1. The Illinois Collaborative Pharmaceutical Task Force
May 15, 2018
Overview of Patient Safety Act
Michael R. Callahan Katten Muchin Rosenman LLP (phone)

2. Background
Congress enacted the Patient Safety and Quality Improvement Act of in response to the IOM report “To Err is Human” to address national concerns over number of preventable errors that were occurring
By granting privilege and confidentiality protections to providers who work with a federally-listed Patient Safety Organization (PSO), the Act was intended to nationally enhance health care quality and safety
AHRQ created the Common Formats to help providers uniformly report to PSOs patient safety event for aggregation and analysis
PSOs are required to collect and analyze data in a standardized manner using the AHRQ Common Formats or some other standardized reporting system

3. Background (cont'd)
NOTE: In a large pharmacy chain with statistically significant data sets the data is collected in a standardized format but not necessarily AHRQ common formats – Common formats would only be needed if the PSO was reporting to the NPSD
Legislative History:
Patient Safety and Quality Improvement Act of 2005
(Patient Safety Act)
Signed into law July 29, 2005
Final rule released November 21, 2008
Rule took effect January 19, 2009

4. The Patient Safety and Quality Improvement Act of 2005
The goal of the Act was to improve patient safety by encouraging voluntary and confidential reporting of health care events that adversely affect patients. To implement the Patient Safety Act, the Department of Health and Human Services issued the Patient Safety and Quality Improvement Rule (Patient Safety Rule).
The Patient Safety Act and the Patient Safety Rule authorize the creation of PSOs to improve quality and safety through the collection and analysis of aggregated, confidential data on patient safety events. This process enables PSOs to more quickly identify patterns of failures and develop strategies to eliminate patient safety risks and hazards.

5. The Patient Safety and Quality Improvement Act of 2005 (cont’d)
Provides privilege & confidentiality protections for information when providers work with Federally listed PSOs to improve quality, safety and healthcare outcomes
Authorizes establishment of “Common Formats” for reporting patient safety events to PSOs
Establishes “Network of Patient Safety Databases” (NPSD)
Requires reporting of findings annually in AHRQ’s National Health Quality / Disparities Reports

6. Equal consistent enforcement
Patient Safety Act
Facilitates development of a safe and protected learning space where providers focus on improving care versus legal or disciplinary implications of findings.
Allows provider organizations to maintain a “Just” culture of
accountability with deliberate PSES set-up.
Learning environment
Enables all licensed providers to receive equal protections.
Supports new healthcare models that place more and more responsibility on non-physician healthcare providers and corporate parent organizations.
Equal consistent enforcement
Enables healthcare providers to collaborate and learn from quality, safety and healthcare outcome initiatives that cross state lines without legal ramifications.
Nationwide and Uniform

7. Patient Safety Act
Supports risk mitigation by creating awareness of provider opportunities that can be gleaned by a PSO that aggregates large volumes of event data across many similar providers.
Early
recognition
Encourages data collection, aggregation and analysis amongst similar providers in a common format to allow for meaningful comparisons and easier identification of improvement opportunities.
Meaningful
comparison
Allows providers to negotiate with PSOs about the quantity and type of data reported and the type of analysis and feedback provided by the PSO.
Flexible
Participation

8. Patient Safety Activities
Efforts to improve patient safety and the quality of health care
delivery;
The collection and analysis of patient safety work product;
The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices;
The utilization of privileged patient safety work product ("PSWP") for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk;

9. Patient Safety Activities (cont’d)
The maintenance of procedures to preserve confidentiality with respect to patient safety work product;
The provision of appropriate security measures with respect to
patient safety work product;
The utilization of qualified staff know as "workforce" members; and
Activities related to the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.

10. What is Patient Safety Work Product (PSWP)?
Requirements
Must be created in PSES
Key dates must be documented
Data which could improve patient safety, health care quality, or health care outcomes
Data assembled or developed by a provider for reporting to
a PSO and are reported to a PSO
Analysis and deliberations conducted within a PSES
Data developed by a PSO to conduct of patient safety activities
Reports
Deliberation
Oral and Written Statement
and Analysis
PSWP
Memoranda
Data
Records

11. Data collected for another reason
What is Not PSWP?
Requirements
Information collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system.
Data removed from a patient
safety evaluation system
Data collected for another reason
Data removed from PSES
Medical record
Discharge information
Not PSWP
Data collected for another reason
Other original record
Billing

12. Patient Safety Evaluation System (PSES)
The collection, management, or analysis of information for reporting to or by a PSO. A provider's PSES is an important determinant of what can, and cannot, become patient safety work product.
Equipment
Virtual space
Staff
Work flow
Policies and Procedures
Physical Space

13. PSES Operations Establish and Implement Your PSES to:
Collect data to improve patient safety, healthcare quality and
healthcare outcomes
Review data and takes action when needed to mitigate harm or improve care
Analyze data and makes recommendations to continuously
improve patient safety, healthcare quality and healthcare outcomes
Conduct Proactive Risk Assessments, in-depth reviews, and aggregate medication errors
Determine which data will/will not be reported to the PSO
Report to PSO
Conduct auditing procedures

14. PSES Operations (cont’d)
Examples in PSES for collecting and reporting to a PSO:
Medication error and near miss reports, investigative analysis, Culture of safety data, Proactive Risk Assessments, Root Cause Analysis, best practices, process improvement plan and corrective actions
Risk Management - incident reports, investigation notes, interview notes, RCA notes, notes from phone calls or conversations, notes which relate to patient safety activities
Outcome/Quality – Pharmacy filling systems edits, procedure changes, focused training on emerging/changing trends in event data, focus on set quality improvement projects and initiatives, clinical protocols

15. PSES Operations (cont’d)
Committee minutes – Those portions of pharmacy meetings pertaining to Pharmacist Peer Review and discussions of patient safety activities, PSO feedback, participating provider safety meetings, monitoring and adjusting of corrective actions plans to ensure patient safety quality improvement

16. PSO Participation Schematic

17. PSWP is Privileged: Not Subject to: subpoenas or court order discovery
FOIA or other similar law
requests from accrediting bodies or CMS
Not Admissible in:
any state, federal or other legal proceeding
state licensure proceedings
hospital peer review
disciplinary proceedings

18. Patient Safety Act Privilege and
Confidentiality Prevail Over State Law Protections
The privileged and confidentiality protections and restriction of disciplinary activity supports development of a Just Learning Culture
State Peer Review
Patient Safety Act
Consistent national standard
Applies in all state and federal proceedings
Scope of covered activities and providers is broader
Protections can never be waived
PSWP can be more freely shared throughout a health care system
PSES can include non-provider
corporate parent
Limited in scope of covered activities and in scope of covered entities
State law protections do not apply in federal claims
State laws usually do not protect information when shared outside the institution – considered waived
Working with a PSO must be implemented in a way that facilitates a Just Learning Environment while taking advantage of privilege and confidentiality protections.

19. PSWP is confidential and not subject to disclosure with limited exceptions
In camera inspection
Direct identifiers removed
Valid written authorization
Please see Patient
Safety
Final
Rule
Criminal
activity
Need protective order for work product
Approved disclosure
Another PSO or provider
Sanctioned by Secretary HHS
HIPAA Privacy Rule Compliant
Equitable Relief of Reporter
Research
Patient Safety Activities
No further disclosure and limits on use
Accrediting Bodies
Affiliated Providers
Confidential
Further disclosure limited to patient safety activities
Business Associates
FDA
Business operations No further disclosure
Contractor
of a Provider
Non – identifiable PSWP
Patient Safety Activities
No further disclosure
Provider to PSO
Patient Safety Activities

20. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (Illinois, 4/7/11)
On July 1, 2010, Walgreens was served with separate subpoenas requesting “all incident reports of medication errors” from 10/31/07 through 7/1/10, involving three of its pharmacists who apparently were under investigation by the Illinois Department of Professional Regulation (“IDFPR”) and the Pharmacy Board.
Walgreens, which had created The Patient Safety Research Foundation, Inc. (“PSRF”), a component PSO that was certified by AHRQ on January 9, 2009, only retained such reports for a single year. What reports it had were collected as part of its PSES and reported to PSRF.

21. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
Consequently, Walgreens declined to produce the reports arguing they were PSWP and therefore not subject to discovery under the PSQIA.
The IDFPR sued Walgreens which responded by filing a Motion to Dismiss.
Although the IDFPR acknowledged that the PSQIA preempts conflicting state law, it essentially argued that Walgreens had not met its burden of establishing that:
That the incident report was actually or functionally reported to a PSO; and
That the reports were also not maintained separately from a PSES thereby waiving the privilege.

22. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
Walgreens submitted affidavits to contend that the responsive documents were collected as part of its Strategic Reporting and Analytical Reporting System (“STARS”) that are reported to PSRF and further, that it did not create, maintain or otherwise have in its possession any other incident reports other than the STARS reports.
IDFPR had submitted its own affidavits which attempted to show that in defense of an age discrimination case brought by one of its pharmacy managers, Walgreens had introduced case inquiry and other reports similar to STARS to establish that the manager was terminated for cause.

23. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
IDFPR argued that this served as evidence that reports, other than STARS reports existed and, further, that such reports were used for different purposes, in this case, to support the manager’s termination.
It should be noted that these reports were prepared in 2006 and
Trial court ruled in favor of Walgreens Motion to Dismiss finding that: “Walgreens STARS reports are incident reports of medication errors sought by the Department in its subpoenas and are patient safety work product and are confidential, privileged and protected from discovery under The Federal Patient Safety and Quality

24. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
Improvement Act (citation), which preempts contrary state laws purporting to permit the Department to obtain such reports ”
The IDFPR appealed and oral argument before the 2nd District Illinois Appellate Court took place on March 6, 2012.
Two amicus curiae briefs were submitted in support of Walgreens by numerous PSOs from around the country including the AMA.
On May 29, 2012, the Appellate Court affirmed that the trial court’s decision to dismiss the IDFPR lawsuit.

25. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
“The Patient Safety Act ‘announces a more general approval of the medical peer review process and more sweeping evidentiary protections for materials used therein’ KD ex rel. Dieffenbach v.
United States, 715 F. Supp. 2d 587, 595 (D. Del. 2010). According to Senate Report No (2003), the purpose of the Patient Safety Act is to encourage a ‘culture of’ Safety ‘and quality in the United States health care system by ‘providing for broad confidentiality and legal protections of information collected and reported voluntarily for the purposes of improving the quality of legal protections of information collected and reported voluntarily for the purposes of improving the quality of medical care and patient safety.’

26. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
The Patient Safety Act provides that ‘patient safety work product
shall be privileged and shall not be ***subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding.’ 42 U.S.C. § 299b-22(a)(2006). Patient safety work product includes any data, reports, records, memoranda, analyses, or written or oral statements that are assembled or developed by a provider for reporting to a patient safety organization and are reported to a patient safety organization. 42 U.S.C. §299b- 21(7) (2006). Excluded as patient safety work product is ‘information that is collected, maintained, or developed separately, or exists separately, from a patient safety evaluation system [PSO]’ U.S.C. § 299b-21(7)(B)(ii) (2006).”

27. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
The court rejected the IDFPR’s arguments that the STARS reports could have been used for a purpose other than reporting to a PSO or that other incident reports were prepared by Walgreens which were responsive to the subpoenas because both claims were sufficiently rebutted by the two affidavits submitted b Walgreens.
Although the age discrimination suit (See Lindsey v. Walgreen Co. (2009 WL (N.D. Ill. Dec. 8, 2009, aff’d 615 F. 3d 873 (7th Cir. 2010)) (per curium)) did identify documents used by Walgreens to terminate the employee.

28. Illinois Department of Financial and Professional Regulation v
Illinois Department of Financial and Professional Regulation v. Walgreens (cont’d)
The court determined that these were “about policy violations, i.e., giving out medications for free and failing to follow directions from supervisors.”
Because none of these documents were considered “incident reports of medication error,” which were the sole materials requested by the IDFPR, the court found them immaterial and affirmed the trial court’s decision to grant Walgreens’ motion to dismiss because no genuine issue of materials fact existed.