DRAFT P01. GenDx Reagents SOW FY25.pdf

STATEMENT OF WORK

Brand Name GenDx NGS Reagents Or Equal

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. Delivery Order Year 1 10/01/2024 – 09/30/2025

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 (or equivalent), #2342356 IndX plate III (or equivalent), and #2342456 IndX plate IV can freely be substituted for #2342156 IndX plate I (or equivalent).

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.