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PSO? PSES? PSWP? You Have Questions, We Have Answers

Part 2 – October 16, 2013

1 Copyright © 2013 Center for Patient Safety. All rights reserved. All or any part of this presentation may not be

reproduced without consent of the Center for Patient Safety.

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2

Eunice Halverson MA

PATIENT SAFETY SPECIALIST CENTER FOR PATIENT SAFETY

Today’s Presenters

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Becky Miller MHA, CPHQ, FACHE, CPPS

EXECUTIVE DIRECTOR CENTER FOR PATIENT SAFETY

Kathy Wire JD, MBA, CPHRM

PROJECT MANAGER CENTER FOR PATIENT SAFETY

Copyright © 2013 Center for Patient Safety. All rights reserved. All or any part of this presentation may not be reproduced without consent of the Center for Patient Safety.

Objectives for Today’s Session

Following this Webinar, participants will be able to:

Understand additional details about establishing a Patient Safety Evaluation System (PSES)

Define Patient Safety Work Product (PSWP) for your organization

Understand how to establish a PSO Workgroup and define your Workforce to gain the most out of PSO participation

Be familiar with the court cases to-date that have supported use of the federal PSO protections for quality and safety work product

Be aware of available PSO services to assist in safety improvement and reducing harm to patients



The Center for Patient Safety (CPS) Journey

One of the first 10 PSOs to certify with AHRQ – in 2008

Serves as a facilitator, convener, educator and central voice on patient safety issues

Integrates safety culture and other key aspects of safety improvement

– Just Culture, CUSP, TeamSTEPPS™ training

– Survey on Patient Safety (SOPS) (hospital, medical office, pharmacy, LTC)

First in nation to develop services for EMS (culture and PSO services)

Integrating Long Term Care PSO services

Partnered with VergeSolutions in 2013

Copyright © 2013 Center for Patient Safety. All rights reserved. All or any part of this presentation may not be


Assumption: basic understanding of PSQIA, PSO, PSES and PSWP

If you missed Part I on September 12, you may view the webinar Slide Deck and listen to the audio

Resource: www.pso.ahrq.gov/psos/overview.htm

Putting it all together: PSO – PSES -- PSWP


http://www2.verge-solutions.com/l/19972/2013-09-19/6fbtf/19972/27740/Slide_Deck.pdf

http://www2.verge-solutions.com/l/19972/2013-09-19/6fbtf/19972/27740/Slide_Deck.pdf

http://www.youtube.com/watch?v=eD66Mi9S_JA&feature=youtu.be

PSQIA Key Provisions – Processes

Patient Safety Activities

Patient Safety Evaluation System (PSES)

Protection of

quality and

safety

discussions and

documents

Protection for

processes


PSES is An “over-arching umbrella” of all your patient safety and quality improvement work

Privileged and confidential under the federal PSQIA of 2005

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Your PSES may contain

information about events, errors, near-misses, quality improvement data, and other patient safety and quality data and information that is developed, investigated, examined, and analyzed by and for your PSES workgroup



Key Provisions – Processes

Patient Safety Activities


Patient Safety Work Product (PSWP)

Protection of

quality and

safety

discussions and

documents

Protection for

processes


Data, reports, records, memoranda, analyses, or written or oral statements which

are assembled or developed by a provider for reporting to a PSO and are reported to a PSO, or

are developed by a PSO for the conduct of patient safety activities, or

identify or constitute the deliberations or analysis of, or identify the fact of reporting pursuant to, a PSES

Copyright © 2013 Center for Patient Safety. All rights reserved. All or any part of this presentation may not be



Types of Activities

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PERSONNEL

LEGAL

PEER REVIEW

QUALITY & SAFETY PROCESSES, SYSTEMS &

DOCUMENTATION

PROCESSES, SYSTEMS & DOCUMENTATION


PROCESSES, SYSTEMS, & DOCUMENTATION





PROCESSES, SYSTEMS, & DOCUMENTATION

Available Protections

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PERSONNEL

LEGAL

PEER REVIEW

QUALITY & SAFETY PATIENT SAFETY AND QUALITY IMPROVEMENT ACT OF 2005

PEER REVIEW PROTECTIONS (PER STATE STATUTE)

ATTORNEY CLIENT PRIVILEGE

PROTECTIONS (PER STATE STATUTE)


• Electronic databases for collecting quality and safety information

• Clinical Committees: i.e. Patient Safety, Quality, Blood Utilization, P&T

• Clinical Improvement Teams i.e. falls, restraints, patient care processes, CUSP teams

• Core Measure Outcome Reviews

• Deep dive into event and near miss data

• Tracer activities

• Safety Huddles/discussions

• Departmental teams

• Executive Walk arounds

• Staff surveys

DOCUMENTS COLLECTED

Tracer Findings

ACTIVITIES

QUALITY & SAFETY IMPROVEMENT: at the facility level

Root Cause

Analyses

Committee/Team

Minutes

Core Measure

Variances

Survey on Patient

Safety Reports

CUSP Team

Documents (from

Huddles, Learning

from Defects, etc.)


• Electronic databases for quality and safety information

• System-wide clinical quality improvement teams

• Review of serious/ sentinel events

• Cases/events identified through internal trigger tools

• System-wide data analysis and deliberation

• Other system level quality & safety activities

QUALITY & SAFETY IMPROVEMENT – at the system/corporate level

ACTIVITIES DOCUMENTS COLLECTED

Event and Near

Miss Reports

Analysis of events

and trending of

near misses

System-wide

Committee/Team

meeting minutes

and analysis

documentation

System-wide

sharing of lessons

learned


Peer Review Activities

• Referral of cases per criteria established for peer review

• Collection of provider-specific clinical information

• Review of providers’ care per medical staff bylaws and rules

• Review and analyze specific cases referred to peer review from committees, teams, other departments

• Outside review/consultation on peer review cases

• Take disciplinary action if necessary

Quality files for

practitioners

Trended quality

and safety data

Documentation

and evaluation of

providers’ care

of patients

Documentation of

disciplinary/

legal action if

necessary

Documentation

from peer review

consultants



Personnel Activities

• Annual performance reviews

• Required skills training and re-checks

• Counseling/Coaching

• Disciplinary action

• Workers compensation reviews

• OSHA reviews

Written

performance

evaluations

Documentation of

in-services and

skills checks and

re-checks

Documentation of

remedial training

when needed

Notes of

disciplinary

discussions with

employee and

course of action



Legal Activities

• Electronic databases for quality and safety information (for level of events referred for claims/legal review)

• Risk Management identification of serious events for potential litigation

• Interview staff and others involved

• Involve attorney

• Inform liability insurer when necessary

• All other activities associated with defense of legal cases

Documentation of

communication

with attorneys

Notes from

serious event

interviews with

staff and others

Documentation

pertaining to

discussions and

correspondence

with liability

insurer



Activities that May Be Maintained Outside of the PSES (as defined in your policy)

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Personnel Legal Peer Review

• Annual performance reviews

• Required skills training and re-checks

• Counseling/Coaching

• Disciplinary action

• Workers compensation reviews

• OSHA reviews

• Referral of cases per criteria established for peer review

• Collection of provider-specific clinical information

• Review of providers’ care per medical staff bylaws and rules

• Review and analyze specific cases referred from committees, teams, other departments

• Outside review or

consultation on peer review cases

• Take disciplinary action if necessary

• Electronic databases for quality and safety information (for level of events referred for claims/legal review)

• Risk Management identification of serious events for potential litigation

• Interview staff and others involved

• Involve attorney

• Inform liability insurer when necessary

• All other activities associated with defense of legal cases


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LOCAL ACTIVITIES • Electronic databases for collecting quality

and safety information

• Clinical Committees: i.e. Patient Safety, Quality, Blood Utilization, P&T

• Clinical Improvement Teams: i.e. falls, restraints, patient care processes, CUSP teams

• Core Measure Outcome Reviews

• Deep dive into event and near miss data

• Tracer activities

• Safety Huddles/discussions

• Departmental teams

• Executive Walk arounds

• Staff surveys

All the documents, discussions, notes, etc… from these activities may be called Patient Safety Work Product.

SYSTEM/CORPORATE ACTIVITIES

• Electronic databases for quality and safety data, including events/near misses

• System-wide clinical quality improvement teams

• Reviews of serious/sentinel events

• Cases/events identified through internal trigger tools

• System-wide data analysis and deliberation

• Other system level quality & safety activities

Quality & Safety Improvement


PSWP

What is NOT PSWP?

Patient’s medical record

Billing and discharge information

Any other original patient or provider record

Information collected, maintained or developed separately, or that exists separately from a PSES



Workforce

• Define your workforce for PSO purposes

• Individuals involved in your patient safety activities

• May consider: – All employees

– Designated department employees/titles

– Medical staff members

– Volunteers

– Students/trainees

– Contractors

– Attorneys

– Liability insurance representatives

– Others whose conduct, in the performance of work for your organization, are under the direct control of the organization, whether or not the organization pays them.



Patient Safety Workgroup

• Core individuals/committees who routinely perform your patient safety and quality analysis and improvement work

• May consider:

– Committees such as safety, QI, PI, medical staff committees, etc.

– CUSP or department teams

– Safety huddles

– Others with special subject matter expertise as deemed necessary for work on specific events or issues may be included in the PSES workgroup activities.



Patient Safety Workgroup

• Educate all PSES workgroup members on the PSQIA provisions and organization PSO policies and definitions.

• All sign confidentiality agreement specific to PSWP - maintain in files.



Confusion re: Using PSWP

• Under PSQIA, PSWP can legally be shared with your workforce for Patient Safety Activities

• Downside of broad distribution: hard to control and maintain effective confidentiality

• Recommended sharing: defined group with relationship to Patient Safety Activities

• PSWP must remain confidential within that group



Step 1:

Identify and assess current event reporting systems and information flow for patient safety and quality improvement activities, considering:

Your incident reporting system, including how patient safety events are identified, reported and managed through risk management/ patient safety/quality improvement/customer services/peer review and credentialing processes

How this data is shared, processed, documented and maintained (a flowchart of your processes is helpful)

Your committee structure where patient safety and quality data and information are discussed/shared



Establishing Your PSES

Step 2:

Based on your assessment, determine which of these activities and events will and will not be included in your PSES.

(Each organization makes this

decision based upon their unique needs.)





Step 3:

Identify and define the scope and function of your PSES in your PSO policy.

(Your PSO should have a template or

other resources to assist you.)



Illinois: The Walgreen Case

• Illinois’ regulatory agency for pharmacists subpoenaed “all incident reports of medication error” involving certain Walgreen pharmacists.

• Walgreen’s argument : Materials were submitted to its PSO and were therefore part of PSWP and not discoverable.

• The agency argued that the documents were retained for purposes other than reporting to a PSO, and thus not protected.

• Illinois’ First District Court of Appeals (Cook County) held:

– Walgreen had defined its PSES and the reports were part of it – The defined information was reported to the PSO – SO: the reports were protected – The fact that information was also used internally (outside the PSO) did not

preclude protection

Illinois Department of Financial and Professional Regulation (IDFPR) v. Walgreen, Company, 2012 IL App (2d) 110452, No. 2-11-0452 (May 29, 2012)


KY: Fancher (trial court only)

• Plaintiff asked for information about sentinel events and RCA’s

• Plaintiff argued that they couldn’t be protected because Joint Commission required that RCA’s be done and reported

• Trial court:

– Info not protected by Attorney/Client privilege or Attorney Work Product

– The information could not be protected as trade secrets

– The PSQIA applied pre-empted state law, which would have allowed discovery of the information

Fancher v. Shields, et al., Jefferson Circuit No. 10-CI-4219 (August 16, 2011)


KY: Norton/Cunningham (Hill)

• Trial court ordered production of information that defendant Norton claimed was PSWP

• Appellate Court acknowledged that KY state law does NOT recognize state PR/quality protection in liability cases

• Court: PSQIA pre-empts state law and protects some peer review/quality material

• Case sent back to trial court for ruling in compliance with the federal law.

• Underlying case was tried without production of the documents; defense verdict. Appeal ended.

• Appeal of companion case (Tibbs/UK Physicians) continues

Norton v. Cunningham, Kentucky Court of Appeals, No. 2012-CA-000646-OA (August 16, 2012)


Cases Following the Statute

• Even if something is reported to PSO, it still must be designated as part of PSES/PSWP: Morgan v. Community Medical Center Healthcare System (Pennsylvania, No. 2008-CV-4859 (Lackawanna Co. June 14, 2011)

• Protected PSWP remains protected regardless of an admission of negligence by the provider: Gooden v. CVS Caremark Corp, No. 11CVA-10885 (Nov. 20, 2012)


Latest Kentucky Case

The Court did not apply the PSQIA protections, BUT:

• No evidence was presented that work took place inside PSES or that materials were protected PSWP

• Attorney simply asserted the privilege

• Provider not even participating with PSO

Mercy Health Partners-Lourdes, Inc. v. Kaltenback, No. 2013-CA-000053-OA, (July 11, 2013)


The “PSO Social Contract”

PSO’s pledge to…

– provide a safe environment in which to report and discuss adverse events, and

– share the learning obtained from the reporting

Healthcare providers pledge to…

– report complete and accurate information about adverse events, near misses and unsafe conditions to the PSO to feed the learning

Together, healthcare providers and PSO’s pledge to focus efforts collectively on improving the safety of care and preventing harm for all patients


Why Participate in a PSO?

Participate in sharing and learning aimed at preventing medical error and patient harm

Collaborate with others to identify prevention strategies

Gain the support and expertise of PSOs to enhance quality and safety processes and practices

Gain federal protections that fill the gaps left from peer review and attorney client privilege protections

Meet the PPACA requirement

PSO participation as a hedge against onerous state mandated reporting legislation



To Learn More

AHRQ PSO Page http://www.pso.ahrq.gov/

Center for Patient Safety PSO Resources & Information - http://www.centerforpatientsafety.org/patient-

safety-organization-pso/



http://www.pso.ahrq.gov/



http://www.centerforpatientsafety.org/

http://www.centerforpatientsafety.org/patient-safety-organization-pso/









Services & Resources Available

Contact Your PSO for Assistance

Contact the Center for Patient Safety (CPS)

PSO Services (Hospital, EMS, LTC, Culture Surveys)

PSO Consultative Services & Resources

PSO Participation Toolkit

Policy Templates (PSES, PSWP, Confidentiality)

Presentation Templates to educate leaders, workforce and committee

and More

Consultative and Education Service Options



QUESTIONS ? ? ?

Center for Patient Safety www.centerforpatientsafety.org


888.935.8272

Contact our PSO Team Project Manager/Analyst: Alex Christgen – [email protected]

Assistant Director: Carol Hafley, MHA, BSN, RN, FACHE – [email protected]

Patient Safety Specialist: Eunice Halverson, MA – [email protected]

Executive Director: Becky Miller, MHA, CPHQ, FACHE, CPPS – [email protected]

Project Manager: Kathryn Wire, JD, MBA, CPHRM – [email protected]


http://www.centerforpatientsafety.org/








mailto:[email protected]



