Current through Register Vol. 50, No. 9, September 20, 2024
A. The initial licensing application process
requires submission and approval of plans and specifications (construction
documents) and requires submission and approval of an initial licensing
application packet, including but not limited to, a facility need review
approval letter. No outpatient abortion facility shall accept patients or
provide abortion services until in compliance with the provisions of this
Chapter.
B. Plan Review Approval.
All plans and specifications (construction documents) submitted by, or on
behalf of, the outpatient abortion facility are required to be submitted and
approved by the Office of State Fire Marshal (OSFM) as part of the licensing
application process.
C. Initial
Licensing Application Packet. An initial licensing application packet for an
outpatient abortion facility shall be obtained from the department. A complete
initial licensing application packet shall be submitted to the department for
approval and onsite survey. The applicant may not provide outpatient abortion
services until properly licensed by the department.
D. To be considered complete, the initial
licensing application packet shall include the following:
1. a completed outpatient abortion facility
initial licensing application and the non-refundable initial licensing
fee;
2. a copy of the approval
letter of the architectural facility plans for the outpatient abortion facility
by the OSFM;
3. a copy of the
on-site inspection report with approval for occupancy from the OSFM;
4. a copy of the health inspection report
from the Office of Public Health (OPH);
5. an organizational chart identifying the
name, position, and title of each person composing the governing body and key
administrative personnel;
6. a
floor sketch or drawing of the premises to be licensed;
7. pursuant to
R.S.
40:2116, a copy of the facility need review
approval letter; and
8. any other
documentation or information required by the department for licensure,
including but not limited to, a copy of any waiver approval letter, if
applicable.
E. If the
initial licensing application packet is incomplete as submitted, the applicant
shall be notified in writing of the missing information and shall have 90
calendar days from receipt of the notification to submit the additional
requested information. If the additional requested information is not timely
submitted to the department within 90 calendar days, the initial licensing
application shall be closed. If an initial licensing application is closed, an
applicant who is still interested in operating an outpatient abortion facility
must submit a newly completed initial licensing application packet and a new
non-refundable initial licensing fee to begin the initial licensing application
process again, subject to any facility need review approval.
F. Initial Licensing Surveys. Upon receipt of
a complete initial licensing application packet, the department shall conduct
an on-site initial licensing survey prior to issuing a full initial license.
The initial licensing survey shall be announced.
1. If it is determined that the applicant is
not in compliance with all applicable federal, state, and local statutes, laws,
rules, regulations, and ordinances, including department rules, regulations,
and fees, governing or relating to outpatient abortion facility's, abortion or
termination procedures, reporting requirements, ultrasound requirements,
informed consent requirements or any other matter addressed by law related to
abortion or abortion procedures, and a potential threat to the health, safety,
and welfare of the patients is presented, the department shall deny the initial
licensing application.
2. If it is
determined that the applicant is in compliance with all applicable federal,
state, and local statutes, laws, rules, regulations, and ordinances, including
department rules, regulations, and fees, governing or relating to outpatient
abortion facility's, abortion or termination procedures, reporting
requirements, ultrasound requirements, informed consent requirements or any
other matter addressed by law related to abortion or abortion procedures, the
department shall issue a full initial license to the applicant.
3. If it is determined that the applicant is
not in compliance with all applicable federal, state, and local statutes, laws,
rules, regulations, and ordinances, including department rules, regulations,
and fees, governing or relating to outpatient abortion facility's, abortion or
termination procedures, reporting requirements, ultrasound requirements,
informed consent requirements or any other matter addressed by law related to
abortion or abortion procedures, but the department, in its sole discretion,
determines that the noncompliance does not present a threat to the health,
safety, and welfare of the patients, the department may issue a provisional
initial license.
G.
Full Initial License. The full initial license issued by the department shall
be valid until the expiration date shown on the license unless the license is
revoked or suspended prior to that date.
H. Provisional Initial License. The
provisional initial license issued by the department shall be valid for a
period not to exceed six months.
1. When a
provisional initial license is issued by the department, the applicant shall
submit a plan of correction to the department for approval and also shall be
required to correct all deficiencies prior to the expiration of the provisional
initial license.
2. Upon receipt of
the applicants plan of correction, the department shall conduct an unannounced
follow-up survey, either on-site or by administrative desk review, to ensure
the applicant is in compliance with all applicable federal, state, and local
statutes, laws, rules, regulations, and ordinances, including department rules,
regulations, and fees, governing or relating to outpatient abortion facility's,
abortion or termination procedures, reporting requirements, ultrasound
requirements, informed consent requirements or any other matter addressed by
law related to abortion or abortion procedures.
a. Following the follow-up survey, if it is
determined that the applicant has corrected all deficiencies and has maintained
compliance during the period of the provisional license, the department shall
issue a full initial license for the remainder of the year.
b. Following the follow-up survey, if it is
determined that the applicant has failed to correct all deficiencies, the
provisional initial license shall expire unless otherwise determined by the
department. The applicant shall be required to submit a newly completed initial
licensing application packet and a new non-refundable initial licensing fee to
begin the initial licensing application process again subject to any facility
need review approval.
I. Informal Reconsideration and
Administrative Appeal. The outpatient abortion facility does not have the right
to request an informal reconsideration and/or an administrative appeal of the
issuance or the expiration of a provisional initial license. An outpatient
abortion facility that has been issued a provisional initial license is
considered licensed and operational for the term of the provisional initial
license. The issuance of a provisional initial license is not considered to be
a denial of an initial licensing application, denial of a license renewal
application, or license revocation for the purposes of this Chapter.
1. Informal Reconsideration. An outpatient
abortion facility that has been issued a provisional initial license has the
right to request an informal reconsideration regarding the validity of the
deficiencies cited during the follow-up survey.
a. The request for an informal
reconsideration must be in writing and received by HSS within five calendar
days of receipt of the statement of deficiencies. If a timely request for an
informal reconsideration is received, HSS shall schedule the informal
reconsideration and notify the outpatient abortion facility in
writing.
b. The request for an
informal reconsideration must identify each disputed deficiency or deficiencies
and the reason for the dispute and include any documentation that demonstrates
that the determination was made in error.
c. Correction of a deficiency or deficiencies
cited in a follow-up survey shall not be the basis for an informal
reconsideration.
d. The outpatient
abortion facility shall be notified in writing of the results of the informal
reconsideration.
2.
Administrative Appeal. An outpatient abortion facility that has been issued a
provisional initial license has the right to request an administrative appeal
regarding the validity of the deficiencies cited during the follow-up survey.
a. The request for an administrative appeal
must be in writing and received by the Division of Administrative Law (DAL), or
its successor, within 15 days of receipt of the statement of deficiencies cited
during the follow-up survey.
b. The
request for an administrative appeal must identify each disputed deficiency or
deficiencies and the reason for the dispute and include any documentation that
demonstrates that the determination was made in error.
c. Correction of a deficiency or deficiencies
cited in a follow-up survey shall not be the basis for an administrative
appeal.
d. Upon expiration of the
provisional initial license, the outpatient abortion facility shall immediately
cease and desist providing abortion services unless the DAL, or its successor,
issues a stay of the expiration.
e.
Stay of the Expiration. The request for a stay of the expiration must be
submitted with the request for an administrative appeal and received by the
DAL, or its successor, within 15 days of receipt of the statement of
deficiencies.
i. Following a contradictory
hearing and only upon a showing that there is no potential harm to the patients
being served by the outpatient abortion facility, the stay may be granted by
the DAL, or its successor.
f. If a timely request for an administrative
appeal is received, the DAL, or its successor, shall conduct the administrative
appeal in accordance with the Administrative Procedure Act.
i. If the final decision of the DAL, or its
successor, is to remove all deficiencies, the outpatient abortion facility's
license shall be granted/re-instated upon the payment of any licensing fees,
outstanding sanctions, or other fees due to the department.
ii. If the final decision of the DAL, or its
successor, is to uphold any of the deficiencies thereby affirming the
expiration of the provisional initial license, the outpatient abortion facility
shall:
(a). immediately cease and desist
providing abortion services as an outpatient abortion facility;
(b). return the outpatient abortion facility
license to the department; and
(c).
notify the department in writing of the secure and confidential location where
the patient medical records will be stored, including the name, physical
address, and contact person, within 10 days of the rendering of the
administrative appeal judgment.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
40:2175.1 et
seq.
