P11. Sources Sought Notice - 36C25626Q0701.pdf

Sources Sought Notice

*= Required Field Sources Sought Notice

SUBJECT* Berman Medical Kädn Laser Therapy System

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25626Q0701

RESPONSE DATE/TIME/ZONE 04-29-2026 12:00 PM CENTRAL TIME,

CHICAGO, USA

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 334510

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist

Caleb Parker

Caleb.Parker@va.gov

PLACE OF PERFORMANCE

ADDRESS Fayetteville VA Medical Center

1100 North College Avenue

Fayetteville, AR 72703-1944

DESCRIPTION

THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is for market research to obtain information regarding the availability and capability of all qualified sources to perform or provide a potential requirement. The responses received from interested vendor will assist the Government in determining the appropriate acquisition method.

The Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16) is seeking to identify potential qualified vendors capable of providing the requirement. This requirement is for the Fayetteville VA Medical Center located at 1100 North College Avenue Fayetteville, AR 72703-1944.

The North American Industry Classification Code (NAICS) is 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing), and PSC code 6515 (Medical and Surgical Instruments, Equipment, and Supplies), with a size standard of 1,250 Employees.

REQUESTED RESPONSES:

All responsible vendors and interested parties please respond to this source sought announcement if you can fulfill the requirements. Responses to this source sought shall include the following information:

1. Your company name, address, contact person name, phone number, fax number, e-mail address(s), UEI number, number of employees, and company website if available.

2. If you are an GSA/FSS contract holder are the referenced services available on your schedule/contract? Provide your company GSA/FSS contract number and contract expiration date, if applicable.

3. If you are a NASA SEWP V contract holder are the referenced services available on your schedule/contract? Provide your company NASA SEWP V contract number, contract group, and contract expiration date, if applicable.

4. Is your company a contract holder on any other federal contract? If so, please provide the contract number.

5. Socio-economic status of business such as but not limited to (Service-Disabled Veteran Owned Small Businesses (SDVOSB) or Veteran Owned Small Businesses (VOSB) SDVOSB/VOSB, 8(a), HUB Zone, Women Owned Small Business, Small disadvantaged business, or Small Business HUB Zone business, Large Business, etc.).

6. Is your company considered small under the NAICS code identified in this source sought announcement?

7. Is your company An authorized distributor for the requirement being offered? If so, can you provide documentation confirming authorization to provide the referenced requirement being offered per the Statement of Work?

8. If your company is a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of contact and size status (if available).

9. Vendors are requested to submit estimated market research pricing with their responses. The estimated pricing will be considered when determining the procurement strategy for the future solicitation. (e.g., if Contracting Officer determines that capable small businesses cannot provide fair and reasonable pricing, then the solicitation will not be set-aside).

Please note: Responses that are incomplete will not be considered. Failure to provide an authorized distributor letter for the product being offered, or failure to fully answer all questions contained within this notice, will result in your response being deemed non-responsive and excluded from further consideration.

CONTACT INFORMATION AND RESPONSE DUE DATE:

Please email all responses to caleb.parker@va.gov. Please respond to this source sought notice no later than 04-29-2026, 12:00 PM Central.

DISCLAIMER: This source sought is issued solely for informational and planning purposes and does not constitute a solicitation. Responses to this notice are not offers and cannot be accepted by the Department of Veterans Affairs to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this source sought notice.

Statement of Work (SOW)

Project: Berman Medical Kädn Laser Therapy System

1. Purpose

The Contractor shall furnish all labor, materials, equipment, logistics, training, documentation, warranty, and support necessary to provide a fully operational medical laser therapy system for clinical use. This includes delivery, onsite installation, configuration, acceptance testing, operator training, and a five (5) year warranty and service coverage.

2. Background

VHSO requires a therapeutic medical laser system to support Whole Health and rehabilitative/therapeutic services. The requirement must comply with applicable medical device safety standards and laser safety regulations and be delivered as a turnkey solution to minimize disruption to clinical operations.

3. Scope of Work

3.1 In-Scope

• Supply of the medical laser therapy platform and specified handpieces/accessories

• Delivery, onsite installation, configuration, and verification at the specified facility

• Operator training and provision of all required documentation

• Acceptance testing and formal handover to the Government

• Five (5) year warranty and service coverage, including annual preventive maintenance (PM)

• Ongoing technical support, updates, calibration, and maintenance per manufacturer guidance

3. System Description & Minimum Technical Requirements Laser Platform: Berman Medical Kädn Laser, 60-Watt, 980nm wavelength, 635nm aiming beam, with continuous/pulsed modes and safety features.

4.1 Laser Platform Salient Characteristics

• Therapeutic wavelength: 980 nm (primary emission)

• Aiming beam: 635 nm red visible beam

• Output power: up to 60 Watts (continuous and pulsed modes)

• Operating modes: Continuous and pulsed with adjustable parameters (duty cycle/frequency)

• Safety features: Key switch, emergency stop, interlock, emission indicator, password or controlled access, fiber connector safety, over-temperature protection

• Emission control: Handpiece or footswitch activation with tactile/visual feedback

• Display and controls: Integrated user interface enabling mode selection, power adjustment, and parameter presets

• System footprint: Portable cart or floor stand compatible; manageable size suitable for clinical environment

• Power: Standard US mains (e.g., 120 V AC), surge protection supported

• Compliance: Must comply with FDA 21 CFR 1040.10 and 1040.11; IEC 60601 applicable parts; ANSI Z136.3; OSHA laser safety requirements

• Accessories: System must include protective eyewear compatible with 980 nm (optical density appropriate for clinical safety), fiber or delivery components, and all accessories required for safe operation and maintenance

4.2 Handpieces and Functional Accessories

The system must include handpiece suites and accessories that provide equivalent therapeutic functionality to the items listed below. Offerors proposing “equal” components shall provide cross-reference that demonstrates functional equivalence and compatibility with the offered laser platform.

• PM3 Physical Therapy Handpiece (or equal) – general therapeutic use

• Ojäi PM5 Physical Therapy Handpiece Suite (or equal) – extended therapeutic functionality

• Kädn Handpiece Suite (or equal) – multipurpose therapy handpieces

• Kädn Zoom Handpiece (or equal) – adjustable/zoom capability

• Carrying case (or equal) – protective transport/storage

• Laser cart (or equal) – safe, stable mounting and mobility

• Surge suppressor (or equal) – mitigates power issues

• Protective eyewear – three (3) pairs, rated for 980 nm with appropriate OD

• User Manual and IFUs – complete documentation for safe operation and maintenance

• Marketing materials (posters set, brochures 200) – clinic-facing engagement materials

• All accessories required to operate the laser therapy system safely and as intended by the manufacturer

Bill of Materials (Minimum)

• Therapeutic laser system meeting salient characteristics (Section 4)

• Required handpieces identified in 4.2 (or equal)

• Three (3) pairs of protective eyewear suitable for 980 nm emission

• Laser cart, surge suppressor, cables/fibers, footswitch/activation control

• Carrying case, user manual/IFUs, service and warranty documentation

• Marketing posters set and 200 brochures

• Five (5) year warranty coverage

Compliance and Regulatory Requirements The delivered system shall meet or exceed:

• FDA 21 CFR 1040.10/1040.11 (laser products)

• IEC 60601 series, including electrical safety and EMC requirements applicable to therapeutic laser devices

• ANSI Z136.3 (Safe Use of Lasers in Health Care)

• OSHA laser safety standards and applicable workplace safety requirements

• Labeling and IFUs shall be clear, accurate, and consistent with regulatory obligations

5. Delivery & Installation

Delivery, Installation, and Commissioning

• Delivery schedule: Within 90 calendar days After Receipt of Order (ARO)

• Shipping address: Veterans Health Care System of the Ozarks, 1100 North College Avenue, Fayetteville, AR 72703

• Packaging/marking: Clearly mark boxes with PO number and department contact; protect device per manufacturer instructions

• Installation: Stage, assemble, connect components, verify power, perform manufacturer-required operational checks, configure presets and safety interlocks

• Commissioning: Perform acceptance testing (Section 10) and obtain formal acceptance by AGR

6. Training

• Onsite clinical operator training (2–4 hours) covering: safety protocols, system controls, handpiece workflows, treatment parameters, maintenance tasks, troubleshooting, and eyewear verification

• Provide training materials: user manual, quick‑reference guides, safety checklist, and training roster documentation

• Remote training availability: Provide virtual training options for refresher or new staff

• Post‑installation support: Q&A period and access to technical support for follow‑up questions

7. Acceptance Testing & Handover

The Contractor shall perform and document all acceptance testing with the COR present. Minimum tests shall include:

• Physical delivery verification against the Bill of Materials (Section 5)

• Power‑on self‑test and system initialization without alarms/faults

• Emission test: Verify output power within manufacturer tolerance using a calibrated power meter; verify pulsed mode frequency and duty cycle settings function as specified

• Safety verification: Key switch, emergency stop, interlock(s), emission indicator(s), activation control (handpiece/footswitch), and password/access controls function as designed

• Eyewear verification: Confirm provided eyewear OD and wavelength ratings suitable for 980 nm; inspect for defects per LSO guidance

• Handpiece verification: Attach/detach, emission control, and parameter selection operate correctly across included handpieces

• Documentation handover: Provide user manual/IFUs, warranty details, maintenance schedule, calibration certificates (if applicable), and training completion roster

• Acceptance: COR signs acceptance after all test steps pass; deficiencies must be corrected prior to acceptance

8. Warranty & Service (5 Years)

• Coverage: Parts, labor, onsite service, software/firmware updates, and remote support for five (5) years from acceptance

• Preventive Maintenance (PM): Annual PM and calibration per manufacturer recommendations; provide PM report to COR within ten (10) business days of completion

• Response Time:

– Initial remote triage within one (1) business day of service request

– Onsite service within three (3) business days for non‑operational events, unless mutually agreed otherwise

• Uptime Assurance: If cumulative downtime exceeds ten (10) business days in any rolling 12‑month period, Contractor shall provide a loaner unit or equivalent mitigation at no additional cost until repaired

• Parts Availability: Contractor shall ensure parts availability for the duration of warranty; if discontinued parts impact serviceability, Contractor shall provide acceptable alternatives at no additional cost

• Software/Updates: Provide any safety, performance, or regulatory updates at no additional cost during the warranty period9. Regulatory & Safety Compliance System must comply with FDA 21 CFR 1040.10/11, IEC 60601, ANSI Z136.3, OSHA requirements, and applicable safety standards.

10. Maintenance & Support Annual PM, calibration, software updates, and inspection of handpieces and accessories.

11. Project Schedule (Target) The Contractor must ensure all deliverables are delivered to the following address and reference the VA’s purchase order number as an Attn: line in the shipping address: Fayetteville Veterans Healthcare of the Ozarks Attn: Purchase order#, 1100 North College Avenue Fayetteville AR 72703.

12. Pricing & Payment Firm-fixed price including equipment, delivery, installation, training, and warranty.

13. Assumptions Facility will provide dedicated electrical outlet, space, and Laser Safety Officer (LSO).

14. Change Control Any change in scope or specifications requires a written change of order and approval by the Contracting Officer.

15. Risk & Mitigation

• Power issues mitigated via surge suppressor

• Training gaps addressed through super-user training

16. Contacts & Approvals Authorized Government Representative:

Christi L. Kraker, Acquisition Utilization Specialist

Record Management Obligations:

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [VHSO] records.

2. Does not include personal materials.

3. Applies to records created, received, or maintained by Contractors pursuant to their [VHSO] contract.

4. May include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [VHSO] policy.

8. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The [Agency] owns the rights to all data and records produced as part of this contract.

All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [VHSO]-provided records management training.

The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of requirements to subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.