The requirement is for FDA approved Molecular panels to be used with FDA approved multiplex PCR instrument to include, shipping costs, software, and in vitro diagnostic respiratory, blood culture identification, and meningitis panels with the following minimum requirements:
1. Respiratory panels shall include the following targets: Adenovirus, Coronavirus (HKU1, NL63, 229E, OC43), Metapneumovirus, Rhinovirus/Enterovirus, Influenza (A, A/H1, a/H3, A/H1-2009, B), Parainfluenza (1,2,3,4), RSV, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae.
2. Blood culture panels shall include the following targets: Enterococcus, Listeria monocytogenes, Staphylococcus, Staphylococcus aureus, Streptococcus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Acinetobacter baumannii, Haemophilus influenza, Neisseria meningitidis, Pseudomonas aeruginosa, Enterobacteriaceae, Enterobacter cloacae complex, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus, Serratia marcescens, Candida albicans, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, and resistance markers (mecA, vanA/B, KPC).
3. Meningitis/Encephalitis panels shall include the following targets: Escherichia coli, Haemophilus influenza, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae, CMV, EV, HSV-1, HSV-1, HHV-6, HPeV, and VZV.
4. Instrument shall accommodate up to 3 or more panels simultaneously and each can be accessed independently and randomly (shall NOT be limited to batch mode testing).
5. Pre-extraction of specimens shall not be required to perform diagnostic panel procedures on the instrument.
6. Results obtained from unprocessed patient specimen shall be obtained in 2 hours or less.
7. Shall include standard warranty and services for repair and maintenance that shall last the life of the contract.
8. Repairs and maintenance shall include labor, parts and replacement equipment required to repair instrument breakdowns and restore full functionality.
9. Technical telephone support shall be available 24 hours a day.
10. Laboratory Information System (CHCS) connection shall support serial interface (ASTM). Vendor will provide middleware for interface if required.
Interested vendors may submit in writing their capabilities and qualifications demonstrating their ability to fulfill the requirement identified in this notice. Responses to this notice must refer to the solicitation number indicated above and include company name, address, and telephone number, point of contact (POC), and brochures which will allow the Government to understand your offerings and options. Capability statements should be submitted to the attention of Donna Tomita, Contract Specialist, email [email protected]. Telephone responses will not be accepted. Responses must be received no later than 6 Sep 2019 at 10:00 AM Hawaii Standard Time.
Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to supply the required equipment. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. No proprietary, classified, confidential, or sensitive information should be included in your response. A determination by the government not to compete this proposed effort on a full and open competition basis, based upon responses to this notice, is solely within the discretion of the government.