Form #2 Form #2 Medical Office SOPS Database Data Use Agreement

Attachment C

Medical Office Survey on Patient Safety Culture Database

Data Use Agreement

Instructions

1. The language contained in this agreement cannot be edited or altered in any form without permission.

2. Data collection vendors may not sign and submit this Data Use Agreement on behalf of a health system, practice, or Medical Office (even if they have been given permission by the health system or Medical Office to handle the actual submission of data). Only a duly appointed representative from a health system, practice, or Medical Office may sign this Data Use Agreement.

3. Please return this signed Data Use Agreement by mail, or fax a signed copy to:

Dawn Nelson

Westat

RA 1161

1600 Research Boulevard

Rockville, MD 20850

Fax: 1-888-852-8277 (toll free)

Phone: 1-888-324-9790 (toll free)

Email: DatabasesOnSafetyCulture@ahrq.hhs.gov

4. Once the Data Use Agreement is accepted it will be signed by Westat and we will mail a signed copy back to you.

M

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

edical Office 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”) which includes any medical offices listed under item 11 on page 2 of this Data Use Agreement.

_________________________________________________________________________________

Name of Medical Office (or Health System/Practice Name if more than one medical office is included in this DUA)

_________________________________________________________________________________

Street Address of Medical Office (or Health System/Practice main location)

_________________________________________________________________________________

City State Zip Code

VERY IMPORTANT: Type or write in the name of the Participating Organization above. If more than one medical office location is represented, list the name of the overall health system or practice above, and under item 11 on page 2 of this Data Use Agreement, IDENTIFY EACH INDIVIDUAL MEDICAL OFFICE LOCATION for which data will be submitted.

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

3. The purpose of the Database is to establish a central repository of MO SOPS survey data to facilitate comparisons across medical offices. The Database will be populated with MO SOPS survey data through the voluntary participation of medical offices that have implemented the MO SOPS survey and are willing to submit their MO SOPS survey data to Westat for inclusion in the Database.

The Database is funded by the Agency for Healthcare Research and Quality (AHRQ) under a contract and the Database is 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 using its discretion as necessary, and it 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 contractual obligations, to obtain Panel input throughout the design, development and administration of the Database. The TEP consists of 12 representatives knowledgeable about hospital, medical office, and nursing home patient safety and quality from various health care organizations, professional societies, and research institutions, as well as government agencies concerned with patient safety and health care.

4. Participating Organizations will provide their MO SOPS 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 below, for inclusion in the MO SOPS Database (this data being collectively referred to as the “Data”), including:

a) A copy of the final MO 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 MO SOPS survey was administered, a copy of each MO SOPS survey instrument administered must be provided with the corresponding results for each version of the survey instrument for which data is submitted;

b) Participating Organization’s final, respondent-level MO 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

3. Selected organizational characteristics data (e.g., ownership, medical specialties represented etc.) and background information related to survey administration (e.g., mode of survey administration, dates of administration, sample size, response rate, etc.).

5. Westat agrees to establish appropriate and necessary administrative, technical, and physical procedures and safeguards to protect the data. Only Westat and duly authorized representatives appointed by AHRQ will have access to the identifiable source data provided by Participating Organization. In addition, Westat will ensure appropriate staff training to protect the confidentiality of the identifiable data and to prevent unauthorized access to it and any unauthorized use of it.

6. Participating Organization’s Data will be accepted into the Database provided that the version of the MO SOPS survey administered by Participating Organization is deemed acceptable by Westat (i.e., not modified substantially from the original MO SOPS instructions and items). Westat will promptly notify the Participating Organization of any problem, if any, 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 the 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. Westat will produce an MO SOPS Comparative Database Report providing aggregate statistics on MO SOPS survey composite scores and items across all Participating Organizations and across various subsets of Participating Organizations (e.g., ownership, medical specialties represented, etc.). The Report will not identify individual Participating Organizations by name. 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 to Participating Organizations and the public through electronic media and at no charge. The Database Report will be in the public domain and may be reproduced without permission.

8. 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.

9. Westat may grant access to Participating Organization’s data files for health care research purposes approved by AHRQ and in accordance with the AHRQ confidentiality statute [at 42 USC 299c-3(c)], according to the following provisions:

1. Access to aggregate data files that do not identify individual Participating Organizations or permit reidentification may be granted by 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., ownership, medical specialties represented, etc.), provided the variables do not permit reidentification.

2. Access to data files specific to an identifiable Participating Organization may be approved only with the express written authorization of the Participating Organization whose data files are requested. Researcher analyses of the data files provided to researchers under these provisions and containing any identifying information, may not be released, disclosed or made public by the researchers without the express written authorization of any Participating Organizations that may be identified in the published research analysis.

10. Westat agrees to use the Data submitted by Participating Organization only for the purposes stated in this agreement.

11. If Participating Organization represents more than one medical office, use the space below to TYPE OR WRITE THE NAME OF EACH INDIVIDUAL MEDICAL OFFICE AND ITS ADDRESS, CITY AND STATE which is represented by Participating Organization and therefore covered under this Data Use Agreement. Attach additional sheet if necessary.

NAME OF MEDICAL OFFICE(S) REPRESENTED ADDRESS, CITY & STATE

PLEASE SIGN, COMPLETE THE INFORMATION BELOW, AND FAX OR MAIL ALL PAGES OF THIS DATA USE AGREEMENT BACK TO WESTAT.

The undersigned individual hereby attests that he/she is duly authorized to represent the named Participating Organization(s) and all medical offices listed under item 11, and in so doing, enters into this Data Use Agreement on behalf of the Participating Organization and the medical offices listed under item 11 and agrees to all the terms specified herein.

Name: _______________________________________________________

Title: ________________________________________________________

_______________________________________________ ______________________________

(Signature) (Date)

Name and address of person from Participating Organization who should be sent the completed Data Use Agreement once it is signed by Westat:

Name of contact (if different from above):____________________________________________

Title (if different from above): _____________________________________________________

Address: ______________________________________________________________________

______________________________________________________________________________

______________________________________________________________________________

Phone number: _________________________________

Fax number: ___________________________________

Email address: ___________________________________________

THIS SECTION TO BE COMPLETED BY WESTAT AFTER IT RECEIVES PARTICIPATING ORGANIZATION’S COMPLETE AND SIGNED DATA USE AGREEMENT.

The undersigned individual hereby attests that he/she is duly authorized to represent Westat in entering into this Data Use Agreement and in agreeing to all the terms specified herein on their behalf.

W. Sherman Edwards

Vice President, Westat

___________________________________________

(Signature)

___________________________________________

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, 540 Gaither Road, Room # 5036, Rockville, MD 20850.

(Date)