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: “Hospital Survey on Patient Safety Culture Comparative Database.”

DATES:

Comments on this notice must be received by May 20, 2019.

ADDRESSES:

Written comments should be submitted to: Doris Lefkowitz, Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov.

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.

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by emails at doris.lefkowitz@AHRQ.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

“Hospital Survey on Patient Safety Culture Comparative Database.”

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. The Hospital Survey on Patient Safety Culture (Hospital SOPS) is designed to enable hospitals to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The Hospital SOPS includes 42 items that measure 12 composites of patient safety culture. AHRQ first made the Hospital SOPS publicly available, along with a Survey User's Guide and other toolkit materials, in November 2004 on the AHRQ website.

The Hospital Survey on Patient Safety Culture Comparative Database (Hospital SOPS Database) consists of data from the Hospital SOPS and may include reportable, non-required supplemental items. Hospitals in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Hospital SOPS Database (OMB NO. 0935-0162, last approved on September 30, 2016) was developed by AHRQ in 2006 in response to requests from hospitals interested in tracking their own survey results. Those organizations submitting data receive a feedback report, as well as a report of the aggregated de-identified findings of the other hospitals submitting data. These reports are used to assist hospital staff in their efforts to improve patient safety culture in their organizations.

Rationale for the Information Collection

The Hospital SOPS and the Hospital SOPS Database support AHRQ's goals of promoting improvements in the quality and safety of health care in hospital settings. The survey, toolkit materials, and database results are all made publicly available on AHRQ's website. Technical assistance is provided by AHRQ through its contractor at no charge to hospitals, to facilitate the use of these materials for hospital patient safety and quality improvement.

This database will:

1. Present results from hospitals that voluntarily submit their data,

2. provide data to hospitals to facilitate internal assessment and learning in the patient safety improvement process, and

3. provide supplemental information to help hospitals identify their strengths and areas with potential for improvement in patient safety culture.

This study is being conducted by AHRQ through its contractor, Westat, 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 surveys and database development. 42 U.S.C. 299a(a)(1) and (8)

Method of Collection

To achieve the goal of this project the following activities and data collections will be implemented:

1. Eligibility and Registration Form—The hospital point-of-contact (POC) completes a number of data submission steps and forms, beginning with the completion of an online Eligibility and Registration Form. The purpose of this form is to collect basic demographic information about the hospital and initiate the registration process.

2. Data Use Agreement—The purpose of the data use agreement, completed by the hospital POC, is to state how data submitted by hospitals will be used and provide privacy assurances.

3. Hospital Site Information Form—The purpose of the site information form, also completed by the hospital POC, is to collect background characteristics of the hospital. This information will be used to analyze data collected with the Hospital SOPS survey.

4. Data Files Submission—POCs upload their data file(s), using hospital data file specifications, to ensure that users submit standardized and consistent data in the way variables are named, coded, and formatted. The number of submissions to the database is likely to vary each year because hospitals do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either a patient safety manager in the hospital or a survey vendor who contracts with a hospital to collect and submit their data. POCs submit data on behalf of 3 hospitals, on average, because many hospitals are part of a health system that includes many hospitals, or the POC is a vendor that is submitting data for multiple hospitals.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 340 POCs, each representing an average of 3 individual hospitals each, will complete the database submission steps and forms annually. Each POC will submit the following:

• Eligibility and registration form (completion is estimated to take about 3 minutes).
• Data Use Agreement (completion is estimated to take about 3 minutes).
• Hospital Information Form (completion is estimated to take about 5 minutes).
• Survey data submission will take an average of one hour.

The total annual burden hours are estimated to be 459 hours. Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $26,572 annually.

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's 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.