Title of Regulation: 12VAC5-66. Regulations Governing Durable Do Not Resuscitate Orders (amending 12VAC5-66-10).

Statutory Authority: §§ 32.1-12 and 32.1-111.4 of the Code of Virginia.

Public Hearing Information: No public hearings are scheduled.

Public Comment Deadline: November 2, 2016.

Effective Date: November 19, 2016.

Agency Contact: Michael Berg, Regulation and Compliance Manager, Office of Emergency Medical Services, Department of Health, 1001 Technology Park Drive, Glen Allen, VA 23059, telephone (804) 888-9131, FAX (804) 371-3108, or email michael.berg@vdh.virginia.gov.

Basis: Section 54.1- 2987.1 of the Code of Virginia provides for the ability for health care practitioners to honor a Durable Do Not Resuscitate Order.

Section 32.1-111.4 authorizes the Board of Health to promulgate regulations for Emergency Medical Services personnel to follow Do Not Resuscitate Orders pursuant to § 54.1.2987.1.

Purpose: The addition of physician order for scope of treatment (POST) within the definition of "Durable Do Not Resuscitate Order" will clarify for EMS providers and health care professionals working at medical facilities that the POST form is a recognized form of a Durable Do Not Resuscitate Order. The additional terminology will add to the health and welfare of the public in allowing another choice in end-of-life decision-making processes.

Rationale for Using Fast-Track Rulemaking Process: During the periodic review of this chapter, only four comments were submitted. All of the comments supported the addition of "POST" to the definition of "Durable Do Not Resuscitate Order." No other stakeholders have voiced any opposition to this recommended addition.

Substance: Within the definition of "Durable Do Not Resuscitate Order" in 12VAC5-66-10, add the following terminology:

""Durable DNR Order" shall also include a physician order for scope of treatment (POST) form. Durable DNR Orders including POST forms shall be completed and signed by a licensed practitioner and signed by the patient or patient's authorized representative."

Issues: The addition of the terminology of "POST" affords the public a clearer understanding of other acceptable "Durable Do Not Resuscitate" forms as identified within the regulations. This permits greater flexibility for practitioners and other allied health care workers to include the patient and emergency medical services providers in the utilization of documentation that clearly recognizes and acknowledges the patient's wishes concerning end of life decisions. There are no additional advantages to the Commonwealth. There are no disadvantages to the public, agency, or the Commonwealth.

Small Business Impact Review Report of Findings: This regulatory action serves as the report of the findings of the regulatory review pursuant to § 2.2-4007.1 of the Code of Virginia.

Department of Planning and Budget's Economic Impact Analysis:

Summary of the Proposed Amendments to Regulation. The State Board of Health (Board) proposes to clarify that a Physician Orders for Scope of Treatment (POST) form is an authorized form of a Durable Do Not Resuscitate (DNR) Order.

Result of Analysis. The benefits likely exceed the costs for all proposed changes.

Estimated Economic Impact. A Durable DNR Order is a written physician's order issued in a form or forms authorized by the Board to withhold cardiopulmonary resuscitation from an individual in the event of a cardiac or respiratory arrest. According to the Virginia Department of Health (VDH), some hospitals in Virginia started utilizing the POST form as a form of a Durable DNR Order with the approval of the Board about five years ago. However, some hospitals have been hesitant to use the POST form as an alternate form despite the Board's policy in the absence of it being addressed in regulation. The proposed change clarifies that the POST form is an authorized form of a Durable DNR order. Thus, the main effect of the proposed change is the clarification of the Board's existing policy on what is considered an authorized Durable DNR Order.

Businesses and Entities Affected. According to VDH, there are more than 51,000 physicians, nurse practitioners, and physician assistants in the Commonwealth. In addition, there are approximately 100 hospitals and 279 nursing facilities. The number of outstanding Durable DNR Orders or POST forms in Virginia is not known.

Localities Particularly Affected. The proposed changes apply statewide.

Projected Impact on Employment. The proposed change is not anticipated to create any impact on employment.

Effects on the Use and Value of Private Property. The proposed change is not anticipated to create any effects on the use and value of private property.

Real Estate Development Costs. No significant impact on real estate development costs is expected.

Small Businesses:

Definition. Pursuant to § 2.2-4007.04 of the Code of Virginia, small business is defined as "a business entity, including its affiliates, that (i) is independently owned and operated and (ii) employs fewer than 500 full-time employees or has gross annual sales of less than $6 million."

Costs and Other Effects. Most physician offices and nursing facilities are considered small businesses. The proposed change is not anticipated to create any significant costs or other effects on them.

Alternative Method that Minimizes Adverse Impact. No adverse impact on small businesses is expected.

Adverse Impacts:

Businesses. Most hospitals are considered non-small business. The proposed change is not anticipated to create any adverse impact on them.

Localities. No adverse impact on localities is expected.

Other Entities. No adverse impact on other entities is expected.

Agency's Response to Economic Impact Analysis: The Virginia Department of Health concurs with the results of the economic impact analysis.

Summary:

The amendment adds a physician order for scope of treatment form to the definition of the term "Durable Do Not Resuscitate Order."

Part I
Definitions

12VAC5-66-10. Definitions.

The following words and terms when used in this chapter shall have the following meanings unless the context clearly indicates otherwise:

"Agent" means an adult appointed by the declarant under an advance directive, executed or made in accordance with the provisions of § 54.1-2983 of the Code of Virginia to make health care decisions for him.

"Alternate Durable DNR jewelry" means a Durable DNR bracelet or necklace issued by a vendor approved by the Virginia Office of Emergency Medical Services. A Durable DNR Order must be obtained by the patient, from a physician, to obtain Alternate Durable DNR jewelry.

"Board" means the State Board of Health.

"Cardiac arrest" means the cessation of a functional heartbeat.

"Commissioner" means the State Health Commissioner.

"Durable Do Not Resuscitate Order" or "Durable DNR Order" means a written physician's order issued pursuant to § 54.1-2987.1 of the Code of Virginia in a form or forms authorized by the board to withhold cardiopulmonary resuscitation from an individual in the event of cardiac or respiratory arrest. For purposes of this chapter, cardiopulmonary resuscitation shall include cardiac compression, endotracheal intubation and other advanced airway management, artificial ventilation, defibrillation, administration of cardiac resuscitative medications, and related procedures. As the terms "advance directive" and "Durable Do Not Resuscitate Order" are used in this article, a Durable Do Not Resuscitate Order or other DNR Order is not and shall not be construed as an advance directive. When used in these regulations, the term "Durable DNR Order" shall include any authorized Alternate Durable DNR jewelry issued in conjunction with an original Durable DNR Order. "Durable DNR Order" shall also include a physician order for scope of treatment (POST) form. Durable DNR orders including POST forms shall be completed and signed by a licensed practitioner and signed by the patient or patient's authorized representative.

"Emergency Medical Services" or "EMS" means the services rendered by an agency licensed by the Virginia Office of Emergency Medical Services, an equivalent agency licensed by another state or a similar agency of the federal government when operating within this Commonwealth.

"Emergency medical services agency" or "EMS agency" means any agency, licensed to engage in the business, service, or regular activity, whether or not for profit, of transporting and/or or rendering immediate medical care to such persons who are sick, injured, wounded or otherwise incapacitated or helpless.

"Incapable of making an informed decision" means the inability of an adult patient, because of mental illness, mental retardation intellectual disability, or any other mental or physical disorder that precludes communication or impairs judgment, to make an informed decision about providing, withholding, or withdrawing a specific medical treatment or course of treatment because he is unable to understand the nature, extent, or probable consequences of the proposed medical decision, or to make a rational evaluation of the risks and benefits of alternatives to that decision. For purposes of this article, persons who are deaf or dysphasic or have other communication disorders but who are otherwise mentally competent and able to communicate by means other than speech, shall not be considered incapable of making an informed decision. The determination that the patient is "incapable of making an informed decision" shall be made in accordance with § 54.1-2983.2 of the Code of Virginia.

"Office of EMS" or "OEMS" means the Virginia Office of Emergency Medical Services. The Virginia Office of Emergency Medical Services is a state office located within the Virginia Department of Health (VDH).

"Other Do Not Resuscitate Order" or "Other DNR Order" means a written physician's order not to resuscitate a patient in the event of cardiac or respiratory arrest on a form other than the authorized state standardized Durable DNR Form under policies and procedures of the health care facility to which the individual who is the subject of the order has been admitted.

"Person authorized to consent on the patient's behalf" means any person authorized by law to consent on behalf of the patient incapable of making an informed decision or, in the case of a minor child, the parent or parents having custody of the child or the child's legal guardian or as otherwise provided by law.

"Physician" means a person licensed to practice medicine in the Commonwealth of Virginia or in the jurisdiction where the treatment is to be rendered or withheld.

"Qualified emergency medical services personnel" means personnel certified to practice as defined by § 32.1-111.1 of the Code of Virginia when acting within the scope of their certification.

"Qualified health care facility" means a facility, program, or organization operated or licensed by the State Board of Health or by the Department of Behavioral Health and Developmental Services (DBHDS) or operated, licensed, or owned by another state agency.

"Qualified health care personnel" means any qualified emergency medical services personnel and any licensed healthcare health care provider or practitioner functioning in any facility, program, or organization operated or licensed by the State Board of Health or by DBHDS or operated, licensed, or owned by another state agency.

"Respiratory arrest" means cessation of breathing.