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The Department of Veterans Affairs Medical Center, Network Contracting Office (NCO) 9, on behalf of Tennessee Valley Healthcare System (TVHS) and Lexington VA Healthcare System, is issuing this source... The Department of Veterans Affairs Medical Center, Network Contracting Office (NCO) 9, on behalf of Tennessee Valley Healthcare System (TVHS) and Lexington VA Healthcare System, is issuing this source sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for a firm-fixed priced indefinite delivery requirement (ID/R) contract to establish a Cost per Reportable Result (CPRR) contract for Automated Glycohemoglobin Instrumentation. The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 334516. THERE IS NO SOLICITATION AT THIS TIME. This request for capability information does not constitute a request for proposals or quotes; submission of any information in response to this market survey is purely voluntary; the government assumes no financial responsibility for any costs incurred. PERIOD OF LOCATIONS: All tests/reagents/instrumentation shall be provided to Nashville, TN, Murfreesboro, TN and Lexington, KY. ESTIMATED PERIOD OF PERFORMANCE: Base plus option four (4) years; April 1, 2020 March 31, 2025. Please provide the following information: 1. Organization name, address, point of contact, email address, Web site address, and telephone number. 2. Business size: small, small disadvantaged, woman-owned, Hub Zone, serviced-disabled veteran-owned small business, veteran-owned small business, large business, etc. 3. Business type under North American Industry Classification System (NAICS) 334516, which contains a size standard of 1,000 Employees, CAGE Code and DUNS Number. 4. Under which NAICS code does your company usually provide the requirements described in items/description list? Please provide rationale for your answer if different from NAICS 334516. 5. Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. IF YOUR ORGANIZATION HAS THE POTENTIAL CAPACITY TO PROVIDE THE FOLLOWING: PRICES AND TERMS: TVHS and Lexington will provide an estimated volume by test but does not guarantee volumes as listed; they are estimates ONLY. TVHS and Lexington pricing will be based on the Cost per reportable result (CPRR). The estimated tests per year for Nashville is 45,000, Murfreesboro 50,000 and Lexington 27,000. DESCRIPTION/ SPECIFICATIONS/ STATEMENT OF WORK: The desired instrumentation shall have the capability of performing and reporting the clinical parameters. The instrument shall 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. 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 dates 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. GENERAL REQUIREMENTS Primary analyzer 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 is required to meet the productivity specifications defined herein. The system must be certified by the National Glycohemoglobin Standardization Program and approved for use as a diagnostic assay for diabetes testing. The system s A1c performance shall be calibrated and traceable to the method used in the Diabetes Control and Complications Trail (DCCT). This data will show evaluation against NGSP reference method targets with an acceptable limit equal to +6% of the accuracy-based target value. This is same information used to evaluate each lab/method by CAP (College of American Pathologists) for the Hemoglobin A1c (GH5) and Hemoglobin A1c Accuracy Calibration Verification/Linearity (LN15) surveys. The analyzer must have a tolerance for wide hemoglobin concentrations (tests unaffected by sedimentation while sample is waiting to be sampled). The analyzer must have minimal interference from hemoglobin variants and must identify common variants. Analyzer must be unaffected by the presence of HbD, HbAS, HbAC, HbF (from 0-25% of total hemoglobin), carbamylated Hb (from 0-2.5% of total hemoglobin) and acetylated Hb (from 0-2.5% of total hemoglobin). Contractor must provide listing of all known interferences. The analyzer must have the ability to detect the presence of major hemoglobinopathies that can affect HPLC or capillary electrophoresis. The system must have a high level of precision specifically the Coefficient of Variation (CV) must be less than 2.5%. Operational Features The instrumentation offered shall have the following: The capacity of performing analysis on tests with complete (100%) separation of the HbA1c peak from hemoglobin variant peaks on the chromatogram. Sufficient capacity and throughput to meet the volume and service demands of a minimum of 60-80 samples at one time with autoload and walk-away capability. 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. The ability to analyze patient specimens up to 96 hours after collection. A bi-directional, bar-coded computer interface compatible with the current VA laboratory information system or any other future laboratory interfaced systems. The fully operational interface (both hardware and software) shall be immediately available for implementation to the VA computerized hospital information system. Equipment should be able to support multiple barcode formats (e.g. Code 39, Code 128) that may be enabled concurrently. Analyzer must be interfaced with Data Innovations. Vendor must provide proof of this interface capability and drivers must exist for Data Innovations. Equipment should accept, at a minimum, 10 characters in the specimen identifier that is alphanumeric. Middleware is included in CPRR and any future updates (software and hardware). Ability to prioritize STAT testing without compromising existing programmed testing. Minimal daily, monthly, and periodic maintenance; no more than one time per day required. Routine maintenance should be required no more than once per day with ability to test 200 samples minimum without added maintenance. The vendor shall take into account that multiple runs of patient samples are performed daily (instead of batching patient samples) due to the demand from the providers for a quicker turnaround time for patient results. Ability to store and retransmit at least 2,000 records in case of interface outage. On board reagent stability sufficient to accommodate high volume use; 500 tests per day. Contractor to provide expiration dates of at least three (3) months for reagents. No requirements for sample pre-treatment. Primary specimen container(s) loaded into a storage area, e.g. tray, rack, wheel, etc. for automated processing; ability to hold 80 samples. Diluting and injecting of the specimen is handled with minimal operator intervention. Ability to accept various types of sample containers. Minimal reagent preparation. Capability to store at least 10,000 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 for the determination of column and detector integrity must be provided. Complete separation of the glycated hemoglobin A1c. 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 patient s name and accession or unique identifier number (UID). An uninterruptible power supply with line conditioner for each instrument provided. An auto sampling system that includes cap piercing closed tube aspiration, auto-loader, and auto-mixing. Primary tube sampling. Specific Equipment Requirements: Controls for primary use (assayed) will be provided. Capability to detect out of range quality control. On-board QC data management system with a minimum storage capacity of monthly QC files and includes Levy-Jennings graphs. Analyzer must have the ability to capture, store and electronically transfer QC data. Capable of directly measuring A1c Hemoglobin by High Performance Liquid Chromatography (HPLC) or capillary electrophoresis. Method Performance/Validation Requirements- Method performance/comparison shall be performed at the expense of the Contractor, which 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. 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. A minimum 5-point linearity analysis that adheres to the Beer-Lambert Law and spans the entire AMR range shall be performed as a minimum. 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. 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 interrupting substances. Carryover Studies. Successful carryover studies shall be completed by the contractor 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). The programs shall be provided to each laboratory at no charge. Reference Range- A reference range must be determined or verified 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 range 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: 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 included on the list of supplies 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), linearity (reportable range), calibration verification, verification of reference interval, carryover, and determination of sensitivity and specificity at no cost to the Government. The Contractor shall perform all statistical analysis as stated in the Method Performance/Validation section above and report data in an organized, clearly comprehensible format. Interface Requirements: The contractor shall provide any and all necessary software support for insuring 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. If a site already has a universal interface box, the Contractor is responsible for everything leading up to the box including any fees 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. 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 Microsoft Word procedure manual in CLSI format or an on-line procedure manual in the instrument software. 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, thimerosal 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), and biochemical oxygen demand. The government will evaluate market information to ascertain potential market capacity to: 1. Provide services consistent in scope and scale with those described in this notice and otherwise anticipated. Secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements. 2. Implement a successful plan that includes: compliance with program schedules; cost containment; meeting and tracking performance. 3. Provide supplies or services under a firm-fixed price indefinite delivery requirements contract. BASED ON THE RESPONSES TO THIS SOURCE SOUGHT NOTICE/MARKET RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FULL AND OPEN COMPETITION. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Submission Instructions: Interested parties who consider themselves qualified to provide these supplies/services are invited to submit a response to this Sources Sought Notice by 9:00 a.m. CST, Friday, January 31, 2020. All responses under this Sources Sought Notice must be emailed to LaShanda.Harrington@va.gov, Subject Line Title: TVHS & Lexington Automated Glycohemoglobin Instrumentation, A1C Testing Supplies & CPRR. SAM: Interested parties shall be register in the System for Award Management (SAM) as prescribed in FAR Clause 52.232-33. The SAM can be obtained by accessing the internet at www.sam.gov or by calling 1-866-606-8220.