N6264519RCES052-Attachment_V-Incubators-International_Biomedical-SD-JA_Redacted.pdf

LOG #: 19-10019

N6264519RCES052 Page 1 of 4 1 Nov 12 Incubators/International Biomedical

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, on behalf of the Navy to meet the requirements of Naval Medical Center San Diego (NMCSD).

2. Nature and/or description of the action.

The proposed action is for three (3) incubators, infant, transport [12-114] for NMCSD. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is International Biomedical of 8206 Cross Park Rd., Austin, TX 78754.

3. Description of the supplies/services required.

The Naval Medical Logistics Command has a requirement for three (3) incubators, infant, transport [12-114] for NMCSD. The incubators shall be mobile units capable of monitoring, ventilating, and protecting neonates in transport. The incubators shall be capable of being used on intubated neonates. The incubators shall have an upper enclosed patient chamber with 360º visibility with at least four (4) hand ports and five (5) access ports for intravenous (IV) and respiratory tubing. The incubators shall have head and front access doors. The incubators shall have a pressure diffusing mattress and a slide out intubation tray. The incubators shall have infant positioning straps.

The incubators shall include a built-in oxygen analyzer, eye shields, and suction. The incubators shall not permit sound levels exceeding 60 dB within the patient chamber. The incubators shall be on rolling carts and shall each include an exam lamp. The incubators shall have a temperature-controlled environment with a skin temperature probe. The incubators shall have digital air temperature control with a minimum temperature of 17ºC (62.6ºF) and a maximum of 39ºC (102.2 ºF).

The incubators shall each include a transport patient monitor with a liquid crystal display (LCD) display screen. The transport patient monitors shall at a minimum monitor electrocardiogram (ECG), Masimo Rainbow SET SpO2 for pulse oximetry, respiration, and non-invasive blood pressure (NIBP). The transport patient monitors shall have a minimum battery life of 5 hours. The incubators shall each include an integrated pediatric/neonatal ventilator that can be used without interruption during transport. The pediatric/neonatal ventilators shall be gas-powered via a pressurized tank or a wall outlet. The pediatric/neonatal ventilators shall deliver continuous flow oxygen at a minimum range of 21-100% oxygen with a minimum frequency range of 2-130 cycles per minute. The pediatric/neonatal ventilators shall deliver tidal volumes at a minimum range of 0-666 cc and a maximum pressure of 70 cmH2O. Each incubator shall store a minimum of four (4) E-cylinder compressed medical gas tanks for transport. The incubators shall be capable of connecting to both the transport E-cylinders and the hospital wall source medical gases.

The incubators shall have maximum dimensions of 21 x 20 x 40 in. (HxWxL). The incubators shall include audible and visual alarms to indicate failure of the system, temperature sensor, power, air flow, alternating current (AC), as well as high temperature and low battery. The incubators shall run on external power supply when stationary but shall be battery powered during transport. The incubators shall have a minimum battery life of 5 hours. The vendor shall include two (2) operator and service manuals each. The power requirements are 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 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.

Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to

N6264519RCES052 Page 2 of 4 1 Nov 12 the location of intended use for installation, and removing all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

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 10 USC 2304(c)(1) and FAR 13.501(a), Only One Responsible Source.

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

Only International Biomedical is capable of providing infant transport incubators that can store a minimum of four

(4) E-cylinder compressed medical gas tanks. Due to the size of NMCSD’s campus, transports can be lengthy in duration. In order to ensure patient safety, a minimum of four (4) E-cylinder compressed medical gas tanks are required to be stored with the incubator for extended periods of patient ventilation. No other vendor can provide an infant transport incubator capable of storing a minimum of four (4) E-cylinder compressed medical gas tanks.

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 Federal Business Opportunities (FBO) in accordance with FAR 5.201. A Notice of Intent (NOI) was psoted on FBO from 24 April 2019 to 09 May 2019. No challenges were received to the NOI.

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

The Contracting Officer will determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval to be fair and reasonable by conducting a price analysis before an award is made.

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 March 2019. It included a search of the Internet using Google, Bing, ECAT, GSA Advantage, and the ECRI Sourcebook. Vendors which can provide infant transport incubators include Advanced Healthcare Technology (AHT), Avante Health Solutions, Draeger, Inc., International Biomedical, Natus Medical Incorporated, Nice Neotech Medical Systems, and VIA Global Health, Inc.

International Biomedical is the only vendor that can provide an infant transport incubator capable of supporting a minimum of four (4) E-cylinder compressed medical gas tanks. AHT, Avante Health Solutions, Draeger, Inc., Natus Medical Incorporated, Nice Neotech Medical Systems, and VIA Global Health, Inc can only provide incubators that are capable of carrying up to two (2) E-cylinder compressed medical gas tanks. Compressed medical gas tanks are required to support mechanical ventilation during transport of neonates within the Neonatal Intensive Care Unit (NICU) and outside of the NICU to other areas of the hospital. Areas within the hospital that may require transport for further patient care include Labor and Delivery (L&D), Main Operating Room (MOR), and multiple radiological study areas. Infant transport incubators are also used for neonatal emergencies that result in resuscitation that occur outside of a clinical or inpatient area. Due to the size of NMCSD, transports can be lengthy in duration. In order to ensure patient safety, a minimum of four (4) E-cylinder compressed medical gas tanks are required to be stored with the incubator for extended periods of patient ventilation.

No other vendor can provide an infant transport incubator capable of storing a minimum of four (4) E-cylinder compressed medical gas tanks. Therefore, only International Biomedical can provide infant transport incubators that meet the minimum requirements of the Government.

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

N/A

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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 5.201. 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.

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Technical and requirements certification I certify that the facts and representations under my cognizance which are included in this J&A and which form a basis for this justification are complete and accurate.

Technical Cognizance

Clinical Engineer, NMLC

Requirements Cognizance

Senior Clinical Engineer, NMLC

CONTRACTING OFFICER CERTIFICATION

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

Contracting Officer