R--Metabolomics

The VHA provides healthcare services for the nations Veteran population. One of the charges of the VHA is to promote research and development dedicated to improving the health and lives of Veterans. The Office of Research and Development (ORD) created the Genomic Medicine Program (GMP) in 2006 to support and lead VA as it moves into the venue of genomic or precision medicine. The VHA Million Veteran Program requires the services of a vendor for metabolomics analyses for human samples. The human plasma samples shall be sent to the contractor facility from the MAVERIC Biorepository in Boston or another VA biorepository. The number of samples to be processed is between 500-1000 over the course of the contract year. The purpose of this synopsis is to gain knowledge of potential qualified sources who can meet the salient characteristics below and their size classification (large business, small business, 8(a), SDVOSB, etc.), relative to NAICS code 334516. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. Contractor Qualifications The contractor shall have the following qualifications, capabilities, and be able to document the following: Headquarters and laboratory facilities where work to be conducted in is located within the Continental United States. No work shall be performed outside of the United States or in any locality outside of the jurisdiction of the laws of the United States. An extensive chemical reference library (>4000) metabolites representing the following major metabolic pathways: Carbohydrate Vitamin Energy Nucleotide Lipid Drug metabolites Microbiome THIS IS A CRITICAL REQUIREMENT. Ability for Sample tracking and management utilizing bar coding to ensure security & traceability of VA samples. Ability to produce documentation of sample handling and processing attributes/audit trail, etc. that would address sample mixing and sample error tracking. Demonstrated prior experience working with partners in government, biotechnology, and academic industries Extensive working experience with unique/unrecoverable patient plasma (EDTA) samples Highly desirable is expertise in statistical and pathway analysis The contractor shall demonstrate that they are certified in Good Laboratory Practice (GLP) Contractors shall be required to submit for a NACI low level background investigation and security clearance in accordance with the VA IT Security Clause and complete the required training and procedures to comply with these requirements. TASKS/REQUIREMENTS. Tasks: The contractor shall provide a detailed Project Management Plan in their proposal to address the following tasks necessary to complete the whole genome sequencing, and shall address the capabilities to provide specific requirements: Additionally, the contractor shall not propose primary and alternative methods within a single proposal. If alternate methodologies are going to be proposed, it is suggested that the contractor submit multiple proposals. Task 1: Provide a detailed VA Sample Security and Data Security Plan: All materials and samples utilized during the course of the contract are the property of the Department of Veterans Affairs and must be handled in a confidential and secure manner. The contractor shall outline in their response: their planned lab Standard Operating Procedures (SOPs) methods for handling and securing of samples including paper and electronic documents, the methods, assurances and processes for destruction of samples and data, details of proposed shipping requirements like method/conditions for shipping, receipt & acknowledgement of shipments, encryption of hard drives (if that is the VA requested delivery method); documentation of security of electronic data delivery (if that is VA requested delivery method) as well as the contractors ability to perform in accordance with and subject to: VA Handbook 6500.1 - Electronic Media Sanitization, VA Directive 6300 Records and Information Management and its Handbook 6300.1 Records management Procedures, National Archives and Records Administration(NARA), FISMA, HIPAA, NIST, and related VA security and privacy control requirements applicable with provisions and clauses within this requirement. This plan shall address how the contractor plans to meet these requirements and shall be required at the time of submitting the proposal. Simply stating or acknowledging the references is unacceptable. Task 2: Attend an initial contract kick-off meeting, and attend as needed meetings through the life of the contract. A kick off meeting will be held in Washington, DC at the Department of Veterans Affairs within 14 days after contract award and shall be attended by all staff on contract. This meeting may take place via teleconference if preferred. The contractor shall be required to communicate with Program staff on an as needed basis throughout the life of the contract via teleconference or videoconference. Task 3: Receipt and storage of VA samples for metabolomics analysis The contractor shall include in proposal in their response to this PWS the outer boundaries of needed plasma sample quality, quantity and shipping requirement which will then be discussed and finalized at the Kick-off meeting. VA will provide the contractor with coded human plasma samples. The samples shall be stored by the contractor at -20 degrees Celsius in locked upright or chest freezers (with emergency back-up power) until the samples are processed for sequencing. Any unused samples are to be destroyed by the contractor as specified by VA policies. Sample tracking and management process shall be in place to ensure security of VA samples. Task 4: Metabolomics Analysis Contractor shall test plasma for quality sufficient to proceed with vendor sequencing procedures, and to confirm quality from VA reporting sent with samples, and to identity match samples before and after sequencing. Contractor shall provide the following services when a task order is issued: Summary report that includes methods used and quality control statistics Raw and scaled data for each biochemical detected Identity of each metabolite and validation method used. Identified compounds should be labeled according to whether they have identities validated by reference standard matched to literature; matched to public database; by molecular formula; are identified only by unique ion feature Quantification of each metabolite Task 5: Provide reports and required Data 1. Monthly Written Report: - This report shall be delivered electronically via email no later than the 1st day of the following month. The report shall track parameters, including: Number of samples completed to desired parameters as requested per the task order Quality control measurements of data (including number of samples that did not meet QC measurement standards) These reports will include any non-compliance issues, to include if and the number of samples that do not meet contractor s QC standards. And, in accordance with the most current industry standards, any other data that may be deemed beneficial to VA by contractor. 2. Required Metabolomics Data Contractor shall supply completed metabolomics analyses data for the VA samples including the data requirements in Task 4, and generated in a secure manner in one or all of the requested formats below: VA approved encrypted hard drives. Encryption shall be in accordance with VA security standards, VA Handbook 6500.6, by shipment of encrypted physical hard drives to VA location (provided by COR) by courier or overnight shipping, and including signature delivery confirmation. Currently the approved drive is 40TB (RAID 0) CSE-40TB4-SU3 (https://www.buslink.com/product.php?prod_id=442). Electronic Data and/or physical hard drives shall be sent to the VA or to an approved federal partner location within one week upon completion of each task order unless a specific schedule is mentioned in the individual task order. Task 6: Destruction of Unused sample and metabolomic data The contractor shall destroy or return unused VA samples, in compliance with relevant sections of VA Handbook 6500.1 and per direction with written approval of the Contracting Officer s Representative or Contracting Officer. The acceptable method of destroying VA samples is by bleaching and certified to that effect. The contractor shall destroy all data associated with VA sample as per direction and with approval of the VA COR/Contracting Officer and in full compliance of the VA Handbook 6500.1 specifically paragraphs 5 and 6. Once the data is received, the VA COR will notify the vendor in writing of the same. The data on the vendor s end shall be destroyed by the vendor after documented completion of initial QC checks by the VA. The vendor should be able to store the raw data for up to 12 months. Type of Contract: Firm Fixed Price This notice is not a request for competitive proposals, however; any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Wednesday, August 23, 2017 at 4 PM, EST. Interest/capability statements may be sent to Lynn Portman at contact@example.gov and should include company name, address, point of contact, business size, SDVOSB/VOSB status, and product information. No telephone responses will be accepted. This notice is to assist the Government in determining sources only. A solicitation is not currently available. If a solicitation is issued, all interested parties must respond to that solicitation announcement separately from the responses to this announcement.