Statement of Work.docx

MODULAR CARDIOVASCULAR CATHETERIZATION LABORATORY UNIT

STATEMENT OF WORK (SOW)

1. GENERAL:

1.1. SUPPLIES AND SERVICES REQUIRED:

1.1.1. The Contractor shall provide a Cardiovascular Catheterization Laboratory Modular Cath Lab Unit and the equipment to perform on-site Cardiovascular Catheterization Laboratory procedures, as described in the following sections of the Statement of Work, to the Edward Hines Jr. Veterans Affairs Hospital (herein referred to as Hines VA).

1.2. PRICING INSTRUCTIONS:

1.2.1. The offeror is instructed to make pricing submissions based on the CLIN’s or Sub-CLIN’s provided.

1.3. PLACE OF DELIVERY AND PERFORMANCE:

1.3.1. Modular Cath Lab Building and equipment shall be provided, on-site, at the Hines VA at 5000 South 5th Avenue, Hines, IL 60141. See the attached site plan.

1.3.2. The Contractor shall be responsible for water and sewer connections up to 10 feet from the trailer’s location.

1.3.3. The Contractor shall be responsible for electrical connections up to 50 feet from the trailer’s location.

1.3.4. The Contractor shall be responsible for telecom, phone, security cabling, fire alarm, and other low voltage connections up to 50 feet from the trailer’s location.

1.4. PERIOD OF PERFORMANCE:

1.4.1. Base Period: 4 months starting within 45 days from award

1.4.1.1. Option periods: 2 month increments for up to 4 months

1.5. DEFINITIONS AND ACRONYMS:

1.5.1. ADA: Americans with Disabilities Act

1.5.2. Cardio: Cardiovascular

1.5.3. Cat 5: Category 5 Cable

1.5.4. Cath: Catheterization

1.5.5. CD-R: Compact Disc, Recordable

1.5.6. CLIN: Contract Line Item Number

1.5.7. CO: Contracting Officer

1.5.8. COR: Contracting Officer’s Representative

1.5.9. CPR: Cardiopulmonary Resuscitation

1.5.10. CPRS: Computerized Patient Recordkeeping System- electronic health record system used by the VA

1.5.11. DICOM: Digital Imaging and Communications in Medicine

1.5.12. FDA: The Food and Drug Administration

1.5.13. FFR: Fractional Flow Reserve

1.5.14. HIPAA: Health Insurance Portability and Accountability Act

1.5.15. ICD: Implantable Cardioverter-defibrillator

1.5.16. IMERS: International Association of Medical Equipment Remarketers & Services

1.5.17. IT: Information Technology

1.5.18. IVUS: Intravascular Ultrasound

1.5.19. JC: Joint Commission

1.5.20. Lab: Laboratory

1.5.21. N.E: Northeast

1.5.22. NEC: National Electric Code

1.5.23. NFPA: National Fire Protection Association

1.5.24. OEM: Original Equipment Manufacturer

1.5.25. IL: Illinois

1.5.26. Hines VA: Edward Hines Jr. VA Hospital

1.5.27. OSHA: Occupational Safety and Health Administration

1.5.28. PACS: Picture Archiving and Communication System

1.5.29. SUB-CLIN: Sub-Contract Line Item Numbers

1.5.30. UPS: Uninterruptible Power Supply

1.5.31. VA: Veterans Affairs

1.5.32. VISTA: The Veterans Information Systems and Technology Architecture

2. SITE VISIT:

2.1. Potential offerors are required to inspect the site, at the Hines VA, where the Modular Cath Lab Building will be installed. Due to unusual site requirements, there might be issues and/or conditions affecting the cost of the installation, removal, labor, equipment, tools, repair, replacement, and maintenance of the Modular Cath Lab Building.

3. TERMS OF CONTRACT:

3.1. The contracts base year is from approximately April 1st through July 31, 2021. After the base period there will be two (2) 2-month option periods. The contract extensions are subject to the availability of Hines VA FY21 and FY22 funds. The Contractor shall perform no services, extensions, or deviations from the contract unless authorized by the Contracting Officer in writing.

4. TRAINING:

4.1. Only Hines VA employees shall provide patient care. The Contractor is required to provide comprehensive training for operation of the Modular Cath Lab Building equipment, software, and hardware. Contractor shall make the necessary arrangements with the COR to schedule training sessions. Training shall not be performed on weekends, after normal business hours (7:30 A.M. to 4:00 P.M.), or federal holidays. The training must be completed before patients can be treated in the Modular Cath Lab Building.

4.2. During the course of training Contractor’s Staff are required to follow all federal, state, and local HIPAA and Privacy laws, rules, and regulations.

5. CUSTOMER SERVICE:

5.1. The Contractor shall have a 24/7 customer service, for the Modular Cath Lab Building, available for the Hines VA.

5.1.1. The 24/7 customer service shall be reachable by phone.

5.1.2. The 24/7 customer service shall provide support on the Contractor supplied equipment, software, and hardware.

5.1.3. Within 24 hours of the phone call made by Hines VA, the Contractor shall have staff on station to initiate the necessary repairs, install replacement parts, upgrade software, etc. with the intent to return the Modular Cath Lab Building to service.

6. USE OF EQUIPMENT:

6.1. After comprehensive training has been completed by the Contractor, qualified Hines VA employees will be authorized to use the Contractor’s furnished equipment to perform cath lab procedures.

7. AUTHORITY:

7.1. This procurement is being conducted under Federal Acquisition Regulation (FAR) Part 12, Acquisition of Commercial Items. The contract is non-exclusive and shall in no way inhibit the Hines VA or the Contractor from entering into other Contractual Obligations.

8. PURPOSE:

8.1. The intent of the contract is to provide an interim Modular Cath Lab Building while new Cath Lab suites and systems are being built and installed at the Hines VA.

9. PROCEDURES TO BE PERFORMED IN THE MODULAR CATH LAB BUILDING:

9.1. Cardiac Cath/ STEMI.

9.2. Intra-aortic Balloon Pump.

9.3. Pericardiocentesis.

9.4. Peripheral Angiography/ Interventions.

9.5. Pacemakers/ ICD.

9.6. Temporary Pacing Wire.

9.7. Coronary Angiography and Interventions.

9.8. Implantable Loop recorder.

10. CONTRACTOR’S FURNISHED EQUIPMENT:

10.1. To achieve high quality diagnostic and interventional imaging and high standards of care, the Contractor’s equipment shall be state-of-the-art.

10.2. Contractor shall provide an equipment list of all Contractor furnished equipment:

10.2.1. Must include the name of the manufacturer, model number, manufacturer’s brochures, pertinent data sheets, equipment specifications, and any special cleaning procedures.

10.3. All imaging equipment must be FDA approved.

10.4. The Modular Cath Lab Building and all Contractor’s provided equipment shall adhere to all applicable local, state, federal, industry, JC, NEC, NFPA, VA, ADA, and OSHA recommendations, rules, regulations, and laws.

10.4.1. This includes when the building is being transported, initial set-up, operation by the Hines VA, disconnection and removal from the Hines VA.

11. EQUIPMENT SPECIFICATIONS:

11.1. All Contractor supplied equipment must be compatible with Hines VA IT systems and firewall requirements.

11.2. The following minimum equipment and capabilities listed in sections 11.3. through 11.16 are required.

11.3. Must have a Cardiac Cath Lab X-ray System.

11.3.1. The procedure table, in the Modular Cath Lab Building, must be capable of the requirements listed in sections 11.3.1.1. through 11.3.1.2.3.1.:

11.3.1.1. Supporting up to 450-pound patients.

11.3.1.2. Padding or mattress on the procedure table to maximize patient comfort during procedures.

11.3.1.2.1. The padding or mattress shall not obstruct or interfere with the Cath Lab procedures as listed in section 9.

11.3.1.2.2. Capable of handling the weight of normal CPR compressions (in an emergency) in addition to a 450-pound patient.

11.3.1.2.3. Must have rails attached to the table on either side of the table.

11.3.1.2.3.1. The rails shall not obstruct or interfere with the Cath Lab procedures as listed in section 9.

11.4. In the resting or neutral position, the X-ray tube must be below the detector.

11.5. Must have a ceiling mounted radiation shield.

11.6. Must have a table X-ray protection shield.

11.7. Must have adequate electrical outlets for ancillary equipment used for Cath Lab and Peripheral procedures as described in section 9.

11.8. Must have a ceiling mounted examination light.

11.9. Must have at least a 10-inch detector on the Cath Lab X-ray System.

11.10. Must have at least three monitors, viewable and diagnostically readable from the table during a procedure, mounted on a ceiling boom or arm in the procedure room.

11.10.1. The information, pictures, and videos displayed on the three monitors in the procedure room shall be duplicated or slaved in or to the control room.

11.11. Must be compatible with the Hines VA Hemodynamic Monitoring System, GE Maclab.

11.12. Must have an image review workstation in the control room.

11.13. Must have DICOM imaging transfer capabilities.

11.14. Must be compatible with the Hines VA’s PACS.

11.15. Contractor will be required to make any adaptations necessary so the Contractor’s equipment is compatible with the Hines VA’s furnished services defined in section 18.

11.16. The Cath Lab X-ray System shall provide consistent images of high technical quality as defined by the manufacturer.

12. TELECOMMUNICATIONS:

12.1. The Modular Cath Lab Building shall be equipped with connections capable of transmitting data and voice through a Government provided cat 5.

12.2. The Contractor’s Modular Cath Lab Building shall be able to connect to VISTA Imaging Network and CPRS to view pertinent patient information and to enter procedure notes by Cardiac Cath Lab personnel.

12.3. The Modular Cath Lab Building shall have at least one phone line in the control room and one phone line in the procedure room.

12.4. The Modular Cath Lab Building shall have adequate cat 5 data ports/jacks for each workstation.

13. BUILDING SPECIFICS:

13.1. The Modular Cath Lab Building must have climate controls inside the building that are easily accessible by Hines VA employees.

13.1.1. The Modular Cath Lab Building climate must be capable of being adjusted to constantly and consistently stay between 66-68 degrees Fahrenheit.

13.2. The patient entry door shall be wide enough to accommodate gurneys, wheelchairs, disabled patients and hospital beds.

13.3. The Modular Cath Lab Building shall have a patient lift provided by the Contractor for patients to enter and exit the trailer Procedure Room. The lift shall be able to accommodate gurneys, wheelchairs, disabled patients and hospital beds. The lift shall be set level with the door threshold to adhere to ABA-compliant floor level changes.

13.4. The Modular Cath Lab Building shall have a service stair provided by the Contractor for staff to enter and exit the trailer Control Room.

13.4.1. The Modular Cath Lab Building service stairs must not connect directly to the procedure room.

13.5. The Modular Cath Lab Building shall have a code button capable of being hooked up to the Hines VA code system.

13.6. The Modular Cath Lab Building shall have a designated procedures room.

13.7. The Modular Cath Lab Building shall have a designated control room.

13.8. The procedure room and the control room must be separated by a lead-lined door that can be opened and closed.

13.9. There must be a window between the procedure room and the control room.

13.9.1. The window must be lead-lined.

13.10. There must be ample lighting in the Modular Cath Lab Building to perform any Cath Lab procedures as defined in section 9.

13.11. There must be an intercom between the procedure room and the control room.

13.11.1. Employees in the control shall be able to utilize the intercom system to talk to fellow staff or patients in the procedure room and vice versa

13.12. The entryway from outside the Modular Cath Lab building into the procedure room must have a door large enough to accommodate the following in sections 13.11.1. through 13.11.3.:

13.12.1. A gurney.

13.12.2. A hospital bed.

13.12.3. An extra wide wheelchair.

13.13. The procedure room door and the control room door must be on the same side of the building.

13.14. The Modular Cath Lab Building must have a fire alarm system which connects to the hospital fire alarm system.

13.14.1. The connection to the hospital fire alarm system will be executed by the Contractor and coordinated with Hines VA Engineering.

13.14.2. The building must have a fire extinguisher that is secured but readily accessible in the event of a fire.

13.14.3. The unit must have an automatic, self-contained fire sprinkler system and fire extinguisher.

13.15. The building must have a scrub sink and area.

13.16. All outside doors leading into the Cath Lab Building must be capable of being locked, from the outside, when not in use.

13.17. The unit cannot be larger than 48 feet long and 16 feet wide. It must be capable of being place on the designated location without blocking the main entrances to the existing Hines buildings.

14. BUILDING SET UP SPECIFICS, MODIFICATIONS, AND FIRE CONTROL SYSTEMS:

14.1. The unit must be leveled as specified by the manufacturers’ requirements for Contractor supplied equipment.

14.2. The building must be capable of withstanding normal Illinois Weather.

14.2.1. The Hines VA is not responsible for ANY weather damage to the Modular Cath Lab Building.

14.3. Modular Cath Lab Building must be able to be modified to accommodate security protocols in accordance with VHA Handbook 1108.01, VHA Handbook 1108.02, Center Memorandum 119-22, VHA Handbook 0730, and any other laws, regulations, or policies that must be followed for the daily operation of the Modular Cath Lab Building.

14.4. All fire control systems and fire extinguishers must be certified in accordance with all applicable laws, regulations, and policies during the period of performance of the Contract. All fire control systems and fire extinguishers must have a current annual inspection tag during the period of performance of the Contract.

14.5. Security Modification Requirements

14.5.1. Must be able to install controlled access locks.

14.5.1.1. Examples, PIV reader, magnetic locks, and changing door lock core

14.6. Medication Modification Requirements

14.6.1. Must be able to install a tabletop Omnicell and cactus sink

14.6.1.1. The tabletop Omnicell must be bolted to a non-mobile table

14.6.1.1.1. Supports must be able to be installed underneath and suspended tables

14.7. Training for Staff

14.7.1. Comprehensive training on how to use the fire extinguishers and fire control system will be provided to all staffing working in the Modular Cath Lab Building.

14.8. Fire Extinguishers

14.8.1. Building must be equipped with fire extinguisher

14.9. Halon Systems

14.9.1. When utilized it must not displace the oxygen. This is vital to ensure staff and patients undergoing procedures can be evacuated without being exposed to an oxygen deficient environment.

14.9.2. Must be equipped with a push and hold button for aborting the Halon System activation.

14.9.3. Must give a sound warning to staff to allow for the button to be pushed.

14.9.4. System must require both the heat and smoke detectors to be activated before activating the Halon System.

14.9.5. Staff must be able to activate the Halon System immediately by a Halon pull station.

14.10. Lighting

14.10.1. All egress lighting and exit signs must be working at the time of delivery and throughout the duration of the lease.

15. EQUIPMENT LIST:

15.1. The Modular Cath Lab Building computers provided by the Contractor shall be equipped with CD and DVD burning capabilities as a backup to network transferred data.

16. ACCESSORY EQUIPMENT:

16.1. Accessory equipment listed below shall be provided by the Contractor:

16.1.1. UPS and power conditioning equipment for Modular Cath Lab Building.

17. ADDITIONAL REQUIREMENTS:

17.1. The Contractor shall provide Hines VA with a Modular Cath Lab Building and equipment that meets or exceeds the following requirements:

17.1.1. Imaging system technology must be approved by the FDA.

17.1.2. Standards of Care and manufacturer standards and/ or recommendations.

17.1.3. Shall have adequate space for the necessary extra staff and/or machines to monitor sedated patients.

18. UTILITIES/SERVICES:

18.1. Utility connections for the Modular Cath Lab Building, as stated in sections 18.2.1. through 18.2.7. must be relatively common and available at a standard commercial facility.

18.2. The following utilities and/or services will be provided by the Hines VA, if necessary, for operation of the Modular Cath Lab Building:

18.2.1. Water to the unit.

18.2.1.1. Water service will be provided within 10 feet of the trailer location. It is the Contractor’s responsibility to connect the water service to the trailer. If multiple lines are needed the Contractor shall be responsible for splitting the distribution of the water service at the trailer.

18.2.2. Electricity to the unit.

18.2.2.1. Electric service will be provided within 50 feet of the trailer location. It is the Contractor’s responsibility to connect the electric service to the trailer. If multiple lines are needed the Contractor shall be responsible for splitting the distribution of the electric service at the trailer.

18.2.3. Sewage from the unit.

18.2.3.1. Sewer service will be provided within 10 feet of the trailer location. It is the Contractor’s responsibility to connect the sewer service to the trailer. If multiple lines are needed the Contractor shall be responsible for splitting the distribution of the sewer service at the trailer.

18.2.4. Telephone Line(s) from the unit.

18.2.4.1. Telephone service will be provided within 50 feet of the trailer location. It is the Contractor’s responsibility to connect the telephone service to the trailer. If multiple lines are needed the Contractor shall be responsible for the distribution of the telephone service at the trailer.

18.2.5. At least Cat 5 data lines from the unit.

18.2.5.1. Telecom service will be provided within 50 feet of the trailer location. It is the Contractor’s responsibility to connect the telecom service to the trailer. If multiple lines are needed the Contractor shall be responsible for the distribution of the telecom service at the trailer.

18.2.6. Housekeeping in and around the unit.

18.2.7. Law Enforcement in and around the unit.

19. EQUIPMENT MAINTENANCE OR REPAIRS:

19.1. The Contractor will be notified, through a phone call and followed up in writing (email) from the CO or COR, if equipment is failing, malfunctioning, or not working properly.

19.2. The Contractor shall be responsible for the following, in sections 19.2.1. through 19.2.3., to the Modular Cath Lab Building and Contractor provided equipment:

19.2.1. Any preventive maintenance.

19.2.1.1. The Contractor shall provide the most recent preventative maintenance checklists on all Contractor provided equipment.

19.2.1.1.1. The checklists provided must include the date the preventive maintenance was performed and clearly show the equipment is within acceptable working parameters as required by the manufacturers’ specifications, Hines VA, and JC.

19.2.2. Any repairs.

19.2.3. Replacement of any kind.

19.3. If any individual is utilized other than a Contractor’s employee or a manufacturer’s certified technician to perform any work on the Modular Cath Lab Building prior approval must be given in writing from the CO.

19.4. All maintenance and repairs on the Modular Cath Lab Building and Contractor’s provided equipment shall be performed in accordance with the manufacturer’s recommendations and standards.

19.5. If the equipment fails, malfunctions, or is not functioning properly repairs will be performed on-site.

19.5.1. Equipment or building repairs will be completed within ONE 1 calendar day, from the initial phone call followed by written notice (email). Refer to section 21 for more details.

20. PARTS:

20.1. The Contractor shall use OEM parts. The Contractor shall not install used parts, rebuilt parts, or parts from another machine without prior written approval from the CO or the COR.

20.2. Hines VA personnel will be assigned once the Modular Cath Lab Building is in place. The Hines VA personnel will establish network connectivity from the Modular Cath Lab Building through the Hines VA IT firewall. The Contractor and Hines VA IT official will discuss firewall security and patient data purging procedures from the Contractor’s computer hard drives and equipment in the Modular Cath Lab Building.

20.3. The Modular Cath Lab Building driver shall be licensed as required to operate the vehicle the building is transported on.

20.4. The Contractor is responsible for delivery of the Modular Cath Lab Building to the Hines VA’s site.

20.5. Hines VA’s Engineering, HTM Service, and OI&T Service are responsible for assisting the Contractor in the coordination of the setup of the building on-site.

21. CONTRACTOR’S REPRESENTATIVES AND PERSONNEL:

21.1. Contractor shall be a member in good standing with the International Association of Medical Equipment Remarketers & Services (IMERS).

21.2. Contractor shall coordinate with the COR to allow adequate time for setup of the Modular Cath Lab Building to avoid delays in patient care.

21.3. Name of responsible individual(s) or main point of contact for the Contractor will be provided, in writing, to the CO and COR prior to delivery, setup, and final acceptance of the trailer.

22. ADDITIONAL CONTRACTOR’S RESPONSIBILITY:

22.1. Prior to the building delivery date, the Contractor shall perform any necessary tests to allow the Modular Cath Lab Building and all associated equipment to be completely operational.

22.2. Consultation with Hines VA Engineering Service is required for coordination of the site utilities.

22.3. Removal of the Contractor’s Equipment and Building:

22.3.1. The Contractor will be responsible for removing the Modular Cath Lab Building and Contractor furnished equipment from the Hines VA. The date of the removal will occur either at the end of the contract, at the end of the month, or as agreed upon, in writing, by the Contractor and CO.

23. CONTRACTOR’S BUILDING REMOVAL OR EXIT FUNCTIONS:

23.1. The actions detailed in sections 24.1.1 through 24.1.3. will be coordinated with the COR and Hines VA IT Service:

23.1.1. Ensure all Hines VA patient data is completely transferred to the HINES VA computer system(s) or servers.

23.1.2. All Hines VA patient information required for Contractor’s record is secured according to HIPAA guidelines.

23.1.3. All Hines VA patient information not required for Contractor’s record is erased from all Contractor equipment and computers.

23.2. The actions detailed in sections 24.2.1 through 24.2.3. will be coordinated with the COR and Hines VA Engineering Service:

23.2.1. All connections from the Modular Cath Lab Building to Hines VA property are properly disconnected, capped, and/or secured by the Contractor.

23.2.2. All temporary site preparations installed by the Contractor shall be removed.

23.2.3. The Contractor’s building and equipment is removed from the Hines VA premises safely and following any applicable federal, state, and local rules, codes, regulations, and laws.

24. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE:

24.1. 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 requirements. This must be completed within 30 days of termination of the contract.

24.2. 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:

24.2.1. Vendor must accept the system without the drive;

24.2.2. 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

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

24.2.4. 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;

24.2.4.1. 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

24.2.4.2. 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.

24.2.4.3. 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.

25. CONTRACTOR SECURITY REQUIREMENTS (HANDBOOK 6500.6):

25.1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

25.1.1. 839.201 Contract clause for Information and Information Technology Security:

25.1.1.1. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

25.1.1.2. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

25.2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

25.2.1. As prescribed in 839.201:

25.2.1.1. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

25.3 SECURITY INCIDENT INVESTIGATION

25.2.2. 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 COR 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.

25.2.3. 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.

25.2.4. 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.

25.2.5. 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.

25.3. LIQUIDATED DAMAGES FOR DATA BREACH

25.3.1. 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.

25.3.2. 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.

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

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

25.3.3.2. Description of the event, including:

25.3.3.3. date of occurrence;

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

25.3.3.5. Number of individuals affected or potentially affected;

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

25.3.3.7. 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;

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

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

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

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

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

25.3.3.13. 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.

25.3.4. 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:

25.3.4.1. Notification;

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

25.3.4.3. Data breach analysis;

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

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

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

25.4. TRAINING

25.4.1. 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:

25.4.1.1. 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;

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

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

25.4.1.4. 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.]

25.4.2. The contractor shall provide to the contracting officer and/or the COR 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.

25.4.3. 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.

25.5. GENERAL

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

25.6. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

25.6.1. 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.

25.6.2. 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.

25.6.3. 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.

25.6.4. 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.

25.6.5. 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.

25.7. VA INFORMATION CUSTODIAL LANGUAGE

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

25.7.2. 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.

25.7.3. 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.

25.7.4. 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.

25.7.5. 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.

25.7.6. 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.

25.7.7. 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.

25.7.8. 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.

25.7.9. 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.

25.7.10. 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.

25.7.11. 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.

25.7.12. 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 COR.

25.7.13. The C&A requirements do not apply, and the Security Accreditation Package is not required:

25.7.14. Training certificates are in place, which ensures the contractor and employee(s) will protect VA sensitive information.

25.8. A&A requirements do not apply, and a Security Accreditation Package is not required.

25.9. SECURITY CONTROLS COMPLIANCE TESTING

25.9.1. 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.