Patient safety organization: What is it and why should we join?

Many healthcare organizations continue to struggle with the reluctance of physicians and other practitioners to participate in the review of quality issues for fear of legal liability or professional sanctions based on the outcome of the review work product. 

 

The Patient Safety Act is an attempt to address the barriers to patient safety and healthcare quality improvement activities in the United States. In implementing the Patient Safety Act, this proposed rule encourages the development of provider-driven, voluntary opportunities for improving patient safety through the relationship between providers of care and a patient safety organization (PSO).

 

In 1999, the Institute of Medicine Report To Err Is Human: Building a Safer Health System shocked the healthcare industry with its findings that “[in the United States], at least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented.” The report estimated that the total national costs of preventable adverse events, including lost income, lost household productivity, permanent and temporary disability, and healthcare costs to be between $17 billion and $29 billion, of which healthcare costs represent one-half.

 

The report further stated that the majority of errors are not the result of individual recklessness or actions of a particular group but rather the result of ineffective or faulty systems, processes, and conditions that lead people to make mistakes. 

 

The first step in improving systems (error-proofing) and reducing medical errors requires the frank and candid review of the error by knowledgeable practitioners. By identifying the root cause of the error, safer and more predictable systems and processes can be designed that support the delivery of quality and safer patient care.

 

A second key component to improving system and process performance is the capability of the organization to compare its performance against other similar organizations. This allows the organization to see whether it is outside of the norm and provides information to set realist performance goals.

 

Currently, protection for the work product of a quality review is provided by each state and generally limited to quality review in hospitals, and it does not cover other healthcare settings. There are variations in the level of protection, including no protection, protection for peer review only, and protection for intra-organization quality review. 

 

Protection seldom extends to information shared with other similar organizations. If peer review–protected information is transmitted outside an individual hospital, the peer review confidentiality privilege for that information is generally considered to be waived. This limits the potential for aggregation of a sufficient number of patient safety events to permit the identification of patterns that could suggest the underlying causes of risks and hazards that then can be used to improve patient safety

 

It is the intent of the Patient Safety Act to provide strong federal confidentiality and privilege protections for quality review information and thereby eliminate the impediments to improving the quality, safety, and outcomes of healthcare services. The Patient Safety Act provides opportunities to accelerate the development of new, voluntary, provider-driven improvement strategies, increase the willingness of healthcare providers to participate in such efforts, and, most notably, set the stage for breakthroughs in our understanding of how best to improve patient safety.

 

These protections will enable all healthcare providers, including multi-facility healthcare systems, to share data within a protected legal environment, both within and across states, without the threat of information being used against the providers. This rule will encourage the formation of new organizations with expertise in patient safety, known as PSOs, that can provide confidential, expert advice to healthcare providers in the analysis of patient safety events.

 

The proposed regulations establish a framework by which hospitals, physicians, and other health care providers may voluntarily report information to a certified PSO on a privileged and confidential basis, for analysis of patient safety events.

 

The proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed “patient safety work product.” The Patient Safety Act also calls for the imposition of monetary penalties for the knowing or reckless disclosure of a patient safety work product by a PSO.

 

Under the proposed rule, a variety of types of organizations—public, private, for-profit, and nonprofit—can become PSOs and offer their consultative expertise to providers regarding patient safety events and quality improvement initiatives. There will be a process for certification and a list of PSOs, which will be implemented by the Agency for Healthcare Research and Quality (AHRQ), and providers can work voluntarily with PSOs to obtain confidential, expert advice in analyzing the patient safety event and other information they collect or develop at their offices, facilities, or institutions. PSOs may also provide feedback and recommendations regarding effective strategies to improve patient safety, as well as proven approaches for implementation of such strategies.

 

In general, a patient safety work product (PSWP) is information gained during the process of patient safety improvement activities and means  “any data, reports, records, memoranda, analyses (e.g., root cause analyses), or written or oral statements that  “could result in improved patient safety, healthcare quality, or healthcare outcomes,” and 1) are assembled or developed by a provider for reporting to a PSO and are actually reported to a PSO or 2) are developed by a PSO for the conduct of patient safety activities.

It is important to note that, under the Patient Safety Act, data assembled for internal use only and not reported to a PSO, even if for quality improvement activities, do not qualify as a PSWP, although such data may be protected under state laws governing peer review. The PSWP must be submitted to the PSO to gain the protection afforded by the Patient Safety Act. 

It is also important to note that providing a PSWP to a PSO does not eliminate the organization’s responsibility to report such occurrences to state or federal organizations (e.g., state department of public health or CMS) as required by law.

The provisions of this proposed rule greatly expand the potential for participation in patient safety activities. The rule, among other things, enables providers across the healthcare industry to report information to a PSO and obtain the benefit of these new confidentiality and privilege protections. The proposed regulation will also enable and assist data aggregation by PSOs across multiple organizations to leverage the possibility of learning from numerous patient safety events across the healthcare system and to facilitate the identification and correction of systemic and other errors.

 

For more information on PSOs, contact Sharon Courage MPH, RN, vice president of hospital services at scourage@greeley or 888/749-3054, ext. 3501.

 

Look for our PSO landing page coming soon.