16 Del. Admin. Code § 6001-I-4.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 6001-I-4.0 - License Application Procedures

4.1 Applicability

4.1.1 Any entity seeking to operate a substance use treatment program or a co-occurring, (substance use disorder with mental health disorders) treatment program shall be licensed in accordance with these regulations for each program it seeks to operate. Each facility's license shall list one or more categories of service that the facility is authorized to provide and the facility's location.

4.1.1.1 Program categories for which licenses may be issued are:

4.1.1.1.1 Residential Detoxification: substance use disorders

4.1.1.1.2 Ambulatory Detoxification (Amdetox):

4.1.1.1.3 Outpatient Treatment: substance use disorders or co-occurring disorders,

4.1.1.1.4 Opioid treatment: substance use disorders,

4.1.1.1.5 Residential Treatment: substance use disorders,

4.1.1.1.6 Transitional residential treatment: substance use disorders.

4.2 Application Procedures

4.2.1 The Division may supply an application packet to all applicants upon request. Applications can also be obtained by visiting the Division's website at: www.dhss.delaware.gov/dhss/dsamh/regs.html.

4.2.2 All persons and agencies applying for the first time for a license shall schedule a meeting with DSAMH Quality Assurance staff for the purpose of receiving needed technical assistance regarding the licensure criteria and procedures.

4.2.3 A separate application shall be completed for each program at each location at which an agency intends to operate a substance use disorder and/or co-occurring program.

4.2.4 The applicant may withdraw the application at any time by notifying the Division in writing.

4.3 Required Information

4.3.1 An applicant for licensure shall submit the following information on forms provided by the Division:

4.3.1.1 Name and address of the applicant;

4.3.1.2 Name, address and qualifications of the agency director, program director and/or partners, including copies of the professional licenses each has been issued by the State of Delaware;

4.3.1.3 Articles of incorporation and bylaws, and/or partnership agreement;

4.3.1.4 Name and address, occupation and place of employment, of the program director, board members, advisory board members, and officers.

4.3.1.5 A chart of the staff organization with names and qualifications;

4.3.1.6 A description of the services to be provided by the program, including a statement of the program philosophy, goals, and objectives and a description of the methodology for each service element;

4.3.1.7 A copy of the program's complete proposed policies and procedures manual if the application is for initial licensure;

4.3.1.8 Documentation of applicable insurance coverage, including protection of the physical and financial resources of the program; coverage for all people, buildings and equipment; professional and general liability insurance; workers' compensation; fidelity bonding sufficient to cover all client funds, property and interests; and automobile insurance when vehicles owned by the program are used for client transportation;

4.3.1.9 A floor plan for any facility not previously licensed;

4.3.1.10 For residential and detoxification facilities, the maximum client capacity requested; and

4.3.1.11 A copy of the program's business license, if required.

4.3.2 Applicants applying for Deemed Status shall meet all standards as outlined in §17.0, § 18.0 and § 19.0 of these standards (as applicable).

4.3.3 Applicants shall supply all information requested on the application. The completed application shall be accompanied by a $15.00 fee in accordance with 16Del.C.§ 2205. The Division shall not consider any application until it is properly completed and payment has been received.

4.4 Application Processing

4.4.1 The Division shall determine whether an application is complete and shall notify the applicant in writing if additional information is required to complete the application or determine the applicant's compliance with these regulations.

4.4.2 The Division shall investigate and consider each completed application. An applicant for renewal shall submit its completed application at least ninety (90), but not more than one hundred and twenty (120), days before its current license expires.

4.5 Investigations and Inspections

4.5.1 By applying for or accepting a license, an applicant or licensee authorizes the Division and its representatives to conduct the inspections and investigations necessary to determine compliance with applicable licensing standards.

4.5.2 Agencies applying for licensure shall have the following information available for inspection by the Division:

4.5.2.1 Materials demonstrating compliance with all related Federal, State and local statutes, ordinances, rules and regulations [e.g., fire, health, building, American's with Disabilities Act] applicable to the facility being licensed,

4.5.2.2 A copy of the program's policies and procedures manual as required in §5.1.4;

4.5.2.3 Materials demonstrating compliance with the relevant sections of Provisions Regarding Modalities of these regulations; and

4.5.2.4 Materials demonstrating compliance with all other applicable licensing authorities and accreditation authorities when applicable.

4.5.3 Investigations and inspections may include on-site inspections of the program and its operation; inspection and copying (in accordance with 42 CFR Part 2 and HIPAA 45 CFR Parts 160 and 164) of program records, clinical records and other documents maintained by the program; and acquisition of other information, including otherwise privileged or confidential information from any other persons who may have information bearing on the applicant's or licensee's compliance or ability to comply with these regulations.

4.5.4 The Division shall review, update and when necessary, amend these regulations no less than every three (3) years.

4.6 Division Report

4.6.1 Upon completion of any inspection, the Division shall compile a Survey Summary Report citing strengths and recommendations for addressing deficiencies in meeting these standards.

4.6.2 The Division shall schedule an exit interview with each program for review of the Survey Summary Report.

4.7 Corrective action plans

4.7.1 Within ten (10) working days after the receipt of a survey summary report, the program shall submit a corrective action plan to the Division, addressing all areas where recommendations were made, unless otherwise directed by the Division.

4.7.2 The corrective action plan shall include a description of the corrective measures the program will take to address the regulation cited in the survey summary report, a target date for implementation of each corrective measure, and a description of the preventive measures implemented to ensure ongoing compliance with these regulations.

4.7.3 The Division may perform follow-up on-site inspections to review the implementation of corrective action plan(s).

4.8 Actions on applications for licensure

4.8.1 On the basis of the information supplied by the applicant and any other information acquired during its investigation and inspection, the Division may take any one of the following actions:

4.8.1.1 Issue or renew a full license for a period of up to two years when the Division determines a program is in substantial compliance with Chapter 22 of Title 16Del.C., and these regulations, and/or has been granted Deemed Status or

4.8.1.2 Issue or renew a full license for a period of up to one year when the Division determines a program is in compliance with Chapter 22 of Title 16Del.C., and these regulations;

4.8.1.3 Issue or renew a full license for a period of up to one year when the Division determines a program that has been granted Deemed Status is not in compliance withChapter 22 of Title 16Del.C. and these regulations or regulations set forth by the accreditation body; or

4.8.1.4 Issue a provisional license for up to one hundred and eighty (180) days when the program is not in compliance with Chapter 22 of Title 16Del.C., or regulations set forth by the accreditation body upon which Deemed Status has been granted (when applicable) and the applicant's failure to meet the requirements of Chapter 22 of Title 16 Delaware Code and these regulations does not jeopardize the health, safety and well-being of clients. The Division may issue one renewal of a provisional license for a period not to exceed ninety (90) days. (The Division's decision to issue a provisional license instead of a full license is final and not subject to administrative appeal;) or

4.8.1.5 Issue a temporary license for up to ninety (90) days when additional time is required by the Division to inspect or investigate theprogram, additional time is required by the applicant to undertake remedial measures or complete a corrective action plan, when the program's failure to meet the requirements of Chapters 22 and 51 of Title 16 Delaware Code, and these regulations does not jeopardize the health, safety and well-being of clients. A temporary license is not renewable and shall expire automatically without notice or hearing. (The Division's decision to issue a temporary license instead of a full or provisional license is final and not subject to administrative appeal,) or

4.8.1.6 Revoke, suspend or deny a license in accordance with §4.9 and §4.10.

4.8.2 The Division may issue a single renewal of a license, for one (1) year, without an on site inspection by the Division.

4.8.3 The Division shall notify the program by mail, phone, email or any combination of the above of its licensure decision.

4.9 Access by the Division

4.9.1 A program is subject to review, which may include on site inspection, with or without notice, by the Division.

4.9.2 The Division's right to monitor shall include complete access to all clients, staff, board members, and to all client, staff, financial and administrative program records needed for the purposes of monitoring or evaluation of the program's compliance with these regulations, financial auditing or for research. The Division may review and copy records in accordance with 42 CFR Part 2 and HIPAA 45 CFR parts 160 and 164.

4.10 Nonassignability; Change in circumstances; Posting

4.10.1 A license for the operation of a substance use program applies to both the program and the premises upon which the program operates. Licenses are not transferable, remain the property of the Division, and shall be returned upon request.

4.10.2 A program's current license shall be posted in a public place at its facility.

4.10.3 The Division issues each license on the basis of information available to it on the date the license is issued. An program or licensee shall give written notice to the Division of any change of program name, ownership, governing authority, premises or location a minimum of thirty (30) days before such change takes effect. The Division will determine within fifteen (15) days whether a new application is required.

4.10.4 Any person or entity acquiring a licensed substance use program shall apply for a new license in accordance with these regulations.

4.10.5 A licensee shall notify the Division in writing sixty (60) days prior to a voluntary closure of any program it is operating. The notice shall detail how the licensee will comply with §8.1.4.

4.10.6 The licensee shall provide written notice to clients no less than thirty (30) days prior to closure and shall make reasonable efforts to place clients in appropriate programs in compliance with §8.1.3.

4.11 Relationship to funding

4.11.1 The issuance of a license to a program is not a commitment of by the Division to fund the program.

4.12 Reasons for denial, suspension or revocation of license

4.12.1 A license may be denied, suspended or revoked for one or more of the following reasons:

4.12.1.1 When a program submits false information to the Division for licensing purposes;

4.12.1.2 When a program fails to cooperate with the Division in connection with a licensing inspection or investigation;

4.12.1.3 When a program has deviated from the category of service listed on its license;

4.12.1.4 When an applicant or program fails to be in compliance with the requirements of these regulations for the types of services for which application was made or for which the program was licensed, as outlined in §4.1.

4.12.1.5 When an applicant or program fails to implement the corrective action plan it submitted pursuant to §4.7, unless the Division approves an extension or modification of the corrective action plan;

4.12.1.6 When a program has violated any part of Title 16Del.C., Chapter 22 or these regulations;

4.12.1.7 When a program has a history of, or currently demonstrates, financial insolvency, such as

4.12.1.7.1 Filing for bankruptcy;

4.12.1.7.2 Being subjected to foreclosure, eviction for failure to pay rent, or termination of utility services for failure to pay bills; or

4.12.1.7.3 Failing to pay such taxes as employment or social security in a timely manner.

4.12.1.8 When the program is in violation of a safety or sanitation law or regulation and fails to correct the violation;

4.12.1.9 When the program, its governing body or owner participates in, condones or is associated with fraud, deceit, coercion, misrepresentation or any other illegal act;

4.12.1.10 When the program, or any of its personnel or governing body violate professional ethics;

4.12.1.11 When the program, or any of its personnel or governing body, permits, aids or abets the commission of an unlawful act within its facilities or permits, aids or abets the commission of an unlawful act involving chemical substances within the program; or

4.12.1.12 When the program, or any of its personnel or governing body, has participated in, condoned, associated with or knows or should have known and has permitted the continuation of any other practice that jeopardizes the safety or health or well being of any client.

4.13 Procedure when a license is denied, suspended or revoked

4.13.1 In accordance with 16Del.C.2208, when the Division determines that an applicant or licensee fails to meet minimum compliance with the requirements of these regulations for the types of services for which application was made or for which the program was licensed or has committed an act or engaged in conduct or practices justifying denial, suspension or revocation of licensure:

4.13.1.1 The Division shall notify the applicant or licensee by certified mail, return receipt requested, of its intent to deny, suspend or revoke the license. The "Notice of Intended Action" shall include the particular reason(s) for the proposed action and provision for a fair hearing.

4.13.2 Within ten (10) days after receipt of the "Notice of Intended Action," an applicant or licensee may request a hearing by delivering a written request to the Division Director in person or by certified mail, return receipt requested. If no such request is made within ten (10) days, the Secretary of the Department shall proceed to deny, revoke or suspend said license as set forth in the notice of proposed action.

4.13.3 Within fifteen (15) days after receipt of an applicant's or licensee's request for a hearing, the Division Director shall issue a "Notice of Hearing" to the applicant or licensee and to the public. The "Notice of Hearing" shall include a statement of the time, place and nature of the hearing, a statement of the legal authority and jurisdiction under which the hearing is to be held; a reference to the particular provisions of the statutes and rules involved; and a short and plain statement of the matters asserted.

4.13.4 All hearings conducted under this subsection shall be governed by procedures authorized by rules of the Department; the Department or its agent may take testimony concerning any matter within its jurisdiction and may administer oaths, summons or subpoenas for any witness and subpoenas duces tecum, which shall be served and returned as provided by law.

4.13.5 At the hearing, the applicant or licensee shall have the right to cross-examine witnesses against it, produce witnesses in its favor and to appear personally or by counsel.

4.13.6 All hearings shall be open to the public and a full record and transcript of the proceedings shall be prepared. The Secretary of the Department shall make a determination, which shall specify the Department's findings of fact and conclusions. A copy of the determination shall be sent by certified mail, return receipt requested, or be personally served upon the applicant or licensee.

4.13.7 Copies of the transcription may be obtained by any interested party on payment of the cost of preparing such copies.

4.14 Procedure for reinstatement of suspended or revoked license

4.14.1 If the licensee has not previously had a license revoked or suspended under these rules, it may, at any time after the suspension or revocation determination is final, request a hearing for the purpose of showing that the reasons for revocation or suspension of the license have been corrected and that the license should be reinstated.

4.14.2 No licensee who has previously had a license suspended or revoked under these rules may request a hearing to reinstate the license prior to one year after the determination becomes final.

4.14.3 The request for a hearing shall be in writing and shall be delivered to the Secretary of the Department in person or by certified mail, return receipt requested.

4.14.4 Any hearing conducted under this subsection shall not operate to stay or supersede any decision revoking or suspending a license.

4.14.5 Hearings under this subsection shall be conducted in accordance with 29Del.C.Chps. 100 and 101 and 4.13 of these regulations.

4.15 Waiver

4.15.1 An application for a waiver from a requirement of these regulations shall be made in writing to the Division's Director of Quality Assurance; it shall specify the regulation from which waiver is sought, demonstrate that each requested waiver is justified by substantial hardship, and describe the alternative practice(s) proposed. The waiver request shall be posted in a prominent place in the facility and outline a process approved by the Division whereby clients can offer comments and feedback specific to the waiver request. The Division's Director of Quality Assurance Unit shall make a recommendation of action on the application to the Division Director or designee. The Division Director or designee will review the request and recommendations and make final waiver request decisions.

4.15.2 No waiver shall be granted if such action would result in an activity or condition that would endanger the health, safety or well-being of a client.

4.15.3 A waiver granted under these regulations shall be in effect for the term of the applicant's license. If a waiver is required for an additional period of time, it shall be requested as part of the licensure renewal process in accordance with §4.15.

4.15.4 An adverse decision by the Division on a request for a waiver may be appealed in accordance with §4.13.

4.15.5 The granting of a waiver does not constitute a modification of any requirement of these regulations.

4.15.6 Licensees shall notify the Division within ten (10) working days when a waiver granted by the Division is no longer needed.

4.15.7 The Division Director may revoke a waiver when the alternative practice proposed in the application for waiver is determined to be ineffectual.

4.15.8 The Division Director may revoke the waiver when the program fails to implement the alternative practice as proposed in the application for waiver.

16 Del. Admin. Code § 6001-I-4.0

14 DE Reg. 471 (11/01/10)