CPS Safety Watch/Alert: AHRQ Guidance

June 20, 2016    |   By: Alex Christgen, BS, CPPS, CPHQ

Patient Safety Organizations (PSOs) and their participants have struggled with interpreting the Patient Safety and Quality Improvement Act (PSQIA) with respect to handling patient safety work that may be necessary to satisfy mandatory reporting or other operational requirements. In an effort to ease anxiety and develop a common understanding, the Agency for Healthcare Research and Quality (AHRQ) has issued a statement (“Guidance”) on the interface of (1) PSO protection of Patient Safety Work Product (PSWP) and (2) mandatory reporting and operational requirements. AHRQ’s statement is available here. Below are some highlights, based on the questions CPS gets most often from its participants. CPS participants can always contact the Center’s staff with questions.

  • The PSQIA has always required that PSO participants keep the information required to satisfy mandatory reporting requirements outside of the PSWP “protected” space. The Guidance reinforces that requirement. However, the PSQIA and the Final Rule allow participants to gather information inside the PSES until they know whether it will need to be reported. If outside reporting is required, then the information gathered in the PSES that has not yet been reported to the PSO can be pulled back out, so that it can be used to satisfy the outside reporting requirement. The Guidance recognizes both this early PSES protection and the opportunity to pull information from the protected space when necessary.
  • Like the Final Rule, the Guidance emphasizes that analysis that takes place in the PSES cannot be “dropped out.” It must remain as PSWP.
  • If a participant has a known obligation under state or federal law to report certain information, the provider should plan on developing it outside the PSES, as it cannot be PSWP.
  • The Kentucky Supreme Court’s Tibbs decision held that work surrounding mandatory state reporting could not be protected, as the state retained the right to investigate how the provider was accomplishing its reporting obligations. AHRQ’s Guidance seems to question that position, noting instead that information related to the required reporting “form” could be protected once the essential reporting obligation has been fulfilled by submitting the actual form, as long as the original documents from which the report was developed are still available.
  • A variety of projects may take place after a patient safety event. AHRQ’s Guidance contains some helpful examples on pp. 6-7 of how that work can be viewed as inside or outside of the PSES, and when it will have to be non-PSWP because of outside reporting requirements.
  • AHRQ encourages PSOs and their participants to work with state agencies and regulators to determine what information they need access to and what can reliably be viewed as PSWP, so that there are fewer confrontations on the front lines about those issues. (NOTE: CPS has historically supported its participants in this communication wherever possible.)
  • The Guidance emphasizes that PSWP is protected because it has been developed for reporting to the PSO, and that the PSES is a protected space for developing that information. CPS has encouraged its participants to view PSO reporting as the end point of their PSES activities, and to actually report to the PSO. AHRQ’s Guidance underscores the importance of reporting.
  • The Guidance specifically mentions hospitals’ requirement under the Conditions of Participation to track adverse events, noting that there is a “legitimate outside obligation” to keep those records. 42 CFR 482.21(a)(2) (https://www.law.cornell.edu/cfr/text/42/482.21). Incident reports have been a flashpoint in many states with respect to surveyors’ ability to see PSWP. PSO participants should carefully consider what routinely reported event information goes into or out of the PSES.  For example, some PSO advisors recommend that basic incident data that includes just patient name, date, location and a brief description would allow regulators to conduct their own investigations while protecting the PSO participant’s deeper investigation and analysis of those events.
  • The action plans or other actions or changes that result from analysis inside the PSES cannot be protected and can always be shared with surveyors.


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