Encouraging Staff to Speak Up about Safety

One of the most important, but difficult, aspects of improving patient safety culture is getting employees to speak openly and freely re: safety concerns.  IHI shares four suggestions of how to improve culture at your organization. Read IHI blog.

AHRQ Guidance: PSOs, Parent Organizations and Affiliated Providers

The Patient Safety and Quality Improvement Act (PSQIA) and its associated regulation allow affiliated providers to share protected PSWP.  Providers are “affiliated” if they either have a parent/subsidiary relationship or are common subsidiaries of a single parent.  The regulation outlines the requirements for those categories, but generally the parent must have control over the subsidiary/affiliated organization.  (We recognize that many non-profit organizations use a term other than “subsidiary,” but we will use it here to generally represent the non-parent.)

AHRQ published a new guidance document in June 2016 which discusses these issues in further detail and also outlines some situations in which potentially related organizations would not qualify as “affiliated.”  The Guidance stresses that the meaning of “parent organization” may be broader than it is in corporate law, and that it depends on “actual organizational control, rather than the organizational structure.”   AHRQ defines “control” as “the authority to control of manage agenda setting, project management, or day-to-day operations” of the subsidiary entity.  AHRQ stated that it intends to retain a great deal of flexibility in this interpretation.  Ownership of enough stock to control the subsidiary also qualifies; the ownership need not be a majority to create control.  A PDF of the new Guidance is available at:  https://pso.ahrq.gov/legislation/assessment.

The Agency is less forgiving in reviewing multi-level arrangements, where a high-level parent sits over a system, which sits over individual provider entities.  The ability to control must reach from the top to the bottom for all these organizations to be affiliated providers.

Items for consideration:

  1. PSO participants relying on the “affiliated provider” provision should review the new Guidance.
  2. Be careful to review other documents and pleadings to make sure that the participant is not making statements denying control in the context of, for example, efforts to establish parent-organization liability in a malpractice case.
  3. Multi-level organizations need to review the Guidance and make sure their PSWP workflow is in compliance. Remember, representatives of a non-affiliated parent can still be part of a facility workforce, so long as they meet the requirements.  And aggregated data can flow to the non-affiliated parent.
  4. A PSO that resides at the upper level of an organization will not be affected by this Guidance, but it will be constrained to follow all PSWP requirements that apply to PSO’s.


The statute and regulation are available at https://pso.ahrq.gov/LEGISLATION.  Participants in the Center for Patient Safety PSO may contact the Center at any time with questions.

CPS Newsletter, Summer Edition Released!

NewsImageThe latest newsletter from the Center for Patient Safety has been released. You won’t want to miss the best practices and patient safety resources in this issue!

View this newsletter

Improving Event Investigation through the Development of SPRINT: Serious Patient Safety Event Rapid Investigation Teams. 4

Facing use of street drugs and alcohol, and decreased availability of medical care and facilities for individuals suffering mental or behavioral illnesses, Liberty Hospital has been able to stem the tide using a multi-disciplinary approach to helping create a safer care environment for staff and patients alike. 6

What the AHRQ guidance means for providers and their patients. 11

Cases involving the Patient Safety and Quality Improvement Act continue to work their way through state and federal courts. 15

New CPS report seeks to raise awareness of safety concerns in the EMS community. 16


  • Call to Action: Change the Statistic
  • Safety Insider
  • Watch Your Step, a Falls Analysis
  • New CPS Report Seeks to Raise EMS Awareness: EMSForward
  • CPS Unveils New Website
  • Put the Focus on Safer Care in EMS Community
  • PSO Update: For PSO Participants

CPS Safety Watch/Alert: AHRQ Guidance

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.

Free Webinar – PSOs: What you should know!

pso-whatyoushouldknowThe Center for Patient Safety is hosting a series of free upcoming webinars to share information and answer questions on how joining a Patient Safety Organization (PSO) can help you improve patient safety at your organization. Each webinar is available for providers in different healthcare settings, including medical offices, ASCs, LTC, EMS, and home care. A hospital-specific webinar was held in April but will be available again in the Fall. Contact the Center for more details.

Each webinar will help organizations and providers:

  1. learn the benefits of joining a PSO
  2. learn how joining a PSO can support your patient safety efforts
  3. learn how PSO protections can apply to your organization

Medical Clinics and Ambulatory Care
5/19/16 from 12-1pm Central     REGISTER

This webinar is open to healthcare professionals in medical offices, physician groups, and ASCs with a desire to improve patient safety and reduce patient risk, including professionals working in quality, risk, patient safety, quality improvement, and legal staff, executive leaders, and outside counsel and consultants for medical offices, ASCs or health systems.

Long Term Care
6/9/16 from 12-1pm Central     REGISTER

This webinar is open to healthcare professionals in LTC with a desire to improve patient safety and reduce patient risk, including professionals working in quality, risk, patient safety, quality improvement, and legal staff, executive leaders, and outside counsel and consultants for long term care or health systems.

Emergency Medical Services
6/16/16 from 12-1pm Central     REGISTER

This webinar is open to healthcare professionals in EMS with a desire to improve patient safety and reduce patient risk, including chiefs, managers, patient safety leaders, and legal staff, executive leaders, and outside counsel and consultants for EMS.

Home Care
9/8/16 from 12-1pm Central     REGISTER

This webinar is open to healthcare professionals in home care (home health, hospice, home and community-based services and private duty) with a desire to improve patient safety and reduce patient risk, including professionals working in quality, risk, patient safety, quality improvement, and legal staff, executive leaders, and outside counsel and consultants for home care.

Center Releases Annual PSO Report

coverIn 1999, the Institute of Medicine (IOM) released its report “To Err Is Human; Building a Safer Health System” which has since changed the face of healthcare in the United States. At that time, the majority of patient safety research and improvement projects were developed for within hospital walls.

However, in January 2016, the National Patient Safety Foundation released its report, “Free From Harm,” which reviewed the progress of patient safety and gave eight recommendations for going forward:

  1. Ensure leaders establish and sustain a safety culture
  2. Create centralized and coordinated oversight of patient safety
  3. Create a common set of safety metrics that reflect meaningful outcomes
  4. Increase funding for research in patient safety and implementation science
  5. Address safety across the entire care continuum
  6. Support the health care workforce
  7. Partner with patients and families for the safest care
  8. Ensure that technology is safe and optimized to improve patient safety

In an effort to encourage organizations to address safety, the Center for Patient Safety’s (CPS) Annual PSO Report provides a high level overview of multiple areas across the healthcare continuum (see #5 above):

  • Hospitals/Ambulatory Surgical Centers/Medical Offices
  • Long-Term Care
  • Emergency Medical Services
  • Home Health/Hospice


CPS is a federally-designated Patient Safety Organization (PSO) in compliance with provisions of the federal Patient Safety and Quality Improvement Act of 2005 (PSQIA). PSOs support the collection, analysis, sharing and learning about the occurrence and prevention of errors and safety concerns. By reinforcing a safety culture that encourages healthcare providers to safely report and share information about vulnerabilities within the healthcare system, PSOs are pivotal in the crusade to prevent medical errors and patient harm.

CPS is positioned to assist new and current participants in gaining this invaluable learning, and obtaining the federal protections that are available within the PSQIA – but, most importantly, to prevent patient harm.

For more information about PSO and safety culture services, contact the Center for Patient Safety at [email protected].

Free Webinar for Hospitals – PSO: What You Should Know

pso-whatyoushouldknowThursday, April 28th from noon-1pm Central Time

The Center for Patient Safety is hosting a webinar to share information and answer questions on how joining a PSO can help you meet the requirements of the new CMS regulation for requirements under the Affordable Care Act by January 2017:

  1.     Learn the benefits of joining a Patient Safety Organization (PSO)
  2.     Learn how joining a PSO can support your patient safety efforts
  3.     Learn how the PSO protections can apply to your organization

This webinar is open to healthcare professionals in hospitals with a desire to improve patient safety and reduce patient risk, including professionals working in quality, risk, patient safety, quality improvement, and legal staff, executive leaders, and outside counsel and consultants for hospitals or health systems. Download flyer.

CPS Safety Watch/Alert: EKG strip

Safety Watch - buttonThe Center for Patient Safety is issuing a PSO Watch in regards to documentation/chart accuracy. An event was shared where there was confusion regarding the appropriate identification of a patient’s EKG strip, resulting in a patient being treated for a dysrhythmia they did not have. This event brought to light many difficulties currently faced by hospitals and EMS providers:

  • Many hospitals are still in the process of transitioning from paper charts to electronic charts, causing confusion with processes.
  • In the hospitals, most units have systems that automatically print patient labels, or have patient names on EKG strips.
  • The ED departments and EMS agencies have very different systems to label orders/tests/blood work/EKG strips which causes confusion and communication breakdown.

To improve accuracy of patient documentation and communication between departments, CPS recommends the following:

  • Review processes for labeling documentation, and labeling placement, in the chart
  • Ensure standardization of processes
  • Reach out to other departments to ensure processes are standardized throughout system
  • Utilize standardized tool for communication/handoff of patient and test results

Free Patient Safety Webinar Series

CPS is partnering with other PSOs to provide a series of educational webinars throughout 2016. Supported by NextPlane Solutions, these webinars will be available at no charge. The first session is hosted by our friends at the North Carolina Quality Center PSO. “Stronger Action Plans: The next chapter in risk management and patient safety.”

Our common goal is to improve patient safety throughout healthcare. By working collaboratively with other Patient Safety Organizations (PSOs), providers can benefit from our shared learnings. We hope you’ll join us on these calls!


Stronger Action Plans:
The next chapter in risk management and patient safety
Hosted by the North Carolina Quality Center Patient Safety Organization
February 16th, 2016 at 1pm ET
Guest speaker: Alan Card, PhD, MPH
Click here to register

Stronger Action Plans: The next chapter in risk management and patient safety
The National Patient Safety Foundation recently released RCA2 Improving Root Cause Analysis and Actions To Prevent Harm. This report noted that the most important step in the RCA2 process is to eliminate or control system hazards or vulnerabilities identified in the contributing factor statements by identification and implementation of stronger actions. Why?… to ensure effective and sustained system improvement. Training and education, although the most popular risk control strategies, have limited impact in actually leading to patient safety improvement.How would you rate your root cause analysis action plans? Studies suggest that collectively, healthcare workers experience significant difficulty in generating and implementing risk reduction strategies. So how can we raise the bar? Alan Card, PhD, MPH, is the author of numerous articles on the frameworks, tools, and techniques of risk management as applied to healthcare. He also serves at the Deputy Editor for the Journal of Healthcare Risk Management, and as an adjunct faculty member in the Department of Management at the University of Notre Dame’s Mendoza College of Business. Join us for this joint Patient Safety Organization webinar that will highlight the need for tools to support and strengthen action planning.

PSO Day 2016 Announced!

The Center for Patient Safety (CPS) is pleased to announce that PSO Day will return as a companion event to our annual patient safety conference.  CPS PSO Day will be April 6, 2016, at the Crowne Plaza in St. Louis, Missouri.  The private event, for CPS PSO participants only, will occur the day prior to the patient safety conference, to be held on April 7 at the same location.  We look forward to seeing participants gather and discuss their successes, network, and participate in Safe Tables.  More to come soon!


PSO Case Law: Ungurian v. Beyzman, et al., 2020 PA Super 105:

A recent Pennsylvania case shows how courts narrowly interpret the PSQIA, ignoring the D & A pathway and the clear language of the Final Rule. (Ungurian v. Beyzman, et al., 2020 PA Super 105). The cour

Joint Commission New Sentinel Event Alert 61: Managing the Risks of Direct Oral Anticoagulants:

The Center for Patient Safety wants to share this important harm-prevention advice from The Joint Commission and its Sentinel Event Alert: Managing the Risks of Direct Oral Anticoagulants. The Joint Commis

CPS Safety Watch/Alert – Culture Can Improve the Control of Multi-Drug Resistant Organisms:

Issue: A number of events reported co CPS’ Patient Safety Organization (PSO) demonstrate poor handoff communication about the patients’ infectious disease status Examples include: Patient with

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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.