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Delaware General AssemblyDelaware RegulationsMonthly Register of RegulationsJanuary 2016

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16 DE Admin. Code 4304
On November 1, 2015 (Volume 19, 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, 2015, after which time the DHSS would review information, factual evidence and public comment to the said proposed regulations.
First, in the definition of "Advance health care directive", the definition seeks to clarify that Advance Health Care Directives (AHCDs) that are valid where executed are to be honored in Delaware. However, the regulatory definition adds the phrase "valid under Delaware law" to the statutory definition. This language suggests that the only out of state AHCDs that are recognized in Delaware are ones that are valid where executed and in Delaware. This requirement would prove unworkable and is inconsistent with the statutory language in 16 Del. Code §2503A(a) and of 16 Del. Code §2517, which plainly states that AHCDs valid where executed are honored in Delaware, whether they strictly comport to Delaware law or not.
From this form, it appears that the Division intends, pursuant to 16 Del.C. §2511A (c), that a patient may revoke a named authorized representative 's authority to void or create a new DMOST only by expressly limiting such authority as evidenced by the patient's signature.
Authority to sign the DMOST under existing Advance Health-Care Directives ("AHCD") for an agent under 16 Del. Code Ch. 25. The proposed regulations at 4.9.1 state "[t]he health-care practitioner shall determine if there is an individual who is the patient's authorized representative. This is determined by referencing the documentation giving such individual the required authority under law. The documentation should establish both that the authorized representative is the person named in this role and that the authorized representative has the authority to sign the DMOST form on behalf of the patient." (emphasis added) Similar language appears at section 4.9.2.2 of the proposed regulations.
While 16 Del.C. §2503A (1) requires only that the authorized representative "has the authority to make decisions with respect to the patient's health-care preferences being made on the DMOST form," the proposed regulations may be construed so as to require an express grant of authority to actually sign the DMOST form.
Many individuals have previously executed a statutory AHCD as provided at 16 Del.C. §2505, or by using the form provided by the Delaware Department of Health and Social Services at http://www .dhss.delaware.gov /dsaapd / files/ad vancedirective.pdf (last visited November 11, 2015). Without modification, neither of these forms expressly grant the agent the "authority to sign the DMOST form on behalf of a patient."
4.9.3 If an authorized representative is executing a DMOST form for a patient without decision-making capacity that directs that life-sustaining treatment be withheld or withdrawn from such patient, the documentation relied upon by the health-care practitioner to determine the authorized representatives authority should indicate that the authorized representative has the authority to make the specific decisions that such authorized representative is indicating on a DMOST form, specifically decisions that direct that life-sustaining treatment be withheld or withdrawn. This is required because an order appointing a guardian of the person may not authorized that life-sustaining treatment be withdrawn or withheld (this is authority that is not part of a guardian of the person's general authority unless indicated in the court order appointing the guardian or a further order addressing the administration of life-sustaining authority), a medical power of attorney may not authorize withholding or withdrawing life-sustaining treatments, or only authorize withdrawing or withholding of life-sustaining treatment, until there has been a determination that the patient has certain conditions that physicians must certify (that a patient is in a permanently unconscious state or is in a terminal state), and a surrogate under the Delaware Surrogate Statute does not have the authority to authorize withholding or withdrawing life-sustaining treatments unless again the patient has certain conditions that physicians must certify (is in a permanently unconscious state or is in a terminal state). In such instances, even if a DMOST form is signed by an authorized representative, the authorized representative will not have the "appropriate authority." Then action taken by health-care providers that rely upon a DMOST form signed by an authorized representative of a patient who does not have the appropriate authority could expose the authorized representative and the health-care providers to liability for improperly withholding or withdrawing life-sustaining treatment from a patient. In the event that a health-care practitioner is unsure as to whether an authorized representative has the appropriate authority, he or she should confirm the authority with the legal authorities of the patient and/or the authorized representative.
THEREFORE, IT IS ORDERED, that the proposed State of Delaware Medical Orders for Scope of Treatment (4304) is adopted and shall become effective April 1, 2016, after publication of the final regulation in the Delaware Register of Regulations.
Purpose: There is a need to update the existing 2003 Pre-Hospital Advance Care Directive (“PACD”) regulations (7 Del. Reg. 85, July 1, 2003) to address the recognition of advance care directives across all health care settings, including, but not limited to, hospitals, long-term care facilities, hospices, emergency medical transport, and home care. As provided in Chapter 25 of Title 16 of the Delaware Code, advance care directives permit individuals to give instructions about their own health care in case they later lack the capacity to do so.
These regulations require the use of a designated form which can be readily recognized and verified during an emergency situation. Since the creation of the PACD form, the practice and use of similar forms has evolved in states across the country. The Medical Orders for Life-Sustaining Treatment (“MOLST”) form reflects the dominant national trend and is being adopted as an updated version of the PACD form.
Delaware’s current PACD loses its authority when a patient changes locations. Patients at the end of life often move from home to hospital to nursing home and with each move, forms and orders must be redone.
Emergency medical services (EMS) personnel work under the license of the State EMS Medical Director. In order for EMS personnel to honor an individual’s request related to end of life decisions, the EMS must have a medical order. The MOLST form serves both as the summary of the individual’s advance care planning decisions and as the medical order.
These MOLST/PACD regulations authorize the Division of Public Health/Office of Emergency Medical Services in conjunction with the Board of Medical Licensure and Discipline, the Delaware Fire Prevention Commission, and other key groups within the State to develop and implement MOLST/PACD protocol. These regulations, protocol, and form standardize the legal advance care directive documentation so that EMS and all health care providers have a readily recognizable form which sets forth the patients’ preferences regarding provision of life-sustaining treatments. The MOLST/PACD forms allow EMS and other health care providers both to identify and to honor an individual’s wishes to the greatest extent possible and to grant individuals the dignity, humanity, and compassion they deserve. Consistent with this intent, other health care providers may choose to honor this form. (Delaware MOLST, Medical Orders for Life-Sustaining Treatment, form is available in PDF format).
“Advance Health Care Directive” shall mean an individual instruction or power of attorney for health care, or both.
“Agent” shall mean an individual designated as power of attorney for health care to make a health care decisions 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, gastrostomies, 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.
Emergency Medical Services (EMS) Provider” shall mean individual providers certified by the Delaware State Fire Commission or the Office of Emergency Medical Services, within the Division of Public Health, Department of Health and Social Services or emergency certified medical dispatchers 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 Emergency Medical Services, or an emergency medical dispatch center under contract with the Department of Public Safety.
“EMS Prehospital Advanced Care Directive Order (PACD)” shall mean an advanced health care directive 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:
“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.
“Individual” means an individual person, legally adult.
“Individual Instruction” means an individual’s direction concerning a health-care decision for the individual.
Medical Orders for Life-Sustaining Treatment” (“MOLST”) means a specific order set for scope of medical treatment and provided on the MOLST form approved by the Division of Public Health.
“Medically Ineffective Treatment” means that, to a reasonable degree of medical certainty, a medical procedure will not:
“Office” shall mean the Office of Emergency Medical Services (EMS) within the Division of Public Health.
"PACD" means an EMS prehospital advanced care directive signed by the individual and the individual’s physician, on forms approved by the Director of Public Health.
Permanent Unconsciousness” means a medical condition that has existed for at least 4 weeks and that has been diagnosed in accordance with currently accepted medical standards and with reasonable medical certainty as total and irreversible loss of consciousness and capacity for interaction with the environment. The term includes, without limitation, a persistent vegetative state or irreversible coma. This condition must be certified in writing in the patient's medical record by the attending physician and by at least 1 other physician who shall be a board-certified neurologist and/or neurosurgeon.
“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 for the individual’s health care.
“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 or 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 patient who lacks capacity; and (4) are identified by the attending physician in accordance with 16 Del.C. §2507 as the person or persons who are to make those decisions.
“Terminal Condition” 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.
5.1.2.1.2 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.
16 Del.C. §2513(b) 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.
12.1 In addition to other immunity that may be provided for in law, 16 Del.C. §2510 provides specific immunity in cases involving the provision, withdrawal, or withholding of care which may be life sustaining in nature.
These DMOST regulations implement 16 Del.C. Ch. 25A which authorizes the Division of Public Health/Office of Emergency Medical Services, in conjunction with the Board of Medical Licensure and Discipline, the Delaware EMS Oversight Council, the Delaware State Fire Prevention Commission, and other key groups within the State to develop and implement DMOST regulations and protocol. These regulations, protocol, and form standardize documentation so that Emergency Medical Service (EMS) personnel and all health[-]care providers have a readily recognizable form which sets forth a patient’s preferences regarding the provision of and the scope of treatment. The DMOST form allows EMS personnel and other health[-]care providers both to identify and to honor an individual’s wishes to the greatest extent possible and to grant individuals the dignity, humanity, and compassion they deserve.
"Advance [hH]ealth-[cC]are [dD]irective (AHCD)” means an [aA]dvance [hH]ealth-[cC]are [dD]irective under 16 Del.C. Ch. 25, a durable power of attorney for health[-]care decisions, or any individual instruction or power of attorney for health care valid under Delaware law [because it is valid] in the state where such document was executed or where the individual executing such document was a resident at the time that such document appointing an agent was executed. Said document must have been executed by the individual authorizing the appointed agent to make decisions about the individual's health care when such individual no longer has decision-making capacity.
Decision-making capacity” means a patient's ability to understand and appreciate the nature and consequences of a particular health[-]care decision, including the benefits and risks of that decision and alternatives to any proposed health care treatment, and to reach an informed health[-]care decision.
Delaware Medical Orders for Scope of Treatment (DMOST)” means a clinical process to facilitate communication between health[-]care professionals and a patient living with serious illness or frailty whose health[-]care practitioner would not be surprised if the patient died within the next year or, if the patient lacks decision-making capacity, the patient’s authorized representative. The process encourages shared, informed medical decision-making.The decisions are memorialized [in on] a completed DMOST form, which contains portable medical orders that respect the patient’s goals for care with respect to the use of CPR and other life-sustaining treatments and medical interventions. The DMOST form is applicable across health[-]care settings, is reviewable, and [the patient controls if it] can be voided.
Department” means the Department of Health and Social Services.
DMOST form” means the standardized document created by the Department that is identified as an Attachment to these regulations, which:
Is used on a voluntary basis by a patient living with serious illness or frailty whose health[-]care practitioner would not be surprised if the patient died within the next year;
Is intended to provide direction to emergency care personnel regarding the use of emergency care and to health[-]care providers regarding the use of life-sustaining treatment by indicating the patient’s preference[s] concerning the scope of treatment, the use of specified interventions, and the intensity of treatment for each intervention;
Is intended to accompany the patient, and to be honored by all personnel attending the patient, across the full range of possible health[-]care settings, including but not limited to the patient’s home, a health[-]care institution, at the scene of a medical emergency, or during transport;
Must be signed by a health[-]care practitioner as defined below.
Emergency-care provider” means an emergency medical technician, paramedic, or first responder authorized under 16 Del.C. Ch 97.
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.
Health[-]care practitioner” means a physician or an individual licensed and authorized to write medical orders pursuant to 24 Del.C. Ch. 17 and Ch. 19 who is providing care for the patient or overseeing the health care provided to the patient and has completed all training required by the Department for individuals participating in the completion of a DMOST form. Over time, a patient’s health[-]care practitioner may change.
Health[-]care provider” means 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. A health[-]care practitioner is also a health[-]care provider.
Life-sustaining treatment” includes any medical intervention, including procedures, administration of medication, or use of a medical device, that maintains life by sustaining, restoring, or supplanting a vital function. It does not include care provided for the purpose of keeping a patient comfortable.
Patient” means an individual who is under the care of the health[-]care practitioner or health[-]care provider.
Patient’s authorized representative” or “authorized representative” means the individual signing a DMOST form on behalf of a patient without decision-making capacity, who has the highest priority to act for the patient under law, and who has the authority to make decisions with respect to the patient’s health[-]care preferences being made on the DMOST form. The health[-]care practitioner shall determine the individual who is the patient’s authorized representative by referencing the documentation giving such individual the required authority under law. Based on the documentation provided by such individual as evidence of his or her authority, the patient’s authorized representative could be an individual designated by a patient under an advance health-care directive, an agent under a medical durable power of attorney for health[-]care decisions, a guardian of the person appointed pursuant to 12 Del.C. Ch. 39 or Ch. 39A, in accordance with the authority granted by the appointing court, a surrogate appointed under 16 Del.C. Ch. 25, or an individual who is otherwise authorized under applicable law to make the health[-]care decisions being made by execution of the DMOST form on the patient’s behalf, if the patient lacks decision-making capacity.
Scope of treatment” means those medical interventions, procedures, medications, and treatments that a patient, in consultation with a health[-]care practitioner, has determined are appropriate, necessary, and desired by and for the patient and will always include the provision of comfort measures. A patient may decline life-sustaining treatment.
Serious illness or frailty” means a condition for which a health[-]care practitioner would not be surprised if a patient died within the next year.
2.1 The DMOST [Ff]orm, including instructions for completion and plain language explanation, is published in these regulations. The DHSS documents in these regulations may not be altered.
2.1.2.5 Section E contains information as to whom the DMOST form was discussed with and it contains a signature block [for where] the patient [to authorize, if they have decision-making capacity, can prohibit] an authorized representative [from voiding] the [ability to void the] DMOST form and [execute executing] a new DMOST form that changes the treatment choices if the patient loses decision-making capacity.
2.1.3 The Signature [blocks]. Section F contains the signature areas for the patient/authorized representative/parent and the health[-]care practitioner. To be valid the form must have [all both] required signatures [in this block].
3.1.4 Includes the signature of the patient’s health[-]care practitioner and the date and time of the health[-]care practitioner’s signature;
3.1.5 If the DMOST form is not signed by the heath-care practitioner in the presence of the patient, the DMOST form will also be signed by the health[-]care provider in whose presence the patient or, [if the patient does not have decision-making capacity,] the patient’s authorized representative [if the patient does not have decision-making capacity,] signed the DMOST form;
3.1.6 The DMOST form shall include a statement that the patient or, if the patient does not have decision-making capacity, the patient’s authorized representative, has been provided with the plain language [statement explanation] explaining the DMOST form, and the consequences of executing the DMOST form, including whether or not the DMOST form may be changed if the patient lacks decision-making capacity.
4.2 A DMOST form can only be used by a patient who is living with a serious illness or frailty whose health[-]care practitioner would not be surprised if the patient died within the next year.
4.3 The health[-]care practitioner must discuss the DMOST form directly with the patient, or if the patient lacks decision-making [capacity], [with] the patient’s authorized representative, prior to completion.
4.7 The patient may have decision-making capacity but be unable to communicate by speaking or writing. [Federal and State laws require that a health care facility provide effective communication for people with communication impairments.] In such situations:
4.7.1 The patient can make his or her health[-]care treatment decisions known through any method by which the patient usually communicates so long as the person interpreting the communication understands the method by which the patient is communicating and the substance of the communication; and
4.7.2 The communication [and how it occurred must be witnessed by the health care practitioner. How the communication occurred and why it is considered reliable] must be documented in the patient’s medical record; and
4.7.3 If a patient cannot physically sign a DMOST form but has communicated that [they want he or she wants] to sign the DMOST form, someone other than the patient can sign the DMOST form on behalf of the patient.
4.9.1 The health[-]care practitioner shall determine if there is an individual who is the patient’s authorized representative. This is determined by referencing the documentation giving such individual the required authority under law. The documentation should establish both that the authorized representative is the person named in this role and that the authorized representative has the authority to [sign make decisions with respect to the patient's health care preferences being made on] the DMOST form on behalf of the patient.
4.9.2 The hierarchy under Delaware [Ll]aw to act as the authorized[-]representative for [a person an individual] without decision-making capacity is as follows:
4.9.2.2 The patient’s most recently appointed Agent in an Advance Health[-]Care Directive or Health Care Power of Attorney, only with the appropriate authority;
4.9.2.3 If the there is no Guardian or Agent or if the designated Guardian or Agent is unavailable, or if the patient revoked an Advance Health[-]Care Directive pursuant to 16 Del.C. §2504, the Surrogate Statute applies and will allow either the individual named by the patient prior to losing decision-making capacity or if none, the individual recognized by the Surrogate Statute, 16 Del.C. §2507, to [act make decisions with respect to the patient's health care preferences being made on the DMOST form on behalf of the patient].
[4.10.1 In the absence of any legal activity to the contrary, biological parents and court-appointed guardians;
5.3 A patient with decision-making capacity[,] may, at any time, void his or her completed DMOST form or otherwise request alternative treatment to the treatment that was ordered on the DMOST form in any manner that indicates the patient’s intent to void the DMOST form.
5.4 If a patient does not have decision-making capacity, an authorized representative may void and/or request a new DMOST form, based on the known wishes of the [person patient], or if unknown, the [person’s patient's] best interest, if the authorized representative has the legal authority to do so and is [permitted to do not prohibited from doing] so on the existing DMOST form completed by the patient.
8.1 In the event of a disagreement between the patient’s authorized representative and the patient’s health[-]care practitioner concerning the patient's decision-making capacity or the appropriate interpretation and application of the terms of a completed DMOST form regarding the patient's course of treatment, the parties:
8.1.1 May seek to resolve the disagreement by means of procedures and practices established by the health[-]care institution, including, but not limited to, consultation with an institutional ethics committee, or with an individual designated by the health[-]care institution for this purpose; or
8.2 A health[-]care provider involved in the patient's care or an administrator of a health[-]care institution may seek to resolve a disagreement concerning the appropriate interpretation and application of the terms of a completed DMOST form to the patient's course of treatment in the same manner as set forth in 8.1.
8.3.1 If the treatment directives of a later Advance Health[-]Care Directive conflict with the patient's directives on a DMOST form, a health[-]care practitioner shall be informed so that the DMOST form can be modified or voided in order to reflect that patient’s later directive.
8.4.1 Is contrary to the most [recent recently] expressed wishes of a patient;
8.5 A health[-]care institution, health[-]care practitioner, or health[-]care provider acting in good faith and in accordance with generally accepted health[-]care standards applicable to the health[-]care institution, health[-]care practitioner, or health[-]care provider is not subject to civil or criminal liability or to discipline for unprofessional conduct for:
8.5.1 Complying with a DMOST form signed by a health[-]care practitioner apparently having authority to make a DMOST for a patient, including a decision to withhold or withdraw health care;
8.5.2 Declining to comply with a DMOST form based on a belief that the health[-]care practitioner then lacked authority to sign a DMOST;
9.3 The Division of Public Health shall take such measures as [are] necessary to assure individual confidentiality.
10.1 A DMOST [Ff]orm transfers with a patient and the medical orders indicated on a DMOST form are valid in every health[-]care setting in Delaware. Copies of a valid DMOST form are valid to the same extent as the original.
Q. What is DMOST?
A. The Delaware Medical Orders for Scope of Treatment (DMOST) form is a portable medical order form. It allows you to make choices about life-sustaining treatments, including among other treatments, CPR (resuscitation) and artificial nutrition.You may request full treatment, limited treatment, or comfort care only.
Q. Who is it for?
A. A DMOST form can be used by a person with a serious illness or frailty, whose health[-]care practitioner would not be surprised if [they the person] died within the next year.
Q. When should it be discussed and signed? Who signs it?
A. A DMOST form is completed after a conversation you have with a health care practitioner. It is signed by you and a physician (MD or DO), an advanced practice registered nurse (APRN), or a physician assistant (PA). The physician/APRN/PA signature makes the choices into portable medical orders.
Q. Who is required to follow the wishes documented on the DMOST form?
A. These orders will be followed by health care providers in any setting (ambulance, long-term care facility, emergency room, hospital, hospice, home, assisted living facility, etc.). It travels with you and is honored when you move to a new [setting location].
Q. Can someone else make DMOST decisions for me?
A. You make health[-]care decisions for yourself as long as you have decision-making capacity. You have the right to change your authorized representative at any time while you have decision-making capacity.
Q. What if I change my mind?
A. If your condition or your choices change, you or your authorized representative should void (cancel) your DMOST form and request a new DMOST be completed with your new choices. You can void a DMOST form if you change your mind but do not want to create a new one. You may not make any changes to the content of the DMOST form. If you want to change your DMOST form you must void your previous form and complete a new one with your health[-]care practitioner. If your DMOST form does not agree with your advance directive, the most recent document will be followed.
Q. Must I do this?
A. The DMOST form is always voluntary and can be voided at any time. A [Hh]ealth care organization is prohibited from requiring you to complete a DMOST form for any reason, including as part of a person’s admission to a health care facility.
It is important to understand that this [DMOST] form contains medical orders. It will be followed by health care providers. For example, if you choose “Do Not Attempt Resuscitation[,][,] and your heart stops, no attempt will be made to restart your heart. If you choose “Intubate/Use Artificial ventilation[,][,] then you may be placed on a breathing machine with a tube in your throat and transferred to an intensive care setting in a hospital.
Q. What will happen to my choices if I travel out of state?
A. Many states, including all the states in our region, currently use a form similar to the DMOST form. Forms from those states which are valid under the Delaware [Ll]aw will be honored in Delaware. DMOST forms will be honored in other states which have reciprocity.
Link to PDF of DMOST form:
Last Updated: December 31 1969 19:00:00.
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