Ala. Admin. Code r. 420-5-1-.01 - General
(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.
Notes
Authors:Rick Harris, W. T. Geary, Jr., M.D., Brian Hale
StatutoryAuthority: Code of Ala. 1975, ยงยง 22-21-20, et seq.
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