Attachment B - SOW.doc

Statement of Work

In-Vitro Diagnostic products 07-06-2021 Phoenix Veterans Administration Health Care System 650 E. Indian School Road Phoenix, AZ 85012

POC: Edward Yee Lead Medical Technologist/Safety Officer Pathology & Laboratory Medicine Service (P&LMS) VISN _22_ Medical Centers

5-year order Period: 09/1/2021 through 08/31/2026 (estimate only)

1.0 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. Red cell-based reagents have a short shelf-life and manufacturers require a contract to anticipate quantities to produce. These cells and reagents are mandated by accreditation agencies, such as CAP, AABB and FDA.

2.0 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.

3.0 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 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, CA | 11301 Wilshire Blvd, Los Angeles CA 90073

- VA Loma Linda, CA | 11201 Benton St., Loma Linda CA 92357

- VA San Diego, CA | 3350 La Jolla Village Dr., San Diego CA 92161

- VA Prescott, AZ | 500 N. State Highway 89, Prescott AZ 86313

4.0 Supply Requirements

The contractor shall provide the following:

1. Cells for ABO back-typing

2. Complement check cells

3. IgG check cells

4. Various anti-sera

5. 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.

6. 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.

5.0 Security Requirements

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 COR, 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.

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

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

7. Risk Control

All cellular reagents will be handled with standard precautions.