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RULES AND REGULATIONS

Title 28--HEALTH
AND SAFETY

DEPARTMENT OF HEALTH

[28 PA. CODE CHS. 1001, 1003, 1005, 1007,
1009, 1011, 1013 AND 1015]

Emergency Medical Services

[30 Pa.B. 5363]

   The Department of Health (Department) hereby adopts amendments to Part VII (relating to emergency medical services), to read as set forth in Annex A.

Purpose and Background

   The Emergency Medical Services Act (EMS act) (35 P. S. §§ 6921--6938) establishes a comprehensive scheme for the regulation of emergency medical services (EMS) in this Commonwealth. It designates the Department as the lead agency for EMS in this Commonwealth and provides that the Department, in consultation with the Pennsylvania Emergency Health Services Council (PEHSC), may adopt regulations as necessary to carry out the purposes of the EMS act. The Department's regulations adopted under the EMS act are set forth in Part VII. Those regulations were adopted on July 1, 1989, and were last amended on September 2, 1995.

   The 1995 amendments were adopted to facilitate the implementation of the act of October 5, 1994 (P. L. 557, No. 82) (Act 82). Act 82 amended the EMS act and authorized the Department to bypass certain rulemaking procedures to adopt interim regulations. That authorization was accompanied by the caveat that the Department later adopt through the customary rulemaking procedures regulations addressing the same subject matter.

   As Act 82 was limited in scope, so too were the interim regulations adopted by the Department on September 2, 1995. Following its adoption of the interim regulations, the Department proposed comprehensive amendments to Part VII at 29 Pa.B. 903 (February 13, 1999). It announced therein that the Department was proposing regulations not only to meet its duty to subject to standard rulemaking procedures the regulations it had adopted through the interim rulemaking process, but also to amend the other regulations in Part VII as needed. The Preamble for the proposed rulemaking afforded a 30-day comment period.

Summary

   Many comments to the proposed rulemaking were received. The comments and the Department's response to them appear in this summary of final rulemaking.

Chapter 1001.  Administration of the EMS System

Subchapter A.  General Provisions

   Section 1001.1 (relating to purpose) explains the purpose of Part VII. No comments addressing this section were received. This section is adopted as proposed.

   Section 1001.2 (relating to definitions) defines terms used in Part VII.

Comment

   The last sentence in the definition of ''ambulance call report,'' which addresses what the report is to contain and how it is to be formatted, contains substantive requirements more properly placed in a regulation pertaining to ambulance call reports.

Response

   The Department agrees. It has removed this sentence from the proposed definition, and has addressed this matter in § 1001.41(a) (relating to data and information requirements for ambulance services).

Comment

   The term ''ambulance call report'' should be changed to ''EMS response report'' because the term does not include reports of responses to calls made by quick response services (QRS).

Response

   The Department accepts the recommendation in part, but not for the reason asserted. The proposed term is consistent with the statutory language. Section 5(b)(3) of the EMS act (35 P. S. § 6925(b)(3)) requires that responding ambulance personnel complete a report for each call to which an ambulance responds. QRS personnel will only be required to complete certain portions of the report when a QRS responds. See § 1015.1(a)(4) (relating to quick response services). Therefore, there is no need to broaden the defined term to suggest that the entire report is to be completed when the response is made by an EMS responder other than an ambulance service. Nevertheless, the Department does believe that a more appropriate and descriptive label should be given to the report. Therefore, the proposed name is replaced with ''EMS patient care report.''

Comment

   The proposed definition of ''board certification'' does not recognize certifications in a medical specialty if the board issuing the certification is not recognized by either the American Board of Medical Specialties (ABMS) or the American Osteopathic Association (AOA). The Department should revise the definition or explain the reason for limiting the definition to certifications in medical specialties recognized by these two groups.

Response

   The Department has decided to limit the definition, as proposed, to include only those certifications issued by boards recognized by the ABMS or the AOA. However, it has removed board certification in emergency medicine as a criterion for qualifying as a regional EMS council medical director, a medical command facility medical director and a medical command physician.

   The proposed rulemaking did not include the certification in emergency medicine issued by the Board of Certification in Emergency Medicine (BCEM). The BCEM is recognized by the American Association of Physician Specialists (AAPS). The primary reason the Department had proposed to exclude the BCEM certification is that emergency medicine certifying boards recognized by the other two organizations, the American Board of Emergency Medicine (ABEM) and the American Osteopathic Board of Emergency Medicine (AOBEM), required, at that time, completion of a 3-year residency in emergency medicine for the certifications they issue, and the BCEM did not. Rather, at the time of the proposal, the BCEM would accept, in lieu of completion of a 3-year emergency medicine residency, completion of a primary care residency and full time emergency medicine practice for 5 years with a minimum of 7,000 hours dedicated to this practice. The BCEM has now revised its certification criteria to require completion of 3 years in an emergency medicine residency program for an initial BCEM certification.

   The Department has elected to substitute completion of 3 years in an emergency medicine residency program for the proposed board certification in emergency medicine criterion. The Department considers completion of an intensive 3 years in an emergency medicine residency to be an appropriate qualifying criterion, without being supplemented by a document from a medical specialty board certifying excellence in emergency medicine. It does not, however, consider the prior practice tract criterion for BCEM certification to be equivalent to an intensive 3-year residency in emergency medicine. As will be explained in this Preamble, there are criteria alternative to the emergency medicine residency criterion which the Department has prescribed. Additionally, the Department includes a grandfather provision in the sections prescribing qualifying criteria for a regional EMS medical director, a medical command facility medical director and a medical command physician, §§ 1003.2--1003.4 (relating to regional EMS medical director; medical command facility medical director; and medical command physician).

Comment

   The Department should revise the proposed definition of ''board certification'' to include the medical specialty certifications issued by the boards functioning under the umbrella of the AAPS, and in particular the board certification in emergency medicine issued by the BCEM.

Response

   The Department rejects this recommendation, as the board certification in emergency medicine criterion has been removed from the final regulations. The Department is not sufficiently familiar with the qualifying criteria for other boards functioning under the umbrella of the AAPS to conclude that the certifications issued by those boards are equivalent to those issued by boards recognized by the ABMS and the AOA.

Comment

   The proposed definition of ''board certification'' should not be altered to include the certification in emergency medicine issued by the BCEM.

Response

   This comment is moot since the final-form regulations do not retain board certification in emergency medicine as a qualifying criterion for any position for which the Department prescribes qualifications.

Comment

   Contrary to the proposal, the definition of ''closest available ambulance'' should not be deleted.

Response

   The Department rejects the recommendation. The term is not used in the regulations. There is no need to define a term that does not appear.

Comment

   The proposed definition of ''direct support of EMS systems'' is too narrow. It needs to reference research as a mechanism to evaluate and improve the EMS system.

Response

   The Department agrees that research is part of the direct support of EMS systems, but only if it is used to help plan, initiate, maintain, expand or improve an EMS system. The Department believes that this concept is clearly conveyed in the proposed definition. Therefore, the Department has not made the recommended revision.

Comment

   The definition of ''EMT-paramedic'' should state that it applies to an individual who is trained in accordance with the current EMT-paramedic NSC rather than the current EMT-NSC.

Response

   The Department agrees. The term ''NSC'' means National standard curriculum. Both ''EMT-NSC'' and ''EMT-paramedic NSC'' are defined. The training EMTs are to receive is to be in accordance with the EMT-NSC, and the training EMT-paramedics are to receive is to be in accordance with the EMT-paramedic NSC. The Department has revised the definition to correct the error.

Comment

   The definition of ''emergency'' should be revised to reflect the American College of Emergency Physician's prudent layperson's definition of ''emergency'' and to be consistent with definitions of ''emergency'' in several Pennsylvania statutes.

Response

   The Department rejects the recommendation. The existing definition of ''emergency'' repeats the definition contained in section 3 of the EMS act (35 P. S. § 6923). The Department is not empowered to change the statutory definition. Moreover, within the context that ''emergency'' is used in the EMS act, a definition that incorporates a prudent layperson's assessment of an emergency is not appropriate. In determining whether an emergency exists and whether treatment and perhaps ambulance transportation to a receiving facility are required, prehospital personnel and medical command physicians need to rely upon their training and experience, not upon standards that a prudent layperson might use. For example, although a prudent layperson may believe that certain symptoms require emergency treatment at a hospital, trained EMS personnel should not use an ambulance to transport an individual with these symptoms to a hospital when they conclude that the individual's condition does not constitute an emergency and does not warrant immediate hospital treatment.

Comment

   The meaning of ''base station'' in the definition of ''Medical Command Base Station Course'' is unclear. The Department should define ''base station.''

Response

   The term ''base station'' refers to the hospital radio command console, which usually includes the radio, antenna and control methods. The medical command course includes instruction on various matters pertaining to medical command, including, but not limited, to base station direction. Moreover, the Department has historically labeled this course as the ''Medical Command Course.'' The Department will continue using that title for the course. The term ''base station'' is removed from the proposed name of the course and is also deleted from other places where it appeared in the proposed rulemaking.

Comment

   The Department's regulations repeatedly refer to ''medical treatment protocols.'' In subparagraph (iv) of the definition of ''medical coordination,'' the term that appears is ''transfer and treatment protocols.'' The term ''medical'' should be inserted before ''treatment.''

Response

   The Department agrees. The term ''medical'' was included in subparagraph (iv) in the proposed rulemaking the Department filed with the Legislative Reference Bureau. An error occurred in reprinting the proposed definition. The Department has corrected the error.

Comment

   The definition of ''medical command'' should be modified to clarify that orders may be given to withhold treatment as well as to administer it.

Response

   The Department agrees. It has added language to the definition to reflect that a medical command from a medical command physician may include medical instructions to a prehospital practitioner to withhold or discontinue treatment. This order should be given by a medical command physician only when EMS standards dictate that treatment will no longer be effective, or when the order is otherwise appropriate under law, such as under an advance directive for health care which directs that life sustaining procedures be withheld or withdrawn.

Comment

   Contrary to the proposal, the definition of ''medical service area'' should not be deleted.

Response

   The Department rejects the recommendation since the term is not used in Part VII.

Comment

   The definition of ''mutual aid response'' should be removed because the use of the term may compromise EMS resource management at public service answering points (PSAPs) and promote inappropriate responses by ambulance services.

Response

   The Department agrees with the comment. The Department has removed the proposed definition of ''mutual aid response.'' This term is not used in the final-form regulations.

Comment

   The definition of ''patient'' should be revised to describe an individual who is believed to need immediate medical attention rather than an individual who requires immediate medical attention.

Response

   The Department agrees and has revised the definition so that the language ''believed to be'' applies to both ''sick, injured, wounded or otherwise incapacitated and helpless'' as well as ''in need of immediate medical attention.'' Any person who is believed to be in one of these states requires immediate medical attention. That medical attention, in some cases, may be nothing more than a medical assessment of the individual's condition. Such an individual becomes a patient, for purposes of the EMS system, and an EMS patient care report needs to be completed for that individual even if the medical assessment leads to the determination that the individual does not require additional emergency medical treatment.

Comment

   The definition of ''prehospital personnel'' should use the term ''health professional'' rather than separately list health professional physicians and prehospital registered nurses, since the statutory and regulatory definitions of ''health professional'' include both types of personnel.

Response

   The Department has decided not to make the recommended revision. The Department recognizes that the definition of ''health professional'' does include both types of personnel. However, the definition of ''prehospital personnel'' is drafted to identify each type of prehospital practitioner separately, so that the reader is not required to resort to another regulation for further clarification. When the regulations refer to both types of practitioners, and distinguishing between the two does not enhance the regulation, the Department uses the term ''health professional'' to refer to them. The Department believes that the distinction here enhances the regulation.

Comment

   In proposed § 1003.31 (relating to credit for continuing education) the term ''prehospital practitioner'' is used throughout, but nowhere is the term defined. Rather, the Department defines the term ''prehospital personnel.'' The Department should delete the term ''prehospital practitioner'' from § 1003.31 and replace it with ''prehospital personnel.''

Response

   The Department rejects the recommendation. The term ''prehospital practitioner'' is employed throughout the proposed regulations, not solely in proposed § 1003.31. The term ''practitioner'' is used to refer to a single individual, while the term ''personnel'' is used to refer to more than one individual. The proposed regulations the Department filed with the LRB included the statement that any one of the personnel listed in the definition of ''prehospital personnel'' is a ''prehospital practitioner.'' The Department addressed both terms because of the dissimilarity between the words ''practitioner'' and ''personnel.'' Due to the confusion caused by its removal from the published version of the proposed definition of ''prehospital personnel,'' the Department has once again included in the final regulation the term ''prehospital practitioner'' and the clarification of its meaning.

Comment

   Contrary to the proposal, the definition of ''primary response area'' should not be deleted.

Response

   The Department rejects the recommendation. The term is not used in the regulations. Furthermore, the Department has been working with the General Assembly and other stakeholders in the Statewide EMS system to develop legislation that will regulate the process for public safety answering points (PSAPs) to dispatch EMS resources. The Department envisions that this legislation will use and define terms such as ''primary responders'' and ''primary response areas.'' The inclusion of these terms in the Department's regulations might cause confusion.

Comment

   Change the proposed term ''public safety answering point (PSAP)'' to some other term more recognizable to the EMS community, possibly ''emergency operations center.''

Response

   The Department rejects this recommendation. The Department believes that ''public safety answering point'' is a term well-recognized by the EMS community as the communications center established to serve as the first point at which calls requesting emergency assistance are received. The Department also took into consideration that the Public Safety Emergency Telephone Act (35 P. S. §§ 7011--7021) and the Pennsylvania Emergency Management Agency, in its regulations, use the same term. See 35 P. S. § 7012 and 4 Pa. Code § 120b.102 (relating to definitions).

Comment

   In the definition of ''receiving facility'' there is a void in the description of the training required of a physician who must be present and available in an emergency department for that emergency department to qualify as a receiving facility. In addition to being trained to manage cardiac, trauma and pediatric emergencies, as proposed, the physician should be required to have training in managing medical and psychiatric emergencies.

Response

   The Department agrees with this comment. It has revised the proposed definition to require that the physician also be required to have training in managing medical and behavioral emergencies.

Comment

   The definition of ''receiving facility'' should require that the physician who must be present and available in an emergency department have training in managing medical emergencies, but need not reference cardiac emergencies since those emergencies would be included in medical emergencies.

Response

   The Department rejects this recommendation. The physician present and available in the emergency department needs to have significant training in the management of cardiac emergencies. Because cardiac patients represent a special subset of medical emergencies, the Department believes that the definition should specifically emphasize training of the physician to manage cardiac emergencies.

Comment

   Because the definition of ''service area'' is used to identify the political subdivisions an ambulance service must notify when it is going out of business, and because any political subdivision that relies on an ambulance service should receive the notice, the definition of ''service area'' should be revised to remove the word ''routinely'' from the proposed language ''area in which an ambulance service routinely provides service.''

Response

   The Department has adopted the definition as proposed. It has elected not to remove the term ''routinely'' because many ambulance services may be called upon to transport a patient to or from a facility or other location which is located in a municipality which does not rely upon the ambulance service and in which the ambulance service seldom does business. Moreover, that location may be quite some distance from where the ambulance service generally operates. It should not be considered to be a part of the service area of the ambulance service. However, there may be some municipalities where an ambulance service seldom operates, but for which it has committed to provide backup services as needed. The Department agrees with the focus of the comment that an ambulance service that is discontinuing operations should also provide notice to these municipalities. To address the concern expressed by the comment, the Department has revised proposed § 1005.15 (relating to discontinuation of service) to require an ambulance service to give notice to a political subdivision that relies upon it in addition to the political subdivisions in its service area.

Comment

   The definition of ''special event'' should be expanded to deal with events that overtax local EMS resources.

Response

   The Department agrees. It has expanded the proposed definition of ''special event'' to include activities conducted not only in areas where access by emergency vehicles might be delayed due to crowd or traffic congestion at or near the event, but also in areas in which the potential need for EMS exceeds local EMS capabilities.

Comment

   The EMS act and § 1005.8 (relating to provisional license) make special provision for renewing provisional licenses issued to volunteer ambulance services. ''Volunteer ambulance service'' should be defined in the regulations since it is not defined in the EMS act.

Response

   The Department agrees with this comment. The Department has added a definition to define the term ''volunteer ambulance service'' as it is defined in section 3 of the Volunteer Fire Company, Ambulance Service and Rescue Squad Assistance Act (72 P. S. § 3943.3). While the Department is not required to use this definition in its regulations, it believes that it is consistent with legislative intent to do so. Both the Volunteer Fire Company, Ambulance Service and Rescue Squad Assistance Act and section 12(m)(2) of the EMS act (35 P. S. § 6932(m)(2)) are provisions enacted by the Legislature to provide special assistance to an entity the Legislature has labeled as a ''volunteer ambulance service.'' The Department believes that the Legislature intended the term to have the same meaning in both statutes. The Department has, however, added clarifying language to ensure that the definition is not construed to apply to a QRS.

Other Changes

   The definition of ''ambulance service affiliate number'' is revised to reflect that the first two digits of the number will designate the county in which the ambulance service maintains its primary headquarters.

   The words ''ALS and BLS'' are removed from the definition of ''emergency medical services'' as a description of the services comprising the defined term because the Department concludes that other support services, such as communication services, are also included. The EMS act does not use the language ''ALS and BLS'' in its definition of ''emergency medical services.'' The Department has also revised the definition of ''regional EMS council'' to provide that it shall be representative of not only public, but also private entities that provide EMS. This makes the regulatory definition consistent with the statutory definition.

   The Department has revised the definition of the proposed term ''ambulance call report,'' which is now ''EMS patient care report,'' because the Department felt the proposed definition might cause confusion in implementation. The definition has been simplified to merely reflect that the report is a report of data and information relating to patient assessment and care. This definition tracts the statutory language better. Section 5(b)(3) of the EMS act provides that each ambulance service shall ensure that its responding personnel complete a report of patient data and information, as prescribed by the Department, for each call to which an ambulance responds. Section 1001.41 requires an ambulance service to complete the report as appropriate. If there is any patient assessment at all, even if the assessment leads to the conclusion that no further EMS is required, a report needs to be completed. The only situation when an ambulance would be involved when no report would be required is when there is a routine transport of a convalescent or other nonemergency case which does not give rise to patient care or even patient assessment. See 35 P. S. § 6932(e)(4) for provisions applicable to these transports.

   The Department has also removed from this section the term ''prehospital personnel training manual.'' The Department has replaced that term in the regulations by referring to a manual addressing the relevant subject matter without giving the manual a title. This affords the Department the flexibility to develop different guidance manuals to address different prehospital personnel subjects.

   The Department has added a definition for ''residency program.'' The meaning of this term is significant because §§ 1003.2--1003.4 include completion of a designated residency program or completion of 3 years in an emergency medicine residency program as criteria for qualifying to serve in different physician capacities in the Statewide EMS system.

   Section 1001.3 (relating to applicability) identifies, in general terms, who is affected by Part VII. No comments addressing this section were received. This section is adopted as proposed.

   Section 1001.4 (relating to exceptions) provides a process for persons to seek an exception to a regulatory requirement that is not also directly imposed by the EMS act.

Comment

   Proposed subsections (a) and (c) address the Department granting exceptions to its regulations for justifiable reasons if, as set forth in subsection (f), the substantive standards of the regulation, are satisfied. The Department should either explain what a justifiable reason is or delete ''justifiable reason'' from subsections (a) and (c), and it should identify those standards of the regulation it considers to be substantive standards.

Response

   The Department is deleting the term ''justifiable reason'' from subsections (a) and (c) and the term ''substantive'' from subsection (f). Upon further consideration of the proposed regulation, the Department concludes that these terms add nothing to the regulation. The basis for granting an exception is explained in subsection (a). The Department may grant an exception when the policy objectives and intentions reflected by the regulations are satisfied, or when compliance would create an unreasonable hardship and granting an exception would not impair the health, safety or welfare of the public. The Department has also reworded subsection (a) to more clearly articulate these criteria.

Comment

   In the discussion of the definition of ''board certification,'' the Department stated that if board certification was required under a particular regulation, and an individual did not have board certification, the Department could consider an application for an exception under this regulation and grant an exception if the candidate could establish that the certification the person received from another certifying agency was issued under standards equal to or greater than those referenced in the definition of ''board certification.'' The Department should explain the phrase ''standards equal to or greater than'' and otherwise describe the process set forth in this section.

Response

   The criteria for granting an exception is set forth in the regulation and discussed in the response to the preceding comment. While the Department perceives that it will not be granting exceptions on a routine basis, this section does permit the Department to grant an exception to any regulation in Part VII to the extent the regulation does not set forth a standard imposed by statute.

   The reference in the preamble to the proposed regulations to an individual seeking an exception to the board certification criterion was used as an example of when this section might be employed. In these final regulations, a board certification criterion is retained only in § 1003.3(b)(2)(ii), but the example is still relevant. In acknowledging that the Department would grant an exception to the board certification requirement if the applicant obtained a certification meeting standards equal or greater to the standards used by the certifying bodies acceptable under the proposed definition of ''board certification,'' the Department was recognizing that this would meet the policy objective of a regulation that includes board certification as a qualifying criterion.

   Over the course of time certifying bodies other than those that satisfy the definition of ''board certification'' might come into existence. They may employ standards to certify the qualifications of medical specialists that are equal to or more stringent than the standards used by the recognized certifying bodies. Even existing certifying bodies that are not recognized under the definition might change their standards for granting certification so that those standards are equal to or more stringent than the standards that are currently acceptable to the Department.

   Because it is not possible to envision all circumstances for granting an exception to each regulation to which an exception may be granted, it is not possible to list specific standards for granting an exception to each regulation with greater specificity than included in this regulation.

   Section 1001.5 (relating to investigation) provides that the Department may investigate persons for compliance with the provisions of the EMS act and Part VII of the Department's regulations.

Comment

   Section 5(b)(13) of the EMS act specifically authorizes the Department to investigate trauma centers and forward the results of its investigation to the Pennsylvania Trauma Systems Foundation (Foundation). The Department should explain its intent for providing that the Department will investigate other matters related to the EMS act and should identify its authority to do so.

Response

   The Department's power to investigate violations of the EMS act is expressly derived from certain provisions of the EMS act and implicitly derived from other provisions of the statute. The Department believes that the reason the Legislature included a specific provision authorizing the Department to investigate trauma centers and share its results with the Foundation is that absent that express grant of authority the remaining language of the statute could not be read to grant that responsibility to the Department. While the Department is given the power to regulate most entities addressed by the EMS act, the express language of the statute dealing with trauma centers gives the Foundation, not the Department, the authority to regulate and set standards for trauma centers. See 35 P. S. § 6926.

   Some of the provisions from which the Department derives its authority to investigate violations of the EMS act are section 2 of the EMS act (35 P. S. § 6922) (legislative intent to assure readily available and coordinated EMS and to maintain an effective and efficient EMS system); section 4(b) of the EMS act (35 P. S. § 6924(b)) (designates the Department as the Commonwealth lead agency for EMS); section 11(j.1) of the EMS act (35 P. S. § 6931(j.1)) (the Department is to investigate possible violations of prehospital personnel and pursue disciplinary action if appropriate); and section 12(l) of the EMS act (the Department is to pursue disciplinary action against ambulance services if they engage in proscribed conduct).

   It is the intent of the Department to investigate complaints against prehospital personnel, as expressly authorized, and to investigate complaints against ambulance services, as implicitly authorized. However, the Department will also investigate complaints against other entities it regulates, such as medical command facilities, receiving facilities, EMS training institutes and continuing education sponsors, to ensure that they are satisfying the statutory requirements and Department regulations adopted under the EMS act which govern their operations. The Department will also conduct preliminary investigations of complaints of unlicensed entities acting as ambulance services and uncertified individuals functioning as prehospital personnel. This conduct is a summary offense under the EMS act. See 35 P. S. §§ 6935 and 6936. The Department will refer information that tends to show unlicensed or uncertified activity to criminal enforcement agencies, or may pursue judicial action to enjoin those activities. These investigations are supported by the statutory language designating the Department as the lead agency for EMS in this Commonwealth, and the legislative intent language that the EMS act operate to assure readily and coordinated EMS, to prevent premature death and reduce suffering and disability, and to maintain and assure an effective and efficient EMS system.

Comment

   This regulation should be revised to assert that the Department will conduct its investigations in conjunction with the regional EMS councils.

Response

   This recommendation is rejected. The Department will conduct most investigations in conjunction with a regional EMS council, but may conduct some investigations on its own. The Department's authority to employ regional EMS councils to assist it in conducting investigations is adequately addressed in §§ 1001.122 and 1001.123 (relating to purpose of regional EMS councils; and responsibilities).

   Section 1001.6 (relating to comprehensive EMS development plan) is amended to provide that the regional EMS development plans will be incorporated into the Statewide EMS development plan. The section is also amended to require public notice and an opportunity for comment before the Department's adoption of a Statewide plan. No comments addressing this section were received. This section is adopted as proposed.

   Section 1001.7 (relating to comprehensive regional EMS development plan) is new. It requires each regional EMS council to develop a regional plan for coordinating and improving the delivery of EMS in the region for which it has been assigned responsibility by the Department. It also requires the regional EMS council to give notice to the public and an opportunity for comment before submitting the plan to the Department for approval.

Comment

   Requiring a regional EMS council to provide public notice and an opportunity for comment on a regional EMS development plan places an excessive burden on the planning process.

Response

   The Department disagrees with the comment. This section is adopted as proposed.

Subchapter B.  Award and Administration of Funding

   The title of this chapter is revised to replace the term ''Contracts'' with ''Funding.'' This change is made because the scope of this chapter is not confined to addressing the distribution of funds through contracts exclusively.

   Section 1001.21 (relating to purpose) describes the purpose of the subchapter on funding. Section 1001.22 (relating to criteria for funding) identifies criteria for the distribution of EMSOF moneys. Section 1001.23 (relating to allocation of funds) identifies some of the factors that are considered in determining the amount of funds to be distributed to eligible recipients. No comments addressing these sections were received. These sections are adopted as proposed, except § 1001.22(a)(10) is revised by inserting ''technician'' and deleting ''service'' in the term ''voluntary rescue service certification program.'' The Department administers a voluntary program for the certification of rescue technicians, not rescue services.

   Section 1001.24 (relating to application for contract) pertains to applications for contracts to plan, initiate, maintain, expand or improve an EMS system. It is amended to clarify that the application process in the section applies only to contracts for these purposes.

Comment

   Since both paragraphs (2) and (3) of the current regulation require applicants for funding to include information about their organizational structure, paragraph (3) may be redundant. Either the term ''organizational structure'' should be removed from paragraph (2) or paragraph (3) should be deleted.

Response

   The Department agrees. The Department has deleted paragraph (3).

   Section 1001.25 (relating to technical assistance) provides that the Department may provide technical assistance to contractors and subcontractors to assist them in carrying out their contracts. It also identifies some of the technical assistance resources the Department may make available.

Comment

   The purpose of the last sentence in subsection (a), which states that ''special consideration shall be given to contractors in rural areas,'' is unclear. The Department should either revise the sentence to clarify its purpose, or delete it.

Response

   The Department agrees that the sentence is unclear. It has revised it to clarify that special consideration will be given to contractors in rural areas to assist them with matters such as recruitment, retention of prehospital personnel, and other matters identified in subsection (a). Special consideration will be extended in recognition that rural areas may lack sufficient manpower and other resources to perform EMS projects unless they receive some additional help.

Other Changes

   The Department has revised subsection (c)(3) to read ''information management resources'' instead of ''management information resources.'' The resources to which the Department intends to refer are those involved in managing information.

   Section 1001.26 (relating to restrictions on contracting) prohibits the Department from contracting with more than one regional EMS council to exercise responsibility for any part of the same EMS region, and provides that a contractor does not have the right to have a contract renewed.

   Section 1001.27 (relating to subcontracting) addresses rights and restrictions on the authority of an entity that enters into a contract with the Department under the EMS act to enter into subcontracts for the performance of contracted duties.

   No comments addressing these sections were received. These sections are adopted as proposed.

   Section 1001.28 (relating to contracts with the Council) is new. It is added to clarify that some of the provisions in the subchapter do not apply to Department contracts with Pennsylvania Emergency Health Services Council (PEHSC). It also provides that the Department will contract with PEHSC to provide it with the funds PEHSC needs to perform the duties imposed upon it by the EMS act, and may contract with PEHSC for it to assist the Department in complying with the EMS act.

Comment

   The Department should not be providing PEHSC with money from Emergency Medical Services Operating Fund (EMSOF).

Response

   This section does not use the term ''EMSOF.'' Nevertheless, in response to the concern asserted, it is noted that an express statutory direction relating to the distribution of EMSOF moneys, added by Act 82, is that some of the moneys be distributed by the Department to PEHSC. See section 14(d) of the EMS act (35 P. S. § 6934(d)).

Subchapter C.  Collection of Data and Information

   Section 1001.41 addresses an ambulance service's responsibility to complete an EMS patient care report and to keep the report confidential. This section has been revised to delete the data elements previously specified. The required data elements will be identified in the EMS patient care report form or in computer software. As discussed previously in responding to a comment pertaining to the proposed definition of ''ambulance call report,'' the data elements are revised from time to time by the Department, in consultation with PEHSC.

   Some of the data identify patient condition and treatment, while other data provide information on how well the EMS system is functioning. This section requires the ambulance service to provide the data solicited by the form. The Department will publish in the Pennsylvania Bulletin a notice specifying the required data elements and which data are to be handled in a confidential manner. Superseding notices will be published as needed. All information contained in the notice will be available on the Department's website.

   This section also requires that certain patient information solicited by the EMS patient care report be reported immediately to a receiving facility. It prescribes the time in which an EMS patient care report is to be completed after termination of services to the patient, and imposes a duty upon an ambulance service to establish a policy prescribing who is to complete the report on behalf of the ambulance service. The Pennsylvania Bulletin notice will designate the data that are to be reported immediately to the receiving facility.

Comment

   The regulation should specify where ambulance services may obtain copies of the required contents and format for the EMS patient care report.

Response

   The Department agrees with this recommendation. Subsection (a) has been revised as previously explained. In addition, it has been revised to relate that paper report forms may be secured from regional EMS councils and that the Department will maintain a list of the software that it has determined to be acceptable. The Department already maintains such a list and encourages software venders to provide the Department with software products they believe should be included on the list so that the Department can evaluate those products and determine if they are acceptable.

Comment

   If the Department chooses to require an ambulance service to complete and submit an EMS patient care report within 24 hours of concluding service, as proposed, the Department should explain the need for the 24-hour requirement and whether there may be exceptions to this reporting standard.

Response

   The completion and submission of an EMS patient care report within a 24-hour time frame is required because patient information, in addition to that which is designated for immediate transmission, needs to be promptly provided to hospital personnel to facilitate the comprehensive care of the patient. Often patients will require care to address problems that were not a priority during the resuscitation phase, but which will impact their quality of life and functionality if not addressed prior to discharge. Hospital stays are increasingly short, decreasing the opportunity for discovery of additional care needs and minimizing the time to coordinate the intervention required to address them. It would be in the patient's best interest if the information would be provided to the hospital immediately, but transmission of the information within 24 hours seems most reasonable when balancing that interest against the burdens imposed upon prehospital personnel.

   The Department may grant exceptions to the 24-hour reporting requirement, but has chosen not to include that statement in the regulation itself. Section 1001.4 provides that the Department may grant a request for an exception to any regulatory standard if the standard does not repeat a statutory requirement. The Department has adopted § 1001.4 to avoid having to include, in several regulations, language stating that exceptions to a standard may be granted.

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