Virology_NAAT_Requirements_18_Dec_15.docx

REQUIREMENTS DOCUMENT

IN SUPPORT OF

AUTOMATED NUCLEIC ACID AMPLIFICATION ASSAYS

FOR USAFSAM/PHE VIROLOGY BRANCH

WRIGHT-PATTERSON AFB, OH

18 December 2015

1. 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 Quantity Indefinite Delivery (IDIQ) contract (base plus three options) for instrumentation, reagents, consumables and support to perform second generation Nucleic Acid Amplification Testing (NAAT) technology for:

Chlamydia trachomatis (CT) & Neisseria gonorrhea (NG) Methicillin-resistant Staphylococcus aureus (MRSA) Clostridium Difficile (C. diff) Herpes Simplex Virus (HSV) 1 & 2

2. MINIMUM SUPPLY/REAGENT REQUIREMENTS: The contractor shall provide all instruments, collection kits, supplies and reagents required for providing results for the required testing, using FDA approved NAAT technology, for all test assays.

a. Estimated Annual Volumes:

b. FDA approved test and collection kits capable of CT/NG detection in vaginal/endocervical, male urethral specimens, and male/female urine specimens for ages down to 14 years old.

c. Estimated Quarterly Requirement: The contractor’s proposal shall include instrumentation, consumable supplies, reagents and control/calibration kits. The contractor will provide reagent and consumables that will accommodate a quarterly workload average of 63,500 tests. Contractor will do their best to ensure quarterly orders are from same batch/lot numbers, and expiration dates are greater than six months from received date, in the event it is not possible, the Contractor will inform USAFSAM/PHEM. In addition, USAFSAM/PHEM will request approximately 4-6 month drop shipments of reagents to be delivered to:

Epidemiology Laboratory Service

USAFSAM/PHE

Bldg 20840 2510 5TH Street

WPAFB, OH 45433

d. The quarterly requirement will be ordered using quarterly delivery orders.

e. Collection Kits: The contractor shall provide all collection kits for the required testing. Collection kits must meet minimum stability requirements of 60 days at 20-24°C (room temperature) for genital samples collected with a swab and 30 days at room temperature for urine samples. The contractor shall propose cost per test amount to include collection devices and drop shipments of the collection devices to stateside and overseas (OCONUS) customers.

f. Collections kits may be ordered through a blanket delivery order. Authorized personnel may place “Oral Calls” through established Delivery Orders. The contractor must ship direct to customers at approximately 225 locations worldwide.

g. Collections kits shall be delivered within 14 calendar days after receipt of order for statewide locations and 20 calendar days after receipt of order for OCONUS locations. There are approximately 225 locations worldwide that will receive these collection kits. Actual delivery location (Ship to/Mark for) will be defined in the individual order.

h. Consumable Supplies: The contractor shall provide extra consumable supplies upon request of USAFSAM/PHEM. Consumable supplies may be ordered through a blanket delivery order. Authorized personnel may place “Oral Calls” through the established Delivery Order.

3. MIMIMUM INSTRUMENTATION REQUIREMENTS:

a. The contractor shall provide fully-automated, walk-away hands-free instrumentation that possesses absolute automation for all phases of molecular diagnostics testing from sample preparation, amplification and detection to reporting results.

b. Sample preparation must include direct tube sampling with no sample manipulation/preparation prior to instrumentation analysis. This includes for CT/NG testing no removal of container caps, no off-board incubation or lysing, no removal of specimen swabs, and no manipulation of urine sample prior to testing on the instrument.

c. Instrument must have liquid level sensing to confirm adequate sample and reagent levels, must be able to process urine and swab samples simultaneously and must be one integrated system.

d. Instrument must be capable of sample barcode reading to identify the accession number and sample order.

e. Additionally, high-volume throughput must be capable of producing both CT and NG analysis result on the same specimen sample within a single batch run or with random-access and continuous sample loading capability.

f. Results must be automatically linked to reagent lot numbers. Positive specimen results must be sorted and identified for potential follow up. All reagents must be FDA-approved with the ability to add additional approved testing if warranted by the DoD. Instrumentation will have automated scheduled maintenance and the ability to run controls/calibrators only once every 24 hours.

g. Upon request, sufficient reagents shall be provided by the contractor for in-house evaluation of each analyte. Following evaluation, each reagent shall exhibit a minimum of 90% specificity and sensitivity in agreement with reagents currently in use (lot-to-lot correlation).

h. Instrumentation shall demonstrate exceptional productivity and a successful first time test run 95% of the time.

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

j. The contractor will comply with all CAP & FDA current and future regulations as required for accreditation.

k. The instrument shall be capable of bidirectional interface with the lab’s current Laboratory Information System, Composite Health Care System (CHCS). Test orders and results must be sent automatically to the instrument and laboratory information system, using auto download and auto verification.

l. The contractor shall be responsible for the transportation, installation, validation support (not limited to correlations, linearity, precision, accuracy, sensitivities, specificities, and standardized operation instructions).

m. The contractor is responsible to provide training to USAFSAM/PHEM personnel.

n. The contractor is responsible to provide initial operation and user maintenance training for two (2) people per instrument, to include roundtrip airfare, ground transportation, hotel accommodations and meals.

o. The contractor is responsible to provide follow up refresher annual training for incumbent or new USAFSAM/PHEM personnel including proper operating procedures and user maintenance for a minimum of one person per year available over the length of the contract.

p. Monitoring of Instrumentation: the contractor shall monitor equipment to ensure a single downtime occurrence does not exceed 24 hours without a service representative on-site response. The contractor must not exceed 24 hours for response to a downtime occurrence on more than two occurrences annually.

q. Maintenance of Instrumentation: The contractor shall be responsible for transportation, maintenance and servicing of equipment. The contractor shall provide all required tools, parts and labor necessary. There will be no more than twelve (12) downtime occurrences per instrument, per year. The contractor will be responsible to replace an instrument that exceeds twelve downtime occurrences per year. Must provide over the phone, instrument technical support during normal duty hours (730-2200 EST).

r. Workload Capabilities of Instrumentation: The contractor shall provide enough instrumentation to meet daily throughput of specimens based on the 63,5000 specimens per quarter and 1500/12 hr work period. This shall include enough redundancy to keep throughput constant even during scheduled PMs, instrument malfunctions of up to 48 hours, and periodic work surges in specimens by up to 50% of average daily volumes up to two times per quarter.