36C26218Q0261-001.pdf

PAGE 1 OF 1. REQUISITION NO.

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

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

TIME

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

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

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

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

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

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

SEE ADDENDUM

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

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

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

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

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

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

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

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

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

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

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

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

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

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 50

36C26218Q0261 01-16-2018

Chae, Won 562-766-2315 01-23-2018

1 PM PST

00262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

X 100

X

532490

$32.5 Million

Net 30

N/A

X

Department of Veterans Affairs

VA Long Beach Healthcare System

5901 East 7th Street

Long Beach CA 90822

00262

Department of Veterans Affairs

Network Contracting Office 22

4811 Airport Plaza Drive

Suite 600

Long Beach CA 90815

Financial Services Center

See CONTINUATION Page

PLEASE REVIEW THE SCHEDULE BELOW FOR DETAILS.

ALL QUESTIONS MUST BE SUBMITTED BY NO LATER THAN JANUARY

18, 2018 @1:00 PM PST VIA EMAIL TO WON.CHAE@VA.GOV

ALL QUOTES MUST BE RECEIVED BY JANUARY 23, 2018 @1:00 PM

PST VIA EMAIL TO WON.CHAE@VA.GOV.

THIS PROCUREMENT IS FOR A FIRM FIXED PRICE (FFP) REQUEST.

PLEASE REVIEW STATEMENT OF WORK AND SALIENT CHARACTERISTICS.

THIS PROCUREMENT IS FOR BASE YEAR WITH FOUR ONE-YEAR

OPTION YEARS.

See CONTINUATION Page

X X

36C26218Q0261

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 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 SALIENT CHARACTERISTICS

B.4 STATEMENT OF WORK (SOW)

SECTION C - CONTRACT CLAUSES

C.1 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2012)

C.2 VAAR 852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

C.3 VAAR 852.246-71 INSPECTION (JAN 2008)

C.4 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2017)

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

C.6 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

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

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN

2011)

E.2 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN

2011)

E.3 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017)

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

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

ITEMS (NOV 2017)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

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

a. GOVERNMENT: Won Chae – Contracting Specialist

VISN 22 - Network Contracting Office (00262)

4811 Airport Plaza Drive, Suite 600

Long Beach, CA 90815

b. Contractor:

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

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [ ]

b. Semi Annually [ ]

c. Other [ X] Upon Receipt

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.

Financial Services Center

P.O. Box 149971

Austin TX 78714-9971 http://www.tungsten-network.com/us/en/veteransaffairs

Monthly invoices shall be submitted to the VA no later than 10 days past the last day of the billing period.

Contractor shall submit electronic invoices via Tungsten network or other acceptable system by VA FSC.

Invoices submitted to VA FSC other than the electronic, will NOT be processed for payment.

Contractor may contact (877) 353-9791 for invoice inquiries. Incomplete and incorrect invoices shall be returned for correction.

ACKNOWLEDGMENT OF modifications: The offeror acknowledges receipt of modifications to the Contract numbered and dated as follows:

AMENDMENT NO DATE

http://www.tungsten-network.com/us/en/veteransaffairs

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 Adaptable Medical

Clean Room Lease, consisting of 1 negative pressure room with anteroom and 1 hazardous storage room/staging room.

Base Year of Lease

Estimated Period of

Performance

06/01/2018 - 05/31/2019

12.00 MO __________________ __________________

0002 Adaptable Medical

Clean Room Lease, consisting of 1 negative pressure room with anteroom and 1

Option Year 1 of Lease

06/01/2019 - 05/31/2020

0003 Adaptable Medical

Clean Room Lease, consisting of 1 negative pressure room with anteroom and 1

Option Year 2 of Lease

06/01/2020 - 05/31/2021

0004 Adaptable Medical

Clean Room Lease, consisting of 1 negative pressure room with anteroom and 1

Option Year 3 of Lease

06/01/2021 - 05/31/2022

0005 Adaptable Medical

Clean Room Lease, consisting of 1 negative pressure room with anteroom and 1

Option Year 4 of Lease

06/01/2022 - 05/31/2023

GRAND TOTAL __________________

B.3 SALIENT CHARACTERISTICS

Environmental Quality and Control must be compliant with USP 797/800

Must provide initial and bi-annual (every 6 months) ISO environment certification by an independent verification company of the ante room, buffer room, and storage room (ISO class, particle counts, air flow exchanges, etc.)

Must provide initial and bi-annual (every 6 months) viable air and surface wipe sampling for HD surface residue or more often as needed to verify containment

Surface wipe sampling must have interior of the containment primary engineering control (C-

PEC) and equipment contained in it, pass-through chambers, surfaces in staging or work areas near the C-PEC, areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area), areas immediately outside the HD buffer room or the C-SCA, and patient administration areas

Facility and Engineering Controls must be compliant with USP 797/800

Containment secondary engineering control (C-SEC) must be externally vented, be physically separated (i.e., a different room from other preparation areas), have an appropriate air exchange minimum of 30 Air Changes Per Hour (ACPH), have a negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas, must have 24/7 operability

The clean room will consist of an anteroom (ISO Class 7) with fixed walls and inward air migration of equal cleanliness classified air into the negative pressure buffer room (ISO Class 7) and negative pressure hazardous storage space (ISO Class 7).

Storage room must be a negative-pressure room that is externally ventilated with at least 12 air changes per hour (ACPH)

Must have a sink available for hand washing and placed in the ante-room at least 1 meter from the entrance to the HD buffer room, have water sources and drains must be located at least 1 meter away from the C-PEC, eyewash station, ISO Class 7 buffer room with an ISO class 7 ante-room with fixed walls, High Efficiency Particulate Air (HEPA)-filtered supply air, provide 24/7 real-time monitoring of the system including air particles, air pressure, temperature, humidity

Modular clean room must fit within designated space of 10’ 10 ¾” by 22’ 7 9/16”

Must be self-contained and self-supporting; inclusive of walls, roof/ceiling, flooring, lighting, electrical, and filtered equipment

Must provide installation services

Modular clean room must meet all seismic integrity requirements

Must provide continuous and on-going support for modular clean room and all related equipment

Must maintain pressure differentials, particle count, temperature, and humidity per USP 797/800 requirements and allow for real-time, 24/7 monitoring of these measurements

Must provide and allow upgrades, redesigns, moves and removal due to changes in future expansion and/or changes in requirements.

Ante room and buffer room must accommodate the following equipment:

o Buffer Room

Glove box isolator: GermFree LFGI (54 x 32 x 80 in)

Stainless steel cart: 36 x 24 in waste bin: 18 x 12 in o Anteroom:

Rolling Cart: 36 x 10 in

Desk: 48 x 24 in

Chair 32 x 32 in

Printer stand: 24 x 24 in o Storage area:

Chemo refrigerator: 42 x 36 x 82 in

Room temp hazardous cabinet/storage area: 44 x 19 x 66 in

B.4 STATEMENT OF WORK (SOW)

I. Background

A. The purpose of this contract is to provide the Tibor Rubin VA Medical Center (TRVAMC) with continuous lease of a Clean Room USP 797/800 Compliant to compound and store hazardous drugs for patient care. Approximately 200 sq. ft.

II. Objectives

A. With respect to the clean room, an overview of this SOW will include the following goals and objectives the TRVAMC has a need to continuously lease a clean room for compounding and storage of hazardous drugs for patient care in a regulatory compliant environment. The lease charge will be by the month.

III. Scope, Tasks, or Requirements

A. The general scope of the work the contractor will be performing is to supply the government

(specifically the TRVAMC) with the lease of clean room constructed inside the existing new pharmacy location with minimum disruption to existing operations that allows for increased functionality and clinical capabilities from a compounding perspective.

B. The clean room will consist of an anteroom (ISO Class 7) with fixed walls and inward air migration of equal cleanliness classified air into the negative pressure buffer room (ISO Class 7) and negative pressure hazardous storage space (ISO Class 7). It requires constant, real-time monitoring for the level of air particles, air pressure, temperature, and humidity.

C. The clean room must be adaptable to provide flexibility with the need to expand, reduce, move, or remove the structure.

D. The clean room must be certified by an independent certification company for ISO environment certification.

E. The clean room will be audited/validated for viable surface and air sampling in compliance with

USP 797/800.

F. The clean room will be OSHPD approved.

IV. Selection Criteria

A. The objective standard of acceptable performance that is to be provided by the contractor is to have a certified clean room the premises, readily available. The contractor should also acknowledge that the clean room is in good working condition and is regularly maintained. The contractor will be liable for damages should patient injury result due to clean room malfunction/failure. The contractor must also indicate that sufficient insurance coverage is maintained for its employees and for its equipment.

V. Delivery Schedule

A. Usage – during the term of this SOW, the TRVAMC shall utilize the contractor’s clean room lease for hazardous compounding.

VI. Government-Furnished Equipment and Government-Furnished Information

A. The TRVAMC certifies that each pharmacist or pharmacy technician designated by the VA to operate within the clean room is trained and competent in the use of that equipment in his or her pharmacy capacity. The VAMC maintains a facility adequate and suitable for the operation of the clean room. VAMC shall perform or cause to be performed all medical services, supervision, diagnosis and patient care in accordance with all applicable professional standards. Further, each designated pharmacist or pharmacy technician shall protect the clean room from damage

(including attempted modification) and shall be liable to the contractor for damages occasioned by improper use or handling, carelessness or neglect of the equipment.

B. The contractor will have the clean room certified and/or licensed on the premises, readily available, on the day when the hazardous compounding procedure(s) is/are being performed.

Only TRVAMC’s employees, while in the performance of their official duties, and not the contractor’s employees, are covered by the Federal Tort Claims Act, 28 U.S.C. §1346(b), 2671 through 2680. The contractor acknowledges that the clean room is in good working condition and is regularly maintained. The contractor will be liable and indemnify the TRVAMC for damages should patient injury result due to clean room malfunction. The contracted vendor acknowledges that it maintains sufficient insurance coverage.

VII. Security

A. The Contractor is required to enter into a Business Associate Agreement (BAA) with the VA. A sample BAA is included in this solicitation.

VIII. Place of Performance

A. This work will be performed at a Government site (specifically in the TRVAMC infusion clinic room) and not at the contractor’s site.

IX. Period of Performance

A. The expected Period of Performance is from June 1, 2018 through May 31, 2019 as the base and four one-year options.

X. Contractor’s Responsibility

A. Contractor will hold and submit certificates of insurance for general liability and malpractice insurance, workmen’s compensation and vehicle insurance. Under no circumstances are

Contractor’s employees considered Tibor Rubin VAMC employees.

B. Technician(s) must be licensed to provide services in the State of California and have clean room training and certificate.

C. The contractor is responsible for keeping equipment in good working order and shall provide all maintenance, repairs, and upgrades to the equipment as required keeping it in optimal condition.

D. Technician(s) are subject to the same quality assurance standards as established by the United

States Pharmacopeia (USP), and the Joint Commission (JC).

E. The Contractor will provide services in accordance with ethical, professional and technical standards of the health care industry.

XI. Services Not Covered

A. Any work other than as specified in the contract shall be identified as a non-priced task, and if determined by the Contracting Officer to be within the overall scope of the contract, work shall be added by a modification to the contract.

B. Any work requested that is identified as outside the scope of the contract shall be addressed by the facility as a separate procurement.

XII. Federal Holidays Observed By the VA

New Year's Day 1 January Labor Day 1st Mon. in Sept

M L King's Birthday 3rd Mon. in Jan Columbus Day 2nd Mon. in Oct

President's Day 3rd Mon. in Feb Veterans Day 11 November

Memorial Day Last Mon. in May Thanksgiving Day 4th Thurs. in Nov

Independence Day 4th of July Christmas Day 25 December

1. Also included would be any other day specifically declared by the President of the United States to be a National Holiday.

2. When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by

U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday.

XIII. Identification, Parking, Smoking, and VA Regulations:

A. The Contractor's FSEs shall wear visible identification at all times while on the premises of the

TRVAMC. The TRVAMC does provide parking. The TRVAMC will not invalidate or make reimbursement for parking violations or charges for the Contractor under any conditions. Smoking is prohibited inside any buildings at the TRVAMC. 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.

XIV. Orientation For Contractor Employees

A. Contractor will attend an orientation meeting as arranged by the Contracting Officer’s

Representative (COR). The VA will schedule this meeting and it will include discussion of the following topics: (VA will provide information to the contractor regarding these topics and will document the meeting)

1. Fire and Safety

2. Infection control

3. Disaster procedures

4. Other

B. The Contractor will be responsible to ensure that Contractor employees coming to the work site will receive the information required above.

C. The Contractor will be responsible to ensure Contractor employees providing work on this contract are fully trained and completely competent to perform the required work.

XV. Contractor Personnel Security Requirements:

All contractor employees who require access to the Department of Veterans Affairs' Contractors computer systems or have access to sensitive information shall be the subject of a background investigation. The contractor is encouraged to have its employee immediately download the background investigation packet from http://www.osp.va.gov/Security_and_Investigations_Center_FF.asp upon notification of contract award. A contractor’s employee shall not commence working at VA under contract until the Contracting

Officer receives notification from the VA Office of Security and Law Enforcement that the contract employee’s application was received complete. A favorable adjudication from the VA Office of Security and Law Enforcement must be received in order for a contractor employee to continue contract performance. This requirement is applicable to all subcontractor personnel.

a. Position Sensitivity - The position sensitivity has been designated as low risk.

b. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries (NACI).

c. Contractor Responsibilities

1. The contractor shall bear the expense of obtaining background investigations. If the Office of

Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month’s invoice(s) for services rendered.

2. It is imperative for the contractor to provide, at the request of VA, a listing of contractor personnel performing services under the contract in order for the background investigation process to commence.

This list will include name (first, middle, last) social security number; date of birth; city, state, and country of birth.

http://www.osp.va.gov/Security_and_Investigations_Center_FF.asp

3. The contractor or their employees shall submit a complete background investigation packet.

Additional guidance and information in completing the required forms, and examples of the forms, can be found at http://www1.va.gov/VABackground_Investigations/page.cfm?pg=2.

The following required forms must be submitted to the VA Office of Security and Law Enforcement before contract performance begins:

(i) Standard Form 85, Questionnaire for Non-Sensitive Positions

(ii) Optional Form 306, Declaration for Federal Employment

(iii) Standard Form 86A (EG), Continuation Sheet for Questionnaire

(iv) Electronic Fingerprint Form

Fingerprinting is required with the background investigation. Fingerprinting can be done at the local VA

Facility. The Electronic Fingerprint Verification Form must be submitted with the above required forms.

4. The Contractor shall inform the contract employee that when filling out Standard Form 85, that there should be no gaps in employment history. Any gaps in employment history on Standard Form 85 may result in OPM rejecting the documentation for investigation and delay contract performance.

5. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract, and at the request of the VA, submit another employee for consideration.

6. The contractor may utilize a private investigating agency if such agency possesses an OPM and

Defense Security Service certification. A Cage Code number must be provided to the VA Office of Security and Law Enforcement. VA Office of Security and Law Enforcement will verify the information and advise the contracting officer whether contractor’s access to the computer systems can be authorized.

7. All contractor employees and subcontractors are required to complete VA’s Privacy training annually. All Contractor employees and subcontractors requiring access to VA computer network are required to complete Cyber Security training courses annually either on-line or hard copy. Documented proof must be provided to the Contracting Officer.

8. The contractor will notify the COR immediately when their employee(s) no longer require access to VA computer systems.

d. Government Responsibilities

1. The contracting officer will request the contractor employee’s background investigation by the

Office of Security and Law Enforcement.

2. The Office of Security and Law Enforcement will notify the contractor with instructions for the contractor's employees, coordinate the background investigations, and notify the contracting officer and contractor of the results of the investigations.

3. The VA facility will pay for requested investigations in advance. A bill for collection will be sent to the contractor to reimburse the VA facility. The contractor will reimburse the VA facility within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractors 1st month’s invoice(s) for services rendered.

4. The current fees associated with background investigations are $210.00 each for low level investigation, $850.00 each for medium level investigation, and $2,900.00 each for high level investigation.

http://www1.va.gov/VABackground_Investigations/page.cfm?pg=2%20

SAC (Special Agreement Check)

All Contractor Employees who require access to the Department of Veterans Affairs computer systems or who have access to sensitive information shall be required to have, at a minimum, a Special Agreement

Check (SAC) which includes electronic fingerprinting. A Contractor Employee shall not perform any contract work (except for any other required orientation and training that does not require access to a VA computer system) until fingerprinting is completed by the local Human Resource Management Service.

Fingerprinting should take place on the first day that a Contractor Employee enters on duty. The

Contracting Officer’s Technical Representative shall facilitate the SAC process for the Contractor and

Contractor Employee.

If the SAC identifies “potentially actionable issues” in connection with a Contractor Employee and it is determined that the Contractor Employee needs to be removed, the Contracting Officer shall notify the

Contractor and the Contractor shall immediately remove that Employee from contract work. The removal of the Employee shall not excuse any failure to meet contract requirements.

SACs and fingerprinting of Contractor Employees will be required even when an Employee will not be working on site at a VA Facility. The Contracting Officer can identify other options for accomplishing these SACs.

XVI. Security Training

Due to the increased emphasis on privacy and information security, the following special contract requirements are established and hereby made part of the contract entered into with the Department of

Veterans Affairs.

a. Privacy Training: Contractor and their sub-contractors assigned work under the contract are required to receive annual training on patient privacy as established by HIPAA statues. Training must meet

VHA’s and the Department of Health and Human Services Standards (HSS) for Privacy of Individually-identifiable health information. Contractor shall provide documented proof to the contracting officer that all employees assigned work and/or having access to protected health information have received annual training. Proof of training is to be forwarded to the COR. Training can be obtained through http://www.insidelms.va.gov/index.shtm. An account must be set up in order to access the training site by visiting https://www.tms.va.gov/plateau/user/login.jsp. page and contacting the local LMS

Administrator or contacting the VA TMS Help Desk by phone at 1-866-496-0463 or via e-mail at vatmshelp@va.gov. For contractors and sub-contractors who do not have access to VHA computer systems, this requirement is met by receiving VHA National Privacy Training, other VHA approved privacy training or contract furnished training that meets the requirements of the HHS standards.

b. Rules of Behavior for Automated Information Systems: Contractor personnel having access to VA

Information Systems are required to read and sign a Rules of Behavior statement which outlines rules of behavior related to VA Automated Information Systems. The COR will provide, through the facility

Information Security Officer (ISO), the Rules of Behavior to the contractor for the respective facility.

c. VA Information Security Awareness Training: Each contractor assigned work under the contract is required to receive and document completion of VA training on Information Security. Training can be obtained through http://www.insidetms.va.gov/index.shtm. An account must be set up in order to access the training site by visiting https://www.tms.va.gov/plateau/user/login.jsp. page and contacting the local

LMS Administrator or contacting the VA TMS Help Desk by phone at 1-866-496-0463 or via e-mail at vatmshelp@va.gov. Contractor shall provide documented proof to the COR that all contractor employees servicing a VA contract have received annual training.

XVII. Access to VA Information and VA Information Systems http://www.insidelms.va.gov/index.shtm https://www.tms.va.gov/plateau/user/login.jsp mailto:vatmshelp@va.gov http://www.insidetms.va.gov/index.shtm https://www.tms.va.gov/plateau/user/login.jsp mailto:vatmshelp@va.gov

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.

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.

XVIII. 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.

XIX. 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, hot fixes, 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 3 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.

XX. 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.

XXI. 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 to VA of a "security incident" as set forth in the

Security Incident Investigation section above. Upon such notification, VA must secure from a non-

Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

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

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

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

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

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

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

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

Incidents, as appropriate; and

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

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

(1) Notification;

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

(3) Data breach analysis;

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

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

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

XXII. Security Controls Compliance Testing

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

XXIII. Training

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

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

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as…