The panel learned that CDPHE is authorized to collect, analyze, and process EMS data. As relevant to the panel’s review, two sources of data are collected: 1) patient care data for all EMS patient contacts, and 2) data required as a condition of an approved waiver request.
Patient Care Data for All EMS Patients.
Licensed ground and air ambulance agencies in Colorado are required to submit to CDPHE patient care data on all encounters that resulted in patient contact. As set forth above, state law does not require licensing of non-transport agencies, such as fire departments, that may also provide emergency medical services. Therefore, those unlicensed non-transport agencies cannot be required to submit patient care data to CDPHE.
Current regulations specify that patient care data be submitted as defined in the National Highway Traffic Safety Administration’s (NHTSA) Office of Emergency Medical Services, NEMSIS Data Dictionary NHTSA Version 3.4.0, EMS Data Standard, published on July 13, 2016 (NEMSIS 3.4.0).[73] The 270 data elements in this Standard are generally entered by the field EMS providers on a patient care report (PCR). A PCR is the patient’s medical record for the prehospital care received. Most EMS agencies are now utilizing computers for data entry instead of paper reports, so PCRs are now referred to as ePCRs (electronic PCRs).
Physical copies of patient care reports are not sent to CDPHE. Instead, CDPHE has acquired software that allows EMS agencies to upload their completed ePCRs to a data repository where CDPHE staff can view and analyze the data contained within the report. At present, 93% of licensed ambulance agencies are submitting NEMSIS-compliant data to the state.
The remaining agencies are non-compliant with the law and regulations requiring the submission of this patient care data. However, the data reporting laws do not provide an enforcement mechanism for non-compliant agencies, and since CDPHE does not oversee ground ambulance agencies, it has no mechanism to enforce their compliance.
Data Required as a Condition of an Approved Waiver Request.
For waivers for ketamine for excited delirium and/or extreme or profound agitation that were issued before July 6, 2021, CDPHE required EMS medical directors or their delegates to submit 40 data elements as determined by CDPHE and EMPAC, including data additional to what was reported in the ePCR. It should be noted that unlike the ePCR data mentioned above, unlicensed non-transport agencies that were approved for a waiver were required to submit waiver data to CDPHE as a condition of their waiver.
CDPHE was authorized to condition a ketamine waiver approval on the submission of additional specified data. CDPHE regulation states that if a waiver is granted, CDPHE may 1) specify the terms and conditions of the waiver, 2) specify the duration of the waiver, and 3) specify any reporting requirements.[74] CDPHE used a Google Form that allowed EMS agencies/medical directors to enter data on all uses of ketamine, including for excited delirium and/or extreme or profound agitation, pain, and RSI. These collected data on ketamine were analyzed by staff and the aggregate statistics were presented annually at an EMPAC meeting.
As set forth above in Section II.C, CDPHE staff presented the panel with data submitted from ePCRs and ketamine data collected via the waiver process, with a focus on the latter. During its presentation, staff acknowledged the limitations with this data, including:
- The intent of the data collection is to evaluate the impact of ketamine on the health, safety and/or welfare of patients. Importantly, the data are used to monitor trends and are not intended to evaluate the overall quality of care provided to the patient. The Colorado Medical Board oversees the practice of medicine, not CDPHE.
- The data are self-reported, without verification of data from multiple sources.
- Until recently, there was no established data standard or data dictionary, allowing variable interpretation of data elements.
- The data do not establish a causal link between the medication and complications or outcome.
1. Expanding Data Submission Requirements
Only licensed transport agencies are legally required to report patient care data to CDPHE. While unlicensed non-transport emergency responders (such as fire agencies) may appear at the scene of an emergency and provide care, they are not required to submit patient care data to CDPHE. Non-transport agencies are an important component of the Colorado EMS system, but they are not fully integrated into the system.
In the context of prehospital ketamine administration, a non-transport agency without a ketamine waiver was allowed to respond to assist a licensed ground ambulance agency that held a ketamine waiver. Under the existing regulatory framework, the non-transport agency is not required to provide CDPHE with a PCR. Consequently, CDPHE does not receive all of the data from all responding EMS responders concerning their encounter with a ketamine patient.
Requiring all responding agencies that provide emergency medical services to submit patient care data would inform a more complete and accurate representation of EMS care in Colorado. This change would require legislative action, however. Therefore, the panel recommends that the General Assembly consider amending the EMS statutes to require all responding agencies to submit these data to CDPHE. The panel further recommends that CDPHE immediately begin requiring non-transport agencies that receive a waiver to administer ketamine to submit PCR data as a condition of the waiver. Before the ketamine waivers for excited delirium were suspended, those agencies only submitted data on ketamine administrations via the Google Form.
2. Data Collection Improvements
Although a patient’s race/ethnicity, zip code of where the encounter occurred, and where the patient resides, are NEMSIS data elements in ePCRs, review of ePCR data shows that the patient race/ethnicity field is often not completed by field providers. Staff informed the panel that this omission frequently occurs because the patient’s medical condition does not allow for self-reporting and EMS providers are not comfortable assigning a patient a particular race/ethnicity.
As far as waivered data, “race/ethnicity” and zip codes are currently not required to be reported. Consequently, the panel recommends that CDPHE’s data collection processes be modified to 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. Staff informed the panel that they have already begun collaborating with other CDPHE divisions that are focused on equity, diversity and inclusion to determine how to train EMS providers to obtain or assign a patient’s race/ethnicity.
The required data for the ketamine waiver program have been imprecise; for example, using a catch-all element called “hypoxia” that is not well-defined and likely includes mild decreases in patient oxygenation levels is typically not considered a true complication. The panel recommends that the data dictionary for the ketamine waiver data requirements be refined so that a more meaningful assessment of complications due to chemical restraint can be made. Expanding the data submission for ketamine waiver beyond the 40 current data elements should be considered. Transitioning this data set to match the national data set used in ePCRs should improve consistency of data terms, reduce staff time and effort in cleaning data, and result in higher quality analyses.
3. Data Analysis
In the past, CDPHE has analyzed ePCR and ketamine waiver data and presented an aggregate report to the EMPAC each year. As mentioned, these data have been used to monitor trends but not for formal research purposes. Most importantly, the data were not intended to evaluate the overall quality of care provided to the patient.
The panel recommends that CDPHE and EMPAC more actively monitor trends in ketamine data usage for system improvement activities. Understanding that privacy and confidentiality laws play a critical role in determining which data can be released to external entities or individuals (including EMPAC, whose members are considered external under confidentiality laws), the panel recommends that the laws governing CDPHE data collection and release be reviewed and revised as necessary to allow CDPHE to provide meaningful data for system improvement while at the same time maintaining patient confidentiality.
One significant law applicable to data collection and analysis requires CDPHE to oversee a continuing quality improvement system (CQI) for the statewide emergency medical and trauma services (EMTS) care system.[75] The law grants CDPHE expansive access to prehospital, hospital, and coroner records of EMTS patients to assess the CQI system for Colorado.[76] However, the law also requires that all information provided shall be confidential; the law states that CQI system data or information related to “the identification of individual patient’s, provider’s, or facility’s care outcomes collected” and “records or reports collected or compiled” as a result of the CQI system are confidential, exempt from Colorado’s open records law, not subject to subpoena or discovery, and are not admissible in any civil action.[77]
Data submission and analysis have greatly advanced since this law was enacted over 20 years ago. At the time, the stringent confidentiality requirements were seen as necessary to protect patients, practitioners, agencies and facilities from negative disclosures and to assure these individuals and entities that CDPHE would carefully protect their data and use the data only for system-wide improvements. Unfortunately, the statutory language has thwarted the EMS system’s need for meaningful data, and significantly limits which data can be shared externally. Moreover, since CDPHE staff are the only ones who can access the data, CDPHE cannot utilize the external subject matter experts available on its advisory councils or in the community at large to provide the level of expertise needed for CQI activities.
The law should be modified to allow CDPHE to release more meaningful data to subject matter experts and the EMTS community while still protecting confidentiality so that CDPHE can comply with its systemic CQI responsibilities. Therefore, the panel recommends that CDPHE engage with the EMTS community and propose that the General Assembly amend the statewide CQI law so as to allow the release of more meaningful data while still protecting confidentiality as appropriate.
PANEL RECOMMENDATIONS
The General Assembly should consider amending the EMS statutes to require all responding agencies to submit ePCR data to CDPHE. The panel further recommends that CDPHE require non-transport agencies that receive a waiver to administer ketamine to submit ePCR data as a condition of the waiver.
CDPHE should modify its data collection processes to 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.
CDPHE should standardize the required submitted data elements between the national ePCR system and the local ketamine waiver data as well as improve data definitions through a review of the data dictionary so that current terms such as hypoxia represent meaningful and important complications of chemical restraint.
The laws governing CDPHE data collection and release should be reviewed and revised as necessary to allow CDPHE to provide meaningful data for system improvement while at the same time maintaining patient confidentiality.
CDPHE should require that enforcement language be added to the waiver requirements for data submission to assure it receives quality data from all agencies using ketamine.