Final_Redacted.pdf

Log #10365-14

Form 02.4G.AB / N0025915RCE0084 Page 1 of 4 1 Nov 2012

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD to meet the requirements of the Naval Medical Center San Diego (NMCSD).

2. Nature and/or description of the action.

The purchase of an automated prescription will-call storage, dispensing & tracking system for completed prescriptions that currently interfaces with existing automation (CHCS/AHLTA and PharmASSIST systems), therefore preventing the dispensing of prescriptions to the wrong beneficiary by electronically verifying the beneficiaries identity and ensures prescriptions of one member are not bundled or associated with another members prescriptions.

The Government intends on awarding a Firm Fixed Price (FFP), five (5) year IDIQ contract. The proposed source is Central Admixture Pharmacy Services (CAPS) 18021 Cowan Ste 250, Irvine CA

92614.

3. Description of the supplies/services required.

This requirement is for preparation and delivery of Intravenous Total Parenteral Nutrition Solutions

(TPN’S) for hospitalized patients at NMCSD. The compounded TPN’s are for critical care patients in

Intensive Care Units (ICU), Neonatal Intensive Care Units (NICU), Pediatric Intensive Care Unit (PICU) who are unable to provide nutrition for themselves and whose health is unstable. With chemistry levels changing daily the adjustment of TPN’s daily is crucial. It is vital for these delicate patients to receive

TPN’s like clockwork without disrupting care or delivery as this can decrease stability, prolong recovery or cause patient to expire. Contractor shall comply with all Federal, State and local laws, regulations and governmental orders, including applicable State Board of Pharmacy regulations and United States

Pharmacopeia (USP) Chapter 797 and Good Compounding Practices (USP 1075).

The systems shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the

FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

funds will be used to procure the supplies on each delivery order. The total anticipated cost for the five year ordering period is .

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is FAR

13.501(a) and U.S.C. 2304(c)(1) – Only one responsible source. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-Cohen Act of 1996).

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Currently, CAPS is the only available company that can provide Total Parenteral Nutrition Solutions locally, adjusting TPN’s levels accordingly, adding new patients on the spot and meeting requirements stat daily as scheduled by 13:00 hours and delivering directly no later than 17:00 hours to NMCSD In-

Form 02.4G.AB / N0025915RCE0084 Page 2 of 4 1 Nov 2012

Patient Pharmacy without disruption in TPN’s service. Contractor complies with state and local laws regulations and governmental orders, including applicable State Board of Pharmacy regulations and

United States Pharmacopeia (USP) Chapter 797 and Good Compounding Practices (USP 1075).

Contractor also provides equipment, component, or computer software provided to NMCSD for the purpose of transmitting prescription orders to Contractor (to include personal computer, monitor, printer, modem, and/or facsimile machine).

After interviewing with Coram, a competitor, they stated that they were not equipped to meet the volume

NMCSD requires. Walmart and Walgreens only make TPN’s for home health care. Home health care is for stable patients who are not in critical care units. Other companies are not local or do not provide service required. Local hospitals are 797 compliant and procure their own TPN’s.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FBO in accordance with FAR 5.202. The Government will evaluate any challenges received.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval (J&A) will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in May through June 2014 by NMCSD Pharmacy Department. Local vendors that can provide TPN’s include Coram, Sharp Infusion Services, and Walgreen’s. Due to these items being time sensitive, vendors must be nearby in order to deliver the requirements within the timeframe needed by the Medical Treatment Facilities (MTF). Coram and Walgreen are unable to meet the needs of NMCSD as it is outside of their scope to handle such a significant requirement. Sharp

Infusion Services only supports Sharp entities and is not authorized to conduct business with NMCSD.

CAPS is the only manufacturer that can meet the minimum requirements of the Government; CAPS distributes these supplies directly and has no authorized distributors.

9. Other facts supporting the use of other than full and open competition.

The NMCSD Pharmacy staff has researched similar Companies and they have been unable to meet the quantity or required daily demands. Other companies use our current contractor to provide service via their companies

10. Listing of Sources, if any, which expressed in writing an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FBO in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

Form 02.4G.AB / N0025915RCE0084 Page 3 of 4 1 Nov 2012

12. Point of Contact

The point of contact at the NMLC, Fort Detrick, Frederick, MD, regarding the contents of the J&A is who can be reached at

Form 02.4G.AB / N0025915RCE0084 Page 4 of 4 1 Nov 2012

TECHNICAL AND REQUIREMENTS CERTIFICATION

Required by FAR 13.501

I certify that the facts and representations under my cognizance which are included in this justification, which form a basis for this justification, are complete and accurate.

Phone Date Technical Reviewer

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Contracting Officer Code 05

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

Office of Counsel Code OOL

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

Code OO