Questions

Disclaimer: While the Patient Safety Act is brief and seems to be simply constructed, the related Final Rule is nuanced and can challenge the understanding of the uninitiated. This is intended as a straightforward introduction for physician and hospital leaders who might be considering the use of our PSO services. It should not replace independent 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 should Connecticut Providers Do?

What Protections are Offered by the Patient Safety Act?

Will the Courts Uphold these Statutory Protections?

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 and analysis of Patient Safety Work Product
  • Feedback to promote a culture of safety and reduce patient risk
  • Large scale data aggregation and analysis
  • Best practice 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 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.

Back to Top

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.

The Affordable Care Act § 1311(h)(1)(A) mandates that all hospitals over 50 beds must establish a Patient Safety Evaluation System and, thereby, a Patient Safety Organization relationship by January 1, 2015 in order to contract with a Qualified Health Plan.

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.

Back to Top

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.

Back to Top

What is Patient Safety Work Product (PSWP)?

Patient Safety Work Product (PSWP) is the regulatory term primarily used to describe the stuff that is protected under the federal Patient Safety Act. Broadly speaking it is information which could result in improved patient safety, quality or outcomes. 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. Nor is material that exists or is developed outside a PSES or material required to meet statutory reporting obligations. Nevertheless, copies of such data can be entered into the PSES and reported to a PSO to further data aggregation and other objectives. Those copies are eligible for protection even if the source material is not.

State-Regulated Patient Safety Work Product

In 2004, the State of Connecticut created an independent structure to protect patient safety activities (CT Public Act No. 04-160). I have been unable to determine whether any other states have passed similar legislation establishing state-specific definitions of patient safety work product. In any case, wherever such statutes exist, there is potential for confusion.

State and federal forms of PSWP are not equivalent. In my work with Connecticut providers, I use the terms "state-regulated PSWP" and "federal PSWP" to keep the distinction clear.

Back to Top

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 identification of the types of information that the organization wants to collect, manage and analyze for the purpose of reporting to a PSO. Once that is done, the details of documentation and PSO reporting can be worked out. While the regulations do not specifically require documentation of the PSES, most organizations should consider developing a policy and procedure. Such documentation will helpful in the event that the organization's assertions of federal protections to PSWP are challenged.

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 periodically.

Back to Top

What should Connecticut Providers Do?

Some background is necessary to properly answer this question. In 2004, the State of Connecticut created an independent structure to protect patient safety activities (CT Public Act No. 04-160). The program is administered by the Department of Public Health (DPH). The statute "encourages" all hospitals and outpatient surgical facilities to work with at least one state-authorized Patient Safety Organization. In practice, DPH has made this a mandate. While the Connecticut statute defines Patient Safety Work Product (PSWP), it does not reference Patient Safety Evaluation System (PSES).

AHRQ has taken the position that PSWP cannot be simultaneously created under both Connecticut State and Federal statutory authority. While PSWP could theoretically be created twice under separate umbrellas, that is neither necessary nor desirable. PSWP created under Connecticut provisions can be reported to a Connecticut-authorized PSO and receive protection. It can simply be entered as a copy into a federally-compliant PSES and, thereby, be reported to an AHRQ-listed PSO.

This is the process that we recommend for Connecticut-based providers. The original state PSWP enjoys the state protections and the federal PSWP copy enjoys federal protections. Presuming that the organization has taken the time to define its federal PSES and establish procedures for creating, managing and reporting state and federal PSWP, both can be reported to QA to QI PSO without additional work.

The advantage to this approach is that the parallel reporting allows patient safety data from Connecticut to be aggregated with that from the rest of the country, which has no other option than to follow the federal standard. The added advantage is that the dual relationship complies with both state mandates and the Affordable Care Act § 1311(h)(1)(A) requirement for all hospitals over 50 beds to establish a Patient Safety Evaluation System and, thereby, a federal Patient Safety Organization relationship by January 1, 2015 in order to contract with a Qualified Health Plan.

Back to Top

What is Protected under the Patient Safety Act?

Federal Patient Safety Work Product (PSWP) is protected under the Patient Safety Act. It is both confidential and privileged. In general, it may not be disclosed, used in disciplinary proceedings, or subjected to subpoena or legal discovery. There are several narrowly defined exceptions to this principle. The specific details are given in §3.204 and §3.206 of the PSO Final Rule. The privilege protections are subject to enforcement by the courts. The confidentiality provisions are subject to enforcement via civil monetary penalties imposed by the Office of Civil Rights on behalf of the Secretary of the Department of Health and Human Services.

These legal protections do not extend to medical records, patient billing or discharge information, the hospital’s business records, information collected to comply with reporting obligations to regulatory agencies, or any other original patient or provider information.

Back to Top

Will the Courts Uphold these Statutory Protections?

It seems likely that they will as long as the proper procedures have been followed to establish a PSES and to handle and document PSWP. It is "normal" practice in the US for the limits of laws to be tested. To date, there has been little such activity. The first major federal appellate court decision rendered on May 29, 2012 strongly upheld the protection of PSWP from legal discovery (Illinois DFPR v. Walgreen). Of 2 reported trial court tests, one upheld the privilege protections and the other found that the hospital failed to meet the requirements for protection (see Katten Health Care Advisory 6/7/2012).

Over the past few years, the pace of PSO-related litigation has increased. While the protections of the Act have generally been upheld as intended, a petition to the US Supreme Court for review of an adverse decision from the Kentucky Supreme Court was scheduled for conference on September 28, 2015. On October 28, a Florida Appellate Court reversed a decision by the trial court which held that patient incident reports could not be considered PSWP because they were required to be collected and maintained under Florida law. The unanimous decision indicated that the Patient Safety Act pre-empts Florida's Amendment 7, which would otherwise make such documents discoverable. Charles v. Southern Baptist

Back to Top

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.

Back to Top

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 - without the need for duplicate data entry.

For QA to QI clients using PREP-MSTM to manage their clinical peer review program, this couldn't be simpler: one system with one process. 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.
  • There is a risk of penalties if the organization makes prohibited disclosure or use of PSWP.

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, documentation of the PSES and the process of PSO reporting are a piece of cake.

Back to Top

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. AHRQ has released initial and revised sets of Common Formats for hospitals and beta versions for hospital readmissions and skilled nursing facilities. Additional sets are being developed for other care environments. PSOs are responsible to support Common Formats whenever possible in their data collection work. See my Common Formats page for additional detail and links.

Back to Top

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 federal 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. An analysis that is initially developed outside the PSES and subsequently entered into the PSES is also subject to the Drop Out Provision if the movements are documented. Any analyses that are developed within the PSES may not be removed. They can, however, be recreated outside the PSES at any time without restriction.

It's important to remember that PSWP may not be used in a disciplinary proceeding. In the rare situation 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 and procedure as whether any such analysis is considered to be conducted 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 copy entered into the PSES and reported to the PSO receives federal protections. While the original is not protected, neither is it encumbered by the confidentiality and disclosure restrictions of the Patient Safety Act.

Back to Top