by Ellen Flynn
RN, MBA, JD, CPPS, Associate Vice President, Safety and Accreditation


A key component of the Patient Safety and Quality Improvement Act of 2005 was the collection of data related to patient safety events for accountability and learning. Fast forward to 2017 and what we often see are organizations placing all quality and safety data into their Patient Safety Evaluation System (PSES), reporting it to the Patient Safety Organization (PSO) and calling it Patient Safety Work Product (PSWP).

If only it were that simple.

The May 2016 HHS Guidance Regarding Patient Safety Work Product and Providers’ External Obligations states that “The Patient Safety Act establishes a protected space or system that is separate, distinct, and resides alongside but does not replace other information collection activities mandated by laws, regulations, and accrediting and licensing requirements as well as voluntary reporting activities that occur for the purpose of maintaining accountability in the health care system.”

The bottom line is that organizations that blur the line by co-mingling information collected for external recordkeeping requirements along with information from their voluntary quality and patient safety work in their PSES, may place the privilege and confidentiality protections of eligible PSWP at risk. 

Facing numerous streams of patient data, how do you identify the most effective method for determining what data belongs with your PSO? To keep data decisions easy, here are five steps to identifying data eligible to be PSWP and how to separate it from other external recordkeeping requirements while simultaneously improving patient safety:

1. Define a quality and safety recordkeeping plan to meet external recordkeeping obligations and maintain the information separate and distinct from PSWP.

2. Clarify those recordkeeping obligations that are unclear with external entities.

3. Define a plan for collecting voluntary quality and patient safety work within your PSES that is separate and distinct from external recordkeeping obligations.

4. Review all information being collected within the PSES for eligibility.

a.    Is it information that could improve patient safety, health care quality and/or outcomes?

b.    Is it being assembled or developed for the purpose of reporting to a PSO and not for other purposes? 

5. Consider sending a copy of information collected to meet external obligations to your PSES and reporting the copy to the PSO. The original data is not eligible to be PSWP, but a copy of the data could be considered PSWP. Providers could conduct further deliberations and analysis on this data within the safe, protected PSES space. The copy and the deliberations and analysis would be privileged and confidential PSWP and promote patient safety learning.

By following these five simple steps, organizations can ensure they collect, retain and report the correct data to meet PSO requirements without placing PSWP privilege and confidentiality protections at risk. For information about the Vizient Patient Safety Program, click here.

About the author. In her role as associate vice president, safety and accreditation for Vizient, Ellen Flynn leads a team responsible for the company’s Safety Intelligence Program and Patient Safety Organization. A leader in her field for nearly a decade, Flynn has more than 20 years of experience in quality improvement and patient safety. She has led quality, safety, patient and family engagement, and regulatory compliance programs in large health systems, academic medical centers, physician groups and hospitals.

Published: March 16, 2017