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SOURCES SOUGHT NOTICE 36C244I0910 MARKET RESEARCH PURPOSE ONLY This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being re... SOURCES SOUGHT NOTICE 36C244I0910 MARKET RESEARCH PURPOSE ONLY This is a SOURCES SOUGHT NOTICE only. Responses to this notice will be used for information and planning purposes. No quotes are being requested or accepted at this time with this notice. The Department of Veterans Affairs has a VISN 4 requirement for VISN Laboratory CPRR Instrumentation - Urinalysis - Chemistry. The North American Industry Classification System (NAICS) code being considered for this procurement is 325413 In-Vitro Diagnostic Substance Manufacturing and the Product Service Code (PSC) is 6515 Medical and Surgical Instruments, Equipment, and Supplies. Below is a draft copy of the Statement of Work (SOW). Responses to this notice should include the following: Company name Data Universal Numbering System (DUNS) number Company s address Point of Contact information (i.e. title, phone number and email address) Company s capability to meet this requirement and any pertinent information which demonstrates the company s ability to meet the above requirements. GSA Federal Supply Schedule contract number, if within scope of this effort (if applicable). Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner? Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company. Company s type of business (small or large) and socioeconomic status whether Service Disable Veteran Owned, Veteran Owned, Hubzone, 8(a), Women Owned, Small Disadvantaged, etc. If applicable, Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) must be verified in www.VetBiz.gov , and be able to meet the limitation on subcontracting in accordance with 13 CFR 125.6; if applicable. All responses shall be submitted in writing via email no later than 12 Noon EST, on July 11th, 2022 to Mrs. Amanda Saunders at Amanda.Saunders@va.gov SUBJECT LINE: VISN Laboratory CPRR Instrumentation - Urinalysis Chemistry E-mail: Amanda.Saunders@va.gov. Facsimile or telephonic responses will not be accepted. Simply responding as an interested party in beta.SAM.gov does not constitute your company as a source. Offeror must provide the above requested information. After review of the responses to this sources sought notice, a solicitation announcement may be published in the near future. Responses to this sources sought announcement are not considered adequate responses to the solicitation announcement. All interested offerors will have to respond to the forthcoming solicitation announcement, in addition to responding to this sources sought notice. All interested parties must be registered with System for Award Management (SAM) at beta.SAM.gov in order to be eligible for award of Government contracts. Statement of Work: VISN Laboratory CPRR Instrumentation - Urinalysis - Chemistry BPA Language: Intent: Pursuant to Federal Supply Schedule (FSS) and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 4) to establish a Blanket Purchase Agreement (BPA) for Automated Urinalysis Instrumentation. The BPA shall be under the FSS Contract, Federal Supply Class (FSC) Group 66 III Cost Per Test (CPT)/Cost Per Reportable Result (CPRR), Clinical Laboratory Analyzers. The government will award the BPA to a single Contractor for Automated Urinalysis Instrumentation. Contractor agrees to the following terms of the BPA exclusively with the VISN 4 facilities listed by Attachment/herein and awarded in the final BPA. However, as requirements change, facilities within VISN 4 may be added or deleted by supplemental agreement of the Government or Contractor. Additional tests/reagents/instrumentation may be added to the BPA as new technology becomes available on the market and added to the base FSS contract. Orders: All products ordered under this BPA, placed against the Federal Supply Schedule Award Contract(s), are subject to the terms and conditions of the FSS contract. This BPA does not obligate any funds. The Government is obligated only to the extent of authorized orders actually issued under the BPA by authorized individuals. Prices and Terms: VISN 4 will provide an estimated volume by test as reflected in Attachment A for each individual medical center and outpatient clinic laboratory. Pricing is based in the AVERAGE daily test volume per instrument/analyzer for each facility. The Government estimates the volumes per facility as listed in Attachment A, but does not guarantee volumes as listed; they are estimates only. Terms of Agreement: This will be a single award, firm-fixed price BPA with one base year and four, one-year options and shall be effective for the term of the FSS Contract including additional FSS extensions. The Contractor is required to immediately notify the CO (Government Contracting Officer), in writing, if at any time the FSS contract upon which this BPA is based, is no longer in force. The resulting BPA shall be automatically extended for the remaining term of the BPA without modification upon any extensions of the contractor s FSS contract. In addition, where a new FSS contract replaces Contractor s current FSS contract, the resulting BPA may be reassigned under the new FSS contract for the remaining term of the BPA with written agreement between Contractor and the contracting officer. This BPA is not a contract. If the Contractor fails to perform in a manner satisfactory to the CO, this BPA may be canceled with thirty (30) days written notice to the Contractor by the CO. This Contractor shall also reserve the right to terminate this contract with 30 days notification to the CO. This BPA shall be reviewed annually. VISN 4 intends to establish the base year of the agreement for the period of August 1, 2022 through July 31, 2023. Identification: Delivery Orders issued shall be identified by their applicable FSS Contract Number and BPA Number. FSS & BPA identification numbers are assigned through the VHA Procurement Activity; CO: (insert identification FSS Contract # and BPA #). FSS Contract # Ordering Method: The participating facilities may order products via Electronic Data Exchange (EDI), telephone, facsimile or other written communication, identifying the products by number, quantity, purchase price, address for delivery, and any special instructions. Description/Specifications/Statement of Work Scope of Procurement: The desired instrumentation shall have the capability of performing 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). Equipment must maintain, or preferably reduce the number of work stations or overall labor required to accomplish the required testing by each laboratory. If the Contractor offers a family of analyzers, VISN 4 technical panel will determine if instrumentation proposed meets the needs of the using facility. Equipment shall be acquired for each of the clinical laboratories at the VISN facilities listed in Attachment A. The Contractor 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. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy. Expiration date must be clearly marked on reagents, 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 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. Definitions: Cost per Patient Reportable Result (CPRR) as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Reportable Clinical Laboratory Analyzers- 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 CLSI. (3) All necessary maintenance to keep the equipment in good operating condition. This element includes both preventive maintenance and emergency repairs, (4) and training for Government personnel. Contractors shall provide delivery, installation and removal of equipment at no additional charge. Cost per Test (CPT) - as defined in the Federal Supply Schedule FSC Group 66, Part III, Cost-Per-Test Clinical Laboratory Analyzers- Contractors are required to provide a price for each test that can be performed on its equipment. The per test 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 and reporting of a test result, (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 are required to 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. Parameter definitions Automated Urine Macroscopic- Chemical analysis of urine to include color, clarity, specific gravity, pH, and the presence/absence of leukocyte esterase, nitrites, total protein, glucose, blood/hemoglobin, ketone, urobilinogen, and bilirubin. Automated Urine Microscopic- Analysis to determine the presence/absence of sediment constituents such as but not limited to red blood cells, white blood cells, casts, crystals, bacteria, etc. 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. (Applies only if selected) Back up Analyzer(s) Equipment required in support of operations for the VA laboratories 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. Specific tests that require back up performance are listed in Attachment A. Contractor shall provide quality control material at a minimum of two levels; normal and elevated/abnormal levels. Operational features - The instrument shall have the following: The capability of performing analysis on 100% of the tests listed in Attachment A. Sufficient capacity and throughput to meet the volume and service demands as defined in Attachment A. Safety features to avoid unnecessary exposure to biohazardous and chemical material. The exposure to and the volume of biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling. A bi-directional, barcoded 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. The accuracy of the barcode reading must have less than a 1% failure rate. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Equipment must accept, at a minimum, BCBC characters in the specimen identifier that is alpha and/or numeric depending on site. Ability to prioritize STAT testing without compromising existing programmed testing. Minimal daily, weekly, monthly, and periodic maintenance. Ability to store and retransmit records (24 hours of maximal instrument throughput) in case of interface outage. On-board reagent stability sufficient to accommodate both high and low volume use. Contractor to provide expiration dates of at least 6 months for reagents. Capability of analyzing small sample volumes (less than 3mL) Capability to detect out of range QC. Ability to accept various types of sample containers. Ability to select either numeric or semi-quantitative result format (ie. mg/dL or large 4+) Ability to set facility developed flags for reflex to automated microscopic testing. Technical Features The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: On-board QC data management system with a minimum storage capacity of QC files including Levy-Jennings graphs. Analyzer must have the ability to capture, store, and electronically transfer QC data. Ability to monitor instrument performance. On-board reagent inventory system. Minimal carryover. Long calibration stability. Minimal reagent, calibrator, and control preparation. Hardware Features The instrumentation shall have the following: A total equipment footprint that when installed in the laboratory shall not impact the functionality/operations of that laboratory. An on-board monitor/screen that is easily readable. 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). An uninterruptible power supply with line conditioner for each instrument provided. Primary tube sampling. Specific Equipment Requirements The instrumentation shall have the following: Ability to comment on QC points to document troubleshooting and QC review. Ability to automatically program the performance of QC testing. Analyzer utilizes windows operating software. Equipment installation and possible reinstallation should the equipment need to be moved due to construction or laboratory redesign at no additional cost for one (1) location within each site. Ability to continuously load specimens. Ability to perform dilutions and perform dilution calculations is preferable. The Microscopic analyzer shall be integrated with the macroscopic analyzer for true walk-away capabilities. Primary and backup analyzers (for larger facilities) shall be from the same manufacturer and offer the same technology. Capable of accepting both conical (i.e., KOVA and various style tubes) and round-bottom sample tubes (including varying sizes of evacuated tubes). Requirement can be met by use of different carriers or inserts, supplied by the Contractor at no additional charge. Printer accommodates both single patient result (for STATS) or batch print options. Ability to detect when manual review of automated microscopic is required. All reagents, controls, and calibrators will be of the same lot number for all users. Lot numbers will be in use at least six (6) months. All sites covered under this BPA will convert to the new yearly lot number within 2 months of each other. Method Performance/Validation The instrumentation shall have the following: Method performance/comparison will be at the expense of the Contractor and will include linearity materials and reagents as required and based on manufacturer s specifications and be consistent with Clinical Laboratory Standards Institute (CLSI) guidelines and related documents, College of American Pathologists (CAP) standard, and Federal regulations. Correlations will be performed for each analyte using a minimum of 20 samples that span the reportable range. The Contractor will analyze results and provide statistical data to support acceptance of the new method. Statistics include at least the mean, bias, slope, y-intercept, correlation coefficient and meet current standards defined by CLSI. Precision study using abnormal material will be performed and shall consist of a within run precision study of 10 normal and 10 abnormal controls and a day to day precision study of normal and abnormal controls for 10 days for a total of 20 values per level. Can be run twice per day if necessary. Where applicable, intra-VISN facility variations should be kept at an absolute minimum. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rates and false negative rates are applied. Specificity studies will be done by review of product literature and assay inserts to determine adverse effects for increased bilirubin, hemolysis, lipemia, or other interrupting substances. Carryover Studies are required to ensure instrument properly flushes probes between specimens. Successful carryover studies shall be completed 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, formerly NCCLS). The program(s) shall be provided to each laboratory at no cost. Reference Range 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 as long as 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. Reports The Contractor shall provide to the Contracting Officer (CO) and other individuals (designated post award) a copy of a quarterly report of sales, by ordering facility, within 30 calendar days after the close of each quarter s business. Reports are to reflect, at a minimum, total net sales amounts before discount, and discount amounts by ordering facility as well as the raw data used to develop these reports. These reports shall be used to monitor the commitment of each facility, reporting the savings realized and shall be shared with each participating facility, personnel associated with acquiring the products, and respective laboratory personnel. Additional invoice charges associated with reagent and/or supply wastage or repair parts included at no charge (per FSS awarded contract) shall not be accepted. There will be no additional charges for any reports required as part of the BPA. Attachment C may be used as a template to provide these quarterly reports. Support Features Commercial marketing The equipment models being offered shall be 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 Reagent 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 FSS contract and required to establish instruments for operation for performance of acceptable 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 the statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. 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-Test 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 - The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all primary and back-up instrumentation and any incremental support equipment, e.g. water system, offered according to the following terms: The Contractor will provide access to a technical assistance center that is available 24 hours per day, 7 days per week with a maximum call back response of two hours. Equipment repair service call shall be provided during routine business hours which are typically 8a.m. to 430 p.m. Certain circumstances may dictate the need for repair service to be conducted outside routine business hours. The Contractor is required to maintain analyzers in working order (able to perform patient testing). The Contractor must be prepared to provide services outside of normal routine hours. Equipment repair response time shall be no more than 3 hours. Preventive maintenance will be performed according to published manufacturer operator s manual and within two weeks of the scheduled date. Reports of service 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 analyzer, Time spent for repair and proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. Each notification of an emergency repair service call is treated as a new separate service call if both the primary and back-up analyzers are not functioning properly. Contractor is required to provide emergency service after core business hours and on weekends. Upgrades - The Contractor shall provide upgrades to both the equipment hardware and software in order to maintain the integrity of the system and the state-of-the-art technology at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to system upgrades that enhance the model of 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 Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the BPA; however, it does refer to significant changes in the hardware operational capability. Ancillary support equipment - The Contractor shall provide, install and maintain through the life of the BPA, 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 (if necessary), water systems (including consumable polishers, filters, etc.), 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. Interface requirements Contractor will provide 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 analyzer is added to the existing universal interface system. Contractor will provide any, and all necessary software support for insuring successful interfacing is established. Specific requirements for the communication of the data stream will be unique to the analyzers system involved and dictated by the manufacturer itself. The Contractor will supply the information necessary to make the determination for type and amount of interfacing analyzers to be supplied. When the Government site has a universal box, the Contractor will be responsible for everything leading up to the box including any incremental fees required to add additional analyzers (ie. licenses, port/cards, cable, software, etc.) to the universal interfacing system. When the Government site does not have a universal interface, and one is needed to optimally interface the analyzer, the Contractor will be responsible for the acquisition of the universal interface box and everything else needed to connect to the VA computerized hospital information system. If there are any software upgrades in the instrument during its life, the Contractor is responsible for ensuring the interface can accommodate any changes in the data stream going to the VA computerized hospital information system. Interface capability for back-up analyzer. 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. 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 make a determination 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 EP...