[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Notices]
[Pages 71972-71973]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30631]


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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 the Office of 
Management and Budget (OMB) to allow the proposed information 
collection project: ``Pilot Data for the Development of a Hospital 
Patient Safety Culture Survey''. In accordance with the Paperwork 
Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), 
AHRQ invites the public to comment on this proposed information 
collection.
    The proposed information collection was previously published in the 
Federal Register on September 23, 2002, and allowed 60 days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment.

DATES: Comments on this notice must be received by January 2, 2003.

ADDRESSES: Written comments should be submitted to: OMB Desk Officer at 
the following address: Allison Eydt, Human Resources and Housing 
Branch, Office of Information and Regulatory Affairs, OMB: New 
Executive Office Building, Room 10235; Washington, DC 20503.
    Comments submitted in response to this notice will be summarized 
and included in the request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.

FOR FURTHER INFORMATION CONTACT: Cynthia D. McMichael, AHRQ Reports 
Clearance Officer, (301) 594-3132.

SUPPLEMENTARY INFORMATION:

Proposed Project

``Pilot Data for the Development of a Hospital Patient Safety Culture 
Survey''

    The project is being conducted in partial response to an AHRQ task 
order entitled ``Patient Safety Measures'' (issued under Contract 290-
96-0004). With AHRQ's Director chairing the Quality Interagency 
Coordination Task Force (QuIC), and AHRQ coordinated the Federal 
response to the Institute of Medicine's (IOM) 1999 report on medical 
errors. The response outlined specific initiatives the QuIC agencies 
would take.
    This project addresses the need for a measurement tool to assess 
patient safety culture within health care institutions.
    The project is to develop a hospital patient safety culture survey, 
conduct cognitive pretesting, collect pilot data using the survey, 
analyze the pilot data to determine the psychometric properties of the 
survey (internal consistently, reliability, response variability, 
etc.), and then, to prepare survey administration procedures 
accordingly. The overall goal of this study is to provide AHRQ with a 
reliable employee survey instrument to assess a hospital's patient 
safety culture. The survey instrument will be made publicly available 
to enable hospitals throughout the nation to evaluate aspects of their 
organizational culture that impact medical errors, error reporting, and 
patient safety.
    The hospital patient safety culture survey to be pilot tested for 
this project is an employee survey that places an emphasis on medical 
error reporting. The survey also includes scales that measure other 
aspects of organizational culture that impact patient safety, such as: 
organizational learning, overall perceptions of safety, compliance with 
procedures, attitudes and frequency of error reporting, nonpunitive 
response to error, reasons errors occur, and employee teamwork. Through 
the proposed project, a reliable hospital

[[Page 71973]]

patient safety culture survey will be developed and then made available 
to the public, to reduce the burden to hospitals in developing their 
own instruments, to reduce the proliferation and use of untested 
instruments, and to foster benchmarking across hospitals.

Method of Collection

    The purpose of this pilot data collection is to gather enough 
survey responses to evaluate the internal consistency, reliability, 
response variability, and other psychometric properties of a newly 
developed survey, not to produce national estimates. Therefore, a 
purposive sample (hand-chosen, non-statistical sample) of 12 hospitals 
will suffice to participate in the study.
    Hospitals will be selected based on two factors: bed size and 
teaching vs. non-teaching status (two large/teaching, two medium/
teaching, two small/teaching, two large/non-teaching, two medium/non-
teaching, two small/non-teaching).
    Surveys will be distributed to 100 employees at each of the 12 
sites (a total of 1,200 employees). A contact person at each hospital 
will be asked to select 100 employees using a systematic random sample 
of employees. The contact person at each hospital will distribute the 
paper surveys to the 100 selected employees at each site. For purposes 
of individual confidentiality, no individuals identifiers will be used, 
so it will not be possible to track individual responses. Respondents 
will be instructed to mail their completed surveys directly to the 
research organization conducting the study using a postage-paid return 
envelope that will be provided. The hospitals will at no time have 
access to individual responses.
    The survey will be distributed to a total of 1,200 hospital 
employees (100 individuals at each of 12 hospitals), with a target 
response rate of 75%, or 900 returned surveys. Standard techniques like 
using a prenotification letter, a cover letter of support from the 
hospital, a follow-up postcard, and distribution of a second survey 
will be used to achieve the target response rate. Respondents should 
take approximately 20 minutes to complete the survey. Therefore, we 
estimate that the respondent burden for completing the survey will be 
300 hours (900 completes multiplied by 20 minutes per completed 
survey).

Estimated Annual Respondent Burden

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                                                                                 Estimated time
                    Data collection effort                        Number of      per respondent  Estimated total
                                                                 respondents      (in minutes)     burden hours
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Safety Culture Survey Pilot..................................             900               20              300
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    Respondents will not be asked to maintain any records. No 
additional equipment purchases will be made to support data collection 
processes or record keeping. Respondents will incur no monetary cost in 
completing the survey.

Estimated Annual Costs to the Federal Government

    The total cost to the government for conducting this survey 
development project is approximately $227,000 which includes the cost 
of survey development, pretesting, data collection, analysis, 
preparation of survey administration procedures, and preparation of a 
final report. The estimated cost of the data collection component is 
$50,000, which includes labor costs, fringe expenses, administrative 
expenses, and costs associated with copying, postage, and telephone 
expenses.

Request for Comments

    In accordance with the Paperwork Reduction legislation cited in the 
summary section above, comments on the AHRQ information collection 
proposal are requested with regard to any of the following:
    (a) Whether the proposed collection of information is necessary for 
the proper performance of functions of the Agency, including whether 
the information will have practical utility;
    (b) The accuracy of the Agency's estimate of the burden (including 
hours and costs) of the proposed collection 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 on 
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 request for OMB approval of the proposed 
information collection. All comments will become a matter of public 
record.

    Dated: November 22, 2002.
Carolyn M. Clancy,
Acting Director.
[FR Doc. 02-30631 Filed 12-2-02; 8:45 am]
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