SOURCES SOUGHT
65 -- Thromboelastometry analyzer, Service and Reagents
- Notice Date
- 1/6/2023 11:00:21 AM
- Notice Type
- Sources Sought
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- 262-NETWORK CONTRACT OFFICE 22 (36C262) Gilbert AZ 85297 USA
- ZIP Code
- 85297
- Solicitation Number
- 36C26223Q0387
- Response Due
- 1/12/2023 1:00:00 PM
- Archive Date
- 03/13/2023
- Point of Contact
- Clift Domen, Contract Specialist, Phone: 562-766-2241
- E-Mail Address
-
Clift.Domen@va.gov
(Clift.Domen@va.gov)
- Awardee
- null
- 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). DISCLAIMER This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a sources sought/RFI only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 325413 (size standard of 1250 Employees). Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office, is seeking sources that can provide a Rotem Sigma thromboelastometry analyzer system, reagents and equipment service that at a minimum meets the following salient characteristics in this Statement of work and in Attachment B with a brand name or equal product for the Southern Arizona VA Healthcare System: STATEMENT OF WORK Period of Performance: Capital equipment purchase, reagents, and service for five (5) years; Base year + four (4) option years. SCOPE The Southern Arizona VA Healthcare System (SAVAHCS) Pathology & Laboratory department requires a thromboelastometry analyzer system to perform whole blood coagulation testing for patients during procedures such as open heart or major vascular surgery. This system informs the physician of the whole blood ability to form a clot in a manner more closely resembling the actual in vivo blood clotting dynamics of the patient. This system allows for more accurate usage of limited and expensive commodities such as platelet concentrates, cryoprecipitate, plasma, and packed red cells. The requested system will afford better patient outcomes due to more timely and accurate administration of proper blood components and anticoagulants during and immediately after procedures. GENERAL REQUIREMENTS The vendor shall provide the most current coagulation combined platforms available, with an ability to detect and minimize the effects of interfering substances such as lipemia, icterus, and hemolysis. The vendor shall provide the facility with Food and Drug Administration (FDA) 510K approved analyzer/equipment, reagents, controls, calibration materials, disposables, and any consumable parts necessary for analyzing/testing on both the primary and back-up analyzers. The vendor shall provide/install any routine and special items required to operate/maintain the equipment/analyzer in optimal condition. Maintenance of printer is responsibility of the customer. Internal temperature and internal quality control documented on the instrument. The vendor is required to provide a continuously stocked inventory of reagents, standards, controls, supplies, disposables, and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. Any consumable that is required to maintain operation that is not available should be communicated clearly before the award, and the technical panel may have a preference to avoid additional purchases outside of the contract. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration dates must be clearly marked on reagent, standards, and control containers. Unexpected changes in methodology/technology shall be at the expense of the vendor. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the designated individuals determined at contract award. Special handling for emergency orders of supplies: In the event that the supplies are found to be defective and unsuitable for use with the vendor s equipment, or the vendor has failed to comply with the requirements for routine supply delivery, or supplies are used in troubleshooting the equipment, the vendor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the vendor shall deliver to the Government site in the most expeditious manner possible without additional cost to the Government, the necessary consumables in sufficient quantity as required to allow operation of the vendor s equipment for one week (under normal Government test load volume). If additional requests for emergency supply delivery are required by the Government, they shall be honored by the vendor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. Equipment Functionality The analyzer shall have comprehensive QC program for all tests which includes minimum the following: QC files may be edited or corrected for errors manually with or without password protection. On-board Quality Control data storage and reporting capabilities. The ability to view and print daily QC and monthly QC results. Westward rules or other QC acceptance criteria built in. Detailed IQCP program for performing qc. System shall perform tests on citrated whole blood. Integrated closed-tube sampling of citrated whole blood tube specimens will be utilized to minimize user error. System should have positive sample identification to reduce possible errors or delay and to improve laboratory efficiency. Testing should be performed on room temperature citrated whole blood, no incubation required. Testing shall be performed utilizing room temperature stored cartridges. Only QC will be reconstituted and premixed. QC requirements for additional hardware will be provided by the vendor. Anesthesiologists in the SAVAHCS operating room are trained to read the Rotem TEMograms. Due to the sensitive nature of vascular surgery and to reduce delay in treatment with retraining tests shall include: EXTEM, activation of clot formation by thromboplastin (tissue factor) Assessment of factors VII, X, V, II, I, platelets, and fibrinolysis INTEM, activation of clot formation via the contact phase. Assessment of factors XII, XI, IX, VIII, X V, II, I, platelets, and fibrinolysis FIBTEM, activation as in EXTEM with the addition of cytochalasin D, a platelet blocking substance. Fibrinogen levels and fibrin polymerization can be assessed in a functional way. Each Rotem TEMogram shall include the following parameters: CT (Clotting time) CFT (Clot formation time) MCF (Maximum clot firmness) ML (Maximum lysis) Interface requirements to be provided by the vendor: Instrument LIS physical connection and drivers shall be compatible with Data innovations technologies system. Remote viewing access software for the operating room. Any additional hardware and software needed to interface the analyzer and technical assistance with interfacing the analyzer. INSTALLATION AND VALIDATION Vendor shall move instruments, free of charge, to final testing location upon completion of validation process. Instrument can be moved by customer without the need for re-validation. Instrument transport /validation statement available from manufacturer upon request. Vendor shall provide the facility with all cross-over supplies and reagents needed at installation and during training of VA staff. Test counts for billing will begin after review/approval of all correlation/linearity studies performed at installation. During installation/set-up, and when bringing new tests on-line, a technical support specialist shall perform all validation studies including installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP standards) normal range studies, staff training, in-services to laboratory personnel and clinicians, and assist with any methodology problems and questions. With modifications, a Clinical / Technical specialist will come onsite to install the device and provide support to the end-users for the first 2-3 days of validation. All additional validation requirements are the responsibility of the customer. This service shall be available during regular office hours on a 5 days/week (M-F 8am-5pm). An on-site Clinical Specialist will work with the trained operator to assist in initial installation and instrument operation for 2-3 days. Prior to providing clinical test results, there is a Validation Period that shall be completed. This is typically 4-5 weeks in duration. This will be the responsibility of the customer. Also Included: Result interpretation training to all users and Physician s/Providers/Clinicians that will be ordering and reading the test results. Assistance with the development of a testing and treatment Algorithm for the Physicians/Providers/Clinicians Pocket Guides for assistance with graph interpretation and a graph interpretation posters Throughout the life of the agreement, the vendor shall provide 24/7 customer telephone support assistance to the user in setting up and maintaining/trouble shooting user-defined assays as additional tests are brought in-house. TRAINING Vendor shall provide all necessary procedure manuals, troubleshooting manuals and operator manuals (also available on computer disk format). Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) format. Onsite training program for operators. SERVICE AND MAINTENANCE Instrument support service shall aid with troubleshooting and repair of the analyzers. On-site service shall be available Monday through Friday during regular business hours (8am-5pm) The vendor shall provide a twenty-four hour/seven-day service hotline with technical support. The vendor shall provide a preventative maintenance schedule to include timely scheduled vendor preventative maintenance visits as required. Recommend an annual PM performed. The vendor shall supply engineering controls if necessary for any heat, humidity, or noise issues that may result from use of the proposed system. Software upgrades are performed at no charge if device is under warranty (1year) or with an active paid Service Agreement. Upgrades are done at time of annual Preventive Maintenance when applicable and can only be performed by certified Werfen Technical Specialists. Vendor shall define daily, weekly, monthly, and as needed maintenance and the time required to perform each maintenance task. Vendor shall indicate which tasks are user level and which are service level. For reagents with hazardous constituents, vendor shall provide a mechanism for the Laboratory to meet local discharge requirements. The vendor shall supply information regarding any hazardous chemicals. OTHER Assessment of testing needs/menus shall be evaluated as needed by the laboratory with communication to the vendor to receive pricing. There shall be easy assimilation for new tests into the pricing test lists without the need for line-item additions to the agreement. Request for instrumentation upgrades or replacement due to workload increase, excessive instrumentation failures/malfunctions, breakdowns, or service calls shall be evaluated as needed/annually by the laboratory with communication to the vendor for modification of the contract. A high incidence of such problems with any equipment/analyzer supplied may indicate probable non-compliance with the terms of this contract and will entitle the facility/clinic to its replacement with another analyzer(s) that can produce the required criteria satisfactorily to the user. The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VA for destruction prior to removal of any analyzer. The vendor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction. 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), 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 state your company s UEI number. (9) Please submit your capabilities in regard to the salient characteristics being provided and any information pertaining to equal to items to establish capabilities for planning purposes? *** Submissions addressing Section (9) 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 Clift.Domen@va.gov. Telephone responses shall not be accepted. Responses must be received no later than Thursday, January 12th, 2023 at 1:00 p.m. PST. 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/bc88e1bd73d845e9bafa4315f893f035/view)
- Place of Performance
- Address: Department of Veterans Affairs Southern Arizona Healthcare System 3601 S. 6th Ave., Tucson, AZ 85723, USA
- Zip Code: 85723
- Country: USA
- Zip Code: 85723
- Record
- SN06558718-F 20230108/230106230104 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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