Note: Terms used in the Patient Safety Act or Rule are summarized here solely for convenience; always rely on the actual text of the Patient Safety Act or Patient Safety Rule in making any determination.
Common Formats is the generic term for the standardized reporting formats, using common language and definitions that AHRQ is developing for reporting safety events from a variety of healthcare settings and throughout the quality improvement cycle. Common Formats will allow aggregation of comparable data at local, PSO, regional, and national levels. For more information, visit the PPC Web site.
The Patient Safety Rule defines a component organization as a unit or division of a legal entity or an entity that is owned, managed, or controlled by one or more legally separate parent organizations (e.g., a subsidiary of an organization would be considered a component organization under the rule). It may be helpful to review the definition of component organization in conjunction with the definition of parent organization; they can be found in section 3.20 of the rule.
With few exceptions, PSWP that is disclosed to another individual or entity pursuant to the disclosure permissions (exceptions) in sections 3.206(b) remains confidential and privileged in the possession of the receiving entity or individual. See section 3.208 of the Patient Safety Rule for the general principle and section 3.204 and 3.206 to review the specific disclosure permissions.
The Patient Safety Rule permits a PSO or a provider to disclose identifiable PSWP for patient safety activities to their contractor.
The Patient Safety Rule refers to the term "copy" in two ways in the definition of patient safety work product. First, when information meets all of the applicable requirements for protection as patient safety work product, any copy of the PSWP is also protected. Second, if information is not eligible for protection as PSWP (e.g., it is from the medical record or a report sent to regulatory authorities), the provider can still send a copy of the information to its PSO. While the copy held by the PSO or by the provider's PSES is protected, that protection does not apply to the original information that exists elsewhere (e.g., the medical record or the copy held by the regulator).
A deficiency is the term used by the Patient Safety Rule to describe a situation in which a PSO is not in compliance with a requirement of the rule or the Patient Safety Act. A PSO is required to correct a deficiency to remain listed as a PSO. See section 3.108 of the rule.
The Patient Safety Rule provides a limited opportunity for a provider to remove patient safety work protections from information that the provider entered into its patient safety evaluation system (PSES) for reporting to a PSO. The drop-out provision can be used for any reason, provided the information that the provider had placed in its PSES has not been reported to a PSO and the provider documents the action and its date. Upon removal, the information is no longer protected. The drop-out provision cannot be used if the information has been reported to a PSO and it does not apply to information that describes or constitutes the deliberations or analyses of a PSES.
The Patient Safety Rule lists entities that are excluded from listing as a PSO. Consult section 3.102(a)(2) of the rule.
The date and time that a PSO's initial period of listing becomes effective. Listing is for renewable 3-year periods. This date will be used as the starting point for calculating the successive 24-month periods in which a PSO must report compliance with the two contract requirement, and it will be the basis for calculating subsequent 3-year periods of continued listing
An entity with expertise in patient safety is authorized by the Secretary to work with providers under the protections of the Patient Safety Act.
An organization that:
- owns a controlling interest or a majority interest in a component organization;
- has the authority to control or manage agenda setting, project management, or day-to-day operations; or
- has the authority to review and override decisions of a component organization. The component organization may be a provider.
It may be helpful to review the definition of parent organization in conjunction with the definition of component organization; they can be found in section 3.20 of the rule. (See Guides for PSOs and Providers for Determining Parent Organization and Affiliated Providers.)
The Patient Safety Rule defines 8 patient safety activities; see section 3.20 of the rule for the list. An entity must attest that it has policies and procedures in place to perform all 8 PSAs at the time it seeks listing as a PSO.
The collection, management, or analysis of information for reporting to or by a PSO. A provider's PSES is an important determinant of what can, and cannot, become patient safety work product. It may be helpful to read the definition of PSES in conjunction with the definition of patient safety work product; they can be found in section 3.20 of the rule.
PSWP applies to information that is privileged and confidential under the Patient Safety Rule. For details on what information can, and cannot, become PSWP, the applicable process and purpose requirements, and the important role of the provider's patient safety evaluation system, see the definition of patient safety work product in section 3.20 of the rule. It may be helpful to read the definition of PSWP in conjunction with the definition of a patient safety evaluation system; they can be found in section 3.20 of the rule.
In the private sector, a provider means:
- an individual or entity licensed or otherwise authorized under State law to provide health care services and
- a parent organization of one or more entities licensed or otherwise authorized to provide health care services.
The definition of provider in section 3.20 of the Patient Rule includes additional language specific to Federal, State, local, or Tribal governments. Consult the definition of provider in section 3.20 of the rule for the complete definition.
Refers to a transparency requirement that is intended to alert providers if a PSO has relationships with other providers that go beyond a Patient Safety Act contract. The requirement applies when a PSO has any other financial, contractual, or reporting relationships with a contracted provider or if the PSO is not managed, controlled, or operated independently from a contracted provider. In such cases, the PSO must disclose these relationships to AHRQ.
The Patient Safety Rule draws a distinction between use and disclosure of patient safety work product (PSWP). The rule does not regulate the use of PSWP within a legal entity by the workforce of, or providers holding privileges with, an entity holding PSWP. In the case of a component PSO, the rule does not regulate the use of PSWP within the component organization. By contrast, the rule regulates disclosures, for which there must be an applicable disclosure permission in the rule. For a better understanding of use and disclosure, review the definitions of disclosure and workforce in section 3.20 of the rule and the permissible disclosures (exceptions to confidentiality) listed in section 3.206.
The Patient Safety Rule permits a PSO to notify AHRQ that it wishes to relinquish its status as a PSO. The process is described in section 3.108(c) of the rule.
For an individual to be considered a member of a PSO's or reporting provider's workforce, the Patient Safety Rule requires that the individual's work performance is under the direct supervision of the PSO or provider, whether or not the individual is paid. For the complete definition, see section 3.20 of the rule. (See PSO Workforce FAQs).