SPECIAL NOTICE
66 -- VISN19 Cepheid Reagents, Test Kits and Supplies
- Notice Date
- 10/7/2020 7:30:00 AM
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- NETWORK CONTRACT OFFICE 19 (36C259) Greenwood Village CO 80111 USA
- ZIP Code
- 80111
- Solicitation Number
- 36C25920Q0632
- Archive Date
- 11/06/2020
- Point of Contact
- Shawna Baumert, Contract Specialist, Phone: 303-712-5732
- E-Mail Address
-
Shawna.Baumert@va.gov
(Shawna.Baumert@va.gov)
- Awardee
- null
- Description
- VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020 Page 1 of 6 LIMITED SOURCES JUSTIFICATION ORDER >SAT FAR PART 8.405-6 Acquisition Plan Action ID: 36C259-20-AP-2229 JOFOC Tracking Number: 2020-08-24T08:05:33 1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 19, 6162 South Willow Drive, Suite 300, Greenwood Village, CO 80111 Organizational Activities: PURCHASE REQUEST (2237): Rocky Mountain Regional VA Medical Center, 1700 N Wheeling St, TBD Funding memo Aurora, CO 80045 VA Sheridan Health Care System, 1898 Fort Road, TBD Funding memo Sheridan, WY 82801 VA Cheyenne Health Care System, 2360 E Pershing Blvd., TBD Funding memo Cheyenne, WY 82001 VA Western Colorado Health Care System, 2121 North Ave, TBD Funding memo Grand Junction, CO 81501 VA Eastern Oklahoma Health Care System, 1011 Honor, TBD Funding memo Heights Dr., Muskogee, OK 74401 Oklahoma City VA Health Care System, 921 NE 13th St, TBD Funding memo Oklahoma City, OK 73104 VA Salt Lake City Health Care System, 500 Foothill Blvd, TBD Funding memo Salt Lake City, UT 84148 (2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The Department of Veterans Affairs requires specialized reagents, test kits and supplies for infectious disease testing to be used on the Cepheid GeneXpert Molecular analyzers that are owned by the above listed seven (7) VISN 19 stations. This will be a sole source, single award BPA. This award will be a firm fixed-price BPA funded by yearly task order by each VA facility. The period of performance will be October 1, 2020 through September 30, 2021, followed by four (4) option years. Order against: FSS Contract Number: GS-07F-0597T (POP: 9/15/2007 through 9/14/22) Name of Proposed Contractor: Cepheid Street Address: 904 Caribbean Drive City, State, Zip: Sunnyvale, CA 94089 Phone: 1-888-838-3222 Description of Supplies or Services: The estimated value of the proposed action is $12,600,000 for 5 years. The estimated value of the base year is $2,510,500.00 The procurement will provide specialized Cepheid infectious disease reagents, test kits and supplies to the Pathology and Laboratory Medicine Services. These products are critical to the support of VA patient care. They support the mission of the VA to provide timely, accurate and appropriate infectious disease results in support of patient care. These products are only available from Cepheid as they are proprietary. The reagents, test kits and supplies to be covered under this BPA will support the following Cepheid GeneXpert Molecular analyzer-based tests: MRSA Xpert MRSA NxG MRSA/SA Xpert Xpress Flu Xpert CT/NG Norovirus Factor II & IV Xpert Check-us-5 SDPS-120 Swabs Xpert MTB/RIF Xpert BCR-ABL Ultra GX Strep A Xpert C. difficile/Epi Flu/RSV The requirement will result in the award of an FSS-BPA with a one-year base period, followed by four (4) one-year options. Base Year October 1, 2020 September 30, 2021 Option Year 1 - October 1, 2021 September 30, 2022 Option Year 2 - October 1, 2022 September 30, 2023 Option Year 3 - October 1, 2023 September 30, 2024 Option Year 4 - October 1, 2024 September 30, 2025 Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service.) FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays: FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; The reagents, test kits and supplies are proprietary to Cepheid in their manufacture, methodology and use. They can only be used in conjunction with Cepheid GeneXpert Molecular analyzers, which are already owned by all the of participating VA stations. Cepheid representative, Elmer Ma, Government Contracts Specialist, verified that Cepheid reagents, test kits and supplies are proprietary to Cepheid based on letter dated August 18, 2020. FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures. FAR 8.405-6(b): Items peculiar to one manufacturer: A patent, copyright or proprietary data limits competition. The proprietary data is: These are direct replacements parts/components for existing equipment. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: This requirement is for Cepheid reagents, test kits and supplies that are necessary for patient care. They are also proprietary to Cepheid. There are currently no alternatives to using Cepheid reagents, test kits and supplies because Cepheid is the only company who can provide the items required. In addition, seven (7) VISN 19 stations already own the Cepheid GeneXpert Molecular analyzer that utilizes the reagents, test kits and supplies provided by this requirement. Reagents, test kits and supplies from any other vendor cannot be used on the Cepheid GeneXpert Molecular analyzer and would require tremendous additional costs (approximately over $1,500,000.00 to replace all seven analyzers)/time to purchase, install and validate new analyzers. Some stations require six months for validation alone. If we were to use a different vendor an LSJ would also be needed because all of the reagents, test kits and supplies are proprietary to each prospective vendor. The current equipment will still be in good working order during this five (5) year BPA. The best value to the Government is to award to Cepheid under a limited source justification. They are the only ones that can be used on the Government owned Cepheid GeneXpert Molecular analyzers. There are no other supplies currently on the market that will fulfill this requirement. The pricing for all required Cepheid reagents, test kits and supplies are listed in the contractor s FSS schedule and has previously been determined by GSA to be Fair and Reasonable. Additional discounts based on volume will be requested. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: A Sources Sought notice 36C25920Q0421 was posted to Contracting Opportunities on 06/03/20 and closed on 06/17/20. No responses were received. In addition, a search in VetBiz was conducted using NAICS code 325413, the states of Wyoming, Colorado, Utah, and Oklahoma along with the key words GeneXpert Modules . It yielded zero (0) SDVOSB/VOSB vendors. CS called and emailed Cepheid representative. Cepheid representative, Elmer Ma, Government Contracts Specialist, verified that Cepheid reagents, test kits and supplies are proprietary to Cepheid based on letter dated August 18, 2020. Any Other Facts Supporting the Justification: Cepheid has provided a letter explaining the proprietary nature of the required tests. There are no other authorized vendors for these tests at this time. The specific reagents, test kits and supplies with regard to these analyzers are offered only through Cepheid. A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: All future requirements for infectious disease testing reagents, test kits and supplies will be competed to the greatest extent practicable, including the consideration of the Veterans First program as well as all other possible small business set-asides. The market will be evaluated to determine if the Government owned Cepheid GeneXpert Molecular analyzers are still the best analyzers to meet the requirement as well as if the reagents, test kits and supplies are still proprietary to Cepheid. Tania A. Urenda 301366 Digitally signed by Tania A. Urenda 301366 Date: 2020.09.01 06:55:04 -06'00' Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. SIGNATURE DATE Tania Urenda Medical Technologist Path / Lab Rocky Mountain Regional VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. RONNIE R JONES 209802 Digitally signed by RONNIE R JONES 209802 Date: 2020.09.01 07:18:35 -06'00' _ CONTRACTING OFFICER SIGNATURE DATE Ronnie Jones Branch Chief, Services 2 NCO 19 One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition. DANNY O. FREEMAN 170000 Digitally signed by DANNY O. FREEMAN 170000 Date: 2020.09.03 16:48:27 -06'00_' 09/03/2020 SIGNATURE DATE Danny O. Freeman Director of Contracting, NCO 19 HIGHER LEVEL APPROVAL (Required for orders over $700,000): VHA RPO HCA Review and Approval (over $700,000 to $68 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. Jordan, Curtis M. Digitally signed by Jordan, Curtis (RPO) M. (RPO) Date: 2020.09.09 14:48:17 -06'00' Curtis M. Jordan DATE Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)
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