Reissuance: Cost-per-Test - Multiplex PCR and Pathogenic Microorganisms

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 e-mail to the below POCs:

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

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

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):

1. 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.
2. 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
  • Coronavirus HKU1
  • Coronavirus NL63
  • Coronavirus 229E
  • Coronavirus OC43
  • 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
     
• COVID-19 assay capable of detecting the 2019 Novel Coronavirus

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, March 23, 2020. 

All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs: