JA_(18-10069)_N0018318RCSU457_Surgical_Kits_-_Legally_Sufficent.pdf

JUSTIFICATION AND APPROVAL

J&A No. 18-10069

JUSTIFICATION AND APPROVAL

FOR USE OF OTHER THAN FULL AND OPEN COMPETITION

1. 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 Portsmouth.

2. Description of the Action Being Approved.

The proposed action is for three (3) ZEVO ACP Self Drilling Sets and (6) SOLERA 4.75 Lumbar Screw System Sets that are compatible with the currently installed Medtronic Stealthstation system. These sets are for nine critical patient surgeries. The proposed source is Medtronic Sofamor Danek USA,Inc. of 1800 Pyramid Place, Memphis TN, 38132-1703 United States. Award of this contract is proposed on a sole source basis for the required Self Drilling Sets and Screw System Sets.

3. Description of Supplies/Services.

The Naval Medical Logistics Command has a requirement for three (3) ZEVO ACP Self Drilling Sets for anterior cervical surgical approaches and six (6) SOLERA 4.75 Lumbar Screw System Sets for posterior lumbar surgical approaches; for a total of nine (9) critical patient surgeries at Naval Medical Center Portsmouth, VA. Navy Operation and Maintenance Fiscal Year 18 funds in the amount of $287,000.00 will be used to procure the ZEVO ACP Self Drilling Sets and SOLERA 4.75 Lumbar Screw System Sets for NMC Portsmouth.

Estimated Dollar Value

The estimated dollar value for this procurement is$287,000.00 using Navy Operation and Maintenance Fiscal Year 18 funds.

4. Statutory Authority Permitting Other Than Full and Open Competition.

The statutory exception permitting other than full and open competition for this acquisition is in accordance with 10 U.S.C. 2304(c)(2) and FAR 13.501 (a) sole source (including brand name).

5. Rationale Justifying Use of Cited Statutory Authority.

There is a critical surgery planned for 01 Jun 2018 and therefore this requirement is determined to be urgent and compelling. Medtronic Sofamor Danek USA, Inc. is the only manufacturer of the surgical equipment/supplies/kits that meet the Government’s minimum requirements. According to the individual diagnosis provided by the surgeon and the respective patient treatment plans for these surgeries, the surgeries cannot be delayed because doing so would cause continued patient suffering and hinder restoring function and mobility in the patients. In addition, patients requiring these urgent emergency surgeries are traveling in some instances long distances to get the intensely invasive surgical procedures completed at Naval Medical Center Portsmouth to reduce their pain and suffering and restore functionality in range of normal standards of mobility. The alternative to the patients not receiving surgical care with the Medtronic required surgical kits, described above, could be a risk of increasing their current pain or physical limitations, sustainment of adverse symptoms, and conditions deteriorating for which they are being treated. As such, the kits are needed timeframe for urgent surgeries that begin on 01 Jun 2018.

In addition, the Main Operating Room at Naval Medical Center Portsmouth currently only possesses Medtronic navigation equipment for procedure –specific spinal cases. Other vendors are used for navigating cranial and total joint procedures not spinal procedures, as all cases for patients in this requirement are for spinal case procedures. The Medtronic navigation equipment purchased for Naval Medical Center Portsmouth; the O-arm and Stealthstation were purchased for $1,116,560. The instrumentation set was previously purchased for $87,272.50. There is no interoperability with different vendor materials with this navigation system and instrumentation system. The proprietary implants are linked with the navigation system and only these implants have been validated by the manufacturer for use with their system. The utilization of any other vendor's implants would be considered not compatible with Medtronic’s previously purchased navigation system.

There have been reported cases where the use of other vendor implants occurred and led to serious complications. As a result, there has been an FDA-issued notice released that specifically addresses this. The overall benefits of this navigation system include increased accuracy due to real-time imaging that interfaces the original scan done preoperatively with the current scan and decreased exposure of radiation for the patient and staff. Additionally, by utilizing Medtronic, each surgical case is limited to only using one set, vice multiple vendors.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

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

Other vendors that can provide drilling sets and screw systems for either cervical or lumbar abnormalities include Globus, Nuvasive, Zimmer-Biomet/LDR, Medtronic, and Depuy. All industry vendors have provided in-services to include hands-on training in the operating room. During these clinic visits and surgical cases, vendors provided informational resources via pamphlets and internet links. Additionally, they have brought in the physical instruments and implants themselves. All vendors offer unique surgical systems that are in line with various surgical approaches required by the patient and surgeon. All vendors will personally deliver surgical instrumentation to the facility where a transfer of custody will occur with the Sterile Processing Department. Medtronic is the sole provider capable of providing all requirements and that is interoperable with existing navigation equipment at Naval Medical Center Portsmouth for spinal cases by 01 Jun 2018.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

NMLC intends to compete an IDC type contract to accommodate future requirements such as these in accordance with FAR and DFARS regulations.

J&A No. 18-10069

CERTIFICATIONS AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

Technical Cognizance:

_____________________ _________________ 757-953-3300___ __________ Signature Name (Printed) Phone No. Date LCDR Jeremy Venske

Requirements Cognizance:

_____________________ __________________ 757-953-5056_____ __________

Shannon Caldow

LEGAL SUFFICIENCY REVIEW

I have determined this Justification is legally sufficient.

_____________________ __________________ _301-619-2150____ __________

Legal Code-00L

CONTRACTING OFFICER CERTIFICATION

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

Code 05 Contracting Officer

JUSTIFICATION AND APPROVAL