36C24618Q9710-001.pdf

STATEMENT OF WORK

RADIOPHARMACEUTICAL ISOTOPES FOR

VAMC RICHMOND, VA

1. GENERAL

Contractor shall provide radiopharmaceutical products in accordance with Public Law 104-262 and 38 USC

8153 for the Department of Veterans Affairs Medical Center, Richmond, Virginia. Contractor and any/all sub-contractors shall be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. The delivery order will specify the item and quantity of the items delivered and the time of delivery. All quantities noted in this solicitation are estimates only; see Section D for estimated volumes.

2. SCOPE

The Contractor is responsible for providing the requested radiopharmaceuticals at the requested time. If the ordered radiopharmaceuticals are not available and cannot be delivered to the VA when needed, the contractor will notify the VA Nuclear Medicine Department and obtain the needed doses from another source, including another nuclear pharmacy, to be delivered as close to the requested time in order to provide timely care to VA patients.

The contractor will provide all radiopharmaceuticals in single dose containers as specified. The cost of each radiopharmaceutical will be calculated on a per vial, per syringe, or a per millicurie amount as indicated in contract pricing.

3. DELIVERY

The contractor will provide, as needed, additional radiopharmaceuticals, within 1 hour of the request during the hours (6:00 AM to 4:30 PM) Monday –Friday.

Identification of radiopharmaceutical delivery personnel will be readily verifiable by identification badge including name of employee and contractor.

Delivery times and dates will be provided when the order is placed. 1st shipment (Monday-Saturday) to be delivered between 6:00 am and 8:00 am. Shipments “called when needed” may be requested during regular work hours, or after regular work hours, as “emergency”, including weekends, holidays and nights. Emergency deliveries may be made on an as needed basis on 365 days a year.

4. CERTIFICATION AND LICENSING

Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the Richmond VA Chief of Staff and approval by the Richmond VA Facility Director.

5. QUALITY

The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than +10% at the time of calibration, from the quantities specified.

Contractor will perform all quality control procedures on each radiopharmaceutical according to applicable requirements of licensing authorities and other regulating bodies. A copy of the results of the quality control procedures must be made available to the Richmond VA Medical Center upon request.

In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COR, the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

a. Provide technical expertise in calibration;

b. Provide professional examination of product; submit results and recommendations to the Contacting

Officer;

c. Make expedient replacement of any product suspected of being deficient

d. Contractor shall make quality control records available to the VA Medical Center upon written request from the Contracting Officer.

e. Quantities expressed in the schedule are estimates based on historical usage for one year. However, quantities may vary based on patient demand

f. Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc.

g. Contractor must provide full credit for unused does of Technetium-99m Myoview (Tetrofosmin) and

Technetium-99m Cardolite (Sestamibi)

h. Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education.

i. Any recalled dose for any reason shall be credited to the service for the full amount.

j. All individual doses shall be traceable to the original elution if requested by the service as per NC pharmacy standards and regulations

k. Any dose deemed below standard by the facility shall be credited toward the account (e.g. unacceptable thyroid, stomach, kidney, or tissue uptake). This shall be determined by the facility RSO and Authorized

User.

l. Substitutions or Generic Brands may only be used with the express written permission of the facility.

m. Contractor will supply Nuclear Medicine Management System for keeping records or QC and QA as required by regulatory agencies.

Contractor will meet all requirements of regulatory agencies for shipment of radioactive isotope between facilities and will strictly adhere to these requirements. Shipments not properly handled according to regulations will not be accepted at the Richmond VA Medical Center.

Contractor will be responsible for all costs for any radiopharmaceuticals and nonradioactive items contracted for if the Richmond VA Medical Center must find an alternate supplier for contracted items.

In the event of a manufacturer or pharmacy recall or quality assurance failure, the contractor will notify the

Richmond VA Nuclear Medicine Service immediately.

A radio-pharmacist in the employment of the successful vendor must be available to:

a. Set up the quality assurance program on radiopharmaceutical preparations required by FDA, NRC, CAP, USP, and the Joint Commission.

b. Act as a reference source concerning questions on regulation of radiopharmaceuticals.

c. Provide reference services for research drugs and radionuclides under research protocols.

d. Provide instruction (continuing education) to technologists on new changes in radiopharmaceutical products and availability.

Quality Assurance Surveillance Plan: Contractor will be monitored for performance of services according to the following criteria, with the incentive/disincentive being past performance ratings:

a. Accuracy of delivered order: all daily deliveries should match order placed.

b. Timeliness of deliveries: all daily deliveries should arrive according to statements above.

c. Compliance of shipping containers: all containers will be secured and labeled according to NRC and

DOT regulations.

d. Radiation safety review: package surveys and wipes for removable contamination will meet NRC and

DOT guidelines.

e. Communication of industry issues: industry shortages or product recalls will be communicated within 24 hours.

BASE YEAR OCT 1, 2018 – SEPT 30, 2019

ITEM DESCRIPTION UNIT

EST.

QTY

UNIT

COST

TOTAL COST

Unit dose of either:

TC-99m MDP 500

TC-99m MAA 100

TC-99m Sulfur Colloid Each 78

TC-99m Pertechnetate

TC-99m DTPA 30

TC-99m Filtered Sulfur Colloid

2 Unit dose of TC-99m DTPA Aerosol

Each 100

3 Unit dose of TC-99m Mebrofenin Each 56

4 TC-99m Mag 3 (Renal) Each 20

5 Tl-201 (Thallium) mCi 500

6 T99 Sestamibi (para-thyroid) Each 100

Delivery fuel surcharge for daily deliveries

Each 525

8 Delivery charges for after hours Each 60

9 Myoview doses(10mci/30mCi) Each 3000

10 I-123 Thyroid Uptake & Scan 200uCi

Cap 56

11 I-123 Met Survey(2mCi) Cap 14

12 I-131 mCi 886

13 Gallium-67 mCi 22

14 In-111 Octreoscan Each 14

15 In-111 DTPA Each 2

16 Ultravent Aerosol Kits Case 14

17 Ultra Tag RBC Kits (5 per box) Box 12

OPTION YEAR ONE OCT 1, 2019 – SEPT 30, 2020

EST.

QTY

UNIT

COST

TOTAL COST

Unit dose of either:

TC-99m MDP 502

TC-99m MAA 102

TC-99m Sulfur Colloid Each 80

TC-99m Pertechnetate 140

TC-99m DTPA 32

TC-99m Filtered Sulfur Colloid 37

Each 102

3 Unit dose of TC-99m Mebrofenin Each 58

4 TC-99m Mag 3 (Renal) Each 22

5 Tl-201 (Thallium) mCi 502

6 T99 Sestamibi (para-thyroid) Each 102

18 Pyrophosphate Cold Vial 70

Cobalt-57 Flood QC source (large rectangular-15mCi)

Each 1

20 Tc-99m Pertechnetate QC doses Each 46

21 Cobalt-57 Spot Markers Each 2

22 Neurolite Each 1

23 Sodium-22 Rod for PET QC Each 1

24 Tc-PYP (Cardiac Amyloid) Each 5

Germanium 68 QC sources for PET Scanner

26 Cobalt 57 12 millicurie Rod Source Each 1

27 Cobalt 57 Pen Source marker 100-200

ESTIMATED TOTAL BASE YEAR

Each 527

8 Delivery charges for after hours Each 62

9 Myoview doses(10mci/30mCi) Each 3002

Cap 58

11 I-123 Met Survey(2mCi) Cap 16

12 I-131 mCi 888

13 Gallium-67 mCi 24

14 In-111 Octreoscan Each 16

15 In-111 DTPA Each 2

16 Ultravent Aerosol Kits Case 14

17 Ultra Tag RBC Kits (5 per box) Box 12

18 Pyrophosphate Cold Vial 72

20 Tc-99m Pertechnetate QC doses Each 48

21 Cobalt-57 Spot Markers Each 2

22 Neurolite Each 1

23 Sodium-22 Rod for PET QC Each 1

24 Tc-PYP (Cardiac Amyloid) Each 7

ESTIMATED TOTAL OPTION YEAR ONE

OPTION YEAR TWO OCT 1, 2020 – SEPT 30, 2021

EST.

QTY

UNIT

COST

TOTAL COST

Unit dose of either:

TC-99m MDP 504

TC-99m MAA 104

TC-99m Sulfur Colloid Each 82

TC-99m Pertechnetate 142

TC-99m DTPA 34

Each 106

4 TC-99m Mag 3 (Renal) Each 20

5 Tl-201 (Thallium) mCi 506

6 T99 Sestamibi (para-thyroid) Each 106

Each 531

8 Delivery charges for after hours Each 66

9 Myoview doses(10mci/30mCi) Each 3004

Cap 562

11 I-123 Met Survey(2mCi) Cap 18

12 I-131 mCi 892

13 Gallium-67 mCi 28

14 In-111 Octreoscan Each 20

15 In-111 DTPA Each 2

16 Ultravent Aerosol Kits Case 14

17 Ultra Tag RBC Kits (5 per box) Box 12

18 Pyrophosphate Cold Vial 76

20 Tc-99m Pertechnetate QC doses Each 52

21 Cobalt-57 Spot Markers Each 2

22 Neurolite Each 1

23 Sodium-22 Rod for PET QC Each 1

24 Tc-PYP (Cardiac Amyloid) Each 11

ESTIMATED TOTAL OPTION YEAR TWO

OPTION YEAR THREE OCT 1, 2021 – SEPT 30, 2022

ITEM

DESCRIPTION UNIT

EST.

QTY

UNIT

COST

TOTAL COST

Unit dose of either:

TC-99m MDP 506

TC-99m MAA 106

TC-99m Sulfur Colloid Each 84

TC-99m Pertechnetate

TC-99m DTPA 36

4 TC-99m Mag 3 (Renal) Each 20

5 Tl-201 (Thallium) mCi 506

6 T99 Sestamibi (para-thyroid) Each 106

9 Myoview doses(10mci/30mCi) Each 3005

12 I-131 mCi 892

13 Gallium-67 mCi 28

14 In-111 Octreoscan Each 20

15 In-111 DTPA Each 2

16 Ultravent Aerosol Kits Case 14

17 Ultra Tag RBC Kits (5 per box) Box 12

18 Pyrophosphate Cold Vial 76

21 Cobalt-57 Spot Markers Each 2

22 Neurolite Each 1

23 Sodium-22 Rod for PET QC Each 1

24 Tc-PYP (Cardiac Amyloid) Each 11

ESTIMATED TOTAL OPTION YEAR THREE

OPTION YEAR FOUR OCT 1, 2022 – SEPT 30, 2023

EST.

QTY

UNIT COST TOTAL COST

Unit dose of either:

TC-99m MDP 506

TC-99m MAA 106

TC-99m Sulfur Colloid Each 84

TC-99m Pertechnetate 144

TC-99m DTPA 36

TC-99m Filtered Sulfur Colloid 41

4 TC-99m Mag 3 (Renal) Each 20

5 Tl-201 (Thallium) mCi 506

6 T99 Sestamibi (para-thyroid) Each 106

9 Myoview doses(10mci/30mCi) Each 3005

12 I-131 mCi 892

13 Gallium-67 mCi 28

14 In-111 Octreoscan Each 20

15 In-111 DTPA Each 2

16 Ultravent Aerosol Kits Case 14

17 Ultra Tag RBC Kits (5 per box) Box 12

18 Pyrophosphate Cold Vial 76

21 Cobalt-57 Spot Markers Each 2

22 Neurolite Each 1

23 Sodium-22 Rod for PET QC Each 1

24 Tc-PYP (Cardiac Amyloid) Each 11

ESTIMATED TOTAL OPTION YEAR FOUR

TOTAL CONTRACT COST

RECORDS MANAGEMENT

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 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.

Source: The National Archives Records Administration (NARA). http://www.archives.gov/records-mgmt/handbook/records-mgmt-language.html

INFORMATION SYSTEM SECURITY –PRIVACY LANGUAGE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same

Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

http://www.archives.gov/records-mgmt/handbook/records-mgmt-language.html http://www.archives.gov/records-mgmt/handbook/records-mgmt-language.html

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.

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.

The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

VA INFORMATION CUSTODIAL LANGUAGE

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).

VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in

VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management

Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media

Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation

(FAR) part 12.

If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by

Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an

MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control

Assessment (CSCA) on a yearly basis and provide it to the COTR.

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.

To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the

Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

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

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

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

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

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

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

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

(3) Data breach analysis;

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

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

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

SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

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

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

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training

Requirements.]

The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.