PSO Legal Update: A new focus on reporting

The Center for Patient Safety’s staff has been fielding a lot of questions about what information can be protected under the Patient Safety and Quality Improvement Act and how that relates to reporting to the PSO.  The basic rules have not changed, but there is some new focus on reporting, which is the touchstone for all the definitions in the Act and the Final Rule.  So, this explanation will start at the beginning.  

The Act defines Patient Safety Evaluation System (PSES) as “the collection, management, or analysis of information for reporting to… a patient safety organization.”  The PSES can collect, manage and analyze; it need not just gather information and report it in its “virgin” form.  Inside the PSES, information can be aggregated, sorted, evaluated or otherwise processed as part of the organization’s patient safety activities.  

The Act has a two-prong definition of Patient Safety Work Product (PSWP).  The first prong is information “assembled or developed by a provider for reporting to a patient safety organization and… reported to a patient safety organization.  AHRQ refers to this as the “reporting pathway.”  That information needs to be gathered for purposes of reporting and actually reported.  The language itself does not address non-reported material.

The second prong of the PSWP definition, though, is the source of much value for PSO participants, as it is what protects the actual work within their PSES.  The Act also defines as PSES items “which identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a patient safety evaluation system.”  To meet this definition, the PSES must conduct some deliberation and analysis of information that it has acquired.  And since the purpose of the PSES is to develop reportable information, the deliberations and analysis must take place in the course of (and generate material related to) synthesizing reported material.

CPS does not believe this means that ONLY information reported to the PSO can be protected.  We do, however, recommend that our participants only try to protect information that comes into the PSES or is developed within the PSES as part of a process that leads to reports to the PSO.  Those reports can be in the form of Common Data Format reports, root cause analysis that you send to a PSO or information that is functionally reported in connection with some actual reporting.  (If you have questions about functional reporting, you should contact CPS.)  And remember, you can meet the reporting requirement by sending your PSO PSWP or non-PSWP.  So, if you need to share a part of your RCA with a regulator, you can still report it and protect the process that developed it.  The point of reporting is to share your learning with others.

CPS staff will continue to remind our participants of the importance of reporting.  We don’t know how much is enough, but we know that an absence of reporting will lead to an absence of protection.