Redacted_J&A_TDP_19-091.pdf

Form 02.4G.AB 18 Apr 2016

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 two (2) ventilators, intensive care, neonatal/pediatrics, high-frequency [18- 793] for Naval Medical Center San Diego (NMCSD). The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Bunnell Incorporated of 436 Lawndale Drive, Salt Lake City, UT 84115-2917.

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

The Naval Medical Logistics Command (NMLC) has a requirement for two (2) ventilators, intensive care, neonatal/pediatrics, high-frequency [18-793] for Naval Medical Center San Diego (NMCSD). The ventilators shall be high-frequency jet ventilators that deliver short, high velocity pulses of gas into infant lungs at fast rates to oxygenate neonatal patients with lung disease. The ventilators shall be capable of ventilating at a minimum rate of 240-600 breaths per minute (bpm). The ventilators shall be capable of delivering a peak inspiratory pressure (PIP) of at least 8-50 cm H20. The ventilators shall have an inspiratory time (I-Time) of at least 0.020-0.034 seconds. The ventilators shall have an integrated automated humidifier and an alarm system to alert clinicians of changes in the patient or ventilator system. The ventilators shall include a box that contains the inhalation valve and pressure transducer.

Each ventilator shall have a spare inhalation valve and pressure transducer box. The ventilators shall have a built-in battery backup to allow for transportation of patients without a disruption in ventilation. The batteries shall charge continuously when the ventilator is plugged into an electrical outlet. Each ventilator shall include a rolling cart and intravenous (IV) pole mounting kit. The units shall include a one (1) year standard warranty. The power requirement is 120 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.

Defense Health Program (DHP) O&M Fiscal Year 19 funds in the amount of $84,945.00 will be used to procure the high-frequency intensive care ventilators.

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 10 U.S.C.

2304(c)(1) and FAR 13.106-1(b)(1) soliciting from a single source.

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

Bunnell Incorporated is the only vendor that can provide a high-frequency ventilator that uses jet ventilation to adequately and safely ventilate neonates with lung disease. No other vendor can provide a high-frequency jet ventilator that is intended for uses jet ventilation to treat neonates with lung disease in the Neonatal Intensive Care Unit (NICU) at NMCSD. Bunnell Incorporated is the only vendor 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 initially in May 2017 and again in February 2019. It included a search of the internet using Google, FDA 510(k) records, and the ECRI Sourcebook. It was determined that the following vendors can provide high-frequency intensive care ventilators: Becton, Bunnell Incorporated, Dickinson and Company, International Biomedical, Percussionaire Corp., SLE Ltd, SensorMedics Corp., Susquehanna Micro, and Vyaire Medical Inc. Of these vendors, only Bunnell Incorporated and Susquehanna Micro can provide high-frequency intensive care ventilators that are capable of jet ventilation.

International Biomedical and Percussionaire Corp. can only provide standard high-frequency ventilators and they are designed solely for neonatal patient transport. Thus, International Biomedical and Percussionaire Corp. do not meet the minimum requirements of the Government. Becton, Dickson and Company, SLE Ltd, SensorMedics Corp., and Vyaire Medical Inc. can only provide high-frequency oscillatory ventilators. High-frequency jet ventilators are a more gentle form of ventilation with passive exhalation to enhance mucociliary clearance and allow for injured areas of the lung to heal. Standard high-frequency ventilators and high-frequency oscillatory ventilators use more pressure to ventilate the lungs of neonates. This may slow recovery and put the infants at higher risk for further lung damage.

Thus, Becton, Dickson and Company, SLE Ltd, SensorMedics Corp., and Vyaire Medical Inc. do not meet the minimum requirement of the Government. Susquehanna Micro can provide a high-frequency intensive care jet ventilator, but it is only FDA 510(k) approved for use in bronchoscopy and laryngoscopy surgeries. The high-frequency intensive care jet ventilator provided by Susquehanna Micro is not permitted for use on infant patients with lung disease. Only Bunnell Incorporated can provide a high-frequency ventilator that uses jet ventilation to adequately and safely ventilate neonates with lung disease. Thus, only Bunnell Incorporated manufactures a ventilator that meets the minimum requirements of the Government.

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, no other sources have 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 Phone 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 E. Gaither, Code 05 Phone Date Contracting Officer