In the 13 years since Patient Safety Organizations (PSOs) were first established, many large institutional providers from all segments of the healthcare field have taken advantage of the benefits they can provide. Relatively few individual practitioners and small practices have sought to participate, however, either because they believe PSOs are cost prohibitive, or assume they will be ineligible because of their size. But there is a PSO for practices of every type and size, and nearly all healthcare providers have important interests that can be served that are well worth the costs. All practitioners should at least possess an accurate, objective understanding of what PSOs are, in order to determine whether alignment will serve the best interests of their practice and patients.
In 2000, the Institute of Medicine (IOM) published its landmark report, To Err is Human, which estimated that between 44,000 and 98,000 hospital patients were dying annually from “preventable medical errors.” The IOM concluded that these human losses — with a projected annual fiscal impact as large as $29 billion — were the result of a fundamental, systemic breakdown in patient safety infrastructure.
To address this crisis, Congress sought to create a learning environment where health care professionals could evaluate medical errors and near-misses free from the scrutiny of regulators and potential litigants. So in 2005, Congress passed legislation creating a voluntary, privileged and confidential reporting system designed to improve patient safety. The centerpiece of that law was the establishment of PSOs.
A PSO can be a private or public entity comprised, at least in part, of medical professionals whose mission and primary purpose is to improve patient safety and the quality of healthcare. PSOs are regulated by the United States Department of Health and Human Services (HHS) and subject to a multistage application and certification process.
There are two types of PSOs: independent PSOs, and component PSOs. An independent PSO is an unaffiliated organization that serves multiple entities and practitioners on a contractual basis, typically charging its members a retainer, based on the services that are requested. A component PSO is either a unit or division of a legal entity; or it is owned, controlled or managed by one or more legally separate parent organizations. Component PSOs are often lean, in-house organizations, consisting of only one executive director and an analyst.
A provider’s needs and resources will dictate whether they should align with an independent PSO, or formulate its own component PSO organization. Unless a primary care physician’s practice is associated with a large provider group, most individual practitioners will find an independent PSO to be more cost effective.
PSO cornerstone: Patient Safety Work Product
By law, all types of PSOs are required to collect and analyze data relating to patient safety and disseminate information designed to improve patient safety, including recommendations, protocols and best practices. PSOs exist to assist practitioners in minimizing patient risk by providing evidence-based feedback based upon the data they collect and analyze.
The confidential data and information collected by PSOs from the providers they serve is called Patient Safety Work Product (“PSWP”), a category of materials that includes any data, reports, research, analyses and other types of information that has the potential to improve patient safety. Typically, PSWP consists of incident reports of actual patient harm and records of near misses. Such information must have been created or collected by a healthcare provider to report to a PSO; and ultimately it must be reported to a PSO, in order to be considered privileged and confidential. Similarly, the analyses and recommendations generated by the PSO and delivered to the providers are considered privileged and confidential PSWP.