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Department of Veterans Affairs
Network Contracting Office (NCO) 16
Request For Information (RFI)

DISCLAIMER: THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS SYNOPSIS IS NOT A REQUEST FOR QUOTE, PROPOSAL, OR BID. This notice is not a solicitation as defined by FAR 2.101, therefore it shall not be construed as a commitment by the Government to enter into a contract, nor does it restrict the Government to an acquisition approach. All information contained in this Request for Information (RFI) is preliminary as well as subject to amendment and is in no way binding on the Government. Information submitted in response to this notice is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. The Government is requesting that restrictive or proprietary markings not be used in response to this notice. If a solicitation is released, it will be synopsized in the Federal Contract Opportunities website or GSA. It is the responsibility of the interested parties to monitor these sites for additional information pertaining to this RFI.

1. Title: (Brand Name or Equal) - Reagents for Ion Torrent Genexus Integrated Sequencing Systems and Genexus Purification System- Little Rock VAMC

2. Purpose: The purpose of this RFI is to identify potential sources which will aid in defining the procurement strategy (e.g., set-aside, sole source, unrestricted) for a solicitation the VA intends on issuing shortly for the following:

Item No
Or Stock#
Description
quantity/Unit
A40263
1 GENEXUS STRIPS 3-GX5 AND 4 COMBO, PN A40263
6 EA
A40261
2 GENEXUS BARCODE 1-32 HD, PN A40261

12 EA
A40266
3 GENEXUS PIPETTE TIPS, PN A40266
14 EA
4483354
4 96-WELL HARD SHELL PLATE CLEAR, PN 4483354
6 EA
A40269
5 ION GX5 CHIP AND GXS COUPLER KIT
9 EA
A40271
6 GENEXUS SEQUENCING KIT, PN A40271
9 EA
A46291
7 ONCOMINE PRECISION ASSAY GX, PN A46291
12 EA
NC1980828
8 GENEXUS FFPE PURIFICATION COMBO, PN NC1980828
20 EA
NC2045359
9 GENEXUS STRIPS 3B-GX5 AND 4 COMBO, PN NC2045359
3 EA
A40257
10 GENEXUS BARCODES 1-96 AS, PN A40257
8 EA
NC2045358
11 ONCOMINE MYELOID ASSAY GX V2, PN NC2045358
11 EA
NC1980836
12 GENEXUS DNA PURIFICATION COMBO, PN NC1980836
20 EA
NC1980837
13 GENEXUS RNA PURIFICATION COMBO, PN NC1980837
20 EA

The anticipated Small Business Administration (SBA) size standard for the North American Industry Classification System (NAICS) code 334516 is 1,000 Employees.
STATEMENT OF WORK

Reagents for the Ion Torrent Genexus Integrated Sequencing Systems and Genexus Purification System (Limited Source)

PURPOSE
The overall purpose is to provide next generation sequencing reagents and supplies for the Central Arkansas Veterans Healthcare System (CAVHS), Pathology and Laboratory Medicine Service, Molecular Diagnostics Laboratory, Room 2E-110, 4300 W. 7th St, Little Rock, AR 72205. The reagents/supplies are required to perform specialized diagnostic and/or genetic testing on veterans FFPE, tissue, blood, and bone marrow samples, and must meet stringent quality control and compliance standards. This will be a Limited Source purchase as the reagents are the proprietary property of Applied Biosystems/Thermo Fisher for use on the existing Thermo Fisher Genexus Integrated Sequencing Systems and Genexus Purification System and should be purchased through Fisher Healthcare. No other source can supply the needed reagents within the timeframes requested. Many of these reagents are very sensitive to temperature, and therefore many must ship on dry ice or ice packs directly to the laboratory.
SCOPE
The Contractor shall be able to provide all listed reagents.
Ordering of reagents will be done on an as need basis with shipments delivered within at least 5 business days.
All products must meet all salient characteristics defined in this section.
All reagents must meet manufacturers and VA specifications.
The Contractor shall perform to the standards in this contract.

SALIENT CHARACTERISTICS
Molecular Diagnostics reagents:
The contractor shall provide the Molecular Diagnostics laboratory the reagents and supplies needed for the operation of the Ion Torrent Genexus Integrated Sequencing Systems and Genexus Purification System that are already onsite. These reagents and supplies will be delivered to Central Arkansas Veterans Healthcare System (CAVHS), Pathology and Laboratory Medicine Service, Molecular Diagnostics Laboratory, Room 2E-110, 4300 W. 7th St, Little Rock, AR 72205.

Ordering of reagents will be done on an as needed basis. (no min or max threshold will be in place)
Reagents will be ordered on an as needed quantity and delivery basis for the duration of the contract as funding allows.
All reagents, consumables, and ancillary items needed for the operation of the Genexus Integrated Sequencers and the Genexus Purification System shall be included in this contract.
All reagents, consumables, and ancillary items needed to perform myeloid and solid tumor testing on the Genexus systems shall be included on this contract.
All the reagents shall be prepackaged and ready for use.
These items shall be of the highest quality, sensitivity and tested to assure precision and accuracy.
Expiration dates must be clearly marked on all reagent containers.
Unexpected changes in methodology/technology shall be at the expense of the contractor.
The contractor shall state the open date stability for the reagents for both room temperature and refrigeration.
The contractor shall package reagents in such a manner as to ensure the integrity of the reagents during transport.
The contractor shall explain their policy on replacement of unsuitable or damaged products or products shipped in error.
The contractor shall supply all Safety Data Sheets for their proposed reagents.
The contractor shall inform the Molecular Diagnostics Supervisor of any reagent recalls or bulletins due to product unavailability due to manufacturing issues.
Alert/Notifications of any delays in shipment as well as any or all technical advisory/recall/alerts, prior to or simultaneously with filed alerts should be forwarded to the Molecular Diagnostics Supervisor.
The contractor shall provide their plan for product availability if supplies/products become scarce or unavailable.

DELIVERY
Delivery of reagents will be on an as needed basis.
2.7.1.1 Molecular Diagnostics Supervisor will place an order for required reagents and supplies based on need with Thermo Fisher - Process for this order placement will be determined after award of contract.
2.7.1.1.1 Shipments should arrive within 5 business days of placement of order.
Contractor shall deliver all reagents acceptably packaged to the Central Arkansas Veterans Healthcare System (CAVHS), Pathology and Laboratory Medicine Service, Molecular Diagnostics Laboratory, Room 2E-110, 4300 W. 7th St, Little Rock, AR 72205.

SITE CONDITIONS
There shall be no smoking, eating, or drinking inside the laboratory at any time.

INSPECTION AND ACCEPTANCE:
The COR shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer.

DELIVERY/STORAGE REQUIREMENTS
Deliver reagent materials to job in manufacturer's original sealed containers with brand name marked thereon.
Package to prevent damage or deterioration during shipment, handling, and storage.
Deliver specified items only when the site is ready to proceed.
Store products in dry condition inside enclosed facilities.
Delivery dates will be communicated when products orders are placed.
Delivery will be coordinated through the Molecular Diagnostics Supervisor.

Installation is not required

INSPECTION AND ACCEPTANCE:
The Molecular Diagnostics Supervisor shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer.

DELIVERABLES
7.1 Items as required for the operation of the Ion Torrent Genexus Integrated Sequencing Systems and Genexus Purification System.

SECURITY REQUIREMENTS
1. GENERAL
Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.
2. SECURITY CLAUSE:
"A&A requirements do not apply--Security Accreditation Package is not required".

3.VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure
VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor s firewall and Web services security controls, if applicable, shall meet or exceed VA s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes.

The options are:
(1) Vendor must accept the system without the drive;
(2) VA s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or
(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase occur that may
(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact;

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be preapproved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed.
The ISO needs to maintain the documentation.
CONFIDENTIALITY AND NONDISCLOSURE
It is agreed that:

a. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

b. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response.

c. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

REFERENCE (S):

1. VA Affairs Handbook 6500, Risk Management Framework for VA Information Systems Tier 3: VA Information Security Program, 10 Mar 2015.

2. Veterans Health Administration Procurement Manual (VHA PM) 11/3/2014.

3. VA Handbook 1901.01, Health Information Management and Health Records 19 Mar 15.

4. VHA Handbook 1605.5, Business Associate Agreements 22 July 2014

5. Privacy Act of 1974 (5 U.S.C. 552a).
Shipping Address:
Central Arkansas Veterans Healthcare System (CAVHS)
2200 Fort Roots Drive
Deliver to: Pathology & Laboratory Medicine Service (P&LMS)
North Little Rock, AR 72114

Responses Requested: The following questions must be answered in response to this RFI.
Answers that are not provided shall be considered non-responsive to the RFI:

a. Where are the requested items/equipment manufactured?

Vendor must attach documentation of this information to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice

b. Are the requested items/equipment manufactured by a Small or Large business? Is the potential vendor in compliance with the Non-Manufacturer Rule (NMR)?

Vendor must attach documentation of this to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice

c. Is the Vendor an authorized distributor with access to Original Equipment Manufacturer (OEM) parts which may be required in performance of this requirement?

The VA does not accept grey market items and therefore the Vendor must attach evidence of this access (Authorized Distributor letter) to be viewed by the government to be considered as part of the Market Research and responsiveness to this Sources Sought notice.
d. Name of potential Contractor that possess the capability to fulfill this requirement. Contractors shall also provide the following:

Point(s) of contact name: _______________________________________________
Address: ___________________________________________________
Telephone number: ___________________________________________
Email address: _______________________________________________

Company's business size: ________________________________________________
Data Universal Numbering System (DUNS) #: _______________________________

e. Is your company considered a small business concern, SB, SDVOSB, VOSB, HUBZone, or 8A concern, with the requisite __________________ NAICS code?

Please provide proof of qualifications.

f. Is your company available under any Government Wide Agency Contract (GWAC), General
Services Administration (GSA) Schedule, Indefinite Delivery Indefinite Quantity (IDIQ), and/or
Blanket Purchase Agreement (BPA)?

If so, please identify the contract number for the Government to review as part of this Market Research.

7. Opportunity/Market Pricing: The Little Rock VA Medical Center is seeking information from potential vendors on their ability to provide the required items/equipment. THIS IS A SOURCES SOUGHT REQUEST FOR INFORMATION (RFI) ONLY. Small Business Concerns are encouraged to provide responses to this RFI in order to assist the Little Rock AR VAMC in determining potential levels of competition and general market pricing available in the industry. Therefore, vendors are requested to submit estimated market research pricing along with their responses to the above. The estimated pricing will be considered when determining the procurement strategy for the forthcoming solicitation.
8. Instructions and Response Guidelines: Questions regarding this RFI shall be submitted no later than 3:00pm (CST), Friday, October 27, 2023 via email to latonya.mack@va.gov

RFI responses are due by 11:00am (CST) Tuesday, October 31, 2023 size is limited to 8.5 x 11 inches, 12-point font, with 1-inch margins in Microsoft Word format via email to latonya.mack@va.gov. The subject line shall read: NO SOLICITATION EXISTS AT THIS TIME. There is no page limitation on subparagraphs 3(a) - 3(f).

VAMC as Market Research and will not be released outside of the Network Contracting Office (NCO) 16.

9. Contact Information:

LaTonya G Mack
LaTonya.Mack@va.gov

Your response to this notice is greatly appreciated!

Attachments/Links