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Patient Safety Organization

QAISys, Inc. is listed as a Patient Safety Organization (PSO) by the Department of Health and Human Services (HHS) in accordance with the 2005 Patient Safety and Quality Improvement Act (PSQIA).  The Agency for Healthcare Research and Quality (AHRQ) is the HHS subsidiary organization that has been charged with providing regulatory oversight of PSOs.  You can view our listing on their website at:

As described by AHRQ:  The goals of the Patient Safety Act are to encourage the expansion of voluntary, provider-driven initiatives to improve the safety of health care; to promote rapid learning about the underlying causes of risks and harms in the delivery of health care; and to share those findings widely, thus speeding the pace of improvement. The Patient Safety Act:

  • Encourages the development of Patient Safety Organizations (PSOs)-organizations that can work with clinicians and health care organizations to identify, analyze, and reduce the risks and hazards associated with patient care.
  • Fosters a culture of safety by establishing strong Federal confidentiality and privilege protections for information assembled and developed by provider organizations, physicians, and other clinicians for deliberations and analyses regarding quality and safety.
  • Accelerates the speed with which solutions can be identified for the risks and hazards associated with patient care by facilitating the aggregation of a sufficient number of events in a protected legal environment.

The following terms and their statutory definitions are pivotal to understanding the sphere of protection afforded by PSQIA.  They are fundamental in defining the relationship between QAISys, Inc. and our client organizations:

A Patient Safety Organization (PSO) is defined as “a private or public entity or component thereof that is listed by the Secretary of the Department of Health and Human Services pursuant to the Patient Safety and Quality Improvement Act of 2005.”[1]

A Patient Safety Evaluation System (PSES) is defined as the “collection, management, or analysis of information for reporting to or by a Patient Safety Organization.”  The PSES is a core concept of the Patient Safety Act through which information, including data, reports, memoranda, analyses, and/or written or oral statements, is collected, maintained, analyzed, and communicated.[2]

Patient Safety Work Product (PSWP) is defined as any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material)  (A)  which could result in improved patient safety, health care quality, or health care outcomes and either  (i)  is assembled or developed by a provider for reporting to a PSO and is reported to a PSO; or  (ii)  is developed by a PSO for the conduct of patient safety activities; or (B) which identifies or constitutes the deliberations or analysis of, or identifies the fact of reporting pursuant to, a patient safety evaluation system.[3] 

Implementation of the QAISys® process effectively creates a PSES that encompasses elements of both QAISys, Inc. and the client organization.  We work with our clients to help clearly define the PSES within their organizations in order to help solidify the PSQIA protection of their internal communications.

The complete text of the Patient Safety and Quality Improvement Act of 2005 (PSQIA) is available at:  Please refer to Section 922 of the statute for a description of the privilege and confidentiality protections provided therein.

We take very seriously the inherent responsibilities that come with the privileges we’ve been granted and are able to extend.  We rely heavily upon AHRQ for guidance with regard to these matters.

Patient Safety Activities

QAISys, Inc. performs, and enables its clients to perform, effective Patient Safety Activities.

Patient Safety Activities are defined in PSQIA as activities that will be conducted by PSOs and providers in the operation of a Patient Safety Evaluation System (PSES).  Patient Safety Activities include the following:

  1. Efforts to improve patient safety and the quality of health care delivery.
  2. The collection and analysis of patient safety work product.
  3. The development and dissemination of information with respect to improving patient safety, such as recommendations, protocols, or information regarding best practices.
  4. The utilization of patient safety work product for the purposes of encouraging a culture of safety and of providing feedback and assistance to effectively minimize patient risk.
  5. The maintenance of procedures to preserve confidentiality with respect to patient safety work product.
  6. The provision of appropriate security measures with respect to patient safety work product.
  7. The utilization of qualified staff.
  8. Activities related to the operation of a PSES and to the provision of feedback to participants in a PSES.[4]

If correctly implemented, QMS and the QAISys® process will facilitate in-depth analysis of our client organizations’ medical imaging services.  QMS may be used to:

  • Discover targets for improvement such as problem exam types or recurring types of detractions for both individuals and groups of technologists.
  • Discover and propagate best practices for the target areas by finding technologists who have consistently high ratings for the specific exam type or detraction.
  • Track the level of performance for each technologist for the targeted area.
  • Track overall quality performance on an ongoing basis.
  • Discover and reward consistent quality performance of technologists in general.
  • Encourage and track improvement where needed.

These kinds of actions fulfill the statutory definition of Patient Safety Activities.  The services we provide that facilitate them are a key to our meeting the regulatory requirements and attaining PSO status.

QAISys, Inc. Support Services

In support of these Patient Safety Activities and in accordance with our service agreement and fee schedule we will:

  1. Create an account for the client organization within QMS under which we will permit and enable the client to submit PSWP to our custody.
  2. Define and formally document the specific PSES formed through interaction between the client organization and QAISys, Inc.
  3. Provide unrestricted access to the account for the client Account Administrator with full use of QMS features (role-based security access for additional users such as modality or location supervisors is available).
  4. Provide ongoing assistance with questions regarding effective implementation and application of the QAISys® system, as well as protections provided through and responsibilities imposed by PSQIA, HITECH, and HIPAA.

We are confident that our services will effectively help our clients meet the increasing demands to consistently perform meaningful and effective Patient Safety Activities.

[1] Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41, at §921(4), 119 Stat. 424, 425.

[2] Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41, at §921(6), 119 Stat. 424, 425.

[3] Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41, at §921(7)(A)(ii), 119 Stat. 424, 426.

[4] Patient Safety and Quality Improvement Act of 2005, Pub. L. No. 109-41, at §921(5), 119 Stat. 424, 425.

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