SOLICITATION NOTICE
65 -- Cost-Per-Test-Laboratory Analyzers
- Notice Date
- 7/9/2014
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N0025915RCE0013
- Archive Date
- 9/30/2014
- Point of Contact
- Derek J. Bell, Phone: 3016196914
- E-Mail Address
-
derek.bell@med.navy.mil
(derek.bell@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- The Naval Medical Logistics Command intends to negotiate on a sole source basis (IAW FAR 13.501) with Gen-Probe (Hologic) 10210 Genetic Center Dr, San Diego, CA, 92121. The contract shall have a period of performance of five (5) years. The requirement is for an IDIQ for a cost per test contract for automated, molecular assay, infectious microorganism laboratory analyzer system for NMC San Diego. The equipment shall be automated systems capable of analyzing nucleic acids from urine and swab samples to test for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis (TV), and Human Papillomavirus (HPV). The systems shall be fully automated, random access robotic systems. The system shall be able to analyze endocervical and vaginal samples, urine samples for both males and females, and male urethral swabs. The system shall be able to test for CT, GC, TV and HPV on the same sample. For CT/GC specimens, the system shall be FDA-approved for testing the following sample types of both symptomatic and asymptomatic males and females: endocervical and vaginal samples, urine samples for both males and females, male urethral swabs and female PreservCyt liquid cytology specimens. The system shall be able to analyze other specimen types, such as rectal swabs, pharyngeal swabs and conjunctival swabs. For HPV specimens, the system shall be FDA-approved for testing female PreservCyt liquid cytology specimens directly or aliquoted into testing containers. If the original cytology specimen must be aliquoted prior to testing, a second instrument that performs automated sample processing (i.e. decapping primary and aliquot tubes, aliquoting and recapping primary and aliquot tubes) shall be included. The HPV assays shall be able to genotype HPV 16 and HPV 18. For TV specimens, the system shall be FDA-approved for testing the following sample types of both symptomatic and asymptomatic females: endocervical and vaginal samples, female urine samples and female PreservCyt liquid cytology specimens. The systems shall utilize nucleic acid amplification testing (NAAT) technology, performing simultaneous amplification and detection of target DNA or rRNA for CT/GC and TV and E6/E7 mRNA for HPV. The system shall be a fully automated system (all analytical steps performed onboard instrument). The automation platform shall be a single platform able to sample directly from patient collection tubes without removing caps and automatically dispense all reagents, perform all automated steps for NAAT. The system shall be capable of performing the following procedures: sample preparation, separation suspension, reagent preparation, hybridization, separation, and detection. The system shall be able to analyze and verify results that will be transmitted to the instrument computer which then utilizes an interface to transmit the results to the DOD Composite Health Care System (CHCS) Laboratory Information System. Specimen flow from start to finish shall be fully automated to include waste collection. The system shall be able to read Code 39 barcodes. The system must have specimen storage stability of at least seven (7) days in a transport container for urine and swap samples stored at 2-30 degrees Celsius. Specimens shall be able to be kept at -20 degrees Celsius for up to 90 days if the time of transport/storage exceeds 30 days. The system shall utilize closed primary testing containers with piercable caps to prevent specimen contamination. The system shall be capable of providing the following throughput per an 8.5 hour shift for the listed tests: Minimum Daily Throughput (per 8.5 hour shift) Test Qty CT 250 GC 250 HPV 80 TV 10 HPV 16/18 genotyping 10 The system shall be capable of expanding the test menu (run additional tests such as those being developed by the company or pending FDA clearance. Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/system such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The equipment shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The equipment shall be installed in compliance with OSHA requirements. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996). There are not set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325413 with a small business size standard of 500. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. Capability statements shall be submitted by email only as a MS Word or Adobe PDF attachment to Derek Bell at derek.bell@med.navy.mil. Statements are due not later than 3:00 PM on 24 Jul 14. No phone calls accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N0025915RCE0013/listing.html)
- Record
- SN03418917-W 20140711/140710022805-0d8b3ec7f96d6c50e45a3e15e4119153 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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