Inactive

36C24E19Q0117 Page 1 of Page 2 of 51 Page 1 of COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS Institutional Review Board Support General Information Document Type: Combined Solicitation/Synopsis ... 36C24E19Q0117 Page 1 of Page 2 of 51 Page 1 of COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS Institutional Review Board Support General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24E19Q0117 Posted Date: 08/26/2019 Original Response Date: 09/09/2019 Current Response Date: 09/09/2019 Product or Service Code: Q301 Medical Laboratory Testing Set Aside (SDVOSB/VOSB): Cascading Set-aside (see cascading instructions below) NAICS Code: 621511 Medical Laboratories Contracting Office Address US Department of Veterans Affairs Regional Procurement Office East Research and Development Team 323 North Shore Dr. Pittsburgh, PA 15212 Description This is an open market combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a separate written solicitation document will not be issued. The government intends to award a purchase order as a result of this combined synopsis / solicitation that will include the terms and conditions set forth herein. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-92. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with a small business size standard of $32.5M. The Regional Procurement Office, Research and Development Team based in Pittsburgh is seeking to procure Institutional Review Board (IRB) Support services in accordance with the specifications. All interested companies shall provide quotation(s) for the following: SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES TASK 1: Audits VA Central IRB files are audited to ensure that all are in compliance with Food and Drug Administration requirements and to note what, if any, if documents are missing. This information is then given to the VA Central IRB Administrator. The task is to perform continuous quality assurance (QA) reviews on VA Central IRB electronic and paper copy medical research files with a particular emphasis on Food and Drug Administration (FDA) regulated studies by: Deliverable 1.1 Conducting paper filing audits on all FDA-regulated studies, comparing them to the electronic files. Deliverable 1.2 Conducting Sharepoint or other electronic platform audits of study actions to ensure required follow-up actions have been adequately tracked to conclusion and that the databases accurately reflect study status. Deliverable 1.3 Reviewing performance metrics from the VA Central IRB Administrative Tracking System (CATS) to make recommendations on process improvement and enhancements to include in required quarterly report to VHA Central Office Institutional Official (IO). TASK 2. Documentation Systems VA Central IRB files are the official records of medical research studies approved by the VA Central IRB and conducted by VA researchers. The task is to maintain the VA Central IRB electronic and paper copy medical research files and other files by: Deliverable 2.1 Creating and labeling folders and then printing and filing all applicable documents for Principal Investigator/Study Chair (PI/SC) New Project Applications and Local Site Investigator (LSI) Applications, for FDA-regulated studies for remote staff, remote CIRB panels, the VA Central IRB Administrator, and on-site study managers. This includes filing documents in chronological order with most recent actions on top and separating various actions with labeled divider sheets. Actions include new study approvals, amendments, and reportable events. Deliverable 2.2 For closed studies, preparing paper folders for retired archival storage and periodically shifting study folders to accommodate newly approved studies, additional LSI folders, and expansion of existing folders into multiple volumes depending upon study activity. Deliverable 2.3 Assisting other ORPP&E staff by filing documents pertaining to Memorandum of Understanding (MOU) records on file with over 100 VA facilities for which the VA Central IRB serves as an IRB of record, filing IRB member personnel records, and granting Sharepoint permissions. TASK 3. VA Central IRB Support The bi-monthly meetings of the VA Central IRB are where reports of research deviations or adverse events are reviewed, new studies and amendments are reviewed and approved and other official business is conducted. The task is to perform administrative support for various VA Central IRB meetings and various VA Central IRB panel meetings by: Deliverable 3.1 Pre-meeting: Preparing meeting agendas, sending meeting notices, reserving conference rooms and scheduling VANTS lines. Deliverable 3.2 Post-meeting: Preparing thorough draft minutes for virtual meetings of the VA Central IRB and VA Central IRB panels for review and edit by the VA Central IRB Administrator and VA Central IRB Co-Chairs or Panel Chairs using the agenda as an outline and recording votes, conflict of interests recusals and other comings and goings of members during the meeting to ensure quorum is always maintained. Deliverable 3.3 For in-person meetings: Reserving conference rooms, preparing and providing security lists and escorts, setting up conference rooms and completing the same tasks as required for virtual meetings. TASK 4. Regulatory Affairs Support Regulatory Affairs is responsible for developing and implementing ORD human subjects research policies. The task is to perform administrative support to Regulatory Affairs by: Deliverable 4.1 Ensuring all checklists and other required documents for the Non-VA Institutional Review Board Application Process are included in the application process, entering applications into the tracking system, and routing documents appropriately to required reviewers. Deliverable 4.2 Maintaining and tracking records of the status of IRB reliance agreements and Federal Wide Assurance (FWA) for non-VA Institutional Review Board including maintaining a database of when IRB reliance agreements are executed, modified, renewed, suspended, or terminated. Deliverable 4.3 Maintaining a database of the status of Federal Wide Assurances for any non-VA IRB used by a VA Facility, including when it is executed with an Office of Research Oversight addendum, modified, suspended, or terminated. TASK 5. Website Support The ORPP&E outward-facing (external) websites provide the public access to general information regarding VA research studies, human volunteer opportunities, links to VA Central IRB policies and other research information. The task is to maintain the external ORPP&E and VA Central IRB websites by: Deliverable 5.1 Identifying and replacing the former office acronym (PRIDE) with the new one (ORPP&E) to include searching the internet for external sites or pages and identifying and replacing acronyms and preparing a list of links to be updated and updating the links. Deliverable 5.2 Looking at ways to make the external ORPP&E and VA Central IRB websites more user-friendly, in coordination with ORD webservice personnel, to change web page layouts, enhance files, and make updates. TASK 6 Cyber-Seminars Cyber-seminars provide educational opportunities for research study staff at VA facilities on topics relevant to human subjects research. The task is to manage the cyber-seminars to support the educational functions of ORPP&E by: Deliverable 6.1 Pre-seminar: creating and sending cyber-seminar invitations with registration information, ensuring cyber-seminar content is uploaded and platform is functional prior to all planned cyber-seminars, reserving conference rooms for presenters and back-up computer/laptop, and tracking attendee registration. Deliverable 6.2 During seminar: managing the platform by assisting with any technical issues occurring during the presentation and preparing questions sent by attendees during the presentation to the presenters. Deliverable 6.3 Post-seminar: facilitating posting of the recording and final slides/handouts after the meeting, issuing and collecting post-meeting evaluation surveys, summarizing data into a meaningful format for ORPP&E leadership, and ensuring cyber-seminar recordings are sent for transcription to the VA Central Transcription Service. SCHEDULE OF DELIVERABLES DELIVERABLE NUMBER ITEM QUANTITY 1.1 Conducting paper filing sample audits on FDA-regulated studies 3 per month 1.2 Conducting Sharepoint or other electronic platform audits of study actions to ensure required follow-up actions have been adequately tracked to conclusion and that the databases accurately reflect study status Monthly 1.3 Reviewing performance metrics from the Central IRB Administrative Tracking System (CATS) to make recommendations on process improvement and enhancements to include in required quarterly report to VHA Central Office Institutional Official (IO) Quarterly 2.1 Maintain documentation systems by creating and labeling folders and then printing and filing all applicable documents for Principal Investigator/Study Chair (PI/SC) New Project Applications and Local Site Investigator (LSI) Applications, for FDA-regulated studies for remote staff, remote CIRB panels, the Central IRB Administrator, and on-site study managers. This includes filing documents in chronological order with most recent actions on top and separating various actions with labeled divider sheets. Actions include new study approvals, amendments, and reportable event. Daily 2.2 For closed studies, preparing folders for retired archival storage and shifting study folders to accommodate newly approved studies, additional LSI folders, and expansion of existing folders into multiple volumes depending upon study activity. Quarterly 2.3 Assisting other ORPP&E staff by filing documents pertaining to Memorandum of Understanding (MOU) records on file with over 100 VA facilities for which the VA Central IRB serves as an IRB of record, filing IRB member personnel records, and granting Sharepoint permissions. Weekly 3.1 Pre-meeting: Preparing meeting agendas, sending meeting notices, reserving conference rooms and scheduling VANTS lines. Weekly 3.2 Post-meeting: Preparing thorough draft minutes for virtual meetings of the VA Central IRB and VA Central IRB panels for review and edit by the VA Central IRB Administrator and VA Central IRB Co-Chairs or Panel Chairs. Bi-Weekly 3.3 For in-person meetings: reserve conference rooms, prepare and provide security lists and escorts, set up conference rooms and complete the same tasks as required for virtual meetings. Semi-annually 4.1 Ensuring all checklists and other required documents for the Non-VA Institutional Review Board Application Process are included in the application process, entering applications into the tracking system, and routing documents appropriately to required reviewers. Weekly 4.2 Maintaining and tracking records of the status of IRB reliance agreements and Federal Wide Assurance (FWA) for non-VA Institutional Review Board including maintaining a database of when IRB reliance agreements are executed, modified, renewed, suspended, or terminated. Monthly 4.3 Maintaining a database of the status of Federal Wide Assurances for any non-VA IRB used by a VA Facility, including when it is executed with an Office of Research Oversight addendum, modified, suspended, or terminated Monthly 5.1 Identifying and replacing the former office acronym (PRIDE) with the new one (ORPP&E) to include searching the internet for external sites or pages and identifying and replacing acronyms and preparing a list of links to be updated and updating the links. Until completed 5.2 Looking at ways to make the external ORPP&E and VA Central IRB websites more user-friendly, in coordination with ORD webservice personnel, to change web page layouts, enhance files, and make updates Until completed 6.1 Pre-seminar: creating and sending cyber-seminar invitations with registration information, ensuring cyber-seminar content is uploaded and platform is functional prior to all planned cyber-seminars, reserving conference rooms for presenters and back-up computer/laptop, and tracking attendee registration Bi-monthly 6.2 During seminar: managing the platform by assisting with any technical issues occurring during the presentation. and preparing questions sent by attendees during the presentation to the presenters Bi-monthly 6.3 Post-seminar: facilitating posting of the recording and final slides/handouts after the meeting, issuing and collecting post-meeting evaluation surveys, summarizing data into a meaningful format for ORPP&E leadership, and ensuring cyber-seminar recordings are sent for transcription to the VA Central Transcription Service Bi-monthly GENERAL REQUIREMENTS The contractor will present a plan for project organization and staffing that demonstrates a knowledge of effective organizational structure, management, and how best to utilize key and other personnel. The contractor will have qualified personnel to complete the tasks unless otherwise stated in a specific contract. The Contractor shall provide, via email, minutes of all government-Contractor meetings. The Contractor shall provide these minutes within three calendar days after completion of the meeting. The government shall provide all IT equipment including computers, software, computer accessories, access to databases as needed, and IT support services. KEY PERSONNEL The Contractor shall be responsible for managing and overseeing the activities of all Contractor personnel, as well as subcontractor efforts used in performance of this effort. The Contractor's management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective support, performed in accordance with the requirements contained in the statement of work. The Contracting Officer may notify the Contractor and request immediate removal of any personnel assigned to the task order by the Contractor that are deemed to have a conflict of interest with the government or if the performance is deemed to be unsatisfactory. The reason for removal will be documented and replacement personnel shall be identified within three business days of the notification. Employment and staffing difficulties shall not be justification for failure to meet established schedules. 1. Key Personnel: The Contractor shall document that the qualifications of the professional, technical and administrative staff proposed are adequate for full performance of tasks. Detailed bios or Curriculum Vitae (CVs) are provided for each proposed staff member. Substitutions shall only be accepted if in compliance with Substitution of Key Personnel" provision identified below. 2. Substitution of Key Personnel: All Contractor requests for approval of substitutions hereunder shall be submitted in writing to the COR and the Contracting Officer at least thirty (30) calendar days in advance of the effective date, whenever possible, and shall provide a detailed explanation of the circumstances necessitating the proposed substitution, a complete resume for the proposed substitute, and any other information requested by the Contracting Officer necessary to approve or disapprove the proposed substitution. New personnel shall not commence work until all necessary security requirements, as defined in Section J, have been fulfilled and resumes provided and accepted. The COR and the Contracting Officer will evaluate such requests and promptly notify the Contractor of approval or disapproval in writing. KEY PERSONNEL QUALIFICATIONS Documented 1-year experience supporting medical research projects such as research assistant, study team member, or research administrative assistant. Documented experience preparing IRB Board meeting agendas and minutes. Documented experience conducting paper-copy document and electronic file audits. Documented experience in conference/meeting management. Documented experience conducting internet searches and identifying information to correct. Documented experience coordinating and managing cyber-seminars or webinars. Familiarity with Human Subjects Research laws, Food and Drug (FDA) Administration requirements, and VHA and ORD medical research regulations/guidelines. Familiarity with medical terminology. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. VA INFORMATION CUSTODIAL LANGUAGE Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. INFORMATION SYSTEM DESIGN AND DEVELOPMENT Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default program files directory and silently install and uninstall. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. The contractor/subcontractor agrees to: Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: The Systems of Records (SOR); and The design, development, or operation work that the contractor/subcontractor is to perform; Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. Operation of a System of Records means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. Record means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. System of Records means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as Systems ), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 5 days. l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. INFORMATION SYSTEM HOSTING, OPERATION, M...