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[Federal Register Volume 78, Number 109 (Thursday, June 6, 2013)]
[Notices]
[Pages 34101-34103]
From the Federal Register Online via the Government Printing 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 OIRA_submission@OMB.EOP.gov (attention: AHRQ's desk officer).

FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ Reports 
Clearance Officer, (301) 427-1477, or by email at 
doris.lefkowitz@AHRQ.hhs.gov.

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