During its investigation, the panel learned that EMPAC, CDPHE’s advisory council, provides technical expertise on matters related to the provision of patient care by EMS providers. It also learned about the process for requests for waivers to the scope of practice rules for paramedics (see “Colorado’s Waiver Process”). The waiver requests are submitted to CDPHE, reviewed by staff, reviewed by the EMPAC and recommended for action, and then formally acted upon by CDPHE.
One of EMPAC’s primary duties is to advise or make recommendations to CDPHE regarding the acts and medications that EMS providers at each level of certification or licensure are authorized to perform or administer under the direction of a physician medical director.[66] These authorized acts and medications are set forth in CDPHE rule as the scope of practice for each level of EMS provider. EMS providers can only perform those acts and medications that are authorized in Colorado’s scope of practice; therefore, EMS providers face disciplinary action if they perform acts or administer medications that are outside of their scope.
As previously noted, CDPHE’s ketamine waiver program for excited delirium and extreme agitation is currently suspended. However, prior to July 6, 2021, the medical director would initiate a waiver request allowing the use of ketamine by submitting an application to CDPHE prior to the next quarterly meeting of EMPAC. The applications required EMS medical directors to develop the protocols and standing orders the EMS provider must follow when performing or administering the waived acts and medications. Protocols describe what medical conditions a medication is used for, the complications and contraindications a medication may have, and the steps the EMS provider must follow when administering the medication. By developing specific protocols that direct EMS personnel how to provide in-scope or waivered acts and medications, EMS medical directors determine the standard of care for their EMS providers.
Besides protocols, EMS medical directors were also required to submit the following information in the application:
- medications/medical acts to be waived;
- indications warranting use of the medications and patient age range;
- EMS provider level, supervision (independent, supervised), and setting (prehospital, and/or interfacility transfer);
- authorization (verbal order, written order, standing order);
- justification of need;
- literature review;
- training plan and instructor information; and
- quality improvement process.
CDPHE staff reviewed the waiver application packets for completeness but, because they are not medical experts, did not perform a qualitative review of the documents. Staff forwarded complete waiver application packets to the EMPAC members. Each packet was reviewed by two EMPAC members, one of whom is an EMS physician, prior to the EMPAC meeting.
At the EMPAC meeting, each waiver application was presented for discussion so that EMPAC members could determine whether it demonstrates a sufficient educational and training platform to ensure the waivered act can be safely performed. The EMS medical director waiver applicant was required to attend the meeting and answer any questions the EMPAC members may have. Following review and discussion, the EMPAC members voted to recommend that the waiver request be approved, denied, or tabled by CDPHE. EMPAC’s recommendations were then forwarded to the CDPHE’s Health Facilities and EMS Division’s Director and the Chief Medical Officer for review and determination of approval, denial or tabling. The length of time a waiver remained in effect was recommended by EMPAC, with the ultimate determination made by CDPHE. Under that process, ketamine waivers were generally issued for a period of three years.
Approved ketamine waiver requests had conditions attached to them, including a reporting requirement. Approved waiver requests for ketamine for excited delirium and/or extreme or profound agitation required the EMS agency/medical director to submit a report to CDPHE within seven days after each administration of ketamine, or within 24 hours if the administration resulted in an adverse outcome or death. CDPHE compiled and presented this data to EMPAC annually. The waiver request approval letter from CDPHE informed the applicants that, if they failed to submit the required data or were otherwise out of compliance with the waiver conditions, their waivers may be suspended or revoked. Thus, although the EMPAC has no direct authority over EMS medical directors, it could recommend conditions for the waiver and, if a medical director was non-compliant with those conditions, could recommend that the waiver be suspended or revoked.
With a few recent exceptions, CDPHE has not been notified of potential medical director non-compliance regarding ketamine waivers. Once notified, CDPHE could open an investigation. Otherwise, CDPHE was required to rely on its review of the self-reported data from the EMS medical directors/agencies for concerning incidents or trends.
As part of the panel’s investigative process, staff reviewed ketamine waiver applications for excited delirium and/or extreme or profound agitation that were submitted to CDPHE over the last three years. The review indicated that the applications showed variability in the content of the application materials, including in the protocols, training requirements, and quality assurance methods. These results partially reflect the fact that CDPHE does not regulate EMS ground ambulance agencies and has never required their medical director applicants to follow a state-mandated protocol. However, CDPHE and EMPAC did develop guidance documents that they expected EMS medical directors to consult when drafting protocols concerning their providers’ administration of ketamine for excited delirium and/or extreme or profound agitation, as well as for pain and RSI. (See Appendix G)
PANEL RECOMMENDATIONS
If a ketamine waiver program for chemical restraint is developed, CDPHE and EMPAC should establish protocols for the administration of ketamine for chemical restraint based on the findings of this panel and recommend that those protocols be utilized by all EMS medical directors applying for a waiver.
CDPHE should require all medical directors who apply for, receive, and operate under ketamine waivers for chemical restraint to supplement their waiver documents in compliance with any updated guidance that EMPAC and/or CDPHE issues during the effective term of the medical directors’ waivers.
Waiver applicants should verify that the EMS medical director and paramedics have completed required training in racial equity and explicit/implicit bias, transfer of care guidelines/opportunities, verbal de-escalation, and patient hand-off.
CDPHE and EMPAC should develop a standardized review tool for EMPAC members to use when reviewing waiver applications.
CDPHE and EMPAC should consider shortening the waiver term – currently set for three years – for ketamine use for chemical restraint.