Notice of Sole Source Award and Redacted J&A - Cost-Per-Test Multiplex – PCR and Pathogenic Microorganism

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:

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

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)

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

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 email

to the below POCs:

Michelle Bartkowski, michelle.m.bartkowski.civ@mail.mil

Medina Woodson, medina.l.woodson.civ@mail.mil

Awarded contract W81K00-20-P-0348 to unknown vendor for unknown amount on 2020-09-26.