Automated_Chemistry_Testing_Requirement_-_22_May_2013.docx

REQUIREMENTS DOCUMENT IN SUPPORT OF

AUTOMATED CHEMISTRY TESTING FOR WRIGHT PATTERSON AFB, OH

The Wright Patterson Air Force Base Medical Laboratory is seeking a fully automated, walk away, fully integrated, random access platform capable of high throughput. WPAFB Med Lab is seeking a BPA (Blanket Purchase Agreement) for instrumentation, reagents, consumables and support to perform, on a single platform:

Instrumentation minimum requirement:

1. Must be capable for high throughput of at least 100-150 tests per hour. The contractor will provide enough instrumentation, reagent and consumables to complete an average daily test load within a 24 hour window. (The daily workload can be estimated from the anticipated annual workload and factoring in MON- FRI testing, including all down days, weekends and federal holidays).

Annual Workload Estimate

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

3. Must sample directly from primary patient tube.

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

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

6. Must automatically dilute patient sample if initial testing is outside the reportable range.

7. Must have automatic clot detection

8. Must have continuous specimen loading capability

9. Must have automatic test reflex capability that are programmable by the user

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 training and vendor specific to cover training that is not covered at onsite training. Offsite training will be a mini mum of two per instrument provided and will be available over the length of this contract. The contractor will provide, all expense to include but not limited to travel, lodging, meals and any additional expense that are training specific.

Instrument Repair and Maintenance:

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

l. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufactures 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 all duty hours

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 call.

6. If a separate water supply is required for the analyzer the maintenance and service will be covered in the contract.

Minimum Reagent Requirements:

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

1. All reagent kits must be FDA approved and will exhibit at least 95% sensitivity and 95% specificity.

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 vendor will be the sole manufacturer and distributor of the test kits

5. The vendor shall comply with all FDA regulations, the College of American Pathologist (CAP) checklist dated 31 Oct 2006.

6. All reagent kits must come from the specific manufacturer that produces the analyzer. The reagents will be analyzer specific, and not outsourced from other companies.