0720-0034_ss-a_11.29.2021

SUPPORTING STATEMENT - PART A

DEPARTMENT OF DEFENSE PATIENT SAFETY CULTURE SURVEY

OMB Control Number: 0720-0034

Summary of Changes from Previously Approved Collection

• Title Change:

  • Agency for Healthcare Research and Quality (AHRQ) Hospital Survey on Patient Safety Culture (HSOPS) 2.0 (previously 1.0)

• Revisions to instruments

  • HSOPS 2.0: The 2.0 version assesses many of the same areas of patient safety culture as HSOPS 1.0, but changes were made to the survey, including re-wording questions and reducing the number of questions. Compared to the last version, which was approved by OMB in 2019, the total number of questions has decreased by six (including supplemental questions relevant to the MHS context added by DHA)

  • Medical Office Survey on Patient Safety Culture: The AHRQ version has not changed, but due to changes in the supplemental questions relevant to the MHS context, the total number of questions has increased by three

1. Need for the Information Collection

The Department of Defense Patient Safety Culture Survey (PSCS) data collection effort is conducted in response to a task order from the Office of the Assistant Secretary of Defense for Health Affairs, Department of Defense (DoD), Defense Health Agency (DHA). Part of the DoD Patient Safety Program’s (PSP’s) mission is to identify and analyze reports on actual and potential problems within the medical systems and processes in each military treatment facility (MTF) within the Military Health System (MHS). The DoD PSP must recommend effective actions to improve patient safety and health care quality throughout the MHS, which comprises approximately 49 MTF hospitals and 465 ambulatory clinics. In support of its mission, the PSP is seeking reinstatement of the OMB control number to administer a web-based patient safety culture survey to a census of staff working in MHS facilities in the Continental United States (CONUS) and internationally (OCONUS) to assess the status of patient safety culture in MHS facilities worldwide.

The 2001 National Defense Authorization Act (NDAA) Section 754 addresses patient safety in military and Veteran’s health care systems (http://www.dod.mil/dodgc/olc/docs/2001NDAA.pdf). The legislation states that the Secretary of Defense (SECDEF) shall establish a patient care error reporting and management system to study occurrences of errors in patient care and that one of the purposes of the system should be “to identify systemic factors that are associated with such occurrences” and “to provide for action to be taken to correct the identified systemic factors” (items b2 and b3). In addition, the legislation states that the SECDEF shall “continue research and development investments to improve communication, coordination, and team work in the provision of health care” (item d4).

As an ongoing response to this legislation, DoD has implemented a web-based patient safety culture survey to obtain MHS staff opinions on patient safety issues such as teamwork, communication, medical error occurrence and response, error reporting, workplace burnout, and overall perceptions of patient safety. The purpose of the survey is to assess the current status of patient safety in MHS facilities, provide baseline input for assessment of patient safety improvement over time, and benchmark results to the Agency for Healthcare Research and Quality (AHRQ) measures. The survey examines patient safety culture from a hospital staff and clinic perspective. The survey results are then used to:

• Raise staff awareness about patient safety,

• Assess the current status of patient safety culture,

• Identify strengths and areas for patient safety culture improvement,

• Identify key drivers associated with high ratings and improvements in patient safety,

• Benchmark results to AHRQ measures,

• Assess levels of workplace burnout and empowerment to improve efficiency,

• Evaluate the cultural impact of patient safety initiatives and interventions,

• Conduct comparisons within and across organizations,

• And examine support levels in leadership.

2. Use of the Information

Who respondents are and why they are responding:

The web-based survey will be administered on a voluntary basis to all staff (military and civilian) working in MHS direct care CONUS and OCONUS facilities, including MTF hospitals and ambulatory and dental services. Responses and respondents will remain anonymous.

There are approximately 139,600 total eligible survey respondents which includes MHS staff, military and civilian employees, assigned to military health facilities throughout CONUS and OCONUS. Of these personnel, approximately 23,000 (about 16%) are contractors, local nationals, volunteers or other civilian MHS staff who are not direct employees of the DoD. Based upon the historical overall response rate of approximately 35%, we anticipate 48,860 total completed responses with approximately 7,820 of those completed surveys resulting from those who are not direct employees of the DoD (contractors, local nationals, volunteers, other non-DoD MHS staff). The survey takes about 10 minutes to complete.

The survey will be completed by all types of medical staff—from housekeeping and security to nurses and physicians, including:

• Hospital staff who have direct contact or interaction with patients (clinical staff, such as nurses, or nonclinical staff, such as unit clerks);

• Hospital staff who may not have direct contact or interaction with patients but whose work directly affects patient care (e.g., staff in units such as pharmacy, laboratory/pathology);

• Hospital-employed physicians or contract physicians who spend most of their work hours in the hospital (e.g., emergency department physicians, hospitalists, pathologists) and physicians in outpatient settings with hospital privileges; and

• Hospital supervisors, managers, and administrators.

Respondents answer this survey as it provides an opportunity to provide anonymous feedback on culture and leadership in MHS facilities that accounts for safety and wellbeing of patients and staff alike. Every individual working within an MTF provides a unique perspective on how the MHS can deliver safe care to patients and direct feedback from staff helps raise awareness about patient safety matters and helps leadership prioritize changes to provide better care.

Collection Instrument and Format:

There are two validated versions of the survey to be implemented, the Agency for Healthcare Research and Quality (AHRQ) Hospital Survey on Patient Safety Culture (HSOPS 2.0), publicly released in 2019, to assess patient safety culture in the hospital setting and the Medical Office Survey on Patient Safety Culture, publicly released in 2011, to assess patient safety culture in the outpatient (clinic/ambulatory) setting. In an effort to reduce respondent burden and improve the survey instrument, AHRQ released the 2.0 version of the Hospital Survey in 2019. The 2.0 version assesses many of the same areas of patient safety culture as HSOPS 1.0, but changes were made to the survey, including re-wording questions and reducing the number of questions. Compared to the last version, which was approved by OMB in 2019, the total number of questions has decreased by six (including supplemental questions relevant to the MHS context added by PSP). The AHRQ Medical Office Survey instrument has not changed since the 2011 release, but due to changes in the supplemental questions relevant to the MHS context, the total number of questions has increased by three.

The development and testing of this patient safety culture survey was funded by AHRQ and sponsored by the DoD as an agency member of the Quality Interagency Coordination Task Force (QuIC), along with ten other Federal agencies. This survey was chosen because it measures a number of different dimensions pertaining to patient safety culture, has demonstrated reliability and validity and will provide the DoD with actionable information about MHS patient safety. As with the previous MHS iteration of the survey, this iteration will include supplemental items determined to be priority areas by PSP leadership. The additional items focus on leadership support, staff burnout, and wellbeing.

The survey will be provided as a web survey. There will be no hard copy surveys administered.

How respondents access, complete and return the collection instrument

Individuals will be invited by email and provided a generic link to the survey hosted on a Zogby Analytics survey platform. Because of the sensitivity of the survey topic, the Patient Safety Program places emphasis on anonymity; to ensure this anonymity, each MTF is responsible for distributing the survey link to staff members rather than the contractor receiving a sampling frame and distributing survey invitations. Each MTF reports the total number of staff eligible to take the survey so that a response rate can be calculated, but no demographic information or any other characteristics are provided.

Once the web survey is completed, respondents must press submit and close their browser. The survey has been submitted when respondents see the message “Your response has been collected. You may now close your browser.”

Invitations and Communications

The PSCS Survey Administration follows the standard invitation and communications protocol to encourage high response rates:

1. Pre-notification email. DoD and/or local MTF leadership (such as the Patient Safety Manager) emails staff at each MTF a pre-notification letter telling them about the upcoming survey and alerting them that they will soon receive an invitation to complete the Web survey. This pre-notification may include a statement of support from DoD leadership. This notification may be complemented with printed flyers and supportive communication from leadership.

2. Survey invitation email. The survey invitation email is sent a few days after sending the pre-notification email. Included is the hyperlink to the Web survey (or instructions for accessing the survey on the hospital intranet). Instructions are provided about whom to contact for help accessing and navigating the survey.

3. Follow-up communications. Email reminders are sent strategically during the fielding period to encourage response. In the message, we thank those who have already completed the survey and encourage others to do so. A maximum of six (6) email reminders will be distributed.

Communication materials are included with this submission.

Handling and Processing of Completed Survey Instruments:

A response is completed and returned through the survey website, and the survey manager (Zogby Analytics) processes the returns in accordance with Data Sharing Agreement protocols. Upon completion of survey fielding, survey data is extracted and processed using SPSS software.

All responses will be collected electronically. Individuals will be invited by email and provided a generic link to the web survey. No personally identifiable information is collected via this survey. Responses and respondents will remain anonymous.

End Result of a Successful Data Collection Effort:

The DoD Patient Safety Culture Survey is critical to evaluate the needs of MHS facilities to promote patient safety culture. The purpose of the Survey on Patient Safety Culture is to measure the culture of patient safety at individual facilities. We therefore consider each facility to be a separate site for the purposes of survey administration and providing facility-specific feedback via results reports.

Survey results will be prepared at the facility and MHS levels. Facilities will benefit by being given the opportunity to receive feedback about their staff’s responses to the survey, which will provide insight into their strengths and areas for improvement. Additionally, the survey will provide an overview of the status of MTF and MHS patient safety to higher leadership, who can then appropriately allocate the resources and tools to decrease medical errors and improve safety.

3. Use of Information Technology

100% of responses will be collected electronically. The survey will be administered electronically, and no hard copy surveys will be administered. The web-based survey, using software by Creative Research Systems, will be administered on a voluntary basis to all staff working MHS direct care CONUS and OCONUS facilities, including MTF hospitals and ambulatory and dental services. Using a web-based survey will accommodate the domestic and international survey dissemination, shorten the field period necessary for data collection and decrease the need for data cleaning since only valid responses can be entered and automatic storage of responses can occur in an electronic database.

4. Non-duplication

The information obtained through this collection is unique and is not already available for use or adaptation from another cleared source.

5. Burden on Small Businesses

This information collection does not impose a significant economic impact on a substantial number of small businesses or entities.

6. Less Frequent Collection

This data collection occurs once every three years, which is less frequent than AHRQ’s recommendation that the surveys be conducted every 20 months. This is the most infrequent collection interval possible to maintain relevant and timely information on the culture of patient safety in hospitals and clinics that is used as inputs into policy and program decisions. If the data collection occurred less frequently, leadership would be lacking relevant information for managing patient safety efforts. The cadence of the data collection is designed to minimize burden on respondents.

7. Paperwork Reduction Act Guidelines

This collection of information does not require collection to be conducted in a manner inconsistent with the guidelines delineated in 5 CFR 1320.5(d)(2).

8. Consultation and Public Comments

Part A: PUBLIC NOTICE

A 60-Day Federal Register Notice (FRN) for the collection published on Tuesday, August 24, 2021. The 60-Day FRN citation is 86 FRN 47302-47303.

One comment was received during the 60-Day Comment Period. It is included below as well as our Agency’s response to the comment.

COMMENT:

I think the proposed information is necessary for a proper performance from the agency. To enhance the quality of the information I think shortening and clarifying your research would be more beneficial and understandable for your readers. By also posting your information to different platforms, it will also allow a wider audience of readers to reach your proposal and support it. I suggest creating a short clip or video that demonstrates or

discusses your proposal and the reasons why others should support it. I also think if you want to reach a younger audience try reaching out on platforms such as Instagram/Twitter. From personal experience I follow many update pages that discuss petitions, bills, new laws, ad government mandates, or simply topics that should be more known by others. By reaching out to these pages I think you can bring more awareness to your ideas, which will get more youth support behind your petition. If you want to reach out to a middle aged audience I suggest maybe Facebook or a podcast that discusses politics/government. I think this proposal is very important and should be supported by more, especially families of veterans/military. By discussing patient safety in veterans/military in the health care system, we are able to take into a careful consideration the people who have served our country and provide them with the care they need. Thank you!

2021-18132

AGENCY RESPONSE:

This is an internal survey to be completed by hospital and medical office staff in the military treatment facilities. The reports will be available for Military Health System and facility leadership in order to understand the patient safety culture in their facility and develop tailored action planning based on their results. Since this is not a public survey, the promotional materials and results are not posted to social media or similar platforms, and are only intended for those military health personnel. The reports will include executive summaries that provide high level findings, to aid in the comprehension of the data.

A 30-Day Federal Register Notice for the collection published on Friday, November 26, 2021. The 30-Day FRN citation is 86 FRN 67454.

Part B: CONSULTATION

No additional consultation apart from soliciting public comments through the 60-Day Federal Register Noticed was conducted for this submission.

9. Gifts or Payment

No payments or gifts are being offered to respondents as an incentive to participate in the collection.

10. Confidentiality

A Privacy Act Statement is not required for this collection because we are not requesting individuals to furnish personal information for a system of records.

A System of Record Notice (SORN) is not required for this collection because records are not retrievable by PII.

A Privacy Impact Assessment (PIA) is not required for this collection because PII is not being collected electronically.

Records Retention and Disposition:

Records will be maintained in accordance with the following approved schedule:

• Subject: Quality Assurance Studies and Analyses of Healthcare Quality.

• Description: Studies and evaluations on a "when required" basis, not resulting in issuance of new standards.

• Disposition: Destroy when 5 years old.

• OSD RCS Series #: 905-02.2

• NARA Authority: NC1-330-77-5

11. Sensitive Questions

No questions considered sensitive are being asked in this collection.

12. Respondent Burden and its Labor Costs

As the Medical Office and Hospital surveys are similar in length, one combined estimate is provided in the subsections below

Part A: ESTIMATION OF RESPONDENT BURDEN

1. Collection Instrument: Hospital and Medical Office Surveys on Patient Safety Culture

   1. Number of Respondents: 7,820

   2. Number of Responses Per Respondent: 1

   3. Number of Total Annual Responses: 7,820

   4. Response Time: 0.16 hours

   5. Respondent Burden Hours: 1,251 hours

2. Total Submission Burden

   1. Total Number of respondents: 7,820

   2. Total Number of Annual responses: 7,820

   3. Total Respondent Buren hours: 1,251 hours

Part B: LABOR COST OF RESPONDENT BURDEN

1. Collection Instrument: Hospital and Medical Office Surveys on Patient Safety Culture

   1. Number of Total Annual Responses: 7,820

   2. Response Time: 0.16 hours

   3. Respondent Hourly Wage: $44.88

   4. Labor Burden per Response: $7.18

   5. Total Labor Burden: $56,148

2. Overall Labor Burden

   1. Total Number of Annual Responses 7,820

   2. Total Labor Burden $56,148

The Respondent hourly wage was determined by using Bureau of Labor Statistics Wage Data (https://www.bls.gov/bls/blswage.htm).

13. Respondent Costs Other Than Burden Hour Costs

There are no annualized costs to respondents other than the labor burden costs addressed in Section 12 of this document to complete this collection.

14. Cost to the Federal Government

a. Labor Cost to the Federal Government

The total cost to the government for conducting the annual web survey data collection is approximately $594,000 in contract costs which includes the cost of government oversight, program planning and management, web survey development, data collection, analysis and feedback report preparation and delivery.

b. Operational and Maintenance Costs

1. Equipment: $0

2. Printing: $0

3. Postage: $0

4. Software Purchases: $0

5. Licensing Costs: $0

6. Other: $0

7. Total: $0

1. Total Operational and Maintenance Costs: $ 0.00

2. Total Labor Cost to the Federal Government: $594,000.00

3. Total Cost to the Federal Government: $594,000.00

15. Reasons for Change in Burden

The survey burden has changed (declined) from when the survey was last approved in 2018 is due to an estimated lower response rate this iteration. The response rate estimate is based on the response rate from 2018.

16. Publication of Results

The results of this information collection will not be published.

17. Non-Display of OMB Expiration Date

We are not seeking approval to omit the display of the expiration date of the OMB approval on the collection instrument.

18. Exceptions to “Certification for Paperwork Reduction Submissions”

We are not requesting any exemptions to the provisions stated in 5 CFR 1320.9.