[29 Pa.B. 903]
[Continued from previous Web Page] Chapter 1005. Licensing of BLS and ALS Ground Ambulance Services
This chapter specifies the licensure and operating criteria for ground ambulance services. The term ''ground'' would be included in the title to clarify that the scope of this chapter relates to ground ambulance services exclusively. Chapter 1007 pertains to air ambulance services.
Section 1005.1 (relating to general provisions) would be amended to state that Chapter 1005 applies to ground ambulance services. Subsection (c) would be revised to identify types of ambulance vehicles an ALS ambulance service may employ rather than modes of ALS ambulance service operations.
Section 1005.2 (relating to applications) would be revised to reflect that there would be a change in some of the information solicited by an application for licensure. The most significant changes are that the application would require that the applicant provide a roster and staffing plan, and identify the physical structures where ambulances will be located or a plan for locating and operating ambulances if not responding out of fixed buildings. Also, the application would require the signature of the principal official of the applicant.
Another change would be that instead of requesting the applicant to identify primary and mutual aid service areas, the application would require the applicant to identify an emergency service it commits to serve when called upon. An ambulance service that generally confines its operations to interfacility transports would not need to commit to providing emergency response to an area, but, if it had an available ambulance and crew, would be required to respond to an emergency if dispatched.
Mutual aid agreements would continue to be encouraged, but they would not be required for licensure. There are three reasons for this. First, some ambulance services engage almost exclusively in interfacility transports. They have little need for mutual aid arrangements. Second, some ambulance services have attempted to keep competitors from locating in their service areas by refusing to enter into mutual aid agreements with them, and have then argued to the Department that those competitors do not meet required standards for licensure because they have no mutual aid agreement. Third, the Department is proposing to revise § 1005.10 (e) (relating to licensure and general operating standards) to require ambulance services to contact PSAPs when unable to respond to an emergency, instead of the ambulance service making its own arrangement for a substitute ambulance service. This should ensure that the most appropriate backup ambulance service is contacted to respond to an emergency, rather than a less appropriate ambulance service that would have been contacted solely to honor a mutual aid agreement.
Subsection (d) would be added to require an ambulance service to file a change of vehicle form within 10 days after placing a new ambulance in operation. If the form would be timely filed, the ambulance service would have authority to continue to use the ambulance unless its authority to do so would be disapproved following Department inspection.
Subsection (e) would require an ambulance service to apply for an amendment of its license prior to substantively altering its plan for locating and operating ambulances. For example, relocating ambulances within the same service area would not be a substantive alteration and would not require an application for amendment. Moving ambulances to establish a new service area would be a substantive alteration and would require an application for an amendment of the license. The Department would need to ensure that all licensure criteria are satisfied at the new or additional location before operations could commence.
Amendments that would change the application procedure are that regional EMS councils would no longer be required to forward a complete and accurate application to the Department, and then await Department direction before scheduling an onsite inspection of the applicant. Regional EMS councils, without Department direction, would simply schedule the inspection when the application is complete and appears to be accurate. Also, regional EMS councils would not be required to review the application for conformance with regional plans before they conduct a survey. Actually, they do not do that currently even though the regulation states that they are supposed to. Instead, the inspector would review the policies and procedures of the applicant during the survey, and ensure that necessary policies are in place.
Section 1005.3 (relating to right to enter, inspect and obtain records) pertains to an ambulance service's duty to permit employes of the Department or regional EMS councils to conduct inspections, review the applicant's or ambulance service's policies, and secure copies of records from it. It would be revised to clarify that the ambulance service has a duty to permit the review and that its failure to do so constitutes misconduct and a basis for discipline.
Section 1005.4 (relating to notification of deficiencies to applicants) pertains to how the Department and the regional EMS council interact with an applicant if there are deficiencies following an onsite inspection. It would be revised to relate that the inspector will provide the applicant with an inspection report specifying deficiencies immediately upon completing the inspection. It would further revise procedures for the regional EMS council securing a plan of correction and conducting a reinspection. Finally, it would provide for Department involvement to address disputes upon the request of the applicant.
Section 1005.5 (relating to licensure) identifies the indicia of licensure issued to ambulance service and directs ambulance services where to place those items. This section would be amended to specify changes in some of the information included in the license certificate. Clarification would be provided that the ambulance decal is considered part of the license and is to be placed in a conspicuous place on the outside of the ambulance. The requirement that a license be posted in a conspicuous place on the ambulance is set forth in section 12(j) of the act.
Section 1005.6 (relating to out-of-State providers) recognizes the statutory permission for ambulance services not licensed in this Commonwealth to transport patients from outside the borders of this Commonwealth to facilities situated inside this Commonwealth's borders. The language would be revised, but no material amendment would be made to this section.
Section 1005.7 (relating to services owned and operated by hospitals) parallels provisions in section 12(r) of the act which permits institutions licensed as hospitals by the Department to operate their own ambulance service without securing a separate license from the Department to operate an ambulance service. In all other matters, the ambulance service operations of hospitals are subject to the requirements of the act and this part. No substantive amendment is proposed to this section.
Section 1005.7a (relating to renewal of ambulance service license) would be new. It would explain that the criteria for the renewal of a license is the same as the criteria would be for securing an initial license if an initial license had been sought at the time the renewal was required. A time period for filing a renewal application prior to the expiration of a current license would be specified.
Section 1005.8 (relating to provisional license) pertains to the license the Department is permitted to issue to an ambulance service when it fails to meet multiple minor licensure requirements, or even a significant requirement, if the Department considers the operation of the ambulance service to be in the public interest. Section 12(m) of the act permits the Department to issue a provisional license for 6 months and to renew it for an additional 6 months under regulations established by the Department, except a renewal may be for 12 months if the ambulance service is a volunteer BLS ambulance service, or a volunteer fire department or rescue service that operates a BLS ambulance service. The only significant change proposed by the Department is that to secure a renewal of a provisional license the applicant would need to show that it had made a good faith effort to comply with a course of correction approved by the Department.
Section 1005.9 (relating to temporary license) pertains to the license that the Department is permitted to issue to an ALS ambulance service that cannot provide service 24 hours a day, 7 days a week. Once again, the most significant factor affecting the Department's decision regarding whether to issue a temporary license under these circumstances is whether the issuance of the license would be in the public's interest. No significant amendment is proposed.
Section 1005.10 (relating to licensure and general operating standards) is the section that enumerates most of the standards an ambulance service needs to meet to become licensed and to continue operations. Compliance with many of the current standards, as well as several of the proposed additional standards, cannot be fully judged until the ambulance service has become licensed and commences operations. The Department proposes to amend the title of the section by including a reference to ''general operating standards'' to emphasize that the enumerated standards continue to apply after ambulance service licensure.
Additional changes proposed are that the ambulance service would need to maintain documentation of its plan for ensuring that minimum staffing requirements are met, a record of calls to which it did not respond and the reasons for not responding, a record of time periods that the ambulance service was not in operation and documentation that appropriate notification was given to relevant PSAPs, and a copy of all policies required by the section.
A BLS ambulance service would be permitted to carry ALS equipment and drugs if it has a medical director who has education and continuing education in ALS prehospital care, provided that the arrangement would be specifically authorized by the Department upon its determination that the arrangement is in the public interest. This has occurred in one remote rural area and may be necessary in others.
A provision of the regulation dealing with who may accompany a patient in the patient compartment, which was inconsistent with language in the act, would be revised to eliminate that inconsistency.
The manner in which ambulance services may meet minimum staffing requirements would be addressed and clarified.
The Department is not empowered by the act to regulate persons who drive ambulances. However, section 12(h)(1) and (4) of the act state that conditions for licensure include that an ambulance service be staffed by responsible people, and that it operate in a safe and efficient manner. Subsection (d)(3) would identify minimum standards a person must meet for the Department to consider a driver to be a ''responsible'' person. The ambulance service would be required to ensure that each person it permits to drive its ambulances meets these requirements.
Subsection (e) would address an ambulance service's duty to communicate with PSAPs. Community Life Support Systems, Inc., et al. v. Department of Health, 689 A.2d 1014 (Pa. Cmwlth. 1997) and Mars Emergency Medical Services, Inc. v. Township of Adams and Borough of Callery, 704 A.2d 1143 (Pa. Cmwlth. 1998), clarify that the Department is not empowered by the act to regulate the dispatching of ambulance services. Nevertheless, as the lead agency for EMS in this Commonwealth, the Department needs to ensure that ambulance services provide information to PSAPs that may influence dispatch decisions. Consequently, the Department is proposing to require an ambulance service to give a PSAP in its area advance notice when it will not be in operation, and to communicate with and provide information to PSAPs as they request to aid them in implementing dispatch protocols.
The responsibility to communicate would continue after an ambulance service receives a call and then determines that it is unable to mobilize its resources to respond to an emergency. These communications from ambulance services will enable the PSAPs to timely contact and dispatch other available EMS providers when the public interest so warrants.
Finally, this portion of the regulation would require ambulance services to respond to calls for emergency assistance as communicated by the PSAPs. Unfortunately, the Department has received reports of ambulance services arguing with each other as to which of them has the right to treat and transport a patient. Financial considerations cannot be permitted to undermine or delay patient care. While there may be some dispute between municipalities, counties and PSAPs as to who has the authority to resolve which ambulance service among two or more similarly licensed ambulance services is best suited to provide care to a patient on a case by case basis, the PSAP is the entity through which ambulance service receives the dispatch communication. The Department believes that an orderly Statewide EMS system is best achieved when ambulance services follow the dispatch directions communicated by PSAPs, regardless of the entity empowered to determine the dispatch protocol.
The Department would also revise the subsection (g) requirements pertaining to the use of lights and other warning devices by providing that an ambulance service may use these devices only when transporting or responding to a call involving a patient who presents or is in good faith perceived to present a combination of circumstances resulting in a need for immediate medical intervention. Driving an ambulance at rapid speeds, even when alerting pedestrians and drivers of other vehicles through the use of warning devices, creates a dangerous situation. That danger should be avoided unless compelling circumstances dictate otherwise.
The subsection (f) provisions relating to scene control would be replaced by provisions addressing who may manage patient care at the scene of the emergency and in the ambulance.
The Department also proposes to impose upon an ambulance service a duty to report to a regional EMS council an accident, injury or fatality involving an ambulance vehicle or a member of an ambulance crew while performing functions on duty. This information will be examined and evaluated in considering how to better protect ambulance personnel and the public during ambulance service operations.
Additional responsibilities that would be imposed would be for an ALS ambulance service to apprise an appropriate regional EMS council as to who has medical command authorization for that ambulance service, and any change in that status, and for an ambulance service to monitor compliance with all requirements the act and the regulations impose upon the ambulance service and its staff.
Section 1005.11 (relating to drug use, control and security) would be amended to better clarify the circumstances under which ambulance services may stock and carry drugs, and would address which drugs may be used, requirements for securing and maintaining those drugs, and who may administer such drugs. Some of the most significant proposals deal with drugs being brought upon a BLS ambulance by ALS personnel when those personnel rendezvous with a BLS ambulance to treat an ALS patient, circumstances under which health professionals may bring drugs upon an ambulance and use those drugs upon patients other than as authorized by the applicable regional transfer and medical treatment protocols, and continuation of hospital ordered medication on an ambulance by a nurse, physician or physician assistant when the ambulance is involved in an interfacility transport.
Section 1005.12 (relating to disciplinary and corrective actions) pertains to the disciplinary process applicable to ambulance services. The title of the section would be changed from ''Grounds for suspension, revocation or refusal of an ambulance service license'' because the scope of this section exceeds the enumeration of grounds for discipline. The most significant amendments proposed would be to add as a basis for discipline not communicating with PSAPs as would be prescribed in § 1005.10(e) (relating to licensure and general operating standards), and revising how the Department would communicate with ambulance services and complainants during and upon completion of complaint investigations.
Section 1005.13 (relating to removal of ambulances from operation) pertains to the removal of an ambulance from operation when there is a mechanical or equipment deficiency that poses a significant threat to the safety of patients or crew. No substantive amendment is being proposed.
Section 1005.14 (relating to invalid coaches) pertains to a statutory exemption from ambulance requirements for vehicles that are used to transport individuals who require assistance, but who are not anticipated to require emergency medical care during transport. No amendment is being proposed.
Section 1005.15 (relating to discontinuance of service) would be new. This section would address and clarify the duty imposed upon an ambulance service, by section 12(q) of the act, to not discontinue its operations prior to giving the public, the Department and political subdivisions in its service area at least 90 days advance notice. The regulation would also require the ambulance service to provide similar notice to emergency communications centers in the EMS region in which it would be ceasing operations.
Chapter 1007. Licensing of Air Ambulance Services--Rotorcraft
This chapter specifies the licensure and operating criteria for air ambulance services. Several sections in Chapter 1005 (relating to licensing of BLS and ALS ground ambulance services), that would be applicable to ground ambulance services, would be equally applicable to air ambulance services. Express provision would be made in this chapter to incorporate applicable provisions in Chapter 1005. Consequently, some of the current sections in this chapter would not be needed. The unnecessary provisions would be deleted.
As a preliminary matter, the Department received comments during the process of developing proposed amendments that the regulations should be extended to entities that operate fixed-wing aircraft that provide medical treatment and transport of patients. The Department is considering the recommendation, but is not prepared to propose regulations regulating such entities at this time.
Section 1007.1 (relating to general provisions) specifies general standards applicable to air ambulance services. The most significant amendment of this regulation would be the addition of a subsection (e). That subsection would specify the sections in Chapter 1005 (relating to licensing of BLS and ALS ground ambulance services) that would apply to air ambulance services as well as ground ambulance services. These would include §§ 1005.3--1005.5, 1005.7a, 1005.8, 1005.9, 1005.11, 1005.13 and 1005.15.
All air ambulance services are licensed to provide ALS care. Some of the sections that would be referenced in subsection (e) would impose different requirements upon a ground ambulance service depending upon whether the service was licensed to provide ALS care or only BLS care. This subsection would clarify that the provisions of those sections which would apply to air ambulance services are those which would apply to ground ALS ambulance services.
Section 1007.2 (relating to applications) specifies the information solicited by applications for air ambulance service licenses. It would be amended to identify changes in some of the information that would be solicited. The section would also be amended to direct the applicant to file the license application with the regional EMS council having responsibility for the region in which the applicant intends to station its air ambulances, and it would prescribe how the application is to be processed by the regional EMS council. The section would further be amended to include a subsection identifying changes in the operations of the air ambulance service which would require a license amendment.
Section 1007.3 (relating to licenses) would be deleted. This section addresses matters such as the Department procedures for reviewing air ambulance license applications and display of the license. Some of the procedures would be revised in § 1007.2 (relating to applications). Other matters would be addressed in § 1005.5 (relating to licensure). Section 1007.1(e) (relating to general provisions) would make § 1005.5 applicable to air ambulance services.
Section 1007.4 (relating to renewal of air ambulance license) would be deleted. This section addresses various procedures to be followed for the renewal of an air ambulance service license. This subject matter would be addressed in § 1005.7a (relating to renewal of ambulance service license). Section 1007.1(e) (relating to general provisions) would make § 1005.7a applicable to air ambulance services.
Section 1007.5 (relating to inspections) would be deleted. This section deals with the authority of Department employes and agents to conduct inspections and investigations of air ambulance services. This subject matter would be addressed in § 1005.3 (relating to right to enter, inspect and obtain records). Section 1007.1(e) (relating to general provisions) would make § 1005.3 applicable to air ambulance services.
Section 1007.6 (relating to notification of deficiencies) would be deleted. This section deals with the process for addressing deficiencies following an inspection of an air ambulance service. This subject matter would be addressed in § 1005.4 (relating to notification of deficiencies to applicants). Section 1007.1(e) (relating to general provisions) would make § 1005.4 applicable to air ambulance services.
Section 1007.7 (relating to licensure and general operating standards) enumerates most of the standards an ambulance service needs to meet to become licensed and to continue operations. The fact that these are ongoing requirements was not conveyed by the title ''Licensure requirements.'' Consequently, the Department proposes to amend the title by adding the language ''general operating'' to also modify ''requirements.'' Moreover, compliance with many of the current standards, as well as several of the proposed additional standards, cannot be fully judged until the ambulance service has become licensed and commences operations.
Many of the matters addressed in proposed amendments to the corresponding section pertaining to ground ambulance services, § 1005.10 (relating to licensure and general operating standards), are also addressed in proposed amendments to this section, such as requirements of the air ambulance service to maintain documentation of its staffing plan, a record of calls to which it did not respond and the reason for not responding, and a copy of policies required by the section. Other similar subject matter addressed in the proposed amendments to this section are what constitutes meeting minimum staffing requirements; responsibilities with respect to communicating with PSAPs; medical command notification responsibilities; monitoring responsibilities; and the duty to maintain written policies and procedures.
A significant change is proposed with respect to the personnel required to meet minimum staffing requirements. The current regulations require that at least one of the crew members be a physician or a nurse. This requirement would be deleted. The staffing requirements would be revised to be the same as that required for a ground ALS ambulance service. This change is required as a matter of law. Section 12(g) of the act dictates the minimum staff that may be required, for licensure purposes, when responding to calls to provide EMS to patients requiring ALS care. The statute makes no distinction between air and ground ALS ambulance services in this regard. The Department has no authority to mandate an air ambulance service to exceed the staffing standards enumerated in section 12(g) of the act. Of course, an air ambulance service is free to exceed the minimum staffing standards prescribed by statute, and should do so if providing proper care to patients requires it to exceed those standards.
Section 1007.8 (relating to disciplinary and corrective actions) deals with the disciplinary process applicable to air ambulance services. The amendments proposed to this section are virtually the same as those proposed to the counterpart section pertaining to ground ambulance services, § 1005.12 (relating to disciplinary and corrective actions).
Section 1007.9 (relating to voluntary discontinuation of service) would be deleted. This section addresses the duty imposed upon an air ambulance service, under section 12(q) of the act, to not discontinue its operations prior to giving advance notice to the Department, political subdivisions in its service area and the public. This subject matter would be addressed in § 1005.15 (relating to discontinuance of service). Section 1007.1(e) (relating to general provisions) would make § 1005.15 applicable to air ambulance services.
Chapter 1009. Medical Command Facilities
This chapter deals with the distinct units in hospitals out of which physicians who qualify as medical command physicians provide medical direction to prehospital personnel when they are providing emergency medical care in prehospital settings and during the interfacility transport of patients.
Section 1009.1 (relating to operational criteria) sets forth the requirements that must be met for a distinct unit in a hospital to function as a medical command facility. The title would be changed from ''Accreditation and operational criteria.'' The reason for deleting the reference to ''accreditation'' is that the act neither requires nor makes provision for the Department to accredit medical command facilities. However, the definition of ''medical command facility'' in section 3 of the act, which states that a medical command facility is a distinct unit in a hospital ''that contains the necessary equipment and personnel for providing medical command to and control to an ambulance service,'' when combined with other provisions of the act which declare that the Department shall serve as the lead agency for EMS in this Commonwealth (35 P. S. § 6925(b)) and shall have the authority to promulgate regulations necessary to carry out the provisions of the act (35 P. S. § 6937.1), implies that the Department shall prescribe the ''necessary equipment and personnel'' for a medical command facility. Some of the more significant amendments proposed to the section are that the medical command facility apprise PSAPs when it is unable to provide medical command, that it have a plan to ensure the availability of medical command in mass casualty situations, and that it provide medical command to prehospital personnel whenever they seek direction.
Section 1009.2 (relating to recognition process) describes the procedure to be followed if a facility chooses to be recognized as a medical command facility by the Department. The title of the section would be changed from ''Accreditation process.'' The reason for the proposed change is that the act does not provide for the accreditation of medical command facilities, but does offer them some degree of protection from civil liability if they are ''recognized'' by the Department. Section 11(j)(4) of the act provides that a medical command facility that is recognized by the Department may not be liable for any civil damages resulting as a consequence of orders issued through it, unless guilty of gross or willful negligence. Conditioning this civil liability protection upon being ''recognized'' by the Department suggests that medical command facilities may operate without the recognition, but would have greater exposure to civil liability if they choose to do so.
This section would be completely rewritten to explain that securing Department recognition reduces a medical command facility's exposure to civil liability. It would also explain the role of the Department and regional EMS councils in the recognition process and the appeal rights of applicants which are denied medical command facility recognition, and it would provide for medical command facility recognition to have a 3-year term.
Section 1009.3 (relating to continuity of medical command) would be deleted. This regulation grandfathered medical command facilities recognized by regional EMS councils prior to July 1, 1989, the date the regulation was promulgated. The regulation is no longer required.
Section 1009.4 (relating to withdrawal of medical command facility recognition) identifies the procedures for conducting inspections and investigating complaints against medical command facilities, the grounds for withdrawal of recognition and procedures for dealing with deficiencies in lieu of withdrawing recognition. The title of the section would be changed from ''Suspension/revocation of accreditation.''
Section 1009.5 (relating to review of medical command facilities) provides for regional EMS councils to conduct biennial reviews of medical command facilities. This section would be amended to permit the Department more flexibility in determining the frequency of reviews. Comprehensive reviews conducted biennially could impose an excessive work burden on some regional EMS councils, while other regional EMS councils could conduct the reviews more frequently. This is because there are many medical command facilities in some EMS regions, and very few in others. The Department anticipates requesting reviews more frequently than once every 2 years, but would modify the scope of some reviews so that they would not involve a comprehensive assessment of compliance with all recognition criteria. The title of the section would be changed from ''Biennial review of facilities.''
Section 1009.6 (relating to discontinuance of service) would be new. This section would require a medical command facility to provide the Department, the appropriate regional EMS council, and providers of EMS for which they routinely medical command, with 60 days notice prior to discontinuing medical command operations.
Chapter 1011. Accreditation of Training Institutes
This chapter pertains to the Department's accreditation of teaching institutes that provide persons with the training required by the Department's regulations to become certified as a first responder, an EMT or an EMT- paramedic, or recognized as a prehospital registered nurse. Matters addressed are the criteria for accreditation, the process to secure accreditation, and the process for denying, withdrawing, or conditioning accreditation.
Section 1011.1 (relating to BLS and ALS training institutes) identifies the criteria to operate as a BLS training institute to provide training leading to certification as a first responder or an EMT, and as an ALS training institute to provide training leading to certification as an EMT-paramedic or a prehospital registered nurse. This section is currently titled ''BLS training institutes'' and deals only with facilities that provide training leading to certification as a first responder or an EMT. Section 1011.2 (relating to ALS training institutes) addresses only the criteria for providing training leading to certification as an EMT-paramedic or recognition as a prehospital registered nurse. The Department concluded that there was a significant amount of duplication in the two sections. It is therefore proposing that the two sections be consolidated into one. Section 1011.2 would be repealed due to the proposed consolidation of the two sections.
Section 1011.3 (relating to accreditation process) identifies the process for an entity to become accredited as a BLS or ALS training institute. The Department proposes to remove provisions relating to hearings when accreditation is denied, and to consolidate them with other hearing provisions in § 1011.4 (relating to denial, restriction or withdrawal of accreditation). The Department also proposes to delete language providing for the automatic accreditation of a training institute accredited by the American Medical Association. Of course, an institute would still be accredited if it would meet the minimum standards imposed by this section. The provision proposed for deletion would be replaced by language providing that if the Department reviews the accreditation standards of another accrediting body, and concludes that they are equal to or greater than the accreditation standards of the Department, the Department could rely upon the accreditation of that accrediting body to abbreviate the Department's own accreditation review.
Section 1011.4 (relating to denial, restriction or withdrawal of accreditation) identifies the procedures for investigating complaints against EMS training institutes, for denying, withdrawing or conditioning accreditation, and for appealing those decisions. The title of the section would be changed from ''Suspension/revocation.''
Chapter 1013. Special Event EMS
This chapter enables entities to have a Department determination as to whether EMS arrangements are adequate when those entities are responsible for the management and administration of a planned and organized activity that places attendees or participants in a defined geographic area where access by emergency vehicles might be delayed due to people or traffic congestion at or near the event.
Section 1013.1 (relating to special event planning requirements) would be amended to clarify that submitting a special event EMS plan to the Department for its approval is not mandated under the act. Nevertheless, as the Commonwealth's lead agency for EMS, the Department believes that this is a public service it should make available to entities desiring such a review. Municipalities may also choose to mandate the review for special events held within their borders. This section would also be amended to reflect that special event EMS plans are to be processed through the regional EMS council assigned responsibility for the region in which the event is to take place. An additional substantive requirement for plan approval would be that it identify measures that have and would be taken to coordinate EMS for the special event with local EMS and public safety agencies, such as ambulance, police, fire, rescue and hospital agencies or organizations.
Section 1013.2 (relating to administration, management and medical direction requirements) would be amended by requiring that a medical command physician provide direction and supervision for the EMS system for it to secure Department approval for a special event involving more than 25,000 people.
Sections 1013.3--1013.7 would not be amended, except that population figures triggering the application of certain standards in §§ 1013.3 and 1013.5 would be adjusted downward by 5,000, and equipment requirements in § 1013.5 would not be confined to BLS equipment.
Section 1013.8 (relating to special event report) would be new. It would require an entity that secured Department approval of a special event EMS plan to file with the appropriate regional EMS council, after concluding a special event, a special event report containing information solicited by the Department in the report form.
Chapter 1015. Quick Response Service Recognition Program
This chapter addresses the mobilization of prehospital personnel to arrive at the scene of emergency and provide EMS in advance of the arrival of an ambulance and its crew. While most areas of this Commonwealth can be reached by an ambulance within a few minutes, there are a few areas, generally rural or remote wilderness areas, where this is not the case. In those areas, the Department, the regional EMS councils and municipal organizations have attempted to form units of prehospital personnel to respond to emergencies prior to the arrival of an ambulance. The label the Department has given to such an early EMS response team is ''quick response service (QRS).''
A shortcoming of the act is that it does not directly provide for the creation or regulation of these quick response teams. While statutory criteria exists for granting licenses and pursuing disciplinary and corrective action against ambulance services, no similar provisions exist relative to the organization of prehospital personnel into early response teams.
Nevertheless, the act contemplates that prehospital personnel arriving at an emergency scene by ambulance, and transporting patients by ambulance, are not to be the exclusive components of prehospital EMS. For example, section 4(4)(i) and (ii) of the act (35 P. S. § 6924(4)(i) and (ii)) direct the Department to coordinate programs to ensure that the Commonwealth's EMS system has an adequate number of vehicles, in addition to ambulances, to transport patients, and that those vehicles be properly staffed and equipped. Also, in 1994 the act was amended by Act 82 to provide for the certification of first responders, which the act describes as persons certified to stabilize and improve a patient's condition in a prehospital setting until more highly trained prehospital personnel arrive at the scene. See section 11(a.1) of the act. This chapter is designed to bring first responders and other authorized personnel who provide preambulance medical assistance to patients into the Commonwealth's EMS system in a more structured manner than has been accomplished by existing regulations.
Section 1015.1 (relating to quick response service) would be new. It would establish criteria for recognition as a QRS, the process for securing the recognition, and provide for renewal. To receive QRS recognition an applicant would have to maintain equipment that the Department will identify in the Pennsylvania Bulletin, have the capability to be dispatched and to communicate with a responding ambulance service, provide EMS only through prehospital personnel and other persons authorized by law to provide the services, provide designated information on an ambulance call report for each call to which it responds, and follow Statewide and regional medical treatment protocols.
Section 1015.2 (relating to discontinuation of service) would be new. It would require a QRS to provide advance notice to the Department, the appropriate regional EMS council, and each political subdivision within its service area before discontinuing services.
Fiscal Impact
The cost to the Department to administer and monitor the continuing education program would increase because an additional staff position would be required in the Department to coordinate the integration of revised continuing education standards. Additionally, the Department would incur costs in developing review processes to incorporate alternative methods of course presentation which would be permitted by the amendments. Also, all currently approved continuing education courses (approximately 700) would need to be re-evaluated and assigned new course numbers to reflect trauma and medical continuing education credit hours for which the course would qualify. The Department would also need to revise the reporting and recordkeeping process for it to process continuing education information. Revision of forms and printing would result in associated costs. One computer work system for the additional staff person would be needed.
The Department would also incur additional costs for the continuing education program to update computer software to maintain a registry of continuing education courses. Also, costs would be incurred in updating continuing education data processing capabilities. The total estimated costs for these expenditures are $100,500 for FY 1998-99.
Currently, physicians who are not board certified in emergency medicine must complete additional courses to maintain recognition as a medical command physician. A physician is required to renew ATLS and ACLS certification on a 4-year and 2-year basis. Of the 3,200 medical command physicians, approximately 23% (736) of them are board certified in emergency medicine and, therefore, are not required to take additional courses. The regulations for other medical command physicians would be revised to require completion of an ATLS course on a one time basis only. Costs for ATLS courses may range from $125--$325. Also, these courses are not readily available in rural areas of the Commonwealth. Physicians frequently need to travel to distant parts of the State to complete ATLS courses. The regulations would result in a cost reduction to that physician population ranging from $308,000--$800,800 every 4 years.
Paperwork Requirements
Medical command facility medical director and medical command physician applications would be revised. The manual the Department distributes to facilities to aid them in meeting medical command facility criteria would need to be revised, reprinted and distributed. The Department would need to do likewise for the manual it distributes to regional EMS councils to aid them in surveying license applicants.
The Department's records for the existing 700 continuing education courses would need to be revised to reflect new course numbers given to them to reflect trauma and medical continuing education credit hours assigned to them. Course forms would need to be revised by institutions offering the courses. They would also incur revised reporting and recordkeeping responsibilities.
In making the transition to the new regulatory standards, the Department intends to employ all opportunity afforded by technology to reduce paperwork and costs.
Effective Date/Sunset Date
The proposed amendments will go into effect when published in the Pennsylvania Bulletin as final regulations. No sunset date will be imposed. The Department will monitor the regulations to ensure that they meet EMS needs within the scope of the Department's authority to address through regulations.
Statutory Authority
Section 17.1 of the act (35 P. S. § 6937.1) provides that the Department, in consultation with the Council, may promulgate regulations as may be necessary to carry out the provisions of the act. Other sections of the act contain more narrow grants of authority to the Department to promulgate regulations.
In section 3 of the act, the definitions of ''advanced life support service medical director'' and ''Commonwealth Emergency Medical Director'' provide that to qualify as either, one must be a medical command physician or meet equivalent qualifications as established by the Department through regulation. In the same section, the definitions of ''emergency medical technician'' and ''emergency medical technician-paramedic'' provide that both are to be certified in accordance with the current National standard curriculum as set forth in the regulations of the Department. See, also, section 11(b)(1)(i) and (d)(1)(i) of the act. The definition of ''medical command'' in section 3 of the act provides that medical command physicians are to meet qualifications prescribed by the Department.
Section 5(2) of the act authorizes the Department to employ regulations to establish standards and criteria governing the award and administration of contracts under the act. Section 5(11) of the act authorizes the Department to adopt regulations to establish standards and criteria for EMS systems.
Section 11(a)(1) of the act provides that the Department shall employ regulations to develop standards for the accreditation of educational institutes for EMS personnel. Section 11(a)(4), (d)(3) and (e) of the act provide that EMT and EMT-paramedics may, in the case of an emergency, perform duties deemed appropriate by the Department in accordance with the Department's regulations. Section 11(d)(2)(ii)(A) and (B), and (e.1)(3)(i) and (ii) of the act provides that ALS service medical directors shall base a decision on whether to grant medical command authorization to an EMT-paramedic or prehospital registered nurse upon the individual's demonstrated competency in knowledge and skills as defined by Department regulation and the individual's completion of continuing education requirements adopted by regulation. Section 11(d)(2)(vi) and (e.1)(5) of the act provide that when an EMT-paramedic or prehospital registered nurse chooses to not seek or maintain medical command authorization, and to function exclusively as an EMT, that person is to apply to the Department for recognition as an EMT under Department regulations. Section 11(f) of the act provides that physicians approved by regional EMS councils as medical command physicians may give medical commands subject to Department regulatory requirements. Section 11(h) and (i) of the act provides that regional EMS council transfer and medical treatment protocols are to be established under Department regulation. Section 11(j)(2) of the act grants immunity, for specified conduct, to EMS students enrolled in approved courses and supervised under Department regulations.
Section 12(b) of the act provides that applications for the renewal of ambulance service licenses shall be made on forms prescribed by the Department in accordance with its regulations. Section 12(d) of the act provides that the Department shall promulgate regulations setting forth minimum essential equipment for BLS and ALS ambulances, as well as design criteria for ambulances.
Section 14(d) of the act (35 P. S. § 6934(d)) provides that the standards the Department employs to disburse moneys from EMSOF to providers of EMS shall be under regulation.
Regulatory Review
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on January 29, 1999, the Department submitted a copy of these proposed amendments to the Independent Regulatory Review Commission (IRRC) and the Chairpersons of the House Health and Human Services Committee and the Senate Public Health and Welfare Committee. In addition to submitting the proposed amendments, the Department has provided IRRC and the Committees with a copy of a detailed Regulatory Analysis Form prepared by the Department in compliance with Executive Order 1996-1, ''Regulatory Review and Promulgation.'' A copy of this material is available to the public upon request.
If IRRC has objections to any portion of the proposed amendments, it will notify the Department within 10 days of the close of the Committees' review period. The notification shall specify the regulatory review criteria which have not been met by that portion. The Regulatory Review Act specifies detailed procedures for review prior to final publication of the regulations, by the Department, the General Assembly and the Governor of objections raised.
Contact Person
Interested persons are invited to submit comments, suggestions or objections regarding the proposal to Margaret E. Trimble, Director, Emergency Medical Services Office, Department of Health, 1027 Health and Welfare Building, P. O. Box 90, Harrisburg, PA 17108, (717) 787-8740, within 30 days after publication of this notice in the Pennsylvania Bulletin. Persons with a disability may also submit comments, suggestions or objections to Margaret Trimble in alternative formats, such as by audio tape, braille, or by using TDD: (717) 783-6514. Persons with a disability who require an alternate format of this document (such as, large print, audio tape, braille) should contact Margaret Trimble so that she may make the necessary arrangements.
GARY L. GURIAN,
Acting SecretaryFiscal Note: 10-143. (1) General Fund; (2) Implementing Year 1998-99 is $34,000; (3) 1st Succeeding Year 1999-00 is $Minimal; 2nd Succeeding Year 2000-01 is $Minimal; 3rd Succeeding Year 2001-02 is $Minimal; 4th Succeeding Year 2002-03 is $Minimal; 5th Succeeding Year 2003-04 is $Minimal; (4) Fiscal Year 1997-98 $6 million; Fiscal Year 1996-97 $8 million; Fiscal Year 1995-96 $6 million; (7) Emergency Medical Services; (8) recommends adoption. The Department can absorb any increased cost associated with these proposed amendments.
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