Requirements Document.pdf

STATEMENT OF WORK

Purchase 9 Stereomicroscopes for IRVLHAF and ARLHAF Microanalytial Sections

Background

The Microanalytical sections at the Irvine Human and Animal Food Laboratory

(IRVLHAF) and Arkansas Human and Animal Food Laboratory (ARLHAF) routinely use stereomicroscopes for the analysis of Filth and BSE regulatory samples. These microscopes are critical to filth plate reading, filth identifications and confirmations, BSE AFM plate reading, BSE AFM identifications and confirmations, reject confirmation, filth exhibit analyses, and consumer complaint analyses. It is common for a Filth analyst to spend 4 – 6 hours at their stereomicroscope on any given day and 20+ hours at this microscope on any given week.

Many stereomicroscopes currently in use at IRVLHAF and ARLHAF are 30+ years old and the labs are seeing a higher frequency of issues (i.e. focusing knob stuck, magnification turret stuck, optics won’t stay in alignment, damage to objectives) with these units requiring some of them to be repaired or taken out of service. These microscopes must be replaced for the following reasons:

1) Reliability – Due to their age, these microscopes are nearing the end of their serviceable life and are more likely to require repair, need additional maintenance, or be taken out of service completely.

2) Ergonomics - These microscopes have poor ergonomics and don’t allow adjustability to the height or angle of the eyepiece tubes. Better ergonomics would potentially decrease strain/repetitive use injury and decrease discomfort to analysts while performing microscopy for long periods of time.

3) Lower quality optics – These microscopes have lower maximum magnification, lower resolution, and less field of view than new stereomicroscopes on the market. With improved optics: A) the speed and efficiency of plate reading will be increased due to better visibility and clarity, B) Identifications will be easier to perform and may not require a compound microscope on some specimens, 3) Eye strain will be reduced which enables longer more comfortable periods of microscopy.

4) Fixed magnification turret – These microscopes have a fixed magnification turret that changes the field of view and magnification in large increments which breaks the line of site and focal point on a specimen during magnification changes. The replacement stereomicroscope will have a continuous zoom knob to change the magnification which will improve plate reading and identification as the line of site on a specimen is constant and changes gradually.

Purpose

The IRVLHAF and ARLHAF Microanalytical sections need to acquire nine (9) new stereomicroscopes (6 to IRVLHAF and 3 to ARLHAF). These microscopes need binocular observation tubes with adjustable viewing angles that will improve ergonomics. The microscopes also need a parfocal continuous zoom mechanism with locking stops at each zoom level/magnification. In addition, the microscopes need to have sufficient magnification range, resolution, field of view, and working distance to efficiently perform microscopy on Filth and BSE samples while also minimizing eye strain to analysts.

Scope

Minimum Technical Specifications

Requirements

The Contractor shall provide 9 stereomicroscopes that each include binocular adjustable observation tubes, anti-static dust covers, goose neck LED illumination, an eye piece micrometer/reticle, 1X achromat objectives, and 10X eye pieces conforming to the specifications below:• 1X achromat objective with maximum working distance greater than or equal to 89mm and numerical aperture 0.10 or greater

• 10X/23B eye pieces distortion-free, dioptric adjustable, with reticle (10mm/0,1 mm) in one eye piece.

• Standard light base (non-transmitted) with the following approximate dimensions

300mm(w) x 280mm (d) x 25mm (h).

• No less than 60x maximum magnification.

• No greater than 7.5X minimum magnification.

• Maximum object field of view no less than 30.0mm.

• Achieves resolution of 300 lp/mm or greater (with 1x objective, 10x eyepieces)

• Binocular observation tubes with adjustable angles ranging from no more than 10º to no less than 50º.

• 2 arm gooseneck LED illumination with the following: 2 LED’s, no less than 10 brightness levels, 11 inches (279.4mm) or greater length, control panel on separate gooseneck, 5600k color temperature, ability to independently control each LED (i.e. both on, left on right off, right on left off), goosenecks LEDs and control panel mounted directly to microscope or built-in to microscope.

• Continuous zoom mechanism with no less than 8 total locking stops for zoom levels/magnifications.

• Parfocal throughout the magnification range.

• Antistatic dust cover for each microscope

• Compatible with digital microscope camera that allows simultaneous observation through eye pieces and camera.

The contractor shall provide training on all features to include system operations, calibration, optimization, and basic preventative maintenance procedures. This shall take place upon system Initial Qualification.

Trade and Service Specifications

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

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

3. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. 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 OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) 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, OEM quality parts.

4. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

5. Preventative maintenance (PM) visit shall be included for the base contract year.

This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM.

6. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training.

7. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification.

Records and Reports

The Contractor shall, commensurate with the completion of each service call relating to the first year warranty, provide the end-user of the equipment with a copy of the field corrective service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being repaired and detailing the reason for the warranty call, a detailed description of the work performed. The parts and the test equipment used to repair the system shall be on the report. This will include the name (s) and contact information of the engineer who performed the repair, and for information purposes, the on-site hours expended, and parts/components replaced.

Security and Privacy Requirements

Section 2 of FDA Security and Privacy Language does not apply to procurements for only hardware and software licenses.

1) The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges.

2) The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-

CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits.

3) The Contractor (and/or any subcontractor) shall ensure that computer software developed on behalf of HHS/FDA or tailored from an open-source product, is fully functional and operates correctly on systems configured in accordance with government policy and federal configuration standards. The contractor shall test applicable products and versions with all relevant and current updates and patches updated prior to installing in the

HHS/FDA environment. No sensitive data shall be used during software testing.

4) The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract.

Section 508 Compliance

The Contractor shall be familiar with Section 508 requirements as described at http://www.section508.gov/ in order to ensure that documents generated as part of the tasks are fully Section 508-accessible using the available COTS tools. Each order will identify the standards applicable to that order.

Deliverables

Deliverable Quantity Delivery Date

Within 60 days of award

Shipping Destinations:

FDA/IRVLHAF

19701 Fairchild

Irvine, CA 92612

FDA/ARLHAF

3900 NCTR Rd., Building 26

Jefferson, AR 72079

Period of Performance