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COMMONWEALTH OF PENNSYLVANIA

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PA Bulletin, Doc. No. 00-1796a

[30 Pa.B. 5363]

[Continued from previous Web Page]

Comment

   The regulation should identify all of the acceptable methods for submitting and transmitting the data in the ambulance call report to the receiving facility.

Response

   The Department agrees that acceptable methods for transmitting the data should be identified in the regulation. However, because of the lack of uniformity in receiving facilities of both equipment that could be used to receive the data and of the security of data received through the equipment, and because of different hospital policies and procedures for maintaining the confidentiality of patient information, the Department is unable to amend the regulation to identify a data-transmission method that would be uniformly acceptable. Therefore, the Department has amended subsection (d) to permit an ambulance service to report the data to a receiving facility in any manner which is acceptable to the receiving facility and which ensures the confidentiality of information which the Department has designated as confidential.

Comment

   The Department should retain in the regulation the list of data the report form will solicit.

Response

   This is not necessary. The report form will change from time to time. Published notices and the form, itself, will identify all information that needs to be reported.

Comment

   If this section is to require an ambulance service to provide essential patient information to the hospital before the ambulance departs from the hospital, the regulation needs to define the information that is essential for immediate transmission.

Response

   As previously explained, the Department will publish a notice in the Pennsylvania Bulletin, and issue superseding notices as necessary, to identify the information that is essential for immediate transmission.

Comment

   The Department should add a section under this subchapter to require an ambulance service to retain a copy of an EMS patient care report for a specified period of time, preferably 7 years from the date of service or 1 year following the age of majority, whichever is later, which is the same period of time during which medical doctors are required to maintain medical records under the State Board of Medicine regulation in 49 Pa. Code § 16.95 (relating to medical records).

Response

   The Department agrees with the recommendation to include a provision requiring ambulance services to retain copies of the EMS patient care report for a specified period of time. The Department has added subsection (f) to require an ambulance service to retain a copy of the record for a minimum of 7 years.

Other Changes

   The Department has revised subsection (a) to specify that the ambulance service is to file a copy of the EMS patient care report within 30 days with the regional EMS council that exercises responsibility for the region in which the responding ambulance is based. Also, wherever the term ''ambulance call report'' appeared in the proposed regulations, the Department has replaced it with ''EMS patient care report.'' This substitution is made throughout the final-form regulations.

   Section 1001.42 (relating to dissemination of information) identifies the circumstances under which an EMS patient care report may be released. This section has been revised to provide that persons who prepare or secure data from an EMS patient care report by virtue of their participation in the Statewide EMS system are required to prohibit access to only those data elements designated as confidential by the Department in the body of the EMS patient care report.

Comment

   The designation of people to whom and circumstances under which the EMS patient care report or confidential information contained in that report may be disclosed should be revised as follows:

   1.  Subsection (a)(3) should permit disclosure ''to the patient or the following authorized persons: the patient's duly appointed attorney-in-fact; court-appointed guardian of the patient's person and/or estate if the patient has been adjudicated as an incapacitated person; the patient's parent or legal guardian if the patient is a minor; the executor/executrix or administrator/administratrix of the patient's estate; or to such other third party as the patient or other authorized person shall direct in a writing signed by the patient or authorized person.''

   2.  Subsection (a)(4) should permit disclosure ''under an order, subpoena or other lawful process of a court of competent jurisdiction.''

   3.  Subsection (a)(7) should be added to authorize disclosure ''to a health care provider to whom responsibility for the patient's care has been transferred or to another health care provider insofar as necessary to facilitate that provider's treatment of the patient.''

Response

   The Department agrees with the focus of this comment and has added language to achieve the intended results. In subsection (a)(3), instead of listing all of the examples identified in the comment, the Department uses the umbrella language ''a person who is authorized to exercise the rights of the patient with respect to securing the information, such as the patient's duly appointed attorney-in-fact.'' This approach avoids the risk that the regulation fails to list a person that should be listed. In subsection (a)(4), the Department uses the term ''order'' as general language, and again provides an example. The example, a subpoena, which is recognized under the Rules of Civil Procedure as an order of the court, is accompanied by language which excludes a subpoena as authorization for release of the information when the information is the type that cannot be released under a subpoena. For example, the Confidentiality of HIV-Related Information Act (35 P. S. §§ 7601--7612) prohibits the release of confidential HIV-related information under a subpoena. Subsection (a)(7) has been added to clarify that the EMS patient care report may be released to a health care provider to whom a patient's medical record may be released under law.

Subchapter D.  Quality Improvement Program

   The title of this subchapter is amended to substitute ''Improvement'' for ''Assurance.'' The term ''quality improvement'' has generally replaced ''quality assurance'' in the health care industry.

   This subchapter is amended to clarify that the quality improvement program operated by the Department and regional EMS councils is to be limited to monitoring and data collection activities. Section 5(b)(10) of the EMS act empowers the Department to establish a quality improvement program only for the purpose of ''monitoring the delivery of [EMS].''

   Section 1001.61 (relating to components) describes the purpose and parameters of the quality improvement program the Department is coordinating for the Statewide EMS system.

Comment

   The terms ''medical care,'' ''prehospital personnel'' and ''providers of EMS,'' which are used in the proposed amendment of this section, need to be defined.

Response

   ''Prehospital personnel'' and ''providers of EMS'' are defined in § 1001.2. ''Medical care'' does not need to be defined. The section makes it clear that the medical care to which it refers is that which is provided ''in the delivery of EMS . . . by prehospital personnel and providers of EMS.''

   Section 1001.62 (relating to regional programs) provides that each regional EMS council shall develop a regional quality improvement program and requires that each program include certain features.

Comment

   A regional EMS council should oversee the process, but not conduct the quality improvement audits itself.

Response

   A regional EMS council will oversee the data collection process. Its review of the quality improvement effort of participants in the EMS system, such as ambulance services, ALS service medical directors, medical command facilities and receiving facilities, will require that it coordinate the data collection process. The process of collecting that data will rarely require a regional EMS council employe to personally visit a provider of EMS.

   Sections 1001.63 and 1001.64 (relating to medical command facilities; and ambulance services), which previously required medical command facilities and ambulance services to participate in the quality improvement program, are replaced with § 1001.65 (relating to cooperation). No comments addressing these sections were received. Sections 1001.63 and 1001.64 are rescinded as proposed.

   Section 1001.65 requires all persons and entities authorized by the Department to participate in the Statewide EMS system to provide the Department and the regional EMS councils with data and reports requested by them to monitor the delivery of EMS as part of quality improvement oversight.

Comment

   The one sentence comprising this section is too long. It should be separated into at least two sentences.

Response

   The Department agrees. The Department has replaced the proposed sentence with two shorter sentences.

Comment

   The subchapter should include a provision requiring medical command facilities to provide ambulance services with patient information to assist the ambulance services in their quality improvement initiatives.

Response

   The Department rejects compelling medical command facilities to engage in this conduct, but encourages them to work with ambulance services to help ambulance services in their quality of care reviews. Patient diagnosis and treatment information secured after the transport of the patient to a receiving facility should be shared on a need-to-know basis exclusively. Otherwise, it should not be disclosed without the patient's consent. However, the medical command facility should provide aggregate data and anecdotal information to ambulance services to assist quality of care reviews conducted by ambulance services.

Subchapter E.  Trauma Centers

   This subchapter, comprised of §§ 1001.81--1001.84, was adopted by the Department under its duty under section 5(b)(12) of the EMS act to integrate trauma centers into the Statewide EMS system. No comments addressing these sections were received. They are adopted as proposed.

Subchapter F.  Requirements for Regional EMS Councils and the Council

   Section 1001.101 (relating to governing body) specifies standards for the governing bodies of PEHSC and regional EMS councils. It is adopted as proposed.

Comment

   The provision that a regional EMS council may be a unit of local government should be retained.

Response

   This recommendation is rejected because this provision is included in § 1001.124 (relating to composition).

   Sections 1001.102 and 1001.103 (relating to council director; and personnel) are deleted. These sections had specified duties of directors of regional EMS councils and PEHSC, and written policies and procedures that are to be in place for both. The rescission is consistent with Executive Order 1996-1. These regulations were burdensome and did not serve a compelling interest. There are also viable nonregulatory alternatives that may be pursued to implement the standards that were included in these regulations if that becomes necessary. If the Department concludes that specific personnel and work policies are required for PEHSC or a regional EMS council to complete a project, the Department may include those terms in the body of the contract covering the project. A few comments were received endorsing the proposed rescission of these sections.

Subchapter G.  Additional Requirements for Regional EMS Councils

   Sections 1001.121, 1001.122 and 1001.124 (relating to designation of regional EMS councils; purpose of regional EMS councils; and composition) specify the criteria the Department will consider in designating regional EMS councils, the responsibility of regional EMS councils to assist the Department in administering the EMS act and Part VII of the Department's regulations, and the types of entities that may serve as regional EMS councils. No comments addressing these sections were received. They are adopted as proposed.

   Section 1001.123 identifies the major responsibilities of regional EMS councils.

Comment

   Proposed paragraph (3) required regional EMS councils to advise PSAPs and political subdivisions of any recommended dispatching criteria that may be developed by the Department, or by the regional EMS council as approved by the Department. Does this pertain to the order in which available EMS resources are to be dispatched, or to the type of EMS resources (ALS or BLS) to be dispatched? Are there any appeal mechanisms if this pertains to the order in which similarly qualified ambulance services are to be dispatched?

Response

   The duty imposed by this subsection applies to both types of dispatching criteria. The Department expects PSAPs to follow Statewide and regional medical treatment protocols in determining whether to dispatch BLS or ALS resources. Regional EMS councils may also recommend medical dispatch protocols. As to the order of dispatch, neither the Department nor regional EMS councils have statutory authority to dictate to PSAPs which ambulance service among similarly licensed services to dispatch first. Consequently, any guidance the Department or regional EMS councils develop in this area would not impose any duty upon PSAPs and political subdivisions and would not be subject to appeal.

Comment

   The last sentence in proposed paragraph (14), which reads ''Recruitment of volunteer expertise available shall be requested when needed,'' does not make sense.

Response

   The Department agrees. It has revised the language to provide that regional EMS councils shall recruit volunteers as needed.

Comment

   Proposed paragraph (20), which stated that one of the functions of a regional EMS council is to perform duties, other than those specifically listed, as deemed appropriate by the Department, should conclude with the language ''regarding the responsibilities of regional EMS councils.''

Response

   The Department agrees with the concern expressed, however it has opted to insert somewhat different language than what was suggested. The Department is authorized to enter into contracts with regional EMS councils ''for the initiation, expansion, maintenance and improvement of [EMS] systems which are in accordance with the Statewide [EMS] development plan.'' See 35 P. S. § 6930(a). This is the language the Department has added to the paragraph, which has been renumbered as paragraph (21).

Comment

   Since the Office of Inspector General of the United States Department of Health and Human Services issued an opinion that the restocking of ambulances by hospitals may constitute illegal remuneration under the Federal antikickback statute, 42 U.S.C.A. § 1320a-7(b), and then later issued opinions that the restocking of ambulances by hospitals through a coordinated system of care might not be a violation, it might enhance the Statewide EMS system to add as an additional responsibility of regional EMS councils, the duty ''to formulate plans, policies and procedures for the restocking of nonreusable ambulance supplies, medications and/or linens by hospitals to whom patients are brought by licensed ambulance services.''

Response

   The Department rejects the recommendation because the Department does not want to direct regional EMS councils to promote a restocking program which the Office of Inspector General of the Department of Health and Human Services may conclude violates the Federal antikickback statute. However, the Department will pursue this matter further with the Federal agency and may revise the regulation in the future to include such a provision.

Other Changes

   Proposed paragraph (18), which referenced a medical command authorization being removed by an ALS ambulance service, has been corrected to reference removal of medical command authorization by the ''ALS service medical director'' for the ambulance service. One comment was received commending inclusion of the requirement in paragraph (18) that regional EMS councils are to notify medical command facilities and ALS service medical directors of an EMT-paramedic who loses medical command authorization. Minor clerical changes have been made to proposed paragraphs (1) and (19).

   The Department received a comment to § 1003.4, that the proposed provisions in that regulation that address a regional EMS council's role in approving physicians as medical command physicians should be removed from that regulation and inserted in this one. The Department has rejected that recommendation for reasons that are explained in the response to that comment under § 1003.4. However, the Department has added a new paragraph (20) to relate that the approval of medical command physicians under § 1003.4(c)(2) is a function of a regional EMS council.

   Section 1001.125 (relating to requirements) deals with matters such as the composition of the regional EMS council when it is a nongovernmental body, and the composition of its advisory council when it is a governmental body. This section is amended to require that if a regional EMS council is a unit of local government it shall have an advisory council representative of the professions and organizations designated in the EMS act's definition of ''emergency medical services council,'' as well as health consumer representation, and that if the regional EMS council is a public or nonprofit organization, its governing body shall satisfy the same representation requirements. One comment questioned inclusion of the word ''major'' in describing certain organizations that should have representation on regional EMS councils. That word was taken directly form the statutory definition, and is retained. The Department received no other comment addressing this regulation.

Subchapter H.  Additional Requirements for the Council

   Sections 1001.141--1001.143 (relating to duties and purpose; meetings and members; and disasters) address requirements for PEHSC in addition to those enumerated in § 1001.101. No comments were received on these sections. The Department has adopted them as proposed.

Subchapter I.  Research in Prehospital Care

   Section 5(b)(3) and (4) of the EMS act contemplate that the Department will permit data collected through the Statewide EMS system to be used for research to identify possible options for improving the system. The Department's planning responsibilities imply that the Department may authorize research to aid it in making planning decisions. This subchapter addresses the procedures for providers of EMS to engage in clinical research investigations or studies that relate to direct patient care in the Statewide EMS system. Section 1001.161 (relating to research) is amended to revise the research proposal review process.

Comment

   The Department should explain why it needs to review research proposals for merit before it refers proposals to PEHSC and regional EMS councils.

Response

   A regional EMS council may not be aware of research the Department has approved or initiated in different parts of this Commonwealth. Based upon the type of research being conducted, the Department may not want to have that research duplicated in another part of this Commonwealth, or may want to recommend a modification of the proposal to supplement existing research. Also, both regional EMS councils and PEHSC receive EMSOF moneys through the Department to pay for their reviews of research proposals. The Department may eliminate the wasteful allocation of the resources of both entities if it concludes that it is clearly not worthwhile to pursue the proposed research. The Commonwealth Emergency Medical Director will be involved in the Department's preliminary review of the research proposal. One change that is made to this section is that the last sentence in subsection (b) is revised to clarify that the review of a research proposal by a regional EMS council and PEHSC is to begin after the Department requests them to proceed with the review.

Chapter 1003.  Personnel

   This chapter addresses qualifications and responsibilities of persons involved in the Statewide EMS system. It also addresses the disciplinary process for prehospital personnel, the medical command authorization process, continuing education requirements and options and the accreditation standards for sponsors of continuing education.

Subchapter A.  Administrative and Supervisory EMS Personnel

   Section 1003.1 (relating to Commonwealth Emergency Medical Director) specifies the duties of the Commonwealth Emergency Medical Director.

Comment

   Proposed subsection (a)(5) lacks clarity due to its length and the subjects covered. The regulation would be clearer if the subject matter is addressed in two paragraphs.

Response

   The Department agrees that proposed subsection (a)(5) could be written to provide greater clarity. The proposed paragraph deals with the Commonwealth Emergency Medical Director's role relative to regional medical treatment protocols and patient transfer protocols. However, not addressed is the Commonwealth Emergency Medical Director's role relative to the Statewide BLS medical treatment protocols. The Department has corrected that oversight by addressing the Commonwealth Emergency Medical Director's role relative to regional medical treatment protocols in paragraph (5), the Statewide BLS medical treatment protocols in paragraph (6) and patient transfer protocols in paragraph (7). The remaining paragraphs are renumbered.

Other Changes

   As discussed in response to a comment under § 1001.161 (relating to research), the Commonwealth Emergency Medical Director will be involved in the review of research proposals pertaining to the Statewide EMS system. That role is set forth in subsection (a)(11).

   As the Department has eliminated all references to ''base station'' in the regulations, the Department has revised subsection (b)(3) so that it states that the Commonwealth Emergency Medical Director will need to have knowledge regarding ''medical command,'' rather than ''base station'' direction of prehospital personnel. No other revisions have been made to the proposal.

   Section 1003.2 (relating to regional EMS medical director) specifies the duties of regional EMS medical directors. It is revised to clarify that the regional EMS medical director does not function independent of the regional EMS council except when acting upon appeals from adverse medical command authorization decisions. That is the only function the EMS act expressly assigns to a regional EMS medical director. See 35 P. S. § 6931(d)(2)(iv) and (e.1)((4).

Comment

   Proposed subsection (a)(1) and (3)--(6) state that the regional EMS medical director's duty is to ''assist'' the regional EMS council in performing certain functions. It is not clear how the regional EMS medical director will provide the assistance. These paragraphs should be made clearer regarding how the regional EMS medical director is to provide the assistance.

Response

   The Department rejects the recommendation. As stated in the Preamble to the proposed regulations, the Department wants to avoid micromanaging the regional EMS councils, some of which are units of county government. These paragraphs are designed to apprise both regional EMS councils and their medical directors that the Department expects the regional EMS medical directors to be involved in certain types of activities of the regional EMS councils. How that involvement is structured is left up to the regional EMS councils. If the Department deems it necessary to impose certain requirements on that relationship for the purpose of performing specific work, it will include those requirements in the contracts it negotiates with the regional EMS councils. None of the paragraphs mentioned in the comment include responsibilities imposed upon regional EMS medical directors by the EMS act.

Changes

   Subsection (b) is revised by the rescission of paragraph (2), which provided that the Secretary could waive the board certification in emergency medicine requirement for a regional EMS medical director upon request of a regional EMS council. This provision is not needed in light of the removal of the board certification in emergency medicine criterion.

   With the rescission of paragraph (2), there is no need for the first paragraph under subsection (b) to be preceded by the paragraph (1) designation. The Department has removed that designation and has revised subsection (b) by redesignating the remaining provisions in the subsection.

   Former subsection (b)(1)(v) included board certification in emergency medicine as a criterion for qualifying as a regional EMS medical director. In that provision, now subsection (b)(5), the Department has replaced the board certification in emergency medicine criterion with the requirement that the physician shall have either completed 3 years in a residency program in emergency medicine or have served as a medical command physician in this Commonwealth prior to October 14, 2000. The reason for this change was previously discussed in addressing comments pertaining to the definition of ''board certification.'' Additional explanation is provided in the response to the first comment discussed under the next section.

   In subsection (b)(3), the term ''base station'' is replaced with ''medical command'' and ''emergency units'' is replaced with ''personnel.''

   Section 1003.3 (relating to medical command facility medical director) specifies the qualifications and responsibilities of a medical command facility medical director.

Comment

   As the regulation is proposed, a physician who is not certified in emergency medicine by a medical specialty certification board recognized by the ABMS or the AOA cannot qualify as a medical command physician.

Response

   This is not accurate either as subsection (b)(1)(ii) (now subsection (b)(2)) was proposed or as it has been finally adopted. Certification in emergency medicine from a board recognized by one of the two entities mentioned in the proposed definition of ''board certification'' would not have been required if the physician had received board certification in surgery, internal medicine, family medicine, pediatrics or anesthesiology. Some physicians who had received the BCEM certification, which was not previously accepted by the Department as a board certification in emergency medicine, are functioning as medical command facility medical directors currently. Each of them has a board certification in one of the medical specialties identified in subsection (b)(2)(iii).

   Notwithstanding the subsection (b)(2)(iii) alternative criterion for becoming a medical command facility medical director, the Department has decided to remove board certification in emergency medicine as one alternative criterion for qualifying as a medical command facility medical director, and to replace it with two alternative qualifying criteria. Those alternatives are that the physician shall have successfully completed 3 years in a residency program in emergency medicine or have served as a medical command physician in this Commonwealth prior to October 1, 2000.

   The Department has concluded that completion of a 3-year emergency medicine residency or satisfaction of subsection (b)(2)(iii) should be the entry alternatives available to physicians who seek to become a medical command facility medical director in this Commonwealth for the first time. Consequently, it has revised subsection (b)(2) to require that any physician who is not already a medical command physician will need to satisfy one of these standards.

   The Department recognizes that some physicians who are already in the system as medical command physicians have not met the standards in subsection (b)(2)(i), or even (b)(2)(iii) as it has been modified. While the Department is not fully comfortable with the qualifications those physicians had to demonstrate to qualify as medical command physicians, as it now believes that those qualifications need to be upgraded or revised, it has had to weigh that discomfort against the chaos that would occur if the Department were to now disqualify as medical command physicians and medical command facility medical directors many physicians who have functioned in those capacities in the EMS system for some time. The Department has concluded that the proper balance is achieved if those physicians who are already functioning in the EMS system as medical command physicians and medical command facility medical directors are permitted to continue to function in those positions without having met either the subsection (b)(2)(i) or (iii) standards. Also considered was the ''on-the-job'' experience these physicians have accumulated. Consequently, the Department has made those standards applicable to only those physicians who have not served as a medical command physician prior to October 14, 2000.

Comment

   Proposed subsection (b)(1)(ii) would substantially duplicate proposed § 1003.4(b)(2). Subsection (b)(1)(i) would require a medical command facility medical director to be a medical command physician. The minimum qualifications for a medical command physician are found in proposed § 1003.4(b). Proposed subsection (b)(1)(ii) should be amended to specify only qualifications in addition to the minimum qualifications for a medical command physician.

Response

   Proposed subsection (b)(1)(ii) (now subsection (b)(2)) cannot be amended to specify only qualifications in addition to the minimum qualifications for a medical command physician, because there is more than one set of criteria by which a physician may qualify as a medical command physician. Proposed § 1003.4(b)(2)(ii) proposed alternative criteria to qualify as a medical command physician. Likewise, subsection (b)(2) includes alternative criteria by which a physician may qualify as a medical command facility medical director. Moreover, the alternatives in the two provisions are not quite the same.

   However, the Department concludes that proposed subsection (b)(1)(ii) lacked clarity and has revised subsection (b)(2) to address that concern. It has also divided subsection (b)(2) into subparagraphs (i)--(iii) to identify the three alternative qualifying criteria.

Comment

   Does a medical command facility medical director need to take the ACLS course every 2 years even if there is no change in the course?

Response

   Yes, if the physician qualifies under subsection (b)(2)(iii) rather than subsection (b)(2)(i) or (ii).

Other Changes

   Proposed subsection (b)(2) is repealed for the same reason that § 1003.2(b)(2) is repealed. This repeal causes proposed subsection (b)(1)(i)--(vi), to be renumbered as subsection (b)(1)--(6).

   Proposed subsection (b)(1)(iv) (now subsection (b)(4))) is reworded from requiring ''experience in base station direction of prehospital emergency units'' to requiring ''experience in providing medical command direction to prehospital personnel.''

   Section 1003.4 specifies the qualifications and responsibilities of a medical command physician.

Comment

   As proposed, a physician who does not have a board certification in emergency medicine cannot qualify as a medical command physician.

Response

   This understanding is not accurate, but the issue is now moot, as board certification in emergency medicine has not been retained as a criterion for qualifying as a medical command physician. Both as proposed and adopted, this section permits a physician without a board certification in emergency medicine, or any other board certification, to qualify as a medical command physician. This is no different than the historical practice.

Comment

   Section 1001.4 does not appear to apply to granting exceptions to the criteria in the proposed section for qualifying as a medical command physician, particularly the board certification criterion.

Response

   This observation is not accurate. None of the criteria to qualify as a medical command physician are directly imposed by the EMS act. Therefore, the Department may grant exceptions to any of the criteria in accordance with § 1001.4. The same is true for the criteria to qualify as a medical command facility medical director in § 1003.3. The Department may grant an exception to the board certification criterion in § 1003.3(b)(2)(iii) even though it is already presented in the regulation as an alternative to other criteria.

Comment

   Proposed subsection (b)(2) concludes with the phrase ''or other programs determined by the Department to meet or exceed the standards of those programs.'' It is not clear what other programs would meet or exceed the standards of board certification in emergency medicine, or whether that language even applies to the board certification in emergency medicine. The Department should explain what other programs will meet or exceed the standard of board certification in emergency medicine and clarify which programs need to be taken only once.

Response

   This comment illustrates that proposed subsection (b)(2) was not clearly written. The Department did not intend to have the previously quoted language apply to the proposed board certification in emergency medicine criterion. It has redrafted paragraph (2) by dividing it into subparagraphs (i)--(iii). The previously quoted language now appears only in subsection (b)(2)(iii). The language has been revised to identify those programs that need to be taken only once.

   The language pertaining to meeting or exceeding the standards of the programs is also included in this subparagraph. Because of the nature of the courses involved, many programs may exist or be developed which duplicate, or include as a component, the subject matter contained in these courses. If these programs are brought to the Department's attention, the Department will maintain a record of them. Physicians seeking to qualify as a medical command physician, who had not completed a course specified in subsection (b)(2)(iii), would be approved without having to go through the § 1001.4 process if they completed one of these programs.

Comment

   The Department should explain the effect of subsection (b)(2) on existing medical command physicians and those who require medical command physician status for their positions who are not board certified, and should also explain the effect on the EMS systems that currently employ medical command physicians who are not board certified.

Response

   Subsection (b)(2) will not significantly impact physicians who are or seek to become medical command physicians. Previously, physicians did not require board certification in emergency medicine to become medical command physicians. There have been regulatory alternatives to the board certification criterion. That has not changed with respect to the new standard of having completed 3 years in an emergency medicine residency program.

   Physicians who had received no board certification in emergency medicine had been required to be currently certified in advanced cardiac life support (ACLS) and advanced trauma life support (ATLS). Maintaining certification requires repeated completion of these courses. These standards are revised to require the physician to have taken or taught an ACLS course within the preceding 2 years, and to have completed at least once the ATLS course, and either the advanced pediatric life support (APLS) course or the pediatric advanced life support (PALS) course.

   The criteria for becoming a medical command physician have been revised, but are no more stringent or burdensome under this regulation than they have been. Physicians who are medical command physicians on October 14, 2000, will be able to continue to serve as medical command physicians. Physicians who have not previously served as medical command physicians in this Commonwealth will be able to serve in that capacity by satisfying the criteria in subsection (b)(2)(i) or (iii). No comment was received contending that those standards in subsection (b)(2)(iii) are too burdensome. One comment was received supporting the changes.

   As to the effect on EMS systems that currently employ medical command physicians who are not board certified in emergency medicine, there should be no impact since those physicians are grandfathered into the systems under subsection (b)(2)(ii).

Comment

   Proposed subsection (c)(2) and (3), which provide parameters for a regional EMS council to employ in approving medical command physicians, should be moved to Chapter 1001, Subchapter G (relating to additional requirements for regional EMS councils). Proposed subsection (d)(1) and (2) set forth requirements for medical command facilities and regional EMS councils, not the medical command physician, and should be moved to Chapter 1001, Subchapter G and Chapter 1009 (relating to medical command facilities).

Response

   The Department prefers to address the subsection (c) mechanisms for approving medical command physicians in the specific section of the regulations that pertains to medical command physicians. The Department believes that most people who are interested in ascertaining how medical command physicians are approved will look first to this section rather than to a section that addresses regional EMS council responsibilities in a general fashion or that pertains to medical command facilities.

   Subsection (d) pertains to notifications that medical command facilities and regional EMS councils are required to provide pertaining to medical command physicians. Both relate to the approval of medical command physicians. Again, this is the reason for the retention in this section of the subsection (d) provisions. In the first instance, a medical command facility is required to alert a regional EMS council that its medical command physicians intend to provide medical command in the region. Those physicians will require the regional EMS council's approval as medical command physicians unless they will only be giving medical command in that region to patients whose treatment originates in a region in which they are already approved. The second provision, providing for a regional EMS council to notify the Department of its approval of a medical command physician, completes the approval loop. However, to facilitate realization that these provisions are contained in this section, the Department has revised the subsection (d) heading to read ''Notice requirements of medical command facility and regional EMS council.''

Comment

   Proposed subsection (c)(2)(ii) would permit a regional EMS council to approve a physician as a medical command physician if the physician completed the voluntary medical command certification program administered by the Department, instead of establishing to the regional EMS council that the physician satisfied the criteria in proposed subsection (b)(1)--(6). The Department should explain for which of the criteria in proposed subsection (b)(1)--(6) completion of the voluntary program would serve as a substitute.

Response

   The Department administers and will continue to administer the voluntary program so that the Department determines through the program that all of the criteria in subsection (b)(1)--(6) are satisfied. Virtually all physicians who secure approval to function as a medical command physician do so by completing the voluntary medical command physician certification program administered by the Department.

Comment

   Proposed subsection (c)(3) requires a physician seeking approval as a medical command physician to establish that he will be working under the auspices of a medical command facility. The Department should revise the proposal to state how the physician is to demonstrate compliance with this requirement.

Response

   The Department agrees with this comment. The Department considers a medical command physician to function under the auspices of a medical command facility when the physician has an arrangement with the facility to provide medical command on its behalf while on duty for the facility, under the direction of its medical director, and under its policies and procedures. It has revised subsection (c)(3) to include this clarification.

Comment

   Proposed subsection (c)(3)(i) permits a regional EMS council to grant a waiver to Department recognition of a facility as a medical command facility. The Department should explain why this waiver is permitted.

Response

   The topic of ''recognition'' of a medical command facility can be somewhat confusing. This is because the EMS act does not require a facility to secure recognition from the Department to function as a medical command facility. Seeking recognition from the Department is optional. The Department believes that this is a weakness of the EMS act. Nevertheless, without securing that recognition the medical command facility would not enjoy the limited civil liability protection afforded by section 11(j)(4) of the EMS act. Consequently, to date, all medical command facilities that operate in this Commonwealth have secured recognition from the Department.

   No waiver to Department ''recognition'' of a medical command facility is authorized by the regulation. The regulation does not permit regional EMS councils to grant ''recognition'' status to medical command facilities.

   This section authorizes a regional EMS council to determine whether a facility meets Department-prescribed standards for a medical command facility in the course of the regional EMS council determining whether a physician affiliated with that facility should be approved as a medical command physician. Subsection (b)(2) provides that to be approved as a medical command physician a physician must function under the auspices of a medical command facility. The regional EMS council needs to determine whether the physician seeking approval from it as a medical command physician satisfies that requirement. To make that determination, the regional EMS council must determine whether the facility identified by the physician is, in fact, a medical command facility. To qualify as a medical command facility, the facility must satisfy all of the requirements for a medical command facility which have been prescribed by the Department in § 1009.1 (relating to operational criteria). Therefore, if the facility the physician identifies has not received Department recognition as a medical command facility, it becomes incumbent upon the regional EMS council to determine whether the facility has met the criteria prescribed by the Department.

Comment

   The proposal should be modified so that it permits a physician to meet the ACLS course requirement by teaching the course. Also, the regulation should be modified to not require the physician to complete the ACLS course if the physician has completed a course providing more comprehensive ACLS training.

Response

   The Department agrees. It has revised the text of subsection (b)(2)(iii) accordingly.

Comment

   Contrary to the proposal, medical command physicians should not be required to provide medical command to prehospital personnel from other parts of this Commonwealth. Those prehospital personnel should be required to contact a medical command physician operating in the EMS region in which they normally function.

Response

   The recommendation is rejected. The Department has received complaints from ambulance services that transport initially stable patients over long distances, that when emergencies arise during transport, and communication with a customary medical command physician cannot be established, medical command physicians unfamiliar with the ambulance service and its prehospital personnel will sometimes decline to provide necessary medical command. This cannot be permitted. Prehospital personnel need to have access to a medical command physician at all times. The recommendation is impractical to implement based upon current communications technology and the costs associated with securing long distance access to medical command physicians.

Other Changes

   Errors occurred in proposed subsection (b)(3) in labeling the years of residency training referenced in that paragraph. The Department has corrected the errors by inserting the term ''graduate'' where appropriate. The Department has also removed the term ''base station'' in subsection (b)(6).

   Section 1003.5 (relating to ALS service medical director) specifies the criteria a physician needs to satisfy to become an ALS service medical director and the responsibilities of an ALS service medical director.

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