Syndromic Testing Reagents Statement of Work VA Portland.docx

Statement of Work (PWS) Request for Molecular Diagnostic Laboratory Reagents (Kits) for Syndromic Testing for Respiratory Panel, Gastrointestinal (GI) panel, Blood culture ID (BCID) panel, and Meningitis (ME) panel testing at VA Portland Health Care System.

Purpose Establish a Base Year plus Four (4) Option Year for reagents (kits) to be used on current in-use Molecular platform. VA owns and has used instrumentation for testing. Needed reagents (kits) are used for detection of needed pathogens found in Respiratory specimens, GI specimens, Blood culture, and CSF (meningitis) specimens.

Scope Vendor will provide Test Kits as needed to perform testing on VA owned molecular analyzer, located in the VA Portland Medical Center Microbiology Department.

The instrument processes kits that must utilize a multiplex PCR (polymerase chain reaction) method, have FDA-cleared assays that simultaneously tests for as many as 20 respiratory pathogen targets, has testing capability to test for common GI pathogens including viruses, bacteria, and parasites with at least 20 targets, at least 40 blood culture identification targets, and up to 14 meningitis/encephalitis targets inclusive of bacteria, viruses and fungi.

The method should have very little hands-on time (2 minutes or less) to set up and have results for respiratory pathogen targets, blood culture, GI pathogens and meningitis/encephalitis targets in one hour. The technique must perform amplification, detection and analysis in one self-contained system. The VA equipment includes software that automatically generates a result for each target in a single report.

Location VA Portland Health Care System, 3710 SW US Veterans Hospital Rd, Portland, OR 97239 Period of Performance

Records Management All records (administrative and program specific) created during the period of the contract belong to VA Portland (VPORHCS).

The C&A requirements do not apply, and a Security Accreditation Package is not required.

Kit/Panel requirements:

1. Respiratory:

Viruses

· Adenovirus

· Coronavirus 229E

· Coronavirus HKU1

· Coronavirus NL63

· Coronavirus OC43

· Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

· Human Metapneumovirus

· Human Rhinovirus/Enterovirus

· Influenza A, including subtypes

· H1, H3 and H1-2009

· Influenza B

· Parainfluenza Virus 1

· Parainfluenza Virus 2

· Parainfluenza Virus 3

· Parainfluenza Virus 4

· Respiratory Syncytial Virus

Bacteria

· Bordetella parapertussis

· Bordetella pertussis

· Chlamydia pneumoniae

· Mycoplasma pneumoniae

2. GI:

· Campylobacter (C. jejuni/C. coli/C. upsaliensis)

· Clostridium difficile (C. difficile) toxin A/B

· Plesiomonas shigelloides

· Salmonella

· Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio cholerae

· Yersinia enterocolitica

· Enteroaggregative Escherichia coli (EAEC)

· Enteropathogenic Escherichia coli (EPEC)

· Enterotoxigenic Escherichia coli (ETEC) lt/st

· Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of the E. coli O157 serogroup within STEC)

· Shigella/ Enteroinvasive Escherichia coli (EIEC)

· Cryptosporidium

· Cyclospora cayetanensis

· Entamoeba histolytica

· Giardia lamblia (also known as G. intestinalis and G. duodenalis)

· Adenovirus F 40/41

· Astrovirus

· Norovirus GI/GII

· Rotavirus A

· Sapovirus (Genogroups I, II, IV, and V)

3. Meningitis (CSF) panel Bacteria:

● Escherichia coli K1

● Haemophilus influenzae

● Listeria monocytogenes

● Neisseria meningitidis

● Streptococcus agalactiae

● Streptococcus pneumoniae Viruses:

● Cytomegalovirus (CMV)

● Enterovirus (EV)

● Herpes simplex virus 1 (HSV-1)

● Herpes simplex virus 2 (HSV-2)

● Human herpesvirus 6 (HHV-6)

● Human parechovirus (HPeV)

● Varicella zoster virus (VZV) Yeast:

● Cryptococcus neoformans/gattii

4. Blood culture ID panel Gram-Negative Bacteria:

· Acinetobacter calcoaceticus-baumannii complex

· Bacteroides fragilis

· Enterobacterales

· Enterobacter cloacae complex

· Escherichia coli

· Klebsiella aerogenes

· Klebsiella oxytoca

· Klebsiella pneumoniae group

· Proteus

· Salmonella

· Serratia marcescens

· Haemophilus influenzae

· Neisseria meningitidis

· Pseudomonas aeruginosa

· Stenotrophomonas maltophilia

Gram-Positive Bacteria:

· Enterococcus faecalis

· Enterococcus faecium

· Listeria monocytogenes

· Staphylococcus

· Staphylococcus aureus

· Staphylococcus epidermidis

· Staphylococcus lugdunensis

· Streptococcus

· Streptococcus agalactiae

· Streptococcus pneumoniae

· Streptococcus pyogenes

Yeast:

· Candida albicans

· Candida auris

· Candida glabrata

· Candida krusei

· Candida parapsilosis

· Candida tropicalis

· Cryptococcus neoformans/gattii

Antimicrobial Resistance Genes:

· Carbapenemases

· IMP

· KPC

· OXA-48-like

· NDM

· VIM

· Colistin Resistance

· mcr-1

· ESBL

· CTX-M

· Methicillin Resistance

· mecA/C

· mecA/C and MREJ (MRSA)

· Vancomycin Resistance

· vanA/B