I. INTRODUCTION

II. REQUESTS FOR PROCEDURES AND MEDICATIONS BEYOND THE BASIC SCOPE OF PRACTICE

A. Frequency of Review
B. Legal Issues
C. Submission of Requests - Undefined Scope of Practice
Category I
Category II
Category III
D. Non-Invasive Diagnostic Procedures
F. Training and Competency Testing

III. TRIAL STUDIES REQUEST FOR APPROVAL-UNDEFINED SCOPE OF PRACTICE

CURRENT COMMITTEE MEMBERSHIP

I. INTRODUCTION

The purpose of these guidelines is to explain the law and regulations regarding procedures and medications which are used by EMT-Paramedics, and to explain the process for requesting additions to the basic scope of practice.

The only procedures and medications which may be used by EMT-Ps are those which are part of the basic scope of practice as defined in regulations, those which are approved by the EMS Authority as part of the undefined scope of practice, or those which are done as part of a trial study as approved by the Authority.

Pursuant to the provisions of AB 2159 (1989), the Scope of Practice Committee (SOPC) of the Emergency Medical Services Medical Directors Association of California (EMDAC) reviews requests and makes recommendations to the Authority regarding additions to the undefined scope of practice (HSC 1797.172 (c)).

This document may be applied to the application process for Local EMS agencies wishing to add items to the scope of practice of EMT-IIs (HS 1797.171 (c)). Although the use of Categories for skills and procedures for EMT-IIs will not apply at this time, the process for requests is identical.

II. REQUESTS FOR PROCEDURES AND MEDICATIONS BEYOND THE BASIC SCOPE OF PRACTICE

A. Frequency of Reviews

Submissions for review by the EMS Authority may be made at any time during the year. Reviews by the SOPC will be done at quarterly intervals, as needed. Packages will be reviewed at the next scheduled meeting of the Committee following receipt of a complete package. If a package is submitted less than thirty days before the next meeting, there may be inadequate time for review.

For Category I requests, only one (1) copy is necessary for submission to the EMS Authority. For Category II requests, ten (10) copies of the submission should be sent to facilitate the review process.

B. Legal Issues

The paramedic scope of practice within a jurisdiction should only include those items in the EMT-P Basic Scope of Practice and those formally approved in writing by the EMS Authority. Items not approved, or those denied, by the EMS Authority should not be used. Submission of a request to the EMS Authority to use a medication or procedure should not be considered approval to begin using the drug or procedure. Use of items not approved poses a liability issue for the local EMS Agency. It is recommended that training, purchase of equipment, or other implementation strategies not be done until approval is received. This eliminates potential waste of time and money in the event the procedure of medication is denied or implementation is delayed.

C. Submission of Requests - Undefined Scope of Practice

The Health and Safety Code requires that any skill or procedure beyond the basic scope of practice be reviewed by the EMDAC SOPC and approved by the EMS Authority before it is implemented. Local EMS agencies must submit a Request for Approval - Undefined Scope of Practice (Form EMSA-0391) to the EMS Authority to add any medications and procedures beyond the basic scope of practice. The medications and procedures approved by the EMS Authority are based on the treatment protocols and the indications as submitted by the local EMS agency. If a local EMS agency utilizes a particular modality for a different role or indication than originally submitted, the EMS Authority must be notified. If a local EMS agency discontinues the use of a procedure or medication, the EMS Authority must be advised. To facilitate a review of each medication and procedure requested, the SOPC divided all skills and procedures identified in an initial survey several years ago into three categories.

Category I

Category I items have demonstrated efficacy in prehospital care. The committee recommended to the EMS Authority that the items in this first category be approved for addition to the undefined scope of practice for EMS agencies if requested by that agency. If a local EMS agency wishes to add one of these modalities, it must submit a request to the Authority. Specifically, policies and procedures to be instituted regarding use, medical control, treatment protocols, quality assurance, and training and competency testing must be included with the request. Requests for items in this category must be accompanied by a Request for Approval - Undefined Scope of Practice with item 8 (Description of training and competency) completed.

The following items are defined as falling within Category I:

• Pediatric endotracheal intubation
• Adult nasotracheal intubation
• Needle cricothyrotomy
• Glucagon
• Procainamide
• KCl ó 40 meq
• Rectal administration of medications (e.g., diazepam)
• Adenosine
• Intraosseous infusions
• Magnesium sulfate
• Verapamil
• Aspirin

Category II is defined as items which are controversial as to their efficacy in prehospital care. The committee felt that items in this category required further documentation by the local EMS agencies implementing them to ensure that they were both safe and efficacious. Only after review of this additional data, would the SOPC be able to make a recommendation on whether to approve it.

Requests for items in this category must be accompanied by a Request for Approval - Undefined Scope of Practice with all items completed.

• Carotid sinus massage
• Mannitol
• Nitrous oxide

Category III items are felt by the committee to generally lack any apparent efficacy or usefulness in the prehospital setting. It was felt by the committee that items placed in this category would not generally be recommended by them as part of the undefined scope of practice. Agencies do have the right to carefully document the rationale for the use of these treatments in the field and may request use of these items. Requests for items in this category must be accompanied by a Request for Approval - Undefined Scope of Practice with all items completed.

Items in this category are:

• Aminophylline
• Dexamethasone
• Hydrocortisone
• Hydroxyzine hydrochloride
• Meperidine hydrochloride
• Metaraminol bitartrate
• Methylprednisolone
• Norepinephrine
• Phenobarbital
• Rotating tourniquets

The Authority has determined that the use of non-invasive diagnostic procedures does not require approval by the SOPC or the Authority. These items presently include:

• Pulse oximetry
• Determination of blood glucose by devices such as the Glucometer after fingerstick
• End-tidal CO2 monitoring

E. Airway Management Issues

Approval for the use of topical vasoconstrictor agents (e.g. neosynephrine) during nasotracheal intubation is not required. However, training on its use should be done as part of the training in nasotracheal intubation for Category I.

The use of the Combitube device for esophageal (and possibly endotracheal) intubation is allowed as part of the basic scope of practice. This device allows the EMS Medical Director to determine which methodology for airway management is appropriate for their circumstances. This device is a different methodology to perform intubation (esophageal or endotracheal). Use of the Combitube does not require approval or review by EMDAC or the EMS Authority. EMT-IIs may use both topical vasoconstrictor agents and the Combitube.

Training and competency testing for this device is required as in all other procedures or medications as part of the basic or undefined scope of practice.

F. Training and Competency Testing

Training and testing, as required to ensure competence, in procedures and drugs approved as part of the undefined scope of practice should be part of the application process (CCR 100144 (b)(14)). Appropriate documentation concerning training should accompany the application and be available for review.

III. TRIAL STUDIES

Items not defined in the basic scope of practice or EMT-P curriculum should be either part of the undefined scope of practice or a trial study (HSC 1797.221). The procedure for trial study submission is found in Title 22, Chapter 4, Section 100145, California Code of Regulations.

Example of trial studies:

• Blood Administration
• IV Heparin
• Nitroglycerin

Questions concerning whether an item should be considered as part of the undefined scope of practice or a trial study have been raised. The Scope of Practice Committee is consulted about new individual items when that skill or medication is proposed. As a general guideline, if the skill or procedure is generally accepted for use in the prehospital setting it should be considered for use as part of the undefined scope of practice. If an item is not extensively used in the prehospital setting or the item's use in the prehospital setting is questionable or experimental, then it would probably be best submitted as a trial study. A few past examples have been added to clarify this thinking.

In the case of a request for high dose epinephrine, neither a request for the undefined scope of practice nor a trial study was required. Since epinephrine is already part of the basic scope of practice, and the EMS Authority and the Scope of Practice Committee do not approve specific dosages, then the local EMS Medical Director could make that determination without a request. Some therapies or procedures fall under the undefined scope of practice rather than as a trial study. For example, administration of Diazepam rectally is beyond the basic scope of practice and a request should be submitted as part of the undefined scope. Although Diazepam is included in the basic scope of practice, rectal administration is not currently taught in the basic EMT-P curriculum. Also, many items such as pediatric endotracheal intubation, adenosine administration, and others are widely accepted for use in the prehospital care system nationwide. With respect to trial studies, several modalities may be continued at this time until further information on their safety and efficacy in the prehospital setting can be obtained. Blood administration, intravenous Heparin and intravenous Nitroglycerin have been considered appropriate for past trial studies.

Trial studies are identified in the existing paramedic regulations on implementation and reporting to the State EMS Commission. If in doubt, the EMS Authority should be contacted to obtain the latest information.

EMS MEDICAL DIRECTOR:

DATE:

LOCAL EMS AGENCY:

NAME OF PROPOSED PROCEDURE OR MEDICATION:

1. DESCRIPTION OF THE PROCEDURE OR MEDICATION REQUESTED:

2. DESCRIPTION OF THE MEDICAL CONDITIONS FOR WHICH THEY WILL BE UTILIZED:

3. ALTERNATIVES (Please describe any alternate therapies considered for the same conditions and any advantages and disadvantages):

4. PATIENT POPULATION THAT WOULD BENEFIT, INCLUDING AN ESTIMATE OF FREQUENCY OF UTILIZATION:

5. OTHER FACTORS OR EXCEPTIONAL CIRCUMSTANCES:

PLEASE ATTACH:

6. ANY SUPPORTING DATA INCLUDING RELEVANT STUDIES AND MEDICAL LITERATURE.

7. RECOMMENDED POLICIES/PROCEDURES TO BE INSTITUTED REGARDING USE, MEDICAL CONTROL, TREATMENT PROTOCOLS, AND QUALITY ASSURANCE OF THE PROCEDURE OR MEDICATION.

8. DESCRIPTION OF THE TRAINING AND COMPETENCY TESTING REQUIRED TO IMPLEMENT THE PROCEDURE OR MEDICATION.

EMSA-0391, Rev. 1/94