SOURCES SOUGHT
A -- Urine Toxicology Screening
- Notice Date
- 6/16/2020 11:39:33 AM
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- 241-NETWORK CONTRACT OFFICE 01 (36C241) TOGUS ME 04330 USA
- ZIP Code
- 04330
- Solicitation Number
- 36C24120Q0396
- Response Due
- 6/23/2020 1:30:00 PM
- Archive Date
- 07/23/2020
- Point of Contact
- Gian V Monteiro-Contractor, Gian V. Monteiro, Phone: 508-583-4500
- E-Mail Address
-
Gian.Monteiro@va.gov
(Gian.Monteiro@va.gov)
- Awardee
- null
- Description
- I. INTRODUCTION: This sources sought notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs (VA). The VA is currently conducting market research to locate qualified, experienced and interested potential sources. Responses will not be considered as quotes, nor will any award be incurred by interested parties in responding to this sources sought announcement. NCO 1 Contracting is seeking interested sources for a future solicitation and procurement. At this time, no solicitation exists. II. BACKGROUND: Boston HealthCare System has a requirement for Urine Toxicology for its Research Department in conjunction with the VA Cooperative Studies Program (CSP) described below:PERFORMANCE WORK STATEMENT I. Background VA Cooperative Studies Program (CSP) is sponsoring a study to compare the effectiveness of two formulations of buprenorphine (subcutaneous vs. sublingual) in Veterans with moderate-to-severe opioid use disorder. These tests will be used for urine toxicology screens needed to provide data over the course of the study. III. General Description of ServiceGENERAL DESCRIPTION OF SERVICE Urine toxicology screen specimens will occur in accordance with participant enrollment and on a standard schedule thereafter. The urine will be used to assess the primary endpoint for abstinence over the life of the study. Urine specimens will be obtained at VA medical centers across the contiguous United States and be delivered to the vendor operated centralized testing facility. Results will not impact dose adjustments for participants in the trial. Samples shall be tested in a consistent manner and vendor shall provide the results (via web portal) to the study coordinating center within 72 hours from the time of shipment from the local VA site. Vendor shall be flexible with sample flow due to shifting and unpredictable recruiting patterns. Vendor shall annually provide copies of CLIA and CAP certifications in addition to reference ranges for assessments conducted for regulatory purposes. Copies shall be provided to the Contracting Officer s Representative or the Cooperative Studies Program (CSP)-Boston Program Manager for this specific research project. Vendor transportation of samples shall be in accordance with all applicable laws and regulations for transporting human urine specimens. Vendor shall ensure samples arrive at testing facility in proper condition for the required testing. IIIIV. Work RequirementsWORK REQUIREMENTS A. Sample Handling Vendor shall provide urine specimen cups appropriate for collection that possess unique barcodes, which can be used to create a crosswalk at the site between the cup and any PHI (PHI exists only at VHA locales and will not be shared with the contracted entity). Vendor personnel and laboratory shall be compliant with all applicable laws and regulations. Lab must be Clinical Laboratory Improvement Amendment (CLIA) approved.. Vendor shall receive specimens between 8:00a.m. and 4:30p.m. Pacific time Monday-Saturday. Materials Required: Collection and shipping supplies for urine toxicology samples Urine collection cup with security seal and specimen label Shipment baggie with absorbent material and Prepaid FedEx Clinical Pak shipping containers The Research Requisition forms used to log urine specimens into the Vendor s system are available in paper format and will be ordered with the urine specimen cups. This Research Requisition form is available at no additional cost. Minor revisions to this form may be required occasionally to ensure participant confidentiality. B. Assays Required Vendor shall perform sample analysis one the following: Urine Toxicology Screens (via Enzyme Immunoassay Screen, Urine) Oxycodone/Noroxycodone Benzodiazepines Ethyl Glucuronide (EtG) (500 ng/mL cutoff) Methadone Fentanyls Tramadol Methylenedioxymethamphetamine (MDMA) Amphetamines Cocaine Metabolite Opiates Cannabinoids (THC) Creatinine THC/Creatine Ratio Confirmation Testing [via gas chromatography (GC), gas chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS)]. Confirmation test will be conducted if initial screen is positive. The confirmation test will provide an exact ng/mL level on the following substances to confirm the sample was above threshold (positive). Fentanyls C. Result Turnaround Time Urine toxicology screens and fentanyl confirmations shall be available in secure web portal, created and maintained by the vendor, within 72 hours from the time of shipment from the local VA site. The web portal shall be able to export the data; just showing the data without the ability to download is not acceptable. D. Results Reporting Data to be provided (at a minimum): specimen ID (study ID), date specimen received, date tested, result (positive/negative for all initial screens; in units designated above for fentanyl confirmation). Data shall be input and uploaded to the designated VA approved, secure portal immediately following test results. Calibration, frequency, and validation of instruments shall be submitted in the vendor s quality control plan. The government shall be informed if usual and customary procedures change due to any circumstance or unforeseen event, to include lab closures. E. Sample Destruction Upon completion of testing and release of results, vendor shall dispose of the specimens according to its standard procedure which is after 3 months in storage for a positive urine toxicology screen results (positive for opioids) and after 2 days for a negative urine toxicology screen results (negative for opioids). IVV. Performance PeriodPERFORMANCE PERIOD Period of performance will be from the date of the award for a base year of 12 months and include up to three four 1-year option periods. Location: Boston HealthCare System VI. OBJECTIVES: Boston HealthCare System is looking for small business concerns, especially Service-Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) contractors that can provide the requested Urine Toxicology for Boston HealthCare System Research within VISN 1. All capable companies are encouraged to respond. The current primary NAICS code is 621511 (Medical Laboratories). VII. SUBMITTAL INFORMATION: Contractors having the skills and capabilities necessary to perform the stated requirements should submit a response as detailed below. Companies should provide clear and unambiguous evidence to substantiate their capability to fulfill the requirements described above. Interested parties shall furnish the following minimum information: i. Company name and address ensure your company is registered in the System for Award Management (SAM) at www.sam.gov. ii. Company point of contact name, telephone number, and email address. iii. Evidence that you are a small business (if applicable): Small Business ensure you are listed as small business in SAM, reps and certifications. Provide the NAICS codes you are listed as a small business under. SDVOSB or VOSB (or in the process of certification) ensure you are certified in the veteran database at www.vetbiz.gov. Provide evidence of certification. iv. If your company holds a Federal Supply Schedule (FSS) Contract, list the Contract Number and SINs. v. Capabilities/Qualifications: A written response providing clear and unambiguous evidence to substantiate the capacity to fulfill this requirement. Description of the capabilities/qualifications/skills your company possesses to perform services described above. vi. Past Experience: Brief summary of the company history relative to similar requirements. Response may provide information on a maximum of three similar projects for which the responder was a prime or subcontractor. It is requested that the above information be provided no later than June 23, 2020 at 4:30PM EDT. Responses should be emailed to the contracting specialist at gian.monteiro@va.gov.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/c559bed9b6ca4ad3bc7816d059d38a4d/view)
- Place of Performance
- Address: Department of Veterans Affairs VA Boston HealthCare System 150 South Huntington Ave, Boston 02130-4817, USA
- Zip Code: 02130-4817
- Country: USA
- Zip Code: 02130-4817
- Record
- SN05693217-F 20200618/200616230210 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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