Supporting Statement Part A 0720-0034_2015-0921

Supporting Statement Part A 0720-0034_2015-0921.doc

Department of Defense (DoD) Patient Safety Culture Survey

OMB: 0720-0034

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OMB—SUPPORTING STATEMENT – PART A

DEPARTMENT OF DEFENSE PATIENT SAFETY CULTURE SURVEY

A.  JUSTIFICATION

1.  Need for the Information Collection

This data collection effort is being 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 is comprised of approximately 55 MTF hospitals and over 360 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 Army, Navy and Air Force 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 plans to implement 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 and overall perceptions of patient safety. The purpose of the survey is to assess the current status of patient safety in MHS facilities as well as to provide baseline input for assessment of patient safety improvement over time.

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 that was publicly released in November 2004, and the Medical Office Survey on Patient Safety Culture to assess patient safety culture in the outpatient (clinic/ambulatory) setting, publicly released in 2011. 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)1, 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.

2.  Use of the Information

The DoD Patient Safety Culture Survey will be critical to evaluate and better assess the needs of MHS facilities to promote patient safety culture. Survey results will be prepared at the facility and Service levels, as well as MHS overall. 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 improvements the survey will provide an overview of the status of Service and MHS patient safety to higher leadership, who can then appropriately allocate the necessary resources and tools to decrease medical errors and improve safety.

3.  Use of Information Technology

The web-based survey, using Results for Research software, will be administered on a voluntary basis to all staff working in Army, Navy and Air Force MHS direct care CONUS and OCONUS facilities, including MTF hospitals and ambulatory and dental services. Responses and respondents will remain anonymous. There are two versions of the survey that may be administered, corresponding to the setting in which care is delivered, either Hospital (inpatient) or Medical Office (outpatient/clinic setting). Individuals will be invited by email and provided a generic link to the web survey. There will be no hard copy surveys administered. 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

There are no other data available that can be used for the purposes of obtaining staff views on patient safety culture, medical error and error reporting from facilities MHS-wide. This data will provide much-needed information to evaluate and better assess the needs of MHS facilities to support a safer environment for MHS patients and beneficiaries.

5.  Burden on Small Business

Only staff from MHS facilities will be surveyed. The 10-minute web survey can be completed at any time during or after work. There is no anticipated impact on small businesses.

6.  Less Frequent Collection

If the proposed data collection is not approved, it will hinder the DoD PSP from its mission to identify actual and potential problems within the MHS. Perhaps more importantly, it will make it difficult to evaluate and assess the needs of MHS facilities to support a safer environment for MHS patients and beneficiaries. It will not be possible to examine trends between the previous administrations of the survey to see if improvements exist in the system, or identify areas where the DoD PSP and each of the Services might focus their efforts to mitigate safety risks. Without administering the Medical Office version of the survey, the information collected may not be as relevant to identifying improvement opportunities in the clinic and outpatient settings.

7.  Paperwork Reduction Act Guidelines

There are no special circumstances that require the collection to be conducted in a manner inconsistent with the guidelines delineated in 5 CFR 1320.5(d)(2).

8.  Consultation and Public Comments

a. Any public comments received in response to the notice and actions taken in response were summarized after the notice has appeared in the Federal Register Vol.79, No. 107, pg. 32237. No comments were received.

b. Extensive consultation was conducted during the development and pilot testing of the two survey versions. Both versions were piloted and validated by AHRQ with university professors, hospital and medical office stakeholders and patient safety experts.

In late 2004, AHRQ piloted the hospital version and gathered data from over 1,200 staff across 21 hospitals. After data analysis, the survey was revised and the final survey (which has been previously administered in this data collection within MHS facilities in 2005, 2008 and 2011) has demonstrated reliability and validity.i

In the 2005 and 2008 previous DoD survey administrations, individuals working in clinics were surveyed using the Hospital version. Qualitative analysis conducted on the DoD 2008 survey data indicated that individuals working in the outpatient/clinic setting did not find the hospital version as relevant to their work, and DoD’s experience was not unique: the civilian sector expressed the need for an outpatient/clinic focused version of the survey as well, prompting AHRQ to sponsor the development of a Medical Office focused version of the survey. In late 2007, AHRQ completed the survey design of the initial outpatient version and conducted pilot testing in more than 200 medical offices. From the pilot, AHRQ gathered data from more than 4,100 survey responses across the nation. Using the pilot results, the survey was refined to assure that items and dimensions in the Medical Office Survey on Patient Safety Culture had sound psychometric properties.ii The medical office survey was used in 2011 within Air Force clinics. From November 2011 and November 2013, over 935 medical offices and 27,103 medical office staff respondents submitted their survey data to AHRQ, which comprises the AHRQ medical office comparative database (http://www.ahrq.gov/professionals/quality-patient-safety/patientsafetyculture/medical-office/2014/mosurv14sum.html). As previous done in the DoD 2011 administration, the DoD will benchmark its medical office results using the AHRQ comparative database, offering MHS clinics the opportunity to compare its data with the civilian sector’s data.

9.  Gifts or Payment

No payments or gifts will be provided to respondents.

10.  Confidentiality

No individual identifiers will be used during data collection so all individual survey responses will be anonymous. Respondents will be asked on the web survey to indicate which MTF site they work in to allow feedback results to be grouped according to MTF. Smaller MTF clinics with 20 or fewer staff will be grouped together so respondents will only be asked to indicate if they work in one of the MTFs listed within the group. In this way, individual anonymity can still be maintained at sites with few staff. All survey responses will be collected through a secure survey web site hosted by the contracted vender. Only aggregated group survey results will be delivered to MHS facilities. Information from previous surveys is retained for the purpose of comparing data and trending with the most recent administration of the survey. As previously stated, no identifiers are collected.

11.  Sensitive Questions

Respondents will be asked to respond to questions about the work environment of their MHS facility and the specific department in which they work. There are no questions of a particularly sensitive nature. The survey is voluntary and there will be no negative consequences for staff that do not complete the survey.

12.  Respondent Burden, and its Labor Costs

a.  Estimation of Respondent Burden

There are a total of approximately 154,000 CONUS and OCONUS MHS staff (estimate from FY2014 TRICARE Report to Congress). Of these staff, approximately 23,100 staff members (about 15 percent) are contractors, local nationals, volunteers or other MHS staff who are not direct employees of the DoD. Since Office of Management and Budget (OMB) approval is required only for the non-DoD staff component, we provide estimates of the respondent burden for only these non-DoD MHS staff. With approximately a 60 percent response rate goal, we anticipate responses from approximately 14,022 non-DoD MHS staff to complete the survey. There is one response per applicant. The estimated time for completing the survey is 10 minutes. The estimated annual burden is provided below.

b.  Labor Cost of Respondent Burden

The affected public are CONUS and OCONUS MHS staff who are not direct employees of the DoD (e.g., contractors, local nationals, volunteers, other non-DoD MHS staff). This comes out to about 15 percent or 14,022 non-DoD MHS staff to complete the survey. The frequency of response is 1; therefore the total annual response is 14,022. The completion time per response is approximately 10 minutes. Therefore the total burden hours are 2,337 hours.

Since the collection requires 10 minutes per respondent and we project 14,022 surveys, the total burden hours are 2,337. Total estimated cost is $27.66 x 2,337 = $64,641.

(Wage of Respondent $27.66) * (10/60) * 14,022 respondents = $64,641.42.

13.  Respondent Costs Other Than Burden Hour Costs

Respondents will not be asked to maintain any records. No additional equipment purchases will be made to support data collection processes or record keeping.

14.  Cost to the Federal Government

The total cost to the government for conducting the one-time web survey data collection is approximately $322,853, which includes the cost of government oversight, program planning and management, web survey development, data collection, analysis and feedback report preparation and delivery. The estimated cost of only the web data collection component is $300,000, which includes labor costs, fringe expenses, administrative expenses and costs associated with web survey development, testing and implementation.

15.  Reasons for Change in Burden

The change in the overall burden stated in OMB Form 83-I reflect an adjustment in the number of potential eligible respondents, 154,000. This number was retrieved from The 2014 TRICARE Report to Congress. It reported 154,000 MHS total staff and of that 23,100 staff members (about 15 percent) are contractors, local nationals, volunteers or other MHS staff who are not direct employees of the DoD. By using an approximate 60 percent expected response rate, we come to a total of 14,022 non-DoD MHS staff to complete the survey. The change neither reflects a change in the actual instrument nor time estimated for a respondent to complete the survey.

16.  Publication of Results

The data collected will be used for internal DoD use only and there are no current plans for outside publication of results.

17.  Non-Display of OMB Expiration Date

The expiration date of the OMB approval will be displayed on the web survey.

18.  Exceptions to "Certification for Paperwork Reduction Submissions"

The proposed data collection does not involve any exceptions to the certification statement identified in line 19 of OMB Form 83-I. As required, the following information – the Agency Disclosure Notice - will be prominently displayed on the web survey:

“The public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to the Department of Defense, Washington Headquarters Services, Executive Services Directorate, Information Management Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100 (0720-0034). Respondents should be aware that notwithstanding any other provision of law, no person shall be subject to any penalty for failing to comply with a collection of information if it does not display a currently valid OMB control number.”



1 The QuIC is comprised of representatives from 11 Federal agencies: Department of Health and Human Services, Labor, Defense, Veterans Affairs, Commerce, Office of Management and Budget, Office of Personnel Management, U.S. Coast Guard, Federal Bureau of Prisons, National Highway Transportation Safety Administration, Federal Trade Commission.


i http://www.ahrq.gov/qual/patientsafetyculture/hospsurvindex.htm

ii http://www.ahrq.gov/qual/patientsafetyculture/mosurvindex.htm



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AuthorPatricia Toppings
Last Modified ByFrederick Licari
File Modified2015-09-21
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