S02 36C25722Q0883.pdf

Special Notice

*= Required Field Special Notice

SUBJECT* Notice of Intent to Sole Source Hemosil D-Dimer Reagents

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 78240

SOLICITATION NUMBER* 36C25722Q0883

ARCHIVE 15 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

PRODUCT SERVICE CODE* 6640

NAICS CODE* 334516

CONTRACTING OFFICE ADDRESS Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

POINT OF CONTACT*

Contract Specialist

Melanie Williams melanie.williams5@va.gov

210-694-6378

ADDITIONAL INFORMATION

AGENCY’S URL www.va.gov

URL DESCRIPTION Department of Veterans Affairs Homepage

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

STATEMENT OF WORK (SOW)

Scope

The South Texas VA Healthcare System (STVHCS) has a continued need for the Hemosil D- Dimer Reagents and supplies for the current leased ACL TOP 750’s housed in the Core Laboratory of Pathology & Laboratory Medicine Service at Audie L. Murphy Memorial Veterans’ Hospital and Kerrville VA Medical Center. The controls, calibrators, reagents, and supplies must be compatible with the ACL TOP 750 Instrumentation. The D-Dimer reagent is currently being used as part of the COVID Triage panel to aid in the screening for venous thromboembolism (VTE), including both pulmonary embolism (PE) and deep vein thrombosis (DVT). This test is critical to patient care for pre-op and management of the current COVID 19 Pandemic.

Technical Requirements

1. The vendor must offer the following brand name Quality Controls and supplies that is compatible following instrumentation

• IL Werfen ACL 750 instrumentation

Item # Description/Part Number* Qty

00020007700 HEMOSIL D-DIMER HS 180

00020008610 HEMOSIL D-DIMER CONTROL 75

2. All reagents, controls, calibrators, and normal donor plasma (for annual lot changes) will be of the same lot number for all users. Lot numbers will be in use at least twelve (12) months.

3. The quality controls must be approved for use by the Food and Drug Administration

(FDA).

4. The contractor shall be able to provide the above listed reagents as needed.

5. The contractor is required to provide a continuously stocked inventory of coagulation reagents and supplies, and any other materials required to properly perform coagulation testing such that Core Laboratory operations are not interrupted. These items shall be of the highest quality, to assure precision and accuracy. Expiration date must be clearly marked all supplies. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award.

6. Special handling for emergency orders of supplies: If the supplies are found to be defective and unsuitable for use with the IL ACL equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the Contractor’s Core Laboratory equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery.

Location(s)

Audie L. Murphy Memorial Veterans’ Hospital 7400 Merton Minter Boulevard San Antonio, TX 78229

Kerrville VA Medical Center 3600 Memorial Boulevard Kerrville, TX 78028

Period of Performance

Base: 10/1/2022 – 9/30/2023 Option Year 1: 10/1/2023 – 9/30/2024 Option Year 2: 10/1/2024 – 9/30/2025 Option Year 3: 10/1/2025 – 9/30/2026 Option Year 4: 10/1/2026 – 9/30/2027

Deliverables/Supplies

Hemosil D-Dimer Reagents and Supplies

Government Inherent Functions:

Contractor shall not perform any inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees, selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

General Duties, Requirements, and Expectations:

1. Be professionally competent to handle required duties.

2. Work with staff to ensure safety measures are in place and documented.

3. Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws required by the Veteran’s Healthcare System and VHA Handbook 1106.1.

Information Systems Officer, Information Protection

The contractor will not have access to VA Desktop computers, nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

Privacy Officer

The contractor will not have access to Patient Health Information (PHI), nor will they have the capability of accessing patient information during the services provided to the VA.

Records Manager

There will be no federal records created, maintained, used or dispositioned with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.].