Agency Information Collection Activities: Proposed Collection; Comment Request

SUPPLEMENTARY INFORMATION:

Proposed Project

Surveys on Patient Safety Culture® (SOPS®) Ambulatory Surgery Center (ASC) Survey Database

In 1999, the Institute of Medicine called for healthcare 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 healthcare, AHRQ developed and pilot tested the Surveys on Patient Safety Culture® (SOPS®) Ambulatory Surgery Centers (ASC) Survey with OMB approval (OMB No. 0935-0216; approved October 31, 2013).

The SOPS-ASC is designed to enable ASCs to assess provider and staff perspectives about patient safety issues, medical error, and error reporting. The survey includes 27 items that measure 8 composites of patient safety culture. In addition to the composite items, the survey includes one item measuring how often ASCs document near-misses; one item asking whether the respondent is in the room during surgeries, procedures, or treatments; and three items about communication before and after surgeries, procedures, or treatments. The survey also includes an overall rating item on patient safety, two items about respondent characteristics, and a section for open-ended comments. AHRQ made the survey publicly available along with a Survey User's Guide and other toolkit materials in May 2015 on the AHRQ website.

The AHRQ SOPS-ASC Database consists of data from the AHRQ ASC Survey on Patient Safety Culture. Ambulatory surgery centers in the U.S. can voluntarily submit data from the survey to AHRQ, through its contractor, Westat. The SOPS ASC Database (OMB No. 0935-0242; last approved on October 7, 2021; expiration date October 31, 2024) was developed by AHRQ in 2019 in response to requests from ASCs interested in tracking their own survey results. Organizations submitting data receive a feedback report, as well as a report of the aggregated, de-identified findings of the other ASCs submitting data. These reports are used to assist ASC staff in their efforts to improve patient safety culture in their organizations.

The SOPS ASC Survey and the SOPS ASC Database support AHRQ's goals of promoting improvements in the quality and safety of healthcare in ASCs. 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 ASCs, to facilitate the use of these materials for ASC patient safety and quality improvement.

The goals of the SOPS-ASC database are:

(1) Presents results from ASCs that voluntarily submit their data;

(2) Provides data to ASCs to facilitate internal assessment and learning in the patient safety improvement process; and

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

To achieve these goals, the following activities and data collections will be implemented:

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

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

(3) Data Use Agreement—The purpose of the data use agreement, completed by the ASC manager, is to state how data submitted by ASCs will be used and provides confidentiality assurances.

(4) SOPS ASC Survey Data File(s) Submission—POCs upload their data file(s), using the SOPS ASC Survey 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 ASCs do not administer the survey and submit data every year. Data submission is typically handled by one POC who is either an ASC administrative manager or a survey vendor who contracts with an ASC to collect and submit its data.

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 ASC Database is done electronically, except the Data Use Agreement (DUA), which ASCs will print, sign, and return (either via fax, by scanning and emailing or uploading to a secure website, or by mailing back). Registration, submission of ASC information, and data upload is handled online through a secure website. Customized feedback reports will be delivered electronically (the person submitting the data will enter a username and password and will have 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. The total burden is estimated to be 86 hours.

(1) Eligibility and Registration Form —Completed once by 60 ASC POCs. The form takes about 3 minutes to complete.

(2) ASC Site Information —Completed an average of 4 times by the 60 ASC POCs. The form takes 5 minutes to complete.

(3) Data Use Agreement —Completed once by 60 ASC POCs. The form takes about 3 minutes to complete.

(4) SOPS ASC Survey Data File(s) Submission —Each of the 60 POCs will submit their SOPS ASC Survey data. The data submission requires an hour on average to complete.

Exhibit 2 shows the estimated annualized cost burden based on the respondents' time to submit their data. The cost burden is estimated to be $4,386 annually.