SAMPLE. Automated External Defibrillator. Standard Operating Procedures. Updated February 2010

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1 SAMPLE Automated External Defibrillator Standard Operating Procedures Updated February 2010 Special thanks to Jim Emerson of EMT 2000 for sharing his plan with the County of Ventura Emergency Medical Services Agency.

2 INTRODUCTION This program brings together state and local regulations, policies, procedures, training requirements and standards, and medical direction required for establishment of the (Your City/Agency name here) Automated External Defibrillator (AED) Program. All employees authorized to perform AED will do so only after approval and with the authorization of (Your Medical Director name here), AED Medical Director for the (Your City/Agency name here). All initial and subsequent AED training will be performed by the (Your AED Training Institution name here). This program will be reviewed by the Ventura County Emergency Medical Services Agency, (Your Medical Director name here) and a representative of the (Your City/Agency name here). By educating, training, and equipping AED operators at various specified locations throughout the (Your City/Agency name here), we have developed an early cardiac care system in attempt to reduce the morbidity and mortality associated with sudden cardiac death. It has been proven that defibrillation can be effective when delivered to the victim of sudden cardiac death as quickly as possible. Our goal is to have life-saving personnel and equipment at the side of a cardiac arrest victim in 3 minutes or less.

3 TABLE OF CONTENTS Section 1 Definitions 2 Compliance with Title 22 Regulations for AED Providers 3 Medical Control Plan 4 Training Guidelines 5 Internal Response and Operational Plan 6 Location of AEDs 7 Authorized AED Operators 8 Memorandums A. (Your AED Equipment name here) AED Operations Guide B. County of Ventura EMS Lay Rescuer AED Program Standards Policy C. AED Good Samaritan Law D. Title 22., Division 9., Chapter 1.8. Lay Rescuer Automated External Defibrillator Regulations

4 SECTION 1 DEFINITIONS Audits are a medical review conducted by the AED Coordinator or Medical Director for an AED use. Lay Rescuer means any person, not otherwise licensed or certified to use the automated external defibrillator, who has met the training standards of this Chapter. 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. Automated External Defibrillator Coordinator is the individual identified by the Medical Director who has certain responsibilities delegated to him or her from the Medical Director. 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 is not breathing. This definition does not apply to individuals who have been prescribed an AED by a physician for use on a specifically identified individual. 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. Case Reviews are a continuing education program conducted by the Medical Director or his designee in which actual run sheets of patient care are reviewed with AED providers. Pre hospital care, in hospital care & patient outcomes are discussed. Internal Emergency Response System means a written Internal Emergency Response 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. Medical Control is the communication of medical direction by the Medical Director to any authorized individual. Medical Director means a physician and surgeon, currently licensed in California, who provides medical oversight to the AED Service Provider as set forth in Section Medical Protocols are the specific care protocols for the authorized individuals when using an AED. Professional BCLS is Basic Cardiac life support training for health care providers that includes one and two person CPR. Response Time is the time from time of dispatch to arrival at scene. Survival is discharge from the hospital with or without neurological deficit.

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6 SECTION 2 COMPLIANCE WITH TITLE 22 REGULATIONS FOR PAD PROVIDERS Article 2. General Training Provisions Application and Scope. (a) Any training program, AED Service Provider or vendor may authorize a Lay Rescuer to apply and operate an AED on an unconscious person who is not breathing only if that Lay Rescuer has successfully completed a CPR and AED course according to the standards prescribed by this chapter. (Your Medical Director name here) is the Medical Director for the (Your City/Agency name here) AED program. All training for the authorized individuals and employees that are volunteering to participate in the AED Program will be administered by (Your Training Institution name here) using (AHA or ARC) Guidelines. (b) The training standards prescribed by this chapter shall apply to employees of the AED service provider and not to licensed, certified or other prehospital emergency medical care personnel as defined by Section of the Health and Safety Code. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , , , and , Health and Safety Code. Section , Civil Code. All training as described in this AED Program will be administered to non-licensed or non-certified (laypersons) authorized individuals and employees. Article 3. AED Training Program Requirements Required Topics and Skills. (a) CPR and AED training shall comply with the American Heart Association or American Red Cross CPR and AED guidelines. The training 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) early activation of Emergency Response Plan, (B) early CPR, (C) early defibrillation, (D) early advanced life support, and (E) internal emergency response plan, if applicable; (4) overview of the local EMS system, including access, and interaction with EMS personnel;

7 (5) assessment of an unconscious patient, to include evaluation of airway and breathing, to determine 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 Lay Rescuer 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 patient s post-shock status to determine if further activation of the AED is necessary; and, (9) the responsibility for continuation of care, such as continued CPR and the repeated shocks, as indicated, until the arrival of more medically qualified personnel. (b) The Lay Rescuer shall maintain current CPR and AED training, as prescribed in this Chapter. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , , and , Health and Safety Code. Section , Civil Code. Each AED operator will be certified according to (Your Training Institution name here) Heartsaver AED program guidelines consisting of: strengthening early access, early CPR, early defibrillation links in the chain of survival and combined CPR/AED training Testing CPR and AED training for Lay Rescuers shall include a competency demonstration of skills on a manikin, directly observed by an instructor which tests the specified conditions prescribed in Section Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , , and , Health and Safety Code. Section , Civil Code Medical Director Requirements Any AED service provider shall have a physician Medical Director who: (a) Meets the qualifications of a Medical Director per Section of this Chapter. (b) Shall ensure that AED Service Provider Lay Rescuer CPR and AED training meets the requirements of this Chapter. (c) Shall review each incident where emergency care or treatment on a person in cardiac arrest is rendered and to ensure that the Internal Emergency Response Plan, along with the CPR and AED standards that the Lay Rescuer was trained to, were followed. (d) Is involved in developing an Internal Emergency Response Plan and to ensure compliance for training, notification and maintenanceas set forth in this Chapter.

8 Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , , and , Health and Safety Code. Section , Civil Code. (Your Medical Director name here) is the Medical Director for the (Your City/Agency name here) AED program and will meet the criteria defined by this regulation. Article 4. AED Service Provider Operational Requirements AED Service Provider Operational Requirements. (a) An AED Service Provider shall ensure their internal AED programs include all of the following: (1) Development of a written Internal Emergency Response Plan which describes the procedures to be followed in the event of an emergency that may involve the use of an AED and complies with the regulations contained in this Chapter. The written Internal Emergency Response Plan shall include, but not be limited to, immediate notification of 911 and trained office personnel at the start of AED procedures. (2) Maintain AEDs in working order and maintain current protocols on the AEDs. (3) That all applicable local EMS policies and procedures are followed. (4) That Lay Rescuers complete a training course in CPR and AED use and maintain current CPR and AED training that complies with requirements of this Chapter at a minimum of every two years and are familiar with the Internal Emergency Response Plan. (5) For every AED unit acquired up to five units, no less than one Lay Rescuer per AED unit shall complete a training course in CPR and AED use that complies with the requirements of this Chapter. After the first five AED units are acquired, one Lay Rescuer shall be trained for each additional five AED units acquired. AED Service Providers shall have Lay Rescuers who should be on site to respond to an emergency that may involve the use of an AED unit during normal operating hours. (6) 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 by the governmental authority under the federal Food and Drug Administration and any other applicable state and federal authority. (7) 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. (8) That a mechanism exists to ensure that any person, either a Lay Rescuer as part of the AEDService Provider, or member of the general public who renders emergency care or treatment on a person in cardiac arrest by using the service provider s AED activates the emergency medical services system as soon as possible, and reports any use of the AED to the Medical Director and the local EMS agency.

9 (9) That there is involvement of a currently licensed California physician and surgeon that meets the requirements of Section of this Chapter. (10) That a mechanism exists that will assure the continued competency of the CPR and AED trained individuals in the AED Service Provider s employ to include periodic training and skills proficiency demonstrations. Note: Authority cited: Sections and , Health and Safety Code. Refernce: Sections , , , and , Health and Safety Code. Section , Civil Code (Your City/Agency name here) AED program will adhere to the operational requirements of these regulations as described in the following Sections of our Standard Operating Procedures.

10 SECTION 3 MEDICAL CONTROL PLAN AED AUDIT AND REVIEW A. The AED Coordinator or Medical Director shall review each AED use for at least the following criteria: a. How was the call for help received b. Witnessed arrest verbally documented on AED device c. Bystander CPR verbally documented on AED device d. Response time to scene e. Appropriate use of the AED f. Equipment properly and quickly setup according to protocol g. Patient's pulse was checked according to protocol h. Authorized Individual properly identified and gives verbal report i. First shock delivered within 90 seconds of initiation of use j. Adequate Basic Life Support maintained k. Reassessment adequate following every shock l. All protocols followed m. Time care was transferred to Advanced Life Support personnel noted on audio n. Appropriate transfer of care to ALS o. Data properly transferred to Medical Control AED REVIEW A. When electrodes are applied and the AED is turned on, together these shall constitute "Use of the AED." After any use of the AED, the AED provider will do the following: 1. Immediately notify AED Coordinator 2. Immediately complete "(Your City/Agency name here) AED Activation Report Form" 3. AED Coordinator will a. Transfer the data to medical control computer by direct connection or modem and print hard copy report. b. Forward copies of all data to (Your AED Training Institution name here), Medical Director and the local EMS Agency. c. Retain a copy of the medical services report form (trip sheet)

11 4. Failure of the AED provider to comply with this section may result in counseling and retraining. 5. The review may be done by telephone for any AED use where protocol was followed, proper analysis was made, and no shock was advised. 6. Within 7 days of use of the AED, the AED Coordinator and/or the Medical Director will contact the Lay Rescuers involved to arrange for an AED review. The review is designed to give the Lay Rescuer feedback on performance of the crew and the AED. The patient outcome will also be discussed. 7. When appropriate, the AED Coordinator and/or the Medical Director will review all information about the call in person with the lay rescuers. CORRECTIVE ACTION FOR DEFICIENCIES A. Any deficiency identified by the AED Coordinator shall be promptly brought to the attention of the Medical Director. The AED Coordinator and the Medical Director will decide on a case-by-case basis what action should be taken on any deficiency identified. B. All deficiencies in personnel performance will be addressed during the AED review with the Lay Rescuers involved. The Medical Director will make the final decision as to when remedial training is necessary for any Lay Rescuer, and requirements of such training. C. All deficiencies in machine performance shall be handled on a case-by-case basis by the (YOUR CITY/AGENCY NAME HERE) with the assistance of the manufacturer's representative if necessary. 1. If the machine is found to be malfunctioning, the AED Coordinator shall be contacted immediately and an incident report will be completed and forwarded to the Medical Director. 2. If the machine is found to be malfunctioning, the AED Coordinator will place the AED unit out of service until it can be repaired or replaced by the Service representative. 3. A maintenance log shall be maintained by the (YOUR CITY/AGENCY NAME HERE) on all machine deficiencies. The log and all incident reports relating to machine performance will be reviewed during the annual AED System Review.

12 MAINTENANCE OF AED EQUIPMENT Each Lay Rescuer shall make a commitment to assuring the equipment is in proper working order. The "Automated Defibrillators: Operator's Shift Checklist" shall be completed weekly and after each AED use. All operator checklists are to be kept on site with each AED. Each site will have an assigned AED operator(s) to complete the weekly checklist on the first working day of each week. ANNUAL AED SYSTEM REVIEW A. Once every year, the (YOUR CITY/AGENCY NAME HERE) shall prepare a report that will contain at least the following: 1. Summary data on use and survivability. 2. Response times on all cardiac arrests and AED uses. 3. Personnel deficiencies in the operation of the AED. 4. AED machine deficiencies. 5. Any trends identified through the AED Medical Control Program. 6. All deviations from protocol. B. Once every year, (YOUR CITY/AGENCY NAME HERE) shall administer a site review of each individual site. Determination of the need for any additional AED sites shall be included in the report. RECORD KEEPING All recorded information, including training and activation reports, will be kept on file by the (YOUR CITY/AGENCY NAME HERE). All records will be readily available to the Medical Director and the (Your City/Agency name here) Human Resources Office. AED PROTOCOLS A. Any deviation from this protocol shall be reported to on-line medical control as soon as radio or telephone contact is made. B. Any deviation from this protocol shall be reported to the (YOUR CITY/AGENCY NAME HERE) using a patient report and the AED computer download immediately after use of the AED. C. All AED machines are to be programmed to the current AHA protocols.

13 SECTION 4 TRAINING GUIDELINES Instructor training requirements All initial and refresher training to be administered by (Your AED Training Institution name here) personnel. All primary AED instructors are certified as AED Instructors. Copies of instructors qualifications and certificates will be on file with the (YOUR CITY/AGENCY NAME HERE) AED Coordinator. Initial training requirements CPR and AED training shall comply with the American Heart Association or American Red Cross CPR and AED standards or equivalent training that utilizes these standards. Record keeping and training documentation Records will be maintained for initial training, instructor training, and continuing education training by the (Your AED Training Institution name here). All training records will be kept for three years. Copies are to be furnished to the (Your City/Agency name here) Human Resources liaison. An updated list of current AED Operators will be forwarded quarterly to the (Your City/Agency name here) Human Resources liaison by the (YOUR CITY/AGENCY NAME HERE) Teaching and training materials (Your Training Institution name here) Heartsaver AED for the Lay Rescuer & First Responder. (Your Training Institution name here) Heartsaver AED for the Lay Rescuer & First Responder Instructor s Tool Kit. This Kit includes Instructor s Manual, Video Tape, Slides, Overheads, Scenarios, etc. Except for the AED training device, all training materials, such as mannequins, are to be supplied by the (Your AED Training Institution name here). The (Your City/Agency name here) shall supply AED training devices.

14 RESPONSE PLAN SECTION 5 INTERNAL RESPONSE & OPERATIONAL PLAN Upon ANY request for medical assistance, the Automated External Defibrillator and personal protective equipment should accompany the rescuer to the scene or be brought to the scene with minimum delay. 911 should be accessed immediately. While responding to a call for help, mentally review the proper steps to be taken if the patient is in cardiac arrest. There should be as little delay as possible in responding to a medical call for help. Upon arriving on the scene, make sure the scene is safe. If not safe, either make it safe or wait for EMS to arrive. Prior to assessing the patient, the AED operators shall protect themselves by putting on medical gloves. 2 pairs of gloves are to be kept with each AED. Eye protection should be worn in the event of blood or other bodily fluids. Assess the patient. If the patient meets defibrillation criteria, immediately proceed according to the operational plans. AED OPERATIONAL PROCEDURES Patient care and AED Operator PATIENT CRITERIA for AED equipment use: Patient assessment, care and treatment are to be used in conjunction with the AED equipment and actions. If obvious death criteria are present, resuscitation should not be started and the AED operator equipment should not be applied. If the victim is pulseless and not breathing from an obvious traumatic situation, CPR should be initiated and the AED should NOT be used. If the patient meets all of the following patient criteria, the AED Operator shall apply the AED equipment to the patient for analysis: Unconscious; Pulseless; Not breathing or agonal respirations; 8 years of age or over (Program Medical Director may allow usage on pt. 1 year of age or older)

15 If the patient does not meet all of the patient criteria, the AED equipment shall not be applied; standard care shall be provided. AED Operator Treatment Procedures: 1. If the patient is found in cardiopulmonary arrest and all patient criteria are met, or the patient develops cardiopulmonary arrest (witnessed cardiac arrest) and the patient criteria are met, the AED operator shall take the following actions after placing AED next to patient s left ear. a. Establish unresponsiveness, activate 911 and internal emergency response system, if applicable, b. Position the patient properly, ensure the patient is in a position/location for safe defibrillation, open the airway, c. Establish breathlessness and give two full ventilations, d. If available, assign someone to provide CPR. If no one can provide CPR, go directly to AED use, e. Open AED equipment, turn on power, f. Begin Verbal Report (Your name, patient s approximate age, estimated duration of time in cardiopulmonary arrest, any medical history, etc.), g. Open adhesive defibrillator pads and cable set, h. Attach defibrillator pads to the patient in the proper locations, stop all CPR and patient contact; and j. Wait for equipment analysis 2. If the AED equipment indicates defibrillation is necessary, the AED will charge fully with an audible tone when ready for defibrillation. Ensure that the patient is in a position and location for safe defibrillation, move the patient to a better location if potentially unsafe for defibrillation. Proceed as follows and in compliance with AED treatment protocol: a. Clear anyone in contact with the patient or in contact with the patient by contact with electrically conductive material by announcing loudly I m clear, you re clear, we re all clear. Visually ensure that no one has contact with the patient and press the shock button. b. Follow voice and visual commands of the AED equipment. c. Once applied to a patient, the AED equipment shall remain applied until EMS personnel with necessary defibrillation equipment assume care.

16 3. Arrival of Emergency Medical Services a. When Emergency Medical Service personnel arrive, immediately hand care over by; b. Announcing arrival of agency on scene and give a verbal report of initial condition of patient, actions taken, amount of shocks delivered (displayed on screen), changes in patient s condition, etc. c. If First Responders arrive prior to the Advanced Life Support provider, do not turn equipment OFF. Give verbal report. Leave the equipment on and attached to the patient. The First Responder will then either take over operation of the AED or instruct you to continue with care under their supervision. d. When the Advanced Life Support provider arrives, the paramedic or EMT will either detach the plug-in connector and attach to their equipment or remove defibrillator pads and attach their own equipment. e. Follow instructions of any arriving EMS personnel SECTION 6 LOCATION OF AEDs

17 The (Your City/Agency name here) has selected the following sites for the placement of Automated External Defibrillators: (Place the name and location of each site where an AED has been placed) Hours of Operation: Monday - Thursday (Hours) Friday Saturday Number of Personnel: Number of Patrons: Location of Automated External Defibrillator: On the office wall just inside the reception desk area, at security, etc. Preferred number of AED Operators: Contact:

18 SECTION 7 (Your City/Agency name here) Employee Automated External Defibrillator Operator Acknowledgement Statement DATE As a volunteer to participate in the (Your City/Agency name here) Automated External Defibrillator (AED) Program as an AED operator, I agree to the following: I have participated in and received certification in an (Your Training Institution name here) CPR training course. I have participated in and received certification in an (Your Training Institution name here) AED training course. NAME SIGNATURE DATE

19 SECTION 8 Memorandums

20 (Your AED Equipment name here) AED Operations Guide

21 Insert your copy of the County of Ventura EMS AED Program Standards Policy 1301

22 California Civil Code Division 3 AED GOOD SAMARITAN LAW Section (a) For purposes of this section, the following definitions shall apply: (1) "AED" or "defibrillator" means an automated or automatic external defibrillator. (2) "CPR" means cardiopulmonary resuscitation. (b) Any person who, in good faith and not for compensation, renders emergency care or treatment by the use of an AED at the scene of an emergency is not liable for any civil damages resulting from any acts or omissions in rendering the emergency care. (c) A person or entity who provides CPR and AED training to a person who renders emergency care pursuant to subdivision (b) is not liable for any civil damages resulting from any acts or omissions of the person rendering the emergency care. (d) A person or entity that acquires an AED for emergency use pursuant to this section is not liable for any civil damages resulting from any acts or omissions in the rendering of the emergency care by use of an AED, if that person or entity has complied with subdivision (b) of Section of the Health and Safety Code. (e) A physician who is involved with the placement of an AED and any person or entity responsible for the site where an AED is located is not liable for any civil damages resulting from any acts or omissions of a person who renders emergency care pursuant to subdivision (b), if that physician, person, or entity has complied with all of the requirements of Section of the Health and Safety Code that apply to that physician, person, or entity. (f) The protections specified in this section do not apply in the case of personal injury or wrongful death that results from the gross negligence or willful or wanton misconduct of the person who renders emergency care or treatment by the use of an AED. (g) Nothing in this section shall relieve a manufacturer, designer, developer, distributor, installer, or supplier of an AED or defibrillator of any liability under any applicable statute or rule of law.

23 California Statutes Pertaining to Automated External Defibrillators Effective January 1, 2006 Health and Safety Code Division 2.5 I. Section The authority may establish minimum standards for the training and use of automatic. external defibirilators II. Section (a) For purposes of this section, "AED" or "defibrillator" means an automated or automatic external defibrillator. (b) In order to ensure public safety, any person or entity that acquires an AED is not liable for any civil damages resulting from any acts or omissions in the rendering of the emergency care under subdivision (b) of Section of the Civil Code, if that person or entity does all of the following: (1) Complies with all regulations governing the placement of an AED. (2) Ensures all of the following: (A) That the AED is maintained and regularly tested according to the operation and maintenance guidelines set forth by the manufacturer, the American Heart Association, and the American Red Cross, and according to any applicable rules and regulations set forth by the governmental authority under the federal Food and Drug Administration and any other applicable state and federal authority. (B) That the AED is checked for readiness after each use and at least once every 30 days if the AED has not been used in the preceding 30 days. Records of these checks shall be maintained. (C) That any person who renders emergency care or treatment on a person in cardiac arrest by using an AED activates the emergency medical services system as soon as possible, and reports any use of the AED to the licensed physician and to the local EMS agency. (D) For every AED unit acquired up to five units, no less than one employee per AED unit shall complete a training course in cardiopulmonary resuscitation and AED use that complies with the regulations adopted by the Emergency Medical Service Authority and the standards of the American Heart Association or the American Red Cross. After the first five AED units are acquired, for each additional five AED units acquired, one employee shall be trained beginning with the first AED unit acquired. Acquirers of AED units shall have trained employees who should be available to respond to an emergency that may involve the use of an AED unit during normal operating hours. (E) That there is a written plan that describes the procedures to be followed in the event of an emergency that may involve the use of an AED, to ensure compliance with the requirements of this section. The written plan shall include, but not be limited to, immediate notification of 911 and trained office personnel at the start of AED procedures. (3) When an AED is placed in a building, building owners shall ensure that tenants annually receive a brochure, approved as to content and style by the American Heart

24 Association or American Red Cross, which describes the proper use of an AED, and also ensure that similar information is posted next to any installed AED. (4) When an AED is placed in a building, no less than once a year, building owners shall notify their tenants as to the location of AED units in the building. (5) When an AED is placed in a public or private K-12 school, the principal shall ensure that the school administrators and staff annually receive a brochure, approved as to contents and style by the American Heart Association or the American Red Cross, that describes the proper use of an AED. The principal shall also ensure that similar information is posted next to every AED. The principal shall, at least annually, notify school employees as to the location of all AED units on the campus. The principal shall designate the trained employees who shall be available to respond to an emergency that may involve the use of an AED during normal operating hours. As used in this paragraph, "normal operating hours" means during the hours of classroom instruction and any school-sponsored activity occurring on school grounds. (c) Any person or entity that supplies an AED shall do all of the following: (1) Notify an agent of the local EMS agency of the existence, location, and type of AED acquired. (2) Provide to the acquirer of the AED all information governing the use, installation, operation, training, and maintenance of the AED. (d) A violation of this provision is not subject to penalties pursuant to Section (e) The protections specified in this section do not apply in the case of personal injury or wrongful death that results from the gross negligence or willful or wanton misconduct of the person who renders emergency care or treatment by the use of an AED. (f) Nothing in this section or Section may be construed to require a building owner or a building manager to acquire and have installed an AED in any building. (g) This section shall remain in effect only until January 1, 2013, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2013, deletes or extends that date (a) For purposes of this section, "AED" or "defibrillator" means an automated or automatic external defibrillator. (b) In order to ensure public safety, any person who acquires an AED shall do all of the following: (1) Comply with all regulations governing the training, use, and placement of an AED. (2) Notify an agent of the local EMS agency of the existence, location, and type of AED acquired. (3) Ensure all of the following: (A) That expected AED users complete a training course in cardiopulmonary resuscitation and AED use that complies with regulations adopted by the Emergency Medical Services (EMS) Authority and the standards of the American Heart Association or the American Red Cross. (B) That the defibrillator is maintained and regularly tested according to the operation and maintenance guidelines set forth by the manufacturer, the American Heart Association, and the American Red Cross, and according to any applicable rules and regulations set forth by the governmental authority under the Federal Food and Drug Administration and any other applicable state and federal authority.

25 (C) That the AED is checked for readiness after each use and at least once every 30 days if the AED has not been used in the preceding 30 days. Records of these periodic checks shall be maintained. (D) That any person who renders emergency care or treatment on a person in cardiac arrest by using an AED activates the emergency medical services system as soon as possible, and reports any use of the AED to the licensed physician and to the local EMS agency. (E) That there is involvement of a licensed physician in developing a program to ensure compliance with regulations and requirements for training, notification, and maintenance. (c) A violation of this provision is not subject to penalties pursuant to Section (d) This section shall become operative on January 1, II. Section (a) (1) Commencing July 1, 2007, every health studio, as defined in subdivision (g) shall acquire an automatic external defibrillator. The requirement to acquire an automatic external defibrillator pursuant to this subdivision shall terminate on July 1, (2) Commencing July 1, 2007, and until July 1, 2012, every health studio, as defined in subdivision (g), shall maintain, and train personnel in the use of, any automatic external defibrillator acquired pursuant to paragraph (1). (3) On or after July 1, 2012, a health studio that elects to continue the installation of an automatic external defibrillator that was acquired pursuant to paragraph (1) shall maintain and train personnel in the use of an automatic external defibrillator pursuant to this section, and shall not be liable for civil damages resulting from the use, attempted use, or nonuse of an automatic external defibrillator as provided by this section. (b) An employee of a health studio who renders emergency care or treatment is not liable for civil damages resulting from the use, attempted use, or nonuse of an automatic external defibrillator, except as provided in subdivision (f). (c) When an employee uses, does not use, or attempts to use, an automatic external defibrillator consistent with the requirements of this section to render emergency care or treatment, the members of the board of directors of the facility shall not be liable for civil damages resulting from any act or omission in rendering the emergency care or treatment, including the use or nonuse of an automatic external defibrillator, except as provided in subdivision (f). (d) Except as provided in subdivision (f), when an employee of a health studio renders emergency care or treatment using an automatic external defibrillator, the owners, managers, employees, or otherwise responsible authorities of the facility shall not be liable for civil damages resulting from any act or omission in the course of rendering that emergency care or treatment, provided that the facility fully complies with subdivision (e). (e) Notwithstanding Section , in order to ensure public safety, a health studio shall do all of the following: (1) Comply with all regulations governing the placement of an automatic external defibrillator. (2) Ensure all of the following: (A) The automatic external defibrillator is maintained and regularly tested according to the operation and maintenance guidelines set forth by the manufacturer, the American Heart Association, or the American Red Cross, and according to any applicable rules and regulations set forth by the governmental authority under the federal Food and Drug Administration and any other applicable state and federal authority.

26 (B) The automatic external defibrillator is checked for readiness after each use and at least once every 30 days if the automatic external defibrillator has not been used in the preceding 30 days. Records of these checks shall be maintained. (C) Any person who renders emergency care or treatment on a person in cardiac arrest by using an automatic external defibrillator activates the emergency medical services system as soon as possible, and reports any use of the automatic external defibrillator to the licensed physician and to the local EMS agency. (D) For every automatic external defibrillator unit acquired, up to five units, no less than one employee per automatic external defibrillator unit shall complete a training course in cardiopulmonary resuscitation and automatic external defibrillator use that complies with the regulations adopted by the Emergency Medical Services Authority and the standards of the American Heart Association or the American Red Cross. After the first five automatic external defibrillator units are acquired, for each additional five automatic external defibrillator units acquired, a minimum of one employee shall be trained beginning with the first additional automatic external defibrillator unit acquired. Acquirers of automatic external defibrillator units shall have trained employees who should be available to respond to an emergency that may involve the use of an automatic external defibrillator unit during normal operating hours. Acquirers of automatic external defibrillator units may need to train additional employees to assure that a trained employee is available at all times. (E) There is a written plan that exists that describes the procedures to be followed in the event of an emergency that may involve the use of an automatic external defibrillator, to ensure compliance with the requirements of this section. The written plan shall include, but not be limited to, immediate notification of 911 and trained office personnel at the start of automatic external defibrillator procedures. (f) Subdivisions (b), (c), and (d) do not apply in the case of personal injury or wrongful death that results from gross negligence or willful or wanton misconduct on the part of the person who uses, attempts to use, or maliciously fails to use an automatic external defibrillator to render emergency care or treatment. (g) For purposes of this section, "health studio" means any facility permitting the use of its facilities and equipment or access to its facilities and equipment, to individuals or groups for physical exercise, body building, reducing, figure development, fitness training, or any other similar purpose, on a membership basis. "Health studio" does not include any hotel or similar business that offers fitness facilities to its registered guests for a fee or as part of the hotel charges. California Code of Regulations Title 22. Social Security Division 9. Prehospital Emergency Medical Services Chapter 1.8. Training Standards and Utilization for Use of the Automated External Defibrillator by Non-Licensed or Non-Certified Personnel As modified January 8, 2009 Article 1. Definitions 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

27 who is not breathing. 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 and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code Lay Rescuer. Lay Rescuer means any person, not otherwise licensed or certified to use the automated external defibrillator, who has met the training standards of this chapter. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , and ,and Health and Safety Code, Section , Civil Code 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 and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code 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 and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code Internal Emergency Response Plan. Internal Emergency Response Plan means a written Internal Emergency Response 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 and , Health and Safety Code. Reference: Sections , , and and , Health and Safety Code. Section , Civil Code Medical Director. Medical Director means a physician and surgeon, currently licensed in California, who provides medical oversight to the AED Service Provider as set forth in Section Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code.

28 Article 2. General Training Provisions Application and Scope. (a) Any training program, AED Service Provider or vendor may authorize a Lay Rescuer to apply and operate an AED on an unconscious person who is not breathing only if that Lay Rescuer has successfully completed a CPR and AED course according to the standards prescribed by this Chapter. (b) The training standards prescribed by this Chapter shall apply to employees of the AED Service Provider and not to licensed, certified or other prehospital emergency medical care personnel as defined by Section of the Health and Safety Code. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , , and , and Health and Safety Code. Section , Civil Code. Article 3. AED Training Program Requirements Required Topics and Skills. (a) CPR and AED training shall comply with the American Heart Association or American Red Cross CPR and AED guidelines. The training 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) early activation of Emergency Response Plan, (B) early CPR, (C) early defibrillation, (D) early advanced life support, and (E) internal emergency response plan, if applicable; (4) overview of the local EMS system, including access, and interaction with EMS personnel; (5) assessment of an unconscious patient, to include evaluation of airway and breathing, to determine 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 lay rescuer 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 patient s post-shock status to determine if further activation of the AED is necessary; and,

29 (9) the responsibility for continuation of care, such as continued CPR and the repeated shocks, as indicated, until the arrival of more medically qualified personnel. (b) The Lay Rescuer shall maintain current CPR and AED training, as prescribed in this Chapter. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code Testing CPR and AED training for Lay Rescuers shall include a competency demonstration of skills on a manikin, directly observed by an instructor which tests the specified conditions prescribed in Section Note: Authority cited: Sections and , and , Health and Safety Code. Section , Civil Code. Article 4. Operational AED Service Provider and Vendor Requiremnts Medical Director Requirements Any AED service provider shall have a physician Medical Director who: (b) Meets the qualifications of a Medical Director per Section of this Chapter. (b) Shall ensure that AED Service Provider s Lay Rescuer CPR and AED training meets the requirements of this Chapter. (c) Shall review each incident where emergency care or treatment on a person in cardiac arrest is rendered and to ensure that the Internal Emergency Response Plan, along with the CPR and AED standards that the Lay Rescuer was trained to, were followed. (d) Is involved in developing an Internal Emergency Response Plan and to ensure compliance for training, notification and maintenance as set forth in this Chapter. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code AED Service Provider Operational Requirements. (a) An AED Service Provider shall ensure their internal AED programs include all of the following: (1) Development of a written Internal Emergency Response Plan which describes the procedures to be followed in the event of an emergency that may involve the use of an AED and complies with the regulations contained in this Chapter. The written Internal lemergency Response Plan shall include, but not be limited to, immediate notification of 911 and trained office personnel at the start of AED procedures. (2) Maintain AEDs in working order and maintain current protocols on the AEDs. (3) That all applicable local EMS policies and procedures are followed.

30 (4) That Lay Rescuers complete a training course in CPR and AED use and maintain current CPR and AED training that complies with requirements of this Chapter at a minimum of every two years and are familiar with the Internal Emergency Response Plan. (5) For every AED unit acquired up to five units, no less than one Lay Rescuer per AED unit shall complete a training course in CPR and AED use that complies with the requirements of this Chapter. After the first five AED units are acquired, one Lay Rescuer shall be trained for each additional five AED units acquired. AED Service Providers shall have Lay Rescuers who should be on site to respond to an emergency that may involve the use of an AED unit during normal operating hours. (6) 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 by the governmental authority under the federal Food and Drug Administration and any other applicable state and federal authority. (7) 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. (8) That a mechanism exists to ensure that any person, either a lay rescuer as part of the AEDService Provider, or member of the general public who renders emergency care or treatment on a person in cardiac arrest by using the service provider s AED activates the emergency medical services system as soon as possible, and reports any use of the AED to the Medical Director and the local EMS agency. (9) That there is involvement of a currently licensed California physician and surgeon that meets the requirements of Section of this Chapter. (10) That a mechanism exists that will assure the continued competency of the CPR and AED trained individuals in the AED Service Provider s employ to include periodic training and skills proficiency demonstrations. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code 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 Provider s responsibility to comply with the regulations contained in this Chapter. (a) Notify the local EMS agency of the existence, location, and type of AED at the time it is acquired. (b) Provide to the acquirer of the AED all information governing the use, installation, operation, training, and, and maintenance of the AED. Note: Authority cited: Sections and , Health and Safety Code. Reference: Sections , , and , and , Health and Safety Code. Section , Civil Code.

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