36C26120Q0627.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

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 94

612-21-1-113-0003

36C26120Q0627 07/02/2020

Moneque Rodriguez 808-539-1304 TIME 07/16/2020 3PM Hawaii Time

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Pacific Islands Health Care System 459 Patterson Rd Honolulu HI 96819-1522

X

Y

325413

1250 Employees

N/A

X

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VANCHCS-Mather 10535 Hospital Way Mather CA 95655

Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Pacific Islands Health Care System 459 Patterson Rd Honolulu HI 96819-1522

Department of Veterans Affairs FMS VA-9(101) Financial Services Center

PO Box 149971 Austin TX 78714-9971

See CONTINUATION Page

Automated Blood Culture and Reagents Single Award IDIQ "See Schedule and Statement of Work"

Ordering Period 1: October 01, 2020 - September 30, 2021 Ordering Period 2: October 01, 2021 - September 30, 2022 Ordering Period 3: October 01, 2022 - September 30, 2023 Ordering Period 4: October 01, 2023 - September 30, 2024 Ordering Period 5: October 01, 2024 - September 30, 2025

See CONTINUATION Page

X X

X 1

Mandy Thompson

36C26120Q0627

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 IT CONTRACT SECURITY

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.216-18 ORDERING (OCT 1995)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.7 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.9 VAAR 852.223-71 SAFETY AND HEALTH (SEP 2019)

C.10 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.11 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.12 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

C.13 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.14 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.15 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAR 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.3 52.204-26 COVERED TELECOMMUNICATIONS EQUIPMENT OR SERVICES—

REPRESENTATION (DEC 2019)

E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.5 52.216-1 TYPE OF CONTRACT (APR 1984)

E.6 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.7 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.8 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.9 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (MAR 2020)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C261 Mandy Thompson

Department of Veterans Affairs

VA Sierra Pacific Network (VISN 21)

VA Pacific Islands Health Care System

459 Patterson Rd

Honolulu HI 96819-1522

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] Upon Delivery and Acceptance

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-9(101) Financial Services Center

PO Box 149971

Austin TX 78714-9971

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

AMENDMENT NO DATE

STATEMENT OF WORK

Automated Blood Culture System and Reagents Cost Per Test

VA Northern California Health Care System (VANCHCS)

Dated 06/18/2020

1. GENERAL REQUIREMENT:

The Department of Pathology and Laboratory Services at VA Northern California Health Care System (VANCHCS), VA Sacramento Medical Center, Mather, California has a requirement for the procurement of reagents and supplies for blood culture analysis, identification of micororganisms, susceptibility testing, gram staining and MRSA screening. The contractor will provide the following analyzers: BacTAlert 3D blood culture analyzer, the Vitek 2, the Maldi-Tof mass spec analyzer and the Previ gram stain instrument. The Maldi-Tof identifies a wide range of micro-organism and the Vitek 2 performs susceptibility testing on the same sample. The Biomerieux computer system uses Myla software to link the BactAlert, Maldi-Tof and Vitek test results together. The Maldi-Tof consumables and the Vitek test cards are small, self-contained test cards and do not require a lot of storage space. E-test strips for MIC susceptibility testing when conventional susceptibility methods cannot be used for an unusual organism or for antibiotics which are not available on the Vitek system. ChromID media for the rapid screening of Staphylococcus aureus and methicillin resistant Staphylococcus aureus (MRSA).

2. SCOPE OF WORK:

2.1 The successful contractor shall furnish all equipment (to include instrument/equipment/(s)), reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct testing under a Cost-per-Test (CPT) Agreement (except as paragraph

2.2 in which contractor will provide only reagents compatible with government equipment).

All equipment and reagents/consumables to conduct testing for automated mass spectrometry rapid microbiology identification, automated antimicrobial susceptibility, gram stain, blood culture testing and automated biochemical microbial identification shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure VANCHCS is able to meet its objectives as listed herein.

2.2 The instruments and software provided to conduct testing as per paragraph 2.1 above will not be government owned, and therefore the contractor will be responsible for maintenance and service of their own instrumentation and software.

3. ORDERING PERIOD:

Ordering Period 1: October 1, 2020 – September 30, 2021 Ordering Period 2: October 1, 2021 – September 30, 2022 Ordering Period 3: October 1, 2022 – September 30, 2023 Ordering Period 4: October 1, 2023 – September 30, 2024 Ordering Period 5: October 1, 2024 – September 30, 2025

3.1 The Government will order items on as-needed basis, and shall only pay for the actual number of tests ordered, received, and accepted by the Government. The quantities listed in the Schedule represent anticipated test volumes for the ordering periods listed; however, quantities could increase and/or decrease during certain periods.

3.2 The inspection and acceptance for all deliverables rendered under this contract will be by the Contracting Officer Representative or designated personnel. The performance by the contractor technician, the quality of services rendered, and any documentation or written material in support of same, shall be subject to continuous inspection, surveillance and review for acceptance by the designated Contracting Officer representative or designee.

4. HOURS OF OPERATION:

The microbiology lab is in operation 24 hours a day, 7 days a week. Normal business hours for administrative personnel are Monday through Friday between the hours of 0730 – 1630 PST.

Contractor shall coordinate maintenance scheduled with Ordering Contracting Officer, COR or designee in no less than 48 hours.

5. SECURITY REQUIREMENTS AND SAFETY:

5.1 SECURITY. The Contractor shall ensure its personnel comply with installation and facility personnel identification and access requirements.

5.2 SAFETY. The Contractor shall ensure its personnel comply with the facility and State safety regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

6. INSTRUMENT/EQUIPMENT REQUIREMENT (OWNED BY CONTRACTOR):

6.1 Contractor shall provide all instruments/equipment necessary to conduct testing as per the

Schedule. The instrument/equipment provided will be utilized for VANCHCS Microbiology department at the VANCHCS, VA Sacramento Medical Center.

6.2 These instruments, to include any connections between the instruments/equipment, shall be approved by the US Food and Drug Administration (FDA).

6.3 The instruments will be able to correctly identify and perform antimicrobial sensitivities from a pure culture of unknown microbiological organism.

6.4 The instruments supplied, all of its associated parts, and all accessories must be maintained at the most up-to-date hardware and software. When necessary to maintain hardware updates, the existing instrument/equipment, associated parts, and accessories must be exchanged by the contractor. All software updates must be coordinated with the COR or designee.

6.5 The instrument system shall be equipped with an Uninterruptible Power Supply (UPS) capable of providing all necessary electrical power to the instrument/equipment system for at least 45 to 60 minutes.

6.6 The instruments shall be able to be connected to the hospital LIS, currently VISTA, or whichever LIS system the hospital uses in the future. The contractor must provide full technical support to ensure that the LIS connectivity is functioning properly.

6.7 The instruments, reagents, and software provided shall comply with the specific requirements listed in this SOW. The instruments and software provided for Automated Microbial Identification and Antimicrobial Susceptibility Testing will not be government owned, and therefore the contractor will be responsible for maintenance and service of the instrumentation and software.

6.8 The data management/quality control software shall be able to generate the following type of reports:

a. Statistical reports - to include positive incidence summary reports, days to detection summary reports, detail reports, positive rate reports, blood culture volume reports, and unconfirmed positive rate reports;

b. Epidemiology reports- to include trending reports, phenotype occurrence reports, phenotype trending reports, susceptibility reports, cumulative by MIC reports, bio-number distribution reports and incidence detail reports; Instrument reports- to include workload reports, load reports, unload reports, and calibration reports.

6.9 Software upgrades. Contractor shall have access to all necessary diagnostic software. All software upgrades, corrective in nature, or which enhance features shall be at no-cost to the government.

6.10 Contractors shall coordinate and conduct a site visit if necessary, to the VANCHCS Microbiology section, for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to potential placement of their instruments in the laboratory. Any changes to the layout of the laboratory, environmental control, or to utilities as currently in existence to accommodate placement of their proposed instruments must be identified.

6.11 Method Verification (Correlation Studies) will include parallel runs with existing equipment. Specificity and Sensitivity shall be equal to or exceed the manufacturer stated claims.

7. PREVENTATIVE MAINTENANCE, FAILURES AND REPAIRS:

7.1 The contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of their equipment.

Contractor shall coordinate with the designated point of contact all scheduled maintenance ideally within ten (10) business days prior to performing preventative maintenance services.

7.2 The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level will be performed by contractor service personnel in accordance with requirements as specified in the contractor’s instrument maintenance manual. The contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required by manufacturer in order to maintain the system in optimal operating condition.

7.3 The contractor shall provide a full-service plan to include the recommended unscheduled and preventive maintenance service for their instrument/equipment period. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, in order to assist customer in troubleshooting problems.

7.4 Preventive maintenance services shall be performed in accordance with the manufacturer’s standard/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

7.5 Upon notification of equipment failure owned by contractor, the contractor shall respond to telephonic requests for unscheduled repair within 24 hours. Should the instrument/equipment become inoperable, the contractor’s Repair Service Engineer / technician shall be on-site within 24 hours of initial notification for routine/emergency failures.

If the equipment is out of service for longer than 72 hours (from the time of service technician’s arrival on site), the contractor shall notify the government point of contract on duty, in writing, as to the reason(s) (i.e. non-availability of parts, etc.) for non-compliance

7.6 If the equipment cannot be repaired, a replacement instrument shall be provided within seven (7) days.

7.7 Within one (1) business day after completion of a repair, the contractor’s representative shall furnish the Point of Contact (POC) one (1) copy of a service report for all services performed.

The service report shall contain, at a minimum, the following information:

a. Nomenclature, date, description of services performed (i.e. preventative maintenance service, or unscheduled repair service)

b. Location of services performed, duration of services performed, list of parts replaced and;

c. Other actions taken to restore operability of the instrument/equipment, name of technician.

**Full report shall be submitted to designated government point of contact**

7.8 Contractor shall notify government of any hazard information before beginning equipment repair and shall comply with the Occupational Safety and Health Administration while performing maintenance on electrical equipment.

8. CUSTOMER SERVICE:

8.1 The Contractor shall provide direct customer service and support, during normal business hours and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

8.2 For Emergency Services and unscheduled services the Contractor’s qualified service technician shall be on-site to provide emergency service (service requiring immediate repair) within 24 hours. The equipment shall be repaired and operational at the minimum of 72 hours after arrival of contractor on site.

8.3 The Contractor shall perform preventive maintenance services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment. Scheduled routine services shall be performed between 0730-1630 LOCAL Monday-Friday, excluding U.S. Holidays.

8.4 The Contractor shall provide a full unscheduled and preventive maintenance service for the instrument/ equipment owned by contractor. All maintenance and repairs shall be inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

8.5 The contractor’s qualified service technician shall be on site to provide routine services;

service requiring immediate repair; and scheduled services for preventive maintenance (as specified in the Contractor’s instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 72 hours after arrival of contractor on site.

8.6 Upon analyzer failure, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours. The equipment shall be repaired and operational within 72 hours after arrival of contractor on site.

8.7 Should the analyzer at VANCHCS become inoperable, the Contractor’s technical repair specialist shall be on-site within 24 hours of initial notification and make the repair within 72 hours after arrival of contractor on site. If the analyzer cannot be repaired within 72 hours after arrival of contractor on site, a replacement analyzer, at no additional cost to the U. S.

Government, will be provided within seven (7) days of the initial notification to be utilized by the U.S. Government until the original instrument is fully repaired and accepted for service.

8.8 During the period when the analyzer is inoperable, the Contractor will arrange the pickup and delivery of critical specimens to a College of American Pathologists accredited clinical laboratory of their choice. The selected laboratory will provide patient reports. Each patient report shall include the testing laboratory’s reference range for the test being performed. The Contractor will be responsible for all costs associated with the provision of this service, including those for delivery of hardcopy patient results, for as long as the analyzer remain inoperable.

8.9 The Contractor shall provide all necessary user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at no additional cost to the U.S.

Government.

9. DELIVERY OF EQUIPMENT

9.1 All equipment (owned by contractor) shall include delivery, installation, maintenance, and removal upon termination of contract. Contractor shall furnish all necessary calibrators/standards and quality control materials necessary to perform the initial method verifications per CLIA/NCCLS/CAP/TJC guidelines.

9.2 The instrument (s)/ equipment shall be delivered to the VA Sacramento Medical Center Laboratory within 30 days or less after contract award as needed for new equipment covered under this SOW. Exact installation location shall be coordinated by contractor and government point of Contracting Officer Representative or designee. Equipment setup, LIS connectivity, on-site training, and method verification studies, shall be completed by vendor personnel within six (6) weeks or less after contract award to ensure that equipment is fully operational.

9.3 SAFETY DATA SHEETS (SDS): The contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL.

The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall contain at a minimum the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

10. REAGENTS/CONSUMABLES:

10.1 All assays shall be FDA approved and must have a minimum shelf life of six (6) months upon receipt by the Government, or, if this shelf life requirement cannot be met the Contractor shall identify the guaranteed shelf life after receipt that can be accommodated in their response to the Solicitation for Bid.

10.2 The manufacturer will provide the required quality control materials and test reagents and ensure that there is minimal change in lot numbers during the contract year.

10.3 All reagents and quality control material shall be provided by the manufacturer of the equipment; be marked with the required storage temperature and expiration dates; be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the U.S. Government acceptance site and be delivered on time at the appropriate storage temperature. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practices and in such a manner to afford adequate protection against any damage during shipment from source to destination.

10.4 The reagents and quality control material must perform within the manufacturer’s stated/published package inserts. Deliveries of required items will be called in to the Contractor by the designated Contracting Officer’s Representative or designee. Orders will be delivered within five (5) business days of requested date of delivery.

10.5 Emergency orders will be delivered using overnight shipping, or, if this shipping requirement cannot be met, the Contractor shall identify the guaranteed emergency order shipping method that can be accommodated in their response to the Solicitation for Bid.

11. TRAINING:

11.1 The Contractor will provide initial operator training off site to one key operator for major analyzers, and additional on-site training to other Microbiology staff.

11.2 All training manuals/guides, instructional literature, and any other related written/electronic material shall be provided. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

11.3 The Contractor shall provide one (1) primary (key) operator training slot per major instrument/equipment. This training will be off-site at the Contractor’s full expense.

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

g. The contractor/subcontractor agrees to:

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

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

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

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

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

SOR.

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

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

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

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

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

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

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

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g.

for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

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

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

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

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

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

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

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

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

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

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

(2) VA's initial medical device 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.

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