On July 29, 2005 President Bush signed the Patient Safety & Quality Improvement Act of 2005 (PSQIA). PSQIA encourages health care providers voluntarily to submit "patient safety work product" information (work product) to federally certified "patient safety organizations" (PSOs). PSQIA further requires PSOs to analyze work product, and to recommend improved safety protocols and best practices to the health care industry.
PSQIA also renders work product privileged and confidential if it is assembled by a health care provider for submission to a PSO. However, protected health information (PHI) and patient medical records, protected from disclosure by the Health Insurance Portability and Accountability Act (HIPAA) and the Maryland Confidentiality of Medical Records Act, may not be disclosed to a PSO, and will not be protected by PSQIA. Only information collected separately from medical records with the intent for use by a PSO qualifies for the PSQIA legal privilege and confidentiality protections.
PSQIA also does not limit or preempt mandatory federal or state reporting laws that require the disclosure of non-PSQIA work product.
Although PSQIA is intended to impact patient safety, that impact will not occur for some time. PSOs will not be available to receive work product until the United States Department of Health and Human Services (HHS) issues regulations for the certification of PSOs. There is no timeline for the promulgation of those regulations. Accordingly, while health care providers should know that PSQIA is coming, there is actually nothing health care providers should do about PSQIA at this time.