[Federal Register Volume 77, Number 175 (Monday, September 10, 2012)]
[Pages 55475-55477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22028]



Agency for Healthcare Research and Quality

 Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Agency for Healthcare Research and Quality, HHS.

ACTION: Notice.


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.

DATES: Comments on this notice must be received by November 9, 2012.

ADDRESSES: Written comments should be submitted to: Doris Lefkowitz, 
Reports Clearance Officer, AHRQ, by email at 
[email protected]. Copies of the proposed collection plans, 
data collection instruments, and specific details on the estimated 
burden can be obtained from the AHRQ Reports Clearance Officer.

[[Page 55476]]

Clearance Officer, (301) 427-1477, or by email at 
[email protected].


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 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 
    There is a growing body of evidence that many adverse medical 
events go unreported in current systems (Weissman et al., 2008). A 
primary 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 medical 
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 an incident or near miss by the 
AHRQ Common Formats. 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 this information from 
consumers and match these consumer reports to the information collected 
by providers, because the two sources may differ. Examining data from 
both sources allows the project to determine to what extent patients 
are able to provide more complete 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 
    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 collections 
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. Medical 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
                                                                     Number of
                    Form name                        Number of     responses per     Hours per     Total burden
                                                    respondents     respondent       response          hours
Safety event intake form and follow up..........             840               1           35/60             490
Health care provider follow up..................              84               1           20/60              28

[[Page 55477]]

    Total.......................................             924              NA              NA             518

    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
                                                     Number of     Total burden   Average hourly    Total cost
                    Form name                       respondents        hours         wage rate        burden
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
* 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
           Cost component                Total cost      Annualized cost
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

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: August 30, 2012.
Carolyn M. Clancy,
[FR Doc. 2012-22028 Filed 9-7-12; 8:45 am]