16 Del. Admin. Code § 4302-4.0

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

Section 4302-4.0 - Certification Process

Within 30 days of receipt of an appropriately completed application from the proposed air ambulance service, the Office will notify the applicant in writing of the approval or disapproval of the application.

4.1 Certification Approval

4.1.1 The Division will issue a certificate to operate an air ambulance service. The OEMS may conduct an on-site inspection to confirm that the applicant service is in compliance with these regulations and other applicable laws.

4.1.2 No certificate to operate an air ambulance service shall be issued unless the applicant satisfies the Division that the certification requirements for the air ambulance, medical supplies and equipment, as well as the qualifications of medical and operating personnel, as discussed herein, have been satisfied.

4.1.3 Certification will be granted only to services that meet all Federal Aviation Regulations (FAR's) specific to the operations of the air medical service.

4.1.4 A certificate will be issued for three years from the date of issue and will remain valid for that time period unless revoked or suspended by the Division.

4.1.5 The current certificate shall be posted in a conspicuous place in the air ambulance operations center and on, or in, the aircraft where it is clearly visible.

4.2 Denial of Certification

4.2.1 If the Division determines that deficiencies exist which warrant denial of the application, the air medical service shall be provided a list of these deficiencies in writing.

4.2.2 The applicant shall have 30 days from receipt of the denial notice in which to:

4.2.2.1 Respond to the Division with plans to correct the deficiencies.

4.2.2.1.1 After review of an acceptable plan, the Division will conduct a re-inspection consistent with an agreed upon time frame.

4.2.2.1.2 If the Division is satisfied with the results of the re-inspection, The Division will promptly issue a certificate of approval. If the Division determines that deficiencies still exist, the Division will give the applicant written notice of disapproval, which shall identify deficiencies. The applicant shall have 30 days from receipt of the second refusal notice in which to request a review of their application and accompanying documents by the Director of the Division of Public Health or their designee.

4.2.2.1.2.1 If the result is a denial of application, the applicant may not reapply for a period of six (6) months.

4.3 Renewal

4.3.1 The service shall submit to the Division the renewal application postmarked at least 60 days prior to the expiration date of the certificate.

4.3.2 The criteria for certification renewal are the same as the current requirements for original certification.

4.4 Inspections

4.4.1 The Division reserves the right to enter and make inspections. All services applying to provide prehospital 911 service will, at a minimum, have an initial inspection prior to execution of the required Memorandum of Agreement allowing them to commence prehospital operations.

4.4.2 Upon request of an agent of the Division during regular business hours, or at other times when a reasonable belief that violations of these regulations may exist, a certificate holder shall produce for inspection, the air ambulance, equipment, personnel and other such items as is determined by the Division's agent.

4.4.3 All records pertaining to the operation of the air medical service must be retained for a minimum of two (2) years.

4.5 Investigatory Procedures

4.5.1 Upon receipt of a written complaint describing specific violations of these regulations the Division will:

4.5.1.1 Initiate an investigation of the specific charges.

4.5.1.2 Notify the air ambulance service of the charges and investigation procedures.

4.5.1.3 Conduct and develop a written report of the investigation.

4.5.1.4 Notify the air ambulance service in writing of the results of the investigation with a request for a written response.

4.5.1.5 The Division will conduct an appropriate follow-up investigation.

4.6 Grounds for Suspension, Revocation or Refusal of an Air Ambulance Certification

4.6.1 The Division may, in compliance with proper administrative procedure as provided by law, suspend, revoke or refuse to issue certificates for the following reasons:

4.6.1.1 A serious violation of these regulations. A serious violation is one that poses a significant threat to the health and safety of the public.

4.6.1.2 Failure of the certified party or applicant to submit a plan to the Division to correct deficiencies and violations cited by the Division by the deadline requested by the Division.

4.6.1.2.1 The plan must correct the deficiencies within the timeframe specified by the Division.

4.6.1.3 The existence of a pattern of deficiencies or violations over a period of three (3) or more years.

4.6.1.4 Fraud or deceit in obtaining or attempting to obtain certification.

4.6.1.5 Lending a certificate or borrowing or using the certificate of another, or knowingly aiding or abetting the improper granting of a certificate.

4.6.1.6 Incompetence, negligence or misconduct in operating the air ambulance service or in providing emergency medical services (EMS) to patients.

4.6.1.7 Failure to employ or contract for a medical director responsible for the care provided by the air ambulance service.

4.6.1.8 Failure to have appropriate medical equipment and supplies required for certification.

4.6.1.9 Failure of the air ambulance service to have an aircraft equipped in compliance with these regulations.

4.6.1.10 Failure of the aircraft operator to maintain required FAA certifications.

4.6.1.11 Failure to employ a sufficient number of certified or licensed personnel to provide services during the time frames identified in the application and approved certification.

4.6.1.12 Failure of the air ambulance service to be available during time periods specified upon in the approved certification. Exceptions to this requirement include unsafe weather conditions, commitment to another flight, grounding due to maintenance or other reasons that would prevent commitment to another flight, grounding due to maintenance or other reasons that would prevent response. The air medical service shall maintain a record of each failure to respond to a request for service, and make the record available upon request to the Division. Financial inability to pay does not constitute sufficient grounds to deny response for emergency air service.

4.6.1.13 Failure of an air ambulance service to notify the Division of the change of ownership or aircraft operation.

4.6.1.14 Abuse or abandonment of a patient.

4.6.1.15 Unauthorized disclosure of medical or other confidential information.

4.6.1.16 Willful preparation or filing of false medical reports or records, or the inducement of another to do so.

4.6.1.17 Destruction of medical records.

4.6.1.18 Refusal to render emergency medical services because of a patient's race, sex, creed, national origin, sexual preference, age, disability, medical problem or financial inability to pay.

4.6.1.19 Misuse or misappropriation of drugs/ medications.

4.6.1.20 Failure to produce requested records for inspection or to permit examination of equipment and facilities shall be grounds for suspension, revocation or denial of certification provided, however, that not certificate shall be suspended, revoked or denied for a period not to exceed sixty days in the event that a dispute regarding the production of such records exists and remains unresolved, except that such suspension or revocation may occur within the sixty day period if the Division determines that such action is necessary to prevent a clear and immediate danger to public health.

4.6.1.21 Other reasons as determined by the Division which pose a significant threat to the health and safety of the public.

4.6.2 If the Division determines that these regulations have been violated, the Division may:

4.6.2.1 Place the service on probation until the deficiency is remedied and accepted by the Division.

4.6.2.1.1 This will include a timeframe and method by which the service must demonstrate the deficiency or violation rectified.

4.6.2.1.2 If an air medical service is unable to demonstrate that the deficiency or violation has been rectified within the specified timeframe it must submit a written progress report to the Director of Public Health requesting a deadline extension.

4.6.2.1.2.1 Failure to comply will result in the 'Probation' status being changed to 'Suspension'.

4.6.2.1.2.2 Failure to correct the deficiencies or violations within the extension period will result in suspension of the certificate.

4.6.2.2 Suspend certification for a period of up to 30 days.

4.6.2.2.1 In circumstances where an alleged violation poses an immediate threat to public health is being investigated, the certification may be suspended during the investigation.

4.6.2.2.2 The Division must investigate the violation and issue a written report containing the findings of the investigation

4.6.2.2.2.1 The report must describe the deficiencies or violations that must be corrected in order to reinstate certification.

4.6.2.2.2.2 A hearing must be scheduled within thirty (30) days of the date of suspension.

4.6.2.2.3 Upon suspension or revocation of an air ambulance certificate, the service shall cease operations and no person may permit or cause the service to continue.

4.6.2.2.4 The air medical service must correct any deficiencies identified to be an immediate danger to public health within the suspension period.

4.6.2.2.4.1 All other deficiencies or violations may be addressed in a correction plan submitted to the Division.

4.6.2.2.4.2 The status of the air medical service certificate will be changed to 'Provisional' for implementation of the corrective plan.

4.6.2.3 Revoke certification.

4.6.2.3.1 Violations or deficiencies that resulted in a 'Suspension' status and have not been rectified pursuant to the requirements of those sections will result in the revocation of the air medical service's certificate.

4.6.2.3.2 A hearing will be scheduled within thirty (30) days of the date of revocation.

4.6.2.4 Continue current certificate status.

4.6.2.5 The Division will provide public notification of their decisions involving probation, suspension-including the length of suspension period, or revocation of an air ambulance service certificate.

4.7 Reinstatement Process

4.7.1 When an air medical service has corrected a problem that has resulted in suspension or revocation of their certificate, it shall notify the Division of Public Health in writing, requesting reinstatement.

4.7.2 Based on the recommendations of the Division, a review will be arranged to verify resolution of the problem.

4.7.3 Outcomes of the review will be:

4.7.3.1 Reinstatement of certification

4.7.3.2 Continuation of suspension or revocation.

4.8 Right of Appeal

4.8.1 Any air medical ambulance service that has had their reapplication for certification denied or their certification revoked or suspended may appeal the decision.

4.8.2 Written notification of the intent to appeal must be received by the Director of Public Health within thirty (30) days of receipt of notice of such denial, suspension or revocation.

4.8.3 The Director or their designee will conduct a hearing on the Division's action.

4.8.4 Information pertinent to the case will be presented by a member of the Division's investigation committee (or the Office of EMS) and a representative of the air medical service.

4.8.5 The hearing panel will make a recommendation to the Director that the decision stand, be reversed, or modified.

4.8.5.1 Specific recommendation for modification shall be outlined.

4.8.6 The Director of Public Health will make a decision based on the hearing panel's recommendations and will provide written notification of the action to the air medical service.

4.8.7 The Division's action shall not be automatically stayed during the pendency of the appeal.

4.9 Voluntary Discontinuation of Service

4.9.1 Certified Air Ambulance Services may not voluntarily discontinue service until ninety (90) days after the certificate holder notifies the Division in writing that the service is to be discontinued.

4.9.2 The Air Ambulance Service shall notify the Division in advance of anticipated temporary discontinuation of service expected to last at least seven (7) consecutive days.

16 Del. Admin. Code § 4302-4.0

4 DE Reg. 1827 (5/1/01)
5 DE Reg. 1727 (3/1/02)