D. Combined Synopsis_Solicitation (Quantstudio Maintenance Agmt).pdf

NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Maintenance and Service Agreement for Two QuantStudio 7 Flex Real-Time PCR Systems (Base plus Two Option Years)

(i) This is a combined synopsis/solicitation for commercial products and commercial services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

proposals are being requested, and a written solicitation will not be issued.

(ii) The solicitation number is 75N95025Q00180 and the solicitation is issued as a Request for

Quotation (RFQ).

This acquisition is for a commercial product or commercial service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures;

and FAR Part 12—Acquisition of Commercial Products and Commercial Services and is not expected to exceed the simplified acquisition threshold.

THIS IS A NON-COMPETITIVE (NOTICE OF INTENT) COMBINED SYNOPSIS SOLICITATION TO AWARD

A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN COMPETITION

(INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisition (OA), on behalf of the National

Institute of Mental Health (NIMH), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to Life Technologies Corporation, 5791 Van Allen Way, Carlsbad, VA 92008 for a Maintenance and Service Agreement for Two

QuantStudio 7 Flex Real-Time PCR Systems (Base plus Two Option Years).

This acquisition is conducted as non-competitive for a commercial product or commercial service and is conducted pursuant to FAR 13.106-1(b)(1).

The rationale for the brand-name justification is that only Life Technologies Corporation has the capability to provide a guaranteed 2-business day response time for on-site service, guaranteed operational uptime exceeding 95%, the capability to dispatch factory-trained service engineers, immediate access to replacement parts from the original manufacturer of the QuantStudio systems, and the capability to provide the necessary software updates for the QuantStudio systems.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through

Federal Acquisition Circular (FAC) Number 2025-03, effective January 17, 2025.

(iv) The associated NAICS code is 811210 and the small business size standard is $34 million.

(v) This requirement is for the following services:

A full coverage, annual preventive maintenance and service agreement for two Government-owned QuantStudio 7 Flex Polymerase Chain Reaction (PCR) systems (serial numbers 278871163 and 278871167).

(vi) The agreement shall include all the following terms:

1. A guaranteed 2-business day on-site response from the original equipment manufacturer

(OEM) or its authorized service provider following a service call.

2. A guaranteed 4-hour phone response when dispatched for a service request.

3. An annual planned maintenance (PM) visit that includes performance of electronic tests to check if the PCR systems are operating properly, performance of a calibration standard, checking and cleaning of the 384-well block, checking and/or restoring alignment of the laser beams, inspection and calibration of laser strength.

4. Spectral Dye Calibration performed during the PM visit. Calibration shall include analysis of signal strength from standard pure dyes to adjust software for correct data output, I Pure Dye Calibration (PDC)-for one block only, provision of certification documentation, and provision of Certificate of Calibration.

5. All labor and travel costs incurred by the Contractor in connection with performing said maintenance and service agreement, with no additional cost charged to the Government.

6. Replacement of parts at no additional cost charged to the Government. All replacement parts shall be OEM-authorized, new or remanufactured.

7. Direct access to service personnel for first-level problem resolutions for operations and set-up related problems.

8. Life Technologies’ Remote Diagnostics software notifications of instrument condition and errors.

9. Data analysis of sample preparation problems, and resolution of computer-related issues.

10. The Contractor must have either an adequate supply of OEM-authorized parts in stock and readily available to the service technicians or be able to obtain any required parts within 24 hours following assessment of PCR systems by OEM-trained and personnel.

11. All service performed on the identified QuantStudio PCR systems shall be performed by OEM-trained and certified personnel who are also certified to service Class IIIB lasers.

12. The Contractor shall supply all replacement parts as required on an exchange (good-as-new) or new part basis to maintain the QuantStudio PCR systems at OEM specifications. All replacement parts/components/sub-assemblies must be certified to the manufacturer’s specifications.

13. The Contractor shall provide service coverage at in-house, first-call level by one OEM-trained and certified service technician/engineer from 9 a.m. to 5 p.m., Monday through Friday, except Federal holidays.

14. The service technician/engineer shall use and/or provide only OEM parts and test instrumentation, and OEM diagnostic software and software enhancements.

15. The agreement shall have a duration of one year commencing the date of acceptance of the Government’s purchase order, and two optional years.

BACKGROUND:

The NIMH Human Brain Collection Core (HBCC) is engaged in collecting human postmortem brains, dissecting and storing the tissues, extracting DNA/RNA, performing genome-wide genotyping and gene expression from the brain tissues, etc. Utilizing the QuantStudio Flex PCR systems for TaqMan gene expression and genotyping assays is an essential part of HBCC’s brain data collection and analysis. The QuantStudio Flex PCR systems are also used by the Clinical and

Translational Neuroscience Branch (CTNB) in the course of processing lymphocyte fraction of blood samples for high molecular weight genomic DNA for further analysis of genetic information, such as gene expression and genotypes.

STATEMENT OF NEED AND OBJECTIVES:

To ensure full functionality and optimal performance of its two QuantStudio 7 Flex Real-Time

PCR Systems (the PCR Systems), the Human Brain Collection Core (HBCC) of the National

Institute of Mental Health (NIMH) requires preventive maintenance and service agreement with the OEM. The objective of this procurement is to obtain contracted support from an authorized service provider for the PCR Systems, which were manufactured by and purchased from Life

Technologies Corporation.

SCOPE OF WORK:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment and instrumentation, not otherwise provided by the Government, as needed to perform the Statement of Work.

Pursuant to a maintenance and service agreement, the Contractor shall provide preventive and regular maintenance, perform repairs as needed, replace parts as needed for all components of the PCR Systems, and shall ensure full functionality of the PCR systems at least 95% of the time throughout the term of the agreement.

SPECIFIC REQUIREMENTS:

As stated in section vi.

EST. PERIOD OF PERFORMANCE:

Base Year: March 30, 2025 to March 29, 2026

Option Year One: March 30, 2026 to March 29, 2027

Option Year Two: March 30, 2027 to March 29, 2028

PLACE OF PERFORMANCE:

NIMH/HBCC

10 Center Drive

Building 10, Room 4N212

Bethesda, Maryland 20892

GOVERNMENT RESPONSIBILITIES:

Upon notification from the field service technician/engineer that access is needed to the location of the PCR systems, the designated Contracting Officer’s Representative (COR) shall provide access to the PCR systems, which are located at NIMH/HBCC, 10 Center Drive, Building

10, Room 4N212, Bethesda, Maryland 20892.

DELIVERABLES:

Documentation shall be provided to the COR showing completion of service on the PCR systems at the conclusion of each service visit. The documentation will include the service ticket number and detail the work performed during the service visit.

REPORTING:

A detailed written report of any service and\or preventive maintenance performed on either

PCR system may be requested by the COR or Contacting Officer at any time during the period of performance. The Contractor or its designee shall provide such report via email within 7 days after submission of the request.

TECHNICAL EVALUATION CRITERIA:

The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

The following factors shall be used to evaluate quotes:

a. Technical capability of the products/services offered to meet the Government requirement;

b. Past performance [see FAR 13.106-2(b)(3)]; and

c. Price.

Technical capability and past performance, when combined, are significantly more important than price.

The Government anticipates award of a firm fixed-price purchase order for this acquisition, and the anticipated period of performance is 12 months from the date of acceptance of the

Government’s order.

A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the

Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(vii) APPLICABLE PROVISIONS AND CLAUSES:

The provision at Federal Acquisition Regulation (FAR) 52.252-1, Solicitation Provisions

Incorporated by Reference (Feb 1998), applies to this acquisition. This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/caac-letters

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Nov 2024)

• FAR 52.204-8, Annual Representations and Certifications (JAN 2025) (DEVIATION FEB

2025) See CAAC_Letter_2025-01_Supplement-1.pdf and CAAC_Letter_2025-

02_Supplement-1.pdf

• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

• FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders – Representation and

Disclosures (Dec 2023)

• FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep

2023)

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability to fulfill all terms of the requirement, as stated in the Statement of Work above. Quotations must include unit price, list price, shipping and handling costs, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), service/product catalog number(s), service description.

• FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and

Commercial Services (May 2024) (DEVIATION Feb 2025) CAAC_Letter_2025-

01_Supplement-1.pdf and CAAC_Letter_2025-02_Supplement-1.pdf

• FAR 52.217-5, Evaluation of Options (July 1990)

• Health and Human Services Acquisition Regulation (HHSAR) 352-259.73, Electronic and

Information Technology Accessibility Notice (December 18, 2015) https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html https://www.acquisition.gov/caac-letters https://www.acquisition.gov/sites/default/files/caac/CAAC_Letter_2025-01_Supplement-1.pdf https://www.acquisition.gov/sites/default/files/caac/CAAC_Letter_2025-02_Supplement-1.pdf https://www.acquisition.gov/sites/default/files/caac/CAAC_Letter_2025-02_Supplement-1.pdf https://www.acquisition.gov/sites/default/files/caac/CAAC_Letter_2025-01_Supplement-1.pdf https://www.acquisition.gov/sites/default/files/caac/CAAC_Letter_2025-01_Supplement-1.pdf https://www.acquisition.gov/sites/default/files/caac/CAAC_Letter_2025-02_Supplement-1.pdf

• NIH Invoice and Payment Provisions with IPP (Mar 2023)

• FAR 52.225-2, Buy American Certificate (Oct 2022)

The clause at FAR 52.217-9 Option to Extend the Term of the Contract applies to this acquisition and is included in full text:

(a) The Government may extend the term of this contract by written notice to the Contractor within 60 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 5 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 3 years.

(End of clause)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. The anticipated contract/order will incorporate one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting

Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses:

https://www.acquisition.gov/browse/index/far

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

• FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial

Services (Nov 2023). Addendum to this clause is included as an attachment.

• HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015)

• HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or

Executive Orders-Commercial Products and Commercial Services (Jan 2025) (DEVIATION

Feb 2025). Per CAAC Letters 2025-01 and 2025-02, FAR 52.222-21 Prohibition of https://www.acquisition.gov/browse/index/far

Segregated Facilities and FAR 52.222-26 Equal Opportunity will not be considered when making award decisions or enforcing requirements.

• FAR 52.222-48, Exemption from Application of the Service Contract Labor Standards to

Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Certification

(May 2014)

• HHSAR 352.239-78, Information and Communication Technology Accessibility Notice (Feb

2024) (DEVIATION)

• HHSAR 352.239-79, Information and Communication Technology Accessibility (Feb 2024)

(DEVIATION)

FAR DEVIATION STATEMENT: TCAAC Letter 2025-01-Supplement 1 and CAAC Letter 2025-02-

Supplement 1 are applicable to this acquisition.

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph

(d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and

Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

The mentioned CAAC Letters may be accessed electronically at this address:

https://www.acquisition.gov/caac-letters.

(ix) Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror

Representations and Certifications-Commercial Products and Commercial Services (May 2024)

(DEVIATION Feb 2025). If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer. See DEVIATION

STATEMENT above regarding applicable CAAC Letters.

The following provisions and clauses apply to this acquisition and are attached in full text.

Offerors MUST complete the provisions/clauses below and submit completed copies as separate documents with the offer.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video

Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation (Oct

2020)

There are no additional contract requirements or terms and conditions applicable to this acquisition.

(x) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

http://www.sam.gov/

(xi) Responses to this solicitation must include clear and convincing evidence of the offeror’s capability to fulfill all terms of the requirement as stated in the Statement of Work above.

Quotations must include unit price, list price, shipping and handling costs, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), service catalog number(s), service description.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All quotations must be received by 5:00 p.m. Eastern Time on March 25, 2025, and reference

Solicitation Number 75N95025Q00180. Responses must be submitted electronically to Marlene

Milgram, Contracting Officer, at marlene.milgram@nih.gov.

A determination by the Government whether to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will be considered to determine whether to proceed on a non-competitive basis as indicated above, or to conduct a competitive procurement.

Fax responses will not be accepted.

http://www.sam.gov/ mailto:marlene.milgram@nih.gov