PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 1001, 1003, 1005,
1007 AND 1051]
Out-of-Hospital Do-Not-Resuscitate Orders
[33 Pa.B. 4450] The Department of Health (Department) is proposing regulations to facilitate the continued implementation of 20 Pa.C.S. §§ 54A01--54A13 (relating to Do-Not-Resuscitate Act) (DNR Act), enacted by the act of June 19, 2002 (P. L. 409, No. 59) (Act 59), as assisted by the Department's interim regulations adopted at 32 Pa.B. 6117--6128 (December 14, 2002). The Department is proposing to continue the division of 28 Pa. Code Part VII (relating to emergency medical services), into Subparts A and B (relating to emergency medical services systems; and matters ancillary to emergency medical services systems), as accomplished by the Department's interim regulations. Subpart A contains regulations the Department has adopted under the Emergency Medical Services Act (EMS Act) (35 P. S. §§ 6921--6938). The interim regulations made amendments in Subpart A to §§ 1001.1--1001.5, 1003.27, 1005.3, 1005.10 and 1007.7. The interim regulations also adopted Subpart B, which contains Chapter 1051 (relating to out-of-hospital do-not-resuscitate orders). The proposed amendments are set forth in Annex A.
Purpose and Background
To facilitate the prompt implementation of the DNR Act, enacted June 19, 2002, effective August 18, 2002, Act 59 required that the Department adopt interim regulations by December 16, 2002. To expedite adoption of the interim regulations, Act 59 exempted their review by the designated standing committees in the House and Senate, and the Independent Regulatory Review Commission (IRRC). The Department adopted interim regulations on December 14, 2002. The interim regulations went into effect on March 1, 2003
Act 59 also requires that following the Department's adoption of interim regulations the Department is to adopt final regulations in accordance with customary rulemaking procedures by February 18, 2004. The Department is proposing these regulations as a prelude to its adoption of the final-form regulations by February 18, 2004.
Summary
Subpart A. Emergency Medical Services Systems The Department proposes to adopt the changes made by the interim regulations to each of the sections affected under Subpart A. Following are the reasons for this decision.
Section 1001.1. Purpose.
When the interim regulations divided Part VII into Subparts A and B, this section was amended to address the purpose of Subpart A rather than the purpose of Part VII. This continues to be appropriate since the Department is proposing to continue the division of its Emergency Medical Services Regulations into two distinct subparts.
Section 1001.2. Definitions.
This section was amended by the interim regulations to provide that the definitions in the section apply throughout Subpart A. The regulation had previously read that the definitions in the section applied throughout Part VII. The preamble to the interim regulations explained that the application of the definitions in this section to all of the regulations in Part VII was no longer practical since some of the terms defined in the section are given different definitions under the DNR Act and the definition section in Chapter 1051 under Subpart B. That explanation continues to apply.
Section 1001.3. Applicability.
This section identified the persons who were affected by Part VII. It had been amended by the interim regulations to identify only persons affected by Subpart A. This limitation remains appropriate.
Section 1001.4. Exceptions.
This section authorized persons to seek exceptions to regulations in Part VII that did not repeat statutory requirements. It was amended by the interim regulations to authorize persons to seek exceptions to only the regulations in Subpart A--that is, to regulations adopted under the EMS Act. Since Subpart A will not apply to the regulations in Subpart B, which are the regulations that facilitate implementation of the DNR Act, this distinction remains appropriate.
Section 1001.5. Investigations.
This section announced that the Department may investigate a possible violation of Part VII. It was amended by the interim regulations to announce that the Department may investigate a possible violation of Subpart A. This distinction remains appropriate for the same reason given in explaining the distinction discussed under the preceding section title
Section 1003.27. Disciplinary and corrective action.
This section addresses the Department's authority to discipline prehospital personnel. Prior to the Department's adoption of the interim regulations, one of the grounds for discipline was violating a duty imposed by Part VII. Subsection (a)(20) was amended by the interim regulations to provide that discipline may be imposed for violating a duty imposed by Subpart A. This limitation continues to be valid, as the Department's disciplinary authority under the EMS Act does not extend to conduct regulated by the DNR Act and the Department's regulations adopted under that act.
Section 1005.3. Right to enter, inspect and obtain records.
Prior to the Department's adoption of the interim regulations, this section addressed the duty of a ground ambulance service to cooperate with the Department when the Department was investigating a violation of Part VII. It was amended by the interim regulations to substitute ''Subpart A'' for ''Part VII.'' Under § 1007.1 (relating to general provisions) this amendment was also applicable to air ambulance services. The continued reference to only Subpart A remains appropriate.
Section 1005.10. Licensure and general operating standards.
This section addresses the standards that an entity needs to satisfy to become licensed as a ground ambulance service and continue to operate as a ground ambulance service. It was amended by the interim regulationsto require a ground ambulance service to maintain written policies and procedures to implement the requirements of Chapter 1051. The need for this requirement continues. The regulation identifies all of the policies that an ambulance service must keep. When the DNR Act was passed it established procedures that EMS personnel must follow when encountering a person in cardiac or respiratory arrest who displays a DNR order, bracelet or necklace. Ambulance services need to ensure that their personnel are aware of those procedures as well as the procedures required by the Department's regulations adopted under Act 59.
Section 1007.7. Licensure and general operating standards.
This section addresses the standards that an entity needs to satisfy to become licensed as an air ambulance service and continue to operate as an air ambulance service. It was amended by the interim regulations to require that an air ambulance service maintain written policies and procedures to implement the requirements of Chapter 1051. The need to continue this requirement for ground ambulance services applies as well to air ambulance services.
Subpart B. Matters Ancillary to Emergency Medical Services Systems Chapter 1051 was adopted by the interim regulations to facilitate implementation of the DNR Act. In addition, it assisted the implementation of an Act 59 amendment to 20 Pa.C.S. §§ 5401--5416 (relating to the Advance Directive for Health Care Act) (ADHCA) that directs emergency medical services (EMS) providers to follow the procedures for implementing an out-of-hospital DNR order when a patient who is experiencing cardiac or respiratory arrest has both an advance declaration issued under the ADHCA and an out-of-hospital DNR order issued under the DNR Act.
As explained in the preamble to the interim regulations, there are significant procedural differences between the two processes. Under the ADHCA, if a patient has issued an advance declaration that directs that no CPR be provided in the event of the patient's cardiac or respiratory arrest, the EMS provider cannot follow that directive until the provider contacts a medical command physician, the medical command physician determines that the declaration is operative, and the medical command physician directs the EMS provider to withhold or discontinue CPR. Under the DNR Act, the EMS provider is empowered to withhold CPR upon observing an out-of-hospital DNR order, bracelet or necklace displayed with the patient; the EMS provider is not required to contact a medical command physician to secure approval.
Except as otherwise noted, the Department is proposing to adopt the interim regulations with a few minor revisions. The reasons for this action are as follows.
GENERAL PROVISIONS Section 1051.1. Purpose.
This section addresses the purposes of the chapter. The primary purpose of the DNR Act and Chapter 1051 of the Department's regulations is to articulate standards for the issuance and revocation of out-of-hospital DNR orders, and compliance with those orders. Nevertheless, one component of the DNR Act departs from this general regulatory scheme. It deals with pregnant patients and establishes special rules that EMS personnel and other health care providers are to follow when dealing with pregnant patients. That section of the DNR Act sets forth specific rules for the administration of out-of-hospital DNR orders issued for pregnant patients. However, it also addresses other types of life-sustaining procedures, other types of orders and directives that address the withholding or withdrawing of life-sustaining procedures, and duties of health care providers (not only EMS personnel) when confronted with such orders. Consequently, this section was drafted in the interim regulations to announce that the chapter deals with special provisions relating to pregnant patients in addition to the general rules applicable to the issuance and revocation of out-of-hospital DNR orders and compliance with those orders. The reasons for this clarification continue to apply.
Section 1051.2. Definitions.
This section provides definitions for terms used in Chapter 1051. The preamble to the interim regulations discussed definitions in this section that required an explanation as to why they were drafted in the manner adopted. The definitions that were given special attention were the definitions of ''attending physician,'' ''EMS provider,'' ''EMS personnel,'' ''health care provider,'' ''patient,'' ''prehospital personnel'' and ''surrogate.'' The substance of that discussion is repeated as follows:
Attending physician
''Attending physician'' is defined in the interim regulations as it is defined in the DNR Act, except a sentence is added stating that a patient may have more than one attending physician. The Department proposes to retain the additional sentence included in the interim definition for several reasons. First, more than one physician may have primary responsibility for the medical care and treatment of a patient. For example, a patient may use a group practice in which multiple physicians handle the patient's medical care. It would be difficult to label one physician as the patient's attending physician if the patient receives services from more than one physician in a group practice. Another example of a patient having more than one primary physician is a patient who has cancer who sees an oncologist on a regular basis in addition to a primary care physician.
Second, depending upon a variety of circumstances it may be difficult for a physician to conclude that he is the ''exclusive'' attending physician. Also, a physician may believe that he or she is the patient's attending physician based upon the information the patient or a surrogate provides to the physician, but some information may be forgotten, withheld or not known by the patient or surrogate.
As a practical matter, a physician who is requested to issue an out-of-hospital DNR order for a patient needs to make a good faith judgment as to whether he is an attending physician of the patient based upon the medical care the physician provides the patient. If the physician determines that the circumstances of the physician-patient relationship do not enable the physician to make that determination, the physician should attempt to supplement that knowledge with information the physician secures after making reasonable inquiries of the patient or the patient's surrogate regarding the medical care the patient is receiving from other physicians.
Health care provider, EMS provider, EMS personnel and prehospital personnel
The DNR Act defines ''health care provider,'' ''[EMS] provider,'' and ''person.'' The Department does not construe the term ''health care provider'' to be restricted to individuals who provide health care. The statutory definition of ''health care provider'' uses the term ''person'' and includes ''personnel recognized'' under the EMS Act. The statute's definition of ''person'' is not limited to an individual. The Department construes the statute's definition of ''health care provider'' to include persons, not limited to individuals, who are licensed, certified or otherwise authorized under Commonwealth laws to administer health care in the ordinary course of their business or profession. Consequently, it interprets the statutory ''health care provider'' definition's reference to ''personnel'' recognized under the EMS Act, to serve as an example of health care providers and not as a limitation on the definition.
The DNR Act defines ''[EMS] provider'' to include each health care provider recognized under the EMS Act, and also an individual recognized to use automated external defibrillators (AEDs) under 42 Pa.C.S. § 8331.2 (relating to good Samaritan civil immunity for use of AEDs). Similar to the Department's interpretation of the statute's definition of ''health care provider,'' the Department interprets the statute's definition of ''[EMS] provider'' to include a person, not limited to an individual, that provides EMS pursuant to authority granted by the EMS Act. The Department's interim definitions of ''health care provider'' and ''EMS provider'' in this section reflect these interpretations.
Additionally, this section defines the terms ''EMS personnel'' and ''prehospital personnel.'' It employs the term ''prehospital personnel'' in defining ''EMS personnel,'' and it employs the term ''EMS personnel'' in defining ''EMS provider.'' Distinctions between ''EMS personnel'' and ''prehospital personnel'' are needed to accommodate the DNR Act's inclusion of persons who have AED good Samaritan civil immunity as an EMS provider authorized to follow an out-of-hospital DNR order.
''Prehospital personnel'' is defined in § 1001.2 (relating to definitions) of the regulations the Department has adopted under the EMS Act, to include ambulance attendants, first responders, EMTs, EMT-paramedics (paramedics), prehospital registered nurses (PHRNs), and health professional physicians. It does not include persons who have AED good Samaritan civil immunity. These persons are not regulated under the EMS Act. The same definition of ''prehospital personnel'' is included in this section. These individuals are authorized by the EMS Act to perform various services for ambulance companies.
Some parts of Chapter 1051 address the responsibilities of both prehospital personnel and good Samaritan users of AEDs, and other parts address the responsibilities of prehospital personnel exclusively. The latter provisions deal with the relationship between prehospital personnel and medical command physicians-a relationship that good Samaritan users of an AEDs do not experience. To distinguish between provisions of the regulations that apply to both prehospital personnel and good Samaritan users of AEDs, and those provisions that apply to prehospital personnel only, the Department defined the term ''EMS personnel'' in the interim regulation to include both types of personnel and uses that term in provisions that apply to both types of personnel. The Department uses the term ''prehospital personnel'' in provisions that apply to prehospital personnel, but do not apply to good Samaritan users of AEDs.
Patient
The DNR Act defines ''out-of-hospital do-not-resuscitate patient'' to be an individual for whom an out-of-hospital DNR order has been issued. It defines ''patient'' to mean the same thing, unless the context indicates otherwise. As used in the DNR Act, ''patient'' and ''out-of-hospital do-not-resuscitate patient'' are not interchangeable. ''Patient'' is employed, for example to refer to an individual who is qualified to receive an out-of-hospital DNR but for whom an out-of-hospital DNR order has not been issued. The interim regulations' definition of ''out-of-hospital [DNR] patient'' appears as it does in the statute. The definition of ''patient'' in the interim regulations applies to an individual who qualifies for an out-of-hospital DNR order by virtue of being in a terminal condition or being in a state of permanent unconsciousness, but who has not received the order. Because this is how the two terms are actually used in the DNR Act, the proposed regulations would continue this distinction.
Surrogate
The DNR Act permits a patient's surrogate to request an out-of hospital DNR order for the patient and to revoke that order. It does not define ''surrogate.'' In the context in which this term is used in the statute, it means a person who has, or persons who jointly have, legal authority to request or revoke an out-of-hospital DNR order. The Department proposes to adopt these definitions and the other definitions in the interim regulation because they continue to be appropriate within the context of the chapter.
§ 1051.3. Applicability.
This section of the interim regulations identifies the major categories of persons to which the chapter applies. It also clarifies that the chapter does not regulate the issuance or implementation of a DNR order executed or to be executed in a hospital, but that it does authorize compliance with an out-of-hospital DNR order in all other settings, including other health care facilities and facilities regulated by other Commonwealth agencies, such as personal care facilities regulated by the Department of Public Welfare. Additionally, it relates that even in a hospital an EMS provider may comply with an out-of-hospital DNR order if the hospital requests an ambulance service to provide EMS to a patient.
Hospital requests for an ambulance service's assistance occasionally occur when an out-of-hospital DNR patient is receiving services at a hospital site that does not handle emergency patients. Notwithstanding the statutory label of ''out-of-hospital [DNR] order,'' a purpose of the DNR Act is to require EMS providers to withhold the execution of standard life-saving protocols when they are called to handle a patient with an out-of-hospital DNR order, bracelet or necklace who is experiencing respiratory or cardiac arrest. Therefore, the proposed regulations would adopt the same applicability provisions that appear in the interim regulation.
PATIENT AND SURROGATE RIGHTS AND RESPONSIBILITIES § 1051.11. Patient qualifications to request and revoke out-of-hospital DNR order.
The DNR Act identifies the types of patients who qualify to request an out-of-hospital DNR order for themselves. It also provides that even if the patient's surrogate requests the order, the patient may revoke it. The interim regulation incorporates that information. It also includes a statement that the patient for whom an out-of-hospital DNR order has been issued may revoke it regardless of that individual's age or physical or mental condition. This is consistent with the provisions of section 54A05(b) and (c) of the DNR Act, which provide that even if the order was secured by a surrogate, the patient may revoke the order regardless of the patient's physical or mental condition. For these reasons, the Department does not propose to change the interim regulation.
§ 1051.12. Surrogate's authority to request and revoke out-of hospital DNR order.
The DNR Act provides that a patient's surrogate may request an out-of-hospital DNR order for the patient if the patient meets certain criteria, and then may later revoke the out-of-hospital DNR order. The interim regulation includes that information. It also explains that the age or physical or mental condition of the patient does not impact the ability of a surrogate to act on the patient's behalf.
This latter provision may seem confusing at first, especially with respect to age. The key to properly understanding this provision is to focus on the fact that the section only applies to persons who satisfy the definition of ''surrogate'' at the time of acting on behalf of a patient. This section does not apply if the age of the patient invalidates the authority of another person to act for the patient, because under that circumstance the person would no longer be the patient's surrogate. For example, if the parent of a child acted as a surrogate for the child before the child reached 18 years of age, and by virtue of the child achieving that age the parent or guardian ceases to qualify to serve as the child's surrogate by operation of law, this section would not apply because the parent would no longer be the child's surrogate. However, a parent or guardian of a child would continue to serve as the surrogate of the child after the child reaches 18 years of age if the child has also been adjudicated to be mentally incompetent. In that event the regulation would apply to the parent or guardian, since the parent or guardian would continue to satisfy the definition of ''surrogate,'' and the age of the child would be irrelevant. Also, persons over 18 years of age, when competent, may designate a surrogate to make decisions for them should they later become incompetent and in a terminal condition or permanently unconscious. For example that may occur by the patient issuing an advance directive for health care that designates another individual to act as the patient's surrogate.
The standards in this regulation continue to be appropriate and, therefore, warrant inclusion in the proposed regulations.
§ 1051.13. Person who loses authority to function as a surrogate.
The responsibilities of a person who loses the authority to function as a patient's surrogate are not addressed in the DNR Act. Subsection (a) of the interim regulation emphasizes that the authority to request an out-of-hospital DNR order for another person, and to revoke that order, is not necessarily an authority that lasts a lifetime. For example, a person may be appointed to act as the guardian of a patient and later be replaced as the patient's guardian.
Subsection (c) of the interim regulation imposes upon a person who has lost the authority to function as a patient's surrogate the duty to make a reasonable effort to contact the physician who issued the out-of-hospital DNR order for the patient to apprise the physician of the change in that person's status and to identify to the physician the patient's new surrogate if there is one. It also requires that person to provide the patient or a replacement surrogate, whomever is appropriate, with the name of the physician and other information to locate the physician. Although the name of the physician would not ordinarily need to be disclosed, since it is on the order, bracelet and necklace, disclosure of the name may need to occur if the DNR items were lost or destroyed. It is proposed that this subsection be advanced to subsection (b).
Subsection (b) of the interim regulation imposes upon a person who has lost the authority to serve as a patient's surrogate the duty to provide the attending physician with information to locate the patient if the physician contacts the former surrogate to advise that the physician misdiagnosed the patient's condition or made an error in determining that the condition was terminal or that the patient was permanently unconscious. This subsection repeats some of the requirements in subsection (b) of the interim regulation and only addresses a former surrogate's duty to cooperate with the patient's attending physician when the physician wants to advise that the physician misdiagnosed the patient's condition or made an error in determining that the condition was terminal or that the patient was permanently unconscious.
The Department proposes to revise this subsection to eliminate the redundancy and broaden its scope. As proposed, a former surrogate would have the duty to provide the physician with information to locate the patient or the patient's current surrogate when the physician contacts the former surrogate for the purpose of providing any information pertinent to the patient. Also, notwithstanding proposed subsection (b)'s requirement that the former surrogate make a good faith effort to contact the attending physician when that person loses surrogate status, the former surrogate may not have made that attempt or the attempt may have failed. This subsection would address the former surrogate's responsibility when contacted by the attending physician under those circumstances. The revised subsection (b) would be moved to subsection (c).
ATTENDING PHYSICIAN RESPONSIBILITIES § 1051.21. Securing out-of-hospital DNR orders, bracelets and necklaces.
This section of the interim regulations informs physicians about how they may secure out-of-hospital DNR orders, bracelets and necklaces. It provides that out-of-hospital DNR bracelets and necklaces are to be purchased from vendors with which the Department has contracted. It further relates that the Department will publish in the Pennsylvania Bulletin a notice identifying the name and address of the vendors. The section also relates that the Department will publish superseding notices in the Pennsylvania Bulletin if and when there is a vendor change.
The procedures in this regulation continue to be the procedures the Department chooses to employ and, therefore, the proposed regulations contain the same procedures. In addition to the use of a Pennsylvania Bulletin notice, the Department has also posted at its website, www.health.state.pa.us, a link to a purchase order form attending physicians may use to purchase out-of-hospital DNR orders, bracelets and necklaces.
§ 1051.22. Issuance of out-of-hospital DNR order.
This section of the interim regulations states that an attending physician may issue an out-of-hospital DNR order and specifies various duties the physician is required to perform before issuing the order. The Department continues to believe that the listed duties are appropriate.
§ 1051.23. Disclosure to patient requesting out-of-hospital DNR order.
This section of the interim regulations identifies the information a patient's attending physician must disclose to the patient before issuing an out-of-hospital DNR order requested by the patient. The regulation does not require the physician to provide the required information verbally, but the physician is required to ensure that the patient has received and understands all of the required information before issuing an out-of-hospital DNR order requested by the patient. The information the attending physician is required to disclose is available through a link at the Department's website. The Department invites physicians to access and copy that information and provide it to appropriate patients and surrogates. The Department continues to consider the disclosures required by the interim regulation to be appropriate.
§ 1051.24. Disclosure to surrogate requesting out-of-hospital DNR order.
This section of the interim regulations identifies the information a patient's attending physician must disclose to the patient's surrogate before issuing an out-of-hospital DNR order requested for the patient by the surrogate. The disclosure required by paragraph (3) of the interim regulation improperly uses the term ''health care provider'' instead of ''EMS provider.'' Subject to making that substitution, the proposed regulation would not differ from the interim regulation. As previously mentioned, the Department makes the required information available through its website and attending physicians are free to access it and provide it to surrogates.
§ 1051.25. Disclosure to patient when surrogate requests out-of-hospital DNR order.
This section of the interim regulations specifies the process the patient's attending physician must follow in deciding the information the physician will provide to the patient when the patient's surrogate requests an out-of-hospital DNR order. The Department continues to believe, as set forth in the regulation, that the physician and surrogate need to work together to identify the information that should be disclosed to the patient unable to make that decision for himself. A unique decision needs to be made for each patient after considering appropriate factors. However, no order should be issued if the attending physician and surrogate cannot reach an agreement.
§ 1051.26. Physician refusal to issue an out-of-hospital DNR order.
This section of the interim regulations prescribes the procedures an attending physician is to follow when the physician is not willing to issue an out-of-hospital DNR order for a patient who qualifies for the order. They require the physician to provide a minimal amount of assistance to enable the patient or surrogate to pursue the matter further with another physician. The Department continues to believe that these procedures are appropriate.
§ 1051.27. Providing out-of-hospital DNR bracelet or necklace.
This section of the interim regulations prohibits an attending physician's issuance of an out-of-hospital DNR bracelet or necklace without also issuing, or having previously issued, an out-of-hospital DNR order for the patient. The issuance of an order is imperative, since it documents that a qualified person applied for an out-of-hospital DNR order and any other DNR item provided and that the attending physician has made the necessary determinations before providing the item. The proposed regulation would not differ from the interim regulation.
§ 1051.28. Documentation.
This section of the interim regulations requires an attending physician to document in an out-of-hospital DNR order whether the physician also provided an out-of-hospital DNR bracelet or necklace for the patient. It also requires the physician to maintain a copy of the order in the patient's medical record. If the physician issues an order and provides the bracelet or necklace at a later time, this section further requires the physician to document in the patient's record the physician's issuance of a bracelet or necklace for the patient. This section is appropriate to retain as it ensures the attending physician's proper documentation and maintenance of pertinent patient information relevant to the physician's issuance of an out-of-hospital DNR item.
§ 1051.29. Duty to contact patient or surrogate.
This section of the interim regulations requires the attending physician to make a reasonable effort to contact the patient or the patient's surrogate, after having issued an out-of-hospital DNR order for the patient, if the physician discovers that the diagnosis of a terminal condition or permanent unconsciousness was in error. The proposed regulation would do the same. The need for this requirement should be obvious. When a physician determines that a medical diagnosis the statute imposes as a precondition to a physician issuing an out-of-hospital DNR order, was made in error, the physician needs to act in a good faith manner to remedy the error by retrieving and destroying the order, and any bracelet or necklace that the physician may have also provided based upon the incorrect diagnosis.
§ 1051.30. Physician destruction of out-of-hospital DNR order, bracelet or necklace.
This section of the interim regulations addresses a physician's responsibilities when a patient or the patient's surrogate returns or has been requested by the physician to return an out-of-hospital DNR order, bracelet or necklace because the physician has determined that a terminal condition or permanently unconscious diagnosis was in error. In addition to requiring the destruction of a returned DNR item, it also requires that the physician shall not mark his records to reflect that the item has been destroyed without having confirmed the destruction of the item. That confirmation may occur without the physician personally destroying or observing the destruction of the item but, in the absence of that, the confirmation of the destruction must be based upon a communication from a reliable person that the item has been destroyed. The proposed regulation would do the same.
EMS PROVIDER RESPONSIBILITIES § 1051.51. Implementation of out-of-hospital DNR order.
This section of the interim regulations deals with EMS provider compliance with out-of-hospital DNR orders and the procedures the provider is to follow if uncertain as to whether an out-of-hospital DNR order is valid or has been revoked. Distinctions are made between individual EMS providers who have good Samaritan civil immunity pro-tection for using an AED and individual EMS providers who are prehospital personnel. The distinctions are based upon the interaction prehospital personnel are able to have with medical command physicians and the general lack of access to medical command physicians by persons who use an AED with good Samaritan civil immunity protection. The proposed regulation would maintain these distinctions.
§ 1052.52. Procedure when both advance directive and out-of-hospital DNR order are present.
This section of the interim regulations explains that when an EMS provider observes both an advance directive for health care directing that no CPR be provided in the event of the patient's cardiac or respiratory arrest, and an out-of-hospital order, bracelet or necklace, the provider is to follow the procedure for complying with the out-of-hospital DNR order. The regulations simply repeat the directive under the Act 59's amendment to section 5413 of the ADHCA (relating to emergency medical services). The Department proposes to adopt the interim regulation with a minor change to correct the incorrect reference to the heading of § 1051.51 in the interim regulation.
PREGNANT PATIENTS § 1051.61. Pregnant patients.
This section of the interim regulations specifies preconditions to a health care provider complying with an order or direction to not provide nutrition, hydration, CPR and other life-sustaining procedures to a pregnant woman. This section essentially repeats the requirements of section 54A11 of the DNR Act (relating to pregnancy). The proposed regulation would do the same.
MEDICAL COMMAND PHYSICIAN RESPONSIBILITIES § 1051.81. Medical command physician responsibilities.
This section of the interim regulations addresses a medical command physician's responsibilities when communicating with an EMS provider who encounters an out-of-hospital DNR patient who is experiencing cardiac or respiratory arrest. Specific subsections address the medical command physician's responsibilities when the EMS provider communicates uncertainty as to whether an out-of-hospital DNR order has been revoked, and the medical command physician's responsibilities when the EMS provider advises that the provider has encountered a pregnant out-of-hospital DNR patient who is experiencing cardiac or respiratory arrest. The proposed regulation would do the same. While the DNR Act does not require an EMS provider who observes a displayed DNR order, bracelet or necklace to contact a medical command physician as a precondition to compliance with the DNR item, except when the patient is a pregnant patient, such contact may nevertheless occur, and is required to occur when the EMS provider encounters confusion. This section is necessary to clarify the medical command physician's responsibilities when contact is made.
ORDERS, BRACELETS AND NECKLACES FROM OTHER STATES § 1051.101. Recognition of other states' out-of-hospital DNR orders.
The DNR Act directs that EMS providers are to comply with out-of-hospital DNR orders issued in another state if that state's orders, bracelets and necklaces are issued in a manner consistent with the laws of the Commonwealth. This section of the interim regulations repeats that responsibility and explains how the Department will apprise EMS providers of the orders, bracelets and necklaces issued in other states that are acceptable in this Commonwealth. The proposed regulation would do the same. The DNR Act requires the bracelets and necklaces to include the printed name and signature of the attending physician, and other information about the attending physician. Due mainly to these requirements, the Department has found no out-of-hospital DNR bracelet or necklace that is effective in another state and meets the requirements of Pennsylvania law. The Department is continuing to review the laws and out-of-hospital DNR order formats applicable in other states to assess whether they comport with Pennsylvania requirements.
Effective Date
The final-form regulations will go into effect when adopted, which should occur on or before February 18, 2004, as required by the DNR Act.
Paperwork
The Department, under a duty imposed upon it by the DNR Act, has already developed an out-of hospital DNR order form, and the specifications for out-of-hospital DNR bracelets and necklaces, for attending physicians to issue for patients who qualify for those orders. A sample order form may be reviewed by using a link at the Department's website. However, to prevent persons other than physicians from securing the order forms, the website version has been marked as a sample. It cannot be copied and used as an order form. Physicians must secure out-of-hospital DNR order forms from the Department's contracted vendor.
The Department has also developed both an electronic and paper process for physicians to use to secure from the Department's contracted vendor out-of-hospital DNR order forms, as well as out-of-hospital DNR bracelets and necklaces. The form physicians are to use to order out-of-hospital DNR forms, bracelets and necklaces is available at a link to the Department's website. A physician may copy the purchase form and send it to the vendor by facsimile or regular mail. Purchase forms may also be secured directly form the vendor. The Department anticipates that it will continue to employ these procedures.
The Department has already completed the paperwork required to contract with a vendor to produce and provide the orders, bracelets and necklaces, and it has contracted with a vendor. It will need to repeat the process from time to time-whenever a contract is about to expire and the Department needs to enter into new contracts.
The Department has published a notice in the Pennsylvania Bulletin identifying the vendor from which attending physicians may procure out-of-hospital DNR order forms, bracelets and necklaces. The Department will also need to publish new notices if a new vendor or vendors are chosen in the future. The Department will also need to publish notices in the Pennsylvania Bulletin identifying states that provide out-of-hospital DNR orders, bracelets and necklaces that EMS providers are to follow, and describing the acceptable out-of-hospital DNR items.
Physicians are now required by the interim regulations to maintain information in patient medical records regarding the issuance of out-of-hospital DNR items, and they are also required to prepare the paperwork to enable them to secure and provide out-of-hospital DNR items for patients. The proposed regulations would not alter these responsibilities.
Financial Impact
The DNR Act and the proposed regulations will save patients and their families, as well as insurers, the costs of paying for continued patient care when patients who are in a terminal condition or who are permanently unconscious receive unwanted but successful CPR following a cardiac or respiratory arrest, that continues and perpetuates, and sometimes worsens, the patient's poor quality of life. These end-of-life costs can continue to burden the family for several years following a patient's death. While the purpose of the DNR Act and Chapter 1051 is to enable a patient in a terminal condition, or the patient's surrogate, to communicate a decision that directs EMS providers to permit the patient to die with dignity, significant health care cost-savings will often be a collateral benefit.
The average annual cost the DNR Act and Chapter 1051 impose over 5 years to the regulated community (attending physicians, patients, and surrogates) is projected to be $47,060. This includes the cost of procuring DNR orders, bracelets and necklaces for distribution in attending physician offices. The current costs are $.11 for an out-of-hospital DNR order form, $1.35 for an out-of-hospital DNR necklace, and $.35 for an out-of-hospital DNR bracelet, plus taxes and shipping costs. A minimum order of 50 of an order, bracelet or necklace is required. The average annual costs over 5 years for State government is projected to be $26,000, which includes development and printing costs for educational materials, training, outreach, and travel needed to assist regional EMS councils and practitioners in the implementation of the statute and the regulations.
It is expected that the overall cost-savings in reducing expensive and undesired end-of-life care will offset other costs incurred in implementing the statute and regulations.
Statutory Authority
Section 6 of Act 59 provides that the Department publish final regulations to assist in the implementation of the DNR Act within 18 months after the effective date of Act 59, which was August 18, 2002.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on August 26, 2003, the Department submitted a copy of these proposed regulations to IRRC and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. In addition to submitting the proposed regulations, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed regulations within 30 days of the close of the public comment period. The comments, recommendations or objections shall specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the regulations, by the Department, the General Assembly and the Governor of comments, recommendation or objections raised.
Contact Person
Interested persons are invited to submit comments, suggestions or objections to the proposed regulations to Margaret E. Trimble, Director of the Emergency Medical Services Office, Department of Health, 1032 Health and Welfare Building, P. O. Box 90, Harrisburg, PA 17108, (717) 787-8740, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability may also submit comments, suggestions or objections to Margaret Trimble in alternative formats, such as by audio, Braille or, for speech or hearing impaired persons, by using V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984[TT]. Persons who require an alternative format of this document should contact Margaret Trimble so that necessary arrangements may be made. The Department will consider the comments it receives in developing final regulations that will be published by February 18, 2004.
CALVIN B. JOHNSON, M.D., M.P.H.,
SecretaryFiscal Note: 10-174. (1) General Fund; (2) Implementing Year 2002-03 is $10,000; (3) 1st Succeeding Year 2003-04 is $26,000; 2nd Succeeding Year 2004-05 is $26,000; 3rd Succeeding Year 2005-06 is $26,000; 4th Succeeding Year is 2006-07 is $26,000; 5th Succeeding Year 2007-08 is $26,000; (4) 2001-02 Program--$29,353,000; 2000-01 Program--$27,453,000; 1999-00 Program--$24,250,000; (7) General Government Operations; (8) recommends adoption. The costs, reflected above, implement the requirements of Act 59 of 2002. These amounts are included in the 2002-03 and 2003-04 budgets.
(Editor's Note: Text proposed to be deleted from the interim regulations contained in Chapter 1051 (Pennsylvania Code pages 1051-1--1051-14 (serial pages (294013) to (294026)) appears in brackets. Text proposed to be added to the interim regulations appears in bold face type. Regular type is used to indicate no proposed changes to the interim regulations. Ellipses refer to the existing text of the interim regulations.)
[Continued on next Web Page]
No part of the information on this site may be reproduced for profit or sold for profit.This material has been drawn directly from the official Pennsylvania Bulletin full text database. Due to the limitations of HTML or differences in display capabilities of different browsers, this version may differ slightly from the official printed version.
