FY27 Rapid Molecular SOW.doc

STATEMENT OF WORK (SOW)

1. Contracting Officer’s Technical Representative (POC)

2. Contract Title Procurement of rapid syndromic molecular testing reagents.

3. Background Purchase order is requested to order specific products necessary to perform rapid syndromic infectious disease diagnostic testing by RT-PCR. This testing is for veterans across Washington State, Oregon, Alaska and Bone Marrow and Solid Organ Transplant patients tested and monitored from across the United States. Testing is performed on direct patient samples including stool, urine, sputum, endotracheal aspirate and nasopharyngeal or nasal/mid-turbinate.

4. Scope Our scope is to acquire specific FDA-approved infectious disease and oncology assays formulated as single-use test cartridges and reagents that are equal to and/or compatible to what is currently being used on the VA owned instrument/analyzer. Required rapid molecular assays include targets for C. difficile, SARS-CoV-2 with Influenza A & B and RSV, Strep A, MTB IVD – Mycobacterium tuberculosis with Rif, MVP-Multiplex Vaginal Panel, GI Panel, MRSA Carba-R, Norovirus, BCR-ABL, FII & FV and vanA PCR. The kit storage temperature should be 2 – 28°C and not require refrigeration. Time and date of delivery to be determined by the PSHCS Microbiology Department.

5. Specific Tasks

The vendor provides reagents, consumables, and test kits that are equal to and/or compatible to what is currently being used on the VA owned instrument/analyzer and will deliver the kits and reagents associated with this contract within a reasonable window of time after ordering has ensued. The vendor will adhere to the priced schedule submitted with the BPA of these materials, of which price of shipping is included in the cost of material. The vendor will provide SDS sheets for all media upon request. Times and dates of delivery to be determined by the PSHCS Microbiology Department. Specific products and their performance requirements that should be orderable are:

Swab specimen collection kits

a. Purchasable swabs through vendor must be compatible with all associated assays and used for the collection of vaginal samples, samples collected in viral transport media, nasopharyngeal swab samples and single use disposable swabs for required testing.

Clostridium difficile and the epidemic 027 strain

a. Detection and differentiation of Clostridioides difficile and the epidemic 027 strain must take less than 45 minutes.

b. The molecular based test should detect the toxin B (tcdB) gene sequence of toxigenic C. difficile and differentiate the presumptive 027/NAP1/BI-associated markers.

SARS-CoV-2

a. This assay must be a fast, real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection by their healthcare provider.

b. The test provides actionable results in as early as 19 minutes for positive samples.

c. Must be designed with three gene targets for the detection of SARS-CoV-2, providing target redundancy to mitigate potential impact of genetic mutations.

SARS-CoV-2/FLU/RSV

a. Multiplexed real-time PCR test intended for the simultaneous in-vitro qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A, influenza B, and/or RSV in nasopharyngeal swab or anterior nasal swab specimens collected from individuals with signs and/or symptoms of respiratory viral infection.

b. The test provides actionable results in as early as 25 minutes for positive samples.

c. Utilizes a multi-gene target approach for the detection of SARS-CoV-2 and influenza providing target redundancy to mitigate the potential impact of genetic shift and drift on strain detection.

d. Detects SARS-CoV-2, influenza A, influenza B, and/or RSV simultaneously.

Multiplex Vaginal Panel (MVP)

a. FDA cleared on-demand PCR test to aid in the diagnosis of vaginal infections in symptomatic women within an hour. Includes the detection of Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis, from a single sample along with organisms associated with bacterial vaginosis.

b. Actionable diagnostic aid for bacterial vaginosis, vulvovaginal candidiasis, and trichomoniasis within 60 minutes, including potential co-infections.

c. On-demand results for 4 separate callouts, bacterial vaginosis, Candida group, C. glabrata/C. krusei, and T. vaginalis from a single sample collection.

d. Allows for vaginal self-swabbing as an FDA approved sample type

Strep A

a. On-demand molecular testing for Group A Strep in as soon as 18 minutes for positive samples.

MTB with Rif

a. Provides fast and accurate detection of Mycobacterium Tuberculosis (MTB) and Rifampicin (RIF) resistance simultaneously from patient samples using a molecular assay.

b. Simple process that allows for results in less than 2 hours

S.aureus and MRSA (multiple MRSA test types)

a. Molecular diagnostic test intended for the detection of methicillin-resistant S. aureus (MRSA) DNA directly from nasal swabs in patients at risk for nasal colonization.

b. Molecular diagnostic test designed for rapid and simultaneous detection of S. aureus and methicillin-resistant S. aureus (MRSA) directly from gram-positive blood cultures.

c. Molecular diagnostic test intended for the detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue infection swabs.

d. Molecular diagnostic test designed for the detection of S. aureus and methicillin-resistant S. aureus (MRSA) from nasal swabs in patients at risk for nasal colonization

GI Panel

a. Qualitative RT-PCR assay capable of detecting the following bacterial, parasitic and viral causes of gastrointestinal disease:

· Campylobacter, Shiga toxin-producing Escherichia coli (STEC) stx1 and stx2, Salmonella, Shigella/Enteroinvasive Escherichia coli (EIEC), Yersinia enterocolitica, Vibrio parahaemolyticus, Vibrio cholerae, Giardia, Cryptosporidium and Norovirus

b. Time to results should take no more than 74 minutes.

c. Sample type should be intended for stool in Cary Blair transport media

Carba-R

a. Rapid molecular detection and differentiation of the IMP, NDM, or VIM metallo-beta-lactamase gene sequences from pure colonies

b. Rectal and perirectal swabs may also be used for carbapenem resistance screening.

c. Assay should take no more than 50 minutes.

vanA

a. Rapid molecular detection of the vanA gene associated with VRE colonization risk to aid in the recognition, prevention, and control of vancomycin-resistant organisms that colonize patients in healthcare settings.

b. Rapid VRE screening for active outbreak prevention and control should take no more than 48 minutes.

Norovirus

a. Rapid molecular detection of Norovirus GI and GII with results available in 90 minutes.

BCR-ABL

a. Rapid molecular quantitative test for BCR::ABL major breakpoint (p210) transcripts that provides highly sensitive and on-demand molecular results, reporting on both the International Scale (IS) and Molecular Response (MR) formats.

b. Results aligned to the IS in a one-page report in approximately 3 hours.

FII & FV

a. FII & FV assay is intended to provide results for Factor II mutation c.*97G>A (formally 20210G>A) and Factor V Leiden c.1601G>A (p.Arg534Gln) as an aid in the diagnosis of suspected thrombophilia.

b. The test is a qualitative molecular genotyping test for fast and simultaneous detection of Factor II and Factor V alleles in approximately 30 minutes.

5.1 Task 1 - Enterprise Management Controls.

Subtask 1 - Integration Management Control Planning.

a. Microbiology employee or supervisor enters request for product from vendor.

b. Purchasing agent places the request with vendor.

c. Vendor ships out product, referencing PO# for payment.

d. Microbiology employee receives product, inspects for discrepancies.

e. Vendor bills for product, Purchasing Agent checks for delivery completeness from end-user.

f. Purchasing agent completes receiving protocol in computer.

g. Microbiology Department uses product to perform rapid diagnostic testing for veteran patients.

5.2 Task 2 – Contract Management

Products are ordered at Seattle by the Microbiology Department in coordination with Administrative Specialist/COR II David Travelstead. The order is sent to the vendor via email, referencing the correct purchase order given from Fiscal and Contracting. Any delivery delays are sent via email to the purchaser in the Microbiology Department, who coordinates with vendor. Vendor sends invoices for payment to the VA Accounting Department in Austin, TX. Austin Automated Payment System posts the invoices for the laboratory to review, and then the invoices will be certified after confirmation of received items.

6. Performance Monitoring The Microbiology Department must adhere to specific standards for all laboratory consumables. These standards are applied to the products ordered from this vendor. COTR and/or any Microbiology employee are responsible to monitor all products for quality. The microbiology laboratory QA Technologist and Supervisor will monitor the system for minimum performance. In the event performance is compromised by either reagent or instrument failures, the company will be contacted for remediation.

7. Security Requirements There are no security related components to this contract request. The vendor will not have access to protected patient information. Protected patient information will not be input into the vendor computer and the vendor computer associated with the testing instrumentation will not be interfaced with any VA networks.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

There is no government furnished equipment associated with this contract.

9. Other Pertinent Information or Special Considerations.

a. Identification of Possible Follow-on Work. None

b. Identification of Potential Conflicts of Interest (COI). None

c. Identification of Non-Disclosure Requirements.

Contractor will not have access to any veteran names or diagnosis.

d. Packaging, Packing and Shipping Instructions.

All reagents shall be shipped according to IATA shipping regulations and in accordance with instruction provided by the Microbiology Laboratory at PSHCS.

e. Inspection and Acceptance Criteria.

Microbiology POC, Supervisor and any other Microbiology employees have specific lab standards to maintain for all products under their care. Upon inspection all reagents shall be shipped according to IATA shipping regulations and in accordance with instruction provided by the Microbiology Laboratory at PSHCS. All shipments will be received at the appropriate temperature (storage conditions) commensurate with instrument and reagent standards.

10. Risk Control

Microbiology is responsible and will accept any risks associated with product, notified by vendor. Only quality controlled and verified results will be released to the medical record.

11. Place of Performance.

Specific area to receive and work with product from vendor is the Microbiology lab at the Seattle Division of VA Puget Sound Medical Center.