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What You Should Know About the Patient Safety and Quality Improvement Act (PSQIA) of 2005

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The Patient Safety and Quality Improvement Act of 2005 was implemented as a way “by which hospitals, doctors and other health care providers may voluntarily report information to certified Patient Safety Organizations (PSOs), on a privileged and confidential basis, for the aggregation and analysis of patient safety events.”

This act is an amendment to the Public Health Service Act and gives health care providers the ability to volunteer any sensitive information related to patient safety without fear of liability. The hope is that more providers will volunteer this information which should increase the quality of patient care and improve patient safety.

Although the Health Insurance Portability and Accountability Act (HIPAA) of 1996 requires health care providers to obtain authorization from patients before disclosing patient information, the Patient Safety and Quality Improvement Act does not require providers to do this. This is because certified Patient Safety Organizations (PSOs) (whom providers disclose patient safety information to) are treated as business associates, and the patient safety activities between providers and PSOs are treated as health care operations. In the Health Insurance Portability and Accountability Act (HIPAA) of 1996, it states that providers may disclose patient information with other business associates when it is part of a health care operation without having to obtain authorization from the patient. Also, because Patient Safety Organizations are treated as business associates, they must tell providers if the information is being used or disclosed in any unethical or illegal way.

Image Copyright Chad McDermott, 2012

It is very important to notify your health care staff of these protections. It is especially important to point out that providers do not have to obtain authorization from the patient before volunteering any information to a PSO about a safety event. A safety event is any event that involves error on the part of any member of the health care staff in regards to patient care. A safety event can have direct impact on patient care, indirect impact on patient care (what’s called a “near miss” or a “close call”) or can be about unsafe facility conditions.

Patient Safety Organizations were created as safe, secure, central units that receive and protect sensitive patient information. These organizations allow health care providers 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.” It is important to note, however, that the act explicitly states that this does not mean providers will no longer need to comply with other Federal, State or local laws pertaining to confidential information that is not covered by the Patient Safety Act.

This patient safety program is voluntary for both the health care provider and the PSO. The program is not federally funded and can be implemented by any provider who wishes to participate. Patient Safety Organizations (PSOs), however, must become certified, and this is overseen by the Agency for Healthcare Research and Quality (AHRQ). Enforcement of the Patient Safety and Quality Improvement Act is overseen by the Office for Civil Rights (OCR). They do perform occasional quality checks and audits to ensure patient information is being handled in a legal and ethical manner. Audits or reviews can be done at any time, without notice. All books, records, accounts and other information that are “pertinent to ascertaining compliance with the applicable confidentiality provisions” must be made available to the permitted compliance official during normal business hours. Also, if someone files a complaint in regards to a violation of the confidentiality provisions, the Office of Civil Rights is permitted to investigate this complaint in order to determine if a civil money penalty should be imposed. All confidential information remains with those who are permitted to investigate potential violations or perform audits.

All information and data collected through patient safety reports is available for health care providers to access. The availability of this data to providers will hopefully help decrease patient safety incidences and increase understanding of these events. An open discussion about safety, without fear of liability, is an opportunity to improve the care provided to patients which will hopefully lead to better patient recovery and overall health.

For more information about the Patient Safety and Quality Improvement Act of 2005, visit the U.S. Department of Health and Human Services’ website at

Lindsey Webster has been a rehabilitation counselor for 15 years and also owns the site Masters in Counseling. She likes to write about different topics related to counseling and careers.

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