Approval and Renewal of EMS Systems

Section 515 Section 515.310  Approval and Renewal of EMS Systems a)         All applicants for EMS System approval shall submit to the Department one copy of a written EMS System Program Plan in a format approved by the Department that complies with Section 515.330 and is authorized by the EMS MD. 1)         The Plan shall clearly identify any portion or item that is not expected to be fully operational by the date of Department approval, and shall specify the expected date for full operation of such portion or item, which shall not exceed one year after Department approval has been issued. 2)         The Department will expect all portions of the proposed Plan to be fully operational upon Department approval unless otherwise identified pursuant to this Section. b)         The Department will review a submitted Program Plan and notify the applicant of any corrections that must be submitted in order to complete the Plan.  The Department will also require the applicant to submit a formal waiver request for any item or portion identified as having a delayed operational date, if the Department finds that: 1)         The item or length of operational delay has not previously been authorized by the Department for other EMS Systems; 2)         The delay would appear to prevent the System from operating in substantial compliance with the Act or this Part upon approval; or 3)         The delay would appear potentially to reduce the quality of medical/EMS care established by the Act and this Part. c)         The Department will conduct an on-site inspection of the applicant Resource Hospital within 90 days after a Program Plan has been accepted as complete. d)         The Department will issue a letter of approval to the applicant EMS System if the inspection indicates compliance with the approved Program Plan, the Act and this Part.  The letter will indicate the level or levels of service that the System is authorized to provide (CCT, ALS, ILS, BLS). e)         A System approval shall be valid for a period of four years, except as allowed in subsection (l). f)         A System seeking renewal of approval shall submit a written request to the Department at least 90 days prior to its renewal date.  The request shall include any proposed revisions to the Program Plan and updates of all letters of commitment required by Section 515.330. g)         The Department will review the request for renewal and notify the System of any corrections that must be submitted to complete the update of the Program Plan. h)         The Department will conduct an on-site renewal inspection of the Resource Hospital during each four-year approval period, and will conduct additional inspections of any System hospital or vehicle provider as necessary to ensure compliance with the Program Plan, the Act and this Part. i)          The Department will issue a letter of renewal approval to the EMS System if the Program Plan is complete, the inspection indicated substantial compliance with the approved Program Plan, the Act and this Part, and there is no Department legal action pending against the System.  The letter will indicate the level or levels of service that the System is authorized to provide (CCT, ALS, ILS, BLS). j)          An approved EMS System shall amend its Program Plan by submitting to the Department the portion or Section in which the change is proposed, along with a letter authorized by the EMS MD that describes the reason or reasons for the change.  The amendment shall not be implemented until approval has been granted by the Department. k)         Changes in any of the following shall be considered modifications of a System Program Plan requiring submission of a proposed amendment: 1)         EMS MD; 2)         Resource, Associate or Participating Hospital, or their specific roles; 3)         System service area; 4)         Written standing orders and policies; 5)         Method or methods of providing EMS services; 6)         Additional vehicle service providers, or changes in their levels of service, specific roles or response areas; 7)         Access and dispatch procedures and mechanisms; 8)         Communications plan; 9)         Equipment and drug requirements; 10)         Education, continuing education and/or examination requirements; 11)         Quality assurance policies; 12)         Data collection and evaluation policies; 13)         Override or bypass/diversion policies; 14)         Disciplinary or suspension policies or procedures. l)          All EMS Systems shall submit to the Department a revised Program Plan that conforms to the requirements of this Part.  The Department will approve Program Plans that meet the requirements of this Part and will establish renewal dates for EMS System approval.