SOURCES SOUGHT
66 -- Point of Care (POC) Urinalysis Testing System 657-23-3-2702-0221
- Notice Date
- 6/16/2023 12:16:18 PM
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- 255-NETWORK CONTRACT OFFICE 15 (36C255) LEAVENWORTH KS 66048 USA
- ZIP Code
- 66048
- Solicitation Number
- 36C25523Q0562
- Response Due
- 6/23/2023 10:00:00 AM
- Archive Date
- 08/22/2023
- Point of Contact
- Albert(Al) Cheeks, Contract Specialist, Phone: (913) 946-1991
- E-Mail Address
-
albert.cheeksJr@va.gov
(albert.cheeksJr@va.gov)
- Awardee
- null
- Description
- THIS REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT DISCLAIMER This RFI 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. 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 RFI. The submission of pricing, capabilities for planning purposes, and other market information is highly encouraged and allowed under this RFI In Accordance With (IAW) FAR Part 15.201(e). SOURCES SOUGHT DESCRIPTION This is NOT a solicitation announcement. This is a RFI/sources sought only. The purpose of this sources sought/RFI is to gain knowledge of potential qualified sources and their size classification relative to NAICS 334516. Responses to this sources sought will be used by the Government to make appropriate acquisition decisions. After review of the responses to this sources sought, a solicitation announcement may be published. Responses to this sources sought synopsis are not considered adequate responses for a solicitation announcement. The Department of Veterans Affairs (VA), VISN 15 Network Contracting Office, is seeking sources that can provide the following: AGREEMENT LANGUAGE INTENT: It is the intent of the Marion VAMC to establish an agreement for Point of Care (POC) Urinalysis Testing. The Government will award an equipment purchase agreement to a single contractor for POC Urinalysis Testing Instrumentation, data management (connection interface), and service. Contractor agrees to the following terms of the agreement exclusively with Marion VAMC and awarded in the final agreement. As requirements change, instruments may be added or deleted by supplemental agreement of the Government and the Contractor. Additional instrumentation and services may be added to the award as new technology becomes available on the market. Marion VAMC will provide an estimated number of instruments. Price will include all components (equipment, data manager system, hardware, software and warranty service) with exception of reagents, necessary to allow for release of a test result into the VISTA computer system. 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 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). Analyzer(s) must be able to perform the complete panel for urinalysis. GENERAL REQUIREMENTS: Test Menu Each participating location will have varied assay requirements. Equipment offered shall provide all reportable assays listed in 2.3.1.2. Equipment offered must, at minimum, be able to report the following measured assays: Urinalysis Testing Menu Creatinine Protein P:C Ratio Ketone Specific Gravity Glucose Blood pH Nitrite Leukocytes Bilirubin Urobilinogen Urea Nitrogen Control Tests Positives Negatives Primary Analyzer(s): Base equipment offered shall fully support the scope of operations. FDA Approval: The instrumentation must be approved by the Food and Drug Administration (FDA) as a waived complex analyzer. Hardware & Software: The instrumentation shall have the following: A benchtop or portable analyzer with a total equipment footprint that when installed 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 patient s name, accession number or unique identifier number (UID), date and time of test. Vendor shall include all hardware, and software necessary for required data management. Vendor must be able to interface results through current Data Innovations or RALS Instrument Manager. All equipment and software required for the interface must be provided. VA Directive 6550 Appendix A- Pre-Procurement Assessment. All devices running windows must be Windows 10 OS at the time of award. Technical Features: Capability of performing 100% of the tests defined in 2.3.1.2.1. Operator management capabilities to track users, including user competency management. Barcode data entry capabilities to limit transcription errors and ensure correct patient and data capture. Quality control management features including QC schedule tracking and lock out features for testing. Barcode scanner for entry of patient, operator ID, reagent and QC information. Equipment must be able to support multiple barcode formats (Code 39, Code 128) that may be enabled concurrently. Expired operator, and failed quality control instrument lock out. Ability to store, retrieve and retransmit test records in case of interface outage. On board reagent inventory system. Reagents capable of room temperature storage are preferred. Expiration date must be clearly marked on reagent, standards, and control containers. Quality Control Positive and negative controls shall be available from manufacturer. Quality Control data management system is preferable. Analyzer must have the ability to capture, store and electronically transfer QC data to software or middleware for management. Analyzer must have the ability to schedule and perform internal or electronic automatic Quality Controls. Preferably, quality controls should be processed using the same pathway as patient s samples. Maintenance Maintenance requirements should be minimal with limited hands-on maintenance. Analyzer should have minimum maintenance downtime. If analyzer is portable, the vendor must supply documentation that movement of the analyzer on a regular basis will not require that the analyzer be re-validated with each move. 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, College of American Pathologists (CAP) 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 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. 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. 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 omitted, 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. 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 required to establish instruments for operation for performance of acceptance testing. The Contractor shall perform, to the satisfaction of the Government, all validation studies as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format at no cost to the Government. Equipment Preventative Maintenance/Repair Service. The Contractor shall be able to provide emergency equipment repair and preventative maintenance on all instrumentation. Service Requirements A technical assistance center shall be available by phone. Nonfunctioning units must be exchanged or repaired and returned to end the user. Equipment repair response time shall be no more than 24 hours. Preventative maintenance will be performed as frequently as published in 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 serial number, type, and model number of equipment proof of repair that includes documentation of a sample run of quality control verifying acceptable performance. 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 agreement; however, it does refer to significant changes in the hardware operational capability. Implementation/transition timeframe - The implementation of the services/requirements described in this solicitation shall be completed no later than 90 days after the award of the agreement. This timeline is based on a reasonable attempt of the contractor to complete all the necessary implementation requirements within the stated timeframe. Contractor shall not be penalized for implementation timelines that extend beyond the 90-day timeframe if the extension is through no fault of the contractor and is a result of delays due to the government. MUST BE AN AUTHORIZED DEALER and PROVIDE LETTER from MFR. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the brand name. If you are interested, and are capable of providing the sought out supplies/services, please provide the requested information as well as the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Does your company have an FSS contract with GSA, VA NAC, NASA SEWP, or any other federal contract, that can be utilized to procure the requirement listed above? If so, please provide the contract number. Please submit your capabilities that show clear, compelling, and convincing evidence that you can meet the requirement described in the attached SOW. Please provide your Unique Entity Identifier (UEI). Responses to this notice shall be submitted via email to Al Cheeks, Albert.CheeksJr@va.gov with email subject line containing, 36C25523Q0529, Point of Care Urinalysis Testing . Telephone responses shall not be accepted. Responses must be received no later than Friday, June 23, 2023 at 1200 CST. If a solicitation is issued it shall be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this sources sought. Responses to this sources sought notice are not a request to be added to a prospective bidders list or to receive a copy of the solicitation
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/0236efc3059c4bb18af3c36b884f0022/view)
- Place of Performance
- Address: Marion VA Medical Center 2401 West Main Street, Marion, IL 62959, USA
- Zip Code: 62959
- Country: USA
- Zip Code: 62959
- Record
- SN06719359-F 20230618/230616230111 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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