Combined_Synopsis-Solicititation_Time_of_Flight.pdf

Combined Synopsis/Solicitation NIH-CC-17-009253

Accurate Mass Q-Time of Flight LC/MS

National Institutes of Health, Clinical Center Positron Emission Technology Dept.

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; quotations are being requested, and a written solicitation document will not be issued. The solicitation is being issued using simplified acquisition procedures under the authority of FAR 13.5 Test Program for Certain Commercial Items.

The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular (FAC) 2005-95, effective 19 Jan 2017.

The associated North American Industrial Classification System (NAICS) code for this procurement is

334516 with a small business size standard of 1,000 employees.

This acquisition is full and Open to all business sizes. Responses are due by 11:00 a.m., August 31, 2017

Eastern Time.

The National Institute of Health, Office of Purchasing and Contracts, is seeking to purchase and maintain an Accurate-Mass Quadrupole Time-of-Flight (Q-TOF) LC/MS System with certified technicians, and new parts directly from the manufacturer for the creation of cGMP quality products in the PET

Department, National Institutes of Health, Clinical Center.

The System purchase, with Options, Warranty, Maintenance, and Qualifications Contract is anticipated to include a 12 month Base Period and four (4) 12 month Option Periods to extend the period of performance. Please see the Statement of Work for details of the requirement.

Contractor must provide pricing for the following equipment and services, Brand Name or Equal, with the salient characteristics described in the following Statement of Work.

Equipment provided must be identified as New, Refurbished, or Demo (previously used for demonstration purposes). All provided equipment must include a twelve month warranty.

Line

Item

Description – Accurate-Mass Q-Time of Flight

LC/MS

Qt y U/I U/P Total ($)

Base Period 9/15/2017 to 9/14/2018

Includes the following items:

1. Agilent 6530 Accurate-Mass Q-TOF LC/MS

(G6530BAR)

1 EA $______ $_______

2. Agilent Multimode ESI/APCI Source Configured for

Q-TOF (G1978B)

1 EA $______ $______

3. 1260 Infinity Binary Pump with solvent selection valve (G1312BR# 304)

1 EA $______ $______

4. Agilent 1260 Infinity High Performance Degasser

(G4225A)

1 EA $______ $______

5. 1260 Infinity II Vialsampler (G7129A and

G7129A#063)

1 EA $______ $______

0006 6. 1260 Infinity Diode-Array Detector (G4212B) 1 EA $______ $______

Option Items

7. METLIN Metabolite Personal Compound Database and Library for Accurate-Mass LC/MS (G3874AA)

1 EA $______ $______

0008 8. Advanced Application Consulting (H2149A) 1 EA $______ $______

0009 9. 1290 Infinity Valve Drive (G1170A) 1 EA $______ $______

0010 10. Valve Kit (G4231A) 1 Kit $______ $______

0011 11. Max-Light Cartridge Cell 60mm (G4212-60007) 1 EA $______ $______

Option Periods

10001

Option Period One (1): Service Maintenance

Agreement Period of Performance estimated 9/15/2018 to 9/14/2019

1 EA

20001

Option Period Two (2): Service Maintenance

Agreement Period of Performance estimated 9/15/2019 to 9/14/2020

1 EA

30001

Option Period Three (3): Service Maintenance

Agreement Period of Performance estimated 9/15/2020 to 9/14/2021

1 EA

40001

Option Period Four (4): Service Maintenance

Agreement Period of Performance estimated 9/15/2021 to 9/14/2022

1 EA

TOTAL including all Option Periods $_______

Accurate-Mass Quadrupole Time-of-Flight

(Q-TOF) LC/MS System

STATEMENT OF WORK

A. Background

The NIH Clinical Center Positron Emission Tomography (PET) Department has just completed the construction of a new PET GMP laboratory within an existing high bay area underneath the NIH

Clinical Center Complex. The new PET cGMP laboratory was designed specifically for the cGMP production of IND or RDRC PET Drug Products in compliance with 21 CFR Part 212 (ostensible USP

<823> - Radiopharmaceuticals for Positron Emission Tomography-Compounding).

The NIH PET Department prepares multiple PET Drug products for the NIH clinic each day. As part of validation PET Drug products undergo extensive study to insure that the IND PET Drug products are free from concerns with respect to Safety, Identity, Strength, Quality and Purity. As such mass spectrometry is not only used to unambiguously identify the Active Pharmaceutical Ingredient (API) but the identity and purity of all the key ingredients used to manufacture the IND PET Drug Products.

B. Purpose

The purpose of this acquisition is to acquire an Accurate-Mass Quadrupole Time-of-Flight (Q-TOF)

LC/MS system to replace an existing Agilent 1946A/C LC‐MS system. The existing LC‐MS system purchased in 2006 has reached its end of guaranteed support date on August 31, 2011. Availability of replacement parts are becoming scarce and in order to avoid instrument downtime, we would like to upgrade to the newest technology. The new Accurate-Mass Q-TOF LC/MS system will have capabilities and technical specifications exceeding those of our current system. The new Agilent

Accurate-Mass Q-TOF LC/MS system MassHunter software is completely compatible with our current data, data libraries and methods. In addition the Agilent OpenLab and Chemstation software, data and methods are compatible with all of our Agilent 1200 Series Liquid Chromatographs (4).

Table 1: Current System (BIO-MED # 47235)

Model Component Description

G1367B-1200 1200 Series High Performance

Autosampler

G1379B-1200 1260 Infinity Micro Degasser.

G1312A-

1100/1200 1200 Series Binary Pump

G1316A-

1100/1200

1200 Thermostatted Column

Compartment

G1315B-

1100/1200 1200 Diode-array Detector

G3251A Ion Source: Dual-Spray ESI Source

G6220A HVY - LC/MSD TOF Mainframe

C. Specifications

1. Agilent 6530 Accurate-Mass Q-TOF LC/MS (G6530BAR)

Accurate Mass Q-TOF. Includes high performance mass spectrometer, MassHunter workstation, installation, standard installation performance tests, familiarization, training, 1-year Service

Warranty update and phone assist. Includes extra monitor and standard printer. (G6530BAR #’s:

780, 880, 44L, 44W and 44P)

Accurate-Mass Q-TOF

2. Agilent Multimode ESI/APCI Source Configured for Q-TOF (G1978B).

Sensitive, Accurate-Mass MS and MS/MS Analyses

True Hi-Def TOF technology, Agilent Jet Stream Thermal Focusing technology and MassHunter

Workstation software — the Accurate-Mass 6530 Q-TOF platform is ideally suited for profiling, identifying, characterizing, and quantifying low molecular-weight compounds and biomolecules with confidence.

Exceptional Mass Accuracy, Sensitivity, and Speed

1–2 ppm MS and 2–4 ppm MS/MS typical mass accuracy dramatically increase confidence in small molecule ID and reduces false positives

20,000 mass resolution distinguishes target analytes from interferences

Up to 5 orders of in-spectrum dynamic range improves detection of trace level targets in the presence of high abundance compounds.

High femtogram sensitivity enables identification of very low-abundance compounds

Fast data acquisition rates of up to 40 spectra/second ensure maximum compatibility with fast

LC and high throughput methods

Wide mass range to 20,000 m/z

Enhances LC/MS Sensitivity 5- to 10-fold

On average, a 5- to 10-fold improvement in MS and MS/MS sensitivity is realized by using Agilent

Jet Stream technology at optimal LC flow rates. Easy to use and tune, Agilent Jet Stream technology is available on the 6530 Accurate-Mass Q-TOF LC/MS to provide maximum sensitivity for multiple applications, including the analysis of drug candidates and trace levels of food contaminants, metabolites or biomarkers.

Powerful Data Mining and Analysis Capabilities

Agilent’s MassHunter Workstation software facilitates faster and easier processing of information-rich data generated by the 6530 Accurate-Mass Q-TOF LC/MS.

Designed for the Most Demanding Applications

The Agilent 6530 Accurate-Mass Q-TOF LC/MS system delivers exceptional MS and MS/MS analyses for applications that demand the highest accurate-mass measurements, without compromising sensitivity and speed.

3. Agilent 1260 Infinity Binary Pump with solvent selection valve (G1312BR# 304)

Features

• Configurable delay volume down to 120 µL together with a flow range up to 5 mL/min provides universal applicability

• Fast and easy change from standard to delay volume

Liquid Chromatography

• High gradient performance even at low % B and narrow-bore flow rates

• Integrated 2-channel-degasser

• The pump is the perfect choice for fast and precise gradients using LC/MS, as well as UV-only systems

• Fully exploits the speed and separation potential of Poroshell (<3 μm particle packings)

4. Agilent 1260 Infinity High Performance Degasser (G4225A)

Type Specification

Number of solvent channels 4

Flow range 0 – 10 mL/min per channel

Internal volume per channel 0.45 mL per channel

Materials in contact with solvent

TFE/PDD Copolymer, FEP, PEEK pH range 1 – 14

5. Agilent 1260 Infinity II Vialsampler (G7129A and G7129A#063).

• Reliable injections from 0.1 to 100 µL

• Capacity for up to 132 vials (2 mL) or up to 36 vials (6 mL)

• Easy adaption for injection volumes up to 1800 µL for applications ranging from microbore to semipreparative chromatography

• Includes a needle flush port for rinsing of outside needle to maintain lowest carryover during routine work

• Integrated column compartment , 3.0 µL heater Integrated column compartment for up to two columns with 3 µL heater volume (providing heating capacity up to 80 °C) for reproducible chromatography data at optimized resolution, for standard analytical flow rates up to 5 mL/min.

Recommended for standard flow rates (G7129A#063).

• Integrated sample cooler as option or upgrade available, providing high cooling capacity for all vials loaded down to 4 °C

• Low internal volume for minimum contribution to a system's total internal volume, which can be even further reduced using "bypass" mode

• Overlapped injections for increased productivity • Injection program available for customizing advanced injections as well as for sample preparation steps upfront injection

Agilent Multidraw Infinity II Upgrade Kit for 1260 Infinity II Vialsampler (G7167-68711)

The Multidraw Upgrade Kit can be installed in any Agilent 1200 Series autosampler. This allows to expand the injection volume of the autosampler to a maximum of 1800 µL. This option is used to introduce reference standards directly into the source and optimize the MS and MS/MS tune for subsequent analyses.

6. Agilent 1260 Infinity Diode-Array Detector (G4212B)

• Wide linear range (typically up to 2.5 AU) - for reliable, simultaneous quantification of primary compounds, by-products and impurities.

• More reliable and robust peak integration process due through less baseline drift.

• Full spectral detection up to 80 Hz for compound identification by spectral libraries or verification of the separation quality with peak purity analysis for conventional and ultrafast LC.

Simultaneous detection of up to 8 signals for increased sensitivity and selectivity.

• Radio frequency identification (RFID) tags for all flow cells and UV lamp provide new levels of data traceability by recording parameters such as cell dimensions, lamp usage, serial number etc.

• Electronic temperature control (ETC) provides maximum baseline stability and practical sensitivity under fluctuating ambient temperature and humidity conditions.

• Reference wavelength for elimination of background interference

• Early maintenance feedback (EMF) for continuous tracking of instrument usage in terms of lamp burn time with user-settable limits and feedback messages

• Extensive diagnostics, error detection and display with Instant Pilot controller and Agilent Lab

Advisor software.

7. METLIN Metabolite Personal Compound Database and Library for Accurate-Mass LC/MS

(G3874AA)

• Personal Compound Database and Library for ~25,000 endogenous metabolites, with ~ 9000 accurate mass MS/MS spectra for over 2300 compounds and retention times for 700 compounds.

• Generates higher confidence compound ID by matching unknown Q-TOF MS/MS spectra to the spectral library

8. Advanced Application Consulting (H2149A).

Method and Application Consulting. On-site consulting for a maximum of 4 participants. 5 Days onsite.

9. Agilent 1290 Infinity Valve Drive (G1170A)

Supporting all QuickChange valve heads, heads, built-in power supply. Includes instrument mounting kit

10. Agilent Valve Kit (G4231A)

2pos/6port Quick-Change valve head. Includes Option 004 is the .12 mm ID capillary kit LDHE

(which matches the binary pump (G1312B) tubing) and works with the G1316C and the G1170A valve drive.

Option Items

11. Agilent Max-Light Cartridge Cell 60mm (G4212-60007)

D. Place of Performance

The equipment shall be delivered, and the maintenance work shall be performed on-site at the

National Institutes of Health / Clinical Center in Bethesda, MD. The installation shall be within the new PET GMP Facility, Analytical Laboratory.

E. Government Furnished Property and Material

Not applicable.

F. Packaging, Packing, and Shipping Instructions

All deliverable materials will be delivered to:

Attn: To be determined at time of award

PET Department

10 Center Drive

Building 10 CRC, Rm. XXX

Bethesda, Maryland 20892

Prior to delivery, the freight service should contact the PET Department at 301-xxx-xxxx or 301-xxx-xxxx. Deliveries are to be made (M-F 7AM – 1PM) to the Building 10, RM TBD (via Building

10 loading dock).

G. Acceptance Criteria

The LC/QTOF-MS System shall be delivered and installed at the NIH PET GMP Facility, Analytical

Laboratory, Bethesda MD. Acceptance will be considered complete only after the installation, installation tests, familiarization and training of PET staff.

Installation Tests

Parameter Measure Specification

Signal to

Noise (SNR)

1 picogram of reserpine SNR for the reserpine in the MS

Mode for the (M+H)+ ion (m/z 609.2807)

SNR > 10:1 RMS

Signal to

Noise (SNR)

1 picogram of reserpine SNR for the reserpine in the

MS/MS Mode (Summed EIC of m/z 174, 195, 397 and 448 product ions of m/z 609.2807 precursor ion)

SNR > 50:1 RMS

Mass

Accuracy

20 picogram Reserpine in the MS Mode for the reserpine

(M+H)+ m/z 609.2807 Better than 2 ppm

Mass

Accuracy

20 picogram Reserpine in the MS/MS Mode (m/z 397.2122 product ion) Better than 5 ppm

H. Service Maintenance Agreement

The Agilent CrossLab Silver service agreement is to begin one year after the Accurate-Mass

Quadrupole Time-of-Flight (Q-TOF) LC/MS System has been accepted.

AGILENT CROSSLAB SILVER COVERAGE:

Preferred Response – Immediate response over on-demand calls to resolve service needs.

On-site Repair Visits – All necessary hardware service visits covered. Coverage includes travel and labor.

Parts Required for Repair –Agilent repair parts are covered. Parts are certified Agilent parts.

Consumables/Supplies Required for Repair – All normal wear-and-tear items such as liners, seals and tubing are included when needed for repair.

Annual On-site Preventive Maintenance – One preventative maintenance visit per year.

Hardware and Software Telephone Support –Technical hardware and software telephone support.

Remote Advisor-Assist – Service requests and remote diagnosis.

Service Guarantee –100% repair coverage guarantee. If Agilent cannot fix an instrument covered by service agreement, Agilent will replace it.

Agilent is the only source for genuine Agilent parts. All support on site is provided by certified Agilent factory trained technicians.

The Agilent CrossLab Silver Service Agreement will cover the following instrumentation:

Part number Description

G6530BA

Accurate Mass Q-TOF Mass Spectrometer. Includes MassHunter workstation.

G1978B Multimode ESI/APCI Source (Configure for QTOF)

G1312B 1260 Infinity Binary Pump with solvent selection valve. (304)

G4225A Agilent 1260 Infinity Micro Degasser

G7129A 1260 Infinity II Vialsampler for use up to 600 bar with Integrated

Column Compartment heater 3.0 μL (063)

G7167-

68711 Multidraw Kit Infinity II

G4212B 1260 Diode-Array Detector.

There is to be four 1 year Option Service Agreement periods that will start immediately after the 1st year warranty period expires.

Agilent CrossLab Silver Service Agreement

Option Period 1 $ _________

Option Period 2 $ _________

Option Period 3 $ _________

Option Period 4 $ _________

Maximum Total $ _________

*Base period to start after 1st year coverage expires

Other Considerations

All service technicians and\or service engineers assigned to this contract must have their service certification submitted to the PET department.

End of Statement of Work

PROVISIONS AND CLAUSES

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items Jan 2017

CLAUSES INCORPORATED BY FULL TEXT

ADDENDUM TO 52.212-4

(v) The non-FAR Part 12 discretionary FAR, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found.

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-5 Covenant Against Contingent Fees MAY 2014

52.203-6 Restrictions On Subcontractor Sales To The Government (Sep

2006) Alternate 1

OCT 1995

52.203-7 Anti-Kickback Procedures MAY 2014

52.203-8 Cancellation, Rescission, And Recovery Of Funds For Illegal Or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014

52.203-12 Limitation On Payments To Influence Certain Federal

Transactions

OCT 2010

52.203-17 Contractor Employee Whistleblower Rights And Requirement To

Inform Employees Of Whistleblower Rights

APR 2014

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content

Paper

MAY 2011

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract

Awards

OCT 2016

52.204-18 Commercial And Government Entity Code Maintenance JUL 2016

52.209-6 Protecting the Government's Interest When Subcontracting With

Contractors Debarred, Suspended, or Proposed for Debarment

OCT 2015

52.222-55 Establishing a Minimum Wage for Contractors (Deviation) DEC 2015

52.222-57 Representation Regarding Compliance with Labor Laws DEC 2016

52.222-59 Compliance with Labor laws (executive Order 13673) DEC 2016

52.222-60 Paycheck Transparency (Executive Order 13673) OCT 2016

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011

52.223-6 Drug Free Workplace MAY 2001

52.229-3 Federal State and Local Taxes FEB 2013

52.232-1 Payments APR 1984

52.232-17 Interest MAY 2014

52.232-18 Availability Of Funds APR 1984

52.232-23 Assignment of Claims MAY 2014

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.237-2 Protection Of Government Buildings, Equipment, And Vegetation APR 1984

52.237-3 Continuity of Services JAN 1991

52.242-13 Bankruptcy JUL 1995

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.245-1 Government Property JAN 2017

52.245-9 Use And Charges APR 2012

52.253-1 Computer Generated Forms JAN 1991

352.222-70 Contractor Cooperation in Equal Employment Opportunity

Investigations

DEC 2015

352.223-70 Safety and Health DEC 2015

352.227-70 Publications and Publicity DEC 2015

352.231-70 Salary Rate Limitation DEC 2015

352.237-74 Non-Discrimination in Service Delivery DEC 2015

52.211-6 -- Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting

Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

52.217-5 -- Evaluation of Options (Jul 1990)

Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

(End of Provision)

52.217-6 Option for Increased Quantity (Mar 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days of anticipated delivery. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

(End of clause)

52.217-7 -- Option for Increased Quantity -- Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within the Period of Performance of the Contract. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

52.217-8 -- Option to Extend Services. (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 calander days.

(End of Clause)

52.217-9 -- Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to the expiration of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 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 66 months.

(End of Clause)

52.219-28 -- Post-Award Small Business Program Re-representation (Jul 2013)

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to the contracting office, along with the contract number and the date on which the rerepresentation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code

_____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

(a) During the term of this contract, the Contractor shall post an employee notice, of such size and in such form, and containing such content as prescribed by the Secretary of Labor, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of the contract, including all places where notices to employees are customarily posted both physically and electronically, in the languages employees speak, in accordance with 29 CFR

471.2(d) and (f).

(1) Physical posting of the employee notice shall be in conspicuous places in and about the Contractor's plants and offices so that the notice is prominent and readily seen by employees who are covered by the

National Labor Relations Act and engage in activities related to the performance of the contract.

(2) If the Contractor customarily posts notices to employees electronically, then the Contractor shall also post the required notice electronically by displaying prominently, on any Web site that is maintained by the Contractor and is customarily used for notices to employees about terms and conditions of employment, a link to the Department of Labor's Web site that contains the full text of the poster. The link to the Department's Web site, as referenced in (b)(3) of this section, must read, ``Important Notice about Employee Rights to Organize and Bargain Collectively with Their Employers.''

(b) This required employee notice, printed by the Department of Labor, may be--

(1) Obtained from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution Avenue, NW., Room N-5609, Washington, DC 20210, (202)

693-0123, or from any field office of the Office of Labor-Management Standards or Office of Federal

Contract Compliance Programs;

(2) Provided by the Federal contracting agency if requested;

(3) Downloaded from the Office of Labor-Management Standards Web site at http://www.dol.gov/olms/regs/compliance/EO13496.htm; or

(4) Reproduced and used as exact duplicate copies of the Department of Labor's official poster.

(c) The required text of the employee notice referred to in this clause is located at Appendix A, Subpart

A, 29 CFR Part 471.

(d) The Contractor shall comply with all provisions of the employee notice and related rules, regulations, and orders of the Secretary of Labor.

(e) In the event that the Contractor does not comply with the requirements set forth in paragraphs (a) through (d) of this clause, this contract may be terminated or suspended in whole or in part, and the

Contractor may be suspended or debarred in accordance with 29 CFR 471.14 and subpart 9.4. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 471, which implements Executive

Order 13496 or as otherwise provided by law.

(f) Subcontracts. (1) The Contractor shall include the substance of this clause, including this paragraph

(f), in every subcontract that exceeds $10,000 and will be performed wholly or partially in the United

States, unless exempted by the rules, regulations, or orders of the Secretary of Labor issued pursuant to section 3 of Executive Order 13496 of January 30, 2009, so that such provisions will be binding upon each subcontractor.

(2) The Contractor shall not procure supplies or services in a way designed to avoid the applicability of

Executive Order 13496 or this clause.

(3) The Contractor shall take such action with respect to any such subcontract as may be directed by the

Secretary of Labor as a means of enforcing such provisions, including the imposition of sanctions for noncompliance.

(4) However, if the Contractor becomes involved in litigation with a subcontractor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United States, through the

Secretary of Labor, to enter into such litigation to protect the interests of the United States.

52.222-42 -- Statement of Equivalent Rates for Federal Hires (May 2014) In compliance with the Service Contract Labor Standards statute, and the regulations of the Secretary of

Labor (29 CFR Part 4), this clause identifies the classes of service employees expected to be employed under the contract and states the wages and fringe benefits payable to each if they were employed by the contracting agency subject to the provisions of 5 U.S.C. 5341 or 5332.

This Statement is for Information Only:

It is not a Wage Determination

Employee Class Monetary Wage Fringe Benefits

52.232-25 -- Prompt Payment (Jul 2013)

(a) Invoice payments—

(5) Computing penalty amount. The Government will compute the interest penalty in accordance with the Office of Management and Budget prompt payment regulations at 5 CFR part 1315.

(i) For the sole purpose of computing an interest penalty that might be due the Contractor, Government acceptance is deemed to occur constructively on the 15th day (unless otherwise specified in this contract) after the Contractor delivers the supplies or performs the services in accordance with the terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor compliance with a contract provision.

If actual acceptance occurs within the constructive acceptance period, the Government will base the determination of an interest penalty on the actual date of acceptance. The constructive acceptance requirement does not, however, compel Government officials to accept supplies or services, perform contract administration functions, or make payment prior to fulfilling their responsibilities.

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 will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

Regulations URLs: (Click on the appropriate regulation.)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

NOTE: After selecting the appropriate regulation above, at the "Table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference (hyperlink).

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

(b) The use in this solicitation or contract of any HHSAR FAR Supplement (48 CFR Chapter 3) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

INVOICE REQUIREMENTS

1) One quarterly invoice per Department or System

2) List name of employees performing work

3) Date and location of performance

4) Exact tests and repairs performed

5) Copy of test results signed by supervisor

6) Total for entire invoice

A. The contractor shall submit the original and a copy of the invoices concurrently as follows:

a. An original mailed to the following designated payment office:

National Institutes of Health

Office of Financial Management

Commercial Accounts, Room 4B-432

2115 East Jefferson Street MSC 8500

Bethesda, Maryland 20892-8500

b. One copy e-mailed to the Contracting Officer’s Representative at:

National Institutes of Health

PET Department

10 Center Dr, MSC tbd

Building 10, Room tbd

Bethesda, Maryland 20892

Email: RDeCederfelt@mail.cc.nih.gov

(End of Addendum to 52.212-4)

PROVISIONS INCORPORATED BY REFERENCE

INSTRUCTIONS TO OFFERORS:

Addendum to FAR 52.212-1, Acceptance of Terms and Conditions This is an Open-Market Combined Synopsis/Solicitation for equipment as defined herein. Offers will be reviewed exclusively based upon information submitted. If the information submitted does not address

52.212-1 Instructions to Offerors--Commercial Items Jan 2017 mailto:RDeCederfelt@mail.cc.nih.gov all the technical characteristics required in this combined solicitation-synopsis, the offer will be rejected.

The Government intends to award a Fixed Price Contract as a result of this Combined

Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL offers shall include a statement regarding the terms and conditions herein as follows:

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

OR

The offeror shall state “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:

Offeror shall list exception(s) and rationale for the exception(s)

Please note that this procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits an offer based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Contract, not the terms and conditions of the offeror’s FSS or GWAC contract, and the statement required above shall be included in the offer.

(End of Addendum to FAR 52.212-1)

Addendum to FAR 52.212-1, Proposal Preparation Instructions

FAR 52.212-1 is hereby amended to reflect the changes shown below as to the specific paragraph revised.

Paragraph (b) Submission of Offers. The following amends this paragraph with respect to the information and documents required for submission in response to this solicitation.

(1) ELECTRONIC OFFERS. The offeror shall submit electronic offers in response to this solicitation unless otherwise specified herein. The offer must arrive by the time specified in the solicitation to the following email address: Lisa.Schaupp@nih.gov .

(2) PROCESS FOR AWARD. Award will be made to the Best Value Offeror consistent with the evaluation criteria discussed at FAR 52.212-2 and Addendum to FAR 52.212-2.

(3) BASIS FOR AWARD. Award will be made to the offeror that proposes: a technical proposal conforming to the requirements of the solicitation; has an acceptable record of past performance; its price is determined to be fair and reasonable by the contracting officer; and the contracting officer determines the offeror is responsible in accordance with FAR Part 9. The Contracting Officer intends to award without discussions, but reserves the right to do so in his or her sole discretion.

(4) The Government may reject a proposal if it is found that any information that has a negative impact on the offeror's past performance record has been deleted, misrepresented, or withheld.

(5) Offers shall remain valid for a period of 90 days from the date offers are due.

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(6) Quotation shall include Certifications and Representations, Technical, Past Performance, and Price as separate parts in the submission.

CERTIFICATIONS & REPRESENTATIONS:

Provide pricing for each Contract Line Item Numbers (CLINS).

52.212-3 - Offeror Representations and Certifications -- Commercial Items(Jan 2017)

Valid Manufacturer Certification and/or license from the manufacturer to perform service on offered equipment

QUOTATION COMPOSITION:

PART I: TECHNICAL

TECHNICAL CAPABILITY - The offeror shall provide sufficient information to demonstrate its understanding of the requirements, providing a concise, detailed, and thorough discussion of its technical capability to successfully provide the equipment and services as required in this solicitation.

The offeror shall also submit with their proposal:

Proposed equipment and services satisfying the descriptions and salient characteristics in the

Statement of Work.

A statement that only manufacturer certified technicians will be dispatched to service this equipment..

Submissions shall meet at least, the Mandatory Service Requirements, and provide all mandatory proposal proofs listed under the heading, “Evaluation Factors,” on page 18 of this solicitation.

PART II: PAST PERFORMANCE.

Offerors shall submit past performance information on at least two (2) but not more than four (4) recent and relevant contracts (within the past three years from the date of the solicitation). If more than four contract references are submitted, only the first four will be evaluated. References may include performance on contracts for Federal, State and local Governments as well as private commercial firms of similar size and scope.

Section 1 – Contract Description Information:

Offeror’s CAGE Code and DUNS Number. Point of Contact (POC) (name, and current address, e-mail address, and telephone and fax numbers). Contracting activity/Administration and current address, Contracting Officer or Technical Representative Name, e-mail address, telephone and fax numbers.

Contract Number and, in the case of Indefinite Delivery type contracts, GSA contracts, and Blanket

Purchase Agreements, include Delivery Order Numbers also; Awarded price; Final or projected final price; Original/Final delivery schedule, including dates of start and completion of delivery.

Section 2 – Performance (See FAR Provision 52.212-2 Addendum Government intends to evaluate.)

Offerors shall provide a specific narrative explanation of each contract listed in Section 1 above describing recency and relevancy of the requirements in this solicitation.

For any contracts that did not/do not meet original schedule or technical performance requirements, provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. The Offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

PART III: PRICE.

Offerors shall provide pricing for all item/s specified on each Contract Line Item Number (CLIN) of the solicitation.

Pricing for each Contract Line Item Number shall identify the equipment as new, refurbished, or demo

Para (g) Contract award. This paragraph is amended to state that the Government may conduct discussions prior to contract award.

Para (j) Data Universal Numbering System (DUNS)/CAGE Code. This paragraph is amended to state that the offeror shall obtain these Codes and include them in the proposal and confirm Registration in

System for Award Management and the Online Representations and Certifications, if you are a US firm.

Award cannot and shall not be made to an offeror without these codes.

Para (m) Proposal Preparation Costs. This solicitation does not commit the Government to pay any costs incurred in the submission of an offer, in making any necessary studies for the preparation thereof, or for any visit(s) the Contracting Officer may request for the purpose of clarification of the offer.

Para (n) The offeror is responsible for ensuring that its proposal is complete. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of any stated claims. The proposal shall not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to perform the requirement.

The offeror shall assume that the Government has no prior knowledge of their experience and will base its evaluation solely on the information presented in the offeror's proposal.

Para (o) Protests received at a level higher than the contracting officer will be referred to the contracting officer. Protestor may request a review by the contracting officer or an independent review at a level higher than the contracting officer. Requests for appeals or independent review will be addressed to the contracting officer for referral to the review authority. Questions on this process will be referred to the cognizant contracting officer identified in the solicitation.

Para (p) The non-FAR Part 12 discretionary FAR, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Addendum to FAR 52.212-1)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: See Addendum to 52.212-2

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the

Government to exercise the option(s).

(c) 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.

(End of provision)

ADDENDUM TO 52.212-2

Paragraph (a) is hereby supplemented with the following:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Award will be made using the best value source selection process.

Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate the proposal and award a contract without discussions.

In the evaluation of all Offerors’ proposals, appropriate consideration is given to three (3) evaluation factors:

Technical, Past Performance and Price are in descending order of importance. Technical is more important than past performance. Technical and Past Performance, when combined, are significantly more important than Price. The importance of price in the evaluation will increase with the degree of equality among quotations of the non-price factors.

To receive consideration for award, a rating of no less than “ACCEPTABLE” must be achieved for the technical capability evaluation factor. For Past Performance, the offeror must receive a rating of no less than ‘SATISFACTORY confidence’ to be considered for award. However, offerors which receive an unknown (neutral) past performance rating will be considered for award.

Questions may be sent to Lisa.Schaupp@nih.gov until 12:00 p.m. Eastern Time August 22, 2017.

Responses to Questions will be posted by 10:00 a.m. August 23, 2017.

EVALUATION FACTORS -- THE FOLLOWING FACTORS WILL BE EVALUATED:

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PART I: TECHNICAL

Mandatory Evaluation Criteria

In order for a proposal to receive full consideration and be eligible for award, the following mandatory requirements must be fully met at the time of the receipt of proposal. Mandatory requirements shall be evaluated on a pass/fail basis. Proposal must address these mandatory requirements and proofs:

Mandatory Supply Requirements:

Offer must include all equipment in new, refurbished or demo state with a twelve month warranty covering all parts and maintenance to the provided equipment as requested in the Statement of

Work

Mandatory Service Requirements:

Preferred Response – Immediate response over on-demand calls to resolve service needs.

On-site Repair Visits – All necessary hardware service visits covered. Coverage includes travel and labor.

Parts Required for Repair –Agilent repair parts are covered. Parts are certified Agilent parts.

Consumables/Supplies Required for Repair – All normal wear-and-tear items such as liners, seals and tubing are included when needed for repair.

Annual On-site Preventive Maintenance – One preventative maintenance visit per year.

Hardware and Software Telephone Support –Technical hardware and software telephone support.

Remote Advisor-Assist – Service requests and remote diagnosis.

Service Guarantee –100% repair coverage guarantee. If the manufacturer cannot fix an instrument covered by service agreement, the manufacturer will replace it.

The service agreement must cover the following equipment. Service coverage must be made by a manufacturer certified technician.

Part

Number Description

G6530BA

Accurate Mass Q-TOF Mass Spectrometer. Includes MassHunter workstation.

G1978B Multimode ESI/APCI Source (Configure for QTOF)

G1312B 1260 Infinity Binary Pump with solvent selection valve. (304)

G4225A 1260 Infinity Micro Degasser

G7129A 1260 Infinity II Vialsampler for use up to 600 bar with Integrated

Column Compartment heater 3.0 μL (063)

G7167-

68711 Multidraw Kit Infinity II

G4212B 1260 Diode-Array Detector.

Technical Capability reflects the Government’s confidence in the offeror’s ability, as demonstrated in its proposal, to perform the requirements as stated in the Statement of Work.

The following adjectival ratings will be used in evaluating each offeror’s technical proposal.

Color Rating Description

Blue Outstanding

Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses. Risk of unsuccessful performance is very low.

Purple Good

Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

Green Acceptable

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

Yellow Marginal

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths. Risk of unsuccessful performance is high.

Red Unacceptable Proposal does not meet requirements and contains one or more deficiencies. Proposal is un-awardable.

PART II: PAST PERFORMANCE

The past performance evaluation results is an assessment of the offeror’s probability of meeting the minimum past performance solicitation requirements. This assessment is based on the offeror’s record of relevant and recent past performance information that pertain to the products and/or services outlined in the solicitation requirements.

Offerors are cautioned that in conducting present and past performance evaluations, the Government may use data provided in the offeror's proposal, any other source available to the Government and data obtained from other sources to include, but not limited, to data independently obtained from other

Government and commercial sources.

After the Government has evaluated Offerors’ past performance for recency and relevancy, the

Government will evaluate Quality of Performance (how well the contractor has performed on contracts).

The Government will assign an Unknown /Neutral rating, meaning the rating is treated neither favorably nor unfavorably, to Offerors with no recent/relevant past performance record or the offeror’s performance record is not available or the information is inadequate such that no meaningful confidence assessment rating can be reasonably assigned.

In this context:

“Offeror” refers to the proposed prime contractor and all proposed major subcontractors or team members. A major subcontractor or team member is defined as one who will be providing at least 25 percent of the contract effort. In either case, the contract or delivery order of the proposed prime contractor and proposed major subcontractors will be assessed individually and the results will then be assessed in their totality to derive the prime offeror’s past performance rating. The Government may consider the offeror’s past performance as an entire team including subcontractors, joint ventures and/or teaming partners, aggregately, rather than an individual contractor basis.

“Recency” - To be recent, the performance effort must have occurred within 3 years from the date of issuance of this solicitation.

“Relevancy” – Relevant performance includes products or services that are the same or similar in scope, magnitude and complexity to the effort described in the solicitation.

The following ratings shall be used in assessing an offeror’s Past Performance Relevancy

Rating Description

Very Relevant

Present/past performance effort involved essentially the same scope and magnitude of effort and complexities this solicitation requires.

Relevant Present/past performance effort involved similar scope and magnitude of effort and complexities this solicitation requires.

Somewhat Relevant Present/past performance effort involved some of the scope and

Magnitude of effort and complexities this solicitation requires.

Not Relevant

Present/past performance effort involved little or none of the scope and magnitude of effort and complexities this solicitation requires.

The following ratings shall be used for the Performance Confidence Assessment.

Performance Confidence

Assessments

Rating Description

Substantial Confidence Based on the…