SOLICITATION NOTICE
66 -- Blood Gas Analyzers
- Notice Date
- 12/13/2019 6:08:19 AM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
- ZIP Code
- 45428
- Solicitation Number
- 36C25020Q0048
- Response Due
- 12/20/2019 8:59:59 PM
- Archive Date
- 01/19/2020
- Point of Contact
- Angie Carpenterangie.carpenter@va.gov
- E-Mail Address
-
angie.carpenter@va.gov
(angie.carpenter@va.gov)
- Awardee
- null
- Description
- Blood Gas Analyzers, Dayton VA Medical CenterRFQ #36C25020Q0048General.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 issued as a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-01, effective November 9, 2019. This solicitation is Full and Open Competition. The associated North American Industrial Classification system (NAICS) Code for this procurement is 334516, with a Small Business Size Standard of 1,000 Employees. The FSC/PSC is 6630.Requirement.The Dayton Veterans Affairs Medical Center (DAY VAMC) is seeking to establish a firm-fixed price, Cost per Reportable Rate (CPRR) Base, Plus Four (4) One (1) Year Option periods agreement for automated blood gas testing. The contractor shall provide two (2) identical analyzers capable of performing fully automated blood gas testing to include:Ionized CalciumpHPCO2PO2BicarbonateBase ExcessTCO2Total HemoglobinCarboxyhemoglobinMethemoglobinOxygen Content (Vol%)Hemoglobin Oxygen SaturationPercent OxyhemoglobinAll interested companies shall provide quotations for the following:DescriptionTests/YearBlood gas testing to include pH, PCO2, PO2, Bicarbonate, TCO2, base excess, Total hemoglobin, percent oxyhemoglobin, carboxyhemoglobin, methemoglobin, hemoglobin oxygen saturation rate and oxygen content1400Ionized Calcium350Methemoglobin15Carboxyhemoglobin40Reagents and supplies based on 1,805 tests per year and quality control-based College of American Pathology, Clinical Laboratory Improvement Act (CLIA), and the Joint Commission requirements at a minimum.Scope. In the measurement of blood gas, co-oximetry, and ionized calcium, the instrument shallmeet the performance characteristics for accuracy and precision as defined by the 1988 CLIA and the Clinical and Laboratory Standards Institute (CLSI). The analyzers must also be approved by the Food and Drug Administration (FDA) for diagnostic utilization. The objectives of this acquisition are to have two (2) identical blood gas instruments that will continue to give high quality results in the least amount of time, adhering to the performance measure of turnaround time of 30 minutes or less , and that there be no delays in reporting around the clock. Because the results of this test need to be available to the provider within 30 minutes or less of receipt in the laboratory, it is especially important that the instrument running this test provides fast blood gas results with accuracy and precision. To avoid possible delays, both analyzers must be ready to process specimens 24 hours a day.Specific Tasks. In addition to having secured approval by the FDA, the instruments shall have the following: Ability to monitor instrument performanceOn Board reagent inventory system No carryover between samplesAnalyzer must be able to sample from any sample s primary tube (example: syringe, whole blood vacutainers, and serum separator tubes). Pouring off any sample or use of an adapter is unacceptableThe ability to run micro samples of less than 100 uLThroughput: 45 seconds or less to results from sample introductionThe instruments must perform the following tests with the option to add testing or other new testing that becomes available in the future, if the need arises.Ionized CalciumpHPCO2PO2BicarbonateBase ExcessTCO2Total HemoglobinCarboxyhemoglobinMethemoglobinOxygen Content (Vol%)Hemoglobin Oxygen SaturationPercent OxyhemoglobinThe contactor is required to provide continuously stocked inventory of reagents, standards, controls, supplies, disposables and any other materials required to properly perform tests on the instruments such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Both analyzers must be up and running 24 hours per day.All supplies and reagents shall have a shelf life of not less than 6 months.Contractor shall provide quality control material that meets CAP and CMS requirements for blood gas testing and does not require an Individualized Quality Control Plan (IQCP).Quality control must be on board and not require any other quality control other than what is loaded on the analyzer. The instrument must possess a bi-directional, bar-coded computer interface compatible with the current VA laboratory information system. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system.Equipment must have barcode reader to scan reagents and patient samples. Equipment must be able to support multiple barcode formats that may be enabled concurrently to include Code 128, Code 39, and codabar. Equipment must accept, at a minimum, 10 characters in specimen identifier that is alphanumeric.The equipment must have no requirements for sample pre-treatment. The instrument must be fully operable with no manual reagent preparationThe instrument must be able to maintain on board reagent stability sufficient to accommodate volume use.The equipment should require minimal maintenance. No daily maintenance and less than 5 minutes of hands on time for any additional maintenance. The instruments methodology must be proven by stringent analytical techniques as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). Instrument must have a history of acceptable coefficient of variation (<3.0%) on College of American Pathologist surveys. In case of interface outage, the instrument must possess the ability to store and transmit patient data for at least 24 hours of instrument throughput. The equipment must have the capability to store at least 500 patient sample results in an onboard or fully connected database for immediate recall. Associated computer operating system must be Microsoft Windows 7-based or higher. Operational noise level should not exceed 70 decibels.Analyzers must automatically calibrate per CAP requirements with no operator involvement. Software must possess automated commands to stop a run if calibration or QC fails.Performance Monitoring. This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute machines, and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin when patient testing begins approximately eight (8) weeks after the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in the contract at an effectiveness level of 90% or more.In the event equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests 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 machine is in actual use. System failure downtime is that 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 shall be required as a basis for 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 will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. Security Requirements.Instrument must meet all security requirements of the Dayton Veterans Administration Medical Center and comply with HIPAA and other national patient data privacy regulations. The instrument must be able to safely and effectively interface with the current laboratory information system with minimal to no intervention from the operator.Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the Contractor at the end of lease, for trade-in, or other purposes. Contractor must accept the system without the drive. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI)Dayton VA Medical Center, Laboratory Information SystemOther Pertinent Information or Special ConsiderationsSize of analyzer should be no larger than 20x20x20 and weight no more than 50 pounds.The instrument need read the barcode of each sample.Analyzer needs to track reagent volumes and alert the end-user through software prompts.Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the contract, as indicated, any and all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support/house the analyzer, and universal interface equipment, etc. In addition, the Contractor shall include all ancillary components that are customarily sold or provided with the model of equipment proposed, e.g. starter kits, tables/stands, etc. Commercial marketing. The equipment models being offered shall be in current production as of the date this offer is submitted. For purposes of this solicitation, current production shall mean that the clinical laboratory analyzer model is being offered as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable. Start-Up Reagents. The Contractor shall provide all reagents, calibrators, controls, consumable/disposable items, parts, accessories and any other item required to establish instrument for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies including: precision, method comparison with current analyzer, accuracy (recovery), linearity (reportable range), calibration verification, verification of reference interval, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all statistical analysis and report data in an organized, clearly comprehensible format. Training: The contractor shall provide key-operator training for 2 operators per analyzer. This shall include training on the operation of the system, data manipulation, and basic troubleshooting and repair. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant.Contractor shall provide operational hands-on training for all other operators as needed for each shift. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Contractor shall provide telephone assistance 24 hours per day, 365 days per year.Contractor will provide on-site service Monday through Friday, 8:00 am to 5:00 pm (local time), excluding national holidays at no charge. However, if both analyzers are inoperable, then vender shall provide on-site service after hours, weekends, and/or holidays as needed at no charge. Contractor shall provide support for analyzers through the life of the analyzers and the contract at no cost. Contractor shall perform all required preventative maintenance at no charge to customer.Contractor shall furnish a designated point of contact for placing orders.Billing will start the month following the start of patient testing.Contractor shall provide quality control peer group submission at no charge.Contractor shall provide both an electronic and hard copy of Operator s Manual and Instructions for Use documents. Contractors are required to provide white-glove delivery, installation and removal of equipment at no additional charge. Waste.Characterization of waste The Contractor shall provide documentation that it has characterized the hazardous nature of all wastes produced by all equipment, devices, reagents, and discharges in accordance with the requirements of the Code of Federal Regulations Title 40 Protection of the Environment Part 261 et seq. and applicable state and local requirements. Documentation shall include a description of the characteristics of the hazardous waste produced as a byproduct of the instrument operations, Safety Data Sheets (SDS) meeting the requirements of the Occupational Safety and Health Administration (OSHA) and Environmental Protection Agency (EPA), the analytical process used to determine the hazardous nature and characteristics of the waste, and the analytical test results. Testing of hazardous waste is to be done in accordance with testing protocol specified for each individual waste as described in the Code of Federal Regulations Title 40 to decide if the waste is a hazardous waste or otherwise regulated. The determination and description shall address the following:Waste toxicity (Reference 40 CFR �261.11 and 40 CFR �261.24)Waste ignitability (Reference 40 CFR �261.21)Waste corrosivity (Reference 40 CFR �261.22)Waste reactivity (Reference 40 CFR �261.23) Hazardous waste from non-specific sources (F-listed) (Reference 40 CFR �261.31)Discarded commercial products (acutely toxic or P-listed and toxic or U-listed) (Reference 40 CFR �261.33)Solid Waste (Reference 40 CFR �261.2)Exclusions (Reference 40 CFR �261.4)The contractor will provide written instructions and training material to ensure VHA laboratory staff are trained as needed to properly operate devices with special emphasis to managing and disposing of hazardous waste in accordance with EPA and state requirements. Additionally, the training provided by the contractor must fulfill Resource Conservation and Recovery Act (RCRA) requirements for training as applicable to devices. Contractor shall provide a description of all wastes the process or equipment may discharge so that the facility can determine whether the discharge meets Local Publicly Owned Treatment Works (POTW), State and Federal discharge requirements. At a minimum the characteristics of ignitability, corrosivity, reactivity and toxicity as defined in 40 CFR �261 must be determined and documented. Any mercury containing reagents must be identified in any concentrations. All test results shall be provided. All listed chemicals (F, U, K and P) found in 40 CFR �261 shall be provided in product information and their concentrations documented. For those materials with a positive hazardous waste determination, a mechanism for the laboratory to meet local discharge requirements (i.e. mercury, thimerosal and formaldehyde) must be developed and SDS sheets must be provided in advance for review. At a minimum, documentation shall include, but not be limited to the concentration/measures of the elements and parameters listed below and must be included with vendor response:Barium (Total)Cadmium (Total)Chromium (Total)Copper (Total)Cyanide (Total)Lead (Total)Mercury (Total)Nickel (Total)Silver (Total)Zinc (Total)Arsenic (Total)Selenium (Total)Tin (Total)pH Flash point (to higher than 200*F)BOD; biochemical oxygen demandThe documentation the contractor provides will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewage systemRisk ControlQC requirements must meet The Joint Commission, CMS, and CAP requirements at a minimum. Calibrators must be traceable to National Institute of Standards and Technology Standard Reference materials. Calibration must compensate for the influence of barometric pressure. The analyzer must have the capability to detect out of range quality control.The analyzer must have the capability of detecting interferences and potential errors with samples in real time.The instrument will have remote support capability with secure software if available with VA approval.There must be an on-board QC data management system and the ability to print monthly reports.Business Associate Agreement (BAA)- A business associate is an entity, including an individual, company, or organization that, on behalf of VHA, performs or assists in the performance of functions or activities involving the use or disclosure of PHI, or that provides certain services involving the disclosure of protected health information (PHI). VHA is a covered entity under the HIPAA Privacy Rule (Privacy Rule). HIPAA regulations require VHA to execute HIPAA-compliant BAAs with certain entities that receives, uses, or discloses VHA PHI in order to perform some activity for VHA. These BAAs obligate VHA business associates to provide the same protections and safeguards to PHI that is required of VHA under the Privacy Rule. Place of PerformanceDayton VA Medical CenterPathology and Laboratory - Clinical Testing Unit4100 W Third StDayton, OH45428-9000Period of Performance Base: One Year, 2020-2021 Option 1: One Year, 2021-2022 Option 2: One Year, 2022-2023 Option 3: One Year, 2023-2024 Option 4: One Year, 2024-2025The VA anticipates a firm-fixed price, base plus four (4) one (1) year option Cost Per Reportable Agreement (CPRA) with establishment of any price increases or multiple year discounts before finalizing the agreement. A performance guarantee and response guarantee will be established to ensure acceptable prompt service and operational reliability of the instrumentation, reagents and other supplies necessary for normal operations. The effective period of this CPRA is Base Year after install and validation of analyzer plus anadditional 8 weeks for procedure writing and method approval by Laboratory Director, with the Government s option to extend this CPRA for four (4) additional one-year periods renewable in one-year increments. If during the interval of this agreement an advance in technology or methodology occurs, the vendor/contractor will provide the upgrade/enhancement or new model at no additional cost to the Government. Applicable Provisions and Clauses.The following clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions - Commercial Items, with the following added as addenda to the clause, Addendum to 52.212-4- 52.216-18; 52.216-22 (Fill-ins); 52.217-9 (Fill-ins); 52.219-18; 852.203-70; 852.211-70; 852.232-72; 852.237-70 852.246-71; FAR 52.252-2; http://www.acquistion.gov/far/index.html, and http://www.va.gov/oal/library/vaar/index.asp/. 52.203-17; 52.204-4; 52.217-8 (Fill-ins); 52.232-40 FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (of which 52.203-6; 52.204-10; 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, and 52.232-33 are applicable). GRAY MARKET LANGUAGE: Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. Offer Evaluation and Award.This is a competitive RFQ that will be evaluated under FAR Parts 12 and 13. The Government will issue a Firm-Fixed Price CPRA resulting from this solicitation to the responsible offeror whose offer conforms to the requirements within this solicitation and will be the most advantageous to the Government. Best value will be how the quotes are evaluated. The following are the evaluation factors used:Technical Capabilities Training CapabilitiesPast Performance (CPARS)Price ComparisonAn offeror s initial quotation shall contain the best terms from a price and technical standpoint. Offerors are reminded that representatives from your company SHALL NOT contact any Dayton VAMC personnel to discuss this RFQ during the solicitation and evaluation process. Submission of Offer.All information shall be submitted in the manner as described below and offerors who do not submit all information may not be considered for award.Contractor shall provide an authorized distribution letter. The contractor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment, such that the OEM warranty and service are provided and maintained by the OEM. All warranty and service associated with the equipment shall be in accordance with the OEM terms and conditions. The contractor shall provide new items ONLY; no remanufactured or gray market items. All items must be covered by the manufacturer s warranty.Quote shall be good for 60 days after close of this solicitation.This solicitation requires registration with the System of Award Management (SAM) prior to award, pursuant to applicable regulations and guidelines.F.O.B. shall be Destination.Quotations are to be broken out to include line item pricing for each line item.Any questions can be submitted by Tuesday, 17 December 2019, no later than 2:00PM EST, via email to angie.carpenter@va.gov. Responses will be posted no later than Wednesday, 18�December 2019. RESPONSES DUE: Friday, 20 December 2019, at 4:00PM EST. Offers will only be accepted electronically via e-mail to angie.carpenter@va.gov. No late submissions will be considered. Enter RFQ 36C25020Q0048, Blood Gas Analyzers in the email subject line.Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. No telephone queries will be accepted.Angie CarpenterContract SpecialistAngie.carpenter@va.gov
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- Place of Performance
- Address: Department of Veterans Affairs;Dayton VA Medical Center;4100 West Third Street;Dayton OH 45428-9000, USA
- Zip Code: 45428-9000
- Country: USA
- Zip Code: 45428-9000
- Record
- SN05516748-F 20191215/191213230259 (samdaily.us)
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