SOW Pyxis Support DRAFT.pdf

STATEMENT OF WORK

This contract is to establish the scope of work between Department of Veterans Affairs (VA) Veterans Health Administration (VHA) and the contractor CareFusion Solutions, LLC, together with its subsidiaries and related legal entities (collectively "CareFusion"). The contractor shall provide a comprehensive service agreement for technical support and maintenance of all Pyxis ES Medstation and Codonics systems at the VA Medical Center Fresno at 2615 East Clinton Avenue, Fresno, CA 93703. The Codonics system is connected to and interfaces directly with Carefusion’s Pyxis system. These services shall be rendered for the Department of Veterans Affairs Central California Health Care System. All services must be provided in strict accordance with the specifications, terms, and conditions outlined in this agreement.

The following equipment located at VACCHCS, Fresno, CA.

Serial Number CRM Contract Product Description Asset Location

42850254 Med KP Add on Site KNOWLEDGE PORTAL

13570805 MED,RM,ROUNDOFFSET,12FT SPLAB

13808211 MEDSTATION,ES,AUX,TOWER,DC SURGERY

13975324 MED,RM,FLATOFFSET,12FT AIC-EYE

13975325 MED,RM,FLATOFFSET,12FT PRIMARY

15736624 MEDSTATION,ES,MAIN,6DR DOGWOOD

15740665 MED,RM,SLIMLINE,25FT DOGWOOD (STORAGE)

15742650 MEDSTATION,ES,AUX,TOWER,SC DOGWOOD

15866113 MED,RM,SLIMLINE,12FT ASPEN

15868397 MEDSTATION,ES,MAIN,6DR CT2NDFLR

15868398 MEDSTATION,ES,AUX,7-DRAWER CT2NDFLR

15869161 MEDSTATION,ES,AUX,TOWER,SC CT2NDFLR

15880108 MED,RM,SLIMLINE,12FT 5EASTCVD

15880366 MEDSTATION,ES,MAIN,6DR 5EASTCVD

15880368 MEDSTATION,ES,MAIN,6DR Z STORAGE (BASEMENT)

15880370 MEDSTATION,ES,AUX,7-DRAWER CEDAR AUX

15880371 MEDSTATION,ES,AUX,7-DRAWER BOON AUX

15881879 MEDSTATION,ES,AUX,TOWER,SC 5EASTCVD

16018735 MED,RM,FLATOFFSET,25FT PRIMARY

16026254 MED,RM,FLATOFFSET,12FT ER-EVAL

16026255 MED,RM,ROUNDOFFSET,12FT 5EAST

16026256 MED,RM,ROUNDOFFSET,12FT CT2NDFLR

16026258 MED,RM,FLATOFFSET,25FT SAMEDAY

16026260 MED,RM,SLIMLINE,12FT STEPDOWN

16027165 MEDSTATION,ES,AUX,TOWER,SC STEPDOWN

16027166 MEDSTATION,ES,AUX,TOWER,SC ASPEN

16027167 MEDSTATION ES TOWER CTROOM

16027169 MEDSTATION ES TOWER IMAGING

16027171 MEDSTATION,ES,AUX,TOWER,SC ER-EVAL

16028872 MEDSTATION,ES,AUX,7-DRAWER STEPDOWN

16028873 MEDSTATION,ES,AUX,7-DRAWER 6EAST

16028874 MEDSTATION,ES,AUX,7-DRAWER ER-EVAL

16028875 MEDSTATION,ES,AUX,7-DRAWER 5EAST

16028877 MEDSTATION,ES,AUX,7-DRAWER ASPEN

16028878 MEDSTATION,ES,AUX,7-DRAWER ER-EVAL

16031947 PYXIS ANESTHESIA SYSTEM ES AOR3

16031948 PYXIS ANESTHESIA SYSTEM ES AOR1

16031949 PYXIS ANESTHESIA SYSTEM ES AOR2

16031950 PYXIS ANESTHESIA SYSTEM ES AOR4

16032520 MEDSTATION,ES,MAIN,5DR,BIN AIC-EYE

16032521 MEDSTATION,ES,MAIN,5DR,BIN PACU

16032522 MEDSTATION,ES,MAIN,5DR,BIN SAMEDAY

16033143 MEDSTATION,ES,MAIN,6DR STEPDOWN

16033144 MEDSTATION,ES,MAIN,6DR 5EAST

16033340 MEDSTATION,ES,MAIN,6DR 6EAST

16033341 MEDSTATION,ES,MAIN,6DR ASPEN

16033342 MEDSTATION,ES,MAIN,6DR ER-EVAL

16033343 MEDSTATION,ES,MAIN,5DR,BIN BOON

16033344 MEDSTATION,ES,MAIN,6DR SURGERY

16033345 MEDSTATION,ES,MAIN,6DR SPLAB

16033346 MEDSTATION,ES,MAIN,5DR,BIN PRIMARY

16033458 MEDSTATION,ES,MAIN,6DR CEDAR

16033459 MEDSTATION,ES,MAIN,5DR,BIN 4W-SHNC

16033460 MEDSTATION,ES,MAIN,5DR,BIN 4E-HNC

16033461 MEDSTATION,ES,MAIN,5DR,BIN GI

16036423 MEDSTATION ES TOWER CTROOM2

16655338 MEDSTATION,ES,MAIN,6DR Visalia OPC

16655341 MEDSTATION,ES,MAIN,6DR Visalia OPC

16655509 MEDSTATION,ES,AUX,7-DRAWER Visalia OPC

16655511 MEDSTATION,ES,AUX,7-DRAWER Visalia OPC

2149058 PyxisES Ref 13CF, RHG-6 Std Bins Visalia OPC

2149113 PyxisES Ref 13CF, RHG-6 Std Bins Visalia OPC

43828668 Enterprise User/Form Mgmt Lic 21-40Mains Z IT

46828968 Codonics SLS 550i printer w/ support AOR1

43828969 Codonics SLS 550i printer w/ support AOR2

43828970 Codonics SLS 550i printer w/ support AOR3

43828971 Codonics SLS 550i printer w/ support AOR4

43828972 Codonics SLS 550i printer w/ support PHARMACY

43828974 Codonics SLS tethered scanner, w/support PHARMACY

43828975 Codonics SLS AT single lic, w/ support AOR1

43828976 Codonics SLS AT single lic, w/ support AOR2

43828977 Codonics SLS AT single lic, w/ support AOR3

43828978 Codonics SLS AT single lic, w/ support AOR4

43828979 Codonics SLS AT single lic, w/ support PHARMACY

43828980 Codonics SLS AT EN single lic w/support AOR1

43828981 Codonics SLS AT EN single lic w/support AOR2

43828982 Codonics SLS AT EN single lic w/support AOR3

43828983 Codonics SLS AT EN single lic w/support AOR4

43828984 Codonics SLS AT EN single lic w/support PHARMACY

43977685 KIT MOUNTING ARM AOR1

43977686 KIT MOUNTING ARM AOR2

43977687 KIT MOUNTING ARM AOR3

43977688 KIT MOUNTING ARM AOR4

43828973 Codonics SLS AT accessory kit w/ support PHARMACY

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

Contractor shall furnish the following:

• Routine Preventive Maintenance as required by the Original Equipment Manufacturer

• Corrective Maintenance which includes all remediations and repairs 24/7 excluding Federal

Holidays.

The following holidays are observed by the Department of Veterans Affairs:

New Year’s Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Juneteenth National Independence Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

Christmas Day

And any other day specifically declared by the President of the United States to be a National

Holiday. When a holiday falls on a Sunday, the following Monday will be observed as a National

Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National

Holiday by U.S. Government agencies. An administrative closure of federal offices by Executive

Order is not a national holiday for the purpose of holiday pay.

• Parts & Labor necessary for PM or CM are provided by the Contractor at no additional customer cost.

• Remote support

• Emergency/Support Telephone Consultation is provided [24] hours per day [7] days a week by the Contractor at no additional customer cost.

1. DEFINITIONS/ACRONYMS:

A. Biomedical Engineering - Supervisor or designee.

B. CO - Contracting Officer.

C. COR - Contracting Officer's Representative.

D. PM - Preventive Maintenance Inspection.

E. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Outpatient Clinic premises.

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

G. NFPA - National Fire Protection Association.

H. OEM - Original Equipment Manufacturer I. TJC – The Joint Commission J. HIPAA – Health Insurance Portability and Accountability Act K. NEC – The National Electric Code

2. CONFORMANCE STANDARDS:

Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, TJC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

3. PREVENTIVE MAINTENANCE (PM):

A. Contractor shall perform Preventive Maintenance inspections as per contract.

B. The contractor shall furnish documentation, including all measurement and calibration data to certify that the system is performing in accordance with the performance specifications.

BD Exception: Field Service Reports will be generated at the conclusion of the service call and will be available electronically through our online service portal or by calling our Technical Support Center. For each service visit, a detailed Equipment Service Report will be required. Each service report shall include:

• Name of the contractor and contracting number.

• Name of the Field Service Engineer (FSE) performing the services.

• Contractor Service Number/Log Number.

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

• Identification of equipment to be serviced, invoice or ID number, manufacturer’s name, device name, model number, serial number and any other manufacturer’s identification numbers.

• Description of problem reported by COR/User.

• Signature from the FSE performing services described.

• Signature from an authorized employee who witnessed services described

4. CORRECTIVE MAINTENANCE (CM):

A. All required parts shall be furnished, except for expendable and consumable parts.

Consumable and expendable parts are defined as items that require replacement on a greater than one-month frequency. Any exceptions shall be noted by the contractor in writing prior to the initiation of the contract.

B. The contractor may at times have access to PHI for the following reasons.

1. To help triage technical issues (med orders, patients, cabinets issues). The contractor will require remote access into the system to perform those functions. The PHI will never leave the VA system.

2. During installation of new software and server migration, a test server may be utilized to validate prior to go-live. Once the new system is live, remote access will be utilized to help support the system per customer request.

BD Exception: Consumables are not included as part of the support plan, regardless of how often they are replaced. Consumables include but not limited to batteries, paper and toner.

5. Software Support A. The contractor shall provide technical support for all the system’s software which includes but limited to: Software updates, patching, repairs.

BD Exception: Software updates to maintain the security or operation of the Software are generally released monthly. BD will push the updates to the customers' device and when the device is rebooted, the update is installed. Software upgrades are included with a contracted support plan during the initial term and are scheduled for a mutually agreeable time. Upgrade means a major enhancement, new features, or other improvements to the software. Hardware, 3rd party software, or any other software that BD generally licenses separately are not included.

6. HOURS OF COVERAGE:

Services are provided 24 hours a day coverage excluding Federal holidays.

7. PARTS:

The contractor shall furnish and replace parts at no cost with next day delivery by 10:30am. The contractor shall have ready access to unique and/or high mortality replacement parts. All parts supplied shall be OEM or equivalent and fully compatible with existing equipment. The contract shall include all parts except for consumable or expendable items. The contractor shall use new or rebuilt parts. Used parts, those removed from another system, shall not be installed without approval by the COR. The contractor is required to install VA supplied parts when said parts are determined to be fully compatible.

The determination of compatibility is at the discretion of the COR.

BD Exception: Contractor will order parts as soon as possible but does not have an SLA when parts are ordered. Many of the commonly used parts are kept on hand with the service technician or they are in a local parts depot and can be accessed right away. If a spare part is not available on hand or in the depot, we can request the part to be shipped within 48 hours based on criticality. Parts shipping is subject to availability and varies on parts and/or shipping delays.

Contractor will only install contractor provided parts as compatibility is determined by the Contractor.

8. SERVICE MANUALS:

VACCHCS shall not provide service manuals or service diagnostic software to the contractor for use in providing services under this contract. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation, (such as: operational and service manuals, schematics, and parts list), which are necessary to meet the performance requirements of this contract.

The location and listing of the service data manuals, by name, and/or the manuals themselves shall be provided to the CO upon request.

BD Exception: BD will provide electronic versions of all applicable user guides. Maintenance manuals are not provided to customers, as BD provides service and support as part of the contract package through the BD Technical Support Center and Field Service technicians.

9. DOCUMENTATION/REPORTS:

The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

A. Name of Contractor B. Name of FSE who performed services.

C. Contractor Service ESR Number/Log Number.

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

E. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

F. Description of Problem Reported by COR/User.

G. Identification of Equipment to be serviced to include the following: Equipment ID #

a. or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

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

I. Signatures from the following:

a. FSE performing services described.

b. VA Employee who witnessed service described.

J. Equipment downtime calculated in accordance with Conformance Standards.

BD Exception: Field Service Reports, to include preventative maintenance, will be generated at the conclusion of the service call and will be available electronically through our online service portal or by calling our Technical Support Center.

For each service visit, a detailed Equipment Service Report will be required. Each service report shall include:

• Name of the contractor and contracting number.

• Name of the Field Service Engineer (FSE) performing the services.

• Contractor Service Number/Log Number.

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

• Identification of equipment to be serviced, invoice or ID number, manufacturer’s name, device name, model number, serial number and any other manufacturer’s identification numbers.

• Description of problem reported by COR/User.

• Signature from the FSE performing services described.

• Signature from an authorized employee who witnessed services described

10. REPORTING REQUIREMENTS:

The contractor shall report to Biomedical Engineering to "check-in" upon arrival and prior to performance of work under this contract. This check-in is mandatory and can be accomplished in person or by phone contact. When the service(s) is/are completed, the FSE shall document the services rendered on a legible ESR(s). The FSE shall be required to check out with the Biomedical Engineering Department (location to be specified at time of contract award) and submit the ESR(s) to the COR. All ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature." If the COR is unavailable, a signed accepted copy of the ESR will be sent to the COR within 5 business days of work completion.

FAILURE TO COMPLY, EITHER IN WHOLE OR IN PART, WITH EITHER THE NOTIFICATION OR ESR

REQUIREMENTS WILL BE DEEMED SIGNIFICANT NON-

COMPLIANCE WITH THE CONTRACT AND MAY BE JUSTIFICATION FOR TERMINATION OF THE

CONTRACT.

BD Exception: Field Service Reports, to include preventative maintenance, will be generated at the conclusion of the service call and will be available electronically through our online service portal or by calling our Technical Support Center.

11. ADDITIONAL CHARGES:

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

12. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (in writing), of the existence or the development of any defects in, or repairs required to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

13. CONDITION OF EQUIPMENT:

The contractor accepts responsibility for the equipment described in Equipment listed on page one of the Statement of Work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

14. COMPETENCY OF PERSONNEL SERVICING EQUIPMENT:

A. Each respondent must have an established business, with an office and full-time staff.

The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) shall have successfully completed a formalized training program, for the equipment identified in Section B. For field experience, the FSE(s) shall have a minimum of two years of experience, with respect to scheduled and unscheduled preventive and remedial maintenance on equipment identified in Section B.

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

BD Exception: Contractor associates are fully qualified and skilled in providing support for the Pyxis products. Contractor will not guarantee years of experience working on specific equipment as experience of specific devices can vary based on other comparable experience. Contractor has sole responsibility for the training provided to associates and for ensuring that associates are fully qualified to provide support.

Contractor does not have a policy to engage VA with training requirements, to provide documentation of competency and certification or to request preapproval from the VA for associates providing support.

15. TEST EQUIPMENT:

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

16. IDENTIFICATION, PARKING, SMOKING, CELLULAR PHONE USE AND VA REGULATIONS:

The contractor's FSE shall wear visible identification at all times while on the premises of the VAOPC. It is the responsibility of the contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police-Security Service. The VAOPC will not invalidate or make reimbursement for parking violations of the contractor under any conditions. Smoking is prohibited inside any buildings at the VAOPC. Cellular phones and two-way radios are not to be used within six feet of any medical equipment. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in a citation answerable in the United States (Federal) District Court, not a local district state, or municipal court.

17. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The contractor shall:

A. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

B. Have policies and procedures that reduce the risk of employee exposure to bloodborne pathogens.

C. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

18. RECORDS MANAGEMENT OBLIGATIONS

Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

Definitions

“Federal Record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record:

3. Includes [Agency] records.

4. Does not include personal materials.

5. Applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

6. May include deliverables and documentation associated with deliverables.

Requirements

Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

[Fresno VA Medical Center] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Fresno VA Medical Center] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Fresno VA Medical Center].

The agency must report promptly to NARA in accordance with 36 CFR 1230.

The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Fresno VA Medical Center] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Fresno VA Medical Center] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Fresno VA Medical Center] policy.

The Contractor shall not create or maintain any records containing any non-public [Fresno VA Medical Center] information that are not specifically tied to or authorized by the contract.

The 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 from public disclosure by an exemption to the Freedom of Information Act.

The [Fresno VA Medical Center] owns the rights to all data and records produced as part of this contract.

All deliverables under the contract are the property of the U.S. Government for which [Fresno VA Health Care System] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

Flowdown of Requirements to Subcontractors

The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

VA Handbook 6500.6 Contract Security Requirements

Appendix B

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY

REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(END OF CLAUSE)

Appendix C:

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION

INTO CONTRACTS, AS APPROPRIATE

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor 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 medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that are used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. This section applies when any person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance 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 shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR

852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or the occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer have a need for access to VA information or VA information systems. Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(2) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company- owned property.

This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(3) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(4) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(5) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor / subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens. Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA- issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

4. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter. Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter;

and

(2) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role- based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.

b. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

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 the VA Office of 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.

e. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

f. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

g. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs.

6. DATA CENTER PROVISIONS. This entire section applies whenever the acquisition requires an interconnection to/from the VA network to/from a non-VA location.

a. The contractor shall ensure the VA network is accessed by in accordance with VA Directive 6500 and IAM security processes specified in the VA Information Security Knowledge Service.

b. The contractor shall ensure network infrastructure and data availability in accordance with VA information system business continuity procedures specified in the VA Information Security Knowledge Service.

c. The contractor shall ensure any connections to the internet or other external networks for information systems occur through managed interfaces utilizing VA approved boundary protection devices (e.g., internet proxies, gateways, routers, firewalls, guards or encrypted tunnels).

d. The contractor shall encrypt all traffic across the segment of the Wide Area Network (WAN) it manages and no unencrypted Out of Band (OOB) Internet Protocol (IP) traffic will traverse the network.

e. The contractor shall ensure tunnel endpoints are routable addresses at each VA operating site.

f. The contractor shall secure access from Local Area Networks (LANs) at co- located sites in accordance with VA TIC Reference Architecture, VA Directive and Handbook 6513, and MOU/ISA process specified in the VA Information Security Knowledge Service.

g. Refer to MOU/ISA E-715 between Department of Veterans Affairs and CareFusion Solutions, LLC/Becton Dickinson (CareFusion).

7. Business Association Agreement.

a. It has been determined that protected health information (PHI) may be used, disclosed, accessed, transmitted, created, stored/maintained, and/or destroyed (providing appropriate proof of destruction in compliance with VA Directive 6371) by the Contractor, and a signed Business Associate Agreement (BAA) will be required. The Contractor will adhere to the requirements set forth within the BAA, referenced in the solicitation, and will comply with all applicable VA/VHA Directives.