10- 144 C.M.R. ch. 112, § 2

Current through 2024-51, December 18, 2024

Section 144-112-2 - LICENSING AND ENFORCEMENT

2.1 Responsibility for compliance. The applicant and licensee must comply with these rules.

2.2 Unlicensed facilities. No person, firm, partnership, association, corporation, or other entity, nor any state, county or local governmental units shall establish, operate, conduct and maintain in the State any hospital for the hospitalization and nursing care of human beings without a license issued by the department. Unless otherwise specified, the term hospital includes any type of hospital, including but not limited to general, critical access, psychiatric or other specialty hospital.

2.3 License not transferable. No license may be assigned or transferred.

2.4 License posted. The license must be conspicuously posted in the facility where it may be seen by the public.

2.5 Application for initial license and renewal.

2.5.1 Application. Either prior to the commencement of operation as a hospital, or thirty (30) days prior to the expiration of the existing license, the applicant or licensee must file an application for a license on forms provided by the department. An application on behalf of a corporation or association must be made by any two officers or by its managing agent. Applicants and licensees must demonstrate satisfactory evidence of compliance with all laws and rules of the State of Maine.

2.5.2 Building lease. The lease for any building or buildings not owned by the applicant or licensee that are used in connection with the provision of patient services on an inpatient or outpatient basis must show clearly in its context which party to the agreement is responsible for the maintenance and upkeep of the property. The department shall be notified at least 72 hours in advance of any changes in the lease that may impact responsibilities for maintenance and upkeep, and compliance with these rules.

2.5.3 Building plans. A set of plans and specifications for each building used in the provision of patient care services, drawn to scale, must be provided to the department. These plans must identify the source of utilities and method of waste disposal. Plans and specifications drawn to scale for proposed changes in the facility, its physical environment or its utilities that materially affect patient care must be approved by the department prior to implementation of proposed changes. Submission of plans and specifications are not required for routine maintenance and repair of the facility.

2.5.4 Beds. The applicant or licensee must identify the number of beds defined for each of the services rendered.

2.5.5 Fire safety inspection. Prior to the issuance of a license, and annually thereafter, the department must receive a written statement, signed by the Commissioner of Public Safety or the proper municipal official designated to make fire safety inspections, that the premises comply with fire safety provisions pursuant to 22 M.R.S.A. §1816.

2.5.6 New services. In order for a license to extend to a new service or other applicable project subject to the Certificate of Need process outlined in 22 M.R.S.A. Chapter 103-A, and any applicable rules promulgated thereunder, the applicant or licensee must request a ruling from the Certificate of Need Unit, Division of Licensing and Regulatory Services.

2.5.7 Plumbing, water supply and sewage disposal. The applicant or licensee must provide evidence that the facility complies with all applicable State laws and rules relating to plumbing, water supply and sewage disposal.

2.5.8 Fee. Licensing fees are nonrefundable.

2.5.8.1 The fee for an initial license is $40 for each bed.

2.5.8.2 The fee for a 2-year renewal license is $80 for each bed.

2.5.8.3 The fee for a temporary license is $15.00.

2.5.8.4 The department may assess a fee for plan review at an hourly rate not to exceed $50 an hour.

2.5.9 Local laws and codes. The applicant or licensee must provide evidence from the appropriate municipal official indicating compliance with all local laws or codes relative to the type of facility for which the license is requested. This requirement is necessary upon initial licensure and whenever a change occurs.

2.5.10 Accreditation reports. A copy of the latest survey by an accrediting body must be on file with the department, if the hospital is accredited.

2.6 Term of license. Pursuant to 22 M.R.S.A. Chapter 405, the term of the license is as follows:

2.6.1 Initial license. An initial license may be issued for up to 12 months.

2.6.2 Renewed license. A license may be renewed for up to 24 months.

2.6.3 Temporary license. A temporary license may be issued for a specified period not to exceed 90 days, during which time corrections specified by the department must be made by the applicant or licensee for compliance with these rules, if in the judgment of the commissioner the best interest of the public will be served.

2.6.4 Conditional license. A conditional license may be issued for a specified period not to exceed 12 months, setting forth conditions that must be met by the applicant or licensee to the satisfaction of the department if in the judgment of the commissioner the best interest of the public will be served.

2.7 Waivers. A waiver may be granted under the following terms and conditions:

2.7.1 The department may waive or modify a provision of these rules as long as the provision is not mandated by state or federal law and does not violate patient rights.

2.7.2 A written request for a waiver must be made at the time of initial or renewal application and submitted to the department.

2.7.3 A request for a waiver must be accompanied by documentation that demonstrates that the terms of the waiver will comply with the intent of the rule. At the request of the department, expert opinion shall be provided.

2.7.4 A waiver shall be granted for a specific period not to exceed the term of the license.

2.7.5 To renew a waiver, the hospital must submit a renewal request to the department ninety (90) days prior to the expiration of the term of the existing license.

2.7.6 A violation of a waiver is enforceable as rule and subject to actions described in Section 2.12 regarding enforcement procedures.

2.8 Issuance of a license. The license issued by the department extends to the premises identified in the application.

2.9 Specifications of a license. The license must specify the following:

2.9.1 the name of the facility,

2.9.2 the name of the Chief Executive Officer or Administrator,

2.9.3 the location of the building(s),

2.9.4 the maximum allowable number of licensed beds,

2.9.5 any state licensing waivers that have been granted,

2.9.6 the effective date and term of the license,

2.9.7 the identification of each level of care, and

2.9.8 the identification of outpatient services.

2.10 Distinct parts. When two or more distinct parts exist within one structure, the license must identify each level of care or outpatient service provided within the structure. When the applicant or licensee has separate facilities located in physically separated structures on the same grounds, one license shall be issued. Facilities operated by the same applicant or licensee on different grounds shall have one license.

2.11 Changes in licensing information. No change in licensed capacity may be implemented, and no new construction, additions or alterations shall commence without the applicant having plans approved by the department. This does not apply to minor alterations which do not effect the primary functional operation or the number of beds, or to routine maintenance and repairs. Changes in Chief Executive Officer or Administrator must be reported to the department within ten (10) working days. A new license shall be issued following notification to the department.

2.12 Enforcement procedures

2.12.1 Voiding a temporary or conditional license. Failure to meet any of the department's conditions immediately voids the temporary or conditional license upon personal service of written notice to the licensee, or, if the licensee cannot be reached for personal service, by personal service to the person in charge.

2.12.1.1 New application. A new application for a regular license may be considered by the department after the conditions set forth by the department at the time of the issuance of the temporary or conditional license have been met and satisfactory evidence of this fact has been furnished to the department.

2.12.2 Refusal to issue a license. The department may refuse to issue a license to the applicant if it finds misrepresentation, materially incorrect or insufficient information on the application, or if the premises do not meet the requirements for issuing a license.

2.12.3 Amending, modifying, or refusing to renew a license. The department may amend, modify or refuse to renew a license in conformity with the Maine Administrative Procedure Act.

2.12.4 Grounds for suspension or revocation. The department may file a complaint with the District Court requesting suspension or revocation of any license based on any of the following grounds:

2.12.4.1 violation of these rules and applicable laws;

2.12.4.2 permitting, aiding or abetting the commission of any illegal act in the facility; or,

2.12.4.3 conduct or practices detrimental to the welfare of a patient.

2.12.5 Suspension or revocation of license. The department may file a complaint with the District Court requesting suspension or revocation of a license pursuant 22 M.R.S.A. §1817.

2.12.5.1 Private psychiatric hospital license suspension or revocation. Pursuant to 22 M.R.S.A. §1783, if the department believes a license for a private psychiatric hospital should be suspended or revoked, the department shall file a statement or complaint with the District Court Judge, designated in the Maine Revised Statutes, Title 5, chapter 375.

2.12.6 Emergency suspension or revocation of license. Whenever, on inspection by the department, conditions are found to exist that, in the opinion of the commissioner, immediately endanger the health or safety of patients in the facility, or create an emergency, the department by its duly authorized agents may, under the emergency provisions of 4 M.R.S.A. §184(6), request that the District Court suspend or revoke the license.

2.13 Appeals. Any person who is aggrieved by a decision of the department to refuse to issue a license or to renew a license, or to issue a conditional license may request an administrative hearing in writing within ten (10) working days of receipt of the decision in accordance with the Administrative Procedures Act, 5 M.R.S.A. §9051et seq. A request for an administrative hearing must specify the reasons of the appeal. Administrative hearings will be held in conformity with the department's Administrative Hearing Regulations.

2.14 Appeal of refusal to issue a license to a private psychiatric hospital. A person aggrieved by the refusal of the department to issue a license to a private psychiatric hospital may file a statement or complaint with the District Court Judge.

2.15 Inspections.

2.15.1 Exemption from state inspection. A hospital is exempt from state licensure inspection if the following conditions apply:

2.15.1.1 The hospital is certified by the Centers for Medicare and Medicaid Services (CMS) for participation in the federal Medicare program, and

2.15.1.2 The hospital holds full accreditation status by a health care facility accrediting organization recognized by the Centers for Medicare and Medicaid Services.

2.15.2 State inspection required. A hospital that is certified by the Centers for Medicare and Medicaid Services for participation in the federal Medicare program but is not accredited by a health care facility accrediting organization recognized by the Centers for Medicare and Medicaid Services, shall be inspected for state licensure purposes by the department every three (3) years for compliance with these rules.

2.15.2.1 The hospital will receive a ten (10) working day notice of the inspection.

2.15.2.2 Federal certification survey findings will be used as evidence of compliance with these rules to avoid duplication of effort and satisfy the requirements of Section 3.1.

2.15.3 Complaints. Regardless of its accreditation status, a hospital may be inspected, without notice, by the department in response to a complaint or suspected violation of these rules, or inspected by another state agency or municipality for violation of building codes, fire codes, life safety codes or for other purposes unrelated to health care facility licensing or accreditation.

2.16 Change in accreditation. The hospital must notify the department of any change in accreditation status within ten (10) days of its occurrence.

2.17 Statement of deficiencies. A statement of deficiencies shall be issued by the department as a result of a determination that a violation of these rules has occurred.

2.17.1 Violations of federal conditions of participation. When a violation under Section 3.1 has occurred, and a federal statement of deficiencies is issued to the applicant or licensee, the plan of correction accepted by the Centers for Medicare and Medicaid Services shall be accepted by the department.

2.17.2 Other violations. The department shall notify the applicant or licensee of any violation of these rules not covered by Section 3.1, and a statement of deficiencies may be issued when the department determines that a plan of correction is necessary.

2.17.3 Corrective action. In the event a facility does not implement its approved plan of correction, the department may direct the facility to implement its plan of correction, or take additional corrective action as specified in these rules.

2.18 Informal conference. Within ten (10) days of receipt of the statement of deficiency, the licensee may request an informal conference to provide evidence to dispute the findings, if a licensee disagrees with the finding of a deficiency by the department. In the event a deficiency relates to one or more standards or conditions of participation, as outlined in Section 4, if the deficiency is upheld by CMS, it is upheld as a state licensing deficiency.

2.19 Receivership. Pursuant to 22 M.R.S.A. Chapter 1666-A, Appointment of Receivers, the department may petition the Superior Court to appoint a receiver to operate the hospital.

2.20 Right of entry. The department and any duly designated representative shall have the right to enter upon and into the premises of any facility licensed pursuant to these rules at any time without threat of injury, verbal abuse or harassment and in the spirit of mutual cooperation in order to determine the status of compliance with the provisions of these rules.

2.20.1 Such right of entry shall extend to any premises which the department has reason to believe is being operated or maintained as a hospital without a license, but no such entry or inspection shall occur without the permission of the owner or person in charge, unless a warrant is first obtained from a court having jurisdiction.

2.20.2 An application for a license pursuant to these rules constitutes permission for complete acquiescence to any entry or inspection for which the license is sought in order to facilitate verification of the information submitted on, or in connection with, such application.

2.20.3 Right of entry shall afford department authorized personnel full access to all records, documents and reports in accordance with the federal Health Insurance Portability and Accountability Act, 42 U.S.C. § 201et seq. ( 42 U.S.C. § 1320 d-2)(1996), or other applicable law. Right of entry gives the department authorization to copy records, documents and reports either manually or by photocopy unless otherwise protected by law, at no expense to the department.

2.21 Construction and renovations. All construction of new buildings for occupancy as a hospital and additions, renovations, alterations or repairs of existing buildings with a total project cost of fifty-thousand ($50k) or more must comply with state and local codes, zoning and building ordinances, and the building and design standards of the American Institute of Architects' 2006 Guidelines for Design and Construction of Health Care Facilities (AIA guidelines). Additions, renovations, alterations or repairs with a total project cost of less than fifty-thousand may require local and municipal permits, and copies must be on file at the facility.

2.21.1 Architectural plans. When architectural plans are required by law or rule, the hospital must file a copy of the plans with the department.

2.21.2 Architect's certification. When architectural plans are required, the hospital must submit to the department, prior to construction, an architect's certification that the drawings and specifications were prepared according to state and local codes, zoning and building ordinances, and the AIA guidelines. When state or local codes take precedence over the AIA guidelines, the architect must so note.

2.21.3 Documentation. Upon completion of the project and prior to occupancy, the following information must be received by the department before a license is issued:

2.21.3.1 Architect's letter of certification, as applicable, that construction conformed to the certified drawings and specifications that were prepared according to code requirements and the AIA guidelines;

2.21.3.2 State Fire Marshal approval; and

2.21.3.3 Documentation of department approval of facility policies and procedures, contractual agreements, staffing plans or materials necessary to determine compliance with these rules, if applicable.

2.21.4 A physical walkthrough may be conducted by the department to determine compliance with these rules.

10- 144 C.M.R. ch. 112, § 2