Sources Sought Notice ---Cost Per Test for Flow Cytometry Reagents Instrumentation.pdf

Flow Cytometry Testing

Sources Sought Notice – Cost-Per-Test- Flow Cytometry Testing:

Reagents and Instrumentation

The Regional Health Contracting Office - Central is issuing this Sources Sought Notice on behalf of San Antonio Military Medical Center, JBSA - Fort Sam Houston, Texas. Any responses to this Sources Sought Notice will be used for planning purposes only. This notice is not a solicitation of binding offers, nor is it a notice to proceed.

The San Antonio Military Medical Center (SAMMC) has a requirement for a Cost-Per-Test Agreement to include reagents instrument/equipment, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct testing to include: CDC Basic panel, Leukemia/Lymphoma, and Stem Cell/CD34 for the Core lab Department at the Brooke Army Medical Center (BAMC) in Fort Sam Houston TX.

Flow cytometry can identify the type of cells in a blood or bone marrow sample, including the types of cancer cells. It detects the type of cancer cells based on either the presence or the absence of certain protein markers (antigens) on a cell’s surface. The most common use of flow cytometry is in the identification of markers on cells, particularly in the immune system (called immunophenotyping). The CDC Basic panel is used to monitor disease progression of HIV/AIDS and the efficacy of treatment.

Leukemia/Lymphoma are also monitored for disease progression and treatment efficacy with flow cytometry.

Vendors that consider themselves capable of providing the required testing are invited to submit a capability statement for the Government to consider via email to the Point of Contact listed herein. This capability statement shall include the following information. If the capability statement does not address ALL of the points below, the vendor will not be considered as capable of providing the required testing:

1. Vendor name (to include CAGE code and DUNS number); Point of Contact (to include email address and phone number); business size.

2. Documentation that demonstrates its ability to provide Cost-Per-Test Agreement to include reagents instrument/equipment, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct testing to include: CDC Basic panel, Leukemia/Lymphoma, and Stem Cell/CD34.

3. Food and Drug Administration (FDA) approval if applicable.

Capability Statement (limited to ten pages), describing how your company meets the below objectives, providing additional proof (such as FDA approval) where appropriate: Basic Requirements: The analyzers and its components to include the workstation should not exceed the following dimensions (7.5 ft. wide, 2.5 feet deep and 2 ft. high) and should be a tabletop analyzer. There is no floor space for anything larger than a tabletop.

A) Flow Cytometer Instrumentation:

1) Must have a minimum 10-color detection capability.

2) Must have sample carousel capable of holding 32 sample tubes or more.

3) Must have barcode reader capable of reading Code 39 barcodes.

4) Unaffected by ambient room temperature variations.

5) Instrument to instrument variation < 3% CV to insure comparable results (i.e., same sample run on multiple instruments during the same day will generate the same result).

6) Automated cell processing station required for standardized whole blood lysis and washing with a minimum 60 samples/hour processing capability.

7) Sample tube mixing on-board prior to sample acquisition – individual tube mixing preferred.

8) Minimal start-up and maintenance time – must be able to perform sample runs within 30 minutes of start-up.

9) Sample carryover < 0.1%.

10) Capable of resolving particles ≤ 1 µm in size from background noise.

11) Data acquisition rate ≥ 10,000 events/second.

12) Bi-directional interface with MHS Genesis required at start-up or within three months if not already available.

13) Ability to perform leukemia/lymphoma panels on blood, bone marrow, tissue, and body fluids with broad range of surface and cytoplasmic B-cell, T-cell, and myeloid antibodies with premixed antibody panels.

14) Ability to perform single platform stem cell and CD3 enumeration on peripheral blood and apheresis products.

15) To perform CDC basic panel (lymphocyte subtyping with D3/CD4/CD8/CD19/CD56).

16) Ability to perform Hairy Cell, Plasma Cell, Sezary Cell testing.

17) Must include LGL tubes and cytoplasmic testing.

18) Two identical flow cytometers with 10 color capability.

19) Four (4) Prep Workstations.

20) Four (4) 20” LCD computer monitors.

21) Ability to print color scatterplots and store scatterplot data for at least 2 years.

22) Functional for 98% of the time during department hours (M-F 0730-1630).

23) Contractor provides quality control plan and mater all computer systems connecting to the network and MHS Genesis must be RMF compliant, have an authority to operate (ATO) and be Health Insurance Portability and Accountability Act (HIPAA) compliant.

24) The analyzers and its components to include the workstation should not exceed the following dimensions (7.5 ft. wide, 2.5 feet deep and 2 ft. high) and should be a tabletop analyzer. There is no floor space for anything larger than tabletop.

25) Government requires delivery of the analyzer/ instrumentation within 30 days and correlated, validated and connected to the DHA system before or on 1 October 2022.

Mandatory Tests:

Test

LEUKEMIA/LYMPHOMA PANEL

CDC BASIC

CD34

VIABILITY

B. Reagents:

1) Shelf life greater than 3 months if in liquid form; greater than 6 months if lyophilized.

2) Monoclonal antibody-fluorochrome combinations preferred. Antibody clones must be available with multiple fluorochromes to increase testing/panel flexibility.

• D3/CD4/CD8/CD19/CD56).

3) Lyophilized reagents with standard reconstitution volumes and diluent preferred.

4) Provided reagents must be FDA-classified IVD or ASR reagents – no RUO reagents can be used to meet testing requirements.

5) Capability of vendor to provide defined pre-mixed panels

The response due date for this Sources Sought Notice is 1:00 PM CST, 23 May 2022. All questions and comments regarding this announcement shall be submitted via e-mail to the below POCs: