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Agency Information Collection Activities: Proposed Collection; Comment Request

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Information about this document as published in the Federal Register.

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Agency for Healthcare Research and Quality, HHS.




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.


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


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.

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Cynthia D. McMichael, AHRQ Reports Clearance Officer, (301) 594-3132.

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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 Start Printed Page 71973patient 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

Data collection effortNumber of respondentsEstimated time per respondent (in minutes)Estimated total burden hours
Safety Culture Survey Pilot90020300

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.

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Dated: November 22, 2002.

Carolyn M. Clancy,

Acting Director.

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[FR Doc. 02-30631 Filed 12-2-02; 8:45 am]