Determining the purpose for which provider-created or -assembled information related to patient safety, health care quality, and health care outcomes was created is a critical step in analyzing whether the information can be categorized as patient safety work product (PSWP). In an advance release of a guidance titled “Patient Safety and Quality Improvement Act of 2005—HHS Guidance Regarding Patient Safety Work Product and Providers’ External Obligations,” HHS, along with the Office for Civil Rights (OCR), and the Agency for Healthcare Research and Quality (AHRQ), provided information for patient safety organizations (PSO), and providers regarding questions related to meeting both the goals of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) (P.L. 109-41) and external obligations for local and federal oversight purposes.
Background. The Patient Safety Act is part of a larger framework designed to balance two goals: (1) improving patient safety and reduce medical errors by creating a “culture of safety” to share and learn from information related to patient safety events; and (2) promoting health care providers’ accountability and transparency through mechanisms such as oversight by regulatory agencies and adjudication in the legal system.
Generally, providers voluntarily collect and report information about patient safety, health care quality, and health care outcomes to PSOs. The providers report such information because the Patient Safety Act provides broad privilege and confidentiality protections for information meeting the definition of PSWP, which alleviates concerns about such information being used against a provider, such as in litigation. At the same time, providers are subject to external obligations regarding certain records about patient safety to ensure their accountability and transparency. The guidance noted that the threat of litigation may provide a disincentive to providers to voluntarily share information.
PSWP. There are three ways that certain information can become PSWP: (1) the information is prepared by a provider for reporting to a PSO and it is reported to the PSO; (2) the information is developed by a PSO for the conduct of patient safety activities; or (3) the information identifies or constitutes the deliberations or analysis of, or identifies the fact of reporting pursuant to, a patient safety evaluation system (PSES).
The first way, referred to as the “reporting pathway,” is the most common method used by providers to create their PSWP. Under the Patient Safety Act, the reporting pathway allows for information that is documented as collected within the provider’s PSES to be PSWP and thus privileged and confidential before it is reported to a PSO. Information prepared for purposes other than reporting to a PSO is not PSWP, such as original patient and provider records, including a patient’s medical record, billing information, and discharge information. PSWP cannot be used to fulfill external obligations such as mandatory requirements placed upon providers by federal and state health regulatory agencies.
Thus, the critical factor in determining whether information is PSWP is dependent upon the information’s prepared purpose. For instance, information related to the functioning of medical equipment is not PSWP if prepared for general upkeep of the equipment, but is PSWP if prepared solely for reporting to a PSO.
External obligations. The agencies noted concerns that some providers might attempt to use the Patient Safety Act protections to avoid their external obligations. PSWP privilege and confidentiality obligations protections do not shield records required by external recordkeeping or reporting requirements. The Patient Safety Act was intended to spur the development of additional information created through voluntary patient safety activities and provide privilege and confidentiality protections for such new information, not for records generated or maintained as part of a providers’ existing mandatory information collection activities.
Separate systems. Providers who are unsure at the time information is being prepared for reporting to the PSO whether similar information would be needed for an external obligation can use the “drop out” provision under the Patient Safety Act. Under the drop out provision, if the provider later determines the information within its PSES that had originally been assembled or developed for reporting to a PSO will be instead used for an external obligation, it is removed from the PSES and is no longer PSWP. This means it is no longer privileged or confidential under the Patient Safety Act. The guidance stressed that the drop out provision should only be used on a case-by-case basis. The drop out provision eliminates the need for a provider to maintain two systems with duplicate information: a PSES containing PSWP and a separate system containing any of that same information where the provider has yet to determine whether it will be needed in the future for another purpose. However, a provider should maintain at least two systems or spaces: a PSES for PSWP and a separate place where it maintains records for external obligations.
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