EMS Insider, Legal Consult

Using Advanced Technology to Pursue Quality & Best Practices

Let’s say you have recently returned from a conference or trade show, where you found a great new piece of technology that you want to implement in your agency. Or, maybe you have been tasked with sourcing a new piece of software or technology to enhance the care and services your agency provides in your community. Before you go jumping off the proverbial bridge into the new technology lake, you owe it to yourself and your agency to ask two very important and fundamental questions: 1) what do I need to do to protect and implement the technology on a local level from a best practice standpoint? And, 2) how can I protect the data coming through that piece of technology from being used by attorneys to find fault regarding our quality efforts?
 

It is no secret that EMS providers are fond of “bright, shiny, new objects.” If it’s cool and it’s new and it will make our jobs easier, we want it! However, recent articles and commentary by leading scientists and experts are sounding the alarm about artificial intelligence (AI) and its impact on our society. Elon Musk and Stephen Hawking have both indicated that we have a window of opportunity to understand, as well place controls around, new technologies, because the consequences of AI are far reaching and could impact our future far beyond our current understanding.

 

Does this mean AI will operate an ambulance today, tomorrow, or next year? Not likely, but it does mean that technology will continue to profoundly affect our society and EMS. Moore’s law states in general terms that processing power will approximately double every 18 months. This shows the exponential growth potential for AI for all segments of our society, including EMS. It seems like we see new technologies daily. Think about the last conference that you attended. How many new or advanced systems were in the vendor hall?

 

What does this mean and why is it important to us in EMS? The EMS industry is rapidly evolving. Initiatives such as Mobile Integrated Healthcare Practice–Community Paramedicine (MIHP-CP), as well as new technology in the areas of telemedicine, patient monitoring devices, ePCR/EHR software and the interoperability of these devices and technologies are taking the industry by storm. Technology is critical to our efforts in saving lives and many new platforms continue to support these efforts every day. Not only can we find real dollar savings as we improve efficiency by integrating these systems, but more importantly, they offer us ways to improve efficiency as well as the quality and performance of the care that we deliver.

 

As EMS professionals, it is important that we welcome technology and look forward to its continued evolution; however, we must also critically evaluate and analyze its value rather than blindly adopting it. It is also important that we insure that technology doesn’t create gaps in patient care or open unexpected legal quagmires. Data is driving the evolution of the industry, and as technology drives more data, we should be cautious that the data is not used against us.

 

Many of the new platforms offer powerful tools to drive data and information far beyond what we would have imagined 20 years ago. While using these new platforms to improve our systems and save dollars, we might be opening a Pandora’s Box of unexpected legal consequences. For example, perhaps you, someone in your agency, or even your medical director, routinely run reports which can be generated by your technology systems, such as IV or intubation success rates, on-scene times, or response time statistics. Now, let’s say you print out those reports and hand them out at meetings so that the data can be evaluated or reviewed by the agency’s medical director, an oversight board, or committee. Sometimes the information contained in those reports is less than favorable to the agency. After all, that is why you are running the reports: to perform quality assurance and quality improvement (QA/QI) activities. Unfortunately, the information gleaned from these reports often does not stop at the meeting; the information derived from our new technology can also be used by attorneys to find fault regarding our quality efforts.

 

The question becomes then, how can EMS providers protect their organizations, while using advanced technology to pursue quality and best practices? While some states offer protections around EMS quality work, others have little to no mention of EMS in quality improvement protection statutes. Furthermore, every law is different with some being very murky and others that have gaps or limitations. However, the federal Patient Safety Quality Improvement Act (PSQIA) offers protection for EMS in all 50 states specifically for reporting and discussion of adverse events, near misses, and dangerous conditions.1

 

 

The PSQIA is considered the gold standard for protecting quality and safety work. The PSQIA and its implementing regulations, establish a framework for healthcare providers to voluntary report information regarding medical errors and safety concerns to a federally listed Patient Safety Organization (PSO).2 Such reporting is privileged and confidential as it relates to the collection and analysis of patient safety events, and information shared within the PSO that is defined as Patient Safety Work Product (PSWP), is generally not subject to subpoena, discovery or admission into evidence in federal, state or local legal proceedings. In addition to the protections, the law is intended to help providers to safely learn and prevent future events from occurring by sharing events to a PSO.

 

Ultimately, the goal is to find a balance between information and data transparency and the risks associated with generating it, while still evaluating the data, performing QA/QI functions, and establishing compliance standards for new practice areas such as MIHP-CP in a safe and protected space. Developing best practices around data collection and evaluation is critical to the future success on all fronts of the EMS industry. Specifically, we need to think about what data is being collected, where that data is going, and who has access to it?

 

The first step before implementing a new system or entering into a new data space should be to do a Failure Mode Evaluation and Analysis (FMEA) of the system. A FMEA would help to offer a comprehensive review of the project and investigate any unintended consequences before implementation. In addition, it would help support a better understanding of the product as you run it through a technological obstacle course. Even if you have a technology platform in place now, it is not too late to go back and investigate and make sure you are not creating legal exposure, and to modify and adjust existing policies around the technology.

 

In the end, the key is identifying what is in your hands from a technology standpoint, having good solid policies and systems in place around the technology, and not jumping into new technology without proper research and due diligence. Consider the following best practice recommendations:

  • Add language to those reports which support your QA/QI efforts that identifies the purpose for which the report was created. Without clear identification that a particular report or data was created for QA/QI purposes and is QA/QI work product, you will have an uphill battle protecting it from legal discovery and having it used against you, your agency, or your staff in various proceedings.
  • Speak with your software vendors to see if they can facilitate the automatic inclusion of such language on reports generated by their software systems.
  • Enlist the assistance of legal counsel knowledgeable in this area to review your QA/QI policies and help craft QA/QI work product identification language to be used on reports.
  • Seriously consider working with a federally listed PSO. Working with a PSO can help support your needs in protecting as well as supporting safer care in our communities.

Finally, remember that the PSQIA, and working with a PSO, can only provide so much protection, and neither is an absolute shield or cloak. However, when applied properly, information shared within the PSO that is defined as Patient Safety Work Product (PSWP), with limited exceptions, is not subject to subpoena, discovery or admission into evidence in federal, state or local civil, criminal, or administrative proceedings, including disciplinary proceedings against a provider.

 

This article scratches only the surface. Be sure to consult with your attorney, a compliance specialist, or a Patient Safety Organization to review your organization’s specific needs and obtain appropriate advice on these and related issues.

Allison J. Bloom, Esq. is an attorney in private law practice in the field of EMS law. Her practice is focused on providing risk management and legal services to EMS and fire agencies, concentrated around governance, legal and regulatory compliance, records and information management compliance, and corporate and business law. Attorney Bloom has published numerous articles and lectures frequently on EMS legal topics. Contact her via e-mail at [email protected].

 

Lee Varner is the EMS Project Manager for the Center for Patient Safety, where he focuses on leading the effort to bring patient safety training and education to EMS providers. His work includes analysis, planning and coordination for EMS projects as well as the redesign and implementation of patient safety strategies. He is also a former field paramedic, fight paramedic and EMS Outreach Coordinator for a hospital system in the Midwest.

 

REFERENCES

1. 42 U.S.C. 299b-21 through 299b-26
2. 42 CFR Part 3