William Hyman: How Promising Is the NPSD?

Fourteen years after the passage of the Patient Safety and Quality Improvement Act, one of the provisions of that law, the Network of Patient Safety Databases (NPSD) is now upon us. The question is, will it actually be useful?

That is different from a broad claim of how useful it could be.

The NPSD was created by the Agency for Healthcare Research and Quality (AHRQ) following the 2005 Patient Safety and Quality Improvement Act. Three years later, this act led to the Patient Safety Rule, which established the operation of the AHRQ’s voluntary Patient Safety Organization (PSO) system. Presently, there are 83 listed PSOs with a mix of national and regional services. These 83 PSOs are also divided among those who serve all providers, and those that have specialties. The PSOs also have a wide rage of size with as few as five contracted providers to more than 100.

The function of a PSO is to receive provider incident reports using common formats that might include patient impacting events as well as close calls. Such information has significant privacy protection during its creation and once in the hands of the PSO. This is supposed to encourage reporting, or at least alleviate some of the fears associated with external reporting.

PSOs provide a variety of services based on reports received or other sources of information. These services include alerts, analysis, comparative reports, education, newsletters and online resources, training and other technical assistance, and other consulting. Other than a few featured cases, there is little data on the actual value of these services.

In order to prevent potentially useful information from being siloed with the separate PSOs, the NPSD is intended to be a national repository of incident reports which can the be further leveraged to create actionable information. Individual PSOs and others can report through the Patient Safety Organization Privacy Protection Center (PSOPPC). At present only 14 POSs are shown to be reporting, although this number might increase with the dawn of the NPSD. In addition, NPSD says that “the stage has been set for breakthroughs in our understanding of how best to improve patient safety.” Of course, how this manifests itself remains to be seen.

As a first step in the public analysis of data received, the NPSD has created some Patient Safety Events Dashboards. One of these is “Device or Medical/Surgical Supply, Including HIT Dashboard,” which includes seven data elements including extent of harm, device description, device description filtered by extent of harm, event description, and event description filtered by extent of harm. HIT events are separated out with a separate listing of type of device (or system) and extent of harm.

It is noted by NPSD that this information is not a representative sample of all such events since reporting to a PSO, and by a PSO, is voluntary. Remember that device reporting to the FDA is mandatory for deaths and serious injuries and the PSO reporting does not replace FDA reporting.

Given the limited data in the NPSD, it is not very granular. For example, type of device has only four categories: medical equipment (55%), surgical supplies (26%), HIT (13%), and implants (6%). Device defects has four categories: defect or failure, unknown, use error, and combination. It seems clear that much more data and much finer analysis will be necessary in order for this kind of information to actually be useful. NPSD says it has plans for additional charting and reporting.

William Hyman, ScD, is an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York. He is also a professor emeritus of biomedical engineering at Texas A&M University.

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