Contracting Office Address

Department of Health and Human Services,

Office of Acquisition and Grants Services (OAGS)

4041 Powder Mill Road, Beltsville, MD 20705.

Description:

(i)This is a Combined/Synopsis Solicitation for Commercial Items prepared in accordance with the format in FAR Part 12, as supplemented with additional information included in this notice.  The requirement will be awarded using Simplified Acquisition Procedures in accordance with FAR Part 13.

(ii)The solicitation number is: 1240488

(iii)The Solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular (FAC) 2021-05, March 10, 2021.

(iv)This is a firm fixed price requirement. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516. This procurement will be for a small business set aside. Vendors must be registered in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov

(v)

 The FDA Winchester Engineering and Analytical Center (WEAC) is responsible for analyzing regulated products for radioactive contaminants and samples for routine surveillance and radiological or nuclear emergencies. WEAC has a Nuclear Regulatory Commission License which requires a radiation safety program to ensures the safety of the workers processing products containing and conducting research involving radioactive material.

A critical aspect of the program is analyzing work areas for removable contamination. Because WEAC is licensed to handle a broad range of radionuclides, the only efficient way to achieve these surveys is by using a high throughput extra low background Liquid Scintillation Counter. Additionally, this unit will support Saxitoxin Method Development at the Northeast Food and Feed Laboratory (NFFL) and the Pacific Northwest Laboratory (PNL). Furthermore, this instrument will be used to conduct ORA-wide contamination surveys of Ion Mobility Spectrometers and Electron Capture Detectors.

In addition to Radiation safety this instrument will also be used as backup for WEAC analysis associated with FDA Food Safety Compliance Programs 7304.019 and 7304.839

Continuing technical support and maintenance from instrument manufacturer are essential for carrying out routine operation. However, our current instrument is over 20 years old and has become obsolete due to new developments in liquid scintillation counting technology. The instrument manufacturer has announced that no additional technical support and maintenance will be provided for our current model. Our Current model has recently shown an efficiency reduction, resulting in longer sample turnover times.

Objectives

 The objectives for the contractor are to:

• • Provide and install a ultra-low background and high sample capacity liquid scintillation (LSC) counter capable of discriminatively analyzing alpha- and beta-emitting radionuclides.
• • Demonstrate system functionalities and acceptable performance per manufacturer’s specifications after installation.
• • Provide onsite training on basic operation, routine maintenance, and system troubleshooting

 Scope

The requested LSC counter shall be provided as off-the-shelf product without the needs for additional post-installation research, development, and validation. It shall have all necessary hardware, accessories, and software for discriminative analysis of alpha and beta radionuclides.

Minimum Technical Specifications

At a minimum, the LSC counter shall meet or exceed the following salient characteristics:

1. Liquid Scintillation Counter

• Must be a liquid scintillation counter capable of performing conventional and Cerenkov counting
• Must include both passive and active background reductions to achieve super low instrument background of <1 CPM for 3H analysis with figure of merit (E2/B) > 800 in Super Low level count mode.
• Must provide a sample loading capacity of >400 samples (20-mL vials) with an overall instrument footprint <19 in. (H) x 41 in. (W) x 45 in. (D)

        • Must include an electrostatic controller to reduce sample static charge

• • include a sample heterogeneity monitor Must be capable of dual-label and triple-label DPM analysis
  • Must include Direct DPM feature to determine single-label DPM in any cocktail without the use of quench standards
  • Must be capable of Dynamic color correction for tracking lower energy specatra over a wide quench range
  • Must equipped with dual alpha/beta pulse shape analyzer that enables the lowest alpha/beta spillover and accurate alpha/beta spillover correction
  • Must be capable of luminescence detection and correction
  • Must be capable of data collection for spectrum unfolding
  • Must be temperature controlled for optimum noise reduction and signal stability
  • Must include an instrument status indicator
  • Must include assay-specific and user-selectable coincidence resolving time
  • Must enable count delay and programmable background reduction
  • Must be capable of 3-D spectral mapping
  • Must enable to replay post-run historical assay with different reprocessing parameters
  • Must include linear 4000 channel multi-channel analyzer (MCA)
  • Must include built in computer with windows 10 operating system

1. Standards for Instrument Performance Evaluation

• • 1 set of 20-mL unquenched LSC standards (3H, 14C, and Background) with one copy of standard certificate
  • 1 set of 20-mL low-level unquenched LSC standards (3H, 14C, and Background) with one copy of standard certificate

1. Laser Printer

• • USB connection
  • Compact design
  • 2-side printing

1. Utility Cart

• • With wheeled for easy moving
  • With shelves to provide storage space

1. System Computer

• • Compact design to save bench space
  • Windows 10 operating system 64-bit
  • One monitor
  • One keyboard
  • One mouse
  • Dual gigabit Ethernet port for network applications
  • Three High Speed USB ports

1. System Software

• • Enable fully automated sample changing and data acquisition
  • Enable password protection of counting protocol
  • Enable performance of instrument QC with running mean & baseline charts & tables
  • Enable sample ID editing and recording

Include easy-to-use software for allowing user to perform sample spectral analysis

• • Provide Excel-compatible data report
  • Intuitive and easy creation of counting protocol
  • Real time display of spectra and counting results
  • Enable instrument performance assessment (IPA)
  • Include all user’s manuals

Shipping, Installation, and Warranty

• • Include shipping and handling fee
  • Include on-site installation
  • Include instrument optimization
  • Demonstrate proper instrument operation after installation
  • Include 1-year warranty against defects
  • Include 1-year warranty against errors and failures in software

1. Operation Training

• • Online operator training including instrument operation, software usage, performance evaluation, and routine maintenance

Essential Accessories

• • Include all necessary parts kits needed for performing instrument calibration and automatic sample changing and counting

Deliverables

Deliverable

Description

Quantity

Date Completed

Installation of liquid scintillation counter

At time of service

Test and verification of full system functionality

At time of service

Online training on basic instrument operation

At time of service

Trade and Service Specifications

The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration.

FOB Point destination to include inside delivery and clean-up of area after installation.

The entire system shall be warranted for parts and labor for a minimum of 1 year from date of formal government acceptance. The warranty must include unlimited telephone/e-mail support for questions regarding operation.

One-year technical assistance and preventative maintenance shall be included.

Offered systems shall be a turn-key solution, i.e. the contractor shall be responsible for providing all hardware, components, and software. The products shall be fit for intended purpose.

The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

The vendor shall demonstrate upon installation that the system meets or exceeds all performance

specifications which have been included in the vendor’s response and/or used are evaluation

criteria for award. The instrument shall not be accepted until those performance specifications have been met.

No subcontractors or other personnel not employed by the offeror shall be utilized for instrument service.

Onsite training on basic operations and familiarization of the installed LSC counter for sample analysis shall be provided to at least one operator.

All service costs, i.e., software, labor, freight, and travel, must be included.

(vi)Delivery schedule.

 Security

Check in with security at front entrance.

Delivery Location

Delivery must be coordinated with ORA/WEAC at least 48 hours in advance:

U. S. FDA Winchester Engineering and Analytical Center Attn: POC to be identified at time of award

109 Holton Street Winchester, MA 01890 USA

(vii)The period of performance: The planned Period of Performance is from

Period of Performance: the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance. Instrument to be delivered no later than June 15, 2021

The provision at FAR 52.212-1 Instructions to Offerors- Commercial Items applies to this solicitation.  The following addenda have been attached to this provision: None.

(viii)The government is not responsible for locating or securing any information, which is not identified in the submission.  To ensure sufficient information is available, vendors must furnish as part of their proposal all descriptive material (such as cuts, illustration, drawings, or other information) necessary for the government to determine whether the product meets their requirements.
 

(ix)Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications- Commercial Items with its offer.

(x)The clause at 52.212-4, Contract Terms and Conditions- Commercial Items, applies to this acquisition.  The following addenda have been attached to the clause: None.

(xi)The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes of Executive Orders-Commercial Items, applies to this acquisition.     The following additional FAR clauses cited in this clause are applicable: 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-37, 52.225-1, 52.225-3, 52.225-13, and 52.232-33.     Clauses and provisions are incorporated by reference and apply to this acquisition.     Clauses and provisions can be obtained at http://www.acquisition.gov.

(xii)A standard commercial warranty is not required.

(xiii)The Defense Priorities and Allocations System and assigned rating are not applicable to this solicitation notice.

(xiv)This announcement constitutes the only solicitation that will be issued. Offers are due, by e-mail, on or before May 18, 2021 by 3:00 pm (Eastern Time). E-mail [email protected]