EMS Insider, Legal Consult

Patient Safety Organizations

In the October issue of EMS Insider, I discussed the idea that as EMS agencies partner with other providers and institutions in their communities to implement mobile integrated healthcare practice/community paramedicine (MIHP-CP) programs, those partners will have certain expectations regarding the existence within the EMS agency of both a comprehensive corporate compliance program and specific compliance controls and systems. But, how does one go about establishing a compliance program or even determining what the proper compliance standards should be for a practice that is in its infancy? Over time, we will address that question in this series. However, establishing uniform compliance standards takes time, energy and data, and cannot be done overnight.
In the meantime, in the absence of uniform formal practice standards and programs, what constitutes an area of risk for individual programs will vary greatly depending on the specific type of services provided, who the partners are that will deliver those services, and each partner’s view and priority of the risks involved. For example, let’s say you are proposing a readmission reduction program in your community. Although the benefit to the hospital is a reduction in penalties for readmissions, the hospital CEO will most likely express concerns about patients being “prevented” or “steered away” from the hospital even when they really need to be taken there. Although both sides agree that there will be strict guidelines and protocols in place for which patients will be enrolled in the program, the criteria for enrollment and how enrolled patients will be managed, the CEO will most likely want to see some kind of real-time data monitoring to ensure compliance by the EMS agency. Likewise, if a problem is identified, the hospital will want assurances that the issue can be addressed and resolved in a confidential and protected manner. After all, no one wants, needs or likes bad press—especially in a practice that is new and novel.
It is only by identifying and monitoring various perceptions of areas of risk that commonalities can be developed, leading to universal compliance standards. While there are any number of ways to identify and monitor risk areas, what is often lacking is the ability do so in a confidential and protected manner. This is especially true when you conduct that monitoring in-house. Hospitals, physicians and other healthcare practitioners are often afforded peer review protections by law. However, many states across the country do not provide adequate confidentiality or peer review protections for EMS agencies and providers. One such avenue to overcome this lack of protection and confidentiality is the use of a Patient Safety Organization (PSO).

What is a PSO?

PSOs are federally-based organizations that provide protection for your safety and quality of work. They can be used for both data collection and peer review-type protections. Created by the Patient Safety and Quality Improvement Act of 2005,1 and regulated by the Patient Safety Rule,2 PSOs provide for the improvement of patient safety and reduction of the incidence of events that adversely affect patient safety. The act established a system of patient safety organizations and a national patient safety database, with the goal of encouraging reporting and broad discussion of adverse events, near misses and dangerous conditions. It also established privilege and confidentiality protections for the Patient Safety Work Product (as defined in the act).
A little-known provision of the Affordable Care Act requires that all hospitals with 50 or more beds will effectively be required to participate in a PSO.3 Although the participation requirement has been delayed until at least 2017, if hospitals wish to continue to do business with qualified health plans that participate in health information exchanges, they will have to contract with a PSO at some point in the future if they have not already. And, while there is currently no requirement that EMS agencies participate in PSOs, it is certainly foreseeable that an agency that contracts with a hospital to provide EMS and/or MIHP-CP services will be required by contract to participate in one as part of the hospital’s compliance initiatives.

The role of a PSO as an MIHPCP compliance adjunct

So, how can a patient safety organization that monitors adverse events, near misses and dangerous conditions help establish compliance standards for MIHP-CP programs? Because, as with any other type of medical practice area, adverse events, near misses and dangerous conditions can (and eventually will) occur in MIHP-CP practice. For example, despite the best efforts of the MIHP-CP team, an enrolled patient is readmitted to the hospital for CHF within 30 days of discharge. Or, a patient who, in accordance with established protocols, appeared stable enough to be seen at a medical clinic upon EMS field assessment, collapses in the taxi on the way to that clinic. Or, a patient receiving athome wound care develops an infection despite proper wound care techniques during routine MIHP-CP visits by the community paramedic or APRN. All of these are considered adverse events, and need to be thoroughly looked at and evaluated to minimize future similar occurrences.

Although it goes without saying that you will do your own internal review and evaluation of each of these incidents, there is no confidentiality protection for having a truly open and honest discussion that leads to quality improvement as opposed to sanctions, nor is there any legal protection from evidence discovery by a lawyer acting for the patient and/or family.

This is where PSOs can be especially helpful. Specifically, PSOs provide protection for:

  • Call review documentation (for example: communication/feedback to your staff about their performance; focused reviews of high risk or other specific concerns)
  • Documentation and conversations related to investigations of incident reports
  • Internal studies on medication and other types of errors
  • Case reviews by your agency’s medical director
  • Regional quality committee meetings (certain conditions must be present)
  • Most any electronic or paper documentation, notes and data related to your agency’s safety and quality improvement processes

The ability to have completely open and candid review and discussions among practitioners across agency and organizational lines in order to properly assess and evaluate the efficacy of your MIHP-CP program from all angles is critical to both the success and sustainability of MIHP-CP initiatives and the establishment of compliance standards and benchmarks. This is especially true with a new field of practice such as MIHP-CP, which is still in the early stages of development as a practice area, and whose course is still being charted.

The fact is, despite our best efforts, things happen that can cause harm. When they do, the last thing you want is to have also caused harm to the reputation of your agency and MIHP-CP program. Without legally sound confidentiality protections in place, efforts to openly review and discuss adverse events, near misses and dangerous conditions run the risk of being discoverable in court. And all it will take is one lawsuit or instance of negative press to cause a loss of confidence in your community partners, payers and participants, and bring about the collapse of an otherwise stellar and very necessary program.

By submitting information and data to a PSO for monitoring, trends can be established across multiple programs providing similar services and, if necessary, alerts can be sent out to all participants to watch out for particular triggers or situations that increase the risk of adverse events, near misses and dangerous conditions, so that they can be avoided or mitigated. Ultimately, it is this collection of information which will lead not only to best practices in the field of MIHP-CP, but also to risk management and compliance standards for this new practice area.

Finally, keep in mind that many hospitals—especially those that are unfamiliar with what EMS agencies and providers actually do—may assume that EMS practitioners are covered by peer review statutes (which, in most states, they are not), simply because their own medical staff are. Be prepared to address this upfront and make sure that the hospital executives you are negotiating with are not making false assumptions. The hospital may have certain requirements for participation in peer review and/or PSO affiliation and may require PSO affiliation as part of MIHP-CP contracting. After all, if the hospital itself is required to participate in one, it will most likely require all of its associated entities and partners to also participate in order to facilitate the open exchange of information for quality improvement and compliance purposes.

For more information about PSOs, visit the Agency for Healthcare Research and Quality (AHRQ) at www.pso.ahrq.gov and/or the Center for Patient Safety at www.centerforpatientsafety.org.4

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


1. 42 U.S.C. 299b-21 through 299b-26.

2. 42 CFR Part 3.

3. Patient Protection and Affordable Care Act, 42 U.S.C. § 18001 et seq. (2010).

4. The Center for Patient Safety is currently the only authorized EMS PSO in the United States.