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[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Notices]
[Pages 9214-9215]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-03492]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality

Common Formats for Patient Safety Data Collection and Event 
Reporting

AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department 
of Health and Human Services (HHS).

ACTION: Notice of Availability--New Common Formats

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SUMMARY: As authorized by the Secretary of HHS, AHRQ coordinates the 
development of common definitions and reporting formats (Common 
Formats) for reporting patient safety events to Patient Safety 
Organizations (PSOs) and other entities. The purpose of this notice is 
to announce the availability of a new type of Common Formats for public 
review and comment--Common Formats for Surveillance--Hospital.

DATES: Ongoing public input.

ADDRESSES: The newly released Common Formats for Surveillance--
Hospital--which includes modules entitled Generic Adverse Event 
Information, Blood or Blood Product, Delivery-Maternal, Delivery-
Neonatal, Device or Medical/Surgical Supply Including Health 
Information Technology (HIT), Fall, Medications, Pressure Ulcer, 
Readmissions, Surgery or Anesthesia, Venous Thromboembolism, and Other 
Outcomes of Interest--can be accessed electronically at the following 
HHS Web site: http://www.PSO.AHRQ.gov/index.html

FOR FURTHER INFORMATION CONTACT: Glenn Egelman, M.D., Center for 
Quality Improvement and Patient Safety, AHRQ, 540 Gaither Road, 
Rockville, MD 20850; Telephone (toll free): (866) 403-3697; Telephone 
(local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY (local): 
(301) 427-1130; Email: PSO@AHRQ.HHS.GOV.

SUPPLEMENTARY INFORMATION:

Background

    The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 
299b-21 to b-26, (Patient Safety Act) and the related Patient Safety 
and Quality Improvement Final Rule, 42 CFR Part 3 (Patient Safety 
Rule), published in the Federal Register on November 21, 2008: 73 FR 
70731-70814, provide for the formation of PSOs, which collect, 
aggregate, and analyze confidential information regarding the quality 
and safety of healthcare delivery. The Patient Safety Act (at 42 U.S.C. 
299b-24(b)(1)(F)) requires PSOs to collect information from providers 
in a standardized manner that permits valid comparisons of similar 
cases among similar providers, to the extent practical and appropriate. 
As explained in 42 CFR 3.102(b)(1)(iii)(A)(1), one option for a PSO to 
satisfy this requirement is by certifying that it is using the 
Secretary's published guidance for common formats and definitions in 
its collection of information from healthcare providers.
    The Patient Safety Act and Patient Safety Rule establish a 
framework by which doctors, hospitals, skilled nursing facilities, and 
other healthcare providers may assemble information regarding patient 
safety events and quality of care. Information that is assembled and 
developed by providers for reporting to 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 
conduct patient safety activities, which may include identifying 
events, patterns of care, and unsafe conditions that increase risks and 
hazards to patients. Definitions and other details about PSOs and 
patient safety work product are included in the Patient Safety Act and 
Patient Safety Rule which can be accessed electronically at: http://www.PSO.AHRQ.gov/REGULATIONS/REGULATIONS.htm.

Definition of Common Formats

    The term Common Formats refers to the common definitions and 
reporting formats, specified by AHRQ, that allow healthcare providers 
to collect and submit standardized information regarding patient safety 
events. The Common Formats are not intended to replace any current 
mandatory reporting system, collaborative/voluntary reporting system, 
research-related reporting system, or other reporting/recording system; 
rather the formats are intended to enhance the ability of healthcare 
providers to report information that is standardized both clinically 
and electronically.
    In collaboration with the interagency 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 skilled nursing facilities--in order to facilitate 
standardized data collection. The scope of Common Formats applies to 
all patient safety concerns including: Incidents--patient safety events 
that reached the patient, whether or not there was harm; near misses or 
close calls--patient safety events that did not reach the patient; and 
unsafe conditions--circumstances that increase the probability of a 
patient safety event.
    Until now, Common Formats have been designed to support only 
traditional event reporting. 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 will facilitate improved detection of 
events and calculation of adverse event rates in populations reviewed.

Common Formats Development

    In anticipation of the need for Common Formats, AHRQ began their 
development by creating an inventory of functioning private and public 
sector patient safety reporting systems. This inventory provides an 
evidence base that informed construction of the Common Formats. The 
inventory includes many systems from the private sector, including 
academic settings, hospital systems, and international reporting 
systems (e.g., from the United Kingdom and the Commonwealth of

[[Page 9215]]

Australia). In addition, virtually all major Federal patient safety 
reporting systems are included, such as those from the Centers for 
Disease Control and Prevention (CDC), the Food and Drug Administration 
(FDA), the Department of Defense (DoD), and the Department of Veterans 
Affairs (VA).
    Since February 2005, AHRQ has convened the PSWG to assist AHRQ with 
developing and maintaining the Common Formats. The PSWG includes major 
health agencies within HHS--CDC, Centers for Medicare and Medicaid 
Services, FDA, Health Resources and Services Administration, Indian 
Health Service, National Institutes of Health, National Library of 
Medicine, Office of the National Coordinator for Health Information 
Technology, Office of Public Health and Science, and Substance Abuse 
and Mental Health Services Administration--as well as the DoD and VA.
    When developing Common Formats, AHRQ first reviews existing patient 
safety event reporting systems from a variety of health care 
organizations. In collaboration with the PSWG and Federal subject 
matter experts, AHRQ drafts and releases beta versions of the Common 
Formats for public review and comment. The PSWG assists AHRQ with 
assuring the consistency of definitions/formats with those of relevant 
government agencies as refinement of the Common Formats continues. To 
the extent practicable, the Common Formats are also aligned with World 
Health Organization (WHO) concepts, framework, and definitions for 
patient safety.

Commenting on Common Formats: Common Formats for Surveillance--Hospital

    To allow for greater participation by the private sector in the 
subsequent development of the Common Formats, AHRQ engaged the NQF, a 
non-profit organization focused on health care quality, to solicit 
comments and advice to guide the further refinement of the Common 
Formats. The NQF then convenes an expert panel to review the comments 
received and provide feedback. Based upon the expert panel's feedback, 
AHRQ, in conjunction with the PSWG, revises and refines the Common 
Formats.
    The Agency is specifically interested in obtaining feedback from 
both the private and public sectors to guide the improvement of the 
formats. Information on how to comment and provide feedback on the 
Common Formats for Surveillance--Hospital is available at: http://www.Qualityforum.ORG/projects/commonformats.aspx.
    More information about the Common Formats can be obtained through 
AHRQ's PSO Web site: http://www.PSO.AHRQ.gov/index.html.

    Dated: February 6, 2014.
Richard Kronick,
Director.
[FR Doc. 2014-03492 Filed 2-14-14; 8:45 am]
BILLING CODE 4160-90-P
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