LSJ_Redacted.pdf

LOG # 10195-14

Form 02.4G.AA/TDP 14-097-14 / PR N6264514RCES032/Page 1 of 3 1 May 14

LIMITED SOURCE JUSTIFICATION

1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY: The Naval Medical Logistics Command, acting on behalf of the Naval Medical Center San Diego (NMCSD), intends to award a delivery order against Federal Supply Schedule (FSS) contract V797P-4736a, pursuant to the authority of the Multiple Award Schedule Program.

2. NATURE/DESCRIPTION OF CONTRACT ACTION: The limited source justification is for a cost-per-reportable-result IDIQ contract for chemistry and microscopy urinalysis analyzers, which will include automated laboratory urine analyzers. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Iris Diagnostics (Beckman Coulter), 9158 Eton Avenue, Chatsworth, CA 91311.

3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES:

Naval Medical Center San Diego has a requirement for cost-per-reportable-result (CPRR) contract for chemistry and microscopy urinalysis, which will include two (2) analyzers, laboratory, urine, automated.

The instrument shall be capable performing the following chemical tests: ascorbic acid, bilirubin, blood, glucose, ketone body, leukocyte esterase, nitrite, pH, protein, specific gravity, urobilinogen. The instrument shall be capable of performing both chemistry and microscopy urinalysis. The instrument shall be capable of handling the estimated yearly workload of approximately 47,000 chemistry tests and 28,000 microscopy tests. The instrument shall be capable of processing at least 60 microscopy samples per hour; the instrument shall also have 60 sample “walk away” or pre-loading capability. The instrument shall be capable of at least 100 chemistry samples per hour. If calibration activities are required, they shall be required at a frequency of no more than monthly.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized distributor for the proposed equipment and supplies.

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.

4. IDENTIFICATION OF THE JUSTIFICATION RATIONALE AND/OR

DEMONSTRATION OF CONTRACTOR’S UNIQUE QUALIFICATIONS: The statutory authority which permits restricting consideration of schedule contractors to fewer than that required in FAR 8.405-1 is 41 U.S.C. 251, as implemented by FAR 8.405-6(b)(1), Only one source is capable of responding. The proposed requirement is for a CPRR contract for chemistry and microscopy urinalysis, which will include two (2) analyzers, laboratory, urine, automated.

In accordance with FAR 8.405-6(b)(1) Only one source is capable of responding.

Form 02.4G.AA/TDP 14-097-14 / PR N6264514RCES032/Page 2 of 3 1 May 14

Iris Diagnostics (Beckman Coulter) is the only vendor that can support a cost-per-test contract which provides an automated urinalysis analyzer that can perform all required chemistry and microscopy urinalysis tests. No other vendor can provide an analyzer that can perform all of the clinically required tests; specifically, only Iris Diagnostics can offer an automated analyzer that can provide ascorbic acid measurements. Ascorbic acid measurements are required to identify possible interference from high ascorbic acid levels (a common source of false negatives for other chemistry urinalysis tests). Only Iris Diagnostics (Beckman Coulter) can meet the requirements of the Government.

5. DETERMINATION OF BEST VALUE: A determination will be made by the ordering activity contracting officer that the order represents the best value consistent with FAR 8.404(d).

The FSS pricing, along with the contractor’s ability to meet our delivery terms will represent the best value to the Government.

6. DESCRIPTION OF MARKET RESEARCH: Market research was conducted in March and April 2014. The market research included a search of the Internet using Google, Bing, GSA Advantage, and the ECRI Sourcebook, as well as a search of scholarly articles using PubMed.

Manufacturers that can provide automated urinalysis analyzers that combine chemistry and microscopy analysis include Iris Diagnostics (Beckman Coulter) and Siemens. Siemens cannot provide an automated urine analyzer that can analyze samples for ascorbic acid. Iris Diagnostics (Beckman Coulter) is the only vendor that can meet the minimum requirements of the Government.

7. ANY OTHER SUPPORTING FACTS: None

8. ACTIONS TAKEN TO REMOVE BARRIERS TO COMPETITION: As the barriers that preclude the agency from the requirements of section 8.405-1 are due to limited vendors on schedule, no actions can be taken by this agency to remove those barriers. If additional vendors are added to the FSS for this equipment, they will be considered as applicable.

Form 02.4G.AA/TDP 14-097-14 / PR N6264514RCES032/Page 3 of 3 1 May 14

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 8.405-6(c) (x)

Technical Cognizance

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION REQUIRED BY FAR 8.405-6(d)(1)

I CERTIFY THAT THIS JUSTIFICATION IS ACCURATE AND COMPLETE TO THE BEST OF MY

KNOWLEDGE.