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How the State of Maryland Puts Your AED Program at Legal Risk

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Highlights: To be approved to operate in the state, Maryland requires automated external defibrillator (AED) programs to obtain Registered Facility Certificates. But Maryland’s emergency medical services (EMS) agency refuses to accept or approve Registered Facility applications that follow the law. Rather, the agency forces AED programs to apply using an unauthorized online registry system that fails to comply with the AED program application and approval requirements the law specifies.

Why it Matters: The EMS agency’s handling of Registered Facility applications puts every Maryland AED program at risk of losing Good Samaritan legal protections, likely reduces the number of AEDs potentially available in the state, improperly forces applicants to disclose private business information to a third-party and serves no identifiable or meaningful purpose. Court involvement, administrative intervention and/or legislative changes will be needed to bring the EMS agency into compliance with its own rules.

Setting the Stage

At Readiness Systems, AED program compliance is one of our core competencies. We manage and fulfill state and local compliance requirements for AED programs nationwide, both directly and on an outsourced basis for industry partners. In our work, we sometimes encounter regulatory agencies seeking to impose burdens on AED programs that go beyond what the rules require. Nowhere is this more frustratingly true than in Maryland.

Maryland currently sits at 47th on the Cato Institute’s regulatory freedom index. If Cato analyzed AED program regulatory policy, Maryland’s EMS bureaucracy would surely land the state at 50th.

Structurally, the Maryland EMS Board (Board) is an 11-member board appointed by the Governor that oversees the Maryland Institute for Emergency Medical Services Systems (MIEMSS). MIEMSS regulates emergency medical services and oversees the state’s public access AED program.

Maryland’s AED law framework can be found in Maryland Education Code § 13-517 and Code of Maryland Regulations (COMAR) Chapters 30.06.01 and .02 (let’s call these the “Rules”). Maryland’s Rules are long and complicated, and they require many things that offer no meaningful benefits to AED programs or the sudden cardiac arrest (SCA) victims they may encounter (our last AED Law Report Card gave Maryland an “F”). Under the Rules, the state imposes registration, maintenance, training, post-event reporting and program documentation requirements on AED programs.

This article focuses on how MIEMSS manages the state’s AED program registration process, creating administrative burdens and legal risks for every AED program.

What the Rules Require

To have an approved AED program, Maryland requires organizations to apply to the EMS Board for a Registered Facility Certificate – something no other state requires. By statute, the EMS Board, through MIEMSS, must issue a Certificate to an organization whose application satisfies the four-criterion outlined in the law (let’s call these the “Application Criteria”).

The Application Criteria are written in such a way that applicants are essentially asked to commit to do the following things in the future:

  1. Comply with the written protocol approved by the EMS Board (it appears the Board has never formally approved the referenced protocol)
  2. Have established procedures in place as required by the EMS Board and designate a trained AED coordinator to manage the AED program (it appears the Board has never formally approved or required the referenced procedures)
  3. Maintain AEDs and related equipment and supplies in accordance with the standards established by the device manufacturer and the FDA (neither AED manufacturers nor the FDA establish AED maintenance “standards”)
  4. Ensure expected AED users have successfully completed a training or refresher training course as required by the EMS Board (it appears the Board has never formally approved or required the referenced training courses)

As a practical matter, the absence of the required protocols, procedures, maintenance standards and training courses makes it technically impossible for the Application Criteria to be met. That said, one can craft an application that, in good faith, addresses each of the law’s elements. That’s what we do. We prepare and submit applications touching on each of the Application Criteria and, further, demonstrating our customers follow the AED Program Best Practices Guide.

Astoundingly, MIEMSS categorically refuses to accept, or issue Registered Facility Certificates based on, applications that follow the Rules. Without any apparent legal support, the agency’s policy is to reject any application centered on the Application Criteria.

What MIEMSS Demands

Rather than following its own Rules, MIEMSS demands that AED programs apply for Registered Facility Certificates by using the Maryland AED Registry (Registry). But the Registry isn’t designed to collect the Application Criteria. Rather, the Registry solicits unrelated information about AEDs, AED accessories, AED program sites, AED inspectors, AED responders, AED program medical directors and AED availability (let’s call these items the “Registry Content”).

Because submitting Registry Content - which is not required under the Rules - fails to satisfy the Application Criteria, forced Registry use makes it literally impossible for AED programs to meet the Rules’ requirements. Notwithstanding this reality, MIEMSS gives AED programs no choice.

There is another troublesome aspect of forced Registry use. The Registry is owned and operated by a private, for-profit company that makes and sells AED equipment and services. Every organization with AEDs in the state is required to supply this third-party, through the Registry, with extensive private information about its AED program. Under the terms of the Registry’s click-through agreement which every AED program must accept, the third-party has the right to access and use this information for any purpose, including marketing its products and services to AED programs and selling the use of AED program data to government agencies. Coercing consent to the disclosure of private business information to a third-party for commercial purposes is clearly outside the scope of MIEMSS’ proper authority and serves no public purpose.

The Rules say AED programs are to “submit an application [for Registered Facility Certification] on the form that the EMS Board requires.” The EMS Board has never approved any application form, including the Registry. The Board cannot approve the Registry form in any event because the Registry does not allow users to satisfy the Application Criteria. Rather, it collects only unrelated Registry Content. 

Bottom line, MIEMSS has gone well outside the bounds of the Rules in demanding Registry use. This puts every AED program in legal jeopardy as explained below.

Good Samaritan Immunity Held Hostage

AED program Good Samaritan legal protections available in Maryland are poorly written and limited in scope. Those immunity protections that do exist are available only to Registered Facilities. MIEMSS holds Registered Facility Certificates hostage, agreeing to release them only to applicants that use the Registry.

MIEMSS’ actions may give crafty plaintiff’s lawyers the ammunition they need to defeat available Good Samaritan legal protections in SCA response lawsuits. Because the Registry collects only Registry Content that does not satisfy the Application Criteria, lawyers can credibly argue that Registered Facility Certificates issued based solely on Registry data are invalid. No Certificate, no immunity.

Interestingly, Registered Facility Certificates issued by MIEMSS state that the applicant “has met all the requirements set forth by the State of Maryland in accordance with Section 13-517 of the Education article of the Annotated Code of Maryland and COMAR 30.06 and is therefore certified.” But MIEMSS has no idea whether an AED program meets referenced legal requirements because the Registry doesn’t address them. Plaintiffs’ lawyers should have an easy time proving the certification statement is false.

Bottom line, applications that follow the Rules are willfully and summarily rejected. Applications submitted using the Registry don’t follow the Rules and thus can’t support issuance of Registered Facility Certificates. This means every Registered Facility Certificate issued in Maryland is arguably invalid putting every AED program at legal risk.

Due Process Rules Ignored

But wait, there’s more! Maryland’s Rules provide an appeal mechanism for AED programs denied a Registered Facility Certificate. To trigger this process, we submitted applications outside the Registry on behalf of several AED program customers. While rejecting the applications, MIEMSS refused to issue Notices of Denial as legally required. Notices of Denial give applicants the opportunity to have a hearing before the EMS Board. No matter how many times we asked, the agency refused to follow its own due process rules. No Notices of Denial. No hearings.

In the end, we were bullied into using the Registry to get the agency to stop hounding our customers directly. But we also submitted supplemental filings that follow the Rules and thus help lower legal risks for our Maryland AED program customers.

At some point, it seems lawyers must get involved. The courts may be the only venue that can force MIEMSS to follow its own Rules.

What's the Point of the Registry, Anyway?

Why the Registry? While the agency claims “that MIEMSS is confident that the Maryland AED Registry is serving an important public purpose,” it has never explained what that purpose is. Nor has it explained whether or how the agency uses Registry information for any purpose. Nothing in the Rules authorizes the agency to collect Registry information or specifies permissive uses of the data.

It appears from our interactions with MIEMSS that the agency so militantly fights to force Registry use so it can satisfy a bureaucratic need to count things. In email communications, MIEMSS touts the fact that, over 20 years, more than 13,000 AEDs have been registered in the state. Is this a number worth bragging about?

Maryland has 1.8 percent of the U.S. population but only 0.26 percent of the estimated 5 million U.S. public access AEDs. On a per capita basis, the state should have well over 90,000 AEDs. It seems likely the state’s AED laws and bureaucratic behavior contribute to this low AED count.

The Registry is essentially an AED program asset tracking system. But most AED programs have their own methods of tracking and managing AED program assets and have no need or desire to duplicate these efforts. Compelled Registry use imposes unnecessary administrative time and cost burdens on AED programs with no associated benefits.

Bottom line, the Maryland AED Registry serves no identifiable or meaningful purpose. It should be removed from the state’s public access defibrillation program framework (see also Realities and Limitations of AED Registry Systems).

Wrapping Things Up

What can Maryland do? Well, it can change the laws. But MIEMSS’ executive director says any effort to amend or improve the current Rules would be resisted by plaintiffs’ lawyers, so there are no plans to do so.

Good to know the trial bar’s interest in preserving the right to sue trumps what ought to be the agency’s mission to help SCA victims and the organizations that (often voluntarily) make AEDs available to them.

Perhaps some interested legislators will step in to force the agency’s hand and create a public policy framework that can save more lives. We’ve made this easy by crafting a Model AED Law, the Sudden Cardiac Arrest Heroes Act (available via the link), that eliminates burdens, strongly protects AED programs and gets AEDs in lots of places.

Absent legislative improvements and/or a dramatic change in MIEMSS’ approach to Registered Facility certification, organizations in Maryland should carefully consider whether to get or keep AEDs in the state (only schools, swimming pools and dental offices are required to have AEDs – for everyone else it’s voluntary). Given the current regulatory environment, the legal risks of having AEDs in Maryland may very well outweigh their benefits. These are the unfortunate consequences of faulty AED laws and misguided EMS agency behavior.

If your organization has AEDs in Maryland, let’s talk. We can implement compliance strategies on your behalf that avoid the Registry, allow you to keep your AEDs in the state and mitigate the risks created by the state’s EMS bureaucracy. If you are a lawyer for an organization with Maryland AEDs, feel free to reach out. If you are a Maryland legislator, we welcome the opportunity to support legislative efforts to make the state a life-saving model.

Have questions or want more information? Please contact us.

Not Legal Advice: The information in this article is not intended to be, does not constitute, and should not be relied upon as legal advice or legal services. Readiness Systems does not provide legal advice or legal services.

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