August 2005

On July 29, 2005, President Bush signed into law the Patient Safety and Quality Improvement Act. The Act provides for the creation of Patient Safety Organizations, which will be established to collect voluntary reports from providers, analyze the data and recommend steps to avoid future mistakes. The Act will cover medication errors, and includes pharmacies and pharmacists as providers.

Significantly, the Act provides that reports will be treated as privileged and confidential, and shall not be:
(1) subject to a Federal, State, or local civil, criminal, or administrative subpoena or order, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(2) subject to discovery in connection with a Federal, State, or local civil, criminal, or administrative proceeding, including in a Federal, State, or local civil or administrative disciplinary proceeding against a provider;
(3) subject to disclosure pursuant to section 552 of title 5, United States Code (commonly known as the Freedom of Information Act) or any other similar Federal, State, or local law;
(4) admitted as evidence in any Federal, State, or local governmental civil proceeding, criminal proceeding, administrative rulemaking proceeding, or administrative adjudicatory proceeding, including any such proceeding against a provider; or
(5) admitted in a professional disciplinary proceeding of a professional disciplinary body established or specifically authorized under State law.

The protections from discovery incorporated into the new law closely mirror the recommendations made by the Institute of Medicine in its 2000 report To Err is Human, Building a Safer Health System.

If you would like more information about the new law, or establishing a peer review/medication error reporting for your company, please contact Ed Rickert at edr@smithrickert.com.