P03 - SDVOSB PM_Part819.7007-7008_Atch1_FAR6_JA_OVER_SAT-NDL-DvJahn2 (Revised_Norton).pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

VHAPM Part 819.7007/7008 Page 1 of 5 Original Date: 08/30/2017 Revision 03 Eff Date: 04/03/2020

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: VA-21-00041535

1. Contracting Activity: Department of Veterans Affairs, VISN 5, VA Maryland Medical Center

512-21-2-874-0216

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

This requirement is for the procurement of FDA approved sterile 1cc luer-lock syringe, sterile 25g x 1in safety needle, and 25g x 1.5in safety needle to support the VA Mass Vaccination program with the support of the National Guard and 4th Mission Requirements. Each VHA Station within VISN 5 is constrained under the MSPV mandate and micro-purchase requirements. The procurements are not able to supply the VA Mass Vaccination program. VAMHCS is actively negotiating with multiple SDVOSB companies for PPE, sterile syringes, and sterile safety needles to support the VA Mass Vaccination Program. Due to global restraints, manufacturers have decreased medical exam glove allocations to the MSPV program by 80% plus.

Manufacturers removed items from contracts due to global shortages. VAMHCS is only working with SDVOSB companies to obtain quotes for PPE. Staff is using current open market price compared with last known FSS contract price to ensure pricing is reasonable to a +/- 10% average.

Staff is using pre-COVID FDA product and manufacturer license to ensure all PPE requests are approved for medical use. Staff is taking every precaution to ensure PPE procurements are not fraudulent.

Description of Supplies/Services Required to Meet the Agency’s Needs:

VAMHCS is requesting the procurement of the following FDA approved sterile 1cc luer-locked syringe, 25g x 1in safety needle, and 25g x 1.5in safety needle. The total estimated cost is $525,000.00 which is at current open market price.

• 250 cases – FDA approved sterile 1cc luer-lock syringe with reduced dead space o $800.00 Per-case –2000 each per case = $2.50 per syringe

Average open market price per case $748.36

• 250 cases – FDA approved sterile 25g x 1in safety needle o $800.00 Per-case – 2000 each per box = $2.50 per needle

Average open market price per case $871.12

• 250 cases – FDA approved sterile 25g x 1.5in safety needle o $205.00 per case – 2000 each per box = $2.50 per needle

Average open market price per case $871.12

VHAPM Part 819.7007/7008 Page 2 of 5

Revision 03 Eff Date: 04/03/2020

3. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7007 or 819.7008 up to $5,000,000. Check the specific VAAR clause used below:

( X ) 819.7007 Sole source awards to a verified service-disabled veteran-owned small business;

or ( ) 819.7008 Sole source awards to a verified veteran-owned small business

As described in paragraph 2 above, only one responsible source and no other supplies or services will satisfy agency requirements. The majority of SDVOSBs and other open market companies require the contract before the manufacturers will allow them to place the order or obtain a position within the monthly production schedule. This is a standard within the manufacturing industry, and severely hinders our ability to obtain supplies in a reasonable timeframe.

The manufacture production schedule is established 1-2 months prior and companies are bidding for a coveted position within the production lineup. When the manufacturer reaches maximum production, the company will wait for the next production schedule meeting. Quotes stemming from production bid style procurement have a 6-8-month scheduling delay, then 1-2-month production before anticipated shipment. DvJahn is proactive and has multiple orders set within manufacture schedule production line. This SDVOSB has reduced the overall impact with production delays and is deemed the only source capable of meeting the defined and critical delivery timeline.

VHA Mass Vaccination program with the National Guard requires the VHA Facility/Station to provide all supplies necessary. The VHA Mass Vaccination program and 4th Mission does not receive HHS vaccination supply support, only Public Health Departments are eligible to receive vaccination supplies. Consequently, the requesting facilities must actively undertake procurement actions outside of the Public Health Departments realms of operation in support of the VHA Mass Vaccination program with the National Guard.

HHS has 40% of all production lot series on direct allocation to support the Public Health Mass Vaccination program. The remaining lot series is reserved for open market procurement. Lot production is different from overall production at the manufacturing level.

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

Only one responsible source and no other supplies or services will satisfy agency requirements. The majority of SDVOSBs and other open market companies require the contract before the manufacturers will allow them to place the order or obtain a position within the monthly production schedule. This is a standard within the manufacturing industry, and severely hinders our ability to obtain supplies in a reasonable timeframe.

The manufacture production schedule is established 1-2 months prior and companies are bidding for a coveted position within the production lineup. When the manufacturer reaches maximum production, the company will wait for the next production schedule meeting. Quotes stemming from production bid style procurement have a 6-8-month scheduling delay, then 1-2-month

VHAPM Part 819.7007/7008 Page 3 of 5

Revision 03 Eff Date: 04/03/2020 production before anticipated shipment. DvJahn is proactive and has multiple orders set within manufacture schedule production line. This SDVOSB has reduced the overall impact with production delays and is deemed the only source capable of meeting the defined and critical delivery timeline.

VHA Mass Vaccination program with the National Guard requires the VHA Facility/Station to provide all supplies necessary. The VHA Mass Vaccination program and 4th Mission does not receive HHS vaccination supply support, only Public Health Departments are eligible to receive vaccination supplies. Consequently, the requesting facilities must actively undertake procurement actions outside of the Public Health Departments realms of operation in support of the VHA Mass Vaccination program with the National Guard.

HHS has 40% of all production lot series on direct allocation to support the Public Health Mass Vaccination program. The remaining lot series is reserved for open market procurement. Lot production is different from overall production at the manufacturing level.

VHA adheres to the same governing qualities as defined with FDA, CDC, JACHO, etc.; however, in December 2019 the FDA allowed emergency authorization (EUA) to various manufacturers and companies which expired in September 2020. These guidelines are used to support this requirement as the global pandemic situation has not changed in regard to the supply items needed. VISN staff reviews each request to ensure the item meets pre-COVID FDA licensing due to the complexity of EUA guidelines. Pre-2019 FDA license ensures the item meets all ASTM and FDA guidelines throughout the manufacturing process and only FDA approved medical items are entering into the VHA facility.

VAMHCS identifies the name brand (MicSafety) only due to confirmed manufacture production schedule to fulfill the total case requirement necessary to meet the need for the VA Mass Vaccination program with the National Guard and its 4th Mission. The referenced FDA document ensures the product was FDA approved prior to December 2019 and is approved for medical use.

Open market bidding for “Safety Needle” or “Syringe” has and will result in fraudulent products being considered for the award of the contract. Note: EUA licenses expired September 2020; however, due to delays within the FDA the database reflects “pending” for FDA license renewal. VAMHCS will require copies of all product FDA licenses on each manufactured item, to include copies of paid invoices if the supply item is currently available within the US to confirm the medical items are FDA approved.

5. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by subpart

5.2 and, if not, which exception under 5.202 applies:

Facility partner, Carrie Parsons (Dobney), utilized the FDA database to obtain pre-COVID FDA approved medical items. Market research for the procurement above supplies above the micro-purchase threshold was conducted by contacting 2nd and 3rd party distribution company sales representatives. The sales representatives are aware of the need, delivery timeframe, product requirement/verification, and if they can support to submit a quote. The VAMHCS market resulted in 1 company indicating the ability to satisfy the requirement: ultimately resulting in a quote submission.

https://www.acquisition.gov/content/part-5-publicizing-contract-actions https://www.acquisition.gov/content/part-5-publicizing-contract-actions https://www.acquisition.gov/content/part-5-publicizing-contract-actions

VHAPM Part 819.7007/7008 Page 4 of 5

Revision 03 Eff Date: 04/03/2020

6. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The price has been determined to be reasonable as compared to the open market prices and within the Independent Government Cost Estimate.

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

Facility partner, Carrie Parsons (Dobney), utilized the FDA database to obtain pre-COVID FDA approved medical items. Market research for the procurement above supplies above the micro-purchase threshold was conducted by contacting 2nd and 3rd party distribution company sales representatives. The sales representatives are aware of the need, delivery timeframe, product requirement/verification, and if they can support to submit a quote. The VAMHCS market resulted in 1 company indicating the ability to satisfy the requirement: ultimately resulting in a quote submission.

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

Current Medical Prime Vendor (MSPV) supplies have decreased allocations by 80%. The MSPV formulary is locked to vendors which are unable to meet the current demand.

Each VHA Station is mandated to use the MSPV program for procurement of medical supplies;

however, due to allocations, the Stations are performing micro-purchases on the open market to support basic operations and cannot support the VA Mass Vaccination program with the National Guard or the 4th Mission.

VAMHCS is reducing the strain after calculating the necessary case quantity required to support the VAMHCS Mass Vaccination program with the National Guard and its 4th Mission by combining the requirement into a single procurement.

Open market bidding for “Sterile Safety Needle” and “Sterile Syringe” has and will result in fraudulent products being considered for the award of the contract. Note: EUA licenses expired September 2020; however, due to delays within the FDA the database reflects “pending” for FDA license renewal. VAMHCS will require copies of all product FDA licenses on each manufactured item, to include copies of paid invoices if the supply item is currently available within the US to confirm the medical items are FDA approved.

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

Facility partner, Carrie Parsons (Dobney), utilized the FDA database to obtain pre-COVID FDA approved medical items. Market research for the procurement above supplies above the micro-purchase threshold was conducted by contacting 2nd and 3rd party distribution company sales representatives. The sales representatives are aware of the need, delivery timeframe, product requirement/verification, and if they can support to submit a quote. The VAMHCS market resulted in 1 company indicating the ability to satisfy the requirement: ultimately resulting in a quote submission.

VHAPM Part 819.7007/7008 Page 5 of 5

Revision 03 Eff Date: 04/03/2020

9. 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:

The current global pandemic environment has precluded the development of any known actions to overcome the present barriers to competition. It is likely that such barriers can only be overcome with a change in manufacturers’ production scheduling algorithm or decrease in the needed quantities of requested supplies; neither of which are within our purview or span of control. The Contracting Office will routinely revisit the situation, conducting market research to ascertain any change or possible alternate avenues of less restricted competition.

10. 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.

(This signature is the requestor’s supervisor, fund control point official, chief of service, someone with responsibility and accountability)

Carrie A. Parsons Date SCMS Acquisitions

VAMHCS

11. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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.

Chantey Bost Date Contracting Officer

DC VAMC

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

Sandra Norton Date NCO 5 / Branch Chief / Contracting Officer

Perry Point VAMC https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx