PSL 503: Policy, Economics & Environment

Unit 7 Legislative Environment:

Impact on Patient Safety Reporting

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Presentation Overview

• Patient safety reporting systems - voluntary and mandatory

• Reasons for protecting reporting systems

• Legal protections for voluntary patient safety reporting systems

• Legal framework for protecting reporting in the Patient Safety and Quality Improvement Act of 2005

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Patient Safety Reporting Systems Two Functions

• Holding healthcare providers publically accountable (mandatory systems)

• Learning from events to make improvements to reduce patient harm (voluntary systems)

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Mandatory Reporting Systems

Mandatory reporting system characteristics– Types of events

• Serious harm or events that should never occur (“never events”)

– Purpose

• Public accountability

– Legal protection

• Generally publically available with varying levels of identification

– Operators

• Generally initiated and maintained by states

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Voluntary Reporting Systems

Voluntary reporting system characteristics– Types of events

• Less serious harm, near miss events, non-harm events (either

recovered from or patient resistance to harm)

– Purpose

• Learning from events and their causes to improve safety

– Legal protection

• Some degree of protection to improve reporting

– Operators

• Generally initiated and maintained by healthcare organizations

Harm Continuum and Access to Patient Safety Reporting System Information

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Where this line is drawn can have consequences for patients seeking information in reporting systems to address their harm in litigation

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Reasons for Protecting Voluntary Reporting Systems

• It’s not possible to correct mistakes without awareness they’re occurring – that is, reporting is essential to safety improvement

• Healthcare practitioners’ and organizations’ fears that reported information will be used against them in litigation is a barrier to their reporting

• Hence, a major reason for protecting voluntary patient safety reporting systems is to remove the fear that the reported information will be used in litigation against those reporting

• In addition, insofar as sharing data across organizations is helpful in identifying patterns, legal protection for data reported outside institutions is desirable

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Protecting Voluntary Reporting Systems

• First, a plaintiff’s attorney might seek information regarding reported events from:

– Person first noticing or reporting the even

– Person/s investigating the event

– Person/s analyzing events

– Event data itself as it is maintained in a database

• Information reported and organized in a reporting system would be most helpful to the plaintiff’s case

• At the same time such use would serve as a strong deterrent to those with the opportunity to report to do so

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Protecting Patient Safety Reporting Systems - Schematic

What are the considerations

governing whether

the plaintiff’s attorney

can gain access to

the information in

the hospital ‘spatient safety

system?

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Potential Legal Protections for Patient Safety Reporting Systems1

• General rules of evidence1

– Remedial action• “a showing that remedial action has been taken after an injury cannot

be admitted as proof that the injury resulted from negligence or a defective product”

– Attorney client privilege1

• “Communications with one’s attorney are privileged from discovery”

– Work product doctrine1

• “protects materials that are created by or on behalf of lawyer in preparation for litigation.

• Peer review privilege1

• Special statutory privileges enacted for particular reporting systems1

1 Kohn LT, Corrigan JM, Donaldson MS. Chapter 6 Protecting voluntary reporting systems from legal discovery. In Kohn LT, Corrigan JM, Donaldson MS (eds). To err is human: Building a safer health system. National Academy Press Washington DC, 2000.

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Patient Safety & Quality Improvement Act of 20051

Patient Safety Organization/s

• “PSOs are organizations that share the goal of improving the safety and quality of health care delivery. Organizations that are eligible to become PSOs include: public or private entities, profit or not-for-profit entities, provider entities such as hospital chains, and other entities that establish special components to serve as PSOs.“1

• “By providing both privilege and confidentiality, PSOs create a secure environment where clinicians and health care organizations can collect, aggregate, and analyze data that enable the identification and reduction of risks and hazards associated with patient care.”1

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

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Patient Safety & Quality Improvement Act of 2005

Patient Safety Work Product

• The goal of the Patient Safety & Quality Improvement Act of 2005 is to create a legal framework within which a provider’s patient safety work product is protected from uses other than for which it is created – that is, for uses other than to improve safety.

• “Patient safety work product is safety data, reports, records, and other materials (e.g. root cause analyses) in oral or written form, including deliberations or analyses that are part of a provider’s patient safety evaluation system.”1

1 Liang BA et al. The Patient Safety and Quality Improvement Act of 2005 Provisions and potential opportunities.

Am J Med Qual 2007; 22:8-12.

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Patient Safety & Quality Improvement Act of 2005

Common Formats

• “PSOs, providers, and other entities will voluntarily contribute de-identified patient safety work product to the NPSD. To simplify reporting and data aggregation, the NPSD will employ common definitions and reporting formats for patient safety events. These interoperable terms are referred to as the common formats.”1

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

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Patient Safety & Quality Improvement Act of 2005

PSO Privacy Protection Center (PSO PPC)

• “To provide PSOs with resources to de-identify patient safety event information prior to sending the information to the NPSD, AHRQ established the Patient Safety Organization (PSO) Privacy Protection Center (PPC).”

• 1 http://www.pso.ahrq.gov/

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Patient Safety & Quality Improvement Act of 2005

Network of Patient Safety Databases (NPSD)

• “The Agency for Healthcare Research and Quality (AHRQ) is responsible for Patient Safety Organization (PSO) operations.”1

• “As data becomes available from PSOs, a Network of Patient Safety Databases (NPSD) will receive, analyze, and report on de-identified and aggregated patient safety event information. The goal of the NPSD is to facilitate aggregation and analyses of patient safety event information to help reduce adverse events and improve health care quality. “1

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