36C25725Q0489.docx

Special Notice

GENERAL INFORMATION

Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

POINT OF CONTACT*

Contract Specialist Susan Flores Susan.flores2@va.gov 210-694-6379

ADDITIONAL INFORMATION

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DESCRIPTION

Special Notice

Special Notice – Notice of Intent to Award a Sole Source Procurement

The Department of Veterans Affairs, Veterans Health Administration, Network Contracting Office 17, intends to award a Firm-Fixed priced, IDIQ contract with three ordering periods to BD Biosciences.

This order is for an IDIQ contract for BD FACSLyric™ flow cytometry system and the BD FACS™ Sample Prep Assistant and testing supplies.

1. Scope: The Contractor will provide one (1) new Sample Preparation System and all ancillary components including all system software, UPSs, monitors, auto-handlers, scanners, printers, instrument stands, technical support, off-site customer training, and business hours service plan. This system must be compatible with the current Flow Cytometers and software currently in use in the laboratory. The current test volume is estimated at 2,000 tests for the quantitative lymphocyte subset and 800 tests for Leukemia/lymphoma Immunophenotyping.

Contractor shall:

A. Deliver, install, and set up the instrument and components.

B. Provide test validation guidance and validation supplies.

C. Provide technical support and guidance.

D. Provide reagents, consumables, and supplies as requested by VANTHCS staff to perform testing utilizing both the sample preparation system and flow cytometers.

E. Provide setup for interfaced result reporting, which includes LIS physical connection and translation (drivers), and any required (additional) interface connection license(s).

F. Provide instrument repairs and scheduled preventive maintenance for the instrument and system components.

G. Provide basic and advanced operator training.

3. Location: The analyzer shall be located, and testing will be performed in the Flow Cytometry section of Client Services & Immunopathology, Room 1B-424, Pathology & Laboratory Medicine Service, VA North Texas Health Care System, 4500 S. Lancaster Rd., Dallas, TX 75216.

4. Performance Requirements: The following are required:

A. System Requirements:

1) Sample Preparation System

a. System designed to work with the BD FACSLyric™ Flow Cytometer that exists in the lab currently.

b. System designed to work with the BD FACSuite™ Application that exists in the lab currently.

c. Automated cocktailing of reagents.

d. Ability to accommodate multiple reagent vials, not vendor specific. Complete list of potential antibody reagents used on the system. (Attachment A)

e. Traceability of specimens, reagent vials, and reagent cocktails.

f. Primary specimen tube loading capability with throughput at <190 minutes.

g. Bidirectional LIS compatibility with Data Innovations and VistA.

h. Capable of onboard washing of sample tubes.

i. Capable of onboard centrifugation of sample tubes.

j. Includes instrument workbench (stand) to accommodate the sample preparation instrument and flow cytometer.

B. Maintenance:

1) The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Preventive Maintenance includes the following:

a) The Sample Preparation System for the entirety of the contract.

b) The two existing BD FACSLyric Flow Cytometers and universal loaders for the entirety of the contract.

c) The existing FACS Sample Prep Assistant for the base year to support validation of the new Sample Preparation System.

2) Delivery of parts or materials for Preventive Maintenance.

3) Testing all components for proper test performance. Equipment shall reproduce results according to the manufacturer’s specifications.

4) After Preventative Maintenance, the Contractor shall submit a detailed work report for notice at no additional cost.

5) The Contractor shall provide all preventive service materials at no additional cost to the government.

C. Technical Support:

1) Support Personnel will be available during business hours each business day, and live representatives via the Contractor’s message center will be available by telephone at all other times.

2) Technical support shall be available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries.

3) On-site technical support shall be available for escalations within 48 hours.

D. On-site Repairs and Service Support:

1) Service support includes the following:

a) The Sample Preparation System for the entirety of the contract.

b) The two existing BD FACSLyric Flow Cytometers and universal loaders for the entirety of the contract.

c) The existing FACS Sample Prep Assistant for the base year to support validation of new Sample Preparation System.

2) For issues that the Contractor determines to require on-site support, the Contractor shall dispatch one or more Support Personnel, normally within 48 business hours after documentation.

3) The Contractor shall submit a detailed work report to include all required materials.

4) The Contractor shall provide all parts and materials (including ancillary components (workstation computer, workstation printer) at no additional cost the government.

5) The Contractor shall remove all parts, equipment or materials replaced, or upgraded by the Contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government.

E. Training: The contractor shall provide the following:

1) Two initial off-site operator training of analyzer

2) Two additional off-site Basic Operator training for BD FACSLyric with BD FACSuite Clinical Software.

3) Handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD’s, CD’s, videos, etc. if required), and editable procedures at no additional cost.

4) Additional on-site training as requested by VANTHCS at no additional charge.

F. Safety:

1) The Contractor shall immediately notify VANTHCS of any changes in reagent kit composition, procedure modification, recall notification, or any changes that will affect the performance of the test or procedure according to FDA regulations.

G. Test Performance:

1) All procedures and equipment must be performed at the manufacturer’s specifications. Deviations from the performance specifications shall be corrected by the Contractor.

2) Test performance will be evaluated by and not limited to performance through peer comparison, quality control, and CAP peer evaluation.

3) The vendor shall reimburse VANTHCS for any costs and/or 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, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

5. Period of Performance: The agreement will be in IDIQ contract for with thres (3) ordering periods:

The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of the vendor's equipment installation inclusive of completed cross-over studies. The Vendor shall be responsible for removing the hard drive and turning it over to the VANTHCS for destruction before removal of any analyzer.

6. Deliverables and Supplies: This order is for the cost per test procurement of an instrument/system for testing by flow cytometry. Reagents and supplies will be purchased under the terms of the reagent rental purchase agreement.

A. The Contractor shall deliver all supplies necessary for test performance at no Government cost.

B. The Contractor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications, and test manuals.

C. The Contractor shall install the equipment and perform test verification according to manufacturer specifications and CAP requirements.

D. The Contractor shall provide supplies: reagents and consumables for WBC Immunophenotyping and CD4/CD8 testing. Additional testing may be added at the discretion of VANTHCS. Any additional testing shall be negotiated between the Contractor and VANTHCS.

E. If requested supplies are on back-order, then the Contractor is to provide information as to the estimated time of availability.

F. The Contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle.

G. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost.

H. Any changes in reagents or equipment modifications shall be immediately disclosed by the Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation within twenty-four hours of its application.

I. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation, and or any other additional cost shall be covered by the Contractor at no additional charge to the government.

7. Contractor Security Contract Requirements: This Contractor requires no access to VANTHCS or any VA information system. The analyzer will be interfaced to the VANTHCS information system through Data Innovations. There will be supervised access when the Contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

8.

This notice is not to be considered a request for quotations or proposals. A contract will not be awarded based on an offer received in response to this notice; however, all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. Proposals or offers received will be used to determine if a comparable source is available and more advantageous to the government. If no affirmative written response is received within 3 days from the publication of this notice, a contract/order will be issued to Cepheid without any further notice.

The proposed contract actions are for services, which the government intends to negotiate with only one source. The anticipated statutory authorities permitting other than full and open competition for the requirement is 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements.

The proposed sole source procurement will be made by a pricing agreement with BD Bioscience.

Special Notice