36C25219Q0742-001.docx

36C25219Q0742

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25219Q0742 07-30-2019

JESSICA RASMUSSEN

414-844-4864 08-15-2019 12:00 0069D Great Lakes Acquisition Center (GLAC) Department of Veterans Affairs 115 S 84th Street, Suite 101 Milwaukee

WI

53214-1476 X Y 325413 1250 Employees N/A X 0069D Department of Veterans Affairs Great Lakes Acquisition Center 115 S 84th St, Suite 101 Milwaukee

WI

53214-1476 36C252 Great Lakes Acquisition Center (GLAC) Department of Veterans Affairs 115 South 84th Street, Suite 101 Milwaukee

WI

53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page Contractor must provide Molecular Pathology testing for the Edward J Hines Jr VA Hospital, Hines, IL. This will include installation, service, repair service, operator training, reagents, and consumables for a cost per reportable result

(CPRR).

This contract will be for a 5-year ordering period.

See CONTINUATION Page X X Jessica Rasmussen Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: ______________________________________ (Contractor’s Name) ______________________________________ (Address) ______________________________________ (City-State-Zip) ______________________________________ (Point of Contact/Title)

PHONE NUMBER ______________________________________

FAX NUMBER ______________________________________

E-MAIL ADDRESS ______________________________________

DUNS NUMBER NO. ______________________________________

b. GOVERNMENT: JESSICA RASMUSSEN, CONTRACT SPECIALIST

DEPARTMENT OF VETERANS AFFAIRS

GREAT LAKES ACQUISITION CENTER

115 S. 84TH ST., STE 100

MILWAUKEE WI 53214

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

52.232-34, Payment by Electronic Funds Transfer - Other than Central Contractor Registration

3. INVOICES: Invoices shall be submitted in arrears in accordance with:

a. 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)

b. UPON ACCEPTANCE OF ITEMS

4. GOVERNMENT INVOICE ADDRESS: All invoices from the contractor shall be submitted electronically in accordance with 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)

FACSIMILE, E-MAIL, AND SCANNED DOCUMENTS ARE NOT ACCEPTABLE FORMS OF SUBMISSION FOR PAYMENT REQUESTS.

For assistance setting up e-Invoice, the below information is provided:

36C25219Q0742

* OB10 e-Invoice Setup Information: 1-877-489-6135

* OB10 e-Invoice email: VA.Registration@ob10.com <http://VA.Registration@ob10.com/>

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

* FSC e-invoice email: vafsccshd@va.gov <http://va.gov/> Page 1 of Page 1 of

STATEMENT OF WORK

The instrument must be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI - formerly NCCLS).

The instrumentation will be acquired for the clinical laboratory located at the following VA facility:

Edward Hines, Jr. VA Hospital, Hines, Illinois (Hines)

A. DEFINITIONS

Molecular Pathology Diagnostics Equipment - Base equipment offered will fully support the scope of their operations (minimal requirements) as defined in this solicitation. Depending upon the technical functionality and the capabilities of the individual manufacturer’s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein.

B. TEST MENU

Refer to Attachment A for a list of desired tests and their estimated annual volumes.

D. GENERAL REQUIREMENTS

1. Operational Features - The instrumentation offered must have:

a) The capability of performing analysis on 100% of the tests listed in the Test Menu (Attachment A).

b) Sufficient capacity and throughput to meet the volume and service demands as defined in the Test Menu (Attachment A).

c) Sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

d) A bi-directional, bar-coded computer interface. The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system (Refer to Brief Summary of VistA Functionality below) at the time of contract award. If the host system software requires the use of a non-proprietary universal interfacing system to provide bi-directional interfacing capabilities, the VISN12 facility laboratories currently use the Data Innovations Instrument Manager system. To achieve connection with those systems, the awarded Contractor is responsible for the cost of the interface. Refer to the following section entitled “Support Features – Computer Interfacing Requirements” for specific details.

Brief Summary of VistA Functionality VistA is a proprietary system to the VA whose functionality includes:

1. Management of patient information through a database,

2. Acceptance of test ordering information,

3. Transmittal of patient laboratory test results

4. Storage and retrieval of patient laboratory test results

VistA is very limited in its functionality to manage laboratory quality control, provide Levy-Jennings plots or administer an instrument maintenance program.

2. Technical Features

The instrumentation must be approved by the Food and Drug Administration (FDA) and must have:

a) Minimal daily maintenance such that the analyzer is not required to be down for more than 30 minutes per day (this is not to exclude longer times for periodic maintenance).

b) Minimal sample pretreatment.

c) A comprehensive quality control package used for daily monitoring of system performance and operator notification upon QC failure.

d) Accurate barcode reading with less than 5% read failures.

3. Hardware Features - The instrumentation must have:

a) A total equipment footprint that when installed in the VA Hines clinical laboratories will not negatively impact the functionality/operations of that laboratory nor will it require significant and/or costly infrastructure changes.

b) A computer with a window-based operating system

c) An on-board, adjustable monitor/screen that is easily readable.

d) A printer that has the capability of printing a patient report with patient demographic information that includes minimally the patient’s name and UID (unique identifier). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract.

e) Uninterruptible Power Supply (UPS) with line conditioner to provide uninterruptible electrical power without electrical voltage fluctuation. Replacement uninterruptible power supply with line conditioners shall be provided as needed, at no additional charge, for the duration of the contract.

4. Support Features

a) Commercial marketing – The equipment models being offered must be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

b) Supplies - The Contractor must provide all reagents, calibrators, controls, consumable/disposable items, parts, and accessories and any other items required to establish instruments for operation and perform all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity.

c) Equipment Preventative Maintenance/Repair Service - The Contractor must provide emergency equipment repair and preventative maintenance on all instrumentation and any incremental support equipment, e.g. water system.

1) A technical assistance center must be available by telephone during routine business hours, Monday through Friday, 8:00am to 4:30pm, with a maximum call back response time of 2 hours.

2) Equipment repair service that cannot be completed through telephone assistance or remote diagnostics will require on-site repair by qualified personnel supplied by the Contractor.

3) On-site repairs will be conducted during routine business hours. Business hours are listed as Monday through Friday, 8:00AM-4:30PM. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. All such arrangements will be coordinated between the Contractor and VA laboratory personnel.

4) Contractor must perform emergency repair service within twenty-four (24) hours of the time of notification of the malfunction.

5) A malfunction incident report will be furnished to the installed site upon completion of each repair call. The report shall include, as a minimum, the following:

a) date and time of arrival

b) serial number, type and model number of equipment

c) time spent for repair, and

d) proof of repair that includes documentation of a sample run of quality control verifying acceptable performance.

6) If the repair record of any individual piece of Contractor’s equipment reflects a downtime of 10% or greater of the normal working days in one calendar month, a determination will be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer’s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement.

7) Each notification for an emergency repair service call will be treated as a separate and new service call.

8) Contractor must provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits must be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment.

d) Upgrades - The Contractor must provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the-art technology at no additional charge to the Government. These must be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system upgrades” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. This does not refer to replacing the original piece of equipment; however, it does refer to significant changes in the hardware operational capability.

e) Ancillary support equipment - The Contractor must provide all ancillary support equipment to fully operate the analyzer(s) as defined in these specifications, e.g. installation of telephone lines for modem operations and cabinetry to support/house the analyzer (if necessary). In addition, the Contractor must include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc.

f) Invoicing – All invoices will be issued monthly in arrears stating the test name, monthly volume of patient reportable results and the individual cost per reportable price as awarded per contract.

g) Computer Interfacing Requirements - The fully operational interface (both hardware and software) must be immediately available for implementation to the VA VistA hospital information system at the time of contract award.

1) The Contractor must provide all hardware required for the connection, implementation and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system. VA Hines clinical laboratories currently employ the Data Innovations Instrument Manager system.

2) Likewise, the Contractor must provide any and all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself. Information necessary to make the determination for type and amount of interfacing equipment is supplied in the chart below.

3) If a site already has a universal interface box, the vendor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the vendor is responsible for the acquisition of the universal interface box and everything else needed to connect with VistA. If there are any software upgrades in the instrument during its life, the vendor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VistA

h) Commercial offerings - The Contractor must provide any additional support material that is routinely provided to equivalent commercial customers and will assist in regulatory compliance, e.g. PC computer diskette of their procedure manual or an on-line procedure manual in the instrument software.

i) Implementation timeframe - The implementation of services/requirements described in this solicitation will be completed no later than 120 days after the award of the contract. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractors will not be penalized for implementation timelines that extend beyond the 120 day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government.

1) The transition period for the awarded contract to have all equipment and peripherals installed and operational at the participating facility shall be from date of award through 120 days. During this same period, all initial training of VA personnel in the operation and maintenance of said equipment shall also be completed.

2) Offerors shall provide with its quotation a plan for transitioning services from the incumbent Contractor to the newly awarded Contractor. Contractor’s submitted transition plan shall not exceed 90 days for the transition of all services including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to confirm to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract.

3) At the end of 120 days from award of the contract, the awarded Contractor shall have full and sole responsibility for services.

j) Characterization of hazardous waste – The Contractor shall provide a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations and address the criteria listed in the Code of Federal Regulations Title 40 “Protection of the Environment” Part 261 et al. The description shall address the following:

E. PRE-WORK ORIENTATION

1. Contractor will attend a pre-work orientation meeting prior to the commencement of work on site. This meeting will be scheduled by the VA.

2. The Contractor will be responsible to ensure that Contractor employees coming to the work site will receive the information required above.

3. The Contractor will be responsible to ensure Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

F. QUOTES

1. It is the clear intent of the Government to award this contract to a single vendor.

2. Contractors must submit their base quotes outlining the proposed equipment. This equipment configuration should be based on the Contractor’s best recommendation for equipment that meets the operational activities and required efficiencies and productivity of the of the laboratory size and scope defined herein.

a) In addition, Contractors are encouraged to offer alternate equipment configurations (optional proposals/packages) that minimally meet the specifications of this solicitation; yet may enhance the operational activities, efficiencies and the productivity of the laboratory.

4. Contractors must submit their pricing proposals using a Cost per Test (CPT) format. The per test price shall include costs covering:

a) 5 year equipment use,

b) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor’s equipment and necessary for the collection and generation of a patient test result. It will also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI-formerly NCCLS),

c) all necessary maintenance and parts to keep the equipment in good operating condition (element includes both preventive maintenance and emergency repairs), and

d) training for Government personnel. Contractors are required to provide delivery, installation and removal of equipment at no additional charge.

3. Contractors must provide commercial literature and other information describing their compliance with the technical specifications and certification of commercially available vendor computer interface to the VA VistA computer system, as well as an equipment implementation schedule. If the commercial literature does not directly address specific specifications identified in this solicitation, the vendor is required to indicate compliance with those specifications in written format.

4. Contractors must provide documentation that the instrumentation offered will perform analyses with a precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI – formerly NCCLS).

5. Contractors must provide a description of all ancillary support equipment that is needed to operate analyzers as defined in the specifications and offered as a part of this agreement.

6. Contractors shall be evaluated on what they propose for molecular testing platform. They will not be evaluated on any other offers made in connection with other instruments or services that the vendor may provide to the VA.

7. Contractors must provide a summary of operator-performed and vendor-performed maintenance procedures including an estimate of time spent in the performance for each category of maintenance.

a) Operator-performed – Contractors must summarize their maintenance procedures and provide an estimate of time spent in performance for each category, e.g. daily, weekly, monthly, semi-annually, etc. The estimate of time spent on daily maintenance would take into consideration starting the equipment from a cold start-up.

b) Contractor-performed - Contractors must describe the frequency of preventive maintenance and provide an estimate of the time required to perform the maintenance.

8. Contractors must provide delivery, installation and removal of equipment at no additional charge.

9. Contractors that offer multiple types of repair service packages that are different than the minimum requirements stated in the specifications are encouraged to offer an associated adjusted price per reportable.

G. EVALUATIONS OF OFFERS

1. Minimum Requirements. Each respondent for award shall meet all the minimum specifications as outlined in General Requirements.

2. The VA will award to the firm whose quotation is most advantageous to the VA considering price and the factors listed below.

a) Required Information. For the VA to evaluate firms on these factors, firms must provide the technical information described in the section above that is entitled Operational Features, in addition to their pricing information. Not providing this information may prevent full consideration of the quotation.

b) Technical Specifications. Contractor’s equipment will be evaluated to determine whether it meets all of the basic technical specifications. All such requirements must be met in order for the Contractor’s equipment to be considered acceptable. In addition, an analysis of the feature limitations and enhancements of the equipment and associated products will be considered. Specific evaluation criteria will include the following:

1) type/features of the FDA approved molecular pathology analyzer

2) specimen collection and storage requirements

3) specimen sample size requirements

4) sample preparation requirements

5) primary tube sampling

6) specimen throughput

7) quality of analysis

8) limits of detection

9) genotypes detected

10) control and reagent stability

11) maintenance requirements

12) footprint/physical characteristics/water, electrical and waste requirements

13) type/features of the data information system

14) FDA approval for HCV diagnosis and monitoring of HIV, HBV, CMV and HCV.

c) The degree to which the equipment has the following Desired but not Required features:

1) ability to have on-line operator’s manual

2) ability to have dial-in ‘remote’ access for the technical service personnel

3) ability to send quality control results to the QAP program through the Internet

4) ability to have on-line maintenance logs, reagent logs, etc.

5) Automatic specimen processing from extraction thru amplification/detection without operator assistance.

d) The degree to which the level of instrumentation being offered is sufficient to perform the workload of VISN12 performed at VA Hines Hospital.

e) The degree to which all ancillary support equipment needed to operate the analyzer will be provided by the vendor.

f) The level of technical and service support will be evaluated.

g) Price. The cost of the equipment acquisition cannot exceed that charged to others for similar services. There needs to be a statement of assurance that the charge for service is not higher than charged others for same service. The prices for Optional Capabilities will be evaluated and these capabilities included in the contract award to the degree that the VA judges these capabilities to be worth the additional cost.

Attachment A

REQUIRED TESTS AND ESTIMATED ANNUAL VOLUMES

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

HIV/HBV/HCV/CMV COST PER TEST ORDERING PERIOD 1

HIV/HBV/HCV/CMV COST PER TEST ORDERING PERIOD 2

HIV/HBV/HCV/CMV COST PER TEST ORDERING PERIOD 3

HIV/HBV/HCV/CMV COST PER TEST ORDERING PERIOD 4

HIV/HBV/HCV/CMV COST PER TEST ORDERING PERIOD 5

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

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

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

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

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

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

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

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

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

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

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

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the 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;

(1) 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

(2) 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.

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 vulnerablity 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…