Inactive

Statement of Work VISN 15 Point of Care (POC) Urinalysis and Pregnancy Testing Page 2 of 2 AGREEMENT LANGUAGE INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referre... Statement of Work VISN 15 Point of Care (POC) Urinalysis and Pregnancy Testing Page 2 of 2 AGREEMENT LANGUAGE INTENT: It is the intent of the Department of Veterans Affairs, (herein afterwards referred to as VISN 15) to establish an agreement for Point of Care (POC) Urinalysis and Pregnancy Testing. The Government will award an equipment lease agreement to a single contractor for POC Urinalysis and Pregnancy Testing Instrumentation, data management (connection interface), and service. Contractor agrees to the following terms of the agreement exclusively with the VISN 15 facilities listed by in Table 1, and awarded in the final agreement. As requirements change, facilities within VISN 15 may be added or deleted by at no additional cost to the government. Additional instrumentation and services may be added to the award as new technology becomes available on the market. VISN 15 will provide an estimated number of instruments, as reflected in Table 1 for each individual medical center and community-based outpatient clinics (CBOCs). Pricing is based on the number of sites participating in POC urinalysis and pregnancy testing. The Government estimates the number of instruments needed as listed in Table 1 but does not guarantee volumes as listed; they are estimates ONLY. BPA price will include all components (equipment, data manager system, hardware, software and 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). Equipment shall be acquired for each of facilities listed in Table 1. Analyzer(s) must be able to perform the complete panel for urinalysis, as well as pregnancy testing. 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 Pregnancy Testing Human chorionic gonadotropin (hCG) 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 for necessary for required data management. A bi-directional computer interface compatible with the current VA laboratory information system (VISTA). The fully operational interface (both hardware and software) shall be immediately available for interfacing to the VA computerized hospital information system. 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. 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. 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 at each VISN 15 location 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. Training. The Contractor shall provide instrument training program that is coordinated with and timely to the equipment installation and appropriate for the size and scope of the facility s services. This shall include detailed, hand-on training on the operation of the system, data management, maintenance, quality control, limitations of tests, data manipulation, and basic troubleshooting and repair. When training occurs on-site, all operators performing testing will be trained by the contractor. When such training occurs off-site, it will include two operators per analyzer in the first year. Thereafter, the Contractor shall provide off-site 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. There shall be no difference in the detail of training provided on-site and off-site. 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. Upon award of an agreement, the transition period for the awarded agreement to have all equipment and peripherals installed and operational by April 1, 2022. 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 project for the transition of all services under the awarded agreement including installation and training of personnel, transition of all testing materials, reagents, and supplies, etc., performance of all correlations and validations with a start date of April 1, 2022. Failure of the Contractor to conform to the transition period shall be considered as sufficient cause to terminate agreement for cause under the Termination for Cause clause of the agreement. On April 1, 2022 the awarded Contractor shall have full and sole responsibility for services under the awarded agreement. Table 1 FACILITY Number of Instruments Leavenworth VAMC 1 St. Louis VAMC 15 Topeka VAMC 1 Kansas City VAMC 10 Wichita VAMC 6 Poplar Bluff 8

Inactive

The Department of Veterans Affairs, NCO 15 Contracting Office intends to release a commercial solicitation, 36C25522Q0082, to establish an agreement for Point of Care (POC) Urinalysis and Pregnancy Te... The Department of Veterans Affairs, NCO 15 Contracting Office intends to release a commercial solicitation, 36C25522Q0082, to establish an agreement for Point of Care (POC) Urinalysis and Pregnancy Testing. This contract period of performance will be for one (1), 12-month, Base Period and four (4), 12-month, Option Periods. The North American Industry Classification System (NAICS) is 334516 Analytical Laboratory Instrument Manufacturing. The RFQ will close on January 3, 2022 at 10:00AM CST. Quotes will be accepted by email only and must be received by Jennifer.Sotomayor@va.gov with the Subject line of the E-mail, specify the solicitation number, 36C25522Q0081 and title, Point of Care (POC) Urinalysis and Pregnancy Testing . By 10:00 AM on January 3, 2022. In accordance with FAR 52.204-7, System for Award Management (SAM), prospective contractors must be registered in SAM at https://www.sam.gov/portal/SAM/#1#1 . Registration is free and prospective contractors are encouraged to visit the SAM website. United States Government contracts cannot be awarded to any contractor that is not registered in SAM.