P03 EMERGENCY JOFOC-C00344.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

COVID-19 Emergency for Nasopharyngeal Swab Collection Kits

36C248-20-AP-3187

OFOC SOP Revision 09 Page 1 of 4 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C248-20-AP-3187

1. Contracting Activity:

Department of Veterans Affairs, VISN 8, C.W. Bill Young VA Medical Center, Bay Pines, FL. 33744.

2237 Number: 516-20-3-2217-0069

2. Nature and/or Description of the Action Being Processed:

This is a COVID-19 Emergency requirement for all seven (7) VISN 8 medical center facilities for 280,000 COVID-19 Nasopharyngeal Test Kits. All Nasopharyngeal Swab Collection Kits will be evenly divided amongst the seven (7) medical centers to include C.W. Bill Young VA Medical Center, Malcom Randall VA Medical Center, Bruce W. Carter VA Medical Center, Orlando VA Medical Center, VA Caribbean Healthcare System, James A. Haley Veterans Hospital, and West Palm Beach VA Medical Center. There is an emergent need for 280,000 COVID-19 Nasopharyngeal Swab Collection Kits which are required to perform COVID-19 testing for patients and staff. There is an international shortage of Nasopharyngeal Swab Collection Kits available for purchase and we have been notified of availability through Hardy Diagnostics, a Small Business that can ship these kits allocating 200 packages per week, per medical center (4,000 tests per week, per site) and manufactured in the US. Inventory cannot be held and are distributed first come – first serve hence the request for an emergency order.

Total Cost: $1,319,668.00

FAR13.5 Simplified Procedures for Certain Commercial Items: This emergency procurement is for COVID-19 280,000 Nasopharyngeal Swab Collection Kits in accordance with FAR 13.5 Simplified Procedures 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/Services Required to Meet the Agency’s Needs:

• Viral Transport Med., 3mL (R99) 14,000 packages (20 per pack) x $81.85= $1,145,900.00

• Flocked NP Swab, Sterile (FSNP/972012) 2,800 packages (100 per pack) x $62.06= $173,768

Total: $1,319,668.00

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Revision 09 Date: 04/17/2020

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

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

(X) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by 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).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

VISN 8 facilities are in emergency need of 280,000 Nasopharyngeal Swab Collection Kits.

Nasopharyngeal Collection is vital in the ability to perform COVID-19 testing for patients and staff.

There is an international shortage of Nasopharyngeal Swab Collection Kits and many customers are experiencing severe manufacturing and supply chain delays which is causing delays in testing. We have been notified of availability of Nasopharyngeal Swab Collection Kits only through Hardy Diagnostics, a Small Business and they manufacture the median in the US.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Due to an emergent need for Nasopharyngeal Swab Collection Kits during the COVID-19 pandemic, a search was conducted for COVID-19 Nasopharyngeal Swab Collection Kits by the VISN 8 office. That search yielded one vendor, Hardy Diagnostics that could meet our need to supply quality kits, made in the US at a fair and reasonable price.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Market research confirms via Google and other searches that the current price for this procurement from Hardy Diagnostics price is lower than one competitor by as much as $550,700.00. Due to the national pandemic many vendors are charging above fair market prices. Hardy Diagnostics original manufacturer’s suggested retail quote was $1,461,824.00 then they offered a $142,156.00 discount making the new total $1,319,668.00 ($4.71 per test). That price has been determined to be fair and reasonable by the CO.

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Revision 09 Date: 04/17/2020

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market Research was conducted IAW FAR Part 10 and revealed that there is an international shortage of Nasopharyngeal Swab Collection Kits especially those manufactured in the US as most are made in China. It also revealed that Hardy Diagnostics is the only company able meet VISN 8 needs for supply and delivery, while also providing excellent customer reviews.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None

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

Hardy Diagnostics

11. 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:

Due to the unforeseen need and emergent nature of this requirement the requesting service was not able to remove or overcome the barriers to competition. However, the requesting service is currently monitoring the market to determine if future COVID-19 test kit needs can be competed when that time arises.

12. Requirements Certification: 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.

Kim Faison Date Acquisition and Utilization Specialist VISN 8 Network Office

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. 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.

Mark L. Cline Date Contracting Officer NCO 8, Bay Pines/Commodities http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

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Revision 09 Date: 04/17/2020

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Pamela A. Srebernak Date

Branch Chief NCO 8, Bay Pines/Commodities

c. VHA RPO HCA Review and Approval: 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 (if over $68 million) or approve ($700K to $68 million) for other than full and open competition.

Joseph Maletta Date Executive Director, RPO East