DRAFT - Statement of Work - Osmometer.docx

VA HANDBOOK 6500.6 APPENDIX C

MARCH 12, 2010

DRAFT STATEMENT OF WORK (SOW)

Advanced Instruments Osmo1 Single-Sample Micro-Osmometer Clinical Chemistry Laboratory Central Arkansas Veterans Healthcare System (CAVHS) Little Rock, AR 72205

1. PURPOSE

1.1. The overall purpose is to establish a purchase contract to provide and install one Advanced Instruments Osmo1 Single-Sample Micro-Osmometer in the Clinical Chemistry Laboratory at Central Arkansas Veterans Healthcare System (CAVHS), 4300 W. 7th St, Little Rock, AR 72205.

1.2. This instrument will be installed in the Clinical Chemistry section of Pathology & Laboratory Medicine Service (P&LMS) and used for measurement of osmolality in serum, plasma, urine, and other body fluids to support patient care and meet CLIA and College of American Pathologists (CAP) requirements.

1.3. Osmolality testing is required for evaluation of electrolyte and water balance, toxic alcohol ingestion, and other critical clinical conditions. A dedicated micro‑osmometer is necessary to support current and projected testing volumes, reduce turnaround time, and improve accuracy and reliability of results.

2. SCOPE

2.1. The Contractor shall provide, transport, install, and test all listed equipment. All products must meet all salient characteristics defined in this section.

2.2. All equipment and installation must meet manufacturer and VA specifications.

2.3. The Contractor shall furnish all materials, parts, tools, supplies, equipment, facilities, and services required for delivery and installation of the supplies and equipment.

2.4. The Contractor is responsible for any missing parts and components not included in order to carry out the installation.

2.5. The equipment will be a bench‑top, single‑sample micro‑osmometer intended for clinical laboratory use to perform quantitative osmolality measurements using the freezing point depression method.

3. Specifications / Salient Characteristics

3.1. Advanced Instruments Osmo1 Single-Sample Micro-Osmometer (or equal)

3.2. Bench‑top/tabletop instrument.

3.3. Uses freezing point depression principle for osmolality measurement.

3.4. Accepts serum, plasma, urine, and other body fluid samples as validated by the laboratory.

3.5. Sample volume requirement: 20 microliters or less per test.

3.6. Measuring range: at least 0–2000 mOsm/kg H₂O.

3.7. Resolution: 1 mOsm/kg H₂O.

3.8. Accuracy and precision must meet or exceed manufacturer’s stated performance claims across the analytical range.

3.9. Throughput sufficient to support routine clinical workload (minimum 20 patient samples per hour).

3.10. Integrated or attached touchscreen user interface.

3.11. Integrated barcode scanner for sample identification.

3.12. Integrated thermal printer for result printouts.

3.13. Capability to store results and operator information internally.

3.14. Connectivity ports (e.g., Ethernet and/or USB) for potential interface to a laboratory information system (LIS) or middleware, if requested by the facility.

3.15. Operation on standard electrical power (100–240 V, 50/60 Hz) with appropriate power cord.

3.16. Compact footprint suitable for placement on existing chemistry laboratory bench space.

3.17. Instrument must support 2‑ or 3‑point calibration and calibration verification to meet CLIA requirements.

3.18. Instrument must include on‑screen or documented step‑by‑step guidance for calibration, quality control, and routine operation.

4. Consumables and Accessories

4.1. The Contractor shall provide initial consumables and accessories required for installation and validation, which shall include, at a minimum:

4.1.1. Micro‑sample test kit(s) suitable for the Osmo1 instrument. Comment by Green, LaQuanah V.: Is there a certain quantity on these consumables that should be provided? Comment by Whiteman, Sean: Enough to cover installation and validation. I cannot say for certain how many this would be but the Contractor would have a good idea. Comment by Whiteman, Sean: The contractor would be responsible for installation and validation, they should bring enough consumables to complete this task.

4.1.2. Calibration standards at multiple osmolality levels (e.g., low, mid, high) sufficient to perform initial calibration and calibration verification.

4.1.3. Quality control materials at low, normal, and high osmolality levels.

4.1.4. Any special sample holders, probes, or tools required for routine operation and maintenance.

5. Installation and validation of unit operation

5.1. The Contractor is responsible to set up and install the unit in final operating condition. Comment by Green, LaQuanah V.: How will installation be coordinated? Comment by Whiteman, Sean: Delivery and installation will be coordinated through the Contracting Officer’s Representative (COR). Comment by Whiteman, Sean: 7.8

5.2. The Contractor must ensure the unit operates according to the manufacturer’s specifications upon completion of installation.

5.3. The Contractor shall assist, as needed, during the site’s verification/validation process (e.g., performance checks, calibration, and quality control setup) to confirm the instrument meets expected performance.

5.4. Onsite training of designated staff

5.4.1. The Contractor shall provide onsite training of designated Clinical Chemistry staff in routine operation, calibration, quality control, and basic maintenance of the unit within two weeks of installation. Comment by Green, LaQuanah V.: About how long post installation should this be done. Should the vendor schedule training with the COR? Comment by Whiteman, Sean: This is usually completed simultaneously during the installation and validation, but if not, yes, schedule with COR. Comment by Whiteman, Sean: I’ve added within 2 weeks for clarification.

5.4.2. When requested by the facility, the Contractor shall provide onsite training of designated Biomedical Engineering staff in basic maintenance and troubleshooting of the unit.

6. Documentation

6.1. The Contractor shall provide complete sets of operator’s manuals (hard copy and digital, if available).

6.2. The Contractor shall provide technical/service manuals, if available (hard copy and/or digital).

6.3. The Contractor shall provide manufacturer recommended maintenance schedules and procedures.

7. DELIVERY AND INSTALLATION

7.1. DELIVERY Comment by Green, LaQuanah V.: All equipment must be delivered to the NLR WH for processing. Comment by Whiteman, Sean: Are you certain? Many times lab equipment to be installed by the vendor is not unboxed until in their final location. Either way is fine with me but the vendor may specify the final location to not void the warranty. Comment by Whiteman, Sean: Added them both but may need clarification.

7.1.1. The Contractor shall deliver all equipment to:

Central Arkansas Veterans Healthcare System (CAVHS) 2200 Fort Roots Drive (Building 182) North Little Rock, Ar. 72114

7.1.2. Final location of instrument:

Central Arkansas Veterans Healthcare System (CAVHS) Pathology & Laboratory Medicine Service – Clinical Chemistry Laboratory 4300 W. 7th St. Little Rock, AR 72205

7.2. Deliver materials in the manufacturer’s original sealed containers with brand name marked thereon.

7.3. 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.

7.4. Deliver specified items only when the site is ready for installation work to proceed.

7.5. Store products in dry conditions inside enclosed facilities, if storage at the VA is required prior to installation.

7.6. Any Government‑requested delayed delivery up to 90 days after the initial delivery date shall be at no additional cost to the Government.

7.7. A pre‑delivery meeting may be conducted prior to initial negotiated delivery date for verification of delivery and installation dates.

7.8. Delivery and installation will be coordinated through the Contracting Officer’s Representative (COR).

7.9. INSTALLATION

7.9.1. Install all equipment to manufacturer’s specifications while maintaining Federal, State, Local, and VA safety standards.

7.9.2. All work shall be completed between 8:00 a.m. and 4:30 p.m., Monday through Friday, excluding Federal holidays.

7.9.3. If there is an operational conflict with installation, night or weekend installation may be required. The Government will provide a minimum 72‑hour notice of change of installation hours.

7.9.4. The Contractor shall coordinate all deliveries, staging areas, installations, and parking arrangements with the COR.

7.9.5. The Contractor shall remove all related shipping debris and clean up any construction associated with delivery and installation of the specified items. The Contractor shall remove all packaging from the VA premises.

7.9.6. The Contractor shall be responsible for any damage to the building that occurs due to Contractor error or neglect.

8. SITE CONDITIONS

8.1. There shall be no smoking, eating, or drinking inside the hospital at any time.

8.2. The Contractor shall comply with all CAVHS infection control, safety, and access requirements while on site.

9. INSPECTION AND ACCEPTANCE

9.1. The Contractor shall conduct a joint inspection with the COR upon delivery and installation of equipment.

9.2. The Contractor shall provide dates of completion of punch list items and replacement parts and/or short‑ship items from the manufacturer.

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

9.4. Final acceptance will be contingent upon:

9.4.1. Successful installation and operation of the osmometer without critical errors.

9.4.2. Completion of onsite training for designated staff.

9.4.3. Successful completion of the laboratory’s verification/validation studies demonstrating that performance meets manufacturer and laboratory requirements.

10. DELIVERABLES

10.1. Equipment

10.1.1. One Advanced Instruments Osmo1 Single-Sample Micro-Osmometer (or VA‑approved equivalent), fully assembled and operational.

10.1.2. All standard accessories required for operation as described under Salient Characteristics.

10.2. Consumables

10.2.1. Initial lot of reagents, standards, and controls sufficient to complete installation and method validation and to support approximately one month of routine testing (or as agreed to by the facility).

10.3. Documentation

10.3.1. Operation and Maintenance Manuals

10.3.1.1. Complete sets of operator’s manuals (hard copy and digital, if available).

10.3.1.2. Technical/service manuals, if available (hard copy and/or digital).

10.3.2. Maintenance Schedule

10.3.2.1. Compilation of all manufacturer‑recommended maintenance and operation materials packaged in binder(s) or electronic format to the COR upon completion of installation.

10.4. Training

10.4.1. Documentation of onsite operator training (attendance sheets, topics covered).

11. OPERATOR TRAINING

11.1. The Contractor shall provide onsite training of the equipment to the users. Operator training shall be coordinated with the CAVHS COR after installation is complete.

11.2. Training shall include, at a minimum:

11.2.1. Instrument start‑up and shut‑down procedures.

11.2.2. Sample handling and testing workflow.

11.2.3. Calibration and calibration verification procedures.

11.2.4. Quality control procedures, including interpretation of QC results and corrective actions.

11.2.5. Routine maintenance, cleaning, and replacement of consumable components.

11.2.6. Basic troubleshooting and error message interpretation.

11.3. Additional follow‑up training sessions shall be available (in person or remote) during the warranty period if requested by the facility.

12. PROTECTION OF PROPERTY

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

12.2. The Contractor shall perform an inspection of the building(s) and grounds with the COR prior to commencing work, as requested, to document pre‑existing conditions.

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

12.4. The Contractor shall provide floor protection while working in all VA facilities. All material handling equipment shall have non‑marking, rubber wheels.

13. SECURITY REQUIREMENTS

13.1. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA personnel regarding information and information system security.

13.2. If the instrument is connected to VA networks or systems, all access and configuration shall comply with VA Office of Information and Technology (OIT) and local Information Security Officer (ISO) requirements.

13.3. The Contractor shall not retain, use, sell, or disseminate any patient‑identifiable information. Any data used for demonstration or testing shall be de‑identified.

13.4. Any additional VA information security, privacy, records management, or training clauses required by VA policy shall apply and are incorporated by reference in this SOW and resultant contract.

14. WARRANTY

14.1. The Contractor shall provide a minimum one‑year manufacturer’s warranty on all parts and labor for the osmometer and associated components, starting upon completion of installation and Government acceptance, unless otherwise specified in the contract.

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

14.3. The Contractor shall provide telephone and/or remote technical support for troubleshooting during normal business hours.

14.4. The Contractor shall perform at least one preventive maintenance visit during the warranty period if specified in the offer, or shall clearly indicate if preventive maintenance is not included.

14.5. Documentation of all maintenance and repairs will be provided to the COR and the Clinical Engineering/Biomedical Engineering department, as applicable.

15. PROTECTION OF PROPERTY

16. SECURITY REQUIREMENTS

16.1. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

16.2. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by 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.

16.3. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, 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.

16.4. 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.

17. CONTRACTOR SECURITY REQUIREMENTS

17.1. 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.

18. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

18.1. A contractor/subcontractor 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.

18.2. 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.

18.3. 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.

18.4. 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.

18.5. 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.

19. VA INFORMATION CUSTODIAL LANGUAGE

19.1. 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

19.2. - General, FAR 52.227-14(d) (1).

19.3. 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.

19.4. 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.

19.5. 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.

19.6. 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.

19.7. 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

19.8. payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

19.9. 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.

19.10. 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.

19.11. 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.

19.12. 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.

19.13. 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.

19.14. 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.

20. SECURITY INCIDENT INVESTIGATION

20.1. 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.

20.2. 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.

20.3. 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.

20.4. 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.

21. LIQUIDATED DAMAGES FOR DATA BREACH

21.1. 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.

21.2. 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.

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

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

21.3.2. Description of the event, including:

21.3.3. date of occurrence;

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

21.3.5. Number of individuals affected or potentially affected;

21.3.6. Names of individuals or groups affected or potentially affected;

21.3.7. 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;

21.3.8. Amount of time the data has been out of VA control;

21.3.9. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

21.3.10. Known misuses of data containing sensitive personal information, if any;

21.3.11. Assessment of the potential harm to the affected individuals;

21.3.12. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

21.3.13. 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.

21.3.14. 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:

21.3.15. Notification;

21.3.16. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

21.3.17. Data breach analysis;

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

21.3.19. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

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

22. TRAINING

22.1. 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:

22.2. 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;

22.3. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

22.4. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

22.5. 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.]

22.6. The contractor shall provide to the contracting officer and/or the COTR a copy of the

23. RECORDS MANAGEMENT OBLIGATIONS

A. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

· Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

· In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

· In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

· [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

· The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

· The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

· The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy.

· The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

· The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

· The [Agency] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

· Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D. Flow down of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

1. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

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