Combine Solicitation – Hi Purity Gamma Detector

Notice Type: Combine Solicitation

Posted Date: 30-MAR-15

Office Address: Department of Health and Human Services; Food and Drug Administration; Office of Acquisitions and Grants Services; 5630 Fishers Lane, Room 2129 Rockville MD 20857-0001

Subject: Hi Purity Gamma Detector

Classification Code: 66 - Instruments & laboratory equipment

Solicitation Number: FDA-SOL-1145353

Contact: Corina L Couch, Contract Specialist, Phone 2404025352, Email [email protected]

Setaside: N/AN/A

Place of Performance (address): 1.One unit will be installed at FDA/WEAC, 109 Holton Street, Winchester, MA 018902.Two units will be installed at Dartmouth College Medical School, Remsen room 851, Vail Building, 37 Dewey Field Rd, Hanover NH, 03755

Place of Performance Country: US

Description: Department of Health and Human Services

Food and Drug Administration

Office of Acquisitions and Grants Services

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1145353. This solicitation is issued as a Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-80, Effective 02 Mar 2015. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Coaxial P-Type High-Purity Germanium Detector with Integrated Electrical Cooling System and Hardened Cryostat 3 EA $ 0002 Digital Spectrum Analyzer and Power Supply 3 EA $ 0003 Transport Cart with Modular Cylindrical Lead Shielding 3 EA $ 0004 Laptop Computer with Ethernet and multiple USB ports, DVD drive, wireless capability, and a LaserJet printer. 3 EA $ 0005 Software for Detector Calibration, Operation, and Nuclide Library Editing 2 EA $ 0006 Installation and Familiarization 2 EA $ 0007Computational Efficiency Calibration Software 2 EA $ 0008 Detector Characterization and Related Application Software and QC Check Source 3 EA $ Total Amount $

I. Background/Intro The FDA Winchester Engineering and Analytical Center (WEAC) is the sole servicing laboratory for analyzing regulated products for radioactive contaminants. As such WEAC is mandated to maintain and alternate location for the continuation of operations (COOP) in the event of an emergency at the lab making it inoperable for radionuclide analysis. The COOP location for WEAC radionuclide analysis is Dartmouth Medical School in Hanover, NH. Memorandum of Understanding (MOU) is in place with this institution, and space has been allotted for the FDA for this purpose. To fulfill this responsibility it is necessary to equip the COOP location with 2 units of equipment capable of measuring foods and other FDA regulated products for contamination of gamma radiation per CFSAN;s data quality objectives. Furthermore, this equipment must be stored at room temperature, and have the ability to analyze samples within 6 hours of start-up. In order to assure the rapid continuation of operations, analysts must be kept familiar with this equipment. Therefore, one unit of the COOP equipment must be available for training at the primary lab, WEAC. All detectors and accessories (laptop, shielding, digital analyzer, etc.) must fit on a mobile cart that can support the weight of the equipment for easy storage and set up. Space is limited in the COOP location. II. Objective The FDA has a need for Hi Purity Gamma Detectors with Integrated Cooling Systems. III. Scope The Hi Purity Gamma Detectors with Integrated Cooling System shall include the following components:

1. Coaxial P-Type High-Purity Germanium detector a. Energy range 20 keV to 3 MeV b. Relative photon peak efficiency >=40% c. Energy resolution <=1.90 keV FWHM @ 1.33 meV d. Peak to compton >=52:1 e. Peak shape <= 1.9 FW .1FM/FWHM f. Peak shape <= 2.8 FW.02M/FWHM g. Endcap size = 76 mm (3.00 in) h. Includes integrated electrical cooling system with hardened cryostat, never needs thermal cycle after partial warming, can be cooled from any temperature, can be stored warm without loss of efficiency or compromise of vacuum. 2. Digital analyzer 3. Transport cart with modular cylindrical lead shielding a. Shielding >= 2.0 inches thickness b. Space inside of shielding/cylindrical sample chamber dimensions: at least: 6 inches tall, 6 inches in diameter. 4. Laptop computer 5. Software for detector calibration, system operation, and radionuclide library building 6. Installation and familiarization 7. Computational efficiency calibration software 8. Detector characterization is required and associated application software and QC check source must be provided

IV. Requirements All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government.

A. System specifications/salient characteristics:

1. P-type High-purity germanium detector - Energy range 20 keV to 3 MeV - Relative photon peak efficiency >=40% - Energy res. <= 1.90 keV FWHM @ 1.33 MeV - Peak to compton >= 52:1 - Peak shape <= 1.9 FW.1M/FWHM - Peak shape <= 2.8 FW.02M/FWHM - Endcap size = 76 mm (3.00 in)

2. Includes integrated Electrical cooling system with hardened cryostat, mechanical cooling system, never needs thermal cycle after partial warming, can be cooled from any temperature, can be stored warm without loss of efficiency or compromise of vacuum. Must include: - Cryostat flange - Chamber coax - Endcap - Preamplifier - Preamp cable set

3. Lead shielding to minimize natural radiation background - Cylindrical (or enough space in sample chamber for cylindrical sample geometry - >= 2.0 inches thickness of lead - Space inside of shielding/ cylindrical sample chamber dimensions: at least: 6 inches tall, 6 inches in diameter

4. All equipment and accessories for each unit must fit on a mobile cart that can support the weight of the system and lead shielding. The mobile cart must be provided along with the detector system.

5. Must be able to be stored at room temperature

6. Must be able to be cooled down and operational within 6 hours of start-up

7. Compact size of each unit - Dimensions of entire unit with accessories and cart not to exceed 4.5 ft tall X 2.5 ft wide X 2.5 ft deep - Smaller is better

8. Digital analyzer for each detector with analysis software and nuclide library

9. Mathematical efficiency calibration software for wide range of source geometries

10. Does not require liquid nitrogen to operate 11. Compatible endcap windows, Aluminum, Carbon Fiber, Beryllium

12. Electrical supply 100-240 V AC (50/60 Hz) auto ranging

13. Audible noise of unit < 60 dB at full operation

14. Cooler life > 200,000 hrs

15. Warranty: 2 years on cooler, 1 year on detector and preamplifier B. General Specifications

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

The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Installation and operator familiarization shall be included for the Gamma Detector system and all components.

The vendor shall demonstrate upon installation that the item meets all performance specifications. The instrument will not be accepted until those performance specifications have been met.

C. Service Maintenance Agreement: The system shall include a one (1) year full manufacturer's warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum 72-hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications.

D. Special instructions The contractor shall deliver and install P-Type Hi Purity Germanium Detector that meets the above listed specifications, including equipment, software, essential documents and licenses. The contractor shall perform initial configuration of the system.

The offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation.

Place(s) of Delivery: 1. One unit will be installed at FDA/WEAC, 109 Holton Street, Winchester, MA 01890 2. Two units will be installed at Dartmouth College Medical School, Remsen room 851, Vail Building, 37 Dewey Field Rd, Hanover NH&lt;/location>, 03755 Delivery Period: Within sixty (60) days after contract award. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html.

The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision.

Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable.

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.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (May 2014), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov.

The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2014), applies to this acquisition with the following addenda:

Invoice Submission:

A. The contractor shall submit one original copy of each invoice to the address specified below:

Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 [email protected]

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award.

C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE.

The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Mar 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). 52.222-21 Prohibition of Segregated Facilities (Feb 1999) 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332)

FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) FAR 52.232-18 Availability of Funds (APR 1984) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html

352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001)

The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

The COR name will be provided at time of award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the contract; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1145353. The quotes are due by email to the point of contact listed below on or before April 06, 2015 by 01:00pm ET.

Please contact Corina Couch at (240) 402-5352 or email at [email protected].

Link/URL: https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1145353/listing.html