36C25619Q0621-001.pdf

36C25619Q0621

Description: Description: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, in conjunction with Far Part 13 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The commercial items procedures of FAR Part 12 will be used. Solicitation# 36C25619Q0621. This solicitation is issued as request for quote (RFQ).

Solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) 2019-01 (effective 01/22/19)

NAICS code is 811219, size standard is $20.5 MILLION.

Place of Performance: Michael E. DeBakey VA Medical Center, 2002 Holcombe BLVD.

77030

Anticipated Performance Period: May 1, 2019 to April 30, 2020 plus four 12 Month Option periods at the discretion of the government to exercise.

All questions pertaining to this solicitation shall be submitted by 9:00am CST April 19, 2019.

Send all questions electronically to anthony.marion2@va.gov.

Only electronic offers will be accepted. Offers shall be submitted to Anthony.marion2@va.gov

NO LATER THAN April 26, 2019 by 9:00 AM CST.

POC: Anthony Marion, Contracting Officer Phone: 713-794-7408

Email: anthony.marion2@va.gov

SECTION A

A.1 APPLICABLE Provisions and Clauses

The provision at 52.212-1 Introduction to Offerors – Commercial, applies to this acquisition.

The provision at 52.212-2 EVALUATION – COMMERCIAL ITEMS (JAN 1999) applies to this acquisition.

All offers shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications –Commercial Items.

The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition and a statement. The addendum to FAR 52.212-4 also applies to this acquisition.

The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders – Commercial Items, applies to this acquisition and all additional FAR clauses cited in the clause are applicable to the acquisition.

Addendum to FAR 52.212-4 Show FAR clauses followed by VAAR clauses in numeric order.

Solicitation contains a list of all clauses incorporated by reference in numeric order under

52.252-2 (see below), starting first with FAR and followed by VAAR.

SECTION B

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 36C256

Department of Veterans Affairs

Network Contracting Office 16

Michael E. DeBakey VA Medical Center

2002 Holcombe BLVD

Houston TX 77030 4298

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 [X]

b. Semi-Annually []

c. Other []

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs

Financial Service 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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY

UNI

T UNIT PRICE AMOUNT

4 QR __________________ __________________

SN 328 Leica CM1860UV Configuration

Contract Period: Base

POP Begin: 05-01-2019

POP End: 04-30-2020

SN 639 Leica CM1860UV Configuration

Contract Period: Base

SN 602 Leica CM1860UV Configuration

Contract Period: Base

SN 330 Leica CM1860UV Configuration

Contract Period: Base

SN 0265256B Peloris II# Dual Retort TissueProcessor

Contract Period: Base

POP Begin: 05-01-2019

LOCAL STOCK NUMBER: 15408.00

SN 341 Leica CM1860 UV Configuration

Contract Period: Base

SN 10010 EG1150C 120V 60Hz

Contract Period: Base

SN 9967 EG1150H

Contract Period: Base

SN 5627 Leica IPC Config.1 - USA

Contract Period: Base

SN 5155 Leica IP S Config.1 - USA

Contract Period: Base

SN 2024 Leica IP S Config.1 - USA

Contract Period: Base

SN 0265750B Peloris II# Dual Retort TissueProcessor

Contract Period: Base

SN 0237 Leica IP S Config.1 - USA

Contract Period: Base

SN 0236 Leica IP S Config.1 - USA

Contract Period: Base

SN 3499 Leica IP S Config.1 - USA

Contract Period: Base

SN 0234 Leica IP S Config.1 - USA

Contract Period: Base

SN 2910 Leica IP S Config.1 - USA

Contract Period: Base

SN 3498 Leica IP S Config.1 - USA

Contract Period: Base

SN 0235 Leica IP S Config.1 - USA

Contract Period: Base

SN 2909 Leica IP S Config.1 - USA

Contract Period: Base

SN 082008 Leica 1850UV Config. US

Contract Period: Base

1 LT __________________ __________________

Emergency Repairs/Unscheduled Services, Software Upgrade and Parts not cover under contract. Not to Exceed $3,000.

Contract Period: Base

Total for Base Year

Contract Period: Base

Contract Period: Option 1

POP Begin: 05-01-2020

POP End: 04-30-2021

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

POP Begin: 05-01-2020

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

Contract Period: Option 1

1022 Emergency

Repairs/Unscheduled

Services, Software

Upgrade and Parts not cover under contract.

Not to Exceed $3,000.

1 LT __________________ __________________

Total for Option Year 1

Contract Period: Option 1

Total for Option Year 1

Contract Period: Option 1

Contract Period: Option 2

POP Begin: 05-01-2021

POP End: 04-30-2022

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

SN 0265256B Peloris II# Dual Retort TissueProcessor

Contract Period: Option 2

POP Begin: 05-01-2021

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2

Contract Period: Option 2 not cover under contract. Not to Exceed $3,000.

Contract Period: Option 2

Total for Option Year 2

Contract Period: Option 2

Contract Period: Option 3

POP Begin: 05-01-2022

POP End: 04-30-2023

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

POP Begin: 05-01-2022

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3

Contract Period: Option 3 not cover under contract. Not to Exceed $3,000.

Contract Period: Option 3

Total for Option Year 3

Contract Period: Option 3

Contract Period: Option 4

POP Begin: 05-01-2023

POP End: 04-30-2024

SN 639 Leica CM1860UV Configuration

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

POP Begin: 05-01-2023

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4

Contract Period: Option 4 not cover under contract. Not to Exceed $3,000.

Contract Period: Option 4

Total for Option Year 4

Contract Period: Option 4

GRAND TOTAL __________________

i. Prior to exercising any option shall the Contracting Officer will ensure that it is still in the governments best interest, with price and other factors considered.

ii. Any extension, in accordance with FAR 52.217-8, shall utilize option 4 pricing.

Thus, the offeror’s total price for the purpose of evaluation will include the base period, 1st option, 2nd option, 3rd option, 4th option, and ½ of the 4th option. As indicated in FAR 52.217-8 the government will have the option provision to extend the performance of the contract up to an additional 6 months when the contractor is provided written notice. Thus, providing separate pricing for the optional six-month extension period is not required

B.3 STATEMENT OF WORK

STATEMENT OF WORK

Leica Equipment

1. GENERAL REQUIREMENT: Michael E. Debakey Medical Center is requesting for a contractor to provide preventative maintenance and service on the Leica equipment at the

Michael E. Debakey Medical Center located at 2002 Holcombe Blvd, Houston, TX 77030. The

Contractor shall furnish all labor, travel, materials, parts, equipment, tools to service and perform yearly preventative maintenance on the government Leica equipment. The Contractor shall provide 24/7 technical support via phone, email and web. In the event the Contractor shall replace any part, the part shall be replaced with certified Original Equipment Manufacturer

(OEM) replacement parts. The full clinic listing of the equipment can be found at the beginning of the document in Section 3 Equipment Identification and Coverage.

2. DEFINITIONS/ACRONYMS:

A. Biomedical Engineer(ing) - Supervisor or designee.

B. CO - Contracting Officer

C. COR - Contracting Officer's 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. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

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

G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the

Emergency Repair has been accomplished or is still in a pending status.

H. Authorization Signature - COR's signature; indicates COR accepts work status as stated in

ESR.

I. NFPA - National Fire Protection Association.

J. CDRH - Center for Devices and Radiological Health.

K. VAMC - Department of Veterans Affairs Medical Center

L. VAH - Department of Veterans Affairs Hospital

3. EQUIPMENT IDENTIFICATION AND COVERAGE:

S/N Description

328/04.2013 Leica CM1860 UV Configuration US

639/10.2013 Leica CM1860 UV Configuration US

602/09.2013 Leica CM1860 UV Configuration US

330/04.2013 Leica CM1860 UV Configuration US

0265256B Peloris II# Dual Retort TissueProcessor

0341/04.2013 Leica CM1860 UV Configuration US

10010/10.2013 EG1150C 120V 60Hz

9967/10.2013 EG1150H

5627 Leica IPC Config.1 - USA

5155 Leica IP S Config.1 - USA

2024/10.2010 Leica IP S Config.1 - USA

0265750B Peloris II# Dual Retort TissueProcessor

0237/10.2004 Leica RM2245 - config. 1

0236/10.2004 Leica RM2245 - config. 1

3499/10.2012 Leica RM2245 - Configuration 1

0234/10.2004 Leica RM2245 - config. 1

2910/08.2012 Leica RM2245 - Configuration 1

3498/10.2013 Leica RM2245 - Configuration 1

0235/10.2004 Leica RM2245 - config. 1

2909/08.2012 Leica RM2245 - Configuration 1

082008 Leica CM1850UV Config. US

4.CONFORMANCE STANDARDS: - Contract service shall ensure that the equipment functions in conformance with the latest published edition of NFPA-99, UL, OSHA, VA, and CDRH.

The contractor shall supply certification of tuberculosis testing completion prior to commencing any work located on the MEDVAMC campus.

5. HOURS OF COVERAGE:

A. Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m., excluding holidays. All service/repairs will be performed during normal hours of coverage unless requested or approved by COR or his designee.

B. Preventive maintenance shall be performed at least yearly or to the OEM’s standards, whichever is more frequent.

C. Hardware/software update/upgrade installations shall be scheduled and performed outside normal hours of coverage at no additional charge to the Government

(unless it would be detrimental to equipment up-time; to be determined by the

COR). Contractor provides software/hardware upgrade/update.

D. Federal Holidays observed by the VAMC are:

New Years' Day

Martin Luther King Day

Presidents' Day

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans' Day

Thanksgiving Day

Christmas Day

“or any other day declared by the President of the United States to be a

Federal holiday”

6. UNSCHEDULED MAINTENANCE (Emergency Repair Service):

A. Contractor shall maintain the equipment in accordance with the manufacturer's specifications. The Contractor will 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 or COR has the authority to approve/request a service call from the

Contractor.

C. Response Time: - Contractor's FSE shall respond with a phone call to the COR or his/her designee within two (2) hours after receipt of telephoned notification twenty-four (24) hours per day. If the problem cannot be corrected by phone, the

FSE will commence work (on-site physical response) within forty-eight (48) hours after receipt of this second notification and will proceed progressively to completion without undue delay.

7. SCHEDULED MAINTENANCE:

A. The Contractor shall perform PM service to ensure that equipment listed in the schedule performs in accordance with Section 3, Conformance Standards. (An outline of the PM procedures and schedule shall be provided to the COR). The

PM shall be performed in accordance against the latest OEM standards. The

Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable).

This documentation shall be provided to the COR at the completion of the PM.

The contractor shall provide written description of Preventive Maintenance

Inspections (PMI). This description shall include an itemized list of the procedures performed, including electrical safety. PM services shall include, but need not be limited to, the following:

1) Cleaning of equipment.

2) Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards or 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 likely to become faulty, fail or become worn.

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

7) Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.

8) Returning the equipment to the operating condition defined in Section 3, Conformance Standards.

9) Providing documentation of services performed.

10) Inspecting and calibrating the hard copy image device.

B. PM services shall be performed in accordance with, and during the hours defined in, Section 4, the preventive maintenance schedule established herein. All exceptions to the PM schedule shall be arranged and approved in advance with the COR.

C. Any charges for parts, services, manuals, tools, or software required to successfully complete scheduled PM are included within this contract, and its agreed upon price, unless specifically stated in writing otherwise.

8. PARTS & TRAVEL: - The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the COR. (The Contractor shall also list any excluded parts under the service contract).

Travel for any and all service and preventative maintenance covered within this contract shall be covered by the contractor and shall not be reimbursed by the CO, VAMC, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances.

9. SERVICE MANUALS/TOOLS/EQUIPMENT: - The VAMC shall not provide tools, (test) equipment, service 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 upon request.

10. DOCUMENTATION/REPORTS: - The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with Section 3, Conformance Standards or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The ESR will consist of a separate PM report for the item(s) covered under the "specific" contract.

Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR shall, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C Contractor service ESR number/log number.

D. Date, time (starting and ending), equipment downtime and hours on-site for service call.

E. VA purchase order numbers covering the call if outside normal working hours.

F. Description of problem reported by COR.

G. Identification of equipment to be serviced:

1) Inventory ID number,

2) Manufacturer's name,

3) Device name,

4) Model number,

5) Serial number,

6) Any other manufacturer's identification numbers.

H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

1) Labor and Travel,

2) Parts (with part numbers),

3) Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).

J. Signatures:

1) FSE performing services described.

2) Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed shall be approved by the

COR before service is completed!

11. REPORTING REQUIREMENTS: - The Contractor shall be required to report to

Biomedical Engineering to log in. 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 Biomedical Engineering and submit the ESR(s) to the COR.

ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature". If the COR is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).

VA Biomedical Contact Persons: Devang Patel, Rikesha George, Gary Benson and Jason

Graham

Location (Building/Room Number): BA-200

Telephone Number & Extension(s): 713-794-7271/7270

Contractor - Provide telephone number(s) to call for your Service Department:

Provide name(s) of authorized contact person(s):

12. LIQUIDATED DAMAGES:

A. Contractor shall be liable to the Government for losses of production due to significant equipment downtime. Significant equipment downtime is that which exceeds twenty-four (24) hours/month. Records regarding downtime will be kept by the COR and the maintenance contractor.

B. Equipment downtime is calculated only from those normal hours of coverage (see

Hours of Coverage Section) that the scheduled equipment is not fully operational.

Downtime will begin when the Contractor is required to be on site (see

Unscheduled Maintenance Section response time definition) after notification by the CO, COR or designated alternate. Downtime will accumulate until the scheduled equipment is returned to full and usual operation and accepted as such by the CO, COR or designated alternate. This does not include scheduled maintenance for PM purposes or when waiting for VA furnished tubes. Refusal of access to the equipment indicates that the unit is up and running and this time will not be considered when determining downtime. Refusal of access to the equipment voids the service call.

C. If downtime exceeds thirty-three (33) consecutive hours, the CO may exercise the option to hire an alternate source to resolve the problem. The decision to exercise this alternative will reside exclusively with the CO. All fees generated by the alternate Contractor(s) will be handled in accordance with Default clause.

D. Monies will be subtracted from the contract if the Contractor fails to meet the up-time requirements using the following formula:

MONTHLY MONTHS

DOWNTIME

23 - 24 hours/month 0%

25 - 26 hours/month 20%

27 - 28 hours/month 40%

29 - 30 hours/month 60%

31 - 32 hours/month 80%

33 or more hours/month 100%

These will be computed for the monthly dollar totals.

13. PAYMENT: - Invoices will be paid in arrears on a quarterly basis. Invoices, SHALL

INCLUDE, at a minimum, the following information: Contract No., Purchase Order No., Item(s) covered (to include serial #'s) by the PMI and covered period of service. Each invoice shall be provided in triplicate.

14. 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.

15. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE: -

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (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 COR with a written estimate of the cost to make necessary repairs.

16. CONDITION OF EQUIPMENT: - The Contractor accepts responsibility for the equipment in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the Contractor‘s repairman shall report their arrival and departure to the COR.

Contractor shall include, at no extra charge, any engineering and software update necessary for continued optimum operation of the equipment listed in this contract.

17. REMOVAL OF EQUIPMENT: - Should a piece of equipment require repair at the

Contractor ‘s plant, the Contractor shall coordinate with the COR the removal of equipment. Government property cannot be removed from the station without a signed

Property Pass. This Property Pass may be obtained from Acquisition & Material

Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor ‘s charge.

18. COMPETENCY OF PERSONNEL SERVICING 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 shall 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 training program, for the equipment. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on Leica equipment.

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 VAMC. 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 VAMC equipment.

The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment.

D. If subcontractor(s) are used, they shall be approved by the CO; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

19. TEST EQUIPMENT: - Prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC.

Test equipment calibration shall be traceable to a national standard.

20. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS: - The

Contractor's FSEs shall wear visible identification at all times while on the premises of the VAMC. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The

VAMC will not invalidate or make reimbursement for parking violations of the

Contractor under any conditions. Smoking is prohibited inside any buildings at the

VAMC and is only permitted in specified smoking areas on the VA medical center campus. 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.

NOTE: - Enter unique or unusual conditions [modify to suit your specific situation(s)] if the above clause is not entirely applicable.

21. SAFETY REQUIREMENTS: - In the performance of this contract, the Contractor shall take such safety precautions as the Contracting Officer, or his/her designee, may determine to be reasonably necessary to protect the lives and health of occupants of the building. The Contractor shall have one supervisory employee, who will disseminate requirements to those who work at our facility, report to the Safety Manager’s office for a one- (1) time training class before working on-site. The Contracting Officer or his/her designee will notify the Contractor of any noncompliance with the foregoing provisions and the action to be taken. The Contractor shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. Such notice, when served on the Contractor or his representative at the site of work, shall be deemed sufficient for the purpose aforesaid. If the Contractor fails or refuses to comply promptly with such notice, the contracting Officer may issue an order stopping all or any part of the work and hold the Contractor in default.

22. 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.

The Vendor will need to access VA systems in order to perform software upgrades, preventative maintenance and maintenance repairs.

23. GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT: -

After the contract has been in force for a period of time, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 43.102, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government.

24. END OF SERVICE PERIOD: - No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting

Officer.

25. MOBILE MEDIA SCANNING:

The Contractor shall identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Personally-owned USB thumb drive utilization is prohibited. Non-VA support personnel shall furnish their own FIPS140-2 certified USB thumb drives, and only with the permission of a designated VA supervisor. All USB drives shall be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is located in the biomedical engineering shop, Building 100, Room

BA200.

26. PRIVACY/SECURITY:

The contractor will not have electronic connectivity to the devices. The Vendor will only have access to patient databases and PHI when physically troubleshooting image quality and other specific imaging related maintenance.

Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property.

28. Gray Market Prevention Language

(a) Gray market items are Original Equipment Manufacturer’s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA

Medical Centers. No remanufactures or gray market items will be acceptable.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

B.4 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 one 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 one 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

N/A

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…