§ 1001.1. Purpose.

 The purpose of this subpart is to plan, guide, assist and coordinate the development of regional EMS systems into a unified Statewide system and to coordinate the system with similar systems in neighboring states, and to otherwise implement the Department’s responsibilities under the act consistent with the Department’s rulemaking authority.

   The provisions of this §  1001.1 amended under the Do-Not-Resuscitate Act, 20 Pa.C.S. Chapter 54.

 The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise:

   ACLS course—Advanced cardiac life support course—A course in advanced cardiac life support sanctioned by the American Heart Association.

   ALS ambulance service—Advanced life support ambulance service—An entity licensed by the Department to provide ALS services by ambulance to seriously ill or injured patients. The term includes mobile ALS ambulance services that may or may not transport patients.

   ALS service medical director—Advanced life support service medical director—A medical command physician or a physician meeting the equivalent qualifications in §  1003.5 (relating to ALS service medical director) who is employed by, contracts with or volunteers with, either directly, or through an intermediary, an ALS ambulance service to make medical command authorization decisions, provide medical guidance and advice to the ALS ambulance service, and evaluate the quality of patient care provided by the prehospital personnel utilized by the ALS ambulance service.


   ALS services—Advanced life support services—The advanced prehospital and interhospital emergency medical care of serious illness or injury by appropriately trained health professionals and EMT-paramedics.

   APLS course—Advanced pediatric life support course—A course in advanced pediatric life support sanctioned by the American Academy of Pediatrics and the American College of Emergency Physicians.

   ATLS course—Advanced trauma life support course—A course in advanced trauma life support sanctioned by the American College of Surgeons Committee on Trauma.

   Act—The Emergency Medical Services Act (35 P. S. § §  6921—6938).

   Air ambulance—A rotorcraft specifically designed, constructed or modified and equipped, used or intended to be used, and maintained or operated for the purpose of providing emergency medical care to, and air transportation of, patients.

   Air ambulance medical director—A medical command physician or a physician meeting the minimum qualifications in §  1003.5 who is employed by, or contracts with, or volunteers with, either directly, or through an intermediary, an air ambulance service to make medical command authorization decisions, provide medical guidance and advice to the air ambulance service, and evaluate the quality of patient care provided by the prehospital personnel utilized by the air ambulance service.

   Air ambulance service—An agency or entity licensed by the Department to provide transportation and ALS care of patients by air ambulance.

   Aircraft operator—The person, company or agency, certified by the FAA, under 14 CFR Part 135 (relating to air taxi operators and commercial operators), to conduct air taxi operations.

   Ambulance—A vehicle specifically designed, constructed or modified and equipped, used or intended to be used, and maintained or operated for the purpose of providing emergency medical care to patients, and the transportation of patients if used for that purpose. The term includes ALS or BLS vehicles that may or may not transport patients.

   Ambulance attendant—An individual who possesses the qualifications in §  1003.21(b) (relating to ambulance attendant).

   Ambulance identification number—A number issued by the Department to each ambulance operated by an ambulance service.

   Ambulance service—An entity which regularly engages in the business or service of providing emergency medical care and transportation of patients in this Commonwealth. The term includes ALS ambulance services that may or may not transport patients.

   Ambulance service affiliate number—A unique number assigned by the Department to an ambulance service, the first two digits of which designate the county in which the ambulance service maintains its primary headquarters.

   BLS ambulance service—Basic life support ambulance service—An entity licensed by the Department to provide BLS services and transportation by ambulance to patients.

   BLS services—Basic life support services—The basic prehospital or interhospital emergency medical care and management of illness or injury performed by specially trained, certified or licensed personnel.

   Basic rescue practices technician—An individual who is certified by the Department to possess the training and skills to perform a rescue operation as taught in a basic rescue practices technician program approved by the Department.

   Basic vehicle rescue technician—An individual who is certified by the Department to possess the training and skills to perform a rescue from a vehicle as taught in a basic vehicle rescue technician program approved by the Department.

   Board certification—Current certification in a medical specialty or subspecialty recognized by either the American Board of Medical Specialties or the American Osteopathic Association.

   CPR—Cardiopulmonary resuscitation—The combination of artificial respiration and circulation which is started immediately as an emergency procedure when cardiac arrest or respiratory arrest occurs.

   CPR course—Cardiopulmonary resuscitation course—A course of instruction in CPR, meeting the Emergency Cardiac Care Committee National Conference on CPR and Emergency Cardiac Care standards. The course shall encompass one and two-rescuer adult, infant and child CPR, and obstructed airway methods.

   Commonwealth Emergency Medical Director—A medical command physician or a physician meeting the equivalent qualifications in §  1003.1 (relating to Commonwealth Emergency Medical Director) and approved by the Department to advise, formulate and direct policy on matters pertaining to EMS.

   Continuing education—Learning activities intended to build upon the education and experiential basis of prehospital personnel for the enhancement of practice, education, administration, research or theory development, to strengthen the quality of care provided.

   Continuing education sponsor—An entity or institution that is accredited by the Department as a sponsor of continuing education courses.

   Council—The Board of Directors of the Pennsylvania Emergency Health Services Council.

   Critical care specialty receiving facility—A facility identified by its capability of providing specialized emergency and continuing care to patients, including, in one of the following medical areas: poisoning, neonatal, spinal cord injury, behavioral, burns, cardiac and trauma.

   Department—The Department of Health of the Commonwealth or a designee.

   Department identification number—A number issued by the Department that identifies an individual who participates in the Statewide EMS system and who has been certified, recognized or otherwise assigned an identification number by the Department.

   Direct support of EMS systems—Activities, equipment and supplies that are involved in the planning, initiation, maintenance, expansion or improvement of EMS systems.

   EMSOF—Emergency Medical Services Operating Fund—Moneys appropriated to the Department under section 14(c) of the act (35 P. S. §  6934(c)) and which are not assigned to the Catastrophic Medical and Rehabilitation Fund.

   EMS—Emergency medical services—The services utilized in responding to the needs of an individual for immediate medical care to prevent loss of life or aggravation of physiological or psychological illness or injury.

   EMS patient care report—A report that provides standardized data and information relating to patient assessment and care.

   EMS system—The arrangement of personnel, facilities and equipment for the effective and coordinated delivery of EMS required in the prevention and management of incidents which occur either as a result of a medical emergency or of an accident, natural disaster or similar situation.

   EMS training institute—Emergency medical services training institute—An institute accredited by the Department to provide a course required for the certification or recognition of a prehospital practitioner.

   EMS training manual—Emergency medical services training manual—A manual adopted by the Department and reviewed biennially by the Council to aid ALS service medical directors in determining whether EMT-paramedics and prehospital registered nurses have demonstrated competency in the knowledge and skills necessary to be granted or maintain medical command authorization.

   EMT—Emergency medical technician—An individual trained to provide prehospital emergency medical treatment and certified as such by the Department in accordance with the current EMT-NSC, as set forth in this part.

   EMT-NSC—Emergency medical technician-National standard curriculum— An outline of knowledge and skills recommended for the education and training of EMTs, as adopted by the United States Department of Transportation.

   EMT-paramedic—Emergency medical technician-paramedic—An individual who is trained to provide prehospital emergency medical treatment at an advanced level and certified as such by the Department in accordance with the current EMT-paramedic NSC, as set forth in this part.

   EMT-paramedic NSC—Emergency medical technician-paramedic National standard curriculum—An outline of knowledge and skills recommended for the education and training of EMT-paramedics, as adopted by the United States Department of Transportation.

   Emergency—A combination of circumstances resulting in a need for immediate medical intervention.

   Emergency department—An area of the hospital dedicated to offering emergency medical evaluation and initial treatment to individuals in need of emergency care.

   FAA—The Federal Aviation Administration.

   FAA certification number—An air taxi/commercial operator operating certificate number assigned by the FAA, authorizing the certificate holder to operate aircraft as required by 14 CFR Part 135.

   Facility—A hospital.

   Federal KKK standards—The minimum standards and specifications for ambulance vehicles adopted by the United States Department of Transportation.

   Federally declared emergency—A state of emergency declared by the President of the United States, upon the request of a governor. Once the President declares the situation a ‘‘major disaster,’’ the Federal government supplements State and local efforts to meet the crisis.

   First responder—An individual who is certified by the Department as a first responder.

   Health professional—A physician who has education and continuing education in ALS services and prehospital care or a prehospital registered nurse.

   Hospital—An institution having an organized medical staff which is primarily engaged in providing to inpatients by or under the supervision of physicians, diagnostic and therapeutic services or rehabilitation services for the care or rehabilitation of injured, disabled, pregnant, diseased, sick or mentally ill persons. The term includes a facility for the diagnosis and treatment of disorders within the scope of specific medical specialties, but not a facility caring exclusively for the mentally ill.

   Invalid coach—A vehicle primarily maintained, operated and intended to be used for routine transport of persons who are convalescent or otherwise nonambulatory and do not ordinarily require emergency medical treatment while in transit. The term does not include an ambulance or another EMS vehicle.

   Medical advisory committee—An advisory body, composed of a majority of physicians, to advise a regional EMS council or the Council on issues that have potential impact on the delivery of emergency medical care.

   Medical audit—A mechanism to evaluate patient care.

   Medical command—An order given by a medical command physician to a prehospital practitioner in a prehospital, interfacility, or emergency care setting in a hospital, to provide immediate medical care to prevent loss of life or aggravation of physiological or psychological illness or injury, or to withdraw or withhold treatment.

   Medical command authorization—Permission given by the ALS service medical director, including an air ambulance medical director, to an EMT-paramedic or a prehospital registered nurse under §  1003.28 (relating to medical command authorization) to perform, on behalf of an ALS ambulance service, ALS services under medical command or in accordance with Department approved regional EMS council transfer and medical treatment protocols when medical command cannot be secured, is disrupted or is not required under the approved regional EMS council transfer and medical treatment protocols.

   Medical Command Course—The course adopted by the Department for medical command physicians and ALS service medical directors which provides an overview of the medical command system.

   Medical command facility—The distinct unit within a facility that contains the necessary equipment and personnel, as prescribed in §  1009.1 (relating to operational criteria) for providing medical command to and control over prehospital personnel when providing medical command.

   Medical command facility medical director—A medical command physician who meets the criteria established by the Department to assume responsibility for the direction and control of the equipment and personnel at a medical command facility.

   Medical command physician—A physician who is approved by a regional EMS council to provide medical command.

   Medical coordination—A system which involves the medical community in all phases of the regional EMS system and consists of the following elements:

     (i)   Designation of a regional medical director.

     (ii)   Responsibility for oversight to assure implementation of all medical requirements, with special emphasis on patient triage and medical treatment protocol.

     (iii)   Effective emergency medical planning and recommendation for Department recognition of online command facilities with medical command physicians who give orders to prehospital patient care providers.

     (iv)   Transfer and medical treatment protocols.

     (v)   Technologic innovations which support the training and operations of the physicians giving orders to prehospital patient care providers.

     (vi)   Technologic innovations which support the training and operations of the EMS program and an effective process for accountability—for example, records, case review and audits.

   Medical record—Documentation of the course of a patient’s condition and treatment, maintained to provide communication among health care providers for current and future patient care.

   Medical treatment protocols—Written prescribed medical procedures.

 NSC—National Standard Curriculum.

   PALS course—Pediatric advanced life support course—A course in advanced pediatric life support sanctioned by the American Heart Association and the American Academy of Pediatrics.

   PSAP—Public safety answering point—A communications center established to serve as the first point at which calls by or on behalf of patients are received requesting emergency medical assistance.

   Patient—An individual who is believed to be sick, injured, wounded or otherwise incapacitated and helpless and in need of immediate medical attention.

   Pennsylvania Trauma Systems Foundation—A nonprofit Pennsylvania corporation whose function is to accredit trauma centers in this Commonwealth.

   Physician—An individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth.

   Prehospital personnel—The term includes any of the following prehospital practitioners:

     (i)   Ambulance attendants.

     (ii)   First responders.

     (iii)   EMTs.

     (iv)   EMT-paramedics.

     (v)   Prehospital registered nurses.

     (vi)   Health professional physicians.

   Prehospital registered nurse—An individual who is recognized by the Department as such under §  1003.25b (relating to prehospital registered nurse).

   Providers of EMS—A facility, BLS ambulance service or ALS ambulance service, or a QRS.

   QRS—Quick response service—An entity recognized by the Department to respond to an emergency and to provide EMS to patients pending the arrival of the prehospital personnel of an ambulance service.

   Receiving facility—A fixed facility that provides an organized emergency department, with a physician who is trained to manage cardiac, trauma, pediatric, medical and behavioral emergencies, and is present in the facility and available to the emergency department 24 hours-a-day, 7 days-a-week, and a registered nurse who is present in the emergency department 24 hours-a-day, 7 days-a-week. The facility shall also comply with Chapter 117 (relating to emergency services).

   Regional EMS council—A nonprofit incorporated entity or appropriate equivalent whose function is to plan, develop, maintain, expand and improve EMS systems within a specific geographical area of this Commonwealth and which is deemed by the Department as being representative of health professions and major private and public and voluntary agencies, organizations and institutions concerned with providing EMS in the region.

   Registered nurse—An individual who has a current original or renewed license to practice nursing in this Commonwealth as a registered nurse.

   Rescue vehicle—A vehicle which is designed or modified and equipped for rescue operations to release persons from entrapment and which is not routinely used for emergency medical care or transport of patients.

   Residency program—Training approved or recognized by the State Board of Medicine or the State Board of Osteopathic Medicine as a program of graduate medical training for physicians.

   Rural area—An area outside urbanized areas as defined by the United States Bureau of the Census.

   Scope of practice—Those emergency medical services that an individual who is certified or recognized by the Department is permitted to perform under the certification or recognition, provided the individual has medical command authorization, if required.

   Secretary—The Secretary of the Department.

   Service area—The area in which an ambulance service routinely provides services.

   Special care unit—An appropriately equipped area of the hospital where provision has been made for a concentration of physicians, registered nurses and others who have special skills and experiences to provide medical care for critically ill patients.

   Special event—A planned and organized activity or contest, which will place participants or attendees, or both, in a defined geographic area in which the potential need for EMS exceeds local EMS capabilities, or where access by emergency vehicles might be delayed due to crowd or traffic congestion at or near the event.

   Special vehicle rescue technician—An individual who is certified by the Department to possess the training and skills to perform special rescue operations as taught in the special vehicle rescue training program approved by the Department.

   State declared emergency—An emergency declared by the Governor.

   Statewide BLS medical treatment protocols—Written medical treatment protocols adopted by the Department that have Statewide application to the delivery of BLS services by prehospital personnel.

   Trauma center—A facility accredited as a trauma center by the Pennsylvania Trauma Systems Foundation.

   Volunteer ambulance service—A nonprofit chartered corporation, association or organization located in this Commonwealth and which is regularly engaged in the service of providing emergency medical care and transportation of patients as an ambulance service.

   The provisions of this §  1001.2 amended under the Do-Not-Resuscitate Act, 20 Pa.C.S. Chapter 54.

   The provisions of this §  1001.2 amended September 1, 1995, effective September 2, 1995, 25 Pa.B. 3685; amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363; amended December 13, 2002, effective March 1, 2003, 32 Pa.B. 6117; amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceding text appears at serial pages (297022) to (297023), (269307) to (269312) and (293991).

 This subpart affects regional EMS councils, the Council, other entities desiring to receive funding from the Department or the regional EMS councils for the provision of EMS, ALS and BLS ambulance services, QRSs, instructors and institutes involved in the training of prehospital personnel including EMTs, EMT-paramedics, first responders, ambulance attendants and health professionals, and trauma centers and local governments involved in the administration and support of EMS.

   The provisions of this §  1001.3 amended under the Do-Not-Resuscitate Act, 20 Pa.C.S. Chapter 54.

 (a)  The Department may grant exceptions to, and departures from, this subpart when the policy objectives and intentions of this subpart are otherwise met or when compliance would create an unreasonable hardship, but would not impair the health, safety or welfare of the public. No exceptions or departures from this subpart will be granted if compliance with the standard is required by statute.

 (b)  Requests for exceptions to this subpart shall be made in writing to the Department. The requests, whether approved or not approved, will be documented and retained on file by the Department. Approved requests shall be retained on file by the applicant during the period the exception remains in effect.

 (c)  A granted request will specify the period during which the exception is operative. Exceptions may be reviewed or extended if the reasons for the original exception continue.

 (d)  An exception granted may be revoked by the Department for just cause. Just cause includes, but is not limited to, failure to meet the conditions for the exception. Notice of the revocation will be in writing and will include the reason for the action of the Department and a specific date upon which the exception will be terminated.

 (e)  In revoking an exception, the Department will provide for a reasonable time between the date of the written notice or revocation and the date of termination of an exception for the holder of the exception to come into compliance with this subpart. Failure to comply after the specified date may result in enforcement proceedings.

 (f)  The Department may, on its own initiative, grant an exception to this subpart if the requirements of subsection (a) are satisfied.

   The provisions of this §  1001.4 amended under the Do-Not-Resuscitate Act, 20 Pa.C.S. Chapter 54.

   The provisions of this §  1001.4 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363; amended December 13, 2002, effective March 1, 2003, 32 Pa.B. 6117; amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceding text appears at serial pages (293992) to (293993).

 The Department may investigate any person, entity or activity for compliance with the act and this subpart.

   The provisions of this §  1001.5 amended under the Do-Not-Resuscitate Act, 20 Pa.C.S. Chapter 54.

 (a)  The Department, with the advice of the Council, will develop and annually update a Statewide EMS development plan for the coordinated delivery of EMS in this Commonwealth.

 (b)  The plan will contain, but not be limited to:

   (1)  An inventory of emergency services resources available in this Commonwealth.

   (2)  An assessment of the effectiveness of the existing services and a determination of the need for additional services.

   (3)  A statement of goals and specific measurable objectives for delivery of EMS to persons in need of the services in this Commonwealth.

   (4)  Methods to be used in achieving the stated objectives.

   (5)  A schedule for achievement of the stated objectives.

   (6)  A method for evaluating the stated objectives.

   (7)  Estimated costs for achieving the stated objectives.

 (c)  The Department will incorporate regional EMS development plans into the Statewide EMS development plan.

 (d)  The Department will adopt a Statewide EMS development plan, and updates to the plan, after public notice, an opportunity for comment and its consideration of comments received, and will make the plan available to the General Assembly and all concerned agencies, entities and individuals who request a copy.

 (a)  A regional EMS council shall develop and annually update a regional EMS development plan for coordinating and improving the delivery of EMS in the region for which it has been assigned responsibility.

 (b)  The plan shall contain:

   (1)  An inventory of emergency services resources available in the region.

   (2)  An assessment of the effectiveness of the existing services and a determination of the need for additional services.

   (3)  A statement of goals and specific measurable objectives for delivery of EMS to persons in need of EMS in the region.

   (4)  Identification of interregional problems and recommended measures to resolve those problems.

   (5)  Methods to be used in achieving stated objectives.

   (6)  A schedule for achievement of the stated objectives.

   (7)  A method for evaluating whether the stated objectives have been achieved.

   (8)  Estimated costs for achieving the stated objectives.

   (9)  Other information as requested by the Department.

 (c)  A regional EMS council shall, in the course of preparing a regional EMS development plan, and updates to the plan, provide public notice and an opportunity for comment. It shall consider all comments before submitting a proposed plan to the Department.

 (d)  A regional EMS development plan shall become final after it is approved by the Department. The regional EMS council shall make the plan available to all concerned agencies, entities and individuals who request a copy.

   The provisions of this §  1001.7 adopted October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363.

Subchapter B. AWARD AND ADMINISTRATION
OF FUNDING

Sec.

§ 1001.21. Purpose.

 This subchapter implements section 5(b)(2) of the act (35 P. S. §  6925(b)(2)), which authorizes the Department to establish, by regulation, standards and criteria governing the award and administration of contracts under the act, and section 10 of the act (35 P. S. §  6930), which authorizes the Secretary to enter into contracts with regional EMS councils and other appropriate entities for the initiation, expansion, maintenance and improvement of EMS systems which are in accordance with the Statewide EMS development plan, and which further autho-
rizes the Secretary to enter into contracts with organizations other than regional EMS councils to assist the Department in complying with the act.

 (a)  A potential contractor or other recipient of funds from the Department, either directly or through the Department’s agent, may receive funding for the following:

   (1)  Public education, information and prevention 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)   Prevention programs, including passenger restraint systems, prudent heart living and general health awareness.

   (2)  Purchasing ambulances, medical equipment and rescue equipment which enables or enhances the delivery of EMS. Equipment will be funded only if approved by the Department.

     (i)   Ambulances will be considered for funding if the funds will be used for the addition or replacement of existing vehicles or parts, by a licensed ambulance service or an entity submitting an application for licensure as an ambulance service.

     (ii)   Medical equipment will be considered for funding if the funds will be used to purchase medical equipment for ambulances, QRSs, rescue services and other emergency services approved by the Department, including police and fire departments and recognized medical command facilities.

     (iii)   Rescue equipment will be considered for funding if the funds will be used to purchase rescue equipment for ambulance services, rescue services, fire departments, QRSs, police agencies and other emergency services approved by the Department.

   (3)  Costs associated with training programs for prehospital personnel.

     (i)   Educational costs associated with the conduct of training programs for prehospital personnel, and for other personnel who are involved in managing interfacility patient transports.

     (ii)   Priority consideration will be given to training programs providing for certification, recertification, recognition and continuing education of individuals actively engaged in providing prehospital or interhospital EMS and rescue services.

   (4)  Costs associated with ambulance service inspections conducted to assist the Department with ambulance service licensure.

   (5)  Purchasing communications equipment, including medical command communications equipment, and alerting equipment for EMS purposes, if the purchases are in accordance with regional EMS council and Statewide telecommunications plans.

   (6)  Purchasing equipment for emergency departments, if the equipment is used or intended to be used in equipment exchange programs with ambulance services. The equipment purchased shall be of a type used by prehospital and interhospital EMS personnel in the care, treatment, stabilization and transportation of 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 the receiving facility.

   (7)  Costs associated with the maintenance and operation of regional EMS councils. Items eligible for funding include:

     (i)   Salaries, wages and benefits of staff.

     (ii)   Travel.

     (iii)   Equipment and supplies.

     (iv)   Leasing of office space.

     (v)   Other costs incidental to the conduct of business which are found by the Department to be necessary and appropriate.

   (8)  Costs associated with the collection and analysis of data necessary to evaluate the effectiveness of EMS systems in providing EMS. These costs may include the processing of both prehospital and hospital data and include the following:

     (i)   Data collection.

     (ii)   Data entry.

     (iii)   Data processing of information.

     (iv)   Analysis and evaluation of data.

     (v)   Dissemination and interpretation of data.

   (9)  Emergency allocations.

     (i)   Costs associated with a State or Federally declared emergency which the Department finds necessary to carry out the purpose of the act. Eligible applicants are those recognized by the regional EMS council as participants in the delivery of emergency medical or rescue services to or in the affected area.

     (ii)   Other emergency allocations found necessary by the Department to provide immediate resources or equipment to an area where the health and safety of the residents of this Commonwealth are in jeopardy.

   (10)  Costs associated with the implementation of voluntary certification or recognition programs, such as a voluntary rescue technician certification program.

   (11)  Other costs determined by the Department to be appropriate and necessary for the implementation of a comprehensive EMS system.

 (b)  Funds will not be made available for any of the following:

   (1)  Acquisition, construction or rehabilitation of facilities or buildings, except renovation as may be necessary for the implementation of 911 and EMS communication systems.

   (2)  The purchase of hospital equipment, unless the equipment is used or intended to be used in an equipment exchange program with ambulance services.

   (3)  Maintenance of ambulances, medical equipment or rescue equipment.

   (4)  Other costs found by the Department to be inappropriate.

   (5)  Costs which are normally borne by patients.

 (c)  The Department will set forth additional priorities for funding on a yearly basis in notices published in the Pennsylvania Bulletin.

 (d)  The Department, by contract or notice published in the Pennsylvania Bulletin, may require a contractor or other applicant for funding to provide matching funds in specified percentages as a condition for receiving funds distributed by the Department or a regional EMS council.

   The provisions of this §  1001.22 amended September 1, 1995, effective September 2, 1995, 25 Pa.B. 3685; amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial pages (247530) to (247532).

 The Department and regional EMS councils will consider the following factors in determining who shall receive funding and in what amount:

   (1)  The total amount of funds available.

   (2)  Conformity of the proposed application to the Statewide EMS development plan.

   (3)  Financial need of the applicant.

   (4)  Funds available to the applicant for the purpose set forth in the application, 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 an EMS system by private, public or government entities, including the Federal government.

   (5)  Economic base of the geographic area served by the applicant.

   (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 published guidelines or policies.

   The provisions of this §  1001.23 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial pages (247532) to (247533).

 To be considered for funding by the Department to plan, initiate, maintain, expand or improve an EMS system, a regional EMS council or other appropriate entity shall submit an application on a form prescribed by the Department and shall provide the following information:

   (1)  The need for planning, initiation, maintenance, expansion or improvement of an EMS system.

   (2)  Data and information which demonstrate the qualifications of the applicant to plan, initiate, expand or improve an EMS system, and which include organizational structure and provision for representation of appropriate entities.

   The provisions of this §  1001.24 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247533).

 (a)  Regional EMS councils and other contracting entities may request technical assistance from the Department, if necessary, for the purpose of carrying out their contracts. Special consideration shall be given to contractors in rural areas to assist with matters such as recruitment, retention of prehospital personnel, ambulance service management, and ambulance equipment, in recognition that rural areas may not have sufficient resources of these types.

 (b)  Technical assistance from the Department may also be available to subcontractors when technical assistance resources are not available from the regional EMS council designated for the applicable area.

 (c)  Examples of technical assistance resources include, but are not limited to:

   (1)  Telecommunications specialists.

   (2)  Public education resources.

   (3)  Information management sources.

   The provisions of this §  1001.25 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247533).

 (a)  The Department will not contract, during the same term of contract, with more than one regional EMS council to exercise responsibility for all or a portion of the same geographic area.

 (b)  A regional EMS council or other contractor does not have the right to have a contract renewed.

   The provisions of this §  1001.26 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247533).

 (a)  A regional EMS council, which has received a contract from the Department, may receive the Department’s written approval to subcontract certain of its contractual duties to other entities as deemed necessary and appropriate for the proper execution of the contract with the Department.

 (b)  A subcontract may not be executed until the Department determines in writing that the subcontract is necessary and appropriate.

 (c)  Subcontractors will be paid on a cost reimbursement basis. The costs will be determined by the Department based on documentation submitted to the Department.

   The provisions of this §  1001.27 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247533).

 Sections 1001.22—1001.27 do not apply to contracts between the Department and the Council. The Department will contract with the Council to provide it funds to perform the services the Council is required to perform under the act, and may contract with the Council for it to assist the Department in complying with other provisions of the act.

   The provisions of this §  1001.28 adopted October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363.

Subchapter C. COLLECTION OF DATA AND
INFORMATION

Sec.

§ 1001.41. Data and information requirements for ambulance services.

 (a)  Ambulance services licensed to operate in this Commonwealth shall collect, maintain and report accurate and reliable patient data and information for calls for assistance in the format prescribed and on paper or electronic forms provided or approved by the Department. An ambulance service shall file the report for any call to which it responds that results in patient care, assessment or refusal of the patient to be assessed. The report shall be made by completing an EMS patient care report and filing it, within 30 days, with the regional EMS council that is assigned responsibilities for the region in which the ambulance is based. It shall contain information specified by the Department. The Department will publish a list of the data elements and the form specifications for the EMS patient care report form in a notice in the Pennsylvania Bulletin and on the Department’s World Wide Web Site. Paper EMS patient care report forms may be secured from regional EMS councils. Electronic reporting shall conform with the requirements published in the Pennsylvania Bulletin notice. The Department will maintain a list of software it has determined to satisfy the requirements for electronic reporting.

 (b)  The Department will identify data items for the EMS patient care report as either confidential or not confidential.

 (c)  An ambulance service shall store the information designated as confidential in secured areas to assure that access to unauthorized persons is prevented, and shall take other necessary measures to ensure that the information is maintained in a confidential manner and is not available for public inspection or dissemination, except as authorized by §  1001.42 (relating to dissemination of information).

 (d)  When an ambulance service transports a patient to a hospital, before its ambulance departs from the hospital, it shall provide to the individual at the hospital assuming responsibility for the patient, either verbally, or in writing or other means by which information is recorded, the patient information designated in the EMS patient care report as essential for immediate transmission for patient care. Within 24 hours following the conclusion of its provision of services to the patient, the ambulance service shall complete the full EMS patient care report and provide a copy or otherwise transmit the data to the receiving facility. The ambulance service may report the data to the receiving facility in any manner acceptable to the receiving facility which ensures the confidentiality of information designated as confidential in the EMS patient care report.

 (e)  The ambulance service shall have a policy for designating which member of the ambulance crew is responsible for completing the EMS patient care report.

 (f)  The ambulance service shall retain a copy of the EMS patient care report for a minimum of 7 years.

   The provisions of this §  1001.41 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial pages (247534) to (247535).

 (a)  A person who collects, has access to, or knowledge of, confidential information collected under §  1001.41 (relating to data and information requirements for ambulance services), by virtue of that person’s participation in the Statewide EMS system, may not provide the EMS patient care report, or disclose the confidential 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 employe of the Department is entitled to obtain the information.

   (2)  To another person or agency under contract with or licensed by the Department and subject to strict supervision by the Department to insure that the use of the data is limited to specific research, planning, quality improvement and complaint investigation purposes and that appropriate measures are taken to protect patient confidentiality.

   (3)  To the patient who is the subject of the information released or to 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.

   (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 activities, with strict attention to patient confidentiality.

   (6)  For the purpose of data entry/retrieval and billing, with strict attention to patient confidentiality.

   (7)  Under §  1001.41 and to another health care provider to whom a patient’s medical record may be released under the law.

 (b)  The Department will regularly disseminate nonconfidential, statistical data collected from EMS patient care reports to providers of EMS for improvement of services.

   The provisions of this §  1001.42 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial pages (247535) to (247536).

   This section cited in 28 Pa. Code §  1001.41 (relating to data and information requirements for ambulance services); 28 Pa. Code §  1005.10 (relating to licensure and general operating standards); 28 Pa. Code §  1007.7 (relating to licensure and general operating requirements); and 28 Pa. Code §  1015.1 (relating to quick response service).

Subchapter D. QUALITY IMPROVEMENT PROGRAM

Sec.

§ 1001.61. Components.

 (a)  The Department, in conjunction with the Council, will identify the necessary components for a Statewide EMS quality improvement program for the Commonwealth’s EMS system. The Statewide EMS quality improvement program shall be operated to monitor the delivery of EMS through the collection of data pertaining to emergency medical care provided by prehospital personnel and providers of EMS.

 (b)  The Department will develop, approve and update a Statewide EMS Quality Improvement Plan in which it will establish goals and reporting thresholds.

 A regional EMS council, after considering input from participants in and persons served by the regional EMS system, shall develop 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 on the regional EMS system including reviewing the quality improvement activities conducted by the ALS service medical directors and medical command facilities within the region.

   (2)  Have a regional quality improvement committee that shall recommend to the regional EMS council ways to improve the delivery of prehospital EMS care within the region based upon State and regional goals and reporting requirements.

   (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.

 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. These individuals and entities shall provide information, data, reports and access to records as requested by the Department and regional EMS councils to monitor the delivery of EMS.

   The provisions of this §  1001.65 adopted October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363.

   This section cited in 28 Pa. Code §  1005.10 (relating to licensure and general operating standardsments); and 28 Pa. Code §  1007.7 (relating to licensure and general operating requirements).

Subchapter E. TRAUMA CENTERS

Sec.

§ 1001.81. Purpose.

 The purpose of this subchapter is to integrate trauma centers into the Statewide EMS system, by providing access to trauma centers and by providing for the effective and appropriate utilization of resources.

 To ensure that trauma centers are integrated into the Statewide EMS system, trauma centers in this Commonwealth shall:

   (1)  Maintain a dedicated telephone number to allow for access by referring community 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 insure the provision of patient outcome and treatment information to the referring facility on each patient referred by that facility to the trauma center.

   (4)  Maintain communications capabilities to allow for direct access by a transferring ground ambulance or air ambulance to insure that patient information and condition updates are available and medical consultation is available to the transferring service. The capabilities shall be in accordance with regional and Statewide EMS telecommunications plans.

 The Department will compile and maintain statistics on mortality and morbidity on multi-system trauma victims. This data collection shall be coordinated and performed in conjunction with other collection activities.

Subchapter F. REQUIREMENTS FOR REGIONAL EMS
COUNCILS AND THE COUNCIL

Sec.

§ 1001.101. Governing body.

 A regional EMS council and the Council shall have a governing body.

   (1)  No more than one staff member of the regional EMS council or Council may sit on the governing body at the same time.

   (2)  If the governing body consists of a board, it shall adopt written policies which include, but are not limited to:

     (i)   A method of selection for membership.

     (ii)   Qualifications for membership.

     (iii)   Criteria for continued membership.

     (iv)   Frequency of meetings.

   (3)  The duties of the governing body shall include, but not be limited to:

     (i)   Selecting a director as the person officially responsible to the governing body.

     (ii)   Identifying the purpose and philosophy.

     (iii)   Describing the organizational structure.

   (4)  The governing body shall make available to the public an annual report which includes, but is not limited to:

     (i)   Activities and accomplishments of the preceding year.

     (ii)   A financial statement of income and expenses.

     (iii)   A statement disclosing the names of officers and directors.

   The provisions of this §  1001.103 reserved October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247539).

Subchapter G. ADDITIONAL REQUIREMENTS FOR
REGIONAL EMS COUNCILS

Sec.

§ 1001.121. Designation of regional EMS councils.

 (a)  The Department will designate a regional EMS council that satisfies the representation requirements in §  1001.125 (relating to requirements) for each geographic area of this Commonwealth.

 (b)  The designation of the geographical area will be based on:

   (1)  Existing usual patient care flow patterns.

   (2)  The capability to provide definitive care services to the majority of general, emergent and critical patients.

   (3)  Financial resources to sustain the EMS system operations.

   (4)  The capability to establish community-wide and regional care programs.

 (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 its region in planning, developing, maintaining, expanding, improving and upgrading the EMS system in its region.

 In addition to other responsibilities imposed upon regional EMS councils by this part, regional EMS councils have responsibility for the following:

   (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 recommended 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)  Assisting hospitals in providing the Department with a comprehensive written plan for emergency care based on community need as provided in §  117.11 (relating to emergency services plan) and in identifying the hospital’s scope of services as provided in §  117.13 (relating to scope of services).

   (6)  Assisting the Department in achieving a unified Statewide EMS system as described in section 4 of the act (35 P. S. §  6924).

   (7)  Assisting the Department in collection and maintenance of standardized patient data and information.

   (8)  Providing ambulance services with data summary reports.

   (9)  Assuring the reasonable availability of training programs, including continuing education programs, for EMS personnel. The programs shall include those that lead to certification or recognition by the Department. Regional EMS councils may also develop and implement additional educational programs.

   (10)  Monitoring medical command facilities and prehospital personnel compliance with minimum standards established by the Department, and ambulance service medical director and medical command physician medical control of prehospital personnel.

   (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 the triage, treatment, transport and transfer of patients to the most appropriate facility. Protocols shall be developed in consultation with the regional EMS council’s medical advisory committee and approved by the Department. Protocols shall, at a minimum:

     (i)   Include a method of identifying patients requiring specialized medical care, utilizing measurable criteria to identify patient referral.

     (ii)   Be based upon the specialty care capabilities of the receiving facilities and available providers of EMS, prehospital personnel, local geodemographic considerations and transport time considerations.

     (iii)   Be distributed to the providers of EMS 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 1003 (relating to personnel) which governs the scope of practice of EMTs, EMT-paramedics and other prehospital personnel.

     (vi)   Be based upon accepted standards of emergency medical care.

     (vii)   Address patient choice regarding receiving facility.

     (viii)   Set forth a procedure for the efficient transfer of patients. When appropriate, these regional protocols shall be developed in consultation with specialty care facilities in the region.

   (13)  Assisting Federal, State or local agencies, upon request, in the provision of onsite mitigation, technical assistance, situation assessment, coordination of functions or postincident 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 and personnel available on a volunteer basis as conditions and circumstances require and recruiting volunteers as needed.

   (15)  Designating a regional medical director.

   (16)  Supervising the regional EMS medical director to assure that the roles and responsibilities in §  1003.2 (relating to regional EMS medical director) are carried out.

   (17)  Assisting prehospital personnel and ambulance services operating in the regional EMS system to meet the licensure, certification, recertification, recognition, biennial registration and continuing education requirements established under the act and this part, and assisting the Department in ensuring that those requirements are met.

   (18)  Apprising medical command facilities and ALS ambulance services in the region when an EMT-paramedic or prehospital registered nurse has had medical command authorization removed by an ALS service medical director for an ALS ambulance service in the region.

   (19)  Developing a conflict of interest policy and requiring employes and officials to agree to the policy in writing.

   (20)  Approving medical command physicians in accordance with §  1003.4(c)(2) (relating to medical command physician).

   (21)  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 development plan.

 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 areawide arrangement or consortium.

   (3)  A public or private nonprofit entity.

 (a)  If the regional EMS council is a unit of local government, it shall have an advisory council which is deemed by the Department to be representative of health care consumers, the health professions, and major private and public and voluntary agencies, organizations and institutions concerned with providing EMS.

 (b)  If the regional EMS council is a public or private nonprofit organization, its governing body shall satisfy the representation requirements in subsection (a).

 (c)  A regional EMS council shall establish and maintain a medical advisory committee and other committees which are necessary to carry out the responsibilities of the regional EMS council.

 (d)  The regional medical advisory committee shall assist the regional EMS council’s medical director in matters of medical coordination.

 (e)  Meetings of the regional EMS council shall be held under the Sunshine Act (65 P. S. § §  271—286).

   The provisions of this §  1001.125 amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247543).

   This section cited in 28 Pa. Code §  1001.121 (relating to designation of regional EMS Council).

Subchapter H. ADDITIONAL REQUIREMENTS FOR
THE COUNCIL

Sec.

§ 1001.141. Duties and purpose.

 The Council shall advise the Department on emergency health services issues that relate to manpower and training, communications, ambulance services, special care units, the content of EMS patient care reports, the content of rules and regulations, standards and policies promulgated by the Department and other subjects as required by the act or deemed appropriate by the Depart-ment or the Council. The Council shall also advise the Department on the content of the Statewide EMS development plan, and proposed revisions to it.

 (a)  Meetings of the Council shall be held under the Sunshine Act (65 P. S. § §  271—286).

 (b)  A voting member of the Council 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 Council constitutes a quorum for the transaction of business.

 In the event of a potential or actual disaster, mass casualty situation or other substantial threat to public health, the Council shall, upon request, assist Federal, State and local agencies in the provision of onsite mitigation, technical assistance, situation assessment, coordination of functions or postincident evaluations. Recruitment of volunteer expertise available to the Council will be requested and utilized as conditions and circumstances necessitate.

Subchapter I. RESEARCH IN PREHOSPITAL CARE

Sec.

§ 1001.161. Research.

 (a)  Clinical investigations or studies that relate to direct patient care may not be conducted by providers of EMS unless the investigation or study is proposed to and approved by the Department.

 (b)  A proposal for clinical investigation or study shall be presented to the Department. If the Department concludes that the proposal may have merit, it shall refer the proposal to the Council, and to the regional EMS council having responsibilities in the region where the investigation or study would be undertaken. The Council and the regional EMS council shall have the proposal reviewed by their medical advisory committees and consider the comments of those committees, and shall forward their recommendations to the Department within 60 days after receiving from the Department a request to review the proposal.

 (c)  The Department will approve or disapprove the proposal within 30 days after receiving the recommendations of the Council and the regional EMS council. If the proposal is approved, the prehospital personnel identified in the proposal may function in accordance with the proposal and under conditions specified by the Department during the term of the clinical investigation or study.

 (d)  A proposal shall include and address the following considerations and items 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 investigations.

   (3)  An estimated duration of the investigation.

   (4)  Consideration of complications or side effects that may be encountered and how they shall be treated.

   (5)  Consideration of how to assure patient confidentiality.

   (6)  Consideration of obtaining informed consent of the patient.

   (7)  Institutional review board approval when required by law.

   (8)  A letter from the researcher who identifies himself as the lead investigator and assumes clinical responsibility for the investigation.

   (9)  A letter from the physician who assumes clinical responsibility for the investigation.

   (10)  A plan for providing the Department with progress reports and a final report on the investigation or study.

 (e)  The Department may direct that the investigation or study be terminated prematurely for its failure to satisfy conditions of approval.

   The provisions of this §  1001.161 amended September 1, 1995, effective September 2, 1995, 25 Pa.B. 3685; amended October 13, 2000, effective October 14, 2000, 30 Pa.B. 5363. Immediately preceding text appears at serial page (247545).