NJDOH Reiterates Licensed Healthcare Facilities’ Documentation Production Obligations

The Department’s memo clarifies that the Federal Patient Safety and Quality Improvement Act of 2005 (PSQIA) does not preempt state or federal reporting obligations and does not relieve licensed facilities of the obligation to comply with such reporting requirements. Pursuant to the PSQIA, patient safety work product, i.e., materials developed exclusively for reporting to a Patient Safety Organization, remain privileged. However, documents required to be maintained or reported under state or federal laws, such as adverse event reports, infection control reports, licensure and certification documentation, patient care records, and other materials necessary for regulatory oversight, do not qualify as patient safety work product and must be disclosed to the Department upon request. The Department also emphasizes that disclosures of protected health information to the Department are permitted under HIPAA without patient authorization where the Department is acting in accordance with its oversight and regulatory authority.