[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Pages 34101-34103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-13341]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) approve the proposed information collection
project: ``A Prototype Consumer Reporting System For Patient Safety
Events.'' In accordance with the Paperwork Reduction Act; 44 U.S.C.
3501-3521, AHRQ invites the public to comment on this proposed
information collection.
This proposed information collection was previously published in
the Federal Register on September 11th, 2012 and allowed 60 days for
public comment. AHRQ received 45 substantive comments and 64 personal
stories from members of the public. These comments and personal stories
raised 37 issues in the wording of the intake form, two issues with
wording in other supporting documentation to the intake form, and 69
design issues that we categorized into 18 types of design concerns. To
address these comments substantial revisions were made to the data
collection tools and supporting documentation. The purpose of this
notice is to allow an additional 30 days for public comment.
DATES: Comments on this notice must be received by July 8, 2013.
ADDRESSES: Written comments should be submitted to: AHRQ's OMB Desk
Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by
email at [email protected] (attention: AHRQ's desk officer).
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports
Clearance Officer, (301) 427-1477, or by email at
[email protected].
SUPPLEMENTARY INFORMATION:
Proposed Project
A Prototype Consumer Reporting System for Patient Safety Events
The Agency for Healthcare Research and Quality (AHRQ) requests that
the Office of Management and Budget (OMB) approve, under the Paperwork
Reduction Act of 1995, AHRQ's
[[Page 34102]]
collection of information for a Prototype Consumer Reporting System for
Patient Safety Events. This project aims to design and test a system
for collecting information from patients about health care safety
events following standard definitions and formats. When complete,
project findings will be available for use by local providers that wish
to create or enhance their own local consumer reporting systems.
There is a growing body of evidence that many adverse medical
events go unreported in current systems (Weissman et al., 2008). One
important reason for this reporting gap is that most reporting systems
do not presently accept or elicit reports from patients and their
families (RTI 2010). AHRQ recognizes that the unique perspective of
health care consumers could reveal important information that is not
reported by health care providers. Patient reports could complement and
enhance reports from providers and thus produce a more complete and
accurate understanding of the prevalence and characteristics of medical
adverse events (RTI, 2010).
In an effort to realize untapped potential of health care consumers
to provide important information about patient safety events, AHRQ has
funded the development of a prototype Consumer Reporting System for
Patient Safety (CRSPS), designed to collect information from patients
about medical errors that resulted or nearly resulted in harm or
injury. The purpose of this project is to test the prototype for its
ability to record data from consumers about patient safety events
defined as an incident or near miss by the AHRQ Common Formats (AHRQ,
2010, details at: www.pso.ahrq.gov/formats/commonfmt.htm).
Currently there is no mechanism for consumers to report information
about patient safety events defined as incidents or near misses by the
AHRQ Common Formats, which were designed for use by providers of care.
Such information is necessary for research on how to improve the
quality of health care, promote patient safety, and reduce medical
errors. There is a need to collect information about patient safety
events from consumers and match these consumer reports to the
information collected by providers, because the two sources may differ
and, even when reporting on the same event, may provide complementary
information. Examining data from both sources allows the project to
determine to what extent patients are able to contribute to more
complete and/or more detailed information.
This research has the following goals:
1. To develop and design a prototype system to collect information
about patient safety events.
2. To develop and test web and telephone modes of a prototype
questionnaire.
3. To develop and test protocols for a follow-up survey of health
care providers.
This demonstration project is being conducted by AHRQ through its
contractor, RAND Corporation, with Brigham and Women's Hospital, Dana
Farber Cancer Institute, and ECRI Institute, pursuant to AHRQ's
statutory authority to conduct and support research on health care and
on systems for the delivery of such care, including activities with
respect to the quality, effectiveness, efficiency, appropriateness and
value of health care services and with respect to quality measurement
and improvement. 42 U.S.C. 299a(a)(1) and (2).
Method of Collection
To achieve the goal of this project the following data collection
efforts will be implemented:
1. Safety event intake form and follow up. The safety event intake
form asks about a medical error or mistake, harm or injury as well as
near misses. Patients, consumers, family members and other caregivers
voluntarily report safety events through a Web site or by telephone.
The questions ask what happened, details of the event, when, where,
whether there was harm, the type of harm, contributing factors,
disclosure, and whether the patient reported the event and to whom.
Information is also collected regarding whether the respondent is
willing to have CRSPS staff follow up to clarify information. If a
respondent consents, CRSPS staff will follow up by phone and ask
questions about any information that was not clear in the initial
report and annotate the report with this information.
2. Health care provider follow up. For the subset of consumers that
consent, patient safety officers at health care provider organizations
who maintain the adverse event reporting system will contribute
supplemental information about the consumer-reported incident which
occurred at their facility. CRSPS staff will contact the health care
organization to share the consumer report with the patient safety
officer or other appointed liaison. The liaison will determine if the
consumer-reported incident matches an event in the provider's Incident
Reporting System, and if so, provide additional information.
Data collected will be analyzed to produce estimates and basic
descriptive statistics on the quantity and type of consumer-reported
patient safety events, examine the variability of responses to
questions, examine the mode of data collection by event types, and
conduct correlations, cross tabulations of responses and other
statistical analysis.
Estimated Annual Respondent Burden
Exhibit 1 shows the estimated annualized burden hours for
respondents' time to participate in this information collection based
on the expected number of respondents, 840 to the intake form and 84 to
the provider follow up. The number of respondents is based on the size
of the selected community, estimates of health care utilization, rates
of adverse events, and response rates in similar investigations. The
intake form is expected to maximally require 25 minutes via the web or
telephone including the optional 10 minutes of follow-up questions,
resulting in a total burden of 490 hours. The health care provider
follow up is expected to take 20 minutes and only occurs for the
estimated 10% of patients consenting; this form carries a total burden
of 28 hours. The total burden is 518 hours annually.
Exhibit 1--Estimated Annualized Burden Hours
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Number of
Form name Number of responses per Hours per Total burden
respondents respondent response hours
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Safety event intake form and follow up......... 840 1 35/60 490
Health care provider follow up................. 84 1 20/60 28
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Total...................................... 924 NA NA 518
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[[Page 34103]]
Exhibit 2 shows the estimated annualized cost burden for patients,
$10,652, and for the health care organization, $885, for a total
annualized cost burden of $11,537. Respondents will not incur any other
costs beyond those associated with their time to participate.
Exhibit 2--Estimated Annualized Cost Burden
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Average
Form Name Number of Total burden hourly wage Total cost
respondents hours rate burden
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Safety event intake form and follow up.......... 840 490 * $21.74 $10,652
Health care provider follow up.................. 84 28 ** 31.61 885
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Total....................................... 924 518 NA 11,537
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* Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
States, May 2011, U.S. Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes_nat.htm#00-0000.
** Based upon the mean of the average wages, National Compensation Survey: Occupational wages in the United
States, May 2011: Occupational Health and Safety Specialists (General Medical and Surgical Hospitals). U.S.
Department of Labor, Bureau of Labor Statistics. http://www.bls.gov/oes/current/oes299011.htm.
Estimated Annual Cost to the Government
AHRQ is supporting the conduct of this project as part of a
contract with the RAND Corporation and the ECRI Institute. The
estimated cost for this work is $899,827.
Exhibit 3--Estimated Annualized Cost
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Annualized
Cost component Total cost cost
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Intake Form Development................. $364,375 $242,917
System Development...................... 413,860 275,907
Project Management...................... 35,325 23,550
Overhead................................ 86,267 57,511
Total............................... 899,827 599,885
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Request for Comments
In accordance with the Paperwork Reduction Act, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of AHRQ health care research and
health care information dissemination functions, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of automated collection techniques or
other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the Agency's subsequent request for OMB approval of the
proposed information collection. All comments will become a matter of
public record.
Dated: May 30, 2013.
Carolyn M. Clancy,
Director.
[FR Doc. 2013-13341 Filed 6-5-13; 8:45 am]
BILLING CODE 4160-90-M