SOLICITATION NOTICE
66 -- Hemochron for VA Tucson
- Notice Date
- 4/18/2019
- Notice Type
- Combine Synopsis/Solicitation
- 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
- 36C26219Q0618
- Response Due
- 4/23/2019
- Archive Date
- 7/22/2019
- Point of Contact
- jason.white2@va.gov
- Small Business Set-Aside
- N/A
- Description
- VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 1 of 1 Original Date: 10/12/17 COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C26219Q0618 Posted Date: 04/18/2019 Original Response Date: 04/23/2019 Current Response Date: 04/23/2019 Product or Service Code: 6640 Set Aside (SDVOSB/VOSB): Unrestricted NAICS Code: 334516 Contracting Office Address Dept. of Veterans Affairs Network Contracting Office (NCO) 22 4811 Airport Plaza Drive Long Beach, CA 90822 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular. The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 with a small business size standard of 1000 employees. The NCO 22, 4811 Airport Plaza Drive, Long Beach, CA 90822 is seeking Hemochron for VA Tucosn. Notice: No remanufactures or gray market items/ supplies will not be acceptable. Interested parties of RFI/RFQ must be an authorized reseller, distributor, or dealer of the O.E.M. (Original Equipment Manufacturer). Verification can be provided by an authorization letter or other documents from the OEM. Equipment shall be in accordance with the OEM terms and conditions. No exceptions, must be a manufacturer authorized distributor. All interested companies shall provide quotations for the following: Supplies 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. Place of Performance Address: 3601 S. 6th Ave. Tucson, AZ Postal Code: 85723-0001 Country: UNITED STATES Award shall be made to the quoter whose quotation offers the best value to the government, considering price and technical acceptability (LPTA). The government will evaluate information based on the following evaluation criteria: Lowest Price Technically Acceptable (LPTA). The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items FAR 52.212-3, Offerors Representations and Certifications Commercial Items Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders VAAR 852.232-72, Electronic Submission of Payment Requests (Nov 2012) The following subparagraphs of FAR 52.212-5 are applicable: b(4) 52.201-10 Reporting Executive Compentation and First-Tier Subcontract Awards (Oct. 2018) b(8) 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) b(22) 52.219-28 Post Award Small Business Program Representation (Jul 2013) b(25) 52.222-3 Convict Labor (June 2003) b(26) 52.222-19 Child Labor- Cooperation with Authorities and Remedies (Jan 2018) b(27) 52.222-21 Prohibition of Segregated Facilities b(28)(i) 52.222-26 Equal Opportunity (Sep 2016) b(30)(i) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) b(33)(i) 52.222-50 Combating Trafficking in Persons (Mar 2015) b(42) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) b(47)(iii), 52.225-3 Buy American-Free Trade Agreements0Israeli Trade Act (May 2014) b(49) 52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008) b(55) 52.232-33 Payment by Electronic Funds Transfer-Other than System for Award Management (Jun 2013) All quoters shall submit the following: 1 copy of the quote. All quotations shall be sent to the contract specialist electronically. This is an open-market combined synopsis/solicitation for products as defined herein. The government intends to award a purchase order or delivery order/task order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quoters must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Quoter shall list exception(s) and rationale for the exception(s). Submission shall be received not later than Tuesday April 23, 2019 by 2:30 p.m. Pacific Time at electronically. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Emailed offers will be accepted. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist: Jason White, JD, Jason.white2@va.gov. Point of Contact Jason White, JD, Contract Specialist, Jason.white2@va.gov. NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (18-APR-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/36C26219Q0618/listing.html)
- Record
- SN05286484-F 20190420/190418230106 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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