16 Del. Admin. Code § 3330-3.0

Current through Register Vol. 28, No. 5, November 1, 2024

Section 3330-3.0 - Licensure Requirements and Procedures

3.1 General Requirements

3.1.1 No person shall establish, conduct or maintain in this State any dialysis center without first obtaining a license from the Department.

3.1.2 A license issued hereunder shall be subject, at any time, to revision or revocation by the State.

3.1.3 A license is not transferable from person to person, entity to entity or from one location to another.

3.1.4 The license shall be posted in a conspicuous place on the licensed premises, at or near the entrance in a manner which is plainly visible and easily read by the public.

3.1.5 Separate licenses are required for dialysis centers maintained in separate locations, even though operated under the same management.

3.1.6 Any dialysis center that undergoes a modification of ownership and control is required to re-apply as a new dialysis center and must meet the current design and construction standards recognized by the Department.

3.1.7 The submission of an application is in no way a guarantee that the completed application will be accepted or that a license will be issued by the Department.

3.1.8 Patients shall not be admitted to a dialysis center until a license has been issued.

3.1.9 The dialysis center shall advise the Department in writing at least 30 calendar days prior to closure of the dialysis center and voluntary surrender of a license.

3.1.10 The dialysis center shall notify the Department in writing at least 30 calendar days prior to adding/removing a service or modifying the station count.

3.2 Application Process

3.2.1 All persons or entities wanting to apply to open a dialysis center shall submit to the Department the following information:

3.2.1.1 A Statement of Intent describing the services to be offered at the dialysis center;

3.2.1.2 A completed application for licensure;

3.2.1.3 The names, addresses and types of facilities previously and currently owned or managed by the applicant;

3.2.1.4 Identity of:

3.2.1.4.1 Each officer and director of the corporation, if the entity is organized as a corporation;

3.2.1.4.2 Each general partner or managing member, if the entity is organized as an unincorporated entity;

3.2.1.4.3 The governing body; and

3.2.1.4.4 Any officers/directors, partners, or managing members, or members of a governing body who have a financial interest in a licensee's operation or related business.

3.2.1.5 Proof of not-for-profit status, if claiming tax-exempt status;

3.2.1.6 Disclosure of any officer, director, partner, employee, managing member or member of the governing body with a felony criminal record;

3.2.1.7 Name of the director and the person designated to act in the absence of the director;

3.2.1.8 A list of management personnel, including credentials;

3.2.1.9 A plan for providing orientation, continuing education, and training for personnel or contractors during the first year of operation;

3.2.1.10 Policy and procedure manuals; and

3.2.1.11 Any other information required by the Department.

3.3 Issuance of Licenses

3.3.1 Initial License

3.3.1.1 An initial license shall be issued for a period of three (3) calendar months to those applicants who meet the requirements for licensure.

3.3.1.2 Once an initial license has been issued, the dialysis center may begin to offer services to patients.

3.3.1.3 All dialysis centers shall have an on-site survey, conducted by the Department, during the first three (3) calendar months of operation.

3.3.1.3.1 If the dialysis center meets the licensure requirements, as contained within these regulations, is in operation and caring for patients at the time of the initial on-site survey, an annual license for the remainder of the licensure year will be issued.

3.3.1.3.2 Facilities that, at the time of the on-site survey, do not meet the definition of a dialysis center or that are not in substantial compliance with these regulations will not be granted a license.

3.3.1.4 An initial license may not be renewed.

3.3.2 Provisional License

3.3.2.1 A provisional license shall be granted, for a period of less than one year, to all dialysis centers that:

3.3.2.1.1 Are not in substantial compliance with these rules and regulations; or

3.3.2.1.2 Fail to renew a license within the timeframe prescribed by these regulations.

3.3.2.2 The Department shall designate the conditions and the time period under which a provisional license is issued.

3.3.2.3 A provisional license may not be renewed unless a plan of correction for coming into substantial compliance with these rules and regulations has been approved by the Department and implemented by the dialysis center.

3.3.2.4 A license will not be granted pursuant to subsection 3.3.2 after the provisional licensure period to any dialysis center that is not in substantial compliance with these rules and regulations.

3.3.3 Annual License

3.3.3.1 An annual license shall be granted, for a period of one year (12 months) to all dialysis centers which are and remain in substantial compliance with these rules and regulations.

3.3.3.2 A license shall be effective for a twelve (12) month period following the date of issue and shall expire one year following such date, unless it is:

3.3.3.2.1 Modified to a provisional license;

3.3.3.2.2 Suspended;

3.3.3.2.3 Revoked; or

3.3.3.2.4 Surrendered prior to the expiration date.

3.3.3.3 All applications for renewal of licenses shall be filed with the Department at least thirty (30) days prior to the expiration date of the license.

3.3.3.4 Dialysis centers which have not been inspected/surveyed during a licensure year may apply for, and be issued, a new license until an inspection/survey is completed.

3.3.3.5 A license may not be issued to a dialysis center which is not in substantial compliance with these regulations or whose deficient practices present an immediate threat to the health and safety of its patients.

3.4 Disciplinary Sanctions

3.4.1 The Department may impose sanctions singly or in combination when it finds a licensee or former licensee has:

3.4.1.1 Violated any of these regulations;

3.4.1.2 Failed to submit a reasonable timetable for correction of deficiencies;

3.4.1.3 Failed to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department;

3.4.1.4 Exhibited a pattern of cyclical deficiencies which extends over a period of 2 or more years;

3.4.1.5 Engaged in any conduct or practices detrimental to the welfare of the patients;

3.4.1.6 Exhibited incompetence, negligence or misconduct in operating the dialysis center in providing services to patients;

3.4.1.7 Mistreated or abused patients cared for by the dialysis center;

3.4.1.8 Violated any statutes relating to medical assistance or Medicare reimbursement for those facilities who participate in those programs; or

3.4.1.9 Refused to allow the Department access to the dialysis center or records for the purpose of conducting inspections/surveys/investigations as deemed necessary by the Department.

3.4.2 Disciplinary sanctions include any of the following:

3.4.2.1 Permanent revocation of a license which extends to:

3.4.2.1.1 The dialysis center;

3.4.2.1.2 Any owner;

3.4.2.1.3 Officers/directors, partners, managing members or members of a governing body who have financial interest of 5% or more in the dialysis center; or

3.4.2.1.4 Corporation officers.

3.4.2.2 Suspension of a license;

3.4.2.3 A letter of reprimand;

3.4.2.4 Placement on provisional status with the following requirements:

3.4.2.4.1 Report regularly to the Department upon the matters which are the basis of the provisional status;

3.4.2.4.2 Limit practice to those areas prescribed by the Department; and/or

3.4.2.4.3 Suspend operations.

3.4.2.5 Refusal of a license;

3.4.2.6 Refusal to renew a license;

3.4.2.7 Other disciplinary action as appropriate.

3.4.3 The Department may request the Superior court impose a civil penalty of not more than $10,000 for a violation of these regulations. Each day a violation continues constitutes a separate violation.

3.4.3.1 In lieu of seeking a civil penalty, the Department, in its discretion, may impose an administrative penalty of not more than $10,000 for a violation of these regulations. Each day constitutes a separate violation.

3.4.3.2 In determining the amount of any civil or administrative penalty imposed, the Court or the Department shall consider the following factors:

3.4.3.2.1 The seriousness of the violation, including the nature, circumstances, extent and gravity of the violation and the threat or potential threat to the health or safety of the patient;

3.4.3.2.2 The history of violations committed by the person or the person's affiliate, agent, employee or controlling person;

3.4.3.2.3 The efforts made by the dialysis center to correct the violation(s);

3.4.3.2.4 Any misrepresentation made to the Department; and

3.4.3.2.5 Any other matter that affects the health, safety or welfare of a patient.

3.4.4 Imposition of a disciplinary action

3.4.4.1 Before any disciplinary action is taken the following shall occur:

3.4.4.1.1 The Department shall give 20 calendar days written notice to the holder of the license, setting forth the reasons for the determination;

3.4.4.1.2 The disciplinary action shall become final 20 calendar days after the mailing of the notice unless the licensee, within such 20-calender-day period, shall give written notice of the dialysis centers desire for a hearing;

3.4.4.1.3 If the licensee give such notice, the dialysis center shall be given a hearing before the Secretary of the Department or his/her designee and may present such evidence as may be proper;

3.4.4.1.4 The Secretary of the Department or his/her designee shall make a determination based upon the evidence presented.

3.4.4.1.5 A written copy of the determination and the reasons upon which it is based shall be sent to the dialysis center;

3.4.4.1.6 The decision shall become final 20 calendar days after the mailing of the determination letter unless the licensee, within the 20-calender-day period, appeals the decision to the appropriate court of the State.

3.4.5 Order to immediately suspend a license

3.4.5.1 In the event the Department identifies activities which the Department determines present an immediate jeopardy or imminent danger to the public health, welfare and safety requiring emergency action, the Department may issue an order temporarily suspending the licensee's license, pending a final hearing on the complaint. No order temporarily suspending a license shall be issued by the Department, with less than 24 hours prior written or oral notice to the licensee or the licensee's attorney so that the licensee may be heard in opposition to the proposed suspension. An order of temporary suspension under this section shall remain in effect for a period not longer than 60 calendar days from the date of the issuance of said order, unless the suspended licensee requests a continuance of the date for the final hearing before the Department. If a continuance is requested, the order of temporary suspension shall remain in effect until the Department has rendered a decision after the final hearing.

3.4.5.2 The licensee, whose license has been temporarily suspended, shall be notified forthwith in writing. Notification shall consist of a copy of the deficiency report and the order of temporary suspension pending a hearing and shall be personally served upon the licensee or sent by mail, return receipt requested, to the licensee's last known address.

3.4.5.3 A licensee whose license has been temporarily suspended pursuant to this section may request an expedited hearing. The Department shall schedule the hearing on an expedited basis provided that the Department receives the licensee's written request for an expedited hearing within 5 calendar days from the date on which the licensee received notification of the Department's decision to temporarily suspend the licensee's license.

3.4.5.4 As soon as possible, but in no event later than 60 calendar days after the issuance of the order of temporary suspension, the Department shall convene a hearing on the reasons for suspension. In the event that a licensee, in a timely manner, requests an expedited hearing, the Department shall convene within 15 calendar days of the receipt by the Department of such a request and shall render a decision within 30 calendar days.

3.4.5.5 In no event shall an order of temporary suspension remain in effect for longer than 60 calendar days unless the suspended licensee requests an extension of the order of temporary suspension pending a final decision of the Department. Upon a final decision of the Department, the order of temporary suspension may be vacated in favor of the disciplinary action ordered by the Department.

3.5 Application for licensure after revocation or voluntary surrender of a license in avoidance of revocation action

3.5.1 The application for license after termination of rights to provide services shall follow the procedure for the initial licensure application.

3.5.2 In addition to the initial licensure application, the dialysis center must also submit and obtain approval of a detailed plan of correction regarding how the dialysis center intends to correct the deficient practices that led to the original termination action. Submission of evidence supporting compliance with the plan of correction and cooperation with Department monitoring during initial licensure status is required for reinstatements to full licensure status.

3.5.3 Upon successful completion of the initial licensure period, the dialysis center will be granted a provisional license for a period of no more than 1 year. The provisional period will be identified by the Department after having considered the circumstances that created the original action for license revocation.

3.5.4 A license will be granted to the dialysis center after the provisional licensure period if:

3.5.4.1 The dialysis center has remained in compliance with these rules and regulations; and

3.5.4.2 The dialysis center fulfilled the expectations of the detailed plan of correction that was created to address the deficient practices that gave rise to the license termination action.

3.5.5 A license will not be granted after the provisional licensure period to any dialysis center that is not in compliance with these rules and regulations.

3.6 Modification of Ownership and Control (MOC)

3.6.1 Any proposed MOC must be reported to the Department in writing a minimum of 30 calendar days prior to the change.

3.6.2 A MOC occurs whenever the ultimate legal authority for the responsibility of the dialysis center's operation is transferred.

3.6.3 A MOC voids the current license in possession of the dialysis center.

3.6.4 A MOC will be treated as an initial license and the dialysis center must meet the current design and construction standards recognized by the Department.

3.6.5 A MOC may include but is not limited to:

3.6.5.1 Transfer of the dialysis center's legal title;

3.6.5.2 Transfer of the full ownership rights;

3.6.5.3 Transfer of the majority interest;

3.6.5.4 Transfer of ownership interest that results in the owner with the majority interest becoming a minority interest owner;

3.6.5.5 Transfer or re-organization that results in an additional majority interest that is equal in ownership rights;

3.6.5.6 Transfer resulting in a measurable impact upon the operational control of the dialysis center;

3.6.5.7 Dissolution of any partnership that owns a controlling interest in the dialysis center;

3.6.5.8 Merger of a dialysis center owner (a corporation) into another corporation where, after the merger, the owner's shares of capitol stock are cancelled; or

3.6.5.9 The consolidation of a corporate dialysis center owner with one or more corporations.

3.6.6 Transactions which do not constitute an MOC include, but are not limited to the following:

3.6.6.1 Changes in the membership of a corporate board of directors or board of trustees;

3.6.6.2 Two or more corporations merge and the originally licensed corporation survives;

3.6.6.3 Changes in the membership of a non-profit corporation; or

3.6.6.4 Corporate stock transfers or sales that do not result in a transfer of interest or ownership.

3.6.7 Applications for licensure, as a result of an MOC must include a description of:

3.6.7.1 Any actual or anticipated change in the health care services provided before the MOC;

3.6.7.2 Any actual or anticipated change in staff, including the composition of staff;

3.6.7.3 Any actual or anticipated change in the policies and procedures; and

3.6.7.4 Any change in the manner of delivery of health care services.

3.7 Fees. Fees shall be in accordance with 16 Del.C. § 122(3) aa.

3.8 Inspection. A representative of the Department shall periodically inspect every dialysis center for which a license has been issued under this chapter. Inspections by authorized representatives of the Department may occur at any time and may be scheduled or unannounced.

16 Del. Admin. Code § 3330-3.0

22 DE Reg. 853( 4/1/2019) (final)