RFI 36C25625Q1356 Flexible Cystoscope Maintenance.pdf

Special Notice

*= Required Field Special Notice

SUBJECT* Flexible Cystoscopes Maintenance

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25625Q1356

RESPONSE DATE/TIME/ZONE 08-21-2025 15:00 CENTRAL TIME, CHICAGO,

USA

ARCHIVE 7 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

PRODUCT SERVICE CODE* J066

NAICS CODE* 339112

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16

Galleria Financial Center

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist

Frank Sanders frank.sanders1@va.gov

(713) 791-1414 x 25729

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov

URL DESCRIPTION Department of Veterans Affairs

AGENCY CONTACT’S EMAIL ADDRESS frank.sanders1@va.gov

EMAIL DESCRIPTION 36C25625Q1356 RFI- Cystoscopes PM

DESCRIPTION

Notice of Intent to Sole Source

The Department of Veteran Affairs, Veterans Health Administration, Network Contracting Office 16, Houston, Texas 77030, intends to negotiate a sole source Firm-Fixed Price contract for the procurement of Support, Services, & Maintenance on the Flexible Video Cystoscopes for Urology cystoscopy procedures, at the Michael E. DeBakey VA Medical Center with KARL STORZ Endoscopy, in accordance with 41 U.S.C. §3304(a)(1) as implemented by FAR 6.302-1.

Only one responsible source and no other supplies or services will satisfy agency requirements.

This is not a request for competitive offers, and no solicitation is available. Market research has determined that these items are highly specialized, are only available from the original source without an unacceptable delay or duplication of cost and no other type of items will satisfy the agency’s requirements. The Government intends to award the contract with an anticipated date of 23 September 2025 to KARL STORZ Endoscopy America Inc., 2151 E Grand Ave, El Segundo, CA 90245 CAGE: 2N355. The intended procurement will be classified under North America Industry Classification System (NAICS) 811210 with a large business size standard of $34M.

THIS NOTICE OF INTENT IS NOT A SOLICITATION OR REQUEST FOR COMPETITIVE

QUOTES. However, interested parties may identify their interest and capability to respond to this requirement no later than the date/time indicated below. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. The information received will normally be considered solely for determining whether to conduct a competitive procurement. The Department of Veterans Affairs will NOT be responsible for any costs incurred by interested parties in responding to this notice of intent.

Only written responses will be considered. All responses from responsible sources will be considered. As a result of analyzing responses to this notice of intent, the Government shall determine if a solicitation will be issued. Any prospective contractor must be registered in the System for Award Management (SAM) to be eligible for the award.

Responses to this notice shall include evidence that the respondent is an Original Equipment Manufacturer (OEM), OEM authorized dealer, authorized distributor or authorized reseller for the medical equipment and system, as verified by an authorization letter from the OEM on OEM letterhead or other document of valid proof for maintenance and service of mail systems equipment and access to software, updates and warranty from the OEM.

Interested parties are encouraged to furnish information by email only with “RESPONSE TO INTENT TO SOLE SOURCE 36C25625Q1356” in the subject line. All documents submitted will not be returned. All interested parties shall submit clear and convincing documentation demonstrating their capabilities to satisfy the requirements listed above to Frank Sanders via e-mail at frank.sanders1@va.gov NO LATER THAN 21 August 2025 at 15:00 PM Central Standard Time. The capability documentation should include general information and technical background describing in detail the prospective contractor's capabilities and experience that will demonstrate the ability to support these requirements.

mailto:frank.sanders1@va.gov

See Attached document: Performance Work Statement - Draft

Flexible Video Cystoscopes Maintenance and Repair

GENERAL REQUIREMENT

The Michael E. DeBakey VA Medical Center (MEDVAMC) is requesting for a contractor to provide preventive maintenance and service on the Flexible Video Cystoscopes for Urology cystoscopy procedures.

EQUIPMENT IDENTIFICATION

Manufacturer Model Quantity Serial Numbers AEMS/MERS

ID

Karl Storz 16 FR. FLEXIBLE

VIDEO CYSTOSCOPE

PDD

1 46010 580 MX1827684

Karl Storz 16 FR. FLEXIBLE

VIDEO CYSTOSCOPE

PDD

3 46244, 46224,55407 580 MX1827668,

580 MX1827683,

580 MX1827623

Karl Storz CCU TELECAM SL II 2 PR781624P, RR783488P

580 MX1827604,

580 MX1833567

Karl Storz OR1 SMARTSCREEN

FOR WD300 AIDA

BELLA

2 TR615221T, TR615198T 580 MX1833564,

580 MX1827601

DEFINITIONS/ACRONYMS

A. Biomedical Engineer(ing) - Supervisor or designee.

B. CO - Contracting Officer

C. COR - Contracting Officer's Representative

D. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

E. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VAMC premises.

F. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

G. Acceptance Signature - VA employee who is authorized to sign-off on the ESR which indicates that the PM or service has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

H. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

I. NFPA - National Fire Protection Association.

DRAFT

J. CDRH - Center for Devices and Radiological Health.

K. VAMC - Department of Veterans Affairs Medical Center

L. VAH - Department of Veterans Affairs Hospital

M. OEM - Original Equipment Manufacture

N. NIST - National Institute of Standards and Technology

CONDITION OF EQUIPMENT

The Contractor accepts responsibility for the equipment in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

SERVICE REQUIREMENTS

HOURS OF COVERAGE

A. Normal hours of coverage are Monday through Friday from 8:00 a.m. to 5:00 p.m. for all maintenance and services, excluding holidays.

B. Any necessary hardware/software update/installations as deemed by the OEM will be scheduled at least three (3) days in advance and shall be performed at no additional charge to the Government (unless it would be detrimental to equipment up-time; to be determined by the COR).

C. Federal Holidays observed by the VAMC are:

New Years' Day Martin Luther King Day Presidents' Day Memorial Day Independence Day Labor Day Columbus Day Veterans' Day Thanksgiving Day Christmas Day

In addition to the days designated as holidays, the Government observes the following days:

Any other day designated by Federal Statute Any other day designated by Executive Order Any other day designated by the President’s Proclamation

D. Preventive maintenance will be performed 1 time a year.

UNSCHEDULED MAINTENANCE (Emergency Repair Service/Corrective Maintenance) A. Contractor shall maintain the equipment in accordance with the manufacturer's latest specifications. The Contractor shall provide repair and exchange services which may consist of calibration, cleaning, oiling, adjusting, replacing parts, and maintaining the equipment, including all intervening calls necessary between regular services and calibrations. All required parts shall be furnished.

B. The CO, COR or designee has the authority to approve/request a loaner or receive technical support from the Contractor.

C. Response Time: - Contractor's FSE must respond to the COR or his/her designee within thirty (30) minutes after receipt of telephoned notification twenty-four (24) hours per day. For exchanges, replacement Cystoscope shall be shipped from vendor within two days from telephoned notification.

Return shipping for the not fully functional cystoscope shall be covered by the vendor; a return label shall be provided to MEDVAMC within 7 days. Shipping costs are included within this contract. On-site equipment repairs shall be completed within 7 days from telephoned notification.

D. Any charges for parts, services, labor, shipping, manuals, tools, installation, firmware or software required to successfully complete unscheduled maintenance or repair are included within this contract unless specifically stated in writing otherwise and approved by the COR in writing. Parts and services not included within this contract are parts that are needed due to the failure of MEDVAMC to operate the system in accordance with the Specifications and the system use by untrained operators. Parts and services needed due to system damage from fire, accident, vandalism, water, smoke, lightning, natural disasters, building structural deficiency or power supply and/or heating, ventilation, or air conditioning fluctuation are also not included within this contract.

E. Contractor shall provide mandatory safety and performance-related updates or remediations to covered equipment. The contractor shall provide all operational software updates to the applicable covered equipment that materially affects the performance of the equipment as deemed necessary by the OEM, without additional charge to the government. These enhancements to the equipment shall be delivered to the government site and installed by the contractor within 30 days of their issuance or date of first commercial availability.

F. The equipment within the Equipment Identification section is subject to change should exchanges be needed. The exchanges shall take the place of the removed equipment as long as the exchange is an equal model.

SCHEDULED MAINTENANCE

A. The Contractor shall perform any scheduled services or repair to ensure that equipment listed in the schedule performs in accordance with Section 3, Conformance Standards. Scheduled maintenance or repair shall be scheduled at least three (3) days in advance with the Contracting Officer Representative (COR).

PARTS

Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or service for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No re-manufactures or gray market items will be acceptable.

The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right to enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA’s election, allowing the Contractor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA facility upon discovery of such items.

The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment. The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the COR. (The Contractor shall also list any excluded parts under the service contract).

TEST EQUIPMENT

Should the COR request it, prior to commencement of work on this contract, the Contractor shall provide the VAMC with a copy of the current calibration certification of all test equipment which is to be used by the Contractor on VAMC's equipment. This certification shall also be provided on a periodic basis when requested by the VAMC. Test equipment calibration shall be traceable to the NIST national standard.

CONTACT INFORMATION

Upon contract award, the Contractor must provide valid and reliable contact information for service, preventative maintenance, emergency and technical assistance requests.

REPORTING REQUIREMENTS

The Contractor shall be required to report to Biomedical Engineering to log in. This check in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR for an "authorization signature" unless otherwise stated by the COR. If the COR is unavailable, a signed, authorized copy of the ESR will be sent to the Contractor after the work can be reviewed (if requested or noted on the ESR).

VA Biomedical Contact Persons: VHAHOUBiomed@va.gov

Location (Building/Room Number): BA-200 mailto:VHAHOUBiomed@va.gov

Telephone Number & Extension(s): 713-794-7271/7270

DOCUMENTATION/REPORTS

The Contractor or Contractor’s FSE shall complete a full service report, in writing, after each equipment repair or exchange (emergency or scheduled) and submit either a hard copy or an electronic version of this report to the COR within 5 days after the service day.

The documentation shall include detailed descriptions of the scheduled and unscheduled maintenance (i.e., Emergency repairs) procedures performed, including replaced parts required to maintain the equipment in accordance with the "Conformance Standards" section or the manufacturer's specifications. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The electronic engineering service report (ESR) will consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C. Contractor service ESR number/log number.

D. Date, time (starting and ending), equipment downtime and hours on-site for service call.

E. VA purchase order numbers covering the call if outside normal working hours.

F. Description of problem reported by COR.

G. Identification of equipment to be serviced:

1) Inventory ID number,

2) Manufacturer's name,

3) Device name,

4) Model number,

5) Serial number,

6) Any other manufacturer's identification numbers.

H. Itemized Description of Service Performed (including, if applicable, Costs associated with after normal working hour services) including:

1) Labor and Travel,

2) Parts (with part numbers),

3) Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed (if applicable - i.e., part(s) not covered or service rendered after normal hours of coverage).

J. Signatures:

1) FSE performing services described.

2) Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR before service is completed!

REMOVAL OF EQUIPMENT

Should a piece of equipment require repair at the Contractor ‘s plant, the Contractor shall coordinate with the COR the removal of equipment. A Property Pass may be obtained from Acquisition & Material Management Service, Personal Property Section, 4A-320 after removal is authorized by the COR. The Contractor may not remove equipment from Government site for minor repairs only. The Contractor shall be responsible for damage or loss of equipment while in the Contractor ‘s charge.

REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the CO and COR (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish the CO and COR with a written estimate of the cost to make necessary repairs.

ADMINISTRATIVE REQUIREMENTS

COMPETENCY OF PERSONNEL SERVICING EQUIPMENT

A. Each respondent must have an established business, with an office and full-time staff. The staff includes a "fully qualified" FSE and a "fully qualified" FSE who will serve as the backup.

B. "Fully Qualified" is based upon training and on experience in the field. For training, the FSE(s) has successfully completed a formalized training program, for the equipment and is OEM Certified. For field experience, the FSE(s) has a minimum of two years of experience (except for equipment newly on the market) with respect to scheduled and unscheduled preventive and remedial maintenance, on the listed equipment in the Equipment Identification Section.

C. The FSEs shall be authorized by the OEM to perform the maintenance services. All work shall be performed by "Fully Qualified", OEM Certified competent FSEs. The Contractor shall provide written assurance of the competency of their personnel and a list of credentials of approved FSEs for each make and model the Contractor services at the VAMC prior to award. The COR may authenticate the training requirements, request locations, training certificates or credentials, and technician location from the Contractor at any time for any personnel who are servicing or installing any equipment. The CO and/or COR specifically reserve the right to reject any of the Contractor's personnel and refuse them permission to work on the VAMC equipment if evidence is not provided when requested.

D. If subcontractor(s) are used, they must be approved by the COR; the Contractor shall submit any proposed change in subcontractor(s) to the CO for approval/disapproval.

The VAMC, CO, COR or any of its and/or their associates, employees or descendants under any conditions or circumstances shall not be held responsible for any safety incident or any injury or any inconvenience experienced by the Contractor, their associates, or subcontractors while performing the services, labor, travel, software upgrades or maintenance included within this contract to the extent applicable by federal, local and state law with federal law taking precedence.

INSURANCE

A. Worker compensation and employer's liability: - Contractors are required to comply with applicable Federal and State Worker Compensation and occupational disease statutes.

B. General Liability: - Contractors are required to have Bodily Injury Liability Insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence.

C. Property Damage Liability: - Contractors are required to have Property Damage Liability insurance coverage of at least $500,000.

ADDITIONAL CHARGES & PAYMENT

There will be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

Any service required which the Contractor believes to be in excess of the contract provisions and require additional payment (e.g., work beyond normal work hours) shall not be performed without prior authorization from the COR. In any case, the VA shall be explicitly notified in advance that additional charges will be incurred, prior to beginning such work. In such instances that the VA agrees the work is not within the scope of the contract, and the VA desires the Contractor to perform service, a separate purchase order will be issued to the Contractor for the work.

The Government shall not be responsible for incidental charges including, but not limited to, parking, tolls, mileage, phone, etc., on straight time or overtime work.

All invoices shall be submitted in arrears, properly prepared in accordance with FAR 52.212-4, contain sufficient details, and match with the service tickets for the work rendered.

A. Invoices

Invoices shall be properly prepared and sent electronically to the VA Financial Services Center for payment processing via their electronic e-Invoice system. Invoices shall be sent in arrears at the beginning of the first month of each quarter following the quarter in which the services were rendered and billed for. At a minimum, all invoices shall include the following details:

Ø Contract No.

Ø Purchase Order No. Correct purchase order number which will be issued by the Contracting Officer after the contract is awarded. Invoices without correct purchase order number shall be rejected and returned to the Contractor.

Ø Item(s) covered (to include serial #'s) Ø Description of the services rendered Ø Billing period in which the services were rendered Ø Invoice number and date

Payments will be made in accordance with the prompt payment act out of the Government annual appropriated funds obligated in a purchase order which will be issued after the contract is awarded.

GOVERNMENT PARTY TO EXECUTE AND MODIFY THE CONTRACT

After the contract has been in force for a period of time, it may be necessary to change and/or modify the operations to provide better service. Pursuant to FAR 43.102, no government personnel other than the Contracting Officer can execute contract modifications on behalf of the government.

END OF SERVICE PERIOD

No service shall be performed under this agreement after the contract expiration date without written authority or direction from the Contracting Officer.

Contractor guarantees all equipment covered in this contract shall be in optimum working condition at the contract expiration date provided that the Contractor is notified of any deficiencies at least one (1) day before the contract expiration date to the COR. Any changes, updates or retrofits made on any component or system shall be reported to the COR for annotation on station equipment manuals and records. For any service call made during normal working hours, the Contractor‘s repairman shall report their arrival and departure to the COR.

INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

PRIVACY/SECURITY

The Contractor will not need to access VA systems to perform software upgrades, preventative maintenance and maintenance repairs.

The Contractor will not have electronic connectivity to the devices. The Contractor will not have access to patient databases with PHI present when troubleshooting equipment issues.

Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO.

Electronic or magnetic data storage devices are not to be removed from VA property.

MOBILE MEDIA SCANNING

The Contractor will identify if removable media (i.e. USB or DVD/CD Device) is required to perform his/her duties. Personally-owned USB thumb drive utilization is prohibited. Non-VA support personnel must furnish their own FIPS140-2 certified USB thumb drives, and only with the permission of a designated VA supervisor. All USB drives must be scanned with an antivirus program running current virus definitions by the local VA staff, prior to connection to any VA device. COR or designee will ensure the removable media is scanned with anti-virus software running current virus definitions prior to connection to any medical device system. The computer system for scanning removable media is located in the Biomedical Engineering shop, Building 100, Room BA200.

End of Performance Work Statement