6550--Thromboelastometry analyzer, Service and Reagents

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 -- Streamlined Procedures for Evaluation and Solicitation for Commercial Items, in conjunction with FAR -- Part 13 Simplified Acquisition Procedures; and supplemented with additional information included in this notice. This solicitation document and incorporated provisions and clauses are those in effect through the Federal Acquisition Circular 2023-01, dated December 30th, 2022. Solicitation 36C26223Q0458 is issued as a Request for Quote (RFQ) and constitutes the only solicitation. The Government intends to award a single Firm-Fixed Price (FFP) award contract. This procurement will be issued under Full and Open Competition. NAICS Code is 325413 and the Small Business Administration s (SBA) size standard is 1,250 Employees. The Government is seeking a contract to acquire Thromboelastometry Analyzer, Service and Reagents. This solicitation is seeking to fulfill the following statement of work: Place of Performance: Southern Arizona VA Healthcare System (SAVAHCS). 3601 S. 6th Ave., Tucson, AZ, 85723 Period of Performance: The period of performance shall be for one (1) base year from date of award plus 4 (1 year) options. Statement of Work SCOPE The Southern Arizona VA Healthcare System (SAVAHCS) Pathology & Laboratory department requires a thrombeolastometry 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. Brand Name or Equal Description/Requirements: Table below is for Equipment, services, and warranty PRODUCT DESCRIPTION Quantity Rotem Sigma System 1 Rotem Live Software (one time) 1 Rotem Live Silver setup (one time) 1 Rotem Sigma warranty/service 1 base year + 4 optional years The Brand Name for the below reagents is Werfen USA LLC. PRODUCT DESCRIPTION PRODUCT # Estimated Annual Quantity (Each) Cartridge Complete + Hep Kit 555502 10 Rotem Sigma Rotrol N, 5/bx 555201 10 Rotem Sigma Rotrol P, 5/bx 555202 10 Period of performance: Base year + 4 Optional years Salient characteristics Must have barcodes on supplies that can be read and tracked by the existing system. Expiration dates of the reagents must clearly be marked. - Must be FDA Approved. Reagents must be able to perform thromboelastometry testing which includes EXTEM, INTEM, FIBTEM and corresponding TEMograms. 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. 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, 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. 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 poster 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 Compact 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 updates are performed at no charge with an active paid Service Agreement. Updates are done at time of annual Preventive Maintenance when applicable and can only be performed by certified 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. SECURITY Information Security The contractor shall follow The Veterans Affair Acquisition Regulation (VAAR) security clause VAAR- 852.273-75 SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES . Contract Clauses (a) The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov (b) To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov Contract Personnel Security 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 that will be satisfactory. The interested parties bear full responsibility to ensure their submission demonstrates to the government that they can provide the services being requested. Provisions 52.212-1, Instructions to Offerors Commercial and 52.212-2, Evaluation Commercial Items are applicable to this acquisition. Furthermore, Provision 52.212-2 is utilizing the lowest price on an Acceptable/Unacceptable evaluation process. Submitting Quote: Offerors shall submit the following via email: 1. Offerors shall fill out all unlocked fill-ins/tabs (define your fill-ins or tabs) of Attachment A conforming to requirements stated by the salient characteristics and the instructions below. a. Offerors shall complete column L of tabs 1 - 5 or unit prices. b. Offerors shall additionally complete columns F H of tabs 1-5 if providing an equivalent product. c. If providing an equivalent product, offerors shall either provide information regarding how their product meets the salient characteristics in this Statement of Work in Column I or alternatively may state where in the offeror s overall submission that information can be found. See 52.211-6 for additional information. 2. Offeror shall provide the following Company information to Attachment A tabs 7 in column B: a. Company Name b. Address c. Telephone Number d. Email e. Point of Contact f. Firm s UEI# Submit all question(s) to Clift Domen at contact@example.gov no later than Thursday, February 23rd, 2023, and before 1:00 PM Pacific Standard Time (PST). Ensure to reference solicitation # 36C26223Q0458 within the subject line of the email. Quotes must be received by Friday, March 3rd, 2023, and before 1:00 PM PST. Email your quote to Clift Domen at contact@example.gov. Ensure to reference solicitation # 36C26223Q0458 within subject line of the email. Quote(s)/offer(s) received after the prescribed deadline, shall be considered non-responsive and will not be considered for award. CONTRACT CLAUSES AND PROVISIONS 52.212-2 - Evaluation Commercial Items (Oct 2014) (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical acceptability shall be established by review of each submitted quote, attachments, and/or information by the designated technical evaluator/s and verification that any brand name or equal to items" meet all the salient characteristics included in this solicitation. No other rating or quantitative value other than acceptable or unacceptable will be assigned. Once technical acceptability has been established, the Contracting Officer shall award to the lowest price. (b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of clause) 52.217-6 - Option for Increased Quantity (Mar 1989) The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the Contractor within 10 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree. (End of clause) 52.217-8 - Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 60 days of contract expiration. (End of clause) 52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66 months. (End of clause) 52.252-2 - Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses and provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ FAR 52.209-6, Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Jun 2020) FAR 52.212-4, Contract Terms and Conditions -- Commercial Items (Oct 2018) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Sep 2021) FAR 52.232-18, Availability of Funds (Apr 1984) FAR 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.233-1, Disputes (May 2014) VAAR 852.203-70, Commercial Advertising (May 2018) VAAR 852.232-72, Electronic Submission of Payments (Nov 2018) (End of Clause) 52.252-1 - Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html https://www.acquisition.gov/vaar FAR 52.204-7, System for Award Management (Oct 2018) FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020) FAR 52.209-7, Information Regarding Responsibility Matters (Oct 2018) FAR 52.233-2, Service of Protest (Sep 2006) VAAR 852.233-70, Protest Content/Alternative Dispute Resolution (Oct 2018) VAAR 852.252-70, Solicitation Provisions or Clauses Incorporated by Reference (Jan 2008) (End of Provision)