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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 07, 2018 FBO #6132
DOCUMENT

Q -- IRB MANAGER PROTOCOL COMPLIANCE WEB-BASED SERVICES - Attachment

Notice Date

9/5/2018
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

US Department of Veterans Affairs;Veterans Health Administration;Service Area Office (SAO) East;323 North Shore Drive, Suite 500;Pittsburgh PA 15212-5319
 

ZIP Code

15212-5319
 

Solicitation Number

36C24E18Q9556
 

Response Due

9/11/2018
 

Archive Date

11/10/2018
 

Point of Contact

Contracting Officer: Michael Haydo
 

Small Business Set-Aside

Service-Disabled Veteran-Owned Small Business
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number 36C24E18Q9556 is issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92. This requirement will be made using a cascading set-aside under the associated NAICS code 621511 with a small business size standard of $32.5 Million. The full solicitation document is included as an attachment to this notice; to include: a list of contract line items, a Description of requirements for the items to be acquired, SOW/PWS, Date(s) and place(s) of delivery, and applicable clauses and provisions. This system will support multiple VA investigators to provide IRB Manager Support Services. SPECIFIC REQUIREMENT Contractor shall provide a web-based research protocol management system for electronic document management and web-based protocol sharing of electronic protocol submissions and reviews. The system shall include the ability to electronically sign documents in compliance with CFR Title 21. System shall allow for utilization of Customers current forms and workflows and provide the following: Unlimited usage and accessibility via World Wide Web. Hosting web interface: 24-hr security, long-term storage, automated backups, multiple fiber carriers, more than one power grid, FIPS 140.2 compliant and 508 compliant. Access for an unlimited number of users. User accounts shall be password protected. Facilitates self-registration with approval by VA. Access to protocol information to be limited to study personnel, research administrative staff, committee reviewers/members and research compliance officer with access control regulated by VA. Full review of research protocols required by the following review boards: Research & Development Committee (R&DC) Institutional Review Board (IRB) Sub Committee for Research Safety (SRS) Financial Conflict of Interest (FCOI) Institutional Animal Care & Use Committee (IACUC) Institutional Biosafety Committee (IBC) Tracking of JJP research protocols submitted and approved by VA Central IRB shall allow for upload of protocol, approved letters, and other relevant correspondence for the Central Institutional Review Board (CIRB) Ability to add review committees as changing needs require. Unlimited smart form wizards for committees that are designed and implemented internally by JJP VAMC Research Service. Wizards shall include VA defined fields with questions that are dynamic in nature and shall direct the user to subsequent questions or additional forms based on the information provided. Questions shall not be repeated throughout any of the wizards. Information compiled from the combination of wizards shall be organized and documented in a clear and concise manner that enables reviewers and committee members to easily interpret the information provided. Reports based on these form wizards shall be accessible by Research Service Administration Staff and have the capability to be queried by or restricted to specific date intervals, investigators, project types, performance locations, or other relevant attributes as determined by said staff. Request to Review Research Proposal Wizard Shall assign Protocol number for all new research proposals, this number will be utilized by all committees for the life of the protocol. Shall include basic protocol information to include, study title, study staff, type of research being conducted, funding source, funding administrator, and performance sites. Questions shall gather basic information about the research staff and their responsibilities so as to determine the additional training and/or credentialing that may be required. Wizard shall be able to identify any and all subcommittees for which approval is required and direct the user on how to access appropriate wizard or upload other committee approvals. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process. Application for Initial IRB Review Wizard Shall not repeat any questions already asked as part of the Request to Review Research Proposal Wizard. Shall request information regarding subject population, risk assessment, informed consent, research procedures, investigational drugs and/or devices, and conflict of interest. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process. Application for Basic Science Study Wizard Shall not repeat any questions already asked as part of the Request to Review Research Proposal Wizard and if applicable, as part of the IRB Review Wizard. Shall request information regarding the use of wet lab space, human cell or tissue samples, shipping of biological hazards, microbial agents, recombinant DNA, animals, chemicals, chemical inventories, controlled substances, ionizing radiation, non-ionizing radiation, and physical hazards. Questions shall be such that the wizard easily directs user to additional forms and/or wizards which will be required as part of the research submission process. VA Data Privacy and Security Plan Wizard Wizard shall identify the types of VA research information being collected to include specific questions regarding how, where, and in what format the information will be stored. Questions shall determine if information is being shared outside of the VA and if so, how is it being transferred and secured, the type of organization to which it is being transferred, and whether it is proposed that any PII or PHI be transferred. Based on answers, smart form shall determine the need for a data use agreement and direct user to a template appropriate for the nature of the data to be transferred and the type of organization that is proposed to receive the data. Wizard shall have the ability to generate a research data inventory report identifying VA research data and its location, in accordance with VHA requirements. System shall include an online forms and documents library that is accessible to Users and is maintained and easily updated by Customer without requiring technical support from Contractor. Protocol submissions shall have the ability to be routed automatically through the online system for appropriate review and/or action by all required parties to include project staff, research admin staff, committee reviewers/members, Privacy & Information Security Officers, other component reviewers and Committee chairs. Routing mechanism shall allow simultaneous access to protocol submissions by multiple individuals, allow Customer to determine the sequence of access of individual parties or groups of individuals to the protocol submission, and allow Customer to notify individual parties when a protocol submission is available for their review and/or action. Electronic stamping capability for approved consent forms should be in compliance with VA and OHRP guidelines. Automatic email notifications with customizable text, identification of recipients, and at timelines specified by the Customer for the following: Upcoming expirations for continuing reviews, for IRB, SRS, IACUC, IBC, FCOI and R&DC Committees. Expiration of personnel qualifications, training, appointment status and scopes of practice. System shall provide details of protocol status at any given time to all affected users. As protocol moves through different steps in the review process, email notification shall be made to the Principal Investigator and to other members of the research team as specified by the Principal Investigator. Tracks all committee membership rosters with dates of expiration of committee appointment and of all relevant training and provides automatic email notices to committee members and committee chair with notice of upcoming expirations. Data tracked for all research staff shall include the following: Name Credentials (up to four) Option to capture three email addresses Study Role VA appointment type with expiration date Scope of practice with expiration date All training records to be linked to research staff and include expiration dates. Direct retrieval of training records from the Collaborative Institutional Training Initiative (CITI) and the VA Talent Management System (TMS). Auditing tools shall be an integral part of the system, identifying edits and reviews of all documents and shall include date/time of any changes as well as identifying the person making the change. The System shall provide for automatic generation of agendas for IRB, SRS, IACUC, IBC, FCOI and R&DC that meet the following requirements: Options for generation of agenda either by VA-defined rules concerning steps of the review process completed, manual selection, or combination of both processes. Agendas shall list protocol title, Principal Investigator, type of review, required component reviews, research staff in conflict with any of the review committee members, and shall have a separate function to additional items as needed. Agendas shall allow editing by committee administrators as needed. The System shall provide for automatic generation of IRB, SRS, IACUC, IBC, FCOI and R&D Committee minutes that meet the following specifications: Minutes shall list protocol title, Principal Investigator, type of review, required component reviews, research staff in conflict with any of the review committee members, details of the vote including numbers for, against, recused, and abstaining. Inclusion of customizable text to reflect discussion of each business item. Minutes shall allow editing by committee administrators as needed. Ability to track and report SAE/AE with reports to include protocol title, investigator, study intervention, or other VA specification. Automatically generated notification/decision letters with customizable text for all protocols approved by the IRB, SRS, IACUC, IBC, FCOI and R&DC. Data Conversion Kit Existing protocol data shall be migrated to new system and shall include basic project information to include title, current staff, current expiration dates for each committee review, BUA if applicable, and type of protocol (one or more of human, animal, or bench). Contractor shall lead a kick off meeting NLT 60 days after contract execution and shall provide a detailed plan for system rollout based on the current practices and needs of the VA. Contractor shall provide onsite training and support during the configuration process that is specifically targeted for the Research Service Administrative Staff which deals with initial set up, applications and use of system. Additional training will be provided via live Webinar as follows: To accommodate varying schedules, training to the following groups will be offered at least twice, with dates to be determined by VA, who will provide a minimum of 30 days notice to Contractor. PI s and research community on system use and submission of research protocols. Committee members on system use and review of research protocols. Customer support shall be offered M-F from 8:00am to 4:00pm Eastern Time, excluding federal holidays. System shall provide Customer the ability to directly query the underlying database/tables through a third-party reporting tool. Additional contract requirement(s) or terms and conditions determined by the contracting officer: Set Aside Cascading set-aside procedures. Any award resulting from this solicitation will be made using a cascading set-aside order of precedence as follows: 1. In accordance with FAR Subpart 19.1405 and VAAR Subpart 819.7005, any award under this solicitation will be made on a competitive basis first to an eligible Service Disabled Veteran Owned small business [SDVOSB] concern provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 2. If there is inadequate competition for award to an SDVOSB concern, the SDVOSB set-aside shall be withdrawn and cascaded to the next contracting order of priority in accordance with VAAR 819.7004, which is Veteran Owned Small Businesses (VOSB) and conducted in accordance with the procedures set forth in VAAR 819.7006 provided that the conditions of 38 U.S.C. 8127(d) are met (the VA Rule of Two) whereby the Contracting Officer receives adequate competition of two or more small business concerns owned and controlled by Veterans, and that the award can be made at a fair and reasonable price that offers the best value to the United States. 3. If there continues to be inadequate competition between SDVOSB and VOSB concerns, the cascading will continue through the contracting order of priority in accordance with VAAR 819.7004 and FAR 19.203. If the contracting officer determines that offers from small business concerns do not meet the solicitation requirements in terms of technical acceptability, past performance, and fair market price, the small business set-aside[s] will be withdrawn and award will be made based on full and open competition. Adequate competition: Adequate competition shall be deemed to exist if At least two competitive offers are received from qualified, responsible business concerns at the set-aside tier under consideration; and Award could be made at fair market price as determined in accordance with FAR 19.202-6. The VA contracting officer reserves the right to consider competitive proposals submitted from all responsible offerors (including large businesses) in determining the fair market price. Due date and submission of quotes: The quotes are due on 9/11/2018 at 10:00 AM and shall be directed electronically to Michael.haydo@va.gov. Quotes shall be marked with the solicitation number. Information regarding the solicitation can be addressed to the Contracting Officer, Michael Haydo, michael.haydo@va.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/23299b2db10df58b210f000c96c4a697)
 

Document(s)

Attachment
 

File Name: 36C24E18Q9556 36C24E18Q9556_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4576639&FileName=36C24E18Q9556-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4576639&FileName=36C24E18Q9556-000.docx

 

File Name: 36C24E18Q9556 36C24E18Q9556.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4576640&FileName=36C24E18Q9556-001.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=4576640&FileName=36C24E18Q9556-001.docx

 

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

Record

SN05074394-W 20180907/180905231813-23299b2db10df58b210f000c96c4a697 (fbodaily.com)
 

Source

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

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