JA_Redacted.pdf

CUI

Control Number: FY25-0113

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

1 NOV 2024

Justification and Approval (J&A) Modified for Federal Acquisition Regulation (FAR) 13.501

1. Identification of the Agency and Contracting Activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division – West (HCD-W), San Diego, CA, to meet the requirements of Naval Medical Center San Diego (NMCSD) for the Ophthalmology Department, 34800 Bob Wilson Dr San Diego, CA 92120.

2. Nature and/or Description of Action being Approved:

DHACA, HCD-W intends to award a 5-year Firm Fixed Price, Blanket Purchase Agreement (BPA) in accordance with FAR 13.501(a).

3. Description of Supplies/Services:

Contractor, OR Elder, Inc. (OREI), a Service-Disabled Veteran-Owned Small Business (SDVOSB), will provide the Government’s requirements below.

The NMCSD Ophthalmology Department has a requirement for ophthalmic surgical supplies manufactured by Alcon to perform Ophthalmic surgery to treat eye diseases, for preventive measures, and to improve patients’ eyesight to improve their quality of life. The purpose of this requirement is to utilize sterile surgical products only provided by Alcon, which are used daily. Alcon products are the only sterile surgical products that are compatible with the current surgical equipment and are utilized daily in both the local and main operating rooms at NMCSD.

Below is the required Alcon product list:

ALCON Product # Product Description

0065002315 MIOSTAT SOLUTION 1.5ML

0065041130 BETADINE 5% (POVIDONE IODINE) 30ML

611.75 FLEXIBLE IRIS RETRACTORS 1 BOX

706.13 MAXGRIP REV DSP FORCEPS,23GA

706.43 REVOLUTION DSP 23G ENDGRASPING

706.44 REVOLUTION DSP 23G ILM FORCEPS

706.52 REVOLUTION DSP 23G CURVED

8065000133 CENTURION® ACTIVE FMS, 0.9MM ULTRA, ABS® BALANCED 30°BEVEL UP

8065005701 ABS HOCKEY STICK BLADE SHARPE ALL ROUND

8065100003 MICROSPONGE SURGICAL SPONGE

8065102020 EYE-PAK DRAPE MICRO-EMBOSSED

8065102920 EYE-PAK DRAPE MICRO-EMBOSSED

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

2 NOV 2024

8065104020 EYE-PAK DRAPE MICRO-EMBOSSED

8065149523 SOFT TIP NEEDLE 23G DISPOSABLE

8065183085 PROVISC 0.85ML 27G

8065183150 DUOVISC (0.55ML PRO/0.50ML VIS) 27G

8065183975 VISCOAT 0.75ML 27G

8065199907 DUOVISC (0.85ML PRO/0.50ML VIS) 27G

8065225703 CAPSULAR TENSION RING 12.3/10MM REFORM

8065225704 CAPSULAR TENSION RING 13.0/11MM REFORM

8065225705 CAPSULAR TENSION RING 14.5/12MM REFORM

8065830077 25+ Ga HYPERVIT Bevel 20K CPM TOTAL PLUS Pak Wide 8065753109 27+ Ga HYPERVIT Bevel 20K CPM TOTAL PLUS Pak 8065830027 ULTRAVIT 27+ Ga Vitrectomy Probe 8065752556 VEKTOR Articulating Illuminating Laser Probe 27g

811.13 FINESSE REFLEX Handle MAXgrip Forceps 27g

711.88 FINESSE SKARSKIN ILM Forceps 27g

337.86 Backflush Soft Tip, DSP 23g

337.84 Backflush Soft Tip, DSP 25g

337.88 Backflush Soft Tip, DSP 27g

338.27 FINESSE Flex Loop 27g

8065751800 ALCON 23G VALVED ENTRY SYSTEM, 6MM (1 PER PACK)

8065751782 ALCON 25G VALVED ENTRY SYSTEM, 6MM (1 PER PACK)

8065751577 CHANDELIER, 25GA W/RFID

8065750957 ASSY,SHIP,CONST ELLAT ION VFC

8065149530 0.8MM SOFT TIP NEEDLE 25G

8065912001 20G CORNEAL/SCLERAL V-LANCE SAT IN FULL HANDLE A-OK

338.25P 25+ CURVED MEMBRANE SCRAPER

705.88P 25+ SHARKSKIN ILM FORCEPS DSP

8065752555 25G ART ICULAT ING ILLUMINAT ED LASER PROBE

8065751593 25G ILLUMINAT ED FLEX CURVED LASER PROBE, RFIDX2

337.91 45D DELAM SPAT ULA DSP 25G

8065750958 ASSY,SHIP,CONST ELLAT N FRAG T IP

618.60' GRIESHABER DSP ASPHERIC MACULAR LENS

8065751572 ILLUMINAT ED PIK, 25 GA W/RFID

705.13P MAXGRIP REV DSP FORCEPS,25GA

8065900163 PFNO KIT 5ML <USA

705.43P REVOLUT ION 25G+ END GRASPING

705.52P REVOLUT ION DSP 25GA+ CURVED

8065601187 SILIKON 1000 8.5ML VIAL

8065752438 TOTAL PLUS,25+,10K VALVE WD

8065425120 25G IRRIGATING CYSTITOME ANGED REVERSE CUT

8065441120 27G IRRIGATING CANNULA J- SHAPED ANT CHAMBER

8065441920 27G AKAHOSHI HYDRODISSECTION CANNULA

8065750352 INFUSION SLEEVE,COAXIAL

8065751177 0.9MM MINI-FLARED ABS 45o Ozil 12

8065751511 POLYMER INTREPID BENT I/A TIP (SINGLE USE)

8065751592 23G ILLUMINATED FLEX CURVED LASER PROBE, RFIDX2

8065751774 CENTURION® IR REMOTE

8065751922 POLYMER INTREPID BIMANUAL I/A HANDPIECE SET 23G (DISPOSABLE)

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

3 NOV 2024

8065752134 CENTURION ULTRAVIT ANTERIOR VITRECTOMY PROBE 23G / 4000CPM

8065752192

CENTURION® ACTIVE FMS, 0.9MM ULTRA, MINI-FLARED ABS® 30°

KELMAN®

8065752436 TOTAL PLUS,23GA,10K VALVE WD

8065752527 RECONSTITUTION RACK

8065752885 POLYMER INTREPID TRANSFORMER I/A HANDPIECE (SINGLE USE)

8065752914 CENTURION® ACTIVE SENTRY OZIL® HP

8065771501 SIDEPORT 15D SAB CLEARCUT SAFETY

8065797002 ISPAN SF6 SULFUR HEXAFLUORIDE 125GM

8065797102 ISPAN C3F8 PERFLUOROPROPANE

8065912301 23G CORNEAL/SCLERAL MVR BLADE STRAIGHT FULL HANDLE

8065921540 1.0MM SIDEPORT ANGLED FULL HANDLE CLEARCUT

8065977757 MONARCH II "A" CARTRIDGES

8065977758 MONARCH II "B" CARTRIDGES

8065977762 MONARCH III "C" CARTRIDGES

8065977763 MONARCH III "D" CARTRIDGES

8065977773 MONARCH III IOL DELIVERY SYST

8065992445 2.4MM SINGLE BEVAL ANGLED CLEARCUT INTREPID

8065992745 2.75MM SLIT SATIN SINGLE BEVEL FULL HANDLE CLEARCUT

8065993045 3.0MM SLIT SATIN SINGLE BEVEL FULL HANDLE CLEARCUT

8065995661 3.5MM IMPLANT SATIN SHORTCUT ANGLED A-OK

8065997501 SOFGUARD EYE SHIELD WITH FLEXIBLE EDGE

CC60WFHOSP SP CLAREON IQ CLEAR (HOSP ONLY)

CCA0T0HOSP CLAREON AUTONOME W/CC60WF UVA (HOSP ONLY)

CCW0T3 CLAREON TORIC UVA

CCW0T4 CLAREON TORIC UVA

CCW0T5 CLAREON TORIC UVA

CCW0T6 CLAREON TORIC UVA

CCW0T7 CLAREON TORIC UVA

CCW0T8 CLAREON TORIC UVA

CCW0T9 CLAREON TORIC UVA

CCWET0 CLAREON VIVITY UVA-(CCWET0)

CCWET3 CLAREON VIVITY TORIC UVA- (CCWET3)

CCWET4 CLAREON VIVITY TORIC UVA- (CCWET4)

CCWET5 CLAREON VIVITY TORIC UVA- (CCWET5)

CCWET6 CLAREON VIVITY TORIC UVA- (CCWET6)

CCWTT0 CLAREON PANOPTIX UVA- (CCWTT0)

CCWTT3 CLAREON PANOPTIX TORIC UVA- (CCWTT3)

CCWTT4 CLAREON PANOPTIX TORIC UVA- (CCWTT4)

CCWTT5 CLAREON PANOPTIX TORIC UVA- (CCWTT5)

CCWTT6 CLAREON PANOPTIX TORIC UVA- (CCWTT6)

CNA0T0HOSP AUTONOME W/SY60WF (HOSP ONLY)

CNW0T3 CLAREON TORIC BLF

CNW0T4 CLAREON TORIC BLF

CNW0T5 CLAREON TORIC BLF

CNW0T6 CLAREON TORIC BLF

CNW0T7 CLAREON TORIC BLF

CNW0T8 CLAREON TORIC BLF

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

4 NOV 2024

CNW0T9 CLAREON TORIC BLF

CNWET0 CLAREON VIVITY-(CNWET0)

CNWET3 CLAREON VIVITY TORIC- (CNWET3)

CNWET4 CLAREON VIVITY TORIC- (CNWET4)

CNWET5 CLAREON VIVITY TORIC- (CNWET5)

CNWET6 CLAREON VIVITY TORIC- (CNWET6)

CNWTT0 CLAREON PANOPTIX-(CNWTT0)

CNWTT3 CLAREON PANOPTIX TORIC UVA- (CNWTT3)

CNWTT4 CLAREON PANOPTIX TORIC- (CNWTT4)

CNWTT5 CLAREON PANOPTIX TORIC- (CNWTT5)

CNWTT6 CLAREON PANOPTIX TORIC- (CNWTT6)

CZ70BD PMMA SP 7.0 OPTIC 12.5 LENGTH

F00022 HYDRUS MICROSTENT US

MA50BM ACRYSOF MP FOLDABLE 6.5 OPTIC

MA60AC ACRYSOF MP FOLDABLE 6.0 OPTIC

MA60MA ACRYSOF MP FOLDABLE 6.0 OPTIC

MTA3U0 PMMA SP 5.5 OPTIC 12.5 LENGTH

MTA4U0 PMMA SP 5.5 OPTIC 13.0 LENGTH

OA7002 PRD-SHIELD, SOFT, COLLAG CORNEAL,QS

SA60AT ACRYSOF SP FOLDABLE 6.0 OPTIC

8065977771 MONARCH II IOL DELIVERY SYSTEM

8065752181 CENTURION ACTIVE FMS, 0.9MM TIPLESS

8065750157 INFINIT I ANTERIOR VIT RECT OMY PROBE PAK 20G / 800CPM

8065790022 0.9MM ABS 30o KELMAN

AS5514-25 LEGACY NAVAL HOSP

8065000138 CENTURION ACTIVE FMS, 0.9MM MICRO SMOOTH, BALANCED 30 BEVEL UP

8065420120 27G IRRIGATING CANNUAL 4MM BEND-TIP

8065772445 2.4MM SLIT SINGLE BEVEL ANGLED CLEARCUT SAFETY

8065420220 25G IRRIGATING CANNUAL 4MM BEND- TIP

8065751774 CENTURION® IR REMOTE

8065000133 CENTURION ACTIVE FMS, 0.9MM ULTRA, ABS BALANCED 30 BEVEL UP

8065921501 15D SIDEPORT 1.52MM FULL HANDLE A- OK

8065000138 CENTURION ACTIVE FMS, 0.9MM MICRO SMOOTH, BALANCED 30 BEVEL UP

8065420120 27G IRRIGATING CANNUAL 4MM BEND-TIP

8065772445 2.4MM SLIT SINGLE BEVEL ANGLED CLEARCUT SAFETY

8065977773 MONARCH III IOL DELIVERY SYST

8065752527 RECONSTITUTION RACK

8065000128 CENTURION ACTIVE FMS, 0.9MM TIPLESS

8065752134 CENTURION ULTRAVIT ANTERIOR VITRECTOMY PROBE 23G/4000CPM

8065183150 DUOVISC (0.55ML PRO/0.50ML VIS) 27G

8065225703 CAPSULAR TENSION RING 12.3 / 10MM

8065225704 CAPSULAR TENSION RING 13.0 /11MM

8065225705 CAPSULAR TENSION RING 14.5 / 12MM REFORM

8065183975 VISCOAT 0.75ML 27G

8065183085 PROVISC 0.85ML 27G

8065750157 INFINITI ANTERIOR VITRECTOMY PROBE PAK 20G / 800CPM

611.75 FLEXIBLE IRIS RETRACTORS 1 BOX

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

6 NOV 2024

4. Statutory Authority Permitting the Sole Source Acquisition:

41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items and 15 U.S.C. 657f as implemented in FAR 6.302-5(b)(6) or 19.1406, sole source awards under the Veterans Benefits Act of 2003.

5. Rationale Justifying Use of Authority Cited:

This sole source justification is prepared using the format at FAR 6.303-2, modified to reflect the procedures in FAR Subpart 13.5 in accordance with 41 U.S.C. 1901. Based on analysis of the market research and previous acquisition history, only sterile surgical products manufactured by Alcon are compatible with the current surgical equipment utilized in the operating rooms at NMCSD. There are only two authorized distributors of these products, OREI and ERA Health LLC dba Veteran’s Health Medical Supply (VHMS). The identified source OREI is an SBA-Certified SDVOSB under NAICS code 339115, in which SBA has determined that SDVOSB concerns are substantially underrepresented in Federal procurement. VHMS is a small business firm. It has been determined that there is no reasonable expectation of receiving quotes from two or more SDVOSB businesses other than OREI. Procuring items manufactured by a different company would mean allotting more funds towards purchasing new equipment in conjunction with these new items, as well as spending a considerable amount of time training providers, and residents, as well as all ancillary services staff in the new system which requires time away from patient care, and affects clinic and surgical workflow. Therefore, the Government intends to procure this requirement as a SDVOSB sole source to OREI in accordance with FAR 13.003(b)(2)(iii), 13.501(a), and 19.1406.

6. Efforts to Obtain Competition:

Market research was conducted by technical experts in March 2025. This research consisted of reviews of similar previous procurements, using search engines in an effort to find open market contractors, and reviewing mandatory sources. Search engines utilized include SAM.gov, FPDS-NG, DHA Inventory, Excess Personal Property, Federal Prison Industries (FPI), AbilityOne, ECAT-DLA, GSA Advantage, and the VA to identify potential sources that can meet the Government’s requirements. The only manufacturer Alcon, and authorized distributor with SBA Certified SDVOSB: OREI can provide the Government’s requirement. OREI responded on 20 March 2025 via email with an approved letter from Alcon that they are an authorized distributor for Alcon products. Additionally, OREI was found to have an excellent customer service based on their current delivery performance under BPA HT941024A0001 compared to Alcon. Therefore, it is in the best interest for the Government to sole source the requirement to OREI in accordance with FAR 6.302-5(b)(6) and FAR 19.1406 SDVOSB Program sole-source awards.

A notice of intent to sole source or synopsis of proposed contract action (NOI # HT941025N0061) was posted on the System for Award Management website (SAM.gov) from 20 March 2025 to 25 March 2025. No additional sources submitted capabilities statements for the Government's consideration.

7. Actions to Increase Competition/Remove or Overcome any Barriers to Competition:

The Ophthalmology Department at NMCSD and DHACA HCD-W will continue to survey and engage the market for any additional potential authorized distributors with Alcon.

8. Market Research:

Market research was conducted by technical experts in March 2025. The market research revealed that only Alcon’s products can meet the Government’s requirement. Only sterile surgical products manufactured by Alcon are compatible with the current surgical equipment utilized in the operating rooms at NMCSD. This research consisted of reviews of similar previous procurements, using search engines in an effort to find open market contractors, and reviewing mandatory/suggested sources. Search engines and websites utilized include SAM.gov, FPDS-NG, DHA Inventory, Excess Personal Property, Federal Prison Industries (FPI), AbilityOne, ECAT-DLA, and GSA

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

7 NOV 2024

Advantage. As a result of the market research, Alcon, OREI, and VHMS were identified as vendors capable of meeting the Government’s requirements. Alcon, a large firm and manufacturer of the sterile surgical products, is not interested in the requirement but recommended its 2 current authorized distributors: OREI and VHMS. OREI and VHMS will better assist Alcon in sales, inventory, technical expertise and delivery support to customers. OREI is a certified SDVOSB and VHMS is a small business firm. OREI is the only certified SDVOSB authorized distributor and was confirmed via email with an approved letter from Alcon. A notice of intent to sole source or synopsis of proposed contract action (NOI # HT941025N0061) was posted on the System for Award Management website (SAM.gov) from 20 March 2025 to 25 March 2025. No additional sources submitted capabilities statements for the Government's consideration. Based on the results of the market research, this requirement shall be sole sourced to OREI, a certified SDVOSB in accordance with FAR 19.1406 SDVOSB Program sole-source awards.

9. Other Facts:

a. Procurement History:

(1) Is this a new requirement? No

(2) If 9.a.(1) is No, was the action just prior to this one competed? No.

(3) If 9.a.(2) is Yes, what has changed where this action cannot be competed? “Not applicable.”

b. Additional Information: DHA issued BPAs N0025921A0002 and N0025921A0005 sole sourced to manufacturer, Alcon and HT941024A0001 sole sourced to Alcon’s authorized distributor, OREI, a certified SDVOSB, for ophthalmic surgical supplies at NMCSD.

10. Interested Sources: Although a special notice is not required in accordance with FAR 5.202(a)(4), a notice of intent to sole source or synopsis of proposed contract action (NOI # HT941025N0061) was posted on the System for Award Management website (SAM.gov) from 20 March 2025 to 25 March 2025. No additional sources submitted capabilities statements for the Government's consideration.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

8 NOV 2024

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

12. Requirements Certification: I certify 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 the anticipated cost to the Government for this contract action will be fair and reasonable.

Basis for Determination: This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5., and the required supplies are commercially available and have been previously procured, which established current and historical information that will be used as a basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.403-1(b)(3). I have determined that the anticipated cost to the Government for this contract action is fair and reasonable, and I certify that this justification is accurate and complete to the best of my knowledge and belief.

14. Legal Review: I have reviewed this justification and have found it to be legally sufficient.

15. Contracting Officer Certification: I certify this justification is accurate and complete to the best of my knowledge and belief.

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

9 NOV 2024

Review

I have reviewed this justification and find it adequate to support the sole source acquisition.

Concurrence

CUI

Source Selection Information - See FAR 2.101 and 3.104-4

10 NOV 2024

Approval Based on the foregoing justification, I hereby approve the procurement of Ophthalmic Surgical Supplies for NMCSD on sole source basis pursuant to the authority of 41 United States Code 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items and 15 U.S.C. 657f as implemented in FAR 6.302-5(b)(6) or 19.1406, sole source awards under the Veterans Benefits Act of 2003, subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.