional safety and abortion facility maintenance;
16. Identification of the administrator and methods
established by the governing body for holding the administrator responsible and
B. These policies and procedures shall be based on
recognized standards and guidelines. A copy of the policies and procedures
approved by the governing body and revisions thereto shall be made available to
the OLC upon request.
A. The governing body shall select an administrator who
shall be responsible for the managerial, operational, financial, and reporting
components of the abortion facility, including but not limited to:
1. Ensuring the development, implementation, and enforcement
of all policies and procedures, including patient rights;
2. Employing qualified personnel and ensuring appropriate
personnel orientation, training, education, and evaluation;
3. Ensuring the accuracy of public information materials
4. Ensuring an effective budgeting and accounting system is
5. Maintaining compliance with applicable laws and
regulations and implementing corrective action.
B. Any change in the position of the administrator shall
be reported immediately by the governing body to the department in writing.
C. A qualified individual shall be appointed in writing to
act in the absence of the administrator.
A. Each abortion facility shall have a staff that is
adequately trained and capable of providing appropriate service and supervision
to patients. The abortion 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 abortion facility shall obtain written applications
for employment from all staff. The abortion facility shall obtain and verify
information on the application as to education, training, experience, and
appropriate professional licensure, if applicable.
C. Each abortion facility shall obtain a criminal history
record check pursuant to § 32.1-126.02 of the Code of Virginia on any
compensated employee not licensed by the Board of Pharmacy, whose job duties
provide access to controlled substances within the abortion facility.
D. The abortion 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.
E. Job descriptions.
1. Written job descriptions that adequately describe the
duties of every position shall be maintained.
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.
F. A personnel file shall be maintained for each staff
member. The records shall be completely and accurately documented, readily
available, including by electronic means 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.
G. Personnel policies and procedures shall include, but
not be limited to:
1. Written job descriptions that specify authority,
responsibility, and qualifications for each job classification;
2. Process for verifying current professional licensing or
certification and training of employees or independent contractors;
3. Process for annually evaluating employee performance and
4. Process for verifying that contractors and their
employees meet the personnel qualifications of the abortion facility; and
5. Process for reporting licensed and certified health care
practitioners for violations of their licensing or certification standards to
the appropriate board within the Department of Health Professions.
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.
12VAC5-412-190. Clinical staff.
A. Physicians and nonphysician health care practitioners
shall constitute the clinical staff. Clinical privileges of physician and
nonphysician 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 abortion facility shall develop,
implement, and maintain policies and procedures to ensure and document that
abortions that occur in the abortion 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 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 trained
health care practitioners remain with the patient until she is discharged from
the abortion facility.
D. Licensed practical nurses, working under direct
supervision and direction of a physician or a registered nurse, may be employed
as components of the clinical staff.
12VAC5-412-200. Patients' rights.
A. Each abortion facility shall establish a protocol relating
to the rights and responsibilities of patients consistent with the current
edition of the Joint Commission Standards of Ambulatory Care. The protocol
shall include a process reasonably designed to inform patients of their rights
and responsibilities, in a language or manner they understand. Patients shall
be given a copy of their rights and responsibilities upon admission.
B. The abortion facility shall establish and maintain
complaint handling procedures which specify the:
1. System for logging receipt, investigation, and
resolution of complaints; and
2. Format of the written record of the findings of each
C. The abortion facility shall designate staff responsible
for complaint resolution, including:
1. Complaint intake, including acknowledgment of
2. Investigation of the complaint;
3. Review of the investigation findings and resolution for
the complaint; and
4. Notification to the complainant of the proposed
resolution within 30 days from the date of receipt of the complaint.
D. Any patient seeking an abortion 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 abortion facility shall provide each patient or her
designee with the name, mailing address, and telephone number of the:
1. Abortion facility contact person; and
2. OLC Complaint Unit, including the toll-free complaint
hotline number. Patients may submit complaints anonymously to the OLC. The
abortion facility shall display a copy of this information in a conspicuous
F. The abortion 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
Quality Management and Infection Prevention
12VAC5-412-210. Quality management.
A. The abortion facility shall implement an ongoing,
comprehensive, integrated, self-assessment program of the quality and
appropriateness of care or services provided, including services provided under
contract or agreement. The program shall include process design, data
collection/analysis, assessment and improvement, and evaluation. The findings
shall be used to correct identified problems and revise policies and practices,
B. The following shall be evaluated to assure adequacy and
appropriateness of services, and to identify unacceptable or unexpected trends
1. Staffing patterns and performance;
2. Supervision appropriate to the level of service;
3. Patient records;
4. Patient satisfaction;
5. Complaint resolution;
6. Infections, complications, and other adverse events; and
7. Staff concerns regarding patient care.
C. A quality improvement committee responsible for the
oversight and supervision of the program shall be established and at a minimum
shall consist of:
1. A physician;
2. A nonphysician health care practitioner;
3. A member of the administrative staff; and
4. An individual with demonstrated ability to represent the
rights and concerns of patients. The individual may be a member of the
In selecting members of this committee, consideration
shall be given to the candidate's abilities and sensitivity to issues relating
to quality of care and services provided to patients.
D. Measures shall be implemented to resolve problems or
concerns that have been identified.
E. Results of the quality improvement program shall be
reported to the licensee at least annually and shall include the deficiencies
identified and recommendations for corrections and improvements. The report
shall be acted upon by the governing body and the facility. All corrective
actions shall be documented. Identified deficiencies that jeopardize patient
safety shall be reported immediately in writing to the licensee by the quality
12VAC5-412-220. Infection prevention.
A. The abortion facility shall have an infection
prevention plan that encompasses the entire abortion 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.
2. All infection prevention policies and procedures shall
be reviewed at least annually by the administrator and appropriate members of
the clinical staff. The annual review process and recommendations for
changes/updates shall be documented in writing.
3. A designated person in the abortion facility shall have
received training in basic infection prevention, and shall also be involved in
the annual review.
B. Written infection prevention policies and procedures
shall include, but not be limited to:
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 abortion facility;
2. Training of all personnel in proper infection prevention
3. Correct hand-washing technique, including indications
for use of soap and water and use of alcohol-based hand rubs;
4. Use of standard precautions;
5. Compliance with [
bloodborne ] pathogen requirements of the U.S. Occupational Safety
and Health Administration;
6. Use of personal protective equipment;
7. Use of safe injection practices;
8. Plans for annual retraining of all personnel in
infection prevention methods;
9. Procedures for monitoring staff adherence to recommended
infection prevention practices; and
10. Procedures for documenting annual retraining of all staff
in recommended infection prevention practices.
C. Written policies and procedures for the management of
the abortion facility, equipment, and supplies shall address the following:
1. Access to hand-washing equipment and adequate supplies
(e.g., soap, alcohol-based hand rubs, disposable towels or hot air driers);
2. Availability of utility sinks, cleaning supplies, and
other materials for cleaning, disposal, storage, and transport of equipment and
3. Appropriate storage for cleaning agents (e.g., locked
cabinets or rooms for chemicals used for cleaning) and product-specific
instructions for use of cleaning agents (e.g., dilution, contact time,
management of accidental exposures);
4. Procedures for handling, storing, and transporting clean
linens, clean/sterile supplies, and equipment;
5. Procedures for handling/temporary storage/transport of
6. Procedures for handling, storing, processing, and
transporting regulated medical waste in accordance with applicable regulations;
7. Procedures for the processing of each type of reusable
medical equipment between uses on different patients. The procedure shall
address: (i) the level of cleaning/disinfection/sterilization to be used for
each type of equipment; (ii) the process (e.g., cleaning, chemical
disinfection, heat sterilization); and (iii) the method for verifying that the
recommended level of disinfection/sterilization has been achieved. The
procedure shall reference the manufacturer's recommendations and any applicable
state or national infection control guidelines;
8. Procedures for appropriate disposal of nonreusable
9. Policies and procedures for maintenance/repair of
equipment in accordance with manufacturer recommendations;
10. Procedures for cleaning of environmental surfaces with
appropriate cleaning products;
11. An effective pest control program, managed in
accordance with local health and environmental regulations; and
12. Other infection prevention procedures necessary to
prevent/control transmission of an infectious agent in the abortion facility as
recommended or required by the department.
D. The abortion facility shall have an employee health
program that includes:
1. Access to recommended vaccines;
2. Procedures for assuring that employees with communicable
diseases are identified and prevented from work activities that could result in
transmission to other personnel or patients;
3. An exposure control plan for [
bloodborne ] pathogens;
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; and
5. Compliance with requirements of the U.S. Occupational
Safety and Health Administration for reporting of workplace-associated injuries
or exposure to infection.
E. The abortion facility shall develop, implement, and
maintain policies and procedures for the following patient education, follow
up, and reporting activities:
1. A procedure for surveillance, documentation, and
tracking of reported infections; and
2. 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.
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.
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. 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
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 family planning and
post-abortion counseling 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
discharge instructions for patients to include instructions to call or return
if signs of infection develop.
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
2. Medical testing shall include a recognized method to
confirm pregnancy and determination or documentation of Rh factor.
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. 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
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
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.
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. 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
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.
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
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
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
3. If using an anesthesia machine, the following shall be
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.
12VAC5-412-260. Administration, storage and dispensing of
A. Controlled substances, as defined in § 54.1-3401
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 [
54.1-3400 et seq.) (§ 54.1-3300 et seq.) ] 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 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 abortion 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
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 Code
12VAC5-412-270. Equipment and supplies.
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:
1. A bed or recliner suitable for recovery;
2. Oxygen with flow meters and masks or equivalent;
3. Mechanical suction;
4. Resuscitation equipment to include, as a minimum,
resuscitation bags and oral airways;
5. Emergency medications, intravenous fluids, and related
supplies and equipment;
6. Sterile suturing equipment and supplies;
7. Adjustable examination light;
8. Containers for soiled linen and waste materials with
12VAC5-412-280. Emergency equipment and supplies.
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 the American Heart Association's
Guidelines for [
Advanced Cardiovascular Life Support
Cardiopulmonary Resuscitation and Emergency Cardiovascular Care ].
Drugs shall include, at a minimum, those to treat the following conditions:
1. Cardiopulmonary arrest;
3. Respiratory distress;
4. Allergic reaction;
5. Narcotic toxicity;
6. Hypovolemic shock; and
7. Vasovagal shock.
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
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.
When emergency transfer is necessary, the responsible physician at the abortion
facility must provide direct communication to the emergency department 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.
Support Services - Health Information Records and Reports
12VAC5-412-300. Health information records.
An accurate and complete clinical record or chart shall be
maintained on each patient. The record or chart shall contain sufficient
information to satisfy the diagnosis or need for the medical or surgical
service. It shall include, but not be limited to the following:
1. Patient identification;
2. Admitting information, including patient history and
3. Signed consent;
4. Confirmation of pregnancy; and
5. Procedure report to include:
a. Physician orders;
b. Laboratory tests, pathologist's report of tissue, and
radiologist's report of x-rays;
c. Anesthesia record;
d. Operative record;
e. Surgical medication and medical treatments;
f. Recovery room notes;
g. Physicians' and nurses' progress notes;
h. Condition at time of discharge;
i. Patient instructions (preoperative and postoperative);
j. Names of referral physicians or agencies; and
6. Any other information required by law to be maintained
in the health information record.
12VAC5-412-310. 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.).
12VAC5-412-320. Required reporting.
A. Abortion facilities shall comply with the fetal death
and induced termination of pregnancy reporting provisions in the Board of
Health Regulations Governing Vital Records (12VAC5-550-120).
B. The abortion facility shall report the following events
1. Any patient, staff, or visitor death;
2. Any serious injury to a patient;
3. Medication errors that necessitate a clinical
intervention other than monitoring;
4. A death or significant injury of a patient or staff member
resulting from a physical assault that occurs within or on the abortion
facility grounds; and
5. Any other incident reported to the malpractice insurance
carrier or in compliance with the federal Safe Medical Devices Act of 1990 (21
USC § 301 et seq. - Pub. L. No. 101-629).
C. Notification of the events listed in subsection B of
this section shall be required within 24 hours of occurrence. Each notice shall
1. Abortion facility name;
2. Type and circumstance of the event being reported;
3. Date of the event; and
4. Actions taken by the abortion facility to protect
patient and staff safety and to prevent recurrence.
D. Compliance with this section does not relieve the
abortion facility from complying with any other applicable reporting or notification
requirements, such as those relating to law-enforcement or professional
E. Records that are confidential under federal or state
law shall be maintained as confidential by the OLC and shall not be further
disclosed by the OLC, except as required or permitted by law.
F. Abortion facilities shall ensure that employees
mandated to report suspected child abuse or neglect under § 63.2-1509 of
the Code of Virginia comply with the reporting requirements of § 63.2-1509
of the Code of Virginia.
Functional Safety and Maintenance
12VAC5-412-330. Abortion facility security and safety.
The abortion facility shall develop, implement, and
maintain policies and procedures to ensure safety within the abortion facility
and on its grounds and to minimize hazards to all occupants. The policies and
procedures shall include, but not be limited to:
1. Abortion 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 abortion facility.
12VAC5-412-340. 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. An abortion facility that participates in community
disaster planning shall establish plans, based on its capabilities, to meet its
responsibilities for providing emergency care.
A. The abortion 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 nonlead-based paint, lacquer, varnish,
or shellac that will allow sanitization.
B. When patient monitoring equipment is utilized, a
written preventive maintenance program shall be developed and implemented. This
equipment shall be checked and/or tested in accordance with manufacturer's
specifications at periodic intervals, not less than annually, to ensure proper
operation and a state of good repair. After repairs and/or alterations are made
to any equipment, the equipment shall be thoroughly tested for proper operation
before it is returned to service. Records shall be maintained on each piece of
equipment to indicate its history of testing and maintenance.
Firefighting ] equipment and systems.
A. Each abortion facility shall establish a monitoring
program for the internal enforcement of all applicable fire and safety laws and
regulations and shall designate a responsible employee for the monitoring
B. All fire protection and alarm systems and other
firefighting equipment shall be inspected and tested in accordance with the
current edition of the Virginia Statewide Fire Prevention Code (§ 27-94 et
seq. of the Code of Virginia) to maintain them in serviceable condition.
C. 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).
Design and Construction
12VAC5-412-370. Local and state codes and standards.
Abortion facilities shall comply with state and local
codes, zoning, and building ordinances and the Virginia Uniform Statewide
Building Code (13VAC5-63). 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 Virginia
Uniform Statewide Building Code pursuant to § 32.1-127.001 of the Code of
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
In order to determine whether the abortion facility is in
compliance with this provision, the commissioner may obtain additional
information from the facility or its architect concerning the design and
construction of the facility.
NOTICE: The following
forms used in administering the regulation were filed by the agency. The forms
are not being published; however, online users of this issue of the Virginia
Register of Regulations may click on the name to access a form. The forms are
also available from the agency contact or may be viewed at the Office of the
Registrar of Regulations, General Assembly Building, 2nd Floor, Richmond,
[ FORMS (12VAC5-412)
for Abortion Facility Licensure (eff. 5/03).
Forms for Recording Work-Related Injuries and Illnesses, 2004. ]
DOCUMENTS INCORPORATED BY REFERENCE (12VAC5-412)
Guidelines for Design and Construction of Health Care
Facilities, [ 2010 Edition, Part 1 and Sections 3.1-1 through 3.1-8
and 3.7 of Part 3, ] Facilities Guidelines Institute (formerly of
the American Institute of Architects), Washington, D.C. [
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/).
Transmitted Diseases Treatment Guidelines, 2010, Centers for Disease Control
and Prevention, U.S. Department of Health and Human Services.
to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe
Care, Centers for Disease Control and Prevention, U.S. Department of Health and
Standards for Ambulatory Care, Rights and Responsibilities
of the Individual, 2011, The Joint Commission, 1515 W. 22nd Street, Suite
1300W, Oak Brook, IL 60523, telephone 1-877-223-2866, email
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. R12-2970; Filed April 25, 2013, 5:06 p.m.