ISSUE #1: SIERRA COUNTY
Recommended Action:
• Accept the 36-month report on Sierra County’s EMT-II Modular Trial Study.
• Approve continuation of the study until the revisions to the EMT-I Regulations take effect (anticipated to be about October 22, 2004).
• Once the EMT-I Regulation revisions take effect, approve a modification to the Sierra County EMT-II Modular Trial Study to include only intravenous lines and administration of 50% dextrose and require 18-month reporting intervals until the EMT-II Regulations are revised.
Fiscal Impact:
None.
Discussion:
Initiated in 1995, the current study involves EMT-Is utilizing intravenous infusion of normal saline and the administration of intravenous glucose, glucagon, albuterol, aspirin, narcan and subcutaneous epinephrine. The EMT-Is also utilize the EMT-I optional skills of endotracheal intubation, Combitube, and automated external defibrillation. Since 1995, two of the five services participating in the study have upgraded to paramedic services.
According to the 36-month report, during the course of the study 72 EMT-II Modular Trial Study cases were reported. The Medical Review Committee deemed all 72 cases appropriate. Nine of the 72 patients received an advanced life support procedure that was credited with saving the patient’s’ life. Twenty-four of the 72 patients received an advanced life support procedure(s) that made a significant improvement without which the patient condition would probably have further deteriorated. The report also states that Northern California EMS has received inquiries from 5 other EMS provider agencies within Northern California’s 11-county jurisdiction that are interested in the trial study and thus, the release of the final EMT-I Regulations.
Once the EMT-I Regulations take effect, the EMT-Is participating in this study will transition to the new optional scope of practice in the regulations. However, Northern California EMS has also requested that the EMT-Is participating in this trial study be allowed to continue the utilization of intravenous lines and administration of 50% dextrose by modifying this trial study until the EMT-II Regulations are revised. If this is approved, they have requested that the Commission on EMS eliminate the requirement for any further trial study reports. They also recommended that the EMT-II Regulations be revised and changed to an EMT-II Modular training program.
It is the EMS Authority’s recommendation that the Sierra County EMT-II Modular Trial Study be approved for continuation until the EMT-I Regulation revisions take effect at which time the EMT-Is could transition to the EMT-I optional scope of practice specified in the EMT-I Regulations. Under this optional scope of practice, EMT-Is would only be able to establish intravenous access under the direct supervision of a California licensed paramedic. The EMS Authority recommends approval of modification of the trial study to include only intravenous lines and administration of 50% dextrose upon the effective date of the EMT-I Regulations and continuation of the modified trial study until the EMT-II Regulations are revised but only if the 18-month reporting intervals are maintained as required by regulation.
ISSUE #2: SANTA BARBARA COUNTY
Recommended Action:
• Accept the 18-month report on Santa Barbara County’s EMT-II Modular Trial Study.
• Approve continuation of the study until the EMT-I Regulation revisions take effect.
Fiscal Impact:
None.
Discussion:
In June 2002, the EMT Expanded Scope Trial Study was approved for three fire agencies in Santa Barbara County. The expanded scope included utilization of a multi-lumen airway, automated external defibrillator and glucometer and the administration of albuterol, nitroglycerin, epinephrine, naloxone, and glucagon.
The purpose of the study was to assess if 72 hours of training is adequate for expanded scope skills performance. Findings indicated that the protocols were chosen correctly 86% of the time and incorrectly 14% of the time.
The majority of patients who received expanded scope procedures and/or medications had maintained (80%) or improved (12%) conditions during EMS care. The average expanded scope patient contact time prior to the arrival of advanced life support was 2.17 minutes.
Results of the study indicate that 72 hours of training may not be adequate for the expanded scope skills performed. The two areas that require additional hours are documentation and patient assessment skills. Therefore, it is the recommendation of Santa Barbara County EMS that expanded scope training be increased from 72 hours to 86 hours with an additional 12 hours included for more comprehensive documentation and patient assessment skills. It is also recommend that there be an additional 12 hours of required annual continuing education training specific to expanded scope skills, along with a mandatory annual skills refresher.
Santa Barbara County EMS has requested, and the EMS Authority recommends, continuation of the study until the revised EMT-I Regulations take effect.
ISSUE #3: RIVERSIDE COUNTY
Recommended Action:
• Accept the 18-month report on Riverside County EMS Agency’s Trial Study on the Use of the Melker Kit for Emergency Cricothyrotomy in Riverside County
• Approve continuation of the trial study for an additional 6 months.
Fiscal Impact:
None.
Discussion:
In February 2003, the EMS Authority approved the initiation of an 18-month trial study by Riverside County EMS utilizing the Melker Emergency Cricothyrotomy Catheter Kit to perform needle cricothyrotomy in the field. Because of the multiple steps required to place an airway when using a Melker Kit, EMSA requested that skills retention be monitored.
According to the 18-month report, eleven advanced life support services in the county participated in the trial study. Only two providers were able to successfully meet the every six months skills review, though most met the requirement within a month of the six-month time frame. Other mandatory and voluntary training was cited as the reason for difficulty in meeting the six-month skills review time frame.
In the 18 months of the study, the needle cricothyrotomy procedure was used once. With only one incidence of use, Riverside County is requesting a six-month extension of the study because additional investigation is needed to determine the efficacy of this procedure. The EMS Authority recommends continuation of the study for another six months.
ISSUE #4: CENTRAL CALIFORNIA EMS AGENCY
Recommended Action
• Receive notification of approval for a trial study regarding the oversight of Emergency Medical Technician-II personnel.
Fiscal Impact:
None.
Discussion:
On March 16, 2004, Tulare County joined the Central California EMS Agency (Agency) bringing EMT-II personnel under the jurisdiction of the Aency. In evaluating the system of oversight of EMT-IIs, the Agency found inconsistencies and shortcomings in the hospital-based oversight program. Consequently, in May 2004, the Agency submitted to the EMS Authority a request for approval for a trial study to evaluate and observe the EMT-II system under a more modern continuous quality improvement system and compare the performance of
EMT-IIs and paramedics.
The trial study request was reviewed by the members of the Scope of Practice Committee of the Emergency Medical Directors’ Association of California on June 22, 2004. The Committee members recommended approval of the study. The EMS Authority approved the study on July 2, 2004. Initiation of the study is scheduled for October 1, 2004.
ISSUE #5: LOS ANGELES COUNTY
Recommended Action:
• Receive notification of withdrawal of Los Angeles County’s participation in the Polyheme Trial Study.
Fiscal Impact:
None.
Discussion:
On October 23, 2003, the EMS Authority approved requests by San Diego and Los Angeles Counties to conduct a trial study entitled, “Protocol Number RTBSE-11-(N): A Phase III, Randomized, Controlled, Open-Label, Multicenter, Parallel Group Study Using Provisions for Exception from Informed Consent Requirements Designed to Evaluate the Safety and Efficacy of Poly SFH-P Injection (Polymerized Human Hemoglobin (Pyridoxylated), Polyheme) When Used to Treat Patients in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Prehospital Setting”. The study is an industry-sponsored study and has been approved by the Food and Drug Administration and is planned to be instituted at about 20 sites nationwide.
In July 2004, the EMS Authority received a letter from Dr. William Koenig, EMS Medical Director for Los Angeles County, asking that the Los Angeles County Polyheme Trial Study be removed from the list. Withdrawal of the study has been requested at this time because Dr. Marc Eckstein is no longer a Principal Investigator for the study. If a determination is made to proceed with the study in the future, a reapplication will be submitted to the EMS Authority.
Enclosures
