P03 SSJ_Germfree mobile unit 02.pdf

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

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C241-20-AP-0962 Contracting Activity: Department of Veterans Affairs, VISN 01, West Haven Medical Center

Nature and/or Description of the Action Being Processed:

The VA Connecticut Healthcare System (VACHS) requires a 5-year contract (1 base year, 4 option years) for leasing a mobile pharmacy compounding center that is compliant with U.S. Pharmacopeia Convention (USP) Chapters 797 and 800. The estimated cost for a five year contract is $1,805,555.00.

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

The VA Connecticut Healthcare System (VACHS) currently has a contract for leasing a mobile pharmacy compounding center through Germfree Laboratories Incorporated. The VACHS requires a continued 5-year contract (1 base year, 4 optional years) for leasing this mobile pharmacy compounding center that is compliant with U.S. Pharmacopeia Convention (USP) Chapters 797 and 800. The mobile pharmacy enables compliant compounding of sterile hazardous pharmaceutical drugs. The unit is located in the parking area outside the southeast perimeter of building 2, and west of building 2A.

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;

( ) (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):

Currently, VA Connecticut (VACT) has a mobile compounding unit in place, provided by Germfree Laboratories Incorporated. This unit is fully operational and compliant with USP Chapters 797 and 800.

VACT needs to continue use of this unit to eliminate a lapse of compliance by removing and installing a new mobile compounding unit. Removal and replacement of this unit from the site would impact and have safety risks to patient care. Removal and re-installation would also cause site prep features needing to be redone. The approximate costs for this process would be $27,000.00 for the removal of the unit, re-leveling the ground, installing a new unit, and making any necessary adjustments to ground again to keep it level.

his entire process would not be cost effective and would cause further delays. As for the current Inpatient Pharmacy IV compounding center within the Medical Center, it is not fully compliant with the aforementioned USP Chapters. It does not meet the required pressure differentials and has experienced water infiltration and therefore is currently not in operation. It is not expected to be in compliance for an indefinite time period and thus, the five year rental of the current mobile compounding unit is required for proper patient care.

OFOC SOP Revision 08 Page 1 of 3 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

OFOC SOP Revision 08

Revision 08 Date: 04/18/2018

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

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

A Sources Sought notice was posted to FBO from 2/12/20 to 2/18/20. Three businesses replied with either an interest in the solicitation or stating they could fulfill the needs. VACHS already has the mobile unit on-site and needs to remain on-site to maintain compliance and avoid impacts to patient care. Market research was conducted on GSA and VIP which showed no other sources that could provide the required trailer in the necessary time frame.

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

An IGCE was provided based on past prices and figuring in the likelihood for a 3% increase in costs to maintain the trailer over 5 years. This will be used to help evaluate the Contractor’s price and in determining if these prices are fair and reasonable.

Description of the Market Research Conducted and the Results:

Market research was conducted on GSA under Leased Heavy Duty Vehicles and Accessories (271-112). This showed an SDVOSB and a small business. The SDVOSB does not provide pharmacy trailers. From past history, the small business had stated that they required several months to manufacture the trailer and then deliver and set-up which is a time frame longer than the West Haven VA has available. The trailer is needed on-site and fully functional on 6/15/2020. Market research was continued on VIP but there were no SD/VOSBs under the appropriate NAICS and PSC. A Sources Sought notice was posted to FBO from 2/12/20 – 2/18/20. One foreign owned business sent a response stating interest in the solicitation but provided no other information. One SDVOSB replied saying they would be able to provide pricing for the materials on the list of specifications. Finally, a small business said they would be able to provide the requested mobile unit. However, VACHS already has the mobile unit on-site and needs it to remain on-site to maintain compliance and avoid impacts to patient care.

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

Removal and replacement of the existing unit from the site would directly impact and have safety risks to patient care. Removal and re-installation would also cause site prep features to need to be redone. A new mobile unit requires a 3 week commissioning project before it can be used. The VA must then self-certify, through a third party, that the unit is clear to use. This would not be cost effective and would cause further delays.

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

- Aviate Enterprises, Inc. | 5844 Price Ave., McClellan, CA 95652

- Modular Devices, Inc. I 6678 Guion Rd., Indianapolis, IN 46268

- Euclid Infotech |201 Eden Rose Shopping Centre, Beverly Park, Kanakia Rd., Thane 401107 India

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 West Haven VAMC strives to implement a pharmacy compounding unit within the Medical Center itself but this requires extensive time, funding, and collaboration between Directors, staff, and Contractors. In the meantime, the rental of the mobile unit is required for proper patient care.

OFOC SOP Revision 08

Revision 08 Date: 04/18/2018 arriah Woodard, Program Spec

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

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.

Darriah Woodard, Program Specialist Date West Haven VAMC

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.

William Prenzler, Branch Chief Date West Haven VAMC

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.

Tammy Fox, Division Chief Manchester VAMC

Date

c. VHA SAO 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 VHA Head of Contracting Activity (HCA)

Darriah N. Digitally signed by Darriah N.

Woodard 491562

Woodard 491562 Date: 2020.02.28 13:53:43 -05'00'

03/02/2020

William A.

Prenzler 145645

Digitally signed by William A.

Prenzler 145645 Date: 2020.03.02 11:02:11 -05'00'

Tammy A Fox 706200

Digitally signed by Tammy A Fox 706200 Date: 2020.03.03 21:13:50 -05'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2020.06.15 09:50:58 -04'00'