RFQ_1214593.pdf

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RFQ #1214593

Benchtop single quadrupole mass spectrometer

1. Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation shall not be issued.

This is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) 2005-101. The North American Industry Classification System

(NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument

Manufacturing, Small Size Standard 1,000 Employees This requirement is set aside for

Small Businesses.

2. Supplies and Services

Background

The Office of Regulatory Science, Division of Bioanalytical Chemistry requires the purchase of a benchtop single quadrupole mass spectrometer for the development of quantitative and qualitative methods in the analysis of contaminants and adulterants in cosmetics, dietary supplements, and foods. The use of a single quadrupole mass spectrometer provides enhanced sensitivity and speed requirements, as compared to existing laboratory equipment, that are critical for the development of quantitative analytical methods.

Objectives

The purchase of single quadrupole mass spectrometer is critical to support the Agency’s mission in the development and validation of quantitative analytical methods for regulatory use.

Scope

Delivery of a Single Quadrupole Mass Spectrometer including:

o Integrated computer-based data system capable of controlling the instrument and associated, user selected, existing gas chromatographic system, acquiring data, and performing subsequent data analysis. The instrument should be supplied with appropriate data analysis software and NIST MS Library.

o Electron impact ionization (EI) and Chemical Ionization (CI) ion sources, which can perform in positive or negative mode o Oil free rough pump o Benchtop design

P a g e | 2 o The instrument must operate with an Agilent 6890N or 7890B gas chromatograph.

o The instrument must include an interface kit to an Agilent 6890N or

7890B gas chromatograph.

• Entire system must be warranted for parts and labor for 12 months from date of installation. Service must be provided by service engineers who are trained and certified by the original manufacturer of the instrument.

Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. System includes one preventative maintenance (PM) visit during one-year warranty period.

• The system must be newly manufactured unit, not used or refurbished, or previously used for demonstration. The instrument must meet all the technical and hardware specifications specified below.

• The vendor is responsible for delivery and installation of the instrument.

The COR/Project officer will perform inspection and acceptance of the mass spectrometer system.

• The vendor will demonstrate upon installation that the item will be all performance specifications by the manufacturer.

• The vendor must include a customer familiarization upon installation.

Technical Requirements

The instrument purchased must meet the following technical requirements:

1. Performing chemical ionization

2. Communicates with, and operates an Agilent 6890N or 7890B gas chromatograph

3. Contains a turbo molecular pump

4. Capable to work with hydrogen

5. Instrument must have an Extractor Ion Source for lower signal to noise

6. Contains a heated gold quadrupole

7. Performs auto tune and evaluates auto tune

8. Scan speed up to 20000 u/sec

9. Mass range 1.6-1050 u

10. Perform electron impact ionization with an inert extractor

11. The instrument shall have a heated monolithic hyperbolic quadrupole

12. The instrument shall have an integrated computer-based data system capable of controlling an Agilent gas chromatograph, 6890N or 7890B, and associated, user selected, data analysis. The instrument shall be supplied with appropriate data analysis software.

13. The operating software shall have an integrated deconvolution and spectral matching data analysis system for identification and quantification of low level targets in complex matrix

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14. The operating system shall perform an automated SIM setup and synchronous SIM/scan

15. The data system shall be able to do CI optimization, in both positive CI and negative CI modes, for common reagent gases

The instrument purchased must include the following hardware specifications:

1. Bench-top dimensions

2. Operates with an IDP-3 dry scroll pump for silent operation

3. Equipped with a GC COMM, LAN and CI COMM interface

4. Equipped with an interface kit for an Agilent 6890N or 7890B gas chromatograph

Deliverables

The vendor is responsible for delivery and installation of the instrument and all components specified above to the

Delivery address:

FDA/CFSAN laboratory

5001 Campus Drive

College Park, MD 20740

If the vendor is not installing on the day of delivery, the delivery should be made to the loading dock and moved into location on the date of installation. The vendor is responsible for installation of the instrument. The vendor will demonstrate upon installation that the item will meet all performance specifications by the manufacturer. The instrument will not be accepted until those performance specifications have been met. The CFSAN project officer will perform inspection and acceptance of the mass spectrometer system. The entire system will be warranted for parts and labor for 12 months from date of installation.

Service and installation must be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers should have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. A customer familarization will be provided at the time of installation.

3. Inspection and Acceptance Criteria

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

The FDA COR is the authorized representative of the Contracting Officer (CO) as specified by the CO. Otherwise, only the CO has authority to act on behalf of the FDA.

Inspection and acceptance will be performed at the FDA. Acceptance of work, materials, services, and reports may be presumed unless otherwise indicated in writing by the

Contracting Officer or the duly authorized representative within 30 days of receipt.

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4. Period of Performance

Delivery shall be no later than 30 days after contract award.

Maintenance and Warranty shall be provided for one year after installation and successful operation.

5. CONTRACT CLAUSES

FAR Clauses Incorporated by Reference:

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates 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 shall make their full text available. Also, the full text of a clause may be accessed electronically at: www.acquisition.gov/far/index.html

52.202-1 Definitions (November 2013)

52.203-5 Covenant Against Contingent Fees (May 2014)

52.203-7 Anti-Kickback Procedures (May 2014)

52.212-4 Contract Terms and Conditions-Commercial Items (May 2015)

52.217-8 Option to Extend Services (Nov 1999) (The Contracting Officer may exercise the option by written notice to the Contractor within 30 (thirty) days of contract expiration).

52.217-9 Option to Extend the Term of the Contract (March 2000) (a The Government may extend the term of this contract by written notice to the Contractor within 30 days of expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15 days before the contract expires.) (c The total duration of this contract, including the exercise of any options under this clause, shall not exceed five

(5) years and six (6) months).

52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004)

FAR Clauses in Full Text:

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OF EXECUTIVE ORDERS—COMMERCIAL ITEMS (DEC 2015)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov

2015) (2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-

77, 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with http://www.acquisition.gov/far/index.html https://www.acquisition.gov/sites/default/files/current/far/html/52_212_213.html#wp1179194

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Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41

U.S.C.

3509).

(3) 52.203-15, Whistleblower Protections under the American Recovery and

Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub L. 111-5) (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009).

X (4) 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards

(Oct

2015) (Pub. L. 109-282) (31 U.S.C. 6101 note). (5) [Reserved]

(6) 52.204-14, Service Contract Reporting Requirements (Jan 2014) (Pub. L. 111-

117, section 743 of Div. C).

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts

(Jan 2014) (Pub. L. 111-117, section 743 of Div. C).

X (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors

Debarred, Suspended, or Proposed for Debarment (Oct 2015) (31 U.S.C. 6101 note).

(Jul 2013) (41 U.S.C.

2313). (10) [Reserved]

(11) (i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15

U.S.C. 657a).

(ii) Alternate I (Nov 2011) of 52.219-3.

(12) (i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small

Business Concerns (Oct 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

(ii) Alternate I (Jan 2011) of 52.219-4.

(13) [Reserved]

X (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C.

644). (ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

(15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

(ii) Alternate I (Oct 1995) of 52.219-7.

(iii) Alternate II (Mar 2004) of 52.219-7.

(16) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)).

(17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2015) (15 U.S.C. 637 (d)(4)).

(ii) Alternate I (Oct 2001) of 52.219-9.

(iii) Alternate II (Oct 2001) of 52.219-9.

(iv) Alternate III (Oct 2015) of 52.219-9.

(18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

X (19) 52.219-14, Limitations on Subcontracting (Nov 2011) (15 U.S.C.

637(a)(14)). (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan

1999) (15 U.S.C.

637(d)(4)(F)(i)).

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(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside

(Nov 2011) (15 U.S.C. 657f).

X (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15

U.S.C.

632(a)(2)).

(23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned

Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

(24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business

(WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C.

637(m)).

X (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

X (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014)

(E.O.

13126).

X (27) 52.222-21, Prohibition of Segregated Facilities (Apr

2015). X (28) 52.222-26, Equal Opportunity (Apr 2015) (E.O.

11246).

X (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

X (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.

793). X (31) 52.222-37, Employment Reports on Veterans (Oct 2015) (38 U.S.C. 4212).

X (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act

(Dec 2010) (E.O. 13496).

X (33) (i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and

E.O. 13627).

(ii) Alternate I (Mar 2015) of 52.222-50, (22 U.S.C. chapter 78 and E.O. 13627).

X (34) 52.222-54, Employment Eligibility Verification (Oct 2015). (E. O. 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(35) (i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-

Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

(36) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun

2014) (E.O.s 13423 and 13514

(ii) Alternate I (Oct 2015) of 52.223-13.

(37) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s

13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

(38) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C.

8259b).

(39) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct

2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

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X (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving

(Aug 2011) (E.O. 13513).

X (41) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

X (42) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (May

2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C.

3805 note, 19

U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-

283, 110-138, 112-41, 112-42, and 112-43).

(ii) Alternate I (May 2014) of 52.225-3.

(iii) Alternate II (May 2014) of 52.225-3.

(iv) Alternate III (May 2014) of 52.225-3.

X (43) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

X (44) 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(45) 52.225-26, Contractors Performing Private Security Functions Outside the

United States (Jul 2013) (Section 862, as amended, of the National Defense

Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C.

5150).

(47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov

2007) (42 U.S.C. 5150).

(48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41

U.S.C. 4505), 10 U.S.C. 2307(f)).

(49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X (50) 52.232-33, Payment by Electronic Funds Transfer— System for Award

Management

(Jul 2013) (31 U.S.C. 3332).

(51) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award

Management (Jul 2013) (31 U.S.C. 3332).

(52) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

X (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(54) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb

2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C.

2631). (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

(1) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495)

(2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

(3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C.

206 and 41 U.S.C. chapter 67).

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(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards --

Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C.206 and

41 U.S.C. chapter 67).

(5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards --

Price

Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to

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

Requirements (May

2014) (41 U.S.C. chapter 67).

(7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to

Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67).

(8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015) (E.O.

13658). (9) 52.226-6, Promoting Excess Food Donation to Nonprofit

Organizations. (May 2014)

(42 U.S.C. 1792).

(10) 52.237-11, Accepting and Dispensing of $1 Coin (Sep 2008) (31 U.S.C.

5112(p)(1)).

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the

Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until

3 years after final payment under this contract or for any shorter period specified in

FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and

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(d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41

U.S.C. 3509). (ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15

U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000

($1.5 million for construction of any public facility), the subcontractor shall include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495).

Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities

(Apr 2015). (v) 52.222-26, Equal Opportunity (Apr

2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29

U.S.C. 793). (viii) 52.222-37, Employment Reports on Veterans (Oct 2015) (38

U.S.C. 4212).

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations

Act (Dec

2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause

52.222-40.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xi) (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter and E.O. 13627).

(B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(xii) 5.222-51, Exemption from Application of the Service Contract Labor Standards to

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

Requirements (May

2014) (41 U.S.C. chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor

Standards to

Contracts for Certain Services--Requirements (May 2014) (41 U.S.C.

chapter 67) (xiv) 52.222-54, Employment Eligibility Verification (Oct

2015) (E. O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015)

(E.O.13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the

United States

(Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for

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Fiscal Year

2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May

2014) (42

U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause

52.226-6 (xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial

Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

HHSAR Clauses Incorporated by Reference

This order incorporates the following U.S. Department of Health and Human Services

Acquisition Regulation (HHSAR) clauses by reference with the same force and effect as if they were given in full text. Upon request, the Contracting Officer shall make their full text available. Also, the full text of a clause may be accessed electronically at the following website: http://www.hhs.gov/policies/hhsar/.

HHSAR Clause Description Date

352.203-70 Anti-lobbying (Dec 2015)

352.215-70 Late proposals and revisions (Dec 2015)

352.223-70 Safety and health (Dec2015)

352.224-70 Privacy Act (Dec 2015)

352.233-71 Litigation and claims (Dec 2015)

6. INSTRUCTIONS TO OFFERORS

Offeror shall include a cover page which shall include a point of contact (name, telephone number, and email address). Dun and Bradstreet (DUNS) number, country of manufacturing of equipment, and certification that all company information listed in the

System for Award Management (SAM) database is complete, accurate, and current.

The award shall be evaluated and awarded as Lowest Price Technically Acceptable.

Quoters shall demonstrate they are capable of satisfying the requirements set forth in this solicitation.

Offerors Response Date and Time

All quotes shall be submitted via email to Susan.Bechtel@fda.hhs.gov by or before 3:00

PM Eastern Time on June 01, 2019 with the subject titled “Requisition 1214593”.

Quotes shall be valid through September 30, 2019 http://www.hhs.gov/policies/hhsar/