Safety First

Patient Safety Organizations (PSOs) are playing an essential in the battle to drive down patient harm. Rory Jaffe, executing director of California Hospital Patient Safety Organization (CHPSO), and Claire Manneh, director of programs, CHPSO and Hospital Quality Institute, explain how a PSO can help providers learn vital lessons.

California Hospital Patient Safety Organization (CHPSO) is one of the first and largest PSOs, with more than 350 members and 990,000 reports collected to date. Patient Safety Organizations (PSOs) were established by a 2005 Federal act: the Patient Safety and Quality Improvement Act (PSQIA). This act instantiated some of the recommendations in the 1999 Institute of Medicine (IOM) report To Err is Human. That report recognized that, once we acknowledged human error as a major factor in healthcare injuries, the task of reducing the incidence and impact of error becomes vitally important.

Just as had occurred in aviation safety, the report recommended the sharing of event information and the development of common approaches to common challenges. In healthcare, because of the potentially chilling effect of malpractice liability, this sharing had to be accompanied by new legal protections. The PSQIA established the standards for PSOs and provided a legal privilege for information shared with PSOs.

CHPSO receives its greatest resource from the data members share into the database. Member organizations voluntarily submit data to CHPSO and the database has a broad range of information. These reports span the range from unsafe conditions, where no patient was involved, to patient death.

“PSOs will be a key component to the creation of a safer healthcare system, one in which we can become as reliable as other high-risk high-consequence industries.”

In turn, CHPSO returns the favor by providing them feedback on the reports with recommendations and resources. Without this turnaround of feedback, the hospitals are merely using the CHPSO database as a data repository, and the incentive for contributing data lessens. Since data received from all the hospitals are not an apples-to-apples comparison, CHPSO relies on the narratives written in the report to identify trends or alerts.

CHPSO has a bird’s eye view into the world of patient safety from our diverse membership. Our members include medical groups, skilled nursing facilities, rural and critical access hospitals, district and private hospitals, and teaching and inner-city hospitals. Mining through the database at the individual and the aggregate levels exposes problems that occur organizationally, systemically, and environmentally.

Some lessons learned

In a broad sense, CHPSO learns from data voluntarily submitted to the database. Most of these events result from the poor design of the healthcare delivery system rather than actions of unqualified or reckless providers.

One of CHPSO’s objectives is to share “free lessons” to both members and public. Members receive extensive feedback on events that were shared with the PSO on a yearly basis. Every other month, CHPSO releases a public newsletter with lessons learned on a range of trends that appear in the database. Sometimes even individual events can provide significant lessons, such as a screwdriver breaking in the middle of surgery with no alternatives readily available, causing the surgeons to have to reoperate to complete the procedure another day. This pointed out the need, when buying new equipment, to prepare contingency plans for equipment malfunction. These articles are shared with the public because it is an occurrence that may help many.

Events reported often are related to items hospitals buy. These are devices, health information technology, tools, and products that are meant to be safe when used as directed but quite dangerous when directions are not precisely followed, and whose designs do not sufficiently guide or enforce correct use.

In one case, a hospital experienced an event involving a suction catheter that proved to be deadly. A suction catheter designed to be attached to a tracheostomy tube had a clear cap on it. This cap had to be removed when the patient was not on a ventilator. Instructions were not in the individual package and it was not clear that this cap was deadly if left on. It eventually killed a patient. CHPSO mined through the database and found other organizations were experiencing a similar issue. CHPSO intervened and spoke to the manufacturer with the backing of a number of concerned hospitals.

Safe Table meetings are another venue where free lessons are shared. A Safe Table is a forum conducted under the PSQIA at which healthcare professionals from member hospitals convene and have an open dialogue about patient safety and quality events and risks. Frank and transparent discussion are encouraged in this confidential and legally privileged setting. Because this is an entirely protected forum, all information shared will remain confidential and members sign a privacy agreement upon arrival at the meeting.

Quite rapidly, participants recognize that, no matter how odd an individual event may be, everyone else shares the same vulnerabilities and no one hospital needs to go it alone when redesigning systems to improve safety. Ultimately we are striving to develop communities of learning and mutual support based upon free exchange of information provided by the PSQIA to accelerate the often difficult progress of healthcare delivery redesign and mitigation of emerging patient risks.

CHPSO also delivers an annual report that provides an overview of the highlights from the prior year. This document is publicly available. The major trends in lessons learned are underscored, as well as analytics on the database itself: number of event reports by category, number of events over the year, and the number of drug classes mentioned in the medications category.

CHPSO was built on a culture of transparency and aims to assist both members and the public. Members are publicly listed on the CHPSO website. Details on the safe table schedule, the annual reports, patient safety alerts and newsletters are all public. CHPSO contributes alerts to the Global Patient Safety Alerts system.

Future challenges

The PSO program still feels as if it were a fledgling although eight years have passed since CHPSO began. A number of challenges make it difficult to provide rapid and broad-based successes in this field.

First, patient safety information is “second class” information. Safety reporting systems are isolated from other systems in the organization, which helps with legal protections but cuts the system off from the rich data available elsewhere, such as in the electronic health record (EHR). That means that safety information is not captured in the normal flow of care, and requires significant additional effort.

Several initiatives have been introduced to alleviate this issue while maintaining the legally-required separation. The Office of the National Coordinator for Health Information Technology (ONC) had a structured data capture initiative that addressed data standards for EHRs and work flows that would allow users to easily pull relevant information from the medical record to populate the incident report and other reports, such as those for the Food and Drug Administration. These efforts were not initially successful. Greater EHR taxonomy standardization and interoperability standards will be needed for this effort to go forward.

Patient safety data is non-standardized among providers. While there are taxonomy standards (the AHRQ Common Formats), few institutions collect information in that format. Databases have to use a standard taxonomy to structure information, so aggregating feeds from multiple providers with multiple native taxonomies is challenging. Recently, CHPSO took over responsibility for providing the software and techniques for mapping from the provider’s taxonomy to the standard one, as having individual organizations manage the process overwhelmed many, and centralized management of the process yields marked economies of scale and improved user-friendliness.

The PSO program is, by design, fragmented. To Err is Human recommended that the PSO initiative be private and voluntary. As instituted by the PSQIA, PSOs develop at will, and many providers can form their own. This creates isolated islands of knowledge, which may remain confined within a single hospital system if that system wishes to do so. This is unlike aviation, in which we would be aghast if we heard that one airline did not tell another of a safety risk it had discovered.

The PSQIA did envision a national storehouse as the final destination for reports, but this too is voluntary, and many PSOs are not contributing to the storehouse, whether due to privacy concerns or data incompatibilities. And the storehouse will have deidentified the data to the point where it will be difficult to share lessons learned in depth. Developing a national learning system will require a greater level of trust by providers of the benign nature of this initiative and of the legal protections involved, and greater national infrastructure for the rich data underlying these reports.

The legal protection for sharing data is also under a cloud. New legal privileges appear rarely, and this one has been vigorously challenged. The law and regulations also have several ambiguities. Recent non-regulatory guidance by AHRQ regarding some aspects of this law conflict with the interpretation of many lawyers regarding the extent of Patient Safety Work Product (PSWP) privilege available for use within a provider organization and it may take some time before legal opinions clarify this, as disputes regarding production of protected records rarely bubble up to higher courts. In spite of this ambiguity, it is clear that giving the information to the PSO in most situations does not significantly increase legal risk for the provider even with a conservative reading of the law, as in most states the privileges providers currently work with internally are not weakened by sharing with a PSO. All agree that the copies the PSO hold have the PSWP privilege even if the originals at the provider do not, with the sole exception being if the provider destroys an unprivileged original.

CHPSO’s mission is to eliminate preventable patient harm and improve the quality of healthcare delivery. These are goals we all share, and PSOs will be a key component to the creation of a safer healthcare system, one in which we can become as reliable as other high-risk high-consequence industries, such as aviation.