DEPARTMENT OF HEALTH AND SOCIAL SERVICES
Office of Emergency Medical Services
ORDER
Pre-Hospital Advanced Care Directive Regulations
Nature Of The Proceedings:
Delaware Health and Social Services (“DHSS”) initiated proceedings to adopt State of Delaware Pre-Hospital Advanced Care Directive Regulations. The DHSS proceedings to adopt regulations were initiated pursuant to 29 Delaware Code Chapter 101 and authority as prescribed by 16 Delaware Code, Chapter 97.
On November 1, 2002 (Volume 6, Issue 5), DHSS published in the Delaware Register of Regulations its notice of proposed regulations, pursuant to 29 Delaware Code Section 10115. It requested that written materials and suggestions from the public concerning the proposed regulations be delivered to DHSS by December 1, 2002, or be presented at a public hearing on November 26, 2002, after which time DHSS would review information, factual evidence and public comment to the said proposed regulations. During the public hearing it was announced that the public comment period would be extended to December 31, 2002, to allow additional time to review the proposed Pre-Hospital Advanced Care Directive form.
Verbal and written comments were received during the public comment period and evaluated. The results of that evaluation are summarized in the accompanying “Summary of Evidence.”
Findings Of Fact:
The Department finds that the proposed regulations, as set forth in the attached copy should be adopted in the best interest of the general public of the State of Delaware.
The proposed regulations include modifications from those published in the November 1, 2002, Register of Regulations, based on comments received during the public comment period. These modifications are deemed not to be substantive in nature.
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Pre-Hospital Advanced Care Directive Regulations are adopted and shall become effective July 10, 2003, after publication of the final regulation in the Delaware Register of Regulations.
Vincent P. Meconi, Secretary, 6/13/2003
Summary Of Evidence
A public hearing was held November 26, 2002 at 9:00 a.m., in the Conference Room of the Office of Emergency Medical Services, Blue Hen Corporate Center, Suite 4-H, 655 S. Bay Road, Dover, Delaware before David P. Walton, Hearing Officer, to discuss the proposed Department of Health and Social Services (DHSS) Pre-Hospital Advanced Care Directive Regulations. Announcements regarding the public hearing were published in the Delaware State News, The News Journal and the Delaware Register of Regulations in accordance with Delaware Law. Andy Kloepfer from the Office of Emergency Medical Services (OEMS) of the Division of Public Health (DPH) made the agency’s presentation. Attendees were allowed and encouraged to discuss and ask questions regarding all sections of the proposed regulations. Testimony was given at the public hearing and six letters were received commenting on the proposed regulations during the public comment period (November 1, 2002 through December 31, 2002). Organizations that commented on the proposed regulations included:
• Delaware Health care Facility Association
• Christiana Care Hospital Services Ethics Committee
• Governor’s Advisory Council for Exceptional Citizens
• State Council for Persons with Disabilities
• Courtland Manor Inc., Nursing and Convalescent Home
• Kent County Department of Public Safety, Emergency Medical Services Division
All public comments and the DHSS (Agency) responses are as follows:
• Would emergency medical services (EMS) respect an Advanced Directive?
Agency Response: The purpose for these regulations is to set the process whereby pre-hospital emergency medical service providers will know the wishes of a patient. Only Delaware Pre-Hospital Advanced Care Directive (PACD) forms authorized by these regulations will be recognized by pre-hospital emergency medical service providers.
• In Delaware for an Advanced Directive to be valid for a resident in a nursing home we have to have a representative come into the office with them and sign as witnesses; would this be a requirement for the PACD form?
Agency Response: No witnesses are needed, however a surrogate can complete the PACD form for a terminally ill person if the person is unable to do so. Physician signature is required on the PACD form.
• Has there been any communication between the Office of Emergency Medical Services and the Division of Long Term Care Residents Protection through survey or anything of written regulation as to who is going to assume the responsibility of the protocols that are being followed?
Agency Response: Long Term Care Resident Protection is not required to make this a survey issue. Electing to have a Pre-Hospital Advanced Care Directive is a self-determination and personal choice matter, not a mandated program.
• Are the facilities that are going to be surveyed regarding these protocols going to be cited if there is a patient in their building that is terminal?
Agency Response: This is not a mandated program. This is about a person with a terminal illness choosing to have a Pre-Hospital Advanced Care Directive for purposes of alerting pre-hospital emergency medical service providers of his or her treatment wishes.
• Who has the responsibility for originating the request for the PACD form to be signed?
Agency Response: This is a personal choice made by each individual.
• Who is going to coordinate this information and educate health care system providers and physicians regarding this regulation and PACD form?
Agency Response: The Office of Emergency Medical Services will coordinate training for health care providers and physicians to include training in each county during the Summer of 2003.
• Who is going to be held liable if the physician does not comply with the completion of the form?
Agency Response: It is beyond the scope of these regulations to assign liability if a physician refuses to sign a patient’s Pre-Hospital Advanced Care Directive form.
• Does this form negate the need for a living will or power of attorney?
Agency Response: No. The PACD form is different and has a different purpose than a living will or power of attorney. The PACD form is specifically designed for pre-hospital EMS providers to determine a terminally ill patient’s treatment wishes.
• If the person is terminal and they have this form (PACD) and they can think through the form, do they also need to have a living will or power of attorney?
Agency Response: The living will, power of attorney and PACD form are separate documents used for different purposes. EMS and the Department will not require a living will or a power of attorney if the PACD form is properly completed and signed by a physician.
• Does the PACD form supercede any other forms?
Agency Response: The PACD form does not supercede any other forms. This is the first of its kind designed specifically for the pre-hospital EMS provider.
• If a person has an Advanced Health Care Directive and is terminally ill, but has not completed a PACD form, will pre-hospital EMS providers ignore the Advanced Health Care Directive?
Agency Response: If a person does not have a properly completed PACD form signed by a physician, pre-hospital EMS providers will follow established resuscitative medical protocols and follow hospital medical direction.
• The “Purpose” section of the regulation includes some questionable representations. For example, it recites that living wills, powers of attorney, and other advance directives do not apply to the pre-hospital environment. To the contrary, the Health-Care Decisions chapter ostensibly includes paramedics under its definition of “health care provider”, i.e., “an individual licensed, certified, or otherwise authorized or permitted by law to provide health care in the ordinary course of business or practice of a profession” [Title 16 Del.C. Sec. 2501(j)]. In general, “health care providers” are directed to comply with an “individual instruction” [Title 16 Del.C. Sec. 2508(d)]. Moreover, the above Sec. 9706(h) manifests a legislative expectation that EMS providers will recognize and honor directives consistent with regulatory standards. Although the Health-Care Decisions chapter also provides that “The initiation of emergency treatment shall be presumed to represent a suspension of an advance health-care directive while receiving such emergency treatment [Title 16 Del.C. Sec. 2504(f)], the effects of this provision is apparently limited by the later enacted Sec. 9706(h) and the presumption may arguably be rebutted by actual knowledge of the directive.
Agency Response: In accordance with Title 16 Del.C. Sec. 9706(h), this regulation specifically applies to EMS providers certified by the Delaware State Fire Commission (Basic EMTs--Emergency Medical Technicians) or the Office of Emergency Medical Services (Paramedics). Additionally, this regulation provides a Delaware Prehospital Advanced Care Directive Form and defines pre-hospital advanced care directive procedures to be used by and for terminally ill patients only. The whole purpose of these regulations is to give a person with a terminal illness the choice as to what type of pre-hospital emergency treatment they desire. In the pre-hospital emergency environment, EMS providers will now have clear, verifiable, and readily recognizable guidance to follow by the presence of a properly executed Prehospital Advanced Care Directive Form. In the absence of a properly executed Prehospital Advanced Care Directive Form, the on-scene EMS provider will follow established emergency medical protocols and emergency medical direction. The Department’s assigned Deputy Attorney General reviewed these Regulations in relationship to the Health-Care Decisions chapter of Title 16 Del.C. and found them to be legally adequate.
• The definitions [Sec. 1.0] are generally derived verbatim from the statute, Title 16 Del.C. Sec. 2501. However, the reference to “terminal illness” should preferably be amended to refer to “terminal condition”. This is the term used in the statute [Title 16 Del.C. Sec. 2501(r)]. Moreover, a “condition” is broader than “illness”.
Agency Response: In accordance with 16 Del.C. Sec. 9706(h)(1), “The regulation shall define pre-hospital advanced care directive procedures to be used for terminally ill patients only.” Based on this statute and advice from the Department’s Deputy Attorney General, terminal illness was used in the regulation.
• Section 3.2 of the regulations is unduly restrictive in representing that blindness, illiteracy, or paralysis of one hand are examples of physical inability to sign a PACD. The Delaware Code [Title 1 Del.C. Sec. 302(23)] provides that a “mark” suffices as a signature if a person cannot write his or her name.
Agency Response: The Department lists these conditions as examples of conditions that “may” prevent a person from being able to physically sign the PACD form. The word “may” was purposely used in this sentence to make this a not all-inclusive statement. Certainly if a person has the legal capacity and is physically able to sign or provides that person’s mark, no agent or surrogate would be necessary.
• The liability limitation section (Sec. 10.0) omits the good faith standard of the statute, Title 16 Del.C. Sec. 2510(b). The regulatory immunity provision is narrower. For example, if an EMS provider made a good faith mistake and did not follow the letter of the Health Care Decisions Act, he would qualify for immunity under the statute but not the regulation.
Agency Response: Section 10.1 of the regulation clearly acknowledges all immunity provided to EMS providers by 16 Del.C., Chapter 25 (Health-Care Decisions). Additionally, in the regulation the Department included immunity for EMS providers from 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 chapter.
• The reciprocity section [Sec. 12.0] provides that an out-of-state EMS DNR form approved by the Division of Public Health will be honored but categorically treated as authorizing only Option B supports [Sec. 4.1.2]. If the out-of-state form clearly requested Option A or Option C supports [Secs. 4.1.1 and 4.1.3], this should be honored. See Title 16 Del.C. Sec. 2517.
Agency Response: As result of this comment and after careful review of the law, the Reciprocity section of the regulation was amended to clarify that out-of-state EMS DNR forms that are approved by the Director of Public Health will be honored under the appropriate Prehospital Advanced Care Directive Option A, B or C.
• The regulations do not seem to cover the statutory prohibition on withholding life sustaining procedures if an individual is pregnant. Compare Title 16 Del.C. Sec. 2503(j).
Agency Response: Based on this comment and after careful review of the law, Section 8.0 of the Pre-Hospital Advanced Care Directive Regulations has been amended to include requirements per the statute indicated.
• The regulations do not seem to cover the statutory authority of an EMS provider to decline to honor a directive based on conscience. Section 4.0 contemplates that the EMS provider will only provide services listed in the regulation, without exception. For example, Option C recites that no form of life saving efforts will be administered by EMS personnel under any circumstances. Under the statute, the EMS provider is authorized to decline to honor the directive based on conscience. Title 16 Del.C Sec. 2508(e).
Agency Response: Based on this comment and after careful review of the law, a paragraph addressing matters of conscience was added to Section 4.0 of the Pre-Hospital Advanced Care Directive Regulations.
• It is very confusing and misleading to call these regulations and the subsequent form “Pre-Hospital Advance Care Directives” then continually follow that with.... (Do Not Resuscitate Orders). This is very confusing and could easily be remedied by simply calling the whole thing “State-wide Do Not Resuscitate Orders”.
Agency Response: In accordance with 16 Del.C. Sec. 9706(h), pre-hospital advanced care directive is the only language authorized to identify the form a terminally ill person may execute to choose pre-hospital emergency treatment options. Additionally, 16 Del.C. Chapter 25, Health-Care Decisions, does not use Do Not Resuscitate Orders terminology. As a result of this comment the words do not resuscitate orders were eliminated from both the Purpose and Definition section of the Regulations. The actual words “Do-Not-Resuscitate-Orders” are now only used twice in the Reciprocity section of the Regulations for clarification purposes. It is important to note that the letters “DNR” are used in the regulation and are assigned the meaning Do Not Resuscitate.
• It is reasonable to have a three tiered approach from more intensive to less intensive life-sustaining interventions, but the descriptions on the Prehospital Advanced Care Directive form for option A, B, and C should be changed to read:
Option A—Maximal restorative care before arrest, then DNR
(This would allow the use of intubation, IV drugs, pressors, cardioversion, but not CPR and defibrillation). The goal of care here is to do everything possible to stabilize the patient and prevent cardiopulmonary arrest.
Option B—Limited restorative care before arrest, then DNR
(This would allow ‘less invasive’ life sustaining care such as IV drugs, NIPPV, oxygen, but not intubation, pressors, cardioversion/defibrillation, or CPR. The goal of care here is to do less invasive life-sustaining care with more emphasis on palliative care and comfort.
Option C—Comfort care only
(This could include oxygen, oral airway, IV drugs aimed at relieving pain or distress such as morphine or lasik, positioning, or transport). The goal of care here is to relieve suffering and provide comfort and not to sustain life.
Agency Response: Under Option A, the full scope of the Delaware Statewide Advanced Life Support (ALS) treatment must be provided to the individual who has selected this option. Therefore, in addition to intubation, defibrillation and CPR would be required to be administered by the EMS field responder under the full scope of restorative interventions permissible under the Delaware Statewide ALS treatment protocol.
Currently, Option B as presented in section 4.0 of the PACD Regulations encompasses both limited care and comfort care for control of signs and symptoms. Additionally, the law uses very prescriptive language that states, “Option B (Basic Life Support) – Limited (Palliative) Care Only Before Arrest....”
Finally in addition to Option A and B above, it was recommended by the Department of Health and Social Services Deputy Attorney General that “Option C (Do Not Resuscitate (DNR)) – No Care Administered of Any Kind” be included as an option for those terminally ill individuals who would want this option.
• As written these regulations are fuzzy-feel good regulations with self contradicting provisions with an overall affect of restricting personal choice in health care.
Agency Response: The proposed regulations were written in accordance with Delaware Code Title 16, Chapter 25, ‘Delaware Death with Dignity Act’. They were written solely for the intent of treatment by emergency medical services (EMS) personnel in the field responding to 911 calls. In accordance with the above referenced Code, the Regulations are specifically centered on those individuals with a terminal illness. The Regulations clearly outline the three optional methods a patient may request in conjunction with their primary physician, and which the EMS field responder personnel are allowed and required to follow and adhere to.
• Section 3.1 clearly requires the diagnosis of a terminal illness before a PACD is effective, appears to allow the creation of a PACD in advance of such declaration. How will EMS personnel differentiate PACD which are effective from those which aren’t? Neither the form nor wallet card has any mention of terminal illness.
Agency Response: In accordance with Delaware Code Title 16, Chapter 25, ‘Delaware Death with Dignity Act’, a Prehospital Advanced Care Directive (PACD) may and will only be issued to an individual by their primary care physician upon the diagnosis and prognosis of a terminal illness. EMS field responder personnel summoned by a 911 call will only honor the one PACD form. Any other similar type form (i.e. internal nursing facility forms, living wills etc....) will not be honored by the EMS field responder personnel. The form does indeed clearly indicate the acknowledgement of terminal illness. At the very top of the first page of the form in bold letters it states, “Pre-Hospital Advanced Care Directive (PACD) For Terminal Illness Only”. In addition, the first sentence of the form reads as follows: “ I, ______________ (please print fill name), request the following emergency medical care in the event I am incapacitated due to my terminal illness, as herein described”. While it is true the proposed draft wallet identification card does not make mention of terminal illness, it must be signed by individual’s treating physician, and therefore is assumed that the terminal illness exists.
• The wallet card is useless duplication and worse would give false belief that advanced directive would be met if you carry the card. In fact you must have the form alone or both form and wallet card for it to be honored. This is very confusing and a waste of time and effort.
Agency Response: The use of a wallet card is a secondary protective method in conjunction with the signed PACD form to ensure the patient’s wishes are carried out and adhered to. In certain circumstances, and EMS field responder could be alerted to the fact that a PACD form exists for an individual through the realization of an individual’s wallet card or wrist bracelet.
• In accepting other states EMS-DNR’s as Option B, the terminal illness issues is circumvented as such a requirement is not necessarily in play elsewhere.
Agency Response: It important to keep the proposed Regulations in perspective. Delaware law does not allow for a Do-Not-Resuscitated (DNR) order. And, the proposed PACD Regulations, in keeping with the law, only allows for individuals diagnosed with a terminal illness by a licensed physician to be able to obtain a PACD. Option B allows for the control of signs and symptoms (comfort acre) before patient arrest. This method of treatment would still allow for an individual’s out-of-state “DNR” order to be honored, but without violating Delaware law and regulation.
• Acceptance of a Medic Alert Bracelet in lieu of the PACD both the terminal illness and physician declaration are by passed. While we favor this approach it does not in essence invalidate the entire regulation.
Agency Response: The presence of a medical bracelet, be it Medic Alert or some other type of bracelet, falls into the same category as the wallet card. It is merely a secondary form of the individual’s wishes, to be used in conjunction with; not in lieu of, the physician signed PACD form. Section 5.0, Methods of Identification, of the proposed PACD Regulations, clearly states: “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”. The bracelet and wallet card are not acceptable in lieu of the signed PACD form; they are acceptable in conjunction with the signed PACD form.
• The regulation conflicts with the Federal Advance Directives Act which requires that any health care provider, who receives federal funding, abide by the Advanced Directives of the patient in whatever form and without regard to a diagnosis of a terminal condition. This regulation therefore puts providers in a position of violating Federal Law or simply not calling for emergency ambulance transport.
Agency Response: Currently, there are eight (8) states without any form of PACD/DNR laws on the books: Delaware, Iowa, Mississippi, Nebraska, North Dakota, Pennsylvania, South Dakota, and Vermont, as well as the District of Columbia. Federal laws of this type do not mandate each individual state’s healthcare laws, as any Federal funding received by an individual state is not specifically mandated for PACD and DNR protocols. Therefore, it is not a violation of the law referenced in the comment. If a patient has a terminal illness, and does not in fact have a signed PACD form, an EMS field responder called to the individual’s location via 911 dispatch will receive full Advanced Life Support.
• Can inmates in prison elect to have a Pre-Hospital Advanced Care Directive?
Agency Response: Any resident of Delaware (including those incarcerated) who has a terminal illness may request a Pre-Hospital Advanced Care Directive from their primary physician. As long as the form and wallet identification card are filled out and signed by both the patient and the physician, then EMS personnel must honor the patient's wishes.
• In Option B it discusses some trauma type treatments. Historically EMS providers only looked at Do-Not-Resuscitate relating to medical conditions. Reading this, it implied that should a patient select Option B and was in a car crash the conditions would apply. Can this be clarified?
Agency Response: Option B Pre-Hospital Advanced Care Directive provides for making the patient comfortable, while not providing any type of life-saving care or effort. If the terminally ill patient is in a car accident, then yes, the PACD form and option selected would need to be followed by the EMS personnel on the scene.
• Are there 2 forms for PACD? It seemed from reading the Regulation that there could be one for the nursing homes and one for EMS providers.
Agency Response: The law and regulation authorizes only one Pre-Hospital Advanced Care Directive (PACD) form that will be recognized and followed by emergency medical service personnel in the pre-hospital emergency environment. Nursing homes may have other Advanced Care Directive forms in accordance with the Death with Dignity Act, but EMS personnel will only recognize the PACD form.
Additionally, minor grammatical, format and clarification changes were made to the proposed Regulations.
The public comment period was open from November 1, 2002 to December 31, 2002.
Verifying documents are attached to the Hearing Officer’s record. The Regulations have been approved by the Delaware Attorney General’s office and the Cabinet Secretary of DHSS.
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 an 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:
1. Selection and discharge of health care providers and institutions;
2. Acceptance or refusal of diagnostic tests, surgical procedures, programs of medication and orders not to resuscitate; and
3. 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 an individual no reasonable expectation of recovery from a terminal illness.
3. 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:
1. Prevent or reduce the deterioration of the health of an individual: or
2. 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. Conditions that 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 [pressure, pressure points, cold packs, tourniquets, etc.), immobilize fractures, and family or other health care provider administered medications for pain control.
4.1.2.1.2 pressure, pressure points, cold packs, tourniquets, etc.), immobilize fractures, and family or other health care provider administered medications for pain control.]
4.1.2.1.2[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 3.2]
[4.1.4 Nothing in this regulation will require an EMS provider to comply with a Pre-Hospital Advanced Care Directive for reasons of conscience.]
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), Chapter 25, Title 16 of the Delaware Code] 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 [affect effect] the power of EMS providers to do the paramedic field termination of resuscitation protocol as approved by the Delaware Board of Medical Practice.
[8.2 A life-sustaining procedure may not be withheld or withdrawn from a patient known to be pregnant, so long as it is probable that the fetus will develop to be viable outside the uterus with the continued application of a life-sustaining procedure. (70 Del. Laws, c.392, § 3.)]
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 Title 16 of the Delaware Code] 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 healthcare under authorization obtained in accordance with [the Health Decisions Act. Title 16, Chapter 25 of the Delaware Code.]
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 Do Not Resuscitate (DNR) orders] 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 orders] as Limited (Palliative) Care Only Before Arrest PACD individuals, [unless otherwise specified by the out-of-state Do Not Resuscitate (DNR) order.]