P03_36C261-25-AP-0125_PM_CM_Parts_redacted.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 4

Revision: 03 Effective Date: 04/15/24

Acquisition ID#: 36C261-25-AP-0129

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID__36C261-25-AP-0129________

1. Contracting Activity: Department of Veterans Affairs, VISN 21, Network Contracting

Office (NCO) 21, VA Medical Center, Fresno

PR Number: 570-25-2-555-0014

2. Nature and/or Description of the Action Being Processed: This requirement is to procure preventative maintenance, corrective maintenance, and replacement parts for four surgical lasers at the VA Central California Healthcare System (VACCHS). Melling is the only manufacturer-authorized provider capable of delivering the specialized services required to maintain these surgical lasers, ensuring that the equipment remains operational and complies with manufacturer standards. This procurement will be awarded as a new, firm-fixed-price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The acquisition involves the procurement of a service agreement for Preventive Maintenance (PM), Corrective Maintenance (CM), and replacement parts for four (4) surgical lasers used at the

VA Central California Healthcare System. The service agreement covers the following specific laser equipment:

HO-YAG Laser - VersaPulse (Manufacturer: Boston Scientific)

HO-YAG Laser - Moses 2.0 Pulse (Manufacturer: Boston Scientific)

Carbon Dioxide Laser - AcuPulse Duo (Manufacturer: Boston Scientific)

ND-YAG Laser - Selecta Duet (Manufacturer: Lumenis Inc.)

Total Estimated Value: $333,631.30

Period of Performance: 11/1/2024 – 10/31/2029 (Base + 4 option years)

4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR

6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

VHAPG Part 806.3 OFOC Page 2 of 4

Revision: 03 Effective Date: 04/15/24

Acquisition ID#: 36C261-25-AP-0129

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the

Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The VACCHS requires a service agreement for PM, CM, and parts replacement for four highly specialized surgical lasers. These lasers include the VersaPulse HO-YAG, Moses 2.0

Pulse HO-YAG, AcuPulse Duo Carbon Dioxide Laser, and Selecta Duet ND-YAG Laser.

The required maintenance ensures these critical medical devices' continued operability and safety, which is essential for performing various surgical procedures within the VACCHS.

The rationale for limiting competition to a single source, Melling, is based on the fact that

Melling is the only manufacturer-authorized service provider for these specific laser models.

Utilizing an unauthorized service provider would result in potential safety risks, compromise warranty conditions, and violate the manufacturer's maintenance requirements.

Furthermore, contracting with another source would result in unacceptable delays in fulfilling the agency's requirements. These delays would directly impact patient care by reducing the availability of fully functional surgical lasers, which are essential for the timely and effective treatment of veterans. The lead time required for a new service provider to gain manufacturer authorization, procure specialized parts, and familiarize itself with the equipment is likely substantial and would negatively affect the VA's ability to provide uninterrupted medical services.

In this case, the unavailability of these specialized lasers would severely impair surgical capabilities, potentially resulting in delayed medical procedures and adverse outcomes for veterans who depend on the VA for critical care. This urgency is directly tied to the VA's mission of promptly providing high-quality healthcare services to veterans. Melling is the only vendor capable of providing the services needed without these unacceptable delays, ensuring surgical procedures can continue without disruption.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Notice of Intent to Sole Source was posted to SAM.gov on October 18, 2024, and closed on October 21, 2024. The notice explicitly outlined the

VACCHS’s need for PM, CM, and replacement parts for four highly specialized surgical lasers. The notice described the equipment requiring service, including HO-YAG and CO2 lasers manufactured by Boston Scientific and Lumenis Inc., and indicated that Melling, LLC.

is the sole authorized service provider for these models. Despite the public posting, no vendors responded, expressing interest or capability to perform the required services. This lack of responses reinforces the assertion that Melling, LLC. is the only viable service provider for this requirement.

Additionally, Boston Scientific and Lumenis Inc., the manufacturers of the surgical lasers, have certified that Melling, LLC. is their sole authorized service provider. This certification confirms that no other vendor is authorized to perform the necessary maintenance and repairs on these highly specialized lasers, ensuring compliance with manufacturer standards and preventing any risk of voiding warranties or jeopardizing patient safety.

VHAPG Part 806.3 OFOC Page 3 of 4

Revision: 03 Effective Date: 04/15/24

Acquisition ID#: 36C261-25-AP-0129

Given that no other potential vendors expressed interest and the manufacturers have confirmed Melling, LLC's sole-source status, no further actions were taken to facilitate competition. The evidence supports the conclusion that Melling, LLC. is the only source capable of meeting the VA's needs without risking unacceptable delays or additional costs associated with the training and certification of other vendors. Therefore, this acquisition is justified under FAR 6.302-1 (Only One Responsible Source).

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: It has been determined that the anticipated cost for this acquisition will be considered fair and reasonable based on a detailed comparison with the independent government cost estimate (IGCE). The quoted price provided by Melling, LLC. aligns with the IGCE and falls within the expected cost range for similar services, which include PM, CM, and replacement parts for four highly specialized surgical lasers.

The quoted price has been confirmed as the final price, with no anticipated price adjustments from the initial quote to the contract award. This assurance has been verified through communications with the vendor, and the CO has documented the finality of the pricing. The contract is for a firm-fixed-price award, so certified cost or pricing data will not be required under the current acquisition threshold. However, additional price analysis was conducted through the IGCE and market research.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: Market research was conducted per FAR

Part 10, VA Acquisition Regulation (VAAR) 810.001-70, and PPM 2016-05 (Revised

August 2019), with particular attention to the requirements of the Veterans First Contracting

Program and the implementation of the Rule of Two under 38 U.S.C. § 8127. The Veteran

Small Business Certification (VetCert) database has been reviewed to determine if two or more service-disabled veteran-owned small businesses (SDVOSBs) or veteran-owned small businesses (VOSBs) could meet the requirement for PM, CM, and parts replacement for four surgical lasers at the VACCHS. Upon searching the VetCert database, it was determined that

Melling, LLC., the manufacturer-authorized service provider for the specified equipment, is a

SDVOSB. No other vendors in the marketplace, including those listed in VetCert, possess the necessary certifications or manufacturer authorization to service these specific laser models.

Therefore, the VA Rule of Two is not satisfied, as Melling, LLC. is the sole SDVOSB capable of providing the required services.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any

Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Currently, no specific actions are planned to foster competition for future acquisitions of the PM, CM, and parts replacement services for the four surgical lasers due to the highly specialized nature of the equipment and the fact that Melling, LLC. is the sole manufacturer-authorized service provider. The barriers to competition primarily stem from