U.S. creates new program for reporting, analyzing adverse medical outcomes

The U.S. has created a new system whereby physicians and health care provider entities can confidentially report adverse medical events, and organizations can collect this data and use it to make safety recommendations.

The new program encourages health care providers to voluntarily report patient safety events to entities called “Patient Safety Organizations,” or PSOs.

PSOs must be listed with the federal Secretary of Health and Human Services and must have the improvement of patient safety as their mission and primary activity. They can receive reports and aggregate and analyze the information in order to provide patient safety guidance and recommendations back to the providers.

PSOs may be public or private, and they may be component organizations of a sponsoring entity, such as a hospital system or a professional society.

Health insurers, though, can’t be PSOs and can’t have a PSO as a component entity.

The government’s goal is to “develop a national system for analyzing and learning from patient safety events,” and the long-term plan calls for a network of patient safety databases.

Confidentiality

The program creates federal confidentiality protections for information that is reported to a PSO, and for the data that is developed by a PSO for various patient safety initiatives, including any root cause analyses.

This information may not be requested by a party in litigation and may not be used at trial, nor can it be admitted in professional disciplinary proceedings before a state licensing board, with certain exceptions.

There are civil monetary penalties for anyone who improperly discloses the information.

Health care providers are not allowed to retaliate against an employee who makes a good faith report, and an accrediting body is not allowed to punish a provider for its good faith participation in the program.

The program is outlined in regulations, effective this past January, that implement the Patient Safety and Quality Improvement Act, which was enacted by Congress in 2005.

The regulations say that the new program “will enable all health care providers, including multi-facility health care systems, to share data within a protected legal environment, both within and across states, without the threat that the information will be used against the subject providers.”

Not a peer review privilege

The program is not the same as a federal peer review privilege.

Since 1986, medical peer review activities in Massachusetts have had robust protection under state laws that, with a few exceptions, make the proceedings, reports and records of peer review committees confidential and protect them against discovery and admissibility in court and administrative proceedings.

In the federal system, however, no such peer review committee privilege exists. As a result, federal judges must weigh various policy considerations when deciding whether to allow peer review material into evidence.

While the new program makes confidential information provided to or by a PSO, it doesn’t create a privilege for peer review materials.

The program also doesn’t relieve Massachusetts health care providers of their obligation to report disciplinary actions, major incidents and legal violations to the Massachusetts Board of Registration in Medicine and the National Practitioner Data Bank. (This includes hospital and professional society discipline, major incident reporting under the Patient Care Assessment program, and individual “snitch” law reporting.)

However, any such reports may not include the work product reported to or developed by a PSO.  This could create challenges for institutional providers with regard to mandatory state reporting of adverse events, depending on how patient safety information is collected and utilized.

The regulations specify that any state laws that impose greater confidentiality restrictions on patient safety materials still apply.

Benefit to physicians

The program is expected to create new venues for the analysis and enhancement of quality heath care in a dedicated and confidential setting, which ultimately should benefit physicians.

In addition, the federal immunity and confidentiality protections may possibly cover some materials that are not currently covered by the Massachusetts peer review protections, although all this will likely have to be worked out on a case-by-case basis in the future.

Dean P. Nicastro is an attorney at Pierce & Mandell, P.C., in Boston. He advises physicians, and physician and other health care organizations on peer review, medical staff matters, regulatory compliance and business
transactions, and also non-profit organizations on corporate and programmatic issues.