About Patient Safety Organizations (PSOs): Did You Know?

December 15, 2014    |   By: Calevir

Now that Patient Safety Organizations (PSOs) have been in existence for more than five years, the federal Patient Safety and Quality Improvement Act (PSQIA) is better understood, and knowledge about the Act has increased. Still, there are a number of questions we commonly receive at the Center for Patient Safety.   Here are the top 10 questions, answered by the Center’s Patient Safety Specialist, Eunice Halverson at [email protected]:

Why should a health care provider join a PSO?
PSOs are independent, external experts who can collect, analyze and aggregate patient safety work product to develop insights into the underlying causes of patient safety events. Communications with PSOs are protected to allay fears of increased liability or fear of sanctions. With this federal protection, healthcare providers can share information with other participants, via the PSO, and learn from each other to ultimately improve patient care. More information is available from the AHRQ on working with a PSO.

What is the Patient Safety Evaluation System (PSES)?
The PSES is a means for the collection, management, analysis, and communication of information for reporting to a PSO. The PSES may include information about events, errors, near-misses, quality improvement data, and other patient safety data and information that is developed by and for the PSES workgroup, and is investigated, examined, and analyzed by the workgroup.

What is Patient Safety Work Product (PSWP)?
PSWP is the information protected by the privilege and confidentiality protections of the PSQIA through a PSO. It is a record that reflects the deliberations and analysis surrounding patient safety and quality improvement activities that are performed within the PSES. PSWP may be data, reports, records, memoranda, analysis, or written or oral statements involved in the development of data and information for reporting to the PSO.

What is non-PSWP?
PSO participating organizations have the option of defining certain documents and information as non-PSWP. These might include Items that have not been reported to the PSO and are voluntarily removed from your PSES by a designated individual/committee. They may be items clearly identified by policy or in writing on the documents as non-PSWP and submitted to the PSES for reporting to the PSO for others to learn from your experience. It’s important to remember that information you designate as non-PSWP, even if it resides in your PSES or has been reported to the PSO, is not protected.

Can PSWP be used for other purposes?
PSWP can be used for “non-PSO reporting” purposes under limited circumstances. Here are the constraints:

  • It can only be shared within the provider’s workforce, as it remains confidential.
  • It needs to be developed primarily to support reporting to the PSO. In other words, if it appears that the primary purpose of developing the information was to use it for other reasons, then the protection will be in jeopardy. If the PSES develops PSWP that could bring value within the organization if used for other purposes, then it can be used. The purpose of the law is to promote safety, after all.
  • PSWP can also be used in work among affiliated providers (those with common ownership and/or managerial control).
  • The regulation addresses this issue at p. 70778: “…[W]e emphasize that the rule does not regulate uses of patient safety work product within a legal entity.”

How do I claim protection under the PSQIA?
Michael Callahan, attorney who helped successfully defend Walgreens in an Illinois PSO case, recommends four actions to prepare the best defense to protect PSWP:

  1. Contract with a certified Patient Safety Organization (PSO).
  2. Develop a comprehensive PSO policy which defines your PSES, PSWP and workforce. Identify and assess your current reporting systems and information flow for patient safety and quality improvement activities and events, considering your event reporting system; how data is shared, processed and documented; as well as your committee structure where patient safety and quality data and information are discussed.
  3. Educate staff about your PSO participation and expectations, ensuring your policy is implemented and followed.
  4. Submit as much PSWP and non-PSWP as possible to the PSO database. Root cause analyses and other types of analysis or lessons learned for any event, near miss or unsafe condition enrich the value of the database. The more accurate the data and information you submit, the greater protection for your quality and safety work and increased learning is achieved from participation with a PSO.

When does our PSWP become protected?
Information collected for submission to the PSES is considered to be PSWP at the time it is collected or developed, unless specifically designated as non-PSWP by designated individuals/committees. The data/information is submitted to the PSES as part of the PSO reporting process. The PSES may also develop new information as part of its deliberations and analysis; any information developed within the PSES is PSWP.

Are there any regulatory requirements relative to what must be submitted to a PSO?
No, your organization should determine what will be submitted based on the definitions in your policy. In 2010, regulatory requirements in Missouri defined which events Missouri Medicaid providers were to submit; however, that regulation was rescinded in June 2012.

My PSO policy has not been updated since we joined the PSO, before 2012. Where can I get assistance?
The Center provides a policy template (embed for participants only) for its participants. In addition, we provide one-on-one consultation to customize your policy to inclusively describe how your patient safety and quality information flows. Contact Eunice Halverson for assistance.

Do PSOs receive federal funds?
PSOs receive no federal funding.


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The Center for Patient Safety believes that collaboration and sharing are the best ways to drive improvement. We strive to provide the right solutions and resources to improve healthcare safety and quality.