0720-0034_ssa_9.24.2024

0720-0034_SSA_9.24.2024.docx

Defense Health Agency Patient Safety Culture Survey

OMB: 0720-0034

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SUPPORTING STATEMENT - PART A

DEFENSE HEALTH AGENCY PATIENT SAFETY CULTURE SURVEY

OMB Control Number: 0720-0034

Summary of Changes from Previously Approved Collection


  • Revisions to instruments

    • Hospital and Medical Office Patient Safety Culture Surveys: The Agency for Healthcare Research and Quality (AHRQ) versions have not changed, but due to changes in the supplemental questions relevant to the Defense Health Agency the total number of additional questions has decreased from 11 to 10.

  • Survey title change

    • The survey title will change from “Department of Defense Patient Safety Culture Survey” to “Defense Health Agency Patient Safety Culture Survey”

  • Respondent burden

    • The respondent burden has not changed in reality, but this document is now capturing active duty and civilian personnel in addition to the contractor personnel who were accounted for in the burden for the last extension of the OMB Control Number.

  • Frequency of survey

    • The survey frequency has changed from every 2-3 years to every 2 years in order to meet external reporting requirements and to align with updates to DHA policy.



1. Need for the Information Collection

The Defense Health Agency (DHA) Patient Safety Culture Survey data collection effort is conducted in response to a task order from the Office of the Assistant Secretary of Defense for Health Affairs (IAW DoDI 6025.13) and DHA (IAW DHA PM 6025.13 Volume 2). Part of the DHA 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 medical treatment facility (MTF) within the DHA. The DHA Headquarters PSP must recommend effective actions to improve patient safety and health care quality throughout the direct care system, which comprises approximately 49 MTF hospitals and 465 ambulatory clinics. In support of its mission, the DHA Headquarters 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 MTFs in both the Continental United States (CONUS) and internationally (OCONUS) to assess the status of patient safety culture in DHA 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 teamwork in the provision of health care” (item d4).

As an ongoing response to this legislation, DHA Headquarters has implemented a web-based patient safety culture survey to obtain DHA staff opinions on patient safety issues. MTF participation in the DHA Patient Safety Culture Survey fulfills The Joint Commission (TJC) accreditation requirements related to assessing patient safety culture and using the results to improve. As part of its Leadership Standards, TJC requires facility leaders regularly evaluate the culture of safety and quality using valid and reliable tools and prioritize and implement changes identified by the evaluation.

Additionally, DHA inpatient MTFs recently began participating in The Leapfrog Hospital Safety Grade (hospitalsafetygrade.org), an initiative that provides a letter grade rating of a hospital’s patient safety measures through more than 30 national performance indicators. Each indicator reflects errors, accidents, injuries, and infections, as well as the systems hospitals have in place to prevent patient harm. This enables all hospitals, including military, to publicly report their progress in quality and safety. DHA is the first federal health system to participate in the Leapfrog Hospital Safety Grade program. Participation in the DHA Patient Safety Culture Survey provides MTFs with data and information assessed by The Leapfrog Group as part of the Hospital Safety Grade calculation.

The purpose of the survey is to assess the current status of patient safety culture and workforce burnout in all DHA MTFs, provide baseline input for assessment of patient safety culture and workforce well-being improvement over time, and benchmark culture results to the Agency for Healthcare Research and Quality (AHRQ) national database. The survey examines patient safety culture and workforce burnout from a hospital staff and clinic perspective. The survey results are then used to:

  • Raise staff awareness about patient safety and workforce burnout,

  • Assess the current status and trends over time of patient safety culture and workforce well-being,

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

  • Identify strengths and areas for improvement in patient safety culture and staff well-being,

  • Identify key drivers associated with positive scores and improvements in patient safety and workforce burnout,

  • Benchmark results to AHRQ national database,

  • Evaluate the cultural impact of patient safety and workforce well-being 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, civilian, and contractors) working in DHA CONUS and OCONUS facilities, including MTF hospitals and ambulatory and dental services. Responses and respondents will remain anonymous. Those at DHA Headquarters will not be participating in the survey, given they do not directly provide patient care.


There are approximately 139,600 total eligible survey respondents which includes military staff, active duty, and civilian employees, assigned to MTFs throughout CONUS and OCONUS. Of these personnel, approximately 23,000 (about 16%) are contractors, local nationals, volunteers, or other civilian DHA (non-Headquarters) staff who are not direct employees of the DoD. Based upon the historical overall response rate of approximately 33%, we anticipate 46,068 total completed responses with approximately 7,370 of those completed surveys resulting from those who are not direct employees of the DoD (contractors, local nationals, volunteers, other non-DoD DHA (non-Headquarters) 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 and ambulatory clinic staff who have direct contact or interaction with patients (clinical staff, such as nurses, or nonclinical staff, such as unit clerks);

  • Hospital and ambulatory clinic 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, 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 and ambulatory clinic supervisors, managers, and administrators.


Respondents answer this survey as it provides an opportunity to provide anonymous feedback on culture and leadership in MTFs that accounts for safety and well-being of patients and staff alike. Every individual working within an MTF provides a unique perspective on how DHA can deliver safe care to patients and direct feedback from staff helps raise awareness about patient safety and staff well-being, helps leadership prioritize changes to provide better care, and fosters a resilient workforce.

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 2021, the total number of questions has decreased by one (due to changes to the supplemental questions relevant to the DHA context modified 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 DHA context, the total number of questions has increased by one.


The original 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 several different dimensions pertaining to patient safety culture, has demonstrated reliability and validity and will provide the DoD with actionable information about patient safety culture in the military medical treatment facilities. As with the previous 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 well-being.


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 and QR code to the survey hosted on a Zogby Analytics survey platform (Zogby Analytics is the contractor supporting this survey effort and has purchased a survey platform from Creative Research Systems.) This is the same vendor/survey platform DHA has used for fielding of the last iteration of this survey that was reinstated by OMB in 2021 and DHA has conducted other Enterprise-wide surveys with this contractor. Because of the sensitivity of the survey topic, the DHA Headquarters Patient Safety Program places emphasis on anonymity; to ensure this anonymity, each MTF is responsible for distributing the survey link and QR code 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. DHA (Headquarters and Networks) 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 and QR code 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 DHA Patient Safety Culture Survey is critical to evaluate the needs of DHA facilities to promote patient safety culture and workforce well-being. The purpose of the Patient Safety Culture Survey is to measure the culture of patient safety and workforce burnout 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 MTF level, including at work area and staff positions within the facility. 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 DHA patient safety culture and staff burnout to higher leadership, who can then appropriately allocate the resources and tools to decrease medical errors and improve safety.


3. Use of Information Technology

All (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 will occur once every two years. DHA will now administer the survey every two years to align with the national standard, to improve the timeliness of patient safety culture information for policy and program development, and to meet requirements for public reporting of Leapfrog Hospital Safety Grade. In past years it was every two to three years. As per AHRQ’s recommendation: On average, hospitals that have submitted to the Hospital Survey on Patient Safety Culture Database more than once readminister the survey every 24 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.


As stated above, all individual MTFs will participate in the DHA Patient Safety Culture Survey every two years to meet Leapfrog reporting requirements. As part of continuous performance improvement in the MTFs, an individual MTF may voluntarily choose to administer an MTF-level culture survey in the alternate year in which the DHA Patient Safety Culture Survey is not administered by the DHA Headquarters. Local continuous performance improvement efforts are expected by The Joint Commission (TJC) – the DHA MTF accreditor organization. Furthermore, this will allow the MTFs to evaluate effectiveness of their culture improvement activities implemented in response to their DHA Patient Safety Culture Survey results.


For the off-year patient safety culture assessments for performance improvement, only nationally recognized tools/survey instruments that are psychometrically tested and shown to be valid and reliable in peer-reviewed literature may be used. MTF participation in any surveys that are part of a clinical quality management and improvement program external to DHA must be approved by Director, DHA in accordance with DoDI 6025.13 (July 26, 2023).


MTFs may modify these tools only per published guidelines. Additionally, MTFs may choose to use selected composite questions from the DHA Patient Safety Culture Survey and other AHRQ supplemental item sets as well as burnout items from the DHA Patient Safety Culture Survey per guidelines that will be provided by DHA. Some examples of the potential surveys that may be used in the alternate year include: TeamSTEPPS Teamwork Perceptions Questionnaire (TTPQ), Patient Safety Climate for Healthcare Organizations, Safety Attitudes Questionnaire, SCORE/SCORE II, Press Ganey Safety Culture Survey, Microsoft Viva Glint Patient Safety Survey, Gallup Patient Safety Culture Survey, and Perceptyx Safety Culture Survey. Survey selection must align with DHA strategy and policy. To reiterate, only the DHA Patient Safety Culture Survey data will be used by the DHA Patient Safety Program Office for Leapfrog Hospital Safety Grade requirements.


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 Thursday, June 20, 2024. The 60-Day FRN citation is 89 FR 51873.

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

August 2, 2024


Department of Defense


Dear Department of Defense


Please - create a change for migrant and citizen veterans


This proposition caught my eyes quite quickly. It is very important that veterans are taken care of emotionally, physically, mentally and spiritually. It’s heartbreaking to know that a majority of homeless persons are veterans and those that served the country. Executive Director, VA Homeless Programs Office by Monica Diaz stated on December 15, 2023 stated, “The data showed that on a single night in January 2023, there were 35,574 Veterans who experienced homelessness in the U.S. This reflects a 7.4% increase in the number of Veterans experiencing homelessness from 2022.” This goes to show that the care and thoughtfulness towards those that risked their lives and their freedom for our safety are close to nonexistent.


This raised so much concern for me because although my husband is a migrant, he’s a exmilitary man from Haiti. Also, there are many migrants that I know that are veterans and they’re not respected in the community. I believe those that served their country that made it to the United States should have some kind of asset or benefit dedicated specially to them. As human beings, anyone that gave their life for another should always be established and honored. This establishment shouldn’t just be hone once a year, it should always be done at every hour and minute. As stated by ye draft, “Secretary shall “continue research and development investments to improve communication, coordination, and teamwork in the provision of health care.” This will a great addition to society, it’ll be a move towards the correct direction.


Sincerely,


Ivonia [Last name redacted]

[Personal e-mail address redacted]


Department Response: While we appreciate the sentiment of this comment, it is not relevant to the DHA Patient Safety Culture Survey as our survey is of DoD medical providers regarding the culture within MTFs.

A 30-Day Federal Register Notice for the collection published on Monday, September 23, 2024. The 30-Day FRN citation is 89 FR 77501.

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:

As applicable, records will be maintained in accordance with the following records disposition schedules:


FILE NUMBER: 905-02

FILE TITLE: Quality Assurance Studies and Analyses of Healthcare Quality Standards

FILE DESCRIPTION: Files pertaining to the quality assurance analysis of DoD, other federal agency, State and local, and other healthcare standards including studies and analyses that result in issuance of new standards.

DISPOSITION: Permanent. Cut off upon completion of standard. Transfer to NARA 25 years after cutoff.

AUTHORITY: NC1-330-77-005, item 905-02a and 905-02c


FILE NUMBER: 905-03

FILE TITLE: Ad Hoc Quality Assurance Studies and Analyses of Healthcare Quality

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

DISPOSITION: Temporary. Cut off upon completion of study. Destroy 5 years after cutoff.

AUTHORITY: NC1-330-77-005, item 905-02b



11. Sensitive Questions


No questions considered sensitive are being asked in this collection.


12. Respondent Burden and its Labor Costs


Part A: ESTIMATION OF RESPONDENT BURDEN


  1. Collection Instrument:

Patient Safety Culture Survey

    1. Number of Respondents: 30,965

    2. Number of Responses Per Respondent: 1

    3. Number of Total Annual Responses: 30,965

    4. Response Time: 10 minutes

    5. Respondent Burden Hours: 5,161


  1. Total Submission Burden

    1. Total Number of respondents: 30,965

    2. Total Number of Annual responses: 30,965

    3. Total Respondent Buren Hours: 5,161


Part B: LABOR COST OF RESPONDENT BURDEN


  1. Collection Instrument:

Patient Safety Culture Survey

    1. Number of Total Annual Responses: 30,965

    2. Response Time: 10 minutes

    3. Respondent Hourly Wage: $37.58

    4. Labor Burden per Response: $6.26

    5. Total Labor Burden: $193,944



  1. Overall Labor Burden

    1. Total Number of Annual Responses: 30,965

    2. Total Labor Burden: $193,944


The respondent hourly wage was determined by using May 2023 U.S. Bureau of Labor Statistics Wage Data for Contractor and Other estimates (https://www.bls.gov/oes/current/oes_nat.htm#00-0000).

Active Duty Military respondents were determined by using 2024 Active Duty Monthly Pay

(https://militarypay.defense.gov/Portals/3/Documents/ActiveDutyTables/2024%20Pay%20Table-Capped-FINAL.pdf) and Reservists were determined using 2024 Military Pay Charts (https://www.military.com/benefits/military-pay/charts).

Civilian government employee pay was determined by using 2024 GS Salary Table (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2024/GS.pdf).


The below tables show the estimated respondent hourly wages broken down by Staff Type, (based on how the survey results are reported out), as well as their labor burden per response. The third table shows the expected number of respondents for each Staff Type, based on 2022 results and historic survey iterations. These are the estimates used to come up with the averages and totals computed above.


Active Duty Officer were calculated using O-5, 10 years of service; Active Duty Enlisted were calculated using E-5, 10 years of service; and Reservists were calculated using E-5, 10 years of service. GS personnel were calculated using GS-8, Step 5.



Staff Type

Hourly Rate

Military - Active duty - Officer

$52.81

Military - Active duty - Enlisted

$25.31

Civilian - Government employee

$27.97

Government Contractor

$49.07

Volunteer

$31.48

Other

$31.48



Staff Type

Labor Burden per Response

Military - Active duty - Officer

$8.98

Military - Active duty - Enlisted

$4.30

Civilian-Government employee

$4.75

Civilian-Contractor

$8.34

Volunteer

$5.35

Other

$5.35



Staff Type

Expected # of Respondents

Total Labor Burden per Staff Position

Military - Active duty - Officer

6,473

$58,127.54

Military - Active duty - Enlisted

6,398

$27,511.40

Civilian - Government employee

10,724

$50,939.00

Government Contractor

6,000

$50,040.00

Volunteer

370

$1,979.50

Other

1,000

$5,350.00



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


Part A: LABOR COST TO THE FEDERAL GOVERNMENT


  1. Collection Instrument(s)

Patient Safety Culture Survey

  1. Number of Total Annual Responses: 30,965

  2. Processing Time per Response: 0 hours

  3. Hourly Wage of Worker(s) Processing Responses: $0

  4. Cost to Process Each Response: $0

  5. Total Cost to Process Responses: $0


  1. Overall Labor Burden to the Federal Government

    1. Total Number of Annual Responses: 30,965

    2. Total Labor Burden: $0


Labor cost to the government calculated based on government oversight of the contract who will be conducting this survey as $30,336.80. All processing is performed by the contractor and are captured in the “other” contract cost in Part B below.


Part B: OPERATIONAL AND MAINTENANCE COSTS


  1. Cost Categories

    1. Equipment: $0

    2. Printing: $0

    3. Postage: $0

    4. Software Purchases: $0

    5. Licensing Costs: $0

    6. Other: The contract cost for conducting this survey is $630,000.


Total Operational and Maintenance Cost: $630,000.


Part C: TOTAL COST TO THE FEDERAL GOVERNMENT


  1. Total Labor Cost to the Federal Government: $30,336.80


  1. Total Operational and Maintenance Costs: $630,000.00


  1. Total Cost to the Federal Government: $660,337



15. Reasons for Change in Burden


The survey burden appears to have increased on paper because we are including all respondents (active duty, civilian, contractor) in this package whereas the last iteration of OMB Control Number reinstatement only included contractor personnel in the burden estimate. Estimates in burden here also reflect the most recent iterations of the survey.


16. Publication of Results


The results of this information collection will not be published in the public domain.


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.



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