Current through Register Vol. 42, No. 11, August 30, 2024
(1)
Legal
Authority for Adoption of Rules. Under and by virtue of authority vested
in it by the Legislature of Alabama (Code of Ala.
1975, Section
22-21-20, et seq.), the State
Board of Health does hereby adopt and promulgate the following rules governing
outpatient abortion or reproductive health centers licensed to operate in the
State of Alabama.
(2)
Definitions (a list of selected terms often used in connection
with these Rules):
(a) "AAC Rule" means
Alabama Administrative Code Rule.
(b) "Abortion" means the use or prescription
of any instrument, medicine, drug, or any other substance or device with the
intent to terminate the pregnancy of a woman known to be pregnant with
knowledge that the termination by those means will with reasonable likelihood
cause the death of the unborn child. Such use or prescription is not an
abortion if done with the intent to save the life or preserve the health of an
unborn child, remove a dead unborn child, or to deliver an unborn child
prematurely in order to preserve the health of both the mother (pregnant woman)
and her unborn child. The term, abortion, as used in these rules, does not
include a procedure or act to terminate the pregnancy of a woman with an
ectopic pregnancy, nor does it include the procedure or act to terminate the
pregnancy of a woman when the fetus has a lethal anomaly. For purposes of these
rules, a lethal fetal anomaly means that the child would die at birth or be
still born. For the purpose of this definition, ectopic pregnancy means any
pregnancy resulting from a fertilized egg that has implanted or attached
outside the uterus. The term also includes a pregnancy resulting from a
fertilized egg implanted inside the cornu of the uterus.
(c) "Abortion Clinic," "Clinic," "Abortion
Facility," or "Facility" means Abortion or Reproductive Health
Center.
(d) "Abortion Inducing
Drug" means a medicine, drug, or any other substance prescribed or dispensed
with the intent of terminating the clinically diagnosable pregnancy of a woman,
with the knowledge that the termination will with reasonable likelihood cause
the death of the unborn child. Use of such drugs to induce abortion is also
known as "medical abortion." This includes off-label use of drugs known to have
abortion-inducing properties, which are prescribed specifically with the intent
of causing an abortion, such as misoprostol (Cytotec), and methotrexate. This
definition does not apply to drugs that may be known to cause an abortion, but
which are prescribed for other medical indications, such as chemotherapeutic
agents and diagnostic drugs.
(e)
"Abortion or Reproductive Health Center" means any health care facility,
institution, physician's office, or place where 10 or more abortions are
performed during any month, or where 100 or more abortions are performed in any
calendar year, or that holds itself out to the public as an abortion provider
by advertising by some public means, such as a newspaper, telephone directory,
magazine, or electronic media, that it performs abortions. This term does not
include a health care facility licensed as a hospital pursuant to Chapter
420-5-7, Ala. Admin. Code.
(f)
"Acute Care Hospital" means a health institution planned, organized, and
maintained for offering to the public, facilities and beds for use in the
diagnosis and treatment of patients requiring in-patient medical care,
out-patient medical care, or other care performed by or under the supervision
of physicians due to illness, disease, injury, deformity, abnormality, or
pregnancy.
(g) "Administer" means
to give or apply a pharmacologic or other therapeutic agent to a
patient.
(h) "Administrator" means
a natural person who is the governing authority of a health care facility or a
natural person who is designated by the governing authority of a health care
facility. Such person must have sufficient authority to interpret and implement
all policies of the owner or proprietor, and must be qualified to perform those
tasks. Such person shall be the addressee of all correspondence and inquiries
from the State Board of Health.
(i)
"Dispense" means to sell, distribute, administer, leave with, give away,
dispose of, deliver, or supply a drug or medicine to the ultimate user or the
user's agent.
(j) "Gestational Age"
means the time that has elapsed since the first day of the woman's last
menstrual period.
(k) "Governing
Authority" means the owner or proprietor of a health care facility, or the
body, such as a board of directors, which exercises control over a health care
facility on behalf of its owner or proprietor.
(l) "Medical Emergency" means a condition
that, based on the applicable standard of care, is likely to result in the
death of the pregnant woman or is likely to result in substantial irreversible
impairment of a major bodily function. An ectopic pregnancy is per se a medical
emergency.
(m) "Physician" means a
person currently licensed by the Medical Licensure Commission, State of
Alabama, to practice medicine or osteopathy pursuant to Code of
Ala. 1975, Section
34-24-50, et seq.
(n) "Prescription" means a physician's order
for the preparation and administration of a drug or device for a
patient.
(o) "Qualified Person"
means an agent of the physician who is a psychologist, licensed social worker,
licensed professional counselor, registered professional nurse, or
physician.
(p) "Registered
Professional Nurse (RN)" means a person currently licensed in the State of
Alabama pursuant to Code of Ala. 1975, Section
34-21-21.
(q) "These Rules" means Rules
420-5-1-.01 through
420-5-1-.04, Chapter 420-5-1,
Abortion or Reproductive Health Centers, Alabama Administrative Code.
(r) "Viable" and "Viability" means that stage
of fetal development when, the life of the fetus may be continued indefinitely
outside the womb by natural or artificial life-supportive systems.
(3)
Type of License.
(a) Regular License. A regular license shall
be issued by the State Board of Health after the Board has determined that the
abortion or reproductive health center is in substantial compliance with the
Rules herein adopted.
(b)
Probational License. The State Board of Health may issue a probational license
when the Board is satisfied that appropriate measures have been taken to
minimize any threat to the health and safety of patients and personnel. A
probational license may not be granted for more than one year.
(4)
Licensing.
(a) Application for License. All abortion or
reproductive health centers shall apply for licensure on a form designated by
the State Board of Health. The application will reflect all data required by
Code of Ala. 1975, Section
22-21-20, et seq.
(b) Application Fee. Each application for
license shall be accompanied by an application fee as mandated by statute. No
application fee shall be refunded. Application fees shall be paid by cash,
check or money order made payable to the Alabama Department of Public
Health.
(c) Name of Facility. Every
abortion or reproductive health center shall be designated by a permanent and
distinctive name which shall not be changed once an application has been
completed and approved.
(d)
Separate License. When more than one facility is operated under the same
operating entity, a separate license shall be required for each facility.
Separate licenses are not required for separate buildings on the same ground
used by the same facility.
(e)
Reissuance of License.
1. The following
changes in the status of the facility will require issuance of a new license.
(i) Change in facility ownership or operating
entity (application fee required).
(ii) Change in facility name (no application
fee required).
(iii)
Relocation.
2. The
governing authority shall file with the State Board of Health an application
for license and application fee (if applicable) 30 days before any proposed
change requiring a new license in order to permit processing of the application
and issuance of the license prior to the desired effective date of the
change.
(5)
Right of Appeal. Any licensee dissatisfied with administrative
decision made in the application of these rules may appeal under the procedures
of the Alabama Administrative Procedure Act, Code of Ala.
1975, Section
41-22-1 et. seq.
(6)
Waivers. Applications for a
waiver to these rules shall be submitted and considered pursuant to the State
Board of Health's Rule-Making Procedures, specifically Rule
420-1-2-.09, Waivers or
Variances, Ala. Admin.Code.:
(7)
Disclosure of Information. Official reports, such as statements of
deficiencies generated by the State Board of Health as a result of on-site
inspections, and plans of correction submitted in response to those statements
of deficiencies, are subject to public disclosure. Information received through
other means and reports, other than statements of deficiencies, shall be deemed
to be confidential and shall not be publicly disclosed except in response to a
valid subpoena or court order or in proceedings involving the affected
facility's license or proceedings involving the license of another facility
operated by the same governing authority. Inspection reports will never contain
the name or other identification of any patient or client in the inspected
facility.
