36C25619Q0819-001.pdf

Statement of Work

Viral NGS Genotyping and Resistance Test System Southeast Louisiana Veterans Healthcare System

New Orleans, LA 03/05/2019

1. PURPOSE

1.1 The purpose of this request is to acquire a Viral NGS Genotyping and Resistance Test System for a basic one year period plus 3 option years at SLVHCS Microbiology Section of the Pathology and Laboratory Medicine Service located on the 4th floor of building D and T at 2400 Canal Street, New Orleans, LA 70119, room 4F122. This acquisition will be on an Indefinite Delivery/Indefinite Quantity Cost Per Test Contract where the Government receives all instrumentation, support equipment, service, preventative maintenance, technical support, instrument/equipment repair reagents, kits, tests and consumables for the cost per test.

This testing is necessary to provide diagnostic and treatment information to providers and to support Infection Control with disease management.

2. SCOPE

2.1 The Contractor shall provide, transport, deliver, install, and test all listed equipment/instrumentation. All products must meet all salient characteristics defined in this statement of work.

2.2 The Contractor shall furnish all supplies, equipment, facilities and services required for delivery and installation of the analyzers.

2.3 The Contractor shall furnish all parts, accessories and any other items/peripherals required for the successful operation of the analyzers.

2.4 The Contractor shall provide shipping, transport, installation, and reagents/products necessary to the test the analyzers for successful operation and function. All products must meet the salient characteristics defined in this statement of work.

2.5 All analyzers and installation must meet manufacturer’s and VA specifications.

2.6 The Contractor is responsible for any missing parts and components not included that are required for installation.

2.7 The analyzers will interface with the government’s computer system to allow complete result transfer to the patient’s electronic record using acceptable VA OI&T processes.

2.8 SALIENT CHARACTERISTICS

2.8.1 Automated Nucleic Acid Purification and Next Generation Sequencing System for HCV and HIV genotype and resistance testing Brand Name Required-Vela Diagnostic Sentosa NGS System Technical Specifications:

• The System shall provide automated sample preparation, nucleic acid extraction, RT-PCR set-up, NGS library preparation, emulsion PCR, Template Preparation, Enrichment, Sequencing, and Primary and Secondary data analysis.

• The contractor shall provide all equipment, parts, accessories, and any other items required for the operation of the analyzer and peripherals necessary for the automated nucleic acid purification and next generation sequencing system for HCV and HIV genotype and resistance testing at no charge to the

Government

• The System shall perform RT-PCR, seal plates after RT-PCR is completed, report results.

• The Contractor shall supply a gas tank safety cart/holder as well as any fitting/tubing/regulator/other supplies for the connection of tank/gas to the instrument/equipment for proper instrument/equipment function at no additional charge to the government.

• The Contractor shall provide all Un-interruptible power suppies for the system at no cost to the Government

• The System shall provide assays for HIV Genotyping which simultaneously genotypes and detects drug resistance mutations, and targets RT/Protease and Intergrase regions.

• The System must provide assays for HCV genotyping which simultaneously genotypes 1-6 and their associated subtypes, as well as resistance associated substitutions identifications, using targets NS3, NS5A, and NS5B.

• The System shall ensure sample and target traceability for NGS workflow, and automated data transfer.

• The Contractor shall provide all clinical instrumentation, support equipment, computers, printers, and supporting software to perform HCV and HIV genotype and resistance testing at SLVHCS at no cost to the Government.

• Reagents/kits shall have a shelf-life of at least 10 months

• The Contractor shall include the cost for all reagents, tests, kits, and consumables in the cost per test. The

Government will only be responsible for the cost per test. The reagents, kits, tests, and consumables shall be delivered as an Indefinite Delivery/Indefinite Quantity Contract.

• Reagents, consumables, and all instrumentation shall be provided for a basic one-year period plus 3 option years.

• System shall be an automated platform with minimal hands on time and a fast turnaround time (within 3 days)

• The Contractor shall provide free replacement of all faulty instruments and equipment, and defective test panels/kits/reagents.

• The Contractor shall allow flexibility for the possibility of future expansion of testing menu using the same instrumentation footprint and software. The Contractor shall be responsible for all costs associated with updates needed to support test menu expansion.

• The Contractor/Manufacturer shall retain ownership and title for the instrumentation and equipment and provide all required on-site service, regular preventative maintenance, repairs, training and technical support at no cost to the Government.

• The Contractor shall provide any required on-site service response 5 days per week or required equipment replacement within 48 hours.

• The system must use unprepared samples with little or no preparation time (measured in minutes).

• User Friendliness: a) Should not require a molecular trained Pathologist to operate the analyzer, perform the test and interpret the results; b) Must provide software and/or supporting instrumentation required to maintain, or improve levels of data retrieval, which can be used for epidemiology, or cost-decreasing measures; c) Must have ease in handling and resolving errors.

• The instruments must meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

• Each system’s component must provide accurate test assay results for sample specimens up to the manufacturer’s defined maximum test per hour without excessive malfunctions, breakdowns, or service calls.

• Testing equipment must be new, state-of-the-art equipment. Remanufactured and discontinued modules will not be accepted.

• The contractor shall provide all upgrades to the Contractor’s/Manufacturer’s proprietary software as it is made available, at no charge to the Government during the lifetime of the use of the instruments/equipment. These enhancements shall be delivered and installed within 30 days of issuance to the commercial market.

• The system being offered is in current production at time of award. For purposes of this solicitation, “current production” shall mean that the clinical laboratory analyzer is being manufactured as new equipment.

• Analyzers must conform to the listed facility’s laboratory space.

• Contractor shall be responsible for providing connection to the patient’s electronic health record (CPRS) at

SLVHCS to include all licensing, middleware and any connecting hardware necessary. Connection should allow bidirectional interface with Vista if desired.

• The Contractor shall be responsible for supplying software to allow complete result transfer to the patient’s electronic record using acceptable VA OI&T processes.

• The Contractor shall provide all necessary startup reagents and supplies required to complete a full validation/verification and correlation study for HIV and HCV resistance testing and future tests.

• Characterization of hazardous waste - The Contractor shall provide a statement and description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations that addresses the elements and criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

2.8.1.1 Waste toxicity (Reference 40CFR261.11 and 40CFR261.24)

2.8.1.2 Waste ignitability (Reference 40cfr261.21)

2.8.1.3 Waste corrosivity (Reference 40CFR261.22)

2.8.1.4 Waste reactivity (Reference 40CFR261.23)

2.8.1.5 Hazardous waste from non-specific sources (F-listed) Reference 40CFR261.31)

2.8.1.6 Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference

40CFR261.33)

2.8.2 Onsite training of three VA key operators and VA technical staff at no cost to the Government

2.8.3 Operation, Technical, Service and Maintenance Manuals (two copies) for all instruments, equipment, and assays at no cost to the Government

2.8.4 Shipping, Delivery, and Installation no cost to the Government

2.8.5 Printer with USB cable no cost to the Government

2.8.6 PRO APC Power-Saving BACK-UPS no cost to the government

2.8.7 Standard Warranty for system/instruments/equipment no cost to the Government

2.8.8 Service, Preventative Maintenance, and Technical Support for instrument/equipment/Assays at no cost to the

Government

2.9 DELIVERY AND INSTALLATION

2.9.1 DELIVERY

2.9.1.1 The Contractor shall deliver all equipment/analyzers/accessories, reagents/kits and consumables to the

Southeast Louisiana Veterans Healthcare System (SLVHCS), Microbiology Section of the Pathology and Laboratory Medicine Service located on the 4th floor of building D and T at 2400 Canal Street, New Orleans, LA 70119 facility on April 5, 2019 to room 4F122.

2.9.1.2 Deliver materials to job in manufacturer’s original sealed containers with brand name marked thereon.

2.9.1.3 Package to prevent damage or deterioration during shipment, handling, storage, and installation. Maintain protective covering in place and in good repair until removal is necessary.

2.9.1.4 Deliver analyzer and specified items only when the site is ready for installation work to proceed.

2.9.1.5 Store products in dry condition inside enclosed facility.

2.9.1.6 Any Government requested delayed delivery up to 90 days after initial award delivery date, shall be at no additional cost to the US Government.

2.9.1.7 A pre-delivery meeting will be conducted 10 days prior to initial award delivery date for verification of delivery and installation dates.

2.9.1.8 Delivery and Installation will be coordinated through the COR.

2.9.1.9 The Contractor shall conduct a joint inspection with the COR upon delivery of the equipment.

2.9.2 INSTALLATION

2.9.2.1 Install all equipment to manufacturer’s specifications maintaining Federal, and Local safety standards.

2.9.2.2 Installation must be completed by April 10, 2019. All work shall be completed between 8:00 a.m. and

4:30 p.m. Monday-Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday

OPM Site.

2.9.2.3 If there is an operational conflict with installation, night or weekend installation may be required. The US

Government will provide a 72 hours’ notice of installation hours.

2.9.2.4 The Contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the

COR.

2.9.2.5 The Contractor shall remove all related shipping materials, debris, and cleanup any construction associated with delivery and installation of the specified items. Contractor shall remove all packaging from the SLVHCS premises after instrument installation. The Contractor shall be responsible for any damage to the building that occurs due to Contractor’s error or neglect.

2.10 SITE CONDITIONS

2.10.1 Smoking, eating or drinking inside the hospital will be contained to authorized areas only.

3. INSPECTION AND ACCEPTANCE

3.1 The Contractor shall conduct a joint inspection with the COR upon delivery.

3.2 The Contactor shall provide the VA COR a list of missing and damaged items found upon inspection and have those items replaced at no cost to the US Government.

3.3 Contractor shall provide dates of completion of punch list items and replacement parts and/or short ship items from the manufacturer(s).

3.4 The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the

VA Contracting Officer.

4. DELIVERABLES

4.1 Operation and Maintenance Manuals:

4.1.1 The Contractor shall provide two sets of printed service, technical, operating manuals upon delivery and installation of equipment.

4.1.2 The Contractor shall provide two sets of digital service, technical, operating manuals upon delivery and installation of equipment.

4.1.3 The Contractor shall deliver a compilation of all manufacturer recommended maintenance schedules and operation materials packaged in binder(s) to COR upon completion of installation.

4.2 The Contractor shall provide and deliver all clinical reagents, calibrators, controls, consumables, disposables items, parts, and accessories required to establish operation and perform all validation/verification studies and method comparison studies.

5. OPERATOR TRAINING

5.1 The Contractor shall provide Vendor led, on-site, instrument trainings for three (3) VA Key

Operators (Technical Staff) and technical staff. The trainings shall include the operation of the hardware and software systems, data manipulation, troubleshooting and repair, instrument validation and method comparison studies. The contractor shall be responsible to ensure three (3) VA Key Operators (Technical Staff) shall be fully trained and competent to operate and troubleshoot both instrument systems. Vendor led on-site trainings shall be completed by April 19, 2019. The Vendor led on-site training shall be available at no cost to the Government and coordinated with the COR.

5.2 As new tests are added to the testing menu in the future, the Contractor shall provide Vendor led, on-site, instrument trainings for three (3) VA Key Operators (Technical Staff) on instrument hardware and software systems, data manipulation, troubleshooting and repair, instrument validation/verification and method comparison studies. The Vendor led on-site training shall be available at no cost to the Government and coordinated with the COR.

5.3 The Contractor shall complete installation and quality assessment of the System by April 10, 2018. All work shall be completed between 8:00 a.m. and 4:30 p.m. Monday-Friday. All federal holidays, excluded. Federal holidays are available at the Federal Holiday OPM Site.

5.4 The Contractor shall coordinate training with the COR so that it is timely to the equipment installation, is consistent with the size and scope of the facility’s services and is minimally equivalent to that offered in the commercial marketplace. The contractor will provide annual training for at least two VA operators per year as needed.

6. PROTECTION OF PROPERTY

6.1 The Contractor shall protect all items from damage. The Contractor shall take precaution against damage to the building(s), ground and furnishings. The Contractor shall repair or replace any items related to building(s) or grounds damaged accidently or on purpose due to actions by the Contractor.

6.2 The Contractor shall perform an inspection of the building (s) and grounds with the COR prior to commencing work, to ensure the Contractor shall be able to repair or replace any items, components, building(s) or grounds damaged due to negligence and/or actions taken by the Contractor. The source of all repairs beyond simple surface cleaning is the facility construction contractor (or appropriate subcontractor), so that building warranty is maintained. Concurrence from the VA Facilities Management POC and COR is required before the Contractor may perform any significant repair work. In all cases, repairs shall utilize materials of the same quality, size, texture, grade, and color to match adjacent existing work.

6.3 The Contractor shall be responsible for security of the areas in which the work is being performed prior to competition.

6.4 The Contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have rubber wheels.

7. SECURITY REQUIREMENTS

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.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. 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.

b. 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.

c. 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.

d. 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.

e. 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.

3. SECURITY INCIDENT INVESTIGATION

a. 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.

b. 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.

c. 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.

d. 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.

4. LIQUIDATED DAMAGES FOR DATA BREACH

a. 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.

b. 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.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) Date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) 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;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised

(Made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy

Incidents, as appropriate; and

(11) 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 $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

5. TRAINING

a. 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:

(1) 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;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) 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.]

b. 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.

c. 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.

d. VA training site is located at www.tms.va.gov

There is only one course the contractor needs to complete and print the certificate at the end. A copy of the completed certificate must be submitted before work begins (within 5 business days of contract award).

http://www.tms.va.gov/

Instructions to get to the Courses in TMS www.tms.va.gov

Log onto the site and create a new user account; if you already don’t have one. Search for your course entitled VA Privacy and Information Security Awareness and Rules of Behavior. Complete course, print certificate (s), and sign/print contractor rules of behavior.

VA Learning University (VALU)

Help Desk: 1-866-496-0463 valmshelp@va.gov

Examples http://www.tms.va.gov/ mailto:valmshelp@va.gov

VA Privacy and Information Security Awareness and Rules of Behavior

6. VA INFORMATION CUSTODIAL LANGUAGE

a. 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).

b. 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.

c. 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.

d. 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.

e. 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.

g. 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.

h. 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.

i. 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.

j. 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.

k. 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.

l. 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.

7. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. 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.

b. 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.

c. 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.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. 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.

f. 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.

g. The contractor/subcontractor agrees to:

(1) 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:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/subcontractor is to perform;

(2) 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.

(1) “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.

(2) “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.

(3) “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.

i. 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.

j. 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.

k. 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 ____ 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.

8. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. 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.

b. 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.

c. 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.

d. 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.

e. 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.

f. 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.

g. 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.

h. 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:

(1) Vendor must accept the system without the drive;

(2) 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

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) 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;

(a) 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

(b) 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 preapproved and described in the purchase order or contract.

(c) 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.

9. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

a. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response.

b. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

8. WARRANTY

8.1 The Contractor shall provide a one year manufacturer’s warranty on all parts and labor.

8.2 The warranty and service shall include all travel and shipping costs associated with any warranty repair.

8.3 The Contractor shall provide standard warranty response on instrumentation, and software as required which shall include preventative maintenance during the warranty period.