65--Verigene Enteric Pathogen Test/Test cartridge

Sources Sought Notice: Verigene Enteric Pathogen Test/Test cartridge For the Ralph H. Johnson VA Medical Center in Charleston, SC. 29401 DESCRIPTION: This is a sources sought to determine the availability of potential sources having the skills and capabilities necessary to provide the SPECIFIED REQUIREMENT. All interested vendors are invited to provide information to contribute to this market survey/sources sought including commercial market information. THIS IS NOT A SOLICITATION ANNOUNCEMENT. This is a sources sought synopsis only. Questions should be submitted by email to contact@example.gov. Provide only the requested information below. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classifications (Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), Hub zone, 8(a), small, small disadvantaged, woman owned small business, FSS/GSA contract schedule holders or large business) relative to NAICS 325413, In-Vitro Diagnostic Substance Manufacturing (size standard 500 Employees). Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought synopsis, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the solicitation announcement in addition to responding to this sources sought announcement. The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. SPECIFIED REQUIREMENT: Network Contracting Office 7, Charleston, SC is seeking sources for a potential contractor to provide the following: Verigene Enteric Pathogen Test/Test cartridge Base plus 4 one year options ITEM DESCRIPTION QTY UNIT 0001 Cost per test, Verigene, Enteric Pathogen test, Reagent Rental Fee for Verigene Reader one (1) each Cat# 10-0000-02 and Verigene Processor SP two (2) each Cat# 10-0000-07 at $18.00 per test for 500 per year = $9,000, which includes shipping fees, reagents, equipment installation, training, system user's manual , and travel. Period of performance is One Year (TBD) 500 EA 0002 Verigene Enteric Pathogen Test/cartridge, 500 per year at $72.25 = $36,125.00. Period of performance is One Year (TBD) 500 EA CHARLESTON VAMC MOLECULAR INSTRUMENTATION STATEMENT OF WORK 1. Proposed Action: The Microbiology Section of the Ralph H. Johnson VAMC Pathology and Laboratory Department in Charleston, SC needs an updated methodology to perform automated and less labor intensive stool culture processing using real-time PCR assays (Moderate complexity testing) for testing of common enteric pathogens. The instrument must be easy to use, simple, and require less hands-on time that current culturing methodology. The instrument must be able to use unprepared clinical samples with little preparation time (approximately 10 minutes or less). 2. Description of Work and Requirements: a. The instrument shall be capable of providing results for the following common pathogenic enteric bacteria, viruses, and genetic virulence markers: i. Campylobacter Group ii. Salmonella spp. iii. Shigella spp. iv. Vibrio Group v. Yersinia enterocolitica vi. Shiga Toxin 1 (stx 1) vii. Shiga Toxin 2 (stx 2) viii. Norovirus ix. Rotavirus b. The PCR instrument shall have a working interface with the VistA computer system. c. The instrument must be able to detect the etiologic agent rapidly. The turnaround time must be less than 2 hours. d. The PCR instrumentation must be able to support the VA's current mission and be flexible to expand/support the VA's future molecular testing needs. e. The vendor must provide an FDA approved, CLIA Moderately complex, fully-integrated and automated analysis instrument. f. Sample extraction, amplification, and detection process should be fully automated in a single-use cartridge and integrated with an automated real-time PCR system. These features contribute to ease of use, productivity, reproducibility, and reduced turnaround time. g. Each assay should have sample processing control and/or an internal control. h. The system must have the ability to process samples continuously, providing true 24/7 results. The system must be simple enough to be operated during any shift and reports resultable by any trained staff member. The system should not have any special lab requirements for PCR setup and testing. i. The vendor is required to provide all needed assistance with the installation, correlation/validation studies required for all PCR testing. The vendor must provide education/training onsite for basic operation and maintenance of the instrument. j. The vendor must provide all necessary procedure manuals in the CLSI (Clinical and Laboratory Standards Institute) format. k. The vendor must provide timely repair or replacement service of any defective parts of the instrument. The vendor is to provide alternative PCR testing if the PCR instrument is down in excess of 48 hours at no additional cost to the government. The costs are to be reimbursed by the vendor for those costs incurred during downtime to include, but not limited to, labor, supplies, and reference laboratory PCR testing. 3. Pricing Schedule: a. The pricing of the molecular testing should be based on Cost per Test (CPT). The reagent cost should include the cost of the instrument, service, parts, labor, training, etc. (all-inclusive pricing). The CPT for each PCR test, complexity, and battery of other molecular tests available for the instrument should be provided. b. As the mission of the VA changes, the VA may add additional testing. 4. FOB - Destination: a. There should not be any additional costs for shipping of reagents/kits. The delivery schedule for test kits will be provided. 5. Estimated Monthly Volumes: a. Stool Culture - 42 specimens a month 6. Contract Time Period: a. This proposal is for the base plus four option years CPT agreement (total of 60 months). The base year will start October 1, 2015 and ends on September 30, 2016. The government may renew or terminate this contract without any cost to the government in the event that the Medical Center does not receive funding or appropriation for molecular PCR testing. b. Any additional costs (such as usage fees, software update fees, and any other costs not included with the equipment/supply costs) must be specified in the CPT proposal. 839.201 Contract clause for Information and Information Technology Security Due to the threat of data breach or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA information is used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Information and/or Information Technology will be accessed or utilized, the contracting officer shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. As prescribed in 839.201, insert the following clause: (a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov (b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site : http://www.iprm.oit.va.gov/Security_and_Privacy_Requirements_for_Contractors.asp APPENDIX C C-2 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. APPENDIX C C-3 a. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold. b. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. c. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. d. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. ~~~END~~~ REQUESTED INFORMATION: (1) STATEMENT OF CAPABILITY: Submit a brief description, ten (10) pages or less that demonstrates how your company has the supervision, facilities, labor and experience to provide the items required. Include past experience in providing these items to the VA, other Government (Federal or State) agency, or for a private facility. Please specify your availability to start date and your address. (2) BUSINESS SIZE AND SOCIO-ECONOMIC STATUS: (a) Indicate whether your business is large or small (b) If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act (d) Indicate if your firm is a certified Hub-zone firm (e) Indicate if your firm is a woman-owned or operated business (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) (g) Include the DUNS number of your firm. (h) State whether your firm is registered with the System for Award Management (SAM) at https://www.sam.gov/portal/public/SAM/ and/or the VetBiz Registry at http://vip.vetbiz.gov/. (i) If not, please NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM and to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. If the requirement is available on your GSA, FSS or GWAC schedule include the schedule number and associated SINs. Responses must be emailed to contact@example.gov no later than 3PM EDT on Friday, January 29, 2016. Your response should include both the STATEMENT OF CAPABILITY and BUSINESS SIZE AND SOCIO-ECONOMIC STATUS information as explained above. Please place "VA247-16-N-0241 Verigene" in the subject line of your email. This notice is to assist the VA in determining sources only. A SOLICITATION IS NOT CURRENTLY AVAILABLE. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.