On July 29, 2005, President Bush signed into law the Patient Safety and Quality Improvement Act of 2005. However, the main feature of that law, creating patient safety organizations, remained in an extended state of legal limbo for three and a half years. To read the entire Patient Safety and Quality Improvement Act of 2005 (The Act), please go to: http://www.pso.ahrq.gov/statute/pl109-41.htm.
In November, the U.S. Department of Health and Human Services (HHS) issued final regulations implementing the Patient Safety and Quality Improvement Act of 2005. These regulations laid the foundation for voluntary, confidential, privileged reporting of safety information by individual providers and groups to Patient Safety Organizations (PSOs).
“Providers” pertain to any individual or entity licensed to deliver healthcare services in the jurisdiction where licensed, and any other individual or entities authorized by the Secretary of HHS—See Sect. 921, subsection 8 of The Act (citation link above). When medical errors occur in hospitals, providers should work in tandem with their institutions to report medical errors to PSOs. The legal protections from discovery also extend to analyses and reports by the PSOs themselves.
The remainder of this article will focus on The Act and some of its key provisions, especially PSOs, their rationale, and how their proper use may move the whole patient safety movement forward at a faster clip.
The Reluctance to Report Medical Errors
It is a central tenet of all quality improvement activities (including patient safety) that whatever is not measured cannot be managed, much less improved. A corollary of this tenet is that whatever is not reported cannot even be measured, much less managed, let alone improved.
However, in this country’s extremely litigious environment, there has been (and, unfortunately, still is) a great reluctance on the part of those in healthcare to report medical errors (even on a voluntary and confidential basis). There has always been the fear that doing so will eventually come back around to ensnare the medical error reporter in some way in any potential litigation which may follow. Medical error reporters have also feared for their jobs if performing this role could get their superiors or perhaps their employer (the hospital) involved in litigation.
Despite these inhibitions, there has been a steadily growing movement toward more disclosure of medical errors around the country in the past few years. The National Conference of State Legislatures has revealed that the majority of states have some kind of medical error reporting laws in place. Since July 1, 2001, the Joint Commission has required hospitals to demonstrate that they provide for the expedited disclosure of medical errors to patients and their immediate families. Nevertheless, the reluctance to report medical errors has continued.
Reasons for The Act of 2005 and Patient Safety Organizations
Dating back to its landmark report published almost 10 years ago in November 1999, the Institute of Medicine of the National Academy of Sciences (created by President Lincoln to advise the U.S. Congress and Presidential Administration on all matters involving science and technology), spotlighted a serious need to capture data about medical errors to help reduce future harm to patients, (Corrigan J, et. al., To Err is Human—Towards a Safer Health System; Institute of Medicine; National Academies Press; Washington, D.C., November, 1999). Over the next several years, healthcare quality improvement and patient safety advocates made several attempts to help fashion and shepherd through the U.S. Congress various ways to protect medical error reporting from discovery in legal proceedings.
Finally, these groups coalesced around the notion that new entities, PSOs, needed to be created, evaluated and certified to serve the country as confidential repositories of reported medical errors and other safety information, which could be protected from discovery in legal actions. The Act authorized the creation of PSOs to improve safety and quality through the collection and analysis of confidential and non-discoverable data on adverse patient events (http://www.pso.ahrq.gov/psos/overview.htm).
Medical errors and other patient safety information reported confidentially to PSOs for the purpose of aggregating information which may be analyzed to identify and eliminate the root causes of adverse events will be protected from discovery in legal actions as provided for by The Act. This provision derives from the broader law which (as a matter of public policy and safety) prohibits the introduction into evidence in legal proceedings the details of subsequent improvements to a dangerous situation which may have been originally responsible for a plaintiff’s injuries.