Code of Maryland Regulations Title 30 This presentation was developed to give the provider an understanding of what regulations are, where they are located for EMS services and providers and how they inapt the day to day operations of EMS in the State of Maryland. Several case studies will be used to demonstrate the impact of State Regulations on emergency Services in Maryland. Maryland Institute for Emergency Medical Services Systems

Objectives Following the completion of this presentation the participant will be able to: Locate and reference the Code of Maryland Regulations (COMAR), Title 30 Describe the impact of Title 30 on the daily operations of emergency services Recognize the Provider Review Process (PRP) Recognize the role of Quality Review as outlined in Title 30 Review each objective with the participants. Locate and Reference… Gives you a source to gather information for yourself when questions arise. Describe the impact… The overview will cover all sections of the State regulations that apply to EMS. Recognize the PRP… Recognize the role of QA...

Why Regulate? Why Regulate? In its infancy MIEMSS established guidelines based on an informal process. The result was inconsistency, and the lack of coordination often caused confusion among providers. There were no formal policies or procedures. No one likes regulations! So why do you need them? Regulations are in place to provide consistency. Without a formal process hospitals could for example simply declare themselves a trauma center or a base station regardless of capability. Regulations are not meant to force the public to respond in a particular manner but to protect the public from_____. There is a standard process to for developing regulations.

Maryland Regulations Regulations are the generally applicable rules under which a state agency operates. The legislature must authorize an agency to promulgate regulations. The agency then must follow detailed rules in drafting and enacting the regulations. To develop regulations an agency must have: Legal approval Review by representation of the states Attorney General Office The process for developing regulations.. MIEMSS uses consensus building to develop regulations. Once consensus (or close to consensus) has been obtained the draft is take to the EMS Board for approval. Regulations developed by MIEMSS have State impact.

What is COMAR? The Regulations of all Maryland Agencies are collected in the Code of Maryland Regulations known as “COMAR”.

COMAR Description COMAR is divided into “Titles”. Each title is numbered and generally represents the rules for a separate state agency. Examples: MIEMSS -Title 30 Department of Health -Title 10

COMAR Description Titles are then broken down into “Subtitles” or “Chapters”. Examples from MIEMSS Title 30: Subtitle 02: Emergency Medical Services Providers Chapter 03: Scope of Practice and Duties

COMAR Description The information in each chapter defines the regulations relating to that title. The chapter is written in outline format (much like the Maryland Medical Protocols) for ease of reference. Each Subtitle contains a list of definitions for terms used in the chapter.

Where Can I Locate a Copy? A copy is located in the reference section of each public library. COMAR can also be located on-line at https://constmail.gov.state.md.us/comar/dsd_web/default.htm

Who Does it Impact? TITLE 30 effects: ...“any EMS service or provider who operates in the State of Maryland”...

Operational Impact Day-to-day influence of Title 30 Licensure / Certification / Credential Scope of Practice and Duties Prohibited Conduct Disciplinary Procedures Operational Suspensions Hearings Summary Suspension of License or Certification

Maryland Title 30 Overview Subtitle 01: General Subtitle 02: Emergency Medical Services Providers Subtitle 03: EMS Operational Programs Subtitle 04: Emergency Medical Services Education Programs and Courses Subtitle 06: Automated External Defibrillation Program

Maryland Title 30 Subtitle 07: Emergency Medical Communications System Subtitle 08: Designation of Trauma and Specialty Referral Centers Subtitle 09: Commercial Ambulances Services Subtitle 05 will cover EMS Regional Councils tentatively beginning July 1, 2002.

Explains “Incorporation by Reference” Subtitle 01 General Explains “Incorporation by Reference” The mechanism for including the Maryland Medical Protocols into COMAR. Designates the MIEMSS “Open Meeting” policy. Outlines the process for the access and/or correction of public records. Governs the procedures for obtaining a declaratory ruling from the EMS Board.

Subtitle 02 Emergency Medical Services Providers Defines the Licensure and Certification Process Including: Establishing fees for testing Requirements for providers Reciprocity Examination and reexamination Issuance of a license or certificate Renewal, surrender and/or reinstatement of a license or certificate Criteria for denial of a license or certificate

Subtitle 02 Emergency Medical Services Providers Chapter 3 of this subtitle establishes the “Scope of Practice” (based on the Maryland Medical Protocols) and duties for all levels of EMS providers including: Emergency Medical Dispatchers First Responders The chapter also contains the requirement that an EMS provider must function under an EMS Operational Program. A jurisdiction has authority for.. In Maryland each county plus the City of Baltimore and City of Annapolis is considered a jurisdiction.

Subtitle 02 Emergency Medical Services Providers Chapter 4 defines “Prohibited Conduct” Outlines the actions that can be taken as a result of prohibited conduct Reprimand or probation Suspend or revoke a license or certificate Deny a license or certificate Refuse to renew a license or certificate Refer to newsletter article and possibly provide for a handout as part of this class.

Subtitle 02 Emergency Medical Services Providers Chapter 05 specifies the disciplinary procedures including: Investigation of incident reports Review by the Provider Review Panel Action by the EMS Board Case resolution conference Hearings EMS Board action How does MIEMSS use the disciplinary process. All information in the Provider Review Process and medical review is considered confidential. EXAMPLES

Subtitle 02 Emergency Medical Services Providers Chapter 5 continued: Designates the composition of the Provider Review Panel Establishes the process for summary suspension of a license or certification Provides confidentiality and admissibility of proceedings, records, and files used throughout the provider review process.

Subtitle 02 Emergency Medical Services Providers Chapter 6: Contains the procedures for administrative hearings regarding: Licensure Certification Disciplinary action of an EMS provider

Subtitle 02 Emergency Medical Services Providers Chapter 7: Governs summary procedures for suspending an EMS providers license or certificate based on the protection of public health, safety or welfare.

Subtitle 03 EMS Operational Programs Defines the criteria for approval of an EMS Operational Program Establishes the policy for Medical Direction including the appointment of the EMS Medical Directors. Provides the guidelines for quality assurance, protocol development and designation of Base stations. Describe an EMS Operational: Currently only a county or a commercial ambulance services can be recognizes as an EMS operational program. There are 23 operational programs in Maryland, plus the City of Baltimore and the City of Annapolis. MIEMSS also recognizes several Federal installations as well. Examples include: Fort Meade Aberdeen Proving Ground National Security Agency

Subtitle 03 EMS Operational Programs Quality Assurance (QA) Each EMS Operational Program must have: A written QA plan approved by the medical director A medical Review Committee It is important to have defined duties. The EMS Jurisdictional Medical Director is responsible for all care provided within the jurisdiction

Quality Assurance Quality assurance plan components Data review Identification and analysis of trends Positive Negative Identification of protocol violations Remediation for patient care issues at the jurisdictional level. What is defined as a State issue? What is defined as a County issue? Jurisdictions are not always able to resolve an issue locally. We don’t want the problem moving to another county. MRC

Quality Assurance Quality assurance plan requirements Notify MIEMSS within 30 days of incidents that may have resulted in patient harm, require disciplinary actions from MIEMSS, or require a change in state protocol. Review written and oral allegations that an EMS provider failed to act in accordance with applicable law or protocol.

Medical Review Committee Medical Review Committee (MRC) responsibilities: Every operational program must designate a MRC. The committee is selected by the operational program and its medical director. It shall be the duty of the MRC with the participation of the medical director to carry out the quality assurance plan. How should the committee be developed? Bring in the experts. Who are they? What are the roles and responsibilities? Confidentiality

Medical Review Committee Medical Review Committee (MRC) responsibilities: The MRC is subject to the confidentiality and immunity provisions as provided by COMAR. Each member must sign a confidentiality agreement.

Subtitle 03 EMS Operational Programs Protocol development is also covered under this subtitle. Chapter 05 section .02 defines the composition of the Protocol Review Committee. This section also established the process for protocol development and approval including: Pilot Protocols Research Protocols Optional Protocols Emergency Protocols

Subtitle 03 EMS Operational Programs Chapter 06 governs the approval and operation of an EMS Base Station. Specific requirements are outlined for: Approval and renewal Specialty centers and consultation centers Out-of-state centers Denial or rescission of approval Appeal process

Subtitle 04 Emergency Medical Services Education Programs and Courses Governs the Educational Programs for: Emergency Medical Dispatchers Basic Life Support Providers Advanced Life Support Providers

Subtitle 04 Emergency Medical Services Education Programs and Courses Governs the Educational Programs for: Emergency Medical Dispatchers Basic Life Support Providers Advanced Life Support Providers Requirements for continuing education programs are also contained within this subtitle.

Subtitle 06 Automated External Defibrillation Program Establishes the criteria for the authorization of “Public Access” AED Programs Specific requirements for PAD programs include: Medical direction Protocols Quality assurance and maintenance Training

Subtitle 07 Emergency Medical Services Communications System Establishes the system for helicopter communication to SYSCOM.

Subtitle 08 Designation of Trauma and Specialty Referral Centers Provides the criteria for the designation of trauma and specialty referral centers. In addition it outlines the following standards for the trauma and specialty referral centers Data Collection and Quality Management Designation and verification criteria Disciplinary Action for subtitle violation

Subtitle 08 Designation of Trauma and Specialty Referral Centers This subtitle establishes the standards for the following: Trauma Centers Burn Centers Specialty Referral Centers Pediatric Trauma Centers Eye Trauma Centers Perinatal and Neonatal Referral Centers

Subtitle 09 Commercial Ambulance Services This subtitle provides the standards for Commercial Ambulance Services in the State of Maryland. Licensing process is defined Operational requirements are established Eligibility, application and renewal procedures are included Record keeping and MIEMSS record submission are outlined

Subtitle 09 Commercial Ambulance Services Commercial Ambulance Services continued Chapter 09 governs the enforcement of commercial ambulance statutes and regulations. A standard commercial ambulance service equipment list (for ALS and BLS) is located in Chapters 10 & 11. The last chapter of the commercial ambulance service subtitle governs the operation of neonatal ambulance services.

Maryland Title 30 Maryland Information System Each operational program shall provide to MIEMSS on a monthly basis a report of patient encounters.

Maryland Title 30 How do we get to compliance? Education Communications Cooperation Consensus

Summary COMAR provides the framework for the Maryland EMS System.

More Information If you need additional information please contact the MIEMSS, Office of the Assistant Attorney General Monty Magee (410) 706-8531 Sarah Sette (410) 706-8514

Maryland Title 30 Questions ??? Comments ???