Current through Register Vol. 51, No. 3, March 20, 2025
A.
Procedures for Initial Licensing. The LDH is the only licensing authority for
hospitals in the state of Louisiana.
1. Any
person, organization or corporation desiring to operate a hospital shall make
application to the LDH on forms prescribed by the department. Such forms may be
obtained electronically via the LDH, HSS website, or from, the LDH, HSS program
desk.
2. An initial applicant shall
as a condition of licensing:
a. submit a
completed initial hospital application packet and other required
documents;
b. submit the required
nonrefundable licensing fees via the department approved manner. No application
packet will be reviewed until payment of the nonrefundable application packet
fee. Except for good cause shown, the applicant shall complete all requirements
of the application packet process within 90 days of initial submission of the
application packet material. Upon 10 working days prior notice, any incomplete
or inactive application packets shall be closed. A new application packet will
be accepted only when accompanied by a nonrefundable application packet
fee.
3. When the required
documentation for licensing is approved and the building is approved for full
permanent occupancy by the Office of State Fire Marshal (OSFM), a survey of the
facility by representatives of HSS shall be conducted at the department's
discretion to determine if the facility meets the standards set forth in
Chapters 93-96.
4. The HSS shall
notify the hospital of the findings of the survey in a statement of
deficiencies. If non-compliance is cited, the notice of the requirements for
the facility's plan of correction will be included.
5. The hospital shall notify the HSS in
writing when the deficiencies have been corrected. Following review of the
hospital's Plan of Correction (POC), HSS may schedule an on-site survey of the
facility.
6. No new hospital
facility shall accept patients until the hospital has written approval and/or a
license issued by HSS.
7. No
patient shall be placed in a room that does not meet all patient room licensing
criteria and that has not been previously approved by HSS.
8. The hospital shall accept only that number
of inpatients for which it is licensed unless prior written approval has been
secured from the department.
B. Issuance of a License
1. The agency shall have authority to issue
two licenses as described below:
a. full
license-issued only to those hospitals that are in substantial compliance with
the rules, the standards governing hospitals and the hospital law. The license
shall be issued by the department for a period of not more than 12 months for
the premises named in the application packet, as determined by the
department;
b. if a hospital is not
in substantial compliance with the rules, the standards governing hospitals and
the hospital law, the department may issue a provisional license up to a period
of six months if there is no immediate and serious threat to the health and
safety of patients.
i. At the discretion of
the department, the provisional license may be extended for an additional
period not to exceed 90 days in order for the hospital to correct the
noncompliance or deficiencies.
ii.
The hospital shall submit a plan of correction to the department for approval
and the provider shall be required to correct all such noncompliance or
deficiencies prior to the expiration of the provisional license.
iii. A follow-up survey shall be conducted
prior to the expiration of the provisional license.
a). If all such noncompliance or deficiencies
are determined by the department to be corrected on a follow-up survey, a full
license may be issued.
b). If all
such noncompliance or deficiencies are not corrected on the follow-up survey,
the provisional license shall expire and the provider shall be required to
begin the licensing process again by submitting a new license application
packet and fee if no timely informal reconsideration or administrative appeal
of the deficiencies is filed pursuant to this
Chapter.
2. The department also has discretion in
denying, suspending or revoking a license where there has been substantial
noncompliance with these requirements in accordance with the hospital law. If a
license is denied, suspended or revoked, an appeal may be made as outlined in
the hospital law (R.S. 40:2110).
a. Suspensive Appeal. A hospital that appeals
the action of the department in denying, suspending or revoking the license may
file a suspensive appeal from the action of the department.
b. A renewal license shall not be issued, nor
will any changes be processed to a hospital's existing license, during the
pendency of an administrative suspensive appeal of the department's decision to
deny, suspend, or revoke a hospital's license for non-compliance.
c. The license for a hospital that is
suspensively operating during the pendency of the appeal process shall be
considered a license under suspensive appeal.
3. The hospital license is not assignable or
transferable and shall be immediately void if a hospital ceases to operate or
if its ownership changes.
4.
Licenses issued to hospitals with off-site locations shall be inclusive of the
licensed off-site beds. In no case may the total number of inpatient beds at
the off-site location exceed the number of inpatient beds at the main
campus.
C. Licensing
Renewal. Licenses shall be renewed at least annually. The renewal application
packet shall be sent by the department to the hospital 75 days prior to the
expiration of its license. The application packet shall contain all forms
required for renewal of the license. A hospital seeking renewal of its license
shall:
1. complete all forms and return them
to the department at least 30 days prior to the expiration date of its current
license; and
2. submit the required
annual/delinquent renewal fees. All fees shall be submitted in the manner
required by the department and are nonrefundable. All state-owned facilities
are exempt from licensing fees.
a. If a
hospital fails to timely renew its license, the license expires on its face and
is considered voluntarily surrendered.
b. There are no appeal rights for such
surrender or non-renewal of the license, as this is a voluntary action on the
part of the hospital.
D. Display of License. The current license
shall be displayed in a conspicuous place in the hospital at all
times.
E. Bed Changes
1. The hospital shall complete and submit the
required bed change application packet.
2. For the application packet to be
considered complete, the appropriate nonrefundable fee as required by state law
shall be submitted to the department in the manner required by the
department.
3. At the discretion of
the department, signed and dated attestations to compliance with these
standards, together with appropriate nonrefundable fees, may be accepted in
lieu of an on-site survey.
4.
Written approval of the bed increase shall be obtained before patients can be
admitted to these beds.
5. No
patient shall be placed in a room that does not meet all patient room licensing
criteria and that has not been previously approved by HSS.
EXCEPTION: During a declaration of emergency, a hospital
may exceed its licensed bed capacity with written notice to the department
within five days of the increase.
F. Eviction of Hospital. If a hospital is
subject to potential eviction proceedings, it shall notify the department
within 23 hours of receiving a notice to vacate.
G. Change in Services
1. Prior to the addition or deletion of a
service or services, the hospital shall notify the department in writing 45
days prior to implementation, if plan review is required, and 15 days prior to
implementation if no plan review is necessary. The hospital shall complete and
submit the appropriate service change packet for the service being added,
deleted, or changed.
2. At the
discretion of the department, signed and dated attestations of compliance with
the standards in these Chapters may be accepted in lieu of an on-site
survey.
3. Written approval for the
service change shall be obtained prior to the area being used for patient
care.
H. Off-Site
Campuses
1. An applicant adding an off-site
campus, as a condition of licensing, shall submit:
a. a completed off-site campus application
packet;
b. the required
nonrefundable licensing fees in the manner required by the
department.
2. Except for
good cause shown, all incomplete and inactive application packets shall be
closed 90 days after receipt of the initial off-site campus application packet.
A new application packet will be accepted only when accompanied by the required
nonrefundable application packet fee.
3. At the discretion of the department,
signed and dated attestations to the compliance with these standards may be
accepted in lieu of an on-site survey.
4. The off-site campus will be issued a
license that is a subset of the hospital's main campus license.
I. Closing Off-Site Campuses. The
hospital shall notify the HSS in writing at least 30 days prior to the closure
of an off-site campus to include the effective date of closure. The original
license of the off-site campus is to be returned to HSS.
J. Duplicate Licenses. The required fee shall
be submitted by the hospital for issuing a duplicate facility
license.
K. Changes to the License.
When changes to the license, such as a name change, address change, or bed
reduction are requested in writing by the hospital, the required non-refundable
fee and applicable application packet shall be submitted to the HSS.
L. Facility within a Facility
1. If more than one health care provider
occupies the same building, premises or physical location, all treatment
facilities and administrative offices for each health care provider shall be
clearly separated from each other by a clearly delineated and recognizable
boundary.
a. Treatment facilities shall
include, but not be limited to consumer beds, wings and operating
rooms.
b. Administrative offices
shall include, but not be limited to medical record rooms and administrative
offices.
c. There shall be clearly
identifiable and distinguishable signs for each facility.
2. If more than one licensed healthcare
provider occupies the same building, premises or physical location, each
healthcare provider shall have its own entrance and single identifiable
geographic address (e.g., suite number). The separate entrance shall have
appropriate signs and shall be clearly identifiable as belonging to a
particular healthcare provider. Nothing in these licensing regulations
prohibits a healthcare provider occupying the same building, premises, or
physical location as another healthcare provider from utilizing the entrance,
hallway, stairs, elevators, or escalators of another healthcare provider to
provide access to its separate entrance.
3. Staff of the hospital within a hospital
shall not be co-mingled with the staff of the host hospital for the delivery of
services within any given shift.
4.
The provisions and requirements of
§9305. L are in addition
to and not excluding any other statutes, laws and/or rules that regulate
hospitals, as set forth in
R.S.
40:2007.
M. Change of Ownership
1. Definition.
Change of Ownership
(CHOW)-the sale or transfer whether by purchase, lease, gift or
otherwise of a hospital by a person/corporation of controlling interest that
results in a change of ownership or control of 30 percent or greater of either
the voting rights or assets of a hospital or that results in the acquiring
person/corporation holding a 50 percent or greater interest in the ownership or
control of the hospital. Examples of actions which constitute a change of
ownership (R.S. 40:2115.11 et seq.).
a. Unincorporated Sole Proprietorship.
Transfer of title and property to another party constitutes a change of
ownership.
b. Corporation. The
merger of the provider corporation into another corporation, or the
consolidation of two or more corporations, resulting in the creation of a new
corporation constitutes a change of ownership. Transfer of corporate stock or
the merger of another corporation into the provider corporation does not
constitute a change of ownership.
c. Partnership. In the case of a partnership,
the removal, addition or substitution of a partner, unless the partners
expressly agree otherwise, as permitted by applicable state law, constitutes a
change of ownership.
d. Leasing.
The lease of all or part of a provider facility constitutes a change of
ownership of the leased portion.
2. No later than 15 working days after the
effective date of the CHOW, the prospective owner(s) or provider representative
shall submit to the department a completed CHOW application packet for hospital
licensing, included but not limited to, the letter of intent, diagram showing
ownership prior to and after the sale, executed legal transaction document, and
a licensing fee consistent with state law. The hospital license is not
transferable from one entity or owner(s) to another.
3. A hospital that holds provisional
licensure or is under license suspension, revocation, denial, or termination
may not undergo a CHOW.
4. A CHOW
of the hospital shall not be submitted at time of the annual renewal of the
hospital's license.
N.
Plan Review. A letter to the Department of Health, Division of Engineering and
Architectural Services, shall accompany the floor plans with a request for a
review of the hospital plans. The letter shall include the types of services
offered, number of licensed beds and licensed patient rooms, geographical
location, and whether it is a relocation, renovation, and/or new construction.
A copy of this letter is to be sent to the Hospital Program Manager.
1. Submission of Plans
a. New Construction. All new construction
shall be done in accordance with the specific requirements of the OSFM and the
Office of Public Health (OPH). The requirements cover new construction in
hospitals, including submission of preliminary plans and the final work
drawings and specifications to each of these agencies. Plan review shall be
performed in accordance with the rules and regulations established by the OSFM.
Plans and specifications shall be prepared by or under the direction of a
licensed architect and/or a qualified licensed engineer and shall include
scaled architectural plans stamped by an architect.
b. Hospitals. No hospital shall hereafter be
licensed without the prior written approval of, and unless in accordance with
plans and specifications approved in advance by the OSFM. This includes new
construction, additions, renovations, or any change in service or hospital type
(e.g., acute care hospital to psychiatric hospital, outpatient surgical
services to inpatient, adult care to pediatric), or the establishment of a
hospital in any healthcare facility or former healthcare facility.
2. Approval of Plans
a. Notice of satisfactory review from the
OSFM constitutes compliance with this requirement if construction begins within
180 days of the date of such notice. This approval shall in no way permit
and/or authorize any omission or deviation from the requirements of any
restrictions, laws, ordinances, codes or rules of any responsible
agency.
b. In the event that
submitted materials do not appear to satisfactorily comply with the 2014
Edition of the Facility Guidelines Institute (FGI), Guidelines for Design and
Construction of Hospitals and Outpatient Facilities, as adopted by the OSFM for
building design and construction, the OSFM shall notify the party submitting
the plans in writing, the particular items in question and request further
explanation and/or confirmation of necessary modifications.
3. Waivers
a. The secretary of the department may,
within his/her sole discretion, grant waivers to building and construction
guidelines or requirements and to provisions of the licensing rules involving
the clinical operation of the hospital. The facility shall submit a waiver
request in writing to the licensing section of the department on forms
prescribed by the department.
b. In
the waiver request, the facility shall demonstrate the following:
i. how patient health, safety, and welfare
will not be compromised if such waiver is granted;
ii. how the quality of care offered will not
be compromised if such waiver is granted; and
iii. the ability of the facility to
completely fulfill all other requirements of the service, condition, or
regulation.
c. The
licensing section of the department shall have each waiver request reviewed by
an internal waiver review committee. In conducting such internal waiver review,
the following shall apply:
i. the waiver
review committee may consult subject matter experts as necessary, including the
Office of State Fire Marshal; and
ii. the waiver review committee may require
the facility to submit risk assessments or other documentation to the
department.
d. The
director of the licensing section of the department shall submit the waiver
review committee's recommendation on each waiver to the secretary, or the
secretary's designee, for final determination.
e. The department shall issue a written
decision of the waiver request to the facility. The granting of any waiver may
be for a specific length of time.
f. The written decision of the waiver request
is final. There is no right to an appeal of the decision of the waiver
request.
g. If any waiver is
granted, it is not transferrable in an ownership change or change of
location.
h. Waivers are subject to
review and revocation upon any change of circumstance related to the waiver or
upon a finding that the health, safety, or welfare of a patient may be
compromised.
i. Any waivers granted
by the department prior to January 15, 2023, shall remain in place, subject to
any time limitations on such waivers; further, such waivers shall be subject to
the following:
i. such waivers are subject to
review or revocation upon any change in circumstance related to the waiver or
upon a finding that the health, safety, or welfare of a patient may be
compromised; and
ii. such waivers
are not transferrable in an ownership change or change of
location.
O. Fire Protection. All hospitals required to
be licensed by the law shall comply with the rules, established fire protection
standards and enforcement policies as promulgated by the Office of State Fire
Marshal. It shall be the primary responsibility of the Office of State Fire
Marshal to determine if applicants are complying with those requirements. No
license shall be issued or renewed without the applicant furnishing a
certificate from the Office of State Fire Marshal stating that the applicant is
complying with their provisions. A provisional license may be issued to the
applicant if the Office of State Fire Marshal issues the applicant a
conditional certificate.
P.
Sanitation and Patient Safety. All hospitals required to be licensed by the law
shall comply with the Rules, Sanitary Code and enforcement policies as
promulgated by the Office of Public Health. It shall be the primary
responsibility of the Office of Public Health to determine if applicants are
complying with those requirements. No initial license shall be issued without
the applicant furnishing a certificate from the Office of Public Health stating
that the applicant is complying with their provisions. A provisional license
may be issued to the applicant if the Office of Public Health issues the
applicant a conditional certificate.
AUTHORITY
NOTE: Promulgated in accordance with
R.S.
40:2100-2115.