6550--Intent to Sole Source VISN Wide Cepheid GeneXpert Test Kits

INTENT TO SOLE SOURCE Department of Veterans Affairs (VA), VISN 04, Altoona VA Medical Center hereby gives notice of the Government s intent to establish a single award fixed price Indefinite Delivery/ Indefinite Quantity (IDIQ) contract for a period of performance of 5 years with Cepheid: 904 Caribbean Dr., Sunnyvale, CA 94089-1189 to acquire Cepheid GeneXpert Test Kits and Supplies. This IDIQ will be used as a simplified method of filling anticipated repetitive needs of laboratory reagents and supplies at the participating duty stations: Altoona VA Medical Center, 2907 Pleasant Valley Boulevard, Altoona, PA 16602-4377, United States. VA Butler Healthcare, 325 New Castle Road, Butler, PA 16001-1138, United States. Coatesville VA Medical Center, 1400 Black Horse Hill Road, Coatesville, PA 19320-2096, United States. Erie VA Medical Center, 135 East 38th Street, Erie, PA 16504-1559, United States. Lebanon VA Medical Center, 1700 South Lincoln Avenue, Lebanon, PA 17042-7529, United States. Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104-4551, United States. VA Pittsburgh Healthcare System, University Drive Campus, University Drive C, Pittsburgh, PA 15240- 1003, United States. VA Pittsburgh Healthcare System, HJ Heinz Campus, 1010 Delafield Road, Pittsburgh, PA 15215-1802, United States. Wilkes-Barre VA Medical Center, 1111 East End Boulevard, Wilkes-Barre, PA 18711-0026, United States. Wilmington VA Medical Center, 1601 Kirkwood Highway, Wilmington, DE 19805-4917, United States. This IDIQ will be established with a single source, Cepheid, because they are the sole manufacturer of the required reagents, kits, and supplies for the GeneXpert Infinity analyzer. Determination of this single source procurement is in accordance with Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1. It is the Government s belief that the proposed candidate is the only provider of the reagents, kits, supplies, and service that are compatible with the GeneXpert Infinity analyzer that can meet the agency s needs. The applicable North American Industry Classification System (NAICS) code is 325413 (In-Vitro Diagnostic Substance Manufacturing) and the Product Service Code (PSC) is 6550 (In Vitro Diagnostic Substances, Reagents, Test Kits and Sets). This notice of intent is not a request for competitive quotes. Telephone requests will not be accepted. However, any business that believes it can provide Cepheid GeneXpert Infinity Molecular Reagents and Supplies may give written notice to contact@example.gov by 2:00PM Eastern Time on September 1, 2023. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to comply with the requirement. Responses will be considered by the Government; however, a determination by the Government not to compete the proposed acquisition based upon responses of this notice is solely within the discretion of the Government. THIS SYNOPSIS DOES NOT COMMIT THE GOVERNMENT TO CONTRACT FOR ANY SUPPLY OR SERVICE. THE GOVERNMENT WILL NOT PAY FOR ANY INFORMATION OR ADMINISTRATIVE COSTS INCURRED IN RESPONSE TO THIS SYNOPSIS. Statement of Work Cost Per Reportable Test Reagent Rental Agreement for Cepheid GeneXpert Instruments, Laboratory Reagents, Controls, and Supplies Purpose Requesting Base period of twelve (12) months plus four (4) additional options of 12 Months (Base Period from September 21, 2023, through September 20, 2024). Cost Per Reportable Test Reagent Rental Agreement for Cepheid GeneXpert Instruments, Laboratory Reagents, Controls and Supplies for C. diff, CT/NG, MTB, MRSA SKIN, CARBA-R, MRSA, STREP A, NOROVIRUS, FLU A, FLU B, RSV, SARS-COV-2, and MVP testing. Current contract number is 36C24421D0130, which is only for reagents. Would like to combine contract to reflect these additional test and instruments. 2. Scope Below is a list of items that the vendor will provide as an agreement in the cost per reportable test reagent rental agreement for Cepheid GeneXpert instruments, Laboratory Reagents, Controls, and Supplies. Vendor will remove current GeneXpert analyzers and replace it with new GeneXpert analyzers which are to be used in VISN 4 facilities. Vendor will provide maintenance for new instruments at the defined recommendations of the manufacturer and provide technical support 24/7. Vendor will provide all necessary Cepheid GeneXpert Laboratory Test Kits and supplies as needed to perform C. diff, CT/NG, MTB, MRSA SKIN, CARBA-R, MRSA, STREP A, NOROVIRUS, FLU A, FLU B, RSV, SARS-COV-2, and MVP testing. Should during the rental of this instrument, another version is released, Pathology and Laboratory Medicine Service in VISN 4 has the right to change to the most recent and updated version should they desire to do so. Vendor will also sponsor and provide training courses for instrumentation. Vendor will provide a warranty on the instrument that will start once instruments are installed and additional warranty service if needed. Vendor will provide initial setup that includes verification/validation of the instrument and any additional technical service during the initial phase of the rental. Testing is cleared by the FDA for in-vitro diagnostic use and is CLIA Moderately Complex Testing. Technical assistance and information will be offered on how to best meet the IQCP process. 3. Location These supplies will be used on the Cepheid GeneXpert Analyzers for the following locations in VISN 4: Duty Station 1: Altoona VA Medical Center, 2907 Pleasant Valley Boulevard, Altoona, PA 16602- 4377, United States. Duty Station 2: VA Butler Healthcare, 325 New Castle Road, Butler, PA 16001-1138, United States. Duty Station 3: Coatesville VA Medical Center, 1400 Black Horse Hill Road, Coatesville, PA 19320- 2096, United States. Duty Station 4: Erie VA Medical Center, 135 East 38th Street, Erie, PA 16504-1559, United States. Duty Station 5: Lebanon VA Medical Center, 1700 South Lincoln Avenue, Lebanon, PA 17042-7529, United States. Duty Station 6: Philadelphia VA Medical Center, 3900 Woodland Avenue, Philadelphia, PA 19104- 4551, United States. Duty Station 7A: VA Pittsburgh Healthcare System, University Drive Campus, University Drive C, Pittsburgh, PA 15240-1003, United States. Duty Station 7B: VA Pittsburgh Healthcare System, HJ Heinz Campus, 1010 Delafield Road, Pittsburgh, PA 15215-1802, United States. Duty Station 8: Wilkes-Barre VA Medical Center, 1111 East End Boulevard, Wilkes-Barre, PA 18711-0026, United States. Duty Station 9: Wilmington VA Medical Center, 1601 Kirkwood Highway, Wilmington, DE 19805- 4917, United States. 4. Performance Requirements: Maintenance: The Vendor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Maintenance includes the following: 4.1.1 Inventory and recording of systems components. 4.1.2 Monthly deliverables shall be received in full. 4.1.3 Test all components for proper test performance. Equipment shall reproduce results according to manufacturer s specifications. 4.1.4 After Preventative Maintenance (PM), the vendor shall submit a detailed work report to the COR for notice at no additional cost to the government. 4.1.5 Delivery of PM parts or material. The vendor shall provide all preventive service materials at no additional cost the government. 4.2. On-call Repairs: On-call repairs are emergency repairs beyond the scheduled maintenance. 4.2.1 The vendor shall provide technical assistance not limited to test performance, or equipment malfunction twenty-four (24) hours a day, seven (7) days a week, including all Federal and religious holidays, via direct communication thru a telephone bank with technically capacitated and certified personnel by the vendor. 4.2.2. The vendor shall respond to a call for on-site repair and be at the job site within two (2) hours during regular working hours, Monday Friday, 0800 16:00 hours. In very urgent cases, an immediate repair can be requested after 1600 hours and on Saturdays, Sundays, and Federal holidays. After repair, the vendor shall submit a detailed work report to include all required materials and is to be at no-charge to the facility. 4.2.3. If the problem cannot be resolved over the phone the vendor will have a service technician dispatched immediately to resolve the problem. Vendor will agree that if the instrument is a rental agreement and should there be ongoing and/or adverse operating issues with the instrument within the year of purchase, the vendor will work to resolves these problems. If the problems cannot be resolved, vendor agrees to either replace the instrument if customer agrees or void the rental agreement. 4.2.2.2 If the malfunction is reported to the vendor not later than 1600 hours, the failure elimination shall be started immediately on the same day. 4.3. For delivery of repairs parts or materials the vendor shall provide all parts and materials at no additional cost the government. 4.3.1 Vendor shall remove all parts, equipment or materials replaced, or upgraded by the vendor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the Government. 4.4 Safety 4.4.1 Vendor shall immediately notify the service of any changes in reagents kits composition, procedure modification, recall notification or any changes that will affect the performance of the test or procedure according to FDA regulations. 4.5 Test Performance 4.5.1 All test and procedures must comply and be approved by the FDA. 4.5.2. All test, procedures, and equipment must perform at manufacturer specifications, deviations from the performance specifications shall be corrected by the vendor. 4.5.3. All test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation according to CLIA 5. Deliverables/Supplies This order is for the cost per test procurement of the GeneXpert instruments under the terms of the reagent rental agreement. (List of test and supplies are listed below in Table 1) 5.1 The vendor shall provide on-site training for new personnel (as required) for testing and procedures of aforementioned, offeror shall conduct instructional course(s) to meet the objectives identified in paragraph 4. In addition, the vendor shall provide handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The vendor shall provide lesson plan, course materials and media (DVD s, CD s, videos, etc. if required) for each procedure at no additional cost. 5.2 The vendor shall deliver all equipment and UPS necessary for test performance at no Government cost. 5.2.1 The vendor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications and test manuals. 5.3 The vendor shall install the equipment and perform test verification according to manufacturer specification, CLIA, FDA and CAP requirements. 5.4 In the event that requested supplies are on back-order, vendor is to inform COR as to the estimated time of availability. 5.4.1 The items on this contract are not on a delivery schedule. Th customer will call vendor with order request for items needed. 5.5 The vendor shall deliver all invoices for review according to the established contract at the end of each billing cycle. 5.5.1 All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost. 5.6 Remedies: 5.6.1 Any changes in reagents or equipment modifications shall be immediately disclosed by the vendor electronically as well as by postal mail with supporting documentation of the change and, detailed guidance against implementation within twenty-four hours of its application or according to FDA guidelines. 5.6.2 Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to outsourcing, transportation and or any other additional cost shall be covered by the vendor at no additional charge to the government. TABLE 1 TABLE OF DELIEVERABLE/CONSUMABLES REGULAR FLOCKEDSWAB W/UTM W/OBEADS 50 PCS ESWAB,LIQUID AMIES, FLOCKED, COPAN,480CFA CEPHEID COLLECTION DEVICE (50) KIT,BCR-ABL UYLTRA,US-IVD,10-TEST KIT,CARBA-R,IVD,GX KIT,CDIFF/EPI,GX,IVD,10-TEST KIT,CDIFF/EPI,GX,IVD,120-TEST KIT,CDIFF,10-TESTS,GX,IVD KIT,C.DIFFICILE,GX,120 TEST,IVD KIT,CT/NG,GX,IVD XPERT CT/NG-120 US-IVD KIT,GX,10-TEST,EBOLA,EUA KIT,EV,10-TESTS,GX,IVD KIT,FII/FV,10-TESTS,GX,IVD KIT,GBS 10-TESTS,GX,IVD KIT,GBS LB,10-TESTS,GX,IVD XPERT GBS LIM BROTH 120 TEST KIT KIT,10-TEST,GBS,LB,XC,US-IVD KIT,MPOX,10 TEST KIT,MRSA,10-TESTS,GX,IVD GENEXPERT MRSA 120 TEST KIT IVD KIT,10-TEST,MRSA NXG,IVD,GX KIT,120-TEST,MRSA NXG,IVD,GX KIT,MRSA/SA BC,10-TESTS,GX,IVD KIT,MRSA/SA SSTI,10-TESTS,GX,IVD KIT,MTB,IVD,US KIT,GX,10-TEST,NOROVIRUS,US-IVD KIT,SA COMP,10-TESTS,GX,IVD KIT,SACOMP,GX,IVD,120-TEST KIT,XPERT TV_US,10-TEST KIT,VANA,10-TESTS,GX,US-IVD BUNDLE,OEM CONTROL REAGENTS,MRSA BUNDLE,OEM CONTROL REAGENTS,MRSA/SA KIT,BCR-ABL ULTRA P 190,10-TESTS,GX,RUO KIT,NPM1 MUTATION,CRUO,GX,10-TEST SINGLE-USE DISPOSABLE SWAB - 120-COUNT A CASE OF CEPHEID COLLECTION DEVICE (500) Nasal swab collection kit for Xpert Flu, xpert FLU/RSV, Xpert Xpress FLU/RSV Ebola Collection NASAL SWAB AND TRANSPORT MEDIUM, 100/KIT COLLECTION KIT, XPERT SWAB, US CE IVD, 50 COLLECTION KIT, XPERT SWAB, US IVD, 50 Collection Kit A urine KIT,XPRESS,COV-2/FLU/RSV PLUS,10 TEST KIT,XPRESS,SARS-COV-2 PLUS,10 TEST KIT,XPRESS,FLU,US-IVD,10 TEST KIT,XPRESS,FLU/RSV,US-IVD,10 TEST KIT,XPRESS,MVP,US-IVD,10 TEST KIT,XPRESS,STREPA,US-IVD,10 TEST KIT,XPRESS,STREPA,US-IVD,120 TEST MINITIP FLOCKEDSWAB W/UTM W/OBEADS 50PCS