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FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 13, 2017 FBO #5742
DOCUMENT

65 -- MRSA Surveillance PCR Testing - Attachment

Notice Date

8/11/2017
 

Notice Type

Attachment
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 4
 

Solicitation Number

VA24417Q1562
 

Response Due

8/18/2017
 

Archive Date

10/17/2017
 

Point of Contact

Stanley Kwasny
 

E-Mail Address

Maureen.Jordan@va.gov
(Maureen.Jordan@va.gov)
 

Small Business Set-Aside

N/A
 

Description

SOURCES SOUGHT NOTICE This is a SOURCES SOUGHT NOTICE ONLY. This is NOT a solicitation for proposals or quotes and does not obligate the Government to award a contract. This notice is for informational and planning purposes only and shall not be construed as a solicitation or an obligation or commitment by the Government, nor is it a Request for Proposal (RFQ) at this time. Responses to this Notice must be in writing. The purpose of this Sources Sought Notice is to conduct market research to determine, in particular, the capability of Small Business firms to provide the services/supplies described below. Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name; (b) address; (c) point of contact; (d) phone, fax and email; (e ) DUNS Number; (f) Cage Code; (g) socioeconomic category (i.e., small business, Service Disabled Veteran Owned Small Business, Veteran Owned Small Business, etc.); (h) a technical/capability statement as well as your existing customers and (i) any GSA Schedule numbers and expiration dates. VA will accept responses from ALL socioeconomic categories in order to gain a more complete understanding of the market for these services. The VA Pittsburgh Healthcare System is seeking information for a Laboratory instrument that can automate their MRSA surveillance PCR testing, our C-diff testing, as well as serve as an automated extraction system for DNA and Total Nucleic Acid from a variety of samples. We also desire an open system that would permit the ability to add user defined methodologies in an effort to utilize one platform for multiple tests. This instrument must be compact with a maximum foot print of 94cm (W) x75cm (D) x72cm (H) so that it can reside on a bench top. The system must include a monitor keyboard and bar code scanner. The system must integrate and automate the sample extraction, amplification and reading functions of our MRSA and C-diff test in a simple sample in result out workflow. The system must have the capacity to load 24 samples on at one time. The system must be capable of yielding high quality nucleic acid extractions from a variety of sample types to include but not limited to urine, plasma, whole blood, sputum and samples in transport media. This will include all costs associated with performing automated molecular MRSA screening testing. In addition, the contract should include pricing for performing lysis and the required capillaries. The contract should also include pricing for any disposables, maintenance items, etc. to properly maintain and operate the analyzer on a daily basis. These items will be permitted to be ordered as needed by the Pittsburgh VA. Salient Characteristics Must be Moderately Complex to allow use by non-Molecular Technologist, allowing 7 day per week testing.   Ability to run assays of future interest, specifically Enteric Stool testing and Parasite testing. The selected vendor must not be susceptible to S. aureus that contain an SCC element lacking the mecA gene. The selected vendor shall employ a methodology that casts the widest net to identify newly emerging MREJ subtypes. The system must not require external Quality Control with every run. This is a key factor for consideration. The system must have the ability to integrate into our LIS system. The system must be an open platform to allow for User Defined Protocols with customizable cycling parameters (time and temperature). The system must be capable of accepting user developed lyophilized reagents as well as wet reagents to maximize ease of use, protocol standardization and minimize waste.. The system must be able to assure proper test set-up with ability to scan in a sample tube bare code ID, match to specific test protocol, flag any error in set-up prior to initiating run and perform all steps to complete sample processing, nucleic acid extraction and PCR set-up and data analysis with walk away automation. The system must be capable of using multiple real time PCR methodologies such as scorpion primer/probes, molecular beacons and TaqMan probes to give flexibility to designing superior performing assays to meet our User Defined Protocol needs. The system must be able to perform independent extraction and amplification of samples to enable the lab to identify and quantify various viruses in support of our Transplant testing programs. The system must be able to extract nucleic acid from multiple patient sample types to be used on other real time PCR platforms in our lab. The system must be designed for efficiency across a range of test volumes and minimize waste by allowing for individual sample reagent setup. The reagent test kits must be able to be stored at room temperature. The reagent and consumable set-up must contain all the necessary pipette tips, reagents, processing and reaction tubes for the nucleic acid extraction, PCR set-up and amplification. This design should standardize set-up, reduce and simplify user interactions and minimize waste and disposables. The system must be capable of performing small sample volume PCR reactions facilitating rapid thermocycling and rapid turnaround time. The system must seal the PCR reaction chamber before target application to reduce the risk of amplicon contamination and cross reactivity. The system must be capable of performing qualitative, quantitative, and multiplexed detection as well as melt-point analysis of Lab Developed tests and provide the necessary flexibility to optimize assay performance. Each PCR reaction must be individually controlled and read by the optical detection system, enabling multiplex detection in real time reactions. This enables mixed assay processing and will dramatically reduce development time as we experiment to establish the parameters that yield the best results. The manufacturer must supply generic extraction reagents optimized for DNA, TNA extraction from patient samples and generic master mix with and without an internal control, providing flexibility and options in developing our own tests and enabling the opportunity to standardize both materials and workflow for the most assays possible. The system must be capable of accepting up to 24 samples at one time but as few as one sample at a time. This provides workflow flexibility and overall efficiency to processing daily workloads. The system must be equipped with at least 5 optical channels and support fluoresce detection of: Color (Spec) Typical Dye (Assay) Wavelength Name Excitation Range Emission Range Green FAM 470/510 470 ± 12 510 ± 6 Yellow TET, VIC 530/555 530 ± 6 555 ± 6 Orange Texas Red, ROX 585/610 585 ± 6 610 ± 6 Red Cy5 625/660 625 ± 6 660 ± 6 Crimson Cy5.5 680/715 680 ± 6 > 710 Not defined null null     For the use of purchased reagents and disposables the contractor will provide all of the required hardware to perform the necessary methodologies. This is specifically for the use of the Pittsburgh VA Medical Center Molecular section only. Specific Tasks. The contractor will be required to provide pricing for all necessary consumables required to perform molecular MRSA screening. In addition, the contractor should include pricing for any disposables, maintenance items, etc. to properly maintain and operate the analyzer on a daily basis. These items will be permitted to be ordered as needed by the Pittsburgh VA. Task 1 Technical and Field Service Subtask 1 Technical Service. Provide technical and functional courses of action to remedy minor trouble shooting that can be accomplished by the technologist within 30 minutes. 24-hour Technical Support is available Monday through Friday, 8:30 A.M. to 5:30 P.M., EST. Subtask 2 Field Service. Included in this Task is the requirement that Field service will be performed Mon-Fri and that all issues will be resolved within a 24 hour time frame from the time service is required. Technical Support is available Monday through Friday, 8:30 A.M. to 5:30 P.M., EST. Task 2 Kit Configurations To maximize sample processing efficiency it is required that the vendor provide the ability for the ordering institution to obtain kit configurations that include 96 tests/kit. Deliverables: The following routine consumables are ordered as needed. However, there may be additional items that are not routine that may be required to be replaced. These will be ordered as needed and costs will go towards the assigned PO#. Some of the items not listed permit different numbers of samples to be performed at one time. Those items may be added as needed to permit increased efficiency of sample processing. Fisher Catalog number BD Catalog number Description Quantity Needed Per Year B443461 443461 BD MAX MRSA XT Kit 700 B437519 437519 MAX Cartridge 24 Lane 24 Pk (576 test) 30 Performance Monitoring It will be the responsibility of the Pittsburgh VA Medical center Immunology/Microbiology Supervisor/designee to monitor all performance issues with the vendor. Timely delivery of supplies, prompt and professional technical service, and 24 hour field service, Mon-Fri, will be evaluated and compared to the terms of the contract. Compliance and quality management performance of the method will be maintained by third party inspections and routine quality testing/review by the College of American Pathologists. Security Requirements In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information requires appropriate security controls to be in place. This is an acquisition or purchase of commodities, goods (e.g. equipment or software), and technical/field service support to maintain the analyzers. VA sensitive information is not involved in the course of these procedures. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). No GFE or GFI will be needed in any capacity. Other Pertinent Information or Special Considerations. The vendor will provide Field Service and resolve all issues within 24 hours, Mon-Fri. The methodology selected will not require 2 controls to be tested for every run, but will utilize Lot to Lot QC. The methodology selected will enable both MRSA and Cdiff to be run concurrently in any volume required without any reagent waste. This will permit Cdiff samples to be run at any time of the day to permit patient discharge as needed. The vendor will offer all of the above special considerations. A methodology that includes all of the special considerations will provide State of the Art testing for our veterans and reduce time to result significantly. Packaging, Packing and Shipping Instructions. There is no special packaging and shipping instructions required. All items are shipped as per the vendor s specifications to ensure quality of products and goods. Inspection and Acceptance Criteria. All received products and goods are examined for quality and acceptability without exception. Acceptable products are signed for by the laboratory. Place of Performance. The equipment and supplies will be located in room 2NW103 (Molecular laboratory). No contractor travel expenses are included. VA Pittsburgh Healthcare System University Drive Pittsburgh, PA 15240 Delivery Schedule. All required items will be ordered as needed directly by the lab and delivered within one (1) week. Reagents will be ordered as needed. The NAICS Code for the expected acquisition is 334516, with a Size Standard of 1,000 employees and the PSC Code is 6550. Any subsequent procurement will be conducted as a commercial item purchase in accordance with FAR Part 12 and as a Simplified Acquisition Procedure in accordance with FAR Part 13. Please email capability statements to: Maureen Jordan at Maureen.Jordan@va.gov and Stanley Kwasny at Stanley.Kwasny@va.gov by 1:00 PM Eastern Time on Friday, August 18, 2017. Telephone inquiries will not be accepted. Please note "VA244-17-Q-1562 MRSA Surveillance PCR Testing Sources Sought Notice" in the subject line of the email. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that the response is complete and sufficiently detailed to allow the Government to determine the organization s qualifications to deliver the services. Respondents are also advised that the Government is under no obligation to acknowledge receipt of the information or provide feedback about any of the information received. After review of the responses received, the Government may issue a pre-solicitation synopsis and solicitation in Federal Business Opportunities. No proprietary, sensitive, confidential or classified information shall be included with your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation. End of Document
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/PiVAMC646/PiVAMC646/VA24417Q1562/listing.html)
 

Document(s)

Attachment
 

File Name: VA244-17-Q-1562 VA244-17-Q-1562.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3726813&FileName=VA244-17-Q-1562-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3726813&FileName=VA244-17-Q-1562-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN04625597-W 20170813/170811232354-dfc79ea03cbe10c7566522b763d06b42 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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