Form # 2 Form # 2 Attachment B: Hospital Data Use Agreement

Survey on Patient Safety Culture Database
Data Use Agreement
Instructions
1. Westat has pre-signed this Data Use Agreement (DUA) in its current form. Any changes or
modifications to the DUA other than those required to complete the DUA, such as contact
information, will require review and execution, by both parties, of a new DUA or addendum.
2. Data collection vendors may not sign and submit this DUA on behalf of a health system or
hospital (even if they have been given permission by the health system or hospital to handle the
actual submission of data). Only a duly appointed representative from a health system or hospital
may sign this DUA.
3. Please sign and return this DUA by mail, scanning and emailing, or faxing a signed copy to:
Willow Burns
RB 1121
1700 Research Boulevard
Rockville, MD 20850
Fax: 1-888-852-8277 (toll free)
Phone: 1-888-324-9790 (toll free)
Email: [email protected]

Form Approved
OMB No. 0935-XXXX
Exp. Date XX/XX/20XX

Survey on Patient Safety Culture Database
Data Use Agreement
1.

This Data Use Agreement (DUA) is made by and between Westat and the organization named below (hereinafter termed
“Participating Organization”) as well as any hospitals listed under item 14 on page 3 of this Data Use Agreement
(collectively the “Parties”).
_____________________________________________________________________________

VERY IMPORTANT: Type or write in the name of the Participating Organization above. If more than one hospital is
represented, list the name of the entire health system above, and under item 14 on page 3 of this Data Use Agreement,
LIST THE NAME OF EACH INDIVIDUAL HOSPITAL for which data will be submitted.
2.

This DUA specifies the terms and conditions of Participating Organization’s submission of its Survey on Patient Safety
Culture (SOPS) data to Westat for participation in the SOPS Database (hereinafter termed the “Database”).

3.

The purpose of the Database is to establish a central repository of SOPS survey data to facilitate comparisons across health
care organizations. The Database will be populated with SOPS survey data through the voluntary participation of
organizations that have implemented the SOPS survey and are willing to submit their SOPS survey data to Westat for
inclusion in the Database.
The Database is funded by the Agency for Healthcare Research and Quality (AHRQ) and managed and administered by
Westat, a private research organization under contract with AHRQ. Westat will operate the Database to comply with the
provisions in this DUA. Within this framework, Westat will manage and administer the Database in its discretion, but will
seek and be guided by the advice and counsel of the SOPS Database Technical Expert Panel (TEP) established by Westat
in accordance with its contract with AHRQ to provide input throughout the design, development and administration of the
Database. The TEP consists of 15 representatives knowledgeable about hospital patient safety and quality from hospital
stakeholder organizations and selected health care systems as well as government agencies concerned with hospital heath
care.

4.

Participating Organizations will provide their survey data to the Database for analysis and reporting according to the terms
specified in this DUA. By agreeing to participate in the Database, each Participating Organization agrees to make a good
faith effort to provide data, as specified by the data specifications outlined for the SOPS Database for inclusion in the
Database (collectively referred to as the “Data”), including:
4.1 A copy of the final SOPS survey instrument(s) administered, including copies of paper and/or web-based versions as
applicable, showing all survey instructions and items administered. If more than one version of the SOPS survey was
administered, a copy of the final SOPS survey instrument must be provided with the corresponding results for each
version for which data will be submitted to the Database;
4.2 Participating Organization’s final, respondent-level SOPS survey data, as collected by Participating Organization itself
or by a survey data collection vendor, according to the data specifications outlined for the Database; and
4.3 Selected organizational characteristics data (e.g., facility type, bed size, teaching status, etc.) and background
information related to survey administration (e.g., mode and dates of administration, sample size, response rate, etc.).

5.

Funding for the routine operation of the Database is provided by AHRQ.

Public reporting burden for this collection of information is estimated to average 3 minutes per
response, the estimated time required to complete the survey. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a
currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to: AHRQ
Reports Clearance Officer Attention: PRA, Paperwork Reduction Project (0935-XXXX) AHRQ,
5600 Fishers Lane, Rockville, MD 20857.
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6.

Participating Organization’s Data will be accepted into the Database provided that the version of the SOPS survey
administered by Participating Organization is deemed acceptable by Westat (i.e., not modified substantially from the
original SOPS instructions and items) and the Data submitted by Participating Organization are deemed acceptable. Westat
will promptly notify Participating Organization of any problem with the survey version(s) administered or with the Data
submitted. If the survey version administered is acceptable but the Data submitted are problematic, Westat will make a
good faith effort to work with Participating Organization to complete or correct the Data submission, but reserves the right
to not include incompatible or flawed Data in the Database.

7. Participating Organization’s data files will be aggregated for comparative purposes along with other Participating
Organizations’ Data in the Database. Only Westat and duly authorized representatives appointed by AHRQ will have
access to the source Data provided by Participating Organization.
8. Westat will produce a standard SOPS Database Comparative Report providing aggregate statistics on SOPS survey
composite scores and items across all Participating Organizations and across various subsets of Participating Organizations
(e.g., by facility type, bed size, etc.). Only aggregate data will be reported, and only when there are sufficient data so that
such aggregation will not permit the identification of Participating Organizations by other Participating Organizations or
the public. The Database Report will be made available in the public domain and to Participating Organizations through
electronic media at no charge. The Report will not identify individual Participating Organizations by name.
9. Westat may conduct psychometric analyses of the aggregate data to examine its distributional properties (variability,
missing data, skewness), and to assess the factor structure and reliability of the safety culture dimensions. In any data
analysis reports that may be produced, such reports will not identify individual Participating Organizations by name and
results will only be reported in a manner that will not permit the identification of Participating Organizations.
10. In accordance with the AHRQ confidentiality statute [at 42 USC 299c-3(c)], Westat agrees to establish appropriate and
necessary administrative, technical, and physical procedures and safeguards including limiting access and appropriate staff
training to protect the confidentiality of the Data and to prevent the unauthorized use or access to it.
11. The AHRQ confidentiality statute, Section 944(c) of the Public Health Service Act (42 U.S.C. 299c-3(c)), requires that
data collected by AHRQ or one of its contractors (including Westat) that identify establishments be used only for the
purposes for which the data were supplied. Westat may grant access to Participating Organization’s data files according to
the following provisions:
11.1

Release of De-Identified Hospital SOPS Data: Access to data files that do not identify individuals or
individual Participating Organizations or their associated hospitals and do not permit re-identification may be
granted by AHRQ and Westat without the specific authorization of Participating Organizations whose data are
included as part of the aggregate data files. These data files may include variables describing the Participating
Organization according to types (e.g., teaching status, hospital bed size categorization, profit status, region, etc.).

11.2

Release of Hospital-Identifiable SOPS Data for Research Purposes: AHRQ and Westat periodically receive
requests from researchers interested in linking Hospital SOPS data to other measures, such as patient safety and
quality outcome data. These studies require hospital-identifiable data, or data that can be linked to a specific
hospital through the use of hospital identifiers such as hospital name, hospital address, AHA ID or Medicare
Provider ID.
Valid purposes for using hospital-identifiable SOPS data include research linking such data to outside datasets.
Valid purposes do not include the use of data concerning Participating Organizations for public reporting,
commercial or competitive purposes involving those Participating Organizations, or to determine the rights,
benefits, or privileges of Participating Organizations.
Individuals requesting hospital-identifiable SOPS data (hereinafter termed “Data Requesters”) sign a
Confidentiality Agreement in which they agree with the following requirements. Data Requesters agree that
they: 1) will not release or disclose any hospital-identifiable SOPS data that identifies persons or Participating
Organizations directly or indirectly and will not release, disclose or make public any identifying information
about Participating Organizations at any time in any analyses or summaries of results; 2) will not attempt to
learn the identity of any person included in the hospital-identifiable SOPS data or to contact any such person for
any purpose and will not attempt to contact Participating Organizations for the purpose of verifying information
supplied in the hospital-identifiable SOPS data set; 3) will not use, and will prohibit others from using or

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disclosing, the hospital-identifiable SOPS data except for the purposes specified in their Research Proposal; 4)
will ensure that the hospital-identifiable SOPS data are kept in a secured environment and that only authorized
users will have access to it; and 5) will limit the use of the hospital-identifiable SOPS data to the individuals
who require access in order to perform activities for the purposes specified in the Research Proposal.
11.2.1

To allow for the release of hospital-identifiable SOPS data for valid research purposes as specified in
11.2, AHRQ and Westat have developed three options for Participating Organizations to indicate their
preferences for providing authorization to release such data. Participating Organizations must select
from one of the options below and provide signature in item 15:
Option 1: Selective release of hospital-identifiable SOPS data to specific Data Requesters
provided by written authorization on a case-by-case basis. If Option 1 is selected (this is the
default if no option is selected in item 15), brief research proposals will periodically be provided to
Participating Organizations for review, asking for written authorization to release their hospitalidentifiable SOPS data to specific Data Requesters. Research proposals will have been reviewed and
approved by Westat and AHRQ before being forwarded to Participating Organizations for review.
Option 2: Pre-approval for release of hospital-identifiable SOPS data to all Data Requesters
whose proposals have been reviewed and approved by AHRQ and Westat. If Option 2 is selected,
Participating Organizations will grant authority to AHRQ and Westat to review and evaluate all
research proposals and authorize release of their hospital-identifiable SOPS data to Data Requesters
whose proposals have been deemed acceptable and approved by AHRQ and Westat. By selecting
Option 2, Participating Organizations entrust the release of their hospital-identifiable SOPS data to
Data Requesters approved by AHRQ and Westat per the valid research purposes specified in 11.2.
Option 3: Prohibiting release of all hospital-identifiable SOPS data. If Option 3 is selected, AHRQ
and Westat will not release Participating Organization’s hospital-identifiable SOPS data to anyone,
including researchers. Participating Organization indicates it does not want to be offered research
proposals to review and will not release its hospital-identifiable SOPS data.

11.2.2

At any time, Participating Organizations may request from Westat a list of approved Data Requesters
who have received Participating Organization’s hospital-identifiable SOPS data and obtain a copy of
the research proposals which state their intended uses of the data.

12. Westat agrees to use the Data submitted by Participating Organization only for the purposes stated in this DUA.
13. Westat has signed this DUA in its current form. Any changes or modifications to the DUA other than those required to
complete the DUA, such as contact information, will require review and execution, by both parties, of a new DUA or
addendum.
14. If Participating Organization represents more than one hospital, use the space below to TYPE OR WRITE THE
NAME OF EACH INDIVIDUAL HOSPITAL AND ITS LOCATION (CITY AND STATE) which is represented
Add
by Participating Organization and therefore covered under this Data Use Agreement. Attach additional sheet if
hospitals
necessary.
as
needed
here

NAME OF HOSPITAL REPRESENTED

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LOCATION (CITY & STATE)

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PLEASE SIGN, COMPLETE THE INFORMATION BELOW, AND RETURN ALL PAGES OF THIS DATA USE
AGREEMENT BACK TO WESTAT.
15. DUA signature and options for release of hospital-identifiable SOPS Data for research purposes (described in item
11.2.1). SELECT ONE OPTION AND SIGN BELOW. If no option is selected, Option 1 becomes the default.

□ Option 1(Default option): Selective release of hospital-identifiable SOPS data to specific Data Requesters
Select
one
option

provided through written authorization on a case-by-case basis.

□ Option 2: Pre-approval for release of hospital-identifiable SOPS data to all Data Requesters whose
proposals have been reviewed and approved by AHRQ and Westat.

□ Option 3: Prohibiting release of all hospital-identifiable SOPS data.
By selecting one of the options above, the duly authorized representative consents to the conditions of release of Participating
Organization’s hospital-identifiable SOPS Data under the conditions specified in item 11.2 relevant to the option selected. If no
option is selected, Option 1 becomes the default selection.
The undersigned individual hereby attests that he/she is duly authorized to represent the Participating Organization and all
hospitals listed under item 14, and in so doing, enters into this Data Use Agreement on behalf of the Participating Organization
and the hospitals listed under item 14 and agrees to all the terms specified herein.
Name: _______________________________________________________
Complete
Name,
Title,
and
Sign here

Title: ________________________________________________________
_______________________________________________
(Signature)

______________________________
(Date)

Participating Organization may change or revoke this consent by sending written notification to Willow Burns, Westat, RB
1121, 1700 Research Boulevard, Rockville, MD 20850. The request for revocation will not apply to Data already authorized
and released prior to receipt of your written request to revoke consent.
16. NAME AND ADDRESS OF PARTICIPATING ORGANIZATION CONTACT
Name and address of person from Participating Organization who is the point of contact for this completed DUA.
Complete
as needed

Name of contact (if different from above):______________________________________________________
Title (if different from above): _______________________________________________________________
Address: _______________________________________________________________________________
_______________________________________________________________________________________
_______________________________________________________________________________________
Phone: ___________________

Fax :___________________

Email:_____________________________

The undersigned individual hereby attests that he/she is duly authorized to represent Westat, and, in so doing, enters into this
Data Use Agreement on behalf of Westat and agrees to all the terms specified herein.
W. Sherman Edwards
Vice-President, Associate Director at Westat
Surveys on Patient Safety Culture Project

Data Use Agreement –Survey on Patient Safety Culture Database

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