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 an extension of the currently approved information collection project: “ Medical Office Survey on Patient Safety Culture Database. ” In accordance with the Paperwork Reduction Act of 1995, AHRQ invites the public to comment on this proposed information collection.

DATES:

Comments on this notice must be received by September 30, 2024.

ADDRESSES:

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

FOR FURTHER INFORMATION CONTACT:

Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at REPORTSCLEARANCEOFFICER@ahrq.hhs.gov.

SUPPLEMENTARY INFORMATION:

Proposed Project

Medical Office Survey on Patient Safety Culture 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 Surveys on Patient Safety Culture® (SOPS®) Medical Office Survey with OMB approval (OMB NO.0935-0131; Approved July 5, 2007).

The survey is designed to enable medical offices to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The survey includes 38 items that measure 10 composites of patient safety culture. In addition to the composite items, 14 items measure staff perceptions of how often medical offices have problems exchanging information with other settings as well as other patient safety and quality issues. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in January 2009, on the AHRQ website.

The AHRQ SOPS Medical Office Database consists of data from the AHRQ Medical Office Survey on Patient Safety Culture and may include reportable, non-required supplemental items. Medical offices in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The SOPS Medical Office Database (OMB NO. 0935-0196, last approved on September 24, 2021) was developed by AHRQ in 2011 in response to requests from medical offices 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 medical offices submitting data. These reports are used to assist medical office staff in their efforts to improve patient safety culture in their organizations.

The goal of the Medical Office Survey on Patient Safety Culture Database is to promote improvements in the quality and safety of healthcare in medical office 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 medical offices, to facilitate the use of these materials for medical office patient safety and quality improvement.

This database:

(1) Presents results from medical offices that voluntarily submit their data,

(2) Provides data to medical offices to facilitate internal assessment and learning in the patient safety improvement process, and

(3) Provides supplemental information to help medical offices identify their strengths and areas with potential for improvement in patient safety culture.

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

(1) Eligibility and Registration Form—The medical office point-of-contact (POC) completes several 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 medical office and initiate the registration process.

(2) Medical Office Site Information Form—The purpose of the site information form, also completed by the medical office POC, is to collect background characteristics of the medical office. This information will be used to analyze data collected with SOPS Medical Office Survey.

(3) Data Use Agreement—The purpose of the data use agreement, completed by the medical office POC, is to state how data submitted by medical offices will be used and provides privacy assurances.

(4) Data File(s) Submission—POCs upload their data file(s), using the medical office data file specifications, to ensure that users submit their data in a standardized way ( e.g., variable names, order, coding, formatting).The number of submissions to the database is likely to vary from submission period to submission period because medical offices do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either an office manager or a survey vendor who contracts with a medical office to collect their data. POCs submit data on behalf of 20 medical offices, on average, because many medical offices are part of a health system that includes many medical office sites, or the POC is a vendor that is submitting data for multiple medical offices.

This study is being conducted by AHRQ through its contractor, Westat, pursuant to AHRQ's statutory authority to conduct and support research on healthcare and on systems for the delivery of such care, including activities with respect to: the quality, effectiveness, efficiency, appropriateness and value of healthcare services; quality measurement and improvement; and database development. 42 U.S.C. 299a(a)(1), (2), and (8).

Method of Collection

All information collection for the SOPS Medical Office Database is done electronically, except the Data Use Agreement (DUA) that medical offices print, sign and return (either via fax, by scanning and emailing or uploading to a secure website, or by mailing back). Registration, submission of medical office information, and data upload is handled online through a secure website. Customized feedback reports are delivered electronically (the person submitting the data will enter a username and password for access to a secure website from which to download their reports).

Estimated Annual Respondent Burden

Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in the database. An estimated 85 POCs, each representing an average of 30 individual medical offices each, will complete the database submission steps and forms. Each POC will submit the following:

1. Eligibility and Registration Form—Estimated to take 3 minutes to complete.

2. Medical Office Site Information Form—Estimated to take 5 minutes to complete.

3. Data Use Agreement—Estimated to take 3 minutes to complete.

4. Survey Data File(s) Submission—Estimated to take 1 hour to complete.

The total burden is estimated to be 308 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 $19,891 annually.

Request for Comments

In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, 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.