Justification and Approval Documentation.pdf

Control Number: 20-RHCO-A-551 Contract Number: W91YTZ20Q0053

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

(8 Sep 2020)

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Command - Atlantic (RHCO-A), Womack Army Medical Center Contracting Cell, Fort Bragg, North Carolina.

2. Description of Action: The Womack Army Medical Center (WAMC) Ophthamology Department and the Operating Room are requesting approval for a new Sole Source Blanket Purchase Agreement (BPA) with Alcon Vision for a three year ordering period, to commence on 01 October 2020 through 30 September 2023. OMA funds will be used for purchases against the BPA Calls and prices will be firm fixed pricing on an annual basis.

3. Description of Supplies/Services: Alcon Vision was chosen for the products as they are currently the sole manufacturer and distributor of Trifocal Intraocular Len (IOL). In order to have access to Alcon Phaco packs and other Alcon products related to eye surgery, these products are required for the Centurion machines. Without these brand-specific packs and any other Alcon items that are crucial to the success of the surgery, we cannot perform cataract surgeries. Alcon also provides an intraocular lens implant, an artificial replacement for the lens of your eye which is part of the surgery to fix cataracts. An intraocular lens implant, or IOL, is made of a clear plastic, and it's about one third the size of a dime. Failure to provide these supplies will result in the diminished healthcare of the patient. WAMC will be the only medical treatment facility covered under this BPA.

a. The service can assist in the treatment of cataract removal and eye surgical procedures. The published prices for a one year or multi year agreement is in place.

b. Other products, supplies and services used, are based on annual published prices.

c. Based on historical data provided by the Ophthamology Department and the Operating Room, the annual estimate for the products and services is $258K.

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 services.

5. Reason for Authority Cited: Alcon Vision, LLC, is the sole manufacturer and distributor of theTrifocal, PanOptix IOL. This product is also doctor preferred over other ALCON Lenses manufactured by ALCON Laboratories, Inc., Fort Worth, TX 76134- 2001. In order to have access to Alcon Phaco packs and other Alcon products as related to eye surgery, these are required for the Centurion machines. Without these brand-specific packs and any other Alcon items that are crucial to the success of the surgery, we cannot perform cataract surgery. This surgery is critical for active duty

(Lenses products provided for WAMC patient care)

For Official Use Only (See FAR 2.101 and 3.104-4) patients and beneficiaries and will meet the mission for Womack Army Medical Center.

ALCON Toric IOLs have the best rotational stability in the market and therefore are most likely to yield consistent results for astigmatism patients. Alcon is currently the only manufacturer of the trifocal IOL which enables patients to see stronger and better which promotes a more-healthy life style. Currently, the Alcon trifocal IOL is the best option available for correction of vision at all distance ranges currently available in the United States. Alcon also manufacturers the preferred 3-piece IOLs which must be available as back-ups lenses for every cataract surgery case. While WAMC does not implant many of these, however, the assurance of access is crucial in the event of a complicated cataract surgery. Additionally, the Alcon model SN60WF lenses have a blue-light blocking yellow tint which some research suggests may be beneficial to the health of the eye. This product is also preferred in certain patient populations. Also, for patients that have undergone unilateral implantation of an SN60WF IOL in the past, and require surgery in their second eye, the similarl tinted IOL is needed. Historically, the SN60WF has been the most commonly implantation IOL at WAMC for many years.

Moreover, Alcon also provides an intraocular lens implant, an artificial replacement for the lens of your eye, which is part of the surgery to correct cataracts. An intraocular lens implant, or IOL, is made of a clear plastic, and it's about a third the size of a dime. There are several different types: Monofocal IOL, the most common. Unlike your natural lens, which can stretch or bend to help your eye focus, this implant stays focused at one fixed distance. If a lens focuses at a distance, a patient may be able to see objects far away;

however, glasses will be needed in order to read or see close up. Multifocal implants, are very similar to glasses with bifocal or progressive lenses, this lens has areas that assist patients to visualize objects at different distances. It could take several months for your brain to adapt so your vision seems natural. Accommodating IOL, is a flexible option which perform more like your natural lens and focuses at more than one distance. A patient is less likely to need reading glasses with this option. Toric IOL, associated with astigmatism, or a cornea that's more football-shaped than round which incurs blurry vision both close up and far away. The Toric IOL len is used to lessen astigmatism so that a patient will not need glasses to correct after your surgery. The surgeon has determined that these products are the most appropriate treatments to achieve the desired surgical outcome for the patient’s eyesight. Failure to provide the needed supplies for these surgeries will result in diminished healthcare for the patients.

6. Efforts to Obtain Competition: The combined synopisis/solication and the Justification & Approval will be posted to the BetaSAM website. If sources are discovered at a later date, future requirements will be competed among approved sources through BetaSam.

a. Effective competition. None

b. Subcontracting competition. N/A.

7. Actions to Increase Competition: If sources are discovered at a later date, future requirements will be competed among approved sources through BetaSam.

8. Market Research: Market research was performed in accordance with FAR Part 10 to identify all qualified sources. Market research was performed using the internet and previous BPAs/Contracts to find qualified sources. ALCON is the only source based on availability of products and services required by the Operating Room as requested by the surgeon after an initial diagnosis of the patients anatomy.

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 quotations received shall be considered.

10. Other Facts:

a. Procurement history. This is a recurring requirement that has historically been awarded on a sole source basis to the Alcon Vision.

(1) Previous contracts with this vendor were W91YTZ18A0027, W91YTZ20P0109, and current “Price List” provided by the company.

(2) Sole source.

(3) FAR 6.302-1 – “Only One Responsible Source and no Other Supplies or Services Will Satisfy Agency Requirements”: 10 U.S.C. 2304(c).

(4) This sole source contract is to assist in the treatment of cataract removal and eye surgical procedures which is crucial to the success of the surgery. Quoted special pricing for products and services is provided by company.

(5) Prior contracts for this requirement were sole source.

(6) Unusual and Compelling Urgency: Each purchase through ALCON has been processed as a non-emergent requirement. These products and services are often required during duty hours and require standard handling and shipping.

(7) A sole source justification was prepared similar to this document. There are no significant changes from the previous justification.

b. Other facts. NA

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: Stefan Lin Title: SGT, Surgical Logistics

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: _____________

Typed Name: Stefan Lin Title: SGT, Surgical Logistics

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.

Alcon Vision offers their products and services to the government from their published price commercial price list. Discounts are offered from the price list if annual or multi-year agreements are in place. Price wll be evaluated on an annual basis compared to previous price lists and purchases. I hereby determine that the anticipated cost to Government for this contract action will be fair and reasonable based on published price lists and previous history.

Signature: _______________________________Date: ________________

Typed Name: Stefan Lin Title: SGT, Surgical Logistics

14. Contracting Officer Certification: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval. Include the following statement:

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

Signature: ________________________________Date: __________

Typed Name: ___________________________ Title: Contracting Officer

Approval

Based on the foregoing justification, I hereby approve the procurement of services and products ($580K) 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: Contracting Officer