65--FY18 New - LAB Electrophoresis Testing (new 5-yr) - PGH | EDA: 10/01/2017 NP | Current MS: PreSolicitation | Status: Matching FSS nomenclature provided. Sending revised Sole Source document to CO for review. (6/20/2017 dmc). Still

STATEMENT OF WORK (SOW) Serum/Urine Protein and Hemoglobin Electrophoresis as of 4/5/2017 P 2. Contract Title. Serum/Urine Protein and Hemoglobin Electrophoresis - - - - - - 3. 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 HbA, but there are small amounts of HbA2 and HbF. 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 HbS and HbC. Hb Lepore, HbE, HbG-Philadelphia, HbD-Los Angeles, and HbO-Arab may be seen less frequently. Electrophoresis is generally considered the best method for separating and identifying hemoglobinopathies. The protocol for hemoglobin electrophoresis involves step-wise 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 HbA, 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. 4. Scope. This contract includes all of the costs associated with performing 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 of the required hardware to perform the necessary methodologies. This contract is specifically for the use of the Pittsburgh VA Medical Center Immunology section only. 5. 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. The contract will include provisions for both Field and Technical Service. The contract will state 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. 24-hour Technical Support is available Monday through Friday, 8:30 A.M. to 5:30 P.M., EST. 5.1 Task 1 Technical and Field Service 5.1.1 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. 5.1.2 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. Task 2 Kit Configurations To maximize sample processing efficiency it is required that the vendor provide the ability for the ordering institution to obtain gel configurations that accommodate 20, 40, 60, 80, and 100 sample SPE/UPE gels. In addition, it is necessary for the vendor to provide 3, 6, 9, and 15 IFE gels upon request. 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. Item # Description/Part Number* Qty Sensor Cleaning Swabs 1113 6 Contact Paper 1361 2 Rep Prep 3100 4 Tips for IFE-15 Multi-Channel Pipette 3355 3 Tip spacers for PIFE-15 Multi-Channel Pipette 3356 1 Disposable Sample Strips Deep Well 3360 2 SPIFE IFE 9/15 DISPO SAMPLE CUPS, 100PK 3363 6 IFE 3/6 Disposable Sample Strips 3368 2 Disposable Sample Strips Shallow Well 3369 1 SPIFE IFE-9 DISPO CUP TRAY 3378 1 SPIFE URINE IFE-6 ACCESSORY KIT 3390 2 SPIFE URINE IFE-9 ACCESSORY KIT 3391 4 IFE-6 Kit 3401 2 TIPS FOR SPIFE 6 CHANNEL PIPETTOR (10PK OF 72 TIPS) 3402 1 SPIFE IFE-3 KIT (30 TESTS) 3406 1 SPIFE IFE-9 KIT (90 TESTS) 3409 12 SPIFE Alk Hb Kit 3415 5 QuickGel Acid Hb Kit for SPIFE 3419 4 SPE Control Normal 3424 5 SPE Control Abnormal 3425 5 UPE Templates 3427 2 Applicator Blades 3451 3 SPE-20 Kit 3462 23 AA2 Hemo Ctrl 5328 2 AFSC Control 5331 4 NEEDLE MODIFICATION 8R220116 2 ESH Peristaltic Pumphead 8JM37040 2 IFE Control Kit 9400 5 IFE IgD Antiserum 9409 2 IFE IgE Antiserum 9410 2 IFE Free Kappa Light chain Antiserum 9412 1 IFE Free Lambda Light chain Antiserum 9413 1 6. 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. Compliance and quality management performance of the method will be maintained by third party inspections and routine quality testing/review by the College of American Pathologists. 7. Security Requirements In accordance with VA policy, contractors storage, generation, transmission or exchanging of VA sensitive information requires appropriate security controls to be in place. This is an acquisition or purchase of commodities, goods (e.g. equipment or software), and technical/field service support to maintain the analyzers. VA sensitive information is involved in the course of these procedures (see Appendix A). 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. Vendor selected will offer the following kit gel configurations: IFE 3 IFE 6 IFE 9 IFE 15 SPE 20 SPE 40 SPE 60 SPE 80 SPE 100 The vendor chosen for this contract will provide Field Service and resolve all issues within 24 hours, Mon-Fri, as has been standard practice with the current vendor. Sample handling system capable of pipetting and performing dilutions for SPE, IFE, Cholesterol (HDL, LDL, & LPa) Lipo, Alk Phos, and Hi-res testing on 20, 40, 60, 80, and 100 sample agrose gels. Electrophoresis separation system has barcode reading capabilities to assure Positive Patient ID. Electrophoresis separation system is capable of utilizing 10, 20, 40, 60, 80, and 100 sample agrose gels. The flexibility to match gel size with the number of samples to be tested reduces cost. The system has a maximum through-put of 1000 SPE & 150 IFE samples per 8hr shift. 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 permanent file retention of non-modified pattern image. Imaging system provides flexibility to scan any manufacture s plates up to a 20cm x 20cm size. Imaging system provides user defined automated interpretation Imaging system provides data base of 1 million samples. Consideration of a different vendor would require that the laboratory perform both a normal range validation study and a mandated correlation study that involves a significant amount of time. In order to compare abnormal gammopathies it is incumbent upon the new vendor to obtain and run side by side against the current methodology. This data is then required to be statistically analyzed and approved by the pathologists and laboratory administration. Different methodologies also require extensive training to educate our staff on how to run and maintain the equipment at optimal levels. This, once again, requires time for the technologists to learn a new system while continuing to run the current system without delay. This is often quite problematic. Changing methods does require that all of the current procedures be re-written and signed off on prior to implementation of the new methodology. This fact needs to be considered as it also is a demanding time requirement. Our current methodology is function quite well and is performed at a very high level. We have been accredited satisfactorily to perform this current method and have not experienced any peer reviewed issues. The current method was endorsed by the pathologists and they have opted to continue performing the testing according to the current methodology. It is the policy of the Pittsburgh VA Medical Center Immunology/Microbiology laboratory to encourage and actively solicit competitive bids from all vendors competing for similar business. Our Electrophoresis business was only responded to by one company. a. Identification of Possible Follow-on Work. Not Applicable b. Identification of Potential Conflicts of Interest (COI). Not applicable. c. Identification of Non-Disclosure Requirements. This is an acquisition or purchase of commodities, goods (e.g. equipment or software), and technical/field service support to maintain the analyzers. VA sensitive information is involved in the course of these procedures. d. Packaging, Packing and Shipping Instructions. There is no special packaging and shipping instructions required. All items are shipped as per the vendor s specifications to ensure quality of products and goods. e. Inspection and Acceptance Criteria. All received products and goods are examined for quality and acceptability without exception. Acceptable products are signed for by the laboratory. 10. Risk Control No additional risk will be undertaken by the laboratory as compared to any other vendor or method. 11. Place of Performance. The equipment and supplies will be located in room 2NW120 (Immunology laboratory). No contractor travel expenses are included in this contract. 12. Period of Performance This contract will be valid for a 1 year time period. In addition, the contract should contain 4 additional option years. The start date of this contract should reflect 10-01-17 through 9-30-18. 13. 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 (Kevin Frank) and Lead Medical Technologist (Alicia Leo) are the designated individuals able to place orders against this contract.