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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 28, 2019 FBO #6487
SOLICITATION NOTICE

Q -- Institutional Review Board (IRB) Support Services

Notice Date

8/26/2019
 

Notice Type

Combine Synopsis/Solicitation
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

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

ZIP Code

15212-5319
 

Solicitation Number

36C24E19Q0117
 

Response Due

9/9/2019
 

Archive Date

12/8/2019
 

Point of Contact

Email: michael.haydo@va.gov
 

Small Business Set-Aside

N/A
 

Description

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, MAINTENANCE, OR USE For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. The contractor/subcontractor s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA s POA&M management process. The contractor/subcontractor must use VA s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. VA prohibits the installation and use of personally-owned or contractor/subcontractor- owned equipment or software on VA s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA- approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: Vendor must accept the system without the drive; VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre- approved and described in the purchase order or contract. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. SECURITY INCIDENT INVESTIGATION The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. LIQUIDATED DAMAGES FOR DATA BREACH Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: Nature of the event (loss, theft, unauthorized access); Description of the event, including: date of occurrence; data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected; Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; Amount of time the data has been out of VA control; The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); Known misuses of data containing sensitive personal information, if any; Assessment of the potential harm to the affected individuals; Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: Notification; One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; Data breach analysis; Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 8. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. TRAINING All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; Successfully complete the appropriate VA privacy training and annually complete required privacy training; and Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. This is a requirement for IRB Support. As a minimum, all responses shall include information that demonstrates the ability to perform in accordance with the solicitation specifications. Place of Performance: The Contractor shall support this effort at the Department of Veterans Affairs, 1100 1st St, NE, Washington, DC   20002, or at approved Contractor facilities as directed by the Contracting Officer s Representative (COR) and mutually agreed to by the Contractor. Period of Performance: One (1) base period of twelve (12) months and two (2) option period of twelve (12) months each. The following provisions and clauses apply to this acquisition: 52.212-1, Instructions to Offerors Commercial, (ix) A statement regarding the applicability of Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with its offer. 52.212-4, Contract Terms and Conditions Commercial Items, The following subparagraphs of FAR 52.212-5 are applicable: (a) All (b) Sections (1)(4)(8)(16)(21)(22)(26)(27)(28)(29)(30)(31)(32)(33)(42)(46)(49)(55) (d) All CONTRACT CLAUSES 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (OCT 2018) 52.216-18 ORDERING (OCT 1995) 52.216-19 ORDER LIMITATIONS (OCT 1995) 52.216-22 INDEFINITE QUANTITY (OCT 1995) 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) SUPPLEMENTAL INSURANCE REQUIREMENTS VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)(DEVIATION) VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING MONITORING AND COMPLIANCE (JUL 2018) VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) 15 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS COMMERCIAL ITEMS (MAY 2019) SOLICITATION PROVISIONS 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (OCT 2018) 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) 52.216-1 TYPE OF CONTRACT (APR 1984) 52.233-2 SERVICE OF PROTEST (SEP 2006) VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018) 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) 52.212-2 EVALUATION COMMERCIAL ITEMS (OCT 2014) 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (OCT 2018) Page 2 of 4 The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. In accordance with 52.212-2, Evaluation Commercial Items, the following will be used to evaluate offers: Award shall be made to the offeror whose quotation offers the best value to the government, considering the cascading procedures outlined below, technical capability, and price. The government will evaluate information based on the following evaluation criteria: (1) meeting the cascading rule of two under any tier; (2) technical capability factor "meeting or exceeding the requirement, and (3) price".     Additional contract requirement(s) or terms and conditions determined by the contracting officer: Set Aside Cascading set-aside procedures with the 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 Service Disabled 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 on the basis of 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: Submission shall be received not later than 09/09/2019 at 10:00 AM EST and shall be directed electronically to Michael.haydo@va.gov. Offer emails shall be marked with the solicitation number in the subject line. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Faxed and telephone offers will not be accepted. Information regarding the solicitation may be addressed to the Contracting Officer, Michael Haydo, michael.haydo@va.gov NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (26-AUG-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
 

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Record

SN05418572-F 20190828/190826230043 (fbodaily.com)
 

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