AN11--Research Lab Services - Blood Serum Assay Testing of Buprenorphine and Norbuprenorphine Levels

SOURCES SOUGHT NOTICE

Sources Sought: This is NOT a solicitation for a proposal, proposal abstract, or quote. The purpose of this notice is to obtain information regarding qualified business sources. The responses to the information requested will assist the Government in determining the appropriate acquisition method.

STATEMENT OF WORK

Contract Title:Â Â CSP #2014Â Blood Serum Assay of Buprenorphine and Norbuprenorphine LevelsÂ

Background: CSP #2014 Comparative Effectiveness of Two Formulations of Buprenorphine for Treating Opioid Use Disorder in Veterans (VA-BRAVE) is a comparative effectiveness study evaluating formulations of buprenorphine in Veterans with opioid use disorder (OUD) across 20 VA sites in the US. This is the first study of its kind in the VA and the first study comparing these two formulations in a real world clinical population. The study is comparing the Food and Drug Administration (FDA)-approved long acting injectable (LAI, (monthly)) buprenorphine (Sublocade), with the current standard of care, sublingual (SL) daily buprenorphine plus naloxone film.

Scope:Â Â CSP #2014 requires blood buprenorphine and norbuprenorphine testing on approximately four hundred ninety-eight (498 participants three (3) times across three (3) years and two hundred fifty (250) samples the fourth year totaling approximately one thousand four hundred ninety-four (1,494) assessments.

Specific Tasks & Deliverables:Â Â

TASK: Collection of blood toxicology samples Â

TASK: shipping supplies for blood toxicology samples to include:Â

Substance abuse screening deviceÂ

acutainer Grey Top Tubes 10 mLÂ

Test Requisition Forms (2 part, pre-printed) Â

Large Zip Locks (to go inside FedEx pack)Â

2 Pouch Specimen baggies (for each case)Â

FedEx overnight shipping Pak/Box with preprinted label to laboratoryÂ

Requirements Result Reporting: Web-based specimen collection and reporting tool (with search, management, printing capabilities) via a secure web portal for CSP personnel to be able to access and export data is required. Results will be made available and maintained by the vendor. Data shall be input and uploaded to the designated vendor web portal and reports will be made available according to the requisition form immediately following test results. Data to be provided (at a minimum): specimen ID (study ID), date blood received, date tested, and result (see output analysis section). The web portal shall be able to export the data; only showing the data without the ability to download is not acceptable. It must provide the ability to locate, view, print and save participant de-identified results. It must allow access to monthly reports, drug statistics, participant summaries, and for real-time tracking from collection through to the report.

 Output Analysis: Blood Toxicology Screens (determination and concentration of drug and/or metabolite) by gas chromatography-mass spectrometry (GC-MS) or liquid chromatography tandem mass spectrometry (LC-MS/MS) of:Â

BuprenorphineÂ

NorbuprenorphineÂ

*** Lab must be CLIA (Clinical Laboratory Improvement Amendments) CertifiedÂ

Period of Performance:Â Â Base plus 2 option years

Place of Performance:Â vendor siteÂ

SUMMARY:

This is a Sources Sought notice and not a request for quotes. This request is solely for the purpose of conducting market research to enhance VHA s understanding of the market s offered products, services, and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought.

This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products and services in response to the requirement. Vendors are invited to submit information relative to their potential of fulfilling this requirement in the form of a capability response that addresses the specific requirement identified in this Sources Sought.

This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy.

RESPONSE

Please provide a capability statement with general understanding of the industry with current knowledge and subcontract networks that would be used to support the requirement as identified herein. Information should suggest, NACIS Code, provide the socioeconomic status for your company and your subcontractors if you are planning on supporting this service with subcontractors. The limitations of subcontracting applies. The primary contractor must hold the required CLIA certification. The primary Contractor must perform more than the management and administrative functions on this requirement, and the primary Contractor must have previous experience in the services requested.

Submittals furnished will not be returned to the sender. No debriefs will be conducted. Eligibility in participating in a future acquisition does not depend upon a response to this notice.

The capability statement must show clear detailed qualifications that will meet this requirement.

Please provide your company s business status and any subcontractors business status: Large, Small, VOSB, or an SDVOSB.

Please include your company s SAM.gov Unique Entity ID (UEI) number. All companies doing business with the Government must be registered in SAM.gov under All Awards at time of solicitation and at time of award.

Proprietary information is neither requested nor desired. If such information is submitted, it must clearly be marked "proprietary" on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit).

Submit responses by email only to annmarie.stewart@va.gov

Timeline: This request will close on stated date within the Government Point of Entry (GPE).

The Department of Veteran Affairs

Contracting Office POC:

Ann Marie Stewart

Contracting Officer

annmarie.stewart@va.gov