Government agencies that issue licenses have, as part of the process, the responsibility to ensure that the license holders are in compliance with applicable laws and regulations. If not, the government agency has the duty to impose appropriate disciplinary sanctions on the holder of that license. CDPHE, as the certification/licensure body for EMS providers, is responsible for ensuring that certifications/licenses are issued to individuals who have met all of the application requirements, and that EMS providers remain compliant with the regulations during the duration of the certification/licensure. The CDPHE regulations that govern EMS provider conduct permit CDPHE to discipline certified/licensed providers for good cause to ensure the public’s health, safety, and welfare. Some examples of grounds for discipline include falsifying documents, practicing outside of scope, failing to follow accepted standards of care, and committing criminal acts.
CDPHE normally becomes aware of noncompliance either through receipt of criminal history background checks or of a complaint submitted by a patient or patient’s loved ones, another oversight agency, other entities within the care system, or other EMS providers. The EMPAC is not a type 1 board like the Colorado Medical Board or Colorado Nursing Board and is not authorized to review confidential investigatory matters. And, unlike these other professional oversight bodies, CDPHE does not make disciplinary determinations concerning EMS providers through an appointed board. Instead, CDPHE staff and multiple levels of management review the information obtained during the investigation to determine whether good cause for disciplinary sanctions exists. CDPHE notifies the EMS provider of possible disciplinary action in accordance with the state Administrative Procedure Act,[72] which provides the individual with due process rights when defending against the proposed disciplinary action.
The panel recognizes that CDPHE’s investigation and disciplinary process for EMS providers is well-established and effective. Nevertheless, it recommends that CDPHE review and improve its method of investigating incidents involving waivered medications or acts by establishing a formalized, codified, objective, and impartial process. The improved process should ensure that investigations are comprehensive and should also take into consideration individual and systemic factors. Moreover, CDPHE should integrate into its investigation and review process all necessary and objective resources (such as expertise, knowledge, and experience), that are required to address and equitably resolve what are often complex medical complaints.
The panel further recommends that this improved investigation process should also include CDPHE review of EMS medical director practices. The Colorado Medical Board, as the regulatory oversight body for physicians and their medical practice, is the only body authorized to institute a disciplinary action against an EMS medical director’s license. However, to the extent CDPHE exercises oversight of these physicians as EMS medical directors, the panel believes there is value in strengthening CDPHE’s processes that assure EMS medical director accountability.
Finally, since CDPHE currently receives data and mandatory reporting information from all EMS medical directors who hold ketamine waivers, the panel recommends that CDPHE implement a formal structured investigation process for all cases warranting further review, including reported cases of severe adverse outcomes or deaths. This investigation process should commence contemporaneous to when the reports are submitted and should be proactive, looking for trends and outliers. Additionally, the process should be comprehensive and probe beyond whether protocols were followed and include, for example, whether the patient was assessed, whether ketamine was the least restrictive alternative, whether the patient was sufficiently monitored, and whether the EMS medical director performed appropriate quality assurance of the administration. Moreover, 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 the prehospital administration of any sedative.
PANEL RECOMMENDATIONS
CDPHE should review and improve its method of investigating incidents involving waivered medications or acts undertaken by EMS providers, and should expand its investigation process to include EMS medical director practices, by establishing a formalized, codified, objective and impartial process.
CDPHE should implement a formal investigation process for all severe adverse outcomes or deaths resulting from the prehospital administration of any sedative.