The PSQIA, A New Standard For Preventing Medical Errors

The Patient Safety and Quality Improvement Act of 2005 or PSQIA for short is a federal healthcare law that was passed by U.S. Congress in 2005. PSQIA was passed to amend the Public Service Health Act that had been passed several decades prior by U.S. Congress in 1944. The purpose of the PSQIA was to reduce the number of deaths that occurred due to medical errors annually in the U.S. These deaths can occur in a number of ways, ranging from adverse effects that are preventable, such as surgical operations that are performed on incorrect body parts, to medications that may be improperly administered to patients in poisonous doses. To this end, the PSQIA contains several provisions aimed towards striking “a balance between maintaining confidentiality and legal protections in reporting safety information and maintaining patients’ rights.”

What are the provisions of the PSQIA?

The PSQIA is a unique law in that it does not establish a single regulatory body that regulates instances of medical error that lead to death in patients, nor does it mandate that healthcare professionals themselves create or participate in a Patient Safety Organization or PSO. To this point, the law does not provide federal funding for the establishment of PSOs or other related organizations that work to improve the safety of American patients, as the law does not function as a traditional error reporting system. Furthermore, the PSQIA does “not pre-empt stronger state legal privileges or other protections of confidentiality.” Instead, the law “is designed to provide an environment in which health care practitioners can voluntarily and anonymously report safety problems, with the idea that conveying these messages will lead to improved care.”

As such, the PSQIA outlines the ways in which healthcare providers and other associated organizations can either establish or serve as PSOs. Generally, speaking, a Patient Safety Organization or PSO is defined as any group, organization, institution, or association that improves healthcare services by way of reducing medical errors. Under the PSQIA, PSOs are offered protections of confidentiality that enable such bodies to both gather and analyze data on the quality of patient care in an effort to reduce any associated safety events that may arise, in accordance with the duties and responsibilities of healthcare providers and hospitals. In order to become a PSO under the guidelines set forth by the PSQIA, an organization or institution must adhere to fifteen statutory requirements, ranging from security requirements to the release of disclosure statements and secretarial findings.

Additionally, the Agency for Healthcare Research and Quality, or the AHRQ for short has also developed a compliance self-assessment guide that PSOs can utilize to ensure that they maintain compliance with the fifteen statutory requirements that were established by the PSQIA. As such, this self-assessment guide contains numerous suggestions concerning patient safety activities, including but not limited to:

• Efforts to improve patient safety, as well as the quality of healthcare delivery.
• The collection and analysis of patient safety work product.
• The development and dissemination of information with respect to the improvement of patient safety, such as protocols, recommendations, and information detailing best practices.
• The utilization of patient safety works product for the purposes of providing feedback assistance effectively and efficiently minimize patient risk, as well as encourage a culture of safety.
• The maintenance of procedures to preserve confidentiality in regards to patient safety work product.
• The implementation and utilization of qualified personnel.
• Other activities related to “the operation of a patient safety evaluation system and to the provision of feedback to participants in a patient safety evaluation system.”

What are the penalties for violating the PSQIA?

While the PSQIA was designed to promote communication between patients, healthcare providers, and employees working on behalf of PSOs, there are a variety of penalties that can be imposed against individuals and organizations who fail to comply with the provisions and requirements set forth in the law. More specifically, while the law does provide protections concerning disclosure from confidentiality protection, there are limitations to these protections. For example, “disclosures to carry out patient safety activities”, “disclosures of nonidentifiable work product”, and “disclosures otherwise allowed under Health Insurance Portability and Accountability Act of 1996 (HIPAA) confidentiality regulations to entities carrying out sanctioned research, evaluation, or demonstration products” are not covered by the confidentiality privileges set forth in the law.

Subsequently, individuals and organizations who violate the provisions of the PSQIA are subject to certain monetary penalties. For instance, “a person who discloses identifiable PSWP in knowing or reckless violation of the Patient Safety Act and 42 CFR part 3 shall be subject to a civil money penalty (CMP) of not more than $10,000 for each act constituting a violation.” What’s more, as the PSQIA was created to work in accordance with the Health Insurance Portability and Accountability Act of 1996 or HIPAA for short, many violations of the PSQIA can also be considered violations of the HIPAA, as the HIPAA states that business associates who are associated with healthcare providers or hospitals must also comply with the provisions and requirements set for by the law.

Despite the many technological advances that have been made in regards to healthcare solutions and surgical procedures, there are still occasions in which a patient may die due to medical error. The PSQIA was enacted to help prevent such occurrences, by ensuring that healthcare providers had a means of providing third parties with crucial data and analysis that could be used to prevent injury or death to patients, without violating the confidentiality or privacy rights of said patients. In accordance with the HIPAA, the PSQIA is one of the foremost ways in which patients within the U.S. can ensure that the medical procedures they undergo are conducted with the utmost level of safety in mind at all times.