PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following revised rule:
Proposed Action:
Amendment of Part 800 of Title 10 NYCRR.
Statutory authority:
Public Health Law, section 3002
Subject:
Emergency Medical Services.
Purpose:
To clarify terminology, eliminate vagueness, address legal statutes/crimes and incorporate modern professional, ethical and moral standards.
Substance of revised rule:
This proposal amends Sections 800.3, 800.6, 800.8, 800.9, 800.15 and 800.16 of Part 800 (Emergency Medical Services) of Title 10 of the Official Code of Rules and Regulations of the State of New York (10 NYCRR) particularly as they relate to certification, recertification and continuing medical education recertification requirements, required conduct of every person certified under Part 800 and the suspension or revocation of certification.
Section 800.3 of 10 NYCRR contains all the definitions that apply to Part 800 (Emergency Medical Services). Definitions amended in this proposal are “emergency medical technician”, “primary territory”, “course sponsor”, and “learning contract”. New definitions added are “continuous practice”, “criminal offense”, “incompetence”, “negligence”, “non-criminal offense”, “patient abandonment”, “patient abuse”, “patient contact”, “regulatory violation”, “scope of practice”, “state approved protocols”, and “treatment”.
Section 800.6 of 10 NYCRR sets forth the Initial Certification Requirements and has been revised to remove the emergency medical technician-defibrillation (EMT-D) category as a level for which certification is available. This section is also revised to reflect the policy of this state to encourage the licensure and employment of person previously convicted of one or more criminal offenses and incorporate Article 23-A of the Corrections Law into the review of applicants’ criminal offenses.
Section 800.8 of 10 NYCRR outlines the Recertification requirements for applicants. This section adds that an applicant must enroll in a recertification course provided by an approved course sponsor as set forth in Section 800.20 (Course Sponsors) and complete the requirements for recertification at the level at which recertification is sought. Also added is that, within one year after passing the practical skills examination, the applicant must pass the State written certification examination for the level at which the certification is sought except at the certified instructor coordinator level and certified lab instructor level. It incorporates Article 23-A of the Corrections Law into the review when people seeking renewals of their certifications have had criminal convictions as defined in Section 800.3.
Section 800.9 of 10 NYCRR contains the Continuing Medical Education Recertification provisions previously titled Continuing Education. This section authorizes candidates who have demonstrated competence in applicable behavioral and performance objectives, and who have demonstrated completion of appropriate continuing medical education may be entitled to have their certification renewed without being required to successfully complete a state practical skills and written examination. It then sets forth the parameters for recertification using continuing medical education and once again applies the provisions of Article 23-A when reviewing the criminal offenses defined in Section 800.3, of those seeking recertification.
Section 800.15 of 10 NYCRR outlines the Required Conduct for every person certified at any level pursuant to Part 800 of 10 NYCRR or Article 30 of the Public Health Law, adhering to currently acceptable prehospital practice standards, maintenance of confidentiality at all times with certain exceptions, and compliance with the terms of a Medical Order of Life Sustaining Treatment (MOLST) form or a non-hospital Do Not Resuscitate (DNR) form, or a patient’s DNR bracelet or necklace with certain exceptions.
Section 800.16 of 10 NYCRR sets forth the Suspension or Revocation of Certification provisions. This section refines the criteria for which a suspension or revocation of certification will apply incorporating the new definitions contained in Section 800.3 and failure to meet the requirements contained in Sections 800.6, 800.8, 800.9 and 800.15.
Revised rule compared with proposed rule:
Substantial revisions were made in sections 800.3, 800.6, 800.8, 800.9, 800.15 and 800.16.
Text of revised proposed rule and any required statements and analyses may be obtained from
Katherine Ceroalo, DOH, Bureau of House Counsel, Reg. Affairs Unit, Room 2438, ESP Tower Building, Albany, NY 12237, (518) 473-7488, email: regsqna@health.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
30 days after publication of this notice.
Revised Regulatory Impact Statement
Statutory Authority:
The authority for the promulgation of this regulation is contained in Public Health Law (PHL) Article 30 (Emergency Medical Services), Section 3002. Section 3002 sets forth the provisions creating the New York State Emergency Medical Services Council and specifies that it shall have the power, by an affirmative vote of a majority of those present, subject to approval by the Commissioner, to enact, and from time to time, amend and repeal, rules and regulations establishing minimum standards for ambulance services, ambulance service certification, advanced life support first response services, the provision of prehospital emergency medical care, public education, the development of a statewide emergency medical services system, the provision of ambulance services outside of the primary territory specified in the ambulance services’ certificate and the training, examination, and certification of certified first responders, emergency medical technicians, and advanced emergency medical technicians; provided, however that such minimum standards must be consistent with the staffing standards established by the staffing standards, ambulance services and advanced life support first response services provisions outlined in PHL Section 3005-a.
Legislative Objectives:
The purpose of PHL Article 30 is to promote the public health, safety and welfare by providing certification for pre-hospital care providers and all advanced life support first response and ambulance services.
Needs and Benefits:
The Department’s Bureau of Emergency Medical Services (BEMS) is charged with enforcement of 10 NYCRR Part 800 (State Emergency Medical Services Code). When the NYS EMS system was founded, the original PHL Article 30 and Title 10 New York Codes Rules and Regulations (NYCRR) Part 800 provisions addressed the provision of emergency medical services at the time; incorporating the practices, standards, ethics, morals, crimes and punishments of the day. In the early 1990’s, PHL Article 30 and 10 NYCRR Part 800 underwent major revisions so as to reflect changes that had occurred over the previous 20 years in EMS and health care and society as a whole. Moreover, these significant changes were enacted so as the Department could maintain the standard of an essential public health service (EMS) provided in the most responsible manner.
Now again, another 20 years later, the Department is faced with trying to apply outdated rules to a modern system. It is impractical and difficult for the Department to try to update what was long ago determined an essential public health service under rules that no longer apply, as well as try to apply rules from two decades ago to situations that did not exist two decades ago.
Of greatest concern is that the current rules make it difficult for the Department to adequately regulate an essential public health service, and for the Commissioner to adequately protect the health and welfare of patients of that service. Just as the Commissioner relies on clear and specific regulations and standards to monitor and discipline physicians in the course of protecting the public, so too must the Commissioner have clear and specific regulations to monitor and discipline EMS providers in order to protect the public.
Section 800.3 contains the definitions used throughout Part 800. Section 800.6 outlines initial certification requirements, and Sections 800.8 and 800.9 outline recertification requirements and continuing medical education recertification requirements respectively. Section 800.15 specifies the required conduct of every person certified under Part 800 and Section 800.16 sets forth the suspension or revocation of certification provisions. These provisions must be updated and replaced with regulatory language that encompasses the various categories of EMS providers and their authorized scope of practice; clarifies terminology and other provisions; identifies inappropriate conduct by EMS providers; ensures that Corrections Law Article 23-A’s balancing test will be used when reviewing applicants and existing providers who have criminal convictions; enhances enforcement of regulatory compliance and discipline of violators; as well as incorporates modern professional standards.
Costs for the Implementation of and Continuing Compliance with these Regulations to the Regulated Entity:
Costs to the regulated parties (EMS providers) will be none; unless the Department finds cause to take action against an EMS provider under the provisions of Sections 800.15 and/or 800.16, at which time (depending on the severity of the case) the EMS provider may be administratively sanctioned including monetary fines, probation, and/or suspension or loss of certification.
Cost to State and Local Government:
Costs to the general public, state and local government will be none. These regulations are directed at the individual EMS provider, not the EMS agency for which the provider works. In that, even if the EMS agency is part of a local municipal government, Department actions taken with respect to Sections 800.15 and or 800.16 will still be upon the individual EMS provider and not the municipality.
Cost to the Department of Health:
Costs to the Department of Health will be none. As stated above these regulations are directed to the individual EMS provider. Department actions taken with respect to Sections 800.15 and or 800.16 will still be upon the individual EMS provider. The Department will not incur any additional costs.
Local Government Mandates:
None. These provisions do not add any additional mandates to local governments.
Paperwork:
No additional new paperwork will be required.
Duplication:
This measure does not duplicate, overlap or conflict with a State or federal statute or rule.
Alternative Approaches:
There are no other viable alternative approaches. Current provisions are outdated and must be updated to reflect appropriate EMS standards and practice.
Federal Requirements:
This regulatory amendment does not exceed any minimum standards of the federal government for the same or similar subject areas. This proposal is intended to update outdated Part 800 provisions with language appropriate and applicable to the modern EMS system of today.
Compliance Schedule:
This proposal will go into effect upon a Notice of Adoption in the New York State Register.
Revised Regulatory Flexibility Analysis, Revised Rural Area Flexibility Analysis and Revised Job Impact Statement
Changes made to the last published rule do not necessitate revision to the previously published Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement.
Assessment of Public Comment
Public comments were submitted to the NYS Department of Health (DOH) in response the proposed changes to Title 10 NYCRR Part 800. Many of the comments were the same or similar. These comments and the Department of Health’s responses are summarized below:
1. COMMENT: Concerns were expressed about the broadness of the definition of “non-criminal offenses.”
RESPONSE: Comments and concerns have been addressed by the substantial narrowing of this definition and the exclusion of the language objected to in many of the comments.
2. COMMENT: Concerns that the definition of patient abandonment would include multiple patient triage situations.
RESPONSE: This concern was addressed by adding language that excludes the medical triage of multiple patients in mass casualty situations.
3. COMMENT: Received suggested language for the inclusion of Medical Orders for Life Sustaining Treatment (MOLST).
RESPONSE: Issues were addressed in the revision.
4. COMMENT: “Continuous Practice” as defined does not include EMS personnel that serve in non-patient care functions. The comments indicated that the definition should include certified EMS providers that serve as administrators, emergency managers, planners, educators, quality assurance officers and other like positions.
RESPONSE: Article 30, section 3002 -2B of the NYS Public Health Law enables those certified EMS providers in continuous practice providing direct patient care to recertify through a continuing medical education process. While there is no dispute that ‘non patient care providing personnel’ are essential to the EMS system, those that are not actively providing direct patient care may not be maintaining the skill and didactic acuity necessary for this method of recertification. There are other recertification options available. Therefore, no change has been made to this section based on the comment.
5. COMMENT: Comment wished to confirm that an EMS provider with a lapsed certification beyond one year will continue to have the ability to recertify by completing and passing the requirements of an appropriate refresher training program.
RESPONSE: This section was clarified to insure that any individual previously certified in NYS will continue to be allowed to recertify their EMS certification by completing and passing the requirements of an appropriate refresher training program.
6. COMMENT: There were many comments and concerns regarding the definition of “criminal offenses”.
RESPONSE: The definition of “criminal offenses” has been entirely re-written to address these comments and to track closely the listed offenses in the underlying statute, Public Health Law Section 3005(8)(ii)(a) and Section 3012(1)(i).
7. COMMENT: There were many comments and concerns about the review process for an individual with criminal convictions described in the proposed Sections 800.6, 8, 9 and 16.
RESPONSE: These sections have been entirely re-written to require that the review process and consideration is in compliance with Article 23-A of the Corrections Law. Additionally, disqualification from certification must be based on a determination that there is a direct relationship between one or more of the criminal offenses and the duties required of this certificate, or that the applicant’s hiring would create an unreasonable risk to property or the safety or welfare of a specific individual or the general public. In determining these issues, the agency will look at the eight factors listed under New York State Correctional Law Section 753.
8. COMMENT: There are a number of comments indicating concern about a requirement of proposed Section 800.15(b)(1) that each EMS care provider involved in the care of a specific patient or a response to an individual incident would be required to complete a separate prehospital patient record.
RESPONSE: This section has been clarified to state the when a certificate holder is acting as part of an organized pre-hospital emergency medical service, the certificate holder responsible for patient care shall accurately complete a pre-hospital care report. This clarification means that every certified provider does not have to complete a separate patient record.
9. COMMENT: Comments regarding definitions for provider certification levels was submitted with suggested specific language.
RESPONSE: While the comments have some validity, the terminology is not supported by Article 30 of the Public Health Law, therefore no changes were made based on the suggested comments.
10. COMMENT: A number of comments identified typographical errors or requested terminology changes.
RESPONSE: We have made the changes as identified.
11. COMMENT: Several comments expressed a sentiment that “stakeholders” were not included in the proposed rule making process. Some specifically mentioned the perceived exclusion of the NYS EMS Council (SEMSCO), and the Regional EMS Councils. There are eighteen (18) of the latter.
RESPONSE: Stakeholders were included in the process. To wit:
1) SEMSCO was included in the process, and in fact, unanimously approved the proposed changes at its January 14, 2015 meeting. SEMSCO is comprised of thirty-one (31) members [PHL 3002(1)]. Eighteen (18) of these members, a majority of the body, represent the various REMSCOs.
2) Comments were received from various EMS trade organizations, REMSCOs, EMS agencies, and even individual EMS providers.
