Inactive

Page 18 of 18 DISCLAIMER This Sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that i... Page 18 of 18 DISCLAIMER This Sources sought is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this sources sought. If you can provide the services as described in the below scope of work description please respond by Friday December 13th, at 3:00PM EST to jami.cade@va.gov with the following information: Company Name Socio Economic Status: I.E. Small Business, Service Disabled Veteran Owned, Veteran owned, Women Owned, etc Email Address Phone Number Physical Address Capability statement pertaining to Scope of Work Limitations on Subcontracting will apply to the resulting solicitation. BPA Language: Intent: 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 Glycohemoglobin Instrumentation. The government will award the BPA to a single Contractor for Automated Glycohemoglobin 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 resulting contract. 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. Period of Performance: VISN 4 intends to establish the base year of the agreement for the period of April 1, 2020 through March 31, 2025. 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 4 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. 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 VISN 4 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. Parameter definitions The system must be certified by the National Glycohemoglobin Standardization Program. Coefficient of Variation (CV) must be less than 2.5%. 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 3 months for reagents. No requirements for sample pre-treatment. A specimen handling/loading system: Primary specimen container(s) loaded into a storage area, ie. tray, wheel, etc. for automated processing. Diluting and injecting of the specimen is handled with minimal operator intervention. Ability to accept various sample containers. Minimal reagent preparation. Capability to store at least 5000 patient results in database for immediate recall. Technical Features The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: Ability to monitor instrument performance. On-board reagent inventory system. Minimal carryover. Long calibration stability. Internal ability to assess column and detector functionality over time. A method determination of column and detector integrity must be provided. Complete separation of the labile and stabile hemoglobin A1C. Methodology that provides minimal interference from common hemoglobin (Hb) variants. 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: Controls for primary use (assayed) will be provided at a minimum of two levels; normal and elevated/abnormal levels. Third party manufacturer preferred for primary (assayed) controls. Linearity materials which are required every 6 months for all analytes due to a CAP requirement for maintaining assays and CLSI method validations to be provided by the Contractor. Capability to detect out of range quality control. On-board QC data management system with a minimum storage capacity of 4 QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store, and electronically transfer QC data. Must have the ability to participate in a VISN 4 QC peer comparison program at no additional charge. 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. Utilize HPLC methodology Primary and backup analyzers (for larger facilities) shall be from the same manufacturer and offer the same technology. Printer accommodates both single patient result (for STATS) or batch print options. 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, shall be run by the current method and proposed method. The systems where multiple sampling modes exist, mode to mode correlation studies must also be performed. 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. 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 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 range that be performed as a minimum. 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. Intra-VISN 4 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 when 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 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 resulting 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 resulting 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, 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 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, thimerosol 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 Contractor 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 will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether or not the waste from each device can legally be disposed of via the sewerage system Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than DDDD days after the award of the BPA. This timeline is based on a reasonable attempt of the Contractor to complete all of the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the DDDD day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government. Upon award of a BPA, the transition period for the awarded BPA to have all equipment and peripherals installed and operational shall be from date of award through 120 days. During this same period all initial training of VA personnel in the operation and maintenance of said award shall also be completed. Contractor shall provide with its quotation an implementation plan for installation of new equipment. Contractor s submitted plan shall not exceed 120 days for the transition of all services under the awarded BPA 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 BPA for cause under the Termination for Cause clause of the BPA. At the end of 120 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 delivery order [or BPA] 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 any BPA at an 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 tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If t...