The availability of an expanded and enhanced Common Formats Version 1.0 and the process for its continued development and refinement have been announced by the Agency for Healthcare Research and Quality (AHRQ). As authorized by HHS, the AHRQ coordinates the development of a set of common definitions and reporting formats (Common Formats) that allow healthcare providers to voluntarily collect and submit standardized information regarding patient safety events. The initial release of the formats, Version 0.1 Beta, was announced in the Federal Register on August 29, 2008 (73 FR 50974-50976). The Common Formats can be accessed electronically at http://www.pso.ahrq.gov/index.html.
Reporting framework. The Patient Safety Act (42 U.S.C. §299b-21 to b-26) and Patient Safety Rule (42 C.F.R. Part 3) establish a framework by which doctors, hospitals, and other healthcare providers may voluntarily report information regarding patient safety events and quality of care. Information that is assembled and developed by providers for reporting to patient safety organizations (PSOs) and the information received and analyzed by PSOs — called “patient safety work product” — is privileged and confidential. Patient safety work product is used to identify events, patterns of care, and unsafe conditions that increase risks and hazards to patients.
Regulatory requirements. The Patient Safety Act and Patient Safety Rule require PSOs to collect patient safety work product from providers in a standardized manner in order to permit valid comparisons of similar cases among similar providers. The collection of patient safety work product allows the aggregation of sufficient data to identify and address underlying causal factors of patient safety problems. In order to facilitate standardized data collection, the Secretary of HHS authorized AHRQ to develop and maintain the Common Formats to improve the safety and quality of healthcare delivery.
Common Formats. AHRQ's Common Formats include: (1) descriptions of patient safety events and unsafe conditions to be reported, (2) delineation of data elements to be collected for specific types of events, (3) specifications for patient safety population reports, (4) technical specifications for electronic data collection and reporting, and (5) a user's guide.
Scope of Common Formats. The scope of Common Formats applies to all patient safety concerns, including: (1) incidents — patient safety events that reached the patient, whether or not there was harm, (2) near misses or close calls — patient safety events that did not reach the patient, and (3) unsafe conditions — circumstances that increase the probability of a patient safety event.
Format types. Version 1.0 includes generic and event-specific formats. The three generic formats pertain to all patient safety concerns and include: a healthcare event reporting form, a patient information form, and a summary of initial report. The eight event-specific formats pertain to frequently-occurring and serious patient safety events, including: blood or blood product, device or medical/surgical supply, fall, healthcare-associated infection, medication or other substance, perinatal, pressure ulcer, and surgery or anesthesia.
Acute care hospital focus. The Common Formats Version 1.0 focuses on patient safety reporting for acute care hospitals. The AHRQ anticipates expanding future versions of the Common Formats to include other settings such as: nursing homes and other bedded facilities; ambulatory surgery centers; other ambulatory care settings, including community health centers, rehabilitation centers, and hemodialysis centers; physician and practitioner offices; and retail establishments such as pharmacies.
The AHRQ welcomes industry feedback. Information on the feedback process can be obtained at http://www.pso.ahrq.gov/index.html.
Source: AHRQ Notice, 74 FR 45457, Sept. 2, 2009.
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