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SAMDAILY.US - ISSUE OF FEBRUARY 14, 2024 SAM #8114
SOURCES SOUGHT

66 -- Supply: i-STAT Point of Care (POC) Blood Analyzer

Notice Date
2/12/2024 8:07:06 AM
 
Notice Type
Sources Sought
 
NAICS
334516 — Analytical Laboratory Instrument Manufacturing
 
Contracting Office
248-NETWORK CONTRACT OFFICE 8 (36C248) TAMPA FL 33637 USA
 
ZIP Code
33637
 
Solicitation Number
36C24824Q0586
 
Response Due
2/16/2024 7:00:00 AM
 
Archive Date
04/16/2024
 
Point of Contact
Leonora Simmons, Contract Specialist, Phone: 813-972-7592
 
E-Mail Address
leonora.simmons@va.gov
(leonora.simmons@va.gov)
 
Awardee
null
 
Description
Sources Sought Notice Please provide information if you are capable of supplying the needs of James A. Haley Veterans Hospital, located at 13000 Bruce B, Downs, Blvd, Tampa, FL. 33612. The JAHVH requires the below-listed equipment and tests. Requirements: The Contractor shall provide fifty-two (52) Point of Care blood analyzers and forty-eight (48) rechargeable downloaders (docking stations) to the James A. Haley Veterans Hospital (JAH VAMC Station: 673), Pathology and Laboratory Medicine Service (PLMS, Mail Code:113) located at 13000 Bruce B. Downs Blvd. Tampa, Florida 33612. Discontinued models are not acceptable. All work is to be performed in accordance with the guidelines established by Federal, State, and Local ordinances, with the FDA, CLIA, TJC, and manufacturer s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein. The requirement covers the parent facility, the James A. Haley VA Medical Center (JAH VAMC), Pathology & Laboratory Medicine Service, Point of Care Department located in Tampa, Florida, and any other current facility and future facility that falls under the JAH VAMC, PLMS testing location, and that is deemed necessary by VA care providers. Equipment: Brand Name only (Abbott) a. Point of Care analyzer must offer a comprehensive menu of tests using a single test system. b. Point of Care Analyzer must be lightweight, portable, and ergonomically designed. c. Point of Care Analyzer must measure and/or perform satisfactorily at any laboratory temperature between 61-86 degrees Fahrenheit (16-30 degrees Celsius), at any laboratory relative humidity of 10 to 90% (non-condensing), and at any barometric pressure of 300-850 mmHg. d. Point of Care analyzer must guide operator through the testing process using standardized operating procedures. e. Point of Care analyzer must require minimal or no maintenance. f. Point of Care analyzer must be interfaceable with VA approved middleware software. g. Point of Care system must meet all FDA, CLIA, CAP, and The Joint Commission (TJC) requirements for point-of-care testing. Functionality and Performance Specifications a. The system must be capable of performing Chemistry Panels including- (Glucose, Sodium, Potassium, Urea Nitrogen, Creatinine, CO2, and Ionized Calcium); Troponin-I, Activated Clotting Time (ACT), Blood Gas Analysis Panels including- (Sodium, Potassium, Ionized Calcium, Glucose, pH, pCO2, pO2, CO2, HCO3, Base Excess, O2Sat, and Hemoglobin), Glucose, Creatinine, Prothrombin Time/International Normalized Ratio (PT/INR). b. The system must be barcode-driven for operator and patient identification. c. The system must lock out unauthorized users. d. The system must block testing unless quality control is acceptable. e. The system must be capable of detecting test and operator errors. f. The system must allow user generated customized test profiles for various areas of testing. g. Test results must upload automatically through a docking station or downloader to the hospital information system. Site Preparation: Specifications shall be furnished in writing by the contractor as part of the equipment proposal. These specifications shall be in such detail as to ensure that the equipment to be installed shall operate efficiently and conform to the manufacturer s claimed specifications. The government shall prepare the site at its own expense and in accordance with the specifications furnished by the contractor. Any alterations or modifications in site preparation that are attributable to incomplete or erroneous specifications provided by the contractor which would involve additional expense to the government, shall be made at the expense of the contractor. Contractor Testing and Inspection: The Contractor is responsible for performing all inspections and tests necessary to substantiate that the equipment, supplies, and services furnished under the contract conform to contract requirements. The VA has the right to test all services always ordered under the contract and placed throughout the term of the contract. Government testing and inspection will not unduly delay any Contractor work being performed nor will it create a defect in services covered by this contract. Estimated Cost-Per-Test The contractor is required to furnish the JAH VAMC with the laboratory instrument(s) system(s) and reagents including cartridges, calibrator, controls, consumables necessary to operate the contractor s equipment, hardware and software upgrades, and equipment service and maintenance necessary to fulfill the test requirements. The JAH VAMC will select the equipment and associated package tailored to its requirements and only will pay for the test assays run on the contractor s equipment (payment rate is at an established average cost-per test figure). The Cost Per Test award will include pricing for our current estimated annual testing: 2000 Troponin-I 2000 Activated Clotting Time 7500 Creatinine 5000 Arterial Blood Gas panel (to include sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2, CO2, HCO3, Base Excess, O2Sat, and hemoglobin) 5000 Chem 8 Panel (to include glucose, sodium, potassium, urea nitrogen, creatinine, carbon dioxide, and ionized calcium). 4000 Glucose 500 PT/INR-Prothrombin Time with International Normalized Ratio. Cost per test includes (a) equipment use, (b) all necessary service and preventive maintenance to keep the equipment in good operating condition, (c) operational hardware and software upgrades, (d) user training for government personnel (e) all reagent cartridges, controls, calibrators, consumables, cleaning solutions, and includes shipping and handling charges for such items. The contractor is required to provide delivery and installation of equipment at no additional charge and return shipping costs at the end of the contract. The Contractor shall install and correlate new instrumentation to current existing instruments. Deliverables The JAH VAMC shall require the contractor to deliver the equipment ordered under this contract not later than THIRTY (30) calendar days after receipt of notice of award. The JAH VAMC reserves the right to thoroughly inspect and investigate the contractor and manufacturer s business reputations and other qualifications, and to reject any bid, irrespective of price, that shall be administratively determined lacking in any of the essentials necessary to assure acceptable standards of performance. Acceptance will normally be consummated upon delivery and, when applicable, installation and completion of personnel training. The VA reserves the right to request a ninety (90) day test and evaluation of one or both pieces of equipment before placing a delivery order under the contract. If the test and evaluation are not successful as determined by the Contracting Officer and Contracting Officer Representative for that VA, those individual VAs will not be required to continue placing a delivery order under this contract, and no default or penalty will accrue. Reagents Delivery Terms The VA shall require the delivery of reagents for all services required under this contract. The contractor shall deliver reagents, shipping cost included, as needed (just in time) from call-online orders within 48 hours. Quality of Reagents, Supplies, and Disposables- The contractor will ensure that all supplies provided/ordered for use on their equipment will be of the quality necessary to produce a quality result. The reagent quality must be high enough to satisfy the proficiency testing standards of the College of American Pathologists (CAP) and The Joint Commission (TJC). If the supplies, including consumables, are found to be defective and unsuitable for use with the contractor s equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 48 hours of receipt of the verbal/ online order for priority delivery from the government activity. This will be done at no cost to the government, in sufficient quantity as required to allow the operation of the contractor s equipment for one week (under normal government test load volume). Returned goods- The VA is responsible for inspecting all products shipped hereunder and giving the contractor written notice of rejection within thirty (30) calendar days following receipt or installation by the contractor. After acceptance, no products purchased hereunder may be returned without the prior authorization of the contractor and in conformity with their return policy. No returns will be authorized after 120 days following shipment to VA. Installation procedures- The contractor shall be responsible for installation, which consists of in-house delivery of all equipment listed on the delivery order connections of all equipment, and interconnecting wiring and cabling if applicable. Upon receipt of notice to proceed with the installation, it shall be the contractor's responsibility to inform the Contracting Officer of any problems that may be anticipated regarding installation which will affect optimum performance once installation is completed. If the progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until the cause of the delay has been eliminated and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed. Upon completion of installation, the equipment will be turned over to the hospital for use. Final acceptance of the equipment and installation will be based upon an inspection and test to be performed within ten (10) calendar days from the date of installation. If equipment passes inspection or if acceptance inspection is not conducted within ten (10) calendar days from installation, the Government shall accept installation with a guaranteed date commencing ten calendar days after installation. Functional and Performance Characteristics Must provide the following functional and performance capabilities to ensure equipment is utilized and maintained according to the requirements of the system: Preventive Maintenance shall be performed per manufacturer s guidelines. Instrument service is to be provided 24 hours per day, 7 days per week including holidays. Expected response to service call time from the initial call to the Contractor to the service engineer arriving on site should be no more than 24 hours including weekdays, weekends, and holidays. 24/7 Technical Support Hotline must be available for in-house troubleshooting. The Cost per test includes costs covering (a) FDA-approved analyzer system (lease), (b) equipment use, downloaders, simulators, and accessories including Uninterruptable Power Supplies for all instruments (UPS) when needed. (c) Software and hardware, (d) all aspects of computer interfacing for all analyzer systems, (e) reagents offered by the vendor, (f) all necessary supplies and consumables, (g) all necessary service, maintenance, and parts to keep the equipment in good operating condition to fulfill the test requirements and produce high-quality patient results, (h) operational hardware and software upgrades, and (i) upon expiration of order(s) and/or termination and/or replacement of equipment, will provide equipment decontamination, turn-in hard drives with VA sensitive information to VA IT Department, and return packing and shipping at no additional charge. All work is to be performed in accordance with the guidelines established by Federal, State, and local ordinances, with the FDA, and manufacturer s guidelines, and with all terms, conditions, provisions, schedules, and specifications provided herein. The contractor will provide analyzers or testing systems, parts, and all operational upgrades to the equipment hardware and operating system software that materially affects the performance of the equipment, without additional charge to the government. These enhancements to the contractor s equipment shall be delivered to the government site and installed by the contractor within 60 days of their issuance or date of first commercial availability. With all equipment, Ownership of Equipment shall remain with the contractor for the life of the contract. All equipment accessories (hardware and software) furnished by the contractor shall accompany the equipment when returned to the contractor. The contractor, upon expiration of order(s) at termination and/or replacement of equipment, will remove the equipment and turn in any hard drives containing VA sensitive information to the VA IT Department. The contractor shall disconnect the equipment and shall be responsible for packing, shipping, and charges required to remove the equipment within ten (10) business days. This base + four years contract involves utilizing current lease vendor analyzers, 34 units total and acquiring more units, 14 total, under a lease-CPT agreement. With all equipment, the standard and acceptance of performance shall begin on the contract awarded date. It shall end on the earlier date of when a certificate of acceptance has been signed or the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformation with the contractor s technical specification or as quoted in any contract at effectiveness level of 90% or more. In the event the equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance test shall continue a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order. Operational use time for performance testing for a system is defined as the accumulated time during which the equipment is in actual use. System failure downtime is the period when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the government makes a bona fide attempt to contact the contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work will be required as a basis for the computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. The government shall maintain appropriate daily records to satisfy the requirements of this paragraph and shall notify the contractor in writing of the date of the first day of the successful performance period. Operations use time and downtime shall be measured in hours and whole minutes. Training and Technical Service The contractor, without additional charge to the government, shall provide training at a government location upon request. In addition, the contractor shall provide supplemental operating training without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. Training of Operating Personnel: The contractor shall provide the services of a qualified technical person, at the time of equipment installation and at such time designated by the Contracting Officer (CO) or Contracting Officer s Representative (COR) to on-site orientation and training to designated personnel in operation and care of equipment; techniques and procedures recommended by manufacturer to achieve maximum dependable, efficient, and economical utilization of equipment. This training shall include actual demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of failure of equipment, provided that such adjustment or action will in no way jeopardize the Government's rights under the contract guarantee clause. This training shall include at least (2) two-day on-site training sessions, all day, upon installation and acceptance of equipment and later, for refresher training. Government s Responsibility The user will perform routine operator maintenance and cleaning as required in the manufacturer s operation and maintenance user manual instructions. No deviation from the manufacturer s guidelines can occur to guarantee the optimal function of the analyzer-equipment system and to safeguard the terms of this contract. The user shall maintain appropriate records to satisfy the requirements of this paragraph. Maintenance The contractor shall provide maintenance (labor, parts, and shipping) to keep the equipment in good operating condition and subject to security regulations. The government shall provide the contractor access to the equipment to perform maintenance services. Preventive maintenance by the contractor shall be provided regular, scheduled maintenance to ensure the continued reliable operation of the equipment. These preventative maintenance visits shall be of a frequency that conforms to the manufacturer s operation and maintenance user manual instructions for the supported equipment. Service Emergency repairs shall be performed within 24 hours after notification that the equipment is inoperative. The scheduled maintenance and service shall be performed by a qualified field service engineer with notice to the Contracting Officer Representative (COR) or designee. James A Haley VA Hospital, Pathology & Laboratory Medicine Service is open 24 hours a day, 7 days a week including holidays. Telephone responses only do not satisfy this requirement. The contractor shall provide the government with a designated point of contact and shall make arrangements to enable this maintenance representative to receive such notification. The contractor shall provide all parts, labor, and shipping needed to repair the malfunction. The travel, per diem and other expenses associated with the repair will be borne by the contractor. Otherwise, all services will be performed at no charge to the Government during this period. The contractor shall furnish a malfunction incident report to the installation upon completion of each maintenance call. The report shall include, as a minimum, the following: (a) date and time of notification, (b) date and time of arrival, (c) serial number type and model number(s) of equipment, (d) time spent for repair, (e) description of malfunction and (f) proof of repair, (e) parts and (f) shall be written verification of quality control for a sample run. The contractor guarantees the availability of servicing and replacement parts for the term of this contract. Technical Upgrades The contractor shall provide supplemental operating training to the government personnel, without additional charge to the government, upon installation of an upgrade in equipment hardware or operating system software connected with the operation of an instrument already furnished. Warranty of Equipment Government requirement for standard manufacturer industry warranty term. The government does not accept an extended warranty, which requires advance payment. Delivery Schedule Delivery performance shall start on 04/01/2024-09-30-2024. Place of Delivery Department of Veterans Affairs, James A. Haley VAMC (Station: 673), 13000 Bruce B. Downs, Blvd. Tampa, FL. 33612. PLMS-Main Laboratory. Including current and future wards and clinics. New Port Richey OPC (Station:673BZ)-Clinical Laboratory,7900 Little Road New Port Richey, FL 34654. Lakeland CBOC (Station: 673GB)-Clinical Laboratory 4237 South Pipkin Rd Lakeland, FL 33811. This source sought is for market research purposes only and it does not commit the Government to contract for any supply or service whatsoever. At this time, The Department of Veteran Affairs is not seeking quotes, and will not accept unsolicited quotes. Respondents are advised that the United States (U.S.), government will not pay for any information or administrative cost incurred in response to this source sought. All costs associated with responding to this source sought will be solely at the responding party s expense. Please be advised that all submissions become Government property and will not be returned. Not responding to this Sources Sought does not preclude participation in any future solicitations. Responses to this notice are not quotes and cannot be accepted by the U.S. Government to form a binding contract. It is the responsibility of the interested parties to monitor the BETA.SAM.GOV (https://sam.gov/) Website for additional information about this RFI. All responses to this Sources Sought shall be submitted to: Leonora Simmons at leonora.simmons@va.gov no later than 02/16/2024 by 10:00 am EST.
 
Web Link
SAM.gov Permalink
(https://sam.gov/opp/752ef71f1886487793bc866290e1960d/view)
 
Place of Performance
Address: 13000 Bruce B. Downs, Blvd, Tampa, FL 33612, USA
Zip Code: 33612
Country: USA
 
Record
SN06963630-F 20240214/240212230051 (samdaily.us)
 
Source
SAM.gov Link to This Notice
(may not be valid after Archive Date)

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