SOW.pdf

For Official Use Only

Statement of Work Adaptive Biotechnologies Corporation (ClonoSEQ®)

Brooke Army Medical Center (BAMC) Fort Sam Houston, Texas 78234

1. Scope: This is a non-personnel service to provide Clinical Reference Testing Services for Brooke

Army Medical Center. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn is responsible to the Government.

2. Requirements: The Contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform clinical reference laboratory testing services as defined in this Statement of Work (SOW) except for those items specified as government.

3. Description of Services:

a. The contractor must be capable of providing comprehensive ClonoSEQ testing support which includes all unique, individually orderable tests and panels, across all the aforementioned disciplines. The contractor must possess sufficient infrastructure to fully support the timely receipt, transport, processing, testing, and reporting of results for the total projected annual requirements across all agencies.

b. The contractor shall provide a pre-paid FedEx label for specimen shipments from BAMC to designated contractor laboratory.

c. A healthcare Hematology/Oncology provider at Brooke Army Medical Center shall collect or obtain appropriate biological specimen (either bone marrow or peripheral blood) from the patient according to established clinical and MTF protocols. The provider shall send the specimen to the BAMC Specimen Processing Lab in preparation for transport/shipment via FedEx to the contractor.

d. BAMC Specimen Processing Lab shall label, package, and prepare specimen for transport to contractor in accordance with laboratory procedures and regulatory requirements.

e. Upon receipt of the specimen, the contractor shall process the specimen in accordance with established contractor guidelines and protocols and provide results to the Hematology/Oncology clinic via the established channels within 7 – 14 days.

f. All tests shall be executed at the Contractor’s premises, or within the Contractor's network of laboratories[affiliate(s) or qualified subcontractor(s)].

g. The Contractor shall ensure every contract laboratory, owned, affiliated, or subcontracted, complies with the Clinical Laboratory Improvement Amendment of 1988 (CLIA), is accredited by the CAP, and complies with all applicable State laws and regulations.

h. The Contractor shall provide ClonoSEQ®, an FDA-cleared in vitro diagnostic (IVD) test service, to detect measurable residual disease (MRD) in bone marrow from patients with multiple myeloma or B-cell acute lymphoblastic leukemia (B-ALL) and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL). The ClonoSEQ® Assay measures minimal residual disease (MRD) to monitor changes in burden of disease during and after treatment.

i. The Contractor shall provide ClonoSEQ® assessments for a maximum of 15 patients annually. Each patient test will include 15 ID (Identification) reports, and then a maximum of 3 subsequent MRD assessments.

j. Upon result of the specimen, the contractor shall generate a formal report document detailing the test results. This report shall be securely transmitted back to the BAMC Hematology/Oncology Clinic through the established channels (via fax and uploaded in the ClonoSEQ portal) within 24-48 hours of result.

k. The contractor shall promptly notify the Hematology/Oncology on-call number in the event that test results cannot be obtained or are inconclusive.

l. The contractor shall promptly report any discrepancies pertaining to shipments, including but not limited to specimen loss resulting from breakage, spillage, leakage, insufficient dry ice, misplacement, or mishandling immediately upon receipt of shipment.

m. Bill of Materials:

i. ClonoSEQ Single Tests

ii. ClonoSEQ 15 ID + 3 MRDs per patient

4. Delivery Requirements: Specimen pickup shall occur via FedEx as needed upon notification that a patient requires this type of testing service. Delivery of results shall be via fax and uploaded electronically through the ClonoSEQ portal.

a. Location: The FedEx delivery/pickup shall take place at the following location:

ATTN: Specimen Processing Robert Ybarra Brooke Army Medical Center 3551 Roger Brooke Dr.

BLDG 3600

JBSA Fort Sam Houston, San Antonio, TX 78234

b. Fax Location: The result of the test shall be faxed to:

ATTN: Hematology/Oncology Clinic Brooke Army Medical Center 3551 Roger Brooke Dr. BLDG 3600 JBSA Fort Sam Houston, San Antonio, TX 78234 Fax Phone: 210-916-9319

*ATTN to the following providers:

Javier A. Padial, MD, Lt Col, USAF MC Kristen Romanelli, DO, MAJ, USA MC Scott Penney, MD, Maj, USAF MC Donald Rees, MD, MAJ, USA, MC

*Any inquiries about specimen may contact the Hematology/Oncology on call phone at 210-266-9493.

c. Schedule: Hours of operation are between 7:00AM and 4:00PM CST, Monday – Friday, except Federal Holidays.

Base year: 01 April 2025 – 31 March 2025 Option Year 1: 01 April 2026– 31 March 2026 Option Year 2: 01 April 2027 – 31March 2027 Option Year 3: 01 April 2028– 31March 2028 Option Year 4: 01 April 2029– 31 March 2029

d. Points of Contact (POC):

Primary:

Taylor Feducia Contracting Officer Representative Phone Number: 210-916-8880 Email: taylor.n.feducia.civ@health.mil

Secondary:

Major Tia Rhodes Moreno OIC Phone Number: 210-916-0930 Email: tia.r.rhodes.mil@health.mil

5. Installation: Brooke Army Medical Center

6. Invoicing Instructions:

All invoices for this contract action shall be submitted into WAWF for payment and emailed to the POCs. Submissions must include an attachment with the invoice for services performed. Invoice will not be submitted until testing is considered resulted.

*If not submitted to the E-Mail addresses shown above, the invoice will be rejected. *

a. Other Points of Contact

i. Technical and Project Management Point of Contact:

Name: Tia Rhodes, Major Title: Moreno (OIC) DPALS E-mail Address: tia.r.rhodes.mil@health.mil Office Phone: 210-916-0623

Name: Robert Ybarra Title: Supervisor, Client Services E-mail Address: Robert.a.ybarra2.civ@health.mil Office Phone: 210-916-9637

ii. Contracting Point of Contact: MRCO-W

Name: (Not Assigned yet) Title: Contracting Specialist E-mail Address:

Office Phone:

Name: (Not Assigned yet) Title: Contracting Officer E-mail Address:

Office Phone:

Name: Taylor N. Feducia Title: Contracting Officer Representative E-mail Address: taylor.n.feducia.civ@health.mil Office Phone: 210-916-8880

b. Final invoices with respect to a specific contract/delivery order/task order shall be clearly marked “FINAL” and submitted within 45 days after period of performance end date specified in contract.