16 Del. Admin. Code § 4301-11.0

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

Section 4301-11.0 - Designation Review

11.1 Purpose

To provide a mechanism to identify conditions that may affect public health and protect public health until the problems are resolved.

11.2 Cause

The Division of Public Health may, in compliance with proper administrative procedures as provided by the law, suspend, revoke, or refuse to issue designation certificates for any of the following reasons:

11.2.1 A serious violation of these regulations. (Defined as one that poses a significant threat to the health and safety of the public.)

11.2.2 Revocation of permit as a BLS Ambulance Service by the Delaware State Fire Prevention Commission.¹⁷

11.2.3 Failure to submit a reasonable timetable to correct deficiencies and violations cited by the Division.

11.2.4 The existence of a continuing pattern of deficiencies.

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

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

11.2.7 Incompetence, negligence, or misconduct in operating or providing ALS Interfacility Transport services. This includes but is not limited to patterns such as a failure to follow medical command or a failure to respond to a transport request.

11.2.8 Failure to employ or contract for a medical director responsible for services as outlined in this regulation.

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

11.2.10 Failure of the ALS Interfacility Transport Organization to notify the Division of Public Health of a change of ownership.

11.2.11 Abuse or abandonment of a patient.

11.2.12 Unauthorized disclosure of medical or other confidential material.

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

11.2.14 Destruction of medical records.

11.2.15 Failure to provide data to the Division of Public Health as required, either through EDIN or via report.

11.2.16 Refusal to render services on the basis of a patient's race, color, creed, gender or sexual orientation, nationality, age, or disability.

11.2.17 Misuse or misappropriation of drugs/ medications.

11.2.18 Failure to produce requested records for inspection or to permit the examination of equipment shall be grounds for suspension or revocation or the denial of certification. However the certificate shall not be suspended, revoked or denied for a period of longer than sixty (60) days in the event that a dispute regarding the production of these records exists and remains unresolved. Such suspension, revocation, or denial may occur for the entire sixty (60) day period if the Division determines that such action is necessary to prevent a clear and immediate danger to public health.

11.2.19 Conviction of the Organization or owner(s) of a crime, including Medicare or Medicaid fraud, relating adversely to the person's capability of owning or operating the Organization.

11.2.20 Non-compliance with COBRA/EMTALA.

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

11.3 Initiation

11.3.1 The Designation Review Process can be initiated by:

11.3.1.1 A written or verbal complaint indicating a violation of these regulations.

11.3.1.2 Failure to participate in data reporting.

11.3.1.3 Failure to correct deficiencies identified by the Division of Public Health.

11.4 Investigation

11.4.1 Upon initiation of the Designation Review Process the Division of Public Health will:

11.4.1.1 Receive written notification of the violation from the identifying agent accompanied by supporting documentation.

11.4.1.2 Convene an investigation panel

11.4.1.2.1 The panel will consist of the Paramedic Administrator (OEMS), the State Medical Director and any other subject matter expert deemed appropriate.

11.4.1.3 The panel will initiate an investigation of the allegation(s).

11.4.1.3.1 The ALS Interfacility Transport Organization will be notified in writing with a request for its written response.

11.4.1.3.2 The investigation panel will conduct an appropriate follow-up investigation.

11.4.1.4 The Investigation Panel will submit its report and recommendation to the Director of the Division of Public Health.

11.4.1.4.1 Panel Recommendations

11.4.1.4.1.1 The panel may recommend any of the following actions:

11.4.1.4.1.1.1 Designation Probation 11.4.1.4.1.1.1.1 The Investigation Panel will determine the recommended length of probation and include recommended conditions that must be met by the end of the probationary period. 11.4.1.4.1.1.1.2 If adopted by the Division Director, these conditions will be verified by a representative of the Division of Public Health at the end of the probationary period or at an earlier time as requested in writing by the Organization. 11.4.1.4.1.1.1.2.1 The Division of Public Health will confirm reinstatement in writing before operations may resume. 11.4.1.4.1.1.1.3 Additional infractions occurring during the probation period will result in an immediate review for Designation Suspension by the Division of Public Health. 11.4.1.4.1.1.1.4 Failure to meet the conditions will result in a review for Designation Suspension by the Division of Public Health.

11.4.1.4.1.1.2 Designation Suspension 11.4.1.4.1.1.2.1 The Investigation Panel will recommend the length of suspension and any conditions to be met for reinstatement. 11.4.1.4.1.1.2.2 If adopted by the Division Director, the Organization may not provide ALS services in Delaware for the duration of the suspension. 11.4.1.4.1.1.2.2.1 A representative of the Division of Public Health must verify that any conditions for reinstatement have been met before ALS services may be resumed. 11.4.1.4.1.1.2.2.2 The Division of Public Health will confirm reinstatement in writing before operations may resume.

11.4.1.4.1.1.3 Designation Revocation 11.4.1.4.1.1.3.1 The Investigation Panel will recommend revocation and any conditions to be met before the Organization may reapply for designation. 11.4.1.4.1.1.3.2 If adopted by the Division Director, the Organization may not provide ALS services in Delaware and may not re-apply for ALS-ITO Designation for a period of not less than one year from the date of Revocation. 11.4.1.4.1.1.3.2.1 The Division of Public Health will verify that any conditions have been met as part of the re-application process.

11.4.1.4.1.2 If probation, suspension or revocation is not recommended the Investigation Panel may recommend follow up monitoring or reporting.

11.4.1.5 The Division Director will provide written notification to the ALS Interfacility Transport Organization of the results of the investigation and the disposition of the Organization's designation.

11.4.1.6 The involved Organization will have the right to contest any decision of the Division of Public Health. Written notification of the intent to contest must be made to the Director of the Division of Public Health within thirty (30) days of notification of action.

11.4.1.6.1 The Division Director shall offer a public hearing to review the decision in accordance with 29

11.4.1.6.2 The Division Director shall name a hearing officer and schedule a hearing in accordance with 29Del.C.101.

11.5 Appeals

11.5.1 The involved Organization will have the right to appeal any decision of the Director of the Division of Public Health. Written notification of the intent to appeal must be made to the Secretary of the Department of Health and Social Services within thirty (30) days of notification of action.

16 Del. Admin. Code § 4301-11.0

4 DE Reg. 1525 (3/1/01)