P02 - RFI Attachment B SOW.pdf

Statement of Work

IVD Reagents and Supplies

To begin 01 Sep 2026

VISN _22_ Medical Centers

This will be a 5 year contract, base plus 4 one-year periods, with a period of performance as shown below:

Base year: 09/01/2026 - 08/31/2027 Option 1: 09/01/2027 - 08/31/2028 Option 2: 09/01/2028 - 08/31/2029 Option 3: 09/01/2029 - 08/31/2030 Option 4: 09/01/2030 - 08/31/2031

1.0 Background

The procurement is for the acquisition of blood bank reagents for manual testing for the Blood Bank departments of the VISN 22 facilities. These reagents and sera have been validated for use at all listed facilities.

2.0 Scope of Work:

The Blood Bank departments at all VISN22 facilities stocks tube antibody screening cells and antibody identification cells for patients with cold antibodies, antibodies to high frequency antigens, and multiple antibodies. This includes the utilization of ABO reverse typing cells, direct antiglobulin check cells, IgG check cells, complement check cells and anti-sera. The reagents and consumables shall be Food & Drug Administration approved (FDA), American Association of Blood Bank (hereafter as AABB) accredited, College of American Pathologist (hereafter as CAP) accredited and have been validated by VISN 22 PALMS..

This contract is for Indefinite-Delivery-Indefinite-Quantity (IDIQ) of these specialized red cells reagents and anti-sera. Red cell-based reagents have a short shelf-life and manufacturers require a contract to anticipate quantities to produce.

This purchase is not associated with equipment. No equipment or instruments will be part of this procurement.

The supply acquisition does not involve connection of contractor-owned IT devices to the VA internal network nor does it involve the storage, generating, transmitting, or exchanging of VA sensitive information, therefore the C&A requirements as outlined in questions 6 & 7 VA Handbook 6500.6 do not apply and a security accreditation package is not required.

3.0 Tasks

The Contractor shall provide all products and materials according to the SOW specifications.

The items required must meet or exceed the specifications listed below.

4.0 General Requirements; the contractor shall provide the following

1. The manufacturer of record is defined as a company whose main occupation is the manufacture of the items purchased which includes:

a. Maintains a factory production line.

b. Maintains a stock of replacement consumables.

c. Maintains consumable literature (package inserts).

d. Maintains and provides published and descriptive scientific literature that directly relates to the consumables that are purchased.

2. The vendor should have the ability to fill emergency supply requests when requested.

3. The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, or other Contractor-related factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

4. The vendor will pay shipping fees for all consumable items ordered.

5. Any additional costs such as industrial funding fees, special shipping and handling fees, or other usage fees must be clearly indicated in the purchase price quote.

All items quoted must be F.O.B. destination. All items shall be shipped to arrive M-F, 8am-4pm, excluding holidays to the following locations:

Phoenix VA Health Care System 650 E. Indian School Road Phoenix, AZ 85012

New Mexico VA Healthcare System 1501 San Pedro SE Albuquerque, New Mexico 87108

Southern Arizona VA Health Care System 3601 South 6th Avenue Tucson, AZ 85723

Long Beach VA Healthcare System 5901 E 7th St Long Beach, CA 90822

VA Greater Los Angeles 11301 Wilshire Blvd Los Angeles CA 90073

VA Loma Linda 11201 Benton St Loma Linda CA 92357

VA San Diego 3350 La Jolla Village Dr San Diego CA 92161

VA Prescott 500 N. State Highway 89 Prescott AZ 86313

5.0 Supply Requirements

The contractor shall provide the following:

1. Cells for ABO back-typing

2. Complement check cells

3. IgG check cells

4. LISS

5. Monoclonal Control / RH Control

6. Anti-A1 Lectin

7. 22% Bovine Serum Albumin

8. Elution Kit

9. Anti IgG

10. Anti C3b, C3d

11. Anti-IgG – C3d

12. Competency testing kit

13. PEG

14. Various anti-sera

15. Anti-C, -c, -E,-e,-Lea. -Leb, -K, M, N, Fya, Fyb, S, s, Jka, Jkb

16. Antibody identification panels of at least 30 unique donor cells. These 30 unique donor cells can come in configurations of less than 30, but must encompass at least 30 unique antibodies in total.

17. A full antigen profile (which includes, but is not limited to: C, c, E, e, V, VS, K, k, Kpa, Kpb, Jsa, Jsb, Jka, Jkb, Fya, Fyb, Fyx, M, N, S, s, U, Uvar, Lua, Lub, Dia, Dib, Coa, Cob, Doa, Dob, Joa, Hy, LWa, LWb, Sc1, & Sc2) including an extended antigen typing by DNA analysis included with each antibody identification panel lot.

18. Contractor shall have available enough of the above reagents and cells to supply all the VISN 22 Blood Banks on a bi-monthly basis, in order to stay within reagent and cell expiration dates.

6.0 Security Requirements

The solicitation is for a reagent only contract; not requiring a network connection. In reference to VHA Handbook 6500.6 Appendix A, Block 6, the reagents included in this contract do not involve connection of IT devices to the VA internal network, therefore the C&A requirements do not apply and a security accreditation package is not required.

In reference to VHA Handbook 6500.6 Appendix A, Block 7, the reagents purchased are not used to store, generate, transmit, or exchange VA sensitive information. Therefore, the following provisions of Appendix C do not apply.

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information protection, patient privacy, and information system security as delineated in this contract.

During contract performance, contractor may require access to VA facility equipment, information systems, or sensitive data; to provide services related to reagent handling and product communications.

VA Course No. VA10176 is privacy training required for VA contractors requiring access to VA facilities for more than 2 consecutive days or any access to VA information systems. Training will be completed prior to being granted access to facilities, equipment, or to the data therein. Training is available on VA TMA website at: https://www.tms.va.gov/SecureAuth35/. Contractor will provide evidence of training to the VA Point of Contact, if requested.

During business communication visits, the contractor may have physical or administrative access, to the reagents included in this contract, which do not capture, store, and/or process VHA sensitive information. No warranty repairs are included in the contract since no equipment purchase is being requested. Vendor will not require access to hard drives or other data storage devices.

7.0 Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

No government furnished equipment nor information will be provided to the contractor.

8.0 Other Pertinent Information or Special Considerations.

None

9.0 Risk Control

All cellular reagents will be handled with standard precautions.