La. Admin. Code tit. 48 § I-9305

Current through Register Vol. 50, No. 11, November 20, 2024

Section I-9305 - Licensing Process

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.

6. Repealed.

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.

1. - 4. Repealed.

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.

c. - d. Repealed.

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.

La. Admin. Code tit. 48, § I-9305

Promulgated by the Department of Health and Human Resources, Office of the Secretary, LR 13:246 (April 1987), amended by the Department of Health and Hospitals, Office of the Secretary, Bureau of Health Services Financing, LR 16:971 (November 1990), LR 21:177 (February 1995), LR 29:2401 (November 2003), amended by the Department of Health and Hospitals, Bureau of Health Services Financing, LR 38:1413 (June 2012), Amended by the Department of Health, Bureau of Health Services Financing, LR 491074 (6/1/2023), RS 40:1722 (January 2016), amended by the Department of Health, Health Standards Section, LR 501475 (10/1/2024).

AUTHORITY NOTE: Promulgated in accordance with R.S. 40:2100-2115.