6550--NEW - STX Flow Cytometry Rgts/Consumables

STATEMENT OF WORK (SOW)

Scope

The STVHCS has a need for a continuous supply of Flow Cytometry reagents and supplies for the government-owned BD FACS Canto II instrumentation housed in the Flow Cytometry Laboratory of the Pathology & Laboratory Medicine Service at Audie L. Murphy VA Hospital. The vendor must provide Becton, Dickinson & Co. (BD) reagents, consumables and supplies and shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy as determined by FDA approval for use on the BD FACS Canto II instrument for patient testing.

Technical Requirements:

The vendor must be able to provide ready to use brand name reagents that are compatible with the BD FACS Canto II instrumentation.

The vendor must be able to provide delivery of the following name brand reagents as needed:

Item #

Description/Part Number*

Qty

334224

FACS Shutdown Solution

Â

30

560087

Hu CD123 APC 7G3 100 Tst

Â

3

560503

Hu CD25 PerCP-Cy5.5 M-A251 50 Tst

Â

10

563644

Hu CD49d PerCP-Cy5.5 9F10 50 Tst

Â

8

560448

Hu CD27 Horizon V450 M-T271 120 Tst

Â

10

551108

Hu CD81 FITC JS-81 100 Tst

Â

10

551112

Hu CD81 APC JS-81 100 Tst

Â

10

552843

Ms Ig Kpa Comp Bead Set 6mL

Â

10

555899

Lysing Buffer 10X Concentrate 100 mL

Â

15

555816

Via-Probe Cell Visability Solution 100 Tst

Â

6

554656

Stain Buffer FBS 500mL

Â

40

564114

Hu CD200 BV421 MRC OX-104 50 Tst

Â

10

349516

Anti-Kappa FITC/Anti-Lambda PE

Â

12

341102

CD10 PE-Cy7 HI10a ASR

Â

12

340997

CD103 PE Ber-ACT8 ASR

Â

15

340867

CD117 PE 104D2 ASR

Â

6

340686

CD13 PE L138 ASR

Â

15

341097

CD138 PerCP-Cy5.5 MI15 ASR

Â

12

340682

CD14 FITC MphiP9 ASR

Â

10

642922

CD15 V450 MMA ASR

Â

15

340705

CD16 PE B73.1 ASR

Â

10

643078

CD19 APC-H7 SJ25C1 ASR

Â

12

341023

CD2 APC L303.1 ASR

Â

15

641405

CD20 APC-H7 L27 ASR

Â

12

642283

CD20 V450 L27 ASR

Â

12

340707

CD22 FITC S-HCL-1 ASR

Â

9

340934

CD23 APC EBVCS-5 ASR

Â

8

340948

CD3 PerCP-Cy5.5 SK7 ASR

Â

13

340680

CD33 APC P67.6 ASR

Â

12

340677

CD38 APC HB7 ASR

Â

10

348799

CD4 PE-Cy7 SK3 ASR

Â

14

647450

CD45 V500-C ASR

Â

17

341099

CD5 PerCP-Cy5.5 L17F12 ASR

Â

10

340724

CD56 PE NCAM16.2 ASR

Â

10

335809

CD56 PE-Cy7 NCAM16.2 ASR

Â

8

340706

CD57 FITC HNK-1 ASR

Â

8

642921

CD7 V450 M-T701 ASR

Â

10

341633

CD79a PerCP-Cy5.5 HM47 ASR

Â

2

641409

CD8 APC-H7 SK1 ASR

Â

9

340946

Glycophorin A PE GAR-2 (HIR2) ASR

Â

2

641402

Anti-HLA-DR APC-H7 L243 (G46-6) ASR

Â

8

341632

Myeloperoxidase PE 5B8 ASR

Â

3

340887

Anti-TCR-Gamma/Delta-1 PE 11F2 ASR

Â

2

340883

Anti-TCR-Alpha/Beta-1 FITC WT31 ASR

Â

2

652359

CD11c PE-Cy7 (B-ly6) ASR

Â

8

340345

BD FACS Clean Solution 5L

Â

20

342003

BD FACSFlow Sheath Fluid 20L

Â

20

335775

BD FACS 7-Color Setup Beads 25 Tests

Â

15

642412

BD CST Beads Kit 150 Tests

Â

5

655051

BD FACSDiva CS&T Research Beads Kit 150T

Â

12

349202

BD FACS Lysing Solution 10X 100mL IVD

Â

10

340499

Multitest CD3/CD8/CD45/CD4 50 Tests IVD

Â

35

662967

Multitest 6-color TBNK Reagent US-IVD

Â

35

340041

Simultest IgG1/IgG2a Isotype Control IVD

Â

4

347213

CD34 PerCP-Cy5.5 8G12 ASR

Â

7

341071

CD45 FITC/CD34 PE 2D1/8G12 50 Tests

Â

3

340930

CD41a PerCP-Cy5.5 HIP8 ASR

Â

3

340715

CD61 FITC RUU-PL7F12 ASR

Â

4

The vendor must be able to sequester reagent lots so that the lot numbers will be the same throughout the contract year.

The reagents must be FDA approved and meet all regulatory guidelines set for by the STVHCS.

The vendor must provide confirmation of order same day as order request is received.

The vendor must provide tracking information and provide an estimated delivery time.

The contractor shall provide a continuously stocked inventory of Flow Cytometry reagents and supplies, and any other materials required to properly perform patient testing such that Flow Cytometry Laboratory operations are not interrupted. These items shall be of the highest quality, to ensure precision and accuracy. Expiration date must be clearly marked on all supplies. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the Flow Cytometry Laboratory equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor shall deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor s Core Laboratory equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

Location

The reagents and supplies will be used on the BD FACS Canto II in the Flow Cytometry laboratory located in the Pathology and Laboratory Medicine Service s San Antonio Laboratory of the STVHCS.

Period of Performance

Base + 4 Option Years

Deliverables/Supplies

As needed name brand BD reagents and supplies for Flow Cytometry testing on the BD FACS Canto II instrumentation. See Attachment A for a full list of reagent and supplies.

Government Inherent Functions:

Contractor shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

General Duties, Requirements, and Expectations:

Contractor shall be an authorized manufacturer of reagents and supplies requested.

Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP).

Information Systems Officer, Information Protection:Â Â Â

The contractor will not have access to VA Desktop computers nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer:Â

The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

Records Manager:Â

There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].