36C24421Q0127.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 60

36C24421Q0127 01-07-2021

Bradley Fasnacht 717-228-5959 01-22-2021

10:00 EST

00244

Department of Veterans Affairs

Network Contracting Office 4

Services Team 5

Logistics & Operational Support Services

Bradley Fasnacht | Contract Specialist

Bradley.Fasnacht2@va.gov

X 100

X

811219

$22 Million

N/A

X

See SOW for Site Specifics

00244

Ref to VAAR: 852.232-72

Electronic Submission of Payment Req http://www.fsc.va.gov/einvoice.asp

(877) 353-9791 (512) 460-5429

See CONTINUATION Page

This solicitation is for the maintenance of GE Anesthesia machines for the multiple locations within Network Contracting

Office 4 (VISN 4)

This procurement is being competed in accordance with

FAR Part 13.

Award is intended to be a five (5) year fixed-Priced

Indefinite Delivery (ID) Indefinite Quantity (IQ) contract utilizing Task Orders to fund and autherize performance contingent upon availability of funding.

Anticipated award effective date is 03/01/2021

Anticipated award expiration date is 02/28/2026

A continuation of the description of services can be found in section "B.2 Statement of Work".

Refer to “Additional Instructions to Offerors” for specific

Instructions on quote submission and evaluation.

All questions shall be emailed to Bradley.Fasnacht2@va.gov no later than 10:00 am EST on 01/14/2021.

See CONTINUATION Page

X X

X 1

Laura E. Scott

Contracting Officer

36C24421Q0127

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

B.3 RECORDS MANAGEMENT LANGUAGE

B.4 6500.6 APPENDIX C

B.5 6500.6 APPENDIX D

B.6 BUSINESS ASSOCIATE AGREEMENT

B.7 PRICE SCHEDULE

B.8 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.216-18 ORDERING (AUG 2020)

C.2 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.3 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.4 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.5 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR 1984)35

C.7 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.8 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.9 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.10 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION

D.2 ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM TO FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL

ITEMS

Additional Instructions to Offerors

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) ... 47

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 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:

Network Contracting Office 4

Contracting Officer: Laura E. Scott Laura.Scott4@va.gov

Contract Specialist: Bradley Fasnacht Bradley.Fasnacht2@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.

Ref to VAAR: 852.232-72

Electronic Submission of Payment Req mailto:Laura.Scott4@va.gov mailto:Bradley.Fasnacht2@va.gov

B.2 STATEMENT OF WORK

DEPARTMENT OF VETERANS AFFAIRS

NCO 4 MULTI-SITE SERVICE

MAINTENANCE OF GE ANESTHESIA MACHINES

DESCRIPTION:

The Department of Veterans Affairs, VISN 4 is contracting for a Firm Fixed Priced (FFP) five (5) year Indefinite Delivery – Indefinite Quantity (ID-IQ) contract for Preventative Maintenance of existing General Electric Anesthesia Machines.

Individual orders will be placed against the ID-IQ on an as needed basis.

The Contractor shall provide all personnel, transportation, equipment, parts, supplies, facilities, supervision, and other items and services necessary to perform the preventative maintenance and repair services as defined in this Statement of Work (SOW).

The Contractor assumes all liability risks for work performed under this contract. The Contractor must assume total liability for all contract employees. The Contractor shall perform to the standards of the contract as indicated in this SOW.

SERVICES:

This is a services contract to provide full preventative maintenance and repairs to government owned General Electric anesthesia machines and associated accessories in accordance with this

Statement of Work.

SERVICE LOCATIONS:

503-Altoona

James E. Van Zandt Veterans Affairs

Medical Center

2907 Pleasant Valley Road Altoona, PA 16602-4305

BLAIR COUNTY

562-Erie

Erie Veterans Affairs Medical Center 135 East 38th Street

Erie, PA 16504-1559

ERIE COUNTY

646-Pittsburgh VA Healthcare System University Drive Campus

University Drive

Pittsburgh, PA 15240-1000

ALLEGHENY COUNTY

646-Pittsburgh VA Healthcare System

H.J. Heinz Campus

1010 Delafield Road

Pittsburgh, PA 15215-1802

ALLEGHENY COUNTY

693-Wilkes-Barre

Wilkes-Barre Veterans Affairs Medical Center 1111 East End Blvd

Wilkes-Barre, PA 18711-0030

LUZERNE COUNTY

460-Wilmington Wilmington Veterans Affairs Medical Center

1601 Kirkwood Highway

Wilmington, DE 19805-4907

NEW CASTLE COUNTY

PERFORMANCE REQUIREMENTS:

Qualification:

Contractor personnel performing work under this must be trained and qualified to work on all components of the anesthesia equipment and the latest revisions of hardware and software as required by the original equipment manufacturer (GE). Contractor personnel performing work under this contract must provide proof of successful completion of training and certification by the original equipment manufacturer (GE).

Preventive Maintenance:

Preventive maintenance / calibration inspections will be coordinated with the Anesthesiology Service and Biomedical Engineering at each facility. Preventive

Maintenance will comply with all applicable regulations and manufacturers specifications, and it will include, but is not limited to the following:

1. Reviewing operating system diagnostics to ensure that the equipment is operating within its specifications.

2. Calibrating and cleaning.

3. Replacing any worn or defective parts.

4. Repairing or replacing any vaporizer specifically listed below that fails the vaporizer efficacy test.

5. Installing and maintaining all software updates/upgrades.

Anesthesia Equipment Manufacturer: See B.7 Price Schedule

Preventive Maintenance Schedule:

Preventive maintenance will be conducted semiannually (twice during the contract year) in the months designated by Biomedical Engineering at each medical facility. Within 30 days of award of contract, Contractor shall contact Biomedical Engineering at each medical center to coordinate and schedule the dates and times for the various preventive maintenance inspections.

Parts:

The Contractor shall furnish and replace all necessary parts as required to return equipment to full manufacturers published specifications. All parts supplied shall be GE parts and compatible with existing equipment. The Contractor shall use new parts only.

Re-built or backward-engineered parts are not permitted.

Technical Support:

Telephone service for technical support will be provided twenty-four (24) hours per day, seven (7) days per week. Contractor shall provide appropriate telephone number(s) for

24-hour access.

Remedial Services and Emergency Repairs:

Contractor shall provide unscheduled remedial services and emergency repairs.

Biomedical Engineering will contact the Contractor to request remedial service or emergency repairs when equipment is operating with diminished capacity or is deemed by Biomedical Engineering to be inoperable. Contractor shall acknowledge receipt of a service call for remedial service and emergency repairs within four (4) hours and shall arrive on site to inspect the equipment within twenty-four (24) hours of the original call.

Service Calls:

After checking with VA Police to receive a VA Badge, Contractor personnel will report to the Biomedical Engineering office prior to performance of services. In the event that the

Contractor reports after normal working hours, the Contractor will report to the supervising official of the equipment to be serviced. Payment for services may be held up if the Contractor does not follow proper reporting procedures.

Routine service calls are hereby defined as necessary to diagnose and repair equipment problems which can be performed during normal working hours. Response time of the

Contractor for routine service calls shall be within twenty-four (24) hours after being officially notified.

Emergency service calls are defined as services required to safeguard the health and well-being of VA patients, and shall be responded to within six (6) hours of being officially notified.

The term “Response time of the Contractor” indicates the physical presence of a fully qualified technician on station within the specified time frame.

“Official notification” is hereby defined as the time a service call is placed with the

Contractor.

Documentation:

The Contractor shall provide individual service reports that reference services performed on the equipment. The following information must be provided in each service report:

1. Date of service

2. Summary of problem and action taken

3. Equipment details (description, equipment ID, serial number, etc.)

4. Labor hours

5. Parts and other expenses

6. Purchase order number

7. Certificate of safety to use anesthesiology equipment following a PMI or repair activity.

The service report must be approved and signed by the Biomedical Engineering representative. A copy of each report must be left with Biomedical Engineering representative at the time the services were completed. In the event that Biomedical Engineering is not available to receive the service report (outside normal working hours), the service report will be left with the supervising official of the equipment serviced.

Repairs and Services not Covered by Contract:

Those costs for repairs and corrections not inclusive must be approved by the Contracting Officer before performance of the service and will be approved by an order modification.

Inadequate or improper repairs performed by the Contractor shall be resolved at no additional cost to the Government.

GENERAL INFORMATION:

COVID-19 or another Novel Virus:

All Contracted Staff shall enter all facilities through one of the sites designated Screening

Checkpoints where all VA Patients, Staff, Contractors and Visitors are asked COVID related questions as well as temperature checks using a touchless solution, and any other process that the CDC may implement in response to the COVID pandemic.

Individuals who do not meet the requirements of the CDC and Department of Veterans

Affairs requirements will be denied entry.

Hours of Operation:

All services will be performed during normal working hours of coverage unless authorized by the Contracting Officer’s Representative (COR).

Normal hours of coverage are Monday through Friday, 8:00 a.m. to 4:30 p.m., excluding federal holidays.

Uniforms:

All employees shall wear contractor provided uniforms, (contractor code of dress), which include pants, shirts or blouses, and protective clothing which are clearly distinguishable from other VAMC uniforms currently in use. The uniform will be worn as designed by the manufacturer. Open toe shoes or sandals will not be worn. A basic leather shoe covering the entire foot is recommended. All personnel will display identification badges on their uniforms, which will show the employee’s last name and the contractor’s full name.

Personal Hygiene:

Contractor’s personnel shall be clean, bathe daily (including hair), and wear a clean uniform daily. Fingernails will be clean and free of dirt. Hair will be neatly trimmed and combed.

Physical Security:

The Contractor shall be responsible for safeguarding all government equipment, information and property provided to Contractor personnel while performing the services described herein.

Security Requirements:

All Contractor personnel are required to wear identification (ID) badges during the entire time they are on the VA grounds. Contractor ID badges must have an identification picture, name of the individual and the represented company depicted on it. VA badges will also need to be worn while on VA grounds and should be obtained through the

Department of Veterans Affairs Police Dispatch Center.

It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from each individual sites Department of

Veterans Affairs Police Department. The Department of Veterans Affairs will not invalidate or make reimbursement for parking violations of the contractor under any conditions.

Smoking is prohibited on Department of Veterans Affairs property. Possession of weapons is prohibited. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

Damage:

Extreme caution shall be exercised to prevent damage to the building and its contents.

Any damage must be reported to the POC immediately for appropriate action.

Any damage to any Government property caused by the contractor will be repaired and or replaced to the satisfaction of the VA at the contractor’s expense.

Damage to the building, its contents or loss of government property, in excess of

$100,000 will require a Report of Survey or Investigation Report by the VA. Appropriate Government personnel will conduct the investigation. The responsible party will be required to replace and/or submit payment for damage or loss.

Access (Keys):

If the POC provides keys for access, it shall be the Contractors responsibility to safeguard and control keys provided.

Confidentiality:

Contractor, any and all personnel employed by Contractor, and any other individuals enlisted by Contractor (sub-contractors, etc.) to meet the requirements of this SOW, shall not disclose any information regarding the patients treated at Department of Veterans

Affairs Facility. All clinical records, including names of patients, Social Security numbers, and any and all medical, administrative, or demographic information that pertains to the patients treated at the VA is strictly confidential. This information is protected under federal regulations. All information and records that pertain to the employees of the VA are also confidential and is protected under law. Contractor and any individuals employed or enlisted by Contractor, may be required to sign

Confidentiality Statement as a condition of being allowed to work at the VA.

SPECIAL CONTRACTOR PROVISIONS:

Interference in Performance Requirements:

The following provisions must be adhered to by contractor personnel throughout the duration of this contract:

Contractor may be required to interrupt their work at any time so as not to interfere with the normal functioning of the facility; e.g. utility services, servicing of fire protection systems, and the passage of facility patients/personnel, etc.

In the event of an emergency, contractor services may be stopped and rescheduled at no additional cost to the government.

Contractor personnel must inform the COR of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling must be made by the COR.

Contractor Responsibilities:

The Contractor must be responsible for ensuring all provided personnel are properly licensed to operate a motor vehicle if operating a motor vehicle on VA property is required.

All contracting staff shall be required to wear company badges with company name and employee name.

If there is a need for work to be performed beyond the scope of this contract. The contractor is required to provide a written cost estimate for any work or materials beyond the scope of this contract. The contractor shall not perform any work or make any purchases beyond the scope without approval from this contracts VA Contracting Officer.

Contractors shall utilize appropriate Personal Protective Equipment.

Government Furnished Property:

The Government will furnish no property.

Government Furnished Services:

The Contractor may use the available utilities (gas, electricity and water) while in the performance of the services defined in this Statement of Work.

END OF STATEMENT OF WORK

B.3 RECORDS MANAGEMENT LANGUAGE

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and

Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the

Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974.

These policies include the preservation of all records created or received regardless of format

[paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract.

The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

B.4 6500.6 APPENDIX C

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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 COTR.

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 COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact

Assessment.

b. The contractor/subcontractor shall certify to the COTR 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;

2) 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

3) 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.

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 10 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 COTR 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 COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

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

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

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

1) Vendor must accept the system without the drive;

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

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

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

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

b. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation.

Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre- approved and described in the purchase order or contract.

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

6. SECURITY INCIDENT INVESTIGATION

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

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

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 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.

a. 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 full compensation affected individual to cover the cost of providing credit protection services to…