V797P2202D-005.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID:___36C261-19-AP-4208__________________

1. Contracting Activity: Department of Veterans Affairs Network Contracting Office (NCO) VISN 21, located at 3801 Miranda Avenue, Palo Alto, CA 94304-1209

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501).

The proposed purchase is to enter into a firm-fixed price contract on the basis of justification for other than full and open competition for the VA Northern California Healthcare System.

The sole source for Radium – 223 is Bayer Healthcare Inc distributed by Cardinal Health.

This purchase is available under FSS contract V797-2202D.

Manufacturer/Contractor: Bayer Healthcare Pharmaceuticals Inc Manufacturer/Contractor POC & phone number: Lauree Casey 425-275-8849 Mfgr/Contractor Address: 100 Bayer Blvd, Whippany, NJ 079811544

Dealer/Rep address/phone number: Cardinal Health

201 Lathrop Way Suite D Sacramento, CA 95815 916-648-2181

3. Description of Supplies or Services:

The estimated value of the proposed action is $334,000.00 for 12 months

Purchase request is for Radium – 223 Therapy protocol to be purchased on as needed basis up to 24 doses. Each dose is based on average patient of 220 pounds. Dose is 1.49 uCi per kilogram.

https://www.gpo.gov/fdsys/pkg/USCODE-2009-title41/pdf/USCODE-2009-title41-chap4-subchapIV-sec251.pdf https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

(CHECK ALL THAT APPLY AND COMPLETE)

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

x Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data.

Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH

FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE

DETERMINATION:

As referenced in FAR 8.404(d):

(d) Pricing. Supplies offered on the schedule are listed at fixed prices. Services offered on the schedule are priced either at hourly rates, or at a fixed price for performance of a specific task (e.g., installation, maintenance, and repair). GSA has already determined the prices of supplies and fixed-price services, and rates for services offered at hourly rates, under schedule contracts to be fair and reasonable. Therefore, ordering activities are not required to make a separate determination of fair and reasonable pricing, except for a price evaluation as required by 8.405- 2(d). By placing an order against a schedule contract using the procedures in 8.405, the https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891

VHAPM Part 808.405-6 Limiting Sources Page 4 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

Carol Lam Date Contracting Officer

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.

Don Neal Date Supply Branch Supervisor