[41 Pa.B. 5865]
[Saturday, October 29, 2011]
Chapter 1029. Medical command facilities and receiving facilities
Subchapter A. Medical command facilities
Through medical command facilities, medical command physicians provide EMS providers with medical direction when needed. This chapter would establish the requirements for medical command facilities.
Section 1029.1 (relating to general provisions) would address the requirements a facility needs to satisfy to secure certification as a medical command facility and the registration of that certification, which will be required at 3-year intervals. A facility would be required to submit its application for certification and the triennial registration of the certification to the regional EMS council responsible for the EMS region where the facility is located. A facility that was recognized as a medical command facility by the Department prior to the effective date of the regulation would be grandfathered and automatically certified as a medical command facility with a current registration of that certification. The initial registration of the certification of a medical command facility that was grandfathered would expire when its recognition as a medical command facility would have expired under the current regulations.
Section 1029.2 (relating to operational requirements) would enumerate standards a medical command facility would need to meet to conduct its operations. One of the requirements would be that it needs to continue to satisfy the requirements under § 1029.1, which apply to securing certification as a medical command facility. The facilities that would be grandfathered under that section would have had to have met those requirements to have been recognized as a medical command facility under the current regulations. Under section 8127(c)(4) of the EMS System Act (relating to medical command facilities), a medical command facility is required to take measures necessary to ensure that a medical command physician is available to provide medical command at all times. Two requirements that would be included in this section to ensure this would be met are that the facility would need to have a contingency agreement with at least one other medical command facility to assure availability of medical command and it will need to notify PSAPs through which it routinely receives requests whenever it would not have a medical command physician available. A significant change from the current requirements is that while now a medical command facility is required to keep a record of medical command communications for 180 days, it would be required to keep a recording or other documentation of medical command communications for 7 years. Documentation of the session other than through a recording would be acceptable if medical command is provided at the patient site rather from the location of the medical command facility.
Section 1029.3 (relating to processing certification and registration applications) would address how regional EMS councils and the Department would process an application for medical command facility certification and the triennial registration of the certification. If after conducting an inspection of the applicant a regional EMS council would determine that the medical command facility or the applicant for medical command facility certification has not satisfied regulatory requirements, the medical command facility or the applicant would be given an opportunity to file a written rebuttal with the Department and the Department would resolve the dispute.
Section 1029.4 (relating to inspections and investigations) would explain that the Department or a regional EMS council would inspect a medical command facility at least once every 3 years and would conduct other investigations as the need arises. It would further require a medical command facility or an applicant for medical command facility certification to fully respond to any inquiry by the Department or a regional EMS council regarding its compliance with the regulations and to provide them with full and free access to examine the facility and its records relating to its operation as a medical command facility.
Section 1029.5 (relating to plan of correction) would provide the Department with the option of requesting a medical command facility to submit a plan of correction to resolve its regulatory violations instead of the Department pursuing disciplinary action against the facility for its infractions. Depending upon the nature of a violation, the Department could also demand that the facility immediately remedy the problem. The facility would have the option of complying with the Department directive, not complying or complying while challenging the violation. If the facility would challenge the violation, the Department would evaluate the rebuttal and rescind the notice of violation if it agrees with the facility. If the facility refuses to comply with the Department directive and the Department pursues disciplinary action, the failure to comply would be another ground for discipline if the underlying violation is proven following a hearing.
Section 1029.6 (relating to discontinuation of service) would require, as does the current regulation, that a medical command facility provide 90 days advance written notice to the Department, relevant regional EMS councils and the EMS agencies for which it routinely provides medical command that it is discontinuing medical command services. It would also require the medical command facility to advertise its discontinuation of service in a newspaper of general circulation in its service area at least 90 days in advance of discontinuing service.
Subchapter B. Receiving facilities
A receiving facility is a facility to which an ambulance transports a patient who requires prompt medical attention in addition to that provided to the patient by EMS providers in the field. Section 1029.21 (relating to receiving facilities) would specify the requirements that a facility would need to satisfy to be recognized by the Department as a receiving facility. This section would require EMS agencies to transport patients to a receiving facility as directed in the Statewide EMS protocols unless directed otherwise by a medical command physician or the Statewide protocols. Some patients, such as those with serious burns or trauma, would benefit if they were transported to a specialty receiving facility, which is a receiving facility with EMS resources in excess of those generally required for a receiving facility, geared to treat patients who require specialized care. This section would require that an EMS agency transport these patients with special needs to a specialty receiving facility if so directed by the Statewide EMS protocols and not otherwise directed by a medical command physician. Sometimes transport to a receiving facility would not be practical because of the patient's overall condition and the time it would take to transport the patient to a receiving facility. The Department would maintain a list of specialized receiving facilities which it would publish and update through notices in the Pennsylvania Bulletin. Finally, this section would require a receiving facility to acknowledge receipt of the patient in writing to the ambulance crew that transported the patient to the receiving facility if that acknowledgement is requested.
Chapter 1031. Complaints, disciplinary actions, adjudications and appeals
Under the EMS System Act, the Department has far more disciplinary authority than it had under the prior EMS act. Under the EMS System Act, the Department has disciplinary authority over EMS providers, EMVOs, EMS agencies, medical command physicians, medical command facility medical directors, medical command facilities, certified EMS instructors, EMS educational institutes, sponsors of continuing education and management companies. It also has authority to impose civil money penalties against entities that conduct EMS operations without being licensed as an EMS agency, individuals who provide EMS without being certified as an EMS provider or having other legal authority to engage in this conduct and vendors of EMS PCR software who engage in certain proscribed conduct. This chapter would address the Department's authority over each of these entities. Often, misconduct by entities regulated by the Department is brought to the Department's attention by persons who file complaints with the Department. This chapter would also guide persons through the complaint process. Additionally, this chapter would set forth a few administrative rules applicable to disciplinary proceedings that would supplement or supersede rules in 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedures) (GRAPP).
Section 1031.1 (relating to administrative and appellate procedure) would specify the statutory and regulatory rules under which administrative proceedings conducted under the EMS System Act would be conducted. In general, administrative proceedings would be conducted under GRAPP. However, subsection (b) would set forth rules that would supplement GRAPP. These rules would address how disciplinary proceedings under the EMS System Act would be initiated, the duty of the parties to a proceeding to plead matters they intend to raise, standards for requesting a continuance of a hearing and requesting an interpreter when needed. It would also explain that adjudications of the Department issued under the EMS System Act and Chapter 1031 may be appealed to the Commonwealth Court.
Section 1031.2 (relating to complaints and investigations) would inform persons who have reason to complain to the Department about the conduct of persons the Department regulates under the EMS System Act, as well as unauthorized practices by persons not licensed or certified under the EMS System Act, about how the complaint and investigation procedures are designed to work. It would apprise persons where they are to file complaints and that the Department's Bureau of Emergency Medical Services (Bureau) will handle complaints on behalf of the people of this Commonwealth to determine whether there has been a violation of the statute or the regulations adopted thereunder. It would also give persons some basic information regarding how their complaints would be handled, as well as inform them about what information they would receive regarding the disposition of a complaint and when they would receive that information.
Section 1031.3 (relating to discipline of EMS providers) would set forth grounds for the Bureau to take disciplinary or corrective action against EMS providers and the types of discipline and corrective sanctions that the Department could impose upon an EMS provider if grounds exist for imposing those sanctions. It would also include a subsection addressing the procedures to be followed if there are grounds for denying the biennial or triennial registration of an EMS provider's certification. If there are grounds for taking action, a new registration would be issued to the EMS provider, if the EMS provider qualifies for it, unless those grounds would justify an automatic or emergency suspension of the certification. An order to show cause would be issued and disciplinary action would be taken against the EMS provider's certification. However, if an EMS provider would not qualify for renewal of the provider's registration because the EMS provider did not secure the continuing education or pass the registration examinations required to renew the registration, a new registration would not be issued. If the EMS provider would challenge the Bureau's determination that these requirements were not satisfied and the Bureau rejected the challenge, the Bureau would issue an order to show cause and it would be the EMS provider's burden to demonstrate satisfaction of the registration requirements. The provision in this section specifying grounds for discipline, like the other sections in this chapter pertaining to the discipline of individuals and entities that hold a certification, license or accreditation issued under the EMS System Act, would also apply to applicants for those certifications, licenses and accreditations, and would present grounds for denying or imposing conditions upon such certifications, licenses and accreditations.
Section 1031.4 (relating to reinstatement of revoked EMS provider certification) would permit an individual whose EMS provider certification has been revoked to apply for reinstatement of the certification after 5 years have elapsed. It would explain the process to apply for reinstatement and the criteria the Department would use to act upon an application for reinstatement. It would further provide that if the Department denies the application, the individual would need to wait for at least a year from the date of the denial before again applying for reinstatement of the certification. This section would repeat the reinstatement requirements in section 8121(d) of the EMS System Act (relating to certification sanctions).
Section 1031.5 (relating to discipline of EMS vehicle operators) would set forth grounds for the Bureau to take disciplinary or corrective action against EMSVOs and identify the types of discipline and corrective sanctions that could be imposed against them. It would also include a subsection dealing with the automatic suspension of an EMSVO's certification for 4 years if the EMSVO is convicted of a criminal offense that involves driving under the influence of alcohol or drugs and for 2 years if the EMSVO is convicted of a criminal offense that involves reckless driving. These automatic suspensions are required under section 8122(f) of the EMS System Act.
Section 1031.6 (relating to emergency suspension of EMS provider and EMS vehicle operator certifications) would provide, as authorized under section 8123(a) of the EMS System Act (relating to suspension of certification), for the emergency suspension of an EMS provider or EMSVO certification if the individual is a clear and immediate danger to the public health and safety. For an emergency suspension to be imposed, the Department would need to be presented with credible evidence of this danger. This section would provide that the Bureau would give the individual a written statement of the factual allegations supporting the action, and that a hearing would be conducted within 30 days to determine if there is prima facie evidence to support the emergency suspension, unless the hearing would be continued at the request of the individual. The section would further provide that the suspension will continue for 180 days if a prima facie case for the emergency suspension is made. That suspension would expire after 180 days unless the Bureau takes action against the individual through the normal disciplinary process and an adjudication is issued, providing otherwise, before 180 days elapse. A provision would be included to allow the emergency suspension to exceed 180 days if agreed upon by the parties. This would most likely occur when the individual whose certification was suspended seeks additional time to prepare for the full disciplinary hearing.
Section 1031.7 (relating to discipline of EMS instructors) would set forth grounds for taking disciplinary or corrective action against EMS instructors who are certified by the Department and the types of discipline and corrective sanctions that could be imposed upon an EMS instructor if sanctions are warranted. As explained in § 1025.1(f), not all instructors in EMS training institutes need to be certified as EMS instructors by the Department. This section would apply only to those instructors who are certified by the Department.
Section 1031.8 (relating to discipline of medical command physicians and medical command facility medical directors) would set forth grounds for the Bureau to take disciplinary or corrective action against medical command physicians and medical command facility medical directors and identify the types of discipline and corrective sanctions that could be imposed against them.
Section 8123(b) of the EMS System Act provides for the automatic suspension of the certification issued under the statute to an individual if that individual is adjudicated to be incapacitated under 20 Pa.C.S. § 5511 (relating to petition and hearing; independent evaluation) or an equivalent statutory provision. It further provides for the lifting of that suspension if that individual has been adjudicated to have regained capacity. Section 1031.9 (relating to automatic suspension for incapacity) would essentially repeat the provisions of the statutory section.
Section 1031.10 (relating to discipline of EMS agencies) would set forth grounds for the Bureau to take disciplinary action against EMS agencies and identify the types of discipline and corrective sanctions that could be imposed against them.
Section 1031.11 (relating to discipline of medical command facilities) would set forth grounds for the Bureau to take disciplinary action against medical command facilities and identify the types of discipline and corrective sanctions that could be imposed against them.
Section 1031.12 and § 1031.13 (relating to discipline of providers of EMS continuing education) would set forth grounds for the Bureau to take disciplinary action against EMS educational institutes and providers of EMS continuing education and specify the types of disciplinary sanctions the Department could impose upon them.
Section 1031.14 (relating to civil money penalty for practicing without a license or certification) would provide for the Department to impose civil money penalties against entities that operate an EMS agency without a license and individuals who provide EMS without a certification. To operate as an EMS agency, an entity would not need to hold itself out as an EMS agency—it would merely need to engage in an activity for which an EMS agency license is required. For example, a business that would not be licensed as an EMS agency could own and operate stretcher or wheelchair vehicles and legally transport by stretcher or wheelchair persons who during transport do not require and are not reasonably expected to require EMS. However, if an entity would transport by stretcher or wheelchair an individual that it knows or should reasonably know requires EMS during transport, that entity would be operating an EMS agency without a license. Under this section, the Department could impose upon it a civil money penalty of $5,000 per day for each day that it engages in the activity.
Section 1031.15 (relating to discipline of vendors of EMS PCR software) would provide for the Department to impose civil money penalties against vendors of EMS PCR forms and software who violate § 1021.43(b) and (d). These subsections enumerate the statutory basis for imposing penalties under section 8106(f) of the EMS System Act. This provision authorizes the Department to assess a vendor of EMS PCRs a civil money penalty of up to $5,000 a day for each day it offers reporting forms or software marketed as appropriate for submitting EMS PCRs if they have not been reviewed and approved by the Department. The software vendor would likewise need to secure Department approval of a substantive modification of the product for use as an EMS PCR to avoid the possibility of the civil money penalty. Moreover, if the Department makes changes to the EMS PCR form, a vendor would not be able to market the form or software for EMS PCR use unless it modifies the product and secures Department approval of the modified product.
Section 1031.16 (relating to discipline of management companies) would set forth standards for the Department to deny, withdraw or condition the approval of an entity to offer management services to EMS agencies.
Chapter 1033—Special event EMS
This chapter would reinstate, with some changes, the current chapter dealing with the Department review of plans to provide EMS and coordinate EMS resources with other resources to promote emergency preparedness at special events. It would enable entities to secure assistance in planning for medical emergencies when they are responsible for the management and administration of a planned activity that places a large volume of attendees and participants in a defined geographic area where access to EMS might otherwise be delayed due to a variety of factors, such as the volume of attendees, scarce EMS resources and traffic congestion. The Department may have the authority, under its power under section 8105(b)(11) of the EMS System Act, to mandate entities to submit special event EMS plans to the Department for its review and approval. Nevertheless, the Department proposes to retain the voluntary character of its current special event EMS plan approval process. As the lead agency for EMS in this Commonwealth, the Department believes that this is a public service that the Department should make available to entities desiring its assistance.
Section 1033.1 (relating to special event EMS planning requirements) would require that the entity responsible for the management and administration of a special event submit its proposed special event EMS plan to the Department through the regional EMS council assigned responsibility for the EMS region in which the special event would be held. The plan could cover a single event or a series of events in a calendar year. The entity would need to submit a new special event EMS plan if it wants to secure Department approval of a plan for special events it will conduct in the next calendar year. This section would also specify the information the Department requires to be included in a special event EMS plan to obtain the Department's review and provide that the plan would need to satisfy the requirements of the chapter to secure Department approval.
Section 1033.2 (relating to administration, management and medical direction requirements) would require that a special event EMS plan identify a special event EMS director and a special event EMS medical director. It would also specify the qualifications and responsibilities of these officials.
Section 1033.3 (relating to special event EMS personnel and capability requirements) would require that EMS providers be certified at appropriate levels based upon the level of EMS approved by the Department in the special event EMS plan. It would also require a number of ambulances to be stationed at the special event that would be based upon the number of persons expected to be present at any one time.
Section 1033.4 (relating to onsite facility requirements) would specify onsite facilities that would need to be present if the persons expected to be present at the special event at any one time exceed 25,000.
Section 1033.5 (relating to communications system requirements) would describe the communications capabilities that would be required of a special event EMS plan.
Section 1033.6 (relating to requirements for educating event attendees regarding access to EMS) would require that the entity responsible for managing and administering the special event demonstrate a plan for educating persons in attendance of the presence and location of EMS and the process for obtaining EMS if needed and for alerting those persons of specific hazards, serious changing conditions and evacuation procedures.
Section 1033.7 (relating to special event report) would require an entity that secured Department approval of a special event EMS plan to file a special event report with the Department, through the relevant regional EMS council, on a special event report form prepared by the Department within 30 days following the last day of the special event.
There could be additional cost to some EMS agencies if they have to operate around the clock, but this is imposed by the EMS System Act, not the regulations. Currently, there is not a requirement for BLS ambulance services and QRSs to meet this standard. The EMS System Act requires that an EMS agency provide service around the clock, but also makes provisions for exceptions. Both the general requirement and the exceptions are captured in this proposed rulemaking. The exceptions include operating under an area wide plan accepted by the Department or operating under a conditional temporary license. In both instances, permission to operate less than 24 hours-a-day, 7 days-a-week would be based upon the Department determining that the permission advances the public interest. It is not possible to calculate the costs that would be incurred by those operations that are operating less than on a full-time basis that will be required to operate on a full-time basis.
There will also be additional costs to EMS agencies for EMS operations that do not now have a medical director. Once again, this additional cost is imposed by the EMS System Act, not the regulations, and it is impossible to estimate the costs. Currently, ALS operations and about 80% of the BLS operations meet this requirement. Some medical directors serve as volunteers and others are paid a significant sum. Plans are for the regional EMS councils, the Pennsylvania Medical Society, the Pennsylvania Chapter of the American College of Emergency Physicians and the Department to work together to assist EMS agencies in meeting this requirement.
There would not be appreciable additional costs or savings to local government since the changes do not affect local government per se. Some of the regional EMS councils are a part of county government. However, they would be performing essentially the same work under the EMS System Act and the proposed regulations as they are currently performing.
There will be an increase in costs to the Department associated with its duty to license and certify EMS providers and other persons and entities involved in the EMS system. A duty to certify these persons did not previously exist. These additional costs will be imposed by the EMS System Act, not the regulations. The costs that will be incurred associated with issuing certification and registrations for EMSVOs, EMRs, AEMTs, PHPEs, medical command physicians and medical command facility medical directors. This will also require the development of additional patches and decals to recognize the new levels of certification with an estimated cost of $1,500 per new type of EMS provider certification.
There will be a need for enhancement to the EMS Registry System software and Agency Application System software with an estimated total cost of $87,590 the first year attributable to adding an additional staff position in the Department's Bureau of Information Technology. Both enhancements will include required improvements to the EMS Registry System and Agency Application System to meet National standards for EMS credentialing. Application is being made for a Federal grant to fund this project.
The Department's disciplinary authority has been expanded under the EMS System Act and the ability to impose civil money penalties has been added. This is repeated in the proposed regulations. Depending upon the type of entity against which action is taken, fines can be up to $1,000 to $5,000 per finable violation. These violations and civil money penalties should generate at least $10,000 per year to return to the EMS Operating Fund.
Additional State saving will be realized in the contract/grant award process by the Department not being required to devote staff time to triennially justify sole source contracting with the regional EMS councils. Section 8112(l) of the EMS System Act provides that the Department may renew a contract or grant with a regional EMS council without engaging in competitive bidding if in performing its duties under the prior grant/contract the regional EMS council demonstrated its ability and commitment to the Department's satisfaction to meets its responsibilities under that grant/contract. This cost-savings measure is repeated in the proposed regulations.
Various provisions of the EMS System Act require an applicant for EMS provider or EMSVO certification to report to the Department misdemeanor, felony and other criminal convictions that are not summary or equivalent offenses and disciplinary sanctions that have been imposed upon a license, certification or other authorization of the applicant to practice an occupation or profession. An applicant for an EMSVO certification is to report to the Department any other conviction of an offense involving reckless driving or driving under the influence of alcohol or drugs. The proposed regulations will require the applicant to also arrange for the custodian of the criminal charging, judgment and sentencing document for each conviction and the custodian of adjudication or other document imposing discipline against the applicant to provide the Department with a certified copy of those records. This will save the Department the cost and time to request and receive the required documents to review in deciding whether to grant, deny or impose conditions on a certification.
The EMS System Act, as well as the proposed regulations, will require the medical director of an EMS agency to conduct an initial and annual assessment of each EMS provider of the EMS agency at or above the advance EMT level and to determine whether to allow the EMS provider to provide skills at the level at which the provider is certified. Once this assessment is completed, there is not an appeal process of the EMS agency medical director's decision. Under the current law, the credentialing determination is called a medical command authorization decision and a decision adverse to the provider's interest can be appealed to the regional EMS medical director and that decision can be appealed to the Department, which decision in turn can be appealed to the Commonwealth Court. This appeal process imposes costs on the affected EMS provider, the medical director who made the decision, the regional EMS council and the Department. The EMS System Act eliminates the appeal process and the associated costs. The proposed regulations will carry this through.
There are a few paperwork requirements that are proposed that are not imposed by the prior EMS act and the regulations adopted thereunder. The proposed regulations foster electronic transmissions. There would, however, be a few changes regarding required paperwork.
Section 1021.41(c) states that when an EMS agency transports a patient to a receiving facility, before its ambulance departs from the receiving facility, the EMS agency having primary responsibility for the patient shall verbally, and in writing or by other means by which information is recorded, report to the individual at the receiving facility the patient information that is essential for immediate transmission for patient care. It further states that the Department will publish a notice in the Pennsylvania Bulletin specifying the types of patient information that are essential for patient care. This patient transfer document would be new. It has already been developed and employed in a pilot project to address the smooth transfer of a patient to a high level of care and to ensure that the prehospital care and other essential patient information is documented.
The current regulations require that a completed EMS PCR be submitted to the hospital within 24 hours. With the development of the patient transfer document, the prompt need for a full patient care record will be less. Therefore, the proposed regulations would allow the EMS provider to submit the completed EMS PCR to the receiving facility to which the patient was transported within 72 hours after the EMS agency concluded patient care, instead of the now required 24 hours. This will be a cost savings to EMS agencies since currently some ambulance services have to pay staff overtime to complete the full EMS PCR and meet current State standards.
Under the EMS System Act, the Department will be licensing for the first time special operations EMS services such as tactical EMS services and mass gathering EMS services. When an EMS agency provides EMS through one of these special operations, its paperwork responsibilities would be somewhat different than the norm. Under § 1027.38, it would need to maintain a log of every patient encounter, but would only be required to complete an EMS PCR for a patient transported by ambulance from the special operations EMS incident who receives EMS exceeding the scope of practice of an EMT. It would also need to complete an EMS PCR for a patient not transported by an ambulance that refuses EMS or dies while under the care of the special operations EMS service. For a patient transported by ambulance, the special operations would need to complete the less extensive written transfer of care form referenced in § 1021.41(c) through which essential patient information is provided.
Effective Date/Sunset Date
Several of the proposed regulations will go into effect when published in the Pennsylvania Bulletin as final-form regulations. Others, as well as the statutory provisions to which they relate, will not go into effect until 180 days after the final-form regulations are published. Under section 9(1) of Act 37, sections 8113(a), (c), (d) and (n), 8114—8120, 8122, 8129—8138 and 8140—8142 of the EMS System Act will not go into effect until 180 days after the final-form regulations are published. Several sections of this proposed rulemaking will not become effective until 180 days after the final-form regulations are published. Additionally, the Department will include among its orders adopting the final-form rulemaking an order directing that the effective date of these regulations will be 180 days after the final-form regulations are published. The Department has coordinated with the Legislative Reference Bureau to ensure that that date will be determined by the Legislative Reference Bureau. A source note under each regulation in the Pennsylvania Code will state the effective date.
A sunset date will not be imposed. The Department will monitor the regulations to ensure that they meet EMS needs that are within the scope of its authority to address through regulations.
There are several provisions in the EMS System Act that expressly confer upon the Department the duty or discretion to adopt regulations. However, section 7 of Act 37 provides that Act 37 shall be liberally construed to authorize the Department to promulgate regulations to carry out the provisions of the EMS System Act and that the absence of express authority to adopt regulations in a provision of the EMS System Act may not be construed to preclude the Department from adopting a regulation to carry out that provision.
Section 8103 of the EMS System Act defines a few terms in a manner that expressly permit the Department to expand the definition by regulation. The term ''EMS agency—emergency medical services agency'' is defined as an entity that may provide EMS through the operation of certain types of services and the deployment of certain vehicles, which are listed in the definition. The definition also provides that the Department may expand the list of services and vehicles through regulation. The definition of ''EMS provider—emergency medical services provider'' identifies the different types of EMS providers certified by the Department. It also empowers the Department to establish by regulation other types of EMS providers to provide specialized EMS. This is also addressed in section 8113(a) of the EMS System Act.
Section 8105 of the EMS System Act includes several provisions that provide for the Department to carry out responsibilities by adopting regulations. Section 8105(b)(2) of the EMS System Act authorizes the Department to establish by regulation standards and criteria governing the awarding and administration of contracts and grants by the Department for the initiation, maintenance and improvement of regional EMS systems. Section 8105(b)(4) of the EMS System Act empowers the Department to collect, under Department regulations, information about patients admitted to various facilities. Section 8105(b)(11) of the EMS System Act authorizes the Department to promulgate regulations to establish standards and criteria for EMS systems. On the other hand, section 8105(c) of the EMS System Act, which addresses the Department establishing EMS protocols for the evaluation, triage, transport, transfer and referral of patients, states that those protocols are not subject to the rulemaking process. Further, section 8109(b)(8) of the EMS System Act, which speaks to regional EMS councils establishing protocols, subject to Department approval, to supplement the Department's EMS protocols, also provides that those protocols are not subject to the rulemaking process.
Section 8106 of the EMS System Act provides that an EMS agency shall report to the Department or a regional EMS council, as directed by Department regulation, information from EMS PCRs solicited through the reporting process.
Section 8108 of the EMS System Act (relating to State Advisory Board) provides that one of the duties of the Board is to advise the Department regarding the content of its regulations.
Section 8113(d)(1) and (2) of the EMS System Act requires the Department to develop standards through regulations for the accreditation and reaccreditation of EMS educational institutes and for the approval of continuing education courses and the accreditation of entities that provide continuing education courses. Section 8113(e) of the EMS System Act establishes standards for taking and passing EMS provider certification examinations. Nevertheless, section 8113(e)(7) of the EMS System Act permits the Department to change those standards through regulations. Section 8113(c) of the EMS System Act provides that applicants for EMS provider certification are to submit their application through a form or an electronic process as prescribed by the Department by regulation.
Sections 8114—8120 of the EMS System Act pertain to the certification and registration requirements for the various types of EMS providers and the scope of their practice. The scope of practice subsections specify the capacities in which the EMS providers may function. Each of these subsections makes provision for the EMS provider to function in additional capacities as authorized by the Department regulation. To practice as an EMS provider an EMS provider requires not only a certification, but current registration of that certification. These sections provide that the application for registration of an EMS provider certification is to be submitted through a form or an electronic process as prescribed by the Department by regulation. They also provide that when the registration has expired and the EMS provider subsequently seeks to register the certification, the EMS provider may secure a current registration of the provider's certification by qualifying for the registration under requirements established by the Department by regulation. To ensure that there is not an unintentional lapse in the registration of an EMS provider certification, the sections also provide that the registration applications are to be submitted at least 30 days prior to when they are to expire. However, the sections also provide for the applications to be submitted within a lesser time before their expiration if permitted by Department regulation.
The provisions in section 8122(a)(1) and (b)(1) of the EMS System Act are similar to those in sections 8113—8120 of the EMS System Act regarding the use of regulations to prescribe the manner in which applications for EMSVO certification and registration of the certification are to be submitted, as well as the use of regulations to prescribe requirements for registering a certification after the registration has expired.
The provisions in section 8124(a)(1) and (b)(1)(i) and (2) of the EMS System Act (relating to emergency medical services instructors) are similar to section 8122(a)(1), (b)(1) and (4) and (c) of the EMS System Act. These provisions apply to persons who seek to become and then become certified EMS instructors (not all EMS instructors need to be certified). Subsection (c) provides that the Department may adopt regulations to set standards for EMS instructors in providing instruction in EMS educational institutes.
Section 8125(b) of the EMS System Act prescribes the roles and responsibilities of an EMS agency medical director. Section 8125(b)(9) of the EMS System Act provides that the EMS agency medical director is to perform other functions as imposed by the Department by regulation.
The provisions in section 8126(b)(1), (c)(1), (f)(1) and (g)(1) of the EMS System Act (relating to medical command physicians and facility medical directors) are similar to those previously referenced that provide for applications for certification and registration of the certification to be submitted through a form or an electronic process as prescribed by the Department. The certifications and registrations are for medical command physicians and medical command facility medical directors. These provisions, unlike prior similar provisions, do not expressly state that the Department is to employ regulations to prescribe the processes.
Section 8127(b) and (e) of the EMS System Act provides for medical command facility certifications and registration of those certifications to be submitted through a form or an electronic process as prescribed by the Department. As in the preceding section, these subsections do not expressly state that the Department is to employ regulations to prescribe the processes. Subsection (c) imposes certification and operational requirements on medical command facilities. Subsection (d) provides that the Department may employ regulations to impose additional requirements on medical command facilities.
Section 8128(b) of the EMS System Act (relating to receiving facilities) specifies requirements that a facility needs to satisfy to qualify to receive patients transported by ambulance. However, it also includes a provision that empowers the Department, through regulations, to authorize special facilities to receive patients transported by ambulance who have special medical needs.
Section 8129 of the EMS System Act includes more provisions that expressly direct or authorize the Department to promulgate regulations than any other section of the EMS System Act. Subsections (b) and (e) provide for EMS agency certifications and registration of those certifications to be submitted through a form or an electronic process as prescribed by the Department. They do not expressly state that the Department is to employ regulations to prescribe these processes. Subsection (a) provides that an entity may not operate as an EMS agency unless it holds an EMS agency license. It specifies various vehicles and services, the operation of which constitutes operating as an EMS agency, but also authorizes the Department to specify by regulation other vehicles and services the operation of which will constitute acting as an EMS agency. Under section 8129(c)(6) of the EMS System Act, an applicant for an EMS agency license shall be in compliance with the regulations adopted under the EMS System Act.
Section 8125(a) of the EMS System Act prescribes in general terms the requirements a physician shall serve as an EMS agency medical director.
Section 8129(c)(5) of the EMS System Act provides that the Department may, by regulation, establish other criteria an applicant for an EMS agency license shall demonstrate that its EMS agency medical director satisfies based upon the types of EMS vehicles the applicant is applying to operate and the types of services it is applying to provide.
Section 8129(f)(1) of the EMS System Act permits an EMS agency to enter into a contract with another entity to manage the EMS agency, but provides that an entity that provides management services for an EMS agency shall be approved by the Department. One of the requirements for approval is that the entity be in compliance with the Department's regulations.
Section 8129(g) of the EMS System Act provides for specified types of EMS vehicles to display a Department-issued inspection sticker as prescribed by the Department by regulation and further provides that the Department, by regulation, may require other types of EMS vehicles to display a Department-issued inspection sticker.
Section 8129(i)(2) of the EMS System Act provides that if an EMS agency operates a communications center that dispatches EMS resources, the activity shall be viewed as part of the EMS agency's licensed operation and subject to the Department's regulations.
Sections 8130—8137 of the EMS System Act deal with various types of vehicles EMS agencies operate and services they provide. Each of these sections includes a subsection that addresses staffing requirements. Section8129(l) of the EMS System Act provides that the Department may by regulation revise some of those staffing standards.
Section 8129(p) of the EMS System Act is the most encompassing subsection of the section addressing rulemaking. It provides that the Department will promulgate regulations setting forth requirements for EMS agencies in this Commonwealth based upon the types of EMS vehicles they operate and the services they provide.
Section 8136 of the EMS System Act (relating to special operations emergency medical services) pertains to types of EMS services that operate in situations or austere environments that require specialized knowledge, equipment or vehicles to access a patient or address a patient's emergency medical needs. Section 8136(a) of the EMS System Act provides that the Department will provide by regulation for specific types of special operations teams. Section 8136(b) of the EMS System Act permits the Department, by regulation, to prescribe additional training and expertise requirements for the EMS agency medical director and the EMS providers who staff a special operations EMS service. Section 8136(c) of the EMS System Act authorizes the Department to employ regulations to establish staffing, equipment, supply and other requirements of these services. Section 8136(d) of the EMS System Act deals with applications to provide special operations EMS services that the Department has not addressed in regulations. It provides that the Department will evaluate the merits of each application on an individual basis and may conditionally deny or grant an application based upon considerations of public health and safety. If further provides that the grant of an application will be subject to compliance with any later-adopted regulations addressing that type of special operations EMS service.
Section 8138 of the EMS System Act (relating to other vehicles and services) authorizes the Department to promulgate regulations to establish EMS vehicle and service standards for EMS vehicles and services not specified in the EMS System Act.
Under section 5(a) of the Regulatory Review Act (71 P. S. § 745.5(a)), on October 11, 2011, the Department submitted a copy of this proposed rulemaking and a copy of a Regulatory Analysis Form to the Independent Regulatory Review Commission (IRRC) and to the Chairpersons of the Senate Committee on Public Health and Welfare and the House Committee on Veterans Affairs and Emergency Preparedness. A copy of this material is available to the public upon request.
Under section 5(g) of the Regulatory Review Act, IRRC may convey any comments, recommendations or objections to the proposed rulemaking within 30 days of the close of the public comment period. The comments, recommendations or objections must specify the regulatory review criteria which have not been met. The Regulatory Review Act specifies detailed procedures for review, prior to final publication of the rulemaking, by the Department, the General Assembly and the Governor of comments, recommendations or objections raised.
Persons interested in providing comments, suggestions or objections regarding the proposed rulemaking should submit them to Joseph W. Schmider, Director, Bureau of Emergency Medical Services, Department of Health, Room 606 Health and Welfare Building, 625 Forster Street, Harrisburg, PA 17120-0701 within 30 days after publication of this proposed rulemaking in the Pennsylvania Bulletin. Persons with a disability who require an alternative format of this proposed rulemaking (for example, large print, audiotape or Braille) should contact Joseph W. Schmider at the previously listed address or at (717) 787-8740 to make the necessary arrangements. Speech or hearing impaired persons may use VTT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT). Persons with a disability may submit their comments, suggestions or objections regarding the proposed rulemaking in alternative formats previously listed.
ELI N. AVILA, MD, JD, MPH, FCLM,
Fiscal Note: 10-190. No fiscal impact; (8) recommends adoption.
TITLE 28. HEALTH AND SAFETY
PART VII. EMERGENCY MEDICAL SERVICES
Subpart A. EMS SYSTEMS
CHAPTER 1001. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1001, which appears in 28 Pa. Code pages 1001-1—1001-29, serial pages (336959), (336960), (297023), (297024), (269307)—(269312), (302695)—(302698), (293995), (293996), (269317)—(269322), (302699)—(302702) and (269327)—(269333).)
Sec. 1001.1—1001.7. (Reserved). 1001.21—1001.28. (Reserved). 1001.41. (Reserved). 1001.42. (Reserved). 1001.61. (Reserved). 1001.62. (Reserved). 1001.65. (Reserved). 1001.81—1001.84. (Reserved). 1001.101. (Reserved). 1001.121—1001.125. (Reserved). 1001.141—1001.143. (Reserved). 1001.161. (Reserved).
CHAPTER 1003. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1003, which appears in 28 Pa. Code pages 1003-1—1003-35, serial pages (282207), (282208), (269337)—(269354), (293997), (293998), (302703), (302704) and (269359)—(269369).)
Sec. 1003.1—1003.5. (Reserved). 1003.21—1003.23. (Reserved). 1003.23a. (Reserved). 1003.24. (Reserved). 1003.25a. (Reserved). 1003.25b. (Reserved). 1003.26—1003.34. (Reserved).
CHAPTER 1005. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1005, which appears in 28 Pa. Code pages 1005-1—1005-19, serial pages (269371), (269372), (294001), (294002), (302705), (302706), (269377)—(269380), (287207), (287208), (302707)—(302710) and (269387)—(269389).)
Sec. 1005.1. (Reserved). 1005.2. (Reserved). 1005.2a. (Reserved). 1005.3—1005.7. (Reserved). 1005.7a. (Reserved). 1005.8—1005.15. (Reserved).
CHAPTER 1007. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1007, which appears in 28 Pa. Code pages 1007-1—1007-10, serial pages (269391)—(269396), (302711), (302712), (294009) and (294010).)
1007.1. (Reserved). 1007.2. (Reserved). 1007.7. (Reserved). 1007.8. (Reserved).
CHAPTER 1009. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1009, which appears in 28 Pa. Code pages 1009-1—1009-5, serial pages (269401)—(269405).)
Sec. 1009.1. (Reserved). 1009.2. (Reserved). 1009.4—1009.6. (Reserved).
CHAPTER 1011. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1011, which appears in 28 Pa. Code pages 1011-1—1011-7, serial pages (269407)—(269413).)
1011.1. (Reserved). 1011.3. (Reserved). 1011.4. (Reserved).
CHAPTER 1013. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1013, which appears in 28 Pa. Code pages 1013-1—1013-5, serial pages (269415)—(269419).)
Sec. 1013.1—1013.8. (Reserved).
CHAPTER 1015. (Reserved)
(Editor's Note: As part of this proposed rulemaking, the Department is proposing to rescind Chapter 1015, which appears in 28 Pa. Code pages 1015-1—1015-3, serial pages (269421), (269422) and (294011).
1015.1. (Reserved). 1015.2. (Reserved).
CHAPTER 1021. ADMINISTRATION OF THE EMS SYSTEM
A. GENERAL PROVISIONS B. AWARD AND ADMINISTRATION OF EMSOF FUNDING C. COLLECTION OF DATA AND INFORMATION D. QUALITY IMPROVEMENT AND PEER REVIEW E. TRAUMA CENTERS F. REGIONAL EMS COUNCILS G. ADVISORY BOARD H. EMS RESEARCH
Subchapter A. GENERAL PROVISIONS
1021.1. Purpose. 1021.2. Definitions. 1021.3. Applicability. 1021.4. Exceptions. 1021.5. Investigations. 1021.6. Comprehensive EMS system plan. 1021.7. Comprehensive regional EMS system plan. 1021.8. EMS data collection.
§ 1021.1. Purpose.
The purpose of this subpart is to facilitate improvement of the Statewide EMS system into a comprehensive and flexible system through coordination of the regional EMS systems, to synchronize the Statewide and regional systems with EMS systems in neighboring states and to otherwise implement the Department's responsibilities under the act consistent with the Department's rulemaking authority.
§ 1021.2. Definitions.
The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise:
ACLS course—Advanced cardiac life support course—A course in advanced cardiac life support sanctioned by the American Heart Association.
AEMT—Advanced emergency medical technician—An individual who is certified by the Department as an advanced EMT.
ALS—Advanced life support.
ALS ambulance—Advanced life support ambulance—An ambulance that is staffed and equipped to provide EMS above the AEMT level and used in the transport of patients.
ALS squad vehicle—Advanced life support squad vehicle—
(i) A vehicle that is maintained or operated to transport EMS providers above the AEMT level, and equipment and supplies, to rendezvous with the crew of an ambulance for the purpose of providing advanced EMS to patients.
(ii) The vehicle is not used in the transport of patients.
APLS course—Advanced pediatric life support course—A course in advanced pediatric life support sanctioned by the American Academy of Pediatrics and the American College of Emergency Physicians.
ATLS course—Advanced trauma life support course—A course in advanced trauma life support sanctioned by the American College of Surgeons Committee on Trauma.
Act—35 Pa.C.S. §§ 8101—8157 (relating to Emergency Medical Services System Act).
Advanced EMS—Advanced emergency medical services—EMS exceeding the scope of practice of an EMT, as authorized by the Department.
Advisory Board—The State Advisory Board, which is the Board of Directors of the Pennsylvania Emergency Health Services Council.
Air ambulance—A rotorcraft specifically designed, constructed or modified and equipped, used or intended to be used and maintained or operated for the purpose of providing emergency medical care to and air transportation of patients.
Ambulance—A ground or air vehicle that is maintained or operated for the purpose of providing EMS to and transportation of patients.
BLS—Basic life support.
BLS ambulance—Basic life support ambulance—An ambulance that is equipped to provide EMS at or below the AEMT level and used in the transport of patients.
BLS squad vehicle—Basic life support squad vehicle—
(i) A vehicle that is maintained or operated to transport EMS providers, and equipment and supplies, to rendezvous with the crew of an ambulance for the purpose of providing to patients EMS at or below the AEMT level.
(ii) The vehicle is not used in the transport of patients.
Basic EMS—Basic emergency medical services—EMS included within but not exceeding the scope of practice of an EMT.
Basic rescue practices technician—An individual who is certified by the Department as possessing the training and skills to perform a rescue operation as taught in a basic rescue practices technician program approved by the Department.
Basic vehicle rescue technician—An individual who is certified by the Department as possessing the training and skills to perform a rescue from a vehicle as taught in a basic vehicle rescue technician program approved by the Department.
(i) The Bureau of Emergency Medical Services of the Department.
(ii) If the Department is reorganized, the office within the Department assigned primary responsibility for administering the act.
CPR—Cardiopulmonary resuscitation—Artificial circulation which is performed as a procedure when cardiac arrest occurs.
CPR course—Cardiopulmonary resuscitation course—A course of instruction in CPR meeting the Emergency Cardiac Care Committee National Conference on CPR and Emergency Cardiac Care standards. The course shall encompass one- and two-rescuer adult, infant and child CPR, and obstructed airway methods.
Commonwealth EMS Medical Director—Commonwealth Emergency Medical Services Medical Director—A physician who is approved by the Department to advise and formulate policy on matters pertaining to EMS.
Continuing education—Learning activities intended to build upon the education and experience of EMS providers and EMSVOs to enhance and strengthen the quality of services provided.
Continuing education course—A unit of continuing education for which the Department will grant an EMS provider or EMSVO continuing education credit.
Continuing education sponsor—An entity or institution that is accredited by the Department as a sponsor of continuing education courses.
Conviction—A judgment of guilt, a plea of guilty or a plea of nolo contendere.
Department—The Department of Health of the Commonwealth.
EMR—Emergency medical responder—An individual who is certified by the Department as an emergency medical responder.
EMS—Emergency medical services—Either of the following:
(i) The medical care, including medical assessment, monitoring, treatment, transportation and observation, which may be provided to a person in responding to an actual or reported emergency to either of the following:
(A) Prevent or protect against loss of life or a deterioration in physiological or psychological condition.
(B) Address pain or morbidity associated with the person's condition.
(ii) The transportation of an individual with medical assessment, monitoring, treatment or observation of the individual who, due to the individual's condition, requires medical assessment, monitoring, treatment or observation during the transport.
EMS agency—Emergency medical services agency—An entity that engages in the business or service of providing EMS to patients within this Commonwealth by operating one or more of the following:
(i) An ambulance service.
(ii) An air ambulance.
(iii) An ALS ambulance.
(iv) An ALS squad vehicle.
(v) An intermediate ALS ambulance.
(vi) An intermediate ALS squad vehicle.
(vii) A BLS ambulance.
(viii) A BLS squad vehicle.
(ix) A QRS.
(x) A special operations EMS service, which includes a tactical EMS service, a wilderness EMS service, an urban search and rescue service and a mass-gathering EMS service.
(xi) Another vehicle or service that provides EMS outside of a health care facility as prescribed by the Department by regulation.
EMS agency dispatch center—Emergency medical services agency dispatch center—A communications center owned, operated or controlled by an EMS agency that dispatches EMS resources due to a PSAP routing emergency callers to it for that purpose or due to the EMS agency receiving calls through an EMS agency provided telephone number through which the EMS agency invites persons to request the EMS agency's response to an emergency.
EMS agency medical director—Emergency medical services agency medical director—A physician who is employed by, contracts with or volunteers with an EMS agency either directly or through an intermediary to evaluate the quality of patient care provided by the EMS providers utilized by the EMS agency and to provide medical guidance and advice to the EMS agency.
EMS agency medical director course—Emergency medical services agency medical director course—A course adopted by the Department for EMS agency medical directors, which provides education in EMS medical direction.
EMS educational institute—Emergency medical services educational institute—An institute accredited by the Department to provide education required for the certification of an EMS provider by the Department.
EMS PCR—Emergency medical services patient care report—A report that provides standardized data and information relating to patient assessment and care.
EMS provider—Emergency medical services provider—The term includes any of the following:
(i) An EMR.
(ii) An EMT.
(iii) An AEMT.
(iv) A paramedic.
(v) A PHRN.
(vi) A PHPE.
(vii) A PHP.
(viii) An individual prescribed by regulation of the Department to provide specialized EMS.
EMS provider educational course—An educational course approved by the Department, other than a CPR course, the successful completion of which is a requirement for securing an EMS provider certification.
EMS system—Emergency medical services system—The arrangement of personnel, facilities and equipment for the delivery of EMS in a geographic area to prevent and manage emergencies.
EMS vehicle—Emergency medical services vehicle—A ground EMS vehicle or an air ambulance.
EMSOF—Emergency Medical Services Operating Fund—Moneys appropriated to the Department under section 8153(a) of the act (relating to support of emergency medical services) and which are not assigned to the Catastrophic Medical and Rehabilitation Fund.
EMSVO—Emergency medical services vehicle operator—An individual who is certified by the Department to operate a ground EMS vehicle.
EMT—Emergency medical technician—An individual who is certified by the Department as an emergency medical technician.
EVOC—Emergency vehicle operator's course.
Emergency—A physiological or psychological illness or injury of an individual so that a prudent layperson who possesses an average knowledge of health and medicine could reasonably expect the absence of immediate EMS to result in one of the following:
(i) Placing the health of the individual or, with respect to a pregnant woman, the health of the woman or her unborn child in serious jeopardy.
(ii) Serious impairment of a bodily function.
(iii) Serious dysfunction of a bodily organ or part.
Emergency department—An area of the hospital dedicated to offering emergency medical evaluation and initial treatment to individuals in need of emergency care.
Facility—A physical location at which an entity operates a health care facility licensed under Federal or State law.
First responder—An individual who is certified by the Department as a first responder.
Ground EMS vehicle—Ground emergency medical services vehicle—The term includes any of the following:
(i) A BLS ambulance.
(ii) A BLS squad vehicle.
(iii) An ALS ambulance.
(iv) An ALS squad vehicle.
Hospital—An institution having an organized medical staff which is primarily engaged in providing to inpatients by or under the supervision of physicians, diagnostic and therapeutic services or rehabilitation services for the care or rehabilitation of injured, disabled, pregnant, diseased, sick or mentally ill persons. The term includes a facility for the diagnosis and treatment of disorders within the scope of specific medical specialties, but not a facility caring exclusively for the mentally ill.
Intermediate ALS ambulance—Intermediate advanced life support ambulance—An ambulance that is staffed and equipped to provide EMS at the AEMT level and used in the transport of patients.
Intermediate ALS squad vehicle—Intermediate advanced life support squad vehicle—
(i) A vehicle that is maintained or operated to transport EMS providers at the AEMT level, and equipment and supplies, to rendezvous with the crew of an ambulance for the purpose of providing advanced EMS to patients.
(ii) The vehicle is not used in the transport of patients.
Medical advisory committee—An advisory body formed to advise a regional EMS council or the Advisory Board on issues that have potential impact on the delivery of emergency medical care.
Medical audit—A mechanism to evaluate patient care.
Medical command course—The course adopted by the Department for medical command physicians which provides an overview of the medical command system.
Medical command facility—A distinct unit that contains the necessary equipment and personnel for providing medical command to and direct medical oversight over EMS providers.
Medical command facility medical director—A medical command physician who meets the criteria established by the Department to assume responsibility for the direction and control of the equipment and personnel at a medical command facility.
Medical command order—An order issued by a medical command physician to an EMS provider who is functioning on behalf of an EMS agency.
Medical command physician—A physician who is certified by the Department to give medical command orders to EMS providers.
Medical coordination—A system which involves the medical community in all phases of the regional EMS system and consists of the following elements:
(i) Designation of a regional EMS medical director.
(ii) Responsibility for oversight to assure implementation of all medical requirements, with special emphasis on patient triage and medical treatment protocol.
(iii) Effective emergency medical planning and recommendation for Department recognition of online command facilities with medical command physicians who give orders to EMS providers.
(iv) Transfer and medical treatment protocols.
(v) Technologic innovations which support the training and operations of the physicians giving orders to EMS providers.
(vi) Technologic innovations which support the training and operations of the EMS program and an effective process for accountability—for example, records, case review and audits.
Medical monitoring—Performing continuous or periodic observations of an individual's condition or continuation of an ordered treatment plan for an individual to prevent pain, suffering or the exacerbation of a preexisting condition.
Medical observation—Performing continuous or periodic observations of an individual's stable condition to determine whether there is a change in that condition.
Medical record—Documentation of the course of a patient's condition and treatment, maintained to provide communication among health care providers for current and future patient care.
PALS course—Pediatric advanced life support course—A course in advanced pediatric life support sanctioned by the American Heart Association and the American Academy of Pediatrics.
PHP—Prehospital emergency medical services physician—A physician who is certified by the Department as a prehospital EMS physician.
PHPE—Prehospital physician extender—A physician assistant who is certified by the Department as a prehospital physician extender.
PHRN—Prehospital registered nurse—A registered nurse who is certified by the Department as a prehospital registered nurse.
PSAP—Public safety answering point—
(i) The Pennsylvania Emergency Management Agency-approved first point at which calls for emergency assistance from individuals are answered.
(ii) A PSAP is operated 24 hours a day.
Paramedic—An individual who is certified by the Department as a paramedic.
Patient—An individual for whom an EMS provider is responsible for one of the following:
(i) Providing EMS on behalf of an EMS agency.
(ii) Required to provide EMS on behalf of an EMS agency because the individual's condition requires or may require medical observation, monitoring, assessment or treatment for an illness, disease, injury or other disability.
Peer review—The evaluation by health care provider of the quality and efficiency of services ordered or performed by EMS providers and physicians who direct or supervise EMS providers under the act and the regulations of the Department.
Peer review committee—A committee of health care providers who engage in peer review under the act.
Physician—An individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth.
QRS—Quick response service—An operation in which EMS providers of an EMS agency:
(i) Respond to an actual, reported or perceived emergency.
(ii) Provide EMS to patients pending the arrival of other EMS providers and resources that have been dispatched to the scene.
Receiving facility—A facility to which an ambulance may transport a patient who requires prompt medical care in addition to that provided by EMS providers who respond to an emergency.
Regional EMS council—Regional emergency medical services council—A nonprofit incorporated entity or appropriate equivalent that is assigned by the Department to:
(i) Plan, develop, maintain, expand and improve EMS systems within a specific geographical area of this Commonwealth.
(ii) Coordinate those systems into a regional EMS system.
Regional EMS medical director—Regional emergency medical services medical director—The medical director of a regional EMS council.
Registered nurse—An individual who has a current original or renewed license to practice nursing in this Commonwealth as a registered nurse.
Residency program—Training approved or recognized by the State Board of Medicine or the State Board of Osteopathic Medicine as a program of graduate medical training for physicians.
Rural area—An area outside urbanized areas as defined by the United States Bureau of the Census.
Scope of practice—The EMS that an individual who is certified by the Department as an EMS provider is permitted to perform under the certification.
Service area—The geographic area in which an EMS agency routinely provides EMS.
Special event—A planned and organized activity or contest, which places participants or attendees, or both, in a defined geographic area in which the potential need for EMS exceeds local EMS capabilities or where access by emergency vehicles might be delayed due to crowd or traffic congestion at or near the event.
Special vehicle rescue technician—An individual who is certified by the Department as possessing the training and skills to perform special rescue operations as taught in the special vehicle rescue training program approved by the Department.
Specialty receiving facility—A facility identified by the Department as a receiving facility based upon its ability to provide specialized emergency and continuing care to patients in one of the following medical areas:
(v) other specialized care.
Statewide EMS protocols—Statewide emergency medical services protocols—Written EMS protocols adopted by the Department that have Statewide application to the delivery of EMS by EMS providers.
Trauma center—A facility accredited as a trauma center by the Trauma Foundation.
Trauma Foundation—The Pennsylvania Trauma Systems Foundation, a nonprofit Pennsylvania corporation whose function is to accredit trauma centers.
§ 1021.3. Applicability.
This subpart affects persons and activities regulated by the Department under the act.
§ 1021.4. Exceptions.
(a) The Department may grant exceptions to, and departures from, this subpart when the policy objectives and intentions of the Department as reflected in this subpart are otherwise met or when compliance would create an unreasonable hardship, but would not impair the health, safety or welfare of the public. Exceptions or departures from this subpart will not be granted if compliance with the standard is required by statute.
(b) Requests for exceptions to this subpart shall be made in writing to the Department. The requests, whether approved or not approved, will be documented and retained on file by the Department in accordance with its document retention schedule. Approved requests shall be retained on file by the applicant during the period the exception remains in effect.
(c) A granted request will specify, if relevant, the period during which the exception is operative. The duration of an exception may be extended if the reasons for the original exception continue. Requests for an exception extension shall be made in writing to the Department.
(d) An exception granted may be revoked by the Department for just cause. Just cause includes, for example, failure to meet the conditions for the exception. Notice of the revocation will be in writing and include the reason for the action of the Department and a specific date upon which the exception will be terminated.
(e) In revoking an exception, the Department will provide for a reasonable time between the date of the written notice or revocation and the date of termination of an exception for the holder of the exception to come into compliance with this subpart. Failure to comply after the specified date may result in enforcement or disciplinary proceedings.
(f) The Department may, on its own initiative, grant an exception to this subpart if the requirements in subsection (a) are satisfied.
§ 1021.5. Investigations.
The Department may investigate any person, entity or activity for compliance with the act and this subpart.
§ 1021.6. Comprehensive EMS system plan.
(a) The Department, with the advice of the Advisory Board, will develop and annually update a Statewide EMS System Plan, which will include both short-range and long-range goals and objectives for the coordinated delivery of EMS in this Commonwealth.
(b) The plan will contain:
(1) An inventory of EMS resources available in this Commonwealth.
(2) An assessment of the effectiveness of the existing Statewide EMS system and a determination of the need for changes to the Statewide EMS system.
(3) Performance measures for delivery of EMS to persons in this Commonwealth.
(4) Methods to be used in achieving stated performance measures.
(5) A schedule for achievement of the stated performance measures.
(6) A method for monitoring and evaluating whether the stated Statewide performance measures are being achieved.
(7) Estimated costs for achieving the stated performance measures.
(c) The Department will incorporate regional EMS system plans into the Statewide EMS System Plan.
(d) The Department will adopt a Statewide EMS System Plan, updates to the plan after public notice, an opportunity for comment and its consideration of comments received. The Department will make the plan available to the General Assembly and concerned agencies, entities and individuals who request a copy.
§ 1021.7. Comprehensive regional EMS system plan.
(a) A regional EMS council shall develop and annually update a regional EMS system plan for coordinating and improving the delivery of EMS in the region for which it has been assigned responsibility.
(b) The plan must contain:
(1) An inventory of EMS resources available in the region.
(2) An assessment of the effectiveness of the existing regional EMS system and a determination of the need for enhancement of the regional EMS system.
(3) A statement of goals and specific measurable objectives for delivery of EMS to persons in the region.
(4) Identification of interregional problems and recommended measures to resolve those problems.
(5) Methods to be used in achieving stated performance measures.
(6) A schedule for achievement of the stated performance measures.
(7) A method for evaluating whether the stated performance measures have been achieved.
(8) Estimated costs for achieving the stated performance measures.
(9) Other information as requested by the Department.
(c) A regional EMS council shall, in the course of preparing a regional EMS system plan and updates to the plan, provide public notice and an opportunity for comment. It shall consider the comments before submitting a proposed plan to the Department.
(d) A regional EMS system plan will become final after it is approved by the Department. The regional EMS council shall make the plan available to concerned agencies, entities and individuals who request a copy.
§ 1021.8. EMS data collection.
(a) Reasons for EMS data collection. The Department, either directly or through regional EMS councils or the Advisory Board, may collect EMS data for the purpose of evaluating the effectiveness of the Statewide and regional EMS system plans and the need to revise those plans and pursue future EMS system initiatives. This will include collecting EMS data to determine the status of the Statewide and regional EMS systems, the degree of compliance with the requirements in the act and this subpart, and the effectiveness of the Statewide and regional EMS systems in reducing morbidity and mortality when the EMS systems are involved.
(b) Duty to provide EMS data and records. Persons regulated by the Department under the act, as well as PSAPs and others dispatchers of EMS resources, shall provide data and access to records, including audio records, without charge, as reasonably requested by the Department, the regional EMS councils or the Advisory Board when they are acting for and on behalf of the Department, to aid the Department, the regional EMS councils and the Advisory Board in conducting the activities referenced in subsection (a) and engaging in an investigation authorized under the act and this subpart.
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