36C25625Q1293.docx

SUBJECT*

629 PLMS BECTON DICKINSON FLOW CYTOMETRY (VA-26-00006502)

GENERAL INFORMATION

Network Contracting Office 16 Southeast Louisiana Veterans HCS 2400 Canal St.

New Orleans LA 70019

POINT OF CONTACT*

Contracting Officer Tiffany Conner tiffany.conner@va.gov

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

NOTICE OF INTENT TO AWARD SOLE SOURCE

I. The Southeast Louisiana Veterans Health Care System (SLVHCS) New Orleans, LA intends to solicit and award a Sole Source, Firm-Fixed-Price contract with a base year and four one-year option periods with one Large Business (LB) source, Becton Dickinson and Company (BDC) at 1 Becton Drive, Franklin Lakes, NJ 07417. BDC is the Original Equipment Manufacturer (OEM) for the government equipment Flow Cytometry Reagents at the SLVHCS Hematology Section.

The contractor will provide all flow cytometry reagents required to perform specialized diagnostic immunophenotyping on patient’s tissue, blood, bone marrow and body fluid samples. All flow cytometry reagents shall meet stringent quality control and compliance standards.

II. The North American Industry Classification (NAICS) code for this acquisition is 325413-In-Vitro Diagnostic Substance Manufacturing. Standard Size in number of employees is 1,250.

III. This purchase will be made under Simplified Acquisition Procedures and Other than Full and Open Competition, as authorized by FAR 6.302-1 and in accordance with FAR 13.106-1(b). The Government intends to award a Firm-Fixed-Price contract, in accordance with FAR 16.202-1.

IV. The anticipated award date is October 1, 2025. The Government intends to award a Firm-Fixed-Price contract

V. Please note that this is not a request for competitive quotes and is being posted for informational purposes only. Interested contractors, in addition, shall provide the following information as an attachment to your response:

1. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or related NAICS codes.

2. State whether your firm is registered with the System for Award Management (SAM) at Sam.gov and/or SBA.gov If not, please NOTE: any future solicitation can only be awarded to a contractor who is registered in the System for Award Management. Include the UIE number of your firm.

Your response should include both the STATEMENT OF CABABILITY, BUSINESS SIZE, SOCIOECONOMIC STATUS AND GSA CONTRACT information as explained below. Please place "Attention: Flow Cytometry” in the subject line of your email. This notice is to assist the VA in determining sources only. A solicitation is not currently available; therefore, DO NOT REQUEST A COPY OF A SOLICITATION THAT DOES NOT EXISTS. If a solicitation is issued it will be announced later, and all interested parties shall respond to that solicitation announcement separately from the responses to this announcement.

VI. Interested parties shall identify their interests and capability to respond to this notice. Any response to this notice shall show clear and convincing evidence that competition would be advantageous to the Government.

Responses must be emailed to tiffany.conner@va.gov no later than 10:00 AM CST, Aug 14, 2025.

Interested parties shall submit clear evidence with the capability to meet government requirements. To include but not limited to:

1. Capability to provide and deliver on an as needed basis name brand products like the flow cytometry reagents and supplies that are compatible with the government.

See Attached Draft Statement of Work (SOW)

Special Notice Special Notice

Special Notice

Statement of Work Flow Cytometry Reagents Southeast Louisiana Veterans Health Care System New Orleans, LA

1. PURPOSE

1.1. The overall purpose is to provide flow cytometry reagents for the Southeast Louisiana Veterans Health Care System (SLVHCS), Pathology and Laboratory Medicine Service Hematology Section, Room 4E122, 2400 Canal St, New Orleans, LA 70119. The reagents are required to perform specialized diagnostic immunophenotyping on patient’s tissue, blood, bone marrow and body fluid 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 the Becton Dickinson Company for use on the existing Becton Dickinson Facs Lyric instrument in the SLVHCS Hematology Section.

2. SCOPE

2.1. The Contractor shall be able to provide all listed reagents.

2.2. Ordering of reagents will be done on an as need basis with shipments delivered within at least 5 business days.

2.3. All products must meet all salient characteristics defined in this section.

2.4. All reagents must meet manufacturers and VA specifications.

2.5. The Contractor shall perform to the standards in this contract.

2.6. SALIENT CHARACTERISTICS

2.6.1 Flow Cytometry reagents:

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 and no shorter than 9 months out. 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 pay all shipping and handling fees for supplies. The contractor shall package reagents in such a manner as to insure 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 Hematology 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 Hematology Supervisor. The contractor shall provide their plan for product availability if supplies/products become scarce or unavailable. Vendor shall provide a VA acceptable itemized bill for all items shipped for payment with each shipment.

2.7. DELIVERY

2.8. Delivery of reagents will be on an as needed basis. First delivery should be no later than November 1, 2025.

2.7.1.1 Hematology Supervisor will place an order for required reagents and supplies based on need with Becton Dickinson Company-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.

2.7.1.2 Reagents and supplies will be selected from attached Appendix A for the duration of the contract.

2.8.1. Contractor shall deliver all reagents acceptably packaged to the Southeast Louisiana Veterans Health Care System (SLVHCS) warehouse at 2400 Canal St, New Orleans, LA 70119.

2.8.2. First delivery shall be as soon as possible after award (NLT 11/01/25), with date of delivery coordinated with COR

2.8.3. Requests for reagents shall be possible up to 16 months after start of award term (up to the maximum dollar amount contracted).

2.9. SITE CONDITIONS

2.9.1. There shall be no smoking, eating, or drinking inside the hospital at any time.

3. INSPECTION AND ACCEPTANCE:

3.1. The COR shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer.

4. DELIVERY/STORAGE REQUIREMENTS

4.1. Deliver reagent materials to job in manufacturer's original sealed containers with brand name marked thereon.

4.2. Package to prevent damage or deterioration during shipment, handling, and storage.

4.3. Deliver specified items only when the site is ready to proceed.

4.4. Store products in dry condition inside enclosed facilities.

4.5. Delivery dates will be communicated when products orders are placed.

4.6. Delivery will be coordinated through the Anatomic Pathology Supervisor.

5. Installation is not required

6. INSPECTION AND ACCEPTANCE:

6.1. The Anatomic Pathology Supervisor shall ensure all items are satisfactory prior to acceptance. Disputes shall be resolved by the Contracting Officer.

7. DELIVERABLES

7.1 Items as defined in Appendix A

8. 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.

4. 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.