Form 2 Attachment B: Pharmacy Database Data Use Agreement

Pharmacy 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 pharmacy corporate office, health system, or pharmacy (even if they have been given permission by the pharmacy corporate office, health system, or pharmacy to handle the actual submission of data). Only a duly appointed representative from a pharmacy corporate office, health system, or pharmacy may sign this Data Use Agreement.

3. Please sign and return a copy of your DUA via:

   1. Email [email protected],

   2. Fax 1-888-852-8277,

   3. Upload to https://sopsdatabase.ahrq.gov/DB/, or

   4. Mail

AHRQ Surveys on Patient Safety Culture Databases

Westat

1600 Research Boulevard

Rockville, MD 20850

1-888-324-9790 (toll free)

1. Please retain a copy of the fully signed and executed DUA for your records.

1. This Data Use Agreement (DUA) is made by and between Westat and the organization named below (hereinafter termed “Participating Organization”) which includes any pharmacies listed under item 13 on page 3 of this Data Use Agreement.

_________________________________________________________________________________

Name of Participating Organization (Pharmacy or Corporate Office/Health System if more than one

pharmacy is included in this DUA)

_________________________________________________________________________________

Street Address of Participating Organization (Pharmacy or Corporate Office/Health System)

_________________________________________________________________________________

City State Zip Code

VERY IMPORTANT: Type or write in the name of the Participating Organization above. If more than one pharmacy location is represented, list the name of the corporate office or overall health system above, and under item 13 on page 3 of this Data Use Agreement, IDENTIFY EACH INDIVIDUAL PHARMACY LOCATION for which data will be submitted.

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

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

The Database is funded by the Agency for Healthcare Research and Quality (AHRQ) 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 representatives knowledgeable about hospital, medical office, nursing home, and pharmacy 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 Pharmacy 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 Database (this data being collectively referred to as the “Data”), including:

a) A copy of the final Pharmacy 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 Pharmacy SOPS survey was administered, a copy of each Pharmacy 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 Pharmacy 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

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 (0935-0218) AHRQ, 5600 Fishers Lane, Rockville, MD 20857.

3. Selected organizational characteristics data (e.g., pharmacy type, average number of prescriptions per week, 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 including limiting access to the Data and providing appropriate staff training to protect the confidentiality of the Data and to prevent the unauthorized use of it or access to it. Only Westat and duly authorized representatives appointed by AHRQ will have access to the identifiable source Data provided by Participating Organization.

6. Participating Organization’s Data will be accepted into the Database provided that the version of the Pharmacy SOPS survey administered by Participating Organization is deemed acceptable by Westat (i.e., not modified substantially from the original Pharmacy SOPS instructions and items) and the Data submitted by Participating Organization are deemed acceptable. Westat will promptly notify the 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 along with other Participating Organizations’ Data in the Database. Westat will produce a Pharmacy SOPS Database Report providing aggregate statistics on Pharmacy SOPS survey composite scores and items across all Participating Organizations and across various subsets of Participating Organizations (e.g., pharmacy type, average number of prescriptions per week, 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 Report will not identify individual Participating Organizations by name. The Database Report will be made available publicly and to Participating Organizations through electronic media at no charge.

8. Westat may conduct analyses of the Data to examine its distributional properties (variability, missing data, skewness), to assess the factor structure and reliability of the safety culture composites, and examine relationships with organizational characteristics data. 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. 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:

1. Access to respondent and organization level data files that do not identify or permit re-identification of individual respondents or Participating Organizations may be granted by Westat without the specific authorization of Participating Organizations whose Data are included as part of the data files. These data files may include variables describing the Participating Organization according to types (e.g., pharmacy type, average number of prescriptions per week, etc.), provided the variables do not permit re-identification of individual respondents or Participating Organizations.

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. 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.

3. Valid purposes for pharmacy de-identifiable and pharmacy identifiable SOPS data 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.

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

11. 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.

12. Participating Organization may change or revoke this consent by sending written notification to the AHRQ Surveys on Patient Safety Culture User Network, Westat, 1600 Research Boulevard, Rockville, MD 20850. Requests for changes or

revocations must be received within 2 weeks of the current year’s data submission deadline to be excluded from the current year’s database and all reporting for that year.

Add pharmacies as

needed

here

13. If Participating Organization represents more than one pharmacy, use the space below to TYPE OR WRITE THE NAME OF EACH INDIVIDUAL PHARMACY AND ITS ADDRESS, CITY AND STATE which is represented by Participating Organization and therefore covered under this Data Use Agreement. Include store or location numbers as needed. Attach additional sheet if necessary.

NAME OF PHARMACIES REPRESENTED ADDRESS, CITY & STATE

14. PLEASE SIGN, COMPLETE THE INFORMATION BELOW, AND RETURN ALL PAGES OF THIS DATA USE AGREEMENT BACK TO WESTAT.

The undersigned individual hereby attests that he/she is duly authorized to represent the Participating Organization(s) and all pharmacies listed under item 13, and in so doing, enters into this Data Use Agreement on behalf of the Participating Organization and the pharmacies listed under item 13 and agrees to all the terms specified herein.

_Complete

Name,

Title,

and

Sign here

Name: _______________________________________________________

Title: ________________________________________________________

_______________________________________________ ______________________________

(Signature) (Date)

14. 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 number: _________________________________

Fax number: ___________________________________

Email address: ___________________________________________

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.

David M. Maklan

Sr. Vice President, Study Area Director at Westat

Surveys on Patient Safety Culture Project