H299--Cleanroom Testing & Cert.

Combined Synopsis-Solicitation for Commercial Items

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Page 3 of 5

Original Date: 10/12/17

Revision 04 Date: 06/10/20

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03.

This solicitation is set-aside for Small Businesses.

The associated North American Industrial Classification System (NAICS) code for this procurement is 561210 with a small business size standard of $41.5 Million.

The FSC/PSC is H299.

The NMVAHCS Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSPCRPCC) in Albuquerque, New Mexico has a requirement for testing and certification of cleanrooms, clean tent, clean bench, and biosafety cabinets.

All interested companies shall provide quotations for the following:

Supplies/Services

Line Item

Description

Quantity

Unit of Measure

Unit Price

Total Price

0001

Cleanrooms and Equipment Testing and Certification Agreement in accordance with Performance Work Statement

1

Year

1001

Cleanrooms and Equipment Testing and Certification Agreement in accordance with Performance Work Statement Option 1

1

Year

2001

Cleanrooms and Equipment Testing and Certification Agreement in accordance with Performance Work Statement Option 2

1

Year

3001

Cleanrooms and Equipment Testing and Certification Agreement in accordance with Performance Work Statement Option 3

1

Year

4001

Cleanrooms and Equipment Testing and Certification Agreement in accordance with Performance Work Statement Option 4

1

Year

Performance Work Statement

Introduction:

This requirement is for testing and certification of cleanrooms, clean tent, clean bench, and biosafety cabinets on behalf of the NMVAHCS Cooperative Studies Program Clinical Research Pharmacy Coordinating Center (CSP CRPCC) in Albuquerque, NM

Background:

The CSP CRPCC requires annual testing services for its cleanrooms and equipment. The cleanrooms and equipment are located at the CSP CRPCC building. The required services include written certification, HEPA Filter leak testing and particle counts for the cleanrooms. These services must meet ISO 14644-1 standards. The required services for the clean benches (hoods) per NSF-49 requirements. The vendor must be NEBB certified and use NEBB standards for all testing.

Cleanrooms and Equipment:

ITEM

LOCATION

REQUIRED SERVICE

Rooms

Rooms 173-180

Classification Air Cleanliness Certification

Storage Room

BPLS Laboratory

Flow Measurement

Storage Room

BPLS Laboratory

Flow Measurement

Storage Room

BPLS Laboratory

Flow Measurement

Clean Tent

Quarantine OR Disposition

Classification Air Cleanliness Certification

Clean Bench

Disposition

HEPA Test, Particle count and certification

BioSafety Cabinet (hood)

BPLS Laboratory

HEPA Test, Particle count and certification

BioSafety Cabinet (hood)

BPLS Laboratory

HEPA Test, Particle count and certification

BioSafety Cabinet (hood)

BPLS Laboratory

HEPA Test, Particle count and certification

BioSafety Cabinet (hood)

Biorepository Laboratory

HEPA Test, Particle count and certification

BioSafety Cabinet (hood)

Biorepository Laboratory

HEPA Test, Particle count and certification

BioSafety Cabinet (hood)

QC Assay Room

HEPA Test, Particle count and certification

Required Services:

Contract service shall provide a Cleanroom performance test and written certification.

Contract service shall provide an annual report detailing all testing and related comments.

Conformance Standards:

Contract service shall ensure that the cleanrooms, clean tent, and associated controlled environments are compliant with ISO 14644-1 air cleanliness standards.

Contract services shall ensure that the Biosafety cabinets (hoods) and clean bench are compliant with NSF/ANSI 49 Class II standards and certified.

Contract service providers are required to be NEBB certified.

Hours of Coverage:

Normal hours of coverage are Monday through Friday from 7:30 am to 4:30 pm New Mexico time (Mountain). All services will be performed during normal hours of coverage unless requested or approved by the COR or his/her designee.

Testing and Certification will be performed as scheduled by the COR or their designee. Testing and Certification will be performed during normal hours of coverage.

Work performed outside the normal hours of coverage must be approved by the COR or his/her designee. Funding for services that are outside the normal coverage hours or on holidays must have approved funding prior to any service being allowed.

Federal Holidays observed by NMVAHCS are:

New Years' Day Labor Day

Martin Luther King Day Columbus Day

Presidents' Day Veterans' Day

Memorial Day Thanksgiving Day

Independence Day Christmas Day

Identification, Smoking, and Department of Veterans Affairs Regulations:

The Contractor's FSEs shall wear visible identification issued by NMVAHCS CSP CRPCC Security at all times while on the premises of NMVAHCS CSP CRPCC. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Smoking and vaping are prohibited anywhere at NMVAHCS CSP CRPCC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

Period of Performance:

Base Year: 06/19/2021 06/18/2022

Option 1: 06/19/2022 06/18/2023

Option 2: 06/19/2023 06/18/2024

Option 3: 06/19/2024 06/18/2025

Option 4: 06/19/2025 06/18/2026

Place of Performance/Place of Delivery

Address:

2401 Centre Ave SE, Albuquerque, NM

Postal Code:

87106

Country:

UNITED STATES

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

FAR 52.212-1, Instructions to Offerors Commercial Items (JUN 2020)

FAR 52.212-3, Offerors Representations and Certifications Commercial Items (FEB 2021)

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018)

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (JAN 2021)

The following subparagraphs of FAR 52.212-5 are applicable:

All quoters shall submit the following: verification of VA Form 10091 and the W-9 sent directly to the paying office in Austin, TX unless the offeror has previously submitted these forms to VA Austin and provides certification of previous work. The FMS Vendor File Update form needs to be submitted in all cases to the Contracting Officer as part of the offer or proposal.

All quotes shall be sent to the contract specialist, Amanda Beck, at Amanda.Beck@va.gov.

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received not later than Friday, May 21st, 2021 at 16:00 Arizona Time. Send submissions to Contract Specialist Amanda Beck at Amanda.Beck@va.gov.

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below no later than Tuesday, May 18th, 2021.

Point of Contact

Amanda Beck, Contract Specialist

Amanda.Beck@va.gov

602-795-4372