PROPOSED RULEMAKING
DEPARTMENT OF HEALTH
[28 PA. CODE CHS. 1001, 1003, 1005, 1007, 1009, 1011, 1013 AND 1015]
Emergency Medical Services
[29 Pa.B. 903] The Department of Health (Department) gives notice that it is proposing to amend 28 Pa. Code Part VII (relating to emergency medical services), to read as set forth in Annex A.
Purpose and Background
Interim regulations were published at 25 Pa.B. 3685 (September 2, 1995), to facilitate implementation of the act of October 5, 1994 (P. L. 557, No. 82) (Act 82) amendments to the Emergency Medical Services Act (act) (35 P. S. §§ 6921--6938). Section 6 of Act 82 authorized the Department to bypass certain rulemaking procedures to adopt the interim regulations, with the caveat that those regulations later be resubmitted through the customary rulemaking procedures.
Amendments to regulations dealing with subject matter addressed by the act, but not addressed by the Act 82 amendments, were not adopted through the interim rulemaking process. The interim regulations were required to be limited in scope to the parameters of Act 82.
Following the Department's adoption of the interim regulations, under House Resolution 92 of 1995, the House Health and Human Services Committee issued a Final Report on the Statewide emergency medical services (EMS) system, addressing the effectiveness of the system and problems in its administration. That report was distributed in November 1996. Thereafter, the Department commenced a review of its EMS regulations in their entirety.
In developing the proposed amendments, the Department pursued early and meaningful input from the regulated community, as required by Executive Order 1996-1 (relating to regulatory review and promulgation). On December 20, 1996, a first draft of proposed amendments was forwarded to the Pennsylvania Emergency Health Service Council (Council) for its comments and recommendations. The Council circulated that draft throughout the State's EMS community, and solicited input from its membership. The Council submitted its comments to the Department in June 1997.
On June 28, 1997, the Department published in the Pennsylvania Bulletin notice that it was seeking early public input with respect to its amendment of the EMS regulations, that members of the public could secure a copy of the Department's preliminary draft, and that a public meeting to discuss amendments would be held on August 4, 1997. Comments were received and the public meeting was convened as scheduled.
Under House Resolution 186 of 1997, the Legislative Budget and Finance Committee (LBFC) conducted a performance audit, beginning on or about July 29, 1997, of how moneys from the Emergency Medical Services Operating Fund were being allocated and spent by the Department and other participants in the Statewide EMS system to whom the funds were distributed by the Department. The LBFC issued its report on February 24, 1998.
On April 1, 1998, the Department distributed, and conducted a public meeting to provide an overview of, a revised set of draft proposed regulations. Comments were solicited through May 1, 1998.
In developing these proposed amendments the Department thoroughly considered the Final Report of the House Health and Human Services Committee based upon House Resolution 92, the Final Report of the LBFC based upon House Resolution 186, the written comments received from the Council and the public, and the oral presentations made by persons who participated in the public meetings. The Department was further assisted by extensive ongoing consultation with the Director of the Council following the August 4, 1997, public meeting.
By this proposed rulemaking the Department is meeting its statutory duty to subject the regulations it adopted through the interim rulemaking process to the standard regulatory oversight procedures. The Department is also taking this opportunity to propose amendments to those regulations, as well as to other regulations it was not authorized to amend through the interim rulemaking process.
It has been 9 years since the Department published its initial regulations under the act. A changed EMS environment in that 9-year time span, statutory amendments, problems brought to the Department's attention in administering the existing regulations, judicial decisions that have clarified the Department's authority and responsibilities under the act, and a statutory duty to process through the customary rulemaking procedures standards the Department has imposed through interim regulations, present compelling reasons for the Department to pursue comprehensive revisions to its EMS regulations at this time.
Summary
The regulations that have been adopted to facilitate administration of the act are presented in the following seven chapters: Chapter 1001 (relating to administration of the EMS system), Chapter 1003 (relating to personnel), Chapter 1005 (relating to licensing of BLS and ALS ambulance services), Chapter 1007 (relating to licensing of air ambulance services--rotorcraft), Chapter 1009 (relating to EMS medical command medical facilities), Chapter 1011 (relating to accreditation of training institutes) and Chapter 1013 (relating to special event EMS). The proposed amendments would retain each of these chapters. Some of the titles would be revised. The proposal would also add Chapter 1015 (relating to quick response services).
Chapter 1001. Administration of the EMS system
This chapter explains the purpose of the Department's EMS regulations, defines terms used in the regulations, identifies standards for the Statewide and regional EMS development plans, prescribes criteria for the Department's distribution of funds, establishes EMS data collection and reporting responsibilities, sets standards for quality assurance programs to monitor the delivery of EMS, creates standards for the integration of trauma facilities into the Statewide EMS system, explains and imposes duties on the regional EMS councils, addresses the relationship between the Department and the Council, and imposes restrictions on EMS research by persons regulated under the act.
Subchapter A. General Provisions
Section 1001.1 (relating to purpose) would be amended to clarify that the Department does not use regulations to address or carry out all of its responsibilities under the act. For example, some of its responsibilities are addressed by contract.
Section 1001.2 (relating to definitions) would be amended to revise several definitions to read more clearly. Definitions would be added for ''APLS--advanced pediatric life support course,'' ''ambulance call report,'' ''ambulance identification number,'' ''board certification,'' ''continuing education,'' ''direct support services,'' ''EMSOF--Emergency Medical Services Operating Fund,'' ''EMS training institute,'' ''Medical Command Base Station Course,'' ''medical treatment protocols,'' ''PALS--pediatric advanced life support course,'' ''physician,'' ''PSAP--public safety answering point,'' ''registered nurse,'' ''service area'' and ''Statewide BLS treatment protocols.''
The definitions would explain what an APLS course, a PALS course and the Medical Command Base Station Course are. It is proposed that successful completion of an APLS or a PALS course, combined with other criteria, be required for a physician to become a medical command physician or an advanced life support (ALS) service medical director if the physician is not board certified in emergency medicine. Completion of the Medical Command Base Station Course has been and would continue to be a requirement for both physician positions.
''Ambulance call report'' would be the label the Department assigns to the form or other reporting mechanism, perhaps through electronic data entry, by which it collects standardized patient data and other information from ambulance services under section 5(b)(3) of the act (35 P. S. § 6925(b)(3)).
''Ambulance identification number'' would replace the present term ''vehicle identification licensure number.'' The change would be made because the Department does not technically license ambulances, and to distinguish the term from the term ''vehicle identification number'' used by the Department of Transportation to identify vehicles.
''Board certification'' would identify private certifying bodies recognized by the Department wherever the regulations specify that a criterion for qualifying for a certain position, such as a medical command physician, requires a board certification in a medical specialty. Reference to these certifying bodies would not, however, preclude the Department from considering persons with certifications issued by other private certifying bodies. The criteria for issuing certifications used by the specified entities would comprise the baseline standards. The Department would grant an exception to the regulation, under § 1001.4 (relating to exceptions), if a candidate could establish that the certification that person received from another certifying agency was issued under standards equal to or greater than those employed by the private certifying bodies referenced in the definition.
A definition of ''continuing education'' would be added to identify the objectives that learning activities would need to be designed to be recognized by the Department for continuing education purposes.
''Direct support of EMS systems'' would be defined because section 17 of the act (35 P. S. § 6937), which requires that at least 75% of all funds available to the Department for the initiation, expansion, maintenance, evaluation and improvement of EMS systems be allocated for the direct support of EMS systems, does not define what is encompassed in the direct support of EMS systems. The lack of a definition was identified as a problem in the LBFC report.
''EMSOF'' would be defined to clarify that in the context of the regulations the term refers to only that portion of the Emergency Medical Services Operating Fund appropriated to the Department for EMS purposes, and does not include that portion of the appropriation assigned to the Catastrophic Medical and Rehabilitation Fund (Head Injury Program).
''EMS training institute'' would be defined to clarify that when that term is used in the regulations it applies only to institutes accredited to offer training leading to mandatory certifications and recognitions issued by the Department under the act. For example, the term does not apply to an institution that offers continuing education exclusively.
Sections 5(c) and 11(h) and (i) of the act (35 P. S. §§ 6925(c) and 6931(h) and (i)) address the establishment of and compliance with medical treatment protocols. The definition of ''medical treatment protocols'' would clarify what is encompassed by this term and replace the definition of ''medical protocols.'' The definition of ''Statewide BLS medical treatment protocols'' would refer to basic life support (BLS) treatment protocols the Department has developed for the Statewide use of prehospital personnel when they are providing BLS services.
The terms ''physician'' and ''registered nurse'' would both be defined to mean a person licensed in this Commonwealth to practice the applicable profession, with a current renewal or registration of that license. Consequently, wherever those terms would appear in the regulations additional language pertaining to the license being a current Pennsylvania license would not be required.
''PSAP--Public safety answering point'' would be used to label entities that dispatch ambulance services and other emergency response resources.
A proposed definition of ''service area'' is included to clarify to which political subdivisions an ambulance service must provide notice when it is going out of business. An ambulance service has a duty under section 12(q) of the act (35 P. S. § 6932(q)) to notify the chief executive officer of each political subdivision in its service area at least 90 days prior to discontinuing service in that area.
The definitions of ''air ambulance medical crew member,'' ''ambulance trip report number,'' ''BLS training institute,'' ''closest available ambulance,'' ''EMS council,'' ''field internship,'' ''field preceptor,'' ''incident location,'' ''licensing agency,'' ''medical protocols,'' ''medical service area,'' ''on-line communication,'' ''Pennsylvania Field Protocols for BLS,'' ''prescribing physician,'' ''primary response area,'' ''quick responder,'' ''transfer agreements'' and ''vehicle licensure identification number'' would be removed. These terms would either no longer appear in the regulations, be replaced by other terms, or not require definition as their meanings would be either clear or otherwise explained in the regulations.
Section 1001.3 (relating to applicability) identifies, in general terms, who is affected by Part VII (relating to emergency medical services) of the Department's regulations. No substantive amendments are proposed.
Section 1001.4 (relating to exceptions) provides a process for persons to seek an exception to a regulatory requirement that is not also directly imposed by the act. It would be amended to clarify that an exception to a regulation in this part may be granted by the Department, on its own initiative, when it determines that the substantive requirements of § 1001.4 have been satisfied. Currently, the regulation provides that an exception may be granted only upon application to the Department.
Section 1001.5 (relating to investigations) provides that the Department may investigate accidents involving ambulances and complaints involving prehospital personnel and EMS providers. These references do not adequately convey the scope of the Department's investigatory activity under the act. The section would be revised to more fully describe the scope of the Department's investigatory activities.
Section 1001.7 (relating to comprehensive regional EMS development plan) would be new. It would require each regional EMS council to develop a regional plan for coordinating and improving the delivery of EMS in the region for which it has been assigned responsibility by the Department. It would require that the regional EMS council give notice to the public and an opportunity for comment before submitting the plan to the Department for approval.
Section 1001.6 (relating to comprehensive EMS development plan) would be amended to provide that the regional EMS development plans would be incorporated into the Statewide EMS development plan. The section would also be amended to require public notice and an opportunity for comment before the Department's adoption of a Statewide plan.
The Statewide EMS development plan serves as a blueprint for how EMS problems are to be addressed and how EMS systems are to be maintained in this Commonwealth. Section 10(a) of the act (35 P. S. § 6930(a)) requires the Department to enter into contracts for the initiation, expansion, maintenance and improvement of EMS systems which are in accordance with the Statewide EMS development plan. This document is a planning document which impacts on the Department's distribution of funds for EMS systems. It is not a vehicle by which the Department is permitted to bypass the rulemaking process to regulate providers of EMS. Consequently, the Department would not be regulating providers of EMS through this document.
Subchapter B. Award and Administration of Funding
The title of this subchapter would be revised to replace the term ''Contracts'' with ''Funding.'' This change is proposed because the scope of this chapter is not and would not be confined to addressing the distribution of funds through contracts exclusively.
Section 1001.21 (relating to purpose) describes the purpose of the subchapter on funding. It would be amended to recognize that section 10(j) of the act permits the Department to contract with entities to assist the Department to comply with the act.
Section 1001.22 (relating to criteria for funding) identifies criteria for the distribution of EMSOF funds to contractors and other recipients of those funds. It would be amended to acknowledge that not all funding provided by the Department is through contracts--such as the distribution of some of the EMSOF moneys to providers of EMS. These are more in the nature of grants. Some of the funding priorities would also be revised.
Section 1001.23 (relating to allocation of funds) identifies some of the factors that are considered in determining the amount of funds to be distributed to eligible recipients. No substantive amendments are proposed.
Section 1001.24 (relating to application for contract) pertains to applications for contracts to plan, initiate, maintain, expand or improve an EMS system. It would be amended to clarify that the application process set forth in the section applies only to contracts for this purpose.
No substantive amendments are proposed to §§ 1001.25--1001.27 (relating to technical assistance; restrictions on contracting; and subcontracting).
Section 1001.28 (relating to contracts with the Council) would be new. It would be added to clarify that some of the provisions in the subchapter do not apply to Department contracts with the Council. It would also provide that the Department will contract with the Council to provide it with the funds the Council needs to perform the duties imposed upon it by the act, and may contract with the Council for it to assist the Department in complying with the act. Act 82 amended section 14(d) of the act (35 P. S. § 6934(d)) to permit the Department to distribute EMSOF moneys to the Council.
Subchapter C. Collection of Data and Information
Section 1001.41 (relating to data and information requirements for ambulance services) addresses an ambulance service's responsibility to complete an ambulance call report and to keep the report confidential. This section would be revised to delete the data elements currently specified. The required data elements are identified in the ambulance call report form and would continue to be so identified. The data elements are revised from time to time by the Department, in consultation with the Council. The data elements currently specified in the regulation are outdated.
Some of the data identifies patient condition and treatment, while other data provides information on how well the EMS system is functioning. The ambulance service would be required to provide the data solicited by the form, and the form would specify which data is to be handled in a confidential manner. The present regulation treats all data as confidential. ''Ambulance call report'' would be defined in § 1001.2 (relating to definitions) in a manner that would permit the report to be completed by the electronic input of data if permitted by the Department.
This section would also be amended to require certain patient information solicited by the ambulance call report to be reported immediately to a receiving facility, prescribe the time in which an ambulance call report is to be completed after termination of services to the patient, and impose a duty upon an ambulance service to establish a policy prescribing who is to complete the report on behalf of the ambulance service. The ambulance call report would designate the data that is to be reported immediately to the receiving facility.
Section 1001.42 (relating to dissemination of information) identifies the circumstances under which an ambulance call report may be released. This section would be revised to provide that persons who prepare or secure data from an ambulance call report by virtue of their participation in the Statewide EMS system are required to prohibit access to only those data elements designated as confidential by the Department in the body of the ambulance call report. There is no need to keep confidential information that does not address the history, assessment or treatment of the patient.
Subchapter D. Quality Improvement Program
The title of this subchapter would be amended to substitute ''Improvement'' for ''Assurance.'' The term ''quality improvement'' has generally replaced ''quality assurance'' in the health care industry.
This subchapter would be amended to clarify that the quality improvement program operated by the Department and regional EMS councils is to be limited to monitoring and data collection activities. Section 5(b)(10) of the act empowers the Department to establish a quality improvement program only for the purpose of ''monitoring the delivery of [EMS].'' The Department is not empowered to impose patient service duties upon providers of EMS or prehospital personnel under this provision. These clarifications would be made in §§ 1001.61 and 1001.62 (relating to components; and regional programs).
Sections 1001.63 and 1001.64 (relating to medical command facilities; and ambulance services), which now require medical command facilities and ambulance services to participate in the quality improvement program, would be deleted and replaced with § 1001.65 (relating to cooperation). This section would require all persons and entities authorized by the Department to participate in the Statewide EMS system to provide the Department and the regional EMS councils with data and reports requested by them to monitor the delivery of EMS as part of quality improvement oversight.
Subchapter E. Trauma Centers
This subchapter, comprised of §§ 1001.81--1001.84, was adopted by the Department under its duty under section 5(b)(12) of the act to integrate trauma centers into the Statewide EMS system. No substantive amendment would be made to these sections.
Subchapter F. Requirements for Regional EMS Councils and the Council
Section 1001.101 (relating to governing body) specifies standards for the governing bodies of the Council and regional EMS councils. It would not be amended.
Sections 1001.102 and 1001.103 (relating to council director; and personnel) would be deleted. These sections specify duties of directors of regional EMS councils and the Council, and written policies and procedures that are to be in place for both. Consistent with Executive Order 1996-1, the Department would delete these regulations because they are burdensome and do not serve a compelling interest, and because there are viable nonregulatory alternatives that may be pursued to implement these standards if they become necessary. The Department believes that it is counterproductive to micro-manage the Council and the regional EMS councils. If the Department concludes that specific personnel and work policies are required for the Council or a regional EMS council to complete a project, the Department may include those terms in the body of the contract covering the project.
Subchapter G. Additional Requirements for Regional EMS Councils
No substantive change would be made to §§ 1001.121, 1001.122 and 1001.124 (relating to designation of regional EMS councils; purpose of regional EMS councils; and composition). Language would be added to § 1001.121 which would require a regional EMS council to be representative of the professions and organizations as prescribed in the statutory definition of ''emergency medical services council'' in section 3 of the act (35 P. S. § 6923). Health care consumer representation would also be required.
Section 1001.123 (relating to responsibilities) identifies the major responsibilities of regional EMS councils. The Department concluded that some of the responsibilities are set forth more than once, in slightly different language. The section would be amended to eliminate the repetition. It would also be amended to require regional EMS councils to: notify emergency communications centers and municipal and county governments of available EMS resources and any dispatch recommendations that it or the Department may develop; assist prehospital personnel and providers of EMS operating in the regional EMS system to meet licensure, certification, recertification, recognition, biennial registration and continuing education requirements, as well as assisting the Department in ensuring that those requirements are met; apprise medical command facilities and ALS ambulance services in the region when an EMT-paramedic or prehospital registered nurse loses medical command authorization for an ambulance service in the region; and develop a conflict of interest policy applicable to its employes and officials.
Section 1001.125 (relating to requirements) deals with matters such as the composition of the regional EMS council when it is a nongovernmental body, and the composition of its advisory council when it is a governmental body. This section would be amended to require that if a regional EMS council is a unit of local government it shall have an advisory council representative of the professions and organizations designated in the act's definition of ''emergency medical services council,'' as well as health consumer representation, and that if the regional EMS council is a public or nonprofit organization, its governing body shall satisfy the same representation requirements. The current regulatory designation of representatives is somewhat confining and not fully consistent with the statutory language prescribing composition. The Department would replace that language with the composition language contained in the act and consider whether the statutory representation requirements are met on a case by case basis.
This section also requires a regional EMS council to have a medical advisory committee. As ''medical advisory committee'' is defined in § 1001.2, a majority of its members must be physicians.
Subchapter H. Additional Requirements for the Council
No substantive revisions would be made to this subchapter, comprised of §§ 1001.141--1001.143.
Subchapter I. Research in Prehospital Care
Section 5(b)(3) and (4) of the act contemplates that the Department will permit data collected through the Statewide EMS system to be used for research to identify possible options for improving the system. The Department's planning responsibilities imply that the Department may authorize research to aid it in making planning decisions. This subchapter addresses the procedures for providers of EMS to engage in clinical investigations or studies that relate to direct patient care in the Statewide EMS system.
Section 1001.161 (relating to research) would be amended to revise the research proposal review process to provide for the proposal to be submitted directly to the Department. The regulation would provide for the Department to then forward the proposal to the Council and the appropriate regional EMS council, for review and recommendation back to the Department, if the Department concludes that the proposal may have merit. Upon receiving those recommendations the regulation would prescribe a 30-day time period for the Department to act. The Department intends the time period for action to be directory; that is, its failure to act within that time period would not result in automatic approval of the proposal. Under current procedures, the Department does not see the proposal until after it is reviewed by the Council and a regional EMS council. The regulation would also require the proposal to include a plan for providing the Department with progress reports and a final report, and provide that the Department may terminate the research prematurely if conditions of approval are not satisfied.
Chapter 1003. Personnel
This chapter addresses qualifications and responsibilities of persons involved in the Statewide EMS system. It also addresses the disciplinary process for prehospital personnel certified or recognized by the Department, the medical command authorization process, continuing education requirements applicable to certain types of prehospital personnel and continuing education options applicable to others, and the accreditation standards for sponsors of continuing education.
Subchapter A. Administrative and Supervisory EMS Personnel
Section 1003.1 (relating to Commonwealth Emergency Medical Director) specifies the duties of the Commonwealth Emergency Medical Director. It would not be revised in a substantive manner.
Section 1003.2 (relating to regional EMS medical director) specifies the duties of regional EMS medical directors. It would be revised to clarify that the regional EMS medical director does not function independent of the regional EMS council except when acting upon appeals from adverse medical command authorization decisions. As the regulation currently reads, it purports to impose upon regional EMS medical directors responsibilities the act imposes upon regional EMS councils. This section would also be amended to exclude a paragraph regarding medical advisory committees. The existing paragraph merely repeats provisions in § 1001.125 (c) and (d) (relating to requirements).
Section 1003.3 (relating to medical command facility medical director) specifies the qualifications and responsibilities of a medical command facility medical director. It would be amended to require that a physician complete either an APLS (advanced pediatric life support) or a PALS (pediatric advanced life support) course, among other criteria, to qualify as a medical command facility medical director if the physician is not board certified in emergency medicine. Completion of an ACLS (advanced cardiac life support) course would be required every 2 years to continue to qualify. Completion of an ATLS (advanced trauma life support) course would be required only once. A similar change would be made to § 1003.4 (relating to medical command physician). The regulation would also be amended to provide that the physician could satisfy some course requirements specifically mentioned in the regulation by completing other programs determined by the Department to meet or exceed the standards of the specified programs.
Section 1003.4 (relating to medical command physician) specifies the qualifications and responsibilities of a medical command physician. It would be amended to include the same options as mentioned in the prior paragraph. Another amendment would be to require a medical command physician to provide medical command whenever it is sought from prehospital personnel. The Department has received complaints from ambulance services that transport initially stable patients over long distances, that when emergencies arise during transport, and communication with a customary medical command physician cannot be established, medical command physicians unfamiliar with the ambulance service and its prehospital personnel will sometimes decline to provide necessary medical command. The amendment would remedy this problem.
To ease the difficulty of working with prehospital personnel with whom a medical command physician is unfamiliar, the regulation would be amended to provide the medical command physician with discretion regarding the treatment protocols to follow. The section would state that in providing medical command to ground ambulances, the medical command physician may follow the transfer and medical treatment protocols that apply either in the EMS region in which treatment originates, or in the EMS region in which the prehospital personnel first receive medical command from the medical command physician.
Procedures for physicians to secure approval as medical command physicians, which are not now addressed in the regulations, would be explained in this section. There has been a widespread perception that it is the Department's responsibility to approve medical command physicians. This is not technically correct. A provision of the act may not authorize the Department to approve medical command physicians. Section 11(f) of the act (35 P. S. § 6931(f)) provides that physicians shall be approved as medical command physicians by regional EMS councils, which shall then notify the Department of the approvals. The Department is, however, responsible for prescribing the criteria physicians must satisfy to qualify as medical command physicians. See definition of ''medical command'' in section 3 of the act. Regional EMS councils are obligated to approve a physician as a medical command physician if the physician meets the prescribed criteria.
The regulation would explain that a physician may seek a determination of medical command physician qualifications directly by a regional EMS council, or may participate in a voluntary medical command physician certification program administered by the Department. If the physician chooses the latter option and receives certification, and demonstrates that he or she will function under the auspices of a medical command facility, the regulation would provide that a regional EMS council to which the physician applies for medical command physician approval shall grant the approval.
Functioning under the auspices of a medical command facility is and would continue to be a requirement for approval of a medical command physician by a regional EMS council. The Department prescribes the equipment and personnel requirements for a medical command facility. See definition of ''medical command facility'' in section 3 of the act. While no provision of the act compels a facility to seek Department approval before operating as a medical command facility, section 11(j)(4) of the act affords civil immunity for good faith medical commands given to prehospital personnel only if the medical command facility has been ''recognized'' by the Department.
The Department administers a program for the recognition of medical command facilities. If a physician applies to a regional EMS council for approval as a medical command physician, and the medical command facility for which the physician intends to function has not received a certificate of recognition from the Department, the physician would need to establish to the regional EMS council that the facility meets the criteria for a medical command facility prescribed by the Department. However, if the facility has a current certificate of recognition from the Department, the regulation would provide that the regional EMS council shall accept the certificate instead of requiring the physician to prove that the facility meets Department-prescribed standards.
Because medical command physicians may provide medical command to ambulance services operating out of more than one region, and may be providing medical command for patients who cross regional borders, the regulation would also require a medical command facility to give notice to the regional EMS council in each region in which it expects medical command physicians functioning under its auspices will be providing medical command, and to explain the circumstances under which medical command would be given in that region.
No substantive change would be made to § 1003.5 (relating to ALS service medical director).
Subchapter B. Prehospital and Other Personnel
Section 1003.21 (relating to ambulance attendant) would be amended to explain the ambulance attendant's role when staffing an ambulance service and to identify the services an ambulance attendant may perform when serving on an ambulance crew. It would also clarify that notwithstanding the structured role that an ambulance attendant performs when serving as a member of an ambulance's crew, an ambulance attendant may provide BLS services separate from an ambulance service in an emergency, with nonmedical good Samaritan civil liability protection.
The 16 years of age criterion now in the regulation would be removed since the act sets no age requirement for an ambulance attendant. The age requirement for an ambulance attendant is regulated by the child labor laws in this Commonwealth, not the act. The child labor laws prohibit a minor under 16 years of age from serving as an ambulance attendant. See sections 2 and 7.3(g) of the Child Labor Law (35 P. S. §§ 42 and 48.3(g)).
The Department of Labor and Industry advises that the following requirements apply to persons under 18 years of age who work for a volunteer ambulance service as an ambulance attendant and who have not graduated from high school or been declared by the chief school administrator to have achieved their academic potential. They are permitted to receive on-the-job training as ambulance attendants only if they have secured employment certificates and are at all times under the constant supervision of an adult ambulance company member. They may not serve as ambulance attendants for more than 8 hours in 1 day, and must be given a half-hour off duty lunch break if they are on duty for more than 5 continuous hours. They may not serve on duty later than 12 a.m. on school nights, nor later than 1 a.m. on Friday or Saturday nights during the school term; however, if they respond to a call prior to the deadline, they may continue to serve during the duration of the response to that call. These requirements may change if the Child Labor Law or regulations adopted under that law are amended.
This section would also be amended to clarify that the services that an ambulance attendant may provide are governed by the first aid skills taught in an advanced first aid course sponsored by the American Red Cross. As new first aid skills are added to the curriculum, an ambulance attendant's scope of practice would expand if the ambulance attendant has received the necessary training. The Department proposes to publish, at least annually, a list of the advanced first aid skills taught in the most recent advanced first aid course sponsored by the American Red Cross.
Provisions would also be added to or incorporated by reference in each section relating to prehospital personnel who perform BLS services exclusively (this section and §§ 1003.22 and 1003.23 (relating to first responder; and EMT)), to permit personnel to perform specified skills only if authorized to do so by the medical director of the ambulance service. For example, this section would permit an ambulance attendant to use an automated external defibrillator when authorized by the ambulance service medical director. While the act requires an ALS ambulance service to have a medical director, it does not require a BLS ambulance service to have a medical director. Nevertheless, personnel on a BLS ambulance service would not be permitted to perform those few skills which the regulations would condition upon medical director approval unless the BLS ambulance service secures the services of a medical director.
Section 1003.22 (relating to first responder) specifies the qualifications and functions of a first responder. It would include scope of practice and good Samaritan amendments similar, but not identical, to those proposed for § 1003.21 (relating to ambulance attendant). The first responder's scope of practice is governed by the BLS training a first responder has received in a course the Department has approved for first responder training. At present, that scope of practice is the scope of services embraced by the Emergency Responder course taught by the American Red Cross--which is also the American Red Cross's basic course in advanced first aid--the course establishing the scope of practice for an ambulance attendant. However, a first responder's scope of practice may exceed that of an ambulance attendant if the Department develops or approves courses for first responder training which teach skills in addition to those taught in an advanced first aid course sponsored by the American Red Cross. The Department proposes to publish, at least annually, a list of first responder skills taught in the most recent courses approved by the Department for first responder training.
Unlike an ambulance attendant, who requires no certification from the Department, to function as a first responder an individual must be certified by the Department and then meet recertification requirements every 3 years. This section would be amended to facilitate entry into the Statewide EMS system of individuals who function or have functioned as first responders in other states, by providing that the Department will accept in lieu of successful completion of the education and tests preapproved by the Department, successful completion of education and tests that led to first responder or an equivalent status in another jurisdiction, provided the Department concludes that those education and testing requirements are equal to or greater than those required for certification in this state. Using this criteria, the Department has accepted and would continue to accept, among other examinations, the written and practical skills examinations administered for the emergency responder certification issued by the American Red Cross.
Section 1003.23 (relating to EMT) specifies the qualifications and role of an EMT. It would be amended similar to the manner in which § 1003.21 (relating to first responder) would be amended. Provisions relating to EMT instructor certification would be removed. That subject matter would be addressed in new §§ 1003.23a and 1011.1 (relating to EMS instructor certification; and BLS and ALS training institutes).
Section 1003.23a (relating to EMS instructor certification) would be new. Current provisions for EMT instructor certification would be removed from § 1003.22 (relating to EMT) and, with some amendments, would be inserted in this section. There is no statutory mandate for EMS instructor certification. However, the Department offers this certification program to potential instructors to improve the quality of training in EMS training institutes.
Section 1003.24 (relating to EMT-paramedic) specifies the qualifications and role of an EMT-paramedic. It would be amended to acknowledge that an EMT-paramedic may provide EMS as a Good Samaritan in addition to providing EMS for an ambulance service.
Transition provisions for persons to convert certain certifications to EMT-paramedic certification, which were needed when the regulations were adopted in 1989, would be deleted as they no longer have any relevance.
As the sections relating to first responders and EMTs would be amended to facilitate entry into the Statewide EMS system of individuals who function or have functioned in those capacities in another state, this section would be similarly amended, by providing that the Department will accept in lieu of successful completion of the education and tests preapproved by the Department, successful completion of education and tests that led to EMT-paramedic status in another jurisdiction, provided the Department concludes that those education and testing requirements are equal to or greater than those required for certification in this Commonwealth.
Scope of practice provisions would be revised to accommodate changes in accepted ALS practice by EMT-paramedics without constantly revisiting and amending the regulation to permit the performance of additional skills. To be able to perform those additional services the EMT-paramedic would be required to receive appropriate training either in a course approved by the Department towards securing certification as an EMT-paramedic, in a course determined by the Department to meet or exceed an EMT-paramedic training course preapproved by the Department, or in a Department-approved continuing education course. The Department proposes to publish, at least annually in the Pennsylvania Bulletin, a list of EMT-paramedic skills taught in the most recent courses approved by the Department for EMT-paramedic training.
Section 11(d)(2)(vi) of the act provides that if an EMT- paramedic loses medical command authorization, and chooses to function at the BLS level, the EMT-paramedic must secure EMT certification in accordance with Department regulations. The practical effect of this provision is that it requires that EMT-paramedic to secure continuing education or pass practical skill and written examinations every 3 years, to replace the annual continuing education and skill proficiency requirements that the EMT-paramedic would have been required to satisfy if medical command authorization had been maintained. The Department would amend the regulation to permit the EMT-paramedic to provide BLS services for 30 days without EMT certification, for the ALS ambulance service under the paramedic's medical command authorization was removed or relinquished, provided that ambulance service's ALS service medical director so authorizes.
Section 1003.25a (relating to health professional physician) would be revised, as some of the preceding sections, to acknowledge that a health professional physician may perform EMS as a medical good Samaritan. It would also be amended to eliminate conditions the section currently specifies for a physician to function as a health professional physician. The act's definition of ''health professional'' states that a physician qualifies to function in that capacity if the physician has ''education and continuing education in [ALS] and prehospital care.'' 35 P. S. § 6923. It does not provide for the Department to certify health professional physicians or to set standards physicians would be required to meet to serve as health professional physicians. Therefore, it is incumbent upon a physician and the ambulance service that uses the physician as a health professional to ensure that the physician is properly educated and experienced to serve in that capacity. If they need assistance in making this assessment they may seek guidance from the Department, regional EMS councils, and professional organizations with relevant expertise, such as the Pennsylvania Chapter of the American College of Emergency Physicians.
Section 1003.25b (relating to prehospital registered nurse) specifies the qualifications and role of a prehospital registered nurse. It would be revised to acknowledge that a prehospital registered nurse may perform EMS as a medical good Samaritan, in addition to functioning as a prehospital registered nurse. It would also include endorsement provisions permitting persons who are licensed as registered nurses in this Commonwealth, who have functioned in the capacity of a prehospital registered nurse in another jurisdiction, to obtain recognition as a prehospital registered nurse from the Department through an abbreviated process. It would further be revised to clarify the scope of practice of a prehospital registered nurse by providing that the person could perform those ALS services authorized by The Professional Nursing Law (63 P. S. §§ 211--225), which exceed the scope of practice of an EMT-paramedic, when authorized by a medical command physician through either direct medical command orders or standing treatment protocols.
Section 1003.26 (relating to rescue personnel) pertains to the Department's certification of rescue personnel. It would be amended to clarify that the Department approves courses for rescue personnel and issues certifications to persons who complete those courses. Receipt of a certification is not, however, required by law as a precondition to freeing an entrapped person. The Department is granted no regulatory oversight over rescue activities under the act. The Department approves rescue programs and issues rescue technician certificates as a public service, in an effort to ensure that there are a sufficient number of personnel throughout this Commonwealth who have appropriate training and skills to perform rescues. The certification would merely reflect the Department's opinion that the person is qualified to perform the rescues taught in the approved course. The section would be revised to clarify that receiving a rescue certification issued by the Department is not a legal precondition to performing rescues.
No substantive change is being proposed to § 1003.27 (relating to disciplinary and corrective action).
Section 1003.28 (relating to medical command authorization) specifies the criteria for an ALS service medical director to grant medical command authorization, and the procedures for EMT-paramedics and prehospital registered nurses to appeal ALS service medical director decisions to deny, restrict or remove medical command authorization. It would be amended in several respects. The options available to the ALS service medical director to assess the competence of the ALS practitioner seeking medical command authorization would be expanded.
Also, there would be limitations on how an ALS service medical director could restrict medical command authorization. The Department believes that patient welfare would be compromised if a patient was treated by an ALS practitioner who was not permitted to perform an ALS skill required by the patient and generally permitted under medical command authorization. Consequently, the regulation would be revised to provide that if the ALS practitioner demonstrated certain deficiencies, the ALS service medical director could continue to extend medical command authorization to the individual with restrictions such as requiring the individual to perform certain functions under on-scene supervision. However, short of withdrawing the practitioner's medical command authorization, an ALS service medical director could not preclude the individual from performing functions within that practitioner's scope of practice as permitted by the medical treatment protocols in the region out of which the individual practices. Another type of restriction that would be authorized would be to prescribe continuing education requirements greater than that required for other ALS personnel serving the ambulance service. This would require that the ALS service medical director has determined that the individual does not demonstrate sufficient competence in performing a skill and that the number of continuing education hours generally required are not sufficient to provide the education the practitioner needs to remedy the problem.
Other amendments would include a provision stating that in hearings in which medical command authorization decisions are appealed the burden of proof is a preponderance of the evidence, and provisions addressing when service of documents is consummated and how time periods for filing hearing documents are to be calculated in the appeal process.
Section 1003.29 (relating to continuing education requirements) specifies the continuing education requirements and options for prehospital personnel. It would also include several amendments. The total number of continuing education credit hours applicable to each category of certified or recognized prehospital practitioner would not change. However, for each type of practitioner a specified number of continuing education hours in medical and trauma education would be designated. Transition periods would be provided before the medical and trauma continuing education requirements would take effect. Also, the Department's existing practice of prorating annual continuing education requirements during the first calendar year an EMT-paramedic is certified or a prehospital registered nurse is recognized, based upon the month the certification or recognition is secured, would be set forth in the regulation.
The options for satisfying continuing education CPR requirements would be expanded. CPR requirements could be met by not only attending a CPR course, but, alternatively, by teaching a CPR course. To secure credit for teaching, the individual would not need to be the primary instructor.
Language would also be added to clarify that an ambulance service is not precluded from imposing continuing education requirements in excess of those required by the regulation, as a condition of employment, except that the ambulance service could not establish individual requirements for ALS practitioners other than as authorized in § 1003.28(c)(2) (relating to medical command authorization).
Current provisions relating to continuing education through endorsement would be relocated in proposed new § 1003.31 (relating to credit for continuing education).
Section 1003.30 (relating to accreditation of sponsors of continuing education) would be amended to permit a continuing education sponsor to secure prior approval of continuing education courses, and permit the continuing education sponsor to assign credit hours to a continuing education course it presents in a classroom setting, if the Department gives it approval to do so after determining that it has demonstrated a history of understanding and compliance with the regulatory standards for providing continuing education to prehospital personnel.
Section 1003.31 (relating to credit for continuing education) would be new. It would define what constitutes a credit hour, and time units of instruction for which credit would be awarded. It would also make provision for continuing education credit to be awarded for teaching, self study courses and other courses not presented in a classroom setting, and for courses offered by organizations with National or state accreditation to provide education. Additional matters that would be addressed are how continuing education credits would be reported to prehospital personnel, and the procedure for resolving disputes when a prehospital practitioner believes that he or she has not received credit that has been earned.
Section 1003.32 (relating to continuing education sponsors) would also be new. This section would specify responsibilities of a continuing education sponsor with respect to keeping records of attendance, reporting attendance, having a mechanism for course evaluation, retaining records, monitoring compliance and making available various reports and records to the Department.
Section 1003.33 (relating to advertising) would be another new section. It would address how a continuing education sponsor may advertise a course approved by the Department, as well as a course for which Department approval is being sought, but has not yet been obtained.
Section 1003.34 (relating to withdrawal of accreditation or course approval) would also be new. It would provide for the Department to withdraw accreditation, downgrade accreditation to provisional status or withdraw approval of a continuing education course applicable to any future presentation of the course.
The Department would delete Subchapter C (relating to air ambulance personnel), and address much of the subject matter of this subchapter in Chapter 1007 (relating to the licensing of air ambulance services--rotorcraft). The Department believes that some of the provisions in this subchapter, such as those in §§ 1003.43 and 1003.44 (relating to air ambulance pilot; and air ambulance communications specialist), exceed the Department's rulemaking authority, since it has been given no authority under the act to regulate either communications specialists or pilots. The more appropriate focus of the Department's regulatory oversight is on the air ambulance service itself.
Also, the provision in § 1003.42 (relating to air ambulance crew members), that requires minimum staff in an air ambulance to consist of two ALS prehospital practitioners, is inconsistent with the staffing requirements of section 12(g) of the act (35 P. S. § 6932(g), which requires an ALS ambulance (no statutory distinction is made between air and ground ALS ambulances) to be staffed by two prehospital personnel but only one ALS practitioner when providing treatment and transport to patients. While the Department continues to encourage air ambulance services to staff air ambulances with a minimum of two ALS practitioners, it has no statutory authority to mandate that minimum staffing complement through regulations.
The Department does have statutory authority to regulate air ambulance services to ensure that they operate in a safe and efficient manner. Consequently, many of the responsibilities that have been in Subchapter C as responsibilities of individuals such as pilots, medical crew members and communications specialists, would be incorporated in amendments to Chapter 1007 and imposed upon the air ambulance service itself.
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