Q301--Lab Supplies - Reagents

THIS IS NOT A SOLICITATION. This is a Sources Sought Notice only and is issued to conduct market research and gain knowledge of current market capabilities. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. This notice is issued solely for information and planning purposes and does not constitute a solicitation or a guarantee to issue a solicitation in the future. This notice does not commit the Government to contract for any supply or service. All information submitted in response to this announcement is voluntary; the Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the Government. Not responding to this notice does not preclude participation in any future solicitation, if issued. This announcement is based on the best information available at this time and is subject to future amendment. The Department of Veterans Affairs, Network Contracting Office 4, is conducting a market survey to identify potential sources to perform a five-year firm fixed price contract for Serum/Urine Protein and Hemoglobin Electrophoresis, for Veterans Integrated Service Network 04 (VISN 04), as follows: STATEMENT OF WORK 1. Background. Hemoglobins (Hb) are a group of proteins whose chief functions are to transport oxygen from the lungs to the tissues and carbon dioxide in the reverse direction. They are composed of polypeptide chains called globin, and iron protoporphyrin heme groups. A specific sequence of amino acids constitutes each of four polypeptide chains. Each normal hemoglobin molecule contains one pair of alpha and one pair of non-alpha chains. The non-alpha chains of fetal hemoglobin are called gamma. A minor (3%) hemoglobin fraction called HbA2 contains alpha and delta chains. Two other chains are formed in the embryo. The major hemoglobin in the erythrocytes of the normal adult is Hb A, but there are small amounts of HbA2 and Hb F. In addition, over 400 mutant hemoglobins are now known, some of which may cause serious clinical effects, especially in the homozygous state or in combination with another abnormal hemoglobin. Wintrobe1 divides the abnormalities of hemoglobin synthesis into three groups. (1) Production of an abnormal protein molecule (e.g., sickle cell anemia) (2) Reduction in the amount of normal protein synthesis (e.g., thalassemia) (3) Developmental anomalies (e.g., hereditary persistence of fetal hemoglobin (HPFH) The two mutant hemoglobins most commonly seen in the United States are Hb S and Hb C. Hb Lepore, Hb E, Hb G-Philadelphia, Hb D-Los Angeles, and Hb O-Arab may be seen less frequently. Electrophoresis is generally considered the best method for separating and identifying hemoglobinopathies. The protocol for hemoglobin electrophoresis involves stepwise use of two systems. Initial electrophoresis is performed in alkaline buffers. Cellulose acetate was the major support medium used because it yields rapid separation of Hb A, F, S, and C and many other mutants with minimal preparation time. However, because of the electrophoretic similarity of many structurally different hemoglobins, the evaluation must be supplemented by citrate agar electrophoresis which measures a property other than electrical charge. 2. Scope. This contract includes all the costs associated with performing fully automated serum, urine, and hemoglobin electrophoresis. In addition, the contract includes pricing for performing immunofixations to identify monoclonal and polyclonal gammopathies. For the use of purchased reagents and disposables the contract provides all the required hardware to perform the necessary methodologies. It is the intent of the VA Pittsburgh to establish a reagent rental style contract such as the cost of loaning the instrument is incorporated in the cost of reagents. The VA will not own the equipment and at the end of the contract the equipment will be removed by the vendor. This contract is specifically for the use of the Pittsburgh VA Medical Center Immunology section only. 3. Specific Tasks. This contract is required to provide pricing for all necessary consumables required to perform serum, urine, and hemoglobin electrophoresis, including quality control materials. In addition, the contract will include pricing for required immunofixations to identify monoclonal and polyclonal gammopathies. These items will be permitted to be ordered as needed by the Pittsburgh VA. 3.1 Task 1 Technical and Field Service 3.1.1 Subtask 1 Technical Service. Provide technical and functional courses of action to remedy minor trouble shooting that can be accomplished by the technologist within 30 minutes. 24-hour Technical Support is available Monday through Friday, 8:30 A.M. to 5:30 P.M., EST. 3.1.2 Subtask 2 Field Service. Included in this Task is the requirement that Field service will be performed Mon-Fri and that all issues will be resolved within a 24-hour time frame from the time service is required. Technical Support is available Monday through Friday, 8:30 A.M. to 5:30 P.M., EST. 4. Deliverables The following routine consumables are ordered as needed. However, there may be additional items that are not routine that may be required to be replaced. These will be ordered as needed and costs will go towards the assigned PO#. Some of the items not listed permit different numbers of samples to be performed at one time. Those items may be added as needed to permit increased efficiency of sample processing. The following table is an estimated list of needed supplies and quantities. Item # Description/Part Number* Qty Sensor Cleaning Swabs 6 Contact Paper 2 Rep Prep 4 Tips for IFE-15 Multi-Channel Pipette 3 Tip spacers for PIFE-15 Multi-Channel Pipette 1 Disposable Sample Strips Deep Well 2 SPIFE IFE 9/15 DISPO SAMPLE CUPS, 100PK 6 IFE 3/6 Disposable Sample Strips 2 Disposable Sample Strips Shallow Well 1 SPIFE IFE-9 DISPO CUP TRAY 1 SPIFE URINE IFE-6 ACCESSORY KIT 2 SPIFE URINE IFE-9 ACCESSORY KIT 4 IFE-6 Kit 2 TIPS FOR SPIFE 6 CHANNEL PIPETTOR (10PK OF 72 TIPS) 1 SPIFE IFE-3 KIT (30 TESTS) 1 SPIFE IFE-9 KIT (90 TESTS) 12 SPIFE Alk Hb Kit 5 QuickGel Acid Hb Kit for SPIFE 4 SPE Control Normal 5 SPE Control Abnormal 5 UPE Templates 2 Applicator Blades 3 SPE-20 Kit 23 AA2 Hemo Ctrl 2 AFSC Control 4 NEEDLE MODIFICATION 2 ESH Peristaltic Pumphead 2 IFE Control Kit 5 IFE IgD Antiserum 2 IFE IgE Antiserum 2 IFE Free Kappa Light chain Antiserum 1 IFE Free Lambda Light Chain Antiserum 1 5. Performance Monitoring It will be the responsibility of the Pittsburgh VA Medical center Immunology/Microbiology Supervisor/designee to monitor all performance issues with the vendor. Timely delivery of supplies, prompt, and professional technical service, and 24-hour field service, Mon-Fri, will be evaluated and compared to the terms of the contract. 7. Security Requirements In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information is not involved with this procurement. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). No GFE or GFI will be needed in any capacity. 9. Other Pertinent Information or Special Considerations. Sample handling system capable of pipetting and performing dilutions. Electrophoresis separation system has barcode reading capabilities to assure Positive Patient ID. The flexibility to match gel size with the number of samples to be tested reduces cost. Multi-channel anti-sera application system. Pre-cast IFE control wells. Imaging system has permanent file retention of both raw and edited sample scan data. Imaging system provides user defined reports allowing SPE and IFE scan presentation on single report. Imaging system provides user defined automated interpretation The vendor will install the analyzer The vendor will assist with validation of the analyzer The vendor will provide training for at least 2 staff members There will be no additional shipping fees. The cost of shipping will be incorporated in the cost of reagents. Any software updates will be provided free of charge. The system must be fully automated The instrument must be able to be interfaced with middle ware Instrument Manager and laboratory information system If applicable, the operating system of the analyzer must be Windows 10 or above 10. Period of Performance This contract will be valid for a base year plus four additional option years. The base year of this contract should reflect 2-11-2023 through 2-10-2024. 11. Delivery Schedule. All required items will be ordered as needed directly by the lab and delivered within one (1) week. All vendor shipped items will be delivered in a vendor determined format. All items will be delivered to the receiving dock at: VA Pittsburgh Healthcare System University Drive Pittsburgh, PA 15240 The Immunopathology Supervisor and QA Medical Technologist are the designated individuals able to place orders against this contract. 12. Other Symplr The vendor will be required to register on the Symplr website https://www.symplr.com/. Symplr will be used to monitor vendor compliance with vaccination and HIPPA requirements listed below. Influenza Vaccination VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical, and administrative, paid, and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities follows VHA Directive 1192. Tuberculosis Prevention Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer. Tests shall be current within the past year. TUBERCULOSIS TESTING: Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel. A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results. The PPD test shall be repeated annually. RUBELLA TESTING: Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella, or a rubella titer of 1.8 or greater. If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR. COVID 19 Contractor shall provide evidence of vaccination records or a negative COVID testing result within 72 hours of planned onsite visitation. This is to include installation, training, maintenance, and repairs. Emergency repairs will be evaluated on a case-by-case situation. HIPAA Training Certificates If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract.