SS Intent Notice TSPOT TB.docx

SPECIAL NOTICE

NOTICE OF INTENT TO AWARD SOLE SOURCE

T-SPOT TB TESTING

36C25621Q1665

The Department of Veterans Affairs, Network Contracting Office NCO 16 in conjunction with the South Central VA Health Care Network (SCVAHCN) intends to award a sole source, firm fixed price BPA (Blanket Purchase Agreement) for referral laboratory testing services using the Oxford T-SPOT®.TB assay. The intent is to solicit and negotiate with only Quest Diagnostics, Inc., 3 Giralda Farms, Madison, NJ 07940 in accordance with FAR 8.405-6, limiting sources. The BPA will be for the period of December 1, 2021 through November 30, 2022 and 2 one-year options and is for the following VISN 16 locations:

The NAICS Code for this procurement is 621511; size standard $32.5M.

Requirements:

Commercial Reference Laboratory with a Federal Supply Schedule (FSS) Federal Supply Class (FSC) Group 621 II Medical Laboratory Testing Services contract currently performing the Oxford T-SPOT®.TB assay for referring customers. The contractor Referral Testing Laboratory shall meet all of the following:

· Currently performing the Interferon-Gamma Release Assay (IGRA) based Oxford T-SPOT ®TB assay under SIN 621-209 Microbiology or 621-211 Serology

· Has capacity and staff to perform the estimated quantities Oxford T-SPOT®. TB assay as provided in Attachment A according to manufacturers’ instructions.

· Provides access to a commercial carrier for pickup and transportation of specimens by providing Jackson VAMC and Little Rock VAMC preprinted shipping labels containing the necessary information including Contractor account number. Note: Scheduled pickup times Monday through Friday will be mutually agreed upon between the contractor and each ordering facility following award.

· Contractor shall provide without additional charge all materials necessary for shipping of specimens to Contractors Laboratory ensuring compliance with all U.S. Department of Transportation (DOT), International Air Transport Association (IATA) state and federal transportation requirements for biological specimens.

· Contractor shall be responsible for all costs associated with shipping patient samples and required specimen collections supplies.

· Electronic data base or web portal to view sample status, reprint and retransmit test reports if needed.

· Site 2 Site (S2S) interconnection via a VPN tunnel is to deliver the electronic ordering of patient lab tests to/from VA LEDI to Contractors laboratory and to deliver the electronic results back to VA’s LEDI System.

· Site 2 Site (S2S) VPN connectivity through a current approved ISA/MOU with VA Enterprise Security Operations (ESO) Specialized Device Security Division (SDSD).

· Contractor Laboratory CLIA License of Accreditation. A complete copy of the certificate displaying all laboratory certification codes including the appropriate code for the performance of the OXFORD T-SPOT.TB® assay.

· Contractor Laboratory current CMS approved accreditation certificate such as College of American Pathologist (CAP) or Joint Commission.

· Contractor shall provide a copy of their standard catalog (printed or electronic) of all reference testing services available.

· Contractor shall provide orderable test code for the Oxford T-SPOT.TB test.

· Contractor shall submit a sample of patient report for Oxford T-SPOT.TB® testing that demonstrates inclusion of all required report elements. A separate report example shall be provided for each possible result condition (Positive, Negative, Borderline and Invalid).

The following shall be provided upon request to demonstrate the commercial reference laboratory currently performs the test and ability to meet the requirements:

· Contractor Laboratory Accreditation Activity Menu reflective of all test currently performed within the laboratory and demonstrating laboratory performs the required T-SPOT®.TB test.

· Contractor shall provide a copy of successfully completed method performance verification studies for the Oxford T-SPOT.TB performed by their laboratory as required by laboratory accrediting agencies that are signed and approved by the Laboratory Director for clinical use.

· Contractor shall provide a list of existing testing instrumentation and ancillary items currently being used to perform Oxford T-SPOT.TB testing.

· Contractor shall submit a copy of their laboratory procedure for proficiency testing surveys and external performance assessments signed by the laboratory director.

· Contractor Laboratory shall provide alternative external assessment results over the last 2 years signed by the Laboratory Director.

Others may identify their interest by responding to this notice via email to Sheila Reed, Contracting Officer at Sheila.reed@va.gov. Include the following in the email subject line: “RFQ 36C25621Q1665 – V16 T-SPOT.TB”. Responses must be received by 3:00pm (central), November 2, 2021.

DISCLAIMER

This notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this notice that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this notice. There is no guarantee, expressed or implicit, that the market research for this acquisition will result in a particular set-aside, sole source award or any other guarantee of award strategy.