DOCUMENT
Q -- Notice of Intent to Sole Source Lab Testing to Prometheus Labs, Inc. - Attachment
- Notice Date
- 5/6/2014
- Notice Type
- Attachment
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- Department of Veterans Affairs;Network Contracting Office 20;8524 N Wall St;Spokane WA 99208
- ZIP Code
- 99208
- Solicitation Number
- VA26014AP2453
- Archive Date
- 6/5/2014
- Point of Contact
- Mark A. Mitchell
- E-Mail Address
-
itchell4@va.gov<br
- Small Business Set-Aside
- N/A
- Description
- DEPARTMENT OF VETERANS AFFAIRS Justification and Approval Under Simplified Acquisition Procedures (SAP) Simplified Acquisition Threshold ($3K to $150K) For Restricting Competition under FAR 13.106-1(b)(1) "Single Source" 1.Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 20, for the Portland VA Medical Center (PVAMC) 2.Nature of the Action Being Processed: Multi-year contract needed for the payment of testing performed at Prometheus Labs Inc. 3.Description of Supplies or Services Required to Meet the Agency's Needs: This procurement under PR # 648-14-2-066-0143 is for patented Testing and monitoring for TPMT.TPMT Enzyme testing provides a quantitative analysis of a patient's thiopurine methyltransferase (TPMT) enzyme activity level. Because each patient metabolizes thiopurines differently, the efficacy and toxicity of thiopurines can vary widely from patient to patient. Knowledge of the TPMT enzyme phenotype may reduce time of response, allow physicians to individualize dosing, identify patients in whom thiopurine therapy should be avoided and help reduce the risk of leukopenia DescriptionPrometheus #Cost each Thiopurine-Methyltransferase3320220 Azathioprinie metabolite monitoring3200370 IBD serology1007445 4.Statutory Authority Permitting Restriction in Competition: (x) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; The statutory authority for restricting competition under SAP, or Single Sourcing, for acquisitions under $150,000 or Simplified Acquisition Threshold (SAT) is 41 U.S.C. 253(c), as implemented by FAR 13.106-1(b)(1). The specific reason for restricting competition is an urgent and compelling need for patented Testing and monitoring for TPMP from a vendor, Athena Diagnostics, that holds the patents. This justification is where in accordance with FAR 6.001(a), acquisitions conducted under FAR 13 for SAP are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2, IAW the VHA SOP for Other Than Full And Open Competition dated 3-22-2011. 5.Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The contractor, Prometheus Labs Inc. can provide patented Testing and monitoring for TPMP.See market research. PROMETHEUS ® TPMT Enzyme testing provides a quantitative analysis of a patient's thiopurine methyltransferase (TPMT) enzyme activity level. Because each patient metabolizes thiopurines differently, the efficacy and toxicity of thiopurines can vary widely from patient to patient. Knowledge of the TPMT enzyme phenotype may reduce time of response, allow physicians to individualize dosing, identify patients in whom thiopurine therapy should be avoided and help reduce the risk of leukopenia. Product Description oA quantitative analysis (phenotype) of TPMT Enzyme activity levels. oPROMETHEUS TPMT Enzyme is only offered at Prometheus. oPatent protected. PROMETHEUS ® Thiopurine Metabolites testing assists physicians in optimizing ongoing dosing of thiopurine immunosuppressant therapy to reach and maintain therapeutic goal. Thiopurine metabolite testing also helps to identify drug metabolite levels that may lead to toxicity and some of the reasons for treatment failure. oA quantitative evaluation of 6-TGN (thioguanine nucleotide) and 6-MMPN (methyl mercaptopurine nucleotide) oPROMETHEUS Thiopurine Metabolites is only offered at Prometheus. oPatent protected. 6.Description of Efforts Made to Ensure that Offers are Solicited from As Many Potential Sources as Deemed Practicable IAW FAR 13.104: Only one source identified that can do testing and monitoring for TPMP. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable - IAW FAR 13.106-3: Prometheus' proposed price is consistent with their commercially published price which is based on Medicare rates. The estimated cost for this base period is $6,000.00 8.Description of the Market Research Conducted and the Results, or Statement of Reasons Market Research was not Conducted (FAR 10): See market research attached. The tests are patented by Prometheus.. 9.Any Other Facts Supporting the Restriction of Competition: None 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None 11.Statement of 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: Lab will continue to search for labs that can perform Testing and monitoring for TPMP. 12. Requirements Certification - IAW FAR 6.303-2(c): I certify that the requirement outlined in this justification is a bonafide 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. 2/12/2014 Name: Ed LymanDate Position:PVAMC Lab Business manager 13.Approvals IAW VHAPM, Volume Six, Chapter VI, SOP 3.2.1: a.Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Name:Date Contracting Officer NCO 20 ( ¦) Acquisitions Team b.NCM/PCM/DESIGNEE: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 for other than full and open competition. NCO 20 ( ¦) Team ManagerDate
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/VA/SpVAMC/VAMCCO80220/VA26014AP2453/listing.html)
- Document(s)
- Attachment
- File Name: VA260-14-P-0504 VA260-14-P-0504.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1348781&FileName=-3595.docx)
- Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1348781&FileName=-3595.docx
- Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
- File Name: VA260-14-P-0504 VA260-14-P-0504.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1348781&FileName=-3595.docx)
- Record
- SN03358509-W 20140508/140506234957-23464d7897d156f6cce345f189446e64 (fbodaily.com)
- Source
-
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