Combine Solicitation – Standalone temperature monitoring system
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Notice Type: Combine Solicitation
Posted Date:
Office Address:
Subject: Standalone temperature monitoring system
Classification Code: 66 - Instruments & laboratory equipment
Solicitation Number: FDASOL1132621
Contact:
Setaside: Total Small BusinessTotal Small Business
Place of Performance (address):
Place of Performance (zipcode): 20708
Place of Performance Country: US
Description:
PART 1 - Intro
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in 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.
This solicitation is issued as a Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13. The solicitations document/incorporated provisions and clauses are those in effect through the current Federal Acquisition Circular: FAC 2005-76.
The associated North American Industry Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing. Small Business Size Standard is 500 employees. This acquisition is set aside 100% for small business concerns.
PART 2 - PRICES/COST CLIN Description Unit Price Qty Unit of Issue Price 0001 Stand Alone Temperature Monitoring System, Delivery , Installation, Training, One Year Warranty
(A) The
PART 3 -STATEMENT OF WORK (SOW)
SYSTEM REQUIREMENTS:
* The monitoring system shall be a stand-alone system and work within the laboratory system. It shall be capable of monitoring a variety of devices which provide a contact closure to generate a signal to the monitoring system. Devices will include, but are not limited to, temperature and carbon dioxide concentration. It shall simultaneously measure, transmit, centrally collect and analyze the temperature data, from multiple instruments in a multi-floor, multi-room, multi-building laboratory facility
Attachments for full dimensions and layouts of the facility and various rooms where the equipment that is to be monitored is located:
1. Attachment 1:Floor Plan of Facility 2. Attachment 2: Freezers, Refrigerators and Incubators
* The system must be user programmable to add contact information (up to 10 telephone numbers) for each probe. The system must provide notification of alarm conditions. A phone line can be provided by the government if required for the notification portion of the system.
* The system shall include a computer controller/server, sufficient to operate the system proposed, that can be centrally located on a multi-floor laboratory facility.
* System shall provide a range of temperature sensing probes that are capable of monitoring temperatures associated with refrigerators, freezers
* All temperature sensing probes shall be capable of continuous monitoring with on board memory to prevent data loss (minimum of 25 days of data collected at 15 minute intervals for each individual instrument.)
* The monitoring system must be capable of archiving data for retrieval and manipulation by users (e.g., data must be retrievable in the form of graphs, tables, etc., from individual probes).
* The system must have a back-up power source in the event of loss of power.
* Monitoring system must be expandable to incorporate other monitoring probe types which may include but are not limited to particle counts, humidity, air pressure, water pressure, air flow, water flow liquid level sensors, etc. System should be expandable to address the needs of the laboratory as it continues to expand, and adaptable (upgradeable) to accommodate changing technologies with minimal changes required to the system infrastructure/software. The
* Installation of system: 12 hours/space as the maximum disruption possible for each affected space.
* Calibration requirements for all temperature sensing devices shall be supportable by the vendor with regard to calibration standards to cover the requirements outlined in A2LA accreditation standards and ISO 17025 using the AOAC guidelines. Additionally the vendor shall provide documentation of full NIST (
1. For A2LA accreditation standards see http://www.a2la.org/, 2. For ISO 17025 guidelines, See http://www.standards.org/standards/listing/iso_17025, 3. For NIST information See http://www.nist.gov/index.html
* The system, including system software, must comply with requirements of the FDA Good Lab Practices regulations, including 21 CFR Part 11. 1. For FDA Good Lab Practices regulations, See: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm CFRPart=58, 2. For 21 CFT Part 11 See: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm 3. The system has to be approved by the
* INSTALLATION: The vendor shall provide inside delivery, installation, setup, and optimization of the system. Warranty period will commence after the installation of the system is accepted by the Program.
* During installation the contractor may shall coordinate activities with facilities staff and the COR. As this is a facility that is currently operating it is possible that not all rooms or equipment will be available at all times.
* If installation of probes inside ultralow freezers requires freezers to be empty or at ambient temperature, then only approximately 20% of the ultralow freezers will be available each week during installation.
* After installation vendor is required to demonstrate full system functionality by conducting an IQ/OQ validation.
* TRAINING: The Contractor shall provide on-site training to approximately 3-5 laboratory personnel within 2 weeks after the system has been delivered, installed and accepted by the Program. * The purpose of the training is to familiarize staff with the proper use of the system including:
- system operations (including software)
- calibration
- optimization
- basic and routine preventative maintenance procedures
- cleaning requirements
- any safety and related safeguards as appropriate;
- information on what users should do if a unit or the system is not functioning properly
- any other topics deemed necessary to familiar
* This training should last 16 hours. * Contractor shall provide all training materials (web based or written) 7 days before installation.
* Warranty and Maintenance/Support Agreement:
1. Warranty: Vendor shall include:
* Trouble shooting for issues that arise during normal operation conditions * Vendor will be responsible for parts, travel, and labor for these site visits * All components of the system shall be covered by a minimum one year warranty, with full replacement of any/all components that fail or malfunction within that timeline
2. Maintenance/Support Agreement: Option year maintenance agreement to cover the following:
* Unlimited Phone and email support during normal business hours, (Monday-Friday,
Period of Performance/Delivery Schedule:
* Stand Alone Temperature Monitoring System, Delivery, Installation, Training, One Year Warranty; Period of Performance:
PART 4 - INSPECTION AND ACCEPTANCE
4.1. For the purpose of this PART, (COR - to be determined upon contract award) is the authorized representative of the Contracting Officer. 4.2. Inspection and acceptance will be performed at the locations identified in 6.1.3. Acceptance is communicated in writing unless otherwise indicated in writing by the Contracting Officer or COR within 30 days of receipt. 4.3. This contract incorporates the following clause, 52.246-2 Inspection of Supplies-Fixed Price (
PART 5 - PLACE OF PERFORMANCE
5.1. DELIVERIES Satisfactory performance of this contract shall be deemed to occur upon delivery, installation of the systems described in PART 3 of this solicitation, training and upon acceptance by the COR, of the services and reports required at the dates specified within PART 3 of this request for proposal.
5.2. PERFORMANCE LOCATION:
The stand-alone temperature monitoring system shall be installed and serviced at the following
Food and Drug Administration CVM MOD 2 8401 MUIRKIRK ROAD
PART 6 - CONTRACT ADMINISTRATION DATA
6.1 CONTRACTING OFFICERS REPRESENTATIVE (COR) The following COR will represent the Government for the purpose of this contract: (To Be Determined Upon Contract Award) 6.1.1 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.
6.1.2 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 RFP; (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.
6.1.3 The contact information for the Contracting Specialist: Gina Jackson [email protected] Tel: 240-402-7590
6.1.4 The contact information for the Contracting Specialist is:
6.2 INVOICE SUBMISSION
FDA Invoice Requirements:
3-Way match : The contractor shall submit one (1) original copy of each invoice to the address specified below:
Invoices submitted under this contract must comply with the requirements set fort in FAR clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other 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 shipment, 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 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 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. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.
Questions regarding invoice payments should be directed to the FDA Payment Office at telephone number provided above.
PART 7- HHSAR AND FAR CLAUSES 7.1 HHSAR CLAUSES INCORPORATED BY REFERENCE
This contract incorporates one or more clauses by reference, noted in Title 48, Federal Acquisition Regulations System, 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: http://farsite.hill.af.mil/VFHHSARA.HTM. HHSAR Clause Description Date 352.202-1 Definitions (
7.2 FAR Clauses 52.252-2
FAR Clause Description Date 52.212-2 Evaluation -- Commercial Items (
52.212-4 Contract Terms and Conditions - Commercial Items (
FAR CLAUSES BY FULL TEXT
52.217-5 Evaluation of Options (
52.217-8 Option to Extend Services (
52.217-9 Option to Extend the term of the Contract (
52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS--COMMERCIAL ITEMS (
(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) 52.222-50, Combating Trafficking in Persons (
Government Holidays Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) or OPM.gov due to inclement weather. January (
PART 9- INSTRUCTIONS TO THE OFFEROR
9.1: CONTRACT TYPE: COMMERCIAL ITEM-FIRM FIXED PRICED
9.2: AWARD CRITERIA: THE GOVERNMENT WILL AWARD THIS REQUIREMENT TO THE LOWEST PRICED TECHNICALLY ACCEPTABLE QUOTE.
9.3 INSTRUCTIONS:
* The Offeror's price quote shall have a technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary * The Offeror's price quote requires that the vendor propose an installation time line that shall detail demolishing work and/or installation of system and the effects on such installation to continuing
To register for the site visit, please contact
9.4: PERIOD OF ACCEPTANCE OF OFFERS: THE OFFERORS AGREE TO HOLD THE PRICES IN ITS OFFER FIRM UNTIL
RESPONSE DATES
Quotes Due Date: All quotes shall be submitted via email [email protected] by
Link/URL: https://www.fbo.gov/spg/HHS/FDA/DCASC/FDASOL1132621/listing.html
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