Immuno_Testing_Req_Doc.docx
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Requirement Document
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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
Annual Workload Estimate
| · Antibodies (Total) to Hepatitis A Virus | 24124 | ||||||
| · Antibodies (IgM) to Hepatitis A Virus | 47764 | ||||||
| · Antibodies (Total) to Hepatitis B Core Antigen | 60962 | ||||||
| · Antibodies (IgM) to Hepatitis B Core Antigen | 3259 | ||||||
| · Antibodies to Hepatitis B Surface Antigen | 73439 | ||||||
| · Hepatitis B Surface Antigen | 82443 | ||||||
| · Hepatitis B Surface Antigen Confirmation | 3000 | ||||||
| · Antibodies (IgG) Hepatitis C Virus | 65884 | ||||||
| · Testosterone Total | 13617 | ||||||
| · Sex Hormone Binding Globulin (SHBG) | 12501 | ||||||
| · Albumin | 12194 | ||||||
| · HgBA1C | 20668 | ||||||
| · Prostatic Specific Antigen, Free | 3500 | ||||||
| · Prostatic Specific Antigen, Total | 3364 | ||||||
| · Antibodies to Thyroglobulin | 2693 | ||||||
| · Antibodies to Thyroid Peroxidase | 5166 | ||||||
| · Antibodies to TSH Receptor | 426 | ||||||
| · T3 | 483 | ||||||
| · T4 | 5172 | ||||||
| · T3, Free | 108 | ||||||
| · T4, Free | 621 | ||||||
| · T Uptake | 1650 | ||||||
| · TSH | 390 | ||||||
| · Immunoglobulin A | 4057 | ||||||
| · PTH, Intact | 722 | ||||||
| · Calcium | 369 | ||||||
| · DHEA Sulfate | 874 | ||||||
| · C-Reactive Protein | 842 | ||||||
| · Iron with TIBC/UIBC | 896 | ||||||
| · BHCG | 642 | ||||||
| · AFP | 622 | ||||||
| · CA 125 | 309 | ||||||
| · CA 15-3 | 171 | ||||||
| · CA 19-9 | 459 | ||||||
| · Cortisol | 488 | ||||||
| · Alpha 1 Antitrypsin | 711 | ||||||
| · C3 | 285 | ||||||
| · C4 | 295 | ||||||
| · Ammonia | 276 | ||||||
| · Insulin | 613 | ||||||
| · APO A | 76 | ||||||
| · APO B | 211 | ||||||
| · Ceruloplasmin | 123 | ||||||
| · Cystatin C | 161 | ||||||
| · Fructosamine | 252 | ||||||
| · Haptoglobin | 298 | ||||||
| · IgG | 214 | ||||||
| · IgM | 210 | ||||||
| · Lipase | 283 | ||||||
| · Rheumatoid Factors | 95 | ||||||
| · Transferrin | 363 | ||||||
| · C-Peptide | 267 | ||||||
| · Estradiol | 121 | ||||||
| · Folate | 131 | ||||||
| · RBC Folate | 210 | ||||||
| · Vitamin B12 | 171 | ||||||
| · Myoglobin | 158 | ||||||
| · Beta 2 Microglobulin | 92 | ||||||
| · High Sensitive C Reactive Protein | 36 | ||||||
| · Ferritin | 26 |
Instrumentation minimum requirement:
1. Must provide Clinical Chemistry and Immunoassays integrated into a single platform with a single point of entry.
2. Must provide immunoassay incubation time of not more than 28 minutes. See above for tests and annual estimated volume.
3. Must be capable of high through put of at least 240 tests per hour.
4. 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).
5. Must have bidirectional computer interface that is compatible with Composite Health Care System (CHCS)
6. Must sample directly from primary patient tube or an aliquot tube.
7. Must have the capability to read sample bar codes
8. Must be able to read more than one bar code symbology
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 automatically dilute patient sample if initial testing is outside the reportable range.
12. Must have automatic clot detection
13. Must have continuous specimen loading capability
14. Must have automatic test reflex capability that are programmable by the user
15. Must have autoverification capabilities
16. Must have tiered pricing based on workload changes projected in future.
Automation Minimum Requirements:
1. Preanalytic decapping of sample tube
2. Preanalytic evaluation of sample integrity
3. Postanalytic sealing/capping of sample tube
4. Postanalytic aliquoting and capping of secondary tube
5. Sorting samples base on ordered test to analyzer
6. Sort samples based on collection date and tube type
7. Preanyltic evaluation sorted to error holding lane for review
8. Capable of programmable rule base interface
Instrument Install and Training Support:
1. Must provide instrument transportation, delivery, and installation, to include calibration, 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. 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.
3. Must provide training and support for automation rules programming.
4. Installation will use current electrical and water supplies.
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 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 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 call.
Reagent Minimum Requirements:
1. Instrument/reagent kits must be FDA approved and will provide analytical sensitivity along the entire range of the manufacturer’s stated measuring range.
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 be the sole manufacturer and distributor of the test kits.
5. The contractor will provide assistance troubleshooting any issues that result from College of American Pathologist (CAP) proficiency testing.
6. The contractor has or is pursuing HIV Ag/AB 4th Gen Combo and this test will be added for use as soon as it is available.
Note to buyer: for all technical questions, please contact the Operations lead: (Capt Tammy Shaw, tammy.shaw@us.af.mil (937-938-3303).
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