S02 Intent to Sole Source 36C24722Q0950.pdf

The Department of Veterans Affairs intends to issue sole-source firm-fixed priced base year and four (4) renewable one-year periods of Instrument Management Maintenance &

Support for use at the Tuscaloosa VA Medical Center located at 3701 Loop Rd, Tuscaloosa, AL 35404.

A sole source procurement will be issued to Data Innovations Inc because they are the only vendor capable of fully performing the service for Instrument Management Maintenance &

Support. Due to the proprietary software required to integrate with the current VA hardware.

This procurement is being conducted in accordance with FAR Part 6.302-1 and 13.106-1(b)(2), "soliciting from a single source." The NAICS code is 511210 and has a size standard of $41.5 million for this procurement.

This notice of intent is not a request for competitive quotes. However, interested parties may identify their interest and capability to respond to the requirement and submit quotations no later than 1:00pm EST, August 8, 2022 to Benford.Brundage@va.gov. Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the

Government.

Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. 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 using the government point of entry. However, responses to this notice will not be considered adequate responses to a solicitation. Determination by the Government not to compete the proposed procurement based upon responses received to this notice is solely within the discretion of the Government.

STATEMENT OF WORK

Tuscaloosa VA Medical Center

Pathology and Laboratory Medicine Service

LABORATORY INSTRUMENT MANAGER SYSTEM

SOFTWARE/LICENSE MAINTENANCE AND SUPPORT SERVICES

1. DESCRIPTION OF SERVICES: Pathology and Laboratory Medicine Service (P&LMS) at the Tuscaloosa VA Medical Center intends to procure a sole source contract with Data Innovations LLC, to provide software/license maintenance and support for the laboratory Instrument Manager Interface.

Competition is restricted on this procurement due to the contractor being the only one responsible source and no other supplies or services will satisfy agency requirements.

Data Innovations, LLC is the original manufacturer of the interface system and maintains sole proprietary ownership over the system and software. No other company can maintain the system.

2. STATEMENT OF WORK: The contractor shall maintain and support the software and hardware that operates the Laboratory Data Innovations System. This system must function twenty-four (24) hours a day, seven (7) days a week, 365 days a year.

Contractor shall provide First response coverage for all Data Innovations system issues from 7 am – 5 pm Central Standard Time (CST), Monday through Friday, excluding holidays, for non-emergency support. Contractor will respond to requests for support based on the severity of the issue being reported using the following priority order:

Critical Priority (system or production connection down), High Priority (significant business impact), Medium Priority (low-impact failure), and Low Priority (assistance).

Contractor will provide patches, updates, enhancements and new versions of the software being covered. They will also provide access to the Driver Download web page for updated and new drivers, access to the Language Locale web page if required and access to the Customer Web Portal. Emergency support is to be available twenty-four

(24) hours a day, seven (7) days a week, 365 days a year. “Emergency issues” are defined as issues that have caused a live system to become inoperative, affecting critical laboratory function. Non-emergency support will be available Monday through Friday, excluding holidays, from 7 am through 5 pm CST and shall be based on priority of the issue as defined in the contract. Contractor shall not be allowed to manage the contract and rely on a subcontractor for repairs and parts. The contractor is to provide 100 percent of all services, parts hardware, proprietary software, and labor for this contract agreement. Adherence to the Joint Commission Accreditation Healthcare Organization (JCAHO) and Original Equipment Manufacturer’s standards is mandatory. Knowledge and accessibility of the proprietary hardware and software is mandatory.

3. BACKGROUND: Data Innovations leads the way with the connections needed to interface automation, instrumentation, information systems and locations. Through the years they have worked with virtually every LIS/HIS and diagnostic equipment manufacturer. That experience translates into faster, easier installations, even installations of connectivity of multiple instruments, in multiple disciples, in multiple sites with multiple LIS systems. P&LMS has undergone a large upgrade to this interface system and due to the sophisticated technical and proprietary nature of this Software and License support it must be maintained under a maintenance/service contract.

4. PERIOD OF PERFORMANCE: One-year base period with four 1-year optional renewals to commence upon contract award.

5. TYPE OF CONTRACT: Variable Price Sole Source contract. Option Year pricing is subject to change based on customer’s unique system configuration. The licenses will be reviewed each renewal period to confirm configuration. If additional licensable options have been added, or if Data Innovations, LLC, has been granted an Economic Pricing Adjustment (EPA) by the GSA, there will be an effect on Option Year pricing. A contract and/or funding modification may be necessary to ensure continued Maintenance and Support coverage for the life of the contract period.

6. LOCATION:

Tuscaloosa V A Medical Center

Laboratory Medicine Service

3701 Loop Road East

Tuscaloosa, Alabama 35404

7. SPECIFIC LICENSING INFORMATION: Contractor must provide renewal/service/maintenance for the following asset summaries for licenses in use at Tuscaloosa V A Medical Center:

a. Instrument Manager Production System License Number 209441:

Software Part Description QTY SW Unit

Price

M&S Unit

Price Line Total

IM-B03

Instrument Manager Base Software with Disaster

Recovery

IM0CX-03

Instrument Manager Interface Connection with Disaster

Recovery

IM-EU-07 End-User Software Connection with HA/DR 13

EP Evaluator Software – Enterprise User License

(Professional)

IM-ODBC-07 Open Data Exchange Connection with HA/DR 1

IM-IN-01N Lab Intelligence 1

IM-MRE-01N Manual Results Entry 1

IM-MA-02 Moving Averages – Moving Medians 1

M-QC-BIN

Peer & Daily QC Integration for Bio-Rad Unity Real-

Time

IM-SM-01N Specimen Management 1

IM-RT-01N Specimen Routing 1

Production System Total: IM License: 209441 Support Level:

b. Instrument Manager License Number 344374:

Software Part Description QTY SW Unit

Price

M&S Unit

Price Line Total

IM-B02-TEST Test – Instrument Manager Base Software 1

IM-CX-01-TEST Test – Instrument Manager Interface Connection 7

IM-EU-01-TEST End User Software Connection for Test System 3

IM-IN-01-TEST Lab Intelligence for Test System 1

IM-MA-02-TEST Test – Moving Averages – Moving Medians 1

IM-MRE-01-TEST Test – Manual Results Entry 1

IM-QC-BI-TEST

Test – Peer & Daily QC Integration for Bio-Rad Unity Real

Time

IM-RT-01-TEST Test – Specimen Routing 1

IM-SM-01-TEST Test – Specimen Management 1

Test System Total: IM License: 344374 Support Level:

GRAND TOTAL: License 209441 and License 344374:

8. CONFORMANCE STANDARDS: All services provided under this contract must be performed in conformance with the Code of Federal Regulations Part 21 (21 CFR), National Fire Protection Agency (NFPA), Occupational Safety and Health Administration (OSHA), Joint Commission Accreditation Healthcare Organization (JCAHO) standards and Original Equipment Manufacturer standards and specifications.

9. HOURS OF WORK:

a. The Contractor shall provide First Response coverage for all Data Innovations system issues from 7 am - 5 pm CST, Monday through Friday, excluding holidays, for non-emergency support.

b. The Contractor shall provide 24/7/365 support for Emergency issues. “Emergency issues” are defined as issues that have caused a live system to become inoperative, affecting critical laboratory functions.

c. The eleven holidays observed by the Federal Government are New Year’s Day, Martin Luther King Day, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day. Also, any other day declared by the President of the United States to be a national holiday.

** Please note that holidays falling on Saturday will be observed on the preceding Friday;

holidays falling on Sunday will be observed on the following Monday.

10. DESCRIPTION OF SERVICES PROVIDED BY THE CONTRACTOR:

a. The Contractor shall provide First response coverage for all Data Innovations system issues from 7 am - 5 pm CST, Monday through Friday, excluding holidays, for non-emergency support.

b. The Contractor shall provide 24/7/365 support is for Emergency issues. “Emergency issues” are defined as issues that have caused a live system to become inoperative, affecting critical laboratory function.

c. The Contractor shall provide all software updates and installation.

d. The Contractor shall provide application software upgrade with installation and clinical education.

e. The Contractor shall provide all consulting services to consist of, but not limited to, providing support and assistance with rules writing and connection(s) configurations.

f. The Contractor shall notify the COR of the existence or development of any defects in, or repairs to the equipment covered under this contract which the Contractor considers he/she is not responsible for under the terms of the contract (such as operator misuse).

g. System check-ups: The contractor shall perform inspections of the system at any time at the request of the COR during the Service Maintenance Agreement period.

NOTE: Any additional charges to be claimed must have been approved by the COR before service is to be performed and a valid purchase order must be obtained prior to initiation of the service repair if outside scope/hours of coverage.

11. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

a. The Contractor’s staff shall include a “fully qualified” Field Service Representative assigned to this area and a “fully qualified” Field Service Representative who shall serve as the backup.

b. “Fully qualified” is based upon training and on experience in the field. For training, the Field Service Representatives must have successfully completed a formalized training program for the equipment covered under this contract. For field experience, the Field Service Engineers must have a minimum of one (1) year of experience providing preventive maintenance and emergency repair services on the same make and model of equipment covered under this contract.

c. Personnel with any laptops, thumb drives or CD/DVD’s intended to be plugged in to the equipment are required to allow these devices to be scanned by Biomedical Engineering personnel for malware before they are plugged into the systems. After repairs are completed, these systems must be brought to Biomedical Engineering personnel to be scanned for possible patient personnel health history.

12. INFORMATION SYSTEMS OFFICER, INFORMATION PROTECTION: The contractor will not have access to Veteran Administration (VA) Desktop computers, nor will they have access to online resources belonging to the government while conducting services in the application of complex adaptive system theory to health care organizations. The certification and accreditation requirements do not apply to this procurement nor is a security accreditation package required. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid-state drives, and non-volatile memory units will remain in VA control and will not be removed from VA custody.

13. PRIVACY OFFICER: The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid-state drives, and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

14. RECORDS MANAGER:

Records Management:

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.

j. 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.

SECTION C - CONTRACT CLAUSES

C.1 FSS RFQ INTRODUCTORY LANGUAGE

The terms and conditions of the contractor's FSS contract (including any contract modifications) apply to all Blanket Purchase Agreements (BPA) and task or delivery orders issued under the contract as a result of this RFQ. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the BPA or task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract. Any unique terms and conditions of a BPA or order issued under the contract that are not a part of the applicable FSS contract will govern. In the event of an inconsistency between the terms and conditions of a BPA or task/delivery order and the Contractor's FSS terms, other than those identified above, the terms of the FSS contract will take precedence.

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within one day.

(End of Clause)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the

Contractor within one day; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five years.

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor.

C.5 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001.

(2) Designated agency office has the meaning given in 5 CFR 1315.2(m).

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests.

(4) Invoice payment has the meaning given in FAR 32.001.

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.)

(2) Any system that conforms to the X12 electronic data interchange

(EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI). The X12

EDI Web site (http://www.x12.org) includes additional information on EDI

810 and 811 formats.

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit http://www.fsc.va.gov/einvoice.asp payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for:

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

MARCH 12, 2010 VA HANDBOOK

6500.6

APPENDIX B

VA Handbook 6500.6 Appendix Clause:

VA Acquisition Regulation Solicitation Provision and Contract Clause

(October 2008)

SUBPART 839.2 – Information and Information Technology Security Requirements

839.201 Contract clause for Information and Information Technology Security

Due to the threat of data breach 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 information is 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).

In solicitations and contracts where VA Information and/or Information Technology will be accessed or utilized, the contracting officer shall insert the clause found at 852.273-75, Security

Requirements for Unclassified Information Technology Resources

852.273-75 - Security Requirements for Unclassified Information

Technology Resources (interim- October 2008)

As prescribed in 839.201, insert the following clause:

(a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce’s National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST’s Web site at:

http://checklists.nist.gov

(b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in “VA Information and Information System Security/Privacy Requirements for IT Contracts” located at the following Web site :

http://www.iprm.oit.va.gov/Security_and_Privacy_Requirements_for_Contractors.asp

MARCH 12, 2010 VA

HANDBOOK 6500.6

APPENDIX C

VA INFORMATION AND INFORMATION SYSTEMS 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.

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.

http://checklists.nist.gov/ http://www.iprm.oit.va.gov/Security_and_Privacy_Requirements_for_Contractors.asp

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 COR.

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 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 COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR 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;

(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, hot-fixes, 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 twenty (20) days.

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 than twenty (20) 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 COR 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.

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 COR. 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 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 preapproved 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 COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

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.

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;

(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…