LSJ_Redacted.docx

Log #17-10005

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 Portsmouth requirements.

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

The proposed action is for Laser Support services to include the provision, maintenance, and transportation of lasers and the staff to provide the operation of lasers to be used in the Directorate for Surgical Services (DSS) at the Naval Medical Center Portsmouth. Government intends to award a Firm Fixed Price (FFP), Indefinite Delivery- Indefinite Quantity (IDIQ)contract with a one (1) year base period and four (4) one-year option periods.. The proposed source is ForTec Medical, Inc., 10125 Wellman Rd, Streetsboro, OH. 44241.

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

Naval Medical Center Portsmouth DSS has a critical need for the provision of medical laser systems and medical laser system specialists to operate the laser systems. Service will be ordered on an as needed basis; the Government will provide a list of scheduled procedures to the contractor generally 15 days prior to the requirement for service. The contractor shall recognize that the schedule provided may change within those 15 days. The Government estimates that about one (1) time per year, 24-hours will be the maximum notice given to the contractor. The contractor must have the ability to provide full on-site support with a minimum 24 hour notice. The government reserves the right to request services in alternate treatment rooms located within the MTF proper.

The Contractor shall provide laser system specialists to support laser procedures in theMedical Treatment Facility (MTF) DSS. The laser system specialists shall provide support for the following medical procedures.

Colposcopy Condyloma ablation Dermal ablation Laparoscopic laser ablation Lithotripsy Laser Laryngeal Microsurgery/ Microlaryngoscopy Photovaporisation Stapedectomy Tympanomastoidectomy Tympanoplasty Vein laser therapy Vulva ablation

The contractor shall arrive on-site at the MTF approximately 15 minutes prior to a scheduled procedure to perform pre-procedure work. This work includes pre-work scrub, equipment set-up, calibration and inspection of the contractor’s equipment by the MTF Biomedical Engineering Office prior to use. Note that the Government inspection of contractor’s laser equipment will be for general discrepancies only and shall not relieve the contractor of any liability related to the operation of the equipment. The Government reserves the right to seek proof of equipment maintenance at any time during contract performance. The contractor shall be prepared to provide documentation of maintenance within 2 business days of request.

Any discrepancies to the attention of the government prior to use for approximately 40 treatment sessions per year. The contractor shall not attempt to repair any government owned equipment. The contractor shall provide laser operators who are certified and/or qualified to operate the listed lasers in the MOR.

The laser equipment used in the MTF MOR is as follows:

Lumenis Versapulse Powersuite Dual 80/100W. Laser for urology procedures, 2100 nm and 1060 nm wavelength, power output up to at least 100W.

Lumenis Ultrapulse Encore. CO2 laser for dermatologic procedures, 10,600 nm wavelength, power output up to 60W-100W.

Ultrapulse Encore Surgical. CO2 laser for surgical/dermatologic procedures, 10,600 nm wavelength, power output up to 60W-100W.

GreenLight HPS Laser System. KTP laser for urology procedures, 532 nm wavelength, power output up to 120W.

The contractor shall provide equipment and laser operators who are certified and/or qualified to operate the lasers listed below:

The current scope is for the listed lasers, but potential to include other lasers as technology changes.

The lasers must be kept up-to-date with manufacturer’s software updates.

Laser for urology procedures, 980nm wavelength, power output up to at least 180W and both pulsed and continuous treatment modes. Include disposable fibers and accessories as needed.

Laser for urology procedures, 532 nm wavelength, power output up to at least 120W. Include disposable fibers and accessories as needed.

Laser for urology procedures, 532 nm wavelength, frequency-doubled, power output up to at least 180W. Include disposable fibers and accessories as needed.

CO2 laser for Ear, Nose, and Throat procedures (ENT), 10600nm wavelength, continuous and pulsed treatment modes, power output up to at least 20W during continuous mode. Include disposable fibers and accessories as needed.

Holmium:yttrium-aluminum-garnet (Ho:YAG) laser for urology, gynecology, gastroenterology, and podiatry, 2100nm wavelength, power output up to at least 60W. Include disposable fibers and accessories as needed.

CO2 laser for dermatological procedures, 10600nm wavelength, power output up to at least 60 W. Include accessories as needed.

CO2 laser for transmyocardial revascularization procedures. Include accessories as needed.

Potassium-titanyl-phosphate (KTP) laser, 532 nm wavelength, power up to 40W. Include disposable fibers and accessories as needed.

KTP laser for ENT procedures, 532nm wavelength, power up to at least 15 W continuous and up to at least 150W during pulsed mode operation. Include disposable fibers and accessories as needed.

Neodymium(Nd):YAG laser for urology, gynecology, gastroenterology, and podiatry, 1064 nm wavelength. Include disposable fibers and accessories as needed.

Argon beam coagulator for coagulation and hemostasis of bleeding tissues. Include disposable grounding pads, laparoscopic probes, and hand pieces.

Frequency-doubled, Q-switch Nd:YAG laser for tattoo removal, 532nm and 1064nm wavelength. Include disposable fibers and accessories as needed.

Navy Operation and Maintenance current year funds will be used for each delivery order. Fiscal Year 17 funds in the amount of $378,775.00 will be used to procure the Laser Support services. Total estimated contract amount is $1,795,383.45

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. 3304(c)(1) and FAR 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements.

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

Fortec Medical, Inc is the only vendor capable of providing the physical use, transportation, maintenance and operation of medical laser systems. While there are other vendors capable of providing the rental, maintenance, or operation of the medical laser systems; only Fortec Medical, Inc. is capable of providing the actual laser systems, and maintenance and transportation of required systems. In addition, they are the only source capable of providing system specialists qualified to operate the laser systems.

Should the government procure these services through another vendor, it would require multiple sources to fill the need which would result in increased costs to the government. No source other than Fortec Medical, Inc. has the capability to provide all services succinctly.

6A 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 are in paragraph 8. This requirement will be posted to Government point of entry (GPE) in accordance with Subpart 5.201

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.

8A 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 and contracting personnel in December 2016. This research consisted of reviews of previous procurements for this type of Laser Support Services and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Yahoo, MSN, and GSA Advantage using the following search words: ‘Laser Support’, ‘Laser Systems Specialists’, ‘Laser Systems’, ‘Laser Systems Support’. Market Research conducted by the technical expert revealed that Walter Reed National Medical Center in Bethesda, MD., utilizes the laser support system model and that Fortec Medical, Inc. fufils the requirement at that respective facility. Finally, a Request for Information (RFI) was posted on Federal Business Opportunities (FBO) on 19 December 2016 with a response date of 26 December 2016 resulting in one response from the current government contractor, Fortec Medical, Inc. Consequently, the Government’s technical experts determined that Fortec Medical, Inc. is the only source that can meet the Government’s requirements. The results of the market research are attached (Attachment A).

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

The requirement for Laser Support Services was competed full and open in March 2014. The contract was awarded to Fortec Medical, Inc. through contract N00189-14-D-Z013, totaling $378,775.00. for the base year and a total of for the four option years.

6. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have expressed, in writing, an interest in the acquisition.

7. 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. In the future, NMLC will conduct market research to determine whether potential sources emerge.

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

Business Manager Operative Support Servics, Naval Medical Center Portsmouth

Requirements Cognizance

Business Manager Operative Support Servics, Naval Medical Center Portsmouth

CONTRACTING OFFICER CERTIFICATION

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

_______________________________________ 301-619-1677_______________________________ Tameka Davis Phone Date Code 05 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.

____________________________________________301-619-2150______________________ Julia Hatch Phone Date Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

____________________________________________301-619-3095______________________ Darin L. Callahan Phone Date Competition Advocate