TITLE 7                 HEALTH

CHAPTER 27       EMERGENCY MEDICAL SERVICES

PART  8                CARDIAC ARREST TARGETED RESPONSE PROGRAM

 

7.27.8.1                   ISSUING AGENCY: New Mexico Department of Health, Public Health Division.

[7.27.8.1 NMAC - N, 7/1/2000]

 

7.27.8.2                   SCOPE: These regulations are applicable to all persons or entities operating an Automated External Defibrillator (AED) Program within the State of New Mexico.  The regulations also apply to all AED training organizations, trainers, Trained Targeted Responders, and Physician Medical Directors affiliated with an AED Program.

                A.            Exemptions: Certain individuals and agencies are exempted from this regulation, as outlined below:

                   (1)  Individuals Authorized by Physicians: As outlined in the Cardiac Arrest Response Act, Section 24-10C-1, et seq., NMSA 1978, nothing precludes a physician from prescribing an AED to a patient for use by the patient’s caregivers on an individual and the use does not require the individual to function in an approved program.

                    (2)  Health Care Professionals: EMS personnel and/or other health care professionals, who are authorized by other laws, regulations, and scopes of practice to use and perform defibrillation in the out-of-hospital environment, while performing official duties or within the scope of their employment.

                   (3)  Military services: The United States Department of Defense and the New Mexico Department of Military Affairs are exempt from this rule when conducting official military operations.

[7.27.8.2 NMAC - N, 7/1/2000]

 

7.27.8.3                   STATUTORY AUTHORITY: These regulations are promulgated pursuant to the following statutory authorities:  1)  the Department of Health Act, Section 9-7-6.E., NMSA 1978, which authorizes the Secretary of the Department of Health to “…make and adopt such reasonable and procedural rules and regulations as may be necessary to carry out the duties of the department and its divisions”; 2) the Cardiac Arrest Response Act, Section 24-10C-4.B., NMSA 1978, which authorizes the Department of Health to approve training programs, and; 3) the Emergency Medical Services Act, Section 24-10B-4.M., NMSA 1978, which authorizes the Department of Health to adopt “rules to establish a cardiac arrest targeted response program pursuant to the Cardiac Arrest Response Act, …”

[7.27.8.3 NMAC - N, 7/1/2000]

 

7.27.8.4                   DURATION: Permanent.

[7.27.8.4 NMAC - N, 7/1/2000]

 

7.27.8.5                   EFFECTIVE DATE: July 1, 2000, unless a later date is cited at the end of a section.

[7.27.8.5 NMAC - N, 7/1/2000]

 

7.27.8.6                   OBJECTIVE: The purpose of these regulations is to outline requirements for the New Mexico Cardiac Arrest Targeted Response Program including: Establishment of a Cardiac Arrest Targeted Response Program, AED Program registration, medical direction, training, notification of local EMS Services and Public Safety Answering Points, reporting, fees, and Bureau responsibilities.

[7.27.8.6 NMAC - N, 7/1/2000]

 

7.27.8.7                   DEFINITIONS:

                A.            “Act” means the Cardiac Arrest Response Act, Section 24-10C-1, et seq., NMSA 1978.

                B.            “Advanced Life Support (ALS)” means advanced pre-hospital and inter-facility care and treatment, including basic and intermediate life support, as prescribed by regulation, which may be performed only by a person licensed as a Paramedic by the Bureau and operating under medical control.

                C.            “AED Program” means a program of Trained Targeted Responders operating under the supervision of a Physician Medical Director that is registered with the Department.

                D.            “Basic Life Support (BLS)” means pre-hospital and inter-facility care and treatment, as prescribed by regulation, which can be performed by all licensed Emergency Medical Technicians.

                E.             “Bureau” means the Injury Prevention and Emergency Medical Services Bureau of the Public Health Division of the New Mexico Department of Health.

                F.             “Defibrillation” means the administration of a controlled electrical charge to the heart to restore a viable cardiac rhythm.

                G.            “Department” means the New Mexico Department of Health.

                H.            “Emergency Medical Service (EMS)” means the services rendered by licensed Emergency Medical Technicians, certified Emergency Medical Services First Responders or Emergency Medical Dispatchers in response to a person’s need for immediate medical care to prevent loss of life or aggravation of physical or psychological illness or injury.

                I.              “Medical Direction” means guidance or supervision provided by a physician as outlined below:

                   (1)  For Emergency Medical Services (EMS): Medical Direction means guidance or supervision to a provider or emergency medical services system and which includes authority over and responsibility for emergency medical dispatch, direct patient care and transport of patients, arrangements for medical control and all other aspects of patient care delivered by a provider.

                   (2)  For the Cardiac Arrest Targeted Response Program: Medical Direction means guidance or supervision for the AED Program including overseeing all aspects of the defibrillation program.  This includes training, emergency medical services coordination, protocol approval, AED deployment strategies, quality assurance and reporting.

                J.             “Physician” means a doctor of medicine or doctor of osteopathy who is licensed or otherwise authorized to practice medicine or osteopathic medicine in New Mexico.

                K.            “Protocols” means predetermined, written medical care plans and includes standing orders.

                L.             “Provider” means a person or entity delivering emergency medical services in New Mexico.

                M.           “Semi-Automated External Defibrillation  (AED)” means a medical device heart monitor and defibrillator that:

                   (1)  has received approval of its pre-market modification filed pursuant to United States Code, Title 21, Section 360(k), from the United States Food and Drug Administration;

(2)  is capable of recognizing cardiac arrest that will respond to defibrillation,  ventricular fibrillation or rapid ventricular tachycardia, and is capable of determining whether defibrillation should be performed; and,

                   (3)  upon determining that defibrillation should be performed, automatically charges and is capable of delivering an electrical impulse to an individual’s heart, following activation by the equipment user.

                N.            “Trained Targeted Responder” means a person who has completed an authorized AED training program and who uses an AED.

[7.27.8.7 NMAC - N, 7/1/2000]

 

7.27.8.8                   Establishment of an AED Program:

                A.            Purpose: The primary reason for establishing an AED Program is to improve response to cardiac defibrillation of a person suffering from sudden cardiac arrest.  Studies have shown that there is a better chance for survival to hospital discharge if a person suffering from sudden cardiac arrest is defibrillated within the first four (4) – six (6) minutes following cardiac arrest.  While defibrillation does not automatically guarantee to restore a person’s heart into a perfusing normal sinus rhythm, it is the only definitive care available for this purpose.  Therefore, persons suffering from sudden cardiac arrest should be defibrillated as quickly as possible.  Defibrillation should also be used with all other elements of the “Chain of Survival” as outlined by the American Heart Association (AHA).  According to AHA, a break in the “Chain of Survival” will result in poor survival rates.  In addition, while links of the “Chain of Survival” (below) must be strong, defibrillation is the single most important factor in determining survival from adult cardiac arrest. The elements of the “Chain of Survival” include:

                   (1)  Early access to emergency services;

                   (2)  Early initiation of cardiopulmonary resuscitation (CPR);

                   (3)  Early defibrillation; and,

                   (4)  Early advanced care by EMT-Paramedics, physicians and/or specially trained nurses.

                B.            AED Program Locations: Cardiac Arrest Targeted Response Programs may be initiated in any venue where people gather, but should be typically targeted to public facilities, businesses, meeting areas, buildings or any location where large quantities of people gather.

[7.27.8.8 NMAC - N, 7/1/2000]

 

7.27.8.9                   AED Program Requirements: Prior to submitting an application for registration, the AED Program Director and Medical Director shall insure that the AED Program incorporates the following requirements:

                A.            AED Program Director: A Program Director shall be identified who manages the Cardiac Arrest Targeted Response Program.  The Program Director shall:

                   (1)  Identify a Physician Medical Director to oversee the AED Program;

                   (2)  Select and identify persons as Trained Targeted Responders;

                   (3)  Maintain AED training records for all Trained Targeted Responders while they are active in the program, and for at least three (3) years thereafter;

                   (4)  Maintain AED Program records including AED maintenance records, Trained Targeted Responder training records, and AED usage records;

                   (5)  Ensure that all Trained Targeted Responders are trained using a training program which has been approved by the Department;

                   (6)  Provide evidence of coordination of the AED program with local EMS services and emergency dispatch agencies, including 911 dispatch agencies;

                   (7)  Register the AED Program with the Department using the application format outlined in Appendix A, and pay registration fees, as outlined in this regulation;

                   (8)  Report all operational uses of the AED to the Department using the reporting format outlined in Appendix B;

                   (9)  Assist the Physician Medical Director with quality assurance review of all operational defibrillations; and,

                   (10)  Ensure AED equipment is maintained in accordance with the manufacturer’s guidelines.

                B.            Physician Medical Director: Each AED Program shall have a Physician Medical Director who provides oversight of the AED Program.  The selected physician shall:

                   (1)  Provide medical leadership, expertise, and oversee the program;

                   (2)  Serve as an advocate and spokesperson for the AED Program;

                   (3)  Ensure that all Trained Targeted Responders are properly trained and their skills are maintained;

                   (4)  Develop and approve medical protocols for the AED Program;

                   (5)  Ensure quality assurance review for all operational AED defibrillations; and,

                   (6)  Assume overall responsibility for how the AED Program is planned and conducted.

                C.            Trained Targeted Responders: Individuals selected by the AED Program Director and/or Physician Medical Director to train and use an AED are identified as Trained Targeted Responders.  Each Trained Targeted Responder:

                   (1)  Prior to participating in an AED program, Trained Targeted Responders shall complete an initial AED training course from a Department approved training program, which is equivalent to the American Heart Association’s Heartsaver AED Course.  The course shall include both cardiopulmonary resuscitation (CPR) and AED training.

                   (2)  At least every two (2) years, Trained Targeted Responders shall recertify in CPR and AED training, by successfully completing a Department approved AED training course, as outlined in section 9.3.1. above;

                   (3)  Activate the emergency medical system using pre-established methods (contact E-911 public safety answering point or local emergency number) during any operational response to a victim of cardiac arrest, and advise that AED is being used;

                   (4)  Comply with Physician Medical Director protocols for operational response to victims of cardiac arrest;

                   (5)  Report all operational responses to victims of cardiac arrest to the AED Program Director and Physician Medical Director and complete a defibrillation report as outlined in Appendix B.  A copy of the report shall be submitted to the Department within twenty (20) calendar days.

                   (6)  Ensure AED’s are maintained and used in accordance with the manufacturer’s guidelines, and inspect AED equipment at least monthly.

                D.            Registration: All AED Programs shall be registered with the Department, as outlined below:

                   (1)  Initial Registration: The initial registration period shall be for a period of four (4) years.  The Program Director for the AED Program shall complete the application provided in Appendix A and submit it to the Department, along with the appropriate fees.

                   (2)  Renewal: AED Programs shall renew the AED Program every four (4) years by completing a new application (Appendix A), submitted to the Department, along with the appropriate fees.

                   (3)  Notification of Changes in Registration:  The Department shall be notified when there is a :

                             (a)  change in AED Program Director;

                             (b)  change in Physician Medical Director;

                             (c)  change in physical address or telephone number; or,

                             (d)  stoppage or cancellation of the AED Program.

                E.             Fees: The Bureau shall establish a fee schedule for AED Programs.  A minimum of seventy five ($75) dollars shall be paid by the AED Program to the Department for initial registration.  For renewal, AED Programs shall pay a minimum fee of fifty ($50) dollars to the Department.

                F.             Notification:  Local EMS services and emergency dispatch agencies shall be notified of the activation and existence of the AED Program. The notification shall include the name of the AED Program Director, Physician Medical Director, location of the program, telephone number, a copy of medical director approved protocols, location of the placement of AED(s), and the operational area where the AED(s) will be used.  The local emergency services and dispatch agencies shall also be notified if an existing AED Program stops or cancels the AED Program.

                G.            AED Selection and Maintenance:

                   (1)  AED Selection: AED Programs shall acquire and use semi-automated cardiac defibrillators.  These devices require the responder to deliver the shock by pushing the shock button.  Automated defibrillators that deliver an electrical impulse to the victim’s heart without user activation (pushing the shock button) are being phased out and in many cases are no longer available.  AED Programs that have a fully automated defibrillator (analyzes and shocks without operator input) may petition the Bureau for a waiver to use an automated defibrillator.  A list of manufacturers of AED’s is available from the Bureau.

                   (2)  Maintenance: AED Programs shall maintain the AED(s) and associated supplies and batteries in accordance with the manufacturer’s suggested guidelines.  AED(s) and batteries shall be inspected/tested at least monthly to insure readiness.  A variance of this inspection requirement may be granted by the Bureau for just cause. Those AED(s) or batteries, which do not pass the monthly inspection, shall be removed from service and the AED Program Director shall be notified immediately.  Trained Targeted Responders shall also be notified when an AED is removed from operational usage.  Likewise, Trained Targeted Responders shall be notified when an AED has been placed back into operation following maintenance.  Maintenance shall only be performed on AED(s) by the manufacturer or their authorized service center.  Batteries shall be checked during the monthly inspection and replaced if they are inoperable.

[7.27.8.9 NMAC - N, 7/1/2000]

                H.            Record Keeping: Establish and maintain a record keeping system that is available for audit.  Include the following information:

                   (1)  List of Trained Targeted Responders;

                   (2)  Dates of training for Trained Targeted Responders including CPR training and AED training;

                   (3)  Copy of medical director approved medical protocols;

                   (4)  Copy of the medical director contract/agreement;

                   (5)  Copy of registration and EMS service notification forms;

                   (6)  AED usage reports/Data collection forms (Appendix C);

                   (7)  Quality assurance review documentation;

                   (8)  AED equipment purchase and maintenance records;

[7.27.8.10 NMAC - N, 7/1/2000]

 

7.27.8.11 Limited Immunity Protections: Limited immunity protections are provided for persons or entities associated with an AED Program.  These protections are provided when the AED Program is established and operated in accordance with these regulations.  AED Programs shall meet all of the program requirements outlined in Section 9, above, to have this limited liability coverage.  The following persons or entities who render emergency care or treatment by the use of an AED under the provisions of the Act, shall not be subject to civil liability provided they have acted with reasonable care and in compliance with the requirements of the Act:

                A.            A physician who provides supervisory services pursuant to the Cardiac Arrest Response Act;

                B.            A person or entity that provides training in cardiopulmonary resuscitation and use of automated external defibrillation;

                C.            A person or entity that acquires an AED pursuant to the Act;

                D.            The owner of the property or facility where the AED is located; and,

                E.             The Trained Targeted Responder.

[7.27.8.11 NMAC - N, 7/1/2000]

7.27.8.12               APPENDIX A

 

NEW MEXICO CARDIAC ARREST RESPONSE AED PROGRAM

REGISTRATION APPLICATION

 

 

 


APPLICATION DATE______/_____/_____                                INITIAL  REGISTRATION                                

                                         MO/  DAY/  YR                                           RENEWAL REGISTRATION

 

AED PROGRAM NAME:                                  

 

AED PROGRAM DIRECTOR:                                                                                           PHONE:     (        )     -                          

 


ADDRESS:

 


OPERATING LOCATION:

 

 

 

 

 


AED  MEDICAL DIRECTOR :                                                                         

 


ADDRESS:                                                                                                                           

 


PHONE:      (        )     -                                          NM LICENSE #:

 

 


Medical Director Signature ______________________________________________________________________

 

AED TRAINING PROGRAM:

 

ADDRESS:

 

INSTRUCTOR NAME:

 


PHONE: (        )     -                               # TRAINED RESPONDERS:

                                                                                (See Required Attachments)            

 

 

AED PLACEMENT LOCATION(s):

 


ADDRESS:                                                                                                                   PHONE:          (        )     -                              

 

 


EMS  NOTIFICATION:                      EMS SERVICE                                     EMERGENCY DISPATCH

DATE: ______/_____/_____                           DATE: ______/_____/_____

                                                                MO/  DAY/  YR                                                    MO/  DAY/  YR   

SERVICE NAME:

 


SERVICE CONTACT:

                                                               

APPENDIX A

 

NEW MEXICO CARDIAC ARREST RESPONSE AED PROGRAM

REGISTRATION APPLICATION (continued)

 

 

 


I/We,                                                                                                      agree to comply with all AED Program

Requirements as set forth in the State of New Mexico, Cardiac Arrest Targeted Response Program, Section 9. A fee of $75.00 (Initial Application)/$50.00 (Renewal Application) is attached.

 

                                                                                                DATE:    ______/_____/_____

Program Director                                                                                        MO/  DAY/  YR                             

 

REQUIRED            ATTACHMENTS:              

                               

 


                Medical Protocols  

                List of Responders, include Name, Address, Phone #, and Training Completion Documentation

 

Mail your application, fee and attachments to the address below.  Make your check payable to the Injury Prevention and EMS Bureau.  If you have questions regarding your application, contact the Bureau at 505-476-7701:

 

Injury Prevention and EMS Bureau

PO Box 26110

Santa Fe, NM 87502-6110

 

[7.27.8.12 NMAC - N, 7/1/2000]

 

7.27.8.13               APPENDIX B

NOTIFICATION OF AED PROGRAM

(Copy to be provided to local EMS Services and Emergency Dispatch Agencies)

 

NOTIFICATION DATE:                                     INITIAL/RENEWAL REGISTRATION DATE:

______/_____/_____                                        ______/_____/_____       

      MO/  DAY/  YR                                                    MO/  DAY/  YR

 


NOTIFICATION TO:                                           EMS Service                                         Emergency Dispatch Agency

 

AED PROGRAM NAME:

 


AED PROGRAM DIRECTOR:                                                                                           PHONE:     (        )     -                          

 


ADDRESS:

 


EFFECTIVE AED PROGRAM START DATE: _____________________________________________________

 

NOTIFICATION OF:  (CHECK ONE)

 


                PROGRAM ACTIVATION (PROVIDE ALL INFORMATION BELOW)

                PROGRAM CANCELLATION

PROGRAM CHANGES

 

 

 


AED PROGRAM LOCATION:

 


ADDRESS:

 


PHONE: (        )     -                               EMS/911 NOTIFIED:           YES                         NO

 


OPERATIONAL AREA:

 


AED PLACEMENT:

 

DIRECTIONS TO LOCATION FOR EMS:

 


 AED  MEDICAL DIRECTOR :                                                                                         PHONE:     (        )     -                          

 


ADDRESS:

 

 


AED EQUIPMENT AT SITE:  LOCATION:

 


 

  # of AEDs                            MANUFACTURER                                                                              MODEL

 

ADDRESS:

 

PHONE: (        )     -                              

 


[7.27.8.13 NMAC - N, 7/1/2000]

 

7.27.8.14               APPENDIX C

AED USAGE DATA COLLECTION FORM

 

 


AED RESPONSE ACTIVITY:           Date: ___/____/____                                         Witnessed Event

                                                                       MO/ DAY/ YR                                               Non-Witnessed Event

 

 

                Residential                            Commercial                                            Industrial

Nursing home                       Agricultural                                           Health Care Facility

Mass gathering                    Recreation

 

Other, Please identify:

 

NAME of AED RESPONDER(S):

 

 


EMS RESPONDING/TRANSPORTING SERVICE(S):

 

 

 


RESPONSE TIMES:

Estimated Collapse/Arrest                                                  AED Responder Scene Arrival

1st AED Defibrillation                                                           EMS Scene Arrival

1ST CPR                                                                  Transport from Scene

 


Total time of event (Time of collapse to transport time)                                Hrs                          Min

Patient Response to AED defibrillation (indicate all that are appropriate):

 


Pulse restored                       Breathing restored                               Consciousness restored

                Pulse Rate                             Respiration

 

Apparent cause of arrest

 

 

Report Submitted By:

 

                                                                                                                                                                 (        )     -                             

Signature                                                                                                                                               Telephone number

 

 


HOSPITAL DATA: (if obtainable from the receiving hospital)  

 

Arrival Time:        

 


Facility Name:                                                                                       Location (City/State):

 


Hospital record number____________

 

 

 

APPENDIX C

AED USAGE DATA COLLECTION FORM (continued)

 

 

On Admission: Presenting rhythm                                                                    Vital Signs

                                                 

ER Disposition: 

 


Discharged to Home

 


                Hospital admission to (list Unit)

                                  (ICU,CCU, etc.)

               

Transfer  to                                                                           for

                                                Facility Name                                                                        Transfer Reason

 


Expired   Cause of death

 


Diagnosed Cause of Arrest

 


Any Device Failure or Injury Associated with AED Use?

 

 


COMMENTS:

 

 

 


Report Submitted By:

                                                                                                                                                                 (        )     -                             

Signature                                                                                                                                               Telephone number

 

[7.27.8.14 NMAC - N, 7/1/2000]

 

7.27.8.15               Appendix D

Guidelines for Establishment of an AED Program

 

The following guidelines may assist with establishing an AED Program for your agency, business, facility, or company.

 

Determine the need or support for an AED Program in your company or facility.  This should be in the form of a letter of support from the chief executive of the company or facility.  Attach the letter to the application.

 


Appoint a Physician Medical Director as described in DOH Regulation NMAC 7.27.8, “Cardiac Arrest Targeted Response Program” .  This may or may not require entering into a contract.  It also may require funds to pay for the medical director.  The Physician Medical Director should complete a “Medical Director Agreement” if a contract is not used.  This written document provides the clear communication of the expectations for the medical director and he/she acknowledges these responsibilities by signing the agreement.

 

Identify individuals and establish a team to implement the AED Program within the company or facility.  If the company or business has already established a medical response team, they may be utilized as long as the requirements of the regulation are maintained.

 


Assure that all team members are trained in cardiopulmonary resuscitation (CPR) and AED operation in accordance with the regulation.  The Department uses the American Heart Association (AHA)  “Heartsaver AED” course as the standard.  Other courses may also be used for this training as long as they have been approved by the Injury Prevention and EMS Bureau (IPEMS Bureau) of the Department of Health.  This training may be scheduled through an AHA Community Training Center (CTC).

 

Purchase a semi-automated AED.  The AED may be purchased through several different vendors.  The requirements for the AED are outlined in the Cardiac Arrest Targeted Response Program Regulations.

 

The Physician Medical Director should develop written medical protocols for response to victims of sudden cardiac arrest, although these could be the standard national protocols outlined by the AHA.  However, all team members should understand these protocols.  In addition, the medical director should approve the team members selected for response.  This ensures that he/she is familiar with the individuals and their level of training/competence.

 

Complete an application for registration as an AED Program and forward it to the IPEMS Bureau along with all supporting documentation.  Include support letters, Physician Medical Director contract or agreement, written medical protocols, list of all approved team members and their training documentation.

 

Once approval of registration is received from the IPEMS Bureau, notify the local EMS Services and emergency dispatch agencies of the establishment of the AED Program, along with location of defibrillators, boundaries of the program operational response area, name of the AED Program Director/Medical Director, and contact information.  A copy of the medical protocols will also be helpful for these agencies to understand how the AED Program Trained Targeted Responders will handle victim encounters.

 

Report all operational usage of the AED to the Physician Medical Director and IPEMS Bureau using the data collection form.

[7.27.8.15 NMAC - N, 7/1/2000]

 

History of 7.27.8 NMAC  Reserved