Current through Register Vol. 50, No. 9, September 20, 2024
A. License Renewal Application Packet. A
license renewal application packet for an outpatient abortion facility shall be
obtained from the department. A complete license renewal application packet
shall be submitted to the department at least 30 calendar days prior to the
expiration of the current license.
B. To be considered complete, the license
renewal application packet shall include the following:
1. a completed outpatient abortion facility
license renewal application and the non-refundable license renewal
fee;
2. a copy of the most current
on-site inspection report with approval for occupancy from the OSFM;
3. a copy of the most current health
inspection report with recommendation for licensing from the OPH;
4. payment of any outstanding fees, fines, or
monies owed to the department; and
5. any other documentation required by the
department for licensure.
C. If the license renewal application packet
is incomplete as submitted, the outpatient abortion facility shall be notified
in writing of the missing information, and shall have 10 calendar days from
receipt of the notification to submit the additional requested information. If
the additional requested information is not received within 10 calendar days or
prior to the expiration of the current license, it will result in the voluntary
non-renewal of the outpatient abortion facility license.
D. Licensing Renewal Annual Licensing Survey.
Upon receipt of a complete license renewal application packet, the department
may conduct an on-site annual licensing survey. This annual licensing survey
shall be unannounced.
1. If it is determined
that the outpatient abortion facility 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
that a potential threat to the health, safety, and welfare of the patients is
presented, the department shall deny the license renewal application.
2. If it is determined that the outpatient
abortion facility 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 renewal license to the outpatient abortion
facility.
3. If it is determined
that the outpatient abortion facility 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 license.
E. The issuance of a full renewal license
does not in any manner affect any previously existing sanction by the
department against an outpatient abortion facility including, but not limited
to, civil fine(s) and/or plan of correction(s).
F. If the department has issued a notice of
license revocation or a notice of immediate suspension of license at the time
the license renewal application packet is submitted, the department shall deny
the license renewal application.
G.
Full Renewal License. The full renewal license issued by the department shall
be valid until the expiration date shown on the license, unless the license is
modified, revoked, or suspended.
H. Provisional License. The provisional
license issued by the department shall be valid for a period not to exceed six
months.
1. At the discretion of the
department, the provisional license may be extended for an additional period
not to exceed 90 calendar days in order for the outpatient abortion facility to
correct the deficiencies cited following any survey.
2. When a provisional license is issued by
the department, the outpatient abortion facility 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 license.
3. Upon receipt of the outpatient abortion
facility's plan of correction, the department shall conduct an unannounced
follow-up survey, either on-site or by desk review, to ensure the outpatient
abortion facility 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 outpatient abortion facility has corrected all deficiencies
and has maintained compliance during the period of the provisional license, the
department may issue a full license for the remainder of the year until the
anniversary date of the issuance of the outpatient abortion facility
license.
b. Following the follow-up
survey, if it determined that the outpatient abortion facility has failed to
correct all deficiencies or has not maintained compliance during the period of
the provisional license, or if new deficiencies are cited during the follow-up
survey that present a threat to the health, safety, and welfare of a patient,
the provisional license shall expire unless otherwise determined by the
department. The outpatient abortion facility shall 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 expiration of a provisional license. An outpatient abortion
facility that has been issued a provisional license is considered licensed and
operational for the term of the provisional license. The issuance of a
provisional 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 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 cited during the follow-up
survey. 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 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 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 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 will 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 remove some but not all
deficiencies, the department shall have the discretion to determine the
operational status of the outpatient abortion facility.
iii. If the final decision of the DAL, or its
successor, is to uphold the deficiencies thereby affirming the expiration of
the provisional 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.
J. Voluntary Non-Renewal of
License
1. If an outpatient abortion facility
fails to timely renew its license, the license shall expire on its face and is
considered to be a voluntary non-renewal of license. At such time, the
outpatient abortion facility shall immediately cease and desist providing
abortions as an outpatient abortion facility.
2. Notice of Voluntary Non-Renewal of
License. The outpatient abortion facility must provide advanced written notice
of its voluntary non-renewal of license at least 30 calendar days prior to the
date of the expiration of the outpatient abortion facility license. The notice
of voluntary non-renewal of the license must be provided to all of the
outpatient abortion facility's staff, including the medical director, to any
patient having an abortion procedure within the last 30 calendar days of
operation, and to HSS.
3. In
addition, the outpatient abortion facility shall notify HSS in writing of the
secure and confidential location where the patient medical records will be
stored, including the name, physical address, and contact person.
4. As this is a voluntary action on the part
of the outpatient abortion facility, no informal reconsideration or
administrative appeal rights shall be available.
AUTHORITY NOTE:
Promulgated in accordance with
R.S.
40:2175.1 et
seq.
