DEPARTMENT OF HEALTH AND SOCIAL SERVICES
Office of Emergency Medical Services
Nature of the Proceedings
EMS Pre-Hospital Advanced Care Directive Regulations,
The attached regulations, "State of Delaware EMS Pre-Hospital Advanced Care Directive Regulations," are being proposed in accordance with 16 Delaware Code, Chapter 97 and the State of Delaware Death with Dignity Act, 16 Delaware Code, Chapter 25.
The proposed regulation defines procedures and processes to be used by Delaware Emergency Medical Service (EMS) personnel when encountering a terminally ill patient who has executed a pre-hospital advanced care directive.
Notice Of Public Hearing
The Office of Emergency Medical Services, Division of Public Health, Department of Health and Social Services will hold a public hearing to discuss the proposed Delaware EMS Pre-Hospital Advanced Care Directive Regulations.
The public hearing will be held on Tuesday, November 26, 2002 at 9:00 AM in the Conference Room of the Office of Emergency Medical Services, Blue Hen Corporate Center, Suite 4-H, 655 S. Bay Road, Dover, Delaware.
Copies of the proposed regulations are available for review by contacting:
Office of Emergency Medical Services
Blue Hen Corporate Center, Suite 4-H
655 Bay Road
Dover, Delaware 19901
Telephone: (302) 739-4710
Anyone wishing to present his or her oral comments at this hearing should contact Debbie Vincent at (302) 739-4710 by Friday, November 22, 2002. Anyone wishing to submit written comments as a supplement to or in lieu of oral testimony should submit such comments by December 1, 2002 to:
David P. Walton, Hearing Officer
Division of Public Health
P.O. Box 637
Dover, Delaware 19903-0637
Pre-Hospital Advanced Care Directive Regulations
Authority: 16 Delaware Code, Chapter 97, Section 9706(h)
Purpose: There is a need to address the recognition of Pre-Hospital Advanced Care Directives (Do-Not-Resuscitate Orders) in conjunction with Advanced Care Directives as provided for in Delaware Code Title 16, Chapter 25, in the pre-hospital emergency environment. These regulations require the use of a specific form of individual identification that can be readily recognized and verified during a pre-hospital emergency. The regulations also detail the legislated immunity for certified providers honoring this order.
While such legal instruments serve individuals well in clinical settings such as hospitals and nursing homes, they pose practical problems in life-threatening situations when emergency medical services (EMS) individuals are called for assistance. Living wills, powers of attorney and other advance directives are often long and complex, can vary greatly in form and content, and do not apply to the pre-hospital environment. Many are hand-written and are impossible to verify on the scene of an emergency. Furthermore, in most states, if an EMS provider is called to a scene, they are legally required to perform life-saving techniques (CPR) even if the individual’s heart has stopped and they are clinically expired. And, they cannot stop these efforts based on a living will or appointed proxy’s request, because advance directives may not apply in EMS related medical emergencies. A Delaware Pre-Hospital Advanced Care Directive is a specific order initiated by the individual and signed by a physician stipulating a specific order for individual non-resuscitation.
A Pre-Hospital Advanced Care Directive regulation authorizes the Division of Public Health/Office of Emergency Medical Services in conjunction with the Board of Medical Practice, the Delaware Fire Prevention Commission, and other key groups within the State to develop and implement an EMS Pre-Hospital Advanced Care Directive (PACD) protocol for EMS providers. This law and protocol standardize the legal advanced care directive documentation so EMS providers have a readily recognizable format upon which they may make a decision. This would also allow EMS providers to honor the individual’s wishes to the greatest extent possible and grant the individual the dignity, humanity and compassion they deserve.
1.0 Definitions
“Advanced health care directive” shall mean an individual instruction or power of attorney for health care, or both.
“Agent” shall mean an individual designated in a power of attorney for health care to make a health care decision for the individual granting the power.
“Artificial nutrition and hydration” means supplying food and water through a conduit, such as a tube or intravenous line where the recipient is not required to chew or swallow voluntarily, including, but not limited to, nasogastric tubes, gastromstomies, jejunostomies and intravenous infusions. Artificial nutrition and hydration does not include assisted feeding, such as spoon or bottle-feeding.
“Capacity” shall mean an individual’s ability to understand the significant benefits, risks and alternatives to proposed health care and to make and communicate a health care decision.
“Declarant” shall mean a individual who executes an advance health care directive.
“Division” shall mean the Division of Public Health.
“DNR” shall mean Do Not Resuscitate. A physician order in writing on forms approved by the Director of the Division of Public Health instructing EMS providers to withhold care as instructed on the order.
“EMS prehospital advanced care directive order (PACD)” shall mean an advanced health care directive/do not resuscitate order as defined in paragraph 1.1, signed by the individual’s physician on forms approved by the Director of the Division of Public Health.
“EMS PACD Program” shall mean the regulations and administrative guidelines promulgated by the Division of Public Health for the administration of this Act.
“Guardian” shall mean a judicially appointed guardian or conservator having authority to make health care decisions for an individual.
“Health care” shall mean any care, treatment, service or procedure to maintain, diagnose or otherwise affect an individual’s physical or mental condition.
“Health care decision” shall mean a decision made by an individual or the individual’s agent, surrogate or guardian regarding the individual’s health care, including:
Selection and discharge of health care providers and institutions;
Acceptance or refusal of diagnostic tests, surgical procedures, programs of medication and orders not to resuscitate; and
Directions to provide, withhold or withdraw artificial nutrition and hydration and all other forms of health care.
“Health care institution” means an institution, facility or agency licensed, certified or otherwise authorized or permitted by law to provide health care in the ordinary course of business or practice of profession.
“Emergency medical services (EMS) provider” shall mean individual providers certified by the Delaware State Fire Prevention Commission or the Office of EMS, or emergency medical dispatchers certified by the National Academy of Emergency Medical Dispatch.
“Emergency medical services (EMS) provider agency” shall mean a provider agency certified by the Delaware State Fire Prevention Commission or the Office of EMS, or an emergency medical dispatch center under contract with the Department of Public Safety.
“Individual” means an individual, corporation, business trust, estate, trust, partnership, association, joint venture, government, governmental subdivision, agency or instrumentality or any other legal or commercial entity.
“Individual instruction” means an individual’s direction concerning a health-care decision for the individual.
“Life-sustaining procedure” means:
Any medical procedure, treatment or intervention that:
1. Utilizes mechanical or other artificial means to sustain, restore, or supplant a spontaneous vital function; and
2. Is of such a nature as to afford a individual no reasonable expectation of recovery from a terminal illness.
Procedures that can include, but are not limited to, assisted ventilation, renal dialysis, surgical procedures, blood transfusions and the administration of drugs, antibiotics and artificial nutrition and hydration.
“Medically ineffective treatment” means that, to a reasonable degree of medical certainty, a medical procedure will not:
Prevent or reduce the deterioration of the health of an individual: or
Prevent the impending death of an individual.
“Office” shall mean the Office of Emergency Medical Services (EMS) within the Division of Public Health.
"PACD" means an EMS prehospital advanced care directive or do not resuscitate order signed by the individual and the individual’s physician, on forms approved by the Director of Public Health.
“Physician” means an individual licensed to practice medicine under Chapter 17 of Title 24 of the Delaware Code.
“Power of attorney for health care” means the designation of an agent to make health care decisions for the individual granting the power.
“Primary physician” or “attending physician” shall mean a physician designated by an individual or the individual’s agent, surrogate or guardian to have primary responsibility for the individual’s health care or, in the absence of a designation, or if the designated physician is not reasonably available, a physician who undertakes the responsibility.
“Reasonably available” shall mean readily able to be contacted without undue effort and willing and able to act in a timely manner considering the urgency of the individual’s health care needs.
“Supervising health care provider” shall mean the primary physician, or if there is no primary physician or the primary physician is not reasonably available, the health care provider who has undertaken primary responsibility for an individual’s health care.
“Surrogate” means an adult individual or individuals who (1) have capacity;(2) are reasonably available; (3) are willing to make health care decisions, including decisions to initiate, refuse to initiate, continue or discontinue the use of a life sustaining procedure on behalf of a individual who lacks capacity; and (4) are identified by the individual’s identification in accordance with this chapter as the individual or individuals who are to make those decisions in accordance with this chapter.
“Terminal illness” means any disease, illness or condition sustained by any human being for which there is no reasonable medical expectation of recovery and which, as a medical probability will result in the death of such human being regardless of the use or discontinuance of medical treatment implemented for the purpose of sustaining life or the life processes.
2.0 Right to Self-Determination
2.1 An individual, legally adult, who is mentally competent, has the right to refuse medical or surgical treatment if such refusal is not contrary to existing public health laws.
3.0 Medical Prerequisites
3.1. Any individual with legal capacity may execute a Pre-Hospital Advanced Care Directive (PACD); however, this Directive will not become effective unless signed by a physician after diagnosis of a terminal illness.
3.2 Individual with legal capacity, who is able to communicate by some reliable, proven means (i.e. verbally, eye blink, finger tap) but is physically unable to sign, may execute a PACD through an agent or surrogate to be effective upon the diagnosis of a terminal illness from a physician in Delaware. Conditionsthat may prevent physical signing of the PACD include, but are not limited to:
3.2.1 Blindness or illiteracy
3.2.2 Severe arthritis
3.2.3 Amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease)
3.2.4 Quadriplegia
3.2.5 Paralysis of the writing hand
3.2.6 Amputation
3.3 Individual who no longer has capacity may be issued a PACD through an agent, guardian or surrogate and the individual’s physician.
3.3.1 Conditions for which a PACD may be issued are:
3.3.1.1 Terminal Illness
4.0 Prehospital Advanced Care Directives
4.1 Prehospital Advanced Care Directive Options
4.1.1 Option A (Advanced Life Support) - “Maximal (Restorative) Care Before Arrest, Then DNR”
4.1.1.1. When this option is selected on an EMS PACD, the individual shall receive the full scope of restorative interventions permissible under the Delaware Statewide ALS treatment protocol (including intubation for respiratory distress, cardiac monitoring, synchronized cardioversion for pulse-present ventricular or supra ventricular tachycardia, cardiac pacing for pulse-present symptomatic bradycardia, insertion of IV’s, and drug therapy), in an attempt to forestall cardiac or respiratory arrest (see Delaware Statewide ALS treatment protocol for full description of permissible interventions).
4.1.2 Option B (Basic Life Support) – “Limited (Palliative) Care Only Before Arrest, Then DNR”
4.1.2.1. Palliative care is defined as supportive care for control of signs and symptoms.
4.1.2.1.1. This includes opening the airway using non-invasive means (e.g. chin lift, jaw thrust, finger sweep, nasopharyngeal airway, oropharyngeal airway and abdominal thrust, O2 administration, suctioning, positioning for comfort, control of external bleeding using standard treatments (dressing, elevation, direct
4.1.2.1.2. pressure, pressure points, cold packs, tourniquets, etc.), immobilize fractures, and family or other health care provider administered medications for pain control.
4.1.2.1.3. Existing IV lines may be in place and, if so, shall be monitored to the extent possible according to the provider’s level of certification and licensure.
4.1.2.2. Inappropriate Care for a Palliative Care Individual includes:
4.1.2.2.1. Pacing, cardioversion, and defibrillation
4.1.2.2.2. Initiation of IV therapy
4.1.2.2.3. EMS Initiated Medications - Except passive oxygen
4.1.2.2.4. CPR
4.1.2.2.5. Intubation (EOA, endotracheal, nasotracheal, or gastric tube)
4.1.2.2.6.. Pneumatic anti-shock garment (PASG)
4.1.2.2.7. Active ventilatory assistance, unless on an out individual ventilator.
4.1.3 Option C (Do Not Resuscitate) – “No Care Administered Of Any Kind”.
4.1.3.1. This option permits an individual to reject care of any kind provided there is a signed order clearly stating this course of action. Where this option is in place, no form of life saving efforts, including but not limited to, the opening of the airway, the administration of oxygen, or any other form of life-saving efforts will be administered by EMS personnel under any circumstances, unless the individual provides some form of communication as indicated in Section 3.1.2A.
5.0 Methods of Identification
5.1 Provided there is a signed PACD, or other approved Division of Public Health signed form, the following are acceptable for implementing the EMS PACD protocol:
5.1.1 Delaware EMS PACD Form
5.1.2 Delaware EMS PACD Wallet Card
5.1.3 Wrist Bracelet to include Medic-Alert Bracelet or other bracelet approved by the Director of the Division of Public Health.
5.1.4 Other State EMS PACD Form
5.2 Even if a signed PACD, or other approved Division of Public Health signed form is present, the following are not acceptable for implementing the EMS PACD protocol:
5.2.1 Advance directives without an EMS PACD
5.2.2 Facility specific PACDs
5.2.3 Notes in medical records
5.2.4 Prescription pad orders
5.2.5 PACD stickers
5.2.6 Any oral request.
5.2.7 Any other device or instrument not listed above as acceptable.
5.3 The Delaware EMS PACD must be completed for all individuals on a standard form approved by the Division of Public Health, and the form must be present.
5.4 If any question exists as to the identity of the individual identified on the Delaware EMS PACD form, the EMS provider shall seek to identify the individual through another form of positive identification.
5.4.1 If in doubt as to the identification of the individual, the EMS provider shall initiate resuscitative efforts.
6.0 Revocation of PACD
6.1 An EMS PACD may be revoked at any time by:
6.1.1 A written cancellation signed by the individual.
6.1.2 An oral statement or gesture of any manner by the individual in the presence of two (2) witnesses, one of whom is a health care provider, requesting only palliative care or resuscitation. If the individual revokes an EMS PACD orally, the EMS PACD notification devices do not need to be destroyed. EMS providers should thoroughly document the circumstances of the revocation. An oral revocation by an individual is only good for the single response or transport for which it was issued.
6.2 During an emergency, when the authorized decision maker is not the individual, this individual cannot revoke an EMS PACD. Because of the difficulty in identifying authorized decision makers in emergent situations, it is incumbent upon an authorized decision maker who has authority to revoke an EMS PACD to do so prior to the emergency if they wish resuscitation for the individual. Under no circumstances, can a person or entity, other than the individual, revoke an EMS PACD during an emergency.
7.0 Section 2513(b) of the Health Care Decision Act (Code of Delaware) makes willful concealment, destruction, falsification or forging of an advance directive, without the individual’s or authorized decision maker’s consent, a class C felony.
8.0 Field Termination
8.1 Nothing in these regulations shall effect the power of EMS providers to do the paramedic field termination of resuscitation protocol as approved by the Delaware Board of Medical Practice.
9.0 Protocol
9.1 The Division of Public Health, in consultation with the Board of Medical Practice and the Delaware Fire Prevention Commission, shall develop and publish a protocol for EMS providers to comply with the requirements of this regulation.
10.0 Limitations of Liability
10.1 In addition to other immunity that may be provided for in law, Section 2510 of the Health Care Decisions Act provides the specific immunity in cases involving the provision, withdrawal, or withholding of care which may be life sustaining in nature.
10.1.1 EMS providers are not subject to criminal prosecution or civil liability or deemed to have engaged in unprofessional conduct as determined by the appropriate licensing, registering, or certifying authority as a result of withholding or withdrawing any health care under authorization obtained in accordance with the Health Care Decisions Act.
11.0 Data Collection/Program Evaluation
11.1 The Division of Public Health shall provide appropriate information, education and training on the EMS PACD Program to health care providers.
11.2 The Division of Public Health shall provide forms for Delaware licensed physicians and hospices, or other authorized health care providers.
11.3 The Division shall monitor the use of EMS PACDs as presented to EMS providers.
11.4 The Division shall take such measures as necessary to assure individual confidentiality.
12.0 Reciprocity
12.1 Standardized EMS DNR from another State approved by the Director of the Division of Public Health shall be honored.
12.2 EMS providers shall treat out-of-state EMS DNR’s as Limited (Palliative) Care Only Before Arrest PACD individuals.