SOLICITATION NOTICE
65 -- Progel Pleural Air Leak Sealant Kit - EMERGENCY
- Notice Date
- 9/13/2012
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 423450
— Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers
- Contracting Office
- Department of Veterans Affairs;Contracting Section;6010 Amarillo Blvd W;Amarillo TX 79106
- ZIP Code
- 79106
- Archive Date
- 7/29/2012
- Point of Contact
- Robert S Miller
- E-Mail Address
-
4-7845<br
- Small Business Set-Aside
- N/A
- Award Number
- VA504-A20015
- Award Date
- 7/19/2012
- Description
- DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition 1. Contracting Activity: The U.S. Department of Veterans Affairs, Contracting Office Amarillo Network Contracting Activity 18, located at 6010 Amarillo Blvd West, Amarillo TX 79106 proposes to enter into a firm-fixed price contract on the basis of justification for other than full and open competition for the VA Amarillo Healthcare System. The Purchase order number is VA504-A20015. 2.Nature and/or Description of the Action Being Processed: This is a new procurement and the contract contemplated will be firm fixed price to NeoMend, at 60 Technology Drive, Irvine, CA 92618. 3.Description of Supplies/Services Required to Meet the Agency ™s Needs: The requirement is to provide the Amarillo VAMC Surgical SVC Thoracic Surgery with ProGel to use to prevent and seal any intra-operative air leaks. This sealant will reduce the average length of stay by 2 days-thus reducing hospital costs and post-op occurrences. Air leaks are the number one complication associated with pulmonary surgery and often lead to other complications (pneumonia, empyema, pneumo thorax, and infection). The contractor is required to deliver the item within one week of contract award on emergent basis. 4.Statutory Authority Permitting Other than Full and Open Competition: 41 USC §253(c) (2), as implemented by FAR 6.302.2 ( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; (X) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 5.Demonstration that the Contractor ™s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): An unusual and compelling urgent requirement for the NeoMend ProGel is needed. NEOMEND is the only manufacturer of such Pleural Air Sealants and the ProGel is the only FDA approved sealant for lung air leaks. This sealant will reduce the average length of stay by 2 days-thus reducing hospital costs and post-op occurrences. Air leaks are the number one complication associated with pulmonary surgery and often lead to other complications (pneumonia, empyema, pneumo thorax, and infection). Surgical Service Thoracic Surgery has used Pro Gel in the past at this facility with good clinical outcomes. Because there are veterans who are currently at risk of post operative occurrences the ProGel is required and the contractor can meet the required delivery of one week from contract award, failure to provide the needed item would not meet the VA mission of providing exceptional healthcare treatment to veterans. 6.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: FedBizOpps Posting: The requirement will not be synopsized in accordance with 5.202(a)(2), in that this acquisition is being conducted under unusual and compelling urgency and the Government would be seriously injured if the agency complies with the time periods specified in 5.203. Efforts to Solicit Other Potential Sources: Market research was not conducted because this is the only FDA approved product for lung air leaks. The requirement cannot be competed because it is the only product that is FDA approved for lung air leaks. Future Acquisition Strategy & Efforts: A one year fixed-price contract with NeoMend for the ProGel will be used to meet the unusual and compelling urgency of the Amarillo VAMC. The one year contract will allow the VA Amarillo Network Contracting Agency enough time to solicit the requirement for a new contract which will be for a 1 (one) year supply of the approved ProGel. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated dollar value for the contract action is for $3444.52. The NeoMend ProGel has been determined to be commercial in accordance with FAR 2.101; cost or pricing data will not be required. Pricing techniques as are described in FAR 15.404-1(b)(2), will be used to establish price fairness and reasonableness. The Contracting Officer determines that the anticipated price will be fair and reasonable based on historical price analysis. Research shows three procurements since January 1, 2012 “ as follows: Neomend Inc., 504-P21314January 11, 2012$3,430.00 Neomend Inc., 504-A20005January 24, 2012$3,442.52 Neomend Inc., 504-A20015July 19, 2012$3,500.86 Market research and analysis was not conducted because this is the only FDA approved product for lung air leaks. The requirement cannot be competed because it is the only product that is FDA approved for lung air leaks. 8.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was not conducted because this is the only FDA approved product for lung air leaks. The requirement cannot be competed because it is the only product that is FDA approved for lung air leaks. 9.Any Other Facts Supporting the Use of Other than Full and Open Competition: Delay in award would result in both a significant amount of thoracic surgeries being delayed and, in emergency situations significantly increase the probability by 50% for post operative occurrences of pneumonia, empyema, pneumo thorax, and infection. Post operative occurrences are costly to the Government. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: See Section VI above. 11.A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: The proposed contract is a onetime one case emergent purchase, which allows the VA Amarillo Network Contracting Activity enough time to compete the requirement. There is a plan to re-contract for the NeoMend ProGel for 1 (one) year. The requirement has been identified and the acquisition planning will commence following the award of this contract. A presolicititaion synopsis will be posted in accordance with FAR 5.201 for the new need. 12.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 and belief. __//Signed//___________________________ ________________________ Michael ChontosDate: August 16, 2012 Surgical Services Thomas E. Creek Medical Center 13.Approvals in accordance with FAR 6.304: IAW 6.302-2, Unusual and Compelling Urgency, Authority granted by 41 U.S.C. 253(c)(2) “ the application, limitations and period of performance concerning this emergency procurement for the Progel pleural air leak sealant kit through the contractor, Neomend Inc, for surgical services at the Thomas E. Creek Medical Center in Amarillo, TX has been met. a.Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. __//Signed//___________________________ ________________________ BENIGNO T. CANALESDate: August 16, 2012 Contracting Officer V1089L3-0806 Thomas E. Creek Medical Center b.VISN/PCA QA (Required $3K and above): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. __//Signed//___________________________ ________________________ Paulette PereiraDate: August 31, 2012 QA/Compliance Procurement Analyst VHA Network 18 (NCO18)/SAO-West c.NCM/PCM (Required $3K and above): I certify the justification meets requirements for other than full and open competition. __//Signed//___________________________ ________________________ Sabrina J. SmithDate: September 10, 2012 Network Contract Manager VISN 18 Network Contract Manager d.SAO QA (If over 500K): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. ___NOT APPLICABLE_____________ ________________________ NameDate Title Facility e.SAO (If over 500K): I certify the justification meets requirements for other than full and open competition. ___NOT APPLICABLE______________ ________________________ NameDate Director Service Area Office, West f.VHA HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $10million) or approve ($500K to 10 million) for other than full and open competition. ___NOT APPLICABLE______________ ________________________ Norbert S. DoyleDate Acting Chief Procurement and Logistics Officer VHA Head of Contracting Activity (HCA) g.VA Deputy Senior Procurement Executive Approval (over $10 million but not exceeding $50 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 other than full and open competition. ___NOT APPLICABLE___________ ________________________ Iris B. CooperDate Deputy Senior Procurement Executive (DSPE) Office of Acquisition and Logistics Department of Veterans Affairs h.VHA Senior Procurement Executive Approval (over $50 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 other than full and open competition. ___NOT APPLICABLE____________ ________________________ Jan R. FryeDate Deputy Assistant Secretary for Acquisition and Logistics Senior Procurement Executive (SPE) Department of Veterans Affairs
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