Active

Contract Opportunity

On behalf of the Robley Rex VA Medical Center , Network Contracting Office (NCO) 9 is issuing this sources sought notice (SSN) as a means of conducting market research to identify parties having an interest in, and the resources to support, this requirement for a firm-fixed-priced, Base plus 4 Options, Indefinite Delivery/Indefinite Quantity (IDIQ) for various radiopharmaceuticals. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 325412 - Pharmaceutical Preparation Manufacturing.

THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for bids, proposals, or quotes; submission of any information in response to this market survey is purely voluntary; and the government assumes no financial responsibility for any costs incurred.

If your organization has the potential capacity to perform these services, please provide the following information:

Organization name, address, point of contact, email address, web site address, and telephone number.

Business size: small, small disadvantaged, woman-owned, Hub Zone, serviced-disabled veteran-owned small business (SDVOSB), veteran owned small business (VOSB), large business, etc.

Business type under NAICS 325412, which contains a size standard of 1,300 employees, Commercial And Government Entity (CAGE) Code and Unique Entity Identification (UEI) Number.

Under which NAICS code does your company usually provide the requirements described in the Statement of Work (SOW) - Please provide rationale for your answer if different from NAICS 325412.

Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational, and staff capability.

Please provide the following information as an attachment to your response:

Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes.

Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each.

Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner?

Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company.

Response to this SSN shall not exceed 10 pages and should include all of the fore-mentioned information. In addition, all submissions should be provided electronically in a Microsoft Word or Adobe Portable Document Format (PDF).

The government will evaluate market information to ascertain potential market capacity to:
Provide services consistent in scope and scale with those described in this notice and otherwise anticipated. Secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements.

Implement a successful plan that includes: compliance with program schedules; cost containment; meeting and tracking performance.

Provide services under a firm-fixed-price contract.

NOTE: Respondent claiming SDVOSB and VOSB status shall be registered and Center for Veterans Enterprise (CVE) verified in VetBiz Registry www.vetbiz.gov.

Based on the responses to this SSN/market research, this requirement may be set-aside for SDVOSBs, VOSBs, small businesses, procured through full and open competition, or sole sourced.

Submission Instructions: Interested parties who consider themselves qualified to perform the services are invited to submit a response to this SSN by 16:00 CT, April 18, 2024. All responses under this SSN must be emailed to Martha.Warren1@va.gov. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

SAM: Interested parties shall be registered in the System for Award Management (SAM) as prescribed in FAR Clause 52.232-33. SAM information can be obtained by accessing the internet at www.sam.gov or by calling 1-866-606-8220.

Disclaimer and Important Notes. This notice does not obligate the government to award a contract or otherwise pay for the information provided in response to this SSN. The government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the government to determine the organization s qualifications to perform the work. Respondents are advised that the government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities (FBO). However, responses to this notice shall not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

See attached SOW.

Radiopharmaceuticals required: Interested vendors must be able to provide ALL of the following items or Nuclear Medicine Service clinically approved alternatives for a Base period plus 4 Option Years:
Products (including software, licenses)
Item #
Description/Part Number*
Qty
1
NUC MED Thyroid Uptake & ScanBB3:C43
I-123- 200 uCi capsule(s)
26
2
NUC MED Thyroid Uptake & Scan
I-123- 100 uCi capsule
7
3
NUC MED CA METS THYROID IMAGING
I -123 - 2-4mCi mini cap
5
4
NUC MED LYMPHOSCINITIGRAPHY
99mTc Filtered S.C. - .5 mCi
15
5
NUC MED HEMANGIOMA LIVER
99mTc 04 - 25 mCi
7
6
NUC MED SPECT LIVER
99mTc 04 - 25 mCi
5
7
NUC MED LIVER/SPLEEN
99mTC Sulfur Colloid - 5 mCi
3
8
NUC MED HEPATOBILIARY/GALLBLADDER
99mTc Choletec 5 mCi
65
9
NUC MED GASTRIC EMPTYING
99mTc Sulfur Colloid - .5mCi
142
10
NUC MED GASTRIC EMPTYING
99mTc DTPA - 1 mCi
1
11
NUC MED GI BLOOD LOSS IMAGING
99mTc 04 - 25 mCi
10
12
NUC MED MECKELS LOCALIZATION
99mTc 04 - 15 mCi
3
13
NUC MED BONE SCAN, WHOLE BODY
99mTc MDP - 20 mCi
150
14
NUC MED BONE (III PHASE)
99mTc MDP - 20 mCi
10
15
NUC MED GATED HEART/MUGA
99mTc 04 - 25 mCi
3
16
NUC MED LUNG PERFUSION V/Q
99mTc MAA 5 mCi
75
17
VENTILIATION LUNG SCAN
99MtC DTPA Aerosol - 25 mCi
50
18
NUC MED PULMONARY QUANTITATIVE
99mTc MAA - 5mCi
2
19
NUC MED RENAL SCAN & FLOW
99mTC MAG3- 10 mCi
12
20
NUC MED INFECTION LOCALIZATION
Tc99M Ceretec WBC - 20 mCi
8
21
NUC MED CISTERNOGRAM
In-111 DTPA - .5 mCi
0
22
RADIOPHARMACEUTICAL THERAPY THYROID
I-131 - physician determined
3
23
NUC MED PARATHYROIDA A A A A A A A A A A A A A A A A A A A A A A A
99mTc Sestamibi (Cardiolite) - 25 mCi
10
24
PET IMAGE WITH CT WHOLE BODYA A A A A A A A A A A A A A
F-18 FDG - 15 mCi
975
25
MYOCARDIAL PERFUSION SINGLE STUDY HIGH DOSE
99mTc Sestamibi (Cardiolite) - 30 mCi
1350
26
MYOCARDIAL PERFUSION MULTIPLE STUDY LOW DOSEA
99mTc Sestamibi (Cardiolite) - 10 mCi
1350
27
Lobenguane Sulfate (Adreview)
I-123 MIBG 1-10 mCi
0
28
Myoview
0
29
Brain Perfusion Imaging Tc99m HMPAO (Ceretec)
2
30
ULTRATAG RBC 5 VIAL KIT / BIODEX STOCK NO. N068B0
15
31
IV-600P Insta/Vent Radioaerosal Kit, Two Tube System
50
32
IV-600PM Insta/Vent Radioaerosal Kit, Two Tube System
10
33
HESPAN/HEPARIN SYRINGE FOR WBC BLOOD TAG
10
34
PHARMACIST CALLOUT AFTER HOURS
50
35
Cu-64 (Dotatate)
40
36
Calibration Service for Survey Meters
5
37
DaTscan Ioflupane
24
38
Ga-68 (dotatate)
0
39
Linearity 99mTc 04 - 300 mCi
2
40
Ba-133 Reference Vial Dose
1
41
Cs-137 Reference Vial Dose
1
42
CO 57 RECTANGULAR 10 mCi COLBALT FLOOD - 10mci
0
43
CO 57 RECTANGULAR 10 mCi COLBALT FLOOD -20mci
0
44
Germanium-68 Annulus Sealed Source
1
45
CO-57 REFERENCE VIAL DOSE
1
46
PERTECHNITATE FOR CONFIRMATORY SHIELDING SURVEY(S) (50-100 mCi)
20


STATEMENT OF WORK
for
Radiopharmaceuticals, Robley Rex VAMC

STATEMENT OF OBJECTIVES
The Contractor will be required to provide radiopharmaceutical supplies and services to the Robley Rex Veterans Affairs Medical Center (Robley Rex VAMC). Services will include, but are not limited to the following:
SCOPE/DELIVERY:
1.1 Contractor will provide the Robley Rex VAMC a copy of their current radioactive material permit or license for the authorized service of a radiopharmacy. The contractor will provide updated copies when permit or license has expired.
1.2 Robley Rex VAMC Nuclear Medicine Technologists (NMT), Authorized Users (AU) or Radiation Safety Officer (RSO) will be authorized to place telephone orders for radiopharmaceuticals, sealed sources, and unsealed materials used for quality control (QC) and performing confirmatory shielding surveys.
1.3 Contractor will supply two (2) phone numbers for ordering after normal business hours. Orders shall be placed the afternoon before the required delivery date for exact quantities of each unit dose or during the business day for patients added on overnight.
1.4 Deliveries will be made to the Robley Rex VAMC, 800 Zorn Avenue, Louisville, KY, 40206-1499 or Robley Rex VAMC 4906 Brownsboro Road Louisville, KY 40222 Nuclear Medicine Hot Lab(s) during normal business hours Monday-Friday 6:30 AM - 4:30 PM. The room number (s) for the Nuclear Medicine Hot Lab(s) will be provided and updated as needed by a NMT, RSO or COR for this contract.
1.5 Four (4) free daily deliveries will be made during routine business hours defined as Monday-Friday 6:30 AM -4:30 PM (excluding holidays) are required.
1.6 Emergency orders can be placed at any time with expected delivery within one (1) hour of the order.
1.7 Deliveries made outside of normal business hours or on the weekend (Saturday/Sunday) and all Federal Holiday (or any other day specifically declared by the President of the United States to be a national holiday) shall be made by contacting the Veterans Affairs Medical Center Police for delivery to the Nuclear Medicine Hot Lab(s) for placement of the packages.
Federal Holidays:
New Year s Day
Martin Luther King s Birthday
President s Day
Memorial Day
Juneteenth Day
Independence Day
Labor Day
Columbus Day
Veterans Day
Thanksgiving Day
Christmas Day

1.8 Individual radiopharmaceuticals and unsealed materials used for QC and performing confirmatory shielding surveys will be provided in unit dose form. Delivered unit doses will be placed in the appropriate Pig designed to reduce exposure from gamma emitting or beta emitting depending on primary ionizing radiation emitters of radiopharmaceutical.
1.9 Radiopharmaceuticals and sealed sources will be delivered in Department of Transportation (DOT) approved shipping containers.
1.10 Contractor shall provide evidence of DOT training for individuals making deliveries.
QUALITY:
2.1 Contractor shall guarantee the quality and purity of the radiopharmaceutical. Quality Control (QC) shall include the use of Federal Drug Administration (FDA) approved products for the medical use in humans with an available NDC number from the manufacturer, lot/control number, and expiration date for the product supplied.
2.2 LEU Tc99m generators will be used for applicable dose preparation.
2.3 Doses shall be prepared in a clean environment and in compliance with United States Pharmacopeia (USP) 825 compounding requirements.
2.3 Testing of material from generators will include the following applicable pH testing, percent tag, aluminum and 99Mo breakthrough as appropriate. Supporting documentation of all quality requirements will be provided upon request.
2.4 All radiopharmaceuticals shall be calibrated and labeled with radiopharmaceutical name, time the dose was prepared, total volume, and total activity, lot number and bar codes for tracking.
2.5 The contractor will pick up radiopharmaceutical dose(s) measuring 20% greater or less than requested for the specific time. A replacement dose will be provided within one (1) hour of contacting the contractor at no additional charge for the replacement dose.
2.6. Consultation service regarding radiopharmaceutical applications, problems, controls, etc. shall be provided twenty-four hours per day, seven days per week, upon request at no charge.
2.7 The contractor must be licensed and in good standing with the state board of pharmacy to operate a radio-pharmacy and possess a radioactive material permit/license issued by the US NRC or an agreement state for the receipt, preparation, and distribution of radiopharmaceuticals and sealed sources. Any notice of violation (NOV) issued against the contractor by licensing and/or regulatory agencies (state of Kentucky, US Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), FDA, and all other agencies state or federal will be provided to the Robley Rex VAMC within 10 business days of the contractor s receipt of the NOV.
WASTE REMOVAL:
3.1 Each workday, the contractor shall remove all radioactive waste generated by contractor supplied radiopharmaceuticals (to include all syringes with a sealable safety insert for return of spent doses that ensure standard precautions of the used syringe and vials and blood borne contaminants) without cost.
3.2 The Contractor will pick up for return (disposal) and prepare for shipment sealed sources being replaced with sealed sources purchased under this contract in a timely manner. The contractor will provide final disposition documentation of the sealed source will be provided to the Robley Rex VAMC RSO.
INVOICES:
4.1 The contractor will provide the Contracting Officer Representative (COR) and the Lead Nuclear Medicine Technologist copy of invoice for review and approval. All invoices will include name of company name and address, point of contact, contract number, dates of services, purchase order number, invoice number, and an itemized listing of charges.
4.2 Invoices shall be paid to the contractor monthly, in arrears, upon. Contractor will submit reviewed and properly prepared invoice for services/ supplies via TUNGSTEN, Austin, Texas for online certification and payment.
SOFTWARE AND BAR CODE SCANNER(S):
5.1 The contractor grants the Robley Rex VAMC a nonexclusive, nontransferable license to possess and use the software package to track inventory received from contractor and QC procedures performed in Nuclear Medicine.
5.2 The software will be in machine-readable form for use on four (4) personal computer(s) located at the Robley Rex VAMC.
5.3 Robley Rex VAMC may not copy or transfer the software or license to another party. Use means loading onto or transmitting to the personal computer(s) and executing storing or displaying thereon.
5.4 The contractor shall deliver to the Robley Rex VAMC the licensed programs in machine readable object code form and support materials sufficient for Robley Rex VAMC s exercise of its rights under this license. This software license shall remain in full force and effect at no charge for the term of this contract provided the Robley Rex VAMC complies with the terms and conditions of this contract.
5.5 Upon termination, for any reason, Robley Rex VAMC shall promptly return the software together with all its copies, modifications, and merged portions in any form to the contractor. The Robley Rex VAMC may not copy, reproduce, sublicense, assign or transfer this license or the software or remove any copyright or other proprietary notices form the licensed software. Any attempt to sublicense, assign, or transfer any of the rights, duties or obligations hereunder is expressly prohibited. The licensed software and all its intellectual property rights, including without limitation, patent, trademark, copyright and trade secret rights in the licensed software are and shall be the property solely of the contractor. The contractor does not warrant that the functions contained in the software will meet Robley Rex VAMC requirements or that the operation of the software will be uninterrupted or error free. The contractor warrants the disk on which the software is furnished, to be free from defects in materials and workmanship under normal use for the period of ninety days from date of delivery to the Robley Rex VAMC as evidenced by a copy of the receipt. The contractor makes no other warranties with regard to the software. The contractor expressly and specifically disclaims any warranty of merchantability or fitness for a particular purpose. The contractor entire liability and Robley Rex VAMC s exclusive remedy shall be: (a) the replacement of any disk not meeting the contractor s limited warranty and which is returned to the contractor within 90 days of the date of delivery; or (b) if the contractor is unable to deliver a replacement disk which is free of defects in materials or workmanship. The Robley Rex VAMC may terminate this agreement by returning the software to the contractor. In no event will the contractor be liable to the Robley Rex VAMC for any damages including and lost profits, lost savings, or other incidental or consequential damages arising out of the use, or inability to use such software or for any claim by any other party.
SITE VISIT: A site visit may be conducted prior to award of the contract.
All radiopharmaceutical items on contract will be shipped.
Contractor will be on-site for drop off deliveries.
Incidental exposure to PHI is possible, but not required for contractor to perform duties.

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

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/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.
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. 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.
The following standard Items relate to records generated in executing this contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C. Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.
2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.
3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.
4. 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 by the Freedom of Information Act.
5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.
6. The Government Agency owns the rights to all data/records produced as part of this contract.
7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.
8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].
9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules
10. 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 this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

4. 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.

5. LIQUIDATED DAMAGES FOR DATA BREACH
a. Consistent with the requirements of 38 U.S.C. A¡×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. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.
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 $37.50 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.
APPENDIX C

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;

The contractor will go to TMS website (www.tms.va.gov) to self -enroll for the following training.
(2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior Training #10176.

(3) a. In order to engage in work at VA, the contractor is required to ensure all contractor employees, who will be working on the contract, complete a mandatory training program titledA VA Privacy Training for Personnel without Access to VA Computer Systems or VA Sensitive Information (VA20939). This training is offered through the VA Talent Management System (TMS), a system that offers web-based training to VA employees and its partners.
Contractor employee will self-enroll for a TMS training profile on the VA TMS by visiting https://www.tms.va.gov/SecureAuth35/.
Once there, the employee will follow the steps that follow to create a profile, launch the mandatory training, and complete the content prior to their next day at VA. Upon completion by all employees, the contractor shall provide their Contracting Officer Representative with each employee s printed certificate of completion from the TMS. This certificate displays the employee s TMS User ID.
b. 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.
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.

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