A.02_USAHCA_Sole_Source_Justification_under_13.501_(25Feb16)_26.pdf

Control Number: 19-RHCO-A-374

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office-Atlantic (RHCO-A), Belvoir Health Contracting Cell, 6021 5th Street, Building 1467, Fort Belvoir, VA 22060.

2. Description of Action: Approval is requested for a new firm-fixed price (FFP) contract for the procurement of Medartis supplies to be used in the Operative Suites at Kimbrough Ambulatory Care Center (KACC), Fort Meade, MD. DHP funds will be used to fund this requirement.

3. Description of Supplies/Services: This requirement is for Medartis supplies. The period of performance is 1 July 2019 through 30 June 2020 plus two 12 month option periods, 1 July 2020 through 30 June 2022.

DESCRIPTION QUANTITY UNIT OF

ISSUE

AMOUNT

Base Year * Medartis Supplies 1 Job $150,000.00 Option Year 1 * Medartis Supplies 1 Job $150,000.00 Option Year 2 * Medartis Supplies 1 Job $150,000.00 Total $450,000.00

*Note: Medartis supplies will consist of the following: drills, screws, bits, grafts, plates and guide wires.

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: Medartis provides an extensive product line of medical supplies required for upper extremity procedures required for surgeries at KACC. Due to the small size and limited capabilities at KACC, the OR only has one full time orthopedic surgeon on staff. All other surgeons are borrowed manpower from much larger Military Treatment Facilities (MTF), including Walter Reed National Military Medical Center (WRNMMC). These surgeons use the Medartis products at WRNMMC. The brand name sole source is important for surgeons performing complex surgeries where differences in equipment and supplies can create complications and increase risk for patients. In order to increase patient safety ensure better patient outcomes, a Brand Name sole source contract is required. The synchronization and standardization

(Medartis Supplies at Kimbrough Ambulatory Care Center, Fort Meade, MD)

For Official Use Only (See FAR 2.101 and 3.104-4) process will allow the surgeons to work seamlessly between the two MTFs without any unnecessary deviations that could potentially lead to significant patient safety problems.

The impact of having surgical tools that are unfamiliar to the surgeon could be catastrophic and lead to unnecessary discomfort for the patient, longer recovery time, and/or require additional/follow-on corrective surgeries. This would cause unnecessary spending of Military Health Care Systems resources, including money and manpower hours involving providers, nurses, and surgical technicians due to complications, additional requirements, and multiple appointments in both the perioperative and postoperative periods. Military and civilian personal are often co-located and transferred between treatment facilities in the MEDDAC and the National Capital Area where FAR 6.302-1(a)(2)(ii)(B) is also applicable regarding existing/follow-on contracts that the surgeons from the other MTF use on a routine basis. If the distributor provides the Brand Name requirement, it will cut down on hours needed to train and gain experience with substitute products whose design differences have the potential for significant adverse impacts in the surgical environment.

6. Efforts to Obtain Competition: A sources sought notice will be published on 07 May 2019 with a closing date of 09 May 2019. To increase competition we requested a review of comparable Osteomed surgical supplies. Surgical assessment of the substitutes, which are offered through Prime Vendor and do not require a contract, were unacceptable by most surgeons and determined to be inferior to Medartis. Additionally, the product line available was limited. An extensive product line is required to support the varied requirements of surgical procedures performed at KACC. Furthermore, competition is already increased based on varied surgeries and providers’ individual training and experience. KACC OR surgeons will be free to use Medartis or other vendors through PV, DAPA, ECAT, or other BPAs/contracts. Multiple vendors and products are required in order to support the surgeon and surgeries if required in the best interest of the patient.

a. Effective competition. There is no known competition anticipated for this acquisition.

b. Subcontracting competition. Award will be to a small business concern. There are no subcontracting possibilities.

7. Actions to Increase Competition: Called various vendors and analyzed procurement history. Requested a by item substitute list from Osteomed, who has their surgical supplies on Prime Vendor. Additionally, we queried surgeons who identified Synthes, Skeletal Dynamics, and Acumed as more superior products with more extensive product lines than Osteomed and comparable to Medartis. Analysis of surgeon demand

For Official Use Only (See FAR 2.101 and 3.104-4) at KACC under the micro purchase threshold procurement patterns indicated that there was no demand for Synthes or Skeletal Dynamics. In addition to Medartis, there was a significant demand for Acumed products, and KACC will also pursue a separate contract through Acumed to support the requirements of the patients at KACC. The additional contract with Medartis will provide the surgeons with an extensive array of equipment and supplies to meet surgical demand and ensure patient care is not compromised by limited supply sources/competition.

8. Market Research: Market Research was conducted in accordance with Far Part 10.

The Small Businesss Dynamic Search revealed the following concerns that are able to provide these supplies under NAICS 339112: 105 HubZone Certified; 66 Certified 8(a);

697 Verteran Ownded: 520 Woman or Women Owned: 19 SDB Certified; 515 Service Disabled Veteran.

9. Interested Sources: To date, no other sources have written to express an interest.

The notices required by FAR 5.201 shall be published, and any bids or proposals received shall be considered.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements. There is only previous contract written, W91YTZ-15-P-0276. This contract consisted of a 12 month base period, 1 Jun 15 – 31 May 16, and four 12 month option periods, 1 Jun 16 – 31 May 20. However, only one option period was exercised; thereby, the contract lapsed upon the completion of Option Period 1, 1 Jun 16 – 31 May 17. The total cost for the contract was $168,154.00. Costs for the base period and sole option period was $63,154.00.

(2) The competitive status of these actions. This was a full and open competitive procurement.

(3) Authority previously cited if less than full and open competition was used. N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) Kimbrough currently owns Medartis equipment and machinery. Procurement of any other brand or type of supplies would not be compatible with the Medartis equipment.

For Official Use Only (See FAR 2.101 and 3.104-4)

JONES.ERIC.G

.1228849851

Digitally signed by

JONES.ERIC.G.1228849851

Date: 2019.05.16 08:48:23 -0_4'_00_'

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. None known.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

b. Other facts. None.

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: Date:

Typed Name: Title:

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

14. Contracting Officer Certification:

For Official Use Only (See FAR 2.101 and 3.104-4)

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

JONES.ERIC.G.1228849 Digitally signed by

Signature: 851

JONES.ERIC.G.1228849851

D_at_e:_20_19_.0_5.1_6_07_:5_4:0_6 _-04_'0_0'_Date: