[Federal Register Volume 75, Number 61 (Wednesday, March 31, 2010)]
[Notices]
[Pages 16140-16142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6781]


-----------------------------------------------------------------------

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), HHS.

ACTION: Notice of Availability--Common Formats Version 1.1.

-----------------------------------------------------------------------

SUMMARY: The Patient Safety and Quality Improvement Act of 2005, 42 
U.S.C. 299b-21 to b-26, (Patient Safety Act) provides for the formation 
of Patient Safety Organizations (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-23) 
authorizes the collection of this information in a standardized manner, 
as explained in 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. As authorized 
by the Secretary of HHS, 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 purpose of this notice 
is to announce the availability of the expanded and enhanced Common 
Formats Version 1.1--including updated event descriptions, reports, 
data elements, and technical specifications for software developers--
and the process for their continued refinement.

DATES: Ongoing public input.

ADDRESSES: The Common Formats Version 1.1 can be accessed 
electronically at the following HHS Web site: http://www.PSO.AHRQ.gov/index.html.

FOR FURTHER INFORMATION CONTACT: Marcy Opstal, Center for Quality 
Improvement and Patient Safety, AHRQ, 540 Gaither Road, Rockville, MD 
20850; Telephone (toll free): (866) 403-3697;

[[Page 16141]]

Telephone (local): (301) 427-1111; TTY (toll free): (866) 438-7231; TTY 
(local): (301) 427-1130; E-mail: [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The Patient Safety Act and Patient Safety Rule 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 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. Definitions and other details about PSOs and 
patient safety work product are included in the Patient Safety Rule.
    The Patient Safety Act and Patient Safety Rule require PSOs, to the 
extent practical and appropriate, 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. Both the Patient Safety Act and Patient Safety 
Rule can be accessed electronically at http://www.PSO.AHRQ.gov/regulations/regulations.htm.
    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. In August 2008, 
AHRQ issued the initial release of the formats, Version 0.1 Beta. The 
second release of the Common Formats, Version 1.0, was announced in the 
Federal Register on September 2, 2009: 74 FR 45457-45458.

Definition of Common Formats

    The term ``Common Formats'' is used to describe clinical 
definitions and technical requirements developed for the uniform 
collection and reporting of patient safety data, including all 
supporting material. 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. 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.
    Common Formats Version 1.1 is currently limited to patient safety 
reporting for acute care hospitals and is designed to support the first 
stage in the improvement cycle. Version 1.1 includes two general types 
of formats, generic and event specific. The generic Common Formats 
pertain to all patient safety concerns. The three generic formats are: 
Healthcare Event Reporting Form, Patient Information Form, and Summary 
of Initial Report. The event-specific Common Formats pertain to 
frequently-occurring and/or serious patient safety events. The eight 
event-specific formats are: Blood or Blood Product, Device or Medical/
surgical Supply, Fall, Healthcare-Associated Infection, Medication or 
Other Substance, Perinatal, Pressure Ulcer, and Surgery or Anesthesia.
    The Common Formats Version 1.1 has a defined focus on patient 
safety reporting for acute care hospitals. It should be noted, however, 
that the privilege and confidentiality protections of the Patient 
Safety Act and Patient Safety Rule apply to patient safety work product 
developed under the aegis of a PSO with respect to healthcare in any 
setting. Future versions of the Common Formats are being developed for 
other settings such as: Skilled nursing facilities (SNFs), ambulatory 
surgery centers, and physician and practitioner offices.
    AHRQ's Common Formats Version 1.1 includes:
     Descriptions of patient safety events and unsafe 
conditions to be reported (event descriptions),
     Specifications for patient safety aggregate reports and 
individual event summaries,
     Delineation of data elements to be collected for specific 
types of events,
     A user's guide and quick guide, and
     Technical specifications for electronic data collection 
and reporting.

Common Formats Development

    In anticipation of the need for Common Formats, AHRQ began their 
development in 2005 by creating an inventory of functioning private and 
public sector patient safety reporting systems. This inventory provides 
an evidence base that informs construction of the Common Formats. The 
inventory now numbers 69 and includes many systems from the private 
sector, including prominent academic settings, hospital systems, and 
international reporting systems (e.g., from the United Kingdom and the 
Commonwealth of 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 coordinated an interagency Federal 
Patient Safety Work Group (PSWG) to assist AHRQ with developing and 
maintaining the Common Formats. The PSWG includes major health agencies 
within the HHS CDC, Centers for Medicare & Medicaid Services, FDA, 
Health Resources and Services Administration, the Indian Health 
Service, the National Institutes of Health, the National Library of 
Medicine, the Office of the National Coordinator for Health Information 
Technology, the Office of Public Health and Science, the Substance 
Abuse and Mental Health Services Administration--as well as the DoD and 
the VA.
    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, contained in their draft International 
Classification for Patient Safety (ICPS).

Common Formats Version 1.1--Technical Specifications Enhancements

    The technical specifications promote standardization by ensuring 
that data collected by PSOs and other entities are clinically and 
electronically comparable. The specifications also provide direction to 
software developers, so the Common Formats can be implemented 
electronically, and to PSOs, so the Common Formats can be submitted 
electronically to the PSO Privacy Protection Center (PPC) for data de-
identification and transmission to the Network of Patient Safety 
Databases (NPSD).
    The technical specifications consist of the following:
     Data dictionary--defines data elements and their 
attributes (data element name, answer values, field length, guide for 
use, etc.) included in Common Formats Version 1.1;

[[Page 16142]]

     Clinical document architecture (CDA) implementation 
guide--provides instructions for developing a Health Level Seven (HL7) 
CDA Extensible Markup Language (XML) file to transmit the Common 
Formats patient safety data from the PSO to the PPC using the Common 
Formats;
     Validation rules and errors document--specifies and 
defines the validation rules that will be applied to the Common Formats 
data elements submitted to the PPC;
     Common Formats flow charts--diagrams the valid paths to 
complete generic and event specific formats (a complete event report);
     Local specifications--provides specifications for 
processing, linking and reporting on events and details specifications 
for reports; and
     Metadata registry--includes descriptive facts about 
information contained in the data dictionary to illustrate how such 
data corresponds with similar data elements used by other Federal 
agencies and standards development organizations [e.g., HL-7, 
International Standards Organization (ISO)].

Commenting on Common Formats Version 1.1

    To allow for greater participation by the private sector in the 
subsequent development of the Common Formats, AHRQ engaged the National 
Quality Forum (NQF), a non-profit organization focused on healthcare 
quality, to solicit comments and advice to guide the further refinement 
of the Common Formats. The NQF began this process with feedback on 
AHRQ's 0.1 Beta release of the Common Formats. The NQF also convened an 
expert panel to review the comments received on Common Formats Version 
1.0 and provide feedback to AHRQ. Based upon the expert panel's 
feedback, AHRQ, in conjunction with the PSWG, has further revised and 
refined the Common Formats that are now available as Version 1.1.
    AHRQ is committed to continuing refinement of the Common Formats. 
The Agency is specifically interested in obtaining feedback from both 
the private and public sectors, particularly from those who use the 
Common Formats, to guide their improvement. Although AHRQ's Version 1.1 
has been developed based on evidence, consensus of the PSWG, public 
comments and input, and feedback from the NQF expert panel, the formats 
do not fully reflect the refinement that comes from large-scale use and 
repeated revision. The process for updating and refining the formats 
will be an iterative one.
    More information on the Common Formats Version 1.1, including the 
feedback process, can be obtained through AHRQ's PSO Web site: http://www.PSO.AHRQ.gov/index.html.

    Dated: March 19, 2010.
Carolyn M. Clancy,
Director.
[FR Doc. 2010-6781 Filed 3-30-10; 8:45 am]
BILLING CODE 4160-90-M