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Overview: Common Formats

The Agency for Healthcare Research and Quality (AHRQ) coordinates the development of Common Formats for patient safety event reporting and analysis. This activity is authorized by the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act) and the Patient Safety and Quality Improvement Final Rule (Patient Safety Rule). A major goal of the legislation is to allow aggregation of data to identify and address underlying causal factors affecting patient quality and safety. This legislation also called for the establishment of Patient Safety Organizations (PSOs) and a Network of Patient Safety Databases (NPSD) to aggregate and analyze patient safety events.

For more information on PSOs, the Patient Safety Act, and the Patient Safety Rule, please see AHRQ's PSO Web site: http://pso.www.ahrq.gov/

In collaboration with the Federal Patient Safety Workgroup (PSWG), the National Quality Forum (NQF), and the public, AHRQ has developed Common Formats for two settings of care - acute care hospitals and nursing homes

Common Formats for Acute Care Hospitals

There are currently three types of acute care Hospital Common Formats: Hospital Common Formats for Event Reporting, Hospital Common Formats for Readmissions, and Hospital Common Formats for Surveillance. After completing a review of the existing patient safety event reporting systems from a variety of health care organizations, AHRQ developed, piloted, drafted and released Version 0.1 Beta of the Common Formats for Event Reporting in August 2008.

AHRQ further collaborated with NQF to solicit feedback on Version 0.1 Beta from private sector organizations and individuals. Based on the NQF's feedback, AHRQ in conjunction with the Patient Safety Workgroup (PSWG) further revised the Hospital Common Formats and released Version 1.0 in September 2009.

The review process was repeated to refine the Hospital Common Formats and incorporate public comments on Version 1.0, prior to finalizing the technical specifications for electronic implementations. Those modified formats for acute care hospitals were made available as Common Formats - Version 1.1 in March of 2010 and included the event-specific modules of Blood or Blood Product; Device or Medical/Surgical Supply; Fall; Healthcare-associated Infection (HAI), Medication or Other Substance; Perinatal; Pressure Ulcer; and Surgery or Anesthesia. In April 2012, AHRQ rolled out Common Formats - Version 1.2, which featured the new event-specific module Venous Thromboembolism (VTE) and revised the Device or Medical/Surgical Supply module to capture patient safety concerns associated with Health Information Technology (HIT) devices. The Common Formats - Version 1.2 includes the event descriptions, sample reports, and forms for both generic and event-specific categories. The Generic Hospital Common Formats forms include the Healthcare Event Reporting Form (HERF), Patient Information Form (PIF), and Summary of Initial Report (SIR), and specify information that is to be collected of pertain to all patient safety concerns. The event-specific categories for Hospital Common Formats ├é┬ôVersion 1.2, allow the collection of structured information of the following patient safety concerns, include Blood or Blood Product; Device or Medical/Surgical Supply, including HIT; Fall; Healthcare-associated Infection (HAI); Medication or Other Substance; Perinatal; Pressure Ulcer; Surgery or Anesthesia; and VTE.

In July 2012, Common Formats - Readmissions - Version 0.1 Beta was released to allow hospitals to aggregate data and analyze readmission attributes. The Readmissions module is primarily designed for use in the acute care hospital environment to gain enhanced understanding about the circumstances surrounding readmissions. These formats can be used within a hospital or healthcare system and may assist hospitals in response to the Affordable Care Act Hospital Readmissions Reduction Program.

In February 2014, AHRQ released Common Formats for Surveillance - Hospital Version - 0.1 Beta, which also includes both generic and event-specific categories. The event-specific categories for patient safety surveillance included in the Beta version are Blood or Blood Product; Delivery-Maternal; Delivery-Neonatal; Device or Medical/Surgical Supply, including HIT; Fall; Medication; Pressure Ulcer; Readmission; Surgery or Anesthesia; VTE, and Other Outcomes of Interest. Common Formats for Surveillance - Hospital are designed to provide through retrospective review of medical records, information that is complementary to that derived from event reporting systems. These formats facilitate improved detection of events and calculation of adverse event rates in populations reviewed.

Common Formats for Nursing Homes

AHRQ released the Common Formats - Nursing Home Version 0.1 Beta in March 2011. The Common Formats - Nursing Home Version 0.1 Beta includes the event descriptions, sample reports, and forms for both generic and event-specific categories. The generic categories of the Common Formats - Nursing Home Version 0.1 Beta version includes the HERF, PIF, and SIR, and pertain to all patient safety concerns. The Beta version for the event-specific categories for the Nursing Home Common Formats includes the Device or Supply, including HIT; Fall; HAI; Pressure Ulcer; and Medication or Other Substance modules.

Common Formats for Community Pharmacy

AHRQ released the Common Formats - Retail Pharmacy Version 0.1 Beta in October 2015. AHRQ worked with the NQF based on the public review and comment received, and developed and released the Common Formats - Community Pharmacy Version 1.0 in December 2016. The Community Pharmacy Version 1.0 module is designed for use in the community pharmacy environment to gain enhanced understanding about the circumstances surrounding patient safety events in the community pharmacy setting. This module is self-contained, covering everything necessary to report patient safety events in the Community Pharmacy event-specific category.

Patient Safety Events - What Gets Reported?

The type of information being collected in the generic Common Formats includes the following:

  • Class of patient safety concern being reported:
    • Incident: A patient safety event that reached the patient, whether or not the patient was harmed.
    • Near miss (or close calls): A patient safety event that did not reach the patient.
    • Unsafe condition: Any circumstance that increases the probability of a patient safety event.

AHRQ Common Formats include:

  • Precise definition of patient safety concerns that comprise all-cause harm
  • Examples of patient safety sample reports
  • Paper forms to guide development of data collection instruments
  • A Users Guide which describes how to use the Formats
  • A meta-data registry with data element attributes and technical specifications for use by developers
AHRQ established and uses a process to develop Common Formats that:
  • Is evidence-based
  • Harmonizes across governmental health agencies
  • Incorporates feedback from the private sector
  • Permits timely updating of these clinically-sensitive formats
AHRQ Common Formats include data elements that are:
  • Structured: Structured data permits sorting of patient safety incidents and near misses for event analysis, as well as for pattern and trending analysis at all levels of the healthcare system. Structured data encompasses important descriptors, known risk factors, and the use of established risk reduction methods to permit efficient analysis of incidents and patterns of patient safety events. Structured data can be aggregated within and across provider organizations, as well as for national reports. Such data are de-identified, where appropriate, in accordance with the Statute and Regulations.
  • Narrative: Narrative information cannot be aggregated, but provides the necessary details about an individual event or condition needed to understand patient safety concerns at the provider and/or PSO levels. The narrative information may also assist with how the provider and/or PSO can act to reduce risk to patients.

Active for Reporting

Common Formats - Hospital Version 1.1 and Hospital Version 1.2 are active for reporting implementation, and use by healthcare providers in hospitals and PSOs.

Additionally, Common Formats - Community Pharmacy Version 1.0 is active for reporting, implementation, and use by community pharmacies and PSOs.

Only active versions of the Common Formats are accepted by the Patient Safety Organization Privacy Protection Center (PSOPPC). Comments may be submitted for all active reporting versions through the NQF Common Formats Web Site.

Common Formats - Hospital Version 1.1, released in March 2010, was the first version of the Common Formats to include full technical specifications for electronic implementation.

Common Formats - Hospital Version 1.2, released in April 2012, incorporates all of the content updates made to the Common Formats and includes full technical specifications for electronic implementations.

Common Formats - Community Pharmacy Version 1.0, released in December 2016, is the first version of Common Formats for the Community Pharmacy setting.

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