Q999--Lease equipment to perform esoteric microbiology and virology immunoassay testing

STATEMENT OF WORK (SOW)

Lyme, CMV, Measles, Mumps, Rubella, VZV

1. Pittsburgh Point of Contact

Name:

Jason Tedrow

Section:

Acquisitions-Veterans Affairs

Address:

University Drive C

Pittsburgh, PA 15240

Phone Number:

Ph# 412-360-1534

Fax Number:

E-Mail Address:

Jason.Tedrow2@va.gov

2. Contract Title. Â Lyme, CMV, Measles, Mumps, Rubella, VZVÂ Â Â Â Â Â Â Â Â Â Â

3. Background.

This contract is required as it is driven by policy to offer the best methodologies and services available that specifically addresses both quality of product and reliability.

In order to keep up with increased workload demands a fully automated test system that can provide automated, high throughput Chemiluminescent Immunoassay (CLIA) testing for CMV, Lyme, Measles, Mumps, Rubella, VZV testing is now standard.

4. Scope.

This contract includes all of the kits and controls associated with performing routine CMV IgG and IgM, Lyme, Measles, Mumps, Rubella, VZV testing on a daily basis.

This contract is specifically for the use of the Pittsburgh VA Medical Center Microbiology section only.

5. Specific Tasks.

This contract is required to provide expedited ordering for necessary consumables required to perform routine and esoteric microbiology and virology immunoassay testing as required for the Pittsburgh VA Medical Center.

These items will be permitted to be ordered as needed by the Pittsburgh VA.

The contract will include provisions for these items to be ordered as needed by the Pittsburgh VA and if needed in an emergency basis. The contract will state that direct ordering can be performed Mon-Fri and that the vendor will be responsible to ship the items as per their shipping schedule.

The cost of using the instrumentation will be factored into the cost of reagents as this is designed to be a reagent rental style agreement.

The instrumentation must be able to interface with the existing VA network and be Windows 10 compatible if applicable.

We require CLIA technology to provide higher throughput and increased sensitivity for lower analytic concentrations.

We required a fully automated analyzer able to run multiple tests at one time, as opposed to running 1 assay at a time, for improved patient result turnaround times.

The selected vendor must be able to provide an analyzer that possesses random access capabilities for all of our infectious disease testing.

The selected vendor must provide computer software that can track QC trends due to the CLIA use of calibration curves.

The selected vendor s analyzer must be able to hold up to 15 reagents on board at the same time and has a database backup and which retains both patient and QC data.

Training will be provided at no charge.

5.1 Task 1 Technical and Field Service

All technical and field service will be included by the vendor at no cost to the Pittsburgh VA.

Technical support must be available by phone 7 days a week from 8am-5pm.

On site service must be available within 24 hours after notification that an issue is not able to be resolved using technical service Mon-Fri.

Task 2 Kit Configurations

Deliverables: Routine kits, buffers, and consumables are ordered as needed. These will be ordered as needed and costs will go towards the assigned PO#.

The kits/products required are as follows:

CMV IgG Assay

CMV IgM Assay

Measles IgG Assay

Borrelia burgdorferi IgG Assay

Borrelia burgdorferi IgM Assay

MUMPS IgG Assay

RUBELLA IgG Assay

VZV IgG Reagent

Control CMV IgG

Control CMV IgM

Control Measles IgG

Control Borrelia burgdorferi

Control Mumps IgG

Control Rubella IgG

Control VZV IgG

Estimated quantities and prices for these reagents have been listed in the IGCE attached to this package.

Kevin Frank and Victor Sierra will be the two obligated ordering officials who will call to place orders on an as needed basis.

6. Performance Monitoring

It will be the responsibility of the Pittsburgh VA Medical center Immunology/Microbiology Supervisor/designee to monitor all performance issues with the vendor. Timely delivery of supplies, quality of product, and Mon-Fri direct ordering will be evaluated and compared to the terms of the contract.

7. Security Requirements

In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information requires appropriate security controls to be in place.

This is an acquisition or purchase of commodities and goods only. VA sensitive information is not involved in the course of these procedures (see Appendix A).

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

No GFE or GFI will be needed in any capacity.

9. Other Pertinent Information or Special Considerations.

It is the policy of the Pittsburgh VA Medical Center Immunology/Microbiology laboratory to encourage and actively solicit competitive bids from all vendors competing for similar business.

c. Identification of Non-Disclosure Requirements.

This is an acquisition or purchase of commodities and goods only. VA sensitive information is not involved in the course of these procedures.

d. Packaging, Packing and Shipping Instructions.

There is no special packaging and shipping instructions required. All items are shipped as per the vendor s specifications to ensure quality of products and goods.

e. Inspection and Acceptance Criteria.

All received products and goods are examined for quality and acceptability without exception. Acceptable products are signed for by the laboratory.

10. Risk Control

No additional risk will be undertaken by the laboratory as compared to any other vendor or method.

11. Place of Performance.

The supplies will be located in room 2NW120 (VIDAS refrigerator).

No contractor travel expenses are included in this contract.

12. Period of Performance

This contract will be valid for a 1 year with 4 additional option years.

The start date of this contract should reflect 3/1/21 through 2/28/26

13. Delivery Schedule.

All required items will be ordered as needed directly by the lab and delivered within one (1) week.

All vendor shipped items will be delivered in a vendor determined format.