Requirements Document.docx

STATEMENT OF WORK

Purchase of two (2) Systems for Monitoring Temperature Performance of PCR Thermal Cyclers and Accessories

1. Background The regulatory laboratories of the Food and Drug Administration (FDA), conduct a range of microbiological analyses on pharmaceutical products to determine if they meet regulatory requirements. Some of the analyses conducted by FDA regulatory laboratories utilize Polymerase Chain Reaction (PCR) Thermal Cyclers which must undergo periodic temperature performance assessment. A system, consisting of an instrument and software is needed to monitor the temperature performance of PCR Thermal Cyclers.

2. Purpose/Objective Purchase of two (2) Systems for Monitoring Temperature Performance of PCR Thermal Cyclers and Accessories, one each for the Irvine Medical Products Laboratory (IRVLMP), Irvine, CA and the New York Medical Products Laboratory (NYLMP), Jamaica, NY.

3. Scope The purchase of two systems for monitoring temperature performance of PCR Thermal Cyclers including any accessories, and the delivery of one each of these systems to the IRVLMP and the NYLMP that meets or exceeds the requirements below:

4. Requirements

The contractor shall provide a Driftcon System or equivalent that shall meet or exceed the following requirements:

4.1 Shall include necessary hardware that is compatible with the 96-well Applied Biosystem Veriti and VeritiPro thermal cyclers, which are closed thermal cyclers.

4.2 The hardware shall be able to capture uniformity and accuracy of temperature, overshoots/undershoots of temperature, ramp rates and hold times of thermal cyclers using sensors that are compatible with a 96-well thermal cycler.

4.3 The hardware shall have a USB cable connection to connect to a computer which captures the temperature data.

4.4 The hardware shall include any accessories necessary to measure the temperatures of the thermal cycler while the lid is in the open position.

4.5 The hardware shall have the following minimum specifications:

4.5.1 Temperature measurement range of at least 10°C to 120°C.

4.5.2 Resolution of 0.001°C.

4.5.3 At least 16 channels.

4.5.4 Measurement interval of at least 500ms.

4.6 The software must be compatible with the hardware system and the Applied Biosystem Veriti and VeritiPro thermal cyclers.

4.7 The software must be able to evaluate a thermal cycler’s performance in comparison to the market specifications of the particular thermal cyclers, specified above.

4.8 The software must be compatible with Microsoft Windows 10, Microsoft Windows 8 and Microsoft Windows 7.

4.9 The software must be able to generate a report showing the data acquired and resulting evaluation of the thermal cycler performance. The report must include an evaluation of the thermal cycler performance to market specifications and include following: Layout of probe placement, heat rate, hold time, Maximum overshoot temperature, Average overshoot temperature, accuracy and uniformity at each temperature measured. Additionally, for each of the specifications listed in the preceding sentence, a determination as to if the market specification has been met must be included. Attachment 1 contains a sample data report.

5. Trade and Service Specifications

5.1 The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

5.2 Contractor is responsible for a turn-key solution, including all necessary accessories, to meet the requirements, purpose and objectives listed herein.

5.3 The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance.

5.3.1 The vendor must also be capable of servicing the instrument through the covered warranty period.

5.3.1.1 The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an Original Equipment Manufacturer (OEM) -trained engineer.

5.3.1.1.1.1 This factory-trained engineer shall have (verified by the OEM) the following:

5.3.1.1.1.1.1.1 access to OEM factory telephone support;

access to the most current OEM factory training for both hardware and software components access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs.

All parts used in PM and repairs must be guaranteed, factory-tested, official equipment manufacturer parts.

6. Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th workday following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

7. Existing Conditions

All government property or systems displaced, altered, or damaged during the performance of this contract other than stated in this SOW shall be restored to its original condition at no cost to the government. These repairs, if needed, shall be executed immediately when the contractor is notified by the CO that such repairs are required due to actions by the contractor or his/her subcontractors.

8. Deliverables or Delivery Schedule

Two (2) Systems for Monitoring the Temperature Performance of PCR Thermal Cyclers and Accessories, one each for IRVLMP, Irvine, CA and NYLMP, Jamaica, NY. meeting or exceeding the requirements stated above will be delivered, in accordance with the following:

Within 30 days of any service or repair being performed within the manufacturer’s warranty period.

9. Delivery Location(s) and Place of Performance One system and accessories delivered to each of the following locations:

POC: To be identified at time of award

FDA/IRVLMP

19701 Fairchild Rd.

Irvine, CA 92612

POC: To be determined at time of award

FDA/NYLMP

158-15 Liberty Avenue Jamaica, NY 11433

10. Period of Performance

The period of performance begins the date of contract award. All requirements shall be completed no later than 30 days after contract award.

Delivery will be accepted during regular business hours (Monday-Friday) during the times of 8:00 AM – 4:00 PM local standard time.