-16801.pdf

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

OFOC SOP Revision 08 Page 1 of 4 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C256-19-AP-2509

1. Contracting Activity: Department of Veterans Affairs, VISN 16, Gulf Coast Veterans Health Care

System, Biloxi, Mississippi 39531 2237#: 520-19-3-677-0130

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

Firm-Fixed price, 6 month contract, Pharmacy Services for Compounding Haxardous Chemotherapy Agents at a FDA Certified 503A Facility.

Estimated Cost: $500,000.00 from date of award through September 30, 2019.

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

Compounding of hazardous chemotherapy drugs at a FDA certified 503A facility. All hazardous chemotherapy agents will be aseptically compounded based on patient specific orders.

Compounding, labeling, and beyond use dating/expiration dating will be based on USP 797, USP 800, and Federal law. Upon completion of compounding, products will be delivered to the Joint Ambulatory Care Clinic (JACC), 790 Veterans Way, Pensacola, FL via courier prior to infusion date.

The JACC has approximately 7-9 patients on any given day, Monday- Friday, for Chemotherapy infusion. Drugs, tubing, and necessary items will be provided by the contractor.

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 FAR 6.302-1;

(X) (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):

VHABILMOHNEB

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Revision 08 Date: 04/18/2018

The VA pharmacists were able to utilize the Navy Hospital for compounding of chemotherapy agents. The Gulf Coast Veterans Health Care System was informed by VA Central Office that the VA could no longer utilize the Navy facility for compounding as the facility is not compliant with VA Standards. As a result, the VA was left with no method to compound the chemotherapy agents needed for patient care. Notification was made on Thursday by VA Central Office that after Friday, the VA needed to find another method to mix thus creating the unusual and compelling urgency to locate a contractor to provide immediate compounding requirements within 72 hours.

The recommended contractor, Avella, has the ability to handle the quantities of compounding agents that the Government requires. In addition, they are able to provide the agents immediately and without delay.

Other local contractors were contacted for the availability and immediate turn around to supply.

There were no other contractors that were able to meet the immediate request to supply the chemotherapy agents to maintain patient scheduled infusions.

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

A search in the VIP database demonstrated 27 SDVOSB and 10VOSB vendors with the NAICS 446110. The keywords “chemotherapy” and “infusion” were used in which returned zero results.

Bioscrip Infusion Partners, another compounding contractor, was contacted and they stated they were not able to assist or take on the requirement at this time.

FPDS was reviewed for current compounding contracts to locate additional sources. Most of the current contracts demonstrate the recommended vendor as the contractor.

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

Reasonable:

As the chemotherapy agents are prescribed, the amounts needed are not known until the type of agent is identified. The contractor invoices for “billable units” rather then invoicing per vial.

Therefore, the government is only getting billed for the dosage of medication specified. For example, if an order calls for 50 milligrams/per ML and the vial is 5 ML, the billable unit will be 1 ML rather than 5 ML. This creates a cost savings to the Government.

In addition, quoted prices are the same listed prices currently utilized for other VA facility locations.

FPDS demonstrates similar contracts comparable to the estimated pricing for this requirement.

It is anticipated that the cost to the Government shall be within the current market pricing illustrated with current contracts and pricing lists with Avella.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

VHABILMOHNEB

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Revision 08 Date: 04/18/2018

Limited market research was performed due to the unusual and compelling circumstances for this requirement.

A search in the VIP database demonstrated 27 SDVOSB and 10VOSB vendors with the NAICS 446110. The keywords “chemotherapy” and “infusion” were used in which returned zero results.

Bioscrip Infusion Partners, another compounding contractor, was contacted and they stated they were not able to assist or take on the requirement at this time.

FPDS was reviewed for current compounding contracts to locate additional sources. Most of the current contracts demonstrate the recommended vendor as the contractor.

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

The requirement was made known to contracting on Friday, 2:45 pm that there was an immediate need to provide compounding of chemotherapy agents within 72 hours. Agents are needed for patients scheduled Monday.

Persons receiving chemotherapy have to maintain treatment schedules. Any deviations from this schedule can significantly impact treatment efforts. In some cases, missed chemotherapy treatments forfeits the remainder of chemotherapy treatments with no recourse to continue any other chemotherapy methods.

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

Avella of Tampa, LLC 1070 E. Brandon, Blvd.

Brandon, FL 33511

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:

This requirement will be for the period from the Date of Award through September 30, 2019. A new package will be submitted for competition as the Government anticpates a continued need for the compounding services for the JACC and Biloxi facilities in FY20.

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.

_____________________________ May 13, 2019 Elizabeth Beatty, PharmD Date Clinical Pharmacy Specialist Facility

OFOC SOP Revision 08 Page 4 of 4

Revision 08 Date: 04/18/2018

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.

Beth A. Cook Date Contracting Officer Network Contracting Office (NCO) 16

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.

Windell Lance Date Branch Chief, Div I, Services C

Network Contracting Office (NCO) 16 http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx