Inactive

Page 2 of 2 This is a Sources Sought notice and is for informational and planning purposes only; it is neither a solicitation announcement nor a request for proposals or quotes and does not obligate t... Page 2 of 2 This is a Sources Sought notice and is for informational and planning purposes only; it is neither a solicitation announcement nor a request for proposals or quotes and does not obligate the Government to award a contract. The purpose of this Sources Sought notice is to determine, in particular, the interest/capability of firms to provide a Laboratory instrument that can automate the VA Medical Center in Pittsburgh s Methicillin Resistant Staph Aureus (MRSA) surveillance polymerase chain reaction (PCR) testing. Here is a DRAFT of the SOW: 1. Contract Title. MRSA Testing          2. Background. The VAMC Pittsburgh Laboratory is seeking a Laboratory instrument that can automate our Methicillin Resistant Staph Aureus (MRSA) surveillance polymerase chain reaction (PCR) testing. 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 key board and bar code scanner. The system must integrate and automate the sample extraction, amplification and reading functions of MRSA and Clostridium difficle (Cdiff) 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. 3. Scope. This contract includes all of the costs associated with performing automated molecular MRSA screening testing. In addition, the contract includes pricing for performing lysis and the required capillaries. The contract will 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 Staphylococcus aureus that contain an staphylococcal cassette chromosome (SCC) element lacking the mecA gene. The selected vendor shall employ a methodology that casts the widest net to identify newly emerging Mec Right Extremity Junction (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 laboratory information system (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 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. 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 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 contract provides all of the required hardware to perform the necessary methodologies. This contract is specifically for the use of the Pittsburgh VA Medical Center Molecular section only. 4. Specific Tasks. This contract is required to provide pricing for all necessary consumables required to perform molecular MRSA screening. In addition, the contract will 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. 4.1 Task 1 Technical and Field Service 4.1.1 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 over the phone. Technical Support is available Monday through Friday, 8:30 A.M. to 5:30 P.M., EST. 4.1.2 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. Field service is defined as a service call where the vendor will have to come on site for repairs. Field service will be included at no cost. 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. Description Quantity Needed Per Year MRSA Reagent Kits 700 MRSA Reaction Chambers 33 5. 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. 6. 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. 7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). No GFE or GFI will be needed in any capacity. 8. Other Pertinent Information or Special Considerations. The vendor chosen for this contract will provide Field Service and resolve all issues within 24 hours, Mon-Fri. 2. The methodology selected will not require 2 controls to be tested for every run, but will utilize Lot to Lot quality control (QC). 3. 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 chosen will offer all of the above special considerations. It is the policy of the Pittsburgh VA Medical Center Immunology/Microbiology laboratory to encourage and actively solicit competitive bids from all vendors competing for similar business. a. Identification of Possible Follow-on Work. Not Applicable b. Identification of Potential Conflicts of Interest (COI). Not applicable. c. Identification of Non-Disclosure Requirements. 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. d. 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. e. 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. 9. Risk Control No additional risk will be undertaken by the laboratory as compared to any other vendor or method. 10. Place of Performance. The equipment and supplies will be located in Room 2NW103 (Molecular laboratory). No contractor travel expenses are included in this contract. 11. Period of Performance This contract will be valid for a base year of one year with four, one-year option periods. The base year effective date of this contract should reflect 10/1/19 9/31/20. 12. 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. All vendor shipped items will be delivered in a vendor determined format. All items will be delivered to the receiving dock at: VA Pittsburgh Healthcare System Attn: Kevin Frank (Bldg 1, Room 2NW108) University Drive Pittsburgh, PA 15240 This notice is being issued in an attempt to determine the level of interest among all socioeconomic groups. Responses will assist VA planners in determining an appropriate acquisition and set-aside strategy which best fits VA requirements. The NAICS code is 339113 with a size standard of 750 employees. Interested vendors are requested to respond to this notice no later than July 2, 2019, at 1:00 PM Eastern Standard Time. With your response, please provide a MAXIMUM two (2) page capability statement (additional attachments/pages will not be reviewed) summarizing experience and past performance in providing this equipment and tests kits. Please provide the name/type of the equipment and measurements. All responses should include the following: socioeconomic group, technical/capability information, ability to meet VA requirements, and your existing customers. The statement should identify your name, address, point of contact, phone number(s), e-mail address(es), business type and size, and DUNS number. If currently a vendor under the VA (or GSA) Federal Supply Schedule (FSS) please provide the contract number(s), listing of Special Item Number(s) (SIN) covered and expiration date. If not a vendor with a current FSS contract, please mention this in the capability statement. Please email capability statements and/or questions to: Maureen Jordan, Contracting Officer at Maureen.Jordan@va.gov. Telephone inquiries will not be accepted. Please mention "36C24419R0108 MRSA Testing Sources Sought Notice" in the subject line of the email. Telephone inquiries will not be accepted.