GenDx Reagents SOW FY26.docx

STATEMENT OF WORK

GenDx NGS Reagents

A. GENERAL INFORMATION

1. The Contractor shall provide next generation sequencing (NGS) reagent kits compatible with the Illumina MiSeq instrument. All reagents must meet the performance characteristics for accuracy and precision as defined by the Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Goods shall be purchased on an as-needed basis by the Iowa City VA Health Care System, 601 Highway 6 West, Iowa City, IA 52246, Immunology Department of Pathology and Laboratory Medicine. This is a firm, fixed price, Indefinite Delivery-Indefinite Quantity (IDIQ) contract.

B. PERIOD OF PERFORMANCE

1. Ordering Period 1: 10/1/2025 – 09/30/2026

2. Ordering Period 2: 10/1/2026-09/30/2027

3. Ordering Period 3: 10/1/2027-09/30/2028

C. REAGENT SPECIFICATIONS

1. Contractor must supply NGS reagent kits used to perform identification of human leukocyte antigen alleles through amplification of A, B, C, DPA1, DPB1, DQA1, DQB1, DRB1, DRB3/4/5.

2. No product substitutions will be accepted without prior approval of the VA Health Care System Laboratory Service Contracting Officer Representative (COR) or designee. Catalog #2342256 IndX plate II, #2342356 IndX plate III, and #2342456 IndX plate IV can freely be substituted for #2342156 IndX plate I.

3. All products purchases are subject to acceptance by the COR or designee. Products that fail to meet quality and control criteria will not be accepted. Products will be rejected, discarded, or returned to the Contractor at the Contractor’s expense if found to be unsatisfactory at time of receipt, or, due to product deterioration prior to outdate. The Iowa City VA will not be financially liable for unacceptable materials.

4. All products must be tested for quality control by the manufacturer. Only products that pass inspection will be sent to Iowa City VA. The Contractor will demonstrate documentation of quality control performance on any item upon request by the COR designee, including Certificate of Analysis, Analytical Standard Certificates of Quality, and/or Chemical Data Sheets.

5. All defective or inferior products must be replaced within 48 business hours at no cost to the Iowa City VA.

6. The Contractor will immediately notify the Contracting Officer and Iowa City VA COR of any recalls of products or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled/defective products at no cost to the Iowa City VA. The Contractor will be liable for all costs of processing recalls.

D. DELIVERY

1. Deliveries will be made Monday through Friday between the hours of 8:00 AM through 4:30 PM, federal holidays accepted. Holidays observed by the Federal Government are as follows:

a. New Year’s Day*

b. Martin Luther King Day (3rd Monday in January)

c. Presidents’ Day (3rd Monday in February)

d. Memorial Day (Last Monday in May)

e. Juneteenth

f. Independence Day*

g. Labor Day (First Monday in September)

h. Indigenous Peoples’ Day/Columbus Day (2nd Monday in October)

i. Veterans Day (November 11th) *

j. Thanksgiving Day*

k. Christmas Day*

l. Any additional Federal Holiday declared by the President of the United States

*Note: If the federal holiday falls on a Saturday it will be officially observed on the Friday before the holiday. If the holiday falls on a Sunday, it will be officially observed on the Monday following the holiday.

E. PRICE/COST SCHEDULE

1. The Government estimates, but does not guarantee, the volume of purchases listed within the Schedule of Items. The Government is obligated only to the extent of authorized purchases actually made and obligated only to the guaranteed minimum.

2. The contractor shall communicate any unit prices changes at least thirty (30) days prior to the price change taking effect.

3. Unless otherwise agreed to, all deliveries shall be accompanied by delivery tickets or sales slips that contain the following information at a minimum:

a. Contractor Name

b. Contract number

c. Date of purchase

d. Date of shipment

e. Description of each item, including (when applicable) model number and Special Item Number (SIN)

f. Quantity for each item in the order

g. Unit price and extended (quantity x unit price) price for each item

F. INVOICING

1. The Contractor shall submit monthly invoices to the Iowa City VA Laboratory Manager/Budget Technician for products delivered. Invoices are due within thirty (30) calendar days after the products are received.

2. All invoices sent to the VA Laboratory shall reference the vendor name and address, the Customer (Iowa City VA), contact phone number and purchase order number. Invoices shall be accurate and shall display the date of order, date of shipment, a description of each item, quantity for each item, and unit price. Orders shall be tax exempt.

3. Vendor Electronic Invoice Submission Methods such as Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

a. Invoices will be electronically submitted to the Tungsten website at https://www.tungsten-network.com/us/support/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review “How to Create an Invoice” within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact:

Tungsten Support:

Phone: 1-877-489-6135 Website: https://www.tungsten-network.com/us/support/ Department of Veterans Affairs Financial Service Center:

Phone: 1-877-353-9791 Email: vafscched@va.gov