FBN1 SOW SAM.pdf

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Attached to
FBN1 Marfan Syndrome Test
Solicitation number
25AP1447
Issued by

About this file

This Statement of Work (SOW) outlines requirements for FBN1 (Marfan Syndrome) single gene analysis testing services for the Pittsburgh VA Medical Center Laboratory. The contract covers all costs associated with performing the FBN1 gene analysis test, including consumables, quality control materials, and any reflex testing required. The test examines the FBN1 gene to identify potential mutations that could confirm Marfan Syndrome diagnosis in symptomatic individuals.

Key operational details include: this is a one-time purchase with items to be ordered as needed and delivered within 14 days; results must be faxed to VA Pittsburgh upon completion per VA security requirements; no government-furnished equipment or information is required; and only designated send-out testing supervisor/designees can place orders. All testing results will be delivered to VA Pittsburgh Healthcare System on University Drive in Pittsburgh, PA. The contract specifies item #482336 for FBN1 Marfan Syndrome single gene analysis with a quantity of 1 unit.

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STATEMENT OF WORK (SOW)

FBN1(Marfan Syndrome) Single Gene Analysis P

1. Contracting Officer’s Representative (COR).

Name:

Section: Pathology Medicine

Address: University Drive

Pittsburgh, PA 15240

Phone Number:

Fax Number:

E-Mail Address:

2. Contract Title. FBN1 (Marfan Syndrome) Single Gene Analysis

3. Background.

FBN1 (Marfan Syndrome) single gene analysis is a genetic test that examines the FBN1 gene, which is directly associated with Marfan Syndrome, to identify potential mutations that could confirm a diagnosis of the condition in an individual exhibiting clinical symptoms.

4. Scope.

This contract includes all the costs associated with performing the FBN1 (Marfan Syndrome) single gene analysis only. In addition, the contract includes pricing for performing the testing and any reflex testing that is associated with the FBN1 (Marfan Syndrome) single gene analysis.

This contract is specifically for the use of the Pittsburgh VA Medical Center Laboratory send out section only.

5. Specific Tasks.

This contract is required to provide pricing for all necessary consumables required to perform the

FBN1 (Marfan Syndrome) single gene analysis including quality control materials. In addition, the contract will include pricing for required reflex testing. These items will be permitted to be ordered as needed by the Pittsburgh VA.

Task 2 – Test Configurations

Deliverables: The following routine FBN1 (Marfan Syndrome) single gene analysis and any reflex testing are ordered as needed.

The following table is the FBN1 (Marfan Syndrome) single gene analysis, and all the reflex tests included in the panel.

Item # Description Qty

482336 FNB1 (Marfan Syndrome) single gene analysis

6. Performance Monitoring

It will be the responsibility of the Pittsburgh VA Medical center send out testing

Supervisor/designee to monitor all performance issues with the vendor. Timely delivery of testing results 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 is faxed to the VA Pittsburgh when results are completed.

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.

1. The send out testing will include all tests listed in the FBN1 (Marfan Syndrome) single gene analysis; results will be delivered in a timely manner.

2. All testing that was not able to be performed will be communicated to supervisor/designee.

10. Period of Performance

This is a one-time purchase of FBN1 (Marfan Syndrome) single gene analysis.

11. Delivery Schedule.

All required items will be ordered as needed directly by the lab and delivered within 14 days.

All testing results will be delivered to:

VA Pittsburgh Healthcare System

University Drive

Pittsburgh, PA 15240

The send out testing supervisor/designee are the designated individuals able to place orders against this contract.

File details come from the government source that posted it. Updated .