36C26119Q1155-001.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 51

570-20-1-223-0005

36C26119Q1155 08-22-2019

Philip Caganap 925-372-2034 08-30-2019

1700 PDT

36C261 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 150 Muir Road Martinez CA 94553-4668

X

334516

1000 Employees

N/A

X

36C640

Department of Veterans Affairs VA Central California Healthcare System 2615 E. Clinton Ave Fresno, CA 93703

36C261

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 150 Muir Road Martinez CA 94553-4668

Department of Veterans Affairs FMS-VA-2(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Microbiology Identification / Susceptibility Laboratory Test System on a Cost-Per-Test Basis

See below for complete details.

VA Contracting POC: Philip "Gabe" Caganap philip.caganap2@va.gov

See CONTINUATION Page

X X

Philip Caganap Contracting Officer

36C26119Q1155

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

B.3 PRICE/COST SCHEDULE

Base Year – 10-01-2019 – 09-30-2020 Option Year 1 – 10-01-2020 – 09-30-2021

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.3 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.4 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

C.5 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.6 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAY 2019)

C.7 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

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

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

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.211-6 BRAND NAME OR EQUAL (AUG 1999)

E.2 52.212-1 INSTRUCTIONS TO CONTRACTORS – COMMERCIAL ITEMS (TAILORED

FOR SAP)

E.3 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

ITEMS

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.4 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 2018)

E.5 52.217-5 EVALUATION OF OPTIONS (JUL 1990)

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:

[Company Contact Person’s Name]: ____________________________ [Company]: ____________________________ [Street Address]: ____________________________ [City, State, Zip]: ____________________________ [Phone number]: ____________________________ [Email address]: ____________________________ [CAGE Number]: ____________________________ [DUNS Number]: ____________________________

b. GOVERNMENT: Philip “Gabe Caganap, Contracting Officer 36C261

VA Sierra Pacific Network (VISN 21) Network Contracting Office 21 (NCO 21) 3230 Peacekeeper Way, Bldg 209 McClellan, CA 95652

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] After Receipt of Order (ARO)

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 FMS-VA-2(101) Financial Services Center

Austin TX 78714-9971

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

AMENDMENT NO DATE

B.2 STATEMENT OF WORK

STATEMENT OF WORK

This is a brand name or equal requirement IAW FAR Part 51.211-6. The information provided below is the description and reflects the capabilities of the brand name item. If submitting a brand name equal, please provide a detailed description of how the quoted Equal item meets and/or exceeds the capabilities described below.

1. SCOPE OF WORK: The contractor will provide the Vitek 2 instrument, including Vilink remote access software, Myla PC, 2 user licenses, warranty enhance-Vitek 2 and necessary service that are required to perform these tests on a Cost-Per-Test basis. The contractor shall provide reagents, controls, ID organism cards, antibiotic sensitive cards plus all other supplies needed to run the Vitek instrument. The contractor shall provide enhanced service package that is 24/7 service. The contractor shall provide, at no additional cost to VA Central California Health Care System (VACCHCS) an electronic interface to receive completed test results directly into the VISTA Lab Package.

Section B.3 lists the tests and supplies currently requested by VACCHCS. Test that can be performed on the quoted analyzer that are not listed in Section B.3 and future FDA approved tests are considered within the scope of this requirement and may be added via a supplemental agreement between the Government and Contractor.

1.1. The contractor shall provide all necessary supplies to run the Vitek instrument.

2. PERFORMANCE STANDARDS, QUALITY ASSURANCE (QA) AND QUALITY IMPROVEMENT (QI)

2.1. Quality Management/Quality Assurance Surveillance: Contractor shall be subject to Quality Management measures, such as provider satisfaction surveys and Peer Reviews.

2.2. Methods of Surveillance: Contractor performance will be monitored by the government using the standards as outlined in this Statement of Work (SOW) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

2.3. Measure: Reagents, controls antibiotic sensitivity cards and other supplies delivered as scheduled Performance Requirement: Supplies are delivered at least monthly.

Standard: All (100%) of supplies are delivered as scheduled.

Surveillance Method: Monthly deliveries received in VACCHCS Laboratory.

2.4. Measure: Adequate supply of Reagents, controls antibiotic sensitivity cards and other supplies for routine testing Performance Requirement: Contractor shall provider and adequate supply of Reagents, controls antibiotic sensitivity cards and other supplies for VACCHCS to perform routine testing without interruption to workflow.

Standard: All (100%) of testing is performed without workflow interruption.

Surveillance Method: No workflow interruptions due to lack of supplies provided by contractor.

3. DELIVERY SCHEDULE

3.1. Supplies, reagents, and calibrators will be delivered at least monthly to:

VA Central California Health Care System Pathology & Laboratory Medicine Service 2615 East Clinton Avenue Fresno, CA 93703 POC: Rosario Casillas

3.2. No deliveries will be scheduled on weekends or the ten (10) holidays observed by the Federal Government as indicated in paragraph 6.2 below.

3.3. No government provided equipment (GPE) will be used or provided.

4. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: Contractor employees shall wear visible company identification at all times while on VACCHCS property. It is the responsibility of the Contractor employees to park in the appropriate designated parking areas. Information of designated parking areas is available from the VA Police Service. VACCHCS will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited on VACCHCS property, except in designated areas. Possession of weapons, illegal drugs or alcohol is prohibited. Enclosed containers, including tool kits, shall be subjected to search. Violations of VACCHCS regulations may result in citation answerable in the United States Federal District Court, not a local district, state, or municipal court.

5. INVOICING AND PAYMENT

5.1. Itemized invoices rendered by the Contractor to VACCHCS for service(s) furnished under this task order shall be invoiced in full for each month in which services were performed. All payments made under this order shall be made monthly in arrears in accordance with FAR Clause 52.212-4. No advance payments will be authorized.

5.2. All invoices applicable to this agreement must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the Contracting Officer (CO).

5.3. Invoices will be submitted for services, on a monthly basis. At a minimum, each invoice must contain the following:

- A brief written synopsis of oversight audit or other services provided during the month

- Dates services were provided

- Name of contract person(s) who provided services

- Contract Line Item Number (CLIN)

- Quantity

- Unit

- Unit Price

- Total cost of services provided

- Contract number

- Remittance address

5.4. All invoices must include the name, title and phone number of the person to be notified in the event of defective invoicing.

5.5. Invoices must be submitted electronically to:

FMS-VA-2 (101) Financial Services Center

Austin, TX 78714-9971

In addition, invoices may also be mailed to:

VA Central California Health Care System Pathology and Laboratory Medicine Service (570/113) 2615 East Clinton Avenue Fresno, CA 93703 Attn: POC TB

5.6. Upon verification of services and prices, payment will be authorized by the Contracting Officers Representative

(COR).

5.7. Payment made during all periods of performance of this agreement shall constitute the total cost for services rendered by the contractor, and shall not exceed the amounts specified in the "Schedule of Supplies and Services" without written request and the written approval from the CO.

6. HOURS OF OPERATION

6.1. Work days: VACCHCS Normal Business Hours are Monday thru Friday, 7:30 AM until 4:30 PM; however, the

VACCHCS laboratory is staffed 24 hours a day, seven days a week. Work days will be based on a mutually agreeable schedule.

6.2. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

− New Year’s Day − President’s Day − Martin Luther King’s Birthday − Memorial Day − Independence Day − Labor Day

− Columbus Day − Veterans Day − Thanksgiving − Christmas

6.3. The payment for any leave, including sick leave or vacation time, is the responsibility of the contractor. Periods of any absences are not paid by the VA.

7. ESTIMATED QUANTITIES: There is no guaranteed minimum or maximum quantity of specimens that will be referred for testing in this agreement. VACCHCS does not imply or guarantee that any fixed number of specimens will be referred during the task order period and will only contact Contractor if services are required. VACCHCS will not be obligated to reimburse the Contractor for any specified amount of services not requested, but will be obligated to make payment for any services received in the quality and quantity as requested.

8. VACCHCS RESPONSIBILITIES

8.1. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

8.2. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

8.3. COR Responsibilities:

COR TBD

Pathology and Laboratory Medicine Service Administrative Officer 2615 E. Clinton Avenue (570/113)

The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

8.4. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled.

9. HANDLING OF RECORDS

9.1. All records will remain the property of the VA under their exclusive control.

9.2. By performing services under this contract, the Contractor is considered part of the VA healthcare activity for purposes of the following statutes and respective regulations implementing these statutes: Title 5 U.S.C Section 552a (Privacy Act), Title 38 U.S.C. Section 5701, Title 38 U.S.C. Section 5705, Title 38 U.S.C Section 7332, and Public Law 104-191 (HIPAA). Contract personnel shall have access to patient medical records and general files only to the extent necessary to perform their contractual duties. Contract personnel shall only release medical information obtained during the course of this contract to those VA medical staff members involved in the necessary care and treatment of the individual patient in which the information pertains. Notwithstanding any other clause and/or provision of this contract, if a request for release or disclosure of information is not necessary for the care and treatment of an individual patient, the Contractor and contract personnel shall not disclose any information contained in general files, patient records, and/or any other individually identifiable health information, including information and records generated by the Contractor in performance of this contract, except pursuant to explicit instruction and written approval from VA. For the purposes of this paragraph, instruction to disclose or copy such records and/or information may only be provided by the following: VA Regional Counsel and Chief, Health Information Management Service/Privacy Officer through the VA Contracting Officer. Violation of the aforementioned statutes may result in criminal and/or civil penalties.

9.3. Contract personnel who obtain access to hardware or media which may manipulate or store drug or alcohol abuse data, sickle cell anemia treatment records, records or tests or treatment for or infection with HIV, medical quality assurance records, or any other sensitive information protected under the statues and implementing regulations previously mentioned in paragraph 6, above, shall not have access to the records unless absolutely necessary to perform their contractual duties. Any contract person who has access to the previously mentioned data and/or information must not disclose it to anyone, including other contract personnel not involved in the performance of the particular contractual duty for which access to this data and/or information was obtained.

9.4. Information or records accessed and/or created by the Contractor in the course of performing services under this contract are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal law, regulations, and/or VA/VHA policy. The Contractor will not copy information contained in VA information systems, either by printing to paper or by copying to another digital format, without the explicit instruction and written approval from of the VA officials, except as is necessary to make single copies in the ordinary course of providing patient care. The Contractor will not commingle the data from VA information systems with information from other sources. Contractor shall report any unauthorized disclosure of VA information to the VA officials.

9.5. If this contract is terminated for any reason, the Contractor will provide VA with all individually identifiable VA patient treatment records or other information in its possession, as well as any copies made pursuant to paragraph 6 above, within seven (7) calendar days of the termination of this contract.

9.6. The Contractor shall follow all VA policies regarding the retention of records. As an alternative, the Contractor may deliver the records to VA for retention.

9.7. The Contractor shall follow all of the previously mentioned statutes and respective regulations implementing these statutes as well as VHA Handbook 1605.1 - Privacy and Release of Information and any other VA/VHA policies and procedures governing the information discussed in this section of the contract. Copies of the information discussed in the aforementioned paragraphs may be viewed by contract personnel in the Office of Health Information Management (see the Privacy Officer). All contract personnel with access to any of the previously mentioned records (electronic or paper) will be required to complete VHA Privacy Policy Training before accessing such record systems. This training must also be completed annually. The COTR will be responsible for ensuring and documenting that this requirement is satisfied.

9.8. Any changes in the laws, regulations, or VA/VHA policies or procedures governing the information covered by this section of the contract, during the term of this contract, shall be deemed to be incorporated into this contract.

9.9. VA has unrestricted access to the records generated by the contractor pursuant to this contract.

10. HIPAA COMPLIANCE: Under HIPAA Privacy and Security Rules, the Contractor providing services under this contract is considered to be a “covered entity,” and thus is not required to enter into a Business Associate Agreement with VA. However, the Contractor must observe Public Law 104-191 and all respective regulations implementing this law while providing services under this contract.

11. POLICIES/HANDBOOKS: The contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

− VA Directive 1663: Health Care Resources Contracting ‐ Buying − http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347 − VHA Directive 2006‐041 “Veterans Health Care Service Standards” (expired but still in effect pending revision) − https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 − VHA Handbook 1100.17: National Practitioner Data Bank Reports ‐ − http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 − VHA Handbook 1100.18 Reporting and Responding To State Licensing Boards − http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 − VHA Handbook 1100.19 Credentialing and Privileging ‐ − http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 − VHA Handbook 1907.01 Health Information Management and Health Records:

− http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 − Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm − VHA Handbook 1106.1: Pathology and Laboratory Medicine Service (P&LMS) Procedures (29JAN2016) − http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169 http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

12. DEFINITIONS/ACRONYMS: Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.

Contracting Officer’s Representative (COR) – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non‐compliance in order that appropriate action can be taken.

HIPAA: Health Insurance Portability and Accountability Act POP: Period of Performance QASP: Quality Assurance Surveillance Plan VISTA (Veterans Integrated Systems Technology Architecture): A PC based system that will capture and store clinical imagery, scanned documents and other non‐textual data files and integrates them into patient’s medical record and with the hospital information system.

Veterans Affairs Medical Center (VAMC): Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean VA Central California Healthcare System.

VACCHCS: Veterans Affairs California Healthcare System

B.3 PRICE/COST SCHEDULE

In accordance with FAR 52.217-6 Option for Increased Quantity, the quantities shown in the price schedule may be increased by up to 30%. The Government may exercise the option for lesser quantities multiple times up to that percentage.

Base Year – 10-01-2019 – 09-30-2020 Item # Brand Name Description/Part Number (Biomerieux) Qty Price Extended Amount

1 VITEK XL Analyzer 1

2 4700027 - Vilink Remote Access Software 1

3 4700031 - Vitek 2 60 1

4 4702708 - Mala® Enhanced Warranty 1

5 4704836 - Mala PC (inc 2 simultaneous user licenses) 1

6 WE-4700031 - Warranty Enhance-Vitek 2 1

7 Pipette Tips, Yellow 0.5-250 micro liter 2 8 Pipette tips 200-1000 mcl 2 9 Saline 500 ML 18 10 Test tube, 132X75 MM, 1 X 2000 2 11 21341 - GN Test Kit VTK2 125 12 21342 - GP Test Kit VTK2 125 13 AST-EXN - AST-EXN Test Kit 230 14 AST-GN-GP - Vitek 2 GN & GP AST Cards 230

TOTAL

Option Year 1 – 10-01-2020 – 09-30-2021 Item # Brand Name Description/Part Number (Biomerieux) Qty Price Extended Amount

1 VITEK XL Analyzer 1

2 4700027 - Vilink Remote Access Software 1

3 4700031 - Vitek 2 60 1

4 4702708 - Mala® Enhanced Warranty 1

5 4704836 - Mala PC (inc 2 simultaneous user licenses) 1

6 WE-4700031 - Warranty Enhance-Vitek 2 1

7 Pipette Tips, Yellow 0.5-250 micro liter 2 8 Pipette tips 200-1000 mcl 2 9 Saline 500 ML 18 10 Test tube, 132X75 MM, 1 X 2000 2 11 21341 - GN Test Kit VTK2 125 12 21342 - GP Test Kit VTK2 125 13 AST-EXN - AST-EXN Test Kit 230 14 AST-GN-GP - Vitek 2 GN & GP AST Cards 230

TOTAL

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA.

This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements.

VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

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

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

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

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

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

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

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

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

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

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

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

6. SECURITY INCIDENT INVESTIGATION

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

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements…