36C26119Q1042-002.docx

36C26119Q1042

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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

640-19-3-280-0043 36C26119Q1042 09-03-2019 Parvinder Brar 559-241-6436 09-13-2019

2:00 PM PST

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno CA 93721 X X 518210 $32.5 Million N/A X Department of Veterans Affairs VA Palo Alto Health Care System 3801 Miranda Ave Palo Alto CA 94304 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno CA 93721

Electronically Submitted through Tungsten Network.

See CONTINUATION Page Polytrauma and Rehabilitation Database Consultant (MS Access) services.

Note 1: This solicitation is set aside 100% for SDVOSB firms All SDVOSB firms must be registered and verified in https://www.vip.vetbiz.va.gov/ at the time of quote submission and prior to award.

Note 2: Offerors shall follow the submission instructions specified in FAR Provisions 52.212-1 and 52.212-2, and their addendums included in this solicitation. Failure to follow the instructions will result in an unfavorable evaluation and may not be considered for award.

See CONTINUATION Page X X Parvinder Brar Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 Parvinder Brar Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Central California Health Care System 855 M Street, Suite 1020 Fresno CA 93721

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

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Electronically Submitted through Tungsten Network.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Contract Period: Base POP Begin: 09-30-2019 POP End: 09-29-2020

Contract Period: Base POP Begin: 09-30-2019 POP End: 09-29-2020

Contract Period: Base POP Begin: 09-30-2019 POP End: 09-29-2020

Contract Period: Base POP Begin: 09-30-2019 POP End: 09-29-2020

Contract Period: Option 1 POP Begin: 09-30-2020 POP End: 09-29-2021

Contract Period: Base POP Begin: 09-30-2020 POP End: 09-29-2021

Contract Period: Base POP Begin: 09-30-2020 POP End: 09-29-2021

Contract Period: Base POP Begin: 09-30-2020 POP End: 09-29-2021

Contract Period: Option 1 POP Begin: 09-30-2021 POP End: 09-29-2022

Contract Period: Base POP Begin: 09-30-2021 POP End: 09-29-2022

Contract Period: Base POP Begin: 09-30-2021 POP End: 09-29-2022

Contract Period: Base POP Begin: 09-30-2021 POP End: 09-29-2022

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Performance Work Statement VA Palo Alto Health Care System (VAPAHCS) Polytrauma and Rehabilitation Database Consultant (MS Access)

1.0 General Information. The Department of Veterans Affairs Palo Alto Health Care System (VAPAHCS) Polytrauma System of Care (PSC) provides excellent veteran-centered patient care using by evidence-based research and practice and driven by data-driven decisions. In 2013, an initiative was taken to create a PSC database to collect relevant information about the patients and stakeholders of the PSC. This database was developed with all internal stakeholders including the Associate Chief of Staff, Program Directors, and key staff so that this database could meet the program needs for VA Central Office, Commission on Accreditation of Rehabilitation Facilities (CARF), and daily internal tracking and reporting. Since 2014, this database has been utilized for several reporting mechanisms.

The structure of the database:

1.1 Population: All patients referred to receive care under the services below

1.2 Program-specific data entry screens and elements:

1.1.1 Inpatient: Polytrauma Rehabilitation Center/Comprehensive Rehabilitation Center (PRC/CRC), and Polytrauma Transitional Rehabilitation Program (PTRP)

1.1.3 Outpatient: Polytrauma Network Site (PNS)

1.1.4 Case management: Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND)

1.1.5 Other programs: Regional Amputation Center (RAC), Spinal Cord Injury (SCI), and Physical Medicine and Rehabilitation (PM&R), and Headache Center for Excellence.

The current PSC database has been previously developed in MS Access. MS Access is supported by the VA and can be supported by current staff. It is intended that the PSC database remain within MS Access. Additionally, several of the programs are utilizing assistive technologies/medical devices with data exporting capabilities. An integration of the PSC database and these assistive technology/medical device data streams is planned.

2.0 Period of Performance (POP)

2.1 The period of performance will be for 1 base year and 2 option years.

2.2 The contractor will work a maximum number of 560 hours, with the estimated breakdown for project segments over the course of the contract:

2.2.1 -- 80 hours – Initial Assessment and Upgrade. The initial 80 work hours will include preparing for working with VA data, assessment of the database and an upgrade the database to meet current needs. This initial time will include adding to the database new data elements as directed by the programs.

2.2.2. – 80 hours -- Development of Headache Center module. These 40 hours will include development of a module focused on all data needs and management of the Headache Center of module. This will include the assessment and implementation of import capabilities from other software related to technology/medical device being utilized.

2.2.3 -- 320 hours – Maintenance of database. Every quarter (4 times a year) at 40 hours each the Database Consultant will update and maintain the database with program requirements.

2.2.4 – 80 hours – Database adhoc requirements. This will include additional needs for the PSC: development/maintenance within the database, import/export/merge of data, technical support, data management consultation.

3.0 Scope of Work – Contractors Tasks and Responsibilities

3.1 The Database Consultant will assess and document the structure of the database (front end and back end) in its current state. The current understanding of the database architecture is it consists of one database with a master individual-level identifier table. There are 4-6 front-end portals with program-specific tables. S/he will provide document its structure and provide recommendations as to upgrade and maintenance needs.

3.2 The Database Consultant will meet with key program personnel to develop individualized specific requirements to meet the needs of the programs, which may include creating new data entry screens and reports. Currently there are approximately 4-6 program-specific front-end portals and about 2-4 data entry tabs per program. There approximately 25 data elements per screen. Documentation related to the database will be conducted and managed by the Database Consultant.

3.3 The Database Consultant will update the database per program-specific requirements and deploy the updated database per requirements for programs. This includes any training, technical support, and customer service required.

3.4 Quarterly, the Database Consultant will meet with the key program personnel and determine any upgrades and changes to the database and will upgrade the database accordingly. Any upgrades or changes to the database will be documented by the Database Consultant.

3.5 The Database Consultant will develop database capabilities to address needs for projects, reports, adhoc inquiries and research within MS Access or another MS product. This includes: integration with assistive technology/medical devices utilized by the PSC and Headache Center, and export/merging of data for storage and analysis.

3.6 The Database Consultant will have access to patient identifying information. The Database Consultant will complete all VA Annual Mandatory Trainings which include but not limited to the following: VA Privacy and Information Security Awareness; Privacy and Health Insurance Portability and Accountability Act (HIPAA) Training; Safety; Security; Compliance and Business Integrity; Compliance and Business Integrity (CBI) Awareness; and Prevention of Workplace Harassment also known as No FEAR.

4.0 Implementation Plan

4.1 The implementation plan (IP) shall include an orientation of the current databases, reviewing program information, review of roles and responsibilities, meeting with the key database stakeholders, and completion of all necessary trainings.

4.1.1 A written and electronic draft of the detailed, customized IP shall be submitted to the COR within fifteen (15) workdays of the Organizational Assessment Briefing as stated in PWS 3.0. The final IP shall be submitted to the COR within ten (10) workdays after submission of the draft plan.

5.0 Type of Contract. The period of performance will be indicated in the contract price schedule and/or on the 1449.

5.1 This is an option year contract; The contract will be awarded at the base year, all other years are option years.

6.0 Expected Outcomes. The expected outcomes of the Database Consultant and the database are:

6.1 Developing a database and infrastructure that aligns with the needs of the service programs

6.2 Developing an understanding of the various service departments and their data needs

6.3 Meeting and providing technical support/consultation with key staff for database development and upgrades and providing recommendations for data structure and reporting

6.4 Maintain and upgrading a database that will provide utility to the services not only as a sustainable data repository, but also as reporting mechanism.

7.0 Other Contractor’s Administrative Responsibilities

7.1 Tour of Duty: Tour of duty of the Database Consultant shall be adjusted as needed to meet the needs of the program. The database shell can be worked on remotely, however clinical data must remain on the VA servers.

7.2 Normal Work Hours for the VA Palo Alto facility is from 8:00am and 4:30pm, Monday through Friday.

7.3 Federal Holidays: The Contractor is not expected to work on Federal Holidays. The holidays are: New Year’s Day; Martin Luther King Birthday, President’s Day; Memorial Day; Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving Day; Christmas Day; and any other day(s) officially declared by the President of the United States to be a federal holiday.

7.4 Travel Costs: Unless specified otherwise within this Solicitation, the Contractor shall include in its price, all labor, travel cost and its related expenses, materials, tools, supplies, equipment, and other expenses necessary to perform this requirement.

8.0 Contractor Qualifications

8.1 Bachelor’s Degree or Trainings as related to database development

8.1.1 At least 5 years of experience developing and maintaining databases for an external organization.

9.0 Government Furnished Equipment (GFP)

9.1 The VAPAHCS will provide office/treatment space and additional equipment as needed (e.g., computers) to complete duties. VAPAHCS will provide technical assistance as necessary.

9.2 Damage to Government Property: The Contractor shall be responsible for any damage to government furnished equipment and property. This includes but is not limited to: audiovisual equipment including speakers, projectors and projection screens; computers; VA furnished equipment; furniture; walls and baseboards; and other interior and exterior surfaces.

10.0 Contractor Furnished Equipment/Property

10.1 The Contractor shall provide the necessary labor, travel, equipment, tools, parts, supplies, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, or materials.

11.0 Security Requirements

11.1 A background check is required for each Contractor intending to provide services to the Government.

11.2 The position sensitivity has been designated as Low Risk.

11.3 The level of background investigation commensurate with the required level of access is Special Agreement Check (SAC) – Fingerprint Only. Fingerprinting will be done at a VA facility designated at the time of award. The VA will bear the cost of the initial SAC.

11.4 Privacy Training: The Contractor may be required to take on-site Privacy Training and any other training identified by VAPAHCS.

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

12.0 Payments and Invoicing

12.1 Once awarded, the Contractor shall register with OB10 to submit and invoice at a later period.

12.2 Billing/Invoicing: The Contractor shall submit invoices on a monthly basis in the arrears. All invoices shall include Contract number, Purchase Order number, Order Date, Period of Performance, and full description of services. The lack of detail or missing information on invoices will be rejected. The Contractor shall submit electronic invoices via OB10. Full instructions on “how-to” register will be provided upon award of contract.

12.3 Adhere to the instructions stated on the Continuation sheet of the SF1449 and VAAR Clause 852.232-72 Electronic Submission of Payment Requests (NOV 2012).

13.0 Contracting Officer Representative (COR)

13.1 The COR will be appointed and delegated by the Contracting Officer (CO). The Delegation Letter will state the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The Contractor will receive a copy of the Delegation Letter from the CO when fully executed.

14.0 Contractor’s Quality Control Plan (QCP)

14.1 The Contractor shall establish a complete quality control (QC) program that all requirements are provided for, as specified in all sections of this contract. One copy of the Contractors QCP shall be provided to the COR for review prior to contract performance. The Contractor’s QCP shall include but not be limited to the following:

14.1.1 A statement describing how the Contractor will meet the basic requirements of this contract (i.e. staffing levels, time to respond to an incident, equipment requirements) shall be provided to COR 15 days after effective date of Contract award and whenever there are major turnover of personnel. A major turn-over would be determined by the COR.

14.1.2 A method for identifying deficiencies in the quality of services performed before the performance deficiency becomes unacceptable.

14.1.3 A method of recording or logging the daily activities of the contractor, which would demonstrate the Contractor's ability to maintain the minimum requirements of this contract.

14.2 The Government will monitor the Contractor's performance using the Contractor’s QCP and the Government’s Quality Assurance Surveillance Plan (QASP) as established by the COR.

14.3 The Contractor shall provide monthly QC assurance report. It shall include the results of the reviews, identification of problems and a plan of correction.

15.0 Quality Assurance Monitoring

15.1 The COR or designated representative will monitor the contractor’s performance to assure that the performance thresholds and standards of performance are met in accordance with the statement of work and the Quality Assurance Surveillance Plan (QASP). In accordance with FAR 52.212-4 (a) “Inspection/Acceptance” the Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The COR may require repair or replacement of nonconforming supplies or re-performance of nonconforming services at no increase in contract price.

15.2 The Contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance standards describe the minimum acceptable level of the service required for each task. These thresholds are critical to mission success.

15.3 The COR will evaluate the services required by each task order to ensure compliance.

15.4 The Contractor shall perform all work required by the task orders in a satisfactory manner in accordance with the appropriate SOW task order sheet. The COR will not consider the task completed until all deficiencies have been corrected.

15.5 The COR will receive complaints from facility personnel and pass them on to the contractor’s quality inspector for correction.

16.0 Contractor’s Contingency / Back-Up Plan.

16.1 The Contractor shall have a contingency / back-up plan in the event the Contractor is unable to perform services or have services performed as scheduled and required. The Contractor shall immediately notify the COR and provide a justification for non-performance and institute the contingency and/or back-up plan as quickly as possible.

16.2 Alternate and Backup Contingency Plan to replace personnel. In the event that the Health Coaches are ill or unable to perform, the Contractor shall provide a “substitute” of equal ability and experience to replace the assigned Health Coach if needed by the program. The replacement shall have the appropriate background checks prior to start of work.

16.3 The Contractor shall furnish a copy of its contingency plan to the COR within 15 days after award of contract. The contingency plan shall have no more than a 24 hour delay before implementation. The contingency plan shall include a toll-free number to be used in case of cancellation due to sudden illness and any other unforeseen event.

B.3 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 3 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 3 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 purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

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

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

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

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

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the 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 individuals affected or potentially affected;

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

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

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

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

(8…