SOW FINAL.docx

Statement of Work

Dosimetry Services

1. REQUIREMENT:

A dosimetry program is highly regulated by the Nuclear Regulatory commission (NRC). Failure to maintain an appropriate dosimetry program and provide individual monitoring devices or equipment could result in regulatory non-compliance with the possibility of fines, lawsuits, and / or the revocation of our permit to use byproduct material under the MML issued to the Department of Veterans Affairs by the NRC. Loss of our permit would result in the termination of all Radiology operations, all other clinical & therapeutic uses of radioactive materials, and the research use of radioactive materials.

2. BACKGROUND:

Specifications for personnel monitoring services for the Columbia VA Health Care System (CVAHCS) are provided herein. Monitoring services are to be provided at the initial setup in the approximate quantities shown below. The contract shall be for a period of one year, with renewal options for four years. The cost of the contract should be presented in terms of the total annual cost, and expressed as the cost per badge type, according to the number of each badge type. No additional charges will be incorporated or expected, with the exception of non-returned or damaged badges and holders, and emergency readings. Credit will be given for all fees assessed for lost/late badges, upon return of same. If personnel monitoring services do not meet specifications, the contract may be terminated by the government.

3. PERIOD OF PERFORMANCE:

4. PLACE OF PERFORMANCE:

Columbia VA Health Care System 6439 Garners Verry Road Columbia, SC 29209 Monday-Friday 0800 am-4:00 PM.

5. PERFORMANCE REQUIREMENTS:

The selected dosimetry vendor service company shall have a well-established and demonstratively successful means of providing the goods and services described in these specifications. This document contains specifications for both the dosimetry devices and the dosimetry service. The dosimetry vendor must be able to demonstrate and provide the licensing and specific requirements listed upon request. The Vendor must be NVLAP certified.

I. Dosimetry Device Specifications: The dosimetry device specifications are described as follows:

a. The selected vendor shall supply necessary personnel monitoring devices of a NVLAP certified type or combination of types. At the present time CVAHCS utilizes 15 services, with an approximate total of all the required number of devices needed for initial setup: 226 monthly Whole-Body devices (Body Badges), including above & below apron devices: 15 monthly Extremity devices (Ring Badges). All of these badges presently are for detection of beta, gamma, and x-rays. Initial set up includes a holder for each body badge, and approximately 30 spare holders. During a contact year, 1-10 area monitors are also normally utilized on a monthly basis.

b. The devices shall be supplied according to the following specifications:

i. The vendor’s dosimetry service shall be currently accredited by the National Voluntary Laboratory Accreditation Program (NVLAP) of the US National Institute of Standards and Technology for all radiation testing categories.

ii. Written specifications shall be provided, prior to bid evaluation, on dosimetry devices defining: (a) Minimum detectable reported dose; (b) Energy discrimination capabilities including accuracy, precision, and (c) Maximum range of reported dose for the various energy ranges concerned, primarily:

1. Less than 100 KeV photons

2. 100 KeV through 250 KeV photons

3. Greater than 250 KeV up to and including Cs-137, Co-60

4. Beta radiations

iii. Dosimetry devices shall be routinely delivered to the customer by the 5th calendar day of each month preceding the next exchange date. Exchange dates are the 15th calendar day, the vendor shall, at no cost to the Government, ship the devices in a manner to ensure delivery by the 3rd business day after notification by the Government.

iv. The delivery of dosimetry devices is required within 7 calendar days of record creation for additional of new personnel or additional badges for existing personnel; unless a rush shipment is requested. The creation of a single record shall automatically provide all individual dosimetry devices of the current month and all subsequent months. When a rush shipment is requested, the dosimetry device(s) shall be received within 3 calendar days of record creation. Express delivery is an option.

v. Shipping containers shall be reusable for return of the devices to vendor. Return shipping labels shall be supplied by the vendor.

vi. The dosimetry devices, including additions, shall separate and packaged by series in wearer # or alphabetical order in accordance with the criteria (“account” or “series”) established by the Government’s Radiation Safety Officer (“RSO”) at the time of setup.

vii. Primary sorting and distinction will include unlimited series separation by groups of users. Series coding shall be alphanumeric.

viii. Minor transactions regarding the vendor service including, but not limited to, user additions, deletions, changes, inquiries, etc., shall be exclusively between the Government’s RSO or designee and the vendor. On-line capability for changes, account information, reports, etc., by the RSO shall be provided.

ix. Shipments shall include individual printed packing lists for each group of users. The individual packing lists shall include the numerical order of the dosimeters. Other information provided in the listing shall include, but is not limited to the following:

1. Social security number, if requested

2. Badge control identification

3. Badge type

4. Prescribed wear period, by date

x. Dosimetry devices shall provide obvious, distinct, color coding for easy special purpose identification while being worn. Dosimeter colors shall alternate with each wear period. Above and below apron badges will also be color coded for easy identification.

xi. The vendor shall provide a method for calculating and reporting Effective Dose Equivalent or Effective Dose automatically for designated badge wearers.

xii. Badges shall be identified with clearly visible printed word “Collar”, “Chest”, or “Waist” or other clear, descriptive nomenclature, to aide in proper wear positioning.

xiii. The ring badge shall have at least three sizes, be waterproof, have a permanent label, and be capable of withstanding cold sterilization. The ring badges shall be color coded for alternate months.

xiv. Body badges shall be waterproof and have a permanent label.

c. The vendor shall have internet access capability such that the Government may be able to that a minimum

i. Add, transfer, or delete personnel

ii. Add additional badges to existing personnel

iii. Review records (wearer, badge type, frequency, dose history, etc.)

iv. Summarize results (exposure levels, ALARA, etc.)

v. Review exposure histories per entire account

vi. Review exposure histories for an individual

vii. Add lifetime cumulative dose for an individual. Dose history can be modified via an e-mail to Government dedicated customer service representative.

viii. Add current year dose for an individual. Dose history can be modified via an e-mail to Government dedicated customer service representative.

ix. Reactivate wearers and badges.

x. Assign spare badges

xi. List unreturned badges

xii. Download data files for unreturned badges

xiii. Download data files for badge readings (exposures for specified periods)

The on-line system shall be sufficiently easy to use such that it is more efficient to use than manually requesting changes by telephone, initial and periodic on-site training shall be provided, at the Government’s request, promptly at service setup by the vendor or at modification of web site.

d. The RSO or designee shall be notified by telephone or email of all readings above the levels set by the RSO within 24 hours from the reading of the dosimeter. The system shall be capable of setting different notification levels for separate series codes within an account.

e. The vendor shall automatically provide permanent records archiving.

f. The vendor shall ensure timely response to customer inquiries by assigning a specific representative who shall be accessible during regular working hours through a toll free phone system.

g. The vendor shall provide emergency processing of dosimetry devices when requested. This processing shall be completed within 24 hours of receipt of the device by the vendor. The RSO or designee shall be notified of the processing results by telephone or email within 24 hours of receipt of the device by the vendor.

h. Charges for unreturned or damaged dosimetry devices shall be:

i. No more than $15.00 per Whole Body Device

ii. No more than $7.00 per Extremity Device

i. The Columbia VA Health Care System shall not be charged for shipping costs associated with the following activities: (a) Duplicate shipments of dosimetry devices; if contractor error, no charge (b) Rush shipments of dosimetry devices (2nd day delivery) associated with but not limited to, personnel additions, transfers, or provision of additional spare badges; (c) Priority shipments of dosimetry devices when devices are not received as specified.

j. The CVAHCS shall not be charged for the following: (a) Set up, transfer, deletion, or reactivation of an monitored individual; (b) Series or group separation (i.e., new series or account); (b) Series or group separation (i.e., new series or account); (c) Complete computer system capabilities as stated including access time (Medical Center owned or vendor provided equipment); (d) Training of personnel to adopt vendor’s service, if necessary; (e) Adjustment of dose record by Radiation Safety Officer; (f) up to 50 extra holders per year, if requested.

II. Other:

a. No presorting of the dosimetry devices by the Government shall be required prior to returning the dosimetry devices to the vendor.

b. The vendor shall provide a means of tracking all unreturned dosimetry devices, including whole body and ring badges. The periodic (monthly, quarterly) reports shall list all individuals on the account or series, whether or not the monitor was worn or returned, and indicating, where appropriate, any monitors which were issued but not worn or not returned for the period of the report. This information shall also obtainable through data file downloads from the on-line computer system. The information shall be available for downloading on at least a monthly basis and shall be capable of tracking unreturned devices for the past 18 calendar months.

c. Radiation dose reports, including monthly, quarterly, year-to-date, lifetime totals, and termination reports shall meet the records requirements of the U.S. NRC and OSHA. The vendor shall automatically provide printed and computer updates of records which have had a dose adjustment made by the RSO.

d. The vendor shall automatically provide an NRC Form 5 or equivalent, at no cost, for each monitored individuals as requested by the RSO.

e. The Vendor shall provide a means of maintaining current year dose and lifetime cumulative doses for individuals as requested by the RSO.

f. Complete dosimetry reports shall be routinely provided to the RSO. A second copy of each report, with any specified omissions such as sex, social security number, and date of birth, shall be provided upon request and issued, if requested, for shipment directly to user group.

g. The dosimetry reports shall include a separate fetal dose estimate for all identified pregnant personnel, provided the Government orders the badge as a fetal badge.

h. The average shipping time of the completed exposure reports shall not exceed 7 calendar days after receipt of the exposed dosimetry devices by the vendor. Radiation exposure and other reports shall be shipped via a carrier which guarantees second working day delivery.

i. The vendor shall automatically provide printed copy wear period, annual summary, and annual statistical summary reports for each account. These summaries shall include a listing by user groups, of every person badged at any time during the year. Other information provided for each listing shall include, but not be limited to, the following: (a) Group or series number; (b) Badge number and type: (c) Annual and lifetime dose; (d) Social security number (e) Date of Birth (f) Sex; (g) Deep dose and shallow dose for each monitoring period; (h) Extremity dose (i) Infernal dose reported by Radiation Safety Officer; (j) Total Effective Dose Equivalent; (k) Data on all currently issued devices regarding late returns, unreturned, and deleted devices.

j. The vendor shall provide a means to electronically download exposure data information using the on-line computer system.

k. The vendor shall provide individual termination summary reports for each individual removed from an account upon request.

l. The CVAHCS shall not be charged for any reports or summaries, written or electronic, including but not limited to the following (a) Individual termination summary reports; (b) Exposure reports; (c) ALARA reports as requested; (d) Annual statistical summary for entire account; (g) Individual NRC Form 5 exposure reports or an accepted equivalent. Form 5 reports are to be delivered to the CVAHCS by the May 1 (or approximately 120 days calendar days) after the end of the previous calendar year.

III. Service Documentation:

a. The vendor shall provide documentation verifying its ability to fulfill the commitments set forth within this document. This documentation shall be provided prior to any contractual agreement and shall include the following; (a) representative samples of reports and summaries as previously specified; (b) Samples of computer generated data in the same format as previously specified; (c) A list of medical centers and hospital customer references, with dosimetry needs similar to those of the CVAHCS.

b. If, at any time during the contract period, the vendor fails to meet any contract specification, the contract may be canceled by the Medical Center with a sixty day letter of notification of cancellation of service.

IV. Other Features or Services:

a. The vendor is requested to provide information and costs for any specialty items (such as MicroStar or InstaDose), services or web features that have not been included above which the vendor would like to offer.

b. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information (Reference VA Handbook 6500.6 Appendix, B,C and D).

c. The A&A requirements do not apply, and that a Security Accreditation Package in not required.

6. INVOICES:

a. Payment will be made upon receipt of a properly prepared detailed invoice, prepared by the Contractor and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain:

· Invoice Number and Date

· Contractor’s Name and Address

· Accurate Purchase Order Number

· Supply or Service provided

· Period Supply or Service Provided

· Total Amount Due

b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge.

c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-invoice email: vafsccshd@va.gov

d. Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

9. TERMINATION FOR CONVENIENCE: In accordance with FAR 52.212-4 (l) The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience.

10. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

a. 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.

b. 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.

c. 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.

d. 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.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. 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.

h. 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.].

i. 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.

MARCH 12, 2010 VA HANDBOOK 6500.6

APPENDIX B

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy.

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. 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).

b. 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.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause:

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.

(END OF CLAUSE)

MARCH 12, 2010 VA HANDBOOK 6500.6

APPENDIX C

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

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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 onsite 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.

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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.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic C-3 PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default “program files” directory and silently install and uninstall.

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

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

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

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

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(2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) “Operation of a System of Records” means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) “Record” means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person’s name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) “System of Records” means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as “Systems”), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days.

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k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

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

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor’s security control procedures must be equivalent to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA’s network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor’s systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

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d. The contractor/subcontractor’s system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA’s POA&M management process. The contractor/subcontractor must use VA’s POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/subcontractor owned equipment or software on VA’s network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA C-7 for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

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

(2) VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. 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 C-8 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.

7. 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;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

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

(1) Notification;

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

(3) Data breach analysis;

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

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

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

8. 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 C-10 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.

9. 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…