J&A_Redacted_-_Sterilizing_Units.pdf

Log #19-10005

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 Hospital (NH) Pensacola and NH Beaufort requirements.

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

This requirement is for three (3) Sterilizing Units, Germicidal Gas, Gaseous Plasma [18-146] for Naval

Hospital Pensacola and Naval Hospital Beaufort. The Government intends on awarding a Firm, Fixed-

Price (FFP) contract. The proposed manufacturer is Johnson & Johnson Health Care Systems, Inc. of 425

Hoes Lane, Piscataway, NJ 08854-4103.

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

Naval Hospital (NH) Pensacola has a requirement for one (1) Sterilizing Unit, Germicidal Gas, Gaseous

Plasma [18-146]. NH Beaufort has a requirement for two (2) Sterilizing Units, Germicidal Gas, Gaseous

Plasma [18-146]. The sterilizers shall be capable of sterilization through the use of low temperature gas plasma generated in an enclosed vacuum chamber using radio frequency or microwaved energy. The units shall be capable of inactivating microorganisms by the combined use of hydrogen peroxide (H2O2) gas sterilant coupled with the generation of free radicals during the plasma phase of the sterilization cycle.

The units shall be validated for low-temperature gas plasma sterilization at temperatures less than 60 ̊ C.

The units shall utilize a H2O2 concentration as the sterilant. The sterilant concentration levels shall be monitored by ultraviolet (UV) sensors within the chamber. The stand-alone units shall be capable of high-level disinfection of flexible endoscopes, light cords, cameras and accessories utilized in arthroscopic and laparoscopic procedures.

Navy Operation and Maintenance Fiscal Year 19 funds in the amount of $260,000.00 will be used to procure Sterilizing Units for NH Pensacola and NH Beaufort. The delivery date for this procurement will be 20 March 2019.

The units shall automatically detect and remove moisture within the vacuum chamber prior to sterilization. The units shall be capable of standard cycle sterilization and processing endoscopes with and without lumens to meet each scope’s manufacturer’s instructions for use (IFU). The sterilizers shall be compatible with the installed base of flexible endoscopes at NH Pensacola and NH Beaufort, including, but not limited to, equipment listed in table 1 and table 2 below. The units shall be compatible with Aesculap sterilization trays. The units shall have one single door for ingress and egress of flexible endoscopes, light cords, cameras and accessories. The electrical power requirements are 208 VAC, 60

Hz.

Table 1: NH Pensacola Inventory

Scope Nomenclature Manufacture

Urology Scopes (flexible, rigid, micro) Olympus

Urology Flexible Scopes Stryker

Cameras Olympus

Light Cords Olympus

Cameras Stryker

Light Cords Stryker

Cystoscopy Scopes Stryker

Arthroscopy Scopes Stryker

ENT Scopes Stryker

Laparoscopy Scopes Stryker

Hysteroscopy Scopes Stryker

Drill & Saw Batteries Stryker

Table 2: NH Beaufort Inventory

Scope Nomenclature Manufacture

Arthroscopes Arthrex Inc.

Arthroscopes Stryker

Cameras Stryker

Light Cords Olympus

Light Cords Stryker

Laparoscopy Scopes Stryker

Drill & Saw Batteries Stryker

Drill Hand piece Smith and Nephew

The units shall meet the validation standards set forth by Association for the Advancement of Medical

Instrumentation (AAMI), International Organization for Standards (ISO) and American National

Standards Institute (ANSI). Sterilization cycles shall meet the International Organization for Standards

ISU14937 – Sterilization of Healthcare Products and AAMI ST58 – Sterilization and High Level

Disinfection in Healthcare Facilities.

NH Beaufort has two (2) units available for trade-in, outlined in the trade-in memo. The vendor shall be responsible for de-installation and removal of the units at NH Pensacola and NH Beaufort.

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.

Contractor 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.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. The vendor is also responsible for the initial instrument operational and performance validations.

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 6.302-1 sole source (including brand name) acquisitions OR 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.

The Johnson & Johnson Health Care Systems, Inc. brand name unit is the only system that holds an FDA-approval for a low temperature gas plasma sterilizer that utilizes a hydrogen peroxide (H2O2) concentration sterilant. The low temperature gas plasma sterilization is required for temperature and moisture sensitive scopes which require sterilization. The Johnson & Johnson Health Care Systems, Inc.

brand name unit is the only system that meets 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 will 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 by technical experts in July 2018. This research consisted of reviews of similar previous procurements and a market survey, using search engines to review open market contractors and Federal Supply Schedule contractors. Searches included utilizing Google, Bing, GSA

Advantage and the ECRI sourcebook catalog. Vendors that can provide low temperature gas plasma sterilizers include Johnson & Johnson Health Care Systems, Inc. (Johnson & Johnson), Getinge USA, Inc.

(Getinge), Steris Corporation (Steris), Tuttnauer, E.A. Fischione Instruments (Fischione), SciCan Ltd.

(SciCan), CISA Group (CISA) and BES Decon.

SciCan, CISA and BES Decon can provide low temperature gas plasma sterilizers, although the available sterilizers are not FDA-approved. Thus, SciCan, CISA and BES Decon do not meet the minimum requirements of the Government. Fischione can provide low temperature gas plasma sterilizers, although the sterilizer does not utilize a hydrogen peroxide (H2O2) concentration sterilant. Additionally, the sterilizers offered by Fischione are not FDA-approved, therefore do not meet the minimum requirements of the Government. Getinge and Steris can provide low temperature sterilizers but their offered products are not functionally capable of the plasma phase in the processing cycle. The plasma phase is beneficial to remove residual H2O2, thus Getinge and Steris do not meet the minimum requirements of the

Government. The low temperature gas plasma sterilizers provided by Tuttnauer are not available in North

America and are not FDA-approved, thus do not meet the minimum requirements of the Government.

Johnson & Johnson is the only vendor that can provide a FDA-approved low temperature gas plasma sterilizer that utilizes a hydrogen peroxide (H2O2) concentration sterilant. Johnson & Johnson is the only vendor that meets the minimum requirements of the Government. Authorized distributors of Johnson and

Johnson include Beacon Point Associates and Geo-Med.

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.