Ala. Admin. Code r. 420-5-1-.01

Current through Register Vol. 43, No. 1, October 31, 2024

Section 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.

Ala. Admin. Code r. 420-5-1-.01

Filed September 1, 1982. Amended: Filed November 16, 1989; May 22, 1990; August 16, 1990. Repealed and Replaced: Filed April 17, 2003; effective May 22, 2003. Amended: Filed January 22, 2004; effective February 26, 2004. Amended: Filed November 15, 2013; effective December 20, 2013.

Amended by Alabama Administrative Monthly Volume XXXIII, Issue No. 01, October 31, 2014, eff. 11/24/2014.

Authors:Rick Harris, W. T. Geary, Jr., M.D., Brian Hale

StatutoryAuthority:Code of Ala. 1975, §§ 22-21-20, et seq.