[41 Pa.B. 5865]
[Saturday, October 29, 2011]
[Continued from previous Web Page]
Subchapter B. AWARD AND ADMINISTRATION OF EMSOF FUNDING Sec.
1021.21. Purpose. 1021.22. Entities eligible to receive EMSOF funds through contracts or grants. 1021.23. Award of contract or grant to a regional EMS council. 1021.24. Use of EMSOF funding by a regional EMS council. 1021.25. Allocation of EMSOF funds to regional EMS councils. 1021.26. Technical assistance. 1021.27. Subcontracting. 1021.28. Contracts and grants with the Advisory Board. § 1021.21. Purpose.
This subchapter implements sections 8112 and 8153 of the act (relating to contracts and grants; and support of emergency medical services), which set forth the standards and criteria governing the award and administration of contracts and grants under the act that are funded by EMSOF funds.
§ 1021.22. Entities eligible to receive EMSOF funds through contracts or grants.
The following entities are eligible to directly receive EMSOF funds from the Department through contracts and grants:
(1) Regional EMS councils.
(2) The Advisory Board.
(3) Other entities to assist the Department in complying with the act.
§ 1021.23. Award of contract or grant to a regional EMS council.
(a) EMSOF funds shall be used by a regional EMS council to plan, initiate, maintain, expand or improve a regional EMS system in a manner that is consistent with the Statewide and relevant regional EMS system plans. To apply for a contract or grant for these purposes, a regional EMS council or entity that seeks to become a regional EMS council shall submit to the Department a contract or grant application on a form prescribed by the Department in which the applicant:
(1) Provides information on the organizational structure of the regional EMS council and its provisions to ensure representation of appropriate entities.
(2) Addresses planning, maintenance and improvement of the applicable regional EMS system.
(3) Demonstrates the qualifications of the applicant to plan, maintain and improve a regional EMS system.
(b) To be awarded a contract or grant to serve as a regional EMS council, the applicant shall demonstrate to the Department's satisfaction that it has:
(1) An appropriate organizational structure.
(2) Made provision for the representation of appropriate entities to meet the requirements in §§ 1021.102 and 1021.103 (relating to structure of regional EMS councils; and governing body).
(3) The qualifications and commitment to plan, maintain and improve a regional EMS system.
(c) Upon expiration of a contract or grant with a regional EMS council, the Department, without undertaking a competitive bidding process, may enter into a new contract or grant with the same entity for that entity to continue to serve as a regional EMS council, if that entity in carrying out the prior contract or grant demonstrated its ability and commitment to the Department's satisfaction to plan, maintain and improve the regional EMS system consistent with the terms of the prior contract or grant.
§ 1021.24. Use of EMSOF funding by a regional EMS council.
(a) A regional EMS council may receive EMSOF funding from the Department for the following purposes:
(1) Providing public education, information, health promotion and prevention programs regarding EMS, including:
(i) Public education programs, including CPR, first aid, instruction regarding 911 systems and how to access EMS systems.
(ii) Public information programs, including passenger and driver safety, specialty services and EMS system awareness programs.
(iii) Health promotion programs, including wellness of EMS workforce and EMS safety programs that promote a culture of safe practices among EMS providers.
(iv) Prevention programs, including passenger restraint systems, prudent heart living and general health awareness, and safety practices to prevent errors in patient care and injuries to EMS providers.
(2) Purchasing ambulances, other EMS vehicles, medical equipment and rescue equipment which enables or enhances the delivery of EMS.
(i) Ambulances and other EMS vehicles will be considered for funding if the funds will be used for the initial acquisition of vehicles or parts, or the addition or replacement of existing vehicles or parts, by an EMS agency or an entity that qualifies for initial licensure as an EMS agency.
(ii) Medical equipment will be considered for funding if the funds will be used to purchase medical equipment for EMS agencies.
(iii) Rescue equipment will be considered for funding if the funds will be used to purchase rescue equipment for EMS agencies or rescue services recognized by the Department or the State Fire Commissioner.
(3) Conducting and ensuring the reasonable availability of training and testing programs for EMS providers. Priority consideration with respect to training will be given to training programs leading to the certification of EMS providers and the continuing education of EMS providers.
(4) Inspecting and investigating EMS agencies, educational institutes and medical facilities, and conducting other inspections and investigations to assist the Department in carrying out its regulatory responsibilities under the act.
(5) Purchasing communications equipment and services, including medical command communications equipment, and alerting equipment for EMS purposes.
(6) Purchasing equipment for emergency departments, if the equipment is used or intended to be used in equipment exchange programs with EMS agencies. The equipment purchased shall be of a type used by EMS agencies in the EMS provided to patients in a prehospital or interhospital setting. It shall be the type of equipment that can be easily or safely removed from the patient upon arrival or during treatment at a receiving facility.
(7) Maintaining and operating a regional EMS council. Items eligible for funding include:
(i) Salaries, wages and benefits of staff.
(ii) Travel.
(iii) Equipment and supplies.
(iv) Leasing office space.
(v) Other costs incidental to the conduct of the business of a regional EMS council which are found by the Department to be necessary and appropriate.
(8) Collecting and analyzing data necessary to evaluate the effectiveness of EMS systems in providing EMS and to administer quality improvement programs. These costs may include the processing of both prehospital and hospital data and include:
(i) Data collection.
(ii) Data entry.
(iii) Data processing of information.
(iv) Data analysis and evaluation.
(v) Data interpretation and dissemination.
(9) Facilitating the merger of EMS agencies or assisting an EMS agency to acquire another EMS agency when the Department determines circumstances exist to the extent that the transaction and financial assistance are needed to serve the public interest.
(10) Recruitment and retention of EMS providers by EMS agencies.
(11) Other costs determined by the Department to be appropriate and necessary for the implementation of a comprehensive regional EMS system.
(b) The Department will set forth additional priorities for funding on a yearly basis in a notice published in the Pennsylvania Bulletin.
(c) Funds appropriated to the Department from the EMSOF will not be made available for the following:
(1) Acquisition, construction or rehabilitation of facilities or buildings, except renovation as may be necessary for the implementation or modification of 911 and EMS communication systems.
(2) Purchase of hospital equipment, other than communications equipment for medical command and receiving facilities, unless the equipment is used or intended to be used in an equipment exchange program with EMS agencies.
(3) Maintenance of ambulances, other EMS vehicles and equipment.
(4) Costs deemed by the Department as inappropriate for carrying out the purposes of the act.
(5) Costs which are normally borne by patients, except for extraordinary costs as determined by the Department.
(d) As approved by the Department, a regional EMS council may make purchases and other expenditures of funds on behalf of EMS agencies, recognized rescue services, accredited educational institutes and medical command facilities for cost-savings purposes. The Department may distribute funds to these entities to make these purchases and other expenditures of funds.
(e) The Department, by contract, grant or notice published in the Pennsylvania Bulletin, may require a regional EMS council or entity to which a regional EMS council distributes funds to provide matching funds in specified percentages as a condition for receiving EMSOF funds.
§ 1021.25. Allocation of EMSOF funds to regional EMS councils.
The Department will consider the following factors in determining the amount of EMSOF funding regional EMS councils receive:
(1) The total amount of funds available.
(2) Conformity of the application for funding to the Statewide EMS System Plan.
(3) Financial need of the regional EMS system.
(4) Funds available to the regional EMS council for the purpose in the application for funding, including non-State contributions, Federal grants or Federal contracts pertaining to EMS. Non-State contributions include cash and in-kind services provided to the contractor or toward the operation of a regional EMS system by private, public or government entities, including the Federal government.
(5) Geographic area.
(6) Population of the geographic area served by the applicant.
(7) Special rural needs of the geographic area served by the applicant.
(8) Potential duplication of services.
(9) Priorities of the Department.
(10) Other factors set forth by the Department in a notice published in the Pennsylvania Bulletin.
§ 1021.26. Technical assistance.
(a) Regional EMS councils that obtain contracts or grants from the Department may request technical assistance from the Department, if necessary, for the purpose of carrying out their contracts or grants. Special consideration will be given to regional EMS councils that serve rural areas to assist with matters such as recruitment, retention of EMS providers, EMS agency management and the use of EMS agency equipment.
(b) Technical assistance from the Department may also be available to subcontractors or other recipients of funds from the regional EMS council when technical assistance resources are not available from the regional EMS council.
(c) Examples of technical assistance resources include:
(1) Communications assistance.
(2) Public education resources.
(3) Information management sources.
§ 1021.27. Subcontracting.
(a) A regional EMS council may receive the Department's written approval to subcontract certain of its duties to other entities as deemed necessary and appropriate for the proper execution of the contract or grant with the Department.
(b) A regional EMS council may not execute a subcontract until the Department determines in writing that the subcontract is necessary and appropriate.
§ 1021.28. Contracts and grants with the Advisory Board.
Sections 1021.22—1021.27 do not apply to contracts or grants between the Department and the Advisory Board. The Department will enter into a contract or grant with the Advisory Board to perform the services the Advisory Board is required to perform under the act. The Department may contract with the Advisory Board for it to assist the Department in complying with other provisions of the act.
Subchapter C. COLLECTION OF DATA AND INFORMATION Sec.
1021.41. EMS patient care reports. 1021.42. Dissemination of information. 1021.43. Vendors of EMS patient care reports. § 1021.41. EMS patient care reports.
(a) EMS agencies shall collect, maintain and electronically report complete, accurate and reliable patient data and other information as solicited on the EMS PCR form for calls for assistance in the format prescribed by the Department. An EMS agency shall file the report for calls to which it responds that result in EMS being provided. The report shall be made by completing an EMS PCR within the time prescribed by the EMS agency's written policies, no later than 72 hours after the EMS agency concludes patient care, and then submitting it, within 30 days, to the regional EMS council that is assigned responsibilities for the region in which the EMS agency initially encounters the patient. An entity located out-of-State, but licensed as an EMS agency by the Department, shall file its EMS PCRs with the regional EMS council with which it has been directed to file its EMS PCRs by the Department. The Department will publish a list of the data elements and the form specifications for the EMS PCR form in a notice in the Pennsylvania Bulletin and on the Department's web site. The reporting shall conform to the requirements in the notice published in the Pennsylvania Bulletin. The Department will maintain a list of software it has determined to satisfy the requirements for electronic reporting.
(b) When an EMS provider relinquishes primary responsibility for the care of a patient to another EMS provider, the EMS provider relinquishing that responsibility shall provide the other EMS provider with the patient information that has been collected.
(c) 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 other means by which information is recorded report to the individual at the receiving facility assuming responsibility for the patient, the patient information that is essential for immediate transmission for patient care. The Department will publish a notice in the Pennsylvania Bulletin specifying the types of patient information that are essential for patient care. The EMS agency shall provide the completed EMS PCR to the receiving facility to which the patient was transported within 72 hours after the EMS agency concluded patient care. Upon request of any other facility that subsequently provides health care services to the patient related to the reason the patient was transported to the original receiving facility, the EMS agency shall provide the completed EMS PCR to that facility within 24 hours of the request or within 72 hours after the EMS agency concluded patient care, whichever is later. The EMS agency shall submit the data to the facility in a mutually acceptable manner to the facility and the EMS agency which ensures the confidentiality of information in the EMS PCR.
(d) An EMS agency shall have a policy for designating which member of its responding crew is responsible for completing an EMS PCR. The designated EMS provider shall ensure that the EMS PCR is accurate and complete and completed within the time prescribed by the EMS agency under subsection (a). When a patient is transported to a receiving facility, an EMS provider of the EMS agency having primary responsibility for the patient shall also ensure that before the ambulance departs from the receiving facility essential patient information is reported to the receiving facility as required under subsection (c).
(e) The EMS agency shall retain a copy of the EMS PCR for a minimum of 7 years.
§ 1021.42. Dissemination of information.
(a) A person who collects, has access to or knowledge of information collected under § 1021.41 (relating to EMS patient care reports), by virtue of that person's participation in the Statewide EMS system, may not provide the EMS PCR, or disclose the information contained in the report or a report or record thereof, except:
(1) To another person who by virtue of that person's office as an employee of the Department or a regional EMS council is entitled to obtain the information.
(2) For research or EMS planning purposes approved by the Department, subject to strict supervision by the Department to ensure that the use of the data is limited to the specific research or planning and that appropriate measures are taken to protect patient confidentiality.
(3) To the patient who is the subject of the report or to a person who is authorized to exercise the rights of the patient with respect to securing the information, such as a person appointed as the patient's health care agent under a health care power of attorney.
(4) Under an order of a court of competent jurisdiction, including a subpoena when it constitutes a court order, except when the information is of a nature that disclosure under a subpoena is not authorized by law.
(5) For the purpose of quality improvement or peer review activities, with strict attention to patient confidentiality.
(6) For the purpose of data entry/retrieval and billing, with strict attention to patient confidentiality.
(7) As authorized under § 1021.41.
(8) To a health care provider to whom a patient's medical record may be released under law.
(b) The Department or a regional EMS council may disseminate nonconfidential, statistical data collected from EMS PCRs to EMS agencies and other participants in the Statewide EMS system for improvement of services.
§ 1021.43. Vendors of EMS patient care reports.
(a) An EMS agency shall submit EMS PCRs as required under § 1021.41 (relating to EMS patient care reports) by using only a software program approved by the Department.
(b) A vendor may not sell or otherwise provide or offer reporting forms or software marketed as appropriate for use in making EMS PCRs unless the vendor submits the product to the Department for review and receives the Department's approval. This also applies to a substantive modification the vendor makes to the reporting form or software. The vendor shall apprise the Department of the modification before marketing the modified form or software regardless of whether the vendor considers the modification to be substantive. EMS agencies may ascertain which vendor products have been approved by the Department under this subsection by contacting the Bureau.
(c) If the Department makes changes to the minimum data elements of the EMS PCR, the Department will publish a notice of the changes in the Pennsylvania Bulletin. The effective date of the changes will not be less than 60 days after publication of the notice.
(d) After publication of the changes, a vendor may not market as appropriate for making EMS PCRs a product that had been approved by the Department prior to the Department publishing the notice of changes, unless the vendor clearly discloses that the forms or software were approved prior to the publication of the changes and may only be used to make EMS PCRs until the changes go into effect.
(e) A vendor may store EMS PCR data on its server for data entry or processing purposes arranged by an EMS agency or a regional EMS council to facilitate the transmission of EMS PCR information among the EMS agency, a receiving facility and the regional EMS council, but may not transmit or provide access to that data to any other entity, except the Department, and may not use the data for any other purpose.
Subchapter D. QUALITY IMPROVEMENT AND PEER REVIEW Sec.
1021.61. Components of Statewide quality improvement program. 1021.62. Regional quality improvement programs. 1021.63. Peer review. 1021.64. Cooperation. § 1021.61. Components of Statewide quality improvement program.
(a) The Department, in conjunction with the Advisory Board, will identify the necessary components for a Statewide EMS quality improvement program for the Statewide EMS system. The Statewide EMS quality improvement program shall be operated to monitor the delivery of EMS.
(b) The Department will develop and update a Statewide EMS Quality Improvement Plan in which it will establish goals and reporting thresholds.
§ 1021.62. Regional quality improvement programs.
A regional EMS council, after considering input from participants in and persons served by the regional EMS system, shall develop, update and implement a regional EMS quality improvement program to monitor the delivery of EMS, which addresses, at a minimum, the quality improvement components identified by the Department. A regional EMS council quality improvement program shall:
(1) Conduct quality improvement audits of the regional EMS system including reviewing the quality improvement activities conducted by the EMS agency medical directors and medical command facilities within the region.
(2) Have a regional quality improvement committee that, in conjunction with the regional medical advisory committee, shall recommend to the regional EMS council ways to improve the delivery of EMS within the region based upon State and regional goals.
(3) Develop and implement a regional EMS quality improvement plan to assess the EMS system in the region.
(4) Investigate complaints concerning the quality of care rendered and forward recommendations and findings to the Department.
(5) Submit to the Department reports as prescribed by the Department.
§ 1021.63. Peer review.
(a) Persons subject to peer review. Peer review under this section may be conducted of EMS providers, EMS agency medical directors and medical command physicians.
(b) Purpose. The purpose of peer review conducted under this section is to evaluate the quality and efficiency of services performed under this part by EMS providers, EMS agency medical directors and medical command physicians. This includes reviews to:
(1) Evaluate and improve the quality of EMS rendered.
(2) Determine whether the direction and supervision of EMS providers was in accordance with accepted standards.
(3) Determine whether the EMS provided or not provided was in accordance with accepted standards of care.
(c) Composition of peer review committee. A peer review committee established under this section may include health care providers such as EMS providers, EMS agency medical directors and other physicians, nurses, physician assistants, EMS agency managers and administrators, hospital personnel with expertise in quality assurance and PSAP dispatchers and administrators.
(d) Proceedings and records of a peer review committee. The proceedings and records of a peer review committee conducted under this section have the same protections from discovery and introduction into evidence in civil proceedings as they would under the Peer Review Protection Act (63 P. S. §§ 425.1—425.4). A person who attends a meeting of a peer review committee has the same right as a person who attends a meeting of a review organization under the Peer Review Protection Act with respect to not testifying in a civil action as to evidence or other matters produced or presented during the peer review proceeding or as to findings, recommendations, evaluations opinions or other actions of the peer review committee or other records thereof. These protections do not apply to records that are reviewed in peer review, but were not created for the sole purpose of being reviewed in a peer review proceeding. A person who testifies before a peer review committee or who is a member of a peer review committee is not protected from testifying as to matters within that person's knowledge, except as to that person's testimony before the peer review committee, matters learned by that person through that person's participation in the peer review committee's proceeding or opinions formed by that person as a result of the peer review proceeding.
(e) Persons who provide information to a peer review committee. A person who provides information to a peer review committee conducting peer review under this section has the same protections from civil and criminal liability as a person who provides information to a review organization under the Peer Review Protection Act.
(f) Members and employees of a peer review committee and persons who furnish professional services to a peer review committee. An individual who is a member or employee of a peer review committee or who provides professional services to a peer review committee conducting peer review under this section has the same protections from civil and criminal liability for the performance of any duty, function or activity required of the peer review committee as a person who performs the duty, function or activity under the Peer Review Protection Act.
§ 1021.64. Cooperation.
Each individual and entity licensed, certified, recognized, accredited or otherwise authorized by the Department to participate in the Statewide EMS system shall cooperate in the Statewide and regional EMS quality improvement programs and peer reviews conducted under the act and this subchapter and shall provide information, data, reports and access to records, including audio records, as reasonably requested by quality improvement and peer review committees to conduct reviews.
Subchapter E. TRAUMA CENTERS Sec.
1021.81. Purpose. 1021.82. Requirements. 1021.83. Complaints. § 1021.81. Purpose.
The purpose of this subchapter is to integrate trauma centers into the Statewide EMS system by providing access to trauma centers and for the effective and appropriate utilization of resources.
§ 1021.82. Requirements.
To ensure that trauma centers are integrated into the Statewide EMS system, trauma centers shall:
(1) Maintain a dedicated telephone number to allow for access by referring hospitals to make arrangements for the most appropriate and expeditious mode of transportation to the trauma center, as well as allow for direct consultation between the two facilities prior to transfer and during the course of treatment of the patient.
(2) Develop and implement outreach education programs to be offered to referring hospitals and emergency services dealing with management of major and multiple systems trauma patients and the capabilities of the trauma center.
(3) Develop and institute a system to ensure the provision of patient outcome and treatment information to the transferring facility and the EMS agency involved in transporting the patient to the transferring facility, if the patient was transferred to the trauma center, or to the EMS agency involved in transporting the patient to the trauma center if the patient was not transferred to the trauma center by another facility, on each patient transported to the trauma center by ambulance.
(4) Maintain a medical command facility to allow for communication between a transporting ground ambulance or air ambulance and the trauma center to ensure that patient information and condition updates are available to the trauma center and that medical consultation is available to the transporting ambulance crew. The capabilities shall be in accordance with regional and Statewide EMS telecommunications plans.
§ 1021.83. Complaints.
The Department will investigate complaints related to the delivery of services by trauma centers and forward the results of the investigation to the Trauma Foundation with a recommendation for action.
Subchapter F. REGIONAL EMS COUNCILS Sec.
1021.101. Designation of regional EMS councils. 1021.102. Structure of regional EMS councils. 1021.103. Governing body. 1021.104. Responsibilities of regional EMS councils. § 1021.101. Designation of regional EMS councils.
(a) The Department will designate a regional EMS council that satisfies the structural and representation requirements in § 1021.102 (relating to structure of regional EMS councils) for each geographic area of this Commonwealth that the Department designates as a regional EMS geographic area for regional EMS system purposes.
(b) The designation of the geographical area will be based on the capability to:
(1) Provide definitive care services to the majority of general, emergent and critical patients.
(2) Establish community-wide and regional care programs.
(3) Interact and liaison with hospitals, other health care facilities and important public health and public safety entities.
(c) The Department will evaluate the performance and effectiveness of each regional EMS council on a periodic basis to assure that each council is appropriately meeting the needs of the EMS region to which it is assigned in planning, developing, maintaining, expanding, improving and upgrading the regional EMS system.
§ 1021.102. Structure of regional EMS councils.
(a) Regional EMS councils shall be organized by one of the following:
(1) A unit of general local government with an advisory council.
(2) A representative public entity administering a compact or other area wide arrangement or consortium.
(3) A public or private nonprofit entity.
(b) If the regional EMS council is a unit of local government it shall have an advisory council which is determined by the Department to be representative of health care consumers, the health professions, and major private, public and volunteer agencies, organizations and institutions concerned with providing EMS.
(c) A regional EMS council shall have a governing body.
(d) A regional EMS council shall have a director who is approved by the Department.
(e) A regional EMS council shall have a medical director and establish committees which are necessary to carry out the responsibilities of the regional EMS council.
§ 1021.103. Governing body.
(a) If the regional EMS council is a public or private nonprofit organization, its governing body shall satisfy the representation requirements in § 1021.102 (relating to structure of regional EMS councils).
(b) If the governing body consists of a board, it shall adopt written policies which include:
(1) A method of selection for board membership.
(2) Qualifications for board membership.
(3) Criteria for continued board membership.
(4) Frequency of meetings.
(c) The duties of the governing body shall include:
(1) Selecting a director who will be responsible for the daily operations of the regional EMS council.
(2) Selecting a regional EMS medical director.
(3) Describing the organizational structure.
(4) Establishing appropriate committees, including a quality improvement committee and a medical advisory committee.
(i) A majority of the members of the medical advisory committee shall be physicians.
(ii) The regional medical advisory committee shall assist the regional EMS medical director in matters of medical coordination and ensure that EMS is provided within the region in a manner that considers patient safety and the quality of EMS.
(5) Monitoring and ensuring the regional EMS council's compliance with contracts and grants from the Department.
(d) The governing body shall make available to the public an annual report which includes:
(1) Activities and accomplishments of the preceding year.
(2) A financial statement of income and expenses.
(3) A statement disclosing the names of officers and directors.
(e) A staff member of a regional EMS council may not serve as a voting member of the governing body.
§ 1021.104. Responsibilities of regional EMS councils.
In addition to other responsibilities imposed upon regional EMS councils by this subpart, regional EMS councils have responsibility for:
(1) Organizing, maintaining, implementing, expanding and improving the EMS system within the geographic area for which the regional EMS council has been assigned responsibilities.
(2) Developing and implementing comprehensive EMS plans, as approved by the Department.
(3) Advising PSAPs and municipal and county governments as to EMS resources available for dispatching and recommending dispatching criteria that may be developed by the Department, or by the regional EMS council as approved by the Department.
(4) Developing, maintaining, implementing, expanding and improving programs of medical coordination. The programs are subject to approval by the Department.
(5) Providing input to hospitals, upon their request, in the development and coordination of a comprehensive written EMS plan.
(6) Assisting the Department in achieving a unified Statewide EMS system and regional EMS system components and goals as described in section 8105 of the act (relating to duties of department).
(7) Assisting the Department in the collection and maintenance of standardized data and information provided through EMS PCRs.
(8) Providing EMS agencies with data summary reports.
(9) Assuring the reasonable availability of training programs, including continuing education programs, for EMS providers. The programs must include those that lead to certification of EMS providers by the Department. Regional EMS councils may also develop and implement additional educational programs.
(10) Monitoring EMS provider, EMS agency, EMS agency medical director, medical command physician, medical command facility medical director and medical command facility compliance with minimum standards established by the Department.
(11) Facilitating the integration of medical command facilities into the regional EMS system in accordance with policies and guidelines established by the Department.
(12) Developing and implementing regional protocols for issues of regional importance that are not addressed by the Statewide EMS protocols. Protocols shall be developed in consultation with the regional EMS council's medical advisory committee and approved by the Department. Protocols must:
(i) Be consistent with the Department's established protocol format.
(ii) Address matters the Department directs regional EMS councils to address.
(iii) Be distributed to EMS agencies within the region.
(iv) Be reviewed annually and revised as necessary in consultation with the regional EMS council's medical advisory committee.
(v) Be consistent with Chapter 1023 (relating to personnel) which governs the scope of practice of EMS providers.
(vi) Be based upon accepted standards of emergency medical care, with consideration given to maximizing patient safety.
(13) Assisting Federal, State and local agencies, upon request, in the provision of onsite mitigation, technical assistance, situation assessment, coordination of functions or post-incident evaluations, in the event of a potential or actual disaster, mass casualty situation or other substantial threat to public health.
(14) Maintaining an inventory of EMS resources, including EMS providers, available in the EMS region and promoting the recruitment, retention and recognition of EMS providers.
(15) Designating a regional EMS medical director.
(16) Supervising the regional EMS medical director to assure that the roles and responsibilities in § 1023.4 (relating to regional EMS medical director) are carried out.
(17) Assisting EMS providers, other persons and EMS agencies operating in the regional EMS system to meet the licensure, certification, registration and continuing education requirements established under the act and this subpart, and assisting the Department in ensuring that those requirements are met.
(18) Having a conflict of interest policy and requiring its employees and officials to agree to the policy in writing.
(19) Assisting the Department in carrying out the act and this part and adhering to policy direction established by the Department.
(20) Performing other duties deemed appropriate by the Department for the initiation, expansion, maintenance and improvement of the regional and Statewide EMS system which are in accordance with the Statewide EMS System Plan.
Subchapter G. ADVISORY BOARD Sec.
1021.121. Duties and purpose. 1021.122. Meetings and members. 1021.123. Disasters. § 1021.121. Duties and purpose.
(a) The Advisory Board shall advise the Department on EMS issues that relate to the following:
(1) Manpower and training.
(2) Communications.
(3) EMS agencies.
(4) The content of EMS PCRs.
(5) The content of rules and regulations.
(6) Standards and policies promulgated by the Department.
(7) The permitted scope of continuing education courses.
(8) Other subjects as required by the act or deemed appropriate by the Department or the Advisory Board.
(9) The content of the Statewide EMS System Plan and proposed revisions to it.
(b) The Advisory Board shall adopt written policies which include:
(1) A method of selection for board membership.
(2) Qualifications for Advisory Board membership.
(3) Criteria for continued Advisory Board membership.
(4) Frequency of meetings.
(c) The Advisory Board shall:
(1) Select a director who is responsible for the daily operations of the Advisory Board and the Pennsylvania Emergency Health Services Council.
(2) Describe its organizational structure.
(3) Establish appropriate committees, including an EMS for children advisory committee to advise on a program to address the emergency medical needs of the pediatric population, and a medical advisory committee with a majority of its members being physicians.
(d) The Advisory Board shall make available to the public an annual report which must include:
(1) A description of its activities and accomplishments of the preceding year.
(2) A financial statement of income and expenses.
(3) A statement disclosing the names of officers and members of the Advisory Board.
§ 1021.122. Meetings and members.
(a) Meetings of the Advisory Board shall be held in accordance with 65 Pa.C.S. Chapter 7 (relating to Sunshine Act) or a successor act.
(b) A voting member of the Advisory Board shall serve a 3-year term. A voting member may not serve more than two consecutive terms.
(c) A simple majority of the voting members of the Advisory Board constitutes a quorum for the transaction of business.
(d) A member of the Advisory Board shall serve without compensation, except for reimbursement of reasonable expenses incurred by members while performing official duties.
(e) A staff member of the Pennsylvania Emergency Health Services Council may not serve as a voting member of the Advisory Board.
§ 1021.123. Disasters.
In the event of a potential or actual disaster, mass casualty situation or other substantial threat to public health, the Advisory Board shall, upon request, assist Federal, State and local agencies in the provision of onsite mitigation, technical assistance, situation assessment, coordination of functions or post-incident evaluations. Recruitment of volunteer expertise available to the Advisory Board will be requested and utilized as conditions and circumstances necessitate.
Subchapter H. EMS RESEARCH Sec.
1021.141. Research. § 1021.141. Research.
(a) Prior to engaging in a clinical investigation or study that relates to the provision of EMS, the principal investigator shall file with the Department a report of the planned investigation or study on a form prescribed by the Department. The principal investigator shall also file with the Department a report at the conclusion of the investigation or study and status reports as requested by the Department.
(b) A person who wants to secure from the Department or a regional EMS council and use, for research purposes, information collected by the Department or a regional EMS council through EMS PCRs, or information collected by the Department or a regional EMS council regarding patients who utilize emergency departments without being admitted to a hospital or who are admitted to a hospital through emergency departments, trauma centers or directly to special care units, shall submit the proposed research project to the Department. If the Department concludes that the proposed use of the information would serve the public interest, it may refer the proposal to the medical advisory committee of the Advisory Board or to one or more of the medical advisory committees of the regional EMS councils for review and recommendation.
(c) If access to and use of the information requested under subsection (b) is approved by the Department, the Department will release or direct the release of the information for the research project under conditions specified by the Department.
(d) A research proposal submitted under subsection (b) must include and address the following in a format specified by the Department:
(1) A specific statement of the hypothesis to be investigated and the clinical significance of the hypothesis.
(2) A specific description of the methodology to be used in the research.
(3) An estimated duration of the research.
(4) An explanation of how patient confidentiality will be protected.
(5) A letter from the principal investigator in which that person identifies himself as the principal investigator and assumes responsibility for compliance with the conditions imposed by the Department.
(6) A plan for providing the Department with progress reports, annually at a minimum, and a final report on the research.
(e) If institutional review board approval is required by law, the Department will not approve access to the requested information until it receives evidence of institutional review board approval.
(f) The Department may direct that the use of the information be terminated if the Department determines that the use of the information fails to satisfy the conditions under which the Department approved use of the information.
(g) An EMS agency or other person that intends to conduct research that would involve an EMS agency violating this part or an EMS protocol adopted or approved by the Department shall apply for an exception to the regulation or protocol under § 1021.4 (relating to exceptions).
(h) This section does not empower the Department to approve research that involves any act otherwise prohibited by law.
CHAPTER 1023. PERSONNEL Subchap.
A. ADMINISTRATIVE AND SUPERVISORY EMS PERSONNEL B. EMS PROVIDERS AND VEHICLE OPERATORS C. OTHER PERSONS ASSOCIATED WITH THE STATEWIDE EMS SYSTEM
Subchapter A. ADMINISTRATIVE AND SUPERVISORY EMS PERSONNEL Sec.
1023.1. EMS agency medical director. 1023.2. Medical command physician. 1023.3. Medical command facility medical director. 1023.4. Regional EMS medical director. 1023.5. Commonwealth EMS Medical Director. § 1023.1. EMS agency medical director.
(a) Roles and responsibilities. An EMS agency medical director is responsible for:
(1) Providing medical guidance and advice to the EMS agency, including:
(i) Reviewing the Statewide EMS protocols and Department-approved regional EMS protocols that are applicable to the EMS agency and ensuring that its EMS providers and other relevant personnel are familiar with the protocols applicable to the EMS agency.
(ii) Performing medical audits of EMS provided by the EMS agency's EMS providers.
(iii) Participating in and reviewing quality improvement and peer reviews of EMS provided by the EMS agency.
(iv) Reviewing regional mass casualty and disaster plans and providing guidance to the EMS agency regarding its provision of EMS under those plans.
(v) Providing guidance to the EMS agency, when applicable, with respect to the ordering, stocking and replacement of medications, and compliance with laws and regulations impacting upon the EMS agency's acquisition, storage and use of those medications.
(vi) Making an initial assessment of each EMS provider at or above the AEMT level to determine whether the EMS provider has the knowledge and skills to competently perform the skills within the EMS provider's scope of practice, and a commitment to adequately perform other functions relevant to the EMS provider providing EMS at that level. This paragraph does not apply if the EMS provider was working for the EMS agency at the same level prior to the physician becoming the medical director for the EMS agency and the EMS provider was credentialed at that EMS agency within the last 12 calendar months as being able to perform at the EMS provider's certification level.
(vii) Making an assessment, within 12 calendar months of the last assessment, of each EMS provider at or above the AEMT level to determine whether the EMS provider has demonstrated competency in the knowledge and skills to perform the skills within the EMS provider's scope of practice, and a commitment to adequately perform other functions relevant to the EMS provider providing EMS at that level.
(viii) Recommending to the EMS agency that an EMS provider not be permitted to provide EMS at the EMS provider's certification level if the EMS agency medical director determines that the EMS provider has not demonstrated competency in the knowledge and skills to perform the skills within the EMS provider's scope of practice, or a commitment to adequately perform other functions relevant to the EMS provider providing EMS at that level, and recommending restrictions on the EMS provider's practice for the EMS agency, if appropriate, to ensure patient safety.
(ix) Providing medical direction for the EMS agency dispatch center if the EMS agency operates an EMS agency dispatch center.
(2) Maintaining a liaison with the regional EMS medical director.
(3) Participating in the regional and Statewide quality improvement programs.
(4) Recommending to the relevant regional EMS council, when appropriate, EMS protocols for inclusion in the Statewide and regional EMS protocols.
(5) Recommending to the Department the suspension, revocation or restriction of an EMS provider's certification.
(b) Minimum qualifications. To qualify and continue to function as an EMS agency medical director, an individual shall:
(1) Be a physician.
(2) Satisfy one of the following:
(i) Have successfully completed an emergency medicine residency program accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine.
(ii) Have successfully completed a residency program in surgery, internal medicine, family medicine, pediatrics or anesthesiology, accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine. The physician shall also have successfully completed or taught the ACLS course within the preceding 2 years and have completed, at least once, the ATLS course and PALS course or APLS course, or other programs determined by the Department to meet or exceed the standards of these programs.
(iii) Have served as an ALS medical director under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)) prior to February 16, 2010.
(3) Have a valid Drug Enforcement Agency number.
(4) Have completed an EMS agency medical director course or an EMS fellowship or other EMS training program that is determined by the Department to be equivalent. This training shall assure that the EMS agency medical director has knowledge of:
(i) The scope of practice of EMS providers.
(ii) The provision of EMS under Statewide EMS protocols.
(iii) The interface between EMS providers and medical command physicians.
(iv) Quality improvement and peer review principles.
(v) Emergency medical dispatch principles and EMS agency communication capabilities.
(vi) EMS system design and operation.
(vii) Federal and State laws and regulations regarding EMS.
(viii) Regional and State mass casualty and disaster plans.
(ix) Patient and EMS provider safety principles.
§ 1023.2. Medical command physician.
(a) Roles and responsibilities. A medical command physician functions under the direction of a medical command facility medical director and the auspices of a medical command facility. A medical command physician is responsible for:
(1) Providing medical command orders to EMS providers whenever they seek direction.
(2) Issuing medical command orders consistent with Statewide protocols and protocols that are in effect either in the region in which EMS originates or the region from which the EMS providers who are providing EMS begin receiving medical command direction. For good cause, a medical command physician may give medical command orders that are inconsistent with these protocols.
(3) Documenting patient information received from EMS providers and medical command orders given to EMS providers if providing medical command at the scene.
(b) Minimum qualifications. To qualify and continue to function as a medical command physician, an individual shall be serving as a medical command physician immediately prior to February 16, 2010, or:
(1) Complete an application for medical command physician certification on a form or through an electronic application process, as prescribed by the Department.
(2) Be a physician.
(3) Satisfy one of the following:
(i) Have successfully completed a residency program in emergency medicine accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine.
(ii) Have had an emergency medicine practice in another jurisdiction and establish to the Department that the physician has a combination of training, education and emergency medicine practice that makes the physician qualified to serve as a medical command physician.
(iii) Have successfully completed or taught the ACLS course within the preceding 2 years and have completed or taught the ATLS course and either an APLS or PALS course or other program determined by the Department to meet or exceed the standards of these programs.
(4) Have an arrangement with a medical command facility to serve as a medical command physician for that facility after receiving certification as a medical command physician.
(5) Be practicing as an emergency medicine physician, be participating as a resident in a second or subsequent year in an emergency medicine residency program accredited by an accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine or have had at least 3 years of experience as a full-time emergency medicine physician.
(6) Have a current Drug Enforcement Agency (DEA) number or be an emergency medicine resident in an emergency medicine residency program accredited by an accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine who is authorized to use a hospital's DEA number for practice within the emergency medicine residency program.
(7) Have successfully completed the medical command course.
(c) Triennial registration. A medical command physician's certification is deemed registered for 3 years. Thereafter, a medical command physician shall triennially register the certification on a form or through an electronic process, as prescribed by the Department. The Department will issue a new registration within 30 days after the application for registration is filed if the application demonstrates that the medical command physician:
(1) Maintains licensure as a physician.
(2) Has an arrangement with a medical command facility to serve as a medical command physician for that facility.
(3) Is practicing as an emergency medicine physician or has had at least 3 years of experience as a full-time emergency medicine physician.
(4) Has completed the most recent update or refresher course that the Department provided on Statewide and other applicable Department-approved EMS protocols.
§ 1023.3. Medical command facility medical director.
(a) Roles and responsibilities. A medical command facility medical director is responsible for the following for the medical command facility:
(1) Medical command.
(2) Quality improvement.
(3) Liaison with regional EMS medical director.
(4) Participation in prehospital training activities.
(5) Clinical and continuing education training of EMS providers.
(6) Verifying to the Department that an applicant for medical command physician certification has an arrangement to serve as a medical command physician for the medical command facility under the direction of the medical command facility medical director and meets all medical command physician certification requirements.
(7) Monitoring the operation of the medical command facility and the performance of its medical command physicians to ensure that they are satisfying all statutory and regulatory requirements.
(8) Reviewing a departure from the Statewide EMS protocols of one of the facility's medical command physicians when requested by the Department and apprising the Department whether the medical command facility medical director believes there is good cause for the departure.
(b) Minimum qualifications. To qualify and continue to function as a medical command facility medical director, an individual shall be serving as a medical command facility medical director immediately prior to February 16, 2010, or:
(1) Complete an application for medical command facility medical director certification on a form or through an electronic application process, as prescribed by the Department.
(2) Currently serve as a medical command physician.
(3) Satisfy one of the following:
(i) Have completed a residency program in emergency medicine accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine.
(ii) Have completed a residency program in surgery, internal medicine, family medicine, pediatrics or anesthesiology accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine and completed or taught the ACLS course within the preceding 2 years, the ATLS course and either an APLS or PALS course or other program determined by the Department to meet or exceed the standards of these programs.
(4) Have experience in prehospital and emergency department care of the acutely ill or injured patient.
(5) Have experience in providing medical command direction to EMS providers.
(6) Have experience in the training of EMS providers above and below the AEMT level.
(7) Have experience in the medical audit, review and critique of EMS providers above and below the AEMT level.
(8) Have an arrangement with a medical command facility to serve as its medical director after receiving certification as a medical command facility medical director.
(c) Triennial registration. A medical command facility medical director's certification is deemed registered for 3 years. Thereafter, a medical command facility medical director shall triennially register the certification on a form or through an electronic process, as prescribed by the Department. The Department will issue a new registration within 30 days after the application for registration is filed if the application demonstrates that the medical command facility medical director shall be:
(1) Serving as a medical command physician and a medical command facility medical director for a medical command facility.
(2) Providing prehospital and emergency department care of acutely ill or injured patients.
(3) Performing medical audit, review and critique of EMS providers above and below the AEMT level.
§ 1023.4. Regional EMS medical director.
(a) Roles and responsibilities. A regional EMS medical director shall carry out the following duties:
(1) Maintain liaison with the Commonwealth EMS Medical Director.
(2) Assist the regional EMS council, after consultation with the regional medical advisory committee, to establish and revise, subject to Department approval, regional EMS protocols.
(3) Assist the regional EMS council to develop, subject to Department approval, criteria to recommend to PSAPs for emergency medical dispatch, including criteria for prearrival instructions, level of care to be dispatched to respond to various clinical conditions, types of EMS resources to be sent and mode of EMS resource response.
(4) Serve as a member of the regional EMS council's quality improvement committee and as that committee's liaison to the regional EMS council's medical advisory committee.
(5) Serve on the State EMS Quality Improvement Committee.
(6) Serve as chairperson of the regional EMS council's medical advisory committee.
(7) Assist, as appropriate, the regional EMS council in its investigations, analysis of investigation information and recommendations to make to the Department on actions the Department should pursue, if any, against certifications, licenses, accreditations and other authorizations issued by the Department under the act.
(8) Review regional plans, procedures and processes for compliance with State standards of EMS.
(b) Minimum qualifications. A regional EMS medical director shall have the following qualifications:
(1) Be a physician.
(2) Experience in prehospital and emergency department care of the acutely ill or injured patient.
(3) Experience as a medical command physician and as an EMS agency medical director or as an ALS service medical director under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)).
(4) Completed a residency program in emergency medicine accredited by a residency program accrediting body recognized by the State Board of Medicine or the State Board of Osteopathic Medicine or have served as a medical command physician in this Commonwealth prior to October 14, 2000.
(5) Experience in the training of EMS providers above and below the AEMT level.
(6) Experience in the medical audit, review and critique of EMS providers above and below the AEMT level.
(c) Disclosure. A regional EMS medical director shall disclose to a regional EMS council and the Department all financial or other interest in entities regulated by the Department under the act and in other matters which present a potential conflict of interest.
§ 1023.5. Commonwealth EMS Medical Director.
(a) Roles and responsibilities. The Commonwealth EMS Medical Director is responsible for:
(1) Providing medical advice and recommendations to the Department regarding the EMS system.
(2) Assisting in the development and implementation of a Statewide EMS quality improvement program.
(3) Evaluating and making recommendations on regional EMS quality improvement programs and on programs to improve patient and provider safety and provider wellness.
(4) Assisting the Department in revising or modifying the scope of practice of EMS providers.
(5) Providing advice and guidance to the Department on investigations and the pursuit of disciplinary actions against EMS providers and other persons and entities regulated by the Department under the act.
(6) Reviewing, evaluating and making recommendations for the Statewide EMS protocols.
(7) Reviewing, evaluating and making recommendations regarding regional EMS protocols that supplement Statewide EMS protocols.
(8) Providing direction and guidance to the regional EMS medical directors for training and quality improvement monitoring and assistance.
(9) Meeting with representatives and committees of regional EMS councils and the Advisory Board as necessary and as directed by the Department to provide guidance and direction.
(10) Reviewing, evaluating and making recommendations to the Department on requests, for research purposes, for data made confidential by the act.
(11) Assisting the Department in the development of regulations under the act.
(12) Providing other services relating to the Department's administration of the act as assigned by the Department.
(b) Minimum qualifications. The Commonwealth EMS Medical Director shall possess the same qualifications as a regional EMS medical director under § 1023.4 (relating to regional EMS medical director).
(c) Disclosure. The Commonwealth EMS Medical Director shall disclose to the Department all financial or other interest in EMS agencies and other entities regulated by the Department and other matters which present a potential conflict of interest.
(d) Prohibition against dual service. A physician may not simultaneously serve as the Commonwealth EMS Medical Director and a regional EMS medical director.
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