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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 04, 2014 FBO #4544
DOCUMENT

Q -- Notice of Intent to Award a Sole Source Procurement Identification & Susceptibility Lab Testing - Attachment

Notice Date

5/2/2014
 

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

VA26014AP2481
 

Archive Date

6/1/2014
 

Point of Contact

Mark A. Mitchell
 

E-Mail Address

321-1918<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: A base plus option year service contract required for the payment of testing performed at University of Texas San Antonio Fungal laboratory. 3.Description of Supplies or Services Required to Meet the Agency's Needs: This procurement under PR # 648-14-2-066-0142 is for identification, susceptibility testing and synergy studies on fungalisolates. The University of Texas San Antonio Health Science Center (HSC) laboratory has the extremely specialized skills required to perform and produce consistently reliable data. The University of Texas HSC offers the best avenue to achieve complete panel of tests including susceptibility testing and measuring voriconazole levels. In order to provide detail diagnoses to patients, accurate and consistent antifungal susceptibility testing is required. The difficulty in performing this type of testing is in the early stages of standardization and the University of Texas San Antonio HSC lab is the leader in performing this testing. This laboratory's methodology is preferred by the Chief of Infectious Diseases at PVAMC and offers the best option for ensuring our veterans receive timely diagnoses and treatment. Link to: University of Texas San Antonio Fungal Laboratory A strong case can be made for therapeutic drug level monitoring (TDM) for treatment of serious mycoses. Reasons include the wide inter-subject variability in antifungal exposure, correlation between low concentration and treatment failure, and correlation between high concentration and drug toxicity. Several studies suggest that outcome of invasive fungal infections correlates with antifungal exposure. Low antifungal levels have been associated with the higher failure rate in patients with confirmed invasive fungal infections that are resistant to treatment. Additionally, voriconazole level testing is difficult to perform to the accuracy necessary to ensure the best treatment options for patients. The University of Texas San Antonio HSC Lab testing provides fast, reliable and consistently good data that allows for more comprehensive range of alternatives for treatment. See table of tests below. Quantities of tests will depend upon patient specifics Line ItemDescriptionCPT CodesEstimate $/per Test 1Amphotericin B Susceptibility87186 / 8718865 2Anidulafungin Susceptibility testing87186 / 8718865 3Caspofungin Susceptibility testing87186 / 8718865 4Micafungin Susceptibility testing87186 / 8718865 5Nystatin Susceptibility testing87186 / 8718865 6Natamycin Susceptibility testing87186 / 8718865 75-Fluocrocytosine Susceptibility87186 / 8718865 8Fluconazole Susceptibility testing87186 / 8718865 9Itracontazole Susceptibility testing87186 / 8718865 10Ketoconazole Susceptibility testing87186 / 8718865 11Voriconazole Susceptibility testing87186 / 8718865 12Posaconazole Susceptibility testing87186 / 8718865 13Miconazole Susceptibility testing87186 / 8718865 14Terconazole Susceptibility testing87186 / 8718865 15Clotrimazole Susceptibility testing87186 / 8718865 16Terbinafine Susceptibility testing87186 / 8718865 17Griseofulvin Susceptibility testing87186 / 8718865 18Mold identification87107 / 87153240 19Yeast identification87107 / 87153240 20Drug synergy testing87999150 21Drug level82491120 4.Statutory Authority Permitting Restriction in Competition: 41 USC §253(c) (1), as implemented by FAR 6.302-1. (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (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; The specific reason for restricting competition is only one responsible source available. In accordance with (IAW) 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 09/23/2013. The results of market research revealed that susceptibility testing is available from other laboratories; however only the University of Texas San Antonio HSC lab provides the advance capabilities that will allow for the following key diagnostic and treatment protocols required by the Portland VAMC. "Fungal identification specimens in any medium supporting growth. "Anti-fungal susceptibility testing methods for yeast testing comply with Clinical and Laboratory Standards Institute (CLSI) M27-A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts. "Anti-fungal susceptibility testing methods for mold testing comply with CLSI M38-A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi "Synergy testing complying with CLSI M27-A3 and M38-A2 with minor modifications to allow for combination testing. "Employ the use of classic checkerboard dilution methods with testing parameters as described in NCCLS documents M27-A2 and M38-A. "Susceptibility testing for over seventeen drugs that identify fungal species. 5.Demonstration that the Contractor's Unique Qualifications or Nature of the A c q u i s i t i o n Requires the Use of the Authority Cited Above (applicability of authority): The contractor, University of Texas can provide identification, susceptibility testing and synergy studies on fungalisolates. Additionally, the contractor is the only laboratory with the advance ability to test for over seventeen key drugs simultaneously that provides faster treatment options to physicians. 6.Description of Efforts made to ensure that Offers are Solicited from As Many P o t e n t i a l Sources as Deemed Practicable IAW FAR 13.104: IAW FAR 13.104 (b), I orally solicited three small businesses on GSA Schedule 621 II, category 621-209. I received a quote from one small business on this schedule; however, the methodology of this lab testing protocol does not meet the standards required by Portland VAMC as indicated in paragraph 4 above. 7.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable - IAW FAR 13.106-3: The services to be procured through this award will be acquired via an Open Market Sole Source award and this service has been procured in the past using Open Market Sole Source under VA260- 13-P-0020. The catalog price has remained unchanged from the previous procurement. The price provided by the University of Texas San Antonio HSC Lab price is $1855.00 compared to scheduled vendor, Cedar Diagnostic Medical laboratory and Pathology price of $3,788.02. The suggested sole source vendor provides a savings of $1933.02 and includes all test required for this procurement. In accordance with FAR 13.106-3(a)(2)(i)(ii), the market research and comparison of previous procurement, the price provided by the University of Texas San Antonio HSC Lab is reasonable and is in the best interest of the government. 8.Description of the Market Research Conducted and the Results, or Statement of Reasons Market Research was not Conducted (FAR 10): The procurement list from Ability One was checked for susceptibility testing with no results. GSA e-Library was checked and returned three small business on schedule 621 II, Medical Laboratory Testing and Analysis Services, category 621-209, Microbiology. The National Acquisition Center (NAC) MedSurg Catalog was searched and revealed three possible contracts for this procurement. 9.Any Other Facts Supporting the Restriction of Competition: The University of Texas San Antonio HSC Lab is the only laboratory that meets all Clinical and Laboratory Standards Institute (CLSI) protocols with the ability to provide consistent reliability of testing that follows of classic checkerboard dilution methods. This methodology is unique to the University of Texas San Antonio lab. Cedar Diagnostics Medical Laboratory and Pathology has an approved schedule contract (V797D- 30073) on schedule 621 II but it is not a mandatory VA schedule. Additionally, this laboratory does not met all the CLSI protocols and methodology required for this procurement. 10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: There are two vendors that have expressed an interest in this acquisition; the University of Texas San Antonio HSC Lab and Cedar Diagnostics Medical Laboratory and Pathology. 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: The reliability of the University of Texas San Antonio HSC Lab and it compliance with all CLSI protocols is in the best interest of the government. Further, this laboratory provides all the required testing needed by the Portland VAMC; whereas, the other laboratories found through market research do not. 12. Requirements Certification - IAW FAR 6.303-2(c): 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. 2/12/2014 Name: Ed LymanDate Position:PVAMC Lab Business manager 13.Approvals IAW VHAPM, Volume Six, Chapter VI, SOP 3.2.1: "Contracting Officer's Certification: (required) I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Digitally signed by brian.thomas3@va.gov brian.thomas3@va.gov DN: cn=brian.thomas3@va.gov Date: 2014.05.01 16:57:33 -07'00' Brian ThomasDate Contracting Officer Network Contracting Office (NCO) 20 "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. Digitally signed by brian.thomas3@va.gov brian.thomas3@va.gov DN: cn=brian.thomas3@va.gov Date: 2014.05.01 16:58:09 -07'00' NCO 20 Specialized Team ManagerDate Brian Thomas
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/SpVAMC/VAMCCO80220/VA26014AP2481/listing.html)
 

Document(s)

Attachment
 

File Name: VA260-14-C-0020 VA260-14-C-0020.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1345272&FileName=VA260-14-C-0020-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1345272&FileName=VA260-14-C-0020-000.docx

 

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

Record

SN03355294-W 20140504/140502234108-3a687f6844b64ee217c59f49b5f91f93 (fbodaily.com)
 

Source

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

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