This section contains recommendations associated with oversight of EMS medical directors as well as recommendations pertaining to CDPHE and its advisory council, the Emergency Medical Practice Advisory Council (EMPAC).
In Colorado, the oversight of EMS medical directors is split among three separate entities: 1) the EMS ground ambulance agency that, as the county licensee, is required to have a medical director; 2) CDPHE, which regulates EMS medical directors as to minimum standards and medical direction oversight requirements; and 3) the Colorado Medical Board, which is authorized to oversee physician medical licensure.
This fragmented oversight system of EMS physician medical directors can, in some instances, result in inconsistent delivery of prehospital medical care and can result in a lack of EMS medical director accountability. The panel members believe that addressing this lack of standardization is an important factor in creating system-wide alignment in, and accountability for, the assessment of persons with behavioral health needs and the potential for ketamine use in the prehospital setting. Therefore, the panel recommends that CDPHE request the legislature to consider whether ground ambulance agency licensing should occur at the state, rather than county, level (see Recommendation D.5). If state regulation is authorized, the panel recommends that CDPHE supplement its regulatory requirements that govern EMS medical directors to improve accountability and to establish standardized patient care in the prehospital setting.
D.1 Panel Recommendation: EMS Medical Directors - Certification and Oversight Requirements
The panel recommends that EMS medical directors:
- Complete a CDPHE-approved training program for EMS medical directors.
- Obtain a certification from CDPHE to serve in the role of an EMS medical director. This certification may be at risk if the medical director is not in compliance with waiver requirements.
- Collaborate with other Colorado EMS medical directors regarding professional matters, including the development of protocols and standards.
- Engage with the EMS agency’s Regional Emergency Medical and Trauma Services Advisory Council (RETAC), including its Regional Medical Director.
D.2 Panel Recommendation: EMS Medical Directors - Protocols
The protocols for ketamine use for chemical restraint developed by EMS medical directors should encompass, at minimum, the following recommendations established by this panel:
- Indications for Chemical Restraints (See also Recommendation B.1)
- Verbal de-escalation (See also Recommendation C.2)
- Police Interaction, Transfer of Care (Hand-off), and Medical Decisions on Scene (See also Recommendation C.3)
- Dosing consistent with Recommendation B.3
- Monitoring consistent with Recommendation B.4
- Accurate patient care reporting, including recording patient race/ethnicity (See also Recommendation D.7)
D.3 Panel Recommendation: EMS Medical Directors - Quality Assurance
The panel recommends that EMS medical directors incorporate the following quality assurance improvements in their agencies:
- Conduct chart reviews of all administrations of ketamine and perform periodic audits comparing electronic patient care reports (ePCRs) to CDPHE ketamine reporting forms.
- Regularly review and monitor data and trends in data for disproportionate impacts on marginalized communities.
- Require full compliance with data reporting requirements.
- Review video and/or audiotapes of paramedic verbal de-escalation attempts, when available.
- Collaborate with local law enforcement organizations to the extent possible to implement joint incident review with body cam footage and any other relevant information.
D.4 Panel Recommendation: CDPHE and EMPAC - Waiver Review and Waiver Requirements
To promote consistency in and sufficiency of required waiver application content, CDPHE and EMPAC should develop a standardized review tool for EMPAC members to use when reviewing ketamine waiver applications for chemical restraint, potentially including a scoring rubric.
CDPHE and EMPAC should consider shortening the waiver term for ketamine use for chemical restraint.
Whenever EMPAC issues updated material guidance concerning ketamine use for chemical restraint, CDPHE should require medical directors who hold existing ketamine waivers to supplement their waiver documents to comply with the updated guidance.
Ketamine waivers should be in compliance with the applicable components of the panel recommendations, specifically:
- Patient-side care: dosing, monitoring
- Paramedic training
- Protocols (indications, verbal de-escalation, police interaction, transfer of care [hand-off], medical decisions, dosing, and monitoring)
- Quality Assurance (QA) and Quality Improvement (QI)
CDPHE should make ketamine waivers contingent upon the requirements that EMS medical directors:
- verify that they and their providers have completed training in racial equity and explicit/implicit bias;
- prove and/or attest that guidelines/protocols for paramedics involving transfer of care, verbal de-escalation and patient hand-off training requirements for paramedics have been satisfied; and
- prove and/or attest that their agencies have conducted or, in the alternative, attempted to conduct transfer of care guidelines training with local law enforcement.
D.5 Panel Recommendation: CDPHE - Ground Ambulance Agency Licensing
In all but two states, ground ambulance agencies are licensed at the state level. Colorado is one of the two exception states since licensing occurs at the county level. CDPHE should request the legislature to consider whether ground ambulance agency licensing at the state level would allow for more uniform standards, protocols and regulatory oversight throughout the state in order to assure appropriate consumer protections.
D.6 Panel Recommendation: CDPHE - Comprehensive Investigation Process
The panel recommends that CDPHE:
- Review the current investigation process for incidents involving waivered medications or acts to ensure that this process is formalized, codified, objective, impartial, and inclusive of parameters to evaluate potential bias in outcomes.
- Ensure investigations are comprehensive and take into consideration both individual and systemic factors.
- Examine whether its existing investigation process provides the needed expertise, knowledge, and experience to address complex medical complaints, as is the case in other state regulatory arenas, e.g., Board of Nursing.
- Implement a standardized internal review process on ketamine reports it receives that indicate severe adverse outcomes or death, and require EMS medical directors to submit additional information as needed by CDPHE. CDPHE should implement a formal structured investigation process for cases warranting further review and should ensure that its review encompasses all aspects of the incident.
- Although the panel’s scope of review is limited to ketamine, it also recommends that CDPHE consider extending this review and investigation process to all severe adverse outcomes or deaths resulting from sedatives that EMS providers administer in the prehospital setting.
D.7 Panel Recommendation: CDPHE - Data
The panel understands that data are essential for analyzing trends and determining whether system improvements in the ketamine waiver program are necessary. To this end, the panel recommends:
- expanding the types of entities that should submit data;
- establishing additional data elements;
- making the data elements consistent with the information already submitted through ePCRs; and
- actively monitoring trends and making trend information available to the public.
Additional entities to submit data:
- Currently only licensed transport agencies have to report patient care data to CDPHE. While unlicensed non-transport emergency responders may appear at the scene of an emergency (such as fire agencies), they are not required to submit patient care data. The legislature should consider requiring all responding agencies to submit this data to CDPHE.
- CDPHE should require all non-transport agencies that receive ketamine waivers to submit ePCR data.
Additional data elements to be submitted:
- CDPHE’s data collection processes should capture race/ethnicity and zip code information in order to analyze whether there is disproportionate use of chemical restraint for marginalized persons and communities of color in Colorado.
Consistency with ePCR data set:
- CDPHE should explore transitioning the current elements collected for the waiver process to mirror the elements collected as part of the national data set for patient care reports.
System improvement activities and transparency:
- CDPHE and EMPAC should actively monitor trends in ketamine data usage for system improvement activities.
- CDPHE’s statutes governing data collection and release should be reviewed and revised as necessary to allow CDPHE to provide meaningful data for system improvement while maintaining confidentiality.
D.8 Panel Recommendation: CDPHE - Referrals to the Colorado Medical Board
The panel recommends that, to the extent a CDPHE investigation of a complaint from any source about an EMS medical director raises concerns about the physician’s performance as an EMS medical director, CDPHE should make a referral to the Colorado Medical Board.
D.9 Panel Recommendation: CDPHE - Written Policies and Regulations
The panel recommends that CDPHE develop written policies and regulations as applicable for the panel recommendations contained in this report, including requirements for a ketamine waiver, investigation of complaints received for alleged waiver violations, enforcement actions that may be taken, and remedies that may be imposed for violations.