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FBO DAILY - FEDBIZOPPS ISSUE OF JANUARY 17, 2015 FBO #4802
DOCUMENT

65 -- EMERGENCY PROCUREMENT, ETA 1-15-15 FOR DEL ON 1-16-15 - Justification and Approval (J&A)

Notice Date

1/15/2015
 

Notice Type

Justification and Approval (J&A)
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office 4
 

Archive Date

2/14/2015
 

Point of Contact

Ronald J Kline
 

E-Mail Address

822-3755<br
 

Small Business Set-Aside

N/A
 

Award Number

VA244-15-P-1937
 

Award Date

1/15/2015
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Exception to Fair Opportunity Memo 1.Contracting Activity: Department of Veterans A/fairs, VISN 04, VAPittsburgh M edical Center 2.Description of Action: Theordering of EGFR and KRAS kitsfor PCR testing of patient tissue. 646-15-2-080-0348, Required Delivery Date is Friday, 1-16-15 3.Description of Supplies or Services : Retrospective analysisfrom several recent large clinical trials in metastatic colorectal cancer {mCRC) have examined the role of mutation in the KRAS gene with the response to treatment using the epidermal growth facto r receptor {EGFR) monoclonal antibody inhibitors cetuximab and panitumumab. These data show that both of these agents are ineffective in patients with the KRAS mutations. Recently published guidelines from the national comprehensive cancer network and the American society of clinical oncology recommend KRAS mutation testing as part of the evaluation on mCRC patients who are being considered for anti EGFR therapy,since the costfor these anti EGFR therapies is expensive. The Therascrenn EGFR RGQ PCR kit from Qiagen has recently been FDA approved for the purpose of testing NSCLC patients for EGFR mutational testing and has recently been validated within our own molecular anatomic patholog y laboratory. This will reduce costs, reduce the amount of hands on work of technologists to increase productivity, as well as streamlining the laboratory workflow. Therefore, we are requesting purchase of the above kit, at a cost of $5,546.75 per kit, for the above reasons. Retrospective analysis from several recent large clinical trials in metastatic colorectal cancer (mCRC) have examined the role of mutation in the KRAS gene with the response to treatment using the epidermal growth factor receptor {EGFR) monoclonal antibody inhibitors cetuximab and panitumumab.These data show that both of these agents are ineffective in patients with the KRAS mutations. Recentl y published guidelines from the national comprehensive cancer network and the American societ y of clinical oncology recommend KRAS mutation testing as part of the evaluation on mCRC patients who are being considered for anti EGFR therapy, since the cost for these anti EGFR therapies is expensive. The Therascrenn KRAS RGQ PCR kit from Qiagen has recently been FDA approved for the purpose of testing NSCLC patients for KRAS mutational testing and has recently been validated within our own molecular anatomic patholog y laboratory. Jn addition to testing mCRC patients, in thefuture our laboratory is also planning on validating the above kit for our non-small cell lung carcinoma (NSCLC) specimens. Thiswill reduce theneed fo purchasing aseparate kitfor our NSCLC specimens for KRAS testing, therefore reducing costs,reducing the amount of hands on work of technologists OFOC SOP Revision 03 Page 1of to increase productivity, as well as streamlining the laboratory work/low. Therefore, we are requesting purchase of the above kit, at a cost of $3,926.10 per kit,for the above reasons. 4.Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section 41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation (FAR) Subpart 16.505 Subpart 16.505(b)(2)(i): ( )FAR Subpart 16.505(b)(2}(i)(A): The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays. ( X ) FAR Subpart 16.505(b}(2}(i)(B): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. ( ) FAR Subpart 16.505(b)(2}(i)(C) : The order must be issuedon a sole-source basis inthe interest of economy and efficiency because it is a logical follow-on to anorder already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order. ( ) FAR Subpart 16.505(b}(2)(i)(D): It is necessary to place an order to satisfy a minimum guarantee. ( ) FAR Subpart 16.505(b)(2)(i)(E): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source".The statutory authority permitting an exception to fair opportunity for this action is 38 U.S.C. 8127(c), known as the Veterans First Contracting Program which provides the authority to directly contract with a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a Veteran-Owned Small Business (VOSB). ( ) FAR Subpart 16.SOS(b}(2}(i )(F} In accordance with section 1331of Public Law 111-240 (15 U.S.C. 644(r)), contracting officers may, at their discretion, set aside orders for any of the small business concerns identified in 19.000(a}(3}. When setting aside orders for small business concerns, the specific small business program eligibility requirements identified in part 19 apply. s.Rationale Supporting Use of Authority Cited Above : Due to the recent FDA clearance of the QIAGEN therascreen EGFR RGQ kit, purchase of new instrumentation and reagents were needed in order to remain compliant with FDA regulations. The Therascreen EGFR PCR kit from Qiagen has been rigorously tested and approved for clinical applications in numerous countries in Europe and Africa. The kit detects 28 of the most common mutations in exons 18-21 of the EGFR gene using combined ARMS r (allele specific PCR) with the Scorpions r real time PCR technology to develop sensitive and robust testfor tumor-borne EGFR mutations that has been validated on the existing equipment in our laboratory. If we have to send these tests out to a reference laboratoryfor direct sequencing, it would be a less sensitive and more costly (approximately +$500 per test result) method. Thus,it has been validated within our lab, using our lab equipment, and, at the OFOC SOP Revision 03 Page 2of cost of $5,546.75for 25 tests, will offer substantial savings to the VAPHS compared tocosts of sending toanoutsidereferencelabfor analysis. Due to the recent FDA clearance of the QIAGEN KRAS RGQ kit, purchase of new instrumentation and reagents were needed in order to remain compliant with FDA regulations. The KRAS RGQ kit from Qiagen has been rigorously tested and approved for clinical applications in numerous countries in Europe and Africa. The kit detects seven mutations in codons 12 & 13 of the KRAS oncogene using combined ARMS r (allele specific PCR) with the Scorpions r real time PCR technology to develop sensitive and robust testfor tumorborne KRAS mutations. Purchase of the KRAS RGQ FDA kit ($3,,926.10for 25 tests) and reagents wiJJ allow us to continue our validated testing and remove the need to send out these tests to a reference laboratory for direct sequencing, which would be a less sensitive and more costly method (approximately $500 per test result). 6.Efforts to Obtain Competition: A description of efforts made toensure that offers are solicited from asmany potentialsources as is practicable. NONE 7.Actions to Increase Competition: Describe actions taken, or that will be taken, toremove or overcome anybarriers tocompetition before initiating anysubsequent acquisitionsfor thesupplies, or services required, including challenges torestrictive datamarkings,data rights,preparation of a performance based work statement, and etc. 8.Market Research:Provide a description of the market research conducted among the contract holders and the results. If market research was not conducted, the reasons it was not conducted should be stated. Whenciting 16.505{b)(2(i)(b} or 16.505{b)(2)(i)(e}, the only possible way to state in paragraph 5 of the J&A that there isonly one contractor who canfulfi ll the agency'sneeds is to conduct market research,and it should be summarized here. QIAGEN's therascreen EGFR and KRAS RGQ kitshave been validated within themolecular lab. Obtaining PCR kits form diff erent companies would result in re-validation within the lab, resulting in increased costs as well as delay inpatient care. Validation of testing must be performed (required by CAP) before it can be used in a clinical setting, which could be in upwards of multiple weeks. 9.Other Facts: EGFR testing using QJAGEN's therascreen EGFR RGQ PCR kit was been validated within the molecular anatomic patholog y laboratory and has been FDA approved. KRAS testing using QIAGEN's therascreen EGFR RGQ PCR kit wasbeenvalidated within the molecular anatomic pathology laboratory and has been FDA approved. Chapter VJ: Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Exception to Fair Opportunity Memo Format Na Title: Chief Medical Technologist Facility: VA Pittsburgh \ ' \ '-\ \ \ Date 11. Determination that Anticipated Cost is Fair and Reasonable: A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable: (insert the methods that will beused todetermine afair and reasonableprice). 12. Contracting Officer's Certification (required): Icertify that the foregoingjustification is accurate and complete to the best of my knowledge and belief. RONALD J. KLINE 152627 Digitally signed by RONALD J. KLINE 152627 DN: dc=gov, dc=va, o=internal, ou=people, 0.9.2342.19200300.100.1.1=ronald.kline@va.go v, cn=RONALD J. KLINE 152627 Date: 2015.01.15 07:50:33 -05'00' Ronald Kline, CO, VAPHS1-15-15 Name Title Facility Date 13.Approvals inaccordance with the VHAPM, Volume 6, Chapter VI: OFOC SOP. This part if filled out by ContractingStaff aspart of theJustification a.Director of Contracting/Designee (Required $150K and above): Icertify the justificati on meets requirements for other than full and open competition. N/A NameDate NCO/PCO XX Director of Contracting or Designee Facility OFOC SOP Revision 03 Page 4 of 5
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/notices/492f60683956a848679f3109a706f6b2)
 

Document(s)

Justification and Approval (J&A)
 

File Name: VA244-15-P-1937 VA244-15-P-1937_1.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1815831&FileName=-5138.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1815831&FileName=-5138.docx

 

File Name: VA244-15-P-1937 P03.SIGNED. SS JUST.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1815832&FileName=-5139.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1815832&FileName=-5139.docx

 

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

Record

SN03617769-W 20150117/150115235313-492f60683956a848679f3109a706f6b2 (fbodaily.com)
 

Source

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