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FBO DAILY ISSUE OF FEBRUARY 17, 2012 FBO #3737
DOCUMENT

65 -- PROGEL PLEURAL AIR LEAK SEALANT KIT - Emergency - Justification and Approval (J&A)

Notice Date

2/15/2012
 

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
 

Solicitation Number

VA25812Q0007
 

Archive Date

1/22/2012
 

Point of Contact

Robert S Miller
 

E-Mail Address

4-7845<br
 

Small Business Set-Aside

N/A
 

Award Number

VA504-A20005
 

Award Date

1/12/2012
 

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-A20005. 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. With the changes in contracting, this product must now be procured through contracting. 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. 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: February 15, 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: February 15, 2012 Supervisory Contract Specialist/C.O. 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: February 15, 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: February 15, 2012 Network Contract Manager VISN 18 Network Contract Manager
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/VA25812Q0007/listing.html)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA504-A20005 VA504-A20005_1.doc (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=297577&FileName=-1224.doc)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=297577&FileName=-1224.doc

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN02675810-W 20120217/120215234403-0d9ef05822ab5fce533b787c2e29ac20 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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