Virus, Bacteria and Parasite Lab Detection System VISN 23 - BPA Virus, Bacteria and Parasite Lab Detection System VISN 23 - BPA
SOURCES SOUGHT: Virus, Bacteria and Parasite Detection System
On behalf of the VA Midwest Healthcare Network (VISN 23), the Fargo VA Medical Center is issuing this sources sought synopsis as a means of conducting market research to identify parties, specifically Veteran-Owned , Small Business (VOSB) or Service Disabled, Veteran Owned, Small Business (SDVOSB) having an interest in, and the resources to support this VISN-Wide requirement. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334516 Analytical Laboratory Instrument Manufacturing . At this time, the Fargo VA is contemplating the purchase of the Virus, Bacteria and Parasite Detection System through the VA FSS (Federal Supply Schedule). This Sources Sought is issued to determine if Veteran-Owned businesses are capable and likely to submit quotes for an equal item.
SALIENT CHARACTERISTICS:
VISN 23 Path & Lab Service
Virus, Bacteria and Parasite Detection System
Background:
VA Midwest Healthcare Network (VISN 23) is requesting a Blanket Purchase Agreement (BPA) for:
Instrumentation (processor, computer, printer, cables, and software)
Validation kits
Consumables (test kits)
Service
Annual training for government personnel onsite once per year. Three VISN sites have this instrumentation and coverage is needed for these systems, as well as additional systems that may be purchased by the Government over the life of the BPA.
Scope:
(1) Instrument
The instrument must utilize a multiplex PCR (polymerase chain reaction) method; have FDA-cleared assays that test for:
Common GI pathogens including viruses, bacteria, and parasites
Up to 27 blood culture identification targets
Up to 20 respiratory pathogen targets
Up to 14 meningitis/encephalitis targets inclusive of bacteria, viruses and fungi.
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 and meningitis/encephalitis 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:
(a) 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, Diarrheagenic E.coli/Shigella, 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.
(b) Blood Culture - Enterococcus, Listeria monocytogenes, Staphylococcus, Streptococcus, Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes, Acinetobacter baumannii, Haemophilus influenza, Neisseria meningitides, 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, antimicrobial resistance genes (mecA - methicillin resistance, vanA/B - vancomycin resistance, KPC - carbapenem resistance).
(c) Respiratory - Adenovirus, Coronavirus HKU1, Coronavirus HKU1, 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 pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae.
(d) Meningitis/Encephalitis - Escherichia coli K1, Haemophilus influenza, Listeria monocytogenes, Neisseria meningitides, Streptococcus agalactiae, Streptococcus pneumoniae, Cytomegalovirus (CMV), Enterovirus, Epstein-Barr virus (EBV), 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, Cryptococcus neoformans.
(2) Validation Kits
All materials needed for verification of respiratory, blood culture identification, GI and meningitis/encephalitis tests as required recommended by the contractor.
(3) Consumables (test kits)
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 up to 27 blood culture identification targets.
To include all reagents/expendables that will detect up to 20 respiratory pathogen targets.
To include all reagents/expendables that will detect up to 14 meningitis/encephalitis targets inclusive of bacteria, viruses and fungi.
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.
(4) Service
Extended warranty or service to keep the equipment in good operating condition (includes both preventive maintenance and emergency repairs) for all instrumentation onsite at VISN 23 facilities for the duration of the agreement.
Equipment repair service shall be provided to each facility during core business hours (8am 5pm, Monday Friday, Eastern Standard Time). Phone service available during these times. a) 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 an emergency repair service call shall be treated as a separate and new service call.
(5) Training
Annual onsite training will be provided for all VISN 23 sites, as requested by the Contracting Officer s Representative (COR) without any additional charge to the Government.
Items required: (estimated annual usage based on previous history):
Item Number
Base Year Product Name/Description
Base Year Estimates
Option Year 1 Estimates
Option Year 2 Estimates
Option Year 3 Estimates
Option Year 4 Estimates
Total
5 year Estimates
FLM1-ASY-0122
Verification Package - FA 2.0 Instrument, RP
0
5
0
0
0
5
FLM1-ASY-0124
Verification Package - FA 2.0 Instrument, BCID
0
5
0
0
0
5
FLM1-ASY-0130
Verification Package - FA 2.0 Instrument, GI
10
5
0
0
0
15
FLM1-ASY-0145
Verification Package - FA 2.0 Instrument, ME
0
5
0
0
0
5
FLM2-ASY-0001
FilmArray 2.0 Instrument Kit
10
5
0
0
0
15
FLM2-ASY-0003
FilmArray 2.0 Computer Kit
6
5
0
0
0
11
FLM2-ASY-0005
Instrument Duo Rack
4
0
0
0
0
4
FLM2-ASY-0008
FilmArray 2.0 Printer Kit
6
5
0
0
0
11
RFIT-ASY-0116
GI Panel, IVD 30 Tests, Kit
86
86
86
86
152
496
RFIT-ASY-0124
Respiratory Panel 30 pouch kit
0
45
45
45
45
180
RFIT-ASY-0126
Blood Culture Identification Panel 30 pouch kit
0
55
95
95
95
340
RFIT-ASY-0118
Meningitis/Encephalitis Panel Kit
0
45
45
45
45
180
FLM1-PRT-0024
Manufacturer s Warranty
10
5
0
0
0
15
FLM1- PRT-0018
Extended Warranty
0
16
21
21
21
79
FLM1- SRV-0007
Non-Warranty FilmArray Service Tier 1
0
2
2
2
2
8
FLM1- SRV-0008
Non-Warranty FilmArray Service Tier 2
0
2
2
2
2
8
FLM1- SRV-0009
Non-Warranty FilmArray Service Tier 3
0
1
1
1
1
4
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 the laboratory needs a repair to an instrument, the vendor will pay for shipment and repairs of the equipment and ensure there is a loaner on hand during the equipment repairs. The vendor will pay to overnight a loaner instrument, if requested by the laboratory manager on site. The laboratory manager will run the quality controls on both the loaner and the repaired instrument to ensure it is working properly. This is up the individual laboratory managers to test and document the results per instrument. The expense for validation between the loaner and repaired instrument will be borne by the vendor.
There will be an upgrade program for all VISN 23 sites that currently utilize older versions of the Film Array System.
The Government reserves the right to add additional VISN 23 Lab sites and testing kits 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, MNB 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
END SALIENT CHARACTERISTICS
THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Submission of any information in response to this market survey is purely voluntary. The Government assumes no financial responsibility for any costs incurred.
If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, web-site address, telephone number, and size and type of ownership of your organization. 2) Tailored capability statements addressing the particulars of this effort. We are seeking Veteran Owned sources, but any Small Business should identify its capability to provide the instrument.
BASED ON THE RESPONSES TO THIS MARKET RESEARCH THROUGH THIS SOURCES SOUGHT NOTICE, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESS OR PROCURED THROUGH FULL AND OPEN COMPETITION, and multiple awards MAY be made. Telephone inquiries will NOT be accepted or acknowledged and no feedback or evaluations will be provided to companies regarding submissions. To reiterate, this Sources Sought Notice is for planning purposes only and is intended to identify any Service Disabled, Veteran Owned, Small Businesses or Veteran Owned, Small Businesses who can support this requirement.
Submission Instructions: Interested parties who consider themselves qualified to perform the above- listed services are invited to submit a response to this Sources Sought Notice by NOON, April 4, 2017. All responses under this Sources Sought Notice must be emailed to janet.lang@va.gov
Jan Lang
janet.lang@va.gov
janet.lang@va.gov
