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“An incentive,” according to the authors of Freakonomics . . . the Hidden Side of Everything, “is simply a means of urging people to do more of a good thing and less of a bad thing.”

So what are the incentives that will encourage medical staff to report medical errors or even “near misses,” reports which could get them fired – or how to get healthcare providers to report medical errors or “near misses,” which could get them sued?

Well, at the very least, we could try protecting medical staff and health providers from these consequences.

That is exactly the goal of the Patient Safety and Quality Improvement Act of 2005 signed into law in July of last year, now “on the books” but awaiting the necessary actions so that it can begin to work. When fully implemented, the U.S. healthcare system may begin to establish some semblance of realistic data concerning the actual number of medical errors and near misses and provide a realistic foundation of data for avoiding them.

A sentinel event

Whatever the accuracy of the Institute of Medicine’s report indicating up to 98,000 deaths annually as the result of treatment mistakes in hospitals (see related story, p. 7), the report served to cast a intense light on the issue and made it clear that it needs to be addressed in a consistent and rational manner. Not too easy, however, if reporting such errors comes with the heavy disincentives of potential firings and lawsuits.

These are the two main issues that the patient safety act addresses as a foundational baseline for creating a broad database of information in order to better understand and reduce these errors and deliver better care.

The act provides for the reporting of these errors to what will be called Patient Safety Organizations (PSOs) in such a way that healthcare workers doing the reporting are protected from being fired, or other penalties, and providers doing the reporting are protected from lawsuits charging liability. (A significant exception is if the reported information relates to a criminal action and, importantly, it cannot be obtained in any other way – a requirement involving the necessary subpoenas.) When organized and put into place, PSOs will be tasked with analyzing errors and near misses and highlighting trends.

Awaiting regulations

While the act is in place, establishment of the PSOs awaits the issuance of the regulations by agencies of the Department of Health and Human Services – and primarily the Agency for Healthcare Research and Quality (AHRQ; Washington) – that are necessary for clarification of a whole variety of issues.

AHRQ “is working with various agencies,” such as the FDA, the Centers for Disease Control and Prevention (Atlanta) and Centers for Medicare & Medicaid Services (CMS; Baltimore), to develop these regulations, Fara Englert, spokesperson for AHRQ, told Biomedical Business & Technology. She said that a “writing group” has the goal of issuing the regulations by this summer, but she offered no guarantee that this timeline would be met. Issuance of the proposed regulations would be followed by a 60- to 90-day period for comment and then release of final regulations.

Overall, Englert said that there has been heavy interest by a variety of organizations in participating in the effort and perhaps becoming a PSO, and that exact parameters for defining and regulating PSOs is a key issue to be addressed by the regulations.

As an example of one key issue, a hospital establishing a PSO may be considered to have a conflict of interest – in terms, perhaps, of under-reporting its errors and near misses – and the act already provides for the secretary of the HHS to determine such a PSO’s ability to be fair, as well as an appeal process.

Key provisions

Following are some of the provisions of the legislation:

PSO guidance:

A PSO must be certified and listed by HHS, renewing the certification every three years.

The PSO’s mission and main activity is to conduct activities intended to improve patient safety and the quality of healthcare delivery.

The PSO collects patient safety information from providers in a standardized manner that enables valid comparisons of the data.

The PSO reports to providers in a manner intended to minimize error and patient risk.

Patient Safety Work Product (PSWP) confidentiality:

The PSO must establish the security measures which maintain the confidentiality of the data and to prevent any disclosures to any related entities.

PSWP is privileged and cannot be disclosed to a variety of legal subpoenas or in discovery or admitted to a wide range of legal proceedings.

PSWP disclosure:

Disclosure can be made if it contains evidence of a criminal act and the information cannot be obtained any other way except from the PSWP.

Disclosure can be made if required if related to an adverse employment action.

Disclosure is authorized to carry out patient safety activities.

Disclosure can be made to a variety of interested parties, such as researchers, under HIPAA confidentiality regulations