36C24821Q0391.docx

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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

36C24821Q0391 02- -2021 Jessica Kiser 407-646-4017 03- -2021

12:00 PM

EST

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827 X X 334516 1000 Employees N/A X 36C672 Department of Veterans Affairs VA Caribbean Healthcare System 10 Casia Street San Juan PR 00921-3201 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Solicitation for Erythrocytes Sedimentation Analyzer for VA Caribbean Healthcare System in San Juan, PR.

Quoters are to email complete quotes to Jessica Kiser via Jessica.Kiser@va.gov no later than 12:00 PM Eastern Standard Time (EST) March 03, 2021.

Quoters must submit the completed 1449 filled out in its entirety to be considered responsive.

All vendors responding to this RFQ must be registered and Certified in the VIP Portal and SAMS Portal with the NAICS Code listed on Block 10 of this RFQ (NAICS 334516).

Please ensure the SF1449 is filled out in its entirety and all requirements under the evaluation criteria is provided at the time of closing for the RFQ to be considered technically acceptable.

X X X 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: 36C248- Contracting Officer: Pedro J. Catinchi, Pedro.CatinchiJaime@va.gov Contract Specialist: Jessica Kiser, Jessica.Kiser@va.gov

Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Orlando VA Healthcare System 13800 Veterans Way Orlando FL 32827

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.

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971

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

B.2 PRICE/COST SCHEDULE/ITEM INFORMATION

Reagent Rental: Erythrocyte Sedimentation Rate (ESR) Analyzer. Cost includes all Equipment and Reagents for 1,500 Tubes per month.

Contract Period: Base POP Begin: 04-01-2021 POP End: 03-31-2022 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing PRODUCT/SERVICE CODE: 6640 - Laboratory Equipment and Supplies MANUFACTURER PART NUMBER (MPN): None

Reagent Rental: Erythrocyte Sedimentation Rate (ESR) Analyzer. Cost includes all Equipment and Reagents for 1,500 Tubes per month.

Contract Period: Option 1 POP Begin: 04-01-2022 POP End: 03-31-2023 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Reagent Rental: Erythrocyte Sedimentation Rate (ESR) Analyzer. Cost includes all Equipment and Reagents for 1,500 Tubes per month.

Contract Period: Option 2 POP Begin: 04-01-2023 POP End: 03-31-2024 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Reagent Rental: Erythrocyte Sedimentation Rate (ESR) Analyzer. Cost includes all Equipment and Reagents for 1,500 Tubes per month.

Contract Period: Option 3 POP Begin: 04-01-2024 POP End: 03-31-2025 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

Reagent Rental: Erythrocyte Sedimentation Rate (ESR) Analyzer. Cost includes all Equipment and Reagents for 1,500 Tubes per month.

Contract Period: Option 4 POP Begin: 04-01-2025 POP End: 03-31-2026 PRINCIPAL NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing

B.3 DELIVERY SCHEDULE

VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 3201

USA

VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 3201

USA

VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 3201

USA

VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 3201

USA

VA Caribbean Healthcare System 10 Casia Street San Juan, PR 00921 3201

USA

36C24821Q0391

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B.4 STATEMENT OF WORK (SOW)

Automated Erythrocyte Sedimentation Rate Analyzer

The Department of Veterans Affairs, VISN 8, Veterans Affairs Caribbean Healthcare System, Pathology and Laboratory Medicine Service, Hematology Section in San Juan, Puerto Rico is requesting the procurement of new Automated Erythrocyte Sedimentation Rate (ESR) analyzers for the VA Caribbean Healthcare System Pathology and Laboratory Service in San Juan P.R. and the Outpatient Clinics of Ponce and Mayagüez. This contract will be awarded for a period of one base year and four-year options.

1) CLINICAL LABORATORY INSTRUMENTS:

a. The ESR automated analyzers are intended for the erythrocyte sedimentation rate measurement. The ESR is a non-specific test that alerts physicians to the possible presence of disease or abnormality in the body. The ESR is determined by measuring, in millimeters per hour, the distance red cells have fallen after separating from the plasma in a vertical sed-rate pipette. This measurement reflects changes in plasma proteins which accompany acute and chronic infections, inflammation, malignancy, multiple myeloma, macroglobulinemia and hyperfibrinogenemia. The ESR is used primarily to follow the progress of inflammatory diseases such as rheumatoid arthritis during treatment.

b. The vendor is required to provide new equipment, which is cost effective and meet the turnaround- time requirement (i.e. 20 minutes or less). Discontinued or refurbished equipment models are not acceptable.

c. The vendor shall continuously provide stocked inventory of reagents, assayed controls, calibrators, consumables (e.g. thermal printer paper) and any other material required to properly perform tests on the equipment such that equipment operation is not interrupted.

d. In the event that the consumables or reagents are found to be defective and unsuitable for use with the vendor equipment or the vendor fails to comply with the requirements routing supply delivery, the vendor shall deliver the consumable supplies within 24 hours after receiving a notification order for priority delivery. The vendor will deliver to the government site in the most expeditious manner possible without additional cost to the government, the necessary consumables in sufficient quantity as required allowing operation until the arrival at the government site of the monthly standing order supply delivery. Failure to resolve with adequate inventory will result on a contract cancellation.

e. The analyzer must eliminate exposure to biohazardous material and/or waste.

2) GENERAL REQUIREMENTS:

a. Only instruments and reagents which are FDA (Federal Drugs Administration) approved shall be considered and shall meet the performance for accuracy and precision as defined by the Clinical Laboratory Improvement Act (CLIA).

b. 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.

c. The vendor shall provide all supplies and services as described herein.

d. Testing quantities are an estimate and are therefore not a guaranteed minimum.

e. A high incidence of problems with any instrumentation/test kits supplied may indicate probable non- compliance with the terms of this contract and will entitle the facility to replacement of equipment/test kits that can produce the required criteria of this contract satisfactorily to the user.

f. The vendor shall provide users with the utility requirements (electrical, guidelines for disposal of waste and hazardous reagents, etc.).

g. An operator’s manual must be furnished with each model supplied.

3) SYSTEM REQUIREMENTS:

a. The vendor shall provide:

i. One main and one back-up (both the same model) automated ESR analyzers for the San Juan clinical laboratory which are capable of performing a volume of approximately 40 tests per day and rapid processing of STAT samples (test that will be performed at least in one hour) without the need to interrupt ongoing testing.

ii. One automated ESR analyzer for each Outpatient Clinic (Ponce and Mayagüez) clinical laboratory which can perform the volume routine testing and rapid processing of STAT samples without the need to interrupt ongoing testing.

iii. One closed tube sampling/cap piercing (instrument sample aspiration without opening the test tubes) capability which reduces the laboratory testing personnel’s risk of injury and potential exposure to bloodborne pathogens.

iv. Quality control Levy-Jennings graphs and quality control peer groups comparison program to comply with accreditation requirements.

v. The equipment must provide the capability of standardization (i.e. ability to share reagents, controls and/or equipment items) between the main laboratory in VA San Juan and the Outpatient clinics of Ponce and Mayagüez.

b. The system shall be user friendly requiring minimal hands-on time with walkaway capability and present clear results for user interpretation.

c. The analyzer shall have the ability to perform test by random access and continuous feed, minimal to no waste generation and available CAP proficiency testing.

4) SERVICE:

a. The vendor shall perform every 6 months or more analyzer preventive maintenance as per our regulatory agencies CAP (College of American Pathologists) and Joint Commission regulations.

b. The vendor must provide analyzer preventive maintenance (PM) as per manufacturer specifications which includes travel costs, labor and the non-consumable parts used during the PM in order to maintain instruments in good operating conditions. These PM visits shall be of a frequency that conforms to the manufacturer’s operation and maintenance instructions for the supported equipment.

c. All items and replacement parts to keep equipment in good operational conditions as well as repairs shall be provided by the vendor during the contract time frame period.

d. The vendor shall provide full technical service available 24 hours/day, 7 days a week including holidays. Emergency repair services shall not exceed 24 hours of the time of malfunction notification.

e. During the contract period in which the repair record of any laboratory equipment reflects a downtime of a 10% or more of the normal working days in one calendar month, a determination will be made by the government site to replace the initial laboratory equipment with new equipment.

f. The vendor shall furnish a malfunction incident report to the COR upon completion of each repair call. The report shall include as a minimum the following:

i. Date and time notified

ii. Date and time of arrival

iii. Serial number, type and model number of the equipment

iv. Time spent for repair

v. Description of malfunction and repair

vi. Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance

g. The vendor shall warrant printers, keyboards and computers of the analyzer during the contract life as integral peripheral equipment items without which the laboratory work is affected, causing service delays due to equipment incomplete/or complete operation without cost to the government.

h. The vendor shall provide and warrant the appropriate UPS (Uninterruptible Power Supply) units according with the equipment model necessary for equipment protection against electrical power failure during the contract life and replace these units when defective at no additional charge.

i. The vendor shall provide all upgrades to equipment hardware and operating system software without additional charge. These enhancements to the vendor equipment shall be delivered to the government site and installed by the vendor after their issuance or date of first commercial availability.

j. The vendor shall provide emergency back-up equipment and validation studies assistance in case it is necessary in order to maintain laboratory testing service continuity.

k. The vendor shall provide onsite Technical Service Specialist assistance during the equipment installation, implementation and validation studies in San Juan and in the Ponce and Mayagüez Outpatient Clinics.

l. Except for manufacturer recommended daily, weekly or monthly user maintenance, the responsibility for maintaining the equipment furnished in complete operating condition shall be solely that of the contractor.

m. The contractor must provide monthly invoices that should be transmitted to Austin.

n. The vendor quality performance will be measured on an annual basis by evaluating the following elements, rating from 1 to 5, unsatisfactory to outstanding performance:

i. Test/assay performance (accuracy, precision and sensitivity)

ii. Instrument performance (minimal downtime and accuracy)

iii. Service-maintenance and repair (contractor has been responsive in resolving any unsatisfactory performance and has taken immediate corrective action)

iv. Deliveries of reagents and supplies (timeliness, accuracy, complete orders, reagent lot consistency, acceptable expiration dates.)

v. Invoicing/Account payable (timeliness and accuracy).

5) INSTALLATION:

a. Site preparation specifications shall be furnished in writing by the vendor as a part of the equipment proposal. In addition, the vendor is responsible for assessing the space available in each facility in order to ensure the right size equipment is provided; thereby not creating a safety hazard.

b. Installation by the vendor must be complete and in accordance to manufacturer’s instructions. It must include:

· Shipment of equipment to the VA San Juan facility and its outpatient clinics in Ponce and Mayagüez

· Unpackaging of the equipment

· Inspection of all parts and accessories to assure that all components are present and undamaged.

· Assembly of the analyzers (including electrical power conditions, drains, etc.) for a normal operation.

· Performing a complete system operation check (mechanical adjustments, calibrations, etc.)

· Configuring test parameters

· Verification of system operation and performance by multiple trial sample runs

· Before leaving the site, the following must be provided: a certified copy verifying the analyzers operation performance, and all required operating manuals

· The vendor will provide Technical Support Specialist for validation studies in San Juan (including correlation studies, evaluation/comparison data and statistical analysis sufficient to satisfy CAP specifications regarding implementation of new tests).

· The vendor shall provide all manpower, reagent/supplies, procedures, instructions to complete validation studies.

c. The vendor will remove instruments when a replacement or termination occurs and will be responsible for all packing and shipping required.

6) TRAINING:

a. The vendor shall provide training for San Juan, Ponce and Mayagüez operators without additional charge to the government. In addition, the vendor must provide supplemental operating training to the operators, without additional charge to the government, upon installation of any upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished.

b. The vendor shall supply all necessary procedure manuals, troubleshooting manuals and operator manuals on binders and digitalized. Procedures must be in the Clinical Laboratory Standards Institute (CLSI) format. The vendor shall provide assistance in creating preventive maintenance and quality control records or logs to meet the needs of the facility.

7) DELIVERY OF SUPPLIES AND SAFETY:

a. The vendor shall continuously provide stocked inventory of reagents, assayed controls, calibrators, consumables (e.g. thermal printer paper) and any other material required to properly perform tests on the equipment such that equipment operation is not interrupted. These items should be of the highest quality ensuring sensitivity, specificity and tested to assure precision and accuracy. The quality of the products should be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO).

b. In the event that the consumables or reagents are found to be defective and unsuitable for use with the vendor equipment or the vendor fails to comply with the requirements routing supply delivery, the vendor shall deliver the consumable supplies within 24 hours after receiving a notification order for priority delivery. The vendor will deliver to the government site in the most expeditious manner possible without additional cost to the government, the necessary consumables in sufficient quantity as required allowing operation until the arrival at the government site of the monthly standing order supply delivery. Failure to resolve with adequate inventory will result on a contract cancellation.

c. The vendor shall immediately notify the government of any changes in reagent kit composition, procedure notification, recall notification, equipment modifications, or any changes that will affect the performance of the test or procedure according to FDA regulations. Notification shall be provided by electronic means as well as by postal mail with supporting documentation of the change and detailed guidance on implementation within 24 hours of its application or according to FDA guidelines.

d. The vendor shall provide all necessary Safety Data Sheets (SDS) records.

8) INTERFACE:

a. The instruments shall be operational and have the capability of connectivity (drivers) with our Laboratory Interface System (Data Innovation). A bi-directional bar-coded computer interface compatible with the current VA laboratory computerized hospital information system.

b. The vendor must ensure LIS support during instrument LIS setup.

9) 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 web site 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 a U.S. citizenship and are able to 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

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

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

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

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

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

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

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

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

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

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

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

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

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

SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the 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.

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) 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 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

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

(3) Data breach analysis;

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

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

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

SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the 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 the following 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 Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor 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.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of persons to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor points of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest…