JA_16-RHCO-P-442_Redacted_ _Initialed.pdf

Control Number: 16-RHCO-P-442

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 PACIFIC-

PROVISIONAL

CLARK ROAD, B339

FORT SHAFTER, HAWAII 95858

2. Description of Action: The action being approved is for a Brand Name Blanket Purchase Agreement (BPA) with Depuy Synthes. DHP funds will be used for this effort.

3. Description of Supplies/Services: The items being purchased are from the Synthes product lines. The items will include Plates and Screws, Intramedullary Nails, Ex Fix and Small Joint Arthroplasty Products, Cervical, Arthroplasty, Interbody, Thorocolumbar Fixation, Motion, Posterior Lumbar Fixation, and Tumor Fracture products. These items work in conjunction with Synthes implants in surgeries.

5 year total estimated value is $7,000,000.00

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: Depuy Synthes products are designed to work together and be inserted only with the use of Synthes instruments and guides. Their FDA approved indications are for Synthes plates to be used in conjunction with Synthes Screws. They have not conducted any testing on the use of other manufacturer’s products to be used with their products. Any such use would be considered off label and not supported.

TAMC currently owns approximately 130 Synthes instrument sets; these sets are routinely used and must be replaced with the same Synthes items to work in conjunction with Synthes implants used in surgeries. TAMC cannot mix and match sets or the instruments will become inoperable. There would be a significant detriment to patient safety if TAMC is unable to purchase the specified implants and instrumentation that is compatible with existing sets that are already in use at TAMC. Surgical cases would become delayed and/or cancelled if we do not have the correct instrumentation to perform the surgery.

Based on the aforementioned, it is in the Government’s best interest to purchase these supplies from Depuy Synthes because these are the only products compatible with the government-owned Synthes kits. Depuy Synthes is the sole manufacturer of the products requested .

SM

DepuySynthes TAMC

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

(25 February 2016) in

6. Efforts to Obtain Competition: This requirement has been synopsized on fbo.gov as a sources sought in accordance with PGI 206.302-1. The results of the internet market research and direct confirmation from the Vendor indicate that Depuy Synthes is the sole manufacturer of the items requested. Three small business distributors were identified through the sources sought posting.

a. Effective competition. The Government will post a Brand Name Only combined synopsis/solicitation.

b. Subcontracting competition. Depuy Synthes has provided a copy of their current Sub- Contracting Plan and has provided a list of three Small Businesses that are direct distributors AMD, Veterans Health and Beacon Point Associates.

7. Actions to Increase Competition: Ongoing market research will be performed to determine if alternative sources of supply become available. Also, discussions will be held with Prime Vendor (Cardinal Health) to discuss the opportunity to carry these items on their catalog.

8. Market Research: Market research conducted over the internet in the past 12 months indicates that this product is commercial in nature. Market research efforts will be continued in order to identify new, alternative sources. Any responsible source may express interest and will be considered for future requirements. However, due to instrument set compatibility , detriments to patient safety and delay/or cancellation of surgeries, it would not be practical or cost effective to purchase other than the recommended Synthes products to meet TAMC’s mission requirements at this time.

9. Interested Sources: This requirement has been synopsized on fbo.gov in accordance with PGI 206.302-1 as a sources sought notice. Three small business distributors, American Medical Depot, Veterans Health and Beacon Point Associates were identified through the sources sought posting. The results of the internet market research and direct confirmation from the Vendor indicate that Depuy Synthes is the sole manufacturer of the items requested.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements.

W81K02-11-A-0043, awarded 21Sept 11 & W81K02-11-A-0031, awarded 19Sept11

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

(25 February 2016)

(2) The competitive status of these actions. Sole Source

(3) Authority previously cited if less than full and open competition was used. FAR 6.302- 1(c), only one responsible source and no other supplies or services will satisfy agency requirements.

(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. Depuy Synthes is the sole manufacturer of Synthes products. In order for TAMC to maintain continuity in their care for patients who received Synthes implants, only Synthes compatible products can be used for those surgical procedures.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources. N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

(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. No significant changes since the last BPA award.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated. Previously planned actions to remove competition barriers were accomplished. The contract specialist posted a sources sought notice on fbo.gov in accordance with PGI 2016.302-1 and three small business distributors were identified through this posting. The Government will also post a Brand Name Only combined synopsis/solicitation. Any interested parties who can meet the Government’s requirements will be considered.

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

(25 February 2016)

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:

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.

Signature: Date:

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. The basis for this determination will be price analysis in accordance with 15.404-1 (b). Certified cost or pricing data is not required per FAR 15.403-1(b)(3).

Signature: Date:

Typed Name: Title:

14. Contracting Officer Certification:

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

Signature: Date:

Typed Name: Title:

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

(25 February 2016)

Approval

Based on the foregoing justification, I hereby approve the procurement of various Synthes surgical products for up to $7,000,000.00 on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: Date:

Typed Name: _Title:_