Notice of Intent to Sole Source_OC-2024-123299_CO approved.pdf

NOTICE OF INTENT TO SOLE SOURCE

In support of Project No: OC-2024-123299

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services, Facilities

Support Branch intends to award a firm fixed price purchase order to LabLogic Systems, Inc., Tampa, FL

33619 for a 12-month preventative maintenance (PM) service agreement with four 12-month Option periods in support of a HIDEX Automated Gamma Counter.

HIDEX is the manufacture of the Automated Gamma Counter and has appointed LabLogic Systems

Inc.(LabLogic) as the authorized Original Equipment Manufacturer (OEM) service provider in the United

States (U.S.) for maintenance services. Any materials or services provided must be fully compatible in terms of form, fit, and function with the existing installed systems, and they must also possess the ability to connect or interface with other pre-existing systems. LabLogic is uniquely positioned to provide essential support services due to the proprietary nature of the equipment. LabLogic is also the only qualified source for equipment upgrades, software updates, and access to OEM parts. Furthermore, they offer proprietary software and employ certified, trained technicians equipped to deliver service for the

HIDEX Automated Gamma Counter.

This procurement is being conducted in accordance with FAR subpart 13.106-1(b)(1)(i) which allows the

Contracting Officer to solicit from one source. The North American Classification System Code is

811210, Other Electronic and Precision Equipment Repair and Maintenance and Product Service Code, J066 – Maintenance/Repair/Rebuild of Equipment – Instruments and Laboratory Equipment.

This notice is being distributed solely to the System for Awards Management website (www.SAM.gov).

As LabLogic Systems Inc. is the only source that can meet the Government’s need at this time, this notice is not a request for competitive quotes. However, if any interested parties, especially a small business believes it can meet the Government’s needs, it may identify their interests and/or capability in relation to this procurement to the Contract Specialist, Iris Johnson, at Iris.Johnson1@fda.hhs.gov no later than

10:00 AM EST on September 09, 2024. Responses sent utilizing other means will not be considered.

Information received will be used solely to determine whether to conduct a competitive procurement. A determination by the Government not to compete the proposed action based upon responses to this notice is at the discretion of the Government.

All responses must include the following business information:

a. Unique Entity Identification (UEI) Number.

b. Company Name, address, primary point of contact and their email and phone number.

c. Type of company (i.e., small business, 8a, woman owned, HubZone, veteran owned, etc.) as validated in SAM.gov. All interested parties must be registered in SAM.gov to receive consideration of government contracts.

DRAFT

STATEMENT OF WORK

OLS NEW GAMMA COUNTER PREVENTATIVE MAINTENANCE SERVICE

AGREEMENT

OC-2024-123299

I. SCOPE

The scope of this contract is to provide continued support services coverage for the FDA

White Oak campus Automated Gamma Counter located in the CORE Lab room B64-

G008. With this coverage in force the service provider shall be able to provide unlimited problem solving, parts, labor, and repair for the LabLogic Hidex Automated Gamma

Counter Serial Number 2190158. The following services shall be provided at a minimum:

• Provide advice and unlimited repairs for such issues as problem solving, parts, and labor.

• Provide guidance for use of, updates to and training for software governing the functions, maintenance, data administration, and troubleshooting of the gamma counter equipment.

II. DELIVERABLES

The service provider shall have the ability to deliver support services such as:

• Onsite training for three (3) end-users to include functions, maintenance, data administration, and basic troubleshooting.

• Allowance for four option years of preventative maintenance, repair, and technical support.

• Unlimited site visits, parts, and repairs as necessary to maintain continued operation of the equipment.

• Provision of Calibrator Standards: I-129, Cs-137, Mn-54, Co-60, Na-22

• Phone and online support for the following:

a. Equipment repairs;

b. Printer issues;

c. Software updates, interoperability issues with FDA laptop.

III. TECHNOLOGICAL REQUIREMENTS

The service provider shall ensure that the Hidex Automated Gamma Counter equipment continues to allow for the following capabilities:

1. Detection of a wide energy range of gammas from 15- 2000 keV;

2. Integrity of the NaI well type crystal detector;

3. Continued performance of the multichannel analyzer;

4. Automatic calculation of decay corrected activities;

5. All results, raw and calculated, can be exported;

6. Integrity of the shielding for Positron Emission Tomography (PET) research with isotopes such as Flourine-18 and Zirconium-89;

7. Function of the integrated Bar Code Reader;

8. Maintain automatic sample changer capability for at least 200 small vials or 75 large vials;

9. Ensure continued function of basic software for quality control, data analysis, and data storage – to include the sample name and description, product website Uniform Resource

Locator (URL), and model/version of all vendor installed software.

10. Windows 10 all-in-one PC: quotes shall include computer specifications that provide the product name, product description, product website Uniform Resource Locator (URL), and software version.

11. Laser Printer for PC Workstation – provide description and specifications compact in size with less than 30” depth and width due to space limitation in laboratory;

12. Functioning Internal Sample Balance - automatic weighing of samples for reporting total activity per mass/volume;

13. Onsite training to include functions, maintenance, data administration, and basic troubleshooting.

IV. DELIVERY/SERVICE LOCATION

The service shall be delivered to the following location:

Attention: Technical Point of Contact (TPOC) will be given at the time of award.

U.S. Food and Drug Administration

Office of Laboratory Safety

10903 New Hampshire Avenue, WO64-G008

Silver Spring, MD, 20993

V. PERIOD OF PERFORMANCE

The resultant order’s period of performance shall be for one 12-month base year, plus (4)

12-month option years.

VI. HOLIDAYS AND GOVERNMENT CLOSURES

The Contractor is not permitted to provide on-site services on the following days that are

Federal Holidays or on any other day designated as a Federal holiday for the Washington, DC area:

New Year’s Day

Martin Luther King Day

President’s Day

Memorial Day

Juneteenth

Independence Day

Labor Day

Columbus Day

Veteran’s Day

Thanksgiving Day

Christmas Day

In the event of inclement weather when the Federal government is closed, the Contractor is not permitted to provide on-site service. The Contractor is also required to follow, as a minimum, other directives issued by the U.S. Office of Personnel Management or other such official for late arrivals due to inclement weather (unless otherwise specified in the

Contract).

In the event the Federal Government is closed by order of the President of the United

States or the U.S. Office of Personnel Management for any reason, or the agency, the center or the building is closed for administrative or safety reasons, the Contractor shall follow directives issued by responsible officials concerning reporting for work.

VII. CONTRACT ADMINISTRATION

The Technical Point of Contact (TPOC) for this requirement:

Name: TBD

Email: TBD

Phone: TBD

Contract Specialist:

Iris Johnson

Email: Iris.Johnson1@fda.hhs.gov

Phone: (301) 796-3353

Contracting Officer:

Sheneil Green

Email: Sheneil.Green@fda.hhs.gov

Phone: (240) 402-9672 mailto:Iris.Johnson1@fda.hhs.gov mailto:Sheneil.Green@fda.hhs.gov