36C25521Q0598.docx

SUBJECT*

NGS Sequencing, STL

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway

Leavenworth KS 66048

POINT OF CONTACT*

Jeanine Wallace jeanine.wallace@va.gov

PLACE OF PERFORMANCE

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.

The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract on the basis of this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.

The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below.

Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The VA Heartland Network 15, Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking a potential qualified contractor to provide a next-generation sequencing (NGS) instrument for the St. Louis VAMC that meet the Statement of Work specifications.

Please see the statement of work on following pages.

NAICS Code: 339112 (Surgical and Medical Instrument Manufacturing) 1000 Employees.

Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. The North American Classification System (NAICS) code for this acquisition is 337215 (Institutional Furniture Manufacturing). The small business size standard is 500 employees. Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail: to jeanine.wallace@va.gov. All information submissions should be received no later than 1PM CST on August 24, 2021. After review of the responses to this announcement, the Government intends to proceed with the acquisition and a subsequent solicitation will be published.

Statement of Work Pathology & Lab, COVID-19 Sequencing Instrument

1. Introduction: This acquisition is for a next-generation sequencing (NGS) instrument. This acquisition will allow us to join the VA’s mission to increase capacity and expand sequencing services of SARS-CoV-2 to all VA medical centers. This instrument would allow us to become a designated regional reference laboratory for our VISN for COVID-19 sequencing, as well as for other NGS future needs.

2. Background: VA has created a network of reference laboratories, called SEQFORCE, throughout the country to offer SARS-CoV-2 sequencing to all VA medical centers. The purpose of the network is to provide epidemiological data about the circulating SARS-CoV-2 strains, investigate outbreaks, determine if certain variants are more transmissible or likely to escape current vaccines, and identify new and emerging strains. The St. Louis VA Molecular lab would like to acquire the specialized instrumentation to join the network of reference labs offering this service. We would also like to procure technology for NGS of other samples such as tissue, FNA, liquid biopsy and blood for future oncology and other NGS needs.

3. Scope: First and foremost, this next-generation sequencing instrument supports an assay for sequencing the SARS-CoV-2 viral genome. By sequencing the viral genome of patients diagnosed with SARS-CoV-2 we will be able to investigate vaccine escape, re-infection, facility or regional outbreaks, and collect epidemiological data on circulating variant strains. This system is highly accurate, requires minimal hands-on time, and provides results for up to 100 samples per week, as required per the agreement to join SEQFORCE. In addition, this NGS analyzer must be capable of preforming sequencing for a variety of sample types including those needed for precision oncology. Required sample volumes should be minimal, as many samples such as those recovered during GNA or liquid biopsy are scant. The system must require minimal hands on time, providing a streamlined sample to answer protocol. Ideally the system can provide integrated and automated nucleic acid purification, library preparation, sequencing and bioinformatics analysis with a turnaround time of less than 48 hours with minimal technologist touchpoints. The system must be user friendly allowing for use in laboratories with zero to minimal NGS experience perform testing. The system must also be able to support the following precision oncology panels/markers that are currently sent to a reference laboratory. If the profiles are not currently available, they must be in the pipeline for the instrument.

SOLID TUMOR CDX

LIQUID CDX

MMR/MSI

BREAST NGS PANEL

NEOTYPE T-CELL NGS

DECIPHER PROSTATE

IGVH-PCR

JAK2/MPL/CALR

TCR-PCR

CLL NGS PANEL

LYMPHOMA NGS PANEL

MYELOID NGS PANEL

BRAF NGS

AML CEBPA-PCR

MYD88 NGS

THYGENEXT

ONCOTYPEDX BREAST

ONCOTYPEDX PROSTATE

4. Objective: The objective of this acquisition is to expand our capabilities and offer NGS services for all VISN 15 VA medical centers at a minimum.

5. Task: To purchase a next-generation sequencing instrument and some reagents.

6. Delivery: The instrument will be delivered to P&LMS Department at the St. Louis (John Cochran) VA Medical Center, Pathology and Laboratory Medicine Service at 1481 West 10th Street915 North Grand Blvd, St. Louis, MO 63106 to the attention of Cari Orth at Lab#113.

7. Security: The selected system will not be integrated into the LIS. Hence, there will be compliance of all Health Insurance Portability and Accountability Act (HIPAA) provisions.

8. Space/Utilities: Electrical and space requirements are sufficient.

9. Cleaning: A 10% bleach solution followed by distilled water is used to clean the instrument.

10. Place of Performance: All testing will be performed at VASTLHCS.

11. Period of Performance: The period of performance is a onetime instrument purchase by the end of FY21 along with an initial reagent purchase. An additional contract may be necessary in the future for the purchase of additional reagents.