Active

Contract Opportunity

VISN 23 Path & Lab Service Line

Virus, Bacteria and Parasite Detection System Indefinite Delivery Indefinite Quantity

Background:

VA Midwest Healthcare Network (VISN 23) is requesting a Biomerieux BioFire Brand Name Only Indefinite Delivery Indefinite Quantity (IDIQ) for (1) instrumentation (processor, computer, printer, cables, and software), (2) validation kits, (3) consumables (test kits), (4) service, and (5) training for government personnel onsite for this 5-Month IDIQ.

Scope:

1. Instrument

The instrument must utilize a multiplex PCR (polymerase chain reaction) method, have FDA- cleared assays that test for (a) common GI pathogens including viruses, bacteria, and parasites,

(b) blood culture identification targets, (c) respiratory pathogen targets and (d) meningitis/encephalitis targets inclusive of bacteria, viruses and fungi, (e) clinically relevant pneumonia targets from sputum (including endotracheal aspirate) and bronchoalveolar lavage (including mini-BAL) samples.

The instrumentation should have very little hands-on time (5 minutes or less) to set up and have results for GI pathogens, blood culture, respiratory pathogen targets, meningitis/encephalitis targets, and clinically relevant pneumonia targets in one hour. The instrument must perform amplification, detection and analysis in one self-contained system. The instrument includes software that automatically generates a result for each target in a single report.

The instrumentation should have the ability to test for the following pathogens:

1. GI - Adenovirus F40/41, Astrovirus, Norovirus GI/GII, Rotovirus A, Sapovirus (I, II, IV, and V), Campylobacter (jejuni, coli and upsaliensis), Clostridium difficile (Toxin A/B), Plesiomonas shigelloides, Salmonella, Yersinia enterocolitica, Vibrio (parahaemolyticus, vulnificus and cholerae), Vibrio cholera, 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.

1. Blood Culture – Enterococcus faecalis, Enterococcus faecium, Listeria monocytogenes, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Acinetobacter calcoaceticus-baumannii complex, Bacteroides fragilis, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Proteus, Salmonella, Serratia marcescens,

Candida albicans, Candida auris, Candida glabrata, Candida krusei, Candida parapsilosis, Candida tropicalis, Cryptococcus neoformans/gattii, IMP, KPC, OXA-48- like, NDM, VIM, mcr-1, CTX-M, mecA/C, mecA/C and MREJ (MRSA), an vanA/B

1. Respiratory – Adenovirus, Coronavirus HKU1, Coronavirus NL63, Coronavirus 229E, Coronavirus OC43, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS- CoV-2), 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.

1. Meningitis/Encephalitis - Escherichia coli K1, Haemophilus influenza, Listeria monocytogenes, Neisseria meningitides, Streptococcus agalactiae, Streptococcus pneumoniae, Cytomegalovirus (CMV), Enterovirus, Herpes simplex virus 1 (HSV-1), Herpes simplex virus 2 (HSV-2), Human herpesvirus 6 (HHV-6), Human parechovirus, Varicella zoster virus (VZV), Cryptococcus gattii/neoformans.

1. Pneumonia - Adenovirus, Coronavirus, Human Metapneumovirus, Human, Rhinovirus/Enterovirus, Influenza A, Influenza B, Parainfluenza Virus, Respiratory Syncytial Virus, mecA/C and MREJ, IMP, KPC, OXA-48-like, NDM, VIM, CTX-M, Acinetobacter calcoaceticus-baumannii complex, Enterobacter cloacae complex, Escherichia coli, Haemophilus influenzae, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae group, Moraxella catarrhalis, Proteus spp., Pseudomonas aeruginosa, Serratia marcescens, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia pneumoniae,

Legionella pneumophila, Mycoplasma pneumoniae

1. Validation Kits

All materials needed for verification of respiratory, blood culture identification, GI, meningitis/encephalitis, and pneumonia tests as available by the contractor. Validation kits must be FDA approved for analysis on Biofire FilmArray Torch and Biofire FilmArray 2.0 analyzers.

1. Consumables (test kits)

Test kits must be FDA approved for analysis on Biofire FilmArray Torch and Biofire FilmArray

2.0 analyzers.

To include all reagents/expendables that will test for common GI pathogens including viruses, bacteria and parasites.

To include all reagents/expendables that will test for blood culture identification targets. To include all reagents/expendables that will detect respiratory pathogen targets.

To include all reagents/expendables that will detect meningitis/encephalitis targets inclusive of bacteria, viruses and fungi.

To include all reagents/expendables that will detect clinically relevant pneumonia targets inclusive of bacteria (typical and atypical), viruses and antimicrobial resistance genes.

All reagents should have the longest outdates possible, contractor will guarantee four months and the VA can request the longest outdate available upon order.

SDS – Safety Data Sheets are required. Any product formulation changes must be accompanied with an updated SDS.

The contractor shall notify, within 24 hours, the appropriate laboratory regarding any recalled reagents. This must be accomplished by telephone and/or certified email/regular mail. The vendor will provide sufficient replacement items to resolve the problem so that there is no break in service experienced. Contractor will support use of alternative reagents if required due to recall or multiple performance issues.

The test kits will be shipped and replenished in quantities as requested by the individual site laboratory. The laboratory departments will request the kits on an as-needed basis. Each site will be invoiced for their own delivery orders. The Contractor will provide direct delivery to the requesting lab at the contractor’s expense. The Laboratory department will order using their usual procedures and referencing the purchase agreement pricing. They will be invoiced for their own orders.

1. Service

Extended warranty or service to keep the equipment in good operating condition (includes both preventive maintenance and emergency repairs) for all instrumentation at VISN 23 facilities for the duration of the agreement.

Equipment repair service shall include options for as needed, as needed with a one-year module warranty, or an extended warranty.

• 
  
  
  
  • As needed: At minimum, depot service. A temporary module will be shipped. The failed module will be returned in the same packaging with the option to retain the new module and forego the repaired unit’s return.
  
  
  • As needed with one year module warranty: At minimum, depot service. A temporary module will be shipped. The failed module will be returned in the same packaging with the option to retain the new module and forego the repaired unit’s return. A one-year warranty will be included on the new or refurbished module.
  
  
  • Extended warranty: At minimum, depot service. A temporary module will be shipped. The failed module will be returned in the same packaging with the option to retain the new module and forego the repaired unit’s return. Extended warranty is paid in advance and includes preventative maintenance.
  
  
  
  

Phone service available shall be provided to each facility during core business hours (8am – 5pm, Monday – Friday, Eastern Standard Time).

Requests for equipment repair response time shall be no more than 48 hours. A malfunction incident report will be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following:

• 
  
  
  
  • Service provided
  
  
  • Date and time notified
  
  
  • Date and time of arrival
  
  
  • Serial number, type and model number of equipment
  
  
  • Time spent for repair
  
  
  • Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance
  
  
  
  

Each notification for repair service call shall be treated as a separate and new service call.

1. Training

Annual training will be provided for all VISN 23 sites, as requested by the COR without any additional charge to the Government.

Items required: (estimated annual usage based on previous history):

Base Year

LIN

Item Number

Base Year Product Name/Description

UO I

Price

Estimate d Quantity

Extende d Price

000

RFIT-ASY-

GI Panel, IVD 30 Tests, Kit

KT

4112.5

1

0116

6

000

RFIT-ASY-

Blood Culture Identification Panel 2 30

KT

3344.9

2

0147

pouch kit

2

000

RFIT-ASY-

BioFire ME Panel 30 pouch kit

KT

5120.8

3

0118

0

000

423742

BioFire RP2.1 Panel 30 Pouch Kit

KT

3344.9

4

2

000

RFIT-ASY-

BioFire PN Panel 30 Pouch Kit

KT

5820.6

5

0144

0

000

RFIT-ASY-

Biofire Joint Infection Panel

KT

7500.0

6

0138

0

000

FLM1-ASY-

Verification Package - FA 2.0

KT

4500.0

7

0130

Instrument, GI

0

000

FLM1-ASY-

Verification Package - FA 2.0

KT

4950.0

8

0145

Instrument, ME

0

000

423743

BioFire RP2.1 Verification Kit

KT

4500.0

9

0

001

423640

BCID2 Verification Kit

KT

4500.0

0

0

001

424181

Biofire Joint Infection Verification Kit

KT

4950.0

1

0

001

FLM1-ASY-

PNEUMO VERIFICATION KIT FLM1-

KT

4950.0

2

0150

ASY-150

0

The annual quantity is only an estimate. Volumes may vary during the life of the agreement.

Contractor will supply a quarterly report to the Contracting Officer’s Representative (COR) that indicates the products and quantities purchased each month. The report will consist of a breakdown which includes: the facility name, products obtained under this agreement, and the volume per month.

All pricing includes FOB destination with 2 day shipping upon order.

In the case of a company merger and/or acquisition, contractors, will immediately notify the Contracting Officer for this BPA and provide a contingency plan of services to assure that no break in service is experienced by the participating facilities.

Verification of Loaner and Repaired Instruments. If a laboratory needs to repair an instrument/module, the vendor will pay for shipment and repairs of the equipment and ensure there is a loaner on hand during the equipment repairs (in accordance with the service or warranty option selected). The vendor will pay to overnight a loaner instrument, if requested by the laboratory manager or designee. The laboratory manager or designee will run the quality controls on both the loaner and the repaired instrument to ensure it is working properly. It is the responsibility of the laboratory manager or designee to test and document results per instrument. The expense for validation between the loaner and repaired instrument will be borne by the vendor.

The Government reserves the right to add additional VISN 23 Lab sites, testing kits, or upgraded/new equipment during the life of this agreement.

All VISN 23 sites may order from this agreement:

Black Hills VA Health Care System - Fort Meade 113 Comanche Road

Fort Meade, SD 57741

Black Hills VA Health Care System – Hot Springs 500 N 5th Street

Hot Springs, SD 57747

Central Iowa VA Health Care System – Des Moines 3600 30th Street

Des Moines, IA 50310-5774

Fargo VA Health Care System 2101 Elm Street

Fargo, ND 58102

Iowa City VA Health Care System 601 Highway 6 West

Iowa City, IA 52246-2208

Nebraska Western Iowa VA Health Care System- Omaha 4101 Woolworth Avenue

Omaha, NE 68105

Minneapolis VA Health Care System One Veterans Drive

Minneapolis, MN 55417

Sioux Falls VA Health Care System 2501 W. 22nd Street

PO Box 5046

Sioux Falls, SD 57117-5046

St. Cloud VA Health Care System 4801 Veterans Drive

Saint Cloud, MN 56303

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