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.” 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 April 8, 2016, and allowed 60 days for public comment. AHRQ received no substantive comments. 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 21, 2016.

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

Hospital Survey on Patient Safety Culture Comparative Database

In 1999, the Institute of Medicine called for health care organizations to develop a “culture of safety” such that their workforce and processes focus on improving the reliability and safety of care for patients (IOM, 1999; To Err is Human: Building a Safer Health System). To respond to the need for tools to assess patient safety culture in health care, AHRQ developed and pilot tested the Hospital Survey on Patient Safety (SOPS)Culture with OMB approval (OMB NO. 0935-0115; Approved 2/4/2003).

The survey is designed to enable hospitals to assess staff opinions about patient safety issues, medical errors, and error reporting. The survey includes 42 items that measure 12 composites of patient safety culture. AHRQ made the survey publicly available on the AHRQ Web site along with a Survey User's Guide and other toolkit materials in November 2004 (located at http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/hospital/index.html ). Since its release, the survey has been voluntarily used by hundreds of hospitals in the U.S.

The Hospital SOPS Comparative Database consists of data from the AHRQ Hospital Survey on Patient Safety Culture. Hospitals in the U.S. are asked to voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The Hospital SOPS Database (OMB NO. 0935-0162, last approved on September 26, 2013) was developed by AHRQ in 2006 in response to requests from hospitals interested in knowing how their patient safety culture survey results compare to those of other hospitals.

Rationale for the information collection. The Hospital SOPS and the Comparative Database support AHRQ's goals of promoting improvements in the quality and safety of health care in hospital settings. The survey, toolkit materials, and comparative database results are all made publicly available on AHRQ's Web site. 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.

Request for information collection approval. AHRQ requests that the Office of Management and Budget (OMB) reapprove, under the Paperwork Reduction Act of 1995, AHRQ's collection of information for the AHRQ Hospital Survey on Patient Safety Culture (Hospital SOPS) Comparative Database; OMB NO. 0935-0162, last approved on September 26, 2013.

This database will:

(1) Allow hospitals to compare their patient safety culture survey results with those of other hospitals,

(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 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 activities and data collections will be implemented:

(1) Eligibility and Registration Form—The hospital pointofcontact (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 determine the eligibility status and initiate the registration process for hospitals seeking to voluntarily submit their Hospital SOPS data to the Hospital SOPS Comparative Database.

(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 provides confidentiality assurances.

(3) Hospital Site Information Form—The purpose of the site information form is to obtain basic information about the characteristics of the hospitals submitting their Hospital SOPS data to the Hospital SOPS Comparative Database (e.g. number of providers and staff, ownership, and teaching status). The hospital POC completes the form.

(4) Data Files Submission—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 manager or a survey vendor who contracts with a hospital to collect its 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.

Survey data from the AHRQ Hospital Survey on Patient Safety Culture is used to produce three types of products: (1) A Hospital SOPS Comparative Database Report that is produced periodically and made publicly available on the AHRQ Web site (see http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/hospital/hosp-reports.html ); (2) Individual Hospital Survey Feedback Reports which are confidential, customized reports produced for each hospital that submits data to the database (the number of reports produced is based on the number of hospitals submitting each year); and (3) Research data sets of individual-level and hospital-level, de-identified data to enable researchers to conduct analyses.

Hospitals are asked to voluntarily submit their Hospital SOPS survey data to the comparative database. The data are then cleaned and aggregated and used to produce a Comparative Database Report that displays averages, standard deviations, and percentile scores on the survey's 42 items and 12 composites of patient safety culture, as well as displaying these results by hospital characteristics (bed size, teaching status, ownership) and respondent characteristics (hospital work area, staff position, and those with direct interaction with patients). In addition, trend data, showing changes in scores over time, are presented from hospitals that have submitted to the database more than once.

Data submitted by hospitals are used to give each hospital its own customized survey feedback report that presents its results compared to the latest comparative database results. If the hospital submits data in two consecutive database submission years, its survey feedback report also presents trend data, comparing its previous and most recent data.

Hospitals use the Hospital SOPS, Comparative Database Reports and Individual Hospital Survey Feedback Reports for a number of purposes, to:

• Raise staff awareness about patient safety.
• Diagnose and assess the current status of patient safety culture in their hospital.
• Identify strengths and areas for improvement in patient safety culture.
• Examine trends in patient safety culture change over time.
• Evaluate the cultural impact of patient safety initiatives and interventions.
• Facilitate meeting Joint Commission hospital accreditation standards in Leadership that require a regular assessment of hospital patient safety culture.
• Compare patient safety culture survey results with other hospitals in their efforts to improve patient safety and quality.

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 304 POCs, each representing an average of 3 individual hospitals each, will complete the database submission steps and forms annually. The POCs typically submit data on behalf of 3 hospitals, on average, because many hospitals are part of a multi-hospital system that is submitting data, or the POC is a vendor that is submitting data for multiple hospitals. Completing the registration form will take about 3 minutes. The Hospital Information Form is completed by all POCs for each of their hospitals (304 × 3 = 912). The total annual burden hours are estimated to be 410.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $21,801 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 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.