Coagulation Lab Testing

DEPARTMENT OF VETERANS AFFAIRS



Justification and Approval (J&A)

For

Other Than Full and Open Competition (>$150K)



1. Contracting Activity: Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 20 facilities including Roseburg Healthcare System, Roseburg, OR; Boise VA Medical Center, Boise, ID; Alaska VA Healthcare System (AVAHS), Anchorage, AK; Mann-Granstaff VA Medical Center, Spokane, WA; VA Puget Sound Health Care System, Seattle, WA; White City VA Medical Center, White City, OR and Walla Walla VA Medical Center, Walla Walla, WA.



2. Nature of the Action Being Processed: This is a new firm-fixed price Blanket Purchase Agreement for the procurement of Coagulation tests - D-dimer, Thrombin Time, Heparin XA, and Fibrinogen testing to include reagents and supplies. This justification and approval is only for the brand name supplies required for the aforementioned test, which are not included on the vendors Federal Supply Schedule.



FAR13.5 Test Program: This procurement is for Coagulation testing/ reagents in accordance with FAR 13.5 Test Program for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.



3. Description of Supplies or Services Required to Meet the Agency's Needs: This procurement is in reference to VISN 20 BPA (Solicitation # VA260-15-Q-0257). The solicitation included Coagulation tests - D-dimer, Thrombin Time, Heparin XA, and Fibrinogen. The vendor will supply the facilities with an automated analyzer at each VISN 20 site. Vendor will supply customer with sufficient supplies, reagents, and consumables to perform testing on the coagulation analyzer systems for each VISN20 facility site based on estimated patient results per month. Estimated period of performance is September 15, 2015 though July31, 2020. Individual estimated quantities and estimated cost are listed below.



Test Annual Est Quantity Annual Est Cost Total Est Cost

D-dimer 4,200 $71,687 $358,435

Thrombin Time 114 $1,430 $7,150

Heparin XA 76 $2,738 $13,690

Fibrinogen testing 1,747 $6,739 $33,695

Total Estimated Cost $412,970



4. Statutory Authority Permitting Other than Full and Open Competition:

FAR 13.5 Test Program: The authority for applying the Commercial Test Program of FAR 13.5 is (Section 4202 of the Clinger-Cohen Act of 1996) and is implemented for restricting competition on this procurement via FAR 13.106-1(b)(2).



(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;



5. Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This justification and approval is only for the brand name supplies required for the aforementioned test, which are not included on the vendors Federal Supply Schedule.



Clinical Laboratories run CAP (College of American Pathologist) unknown samples and are compiled and published. Diagnostica Stago (Stago) instrument peer group comparison would not be available if non-Stago products were used. Proprietary use of Stago Reagents with Stago Instrumentation meets CAP requirements. This protocol of Coagulation Analyzer/reagent paring is the industry standard. Critical function of pre-calibration for D-Dimer and Fibrinogen testing would not be available on STA Compact MAX without the proprietary use of Stago reagents D-dimer and Fibrinogen reagents.



Accordingly, Diagnostica Stago is the only firm capable of providing the supplies described in Section III above without the Veteran's Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition.



6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market survey was performed and there were four companies listed on GSA eBuy category 605-3A.



7. Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: Steps have been taken to ensure the cost is determined fair and reasonable. Pricing was compared to catalog pricing, previous contract pricing and market analysis.



8. Description of the Market Research Conducted and the Results, or Statement of Reasons Market Research was not Conducted: Market survey was performed and there were four companies listed on GSA eBuy category 605-3A.



9. Any Other Facts Supporting the Restriction of Competition:







10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Diagnostica Stago



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 additional test are being considered for addition to the vendors FSS schedule.





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.



_____________________________ _______________________

Name: Elizabeth Kiso Date

Position: Hematology Supervisor





13. Approvals IAW VHAPM, Volume Six, Chapter VI: OFOC SOP:



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: Scott Eberle Date

Title: Supervisory Contracting Officer

Facility: NCO 20





b. Director of Contracting /Designee (Required $150K and above): I certify the justification meets requirements for other than full and open competition.







_____________________________ ________________________

Name: Richard Steffey Date

Title: NCO 20 Director of Contracting or Designee

Facility: NCO 20