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TITLE 22 - SOCIAL SECURITY TRAINING STANDARDS FOR USE OF THE AUTOMATED EXTERNAL DEFIBRILLATOR BY NON-LICENSED OR NON-CERTIFIED PERSONNEL

California Code of Regulations - Chapter 1.8 Division 9. Prehospital Emergency Medical Services

ARTICLE 1 - DEFINITIONS
¤100031 - AED Service Provider

"AED Service Provider" means any agency, business, organization or individual who purchases an AED for use in a medical emergency involving an unconscious, person who has no signs of circulation. This definition does not apply to individuals who have been prescribed an AED by a physician for use on a specifically identified individual. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.

¤100032 - Authorized Individual

"Authorized individual" means any person, not otherwise licensed or certified to use the automated external defibrillator, who has met the training standards of this chapter, and has been issued a prescription for use of an automated external defibrillator on a patient not specifically identified at the time the physician's prescription is given. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5 and 1797.190, Health and Safety Code, Section 1714.21, Civil Code.

¤100033 - Automated External Defibrillator

"Automated external defibrillator" or "AED" means an external defibrillator that after user activation is capable of cardiac rhythm analysis and will charge and deliver a shock, either automatically or by user interaction, after electronically detecting and assessing ventricular fibrillation or rapid ventricular tachycardia. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.

¤100034 - Cardiopulmonary Resuscitation

"Cardiopulmonary resuscitation" or "CPR" means a basic emergency procedure for life support, consisting of artificial respiration, manual external cardiac massage, and maneuvers for relief of foreign body airway obstruction. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.

¤100035 - Internal Emergency Response System

"Internal Emergency Response System" means a plan of action which utilizes responders within a facility to activate the "9-1-1" emergency system, and which provides for the access, coordination, and management of immediate medical care to seriously ill or injured individuals. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.

¤100036 - Prescribing Physician

"Prescribing physician" means a physician and surgeon, licensed in California, who issues a written order for the use of the automated external defibrillator to authorized individual(s). Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.

ARTICLE 2 - GENERAL - TRAINING PROVISIONS
¤100037 - Application and Scope
  1. Any physician and surgeon licensed in California may authorize an individual to apply and operate an AED on an unconscious person who has no signs of circulation only if that authorized individual has been successfully trained according to the standards prescribed by this chapter.
  2. The training standards prescribed by this chapter shall not apply to licensed, certified or other prehospital emergency medical care personnel as defined by Section 1797.189 of the Health and Safety Code. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.189, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.
ARTICLE 3 - TRAINING STANDARDS
¤100038 - Required Hours and Topics
  1. The AED training component shall comply with the American Heart Association or American Red Cross standards. The course shall consist of not less than four hours, which shall include the following topics and skills:
    1. basic CPR skills
    2. proper use, maintenance and periodic inspection of the AED;
    3. the importance of: (A) CPR, (B) defibrillation, (C) advanced life support, (D) adequate airway care, and (E) internal emergency response system, if applicable;
    4. overview of the local EMS system, including 9-1-1 access, and interaction with EMS personnel;
    5. assessment of an unconscious patient, to include evaluation of airway, breathing and circulation, to determine if cardiac arrest has occurred and the appropriateness of applying and activating an AED;
    6. information relating to defibrillator safety precautions to enable the individual to administer shock without jeopardizing the safety of the patient or the authorized individual or other nearby persons to include, but not be limited to; (A) age and weight restrictions for use of the AED, (B) presence of water or liquid on or around the victim, (C) presence of transdermal medications, and (D) implantable pacemakers or automatic implantable cardioverter-defibrillators;
    7. recognition that an electrical shock has been delivered to the patient and that the defibrillator is no longer charged;
    8. rapid, accurate assessment of the patientÕs post-shock status to determine if further activation of the AED is necessary; and,
    9. authorized individualÕs responsibility for continuation of care, such as the repeated shocks if necessary, and/or accompaniment to the hospital, if indicated, or until the arrival of more medically qualified personnel. (b) The required hours for an AED training program can be reduced by no more than two hours for students who can show they have been certified in a basic CPR course in the past year and demonstrate to a qualified CPR instructor that they are proficient in the current techniques of CPR. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.
¤100039 - Medical Director Requirements

Any AED training course for non-licensed or non-certified personnel shall have a physician medical director who: (a) Meets the qualifications of a prescribing physician. (b) Shall approve a process to ensure instructors are properly qualified to the AED instructor standards established by the American Heart Association or the American Red Cross and ensure that instructors are trained to the course content. (c) Shall ensure that all courses meet the requirements of this chapter. (d) May also serve as the "prescribing physician." Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.

¤100040 - Testing

In order for an individual to be authorized to use the AED, the individual shall pass a written and skills examination, which tests the ability to assess and manage the specified conditions prescribed in Section 100038. February 12, 2003 Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. 1 Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. 2 Section 1714.21, Civil Code.

¤100041 - Written Validation

The prescribing physician shall issue to the authorized individual a written validation or other documented proof of the authorized individualÕs ability to use an AED. The requirements for a "Written Validation" and "Prescription for Use" can both be satisfied by the issuance of a written certification card from an AED training program. The prescribing physicianÕs signature shall be on file with the AED training program authorizing the issuance of the written certification card upon successful completion of the required training. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.

ARTICLE 4 - OPERATIONAL AED SERVICE PROVIDER/VENDOR REQUIREMENTS
¤100042 - Operational Requirements
  1. An AED Service Provider shall ensure their internal AED programs include all of the following:
    1. Development of an Internal Emergency Response System which complies with the regulations contained in this Chapter.
    2. Notification of the local EMS agency of the existence, location and type of AED at the time it is acquired.
    3. That all applicable local EMS policies and procedures are followed.
    4. That expected AED users complete a training course in CPR and AED use that complies with requirements of this chapter and the standards of the American Heart Association or the American Red Cross.
    5. That the defibrillator is maintained and regularly tested according to the operation and maintenance guidelines set forth by the manufacturer, and according to any applicable rules and regulations set forth b y the governmental authority under the federal Food and Drug Administration and any other applicable state and federal authority.
    6. That the defibrillator is checked for readiness after each use and at least once every 30 days if the AED has not been used in the previous 30 days. Records of these periodic checks shall be maintained.
    7. That a mechanism exists to ensure that any person, either an employee or agent of the AED service provider, or member of the general public who renders emergency care or treatment on a person in cardiac arrest by using the service providerÕs AED activates the emergency medical services system as soon as possible, and reports any use of the AED to the local EMS agency.
    8. That there is involvement of a California licensed physician and surgeon in developing an Internal Emergency Response System and to ensure compliance with these regulations and requirements for training, notification and maintenance.
    9. That a mechanism exists that will assure the continued competency of the authorized individuals in the AED Service ProviderÕs employ to include periodic training and skills proficiency demonstrations. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.
¤100043 - AED Vendor Requirements

Any AED vendor who sells an AED to an AED Service Provider shall notify the AED Service Provider, at the time of purchase, both orally and in writing of the AED Service ProviderÕs responsibility to comply with the regulations contained in this Chapter. Note: Authority cited: Sections 1797.107 and 1797.190, Health and Safety Code. Reference: Sections 1797.5, 1797.190, and 1797.196, Health and Safety Code. Section 1714.21, Civil Code.


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