36C24418Q0466-000.docx

FedBizOpps Justification and Approval Notice

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* = Required Field FedBizOpps Justification and Approval Notice Rev. March 2010 PR return to FCP 4/5/18, sad|Modification V797P2025D PRE SOLICITATION |PRE SOLICITATION this is going to have a review for a 2268, 4/10/18,sad|NO AP msg to req 4/3vu 15240 36C24418Q0466 N 621511 Department of Veterans Affairs Network Contracting Office 4 Steven Danylo Steven.Danylo@va.gov

FAR 6.302-1

V797P-2025D 200,600.00 04-16-2018

OXFORD IMMUNOTEC, INC.

700 NICKERSON RD, STE 200

MARLBOROUGH

MA

01752 syeven.danylo@va.gov

STATEMENT OF WORK FOR BLOOD TESTING FOR MYCOBACTERIUM TUBERCULOSIS (TSPOTS)

It is the intent of the Department of Veterans Affairs Medical Center, Pittsburgh (VAMC) to establish a contract for testing of blood samples for Mycobacterium tuberculosis.

1. The contractor must meet all the standards of all licensing and accreditation agencies to include the following: Joint Commission (JC), College of American Pathologists (CAP), Occupational Safety and Health Administration (OSHA) and Food & Drug Administration (FDA).

2. The contractor will supply test requisition forms to the VA Medical Center which will have a pre-printed Account Number on them and the VA Medical Center’s name and location. These requisitions will be used to accompany any samples that are sent to the Reference laboratory.

3. The contractor will supply the specimen packaging boxes that meet the standards for Shipping of Diagnostic Specimens as stated in the Code of Federal Regulations. The specimen packaging boxes will have the postage pre-paid to be sent as same day delivery.

4. The employees of the VA Medical Center will fill out a Test Requisition Form with all the pertinent information required to include the patient’s full name, patient’s full social security number, the patient’s date of birth, the date and time of collection of the specimen.

5. The contractor will employ UPS or FEDX to pick up (when called) at any of the following locations: Pittsburgh VAMC University Drive , Pittsburgh Pa. 15240.

6. This contract provides for the blood tests for Mycobacterium tuberculosis using the Interferon-Gamma Release Assay that has been approved by the FDA. The following is also a list of requirements for this testing:

· The test must detect the presence of latent or active tuberculosis by the expression of interferon gamma by the effector T-Cells that are associated with M. Tuberculosis.

· Both the sensitivity and specificity of the IRGA must be above 95% in each category

· Testing must be viable on all populations including immunosuppressed and BCG vaccinated populations as well as post contact testing. The test must address the immune status of a patient when being tested for M. Tuberculosis.

· Tests must be able to be drawn in all CBOC locations and sent to the main laboratory or directly to the testing laboratory

· The test must follow recommendations of the CDC guidelines for tuberculosis testing, including the use of a borderline result, to improve test accuracy.

· The blood sample must be easy to collect and require no pre-analytics at the site of draw

· IGRA blood samples must be able to be kept at room temperature throughout a single business day at each collecting location

· The test must be resulted in a period not to exceed two business days (48 hours) from the time of draw

· The laboratory must allow for draws on at least one day of the weekend so as not to delay a result from coming back.

7. Contractor will provide for an adequate way of sending results back to the VA Medical Center Laboratory.

8. Invoices for services provided under this agreement should be mailed monthly in arrears in accordance with the FAR 32.9. Contractor shall mail invoices for services provided under this contract to: Pittsburgh VAMC University Drive , Pittsburgh Pa. 15240.

9. Invoices for services provided under this agreement should also be faxed monthly in arrears to Austin, Texas to the following fax number:

End of Document