DOCUMENT
65 -- PRIVIGEN 10% VARIOUS SIZES - Justification and Approval (J&A)
- Notice Date
- 12/29/2016
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 20;1495 Wilmington Drive, Suite 360;DuPont WA 98327
- ZIP Code
- 98327
- Archive Date
- 11/26/2016
- Point of Contact
- Contact POC: Brad Feagan
- Small Business Set-Aside
- N/A
- Award Number
- VA260-17-P-0102
- Award Date
- 10/27/2016
- Description
- Chapter VI: Other Than Full and Open Competition (OFOC) SOP Attachment 3: Request for Sole Source Justification Format >$150K OFOC SOP Revision 05 Page 3 of 3 Original Date: 03/22/11 Revision 05 Date: 05/02/2016 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>$150K) Acquisition Plan Action ID: VA260-17-AP-0549 Contracting Activity: Department of Veterans Affairs, VISN 20, 663 VA PUGET SOUND HEALTH CARE VA Puget Sound health care, pharmacy 2237#: 663-17-1-022-0231 Nature and/or Description of the Action Being Processed: Medication purchase (expendable supply item) for patient care: Privigen - 10% Liquid Intravenous - Immunoglobulin (IVIg) Therapy $170940.00/2220 GRAMS McKesson Plasma and Biologics 1-877-625-2566 Contact name: John L. Meinhardt FAR13.5 Simplified Procedures for Certain Commercial Items: This procurement is for: 154 total grams of expendable supply item, medication called: Privigen - 10% Liquid Intravenous Immunoglobulin (IVIg) Therapy. For direct Patient care that helps protect the health of patients with PI by supplying their immune system with antibodies to help prevent infections.... In supplementation, IVIg therapy is used to provide protective antibodies to patients with immunodeficiencies. Description of Supplies/Services Required to Meet the Agency s Needs: Privigen - 10% Liquid Intravenous Immunoglobulin (IVIg) Therapy 5 gram vial, 50ml,qty: 24 vial 2) Privigen - 10% Liquid Intravenous Immunoglobulin (IVIg) Therapy 10 gram vial, 50ml,qty:50 vial 3) Privigen - 10% Liquid Intravenous Immunoglobulin (IVIg) Therapy 20 gram vial, 50ml,qty:80 vial Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(1), as implemented by FAR 6.302-1. The specific paragraph must be cited. Most likely, only the -1 or -2 authorities will be cited. Please be aware that failure to adequately plan for future requirements does not constitute appropriate use of the unusual and compelling urgency statutory authority. ( ) (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; FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2). Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This is an injectable medication needed ASAP. The usual contracted item is on a back order, and this approved alternative via OM McKesson government source may run out of supply because everyone else is switching to using this medication. This medication is used in direct patient care. Privigen is a therapy that helps protect the health of patients with PI by supplying their immune system with antibodies to help prevent infections.... In supplementation, IVIg therapy is used to provide protective antibodies to patients with immunodeficiencies. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Contacted two other companies for prices, they were both higher in cost. Also Mckesson is a primary contracted vendor for VA hospitals and has an established distribution network for pharmaceuticals and has the ability to get us this product by the time required. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: 1) Privigen 5 gram ordered by IHS (Government entity) 10/05/2016 $385 a unit PO IPMCNB17001, 2) Privigen 10 gram ordered by IHS (Government entity) 10/05/2016 $770 a unit PO IPMCNB17001, 3) Privigen 20 gram ordered by IHS (Government entity) 10/05/2016 $1540 a unit PO IPMCNB17001 for a total of $73,150.00 (Same pricing to the VAMC) Procurement for Indian Health Services per REP: John Meinhardt@mckesson.com 615-848-6133 Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Contacted two other companies for prices, they were both higher in cost. Also McKesson is a primary contracted vendor for VA hospitals and has an established distribution network for pharmaceuticals and has the ability to get us this product by the time required. Any Other Facts Supporting the Use of Other than Full and Open Competition: See #6 Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: N/A. 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: To identify the need of product(s) before this elevates to and emergency action. Approvals in accordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. Contracting Officer or Designee s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Prepared by: Brad Feagan _____________________________ ________________________ Jacob Jackson Date Contracting Officer
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- Document(s)
- Justification and Approval (J&A)
- File Name: VA260-17-P-0102 VA260-17-P-0102_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3186733&FileName=-9417.docx)
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- File Name: VA260-17-P-0102 VA260-17-P-0102_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=3186733&FileName=-9417.docx)
- Record
- SN04360911-W 20161231/161229234118-06f4dcafb71f2772b4453fe0f6e1bdf9 (fbodaily.com)
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