Designing Effective PSES Programs in the Wake of

HHS GuidancePEGGY BINZERAQIPS

PSOs  and  Healthcare  Providers  Advancing  Patient  Safety

Caveats• This is not legal advice.• Any characters in any stories

or examples are factious - Any likeness to real people, events, or PSWP is purely coincidental.

• Please ask questions along the way. This webinar is for you.

• If you have specific questions contact your PSO or me.

Understanding the Guidance

• What the Guidance provides• What PSES’s are affected by the guidance• Specific Examples of the 3 different pathways

to create PSWP.• How to comply with Accreditation

requirements using PSWP.• Specific Examples of Analysis (including

RCAs)• Best Practices to work with CMS/State

Surveyors

Purpose of Guidance• Intent of the guidance: To promote

health care providers’ accountability and transparency through mechanisms such as oversight by regulatory agencies and adjudication in the legal system and balance that with the need for safety culture and need to learn from mistakes;

• Intent of PSQIA (according to guidance) to protect the “additional information” and “new information” such as contributing factors.

Application• Only affects providers using the “reporting

pathway” that is typically used for incident reports.

• Does not affect providers who maintain separate systems for the PSES and for external obligations.

• Does not affect the “analysis” pathways (“analysis and deliberations” or “PSO pathways”), which are used for registries, RCA’s, peer review, surveillance review, and other analytics.

Changes to the Law and Regulations

• Materials needed for “external obligations” are original records and cannot be PSWP, whether or not the information is inside or outside the PSES.

• External obligations include recordkeeping or reporting obligations, public health surveillance (FDA reporting, CDC reporting), accreditation (except Peer Review and RCA’s); licensure

• Reporting systems – must keep two systems or spaces within the systems for required information and for “additional” information.

• Information available before the PSQIA passed (July 2005) is available today. (If state law provides protections for incident reports they are still protected from trial lawyers.)

Example External Obligation: QAPI CoP

The CMS hospital Condition of Participation (CoP) for Quality Assessment and Performance Improvement (QAPI) at 42 CFR 482.21(a)(2) requires hospitals to track adverse patient events. Further, hospitals are obliged to use the data to monitor the effectiveness and safety of services (42 CFR 482.21(b), analyze the causes of adverse patient events, and implement actions and mechanisms to prevent recurrence (42 CFR 482.21(c)(2). (Can use AHRQ common formats to meet QAPI requirements. Survey and Certification Memorandum, March 15, 2013)

CMS Said…• CMS has reinterpreted the QAPI regulations

to require that providers share incident reports with surveyors – the regulation requires recordkeeping and thus they can have access to the records.

• CMS promised to train surveyors who have inappropriately demanded RCAs and other analysis as it is clearly PSWP.

• They will incentivize provider to share “Patterns and Trends” of events.

3 PSQIA Pathways

Pathways to Develop PSWPAny data, reports, records, memoranda, analysis (such as root cause analysis), or written or oral statements which are: 1. assembled or developed by a provider [for the sole purpose] for

reporting to a patient safety organization and are reported to a patient safety organization OR

The reporting pathway is not self-effectuating and the PSWP designation at the hospital can be removed by courts and the administration.2. developed by a PSO for the conduct of Patient Safety Activities

– and which could result in improved patient safety, health care quality, or health care outcomes OR

PSO pathway is self-effectuating and only limited by the purpose that the PSWP could improve patient safety, quality of care or health care outcomes.3. which identify or constitute the deliberations or analysis of a

patient safety evaluation system OR The analysis and deliberations (A&D) pathway is self-effectuating and has no purpose limitation and no limits on analysis. Information collected is PSWP; analysis, including root cause analysis, is PSWP; a summary of the RCA is PSWP. All PSWP is “disclosed” to the PSO. (Note the analysis being performed must be conducted in the PSES.)

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Protections for the PSO• A PSO Cannot be Compelled: A patient safety

organization cannot be compelled to disclose information collected or developed whether or not such information is patient safety work product unless the court or government can:– Identify the specific information,– Prove the information is not patient safety work

product, and – Show they cannot reasonably available from another

source.• The exception is for a criminal action• CMS respects the PSO protections

Examples of PSWP using the Different

Pathways

Information related to the functioning of medical equipment (e.g., EHR, Medical

Device)Not  PSWP  if  prepared  for:

• For upkeep of equipment (e.g., original equipment maintenance logs) to maintain a warranty, or for an external obligation (e.g., CMS requires some equipment logs to be maintained).

Reporting Pathway: Could Be PSWP If Information Is Not Required for Another Purpose and Is Prepared Solely For Reporting to a PSO.

• Following a patient incident, a provider develops information about possible equipment malfunctions for reporting to a PSO. The PSO can aggregate it with other rare events from other reporting providers to identify risks and hazards.

Information related to the functioning of medical equipment (con’t)

A&D Pathway: • A provider collects

information on equipment malfunction and patient harm to conduct an RCA on an equipment malfunction in the PSES. Asks the equipment manufacturer to assist in the analysis in a convening/Safe Table in the PSES.

• Provider discloses malfunction and results of RCA to PSO to share with other providers.

PSO Pathway:• Convenes providers and

manufacturer to conduct an RCA, develop best practices, workflow changes, device design, etc….

• PSO shares best practices with all providers

A list of provider staff who were present at the time a patient incident occurred

Not PSWP if purpose is:• To ensure appropriate

levels of clinician availability (e.g., routine personnel schedules), or for compliance purposes.

Reporting Pathway: Could be PSWP if Information is not required for another purpose and is Prepared solely for Reporting to a PSO.

• Following the incident, a provider originally assembles the list for reporting to a PSO so the PSO can analyze the levels and types of staff involved in the incident.

A list of provider staff who were present at the time a patient incident occurred (Con’t)

A&D Pathway• Provider collects a list of

levels and types of staffing so provider can analyze events related to staffing (e.g., falls related to staffing; efficiency related to staffing).

• Can disclose results and best practices with PSO.

PSO Pathway• Convening on events

related to staffing to develop best practices, recommendations, etc…

Written Reports of Witness Accounts of What they Observed at the Time of a Patient

Incident

Not  PSWP  if  prepared  for• For internal risk

management (claims and liability)

Reporting Pathway: Could be PSWP if Information is not required for another purpose and is Prepared solely for Reporting to a PSO.

• The provider originally prepares the written reports for reporting to the PSO so that the richness of the narrative can be mined for contributing factors.

(Example: incident reports that ask for results of RCA and contributing factors and provide for a narrative in the report.)

Written Reports of Witness Accounts of What they Observed at the Time of a Patient

Incident (Con’t)

A&D Pathway• Convening/Safe  Table• Second  Victim  Programs

PSO Pathway• Convening/Safe  Table

Information Related to Care or Treatment Provided to the Patient

Not  PSWP• As  part  of  the  patient’s  

original  medical  record.

Reporting Pathway: Could be PSWP if Information is not required for another purpose and is Prepared solely for Reporting to a PSO.

• The  provider  documents  all  patient  allergic  reactions  in  the  medical  record  then  prepares  a  list  of  patients  that  have  exhibited  the  reaction  to  determine  if  newly-­‐instituted  procedures  for  reducing  risk  were  followed  specifically  for  the  PSO.    The  lists  of  patients  exhibiting  the  reaction  prepared  for  reporting  to  the  PSO  could  be  PSWP,  but  the  original  patient  medical  records  would  not.

Information Related to Care or Treatment Provided to the Patient

A&D  Pathway• Example  in  legislative  history  –

collecting  information  out  of  medical  records  to  analyze  for  quality  of  patient  care.    Analysis  is  protected  – pieces  of  medical  record  collected  is  PSWP  as  a  roadmap  to  identify  the  analysis.  Original  medical  record  is  not  PSWP.

• Centralized  Peer  Review  System  or  peer  review  Coop

PSO  Pathway• Patient  Clinical  registry• Surveillance  review  for  

medically  unnecessary  procedures

Working with a PSO: Another ApproachPROVIDER  OR  OTHER  Sources

Collect  data  for  Analysis  (Data  may  or  may  not  be  PSWP  or  not)

PROVIDER  PSES• Data  is  PSWP  if  it  can  identify  the  analysis,  

deliberations  or  the  fact  of  reporting  (copies  are  PSWP)

• Document  the  date  the  data  enters  the  PSES• Analyze  or  deliberate  (PSWP  without  reporting  to  the  

PSO)• Disclose  PSWP  to  PSO  [can  be  data,  analysis  or  best  

practice]

PSO  PSES• Conduct  Patient  Safety  Activities• Develop  and  provide  feedback• If  applicable,  can  report  to  PSOPPC

Elements of the A&D Pathway

• Information is PSWP:– if collected or compiled for analysis (can be nonPSWP –

incident reports, information from medical records that is collected) – that can identify the analysis that is occurring in the PSES;

– if it is analysis that occurs in the PSES;– if it is deliberations or communications (safe table discussions);– The analysis being conducted.

• Must have a documented PSES• Must document when information enters PSES• Can use analysis and results for any purpose in the provider

entity.• Cannot drop out analysis but can disclose nonidentifiable

analysis and results.

Why is this Important• Integrated Care – ACO, CIN, MSO, etc…

PSQIA is only protections for sharing quality information among unaffiliated providers.

• Clinical registries – PSQIA only Protections to protect analysis and “additional information.”

• Performance Tools – dashboards and scorecards.

• Big Data and New analysis (predictive analytics) – PSQIA only protections to share analytics.

High Reliability of CareEstablish  clinical  

guidelines  and  best  practices

Collect  data  by  each  facility

Review  for  Quality

Validate  findings  and  best  practices

Share  data  (reactive  to  proactive)

Raise  standards  through  system-­‐wide  learning

Best Practices to Work with CMS/State Surveyors

Provider Designs its Programs

• Provider determines what is required for external obligations

• Provider determines what is “additional information” that can be PSWP(In a memorandum march 2015 CMS said that providers can meet its reporting obligations using the common formats.)

• Provider determines what analysis can be conducted in the PSES: Root Cause Analysis, Patterns and trends, predictive analysis, performance tools (dashboards and scorecards)

How to Prepare for a Survey

• Provider makes a list of all the data surveyors can see that meets external obligations (state and Federal)

• Provider should not list what is PSWP – Our experience is that CMS Surveyor will ask for everything on the list – including protected analysis (See NorMet)

• Provider with other providers meet with state surveyor agency to educate them on the PSQIA and discuss what information is necessary to comply with survey.

What if Information has Been Reported to the PSO

• If required to be reported (e.g., measures/outcomes) it is NOT PSWP even if it is in the PSES. (Opportunity to protect analysis when calculating a measure.)

• Provider can determine that it is was mistakenly deemed as PSWP and pull it out of the PSES.

• Recreate analysis outside the PSES.• Disclosure permission

– All providers agree (protections are maintained) (can make this agreement a condition of privileges or employment)

– FDA disclosure (example device failure/problem discovered in an RCA) RCA remains PSWP.

– Disclosure to an accrediting body (within the PSES and remains privileged and confidential.

Best Practice if CMS Surveyors Take PSWP

• Be sure the document is clearly marked as PSWP.

• Ask Surveyor to sign documentation to document the disclosure and a confidentiality agreement.

• Precedent – HIPAA lawyers will advise clients to have CDC sign a disclosure statement when they take PHI for public health surveillance.

Accreditation• RCA conducted in PSES is PSWP (An RCA is not

specifically required under QAPI.)• Can use PSWP in Credentialing Action (see final

rule).• CMS must have access to results of a credentialing

action.• Can voluntarily disclose RCA PSWP to Accrediting

body.• AQIPS has Confidentiality with The Joint

Commission and other accrediting bodies.• Best practice to have the Surveyor sign a

confidentiality agreement to document the disclosure to the accrediting body.

Next Webinar• Sept 6 – Using PSQIA Protections for

Integrated Care• Future – Confidentiality Training• PSES Training• Any Suggestions?