Requirement_Autoimmune_testing_2015.docx

REQUIREMENTS DOCUMENT

IN SUPPORT OF

AUTOMATED IMMUNODIAGNOSITICS TESTING FOR USAFSAM/PHE

WRIGHT PATTERSON AFB, OH

The United States Air Force School of Aerospace Medicine (USAFSAM/PHE) is seeking a fully automated, walk away, fully integrated, random access platform capable of high throughput. USAFSAM/PHE is seeking an Indefinite Delivery Indefinite Quantity (IDIQ) contract (base plus four options) for instrumentation, reagents, consumables and support to perform chemistry and immunology assays in an integrated platform with a single point of entry

1.0 Tests required/Annual Workload Estimates

1.1 Microscope Minimum Requirements

1. Must have ability to view slides through oculars, no dark room required.

2. Must have FDA approved automatic pattern recognition of 7 patterns (Homogenous, Speckled, Centromere, Nucleolar, Cytoplasmic, Negative, Nuclear Rim, Mitotic).

3. Must be able to recognize mixed patterns.

4. Must be able to read screen 200 samples within an hour.

1.2 Other Instrumentation Requirements

1. Must be able to perform the above tests.

2. The contractor will provide enough instrumentation, reagent and consumables to complete an average daily test load within a 12-hour window. (The daily workload can be estimated from the anticipated annual workload and factoring in TUE - SAT testing, except on federal holidays).

3. Must have bidirectional computer interface that is compatible with Composite Health Care System (CHCS).

4. Must have patient sample barcode reading.

5. Must be able to read more than one bar code symbology.

6. Must sample directly from primary patient tube or an aliquot tube.

7. Must have automatic clot detection.

8. Must have automatic reflex testing capability, user programmable.

9. Must have the capability of reloading sample, reagent and supplies without interruption from sample processing.

10. Must detect if primary patient sample has inadequate volume for required testing.

11. Must have ability to multiplex multiple tests on one slide.

12. Must have capability of reloading sample, reagent and supplies without interruption from sample processing.

1.3 Instrument Install and Training Support:

1. Must provide instrument transportation, delivery, and installation, to include calibration and test and system validation support.

2. Must provide training to include: onsite or offsite training. Onsite training will be a minimum of once per year (to accommodate rotation of personnel). Off site training will be a minimum of two per instrument provided plus two per year over the length of the contract. The contractor will provide, all expense to include but not limited to travel, lodging, meals and any additional expense that are training specific.

1.4 Instrument Repair and Maintenance:

At a minimum, the contractor will provide the following maintenance and repair services:

1. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufacturer’s guidelines.

2. Must provide all required tools, parts and labor as necessary to keep the instrument operational.

3. Must provide over the phone, instrument technical support during normal duty hours (0730 - 2200 EST).

4. The contractor will monitor equipment to ensure instrument downtime will not exceed 48 hours for a single occurrence.

5. In the event of an instrument failure, the contractor will provide onsite technical support with a response time of <24 hours. The contractor is responsible for all tools, parts, travel/lodging and labor that are necessary to bring the instrumentation back online in <48 hours from service.

1.5 Reagent minimum requirements:

1. All reagents except for Anticardiolipin, Borrelia Burgdorferi, Helicobacter Pylori, Calprotectin, Saccharomyces cerevisiae and Rhuematois Factor must be FDA approved. Once FDA approved, the aforementioned tests will be placed into use within the Epidemiology Laboratory.

2. Upon request, sufficient reagents shall be provided by the vendor for in-house evaluation of each analyte.

3. Following evaluation, each test kits shall exhibit at least 95% agreement with test kits currently in use in the Immunodiagnostics Laboratory.

4. The contractor will provide assistance troubleshooting any issues that result from College of American Pathologist (CAP) proficiency testing.