Requirements_Micro_ID__AST_2_Feb_16_combined_with_MDG.pdf

DRAFT

REQUIREMENTS DOCUMENT

IN SUPPORT OF

AUTOMATED MICROBIOLOGY IDENTIFICATION (ID) & ANTIBIOTIC

SUSEPTIBILITY TESTING (AST) FOR USAFSAM/PHE AND 88TH DTS/SGQC

WRIGHT PATTERSON AFB, OH

The United States Air Force School of Aerospace Medicine (USAFSAM/PHE) and Wright- Patterson AFB Diagnostic and Therapeutic Squadron Laboratory (88th DTS/SGQC) are seeking a fully automated, walk away, fully integrated, random access platform capable of high throughput. We are seeking a Blanket Purchase Agreement (BPA) contract (base plus four options) for instrumentation, reagents, consumables and support to perform, on a middleware integrated testing system for:

USAFSAM/PHE ID by Mass Spectrometer (MS), Biochemical ID, and AST Estimated Workload

Culture Source/Type Annual Quantity Biochemical ID 300

AST 3000

MS ID 5100

88 MDG ID by Mass Spectrometer (MS), Biochemical ID, and AST

Estimated Workload Culture Source/Type Annual Quantity

Biochemical ID 4500

AST 3500

MS ID Sent to USAFSAM/PHE

• Growth capabilities for more samples over the life of the contract. Show tiered pricing for total volumes:

Tier 1 (initial):

Culture Source/Type Annual Quantity Biochemical ID 4800

AST 7500

MS ID 5100

Tier 2:

Culture Source/Type Annual Quantity

Biochemical ID 4800

AST 10000

MS ID 8000

Tier 3:

Culture Source/Type Annual Quantity Biochemical ID 4800

AST 12000

MS ID 10000

Tier 4:

Culture Source/Type Annual Quantity

Biochemical ID 4800

AST 14000

MS ID 12000

Biochemical Identification and Antibiotic Susceptibility Instrumentation Minimum Requirement:

1. Must provide a test system at the 88th DTS/SGQC and at USAFSAM/PHE.

2. Must have an automated microbiology platform capable of identification and susceptibility testing.

3. Must have onboard panel inoculation.

4. Must be associated with a matrix Assisted Desorption/Ionization Time of Flight

(MALDI-TOF) Mass Spectrometer.

5. Must perform susceptibility testing using minimum inhibitory concentration standards.

6. Must have capability of performing rapid identifications and susceptibilities.

7. Must require no additional reagents.

8. Must have a system to create a standardized inoculum.

9. Must be able to select from identification only panels, and antibiotic susceptibility only panels.

10. Must have the capability to detect resistance in key pathogens (such as MRSA, VRE, and

KPC).

11. Must be capable of processing 60 panels per day and can upgrade to 120 panels per day as needed. The contractor will provide enough instrumentation, reagent and consumables to complete approximately 10,000 panels per year.

12. Must be able to complete ID panels in an average of 5 hours and AST panels within an average of 4-8 hours.

13. Must be able to ID and perform ASTs on at a minimum acid fast bacilli, aerobic, throat, blood, fungus, stool, respiratory, urine, and anerobic specimens/cultures.

14. Must have specialty identification panels (Yeast, Anaerobes, Haemophilus).

15. Must have software to provide automated detection of atypical results.

16. Must have a variety of susceptibility panel choices to meet the diverse formulary of our customers.

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

18. Must have continuous specimen loading capability

19. Must have bar code reading for sample identification

20. Auto-discrimination (reads more than one bar code symbology)

Mass Spectrometer Instrumentation Minimum Requirements:

1. Must place instrumentation at USAFSAM/PHE with capabilities for 88th DTS/SGQC to utilize the test system.

2. Must be associated with a matrix Assisted Desorption/Ionization Time of Flight (MALDI-TOF) Mass Spectrometer.

3. Sample bar code reading

4. Auto-discrimination (reads more than one bar code symbology)

5. Must have a robust FDA approved data base to include esoteric organisms without additional cost (numerous aerobic gram pos/neg, anaerobic, fungal/yeast, haemophilus, mycobacterium).

6. Must have a proprietary advanced spectra classifier which uses a weighted bin matrix to enable greater accuracy of identification.

7. Must have a data base with a large number of Research Use Only organisms that are being consistently submitted to the FDA for diagnostic clearance. Once organisms are cleared they will be available in the FDA approved data base at no additional charge.

8. Must be capable of processing approximately 12,000 identifications per year.

Middleware Instrumentation Minimum Requirements:

1. Must have auto-verification capabilities.

2. Must have software to provide automated detection of atypical results.

3. Must have a bidirectional laboratory interface system (LIS) that is compatible with the

Composite Health Care System (CHCS) or the current LIS system of the epidemiology laboratory.

4. Must provide a seamless interface link between the Biochemical Identification and Antibiotic Susceptibility Instrumentation and the MALDI-TOF Mass Spectrometer Instrumentation.

5. Must provide a seamless interface link between the Biochemical Identification and Antibiotic Susceptibility Instrumentation and the BACTEC Blood Culture Instrumentation.

6. Must be able to generate epidemiology reports from patient data.

7. Must have a quality control program that performs accurately with very few discrepancies.

8. Operating systems will run on Windows 7 or newer (equivalent) and will be upgraded as necessary to ensure system is maintained in accordance with Air Force guidance. Will not install any system with Windows XP.

9. Must provide middleware server for both the 88th DTS/SGQC and USAFSAM/PHE.

Easy Mag Reagent Minimum Requirements:

1. Must provide reagents and consumables for the Easy Mag instruments currently owned by USAFSAM/PHE.

2. Must be able to provide a large sequesterable amount of reagents of at least 90% of the estimated quantity with expiration dates of at least 12 months on a single lot number.

3. The order of reagents will be available as a single shipment for the year to provide enough extraction for respiratory testing at peak season.

4. Additional reagents may be ordered on an as needed basis within limits of the scope of the contract:

a. Easy Mag Buffer 1, 2, and 3

b. Easy Mag Disposables

c. Easy Mag Magnetic Sillica

d. Easy Mag Lysis Buffer, 2 mL

Film Array Reagent Minimum Requirements:

1. Must provide reagents and consumables for the Film Array instruments currently owned by USAFSAM/PHE.

2. Must be able to provide a large sequesterable amount of reagents of at least 90% of the estimated quantity with expiration dates of at least 12 months on a single lot number.

3. The order of reagents will be available as a single shipment for the year to provide enough extraction for respiratory testing at peak season.

4. Additional reagents may be ordered on an as needed basis within limits of the scope of the contract:

a. Film Array Respiratory Panel

b. Film Array GI Panel

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. Off site training will be a minimum of four initial training slots and two additional training slots per year provided (split evenly between PHE and the SGQC) and will be available over the length of this contract (advanced user training available to previously trained techs). 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 programming and troubleshooting with instrument LIS.

4. If the testing capabilities increase beyond the capabilities of the instrument additional instrumentation will be provided to continue testing.

Instrument Repair and Maintenance:

1. Must have low (<10 minutes) daily maintenance requirements.

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

3. Must provide onsite maintenance (monthly, quarterly, annually, etc.) in accordance with manufactures guidelines every year of the contract.

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

5. Must provide over the phone, instrument technical support during normal duty hours

(Monday through Sunday 24 hours per day 7 days per week).

6. For the 88th DTS/SGQC must provide onsite technical support 24 hours per day 7 days per week every year for the length of the contract.

7. For USAFSAM/PHE must provide onsite technical support during normal duty hours

(Monday – Friday 730-2000) for the first contract year and then every year after must be provided onsite technical support 24 hours per day 7 days per week.

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

9. 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 <24 hours from service call.

10. Onsite service will be provided for any needed alignments and any modifications for the MALDI-TOF Mass Spectrometer to function at its optimum capability. If required, due to quality control results, a regular schedule of service will be established to ensure this happens as often as would normally be required through an internet connection.

Reagent Minimum Requirements:

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

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

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

4. The contractor will be the sole manufacturer and distributor of reagents.

5. Panels must have a long shelf life (>9 months).

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

7. The contractor shall comply with all FDA regulations, the current CAP checklist, and

Clinical Laboratory Standards Institute (CLSI) recommendations.