36C24824Q0526_1.docx

36C24824Q0526

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.

UEI:

EFT:

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. SIGNAT

URE 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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

673-24-3-023-0817 36C24824Q0526 02-21 -2024 Leonora Simmons 813-972-7592 02-28 -2024 10:00

EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637 X 334516 1000 Employees N/A X Department of Veterans Affairs James A. Haley Veterans Hospital (90C) 13000 Bruce B. Downs Blvd Tampa FL 33612 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Tampa FL 33637

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 See CONTINUATION Page Quoters shall provide products and services in accordance with the SON and price/cost/schedule.

Equal brand quotes must accompany brochures Quoters shall submit an authorization letter from the Original Equipment Manufacturer (OEM).

Note: Read the full evaluation criteria before submitting a quote. Only complete quotes will be accepted.

This RFQ is not to purchase equipment but to lease the equipment and to procure the reagents and test kits.

See CONTINUATION Page X Leonora Simmons 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 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) 8875 Hidden River Pkwy Suite 525 Tampa FL 33637

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.

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

36C24824Q0526

Page 1 of Page 1 of

B.2 STATEMENT OF NEED

Autoimmune analyzer testing system, reagents, supplies, and consumables.

1. GENERAL:

1.1 The Contractor shall provide Food and Drug Administration (FDA) approved, Cost-Per-Test (CPT) capable of performing FDA-approved patient testing, brand name or equal to (BioRad Laboratories Inc) CPT assays to include ANA; Vasculitis; Anti-CCP IgG; APLS IgA-IgG-IgM; EBV IgG-IgM; HSV ½; Celiac IgA-IgG; MMRV IgG; Syphilis Total & RPR; and Lyme. The requirement is for James A. Haley VA Medical Center (JAH VAMC), Pathology & Laboratory Medicine Service, Hematology Department, Tampa, Florida.

1.2 The requirement is for James A. Haley VA Medical Center (JAH VAMC), Pathology & Laboratory Medicine Service, Hematology Departments, Tampa, Florida. This requirement includes any other future JAH VAMC testing location deemed necessary by VA care providers.

2. BACKGROUND:

2.1 Currently, The James A. Haley Veterans Hospital (JAHVH), Pathology & Laboratory Medicine Service has a short-term (6 months) contract, reference number 36C24824F0009 procurement in place to enable the hospital to continue to lease and order the required FDA-approved, Cost-Per-Test (CPT) autoimmune analyzer testing system and test kits. The reference contract will expire on 03/31/2024, the JAHVH needs to pursue a base and four option year contract. The contract will include vendor-provided equipment, FDA-approved reagents, supplies, and consumables for autoimmune testing to provide care for our VA patient population.

3. PURPOSE:

3.1 The ability to continue to perform autoimmune testing using the Contractor’s FDA-approved automated analyzer system utilizing FDA-approved reagents, supplies and consumables to provide care for our VA patient population.

4. SCOPE:

4.1 JAH VAMC is requesting equipment and test kits that meet all the minimum physical, functional and performance features of the listed salient characteristics in this section. These salient characteristics are essential to the technical requirements to continue to meet the needs of the government. The Contractor shall maintain this testing system and continue to provide these assay requirements for period of performance 04/01/2024 through 03/31/2029.

5. EQUIPMENT:

5.1 Contractor shall provide FDA-approved, fully automated, and integrated analyzer testing system, printer, computer, Uninterruptable Power Supplies (UPS) for the analyzer, and accessories required for equipment usage.

5.2 Below are the salient characteristics of the autoimmune FDA-approved instrument and FDA-approved reagents capable of performing ANA; Vasculitis; Anti-CCP IgG; APLS IgA-IgG-IgM; EBV IgG-IgM; HSV ½; Celiac IgA-IgG; MMRV IgG; Syphilis Total & RPR; and Lyme testing with specific functionality and performance-based requirements of the system:

5.3 General instrument characteristics include ability to run FDA-approved patient testing for 100% of the below listed tests on FDA-approved, fully automated, random access, testing platform with priority processing:

Brand: BioRad Laboratories Inc.

a. Sufficient capacity and throughput to meet the volume and service demands as defined in the tests and volumes listed in section a. above.

b. Bar-coded primary patient sample tube entry capabilities.

c. Ability to run multiple assay protocols simultaneously.

d. Contractor shall provide all necessary software and hardware for the systems’ valid, acceptable, bidirectional interface data transmission through Data Innovation (DI) Instrument Manager (IM) middleware network connections.

e. Contractor shall provide all necessary system interface hardware and software upgrades as required for VA network compliance.

f. Contractor shall provide all upgrades to the equipment hardware and operating system software.

g. Operator and Service Manual shall be furnished with each model supplied. Electronic formats are acceptable.

h. Procedures shall be provided in accordance with the Clinical and Laboratory Standards Institute (CLSI) in editable format.

i. Contractor to provide all test kits, reagents, calibrators, controls, supplies, consumables, and Contractor assistance required for any instrument and method validations.

j. Additional testing may be added in support of patient care needs as determined by care providers.

k. Computer systems (CPUs, Monitors, Keyboards, Printers), and UPSs provided by Contractor for the instrument throughout contract period.

l. Our laboratory working space dimensions in inches (“) are listed below. Contractor’s analyzer system must fit within space listed below:

i. 53” Height x 51” Width x 34” Depth.

m. Electrical Characteristics:

i. 100-240 VAC at 50-60Hz, 1000 Watts.

6. DELIVERABLES:

6.1 BioPlex 2200 Instrument System, MPN 660000, with UPS Back-Up System, MPN 660-0517, including service & maintenance, supplies/consumables included in price of reagents, QTY 12 MO

7. Reagent Kits: BioRad Laboratories Inc.

7.1

8. FUNCTIONAL AND PERFORMANCE CHARACTERISTICS:

8.1 Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to requirements of the system:

a. Preventive Maintenance shall be performed per manufacturer’s guidelines.

b. Instrument service to be provided during routine business hours. 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.

c. Expected response to service call time from initial call to Contractor to service engineer arriving on site should be no more than 24 hours.

d. Technical Support Hotline must be available for in-house troubleshooting.

8.2 The Cost per-test includes costs covering (a) FDA-approved instrument system (lease), (b) equipment use, computers, printers and accessories including Uninterruptable Power Supply (UPS) for the instrument, (c) Software and hardware, (d) all aspects of computer interfacing for the analyzer system, (e) reagents offered by vendor, (f) all necessary supplies and consumables, (g) all necessary service, maintenance and parts to keep the equipment in good operating condition to fulfill the test requirements and produce high quality patient results, (h) operational hardware and software upgrades, (i) user training for government personnel, and (j) upon expiration of order(s) and/or termination and/or replacement of equipment, will provide equipment decontamination, turn-in hard drives with VA sensitive information to VA IT Department, and return packing and shipping at no additional charge.

8.3 Contractor is required to provide delivery and installation of any needed equipment at no additional charge. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances, with the FDA, and manufacturer’s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein.

8.4 The contractor shall provide all operational upgrades to the equipment hardware and operating system software that materially affect the performance of the equipment, without additional charge to the government. Any enhancements to the contractor’s equipment shall be delivered to the government site and installed by the contractor within 30 days of their issuance or date of first commercial availability. Discontinued or refurbished analyzers or testing system models are not acceptable.

8.5 All models shall continue to perform satisfactorily at any laboratory temperature between 59- and 86-degrees F (15 and 30 degrees Celsius). All models shall perform satisfactorily at any laboratory relative humidity of 10 to 70%. An electronic operator’s manual must be furnished with each model supplied. Trade-in of existing equipment will be negotiated at James A. Haley, and not included in the scope of this contract.

8.6 Ownership of Existing Equipment shall remain with the contractor for the life of the contract. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor.

8.7 The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will decontaminate and remove the equipment and turn in any hard drives containing VA sensitive information to VA IT Department. The contractor will disconnect the equipment and will be responsible for all decontamination, packing, shipping, and charges required to remove the equipment within ten business days.

8.8 Operational use time for performance testing for a system is defined as the accumulated time during which the equipment is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fine attempt to contact the contractor’s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition.

8.9 During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours.

8.10 The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes.

8.11 Operations use time and downtime shall be measured in hours and whole minutes.

9. GOVERNMENT’S RESPONSIBILITY:

9.1 The user will perform daily routine operator maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions.

10. TRAINING OF OPERATING PERSONNEL: The contractor shall provide the services of a qualified technical person, as needed, for equipment and at such time designated by Contracting Officer's Representative (COR) for on-site orientation and training for designated personnel in: (1) operation and care of equipment; (2) techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment.

11. PERFORMANCE, DELIVERY, INSPECTION AND ACCEPTANCE:

12. Reagents Delivery terms, Quality of Reagents, Supplies and Consumables:

12.1 The VA shall continue to require the delivery of reagents, supplies and consumables for all services required under this contract.

12.2 The contractor shall continue to deliver reagents, supplies and consumables, shipping cost included, from monthly call orders placed by JAHVH representative.

12.3 The contractor will assure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce high-quality, accurate patient results.

12.4 The FDA-approved reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and Joint Commission (JC).

13. MAINTENANCE:

13.1 The contractor shall provide maintenance (labor, parts, and shipping) to keep the equipment in good operating condition and subject to security regulations.

13.2 The government shall provide the contractor access to the equipment to perform maintenance services.

13.3 Preventive maintenance by contractor will provide regular, scheduled maintenance to assure the continued reliable operation of the equipment. These preventive maintenance visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment.

14. SERVICE:

14.1 Emergency repairs shall be performed within 12 hours after notification that the equipment is inoperative.

14.2 The scheduled maintenance and service shall be performed by a qualified engineer with notice to the Contracting Officer Representative (COR). James A Haley VA Hospital, Pathology & Laboratory Medicine Service is open 24 hours a day, 7 days a week including holidays.

14.3 Telephone response does not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable his maintenance representative to receive such notification.

14.4 The contractor will provide all parts, labor and shipping needed to repair the malfunction.

14.5 The travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the Government during this period.

14.6 The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call.

14.7 The report shall include, as a minimum, the following: (a date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair. Parts (e) and (f) shall be written verification of quality control for a sample run.

15. TECHINCAL UPGRADES:

15.1 Contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

16. WARRANTY OF EQUIPMENT:

16.1 Government requirement for standard manufacturer industry warranty term. Government does not accept extended warranty, which requires advance payment.

17. DELIVERY SCHEDULE:

17.1 Delivery performance shall start on 04/01/2024.

18. PLACE OF DELIVERY:

18.1 Warehousing Department, James A. Haley Veterans Hospital, 13000 Bruce B. Downs Blvd, Tampa, FL 33612.

With Sensitive Data and Training

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

a. 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.

b. 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.

c. 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.

d. 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.

Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs’ computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law Enforcement prior to contract performance. This requirement is applicable to all subcontractor personnel requiring the same access. If the investigation is not completed prior to the start date of the contract the contractor will be responsible for the actions of those individuals that provide or perform work for the VA.

1. Position Sensitivity – The position sensitivity has been designated as ( low) risk.

2. Background Investigation – The level of background investigation commensurate with the required level of access is National Agency Check (NACI) with written inquiries.

3. Contractor Responsibilities:

a. The contractor shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM), the contractor shall reimburse the VA within 30 days.

The website which provides information on the cost of the security investigation is:

www.opm.gov\extra\investigate – Select Federal Investigations Notices (FIN 01-01)

b. The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain U.S. citizenship and can read, write, speak, and understand the English language.

c. The contractor will provide to the Contracting Officer prior to award the following: (1) List of names of contract personnel. (2) Social security numbers of contractor personnel. (3) Home address of contractor personnel or the contractor address.

The Contracting Officer will submit the above information to the Office of Security and Law Enforcement, Washington, D.C. The Office of Security and Law Enforcement will provide the necessary investigative forms (these forms are indicated in paragraph 3.d. below) to the contractor’s personnel, coordinate the background investigations with OPM and notify the Contracting Officer and contractor of the results of the investigation.

d. The contractor shall submit or have their employees submit the following required forms to the VA Office of Security and Law Enforcement within 30 days of receipt:

(i) Standard From 85P, Questionnaire for Public Trust Positions

(ii) Standard Form 85P-S, Supplemental Questionnaire for Selected Positions

(iii) FD 258, U.S. Department of Justice Fingerprint Applicant Chart

(iv) VA Form 0710, Authority for Release of Information Form

(v) Optional Form 306, Declaration for Federal Employment

(vi) Optional Form 612, Optional Application for Federal Employment

d. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

e. Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

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 the 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 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 the VA’s information is returned to the VA or destroyed in accordance with the 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, the 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 1600.1, 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, the confidentiality of medical quality assurance records, and/or Title 38 U.S.C. 7332, the 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.

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.

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. However, it is the policy of the VA to forego the collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

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, the 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. The 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, and disability code;

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

d. Based on the determinations of the independent risk analysis; the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 for affected individuals to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

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

(3) Data breach analysis;

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

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

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

SECURITY CONTROLS COMPLIANCE TESTING :

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

TRAINING:

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete VA Privacy and Information Security Awareness and Rules of Behavior Training and Privacy and HIPAA Training and HIPAA Training before being granted access to VA information and its systems.

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Rules of Behavior before being granted access to VA information and its systems.

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

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

The Certification and Accreditation (C&A) requirements do not apply and a Security Accreditation Package is not required for this SOW.

*** IF APPLICABLE***

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 the implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

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

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

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