J&A_TDP_18-030_v2.doc

Log #xx-xxxxx (if > $150K)

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition.”

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

2. Nature and/or description of the action being approved.

The proposed action is for one (1) urodynamic measurement system [14-307] for NMCSD. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed manufacturer is Laborie Medical Technologies, Corp. of 400 Avenue D, Suite 10, Williston, VT 05495.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The Naval Medical Logistics Command has a requirement for one (1) urodynamic measurement system [14-307] for Naval Medical Center San Diego (NMCSD). The urodynamic measurement equipment shall be capable of examining the bladder, sphincter, and urethra, so as to evaluate the storage and release of urine in both adult and pediatric patients. The following bladder functions shall be diagnosable by the provided solution: urge incontinence, stress incontinence, urinary retention, urinary frequency, nocturia, hesitancy, and various storage and micturition issues. The urodynamic equipment shall be capable of performing urodynamic studies, including uroflow tests, electromyography (EMG), postvoid residual (PVR) urine measurements, simultaneous voiding cystometrography (CMG), and filling CMG. The urodynamic equipment shall capture pictures and video of the bladder during the filling and voiding of urodynamic tests. All urodynamic study imaging and procedural results shall be recordable and printable by the urodynamic monitoring system. Additionally, the urodynamic equipment shall have the cordless interfacing for patient safety and wireless recording of urodynamic procedures and measurements, such as catheterization, EMG, and uroflow.

The urodynamic equipment shall be compatible with the existing Dornier urological/radiographic/fluoroscopic procedure table. The urodynamic measurement system shall allow for dual visualization of the bladder in real-time and x-ray images in simultaneous urology and radiology procedure, especially for pediatric patients. The urodynamic equipment shall be mobile to allow for various room set-ups. In addition, the urodynamic equipment should include pump control for empty bag detection, button-controlled transducers for patient use, dedicated computer, and patient towers. The urodynamic measurement system shall read and transfer data from the existing Laborie urodynamic equipment. The system shall interface with the various x-ray units and ultrasound equipment in the Urology Department at NMCSD. The provided solution shall include all urodynamic software, roam, EMG, commode chair and funnel, printer, sensory array accessories, video accessories (i.e. computers, cables), urodynamic education courses, and the in-service kit. The power requirements are 110 VAC, 60 Hz.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

DHP Operation and Maintenance Fiscal Year 18 funds in the amount of $93,549.00 will be used to procure the urodynamic measurement equipment.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is FAR 13.106-1(b)(1) soliciting from a single source (including brand name.)

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

Aquarius XT Urodynamic Analyzer, manufactured by Laborie Medical Technologies (Laborie) is the only urodynamic measurement equipment that can provide both video recording capability and dual procedure (i.e. urology and radiology) capability, with simultaneous visualization of bladder in real-time and x-ray images. No other manufacturer’s product can provide both video recording capability and dual procedure (i.e. urology and radiology) capability, with simultaneous visualization of bladder in real-time and x-ray images. Thus, the Aqarius XT Urodynamic Analyzer is the only analyzer that can meet the minimum requirements of the Government.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202.

7. A 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 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. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted in November 2017. Research included references and information derived from Internet searches via Google, GSA Advantage, Defense Medical Logistics Standard Support (DMLSS), and the ECRI Sourcebook. It was determined that urodynamic measurement equipment can be provided by the following vendors: CooperVision, Inc., Laborie Medical Technologies, Corp. (Laborie), Neomedix Systems Pty, Ltd., and SRS Medical Corp. Although SRS Medical Corp. manufactures the EasyPro that is available on the Federal Supply Schedule, the urodynamic measurement unit is not capable of video recording or displaying of bladder or x-ray images. Similarly, the urodynamic measurement equipment from Cooper Vision, Inc. is not capable of video recording and displaying of bladder or x-ray images; the Cooper Vision Lumax FiberOptic Cystometry System can only display flow pattern graphs. Although the urodynamic equipment manufactured by Neomedix Systems Pty, Ltd. is capable of displaying simultaneous flow patterns, as well as live video images from fluoroscopy or ultrasound video signals, it cannot conduct two separate studies (ex. urology and radiology procedures) necessary for pediatric patient cases. Furthermore, only Aquarius XT Urodynamic Analyzer, manufactured by Laborie can provide urodynamic measurement equipment capable of video recording and displaying bladder and x-ray images, as well as perform simultaneous urodynamic procedures. Thus, only Laborie manufactures urodynamic equipment that meets the minimum requirements of the Government. Veterans Healthcare Supply Solutions, Inc. is an authorized distributer of Laborie products.

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

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, only Veterans Healthcare Supply Solutions, Inc has written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the 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. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

301-619-1101

Dr. Anthony Metzger, Code 03 Phone Date

Clinical Engineer, NMLC

Requirements Cognizance

301-619-7002

Anthony Angelo, Code 03

Date

Senior Clinical Engineer, NMLC

CONTRACTING OFFICER CERTIFICATION

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

301-619-8594

Carrie Gaither

Date

Code 05

Contracting Officer

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.

____________________________________________301-619-2150______________________

Counsel Phone Date

Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

____________________________________________301-619-3095______________________

Darin L. Callahan

Date

Competition Advocate Form 02.4G.AB

18 Apr 2016