J A_Redacted.pdf

Log #16-10145

Form 02.4G.AB | TDP 16-125 Page 1 of 4 30 March 2015

JUSTIFICATION AND APPROVAL

FOR 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 the requirements of Naval Hospital Camp Pendleton (NHCP).

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

The proposed action is for maintenance support of Stryker endoscopy & surgical equipment, including all preventative maintenance, corrective maintenance, applicable parts, and labor. The Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is Stryker Corporation, 2825 Airview Blvd., Kalamazoo, MI, 49002-1802, United States of America.

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

The requirement is to support and maintain designated, Government-owned Stryker Corporation endoscopy and surgical equipment located at Naval Hospital Camp Pendleton (NHCP). Specific devices are included in the performance work statement.

The maintenance for the medical equipment shall include unlimited telephone support, regularly scheduled preventive maintenance, inspections, calibrations, corrective maintenance tasks, and unlimited emergency repair actions by vendor field service personnel, as outlined in the performance work statement.

To ensure equipment operation, the Contractor shall provide all parts, labor, materials, and freight shipping for the scheduled (preventive) and unscheduled (corrective) maintenance of NHCP Stryker endoscopy equipment and Stryker surgical equipment, as stipulated in the performance work statement.

When product recalls or upgrades are necessary to maintain the equipment in service within the original manufacturer’s specifications, the Contractor shall obtain and install same. If the equipment cannot be repaired or maintained for clinical use, the devices shall be replaced. Replacement for existing equipment, deemed damaged, shall be sent to NHCP within 8 business hours of initial equipment damage report. Replacement must be the exact same part/model number, generation, and image quality of equipment as the damaged item. Contractor must provide unlimited replacement quantities for equipment.

The aggregate amount of equipment covered under the contract shall have the ability to fluctuate throughout the term of the contract. This fluctuation may result from the removal of aged, unrepairable, past service life, or past useful life equipment from the service contract and the addition of new or warranty-free equipment. The collective requirement and level of effort will remain relatively constant over the life of the contract.

The Contractor shall maintain this equipment within the original equipment manufacturers (OEM) specifications, in accordance with all US, State, and Local laws and regulations, US NAVY regulations, US NAVY instructions, and Joint Commission requirements. The Joint Commission’s requirements are specified in its Comprehensive Accreditation Manual for Hospitals (CAMH), readily found on jointcommission.org. US NAVY regulations and instructions will be made available upon request.

This contract shall provide support coverage 0800 – 1700 (Pacific Time), Monday through Friday, unless otherwise specified in the equipment listing. Maintenance and support shall be provided for a one (1)

Form 02.4G.AB | TDP 16-125 Page 2 of 4 30 March 2015 year period of performance spanning 01 Aug 2016 to 31 July 2017, including four subsequent option years.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems, 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.

FY16 funds in the amount of will be used to fund the base year of this maintenance and on-site support agreement. Total contract value for all five (5) years is estimated at .

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

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

Stryker, the original equipment manufacturer (OEM), is the only company with the technical expertise and knowledge to repair this endoscopy equipment and surgical systems. The technology and designs are proprietary to the Stryker Corporation and, in many cases, patented. As such, Stryker will not divulge this information to entities outside its organization. No other vendor besides Stryker is capable of meeting the minimum requirements.

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 www.fbo.gov in accordance with FAR 5.202. The Government will evaluate any responses received.

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 March 2016. The market research conducted included a search of the Internet using Google, Bing, GSA Advantage, EDA, and the ECRI Sourcebook. There have been previous, local maintenance contracts for Stryker equipment at Naval Hospital Camp Pendleton; these agreements were analyzed as a part of the independent government cost estimate. Further, prior market research was conducted for the purposes of establishing similar maintenance and support agreements for NMC

San Diego and NH Jacksonville. These investigations yielded the same results as were found in the most current review.

There are other vendors of endoscopy and surgical equipment and maintenance services, but none of these vendors are trained or certified to maintain the Government-owned Stryker equipment utilized at

Naval Hospital Camp Pendleton. Stryker does not train or certify other entities to repair or maintain Stryker products. Only the services provided by Stryker are capable of supporting Stryker surgical and

Form 02.4G.AB | TDP 16-125 Page 3 of 4 30 March 2015 endoscopy equipment. Stryker Corporation is the only vendor which can meet the minimum requirements of the Government.

9. 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. This requirement will be posted on www.fbo.gov in accordance with FAR 5.202. 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.

Form 02.4G.AB | TDP 16-125 Page 4 of 4 30 March 2015

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

Phone Date

Technical Reviewer

Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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

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.

Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

Competition Advocate