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FBO DAILY - FEDBIZOPPS ISSUE OF DECEMBER 25, 2014 FBO #4779
DOCUMENT

A -- MIRECC Research Data Collection, Database Creation and Management Services - Attachment

Notice Date

12/23/2014
 

Notice Type

Attachment
 

NAICS

541711 — Research and Development in Biotechnology
 

Contracting Office

Department of Veterans Affairs;VAMC (512);VISN 5 Contract Satellite Office;209 West Fayette Street, Suite 605-618;Baltimore, Maryland 21201
 

ZIP Code

21201
 

Solicitation Number

VA24515R0038
 

Response Due

1/12/2015
 

Archive Date

3/13/2015
 

Point of Contact

Suma T. Legesse
 

E-Mail Address

512)<br
 

Small Business Set-Aside

N/A
 

Description

Statement of Work Mental Illness Research Education Clinical Center (MIRECC) Dr. Richard Goldberg, Director Veterans Administration 10 N. Greene Street, Annex Baltimore Maryland 21201 Period of Performance: February 1, 2015 to January 31, 2015 Agreement: 1.Scope of Work: This contract reflects the tasks associated with the bioinformatics support for the VA VISN 5 Mental Illness Research, Education and Clinical Center (MIRECC) research investigators. The vendor will 1) create data elements for research studies; 2) create acceptable data forms for data collection utilizing a paper or web based system; and 3) maintain the HIPAA compliant database(s) for data related to all MIRECC Investigator research projects. 2.Background: The MIRECC research investigators must have a system and process to collect and store research participant data. This process and the database was created through an earlier contract/agreement with the University of Maryland, Department of Epidemiology and Public Health, Bioinformatics Core (BC) who now maintains active ongoing MIRECC research data in a database. 3.Objectives: This Statement of Work describes data collection, database creation and management services defined as follows: a.Creation and maintenance of study specific data dictionary to include naming conventions, definitions and ranges for data dictionary items; b.Implementation of the database will include development of relational data tables to accommodate each data component; c.Ensure the full capability of entering data thru a web based or paper system (TeleForm Application, Redcap, etc.) to scan, review, validate, edit, and approve data items prior to entry into the system; d.Maintain the HIPAA compliant de-identified database server, its operating system and software related to the system; e.Maintain strict standards for granting users access to its servers and systems. 4.Work Requirements: The contractor shall perform the following functions: a. Maintenance of study database- i.The vendor will maintain the HIPAA compliant database(s) for data related to all MIRECC Investigator research projects which will include the following tasks: 1.The vendor will create a data dictionary that provides details about each data item and acceptable ranges and limits of these items. These items will be in a format suitable to provide adequate documentation for the MIRECC staff to develop reports or conduct data analyses. The MIRECC staff will provide naming conventions, definitions and ranges for data dictionary items to the vendor staff, if available. If no definitions are available, the vendor will develop these after consultation with MIRECC personnel. 2.The implementation of the database will include development of relational data tables to accommodate each data component. The vendor will set up a link that will allow Statistical Analysis System (SAS), Statistical Package for the Social Sciences (SPSS), Excel or Access to directly access read only, de-identified study data from the database to MIRECC staff who have been granted rights by the Principle Investigator (PI) or Co-PI. The MIRECC PI or Co-PI will determine who has access to this link and then provide the vendor with documentation (form provided by the vendor) of HIPAA and VA training compliance. The vendor will create views such that identified MIRECC staff will have read rights to de-identified data pertaining to each study according to the roles that are set for study personnel. Study personnel roles will be determined by the Principal Investigator for each study. 3.Specifically for each project, the vendor will create views such that the MIRECC staff may access specific data sets that are held in the database via software specifically created by the vendor. The interface will have unique components in consultation with VA regulations and HIPAA compliant security. 4.The vendor will attend information exchange meetings as needed. MIRECC staff will contact any outside data coordination centers directly for specifications of data management requirements or regulations for this project. The MIRECC staff will be responsible for informing the vendor staff of these specifications. 5.The vendor staff will be available by appointment to any authority identified by MIRECC staff for audit of the study database. ii.Management of records 1.The vendor will ensure the full capability of entering data thru a web based or paper system (TeleForm Application, Redcap, etc.) to scan, review, validate, edit, and approve data items prior to entry into the system. The MIRECC staff will be responsible for having access to IBM compatible computers, with a minimum of Windows XP operating system. 2.The vendor will be available during normal working hours (8:00am to 4:30pm) to assist MIRECC staff with operational issues. In the event that the system becomes inoperable, the vendor will investigate and repair problems in the system at no cost to the VA. 3.The vendor will also provide the ability to view an electronic image (which can be printed for source document) of the data collection forms to help resolve errors or problems. The vendor will provide these if MIRECC staff do not have the appropriate equipment. b.Data - The MIRECC data stored in the database shall not contain any of the 18 HIPPAA Protected Health Information (PHI) elements, nor any other data that can be construed as identifiable singularly or in conjunction with other variables. The link file that contains the connection between the identifying number used to store data in the database and personally identifying information will be kept behind the VA firewall by MIRECC staff. c.Design and development of scan able forms - i.The vendor will develop data collection forms (web or paper based) according to specifications provided by MIRECC staff. The vendor may use existing templates in the development of study-specific forms. The development of forms may include up to three sessions for review of draft forms and amendments to the forms. ii.The vendor will have in place procedures for testing the data collection form before it goes into production and will provide documentation of this to the MIRECC investigator upon request. The vendor will perform quality control procedures to test the accuracy of the first 10 records of each new table to verify that the data is going in correctly. If the MIRECC staff responds with corrected data via QC reports, the vendor will implement the corrections bringing the error rate closer to 0%. d.Systems Support - The vendor staff will also provide the following support: i.House and provide internet-based access to the de-identified database for MIRECC staff; ii.Maintain the HIPAA compliant de-identified database server, its operating system and software related to the system; iii.Maintain the HIPAA compliant study database, implement user accounts, and maintain daily database backups; iv.Provide access to MSQL Server and MySQL tools needed to support the above information management functions; v.Provide access to a central TeleForm server that will digitize and verify data entered at a web page, sent by fax, or paper forms and send this data to the database; vi.Provide a contact during normal working hours that will be able to troubleshoot problems in the system and bring the system back on line, if necessary; and vii.Provide access to periodic reports (Excel spreadsheets) on the accumulation of records in a table at intervals determined by the MIRECC investigator or staff. e.The vendor agrees to provide a high standard of professional service and perform the aforementioned tasks within the time and funds available for the center. The vendor also agrees to maintain, as confidential, all information furnished by MIRECC staff and designated as such, except for any information that is already in the public domain. f.Quality Standards - The vendor will maintain strict standards for granting users access to its servers and systems. i.A user will be granted an account in the research database and access to a particular protocol only through written authorization of the principal investigator (PI) for the study, or their designated administrator. Every PI or administrator maintains full control over the list of users and roles in the database related to their protocol. ii.The research database will use Oracle 10 g database management system (DBMS) and reside on a secure server behind a firewall in a special HIPPAA user's zone. Backups will be made daily and each month a backup tape will be stored in a secure off-site location. iii.Security measures to prevent unauthorized access, including mandatory periodic password changes and automatic logoff from inactive connections will be part of the system. iv.All changes to data collected on the study forms will be restricted to specific personnel. An audit log will be maintained which contains the previous value, the new value and the reason for the change. 5.Description of Tasks and Associated Deliverables - a.Task 1 - Staff Access List - The vendor will provide to the Contract Officer's Representative (COR) a list of all study protocols by Principal Investigator with all individuals who have been granted secure access to each study. Any corrections due to new staff or staff departure will be addressed by the COR with the PI or Co-PI, then with the vendor. b.Task 2 - Research Study Specific Database Setup - Creation and maintenance of study specific data dictionary, implementation of the database, and form validation (3.a-c). The MIRECC investigator must approve of the research specific data dictionary, database and form validation prior to invoice being approved by the COR. c.Task 3 - Maintain the HIPAA compliant de-identified database server, its operating system and software related to the system. d.Each invoice submitted for tasks above must include at least the following information: i.Contract Number ii.Task Name and Number iii.Invoice Number and Date iv.Invoice Cost v.Performance Start and End Dates 6.Deliverable Schedule DescriptionRequirementsDelivery Date Task 1 - Staff Access ListThe vendor shall provide to the COR a report of all individuals who have electronic access to each MIRECC study. The report shall include study name, PI, employee name, and date the employee was granted/removed access.Quarterly Task 2 - Research Study Specific Database SetupThe vendor shall develop research study -specific database in compliance with SOW (teleform, data dictionary, data table, etc.)Within 60 days of request to the vendor Task 3 - Database Maintenance The vendor shall maintain the research study database in a HIPPA compliant environment and provide verification that all aspects required in the SOW are being met. Quarterly
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAMHCS512/VAMHCS512/VA24515R0038/listing.html)
 

Document(s)

Attachment
 

File Name: VA245-15-R-0038 VA245-15-R-0038_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1787586&FileName=VA245-15-R-0038-002.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1787586&FileName=VA245-15-R-0038-002.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03603932-W 20141225/141223235018-b10eb6c0cae454ddda83b1c04ffe1756 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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