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RULES AND REGULATIONS

Title 28--HEALTH AND SAFETY

DEPARTMENT OF HEALTH

[28 PA. CODE CHS. 1001, 1003, 1005,
1007 AND 1051]

Out-of-Hospital Do-Not-Resuscitate Orders

[32 Pa.B. 6117]

   The Department of Health (Department) is adopting interim regulations to facilitate implementation of 20 Pa.C.S. Chapter 54 (relating to the Do-Not-Resuscitate Act) (DNR Act) enacted by the act of June 19, 2002 (P. L. 409, No. 59) (Act 59). Under the interim regulations, the Department is dividing 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). Subpart A contains regulations the Department has adopted under the Emergency Medical Services Act (35 P. S. §§ 6921--6938). Amendments are made in Subpart A to §§ 1001.1--1001.5, 1003.27, 1005.3, 1005.10 and 1007.7. Subpart B contains new Chapter 1051 (relating to out-of-hospital do-not-resuscitate orders). The amendments and additions are set forth in Annex A.

Purpose and Background

   Act 59 requires that the Department adopt interim regulations by December 16, 2002, to facilitate its implementation. In developing the interim regulations, the Department has conferred with the State Advisory Council (Council) and Commonwealth agencies such as the Department of Aging, the Department of Education, the Department of Public Welfare and the Pennsylvania Emergency Management Agency. It also convened a public hearing on the interim regulations on September 12, 2002, prior to which it distributed a preliminary draft of the interim regulations to persons who requested the preliminary draft. Notice of the public hearing was published at 32 Pa.B. 4208 (August 24, 2002). In adopting the interim regulations, the Department has considered the comments of the Council, other Commonwealth agencies and other persons who have provided comments to the Department.

   Section 6 of Act 59 exempts the interim regulations from review under the Regulatory Review Act (71 P. S. §§ 745.1--745.14). Act 59 does not exempt the regulations from the act of July 31, 1968 (P. L. 769, No. 240) (45 P. S. §§ 1101--1611), know as the Commonwealth Documents Law (CDL). Act 59 went into effect on August 19, 2002, and requires that the interim regulations be adopted within 120 days thereafter, following at least one public hearing on the interim regulations. Based upon Act 59's requirement that the Department convene a public meeting on the interim regulations before adopting them, and the short period of time Act 59 gave the Department to adopt interim regulations, it appears that the General Assembly intended to exempt the Department from proposing regulations, as generally required by sections 201 and 202 of the CDL (45 P. S. §§ 1201 and 1202) for final regulations, before adopting the interim regulations. Assuming, however, that sections 201 and 202 of the CDL do apply to the interim regulations, the Department has determined to proceed with the interim regulations without prior proposed rulemaking, under section 204(3) of the CDL (45 P. S. § 1204(3)), on the grounds that following the procedures for proposed rulemaking would be impractical and contrary to the public interest.

   It is impractical to proceed with proposed rulemaking before final adoption because of the very short time Act 59 gave the Department to adopt interim regulations, after the effective date of Act 59. Additionally, these regulations need to be adopted expeditiously so that the Department has time to ensure that curricula is revised in emergency medical services (EMS) training institutes to incorporate the requirements of these regulations before out-of-hospital DNR orders, bracelets and necklaces are made available by the Department. The DNR Act provides that these items are to be made available by February 14, 2003. It is also contrary to the public interest to proceed with proposed rulemaking because to do so would delay adoption of the regulations, which are being promulgated to promote the public interest, past the deadline directed by statute for the adoption of the interim regulations.

   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 will propose regulations before adopting final regulations by that date.

Summary

Subpart A.  Emergency Medical Services Systems

Section 1001.1.  Purpose.

   This section is amended to address the purpose of Subpart A rather than the purpose of Part VII.

Section 1001.2.  Definitions.

   This section is amended to provide that the definitions in the section apply throughout Subpart A. The regulation had read that the definitions in the section applied throughout Part VII. This is 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.

Section 1001.3.  Applicability.

   This section identified the persons who were affected by Part VII. It has been amended to identify persons affected by Subpart A.

Section 1001.4.  Exceptions.

   This section authorized persons to seek exceptions to regulations in Part VII that did not repeat statutory requirements. It has been amended to authorize persons to seek exceptions to regulations in Subpart A.

Section 1001.5.  Investigations.

   This section announced that the Department may investigate a possible violation of Part VII. It has been amended to announce that the Department may investigate a possible violation of Subpart A.

Section 1003.27.  Disciplinary and corrective action.

   This section addresses the Department's authority to discipline prehospital personnel. One of the grounds for discipline was violating a duty imposed by Part VII. Subsection (a)(20) has been amended to provide that discipline may be imposed for violating a duty imposed by Subpart A.

Section 1005.3.  Right to enter, inspect and obtain records.

   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 has been amended to substitute ''Subpart A'' for ''Part VII.'' Under § 1007.1 (relating to general provisions), this amendment is also applicable to air ambulance services.

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 is amended to require a ground ambulance service to maintain written policies and procedures to implement the requirements of Chapter 1051.

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 is amended to require that an air ambulance service maintain written policies and procedures to implement the requirements of Chapter 1051.

Subpart B.  Matters Ancillary to Emergency Medical Services Systems

   Chapter 1051 is adopted to facilitate implementation of the DNR Act. In addition, it assists the implementation of an Act 59 amendment to 20 Pa.C.S. §§ 5401--5416 (relating to the Advance Directive for Health Care Act) that directs EMS providers to follow the procedures for implementing an out-of-hospital DNR order when a patient experiencing cardiac or respiratory arrest has both an advance declaration issued under the Advance Directive for Health Care Act and an out-of-hospital DNR order issued under the DNR Act.

   There are significant procedural differences between the two processes. Under the Advance Directive for Health Care Act, 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.

General Provisions

Section 1051.1.  Purpose.

   This section addresses the purposes of the chapter. While a primary purpose of the DNR Act and the chapter is to articulate standards for the issuance and revocation of out-of-hospital DNR orders, a component of the DNR Act deals with pregnant patients. That component sets forth specific rules for the administration of out-of-hospital DNR orders issued for pregnant patients. Also, it 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 when confronted with these orders. Consequently, this section announces that the chapter deals with these special provisions relating to pregnant patients in addition to the general rules applicable to the issuance, administration and revocation of out-of-hospital DNR orders.

Section 1051.2.  Definitions.

   This section provides definitions for terms used in the chapter. Requiring some discussion are the definitions of ''attending physician,'' ''EMS provider,'' ''EMS personnel,'' ''health care provider,'' ''patient,'' ''prehospital personnel'' and ''surrogate.''

''Attending physician''

   ''Attending physician'' is defined as it is defined in the DNR Act, except a sentence is added stating that a patient may have more than one attending physician. 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. Another example is that a patient who has cancer may see an oncologist on a regular basis in addition to a primary care physician.

   Depending upon a variety of circumstances it may be difficult to conclude that one physician is the ''exclusive'' attending physician. Also, a physician may believe that the physician 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.

   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 the physician 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 ''[EMS] provider,'' ''health care provider'' and ''person.'' 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 under authority granted by the EMS Act. The Department's 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.''

   ''Prehospital personnel'' is defined in § 1002.1 (relating to definitions) that 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. That definition is included in this section. These individuals are authorized by the EMS Act to perform various services for ambulance companies. However, unlike the DNR Act's definition of ''[EMS] provider,'' the definition of ''prehospital personnel'' does not include an individual who enjoys good Samaritan civil immunity to use an AED.

   Some parts of Chapter 1051 address the responsibilities of 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 share. To distinguish between provisions of the regulations that apply to prehospital personnel and good Samaritan users of AEDs, and those provisions that apply to prehospital personnel only, the Department has defined the term ''EMS personnel'' 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''

   Act 59 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 Act 59, ''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 not, necessarily, for whom an out-of-hospital DNR order has been issued. This is the manner in which the term ''patient'' is defined in this section.

''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. That is how the Department defines the term in its regulations.

§ 1051.3.  Applicability.

   This section 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.

Patient and Surrogate Rights and Responsibilities

§ 1005.11.  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. This regulation incorporates that information.

§ 1005.12.  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. This section conveys 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. The only patient conditions that are relevant are that a patient is in a terminal condition, or is permanently unconscious and has an operative advance declaration.

§ 1005.13.  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) 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 (b) imposes upon a person who acted as a patient's surrogate when requesting an out-of-hospital DNR order for the patient, but who has since lost the authority to function as the patient's surrogate, to cooper-ate with the physician who issued that order and who is seeking to locate the patient or the patient's surrogate. A physician may contact a surrogate who requested an out-of-hospital DNR to convey important information about the patient's condition, including 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 information needs to be conveyed to the patient if the patient is competent to make health care decisions for himself. If the patient is not competent to make those decisions, the information needs to be conveyed to the person who is the patient's current surrogate. The patient's former surrogate, when contacted by the patient's physician, is required to provide the physician information to locate the current surrogate if that information is possessed by the former surrogate.

   Subsection (c) also imposes upon a person who has lost the authority to serve as a patient's surrogate, the duty to provide the patient or the patient's new surrogate, as appropriate, the name of the physician who issued the out-of-hospital DNR order for the patient and any other information the surrogate has to help the patient or replacement surrogate locate the physician who issued the out-of-hospital DNR order.

Attending Physician Responsibilities

§ 1051.21.  Securing out-of-hospital DNR orders, bracelets and necklaces.

   This section 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 a vendor with which the Department has contracted. 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 there is a vendor change.

§ 1051.22.  Issuance of out-of-hospital DNR order.

   This section relates 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.

§ 1051.23.  Disclosures to patient requesting out-of-hospital DNR order.

   This section 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 for the patient that is requested by the patient.

§ 1051.24.  Disclosures to surrogate requesting out-of-hospital DNR order.

   This section 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.

§ 1051.25.  Disclosures to patient when surrogate requests out-of-hospital DNR order.

   This section specifies the process the patient's attending physician must follow in deciding the information the physician will provide to the patient when an out-of-hospital DNR order is requested by the patient's surrogate.

§ 1051.26.  Physician refusal to issue an out-of-hospital DNR order.

   This section 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.

§ 1051.27.  Providing out-of-hospital DNR bracelet or necklace.

   This section 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.

§ 1051.28.  Documentation.

   This section requires an attending physician to assert 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.

§ 1051.29.  Duty to contact patient or surrogate.

   This section 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.

§ 1051.30.  Physician destruction of out-of-hospital DNR order, bracelet or necklace.

   This section 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.

EMS Provider Responsibilities

§ 1051.51.  Implementation of out-of-hospital DNR order.

   This section 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.

§ 1051.52.  Procedure when both advance directive and out-of-hospital DNR order are present.

   This section 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 DNR order, bracelet or necklace, the provider is to follow the procedure for complying with the out-of-hospital DNR order.

Pregnant Patients

§ 1051.61.  Pregnant patients.

   This section 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.

Medical Command Physician Responsibilities

§ 1051.81.  Medical command physician responsibilities.

   This section 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.

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 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.

Effective Date

   The amendments will go into effect on March 1, 2003. The effective date is postponed following the publication of the regulations for several reasons. First, the amendments to §§ 1005.10 and 1007.7 (relating to licensure and general operating standards; and licensure and general operating standards) require an ambulance service to have written policies and procedures relating to Chapter 1051. Ambulance services will need time to adopt those policies and procedures. Second, as a practical matter, the regulations cannot go into effect until the out-of-hospital DNR orders, bracelets and necklaces are available. They are not available at this time. Section 54A04 of the DNR Act (relating to orders, bracelets and necklaces) gives the Department 180 days after the effective date of that act, which is February 14, 2003, to make those items available. Third, section 4 of Act 59 requires the Department to develop and make available to health care providers materials relating to the DNR Act and the Department's regulations. Fourth, section 4 of Act 59 also requires that the curricula for securing prehospital personnel certifications and recognitions be modified to include the requirements of Act 59 and these regulations. Each of these tasks requires time to complete and dictates that the effective date of the regulations be postponed for a period of time following publication of the interim regulations in the Pennsylvania Bulletin.

Paperwork

   The Department will need to develop an out-of-hospital DNR order form for attending physicians to issue for patients who qualify for those orders. The Department will need to develop a paper or electronic process for physicians to secure those orders from the Department or its designee.

   Attending physicians will also need to follow a paper or electronic process to secure out-of-hospital DNR bracelets and necklaces from a vendor contracted by the Department to manufacturer those bracelets and necklaces. The Department will need to complete the paperwork required to contract with vendors to produce the bracelets and necklaces.

   The Department will need to publish notices in the Pennsylvania Bulletin identifying vendors from which attending physicians may procure out-of-hospital DNR bracelets and necklaces. 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 will need to maintain information in patient medical records regarding the issuance of out-of-hospital DNR items, and prepare the paperwork or electronic entries to secure and provide out-of-hospital DNR items for patients.

Financial Impact

   The DNR Act and the 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 that continues and perpetuates the patient's poor quality of life following a cardiac or respiratory arrest. 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 $65,000. This includes the cost of procuring DNR orders, bracelets and necklaces for distribution in attending physician offices. The average annual costs over 5 years for State government is projected to be $36,000, 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 interim regulations regarding implementation of the DNR Act.

Regulatory Review

   Under section 6 of Act 59, the Department, upon completion of at least one public hearing, and within 120 days after the effective date of Act 59, is to publish interim regulations regarding implementation of the DNR Act. The interim regulations are not subject to the Regulatory Review Act. Under the same section of Act 59, the Department is to adopt final regulations within 18 months after the effective date of Act 59.

   The Office of Attorney General has reviewed the interim regulations. The interim regulations were approved on December 2, 2002.

Contact Person

   Interested persons are invited to submit comments, suggestions or objections to the interim 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 proposed regulations that will be published in advance of the Department adopting final regulations by February 18, 2004.

Findings

   The Department finds that:

   (1)  Proposed rulemaking in advance of the interim regulations is not required under section 6 of Act 59, or, if the proposed rulemaking requirements of sections 201 and 202 of the CDL are applicable, the interim regulations are exempt from those requirements under section 204(3) of the CDL because publishing proposed rulemaking in advance of the interim regulations would be impractical and contrary to the public interest.

   (2)  A public hearing was held prior to the adoption of the interim regulations as required by section 6 of Act 59 and all comments received by the Department were considered.

   (3)  The adoption of the interim regulations in the manner provided by this order is necessary and appropriate for the administration of the authorizing statute.

Order

   The Department, acting under the authorizing statute, orders that:

   (a)  The regulations of the Department, 28 Pa. Code Part VII, are amended by amending §§ 1001.1--1001.5, 1003.27, 1005.3, 1005.10 and 1007.7; and by adding §§ 1051.1--1051.3, 1051.11--1051.13, 1051.21--1051.30, 1051.51, 1051.52, 1051.61, 1051.81 and 1051.101 to read as set forth in Annex A, with ellipses referring to the existing text of the regulations.

   (b)  The Secretary of Health shall submit this order and Annex A to the Office of General Counsel and the Office of Attorney General for approval as required by law.

   (c)  The Secretary of Health shall certify this order and Annex A and deposit them with the Legislative Reference Bureau as required by law.

   (d)  The final-omitted rulemaking shall take effect March 1, 2003.

ROBERT S. ZIMMERMAN, Jr.,   
Secretary

   Fiscal Note: 10-171 (1)  General Fund; (2)  Implementing Year 2002-03 is $10,000; (3)  1st Succeeding Year 2003-04 is $36,000; 2nd Succeeding Year 2004-05 is $36,000; 3rd Succeeding Year 2005-06 is $36,000; 4th Succeeding Year 2006-07 is $36,000; 5th Succeeding Year 2007-08 is $36,000; (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 figures are included in the Governor's Executive Budget.

Annex A

TITLE 28.  HEALTH AND SAFETY

PART VII.  EMERGENCY MEDICAL SERVICES

Subpart A.  EMERGENCY MEDICAL SERVICES SYSTEM

CHAPTER 1001.  ADMINISTRATION OF THE EMS SYSTEM

Subchapter A.  GENERAL PROVISIONS

GENERAL INFORMATION

§ 1001.1.  Purpose.

   The purpose of this subpart is to plan, guide, assist and coordinate the development of regional EMS systems into a unified Statewide system and to coordinate the system with similar systems in neighboring states, and to otherwise implement the Department's responsibilities under the act consistent with the Department's rulemaking authority

§ 1001.2.  Definitions.

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

*      *      *      *      *

§ 1001.3.  Applicability.

   This subpart affects regional EMS councils, the Council, other entities desiring to receive funding from the Department or the regional EMS councils for the provision of EMS, ALS and BLS ambulance services, QRSs, instructors and institutes involved in the training of prehospital personnel including EMTs, EMT-paramedics, first responders, ambulance attendants and health professionals, and trauma centers and local governments involved in the administration and support of EMS.

§ 1001.4.  Exceptions.

   (a)  The Department may grant exceptions to, and departures from, this subpart when the policy objectives and intentions of this subpart are otherwise met or when compliance would create an unreasonable hardship, but would not impair the health, safety or welfare of the public. No exceptions or departures from this subpart will be granted if compliance with the standard is required by statute.

   (b)  Requests for exceptions to this subpart shall be made in writing to the Department. The requests, whether approved or not approved, will be documented and retained on file by the Department. Approved requests shall be retained on file by the applicant during the period the exception remains in effect.

   (c)  A granted request will specify the period during which the exception is operative. Exceptions may be reviewed or extended if the reasons for the original exception continue.

   (d)  An exception granted may be revoked by the Department for just cause. Just cause includes, but is not limited to, failure to meet the conditions for the exception. Notice of the revocation will be in writing and will include the reason for the action of the Department and a specific date upon which the exception will be terminated.

   (e)  In revoking an exception, the Department will provide for a reasonable time between the date of the written notice or revocation and the date of termination of an exception for the holder of the exception to come into compliance with this subpart. Failure to comply after the specified date may result in enforcement proceedings.

   (f)  The Department may, on its own initiative, grant an exception to this subpart if the requirements of subsection (a) are satisfied.

§ 1001.5.  Investigation.

   The Department may investigate any person, entity or activity for compliance with the act and this subpart.

CHAPTER 1003.  PERSONNEL

Subchapter B.  PREHOSPITAL EMS PERSONNEL

§ 1003.27.  Disciplinary and corrective action.

   (a)  The Department may, upon investigation, hearing and disposition, impose upon prehospital personnel who are certified or recognized by the Department one or more of the disciplinary or corrective measures in subsection (c) for one or more of the following reasons:

*      *      *      *      *

   (20)  Violating a duty imposed by the act, this subpart or an order of the Department previously entered in a disciplinary proceeding.

*      *      *      *      *

CHAPTER 1005.  LICENSING OF BLS AND ALS GROUND AMBULANCE SERVICES

§ 1005.3.  Right to enter, inspect and obtain records.

   (a)  Upon the request of an employee or agent of the Department during regular and usual business hours, or at other times when that person possesses a reasonable belief that violations of this subpart may exist, a licensee shall:

   (1)  Produce for inspection records maintained under § 1001.41 (relating to data and information requirements for ambulance services).

   (2)  Produce for inspection, permit copying, and provide within a reasonable period of time, records that pertain to personnel and their qualifications, staffing, equipment, supplies, and policies and procedures required under § 1005.10 (relating to licensure and general operating standards).

   (3)  Permit the person to examine vehicles, required equipment and supplies and security facilities.

   (b)  The Department's representative shall advise the licensee that the inspection is being conducted under section 12(k) of the act (35 P. S. § 6932(k)) and this chapter.

   (c)  Failure of a licensee to produce records or to permit an examination as required by this section constitutes misconduct in operating the ambulance service and shall be grounds for disciplinary sanctions or denial of license.

§ 1005.10.  Licensure and general operating standards.

*      *      *      *      *

   (l)  Policies and procedures. An ambulance service shall maintain written policies and procedures addressing each of the requirements imposed by this section, as well as the requirements imposed by §§ 1001.41, 1001.42, 1001.65, 1005.11 and Chapter 1051 (relating to out-of-hospital do-not-resuscitate orders), and shall also maintain written policies and procedures addressing infection control, management of personnel safety, substance abuse in the workplace, and the placement and operation of its ambulances.

CHAPTER 1007.  LICENSING OF AIR AMBULANCE SERVICES--ROTORCRAFT

§ 1007.7.  Licensure and general operating standards.

*      *      *      *      *

   (n)  Policies and procedures. An air ambulance service shall maintain written policies and procedures addressing each of the requirements imposed by this section, as well as the requirements imposed by §§ 1001.41, 1001.42, 1001.65 (relating to data and information requirements for ambulance services; dissemination of information; and cooperation) and Chapter 1051 (relating to out-of-hospital do-not-resuscitate orders) and shall also maintain written policies and procedures addressing infection control, management of personnel safety, substance abuse in the workplace, and the placement and operation of its air ambulances.

Subpart B.  MATTERS ANCILIARY TO EMERGENCY MEDICAL SERVICES SYSTEMS

CHAPTER 1051.  OUT-OF-HOSPITAL DO-NOT-RECUSCITATE ORDERS

GENERAL PROVISIONS

Sec.

1051.1.Purpose.
1051.2.Definitions.
1051.3.Applicability.

PATIENT AND SURROGATE RIGHTS AND RESPONSIBILITIES

1051.11.Patient qualifications to request and revoke out-of-hospital DNR order.
1051.12.Surrogate's authority to request and revoke out-of-hospital DNR order.
1051.13.Person who loses authority to function as a surrogate.

ATTENDING PHYSICIAL RESPONSIBILITIES

1051.21.Securing out-of-hospital DNR orders, bracelets and necklaces.
1051.22.Issuance of out-of-hospital DNR order.
1051.23.Disclosures to patient requesting out-of-hospital DNR order.
1051.24.Disclosures to surrogate requesting out-of-hospital DNR order.
1051.25.Disclosures to patient when surrogate requests out-of-hospital DNR order.
1051.26.Physician refusal to issue an out-of-hospital DNR order.
1051.27.Providing out-of-hospital DNR bracelet or necklace.
1051.28.Documentation.
1051.29.Duty to contact patient or surrogate.
1051.30.Physician destruction of out-of-hospital DNR order, bracelet or necklace.

EMS PROVIDER RESPONSIBILITIES

1051.51.Implementation of out-of-hospital DNR order.
1051.52.Procedure when both advance directive and out-of-hospital DNR order are present.

PREGNANT PATIENTS

1051.61.Pregnant patients.

MEDICAL COMMAND PHYSICIAN RESPONSIBILITIES

1051.81.Medical command physician responsibilities.

ORDERS, BRACELETS AND NECKLACES FROM OTHER STATES

1051.101.Recognition of other states' out-of-hospital DNR orders.

GENERAL PROVISIONS

§ 1051.1.  Purpose.

   This chapter provides standards for the issuance and revocation of out-of-hospital DNR orders and compliance with those orders. An additional purpose of this chapter is to address how health care providers are to deal with orders or directions to not provide life-sustaining treatment, CPR, nutrition or hydration to a pregnant woman.

§ 1051.2.  Definitions.

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

   Advance directive--A directive for health care in a declaration issued under 20 Pa.C.S. Chapter 54 (relating to the Advance Directive for Health Care Act).

   Attending physician--A physician who has primary responsibility for the medical care and treatment of a patient. A patient may have more than one attending physician.

   CPR--Cardiopulmonary resuscitation--Cardiac compression, invasive airway techniques, artificial ventilation, defibrillation and other related procedures used to resuscitate a patient or to prolong the life of a patient.

   Declarant--As defined in 20 Pa.C.S. § 5403 (relating to definitions).

   Declaration--As defined in 20 Pa.C.S. § 5403.

   Department--The Department of Health of the Commonwealth.

   DNR--Do not resuscitate.

   EMS personnel--Emergency medical services personnel--Prehospital personnel and individuals given good Samaritan civil immunity protection when using an automated external defibrillator under 42 Pa.C.S. § 8331.2 (relating to good Samaritan civil immunity for use of automated external defibrillators).

   EMS provider--Emergency medical services provider--EMS personnel, a medical command physician and, as defined in § 1001.2 (relating to definitions), an advance life support service medical director, medical command facility medical director, medical command facility, ambulance service and quick response service.

   Health care provider--A person who is licensed, certified or otherwise authorized to administer health care in the ordinary course of a business or practice of a profession. The term includes EMS providers.

   Invasive airway technique--Any advanced airway technique, including endotracheal intubation.

   Life-sustaining treatment--

   (i)  A medical procedure or intervention that, when administered to a patient, will serve only to prolong the process of dying or to maintain the patient in a state of permanent unconsciousness.

   (ii)  The term includes nutrition and hydration administered by gastric tube or intraveneously or any other artificial or invasive means if the order of the patient so specifically provides.

   Medical command physician--A physician who is approved by a regional emergency medical services council to provide medical command.

   Out-of-hospital DNR bracelet--A bracelet which signifies that an out-of-hospital DNR order has been issued.

   Out-of-hospital DNR necklace--A necklace which signifies that an out-of-hospital DNR order has been issued.

   Out-of-hospital DNR order--A written order, the form for which is supplied by the Department or its designee under this chapter, that is issued by an attending physician and directs EMS providers to withhold CPR from the patient in the event of cardiac or respiratory arrest.

   Out-of-hospital DNR patient--A patient for whom an attending physician has issued an out-of-hospital DNR order.

   Patient--One of the following:

   (i)  An individual who is in a terminal condition.

   (ii)  A declarant whose declaration has become operative under 20 Pa.C.S. § 5405(2) (relating to when declaration becomes operative) and which provides that no CPR be provided in the event of the declarant's cardiac or respiratory arrest if the declarant becomes permanently unconscious, or designates a surrogate to make that decision under those circumstances

   Permanently unconscious--

   (i)  A medical condition 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.

   (ii)  The term includes, without limitation, a persistent vegetative state or irreversible coma.

   Person--An individual, corporation, partnership, association or Federal, State or local government or governmental agency.

   Physician--An individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth.

   Prehospital personnel--The term includes any of the following prehospital practitioners:

   (i)  Ambulance attendants.

   (ii)  First responders.

   (iii)  Emergency medical technicians (EMTs).

   (iv)  EMT-paramedics.

   (v)  Prehospital registered nurses.

   (vi)  Health professional physicians.

   Surrogate--An individual who has, or individuals who collectively have, legal authority to request an out-of-hospital DNR order for another individual or to revoke that order.

   Terminal condition--An incurable and irreversible medical condition in an advanced state caused by injury, disease or physical illness which will, in the opinion of the attending physician, to a reasonable degree of medical certainty, result in death regardless of the continued application of life-sustaining treatment.

§ 1051.3.  Applicability.

   (a)  This chapter applies to the following:

   (1)  Health care providers.

   (2)  Attending physicians.

   (3)  Patients.

   (4)  Surrogates.

   (b)  This chapter neither compels nor prohibits health care provider compliance with an out-of-hospital DNR order in a hospital. In a hospital, an EMS provider shall comply with an out-of-hospital DNR order only if responding on behalf of an ambulance service to a call the hospital makes for ambulance service assistance.

   (c)  This chapter does not regulate the issuance of or compliance with a DNR order issued in a hospital to be followed in that hospital.

   (d)  This chapter permits EMS providers to comply with out-of-hospital DNR orders in all settings other than a hospital, except as set forth in subsection (b), including personal care facilities and all other health care facilities.

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