[41 Pa.B. 5865]
[Saturday, October 29, 2011]
[Continued from previous Web Page]
Subchapter C. OTHER PERSONS ASSOCIATED WITH THE STATEWIDE EMS SYSTEM Sec.
1023.51. Certified EMS instructors. 1023.52. Rescue personnel. § 1023.51. Certified EMS instructors.
(a) Certification. The Department will certify as an EMS instructor an individual who meets the following qualifications:
(1) Has completed an application for EMS instructor certification on a form or through an electronic process, as prescribed by the Department.
(2) Is 18 years of age or older.
(3) Has successfully completed an EMS instructor course approved by the Department or possesses, at a minimum, a bachelor's degree in education or a teacher's certification in education.
(4) Has provided at least 20 hours of instruction time in an EMS provider educational course monitored by a certified EMS instructor designated by the EMS educational institute's administrative director.
(5) Possesses current certification as an EMT or higher level EMS provider.
(6) Possesses current certification in CPR or current certification as a CPR instructor.
(7) Possesses at least 1 year experience in providing EMS as an EMT or higher level EMS provider.
(b) Triennial registration. An EMS instructor certification is deemed registered for 3 years. Thereafter, an EMS instructor shall triennially register the certification by completing a form or through an electronic process, as prescribed by the Department. An EMS instructor shall submit the form or complete the electronic process at least 30 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the EMS instructor certification not being registered again before the prior registration expires. The Department will issue a new registration within 30 days after the EMS instructor completes the form or the electronic process if the information provided establishes that the EMS instructor has met the following requirements:
(1) Has provided documentation to the Department to establish that the individual conducted at least 60 hours of teaching EMS provider or rescue courses during the previous 3 years.
(2) Possesses current registration of a certification as an EMT or higher level EMS provider.
(3) Possesses current certification in CPR or a current certification as a CPR instructor.
(c) Standards for providing instruction. An EMS instructor shall satisfy the following in providing instruction in an EMS educational institute:
(1) Present EMS educational program course materials as required under § 1025.1(h)(6) (relating to accreditation and operational requirements of EMS educational institutes).
(2) Utilize a variety of instructional strategies, adapting to students with diverse backgrounds and different learning styles.
(3) Establish and clearly communicate to students the goals and objectives for the certification class being taught and administer periodic evaluations to assess whether those goals and objectives are being met.
(4) Maintain class order and discipline, manage the classroom learning environment and monitor the effectiveness of instruction.
(5) Ensure proper class time management with particular attention to completion of required class hours.
§ 1023.52. Rescue personnel.
(a) Basic rescue practices technician.
(1) Roles and responsibilities. A basic rescue practices technician is an individual certified by the Department as possessing the training and skills to perform rescue skills in accordance with the basic rescue practices course approved by the Department in consultation with the State Fire Commissioner. A basic rescue practices technician utilizes basic tools and equipment of the rescue service to perform a safe and efficient rescue operation.
(2) Minimum qualifications. To secure certification as a basic rescue practices technician, an applicant shall make application for basic rescue practices technician certification on a form or through an electronic process, as prescribed by the Department, and shall have successfully completed a training program for basic rescue practices approved by the Department and a written basic rescue practices test developed by the Department.
(b) Basic vehicle rescue technician.
(1) Roles and responsibilities. A basic vehicle rescue technician is an individual certified by the Department as possessing the training and skills to perform rescue skills in accordance with the basic vehicle rescue course approved by the Department in consultation with the State Fire Commissioner. The program provides the student with the knowledge and skills necessary to achieve the rescue of persons involved in automobile accidents.
(2) Minimum qualifications. To secure certification as a basic vehicle rescue technician, an applicant shall make application for basic vehicle rescue practices technician certification on a form or through an electronic process, as prescribed by the Department, and shall have successfully completed a training program for basic vehicle rescue approved by the Department and a written basic vehicle rescue practices test developed by the Department.
(c) Special vehicle rescue technician.
(1) Roles and responsibilities. A special vehicle rescue technician is an individual certified by the Department as possessing the training and skills to perform rescues in accordance with the specialized rescue training course approved by the Department in consultation with the State Fire Commissioner.
(2) Minimum qualifications. To secure certification as a special vehicle rescue technician, an applicant shall make application for special vehicle rescue practices technician certification on a form or through an electronic process, as prescribed by the Department, and shall have successfully completed a training program for specialized vehicle rescue approved by the Department and a written special vehicle rescue technician test developed by the Department.
(d) Rescue instructor. The Department will develop a program in consultation with the State Fire Commissioner providing for the certification of rescue instructors. Courses that seek Department approval as a rescue training course for a basic rescue practices technician, basic vehicle rescue technician or special vehicle rescue technician shall be taught by certified rescue instructors.
(e) Certificates. The rescue technician certifications issued by the Department under this section do not constitute a legal prerequisite for the performance of rescues. The rescue instructor certifications issued by the Department under this section do not constitute a legal prerequisite for serving as a rescue instructor in programs other than rescue training courses approved by the Department. The Department approves the rescue programs and issues the certifications referenced within this section to promote the Statewide EMS system having personnel with sufficient education and skills to perform rescues.
CHAPTER 1025. EDUCATION Subchap.
A. EMS EDUCATIONAL INSTITUTES B. EMS CONTINUING EDUCATION COURSES
Subchapter A. EMS EDUCATIONAL INSTITUTES Sec.
1025.1. Accreditation and operational requirements of EMS educational institutes. 1025.2. Accreditation process. 1025.3. Advertising. § 1025.1. Accreditation and operational requirements of EMS educational institutes.
(a) Eligible entity. An EMS educational institute shall be a secondary or postsecondary institution, hospital, regional EMS council, an educational institute in a branch of the armed forces or another entity which meets the criteria in this chapter.
(b) Educational programs.
(1) An EMS educational institute that is accredited by the Department to offer BLS educational courses (BLS educational institute) shall evidence the ability to conduct one or more of the following EMS provider educational courses:
(i) Emergency medical responder course.
(ii) Emergency medical technician course.
(2) An EMS educational institute that is accredited by the Department to offer ALS educational courses (ALS educational institute) shall evidence the ability to conduct one or more of the following EMS provider educational courses:
(i) Advanced emergency medical technician course.
(ii) Paramedic course.
(3) An EMS educational institute shall register with the Department the location and staffing plan of a course it offers towards satisfying an EMS provider certification educational requirement at least 30 business days before the first class is held.
(c) Advisory committee.
(1) An EMS educational institute shall have an advisory committee that is comprised of representatives of the EMS communities that have an interest in the EMS provider educational courses the institute offers, and which also includes a representative of an appropriate regional EMS council and the institute's medical director.
(2) The advisory committee shall meet at least annually and assist program personnel in formulating and periodically revising appropriate goals and objectives and in monitoring the EMS educational institute's performance.
(d) Disclosure to students and prospective students. An EMS educational institute shall disclose the following to students and prospective students:
(1) The institute's accreditation status.
(2) The Department is the accrediting body, the contact information for the Department and the regional EMS councils where its courses are offered, as provided to the institute by the Department and those regional EMS councils.
(3) The institute's admissions, discipline and discharge policies and practices.
(4) The functional job analysis of each EMS provider classification for which it is offering an EMS provider educational course.
(5) The requirements for completing each EMS provider educational course it offers, including, to the extent known, advance notice of the books and materials required for each course.
(6) The tuition fees and other costs involved in completing each EMS provider educational course.
(7) The policy and process for withdrawal from a course and the refund of tuition and other fees.
(8) Information as to how students may perform clinical work while enrolled in an EMS provider educational course.
(9) The percentage of students for the previous 3 years who enrolled in and completed each EMS provider educational course offered by the institute.
(10) The percentage of students for the previous 3 years, for each EMS provider educational course, who obtained EMS provider certification, and a percentage of the students who obtained certification after a first examination.
(11) The regulatory requirements for testing leading to EMS provider certification.
(12) The EMS educational institute's policies for the prevention of sexual harassment.
(e) Medical director.
(1) An EMS educational institute shall have a medical director who is a physician. The medical director shall be experienced in emergency medical care and have demonstrated ability in education and administration.
(2) The responsibilities of the medical director shall include:
(i) Reviewing course content to ensure compliance with this chapter.
(ii) Reviewing and approving the EMS educational institute's criteria for the recruitment, selection and orientation of educational institute faculty.
(iii) Providing technical advice and assistance to the EMS educational institute faculty and students.
(iv) Reviewing the quality and medical content of the education and compliance with protocols.
(v) Participating in the review of new technology for training and education.
(3) Additional responsibilities for a medical director of an ALS educational institute include:
(i) Approving the content of course written and practical skills examinations.
(ii) Identifying and approving facilities where students are to fulfill clinical and field internship requirements.
(iii) Identifying and approving individuals to serve as field and clinical preceptors to supervise and evaluate student performance when fulfilling clinical and field internship requirements.
(iv) Signing skill verification forms for students who demonstrate the knowledge and skills required for successful completion of the EMS provider educational course and entry level competency for the EMS provider for which the EMS provider educational course is offered.
(f) Administrative director.
(1) A BLS educational institute shall have an administrative director who has at least 2 years of experience in administration and 3 years of experience in prehospital care.
(2) An ALS educational institute shall have an administrative director who has at least 2 years of experience in administration and 3 years of experience in ALS prehospital care, and who has a Bachelor's degree from an accredited school of higher education and an EMS provider certification above the AEMT level.
(3) Responsibilities of the administrative director include ensuring:
(i) The adequacy of the system for processing student applications and the adequacy of the student selection process.
(ii) The adequacy of the process for the screening and selection of instructors for the EMS educational institute.
(iii) The EMS educational institute maintains an adequate inventory of necessary educational equipment and that the training equipment is properly prepared and maintained.
(iv) The adequate administration of the course and written and practical skills examinations involved in the course.
(v) There is an adequate system for the maintenance of student records and files.
(vi) There is an appropriate mechanism to resolve disputes between students and faculty.
(4) The administrative director shall serve as the contact person and liaison between the EMS educational institute and the Department and regional EMS councils. The administrative director may designate another person to perform those functions and monitor that person's performance to ensure that the contact and liaison responsibilities are being satisfied.
(g) Course coordinator.
(1) The EMS educational institute shall designate a course coordinator for each EMS provider educational course conducted by the educational institute.
(2) A course coordinator shall satisfy the following requirements:
(i) Reading and language skills commensurate with the resource materials to be utilized in the course.
(ii) Knowledge of the Statewide EMS protocols and of the regional EMS protocols for each EMS region where the course is offered.
(iii) Three years of clinical experience providing prehospital care as an EMS provider at or above the EMT level.
(iv) Certification as an EMS instructor.
(3) The 3 years of clinical experience providing prehospital care of a course coordinator for an ALS educational course shall be as an EMS provider above the AEMT level.
(4) A course coordinator is responsible for the management and supervision of each EMS provider educational course offered by the educational institute for which that individual serves as a course coordinator.
(5) Specific duties of a course coordinator shall be assigned by the EMS educational institute.
(6) One person may serve both as the administrative director and a course coordinator.
(h) Instructors.
(1) An EMS educational institute shall ensure the availability of qualified and responsible instructors for each EMS provider educational course.
(2) The EMS educational institute shall make available faculty development for EMS instructors in the concepts of utilizing a variety of instructional strategies, adapting to students with diverse backgrounds and different learning styles and be responsible for ensuring that its instructors are competent in providing education employing those instructional strategies.
(3) An instructor shall be 18 years of age or older and possess a high school diploma or GED equivalent.
(4) At least 75% of the instruction provided in EMS provider educational courses shall be provided by instructors who are either of the following:
(i) EMS instructors certified by the Department who have at least 3 years of experience as an EMS provider at or above the level they are teaching and at least 2 years of experience in teaching an EMS provider educational course at or above the level they are teaching.
(ii) Determined by the course coordinator and the medical director of the EMS educational institute to meet or exceed these standards.
(5) The EMS educational institute's medical director, in consultation with appropriate course coordinators, is responsible for verifying the special expertise of an instructor who does not satisfy the requirements in paragraph (4) and for specifying the portions of the curriculum that are appropriate for the instructor to teach.
(6) Instructors are responsible for presenting course materials in accordance with the curriculum established or approved for the course by the Department for the EMS provider level of the course and the Statewide EMS protocols applicable to that EMS provider level.
(i) Clinical preceptors.
(1) An EMS educational institute shall ensure the availability of clinical preceptors for each EMS provider educational course.
(2) A clinical preceptor is responsible for the supervision and evaluation of students while fulfilling clinical requirements for an EMS provider educational course.
(j) Field preceptors.
(1) An EMS educational institute shall ensure the availability of qualified field preceptors for each student enrolled in an EMS provider educational course at or above the AEMT level.
(2) An EMS educational institute shall ensure the availability of a qualified field preceptor for each student enrolled in an EMS provider educational course below the AEMT level for whom it provides a field internship.
(3) An EMS educational institute shall use as a field preceptor for an EMS provider educational course an EMS provider who is certified and practicing at or above the level of the EMS provider certification for which the course is being taught.
(4) A field preceptor is responsible for the supervision and evaluation of students while fulfilling a field internship for an EMS provider educational course. A field preceptor shall directly supervise a student's performance of any EMS skill for which the student does not have an EMS provider certification under which the student is authorized to perform the skill.
(k) Facilities and equipment. An EMS educational institute shall:
(1) Maintain educational facilities necessary for the provision of EMS provider educational courses, including satisfying applicable State and Federal standards to address the needs of persons with disabilities. The facilities shall include classrooms and space for equipment storage and be of sufficient size and quality to conduct didactic and practical skill performance sessions.
(2) Provide, properly prepare and maintain the essential equipment, including simulators and task trainers, and the supplies to administer the course.
(l) Operating procedures. An EMS educational institute shall:
(1) Adopt and implement a nondiscrimination policy with respect to student selection and faculty recruitment.
(2) Maintain a file on each enrolled student which includes class performance, practical and written examination results, and reports made concerning the progress of the student during the EMS provider educational course.
(3) Provide a mechanism by which students may grieve decisions made by the institute regarding dismissal from an EMS provider educational course or other disciplinary action.
(4) Provide students with preparation for testing leading to EMS provider certification.
(5) Have a policy regarding the transfer of a student into or out of an EMS provider educational course from one EMS educational institute to another.
(6) Have a continuing quality improvement process in place for students, instructors and clinical evaluation.
(7) Require each student applicant to complete an application for enrollment provided by the Department.
(8) Prepare a course completion form for each student who successfully completes the EMS provider educational course and, no later than 14 days after the educational course has concluded, forward that form to the regional EMS council having responsibility in the EMS region where the EMS educational institute operates.
(9) Participate in EMS educational institute system evaluation activities as requested by the Department.
(10) Require each student to complete and submit the form or complete the electronic process, as prescribed by the Department, under § 1023.21(b) (relating to general rights and responsibilities) for reporting criminal convictions, discipline and exclusion from a State or Federal health care program. The EMS educational institute shall inform each student of the duty to update the report if there is a change in this information before the Department acts upon the student's application for EMS provider certification.
(11) Forward a copy of the form completed under paragraph (10) to the regional EMS council having responsibility in the EMS region where the EMS educational institute operates, no later than 14 days after the first class session.
(m) Providing access to facility and records. An EMS educational institute and an applicant for EMS educational institute accreditation shall promptly make available to the Department or a regional EMS council, upon request, its educational facility for inspection and provide them with complete and accurate records relating to the institute's compliance with the requirements in this subchapter.
(n) Transitional requirements. This section applies to an EMS educational institute that is accredited on ______ (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) beginning with its initial application for reaccreditation as an EMS educational institute on or after ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) and to its operations as an EMS educational institute beginning with its accreditation under that application.
§ 1025.2. Accreditation process.
An EMS educational institute shall meet the following requirements to be accredited by the Department:
(1) The applicant shall submit an application for accreditation on forms or through an electronic process, as prescribed by the Department, to the regional EMS council having responsibility in the EMS region where the EMS educational institute intends to conduct its primary operations. An applicant for reaccreditation shall submit the application at least 180 days, but not more than 1 year, prior to expiration of the current accreditation.
(2) The regional EMS council shall review the application for completeness and accuracy.
(3) The regional EMS council shall have 30 days in which to review the application, conduct an onsite assessment of the institute and determine whether the applicant has satisfied the requirements in § 1025.1 (relating to accreditation and operational requirements of EMS educational institutes).
(4) The regional EMS council shall forward to the Department the application for accreditation either with an endorsement or an explanation as to why the application has not been endorsed, citing regulatory standards it believes have not been satisfied.
(5) Within 150 days of receipt, the Department will review the application and make one of the following determinations:
(i) Full accreditation. The EMS educational institute meets the criteria in § 1025.1, as applicable, and will be accredited to operate for 3 years.
(ii) Conditional accreditation. The EMS educational institute does not meet criteria in § 1025.1, as applicable, but the deficiencies identified are deemed correctable by the Department. The EMS educational institute will be allowed to proceed or continue to provide accredited EMS education with close observation by the Department. Deficiencies which prevent full accreditation shall be enumerated and corrected within a time period specified by the Department. Conditional accreditation may not exceed 1 year and may not be renewed.
(iii) Nonaccreditation. The institute does not meet criteria in § 1025.1 and the deficiencies identified are deemed to be serious enough to preclude any type of accreditation.
(6) An EMS educational institute that has received full or conditional accreditation shall submit status reports to the Department as requested.
(7) Prior to and during accreditation, an EMS educational institute is subject to review, including inspection of records, facilities and equipment by the Department. An authorized representative of the Department may enter, visit and inspect an accredited EMS educational institute or a facility operated by or in connection with the EMS educational institute with or without prior notification. The Department may accept the survey results of another accrediting body if the Department determines that the accreditation standards of the other accrediting body are equal to or exceed the standards in this chapter, and that the survey process employed by the other accrediting body is adequate to gather the information necessary for the Department to make an accreditation decision.
(8) An EMS educational institute shall advise the Department at least 90 days prior to an intended change of ownership or control of the institute. Accreditation is not transferable to new owners or controlling parties.
(9) An EMS educational institute that intends to conduct an EMS educational course in an EMS region under the jurisdiction of a regional EMS council other than that through which it submitted its application for accreditation shall file a written application to amend its accreditation with the regional EMS council having responsibility for the region in which it intends to conduct these courses. That application shall be processed by that regional EMS council and acted upon by the Department within 90 days.
§ 1025.3. Advertising.
(a) An entity may advertise an educational course in a manner that states or suggests that the successful completion of the course satisfies the EMS provider educational course requirement for an EMS provider certification issued by the Department only after the entity has been accredited by the Department as an EMS educational institute and the course has been approved by the Department for that purpose under § 1025.2 (relating to accreditation process).
(b) When an EMS provider educational course has been approved under § 1025.2, the EMS education institute shall announce the following in its brochures or registration materials: This course has been approved by the Pennsylvania Department of Health as meeting the educational course requirement that an applicant for certification as a/an (the type of EMS provider or EMS vehicle operator to which the course applies) needs to satisfy to be certified by the Pennsylvania Department of Health as a/an (the type of EMS provider or EMS vehicle operator to which the course applies).
Subchapter B. EMS CONTINUING
EDUCATION COURSESSec.
1025.21. Accreditation of sponsors of continuing education. 1025.22. Responsibilities of continuing education sponsors. 1025.23. Advertising. § 1025.21. Accreditation of sponsors of continuing education.
(a) Entities and institutions may apply for accreditation as a continuing education sponsor by submitting to the Department an application on a form or through an electronic process, as prescribed by the Department. The applicant shall supply the information requested in the application. The Department will grant accreditation to an applicant for accreditation as a continuing education sponsor if the applicant satisfies the Department that the courses the applicant offers meet the following minimum standards:
(1) The courses shall be of intellectual and practical content.
(2) The courses shall contribute directly to the professional competence, skills and education of EMS providers or EMSVOs.
(3) The course instructors shall possess the necessary practical and academic skills to conduct the course effectively.
(4) Course materials shall be well written, carefully prepared, readable and distributed to attendees at or before the time the course is offered whenever practical.
(5) The courses shall be presented by a qualified responsible instructor in a suitable setting devoted to the educational purpose of the course.
(b) Accreditation of the continuing education sponsor will be effective for 3 calendar years.
(c) At least 90 days prior to expiration of the 3-year accreditation period, a continuing education sponsor shall apply to the Department for renewal of the sponsor's accreditation on a form or through an electronic process, as prescribed by the Department. The Department will renew the sponsor's accreditation if the sponsor meets the following requirements:
(1) The sponsor has presented, within the preceding 3 years, a continuing education course or courses on at least five occasions which met the minimum standards in subsection (a).
(2) The sponsor establishes to the Department's satisfaction that future courses to be offered by the sponsor will meet the minimum standards in subsection (a).
(3) The sponsor has satisfied its responsibilities under § 1025.22 (relating to responsibilities of continuing education sponsors).
§ 1025.22. Responsibilities of continuing education sponsors.
(a) Course approval. A continuing education sponsor shall submit, to the regional EMS council that exercises responsibility for the EMS region in which the continuing education sponsor intends to conduct a new continuing education course, an application for approval of that continuing education course. The continuing education sponsor shall submit that application at least 30 days prior to the date the continuing education sponsor expects to conduct the course.
(b) Registration of course. A continuing education sponsor may not offer, for continuing education credit, a course for which it or another continuing education sponsor has received approval to offer as a continuing education course without registering with the Department the location of the class through which it intends to offer that course for continuing education credit at least 30 days before the class is held.
(c) Record of attendance. A continuing education sponsor shall maintain a record of attendance for a course presented in a classroom setting by maintaining a check-in/check-out process approved by the Department and assign at least one person to ensure that the individuals attending the course check in when entering and check out when leaving. If an individual enters a course after the starting time, or leaves a course before the finishing time, the assigned person shall ensure that the time of arrival or departure is recorded for the individual.
(d) Reporting attendance. A continuing education sponsor shall report to the Department, in the manner and format prescribed by the Department, attendance at each continuing education course presented in a classroom setting within 10 days after the course has been presented.
(e) Course evaluation. A continuing education sponsor shall develop and implement methods to evaluate its course offerings to determine their effectiveness. The methods of evaluation shall include providing a course evaluation form to each person who attends a course. The continuing education sponsor shall provide a copy of the completed course evaluation forms to the regional EMS council within 10 days after the course has been presented.
(f) Record retention. The continuing education sponsor shall retain the completed course evaluation forms for each course it presents and the check-in/check-out record for each course it presents in a classroom setting. These records shall be retained for at least 4 years from the presentation of the course.
(g) Providing access to records. A continuing education sponsor and an applicant for accreditation as a continuing education sponsor shall promptly make available for inspection and provide the Department or a regional EMS council with complete and accurate records relating to its compliance with the requirements in this subchapter as requested by the Department or a regional EMS council.
(h) Course not presented in a classroom setting. A continuing education sponsor shall be exempt from the requirements in subsections (a) and (b) for a course which is not presented in a classroom setting, if the course is approved by the Department for credit when presented in that manner. When presenting the course to the Department for approval for credit, the continuing education sponsor shall present a procedure for monitoring, confirming and reporting EMS provider or EMSVO participation in a manner that achieves the purposes of subsections (a) and (b).
(i) Monitoring responsibilities. A continuing education sponsor shall ensure that a course was presented in a manner that met all of the educational objectives for the course and determine whether each EMS provider or EMSVO who enrolled in the course met the requirements in this chapter and the continuing education sponsor to receive credit for completing the course.
(j) Course completion. A continuing education sponsor shall report to the Department, in a manner and format prescribed by the Department, completion of a course by an EMS provider or EMSVO and identify to the Department an EMS provider or EMSVO who seeks credit for a course but who did not meet the requirements of the continuing education sponsor or this chapter to receive continuing education credit. The continuing education sponsor shall also provide an EMS provider or EMSVO who completes a course with a document certifying completion of the course.
§ 1025.23. Advertising.
(a) A continuing education sponsor may advertise a course as a continuing education course in a manner that states or suggests that the course meets the requirements in this chapter only if the course has been approved by the Department to be offered by that continuing education sponsor.
(b) When a course has been approved for continuing education credit, the continuing education sponsor shall announce in the following its brochures or registration materials: This course has been approved by the Pennsylvania Department of Health for (the approved number of hours) of continuing education credit for (the type of EMS provider(s) or EMS vehicle operator to which the course applies).
(c) If a continuing education sponsor advertises that it has applied to the Department to secure continuing education credit for a course, prior to presenting the course it shall disclose to all enrollees whether the course has been approved or disapproved for credit.
CHAPTER 1027. EMS AGENCIES Subchap.
A. GENERAL REQUIREMENTS B. EMS AGENCY SERVICES C. MISCELLANEOUS
Subchapter A. GENERAL REQUIREMENTS Sec.
1027.1. General provisions. 1027.2. License and registration applications. 1027.3. Licensure and general operating standards. 1027.4. Medication use, control and security. 1027.5. Statewide EMS response plan. 1027.6. EMS vehicle fleet. 1027.7. Removal of EMS vehicles from operation. 1027.8. Right to enter, inspect and obtain records. 1027.9. Notification of deficiencies to applicants. 1027.10. Plan of correction. 1027.11. Conditional temporary license. 1027.12. Discontinuation or movement of operations or reduction of service. 1027.13. Management companies. § 1027.1. General provisions.
(a) License required. A person, or other entity, as an owner, agent or otherwise, may not operate, conduct, maintain, advertise or otherwise engage in or profess to be engaged in operating an EMS agency in this Commonwealth unless that person holds a license as an EMS agency and a current registration of that license issued by the Department or is exempt from these requirements. By way of example, an entity is operating an EMS agency if it operates any of the following:
(1) An ambulance service.
(i) BLS ambulance service.
(ii) Intermediate ALS ambulance service.
(iii) ALS ambulance service, including a critical care transport ambulance service.
(iv) Air ambulance service.
(2) A squad service.
(i) BLS squad service.
(ii) Intermediate squad service.
(iii) ALS squad service.
(3) A QRS.
(4) A special operations EMS service.
(i) Tactical EMS service.
(ii) Wilderness EMS service.
(iii) Mass-gathering EMS service.
(iv) Urban search and rescue service.
(b) License requirements. The Department will license an applicant as an EMS agency if the Department is satisfied that the applicant has met the following requirements:
(1) The applicant and persons having a substantial ownership interest in the applicant are responsible persons and the EMS agency shall be staffed by and conduct its activities through responsible persons. For purposes of this paragraph:
(i) A responsible person is a person who has not engaged in an act contrary to justice, honesty or good morals which indicates that the person is likely to betray the public trust in carrying out the activities of the EMS agency, or is a person who has engaged in this type of conduct but has been rehabilitated and is not likely to again betray the public trust.
(ii) A person has a substantial ownership in the applicant if the person has equity in the capital, stock or the profits of the applicant equal to 5% or more of the property or assets of the applicant.
(iii) A person staffs an EMS agency if the person engages in activity integral to the operation of the EMS agency, including participating in the making or execution of management decisions, providing EMS, billing, calltaking and dispatching.
(2) The applicant meets the supply and equipment requirements for each EMS vehicle and type of EMS service it makes application to offer, and demonstrates that it shall be maintained and operated to safely and efficiently operate those vehicles and render those services.
(3) The applicant shall meet staffing standards for the vehicles it seeks to operate and the services it seeks to provide. Subject to the exceptions in § 1027.5 (relating to Statewide EMS response plan), this includes providing EMS services 24 hours-a-day, 7 days-a-week or participating in a county-level or broader-level EMS response plan approved by the Department.
(4) The applicant shall provide safe services that are adequate for the emergency medical care, treatment and comfort and, when applicable, the transportation of patients.
(5) The applicant has an EMS agency medical director who satisfies requirements established by the Department based upon the types of services it seeks to provide and the EMS vehicles it seeks to operate.
(6) The applicant satisfies the regulatory requirements relating to making its application for a license and has adopted policies and procedures adequate to ensure compliance with the requirements in the act, this part and notices the Department publishes in the Pennsylvania Bulletin that are applicable to its operations.
(c) License certificate. The Department will issue a license certificate to an applicant that it licenses as an EMS agency. The license certificate will specify the name of the EMS agency, its license number, the address of its primary operational headquarters and the date the license was issued. The Department will also issue with the license certificate a document that specifies the type or types of EMS agency services the EMS agency is licensed to provide, the types of EMS vehicles the agency will operate, the locations out of which it is authorized to provide that service or services if more than one location is involved, the fictitious name, if any, under which it conducts its operations at each location involved, and the name of the regional EMS council through which the license application was processed. The Department will replace that document if there is a need to change the information on it due to a license amendment.
(d) License registration. An EMS agency requires both an EMS agency license and current registration of that license to conduct its operations. When the Department registers an EMS agency's license it will issue a registration certificate to the EMS agency that specifies the name of the EMS agency, its license number, the address of its primary operational headquarters and the dates the registration is effective and will expire.
(e) Transition for ambulance services and QRSs.
(1) An entity that is licensed as an ambulance service or recognized as a QRS by the Department, or a hospital that operates an ambulance service or QRS under its hospital license, immediately prior to ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) will be licensed by the Department as an EMS agency, with a current registration of that license on ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) if the records of the Department reflect that the ambulance service, QRS or hospital has an EMS agency medical director. The license and registration will authorize the EMS agency to operate the EMS vehicles and provide the services it was authorized to operate and provide when licensed as an ambulance service, recognized as a QRS, or operated under a hospital license.
(2) An entity that is licensed as an ambulance service or recognized as a QRS by the Department, or operates an ambulance service under a hospital license, immediately prior to ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) that does not have an EMS agency medical director may continue to operate as an ambulance service or QRS under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)) until ______ , (Editor's Note: The blank refers to 180 days after the effective date of adoption of this proposed rulemaking.) without securing an EMS agency license.
§ 1027.2. License and registration applications.
(a) License application. An application for an EMS agency license shall be submitted on a form or through an electronic process, as prescribed by the Department. The application must contain the following information as well as an additional information and documents that may be solicited by the application form:
(1) The name and mailing address of the applicant and a primary contact person and telephone number at which that person can be reached.
(2) The name under which the applicant will be holding itself out to the public in conducting its EMS agency operations and the address of its primary location in this Commonwealth out of which it will be conducting its EMS agency operations. If the applicant seeks to conduct EMS agency operations out of more than one location, the address of its primary operational headquarters and each other location out of which it intends to operate. If the applicant will be holding itself out to the public under different fictitious names for the EMS agency operations it will conduct at different locations, the fictitious name under which it intends to operate at each location.
(3) The manner in which the applicant is organized—corporation, partnership, limited liability company, sole proprietorship, and the like.
(4) The tax status of the applicant—profit or nonprofit.
(5) The type of EMS service or services the applicant intends to provide.
(6) The geographic area for which the applicant intends to provide the service for each type of service it intends to operate. If the service is a type of service that is dispatched by a PSAP, the geographic area, if any, in which it plans to routinely respond to emergency dispatches.
(7) A personnel roster and staffing plan or personnel rosters and staffing plans, if applicable.
(8) The number and types of EMS vehicles to be operated by the applicant and identifying information for each EMS vehicle.
(9) The communication access and capabilities of the applicant.
(10) A full description of the EMS agency services that it intends to provide out of each location and how it intends to respond to emergency calls if it will not conduct operations out of a fixed location or locations.
(11) The names, titles and summary of responsibilities of persons who will be staffing the EMS agency as officers, directors or other EMS agency officials, and the same information pertaining to them that an EMS provider is required to report under § 1023.21(b)(1) and (2) (relating to general rights and responsibilities).
(12) Information concerning any arrangement in which it has entered to manage an EMS agency or any contract with an entity for that entity to exercise operational or managerial control over the EMS agency, or to conduct the day-to-day operations of the EMS agency.
(13) A statement attesting to the veracity of the application, which shall be signed by the principal official of the applicant.
(b) Submission of license application. The applicant shall submit the application to the regional EMS council exercising responsibility for the EMS region in which the applicant will conduct its operations if licensed. If the applicant seeks a license to conduct EMS agency operations in more than one region, it shall choose a primary operational headquarters and submit its license application to the regional EMS council that exercises responsibility for the region in which that primary operational headquarters is located. If the applicant's primary operational headquarters is located outside this Commonwealth, the applicant shall contact the Department for direction as to the regional EMS council to which it is to submit its application.
(c) Processing the license application.
(1) The regional EMS council that receives a license application shall review the application for completeness and accuracy. It shall also provide a copy of the application to each regional EMS council that exercises responsibility for an EMS region in which the applicant intends to conduct EMS agency operations. If more than one regional EMS council is involved in the review, they shall coordinate their review with the regional EMS council that exercises responsibility for the EMS region in which the applicant's primary operational headquarters is located, and that regional EMS council shall communicate with the applicant regarding any issues presented by the application.
(2) The regional EMS council that has responsibility for communicating with the applicant under paragraph (1) shall return an incomplete application to the applicant within 14 days of receipt.
(3) If the regional EMS council that has responsibility for communicating with the applicant under paragraph (1) determines that the application contains inaccurate information, and that the nature of the inaccurate information does not suggest fraud or deceit in attempting to obtain a license, the regional EMS council shall return the application to the applicant for correction.
(4) Upon receipt of a complete application, and its verification of the accuracy of the information provided in the application which is verifiable without an onsite inspection, the regional EMS council shall schedule and conduct an onsite inspection of the applicant's vehicles, equipment and personnel qualifications, as well as other matters that bear upon whether the applicant satisfies the statutory and regulatory criteria for licensure. The inspection shall be performed within 45 days after receipt by the regional EMS council of an application that is complete and, if requested by the regional EMS council, that has been corrected. If the applicant seeks to conduct EMS agency operations in more than one EMS region, the regional EMS council that has responsibility for communicating with the applicant under paragraph (1) may seek the assistance of other relevant regional EMS councils in conducting onsite surveys.
(5) Upon completion of its review, the regional EMS council that has responsibility for communicating with the applicant under paragraph (1) shall forward the application to the Department, with the regional EMS council's assessment as to whether applicable statutory and regulatory requirements are satisfied. If the regional EMS council determines that the application contains inaccurate information that suggests fraud or deceit by the applicant in attempting to obtain a license, the regional EMS council may forward the application to the Department without having conducted an onsite inspection and await instructions from the Department as to whether an onsite inspection should be conducted.
(d) Amendment of license.
(1) An EMS agency shall apply for and secure an amendment of its license prior to changing the location of any of its operations, the days or hours of the services it provides or the types of services it provides, or prior to arranging for an entity to exercise operational or managerial control over the EMS agency or to conduct the day-to-day operations of the EMS agency.
(2) An EMS agency shall submit its application for amendment of its license on a form or through an electronic process, as prescribed by the Department, to the regional EMS council responsible for the EMS region in which the EMS agency maintains its primary operational headquarters. That regional EMS council shall process the application for amendment as set forth in subsections (b) and (c).
(e) Triennial registration. An EMS agency's license is deemed registered for 3 years after issuance, except for an EMS agency that transitions from an ambulance service, a QRS, an ambulance service that operated under a hospital license on ______ , (Editor's Note: The blank refers to the effective date of adoption of this proposed rulemaking.) under § 1027.1(e) (relating to general provisions), in which case the initial registration shall expire when its license or recognition would have expired under the Emergency Medical Services Act (35 P. S. §§ 6921—6938) (repealed by the act of August 18, 2009 (P. L. 308, No. 37)) or, in the case of a hospital, under the Health Care Facilities Act (35 P. S. §§ 448.101—448.904b). Thereafter, an EMS agency shall triennially register the license by completing a form or through an electronic process, as prescribed by the Department, and filing it with the regional EMS council responsible for the EMS region in which the EMS agency maintains its primary operational headquarters. An EMS agency shall submit the form or complete the electronic process at least 120 days prior to the expiration of a current registration. Failure to do so in a timely manner may result in the EMS agency license not being registered again before the prior registration expires. The Department will act on an application for registration within 90 days after a regional EMS council receives a complete and accurate application. The Department may also deny an application after it is received by a regional EMS council if it contains false information, subject to notice and an opportunity for a hearing before the denial would become effective, or it may grant the application and then pursue disciplinary action against the EMS agency based upon the false information provided.
§ 1027.3. Licensure and general operating standards.
(a) Documentation requirements for licensure. An applicant for an EMS agency license shall have the following documents available for inspection by the Department or a regional EMS council:
(1) A roster of active personnel, including the EMS agency medical director, with certification and registration documentation including certification numbers and dates of registration expiration for each EMS provider and EMSVO.
(2) A record of the age of each EMS provider and EMSVO and a copy of the driver's license for each EMSVO.
(3) Documentation, if applicable, of the initial and most recent review of each EMS provider's competence by the EMS agency medical director and the EMS provider certification level at which each EMS provider is permitted to practice.
(4) Its process for scheduling staff to ensure that the minimum staffing requirements as required by this chapter are met.
(5) Identification of persons who are responsible for making operating and policy decisions for the EMS agency, such as officers, directors and other EMS agency officials.
(6) Criminal, disciplinary and exclusion information for all persons who staff the EMS agency as required under subsection (f).
(7) Copies of the Statewide and applicable regional EMS protocols.
(8) Copies of the written policies required under this section.
(9) Copies of documents by which it agrees to manage another EMS agency or to be managed by another entity.
(b) Documentation requirements after licensure. An EMS agency shall have the following documents available for inspection by the Department or a regional EMS council when it applies for registration of its license and at all other times:
(1) The documents that are required to be available for inspection under subsection (a).
(2) EMS PCRs.
(3) Call volume records from the previous year's operations. These records must include a record of each call received requesting the EMS agency to respond to an emergency, as well as a notation of whether it responded to the call and the reason if it did not respond.
(4) A record of the time periods for which the EMS agency notified the PSAP, under subsection (g)(1), that it would not be available to respond to a call.
(c) EMS vehicles, equipment and supplies. The Department will publish in the Pennsylvania Bulletin, and update as necessary, vehicle construction, and equipment and supply requirements for EMS agencies based upon the types of services they provide and the EMS vehicles they operate. Required equipment and supplies shall be carried and readily available in working order.
(d) Use of persons under 18 years of age. The EMS agency shall comply with the Child Labor Law (43 P. S. §§ 41—66.1) and regulations adopted under the Child Labor Law when it is using persons under 18 years of age to staff its operations. The EMS agency shall also ensure that an EMS provider under 18 years of age, when providing EMS on behalf of the EMS agency, is directly supervised by an EMS provider who is at least 21 years of age who has the same or higher level of EMS provider certification and at least 1 year of active practice as an EMS provider.
(e) EMS agency medical director. An EMS agency shall have an EMS agency medical director.
(f) Responsible staff. An EMS agency shall ensure that persons who staff the EMS agency, including its officers, directors and other members of its management team, EMS providers and EMSVOs, are responsible persons. In making that determination, it shall require each person who staffs the EMS agency to provide it with the information and documentation an EMS provider is required to provide to the Department under § 1023.21(b) (relating to general rights and responsibilities) and require each EMSVO to provide it with the information and documentation an EMSVO is required to provide to the Department under § 1023.21(b), and to update that information if and when additional convictions, disciplinary sanctions and exclusions occur. The EMS agency shall consider this information in determining whether the person is a responsible person. An EMS agency shall also provide the Department with advance notice, 30 days if possible, of any change in its management personnel to include as a new member of its management team a person who has reported to it information required under this subsection.
(g) Communicating with PSAPs.
(1) Responsibility to communicate unavailability. An EMS agency shall apprise the PSAP in its area, in advance, as to when it will not be in operation due to inadequate staffing or for another reason and when its resources are committed in a manner that it will not be able to respond with an EMS vehicle, if applicable and required staff, to a request to provide EMS.
(2) Responsibility to communicate delayed response. An EMS agency shall apprise the PSAP, as soon as practical after receiving a dispatch call from the PSAP, if it is not able to have an appropriate EMS vehicle, if applicable, or otherwise provide the requested level of service, including having the required staff en route to an emergency within the time as may be prescribed by a PSAP for that type of dispatch.
(3) Responsibility to communicate with PSAP generally. An EMS agency shall provide a PSAP with information, and otherwise communicate with a PSAP, as the PSAP requests to enhance the ability of the PSAP to make dispatch decisions.
(4) Response to dispatch by PSAP. An EMS agency shall respond to a call for emergency assistance as communicated by the PSAP, provided it is able to respond as requested. An EMS agency is able to respond as requested if it has the staff and an operational EMS vehicle, if needed, capable of responding to the dispatch. An EMS agency may not refuse to respond to a dispatch based upon a desire to keep staff or an EMS vehicle in reserve to respond to other calls to which it has not already committed.
(h) Dispatching.
(1) An EMS agency dispatch center shall use calltakers and dispatchers who are certified and maintain certification as calltakers and dispatchers by the Pennsylvania Emergency Management Agency under 35 Pa.C.S. § 5303(a)(6) (relating to telecommunications management).
(i) A calltaker is responsible for taking calls seeking EMS and for gathering the essential information from the caller to determine whether EMS is needed and, if required, the location to which EMS resources need to be sent.
(ii) A dispatcher is responsible for taking the information gathered by the calltaker, determining the appropriate EMS response to the situation and dispatching the EMS resources needed to respond to the EMS needs of the patient or patients.
(2) With the exception of the responsibilities calltakers and dispatchers have under paragraph (1), paragraph (1) shall be effective ______ (Editor's Note: The blank refers to 2 years after the effective date of adoption of this proposed rulemaking.).
(3) The costs of the Pennsylvania Emergency Management Agency and a county or municipality associated with the training, certification and recertification of an EMS agency dispatch center's calltakers and dispatchers shall be the responsibility of the EMS agency.
(4) An EMS agency that operates an EMS agency dispatch center shall:
(i) Establish and maintain policies and procedures to aid in directing the daily operations of its telecommunications staff.
(ii) Require its calltakers and dispatchers to satisfy the performance standards in 4 Pa. Code § 120d.105 (relating to quality assurance review standards)
(iii) Have a quality assurance reviewer who is qualified to perform and performs the quality assurance review functions specified in 4 Pa. Code § 120d.104 (relating to time frames and procedures for quality assurance reviews). The quality assurance reviewer shall be a member of the EMS agency's quality improvement committee and that committee shall also be responsible for the quality improvement of the EMS agency dispatch center and shall participate in the county PSAP quality assurance process.
(iv) Refer to the PSAP in its area any request for emergency EMS for which it is unable to dispatch appropriate EMS resources within the time prescribed by the PSAP.
(5) References in 4 Pa. Code §§ 120d.104 and 120d.105 to the Pennsylvania Emergency Management Agency, 911 communications centers and remote dispatch points are replaced with the Department and EMS agency dispatch centers for the purpose of this regulation.
(6) Effective ______ , (Editor's Note: The blank refers to 270 days after the effective date of adoption of this proposed rulemaking.) an EMS agency dispatch center shall use the emergency medical dispatch program used by the 911 emergency communications center of the county in which the EMS agency dispatch center is located.
(i) Patient management. All aspects of patient management are to be handled by an EMS provider with the level of certification necessary to care for the patient based upon the condition of the patient.
(j) Use of lights and other warning devices. Ground EMS vehicles may not use emergency lights or audible warning devices unless they do so in accordance with the standards imposed under 75 Pa.C.S. (relating to Vehicle Code). When transporting or responding to a call involving a patient who presents or is in good faith perceived to present a combination of circumstances that may lead to worsened patient outcomes if additional medical intervention were delayed by the amount of time that is estimated to be saved by the use of emergency lights or audible warning devices. Lights and a siren may be used on an ambulance when transporting a patient only when medical intervention is beyond the capabilities of the ambulance crew using available supplies and equipment.
(k) Weapons and explosives. Weapons and explosives may not be worn by EMS providers or EMSVOs or carried aboard an EMS vehicle. This subsection does not apply to law enforcement officers who are serving in an authorized law enforcement capacity.
(l) Accident, injury and fatality reporting. An EMS agency shall report to the appropriate regional EMS council, in a form or electronically, as prescribed by the Department, an EMS vehicle accident that is reportable under 75 Pa.C.S. and an accident or injury to an individual that occurs in the line of duty of the EMS agency that results in a fatality or medical treatment by a licensed health care practitioner. The report shall be made within 24 hours after the accident or injury. The report of a fatality shall be made within 8 hours after the fatality.
(m) Committees. An EMS agency shall have a safety committee and a quality improvement committee that meet at least quarterly.
(n) EMS provider credentialing. The EMS agency shall maintain a record for 7 years of the EMS agency medical director's assessments and recommendations provided under § 1023.1(a)(1)(vi)—(viii) (relating to EMS agency medical director). An EMS agency may not permit an EMS provider at or above the AEMT level to provide EMS at the EMS provider's certification level if the EMS agency medical director determines that the EMS provider has not demonstrated the knowledge and skills to competently perform the skills within the scope of practice at that level or the commitment to adequately perform other functions relevant to an EMS provider providing EMS at that level. Under these circumstances, an EMS agency may continue to permit the EMS provider to provide EMS for the EMS agency only in accordance with the restrictions as the EMS agency medical director may prescribe. The EMS agency shall notify the Department within 10 days after it makes a decision to allow an EMS provider to practice at a lower level based upon the assessment of the EMS provider's skills and other qualifications by the EMS agency medical director, or a decision to terminate the EMS agency's use of the EMS provider based upon its consideration of the EMS agency medical director's assessment.
(o) Display of license and registration certificates. The EMS agency shall display its license certificate and the certificate evidencing current registration of its license in a public and conspicuous place in the EMS agency's primary operational headquarters.
(p) Monitoring compliance. An EMS agency shall monitor compliance with the requirements that the act and this part impose upon the EMS agency and its staff. An EMS agency shall file a written report with the Department if it determines that an EMS provider or EMSVO who is on the staff of the EMS agency, or who has recently left the EMS agency, has engaged in conduct not previously reported to the Department, for which the Department may impose disciplinary sanctions under § 1031.3 or § 1031.5 (relating to discipline of EMS providers; and discipline of EMS vehicle operators). The duty to report pertains to conduct that occurs during a period of time in which the EMS provider or EMSVO is functioning for the EMS agency.
(q) Policies and procedures. An EMS agency shall maintain written policies and procedures ensuring that each of the requirements imposed under this section, as well as the requirements imposed under §§ 1021.8(b), 1021.41, 1021.42, 1021.64 and 1027.4 and Chapter 1051 (relating to out-of-hospital do-not-resuscitate orders), are satisfied by the EMS agency and its staff. It shall also maintain written policies and procedures addressing infection control, management of personnel safety and the safe operation of EMS vehicles, storage and environmental control of medications, substance abuse in the workplace and the placement and operation of its resources, and ensure that appropriate staff are familiar with these policies and procedures.
§ 1027.4. Medication use, control and security.
(a) An EMS agency may stock medications as approved by the Department and shall store medications in a temperature-controlled environment, secured in conformance with the Statewide EMS protocols and the EMS agency's policy and procedures on the storage and environmental control of medications. Additional medications may be stocked by an EMS agency as approved by the EMS agency medical director and the Department if the EMS agency uses PHPEs, PHRNs or PHPs.
(b) The Department will publish at least annually by notice in the Pennsylvania Bulletin a list of medications approved for use by EMS agencies, by EMS provider certification level and a list of medications that an EMS agency is required to stock based upon the type of EMS service it is licensed to provide.
(c) An EMS agency may procure and replace medications, from a hospital, pharmacy or from a medical supply company, if not otherwise prohibited by law.
(d) EMS providers, other than a PHP, may administer to a patient, or assist the patient to administer, medications previously prescribed for that patient, as specified in the Statewide EMS protocols or as authorized by a medical command physician. A PHP may administer to a patient, or assist the patient to administer, medication that was previously prescribed for the patient.
(1) An EMS provider, other than a PHPE, PHRN or PHP, is restricted to administering medications, not previously prescribed for a patient, as permitted by the Statewide EMS protocols.
(2) A PHPE or PHRN may administer medications, not previously prescribed for a patient, in addition to those permitted by the Statewide EMS protocols, provided the PHPE or PHRN has received approval to do so by the EMS agency medical director, and has been ordered to administer the medication by the medical command physician. A PHP may administer any medication that the PHP has authority to administer by virtue of the PHP's license to practice medicine or osteopathic medicine.
(e) The EMS agency shall adequately monitor and direct the use, control and security of medications provided to the EMS agency. This includes:
(1) Ensuring proper labeling and preventing adulteration or misbranding of medications, and ensuring medications are not used beyond their expiration dates.
(2) Storing medications as required under The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. §§ 780-101—780-144), and as otherwise required to maintain the efficacy of medications and prevent misappropriation.
(3) Including in the EMS PCR information as to the administration of medications by patient name, medication identification, date and time of administration, manner of administration, dosage, name of the medical command physician who gave the order to administer the medication and name of person administering the medication.
(4) Maintaining records of medications administered, lost or otherwise disposed of and records of medications received and replaced.
(5) Providing the pharmacy, physician or hospital that is requested to replace a medication with a written record of the use and administration or loss or other disposition of the medication, which identifies the patient and includes any other information required by law.
(6) Ensuring, in the event of an unexplained loss or theft of a controlled substance, that the dispensing pharmacy, physician or hospital has contacted local police or State Police and the Department's Drugs, Devices and Cosmetics Office and has filed a DEA Form 106 with the Federal Drug Enforcement Administration.
(7) Disposing of medications as required under The Controlled Substance, Drug, Device and Cosmetic Act.
(8) Arranging for the original dispensing pharmacy, physician or hospital, or its EMS agency medical director, to provide it consultation and other assistance necessary to ensure that it meets the requirements in this section.
(9) Securing medications in a manner so that only those EMS providers authorized to administer the medications in providing EMS have access to those medications.
§ 1027.5. Statewide EMS response plan.
An EMS agency may provide an EMS service at a location through which it is licensed to provide that service, less than 24 hours-a-day, 7 days-a-week, as follows:
(1) Day or time requirements are not applicable to an EMS agency's operation of an air ambulance service.
(2) A tactical EMS response service shall be available at all times that a law enforcement service with which it is affiliated requests its participation in a tactical law enforcement operation.
(3) An EMS agency may operate any EMS service less than 24 hours-a-day, 7 days-a-week, out of any location through which it is licensed to provide the service, in accordance with a county-level or broader-level EMS response plan approved by the Department.
§ 1027.6. EMS vehicle fleet.
(a) Inspection of EMS vehicles. When an applicant for an EMS agency license is inspected, a Department or regional EMS council inspector will inspect each vehicle the applicant intends to operate as an EMS vehicle. If the vehicle satisfies the requirements for the type of EMS vehicle designated by the applicant, and the applicant otherwise satisfies the requirements for licensure and to conduct a service for which the EMS vehicle will be used, the inspector will affix a date stripe, with an inspection and expiration date, to two decals appropriate to that type of EMS vehicle and provide the decals to the applicant. The applicant shall place a decal in a prominent location on each side of the vehicle. The applicant may not operate the vehicle as an EMS vehicle until the applicant is licensed as an EMS agency and it affixes the decals to the EMS vehicle.
(b) Permanent change. Before operating an additional or permanent replacement EMS vehicle, an EMS agency shall submit an application for amendment of its license to the regional EMS council through which its license application was processed. The EMS agency may not operate that vehicle as an EMS vehicle unless, as described in subsection (a), it is authorized to do so following an inspection of the vehicle and it affixes decals to the vehicle.
(c) Temporary change. An EMS agency may operate a temporary replacement EMS vehicle without securing prior approval from the Department. It shall submit a temporary change of vehicle form to the regional EMS council through which its license application was processed, by facsimile, e-mail or regular mail before putting the EMS vehicle in service. In the form the EMS agency shall attest to the fact that the EMS vehicle satisfies the requirements for that type of EMS vehicle that are imposed by regulation and notices published in the Pennsylvania Bulletin. Upon submitting a temporary change of vehicle form, the EMS agency may continue to operate the temporary replacement EMS vehicle unless its authority to do so is disapproved by the inspector following an inspection of the EMS vehicle. Upon receiving a temporary change in vehicle form, the regional EMS council shall issue a letter which acknowledges receipt of the temporary change of vehicle form and authorizes the EMS agency to operate the replacement EMS vehicle for 7 days based upon its attestation that the vehicle satisfies all requirements. That time period may be extended by the regional EMS council, by letter.
(d) Triennial inspections. A Department or regional EMS council inspector will inspect an EMS agency's EMS vehicles when the inspector conducts the inspection of the EMS agency for the triennial registration of the EMS agency's license. If an EMS vehicle satisfies all requirements the inspector will affix a new date stripe to each decal to reflect that the vehicle has satisfied EMS vehicle inspection requirements. If the vehicle does not satisfy the requirements, the inspector will not affix a new date stripe to each decal and the EMS agency may not operate the vehicle as an EMS vehicle unless and until the vehicle is reinspected, satisfies all requirements, and the inspector affixes a new date stripe on each decal.
(e) Removal of decals. A Department or regional EMS council inspector will require the EMS agency to remove the decals from an EMS vehicle when directed by the Department under § 1027.7(b) (relating to removal of EMS vehicles from operation). An EMS agency shall remove the decals from an EMS vehicle when the EMS agency transfers the title or operation of the EMS vehicle to another entity, other than to enable another EMS agency to operate the EMS vehicle as a temporary replacement vehicle under subsection (c), or when it discontinues use of the vehicle as an EMS vehicle.
(f) Ambulance requirements. An ambulance must meet the following minimum requirements:
(1) It must have a patient care compartment that is designed to carry at least one patient on a stretcher that is securely mounted to the ambulance and that enables transportation in both the supine and seated upright positions.
(2) It must have a patient care compartment that is designed to provide sufficient access to a patient's body to perform and maintain ALS skills, including adequate space for one caregiver to sit superior to the patient's head to perform required ALS airway skills, and other EMS required by the Statewide EMS protocols.
(3) It must have a design that does not compromise patient safety during loading, unloading or patient transport. It must be equipped with a door that will allow loading and unloading of the patient without excessive maneuvering.
(4) It must be equipped with permanently installed climate control equipment to provide an environment appropriate for the medical needs of a patient.
(5) It must have interior lighting adequate to enable medical care to be provided and patient status monitored without interfering with the vehicle operator's vision.
(6) It must be designed for patient safety so that the patient is isolated from the operator's compartment in a manner that minimizes distractions to the vehicle operator during patient transport and prevents interference with the operator's manipulation of vehicle controls.
(7) It must be equipped with appropriate patient restraints and with restraints in every seating position within the patient compartment.
(8) An ALS ambulance used for critical care transports and an air ambulance must be equipped with 110 V electrical output with a minimum of four appropriate outlets within the patient compartment with the ability to operate the vehicle while operating medical equipment using all outlets simultaneously.
(9) It must have enough space to accommodate the loading, unloading and transport of an infant isolette and permit sufficient access to the infant's entire body to begin and maintain ALS and other treatment modalities within the isolette.
(10) It must be equipped with two-way radios capable of communication with medical command facilities, receiving facility communications centers, PSAPs and ambulances for the purpose of communicating medical information and assuring the continuity of resources for patient care needs.
(11) It must carry an oxygen supply that is capable of providing high flow oxygen at more than 25 liters per minute to a patient for the anticipated duration of patient transport.
§ 1027.7. Removal of EMS vehicles from operation.
(a) When an EMS vehicle manifests evidence of a mechanical or equipment deficiency which poses a significant threat to the health or safety of patients or crew, the EMS agency shall immediately suspend the vehicle from operation. An EMS agency may not operate an EMS vehicle that it has suspended from operation until the deficiency has been corrected.
(b) When an EMS vehicle, upon examination by the Department or a regional EMS council, manifests evidence of a mechanical or equipment deficiency which poses a significant threat to the health or safety of patients or crew, the EMS agency shall immediately suspend it from operation as directed by the Department. An EMS agency may not operate as an EMS vehicle a vehicle which has been suspended from operation by the Department until the Department has confirmed to the EMS agency that the deficiency has been corrected.
§ 1027.8. Right to enter, inspect and obtain records.
(a) Upon the request of an employee or agent of the Department during regular and usual business hours, or at other times when that person possesses a reasonable belief that violations of this subpart may exist, an EMS agency or applicant for an EMS agency license shall:
(1) Produce for inspection records maintained under § 1021.41 (relating to EMS patient care reports).
(2) Produce for inspection, permit copying and provide within a reasonable period of time as directed by the Department, records that pertain to personnel and their qualifications, staffing, equipment, supplies, and policies and procedures required under § 1027.3 (relating to licensure and general operating standards).
(3) Permit the person to examine EMS vehicles, equipment and supplies, and security arrangements.
(b) The Department's representative shall advise the licensee or applicant that the inspection is being conducted under section 8129(h) of the act (relating to emergency medical services agencies) and this subpart.
(c) Failure of an EMS agency or an applicant for an EMS agency license to produce records or to permit an examination as required by this section is a ground for imposing disciplinary sanctions upon the EMS agency and denying an application for an EMS agency license.
§ 1027.9. Notification of deficiencies to applicants.
(a) Upon completion of an inspection under an application for a license, registration of a license or an amendment of a license, the inspector shall provide the applicant with an inspection report specifying the results of the inspection.
(b) If the inspection reveals deficiencies that can be corrected and the inspector determines that the deficiencies warrant a reinspection, the inspector shall give the applicant written notice of the matters to be reinspected and copy the Department on the notice.
(c) If the type of deficiency requires a plan of correction, the applicant shall have 30 days in which to provide the inspector with a plan to correct the deficiency. If the plan is found to be acceptable by the regional EMS council, the inspector will conduct a reinspection in accordance with the time frame given in the plan of correction.
(d) If the applicant disagrees with a deficiency cited by the inspector following the inspection or reinspection, or the regional EMS council's rejection of a plan of correction, the applicant shall apprise the Department of the matter in dispute in writing within 10 days of the inspection or rejection of the plan of correction and the Department will resolve the dispute within 30 days of receipt of the written notification.
(e) The Department will act upon the application within 30 days after the inspection process has been completed, unless the Department requires additional time to complete an investigation of those qualifications of the applicant which cannot, for just cause, be determined through the inspection process.
(f) Nothing in this section shall be construed to preclude the Department from identifying to the EMS agency statutory or regulatory violations not identified by the inspector, or from requiring the EMS agency to file a plan of correction to correct those deficiencies or taking immediate action to correct those deficiencies, or from taking disciplinary action against an EMS agency for a statutory or regulatory violation that cannot be corrected or for which the Department determines that disciplinary action best serves the public interest.
§ 1027.10. Plan of correction.
(a) Notification of violation. Upon determining that an EMS agency has violated the act or this chapter, the Department may issue a written notice to the EMS agency specifying the violation. The notice will require the EMS agency to take immediate action to discontinue the violation or to submit a plan of correction, or both, to bring the EMS agency into compliance. If the EMS agency cannot remedy the problem immediately and a plan of correction is therefore required, the Department may direct that the violation be remedied within a specified period of time.
(b) Response by EMS agency. After receiving the notice of violation, the EMS agency shall do one of the following:
(1) Comply with the requirements specified in the notice of violation.
(2) Refuse to comply with one or more of the requirements specified in the notice of violation and apprise the Department of its decision, with an explanation, within the time and manner specified in the notice of violation.
(3) Comply with the requirements specified in the notice of violation and apprise the Department of its decision, within the time and manner specified in the notice of violation of any violation identified in the notice of violation with which it disagrees, supported by an explanation for its disagreement.
(c) EMS agency disagreement or refusal to comply. If the EMS agency fails to comply with any of the directives in the notice of violation and responds as required under subsection (b)(2), or disagrees with any of the violations identified and responds as required under subsection (b)(3), the Department will evaluate the explanation provided by the EMS agency to determine whether the response was justified. If the Department determines that the response was justified in whole or part, it will inform the EMS agency and rescind any violation identified or directive given in the notice of violation that the Department determines should not have applied.
(d) Consequence of failure to comply. An EMS agency's response to a notice of violation under subsection (b)(2) does not act to stay any of the directives in the notice of violation. An EMS agency's failure to comply with a directive in the notice of violation constitutes a ground for discipline if the violation to which the directive relates is found to be true following a hearing.
§ 1027.11. Conditional temporary license.
When an EMS agency or an applicant for an EMS agency license does not provide service 24 hours-a-day, 7 days-a-week, and does not participate in a county-level or broader level EMS response plan, the Department will issue the EMS agency a conditional temporary license, subject to terms the Department determines to be appropriate, if the Department deems it is in the public interest to do so. The conditional temporary license is valid for 1 year and may be renewed as many times as the Department deems it is in the public interest to do so. If the EMS agency does not agree to the terms under which the Department would grant the EMS agency a conditional temporary license, the Department will take disciplinary action against the EMS agency for failing to either provide service 24 hours-a-day, 7 days-a-week, or participate in a county-level or broader level EMS response plan.
§ 1027.12. Discontinuation or movement of operations or reduction of service.
An EMS agency shall give at least 90 days advance notice to each appropriate regional EMS council, PSAP and chief executive officer of a political subdivision within its service area, as well as the chief executive officer of each political subdivision outside of its service area that relies upon it for service even if not provided on a routine basis, before it discontinues its operations or providing an EMS service out of any location at which it is licensed to provide that service or reducing the days or hours it provides the service. The EMS agency shall also advertise notice of its intent to discontinue operations or a service, or reduce the days or hours it provides the service, in a newspaper of general circulation in its service area at least 90 days in advance of discontinuing its operations or a service, or reducing the days or hours it provides the service, and shall provide the Department with written notice that it has met these responsibilities at least 90 days in advance of taking action. This section does not apply if the Department revokes, suspends or restricts the EMS agency's license under terms that do not afford the EMS agency the opportunity to comply with this section.
§ 1027.13. Management companies.
(a) Information required to secure approval. Subject to Department approval, an entity may offer management services to EMS agencies. Management services involve exercising operational or managerial control over an EMS agency or conducting the day-to-day operations of the EMS agency. To secure Department approval, the entity shall provide to the Department, on a form or through an electronic process, as prescribed by the Department, the following information and other information as the Department may require:
(1) Its name, including a fictitious name it has registered, its mailing address, and a primary contact person and telephone number at which that person can be reached.
(2) The manner in which the applicant is organized—corporation, partnership, limited liability company, sole proprietorship, and the like.
(3) A description of the management services it offers.
(4) The names, titles and summary of responsibilities of persons who will be staffing the entity as officers, directors or other officials, and the same information pertaining to the entity and to its officers, directors or other officials, that an applicant for an EMS provider is required to report under § 1023.21(b)(1) and (2) (relating to general rights and responsibilities).
(5) A statement attesting to the veracity of the information provided, which shall be signed by the principal official of the entity.
(b) Updating information. An entity approved by the Department to provide management services shall provide the Department on a form or through an electronic process, as prescribed by the Department, any change in the information provided under subsection (a) within 10 days after the change.
(c) Approval. After receipt of the information required under subsection (a), the Department will approve an entity to offer management services to EMS agencies, subject to possible disapproval under § 1031.16 (relating to discipline of management companies).
(d) Registry. The Department will maintain a registry of entities approved by the Department to provide management services to EMS agencies.
(e) Disclosures to EMS agencies. An entity that has received approval from the Department to offer management services to EMS agencies shall provide the same information to an EMS agency that it provides to the Department under subsection (a)(1)—(4) before it contracts with the EMS agency to provide management services for the EMS agency. The entity shall provide the EMS agency with any change in that information within 10 days after the change, except it shall immediately inform the EMS agency of any suspension or revocation of its approval or condition imposed upon it by the Department under § 1031.16.
(f) Effective date. The effective date of this section is ______ (Editor's Note: The blank refers to 360 days after the effective date of adoption of this proposed rulemaking.). By ______ , (Editor's Note: The blank refers to 360 days after the effective date of adoption of this proposed rulemaking.) an entity that is under contract with an EMS agency to provide management services for the EMS agency on ______ , (Editor's Note: The blank refers to 360 days after the effective date of adoption of this proposed rulemaking.) shall make the same disclosures to the EMS agency as required in subsection (e).
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