DEPARTMENT OF HEALTH
[ 28 PA. CODE CHS. 1001, 1003, 1005, 1007, 1009, 1011, 1013, 1015, 1021, 1023, 1025, 1027, 1029, 1031 AND 1033 ]
Emergency Medical Services System
[41 Pa.B. 5865]
[Saturday, October 29, 2011]
The Department of Health (Department) proposes to rescind Chapters 1001, 1003, 1005, 1007, 1009, 1011, 1013 and 1015 and adopt Chapters 1021, 1023, 1025, 1027, 1029, 1031 and 1033 to read as set forth in Annex A.
Purpose and Background
The purpose of this proposed rulemaking is to facilitate implementation 35 Pa.C.S. §§ 8101—8157 (relating to Emergency Medical Services System Act) (EMS System Act). The EMS System Act repealed the Emergency Medical Services Act (prior EMS act) (35 P. S. §§ 6921—6938). The prior EMS act was the initial statute providing for the licensing and regulation of ambulance services in this Commonwealth. With the enactment of the EMS System Act, the Commonwealth has taken a significant step in moving forward with a comprehensive Statewide emergency medical services (EMS) system that is more responsive to the needs of the people of this Commonwealth. The EMS System Act is designed to achieve a higher quality, more flexible and better coordinated EMS system than that which was fostered under the prior EMS act.
Efforts to replace the prior EMS act began over 10 years ago when the Pennsylvania Emergency Health Services Council (PEHSC) proposed consideration of a new EMS statute and formed several work groups to evaluate the different facets of the EMS system. These work groups recommended to the PEHSC and the PEHSC Board (Advisory Board) ultimately recommended to the Department several areas where statutory amendments were needed. The Advisory Board is designated by the EMS System Act to advise the Department on EMS matters. As the Department and the EMS community worked on amendments, it became clear that the scope of the necessary amendments dictated the need for a new statute. Senate Resolution 60 of 2005 also recognized weaknesses in the prior EMS act and recommended that this initiative be pursued. The development of new EMS legislation ensued and was spearheaded by the Department. Throughout that process, the Department engaged both private and government stakeholders and held more than 55 town meetings across this Commonwealth to discuss the draft legislation at various stages of its development. Throughout development of the legislation, the Department posted versions of the draft legislation on its web site and solicited comments.
During its development, major private sector organizations such as the Pennsylvania Medical Society, the Pennsylvania Chapter of the American College of Emergency Physicians, PEHSC, the Pennsylvania Trauma Systems Foundation and the Ambulance Association of Pennsylvania expressed support for this legislation. Throughout the process, the Department also consulted with sister agencies such as the Department of Public Welfare, the Department of State, the Department of Aging, the Department of Transportation, the State Police, the Pennsylvania Emergency Management Agency (PEMA) and the Pennsylvania Public Utility Commission on matters of mutual concern to the Department and those agencies that could be addressed in the new EMS legislation. Issues presented by those matters were resolved among the agencies.
A key feature of the EMS System Act is that it includes several provisions that will enable the EMS system, without the need for further statutory amendments, to quickly adapt and evolve to meet the changing needs of the people of this Commonwealth for emergency and urgent prehospital and interfacility medical care. Some of the key elements of the EMS System Act not included in the prior EMS act are as follows:
• The scope of practice of EMS personnel closely tracks the EMS Scope of Practice Model that the National Association of State EMS Officials has developed for the National Highway Traffic Safety Administration.
• The Department is empowered to establish through regulations new types of EMS providers to meet specialized EMS needs as they are identified.
• The Department is empowered to expand the scope of practice of EMS personnel as the EMS practice model changes.
• Licenses and certifications will be permanent, subject to removal for disciplinary reasons, but continued practice will be conditioned upon a biennial or triennial registration of the license or certification and continued practice of EMS providers will also be predicated on them meeting continuing education requirements or passing written and practical skills tests.
• Ambulance services, which had to meet specified staffing and vehicle requirements under the prior EMS act, will be replaced by EMS agencies, which may have a myriad of configurations and provide different types of EMS (such as ambulance service, quick response service (QRS), wilderness EMS service and tactical EMS service). EMS agencies will be required to meet standards pertinent to the services they are licensed to offer.
• EMS agencies will be required to have a medical director.
• Ambulance drivers, who were not regulated under the prior EMS act, will need to become certified and regulated. Ambulance attendants, who were also not regulated under the prior EMS act, will be certified and regulated as emergency medical responders (EMR).
• The Department is granted emergency suspension powers to deal with an EMS provider or EMS vehicle operator (EMSVO) who presents a clear and immediate danger to the public health and safety.
• The Department's disciplinary options are expanded to include the issuance of civil money penalties and the Department is granted jurisdiction to fine unlicensed entities that function as EMS agencies and uncertified persons who practice as EMS providers.
• The Department is empowered to enter into reciprocity agreements with others states for the certification of EMS providers.
• The Department is given the authority to enter into agreements with other states which may include, as appropriate to effectuate the purposes of the EMS System Act, the acceptance of EMS resources in other states that do not fully satisfy the requirements in the EMS System Act.
• The Department is empowered to issue conditional temporary licenses indefinitely if the Department determines it is in the public interest to do so.
• Medical command physicians, medical command facilities and medical command facility medical directors will be certified and regulated by the Department. None of these were certified by the Department under the prior EMS act.
• Physician assistants are provided a pathway, as nurses were afforded under the prior EMS act and continue to be afforded under the EMS System Act, to become EMS providers based upon their education and experience.
• Standards are set forth as to when EMS providers are to have access to persons in need of EMS in a police incident and how police and EMS providers are to handle persons who need to be transported to a hospital for emergency medical care, but to whom the police also need access or to take into custody.
• A peer review system is established for EMS providers and physicians who direct or supervise EMS providers.
• EMS agencies will be empowered to provide community-based health promotion services that are integrated into the overall health care system.
In developing this proposed rulemaking, the Department once again engaged the EMS community, including major stakeholder organizations, as well as other government agencies. The 2-year time period given to the Department to adopt final regulations did not afford the Department as much time to interact with these entities in developing this proposed rulemaking as the time the Department had to interact with them while spearheading the drafting of the EMS System Act. However, the Department did conduct approximately 40 stakeholder meetings throughout this Commonwealth and will continue to engage the stakeholders after the proposed rulemaking is published as it moves toward the adoption of final regulations.
The proposed rulemaking contains the following seven chapters: Chapter 1021 (relating to administration of the EMS system); Chapter 1023 (relating to personnel); Chapter 1025 (relating to education); Chapter 1027 (relating to EMS agencies); Chapter 1029 (relating to medical command facilities and receiving facilities); Chapter 1031 (relating to complaints, disciplinary actions, adjudications and appeals); and Chapter 1033 (relating to special event EMS).
Chapter 1021. Administration of the EMS system
This chapter would explain the purpose of the EMS system regulations, define terms used in the regulations, identify standards for the Statewide and regional EMS system plans, prescribe criteria for the Department's distribution of Emergency Medical Services Operating Fund (EMSOF) money, impose EMS data collection and reporting responsibilities, set standards for quality improvement programs, expand upon standards in the EMS System Act regulating vendors of EMS patient care report (PCR) software, address the peer review process conducted under the EMS System Act, establish standards for the integration of trauma facilities into the Statewide EMS system, explain and impose duties on the regional EMS councils, describe the relationship between the Department and the Advisory Board and impose standards for accessing and using for research data that is made confidential under the EMS System Act except for certain enumerated purposes.
Subchapter A. General provisions
Part VII (relating to emergency medical services) is divided into two subparts. This proposed rulemaking would amend Subpart A (relating to EMS systems). Section 1021.1 (relating to purpose) would explain that the purpose of Subpart A is to employ the regulations in that subpart, consistent with the Department's rulemaking authority under the EMS System Act, to integrate the regional EMS systems into a unified Statewide system, improve the Statewide EMS system and coordinate the Statewide and regional EMS systems with similar systems in other states.
Section 1021.2 (relating to definitions) would set forth definitions of various terms that would be used in the regulations. Some of the terms defined in the current regulations that were adopted under the prior EMS act would continue to be defined in this section. For the most part, they would be defined the same way. A number of terms defined in the regulations adopted under the prior EMS act are no longer relevant and would not be included in this section. Several terms would be new. Some terms would be derived from the EMS System Act.
Section 1021.3 (relating to applicability) would explain that the regulations in Subpart A apply to persons and activities regulated by the Department under the EMS System Act.
Section 1021.4 (relating to exceptions) would provide a process for persons to seek an exception to a regulatory requirement that is not also directly imposed by the EMS System Act. The process would be virtually the same as the regulation adopted under the prior EMS act regarding the granting of exceptions. Exceptions would be granted when the policy objectives and intentions of the Department as reflected in Subpart A are otherwise met or when compliance would create an unreasonable hardship and granting the exception would not jeopardize the health, safety or welfare of the public. This section would also address the Department granting an exception on its own initiative when the aforementioned standards are satisfied.
Section 1021.5 (relating to investigations) would provide that the Department may investigate any person, entity or activity to ensure compliance with the EMS System Act and Subpart A.
Section 1021.6 (relating to comprehensive EMS system plan) would provide for continued implementation and improvement of the Statewide EMS System Plan. The prior EMS act referred to the Statewide plan as a development plan. The need now is for a plan to continue to administer and improve the Statewide EMS system. In fact, the Statewide EMS Development Plan has already evolved into a plan such as this. This section would set forth what needs to be addressed in the plan and provide for the plan to be annually reviewed and updated as needed. Public notice of intended updates would be required and the public would be provided an opportunity to comment on proposed updates before the Department updates the plan. The Statewide plan would also incorporate regional EMS system plans after they are approved by the Department.
The Statewide EMS System Plan would serve as a blueprint for how EMS problems are to be addressed and how EMS systems are to be maintained in the Commonwealth. Section 8112(a) of the EMS System Act (relating to contracts and grants) requires the Department to enter into contracts or grants with regional EMS councils for the initiation, expansion, maintenance and improvement of EMS systems which are in accordance with the Statewide EMS System Plan. This document, therefore, will also impact the Department's distribution of funds for EMS systems.
Section 1021.7 (relating to comprehensive regional EMS system plan) would require each regional EMS council to develop and update a regional EMS system plan for coordinating and improving the delivery of EMS in the region for which the Department has assigned it responsibility. This section would state what needs to be addressed in a regional EMS system plan. It would also parallel proposed § 1021.6 relative to regional EMS councils giving notice to the public of proposed updates to the regional plan and an opportunity for comment before submitting the plan to the Department for approval. Since the regional plan would become part of the Statewide plan, and the Department's distribution of funds to regional EMS councils will be consistent with the Statewide plan, the regional EMS system plans would also affect the Department's distribution of funds for regional EMS systems.
Section 1021.8 (relating to EMS data collection) would expand upon the Department's duty under section 8111(c) of the EMS System Act (relating to comprehensive plan) to collect and analyze EMS data for various purposes, including evaluating the effectiveness of the Statewide and regional EMS systems in reducing morbidity and mortality associated with responses to medical emergencies, aiding efforts to improve the Statewide and regional EMS system plans and facilitating the Department's ability to conduct investigations authorized under the EMS System Act. It would also address the statutory responsibility of persons regulated by the Department under the EMS System Act and dispatchers of EMS resources to cooperate with the Department directly, or through the regional EMS councils and the Advisory Board, in providing data as reasonably requested by them for these purposes.
Subchapter B. Award and administration of EMSOF funding
Section 1021.21 (relating to purpose) would explain that the purpose of Subchapter B (relating to award and administration of EMSOF funding) would be to set forth the standards and criteria governing the award and administration of contracts and grants under the EMS System Act that are funded by EMSOF funds.
Section 1021.22 (relating to entities eligible to receive EMSOF funds through contracts or grants) would identify the types of entities that are eligible to receive EMSOF money directly from the Department.
Section 1021.23 (relating to award of contract or grant to a regional EMS council) would deal with EMSOF money provided to a regional EMS council by the Department. It would explain how a regional EMS council would be required to apply for those funds and the criteria a regional EMS council would need to satisfy to be awarded a contract or grant to use and distribute those funds. It would also convey, as authorized under section 8112(l) of the EMS System Act, that the Department, without undertaking a competitive bidding process, may enter into a new contract or grant with a regional EMS council if, in carrying out the prior grant or contract to oversee a regional EMS system, the regional EMS council demonstrated its ability and commitment to the Department's satisfaction to plan, maintain and improve the regional EMS system consistent with the terms of the contract or grant.
Section 1021.24 (relating to use of EMSOF funding by a regional EMS council) would specify the various programs, vehicles, equipment and other items for which a regional EMS council is permitted to spend and distribute EMSOF money, and would identify certain uses of these funds that are not permitted. It would also clarify that for cost-savings purposes, regional EMS councils may make expenditures of funds on behalf of EMS agencies and certain other entities that operate in the regional EMS system, but that the Department may require matching funds in specified percentages as a condition for EMS agencies receiving, or regional EMS councils using, EMSOF funds for those purposes.
Section 1021.25 (relating to allocation of EMSOF funds to regional EMS councils) would list the factors the Department would consider in determining the amount of EMSOF funds it would provide to a regional EMS council.
Section 1021.26 (relating to technical assistance) would provide that a regional EMS council that receives a contract or grant from the Department may seek technical assistance from the Department to aid it in carrying out the contract or grant and that the Department will give special consideration to requests for technical assistance from regional EMS councils that serve rural areas.
Section 1021.27 (relating to subcontracting) would permit a regional EMS council to subcontract some of its responsibilities, subject to prior approval by the Department.
Section 1021.28 (relating to contracts and grants with the Advisory Board) would clarify that the provisions in Subchapter B that apply to grants and contracts between the Department and regional EMS councils do not apply to grants and contracts between the Department and the Advisory Board.
Subchapter C. Collection of data and information
With few exceptions, an EMS agency is required to prepare an EMS PCR when it is called to provide EMS and encounters a patient or a person who has been identified as a patient and for whom an EMS provider is required to conduct a medical assessment. If the patient needs to be transported to a receiving facility, this report contains information essential for the continuation of care. The information the EMS PCRs contain for these patients and patients who are not transported to a receiving facility is also useful for quality improvement activities, peer review and EMS system planning. This subchapter would address the preparation of EMS PCRs, the reporting of essential patient information by EMS providers when they transport a patient to a receiving facility, prohibitions on the disclosure of EMS PCRs and the information contained therein and requirements imposed upon vendors who market software for the preparation of EMS PCRs.
Section 1021.41 (relating to EMS patient care reports) would address an EMS agency's responsibility to complete an EMS PCR when it provides EMS and to provide the report to a regional EMS council. It would also impose a responsibility on an EMS provider who relinquishes primary responsibility for a patient to another EMS provider to provide the EMS provider who assumes primary responsibility for the patient with all patient information collected. It would further impose upon the EMS agency having primary responsibility for the patient during the transport to a receiving facility the duty to provide important patient information to the person at the receiving facility who assumes responsibility for the patient. It would require that for a patient who is transported to a receiving facility, before a complete EMS PCR needs to be completed, the transporting ambulance crew shall provide essential patient information to the receiving facility. The Department would publish, by notice in the Pennsylvania Bulletin, the types of information considered essential patient information. This abbreviated form is currently being field tested. The EMS agency would then be required to complete and provide the full EMS PCR to the receiving facility within 72 hours after concluding patient care and to subsequent patient caregivers within 24 hours after they make a request of the EMS agency, provided that the 24-hour time period would not expire before the initial 72-hour time period expires. It would further require an EMS agency to retain a copy of the EMS PCR for a minimum of 7 years.
Section 1021.42 (relating to dissemination of information) would assert that an EMS PCR is a confidential document that may be disseminated only as set forth in that section.
Section 1021.43 (relating to vendors of EMS patient care reports) would repeat some of the requirements in the EMS System Act pertaining to EMS PCR vendors and would also impose additional requirements on vendors of EMS PCRs and EMS PCR software. It would require EMS agencies to submit EMS PCRs using only a software program approved by the Department and it would require vendors of software marketed as appropriate for use in making EMS PCRs to first submit the software to the Department and secure the Department's approval of the software, and to do likewise if they make any substantive change to the software. This section would also make provision for the Department to change the data elements in an EMS PCR by publishing a notice of those changes in the Pennsylvania Bulletin at least 60 days prior to the changes going into effect. After publication of the changes, a vendor would not be able to market existing software for making EMS PCRs without disclosing that the software was approved before the changes were made and that it may only be used to make EMS PCRs until the changes go into effect. Restrictions would also be imposed upon a software vendor of EMS PCRs when it stores EMS PCR data on a server.
Subchapter D. Quality improvement and peer review
This subchapter would address the Statewide EMS Quality Improvement Program, regional EMS quality improvement programs and peer review conducted under the EMS System Act.
Section 1021.61 (relating to components of Statewide quality improvement program) would explain that the Statewide EMS Quality Improvement Program is operated to monitor and improve the delivery of EMS and that the Department, with the assistance of the Advisory Board, will identify the necessary components for a Statewide EMS Quality Improvement Program for the EMS system in this Commonwealth and update the Statewide EMS Quality Improvement Plan.
Section 1021.62 (relating to regional quality improvement programs) would deal with regional EMS councils establishing and updating regional EMS quality improvement programs and would describe the different facets of those programs to be administered by the regional EMS councils.
Section 1021.63 (relating to peer review) would identify EMS providers, EMS agency medical directors and medical command physicians as the persons who are subject to peer review under the EMS System Act. The definition of ''peer review'' in section 8103 of the EMS System Act (relating to definitions) classifies persons subject to peer review as ''[EMS] providers and physicians who direct or supervise EMS providers under [the EMS System Act] and regulations of the Department.'' EMS agency medical directors and medical command physicians are the physicians who direct and supervise EMS providers under the EMS System Act.
The EMS System Act also states that the peer reviews are to be conducted by ''health care providers,'' but does not define the term. The Department consulted the Peer Review Protection Act (63 P. S. §§ 425.1—425.4) for guidance it could provide in this regard. The Peer Review Protection Act refers to each person empowered to conduct peer reviews under that act as a ''professional health care provider'' and defines these persons as ''individuals and organizations who are approved, licensed or otherwise regulated to practice or operate in the health care field under the laws of the Commonwealth....'' It then lists examples of these individuals and organizations. See the definition of ''professional health care provider'' in section 2 of the Peer Review Protection Act (63 P. S. § 425.2). The Department considered these examples in developing examples of health care providers who may conduct peer review under the EMS System Act.
Section 1021.64 (relating to cooperation) would require entities regulated by the Department to cooperate with the Statewide and regional EMS quality improvement programs and, if requested, provide the Department and regional EMS councils the data, reports and access to records as reasonably requested by them to conduct quality improvement and peer reviews.
Subchapter E. Trauma centers
This subchapter would be adopted to help the Department carry out its responsibility under section 8105(b)(12) of the EMS System Act (relating to duties of department) to integrate trauma centers into the Statewide EMS system.
Section 1021.81 (relating to purpose) would explain that to accomplish this statutory objective the subchapter would provide for access to trauma centers and for the effective and appropriate utilization of EMS resources.
Section 1021.82 (relating to requirements) would provide that to integrate trauma centers into the Statewide EMS system, trauma centers will be required to: 1) maintain a dedicated telephone number for communication between the trauma center and a transferring hospital; 2) implement outreach programs to provide education on the management of major and multiple systems trauma patients and the capabilities of the trauma center; 3) provide patient outcome and treatment information to the transferring facility and the EMS agency or agencies involved in providing EMS to the trauma patient; and 4) maintain a medical command facility to enable direct communication between the trauma center and the ambulance crew transporting the patient to the trauma center so that patient information and changes in patient condition are immediately available to the trauma center and medical consultation is immediately available to the transporting ambulance crew.
Section 1021.83 (relating to complaints) would provide, as required under section 8105(b)(15) of the EMS System Act, that the Department will investigate complaints concerning the delivery of services by trauma centers and report the investigation results to the Pennsylvania Trauma Systems Foundation.
Subchapter F. Regional EMS councils
The EMS System Act provides for the Department to divide this Commonwealth into EMS regions and to assign a regional EMS council to each EMS region to exercise certain responsibilities for the region, including helping the Department to carry out its responsibilities under the EMS System Act. See the definition of ''regional EMS council'' in section 8103 of the EMS System Act, section 8105(a) and (b)(2) of the EMS System Act and sections 8104(a)(9) and 8109(a) of the EMS System Act (relating to emergency medical services system programs; and regional emergency medical services councils). This subchapter would address the Department's designation of EMS regions and the assignment of regional EMS councils to those regions, the structure of regional EMS councils and the responsibilities of regional EMS councils.
Section 1021.101 (relating to designation of regional EMS councils) would explain how regional EMS areas are designated.
Section 1021.102 (relating to structure of regional EMS councils) would identify the types of entities that may serve as a regional EMS council. It would also prescribe certain structural requirements for a regional EMS council, including that it have a governing body and a director and a regional EMS medical director and that it establish committees as needed to carry out its responsibilities.
Section 1021.103 (relating to governing body) would specify the representation requirements for a regional EMS council's governing body and core responsibilities of the governing body. It would also prohibit a staff member of a regional EMS council from serving as a voting member of the governing body.
Section 1021.104 (relating to responsibilities of regional EMS councils) would list 19 specific duties of regional EMS councils, as well as the duty to perform other tasks as assigned by the Department. A few of these responsibilities would include assisting the Department in the collection and maintenance of data provided through EMS PCRs, assisting entities regulated by the Department under the EMS System Act in meeting responsibilities imposed upon them by the EMS System Act and regulations adopted by the Department under the EMS System Act, and monitoring entities regulated under the EMS System Act to determine whether they are in compliance with the responsibilities imposed upon them by the EMS System Act and the regulations.
Subchapter G. Advisory Board
As previously noted, the EMS System Act designates the board of directors of PEHSC as the Advisory Board to the Department on EMS matters. Among its other responsibilities, the Advisory Board is to serve as the forum for discussion of the content of the Statewide EMS System Plan and advise the Department on EMS policy and regulations. The Advisory Board is funded with EMSOF funds, which it would secure through grants and contracts with the Department.
Section 1021.121 (relating to duties and purpose) would address the responsibilities of the Advisory Board. It would also prescribe certain structural requirements of the Advisory Board, including that it have a governing body and a director and that it establish committees, including a medical advisory committee and an EMS for children advisory committee, as needed to carry out its responsibilities.
Section 1021.122 (relating to meetings and members) would set forth certain requirements for Advisory Board meetings and membership.
Section 1021.123 (relating to disasters) would prescribe roles for the Advisory Board when this Commonwealth is confronted with a disaster, mass casualty event or other substantial threat to the public health and safety.
Subchapter H. EMS research
As previously noted, in general, EMS agencies are to prepare an EMS PCR for each patient to whom they provide EMS and they are to forward these reports to regional EMS councils. Section 8106(e) of the EMS System Act (relating to emergency medical services patient care reports) provides that these reports and the information in them are confidential except for certain purposes. One of the purposes for which the information may be released is for research approved by the Department, subject to Department approval and supervision to ensure that the use of the information is strictly limited to the approved research. See section 8106(e)(2) of the EMS System Act. Additionally, the Department may collect data regarding patients who utilize emergency departments, in a manner that protects the confidentiality of patient records, but the Department may also permit the use of such data for limited purposes, including research. See section 8105(b)(4) of the EMS System Act. This subchapter would be comprised of a single regulation, § 1021.141 (relating to research). This regulation would specify the process for procuring Department approval for use of the information for research under both provisions.
Chapter 1023. Personnel
This chapter would address qualifications and responsibilities of persons to whom the EMS System Act assigns specified roles and responsibilities in the Statewide EMS system.
Subchapter A. Administrative and supervisory EMS personnel
This subchapter would identify the categories of physicians to whom the EMS System Act assigns administrative and supervisory responsibilities in the administration of the Statewide and regional EMS systems. As stated in section 8102 of the EMS System Act (relating to declaration of policy), these systems serve as health care safety nets for many people in this Commonwealth and are to be fully integrated with the overall health care system to identify, modify and manage illness and injury. Physicians with appropriate qualifications are given essential functions in these EMS systems to ensure that those systems operate as intended with respect to ensuring that the EMS needs of persons who require EMS are met.
Section 1023.1 (relating to EMS agency medical director) would establish the responsibilities of and the minimum qualifications for physicians to act as EMS agency medical directors. Every EMS agency will be required to have a medical director, known as the EMS agency medical director. It will be the responsibility of this physician to evaluate the competence of EMS providers who work for the EMS agency, to evaluate the quality of patient care provided by the EMS agency and to provide medical guidance and advice to the EMS agency and its EMS providers. If an EMS agency medical director determines that an EMS provider at or above the advanced emergency medical technicians (AEMT) level has not maintained competence in performing skills at the level the EMS provider is certified, the EMS agency medical director will be responsible for specifying the level of practice in which the EMS provider may engage for the EMS agency. An EMS agency medical director will also be responsible for being acquainted with the Statewide and other Department-approved EMS protocols that apply to the EMS agency with which that physician is associated and for ensuring that the EMS agency's EMS providers are familiar with the protocols that apply to the delivery of EMS within their scope of practice.
Section 1023.2 (relating to medical command physician) would establish the responsibilities of and the minimum qualifications for physicians to act as medical command physicians. Medical command physicians are the physicians who provide EMS providers medical direction, generally by radio, when they seek direction while providing EMS to patients. This may occur because the EMS provider believes that medical direction is needed or helpful or because applicable EMS protocols dictate contact with medical command under the circumstances presented. These physicians, like EMS agency medical directors, shall be familiar with the Statewide and other relevant Department-approved protocols. They would generally be required to provide medical direction to EMS providers consistent with these protocols, but they would have the authority to depart from the protocols when there is good cause to do so. To serve as a medical command physician, a physician would need to be certified by the Department. A medical command physician would also need to register that certification with the Department at 3-year intervals and would need to meet specified requirements to do so.
Section 1023.3 (relating to medical command facility medical director) would establish the responsibilities of and the minimum qualifications for physicians to act as medical command facility medical directors. Medical command physicians function under the auspices of a medical command facility and under the direction and supervision of a medical command facility medical director. The medical command facility medical director would be responsible for ensuring that the medical command physicians who operate under the auspices of the medical command facility are carrying out the regulatory responsibilities that would be imposed upon them and are providing appropriate medical direction to EMS providers. The medical command facility medical director would also be responsible for ensuring that the medical command facility is compliant with its statutory and regulatory responsibilities. Like the medical command physician, to serve as a medical command facility medical director a physician would need to be certified by the Department and would be required to register that certification with the Department at 3-year intervals by satisfying the registration requirements that would be imposed by the regulations.
Section 1023.4 (relating to regional EMS medical director) would establish the responsibilities of and the minimum qualifications for physicians to act as regional EMS medical directors. This Commonwealth is currently divided into 16 EMS regions. For each of these regions, the Department has designated and contracted with an entity to serve as a regional EMS council. Each regional EMS council would assist the Department in administering the EMS System Act. Some of a regional EMS council's activities, such as the quality improvement reviews, require medical oversight. There are other matters in which a regional EMS medical director is involved and called upon to provide medical leadership. These responsibilities would continue to apply.
Section 1023.5 (relating to Commonwealth EMS Medical Director) would establish the responsibilities of and the minimum qualifications for a physician to qualify as the Commonwealth EMS Medical Director. The Commonwealth EMS Medical Director (currently referred to as the Commonwealth Emergency Medical Director) is a physician who is approved and employed by the Department to advise it and formulate policy on EMS matters. Some of the responsibilities of the Commonwealth EMS Medical Director would be to lead the development and amendment of Statewide EMS protocols, to assist in the development and implementation of a Statewide EMS quality improvement program and to serve as the Department's medical liaison to the regional EMS medical directors and the medical advisory committees of the regional EMS councils and the Advisory Board.
Subchapter B. EMS providers and vehicle operators
The persons who provide EMS to persons in need of EMS are the EMS providers (referred to in the current regulations as ''prehospital personnel''). EMS providers, with appropriate equipment and supplies, are generally transported by ambulance to scenes where their services are required. Persons who drive ambulances and certain other ground EMS vehicles, such as squad vehicles, are EMSVOs. Many EMS providers will also be EMSVOs. This subchapter would identify the various classes of EMS providers and address their roles and responsibilities, the requirements they need to satisfy to become certified and to maintain current registration of their certification and the skills they will be permitted to perform. It would also address the role of EMSVOs and the requirements they will need to satisfy to become certified and maintain current registration of their certification.
Section 1023.21 (relating to general rights and responsibilities) would address various rights given to and various responsibilities imposed upon EMS providers and EMSVOs. Most of these rights and responsibilities are in the EMS System Act. This section would require EMS providers and EMSVOs to ensure that the Department has their current mailing address, regardless of whether they maintain current registration of their certifications. It would also require EMS providers and EMSVOs, as well as applicants for EMS provider and EMSVO certifications, to report to the Department various matters that the Department may take into consideration in acting upon applications for certification and in evaluating whether disciplinary sanctions should be pursued against EMS providers and EMSVOs. Matters that need to be reported under the EMS System Act include various types of convictions, disciplinary sanctions and exclusions from Federal and State health care programs. Section 8113(i)(3) of the EMS System Act (relating to emergency medical services providers) requires that the Department be provided certified copies of records of these matters and prohibits the Department from certifying an applicant if the Department does not receive a certified copy of the relevant document unless the applicant establishes that the document does not exist. This section would explain those requirements.
This section would also repeat various examination rights and responsibilities of persons seeking to become EMS providers that are imposed by statute, impose upon EMS providers and EMSVOs the responsibility to display their certification credentials when requested while providing EMS or operating an EMS vehicle and require EMS providers other than prehospital EMS physicians (PHP) to provide EMS only under EMS protocols and medical command direction.
Each section of the EMS System Act that pertains to the certification of an EMS provider includes a provision which states that if that person does not renew the registration of the person's EMS provider certification before it expires, the EMS provider may renew the registration at a later date under standards the Department prescribes by regulation. With few exceptions, the EMS System Act gives an EMS provider the option of timely renewing a registration by either satisfying continuing education requirements or passing written and practical skills registration examinations. To renew a registration within the 2 years after its expiration, this section would require an EMS provider to complete both core continuing education requirements that the Department prescribes and the written registration examination. If more than 2 years have elapsed since the expiration of a registration before the EMS provider seeks to renew the registration, the EMS provider would need to complete the core continuing education requirements that the EMS provider had missed during the period of time the provider's certification was not renewed and would also need to pass both the written and practical registration examinations. Prehospital physician extenders (PHPE), prehospital registered nurses (PHRN) and PHPs will not have the option of taking examinations to secure timely renewal of the registration of their certifications. However, if they would seek to renew their registrations after the registrations expire, they would need to take and pass the same registration examinations as paramedics to obtain a current registration.
Special provisions are included in section 8113(o) of the EMS System Act for EMS providers and EMSVOs who are unable to satisfy the standard continuing education option for renewing the registration of their certification because they are in the armed forces and are on an active tour of duty. Subsection (d) would provide that if their registrations expire during their tour of duty or will expire within 12 months after their return from military service, they may secure an exception to the continuing education requirements from the Department. The Department could give them an extension of time to meet the continuing education requirements. EMS providers could also secure the Department endorsement of their relevant military service as satisfying some or all of their continuing education requirements. The Department's regulation would provide for the Department to address requests for an exception on a case-by-case basis.
Section 8113(o) of the EMS System Act also provides that an EMS provider in military service who is certified at or above the AEMT level who returns from active duty shall have the provider's competency in providing EMS evaluated by an EMS agency medical director before the EMS provider is permitted to perform skills for the EMS agency with which the EMS agency medical director is associated. The regulation would also state this requirement.
Another topic that would be addressed in this section would be the potential downgrading of the level of care an EMS provider is permitted to provide for an EMS agency based upon an assessment of the EMS provider's competency by the EMS agency medical director. Section 8125(b) of the EMS System Act (relating to medical director of emergency medical services agency) provides that an EMS agency medical director is to conduct, for the EMS agency with which the physician is associated, initial and annual assessments of the knowledge and skills competency an EMS provider, at or above the AEMT level, shall possess to perform EMS at that level for the EMS agency. Section 8129(k) of the EMS System Act (relating to emergency medical services agencies) provides that if an EMS agency medical director apprises the EMS agency that the EMS provider is not competent to provide services at the level at which the EMS provider is certified, the EMS agency may not permit the provider to practice at that level, but may permit the provider to practice at a lower level if authorized to do so by the EMS agency medical director. Section 8113(m) of the EMS System Act would give an EMS provider at or above the AEMT level who has been assessed as being deficient in skills at the level for which the EMS provider is certified the option to either continue to meet the registration requirement for the provider's level of certification or to apply for and secure certification at the lower EMS provider level. Subsection (g) would expand upon these options. It would further provide that an EMS provider who transitions to a lower level of certification or practice may not display any indicia of higher level certification when providing EMS at the lower level and that the EMS provider shall disclose the downgrade to each EMS agency for which the provider is providing EMS or seeks to provide EMS, as well as to the regional EMS councils responsible for the EMS regions in which those EMS agencies are headquartered.
Finally, subsection (i) would address the rights and responsibilities of an EMS provider with respect to providing EMS to a patient when arriving at the scene of a police incident where a law enforcement officer is present and is exercising control over the scene.
Section 1023.22 (relating to EMS vehicle operator) would address standards for the certification of an EMSVO, the recurring registrations of that certification and the activity in which an EMSVO is authorized to engage. Prior to the enactment of the EMS System Act, there was no statutory authority for the Department to certify and regulate the activity of persons entrusted with driving an ambulance, or what is now referred to as a squad vehicle. Section 8122 of the EMS System Act (relating to emergency medical services vehicle operators) confers that authority on the Department for the first time. Under this section, the certification and registration would permit an EMSVO to operate any ground EMS vehicle the EMS agency authorizes the operator to drive. The registration period, in general, would be for 3 years. However, if the EMSVO is also certified as an AEMT or higher level EMS provider, the registration period will be 2 years. If the EMSVO is certified as any type of EMS provider the registration period for the EMSVO certification would coincide with the registration period for the EMS provider certification. The registration could be renewed by completing the requisite continuing education, which would be two or three credits, depending upon the length of the registration period involved. Under section 8122 of the EMS System Act, an EMSVO who operates an EMS vehicle only for an EMS agency's QRS would not have registration requirements to satisfy.
Sections 1023.23—1023.30 would pertain to EMS providers that will be certified by the Department. Section 1023.23 (relating to ambulance attendant and first responder) would deal with the elimination of the ambulance attendant and first responder classifications under the prior EMS act and the transition of these persons to EMR certification under the EMS System Act. First responders are the lowest level EMS providers currently certified. Ambulance attendants are persons who meet some very minimal requirements under the prior EMS act under which they are permitted to attend to patients as part of an ambulance crew and perform certain basic life support (BLS) skills. Currently, ambulance attendants are not certified or otherwise regulated by the Department. The Department's only regulation of their conduct is indirect and derives from the Department's authority to regulate ambulance services. This changed under the EMS System Act. Ambulance attendant and first responder personnel classifications are abolished and these providers become EMRs. This section would provide for the automatic issuance of EMR certifications to first responders and would give ambulance attendants 180 days to provide documentation to the Department to establish that they have been ambulance attendants and are, therefore, qualified for EMR certification. The section would further provide for the automatic registration of the EMR certifications when those certifications are issued to the former first responders and ambulance attendants and for the initial registrations to expire when their certification as a first responder and qualifications as an ambulance attendant would have expired under the prior EMS act.
Sections 1023.24—1023.30 are primarily structured in the same fashion and each would deal with a specific type of EMS provider. Each section would address the roles and responsibilities of the EMS provider to which it applies, the criteria for certification of that EMS provider, the standards for the registration of that certification and the scope of practice of the EMS provider. The EMS providers would be EMRs, emergency medical technicians (EMT), AEMTs, paramedics, PHPEs, PHRNs and PHPs. Each subsection dealing with scope of practice would identify the primary skill areas for the EMS provider and would provide that the specific skills that type of EMS provider would be permitted to perform would be specified through a notice in the Pennsylvania Bulletin. The scope of practice of each higher level EMS provider, through paramedics, would include the scope of practice of the immediately lower level EMS provider as well as additional skills.
Section 1023.26 (relating to advanced emergency medical technician) would deal with a new level of EMS provider in this Commonwealth, which will be an intermediate level EMS provider certified to perform the skills an EMT is certified to perform, plus additional advanced life support (ALS) skills, as designated by the Department, which include interventions and administration of medications with certain advanced equipment. Many other states also certify an EMS provider between the EMT and paramedic levels that is authorized to perform all of the skills an EMT is certified to perform and some of the additional ALS skills a paramedic is certified to perform. Some states label this EMS provider an ''advanced EMT'' and other states label this EMS provider an ''EMT—intermediate'' or ''EMT-I.'' Medicare regulations employ the term EMT—Intermediate and define that EMS provider within the definition of ''advanced life support personnel'' in 42 CFR 414.605 (relating to definitions), as follows:An individual who is qualified, in accordance with State and local laws, as an EMT-Basic and who is also qualified in accordance with State and local laws to perform essential advanced techniques and to administer a limited number of medications.
When the Department begins to certify AEMTs, an AEMT will be an EMS provider who satisfies the Medicare definition of ''EMT—Intermediate.''
PHPEs, PHRNs and PHPs would be physician assistants, registered nurses and physicians who qualify for certification as EMS providers by virtue of their health care practitioner licenses and by satisfying additional requirements. As specified in sections 8118 and 8119 of the EMS System Act (relating to prehospital registered nurses; and prehospital physician extenders), PHPEs and PHRNs would have the same scope of practice as a paramedic, plus they would be permitted to perform skills within the scope of their licenses provided that they received authority to perform those skills through EMS protocols or under the orders of a medical command physician. PHPs would be able to perform physician skills within the scope of the physician's practice without restrictions. Additionally, as provided for in section 8113(g) of the EMS System Act, these sections would make provision for the Department to expand the list of skills each type of EMS provider may perform under protocol or medical command order through publication of a notice in the Pennsylvania Bulletin.
Except as already noted for ambulance attendants and first responders who become EMRs, the initial and subsequent registration period for EMR and EMT certifications is 3 years and the registration period for all other EMS provider certifications is 2 years. Each section would specify criteria for the certification of the EMS provider to which it applies and for registration of the EMS provider's certification. The initial registration would begin with the certification of the EMS provider. The term of the initial registration would vary depending upon factors explained in each regulation. Subsequent registration periods for the EMS providers would be for the standard 2 or 3 years, depending upon the type of EMS provider involved.
For various types of EMS providers who are certified or otherwise permitted to practice under the prior EMS Act, this section would provide a grace period to accommodate those providers being able to continue to function pending their certification as a new type of EMS provider. This would apply to ambulance attendants becoming EMRs and health professional physicians becoming PHPs.
Finally, both the level of practice and the types of services in which each type of EMS provider may participate would be defined in general terms.
Section 1023.31 (relating to continuing education requirements) would specify the continuing education requirements each type of EMS provider and an EMSVO would need to meet to secure timely registration of their certifications if they sought to renew their certifications by satisfying continuing education requirements. EMRs, EMTs, AEMTs and paramedics would have the option of securing a new registration by taking and passing registration examinations instead of satisfying continuing education requirements. PHPEs, PHRNs and PHPs would not have that option. For the EMSVO and each type of EMS provider, this section would specify the total number of continuing education credits needed as well as a lesser number of core continuing education requirements in designated subject matter or courses, within the total number of credits, that the Department would specify through a notice in the Pennsylvania Bulletin.
Section 1023.32 (relating to credit for continuing education) would specify the types of courses for which credit would be awarded by the Department and the manner in which the Department would assign credit to those courses. It would also provide for the creation of a Statewide registry of continuing education records that EMSVO and EMS providers may access to secure their own record through a secure access process and would establish a procedure for them to resolve discrepancies between their records of the continuing education they completed and the record in the registry.
Section 8113(f) of the EMS System Act authorizes the Department to issue EMS provider certifications and registrations through reciprocity or endorsement. To grant an EMS provider certification or registration through endorsement, the Department would endorse an examination or an educational course that an applicant for EMS provider certification, or registration of an EMS provider certification, has taken as meeting or exceeding the standards the Department imposes for the certification and registration examinations and courses it approves. To grant an EMS provider certification through reciprocity, the Department would review the criteria for EMS provider certification in another state, determine if the other state's criteria was substantially equivalent to the criteria for a similar certification the Department issues and then enter into an agreement with its counterpart certifying agency in the other state that each will issue a certification to an applicant similarly certified in the other state.
Sections 1023.33 and 1023.34 (relating to endorsement of course or examination; and reciprocity) would set forth the standards for the Department to grant endorsement of courses and examinations for EMS provider certification and registration purposes and for the Department to grant EMS provider certifications predicated on a reciprocity agreement with another state. The section dealing with reciprocity would include the caveat that a reciprocity agreement with its counterpart in another state would not deprive the Department of its right to deny reciprocal certification to an applicant based upon disciplinary considerations.
Subchapter C. Other persons associated with the Statewide EMS System
In addition to EMS providers and EMSVOs and the physicians who direct and supervise them, EMS instructors and rescue technicians and instructors are integral to an EMS system. Issues regarding them are addressed in these regulations generally and, specifically, in this subchapter.
EMS instructors teach courses in EMS educational institutes. In § 1025.1(h) (relating to accreditation and operational requirements of EMS educational institutes), the Department would impose upon the EMS educational institutes the standards their instructors would need to satisfy. Section 1023.51 (relating to certified EMS instructors) would set standards for persons to be certified as EMS instructors by the Department. Like EMS providers and EMSVOs, their certifications will be subject to a registration requirement. The regulation would also include requirements for the registration of their certifications. A certified instructor will not be able to teach under the certification unless it is currently registered. However, as discussed under § 1025.1, not all of an EMS educational institute's instructors need to be certified as EMS instructors by the Department.
Rescue technicians function hand-in-hand with EMS providers. Frequently persons who require EMS need to be rescued from vehicles or other places where they may be entrapped. The Department does not regulate rescue personnel, but as the lead agency for EMS in this Commonwealth, it, in collaboration with the State Fire Commissioner, has developed rescue technician courses and a rescue technician certification process to promote the proper education and training of persons who would seek to free entrapped persons. Section 1023.52 (relating to rescue personnel) would continue the rescue technician certification program provided for in the current regulations. As is the case now, participation in the program in offering rescue technician training courses, or in serving as an instructor or completing the rescue technician certification process, would be entirely on a voluntary basis. Subsection (e) would make it clear that participation in the program would not be required to offer a rescue training program, teach a rescue course or perform rescues.
Chapter 1025. Education
Some persons who now qualify for EMS provider certification, such as some registered nurses and physicians, receive the education they need to serve as an EMS provider through the courses they took to be licensed as nurses and physicians and the continuing education courses they took to improve their skills. Under the EMS System Act, they, as well as physician assistants, will be tested to ensure that they are competent to be certified as EMS providers. Other persons need to take EMS provider education courses to meet the educational requirement for certification. Under section 8105(a)(6) of the EMS System Act, the Department is required to define and approve educational programs and accredit educational institutes for the education and training of EMS providers. In this chapter, the Department would establish accreditation and operational standards for EMS educational institutes and sponsors of continuing education programs for EMS providers and EMSVOs.
Subchapter A. EMS educational institutes
Section 1025.1 would impose the accreditation and operational requirements for EMS educational institutes. This section would address the types of entities eligible to become accredited and reaccredited as an EMS educational institute, the institute's duty to establish an advisory committee and the responsibilities of that advisory committee, and the responsibilities of the institute with respect to its administration and operation, and the instruction it provides.
There would be two types of EMS educational institutes—an ALS educational institute and a BLS educational institute. The institutes would be classified, as explained in subsection (b), based upon the courses they would provide. Some of the standards for the accreditation and operation of an EMS educational institute would be different based upon the ALS or BLS classification of the institute. Of course, some ALS institutes also provide BLS courses. Those institutes would primarily be held to the higher standards for ALS institutes, but, as to some matters, to lesser standards with respect to the EMR and the EMT courses they offer.
Each EMS educational institute would need to have a medical director, an administrative director, a course coordinator for each EMS provider educational course it offers, EMS instructors, clinical preceptors and field preceptors, as appropriate. The section would specify the qualifications each would need to satisfy and impose upon each certain duties. The EMS educational institute would be responsible for ensuring that these standards were met. Subsection (c) would specify the responsibilities of the advisory committee.
Additionally, this section would enumerate matters the EMS educational institute would need to disclose to students and prospective students and would prescribe various facility, equipment, supply and other operational requirements.
Standards regarding the EMS educational institute's use of instructors would be imposed, but would be flexible. At least 75% of the instruction would need to be provided by persons certified by the Department as EMS instructors. They would need to have a prescribed number of years' experience as an EMS provider and as an EMS instructor in teaching a course at or above the level of EMS provider certification they would be teaching. Alternatively, the regulation would permit the EMS educational institute to fill this 75% teaching quota with persons approved by the institute's medical director and course coordinators as meeting or exceeding the certification requirements. The remaining 25% of the education in the EMS provider educational courses offered could be provided by other persons if they have special expertise in the subject matter they would be teaching, as determined by the medical director in consultation with the course coordinators.
This section would also include a provision requiring the EMS educational institute and an applicant for accreditation as an EMS educational institute to provide the Department or a regional EMS council with access to its records and its facility, for inspection purposes, to monitor its compliance with the requirements of the subchapter.
Finally, as many EMS educational institutes will be operating within a 3-year accreditation cycle when this regulation goes into effect, and will be operating under standards different than those that would be imposed by this section, subsection (l) would provide that the standards imposed by the section would not apply to an EMS educational institute until it makes its initial application for accreditation after the regulation becomes effective.
Section 1025.2 (relating to accreditation process) would address the procedure to apply for accreditation as an EMS educational institute and explain how that application would be processed. It would also identify the accreditation decisions that could be reached from full accreditation to nonaccreditation and explain what each classification entails. The procedures for appealing a decision denying or granting conditional accreditation would be addressed in § 1031.12 (relating to discipline of EMS educational institutes). The provisions for denials of license, accreditations and certification, and disciplinary actions against entities that are licensed, certified or accredited under the EMS System Act and this subpart would be in that chapter.
Section 1025.3 (relating to advertising) would preclude an entity from advertising a course in a manner that states or suggests that the successful completion of the course satisfies the EMS educational course requirement for EMS provider certification, unless the entity has been accredited by the Department as an EMS educational institute and the course has been approved by the Department for that purpose. It would also impose requirements with respect to language that needs to be inserted in the accredited institute's brochures and registration materials relating to offering the course.
Subchapter B. EMS continuing education courses
As previously stated, some types of EMS providers have the option of renewing the registrations of their EMS provider certifications by either satisfying continuing education requirements or taking registration renewal examinations. The sections of the EMS System Act that address the registrations of these certifications each provide for the registrations to be secured by the EMS provider or EMSVO securing credits in continuing education programs approved by the Department.
Section 1025.21 (relating to accreditation of sponsors of continuing education) would establish the standards for entities to become a sponsor of continuing education programs and for those entities to become reaccredited as continuing education sponsors.
Section 1025.22 (relating to responsibilities of continuing education sponsors) would address the administrative responsibilities that continuing education sponsors would need to satisfy. It would address matters such as maintaining a record of attendance for courses given in a classroom setting, the reporting of attendance, evaluating courses to determine their effectiveness, retaining records and providing access to those records for the Department review, monitoring compliance with responsibilities and reporting to the Department an EMS provider's or EMSVO's completion of a continuing education course. In the past, some continuing education sponsors have offered a continuing education course that another sponsor has developed without notifying the Department that it was offering the course. The Department would then receive notification of course completion by EMS providers when the Department did not have a record of the course being given by a continuing education sponsor. Consequently, this section would also include a provision requiring that before a continuing education sponsor may offer for continuing education credit a course developed by it or another continuing education sponsor, it must register with the Department the location where it will offer that course. If the course is completed by an EMS provider or EMSVO without the continuing education sponsor first registering the course with the Department, the Department would give the EMS provider or EMSVO credit for completing the course unless upon review the Department finds that the course was presented in a manner that rendered it unacceptable for credits. In that case, the Department would likely take disciplinary action against the continuing education sponsor for failing to comply with this regulation.
Section 1025.23 (relating to advertising) would feature the same types of provisions that § 1023.3 would contain in regulating the advertisement of EMS provider educational programs by EMS educational institutes. It would also provide that a continuing education sponsor may not advertise a course for continuing education credit unless the sponsor has been approved by the Department to offer the course.
Chapter 1027. EMS agencies
This chapter would address the licensing and regulation of EMS agencies. Under the prior EMS act, the Department licensed ambulance services. The licensure standards in the prior EMS act were directed to the ambulance services' operation of ambulances and squad vehicles, which, under the prior EMS act, were also considered to be ambulances. In developing the EMS System Act, the General Assembly recognized the need to provide for an EMS system far more evolved and sophisticated than one confined to the operation of ambulances. Consequently, it provided for the licensing of EMS agencies that would be empowered to conduct a variety of EMS operations based upon their focus and qualifications. While under the prior EMS act the term ''ambulance service'' referred to an organization that operates ambulances, under the EMS System Act the term ''ambulance service'' refers to a type of EMS service an EMS agency may be licensed to provide. Under the EMS System Act, an entity does not need to operate an ambulance service to be licensed as an EMS agency, but if it provides any of the myriad of EMS services described in the EMS System Act it will need to be licensed as an EMS agency and will be subject to the EMS System Act and the Department's regulations place on EMS agencies.
Subchapter A. General requirements
Subchapter A (relating to general requirements) would include sections that apply to EMS agencies, regardless of the services they are licensed to provide.
Section 1027.1 (relating to general provisions) would specify types of EMS operations for which an entity would need an EMS agency license. It would address, in general terms, the requirements an applicant would need to satisfy to qualify for an EMS agency license and the type of information that would be included on the license and license registration documents the Department would issue to EMS agencies. Additionally, it would include provisions facilitating the transition to EMS agency licensure of ambulance services and QRSs that are currently operating under a license or other authorization issued under the prior EMS act.
Section 1027.2 (relating to license and registration applications) would deal with applications for EMS agency licenses, as well as the amendment and the triennial registration of those licenses. It would specify some of the information that would be solicited in the license application form and provide direction regarding where an applicant is to submit its license application. It would provide that applications for a license, amendment of a license and registration of a license are to be filed with a regional EMS council and it would explain how the applicant would determine the regional EMS council to which it is to submit these applications. It would also explain how a regional EMS council would process a license application. Additionally, it would identify the types of changes to an EMS agency's operations that would require an EMS agency to secure an amendment of its license.
Section 1027.3 (relating to licensure and general operating standards) would address various requirements that an applicant for an EMS agency license and an EMS agency would need to satisfy. Unlike § 1027.1, which would deal with the requirements for the issuance of an EMS agency license, the primary focus of this section would be operational standards an EMS agency would need to satisfy when it is providing EMS. One of the topics addressed is the records that would need to be made available to the Department or a regional EMS council for inspection by an applicant for an EMS agency license and by an EMS agency after it is licensed. An EMS agency, once it begins operations, would be required to make available for inspection certain records in addition to those it was required to make available for inspection when it applied for licensure. This section would also impose upon EMS agencies duties pertaining to vehicles, equipment, supplies, staffing, the use of persons under 18 years of age, interacting with public safety answering points (PSAP), patient management, use of lights and warning devices, dispatching, exclusion of weapons and explosives, reporting of EMS vehicle accidents, reporting of injuries and fatalities incurred by EMS providers in the line of duty, committees, EMS provider credentialing, display of license and registration certificates, monitoring compliance by the agency and its staff with requirements of the EMS System Act and the regulations, and establishing and adhering to certain policies and procedures.
The EMS agency dispatching requirements would apply to only those EMS agencies that operate a communications center to which a PSAP routes callers for the EMS agency to carry out the PSAP dispatching function, or which advertises a number to the public through which the public can seek an emergency EMS response instead of calling a PSAP. Under section 8129(i) of the EMS System Act, the call takers and dispatchers at a dispatch center would need to satisfy the requirements imposed upon call takers and dispatchers by 35 Pa.C.S. § 5303(a)(6) (relating to telecommunications management). The Department has coordinated with PEMA for PEMA to certify and recertify those call takers and dispatchers if the requisite standards are met. This section would set forth the standards for the certification and recertification of those persons as well as quality assurance and other standards that an EMS agency dispatch center would need to satisfy. It would also require an EMS agency dispatch center to employ the emergency medical dispatch program used by the 911 emergency communications center of the county in which the EMS agency dispatch center is located. However, in extraordinary cases, the EMS agency could seek an exception under § 1021.4 to use another dispatch program. Under § 1023.1, if an EMS agency operates an EMS agency dispatch center its medical director will be required to provide medical direction for the dispatch center.
Section 1027.4 (relating to medication use, control and security) would set standards for an EMS agency's use of medications. It would provide that the Department will publish at least annually in the Pennsylvania Bulletin a notice listing the medications approved for use by EMS providers at their various certification levels. The notice would list the medications that an EMS agency is required to stock based upon the type of EMS service it is licensed to provide. It would also address the scope of authority of each type of EMS provider to administer medications to patients and it would impose upon an EMS agency various responsibilities with respect to monitoring and directing the use, control and security of the medications it is authorized to stock.
Section 1027.5 (relating to Statewide EMS response plan) would establish Statewide exceptions to the general requirement that an EMS agency provide its services 24 hours-a-day, 7 days-a-week. Section 8140 of the EMS System Act (relating to conditional temporary licenses) authorizes an EMS agency to depart from this requirement if it participates in a county-wide or larger area-wide EMS response plan approved by the Department that permits otherwise. Section 1027.5 would exempt EMS agencies that provide an air ambulance service from providing those services every day around the clock. It would also provide a different response requirement for an EMS agency's operation of a tactical EMS service.
Section 1027.6 (relating to EMS vehicle fleet) would deal with the EMS vehicles an EMS agency is authorized to use. It would require that a vehicle pass an EMS vehicle inspection by the Department or regional EMS council inspector before it may be used as an EMS vehicle and it would provide for the placement on an EMS vehicle that passes the inspection of decals with date stripes to reflect the date of inspection and the expiration date. Certain exceptions would be provided for a vehicle deployed as an EMS vehicle for a short temporary period. This section would also address the steps an EMS agency would need to take before adding an EMS vehicle to its fleet or permanently or temporarily replacing an EMS vehicle. To operate a temporary replacement EMS vehicle, the EMS agency would need to submit a temporary change of vehicle form in which it would attest to the fact that the vehicle satisfies the requirements applicable to the type of EMS vehicle for which it will be used. Upon receiving that form, a regional EMS council would issue a letter authorizing the use of the replacement vehicle for a short period of time. An EMS agency that wants to add an EMS vehicle to its fleet would need to apply for an amendment of its license. The section would also require the inspection of an EMS agency's EMS vehicles as part of the process of an EMS agency securing the triennial registration of its license. It would also specify the circumstance in which an EMS agency will be required to remove the decals from an EMS vehicle. Finally, this section would enumerate requirements that are applicable to all ambulances.
Section 1027.7 (relating to removal of EMS vehicles from operation) would require an EMS agency to immediately remove an EMS vehicle from operation when there is a mechanical or equipment problem that poses a significant threat to the safety of patients or crew and to not again use the vehicle until the problem has been corrected. It would further provide that if after inspection the Department directs that an EMS vehicle be removed from operation, the EMS agency may not again operate that vehicle until the Department has confirmed to the EMS agency that the Department is satisfied that the problem has been resolved.
Section 1027.8 (relating to right to enter, inspect and obtain records) would address the responsibility of an EMS agency or an applicant for an EMS agency license to permit an employee or agent of the Department to inspect its records, EMS vehicles, supplies, equipment and security facilities to ensure that the EMS agency or applicant is in compliance with its duties under the EMS System Act and the regulations. It would also require the EMS agency or applicant to permit the copying of certain records. Section 8142(a)(1) of the EMS System Act (relating to emergency medical services agency license sanctions) provides that the failure of an EMS agency or an applicant for an EMS agency license to comply with a the Department regulation is a ground for discipline, including refusing to issue an EMS agency license to an applicant. Section 1027.8(c) would emphasize that failure to comply with this regulation would be a ground for an action.
Section 1027.9 (relating to notification of deficiencies to applicants) would address the process for dealing with an application for an EMS agency license, the registration of a license and an amendment of a license when the inspection that follows receipt of the application reveals deficiencies. The section would provide that the inspector will give the applicant an inspection report and, if there are deficiencies, identify whether a reinspection or plan of correction will be required or whether the problem can be resolved without the need for either. It would further address the applicant's right to dispute a deficiency cited by an inspector or a regional EMS council's rejection of its plan of correction, and to have the Department resolve the dispute. Finally, it would clarify that the Department may identify to the applicant deficiencies not identified by an inspector at the time the inspection report is provided, that the Department may independently require the applicant to submit a plan of correction or take immediate action to resolve a deficiency and that the Department may take disciplinary action if it determines that this action best serves the public interest.
Section 1027.10 (relating to plan of correction) would provide that if the Department has determined that an EMS agency has violated a requirement imposed by the EMS System Act or a regulation promulgated under the EMS System Act, the Department may direct the EMS agency to take immediate action to correct the violation or to submit a plan of correction. It would also address the type of responses an EMS agency may make to the direction, specify the process that would follow if an EMS agency refuses to comply with the direction or otherwise challenges the determination that it has committed a violation and explain that an EMS agency's failure to comply with the direction constitutes a basis for discipline if the underlying violation of which the EMS agency is accused is substantiated following a hearing.
Section 1027.11 (relating to conditional temporary license) would address the circumstances under which the Department may issue a conditional temporary license. Under the prior EMS act, there were two types of licenses that the Department could issue, other than a standard license, when the licensee failed to satisfy certain licensure requirements. These were a provisional license and a temporary license. Under section 8140 of the EMS System Act, the conditional temporary license replaces those types of licenses. The Department will have the discretion to issue this type of license to an EMS agency if the EMS agency cannot provide services 24 hours-a-day, 7 days-a-week or does not participate in a county or broader-level EMS response plan, approved by the Department, under which arrangements are made for it to operate less than 24 hours-a-day, 7 days-a-week. The Department would issue this type of license only when it determines it would be in the public interest to do so. A conditional temporary license would be valid for only 1 year but, unlike for the current provisional and temporary licenses, there is not a statutory limitation on the Department with respect to the number of times it may renew a license. A conditional temporary license will be subject to the terms and conditions as the Department deems appropriate. This section would provide for the Department to take disciplinary action against an EMS agency that cannot operate in compliance with the EMS System Act without a conditional temporary license, but which refuses to agree to the terms and conditions the Department attaches to its issuance of the conditional temporary license.
Section 1027.12 (relating to discontinuation or movement of operations or reduction of service) would direct an EMS agency regarding the notices it shall provide before discontinuing an EMS service it is licensed to provide or reducing the hours it provides an EMS service. Section 8129(o) of the EMS System Act requires an EMS agency to provide 90 days advance notice to various different entities before it engages in an action. In addition to providing notice to the Department, the EMS System Act requires that an EMS agency publish notice of its intent in the EMS agency's service area and that it notify the chief executive officer of each political subdivision in its service area of its intent. This regulation would clarify that an EMS agency is permitted to discontinue a service or reduce the hours it provides the service, without providing these various notices, if ordered to do so by the Department. That could occur, for example, as a result of a disciplinary proceeding.
Section 1027.13 (relating to management companies) would deal with the Department's approval of an entity to offer management services to an EMS agency. Under section 8129(f) of the EMS System Act, an EMS agency may enter into a contract with another entity for that entity to manage the EMS agency if that entity has been approved by the Department to manage EMS agencies. The EMS System Act does not define what managing an EMS agency entails. This section would explain that management services involve exercising operational or managerial control over an EMS agency or conducting the day-to-day operations of the EMS agency. To qualify for Department approval to manage EMS agencies, an entity needs to be a responsible person and comply with the EMS System Act and the applicable regulations. This section would either explain or reference those standards. This section would also address the application process, require a management company to update any change in the information it provided in the application for Department approval and require management companies to make certain disclosures to EMS agencies with which it contracts to provide management services. Additionally, the regulation would provide for the Department to maintain a registry of entities it has approved to offer management services to EMS agencies.
Subchapter B. EMS agency services
This subchapter would identify the types of EMS services an EMS agency could be licensed to provide and would address specific requirements an EMS agency would need to satisfy in providing each of these services. For each type of service covered by this subchapter, the equipment and supply requirements would be listed in a notice published in the Pennsylvania Bulletin, as required under section 8129(j) of the EMS System Act.
Section 1027.31 (relating to general standards for providing EMS) would specify eight overarching requirements for providing EMS applicable to the provision of EMS services. One of the requirements would be that when multiple EMS providers are dispatched to a scene, the first EMS provider to arrive, regardless of skill level, shall begin providing EMS to the patient. Another requirement would be that if a crew of an EMS agency service needs additional assistance in attending to the needs of a patient or patients, it is to contact a PSAP to request that assistance.
Section 1027.32 (relating to quick response service) would explain that the purpose of a QRS is to respond to calls for EMS and provide EMS to patients before an ambulance arrives. It would clarify that a QRS may respond to a call for EMS with a single EMS provider and does not need to respond with an EMS vehicle or a vehicle. However, it would further provide that if a QRS does respond with a BLS or ALS squad vehicle, the driver of the squad vehicle would need to be an EMSVO. This section would also address certain facets of the transfer of a patient from a QRS to an ambulance service when the crew of an ambulance arrives at the scene.
Section 1027.33 (relating to basic life support ambulance service) would explain that the purpose of an EMS agency that operates a BLS ambulance service is to operate one or more BLS ambulances staffed by a crew capable of providing all facets of EMS to a patient who requires EMS at the EMT or AEMT level. The facets of EMS include medical assessment, triage, monitoring, observation and treatment. The minimum staffing for a BLS ambulance shall be at an EMT level. However, if the EMS agency is licensed to operate a BLS ambulance at the AEMT level, the EMS agency shall staff, equip and supply a BLS ambulance at that level when it chooses or needs to operate a BLS ambulance at the level. When a BLS ambulance is so staffed, equipped and supplied, it is operating at an intermediate ALS level rather than at a BLS level. This section would specify the staffing standards at both levels. This section would clarify that although a full BLS ambulance crew is required to respond to a call for EMS, the crew members need not all respond in the ambulance, but the ambulance would need to be fully staffed when transporting a patient. This section would also address the responsibilities of a BLS ambulance crew when it is dispatched with higher level ambulance crews, such as the crew of an ALS squad vehicle, an ALS ambulance or an air ambulance. Finally, this section would authorize a BLS ambulance crew to transport from one receiving facility to another a patient who requires EMS above the skill level of that crew when the sending or receiving facility provides the personnel, equipment and supplies, not present on the ambulance, which are needed for the safe transport of the patient.
Section 1027.34 (relating to advanced life support ambulance service) would explain that the purpose of an EMS agency that operates an ALS ambulance service is to operate one or more ALS ambulances staffed by a crew capable of providing the full array of EMS to a patient who requires EMS above the skill level of an AEMT. It would also specify the staffing standards for an ALS ambulance. Just as for a BLS ambulance, this section would explain that the crew members of an ALS ambulance need not all respond in the ambulance, but the ambulance would need to be fully staffed when transporting a patient. This section would also address the responsibilities of an ALS ambulance crew when it is dispatched with a BLS ambulance crew. It would further explain that if an ALS ambulance is used in providing EMS to a patient identified as needing EMS at or below the AEMT level, the staffing and other requirements for the ALS ambulance would be the same as for a BLS ambulance.
Section 1027.35 (relating to advance life support squad service) would explain that the purpose of an EMS agency that operates an ALS squad service is to operate one or more ALS squad vehicles to transport an EMS provider above the skill level of an AEMT, along with equipment and supplies, to rendezvous with an ambulance crew to provide EMS to a patient who requires EMS above the skill level of an AEMT. This section would specify the staffing standards for an ALS squad vehicle. It would also address the responsibilities of an ALS squad vehicle crew when it is dispatched with a BLS ambulance crew.
Section 1027.36 (relating to critical care transport ambulance service) would explain that the purpose of an EMS agency that operates a critical care transport ambulance service is to operate one or more ALS ambulances staffed by a crew capable of providing the full array of EMS to a patient who requires EMS at the skill level needed to attend to and transport critically ill or injured patients between receiving facilities. This section would also specify the staffing standards for an ALS ambulance when used for this purpose. While only one EMS provider would need to accompany a patient in the patient compartment of an ambulance during most ambulance transports, this section would require that two EMS providers attend to the critically ill patient during ambulance transport and would require that both EMS providers be certified above the AEMT level, with one of them having successfully completed a critical care transport educational program approved by the Department. The critically ill or injured patient requires EMS above the skill level of a paramedic. A critical care transport educational program approved by the Department would be designed by the Department to ensure that the EMS provider has completed education above the paramedic level to provide care that would normally be provided by one or more health professionals in an appropriate specialty area, such as respiratory or cardiovascular care.
Section 1027.37 (relating to air ambulance service) would explain that the purpose of an EMS agency that operates an air ambulance service is to operate one or more air ambulances staffed by a crew capable of providing the full array of EMS to a patient. This section would also specify the staffing standards for an air ambulance. Generally, an air ambulance crew would need to include two EMS providers certified above the AEMT level, with one of them having successfully completed an air ambulance transport educational program approved by the Department. However, due to weight considerations and the occasional need for the presence of a health care provider with other health care expertise, this section would also permit another type of health care provider to substitute for one of these EMS providers provided the EMS agency submits a plan to the Department for this substitution and the plan is approved by the Department. Special requirements unique to the operation of an air ambulance would also be imposed and a process would be included for an EMS agency that operates an air ambulance service to adopt EMS protocols that supplement the Department's EMS protocols.
Section 1027.38 (relating to special operations EMS services) would explain the purposes of a tactical EMS service, a wilderness EMS service, an urban search and rescue EMS service and a mass-gathering EMS service. It would also specify special requirements for each of them. Additionally, subsection (g) would permit an EMS agency or an applicant for an EMS agency license to apply for a type of special operations EMS service not addressed in the regulations. It would provide that the Department will consider each request on its own merits and that the Department will grant, conditionally grant or deny the request as the Department deems appropriate to protect the public interest. It would further provide that an EMS agency granted permission to operate an EMS service will be subject to later adopted regulations that may apply to that type of service. Subsection (h) would explain that an EMS agency is not required to be licensed to conduct a special operations EMS service to respond to a call requesting EMS under circumstances in which a special operations EMS service would be appropriate. However, unless licensed to conduct that special operations EMS service, it would enjoy none of the exceptions applicable to an EMS agency licensed to conduct that type of service.
In drafting this proposed rulemaking, the Department also considered proposing the regulation of ski patrol EMS services. The Department met with and continues to meet with stakeholders, including representatives of the Pennsylvania Ski Areas Association and National Ski Patrol, concerning the appropriate oversight of EMS provided in ski areas in this Commonwealth. The Department is currently working with stakeholders to establish a voluntary program in which ski patrol EMS services may participate. The Department encourages comments on this matter.
Subchapter C. Miscellaneous
Section 1027.51 (relating to stretcher and wheelchair vehicles) would explain that stretcher vehicles and wheelchair vehicles are vehicles that may be commercially used to transport by stretcher or wheelchair a person who does not receive and cannot reasonably be anticipated to require any EMS during transport. Under section 8129(a) of the EMS System Act, sections 8139(c) and 8156(a) of the EMS System Act (relating to stretcher and wheelchair vehicles; and penalties) and section 9 of the act of August 18, 2009 (P. L. 308, No. 37) (Act 37), when the regulations go into effect under which the Department may license EMS agencies, an entity will commit a misdemeanor of the third degree if it transports by stretcher or wheelchair vehicle a person who that entity knows or should reasonably know requires EMS during the transport. More pertinent to the Department's authority, under these same provisions, as well as section 8142 of the EMS System Act, when the regulations go into effect under which the Department may license EMS agencies, an EMS agency that impermissibly uses a stretcher vehicle will be subject to disciplinary action by the Department and an entity not licensed as an EMS agency that engages in this conduct will be subject to a civil penalty levied by the Department of up to $5,000 a day for each day it engages in the prohibited conduct.
Section 1027.52 (relating to out-of-State providers) would identify the limited circumstances that an entity located out-of-State does not need to be licensed as an EMS agency by the Department to provide EMS in this Commonwealth.
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