36C26121Q0738_1.docx

Contract Opportunity Presolicitation Notice

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* = Required Field Contract Opportunity Presolicitation Notice J066 Pharmacy Laminar Flow Hoods and Isolators Certification and Testing 95652-2609 36C26121Q0738 06-04-2021 15:00

PACIFIC TIME, LOS ANGELES, USA

N

SBA

811219 Department of Veterans Affairs VA Sierra Pacific Network (VISN 21) VA Northern California HealthCare System 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609

CONTRACT SPECIALIST

JOHN DA SILVA

John.Dasilva@VA.gov 925-356-5881 Veterans Affairs Southern Nevada Healthcare System 6900 North Pecos rd North Las Vegas

NV

89086 United States VAMC Southern Nevada Healthcare System Statement of Work (SOW) 2237#: 593-21-3-140-0214

1. CONTRACT TITLE. Certification and Testing of Pharmacy Cleanrooms, Laminar Flow Hoods, and Isolators.

2. DEFINITIONS. Testing and Certification Service Contract.

3. SCOPE OF WORK : Contractor shall provide tests and certifications to all Pharmacy Cleanrooms, Laminar Flow Hoods and Isolators at Oncology Suite and Main Pharmacy Suite and SCA at the VA SNHCS 6900 North Pecos Road, North Las Vegas, NV 89086.

4. SPECIFIC TASKS: Testing and Certification of Pharmacy Cleanrooms, Laminar Flow Hood, and Isolators as per accordance with USP 797/800 CETA ISO Standards 14644 and IES-006 specifications.

a. Specific Equipment List as follows:

i. EE80961; BVBI – 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18930

ii. EE80962; BVBI – 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18932

iii. EE80963; BVBI – 4SSRX Laminar Flow Hood; S/N 4S-15-BVBI-18931

iv. EE80964; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18927

v. EE80965; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18926

vi. EE80966; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18929

vii. EE80967; LFGI-3USP Laminar Flow Hood; S/N 3S-15-LGU-18928

b. Specific Tasks as Follows:

i. Monthly Surface Sampling Testing for Oncology Suite IV Room on (2) CACIs, (1) LAFW, (1) negative pressure buffer room and (1) positive pressure buffer room.

ii. 2 CACIs, 1 LAFW, 1 negative pressure buffer room, 1 positive pressure buffer room, 1 positive pressure ante room.

iii. 2 CACIs, 2 LAFW, 1 negative pressure buffer room, 1 positive pressure buffer room, 1 positive pressure ante room.

iv. 2 CACIs, 2 LAFW, 1 negative pressure buffer room, 1 positive pressure buffer room, 1 positive pressure ante room.

v. Cost of the monthly surface sampling for the LAFW located in an SCA.

vi. Cost of the Bi-Annual certification for the LAFW located in an SCA.

5. PERIOD AND PLACE OF PERFORMANCE.

Base Year: 6/23/2021 - 6/22/2022 Option Year 1: 6/23/2022 - 6/22/2023 Option Year 2: 6/23/2023 - 6/22/2024 Option Year 3: 6/23/2024 - 6/22/2025 Option Year 4: 6/23/2025 – 6/22/2026

Place: VAMC 6900 North Pecos Road, North Las Vegas, Nevada, 89086

6. CONTRACTING OFFICER’S REPRESENTATIVE (COR).

The Contractor shall not accept any instructions issued by any other person(s) other than the Contracting Officer. The Government may appoint a COR. If so, a Delegation of Authority letter shall be forwarded to the using service and the Contractor after contract has been signed, identifying the individual(s) as the COR(s)

7. SECURITY

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

A prohibition on unauthorized disclosure: "Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor 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." See VA Handbook 6500.6, Appendix C, paragraph 3.a.

A requirement for data breach notification: Upon discovery 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, the contractor/subcontractor shall immediately and simultaneously notify the COR, the designated ISO, and Privacy Officer for the contract. 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. See VA Handbook 6500.6, Appendix C, paragraph 6.a.

A requirement to pay liquidated damages in the event of a data breach: "In the event of a data breach or privacy incident involving any SPI the contractor processes or maintains under this contract, the contractor shall be liable to VA for liquidated damages for a specified amount per affected individual to cover the cost of providing credit protection services to those individuals." See VA Handbook 6500.6, Appendix C, paragraph 7.a., 7.d.

A requirement for annual security/privacy awareness training: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall complete on an annual basis either: (i) the VA security/privacy awareness training (contains VA's security/privacy requirements) within 1 week of the initiation of the contract, or (ii) security awareness training provided or arranged by the contractor that conforms to VA's security/privacy requirements as delineated in the hard copy of the VA security awareness training provided to the contractor. If the contractor provides their own training that conforms to VA's requirements, they will provide the COR or CO, a yearly report (due annually on the date of the contract initiation) stating that all applicable employees involved in VA's contract have received their annual security/privacy training that meets VA's requirements and the total number of employees trained. See VA Handbook 6500.6, Appendix C, paragraph 9.

A requirement to sign VA's Rules of Behavior: "Before being granted access to VA information or information systems, all contractor employees and subcontractor employees requiring such access shall sign on an annual basis an acknowledgment that they have read, understand, and agree to abide by VA's Contractor Rules of Behavior which is attached to this contract." See VA Handbook 6500.6, Appendix C, paragraph 9, Appendix D. Note: If a medical device vendor anticipates that the services under the contract will be performed by 10 or more individuals, the Contractor Rules of Behavior may be signed by the vendor's designated representative. The contract must reflect by signing the Rules of Behavior on behalf of the vendor that the designated representative agrees to ensure that all such individuals review and understand the Contractor Rules of Behavior when accessing VA's information and information systems.

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." See VA Handbook 6500.6, Appendix C, paragraph 5.h., for the specific options.

8. INVOICE AND PAYMENTS. Payment to be made in arrears. Contractor shall submit invoice in the original, addressed to:

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin, TX 78714

Toll-free telephone number: 877-353-9791 Fax Number: 512-460-5540

The invoice SHALL be itemized to include the following information. Any information listed below not provided on an invoice shall render that invoice incomplete and the invoice shall be returned for immediate correction.