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SOURCES SOUGHT This is a Sources Sought Synopsis (SSS) ONLY. The U.S. Government is conducting market research only to determine the availability of qualified sources capable of providing Automated Bl... SOURCES SOUGHT This is a Sources Sought Synopsis (SSS) ONLY. The U.S. Government is conducting market research only to determine the availability of qualified sources capable of providing Automated Blood Gas Instrumentation Cost Per Test (CPT)/Cost Per Reportable Result (CPRR) Reagents & Consumables. Potential Contractors are invited to provide a response via e-mail to Contract Specialist at ross.byrne@va.gov by Apr 9, 2021 11:00 a.m. (PT). Responses will be used to determine the appropriate strategy for a potential acquisition. Please clearly identify any information your company considers sensitive or proprietary. This notice is issued solely for information and planning purposes. It does not constitute a Request for Quotation (RFQ), or a promise to issue an RFQ in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, or proposals at this time and will not accept unsolicited quotes in response to this sources sought synopsis. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ, if any is issued. BACKGROUND: The Portland VA Medical Center, Portland Oregon, has a requirement for a Contractor to provide Automated Blood Gas Instrumentation CPT/CPRR Reagents & Consumables. Please draft Statement of Work below for requirements. NAICS: 325413, In-Vitro Diagnostic Substance Manufacturing Interested potential Contractors please provide the following. 1) Company Name, address, point of contact, phone number, email address, and DUNS Please indicate business size: Small Disadvantage Business (SDB)____ 8(a)____ Historically Underutilized Business Zone (HUBZone)____ Service-Disabled Veteran-Owned Small Business (SDVOSB)____ Veteran-Owned Small Business (VOSB)_____ Economically Disadvantaged Women-Owned Small Business (EDWOSB)_____ Women-Owned Small Business concerns (WOSB)_____ Small Business_____ Large Business_____ Please state if you possess a Federal Supply Schedule (FSS)________ 2) Please submit a capability statement (maximum three pages) with enough information to demonstrate to the Veterans Affairs that your company can provide the Automated Blood Gas Instrumentation CPT/CPRR Reagents & Consumables as required in the attached Draft Statement of Work. In particular, your capability statement shall illustrate your company s capability of providing the following: 1)A Food and Drug Administration (FDA) approved instrument(s) capable of testing venous and arterial blood for the measurement of pH,  pCO2, pO2, Sodium, Potassium, Chloride, Lactic Acid, Ionized Calcium, Total Hemoglobin and derivatives, and Pleural Fluid pH and report calculated values for Bicarbonate, Base Estimate of Blood, Ionized Calcium Corrected for pH, Patient Temperature Correction for pH, pCO2 & pO2, Hemoglobin Oxygen Saturation, Total Oxygen Content, and Anion Gap 2)An instrument(s) that performs automatic calibrations and three levels of quality control analysis at predetermine times. 3)Installation and training upon delivery of the instrument(s) 4)24/7 on-site service. **Draft Statement of Work: 1.0 Title: Automated Blood Gas Instrumentation CPT/CPRR Reagents and Consumables 2.0 Background: The VA Portland Health Care System requires a Contractor to provide high capacity Blood Gas Instruments via a Cost Per Test (CPT) & Cost Per Reportable Results (CPRR) contract. The contract for these CPT instruments must include the instrument(s), training, service, all reagents and consumable supplies required to perform blood gas analysis. The instruments must measure venous and arterial blood pH, pCO2, pO2, Sodium, Potassium, Chloride, Lactic Acid, Ionized Calcium, Total Hemoglobin and derivatives, and Pleural Fluid pH and report calculated values for Bicarbonate, Base Estimate of Blood, Ionized Calcium Corrected for pH, Patient Temperature Correction for pH, pCO2 & pO2, Hemoglobin Oxygen Saturation, Total Oxygen Content, and Anion Gap. In addition, the instruments must perform calibration and three levels of Quality Control analysis automatically at predetermined times. 2.1 Scope of Work 2.1.1. The required instrumentation shall have the capability of performing and/or reporting the clinical parameters as defined in the statement of work. The instrument shall have random access capability (if discrete testing is required) and be able to simultaneously perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI). The Contractor shall provide the facility with Food and Drug Administration (FDA) approved analyzer/equipment and printer, reagents, controls, calibrators, linearity material, disposables, any consumable parts or supplies necessary for analyzing/testing, and printing results from the analyzer and services as described herein to VAPORHCS in accordance with the applicable Federal Supply Schedule contract. Contractor shall list the consumable parts provided. Contractor shall state any parameter/function that is pending FDA approval at the time of the submission. A listing of the estimated yearly quantity is provided under this agreement located in Attachment 1 (Test Menu and Volumes). Quantities listed in the attachment are estimates based upon prior history of actual volumes and are intended to provide the potential contractor a basis for calculating their pricing. They are not a guaranteed minimum. These volumes can be utilized by interested contractors to submit their cost proposal. The pricing shall be based on new state-of-the-art equipment. Remanufactured or used models will not be accepted. The Contractor s offered equipment shall conform to the facilities existing space. Each instrument s size shall be not greater than 24 inches wide, 24 inches high, and 24 inches deep due to current space constraints in the laboratory. The Contractor shall 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. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagent, standards and control containers. Unexpected changes in methodology/technology shall be at the expense of the Contractor. 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 Contractor s equipment, or the Contractor has failed to comply with the requirements for routine supply delivery, the Contractor is required to deliver the supplies within 24 hours of receipt of a verbal order for emergency delivery. If either circumstance has occurred, the Contractor 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 Contractor 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 Contractor until the arrival at the laboratory of the monthly standing order/routine supplies delivery. The analyzer/equipment must meet the test volume in Attachment 1 (Test Menu and Volumes) and match or improve the turnaround time requirements. The system should streamline all aspects of testing, thereby improving efficiency and productivity of the using facility. DEFINITIONS: Cost per Patient Reportable Result (CPRR)- The per patient reportable result price shall include costs covering: (1) 5 year equipment use, (2) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories and any other item required for the proper operation of the Contractor s equipment and necessary for the generation of a patient reportable result. This per patient reportable result price shall also encompass all costs associated with dilution; repeat and confirmatory testing required producing a single patient reportable result. It shall also include the material to perform as well as all other costs associated with quality control, calibration and correlation study testing that is prescribed by the Clinical and Laboratory Standards Institute (CLSI). (3) all necessary maintenance to keep the equipment in good operating condition (This element includes both preventive maintenance and emergency repairs) and (4) training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. 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. TEST MENU: Refer to Attachment A for desired test menu and estimated annual volumes. GENERAL REQUIREMENTS: Primary analyzer(s) Base equipment offered that shall fully support the scope of operations (minimal requirements). Depending upon the technical functionality and the capabilities of the individual manufacturer s instrumentation, one analyzer or multiple analyzers may be required to meet the productivity specifications defined herein. In those instances, the additional analyzer(s) shall, likewise, be considered primary instrumentation and shall meet all the technical specifications of this solicitation. Those additional analyzer(s) offered meeting the definition of a primary analyzer shall be equivalent to a back-up analyzer (see definition below) and shall replace the requirement for offering that category of equipment. Back-up Analyzer(s) - Equipment required in support of operations for the VA laboratory in the event the primary analyzer(s) becomes non-operational/non-functional. This category of equipment shall only be operated during periods of time when the primary instrumentation is not available for use. As such, the requirements for consumable supplies, i.e. reagents, quality control material, calibrators, etc., shall be minimal and corollary to the successful operation of the primary instrumentation. Technical Features - The desired blood gas/critical care metabolite instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the capability of performing or reporting the following parameters (FDA approved) on arterial, venous, or mixed venous whole blood specimens: pH, pO2, pCO2, hemoglobin, sodium, potassium, chloride, ionized calcium and/or normalized calcium, glucose, lactic acid, base excess, bicarbonate, total carbon dioxide (TCO2), oxygen saturation and co-oximetry, including Oxyhemoglobin, Carboxyhemoglobin, and Methemoglobin. In addition, the instrumentation must be approved by the FDA for performing and reporting pH measurements on Pleural Fluids. The instrument must be able to perform the complete profile described above discretely by either direct or indirect (calculated) measurement and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute (CLSI). In addition, the analyses must take place on a single instrument and a single specimen. Operational Features The instrumentation offered shall have the following: 2.4.4.1 Sufficient safety features to avoid unnecessary exposure to biohazardous and chemical material. The volume of biohazardous and chemical waste generated by the equipment must be minimal and require a minimum amount of handling. 2.4.4.2 A sampling system that is automatic, easy to operate, safe and can accommodate any sample type without any additional adapter devices. The sampling system must have: 2.4.4.2.1 The ability to aspirate directly from a syringe or an evacuated blood collection tube. 2.4.4.2.2 The capability of walk away processing that negates the need for additional instrument prompting. 2.4.4.2.3 An error detection system that promptly notifies the operator that a sample is not positioned properly or there is insufficient sample quantity. 2.4.4.2.4 An early clot detection feature that immediately alerts the operator to the suspected existence of a fibrin clot in the specimen. 2.4.4.3 A consumable supply system that maximizes the efficiency and productivity of the equipment. This includes: 2.4.4.3.1 Ready to use reagents, when applicable 2.4.4.3.2 The maintenance of reagent stability on the equipment 2.4.4.3.3 Packaging that is maximized to accommodate the varying specimen volumes at the individual VA facilities and does not require a frequent exchange of inventory on the equipment. 2.4.4.3.4 Minimal wastage of consumables. 2.4.4.3.5 Supplying calibration verification material at least twice per year to validate equipment performance prior to College of American Pathologists survey validation. 2.4.4.3.6 The ability to sequester a single lots of quality control material, both external and internal in enough quantity to supply the facility for, at least one year of operation to reduce the need to change lot numbers of material. Quality Control Material/System that will: Include 3 levels of controls that represent both high and low values for each analyte tested. Quality Control should be processed using the same pathway as patient samples. Volume of external and/or internal on-board quality control material to meet the daily quality control requirements for every 24 hours of operation. For analysis every 8 hours of operation and, For troubleshooting\, as needed. The contractor shall explain the external and/or internal QC testing process and its frequency for the proposed instrumentation. A quality assurance system that will: Automatically perform system checks and/or system calibrations in accordance with the minimum regulatory requirements. Monitor temperature and barometric pressure. The calibration shall compensate for the influence of barometric pressure. Allow the operator to preprogram the analysis of quality control material. Perform automatic corrective action on the system if the results of the quality control testing are not acceptable. 2.4.4.6. A diagnostic error detection system that will: 2.4.4.5.1. Alert the operator to a calibration drift. 2.4.4.5.2. Provide troubleshooting help, guiding the operator toward corrective action. If the assistance is in the form of computer tutorials, the system must have the capability to print the procedures. 2.4.4.7. Minimal daily and periodic maintenance. The electrodes used on an electrode-based system must have minimal maintenance. Electrode replacement must be accomplished easily. The new electrode must be operational within two (2) hours of replacement. 2.4.4.8. An on-board information management computer system. The information management system must have: 2.4.4.8.1. Sufficient capacity to store and retransmit records (24 hours maximal instrument throughput) in case of interface outage. The system shall have the ability to edit the sample/patient identifier after the interface downtime and then be able to retransmit the sample/patient information to the host for verification. 2.4.4.8.2. A quality program that evaluates quality control material for acceptability and locks out assays that have failed quality control results. 2.4.4.8.3. An instrument maintenance tracking system must also be available with the capability to store these records for a period of two years. 2.4.4.9. 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 at the time of contract award. The awarded vendor will be responsible for the cost of the interface. 2.4.4.9.1. The accuracy of the barcode reading must have less than a 1% failure rate. 2.4.4.9.2. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. 2.4.4.9.3. Equipment must accept, at a minimum, 15 characters in the specimen identifier that is alpha and/or numeric, depending on the site. Hardware Features The instrumentation offered shall have the following: A sample path design that allows for easy fibrin clot removal without hardware disassembly. An on-board, adjustable screen/ monitor that is easily readable. A total equipment footprint that, when installed in the laboratory, shall not impact the functionality / operations of that laboratory. A printer that has the capability of printing a patient report with patient demographic information that includes minimally the accession or unique identifier number (UID). Replacement printers shall be provided as needed, at no additional charge, for the duration of the contract. An uninterruptible power supply with line conditioner for each instrument provided under this contract. Replacement uninterruptible power supply with line conditioners shall be provided as needed, at no additional charge, for the duration of this contract. An equipment mean failure rate of greater than 60 days. Upgrades to both the equipment hardware and software in order to maintain the integrity of the system and state-of-the-art technology at no additional charge to the Government. This requirement only applies to system upgrades that enhance the model of the equipment being offered, i.e. new version of software, correction of hardware defect, upgrade offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer vendor supported, etc. Method Performance/Validation Requirements Method performance/comparison shall be at the expense of and performed by the contractor, and shall include linearity material, reagents, and controls, and be consistent with current CLSI guidelines related documents, College of American Pathologist (CAP) standards, and Federal regulations. All studies performed will be appropriate for the required tests menu and sample type, i.e., arterial, venous, and mixed whole blood. The studies must be approved by the Laboratory Director and be made available electronically. These requirements shall be in effect during installation and any future changes to the test menu and/or method updates. The required studies are: Correlation studies for each analyte. A minimum of 20 samples spanning the reportable range, shall be run by the present and the proposed method. In systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. Contractor shall analyze results and provide statistical data to support acceptance of the new method for above studies. Statistics shall consist of at least mean, bias, slope, y-intercept, correlation coefficient, ROC analysis, and meet current standards defined by CLSI. Analytical Measurement Range (AMR) Validation shall be performed on proposed instrument(s) for each analyte to validate the reportable range. The material must have values, which are near the low, mid, and high values of the AMR and be of appropriate matrix for the clinical specimens assayed by that method. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire reportable range shall be performed as a minimum. Precision study using normal and abnormal control material. This shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day-to-day precision study of normal controls and abnormal controls for 10 days (may be run twice a day) for a total of 20 values per level of control. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Carryover Studies. Successful carryover studies shall be completed by the contractor on all analyzers during installation. These studies shall be performed using either contractor developed program(s) or program(s) developed by a third party (CAP/CLSI). The programs shall be provided to each laboratory at no charge. Internal Barometer Check. If the instrument has an internal barometer, its function should be checked by comparing its values to a reliable independent measurement on installation and per the manufacturer s guideline. This check should be performed by the vendor. A reference range must be determined for each test following CLSI guidelines. Samples used for the reference range study must be representative of the patient population being tested. Reference range assessment must be performed for each lab. One of the following protocols shall be used: A verification of the manufacturer s suggested reference range may be performed if the suggested range is based on a comparable population of test subjects. The manufacturer shall provide specific information defining how the suggested range was determined. A minimum of 20 reference individuals shall be used to verify the manufacturer s range. Any apparent outliers should be discarded, and new specimens obtained to provide a statistically valid verification. If the suggested manufacturer s range is not appropriate for the patient population, a reference range shall be established. Establishing a reference must follow CLSI guidelines. This requires a minimum of 120 reference individuals to be used to establish a reference range. The reference interval should be determined using the nonparametric method. If a laboratory is currently using the proposed instrument/reagent system, the in-use reference range can be transferred to the new system if a method comparison study between the two systems proves to be acceptable. If comparison studies are not acceptable, one of the two above items must be performed. Support Features 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 included on the list of supplies defined in the Federal Supply Schedule contract and required to establish instruments for operation for performance of acceptance testing. The Contractor shall assist the Government with validation and method comparison studies. All materials and reagents needed for such correlation shall be provided at no cost to the Government. The Contractor shall perform all of the statistical analysis and report data in an organized, clearly comprehensible format. This process shall be completed within two weeks of installation of the analyzer at each site and shall be consistent with current CLSI and related documents, CAP Standards and Federal Regulations. Training. The Contractor shall provide an instrument training program that is coordinated with and timely to the equipment installation, sufficient to the size and scope of the facility s services and minimally equivalent to the terms and conditions for training defined in the Contractor s Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Reportable-Result Clinical Laboratory Analyzers contract. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Thereafter, the Contractor shall provide training for minimally one operator per facility per year at the discretion of the Government for each model of instrumentation placed. Utilization of the training slots shall be mutually agreed upon between the VA and the Contractor. A training program that involves off-site travel shall include the cost of airfare, room and board for each participant. Equipment Preventative Maintenance/Repair Service. A technical assistance center must be available 24 hours per day, 7 days per week, with a maximum call back response time of 1 hours. The vendor must provide on-site service 24 hours per day, 7 days per week on all instruments placed. The maximum response time for on-site service will be 24 hours. All such arrangements shall be coordinated between the Contractor and VA laboratory personnel. Preventative maintenance will be performed on-site as frequently as published in the manufacturer s operator s manual and within 2 weeks of the scheduled due date. A malfunction incident report shall be furnished to the Laboratory upon completion of each repair call. The report shall include, as a minimum, the following: Date and time notified Date and time of arrival Serial number, type and model number of equipment Time spent for repair, and Proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Each notification for an emergency repair service call shall be treated as a separate and new service call. Ancillary support equipment. The Contractor shall provide, install and maintain through the life of the BPA, as indicated, all ancillary support equipment to fully operate the analyzer as defined in these specifications, e.g. cabinetry to support / house the analyzer (if necessary), water systems (including consumable polishers, filters, etc.), and universal interface equipment, etc. 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. Interface Requirements The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface and any incremental fee that is required each time an instrument is added to an existing universal interface system. The Contractor shall provide all necessary software support for insuring that successful interfacing has been established. Specific requirements for the communication of the data streams will be unique to the instrument system involved and dictated by the manufacturer itself If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any incremental fee required to add additional equipment (e.g. licenses, ports/cards, cables, software, etc.) to the universal interfacing system. If a site does not have a universal interface and one is needed to optimally interface the instrument, then the Contractor is responsible for the acquisition of the universal interface box and everything else needed to connect with VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for seeing that the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. Commercial offerings - The Contractor shall provide any additional support material that is routinely provided to equivalent commercial customers and assists in regulatory compliance, e.g. Computer disc containing their procedure manual in CLSI format or an on-line procedure manual in the instrument software. 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 demand The documentation the Contractor provides shall 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 sewerage system Implementation/transition timeframe - Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted plan shall not exceed 60 days for the transition of all services under the awarded contract including installation and training of personnel, transition of all testing materials, reagents and supplies, etc., performance of all correlations and validations. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate contract for cause under the Termination for Cause clause of the contract. At the end of 60 days from award of the BPA, the awarded Contractor shall have full and sole responsibility for services under the awarded BPA. Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the contract 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 on 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 that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on 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 in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall recei...