- HHS issued guidance Tuesday clarifying what can be called a patient safety work product (PSWP) under the Patient Safety Quality Improvement Act.
- Under the 2005 law, providers report PSWP to patient safety organizations, which aggregate it, assess it and advise providers on how to avoid future hazards.
- The 22-page guidance, which was jointly issued by the HHS’ Office for Civil Rights and the Agency for Healthcare Research and Quality, means that providers must now be more transparent about their patient records.
The Patient Safety Act created a voluntary reporting system to boost the data used to analyze and fix patient safety issues.
The intent was to fuel the development of additional information via voluntary patient safety activities and provide privilege and confidentiality protections for that information — not to protect records that are part of providers’ existing mandatory information collection activities, the guidance notes.
But some providers are improperly hiding certain patient information behind the veil of PSWP, while others store all information in their patient safety evaluation system (PSES) and claim it is PSWP and not releasable, according to the guidance. Still others create records to comply with external commitments not covered by PSES and refuse to reveal it, asserting it’s PSWP.
The document clarifies a number of issues, including what patient information is PSWP, and when data can be removed from a patient safety evaluation system.
"Specifically excluded from the definition of PSWP is, 'a patient’s medical record, billing and discharge information, or any other original patient or provider information,'” the guidance states.
"The Patient Safety Act and Rule also exclude from the PSWP definition 'information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.'"