36C24722Q0379.docx

36C24722Q0379

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

619-22-2-244-0009 36C24722Q0379 02-01-2022 Niki Wilkins 2059338101 02-21-2022 10am

CST

Department of Veterans Affairs Central Alabama Healthcare System West Campus 215 Perry Hill Road Montgomery

AL

36109 X X 334516 1000 Employees N/A X

DEPARTMENT OF VETERANS AFFAIRS

Central Alabama Healthcare System 215 Perry Hill Road Montgomery

AL

36109 Department of Veterans Affairs Central Alabama Healthcare System 215 Perry Hill Road Montgomery

AL

36109

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page Biomerieux Analyzer Model: BACT/Alert Comb s/n 411CR5324 Please email Niki.wilkins@va.gov for all questions.

See CONTINUATION Page x X x Niki Wilkins Contracting Officer Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

STATEMENT OF WORK

B.1 EQUIPMENT:

Equipment serviced and maintained for the Department of Veterans Affairs Medical Center, Central Alabama Veterans Health Care System, 215 Perry Hill Road, Montgomery, Alabama 36109.

Equipment:

1) Biomerieux Lab Analyzer, model: BACT/ALERT COMBO, S/N: 411CR534, Location: 1D106-001-MO, EE# 79376, and accessoires.

B.1.2 DEFINITIONS/ACRONYMS:

A. HTM Staff Engineer (William Piper) or designee, Room 216-007-MO, Building 7, Telephone 334-273-6258 West Campus, 215 Perry Hill Road, Montgomery, Al. 36109 B. CO - Contracting Officer C. COTR - Contracting Officer Technical Representative.

D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

E. FSE - Field Service Engineer. This is a person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the Department of Veterans Affairs Medical Center premises.

F. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and condition of the contract.

G. Acceptance Signature. VA employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

H. Authorization Signature. COTR's signature; indicates COTR accept work status as stated in ESR.

I. NFPA - National Fire Protection Association.

J. CDRH - Center for Devices and Radiological Health.

K. OSHA - Occupational Safety and Health Administration.

L. JCAHO - Joint Commission on Accreditation of Healthcare Organizations.

M. FDA - Food and Drug Administration.

N. DVAMC - Department of Veterans Affairs Medical Center.

O. ISO 9001 – International Organization for Standardization standard.

N. Normal Working Hours - Monday through Friday, 8:00 a.m. - 4:30 p.m., excluding weekends and Federal Holidays.

B.1.3 CONFORMANCE STANDARDS:

Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, OSHA, CDRH, JCAHO, FDA, ISO 9001, and manufacturer specifications.

B.1.4 HOURS OF COVERAGE:

A. Normal hours of coverage shall be Monday through Friday from 8:00 a.m. to 4:30 p.m., excluding weekends and federal holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COTR.

B. Preventive maintenance inspections are to be scheduled at least five days in advance with Contracting Officer’s Technical Representative (COTR). Coordination may be done by telephone.

C. Preventive maintenance inspections will be performed annually in July.

D. Federal Holidays observed by the DVAMC are: New Year’s Day, Labor Day, Martin Luther King Day, Columbus Day, President's Day, Veterans Day, Memorial Day, Thanksgiving Day, Independence Day, Christmas Day.

B.1.5 UNSCHEDULED MAINTENANCE:

A. The contractor shall maintain the equipment in accordance with B.1.3; Conformance Standards. The contractor shall provide repair service which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

B. The CO, COTR or designated alternate has the authority to approve/request a service call from the contractor.

C. Response Time: Contractor's FSE must respond with a telephone call to the COTR and his/her designee within one (1) hour after receipt of telephoned notification 24 hours per day. If the problem cannot be corrected by phone, the FSE will commence work (on-site physical response) within eight (8) hours after receipt of notification and will proceed progressively to completion without undue delay.

For example, if hours of coverage are 8:00 a.m. to 4:30 p.m., a 8 hour response means, if a call is placed at 3:45 p.m. Monday, August 10, the FSE must start on-site service before 3:15 p.m. Tuesday, August 11, except when outside hours of coverage is authorized by the COTR.

B.1.6 SCHEDULED MAINTENANCE:

A. The contractor shall perform annual PM Service in July to ensure that equipment listed in the schedule performs in accordance with B.1.3; Conformance Standards. The contractor shall provide and utilize procedures and checklists, with worksheet originals indicating work performed and actual values obtained (as applicable) and shall provide said documentation to the COTR at the completion of the PM.

PM services shall include, but may not be limited to, the following:

1. Cleaning of equipment.

2. Reviewing operating system software diagnostics to ensure that the system is operating to the manufacturer's specifications.

3. Calibrating and lubricating the equipment.

4. Performing remedial maintenance of non-emergent nature.

5. Testing and replacing faulty and worn parts and/or parts which are likely to become faulty, fail or become worn.

6. Inspecting, and replacing where indicated, tubing for wear and fraying.

7. Measuring, adjusting and calibrating as necessary.

8. Inspecting, and replacing where indicated, electrical wiring and cables for wear and fraying.

9. Inspecting and replacing where indicated, all mechanical components including, for mechanical integrity, safety, and performance.

10. Apply gummed label, dated & signed, certifying performance and safety to meet MFG'S published specifications as of that date.

11. Returning the equipment to the operating condition defined in B.1.3; Conformance Standards.

12. Providing documentation (worksheet) of services performed on each machine tested.

A. PM Services shall be performed in accordance with, and during the hours defined in, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COTR. Any charges for parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and it’s agreed upon price, unless specifically stated in writing otherwise.

B. The contractor shall furnish documentation, including all measurements and calibration data.

C. The contractor shall furnish all backup documentation to ensure that the system is performing in accordance with B-3; Conformance Standards.

B.1.7 AUTHORIZED SERVICES:

Only services specified within the contract are authorized. Before performing any service or repair of a non-contract nature, the Contracting Officer or his/her designee must be advised of the reason for this additional work. If appropriate, the Contracting Officer or his/her designee may authorize the additional services or repairs under a separate purchase authorization. Contractor is cautioned that only the Contracting Officer or his/her designee may authorize additional services or repairs and reimbursement will not be made unless this prior authorization is obtained.

B.1.8 PARTS:

The contract shall include all parts, software, components, and system(s) device(s) {display monitors, CPU’s, printers, UPS, etc. of the system(s)}. The contractor furnishes all parts, the parts shall be OEM parts to meet up-time requirements (consumables are not covered). The contractor should have ready access to unique and/or high mortality OEM replacement parts. All parts supplied shall be compatible with existing equipment. The contractor shall use new parts. Re-built parts or used parts, those removed from other equipment, shall not be installed without written approval by the COTR.

B.1.9 WARRANY:

The contractor shall provide warranty on the integrity of workmanship, labor, parts, service, testing, repair, inspection, and certification. The warranty period shall be for 90 days after the repair, inspection, and/or certification.

B.1.10 SERVICE MANUALS:

The DVAMC shall not provide services manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as; operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO or COTR upon request.

B.1.11 DOCUMENTATION/REPORTS:

The documentation will include detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in B.1.3; Conformance Standards. In addition, each ESR shall, at a minimum, document the following data legibly and in complete detail:

A. Name of Contractor.

B. Name of FSE who performed services.

C. Contractor Service ESR Number/Log Number.

D. Date, Time (starting and ending), and Hours-On-Site for service call.

E. Description of Problem Reported by COTR/User.

F. Identification of Equipment to be serviced: INV. ID number, Manufacture's name, Device Name, Model number, Serial number, and any other Manufacturer's identification numbers.

G. Itemized Description of Service Performed, including: Labor and Travel, Parts (with part numbers), Materials and Circuit Location of problem/corrective action.

H. Total Cost to be billed.

I. Signatures:

1. FSE performing services described.

2. VA Employee who witnessed service described may initial said ESR, but only the COTR has the authority to sign the ESR.

J. Equipment downtime.

K. VA Purchase Order Number.

L. Test equipment used shall be listed on service ticket of each device.

M. Provide separate service ticket for each device.

N. List all the test equipment used on the device on each service ticket to meet ISO 9001 standard.

NOTE: ANY ADDITIONAL CHARGES CLAIMED MUST BE APPROVED BY THE COTR BEFORE SERVICE IS COMPLETED!

B.1.12 SPECIAL CONTRACT REUIREMENTS:

CONTRACTOR SUBMITTALS: The Contractor will furnish a copy of its preventive maintenance/certification inspection procedures for each model of device which will be used during the preventive maintenance/calibration inspection services of this contract to the Contracting Officer’s Technical Representative (COTR). These preventive maintenance/certification inspection procedures are required by the Government as a condition of the facility’s JCAHO accreditation and must be received before any invoice can be certified for payment.

B.1.13 REPORTING REQUIREMENTS:

The contractor shall be required to report to the HTM Staff Engineer or designee. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR (s). The FSE shall be required to log out with the HTM Staff Engineer or designee, and submit the ESR (s) to the COTR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COTR for an "authorization signature". If the COTR is unavailable a signed, authorized, copy of the ESR will be sent to the contractor after the work can be reviewed (if request or noted on the ESR).

B.1.14 PAYMENT:

Invoices will be paid in arrears on a quarterly basis.

Invoice at the end of December, at the end of March, at the end of June, and at the end of September. Invoices shall be line itemized.

NOTE: Payment of invoices may be delayed if the appropriate documentation/reports are not properly completed and submitted to the Biomedical Section Manager as required.

B.1.15 REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but not later than 24 consecutive hours after discovery notify the CO and COTR, in writing, of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract.

The contractor shall furnish the CO and COTR with a written estimate of the cost to make necessary repairs.

B.1.16 ADDITIONAL CHARGES:

There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts.

B.1.17 CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in the schedule "as is" condition. Failure to inspect the equipment prior to contract award shall not relieve the contractor from performance of the requirements of this contract.

B.1.18 BIDDER’S QUALIFICATIONS:

The Bidder is required to submit sufficient evidence of adequate equipment, facilities, personnel and necessary experience to establish responsibility and integrity to meet the requirements of this contract. Any bidder, who does not have adequate experience, personnel and/or equipment, in the opinion of the Contracting Officer, will be rejected. To assist in this determination, offeror is required to furnish the following information:

A. Number of years experience performing the type of services indicated within:

B. Number of personnel regularly employed on a full-time basis:

C. Bidders who have not previously provided the same or similar type services at this Medical Center are required to furnish for evaluation purposes, the names, addresses and telephone numbers of three (3) companies for whom exact services have been furnished.

D. Provide certification that contractor has manufacturer updated maintenance software, manuals, and parts.

B.1.19 COMPETENCY OF PERSONNELSERVICING EQUIPMENT:

A. Each respondent shall have an established business, with an office and full time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized manufacturer training programs within the last two years, for the equipment identified in the equipment schedule, and annual refresher course. For field experience, the FSE(s) has a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance, on equipment listed.

C. The FSEs shall be authorized by the contractor to perform the maintenance services. All work shall be performed by "Fully Qualified" competent FSEs. The contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the contractor services at the DVAMC. The CO may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any DVAMC equipment. The CO and/or the COTR specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the DVAMC equipment.

D. Subcontractor will not be used under this contract.

B.1.20 TEST EQUIPMENT:

Test equipment shall meet ISO 9001 standards.

Prior to commencement of work on this contract, the contractor shall provide the DVAMC with a copy of the current calibration certification of all test equipment which is to be used by the contractor on DVAMC's equipment. This certification shall also be provided on a periodic basis when requested by the DVAMC. Test equipment calibration shall be traceable to a national standard.

B.1.21 IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The Contractor's FSE shall wear visible identification at all times while on the premises of the DVAMC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the DVAMC Police Section. The DVAMC will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the DVAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

B.1.22 Obtaining a VA IDENTIFICATION Badge:

Within the first month of the service contract, the contractor’s service technician(s) to arrange with the Biomedical Section Manager to obtain identification badge. The process requires contractor’s service technician(s) to bring two (2) valid forms of identification, completion of VA Form 0711, finger prints, photograph, and possible background check. The process of receiving the Identification badge takes 2-4 weeks.

B.1.23 INSURANCE:

A. Worker compensation and employer's liability. Contractors are required to comply with applicable Federal and State Worker Compensation and Occupational Disease Statutes.

B. General Liability. Contractors are required to have Bodily Injury Liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

C. Property Damage Liability. Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.

D. Medical Liability. Contractors are required to have Indemnification and Medical Liability insurance coverage of at least $1,000,000.

B.1.24 PERFORMANCE REQUIREMENTS SUMMARY:

A. SUMMARY TABLE:

Factor No.

Performance Indicator

Performance Standard Method – Type of Surveillance

INCENTIVE/

DISINCENTIVE

(Max of 10%) Deduction Amount on each late testing, preventive maintenance and/or certification on the certification billing.

(Max of 10%) Deduction Amount on each late documentation on the certification billing.

B. Performance Requirements Summary Method of Application:

The Contractor is required to perform all the work specified in the performance work statement. If the contractor fails to perform a specific element of the work, payments for the task in question will be subject to reductions as specified. Any amount deducted for deviation from the required performance will be reflected in an amount commensurate with the task.

B.1.25 DISCONTINUANCE OF SERVICE:

The Government reserves the right to terminate service on a particular device(s) meeting replacement criteria upon thirty (30) days written notice to the Contractor.

B.1.26 FAILING TO RESPOND:

Failure to perform any of the services set forth in this contract will be considered for invoking provisions of Default.

B.1.27 VA HANDBOOK 6500.6 APPENDIX CLAUSE:

The C&A requirements apply and that a Security Accreditation Package and BAA is required.

Appendix C:

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

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.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

1. A contractor/subcontrator 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.

1. 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.

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.

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.

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.

VA INFORMATION CUSTODIAL LANGUAGE

1. 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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

SECURITY INCIDENT INVESTIGATION

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

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.

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.

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

LIQUIDATED DAMAGES FOR DATA BREACH

1. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

1. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

1. Each risk analysis shall address all relevant information concerning the data breach, including the following:

1. Nature of the event (loss, theft, unauthorized access);

1. Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

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

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

(1) Notification;

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

(3) Data breach analysis;

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

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

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

TRAINING

1. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

1. Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

1. Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

1. Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

1. Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

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

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

B.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Requesting Base Year and Four (4) Option Years, Refer to the Statement of Work (SOW) for details.

BIOMERIEUX ANALYZER, MODEL: BACT/ALERT COMB, S/N:411CR5324, LOCATION: 1D114-001-MO, EE# 79376.

B.2 DELIVERY SCHEDULE

1.00

4.00

B.3 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

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

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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