HHS clarifies Patient Safety Quality Improvement Act requirements

Providers who have been trying to shield patient records from view by hiding behind the Patient Safety Quality Improvement Act (PSQIA) can no longer do so with the release of guidance clarifying the law's requirements. 

The guidance clarifies what information can be called patient safety work product (PSWP). The PSQIA established a voluntary reporting system to enhance the data available to assess and resolve patient safety issues. The Health and Human Service Department's Office for Civil Rights (OCR) and Agency for Healthcare Research and Quality (AHRQ) jointly released the guidance.

Under the safety quality act, providers report PSWP to patient safety organizations (PSOs) that then aggregate and analyze it and give feedback to encourage learning and prevent future errors. PSWP receives federal privilege and confidentiality protection. Information can become PSWP if a provider prepares to report it to a PSO and does report it, a PSO develops it, or a provider places it in its patient safety evaluation system (PSES) to be reported to a PSO.

OCR and AHRQ note that some providers appear to be calling some patient information PSWP when it does not meet that definition. Others maintain patient records only in their PSES and refuse to disclose it, asserting that it's PSWP, or develop records to meet external obligations outside of the PSES, then destroy the original and refusing to disclose the remaining copy, claiming that it is PSWP. 

The guidance clarified when information is and is not PSWP, when information can be removed from a PSES, and other issues. For instance, the guidance clarified that a patient's medical record, billing and discharge information or other original patient or provider information is not PSWP, nor is information prepared for purposes other than reporting to a PSO.  Only information that is intended to be reported to a PSO should be put into a provider's PSES. Moreover, any external reporting or record keeping obligations cannot be met with PSWP.  

"The Patient Safety Act was not designed to prevent patients who believed they were harmed from obtaining the records about their care that they were able to obtain prior to the enactment of the Patient Safety Act," the guidance states.

To learn more:
- read the guidance