SOURCES SOUGHT
66 -- Hemochron for VA Tucson
- Notice Date
- 3/12/2019
- Notice Type
- Synopsis
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 22;4811 Airport Plaza Drive;Suite 600;Long Beach CA 90815
- ZIP Code
- 90815
- Solicitation Number
- 36C26219Q0481
- Response Due
- 3/19/2019
- Archive Date
- 6/17/2019
- Point of Contact
- jason.white2@va.gov
- Small Business Set-Aside
- N/A
- Description
- THIS REQUEST FOR INFORMATION (RFI) IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. THE SUBMISSION OF PRICING, CAPABILITIES FOR PLANNING PURPOSES, AND OTHER MARKET INFORMATION IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI IN ACCORDANCE WITH (IAW) FAR 15.201(e). This is not a solicitation announcement. This is a sources sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSB) under NAICS 334516. 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 in the FedBizOpps or GSA eBuy websites. 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 Department of Veterans Affairs, Network 22 Contracts Office, is seeking sources for Hemochron for VA Tucson. GENERAL INFORMATION CLIN Description QTY 1 Hemochron Signature Elite Instruments 7 ea. STATEMENT OF WORK SCOPE The Southern Arizona VA Healthcare System (SAVAHCS) Pathology and Laboratory Medicine Service (P&LMS) - Point of Care (POC) section requires a test system that performs individual point-of-care coagulation tests on a fresh whole blood with a single-use disposable test device (e.g. cuvette) using a mechanical optical fibrin clot detection method. POC section of the SAVAHCS P&LMS requests seven Hemochron Signature Elites that are FDA approved for the Activated Clotting Time (ACT) tests for low and high heparin dose ranges. The vendor/manufacturer shall provide all equipment, reagents, calibration materials, quality controls, supplies, parts, accessories and any other item required for the proper operation of its contractor owned instruments to complete successful validation studies required. The instruments provided by the contractor shall be portable, bedside units for use primarily in the clinical areas of the hospital. We request specific, high quality Brand Name or Equivalent for the following instruments: Refer to informal Instrumentation Laboratory and Government Scientific Source quotes for Hemochron Signature ELITE Coagulation System. General Requirements: All models of clinical laboratory instruments shall be capable of producing accurate and reproducible assays on blood by established in vitro diagnostics methods. Models shall provide accurate test assay result for sample specimens up to the manufacturer s defined maximum test per hour without excessive malfunctions, breakdowns or service calls. All equipment shall be current state-of-the-art equipment. Remanufactured and discontinued models will not be accepted. The contractor shall provide all upgrades to the equipment hardware and operating system software, at no additional cost to the Government. The contractor shall provide technical support for the software programs required for data management and interfacing results into VISTA. An operator s manual shall be furnished with each instrument supplied to SAVAHCS as the equipment is delivered and updates to the manual shall be provided The Hemochron Signature Elite initial validation will be supported by the vendor/manufacturer The Hemochron Signature Elite vendor/manufacturer will assist with a training plan for product implementation. System Requirements: In addition to the general requirements, the vendor/manufacturer shall meet the following requirements. The contractor s unit shall have software that is fully VISTA compatible, capable to transfer data from the unit facilities middleware to the VISTA system (without upgrade or other software modification), and all hardware/software necessary to transfer data into patient files in VISTA shall be provided at no additional cost to SAVAHCS. This may require the use of middleware to get patient results from the instrument to VISTA (which will be under a separate contract). Must connect with standard HL7 interface. The system must be FDA approved for non-waived point of care coagulation testing for professional use. The instrument shall be easily able to accommodate standard infection control practice such as isolation protocols and cleaning in-between patients. The instrument must be portable and hand-held for ease of use at the point of care site. It must be capable of operating on a rechargeable battery and on AC power as needed. The instrument must be configurable to allow use only by authorized operators and to allow use only if specified Quality Control (QC) testing has been performed. The instrument must lock out any other instrument functions until processing of the lockout trigger(s) is successfully completed. To meet regulatory requirements the instrument must perform automatic internal electronic quality control checks at intervals programmed by the operator. Before a test the instrument should perform an automatic self-check to verify that there is adequate battery power, that the test device is warmed to the correct testing temperature, that the specimen is present and of sufficient volume to test and that internal timers are functioning correctly. If one or more of these checks fails, the instrument should prohibit testing and display an appropriate error message. The instrument must utilize whole blood or simulated whole blood quality control materials. Instrument must use test devices that have a room temperature stability of at least 60 days. Instrument must use a device that includes a sample overflow area which minimizes biohazard exposure and cuvette failure. Instrument must have an easy to read display screen, a keyboard and barcode scanner to enter patient, operator and reagent lot information. Instrument is capable of managing operator and reagent data directly on the device using the keypad and/or barcode reader and through any commercially available interface system. Provide download interval lock out, QC lock out and operator lock out. The instrument must have automatic self-calibration. Instrument Requirements: The Hemochron Signature Elite shall be no larger than 3.7 (depth) x 7.5 (width) x 2.0 (height). The Hemochron Signature Elite should weigh no more than 1.2 lbs. The Hemochron Signature Elite should have an operating environment of (15-30 deg. Celcius) or 64-86 °F. The Hemochron Signature Elite should have a UL electrical rating 100V-240V AC. Supply Requirements: The vendor/distributor must provide, in easy-to-understand plain English, all necessary procedure manuals, troubleshooting manuals, and operator manuals. All necessary accessories required for operating the Hemochron Signature Elite should be listed as an addendum in the pricing schedule. Repair & Maintenance Services: The manufacturer of the instrument system should define maintenance requirements and indicate what maintenance is performed by the end-user and what maintenance is performed by the manufacturer. Pre-Installation Assessment: The vendor will provide environmental requirements (heat/cool, humidity, light, etc.) and recommendations for instrument and testing material storage. Technical capability: Provide dimensions of the system (key element) Describe any environmental impact issues that instrumentation may create (water requirements, media disposal, etc.). Describe user friendliness. Describe ability to trouble-shoot system. Support Services: Technical support should be available Monday-Friday 8:00am to 4:30pm Arizona time and should be through one contractor (preferably the manufacturer of the instrument). This contract should assist the SAVAHCS to pursue the goal of being a good steward in our community by eliminating, minimizing or mitigating adverse environmental impacts. The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Small Business or Large Business, etc. (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer or distributor of the items being referenced above (or equivalent product/solution)? What is the manufacturing country of origin of these items? (4) If you re a small business and you are an authorized distributor/reseller for the items identified above (or equivalent product/solution), do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (5) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with NASA SEWP or any other federal contract? If so, please provide the contract type and number. (6) If you are an FSS GSA/NAC or NASA SEWP contract holder or other federal contract holder, are the referenced items/solutions available on your schedule/contract? (7) Please provide general pricing for your products/solutions for market research purposes. (8) Please submit your capabilities in regards to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (8) should show clear, compelling and convincing*** evidence that all equal to items" meet all required salient characteristics. Responses to this notice shall be submitted via email to Jason.white2@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Tuesday, 19 March 2019 at 2:30 pm (Pacific Time). If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this request for information. Responses to this notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (12-MAR-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/VA/LBVANBC/VAMD/36C26219Q0481/listing.html)
- Record
- SN05247024-F 20190314/190312230017 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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