This notice is being reissued with the removal of COVID-19, and all are welcome to respond, including those who may have responded previously.
The Regional Health Contracting Office-Central (RHCO-C) is issuing this Sources Sought Notice to find potential sources to provide equipment and reagents/consumables on a reagent rental (i.e., cost-per-test) arrangement for a multiplex polymerase chain reaction (PCR) diagnostic system for pathogenic microorganisms for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center, JBSA Fort Sam Houston - Texas. A base period of performance plus four (4) option periods are contemplated.
THIS IS NOT A SOLICITATION ANNOUNCEMENT – This is a Sources Sought Notice and is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ) or a promise to issue an RFQ in the future. Solicitations are not available at this time and requests for a solicitation will not receive a response. This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever. All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government. Not responding to this Sources Sought Notice does not preclude participation in any future RFQ, should one be issued. It is the responsibility of the potential offerors to monitor this site for additional information pertaining to this requirement.
The Government will use responses to this notice in formulating its acquisition strategy. If the Government does not receive sufficient information in response to this notice to verify the potential for competition exists, it is possible that a sole-source contract, supported by a Justification and Approval document, will be issued to support the Government's requirement.
RHCO-C is seeking the following information (please answer paragraph below with your response):
Company name, DUNS number, CAGE code, and point of contact information (including phone number and email address), and socio-economic category(ies) as related to NAICS 325413 (In-Vitro Diagnostic Substance Manufacturing), such as 8(a), HUBZone, Women-Owned, Service-Disabled Veteran-Owned, Small, or Other-than-Small.
Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate:
I. Respiratory Panel
a. Provides reagents and controls for the following comprehensive infectious disease assays
Respiratory panel capable of detecting 20 pathogens
Adenovirus
Human Metapneumovirus
Human Rhinovirus/Enterovirus
Influenza A
Influenza A/H1
Influenza A/H3
Influenza A/H1-2009
Influenza B
Parainfluenza Virus 1
Parainfluenza Virus 2
Parainfluenza Virus 3
Parainfluenza Virus 4
Respiratory Syncytial Virus
Bordetella parapertussis
Bordetella pertussis
Chlamydia pneumoniae
Mycoplasma pneumoniae
II. Gastrointestinal Panel
Gastrointestinal panel capable of detecting 22 pathogens
Campylobacter (jejuni, coli, and upsaliensis)
Clostridium difficile (toxin A/B)
Plesiomonas shigelloides
Salmonella
Yersinia enterocolitica
Vibrio (parahaemolyticus, vulnificus, and cholerae)
Vibrio cholerae
Enteroaggregative E. coli (EAEC)
Enteropathogenic E. coli (EPEC)
Enterotoxigenic E. coli (ETEC) lt/st
Shiga-like toxin-producing E. coli (STEC) stx1/stx2
E. coli O157
Shigella/Enteroinvasive E. coli (EIEC)
Cryptosporidium
Cyclospora cayetanensis
Entamoeba histolytica
Giardia lamblia
Adenovirus F40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus (I, II, IV, and V)
III. Blood Culture Panel
Blood Culture panel capable of detecting 24 pathogens and 3 antibiotic resistance markers
Enterococcus
Listeria monocytogenes
Stapylcoccus
Staphylococcus aureus
Streptococcus
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes
Acinetobacter baumannii Haemophilus influenzae
Niesseria meningitidis
Pseudomonas aeruginosa
Enterobacteriaeceae
Enterobacter cloacae complex
Escherichia coli
Klebsiella oxytoa
Klebsiella pneumoniae
Proteus
Serratia marcescens
Candida albicans
Candida glabrata
Candida krusei
Candida parasilosis
Candida tropicalis
MecA – methicillin resistance
VanA/B – vancomycin resistance
KPC – carbapenem resistance
IV. Meningitis/Encephalitis Panel
Meningitis/encephalitis panel capable of detecting 14 pathogens
Escherichia coli K1
Haemophilus influenzaeListeria monocytogenes
Neisseria meningitidis
Streptococcus agalactiae
Streptococcus pneumoniae
Cytomegalovirus
Enterovirus
Herpes simplex virus 1
Herpes simplex virus 2
Human herpesvirus 6
Human parechovirus
Varicella zoster virus
Cryptococcus neoformans/gattii
b. Reagents must have been evaluated and approved by the Food and Drug Administration (FDA) for use OR be on track to obtain an Emergency Use Authorization by the FDA no later than 30 April 2020
c. Ability to ensure proper cold-chain management of supply during shipping
d. Overnight shipping when requested; otherwise, shipments arrive at the facility no more than five (5) days after receipt of order. Ensure reagent expiration date is at least four months (or more) from received date. Ensure no cost replacement of supplies if damaged or out of temperature upon arrival as determined by end user.
e. Provide at least two (2) analyzers that are FDA approved and any service required to maintain those analyzers
Shall have identification of different classes of common infecting microorganisms (i.e., bacteria, viruses, yeasts, and parasites) found in each specimen type
Shall be modular and expandable to accommodate possible changing requirements, up or down
Shall have minimal hands-on time for set-up (e.g., 10 minutes or less); walk-away for analysis with minimal training time required of medical technologies (e.g., 2 hours or less) and minimal maintenance (e.g., 1 hour per week or less)
Provide direct customer service during normal business hours, excluding weekends and holidays
f. Must have quality control reporting that meets or exceeds all accreditation requirements outlined by the College of American Pathologists.
g. Provide recall or advisory information within 2 days of notice to end user.
h. Shall provide results available in less than 90 minutes.
The response due date for this Sources Sought Notice is 4PM CST, April 16, 2020.
All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs:
Michelle Bartkowski, [email protected]
Medina Woodson, [email protected]