6 Colo. Code Regs. § 1015-3-2-12
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1015-3-2-12 - Waivers to Scope of Practice for EMS Providers in Prehospital Settings12.1 Any EMS agency medical director may apply to the Department for a waiver to the scope of practice set forth in these rules for EMS providers under his or her supervision in specific circumstances, based on established need, provided that on-going quality assurance of each EMS provider's competency is maintained by the medical director. Waivers to scope of practice are limited to prehospital settings.12.2 A waiver is not necessary for the allowed medical acts listed in Appendices A, B, C, or D of this rule.12.2.1 In addition to the medical acts allowed in Section 12.2, a P-CC does not require a waiver for the allowed medical acts listed in Appendices E and F.12.2.2 In addition to the medical acts allowed in Section 12.2, a P-CP does not require a waiver for the allowed out-of-hospital medical services listed in Appendix G when providing medical services in a CIHCS agency setting.12.3 All levels of EMS provider may, under the supervision and authorization of an EMS agency medical director, perform specific skills or administer specific medications not listed in Appendices A, B, C, D, E, or F of this rule, only if the EMS agency medical director has been granted a waiver from the Department for that specific skill or medication. 12.3.1 Waivered skills or medication administration may be authorized by the EMS agency medical director under standing orders or direct verbal orders of a physician, including by electronic communications.12.3.2 No EMS provider shall function beyond the scope of practice identified in these rules for their level until their EMS agency medical director has received official written confirmation of the waiver being granted by the Department.12.4 EMS agency medical directors seeking a waiver shall submit a completed application to the Department in a form and manner determined by the Department. 12.4.1 The application shall include, but not be limited to, a description of the act or medication to be waived, information regarding the justification for the waiver, the proposed education, training, and quality assurance process, literature review, and copies of the applicable protocols. The forms and affidavit required by Section 5 of these rules shall also be included.12.4.2 The Department may require the applicant to provide additional information if the initial application is determined to be insufficient.12.4.3 An application shall not be considered complete until the required information is submitted.12.4.4 The completed waiver application shall be submitted to the Department in a timely fashion as specified by the Department.12.4.5 The application shall be a matter of public record and is subject to disclosure requirements under the Colorado Open Records Act (Section 24-72-200.1et seq., C.R.S.).12.5 The EMPAC shall review waiver requests and make recommendations to the Department. The EMPAC may make recommendations, including but not limited to: deny, approve, table, request more information from the EMS agency medical director, or impose special conditions on the waiver.12.6 After receiving recommendations from the EMPAC, the Department shall make a decision on the waiver request and send notice of that decision to the EMS agency medical director within thirty (30) calendar days of the recommendation. If granted, the notice shall include the effective date and expiration date of the waiver. 12.6.1 If the waiver is granted, the Department may:A) Specify the terms and conditions of the waiver.B) Specify the duration of the waiver.C) Specify any reporting requirements.12.6.2 The Department may require the submission of data or other information regarding waivers.A) Unless otherwise specified by the Department, any data or information submitted to the Department shall not contain patient-identifying information.B) If the Department requires submission of data or reports containing patient-identifying information for purposes of overseeing a statewide continuing quality improvement system, that information shall be kept confidential pursuant to Section 25-3.5-704(2)(h)(I)(E), C.R.S.C) If the Department requires submission of data, information, records, or reports related to the identification of individual patient's, provider's, or facility's care outcomes for purposes of overseeing a statewide continuing quality improvement system, that information shall be kept confidential pursuant to Section 25-3.5-704(2)(h)(II), C.R.S.12.6.3 The Department may deny, revoke, or suspend a waiver if it determines: A) That its approval or continuation jeopardizes the health, safety, and/or welfare of patients.B) The EMS agency medical director has provided false or misleading information in the waiver application.C) The EMS agency medical director has failed to comply with conditions or reporting on an approved waiver.D) That a change in federal or state law prohibits continuation of the waiver.12.7 If the Department denies a waiver application or revokes or suspends a waiver, it shall provide the EMS agency medical director with a notice explaining the basis for the action. The notice shall also inform the EMS agency medical director of his or her right to appeal and the procedure for appealing the action.12.8 Appeals of Departmental actions shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, et seq., C.R.S.12.9 If the rule pertaining to a waived medical act is amended or repealed obviating the need for the waiver, the waiver shall expire on the effective date of the rule change. 12.10 If an EMS agency medical director has made timely and sufficient application for renewal of a waiver and the Department fails to take action on the application prior to the waiver's expiration date, the existing waiver shall not expire until the Department acts upon the application. The Department, in its sole discretion, shall determine whether the application was timely and sufficient.12.11 In the case of exigent circumstances, including but not limited to the death or incapacitation of an EMS agency medical director or the termination of the relationship between a EMS agency medical director and an EMS service agency, the Department may transfer waivers upon request by a replacement EMS agency medical director for a period not to exceed six (6) months. The EMS agency medical director shall then apply for new waiver(s) for consideration and Department action within sixty (60) days of the transfer.37 CR 12, June 25, 2014, effective 5/21/201437 CR 12, June 25, 2014, effective 7/15/201437 CR 22, November 25, 2014, effective 12/15/201438 CR 24, December 25, 2015, effective 1/14/201640 CR 10, May 25, 2017, effective 7/1/201740 CR 20, October 25, 2017, effective 1/1/201840 CR 21, November 10, 2017, effective 1/1/201841 CR 23, December 10, 2018, effective 1/14/201943 CR 22, November 25, 2020, effective 1/1/202144 CR 23, December 10, 2021, effective 12/30/202145 CR 10, May 25, 2022, effective 6/14/2022