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This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this So... This is a SOURCES SOUGHT announcement only. It is neither a solicitation announcement nor a request for proposal or quote and does not obligate the Government to award a contract. Responses to this Sources Sought must be in writing. The purpose of this Sources Sought Announcement is for market research, to make appropriate acquisition decisions, and to gain knowledge of potential qualified businesses capable of providing the following: POC INR Testing for the VISN 15 *** See Statement of Work below for details *** If this is within your capability, please respond with the information below: Company Name Address Point of Contact Phone, Fax, and Email UEI number GSA Contract (as applicable) Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications to be considered for award. In addition, FAR 4.11 states that prospective contractors shall be registered in the System for Award Management (www.SAM.gov) database. All Service-Disabled Veteran Owned Small Businesses (SDVOSB) and Veteran Owned Small Businesses (VOSB) shall be verified in VetCert at https://veterans.certify.sba.gov Point of Contact for this Sources Sought is: veronica.flores@va.gov (913) 946 - 1167 Department of Veterans Affairs Network Contracting Office -15 3450 S. 4th Street Trafficway Leavenworth, KS. 66048. STATEMENT OF REQUIREMENT FOR VISN 15 - Prothrombin Time Point of Care Testing- Cost Per Testing SCOPE OF PROCUREMENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish a Cost per Test (CPT) agreement for POC INR Instrumentation, supplies and middleware connectivity. The Government will award a Cost per Kit to a single contractor for POC INR testing. The desired instrument shall have capability to perform testing 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 shall be acquired for each of the clinical laboratories located at the VISN 15 facilities that have been identified 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 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. Estimated volumes of reagents can be found in Attachment B. Special handling for emergency orders of supplies: If 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 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) 4 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 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. MOU The VA utilizes a Memorandum of Understanding (MOU) to document the terms and conditions for sharing data and information resources in a secure manner. The following supporting information within the MOU will define the purpose of the interconnection, identify relative authorities, specify the responsibilities of both organizations, and define the terms of the agreement. Additionally, the MOU provides details pertaining to apportionment of cost and timeline for terminating or reauthorizing the interconnection. ISA Technical details on how the interconnection is established or maintained are included within the Interconnection Security Agreement (ISA). A system interconnection is a direct connection between two or more information technology (IT) systems for the purpose of sharing data and other information resources. The VA uses the ISA to formally document the reasons, methodology, and approvals for interconnecting IT systems; to identify the basic components of an interconnection; to identify methods and levels of interconnectivity; and to discuss potential security risks associated with the interconnections. Parameter definitions PT Prothrombin Time INR International Normalized Ratio GENERAL REQUIREMENTS: Operational Features- The instrumentation offered shall have the capability to perform; Prothrombin Times and INR testing as a CLIA waived analyte Prothrombin Time assay at locations that are remote from the laboratory, such as Community Based Outpatient Clinics (CBOC) Bi-directional 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. Technical Features - The instrumentation must be approved by the Food and Drug Administration (FDA) and shall have the following: CLIA Waived Complexity status Operator and patient identification tracking Expired operator, failed quality control and invalid lot number instrument lock out Ability to detect poor reagent or strip integrity Ability to process whole blood samples No requirement for micropipette (sample transfer tubes) for application of blood for capillary test option Test process time of less than 120 seconds Capability to add user configurable comments Strip technology that is insensitive to Heparin System that has the same strip technology approved for both clinical and home-based testing Ability to correlate INR values of 3.5 or less with main laboratory coagulation instrumentation within +/- 0.5 Ability to correlate INR values of greater than 3.5 with main laboratory coagulation instrumentation within +/- 20% Measurement range should span range of INR values 0.8 8.0 Hardware Features The instrumentation shall have the following: Rechargeable batteries Meter weight of less than 16 ounces Method Performance/Validation Requirements Method performance/comparison shall be at the expense of the Contractor, shall include linearity material and reagents, and be consistent with current CLSI guidelines and related documents, The Joint Commission (TJC) standards and Federal regulations. 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 provide technical support specialist to assist with studies and to 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, and meet current standards defined by CLSI. Vendor should provide correlation studies between POC device and main laboratory analyzers to show correlation results. 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. 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. Intra-VISN facility variations should be kept at an absolute minimum. Sensitivity. Sensitivity may be validated concurrently with correlation studies. Mathematical calculations to determine efficiency, sensitivity, false positive rate, and false negative rate are applied. Specificity Studies. A review of product literature and assay inserts to determine any adverse effects for increased bilirubin, hemolysis, lipemia, or other interfering substances. Testing will not be implemented at the individual facilities for the selected system if the validation fails statistical studies. 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 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 The equipment models being offered shall be in current production as of the date this offer is submitted. 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 perform, to the satisfaction of the Government, all validation studies including precision, method comparison with current analyzer, accuracy (recovery), 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. Upon Installation: The Contractor shall provide an instrument training program for at least two operators per facility at no charge to the Government that is coordinated with and timely with the equipment installation, sufficient to the size and scope of the facility s services. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. Service Requirements 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: A technical assistance center shall be available by telephone 24 hours per day, 7 days per week with maximum call back response time of 1 hour. The contractor shall provide the necessary information to replace an inoperable device. This replacement shall include meters, charging bases, and rechargeable batteries at no additional cost. A minimum acceptable service shall also include replacement delivery of items to be replaced with overnight service, but no longer than one (1) business day from the time of service ticket confirmation. Upgrades - The Contractor shall provide upgrades to the equipment hardware, bidirectional interface, and software to maintain the integrity of the system and the state-of the art technology, at no additional charge to the Government (for sites that are interested). 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., universal interface equipment. 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, etc. Interface Requirements The contractor shall be responsible for providing middleware connectivity for the meters using RALS. Cost for middleware must be included in reagents price. The Contractor shall be responsible for providing all hardware required for the connection, implementation, and operation of the interface to the universal interface being utilized at VISN 15 VA Medical Centers. The Contractor shall provide all necessary software support for ensuring 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. Information necessary to make the determination for type and amount of interfacing equipment is supplied in Attachment B. 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. Contractor shall provide copies of current ISA/MOU and BAA that are applicable for remote connection to the interface system used to manage to testing system. Cerner Compatibility Statement Vendors providing a bid to this requirement shall provide a Cerner Compatibility Statement (CCS)from the OEM of the equipment. The CCS must include the following: An OEM attestation that the product proposed is Cerner verified. The statement must be dated within 60 days of the quote to ensure it is recent and accurate. A list of VA healthcare organizations that have deployed the device/system with the Cerner EHR. Details related to any data to be transmitted to Cerner. The statement must provide an OEM point of contact for questions or concerns related to Cerner compatibility. The proposal must declare if the device/system does not connect to the network or electronic medical record. Vendor bids that do not include a CCS directly from the OEM will be disqualified. All devices running windows must be Windows 10 OS at the time of award. 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 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 will be used to work with the VAMC and the public and/or private organization (e.g., POTW) to determine whether the waste from each device can legally be disposed of via the sewerage system.