Questions

Disclaimer: The Patient Safety Act and related Final Rule are thick with nuance and can be challenging to fully understand. This is intended as a simplified introduction for physician and hospital leaders who might be considering the use of our PSO services. It should not replace study of the applicable regulations or legal consultation.

Overview

The Patient Safety and Quality Improvement Act of 2005 created a general framework to support and protect voluntary initiatives to improve quality and patient safety in all healthcare settings through reporting to Patient Safety Organizations. The Act opened the door to standardized, large scale data aggregation and information sharing. It has great potential to stimulate more rapid advancement of a culture of safety in healthcare. The regulations are administered on behalf of the Secretary of Health Education and Welfare by the Agency for Healthcare Research and Quality. For administrative purposes, AHRQ promulgated the Final Rule in 2009 after an extended period of open comment on the initial Proposed Rule.

What is a Patient Safety Organization (PSO)?

Why should We Contract with a Patient Safety Organization (PSO)?

Can We Contract with more than One Patient Safety Organization (PSO)?

What is Patient Safety Work Product (PSWP)?

What is a Patient Safety Evaluation System (PSES)?

What is the Cost to Contract with a PSO?

How is Patient Safety Work Product (PSWP) Reported to a PSO?

What's the Downside to PSO Reporting?

What are the Common Formats?

What is the Drop Out Provision?

What is a Patient Safety Organization (PSO)?

The PSO is the entity designated by statute to receive Patient Safety Work Product (PSWP) from contracted providers. The process of reporting PSWP to a PSO confers the privileges and protections of the Act. The role of the PSO is to work with multiple healthcare organizations and their associated clinicians to identify, analyze, and reduce the risks and hazards associated with patient care. The PSO brings special expertise to complement the work that providers are already doing. This may include:

  • Receipt of Patient Safety Work Product
  • Event analysis
  • Data aggregation and analysis
  • Best practices recommendations
  • Consultative support for quality and safety improvement

The Act includes specific criteria for certification as a "listed" PSO. The Final Rule defines the requirements and process for initial certification and continued listing.

QA to QI Consulting meets these requirements and is listed by AHRQ. We focus on receipt of PSWP related to clinical peer review. We provide tools and support for clinical peer review process improvement. We do not currently support general incident reporting when unrelated to peer review.

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Why should We Contract with a Patient Safety Organization (PSO)?

A Patient Safety Organization relationship can help your organization advance a culture of safety. It offers Federal protections for your event identification and review processes. This can be of great benefit in states with poor statutory protections. By protecting the reporter, you can engage clinicians in patient safety by making it safe to self-report adverse events, no harm events, near misses and hazardous conditions worthy of review.

When you send reports about patient safety events to a PSO, you contribute to a large database and leverage the value of the work being done in your organization with that being done elsewhere. The PSO is responsible to analyze that aggregate data, identify trends, and provide feedback and recommendations for improved safety.

The PSO can also assist you with event analysis and provide consultative support for projects designed to improve quality and safety.

For QA to QI clients using PREP-MSTM to manage their clinical peer review program, the PSO relationship is a built-in bonus. Contracts with another PSO can be entertained, if desired, for general adverse event reporting or other services.

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Can We Contract with more than One Patient Safety Organization (PSO)?

Yes. There is no statutory limit on the number of PSO contracts that a provider can have.

Given the diversity of services available, it might make perfectly good business sense to have more than one PSO relationship.

For QA to QI clients using PREP-MSTM to manage their clinical peer review program and simultaneously obtain PSO protection, a contract with another PSO may be desired for general adverse event reporting.

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What is Patient Safety Work Product (PSWP)?

Patient Safety Work Product (PSWP) is the regulatory term used to describe the stuff that is protected under the Patient Safety Act. It comes in 3 flavors:

For provider organizations, the distinction between data collected and analyses is important because collected data is subject to the Drop Out Provision. Analyses conducted within the PSES are always protected and cannot be removed.

Note: The regulations do not restrict the use of analytic methods such as RCA or peer review outside the PSES. Analyses may always be re-created or repeated from original source material. The original medical record and hospital financial systems transactions are never considered PSWP. Nevertheless, copies of such data can be entered into the PSES and reported to a PSO to further data aggregation and other objectives.

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What is a Patient Safety Evaluation System (PSES)?

Patient Safety Evaluation System (PSES) is a regulatory term used to describe the provider’s process and protected space for collecting, managing and analyzing information about patient safety events for the purpose of reporting to a PSO. Most providers already manage this sensitive information in relation to their Risk Management or Quality Management program. The new element will be the process of reporting to the PSO and maintaining related documentation. The regulations do not specifically require documentation of the PSES, but most organizations will find it helpful to develop a policy and procedure.

For QA to QI clients using PREP-MSTM to manage their clinical peer review program, this couldn't be simpler. PREP-MSTM and the review committees constitute the core of the PSES. The peer review policy documents the PSES. PSO reporting involves no more than securely transmitting an electronic copy of the encrypted back end database once every 2-3 months.

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What is the Cost to Contract with a PSO?

The cost will vary among PSOs depending on the scope of services desired.

QA to QI clients who license the PREP-MSTM clinical peer review program management software pay no additional fee for PSO reporting and related statutory protection.

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How is Patient Safety Work Product (PSWP) Reported to a PSO?

The regulations do not require any specific mechanism, other than mandating due diligence in using a channel with adequate security to meet HIPPA/HITECH requirements. Photocopies, fax, and electronic methods are available. From a process perspective, however, you would like the mechanism to be as painless as possible.

For QA to QI clients using PREP-MSTM to manage their clinical peer review program, this couldn't be simpler. PSO reporting involves no more than securely transmitting an electronic copy of the encrypted back end database once every 2-3 months.

What's the Downside to PSO Reporting?

Practically speaking, PSO reporting provides federal protections to sensitive information and enables promotion of a culture of safety through self-reporting of adverse events. There is little downside to these substantial benefits.

These are the main considerations:

  • You'll need to invest modest effort to become familiar with the regulations, engage a PSO contract and set up related policies and procedures.
  • If systems and processes are not well matched, reporting PSWP to a PSO could be burdensome.
  • There is a small risk of re-work to recreate any analyses made within the PSES that later prove to be needed for otherwise non-disclosable purposes. The Drop Out Provision of the regulations serves to minimize this risk.

From this perspective, a close look at the work flow requirements for PSO reporting should be a primary consideration in your decision-making.

For QA to QI clients using PREP-MSTM to manage their clinical peer review program, these become non-issues.

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What are the Common Formats?

The Common Formats are sets of standards for patient safety related data. The are intended to enable interoperability and data sharing on a national level. They include form specifications for various types of event reports and their component data elements, as well as a complete data dictionary defining XML data file requirements for reporting to the national database. The initial set of Common Formats addressed the acute care hospital setting. Additional sets are being developed for other care environments. PSOs are responsible to support Common Formats whenever possible in their data collection work.

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What is the Drop Out Provision?

The Drop Out Provision

The Drop Out Provision is intended to help providers manage the confidentiality and privilege restrictions on PSWP, particularly with respect to external reporting requirements. It enables the default policy that data collected on all patient safety events will be included in the PSES from the date of identification or reporting. Such a policy maximizes the available protections. Because PSWP may not be used for most external reporting purposes, the Drop Out Provision allows time for a decision to be made regarding the reportability of any specific event. Prior to PSO reporting, data collected as PSWP may be removed from the PSES to fulfill such obligations. This prevents needless rework. Analyses, however, may not be removed.

Similarly, PSWP may not be used in a disciplinary proceeding. Thus, in the rare case that an event identified for peer review might lead to a disciplinary action, the case can be removed from the PSES prior to peer review. The actual process of peer review need not be different. It is simply a matter of policy as whether such an analysis is considered to be inside or outside the PSES.

In most situations, I believe the benefits of staying within the PSES by default vastly outweigh the potential need for re-work. Others may disagree. For example, in California where peer review protections against discovery have been consistently upheld by the courts, some attorneys advise invoking the Drop Out Provision by default. They like to see peer review conducted outside the PSES so that the results of past reviews can always be used if needed in a disciplinary hearing. If this is your preference, the findings from peer review can still be entered into the PSES as a copy for PSO reporting purposes. In that case, the original is not protected, but neither is it encumbered. Optionally, the original could be entered into the PSES after determination that it would never be needed for disciplinary purposes.

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