V797P-3177M-001.pdf

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405-6 Limiting Sources Page 1 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: _36C26318N0696____________________

1. Contracting Activity: Department of Veterans Affairs, NCO 23, St. Cloud VA Health Care System, 4801 Veterans Drive, MN 56303. Organization Activity: Minneapolis VA Health Care System (MVAHCS), One Veterans Drive Minneapolis, MN 55417, 618-18-3-030-0193.

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501).

Emergency, firm fixed price delivery order for dental Solara and Titan handpieces for the Minneapolis VA Dental Clinic from DentalEz Inc off their FSS schedule.

Order against: FSS Contract Number: _V797P-3177M________________________

Name of Proposed Contractor: DentalEz Inc Street Address: 2 W Liberty Blvd Ste 160 City, State, Zip: Malvern, PA 19355 Phone: 708-466-8220

3. Description of Supplies or Services:

The estimated value of the proposed action is

A request for star dental lube free motor, motor to angle adapter, prophy angle, latch angle, straight nose cone, and Solara high speed handpiece with enough of each to manage the internal dental clinic as well as the Ramsey clinic at full function, with 2 days of supplies available. These components can be connected together in different combinations to form one of the four styles of dental handpieces used during clinical exams and procedures to clean, polish, cut and drill teeth. This makes the need for rapid turnaround obsolete and the risk for patient cancellation due to the unavailability of equipment almost nothing. The Conra angle auto latch is the dental handpiece angle that is fitted with a disposable bur, file or drill and used during procedure to clean out an infected tooth, was selected as it works with the current supply of disposable burs, files, and bits and the tension fit high speed handpiece is functional with the current disposable option. A combination of individual items can be combined to replace the current contra angle high speed handpiece, contra angle slow speed handpiece, and the straight handpiece, which have oil leak issues with motor sterilization.

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and (C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

This was an emergency procurement that needed to be processed immediately to prevent the cancelation of patient cases and the potential for clinic closures due to an Issue Brief received by the Minneapolis VA from DC Central Office due to the inability to appropriately reprocess their dental handpieces between each patient use and keep enough in circulation not to impact patient care. The

VHAPM Part 808.405-6 Limiting Sources Page 2 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018 high demand for dental reprocessing also has potential impact on other areas as SPS is needing to turn over a high volume of handpieces daily to meet dental needs for both the Minneapolis and Ramsey clinics.

The purchase of DentalEz handpieces replaces the current Midwest and Adec models of handpieces being used with the Minneapolis and Ramsey clinics electric motor and air driven devices. It was discovered that SPS is unable to reprocess the current Midwest air driven units with the equipment and processes currently used in house. Sterilization of the Adec air driven handpieces can be performed, so these are still in circulation. However, most of the air driven handpieces in stock are the Midwest models which require sterilization at a parameter requiring additional programing and the oiling and cleaning of the handpieces to meet the requirements as laid out in the IFU, cannot be achieved. To be compliant to the cleaning and oiling of these units, the purchase of additional Midwest specific equipment necessary for the cleaning, lubrication circulation through the bearings, and the purging of excess oil from the handpiece would need to be done. It is unknown if it would eliminate the issue of oil on the packaging, however it is not a direction investigated because a large amount of the Midwest handpieces exceed their functional lifespan and the dental clinic reports issues with “slipping” of the rotary drive, and other mechanical malfunctions.

The Minneapolis and Ramsey Clinics also cannot continue to utilize their Adec electric motor handpieces. SPS lacks the ability to purge excess oil which results in the presence of excess oil being expelled onto the sterile packaging at one of several various stages of packaging and sterilizing. This has caused triple work for SPS as these items need to be recleaned and reprocessed up to 3 times each before they were functional. There are currently 27 exam rooms between the Minneapolis and Ramsey clinics with each room using up to 6 motors and handpiece combinations a day on two lines creating a need for a minimum of 324 motors to be needed in one day to function at full clinical capacity. The Minneapolis VA does not have enough electric motors to accommodate multiple reprocessing and they are experiencing a loss of approximately 50% due to malfunction from the water invasion. When the Issue Brief was received from Central Office the Minneapolis VA had 54 motors available. An emergency procurement was awarded on 4/27/2018 for an additional 50 motors giving the facility roughly 105 functioning motors. Due to the lack of motors, clinics were dropped from being able to utilize both electric cables (one for high speed and one for low speed) to switching out motors depending on their need over the course of the patient exam. An additional 700 electric motors at approximately per motor for a total of would need to be purchased to meet current demand. That total does not take into account the future additional purchases that would be required due to the 50% loss rate currently being experienced from processing and sterilization. Purchasing these additional electric motors also would not address the multiple audit findings due to the oil leakage issue.

The DentalEz handpieces were identified as a solution to this emergency to meet the sterilization between patient use requirement of the Issue Brief from DC Central Office as well as oil leakage audit findings. The DentalEz handpieces are lubrication free which eliminates the potential for oil leakage onto the sterile packaging that was occurring with the electric handpieces and are compatible with the current ADEC chair without the need for an additional cable system and with a coupler/swivel not needing to be sterilized it allows for two lines in each exam room with minimal cost.

These new handpieces meet the clinics needs with fewer items through the combination of pieces for use for various tasks during a dental exam. The cost of one entire DentalEZ handpiece setup along with coupler are less than the cost of one of the previous motors, not including the cost of the electric motor handpieces, that required sterilization. The new system also will not suffer the loss rate experienced with the electronic motor. The emergency procurement for these items was needed to address the Issue Brief and audit findings immediately in order to prevent the cancelation of patient exams and the possible closure of the Minneapolis and Ramsey Dental clinics.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If

FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data. Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION:

This was an emergency procurement for supplies off DentalEz Inc’s FSS schedule. The FSS prices were already determined fair and reasonable at the time contract award.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS

OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

For this emergency procurement VetBiz was searched under NAICS code 339114 which returned 106 results. GSA was searched under SIN 65 II C categories 30B, 32A, 32B and 33B. This search only identified 1 verified SDVOSB vendor who is not an authorized distributor for DentalEz products.

DentalEz, a small business, is the manufacture of the Solara and Titan dental handpieces with FSS contract V797P-3177M. DentalEZ identified one SDVOSB vendor that is authorized to distribute their handpieces via the open market. Based on this research the rule of two was not met and due to the emergent nature of the request a sole source award was made to DentalEz Inc off their FSS contract.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: NA

(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION

FOR THE SUPPLIES OR SERVICES IS MADE:

Future procurements that do not require an emergent award will be competed.

(9) REQUIREMENTS CERTIFICATION: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

VHAPM Part 808.405-6 Limiting Sources Page 4 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

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