RFQ 36C24420Q0943_PM-Repair R-D Equip_Pitt.pdf

31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT)

Richard J. Anzelone

Contracting Officer

30c. DATE SIGNED

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

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

1. REQUISITION NO.

646-20-4-046-0176

INFORMATION CALL: Stanley Kwasny 412-822-3781 TIME 08-26-2020

12:00 PM

9. ISSUED BY CODE 00244 10. THIS ACQUISITION IS X UNRESTRICTED OR SET ASIDE: % FOR:

Department of Veterans Affairs

Network Contracting Office 4

SMALL BUSINESS WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

Stanley Kwasny

HUBZONE SMALL

BUSINESS

SMALL BUSINESS PROGRAM

EDWOSB

NAICS: 811219

stanley.kwasny@va.gov SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS 8(A)

SIZE STANDARD:

$22 Million

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

N/A

14. METHOD OF SOLICITATION

15. DELIVER TO CODE 16. ADMINISTERED BY

X RFQ IFB

CODE

RFP

00244

VA Pittsburgh Healthcare System

University Drive Campus

Research Office Building B30

4100 Aliquippa Street

Pittsburgh PA 15240

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE

Department of Veterans Affairs

Network Contracting Office 4

18a. PAYMENT WILL BE MADE BY CODE

Austin Payment Center

Department of Veterans Affairs

PO Box 149971

Austin TX 78714-9971

PHONE:(877) 353-9791 FAX: (512) 460-5429

TELEPHONE NO. DUNS: DUNS+4:

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. See CONTINUATION Page 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES

Provide Full-Service Preventative Maintenance and Corrective

Maintenance Repairs for medical equipment located at the VA

Pittsburgh Healthcare System Research Lab in accordance with the Statement of Work (SOW).

Period of Performance: Base year and four (4), one-year

Option Periods (See attached Price/Cost Schedule).

Response Due Date/Time (Eastern Standard Time): See Block 8

IMPORTANT: For Submission Requirements and Time Period for

Questions - See Section E: Addendum to FAR 52.212-1.

QUANTITY UNIT UNIT PRICE AMOUNT

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

25. ACCOUNTING AND APPROPRIATION DATA See CONTINUATION Page 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

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

X ARE

ARE

ARE NOT ATTACHED.

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

29. AWARD OF CONTRACT: REF. OFFER

DATED . YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

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) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 1449 (REV. 2/2012)

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

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

36C24420Q0943 08-18-2020

7. FOR SOLICITATION a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL mailto:stanley.kwasny@va.gov

36C24420Q0943

Table of Contents

SECTION A

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

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK

A. GENERAL GUIDANCE:

B. GENERAL REQUIREMENTS:

F. SCHEDULE FOR DELIVERABLES:

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.5 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.6 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019)

E.2 52.216-1 TYPE OF CONTRACT (APR 1984)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (JUN 2020)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contract Specialist: Stanley Kwasny

Department of Veterans Affairs Network Contracting Office 4

Stanley Kwasny - stanley.kwasny@va.gov

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

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

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly

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.

Austin Payment Center

Department of Veterans Affairs

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

mailto:stanley.kwasny@va.gov

B.2 STATEMENT OF WORK

Statement of Work (SOW)

A. GENERAL GUIDANCE:

1. Title: Full-service maintenance of various medical equipment for the research lab.

2. Location: VA Pittsburgh Healthcare System (VAPHS)

Research Office Building B30

4100 Aliquippa Street

Pittsburgh, PA 15219

3. Background: This contract is issued to ensure the continuous reliability of the research equipment and auxiliary equipment identified in this SOW. The units require repair and maintenance by trained personnel using manufacturer approved parts and specifications. The reliable and accurate operation of this equipment at all times is considered critical to the research program of the VA.

4. Performance period: Base year plus option years, see delivery schedule.

5. Type of Contract: Firm-fixed-price.

B. GENERAL REQUIREMENTS:

1. This agreement includes all preventative maintenance and corrective maintenance repairs for the equipment to ensure continuous reliability.

a. Equipment to be Serviced:

i. Each of the following items are to be serviced in accordance with the specifications, terms and conditions of this contract.

b. Corrective Maintenance:

i. The Contractor shall maintain the equipment in accordance with the manufacturer’s specifications. Service for corrective maintenance will be provided per hours of coverage defined in Section B.1e. Contractor shall provide unlimited telephone technical support, clinical applications telephone support, labor, travel, and parts, unless specifically excluded.

ii. Service calls to the Contractor requesting service are only authorized when they are received from the Technical Point of Contact (POC), Contracting Officer (CO), or designated alternates.

iii. Outside of the Contract’s hours of coverage, emergency on-site services require authorization by the CO. If staff other than the designated POC place calls requesting services, the Contractor shall contact the CO and verify the request. Service responses on calls from unauthorized personnel can result in nonpayment.

iv. Uncorrected deficiencies or unfavorable histories of downtime can result in the termination of this contract.

v. Contractor will not be held responsible for repairs due to VA personnel human error, equipment abuse, power surges, or environmental changes.

c. Preventative Maintenance (PM):

i. The PM services shall be provided within the first six (6) weeks of the initial award and within the first six (6) weeks of all option year awards.

ii. The Contractor shall perform PM service to ensure that equipment listed in Section B.1a performs in accordance with Section D Conformance

Standards. Any exceptions to the PM schedule shall be arranged and approved in advance with the Technical POC and provided in writing to the CO.

iii. The Contractor shall provide complete and original documentation indicating PM work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to the Technical POC at the completion of the PM service.

iv. Parts, travel, and labor necessary for PM are provided by awarded contractor at no additional customer cost.

v. Any charges for materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools required for the Contractor to successfully complete scheduled PM shall be provided by the Contractor and are included within this contract, and its agreed upon price.

vi. Preventative maintenance will be provided at a scheduled time and must be scheduled at least one week in advance to minimize the impact to scheduling. All exceptions to the preventative maintenance schedule and procedure shall be addressed and approved in advanced with the

Technical POC. A designated staff member will accompany the

Contractor as an observer during the inspection. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system.

Maintenance work and inspections may be combined at the approval of the Technical POC if down time is not considered significant.

vii. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and Technical POC, 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 Technical POC with a written estimate of the cost to make necessary repairs.

d. Parts, Software and Additional Discounts

i. All parts supplied shall be Original Equipment Manufacturer (OEM) and fully compatible with existing equipment. No refurbished part shall be used in the repairs of units covered in this contract. Used parts, those removed from another system, shall not be installed without approval by the Technical POC. All defective parts replaced become the property of the Contractor, unless otherwise specified by the Technical POC.

ii. Software patches, software enhancements (without hardware changes), and quality updates are included under the terms of this contract and shall be applied in accordance with manufacturer specifications.

1. Upon release from the OEM, software updates must be provided within a month.

e. Hours of Coverage:

i. The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F), excluding holidays.

ii. All services shall be performed during these normal hours of coverage unless one of the following conditions exists:

1. The contractor wishes to furnish services at a time that is outside of the normal hours of coverage, at no additional cost to the

Government, the contractor submits a request to the Technical

POC prior to the proposed start of the work, and the request is approved in writing by the POC before work is begun.

2. The Technical POC directs that the services be furnished at a time that is outside the normal hours of coverage and the additional cost is recommended by the POC and authorized by the CO.

iii. Customer service shall respond to service request calls 24 hours a day, 7 days a week and all holidays.

iv. Work performed outside the normal hours of coverage must be preapproved by the Technical POC. The Contractor will provide a written estimate of the charges prior to approval of the work.

v. Work performed outside the normal hours of coverage at the request of

Field Service Engineer (FSE)/contractor shall be considered service performed during normal hours of coverage.

vi. There will be no additional charge for time spent waiting at the site during or after the normal hours of coverage for delivery of parts

Note: Any hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government.

vii. Federal Holidays Observed by the VA Medical Center

New Year’s Day, Martin Luther King, Jr. Day, President’s Day (Washington’s birthday), Memorial Day , Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day, and any other day specifically designated by the President of the United

States.

f. Customer Notification:

i. Contractor shall notify the Technical POC and the Police service when they arrive on site. Contractor will schedule all services with the POC.

ii. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s) per Section E.

iii. The FSE shall be required to check out with the Technical POC and submit the ESR(s) to the POC. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the POC for an

"authorization signature." If the POC is unavailable, a signed accepted copy of the ESR will be sent to the POC within five business days of work completion.

IV. FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH

EITHER THE NOTIFICATION OR ESR REQUIREMENTS WILL BE

DEEMED SIGNIFICANT NON-COMPLIANCE WITH THE CONTRACT

AND MAY BE JUSTIFICATION FOR TERMINATION OF THE

CONTRACT.

D. CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of National Fire Protection Association-99, Joint

Commission, National Electrical Code, Occupation Safety and Health Administration, Health

Insurance Portability and Accountability Act, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the current performance specifications as established in the OEM’s technical specifications.

Upon equipment failure, the contractor is required to return the equipment to fully functional and operating status. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

E. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the

Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

1. Name of Contractor

2. Name of FSE who performed services.

3. Contractor Service ESR Number/Log Number.

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

5. VA Purchase Obligation (PO) numbers (if any) covering the call, if outside normal working hours.

6. Description of Problem Reported by the Technical POC/User.

7. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

8. Itemized Description of Service(s) Performed (including costs associated with after normal working hour services), including: Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

9. Signatures from the following:

a. FSE performing services described.

b. VA Employee who witnessed service described.

10. Equipment downtime calculated in accordance with Conformance Standards.

F. SCHEDULE FOR DELIVERABLES:

Draft copies of deliverables shall be provided to the Technical POC at VAPHS before the contractor leaves the facility at each visit. If a final copy can be provided at that time then a draft copy is not necessary, final copies must be provided within 5 business days of the time of each deliverable.

H. SERVICE MANUALS/TOOLS/EQUIPMENT:

1. VAPHS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. 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.

2. Prior to commencement of work on this contract, the contractor shall make available if requested a copy of the current calibration certification of all test equipment that is to be used by the contractor in performing work under the contract. This certification shall also be provided on a periodic basis when requested by VAPHS. Test equipment calibration shall be traceable to a national standard.

I. CONDITION OF EQUIPMENT:

Upon award, the Contractor shall inspect the equipment to identify preexisting nonconformance issues. The FSE shall provide a report to the Technical POC detailing the problem and provide a quote to repair the preexisting condition. The Contractor is not authorized by this contract to perform any repair of a condition that existed prior to the award of this contract if not covered under the terms of the contract.

J. CONTRACTOR EXPERIENCE REQUIREMENTS:

1. FSE must be either a direct OEM technician or possess a factory certification if offered by the OEM. Proof must be provided with the offer.

2. Each respondent must 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.

3. "Fully Qualified" is based upon training and on experience in the field. For training, the

FSE(s) shall have successfully completed a formalized training program, for the equipment or similar equipment identified in Section B.1a. To be valid, the training shall be completed within the last 2 years, or a certificate of the original training program and a recent class completion (on equipment identified in Section B.1a) to certify FSE’s continual education must be provided. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment. Additionally, FSE(s) must provide proof of service key dongle ownership upon request by VAPHS to confirm they can service and troubleshoot the equipment in its entire capacity; refusal or lack of ownership void all training and field experience requirements met.

4. The FSE(s) shall be authorized by the contractor to perform the maintenance services as required. 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

VAPHS. The CO may authenticate the training requirements, request copies of training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VAPHS equipment. The CO and/or the Technical POC specifically reserve the right to reject any of the contractor's personnel and refuse them permission to work on the VAPHS equipment.

5. Any Contractor personnel must provide a copy of: 1) Tuberculosis (Tb) vaccination documentation, 2) flu vaccination documentation and 3) copy of HIPAA compliance training certificate.

6. If a subcontractor is utilized to fulfill the requirements of this contract, the subcontractor must be pre-approved by VAPHS and must be responsible for maintaining the requirements stated herein. VAPHS reserves the right to meet all associated subcontractors to determine their qualifications and ability to service, prior to contract award. Failure of subcontractor to comply, either in whole or in part, with this SOW requirements is grounds for dismissal.

L. INFLUENZA PREVENTION PROGRAM:

1. VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps.

Healthcare personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. Those HCP unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center.

2. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation:

a. Documentation of vaccination, e.g., signed record of immunization from a healthcare provider or pharmacy, or a copy of medical records documenting the vaccination.

b. Completed Healthcare Personnel Influenza Vaccination Form (Attachment B of

VHA Directive 1192) if unwilling or unable to receive the vaccine.

3. The contractor is required to submit annual certification to the Technical POC that all contract staff performing services at VA facilities are in compliance with the VHA

Directive 1192.

M. REQUIREMENTS FOR COVID:

1. Requirements will be based on CDC guidelines and PA State requirements and may cease at any time:

a. Non-contact Infrared Thermometer Body Temperature:

b. All contractor staff will have their temperature checked before starting each day.

c. Per CDC guidelines, if the Contractor has a temperature above 100.4 degrees, the work must be re-scheduled.

d. All customers interacting with contractor staff must wear a mask, unless medical condition(s) prohibit. Masks will be provided if needed.

e. Social distancing is encouraged per CDC guidelines.

N. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA

REGULATIONS:

1. The contractor's FSE shall wear visible identification at all times while on the premises of

VAPHS. Identification shall include, as a minimum, the employee’s name, position, and the contractor’s trade name.

2. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. VAPHS will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

3. Smoking is prohibited inside any buildings and on premise at VAPHS. This covers all smoking and tobacco products, including but not limited to:

a. Cigarettes

b. Cigars

c. Pipes

d. Any other combustion of tobacco

e. Electronic nicotine delivery systems (ENDS), including but not limited to electronic or e-cigarettes, vape pens, or e-cigars.

f. Chewing tobacco

4. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the

United States (Federal) District Court, not a local district state, or municipal court.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001 12.00 MO

Preventative Maintenance and repairs for eight medical equipment items.

Contract Period: Base POP Begin: 09-15-2020 POP End: 09-14-2021

1001 12.00 MO

Preventative Maintenance and repairs for eight medical equipment items.

Contract Period:

POP Begin: 09-15-2021 POP End: 09-14-2022

2001 12.00 MO

for eight medical equipment items.

Contract Period:

POP Begin: 09-15-2022 POP End: 09-14-2023

3001 12.00 MO

for eight medical equipment items.

Contract Period:

POP Begin: 09-15-2023 POP End: 09-14-2024

4001 12.00 MO

for eight medical equipment items.

Contract Period:

POP Begin: 09-15-2024 POP End: 09-14-2025

GRAND TOTAL

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 days.

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

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

for the convenience of VA) shall only be granted with approval of the contracting officer and the

VA Assistant Secretary for Office of Information and Technology.

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

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerablity scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A

Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA

Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally

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

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification

Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the

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

Office can provide guidance on whether a new C&A would be necessary.

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

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

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA

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

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

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

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

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

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

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

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

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

ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the

COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident

(including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

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

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with

VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

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

b. The contractor/subcontractor shall provide notice…