36C25726Q0583 ENT URO Scope Consumables.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

674-26-2-029-0017

36C25726Q0583 05-20-2026

Matt Lee 210-393-9281 05-29-2026

12PM CDT

36C257 Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240 x

334510

150 Employees

N/A

X

36C674

Department of Veterans Affairs Olin E. Teague Veterans Medical Center 1901 Veterans Memorial Drive Attn: Logistics Temple TX 76504

36C257

Department Of Veterans Affairs Network Contracting Office 17

5441 Babcock Road Ste. 302 San Antonio TX 78240

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791 (512) 460-5540

See CONTINUATION Page

Requirement being procured as unrestricted Brand Name or Equal.

Please see Section B for Statement of Work, Evaluation Factors and Price / Cost Schedule.

Please submit all questions to matthew.lee5@va.gov by 05/21/2026 @12PM NOON CST.

Please review 52.212 2 and basis for award evaluation criteria.

Please submit all documentation VIA email matthew.lee5@va.gov

Please submit all price listings (quotes) to matthew.lee5@va.gov by 05/29/2026 @12PM CST.

IMPORTANT: FAIL TO INCLUDE ALL REQUIRED DOCUMENTATION AND

INFORMATION WILL BE REJECTED AND WILL NOT BE CONSIDERED FOR

AWARD.

See CONTINUATION Page

X X

X 1

TBD

Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

B.4 STATEMENT OF WORK

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.3 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE

ITEM (MAR 1989)

C.4 52.222-90 ADDRESSING DEI DISCRIMINATION BY FEDERAL CONTRACTORS

(APR 2026)

C5 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.3 52.216-1 TYPE OF CONTRACT (NOV 2025) (DEVIATION)

E.4 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.5 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.6 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025)

E.7 52.225-4 BUY AMERICAN—FREE TRADE AGREEMENTS—ISRAELI TRADE ACT

CERTIFICATE (DEVIATION) (NOV 2025)

36C25726Q0583

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR: TBD

b. GOVERNMENT: Contracting Officer 36C257 TBD

Department Of Veterans Affairs

Network Contracting Office 17

5441 Babcock Road Ste. 302

San Antonio TX 78240

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] UPON RECEIPT

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMB

ER

DESCRIPTION

OF

SUPPLIES/SERV

ICES

QUANTI

TY

UNI

T UNIT PRICE AMOUNT

3.00 EA ______________

LITHOTRIPSY TRANSDUCTER

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary

*BRAND NAME OR EQUAL*

3.00 EA ______________

LITHOTRIPSY NOSE CONE

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

1.00 EA ______________

LITHOTRIPSY SYSTEM

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

6.00 EA ______________

WORKING INSERT 8.5 MM 8FR

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

5.00 EA ______________

STERILIZATION TRAY

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

STERILIZATION MAT

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

2.00 EA ______________

BIOPSY FRCPS, SPOON TYPE OPTICAL

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

FLEXIBLE FOREIGN BODY FORCEPTS 7F

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

CYSTO SHEAT 17FR

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

ATTACHMENT W/ AUTOVALVE FOR A3336

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

STERILIZATION TRAY HOLDER

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

STROBOSCOPY SYSTEM

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

4.00 EA ______________

STERILE CASE FLEXIBLE VIDEO

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

12.00 EA ______________

LUER-SPLIT FORCEPS/IRRIGATION PLUG

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

5.00 BX ______________

SEAL KIT, 6-12FR

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

UNIVERSAL STOPCOCK LUER LOCK

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

STERILIZATION TRAY

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

STERILIZATION MAT

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

MOBILE TROLLEY SET 3

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

COMPACT LCD MONITOR ARM

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

HD-SDI CABLE

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

SEMI INLINE RATCHET

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

MONOPOLAR HAND INSTRUMENT

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

DEACTIVATABLE RATCHET

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

FLUSHING PUMP

PRINCIPAL NAICS CODE: 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing PRODUCT/SERVICE CODE: 6525 - Imaging

GRAND TOTAL ______________

B.3 DELIVERY SCHEDULE

ITEM

NUMBER SHIPPING INFORMATION QUANTITY

DELIVERY

DATE

0001-

SHIP TO: Olin E. Teague Veterans Medical Center 1901 Veterans Memorial Drive Attn: Warehouse Temple, TX 76504

US

ALL 12/31/2026

MARK FOR: TBD

FOB: DESTINATION

B.4 STATEMENT OF WORK

Introduction/Background

The Central Texas Veterans Healthcare System (CTVHCS) requires the purchase of specialized endoscopy equipment and consumables for use with its leased medical scope equipment. This equipment supports diagnostic and therapeutic procedures in the Surgical Services departments, including urology (URO), ear-nose-throat (ENT), and general surgical endoscopy (SE). These consumables are required for facilities in

Temple and Austin. This procurement is crucial for ensuring the uninterrupted and safe performance of medical procedures by providing essential, compatible, and often single-use, accessories. This procurement shall be brand name or equal.

The base period for this purchase is for one year, with no optional years to extend the period of performance.

Period of Performance (POP):

05/30/2026 – 05/29/2027

1. Statement of Need

To ensure the safe and effective operation of its newly leased scope equipment, the Central Texas Veterans Healthcare System (CTVHCS) must procure additional specialized endoscopy equipment and consumables that are compatible with VA-owned Olympus endoscope lithotripters and flush pumps. Single-use, items—such as specialized forceps, sterilization accessories, and system-compatible components. The objective is to establish a readily available supply chain for these consumables through a competitive process that maximizes participation from Service-Disabled Veteran- Owned Small Businesses (SDVOSBs), thereby ensuring uninterrupted service, upholding the highest standards of patient safety, and promoting seamless interoperability across all relevant CTVHCS facilities.

2. Scope of Work

2.1. Period of Performance

2.1.1. This contract is for a single, one-time delivery of the specified quantity of consumables. No additional options for follow-on deliveries are included.

2.1.2. Final dates contingent upon contract award.

2.2. General Requirements

2.2.1. The Contractor shall, upon contract award, provide a one-time, bulk delivery of all consumables, accessories, and replacement items specified in the table below.

2.2.2. All items delivered must be fully compatible and interoperable with the existing leased scope systems utilized by the Surgical Services departments (Urology, ENT, and general Surgical Endoscopy) at CTVHCS facilities in Temple and Austin.

2.2.3. The Contractor is required to deliver the entire quantity of all requested items within 90 calendar days of the contract award date. No partial shipments are authorized unless explicitly approved in writing by the Contracting Officer.

2.3. Specific Consumables/Equipment by Department

The Contractor shall provide the following items in a single delivery, organized by the department that will utilize them.

ITEM DESCRIPTION QTY

TEMPLE URO

LITHOTRIPSY TRANSDUCTER 3

LITHOTRIPSY NOSE CONE 3

LITHOTRIPSY SYSTEM 1

WORKING INSERT 8.5 MM 8FR 6

STERILIZATION TRAY 5

STERILIZATION MAT 5

BIOPSY FRCPS, SPOON TYPE OPTICAL 2

FLEXIBLE FOREIGN BODY FORCEPTS 7F 1

CYSTO SHEAT 17FR 2

ATTACHMENT W/ AUTOVALVE FOR A3336 1

STERILIZATION TRAY HOLDER 5

TEMPLE ENT

STROBOSCOPY SYSTEM 1

STERILE CASE FLEXIBLE VIDEO 4

AUSTIN URO

LUER-SPLIT FORCEPS/IRRIGATION PLUG 12

SEAL KIT, 6-12FR 5

UNIVERSAL STOPCOCK LUER LOCK 12

STERILIZATION TRAY 6

STERILIZATION MAT 6

MOBILE TROLLEY SET 3 1

COMPACT LCD MONITOR ARM 1

HD-SDI CABLE 1

SE

SEMI INLINE RATCHET 2

MONOPOLAR HAND INSTRUMENT 12

DEACTIVATABLE RATCHET 12

FLUSHING PUMP 2

2.4. SALIENT CHARACTERSTICS

This represents the minimum essential salient characteristics for the items listed below.

Products offered must meet or exceed these characteristics to be considered equal. All offered items must be new, unused, and constructed of medical-grade materials. Items must be compatible with existing clinical equipment and sterilization processes used within the facility.

1. LITHOTRIPSY TRANSDUCER

• Provides focused acoustic or ultrasonic energy for stone fragmentation.

• Stable energy output within designated frequency range.

• Compatible with standard lithotripsy systems.

• Suitable for repeated sterilization without degradation.

2. LITHOTRIPSY NOSE CONE

• Medical-grade, durable construction.

• Fits securely onto compatible transducer or handpiece.

• Directs energy accurately to targeted area.

• Maintains structural stability during high-frequency vibration.

3. LITHOTRIPSY SYSTEM

• Provides controlled lithotripsy energy (ultrasonic/pneumatic/combination).

• Includes console, handpiece, footswitch, and necessary connectors.

• Adjustable energy levels for various stone densities.

• Includes overheating protection and automatic shutoff safety features.

4. WORKING INSERT, 8.5 MM / 8 FR

• Dimensions must not exceed 8.5 mm and 8 French size.

• Smooth internal lumen for instrumentation.

• Compatible with corresponding endoscopic systems.

5. STERILIZATION TRAY

• Rigid tray suitable for steam/gas sterilization.

• Venting for sterilization penetration.

• Secure lid or locking features.

• Appropriate size for intended instruments.

6. STERILIZATION MAT

• Non-slip silicone or heat-resistant equivalent.

• Protects instruments during processing.

• Fully compatible with high-temperature sterilization.

7. BIOPSY FORCEPS, SPOON-TYPE, OPTICAL

• Compatible with required optical channels.

• Spoon-type jaws for tissue collection.

• Sterilizable, corrosion-resistant construction.

8. FLEXIBLE FOREIGN BODY FORCEPS, 7 FR

• Flexible 7 French shaft.

• Secure grasping mechanism for retrieval.

• Reusable and sterilization-safe.

9. CYSTOSCOPE SHEATH, 17 FR

• 17 French outer diameter.

• Compatible with standard telescopes and obturators.

• Includes irrigation and working channels.

10. ATTACHMENT WITH AUTOVALVE (A3336 OR EQUIVALENT)

• Provides automatic valve control for irrigation/insufflation.

• Leak-free operation under clinical conditions.

• Fully sterilization-safe.

11. STERILIZATION TRAY HOLDER

• Supports one or multiple sterilization trays.

• Durable, chemical-resistant material.

• Stable, non-slip construction.

12. STROBOSCOPY SYSTEM

• Provides synchronized strobe illumination for vocal fold visualization.

• High-resolution imaging with adjustable frame rates.

• Real-time and slow-motion capability.

• Includes camera, light source, control unit, and recording compatibility.

13. STERILE CASE FOR FLEXIBLE VIDEO SCOPE

• Protects flexible video endoscopes in a sterile environment.

• Rigid/semi-rigid sterilizable construction.

• Internal supports prevent bending or kinking.

14. LUER-SPLIT FORCEPS / IRRIGATION PLUG

• Standard luer-lock compatibility.

• Allows instrument passage while maintaining irrigation.

• Designed for leak-resistant operation.

15. SEAL KIT, 6–12 FR

• Accepts instruments sized 6 through 12 French.

• Airtight/watertight seals, gaskets, or O-rings.

• Sterilization-compatible elastomer materials.

16. UNIVERSAL STOPCOCK, LUER LOCK

• Luer-lock compatible.

• 1-, 2-, or 3-way fluid control.

• Leak-free and sterilization-safe construction.

17. STERILIZATION TRAY

• Meets all specifications listed in item 5.

18. STERILIZATION MAT

• Meets all specifications listed in item 6.

19. MOBILE TROLLEY (SET OF 3)

• Medical-grade carts with locking casters.

• Capable of supporting equipment load safely.

• Includes shelving or mounting platforms.

• Provided as a set of three units.

20. COMPACT LCD MONITOR ARM

• Multi-axis motion and adjustable tilt.

• Supports weight and VESA pattern of facility monitors.

• Cleanable, medical-appropriate construction.

• Integrated cable-management preferred.

21. HD-SDI CABLE

• Supports uncompressed HD video (1080p or greater).

• Shielded to prevent signal interference.

• Includes BNC connectors.

• Correct length for intended system configuration.

22. SEMI INLINE RATCHET

• Provides controlled incremental movement.

• Semi-inline configuration for surgical instruments.

• Corrosion-resistant and sterilizable.

23. MONOPOLAR HAND INSTRUMENT

• Compatible with monopolar electrosurgical generators.

• Insulated shaft with ergonomic handle.

• Suitable for precision dissection and coagulation.

24. DEACTIVATABLE RATCHET

• Mechanism switches between ratcheted and free movement.

• Smooth activation/deactivation.

• Constructed of sterilizable, durable materials.

25. FLUSHING PUMP

• Provides adjustable continuous irrigation for endoscopy.

• Compatible with standard tubing and luer-lock fittings.

• Pressure-controlled with safety protections.

• Suitable for OR electrical and equipment standards.

2.5. Delivery and Acceptance

2.5.1. Delivery Location: All items shall be delivered to the designated central receiving warehouse at the Olin E. Teague Medical Center in Temple (1901 Veterans Memorial Drive building 206).

2.5.2. Delivery Documentation: The entire delivery must be accompanied by a single packing slip that details the contents, quantities, item descriptions, and corresponding purchase order number(s).

2.5.3. Acceptance: All delivered items will be inspected for compliance with the specifications. Acceptance by the Government shall be contingent upon the verification of all items listed in the table, their full compatibility with existing equipment, and their arrival in new, undamaged condition.

2.6. Quality Assurance

2.6.1. Product Standards: All consumables provided must meet or exceed the technical specifications defined by CTVHCS and must be manufactured in accordance with all applicable medical device quality standards.

2.6.2. Product Condition: All delivered items must be new, in original manufacturer-sealed packaging, and free from any defects or damage. Any defective or damaged items discovered upon inspection will be grounds for rejection of the entire lot.

2.6.3. Technical Support: The Contractor shall provide limited technical support to address any immediate issues regarding the delivered items' compatibility or performance with the leased equipment upon delivery.

3. TECHNICAL SPECIFICATIONS

Department Item Description Technical Specifications

Temple Uro LITHOTRIPSY

TRANSDUCER

Technology: Compatible with dual-action lithotripsy systems purchased from Olympus. Combe ultrasonic and ballistic energy. Must provide a frequency range of 20-30 kHz for ultrasonic energy and a pressure range of 20-30 bar for ballistic energy. Control: Integrated single-handpiece activation with dedicated controls for power levels and suction.

Temple Uro LITHOTRIPSY NOSE

CONE

Design: Protective nose cone that securely attaches to the transducer.

Compatibility: Compatible with a range of probe diameters, specifically from 1.5 mm to 3.76 mm. Must ensure full functionality and probe stability with va-owned Olympus lithotripsy system.

Temple Uro LITHOTRIPSY

SYSTEM

Technology: Integrated system for fragmentation and aspiration of calculi.

Must deliver a combined power output of at least 50W for ultrasonic energy. User Interface: Manual, single-handpiece activation with integrated suction control, eliminating the need for a footswitch.

Temple Uro WORKING INSERT Dimensions: Outer diameter of 8.5 mm and 8 French gauge. The working length must be between 30 cm and 40 cm.

Construction: Modular and autoclavable, made from medical-grade stainless steel.

Locking Mechanism: Features a secure locking system for quick and stable assembly. OES-PRO 8.5 MM 8FR.

Temple Uro STERILIZATION TRAY Materials: Anodized aluminum or sterilizable plastic.

Features: Includes a base, a perforated lid, a locking mechanism, and silicone finger mats for instrument organization.

Dimensions: Various sizes are acceptable, with a minimum internal dimension of 4" x 6.5" x 0.75".

Temple Uro STERILIZATION MAT Materials: High-grade silicone, temperature resistant up to 275°F (135°C). Features: Raised structures to cushion and protect instruments.

Temple Uro BIOPSY FORCEPS Application: Designed for optical biopsy procedures via an endoscope. Jaw Type: Spoon-shaped jaws.

Material: Constructed from high-quality medical-grade stainless steel.

Dimensions: Working length must be between 400 mm and 450 mm.

Action: May feature a spring-loaded or double-action closure. Optical

Temple Uro FLEXIBLE FOREIGN

BODY FORCEPTS

Size: 7 French gauge. Features: Double-action jaw for grasping foreign objects.

The shaft must have a minimum diameter of 2.3 mm. Material: Flexible, medical-grade stainless steel shaft.

Dimensions: Working length must be between 40 cm and 45 cm.

Temple Uro CYSTO SHEATH Size: 17 French gauge diameter.

Configuration: May include one or more channels (e.g., for irrigation or a laser fiber) and stopcocks for fluid management. Compatibility: Compatible with standard rigid or flexible cystoscopes. Material: High-quality medical-grade metal (stainless steel).

Temple Uro ATTACHMENT W/

AUTOVALVE

Compatibility: The attachment must be compatible with the specific legacy A3336 system. Features: Includes an integrated autovalve for automated irrigation and fluid control.

Sterilization: Must be autoclavable.

Temple Uro STERILIZATION TRAY

HOLDER

Materials: High-quality stainless steel.

Features: Durable and compatible with high-temperature sterilization methods.

Includes a secure locking mechanism to hold trays during transport and sterilization.

Temple ENT STROBOSCOPY

SYSTEM

Technology: LED-based light source for vocal fold stroboscopy.

Performance: Provides flicker-free images (frequency ≥ 60 Hz) and uniform illumination. The light intensity must be adjustable from 0 to 100%.

Control: Includes an adjustable flash rate and brightness, compatible with a range of air and throat microphones.

Temple ENT STERILE CASE

FLEXIBLE VIDEO

Dimensions: Internal dimensions of at least 23.5" x 11" x 4". Function: Provides a sterile barrier for the storage and transport of flexible video endoscopes.

Compatibility: Compatible with standard flexible video scopes with outer diameters of 2-5 mm and working lengths of 30-60 cm.

Austin Uro LUER-SPLIT

FORCEPS/IRRIGATION

PLUG

Function: Reusable plug for controlling fluid flow through endoscope channels.

Connection: Luer-split design for secure attachment to endoscopes.

Compatibility: Compatible with standard endoscopy equipment (e.g., Olympus, Pentax, Fujinon).

Austin Uro SEAL KIT, 6-12FR, Contents: Contains 12 silicone seals per box. Compatibility: Seals for urology accessories with diameters ranging from 6 to 12 French. Application: Used to create a leak-resistant seal to prevent fluid backflow.

Austin Uro UNIVERSAL

STOPCOCK LUER

LOCK

Type: Universal stopcock with a luer lock connection. 75U. Function: Controls fluid flow with a 360-degree rotation.

Material: Reusable, made from medical-grade materials, and autoclavable.

Austin Uro MOBILE TROLLEY US

SET

Features: A mobile trolley system with a minimum of three shelves, designed for medical equipment.

Compatibility: Compatible with standard endoscopic tower components and monitors. The system must include integrated cable management and a minimum weight capacity of 200 lbs.

Dimensions: Overall dimensions must not exceed 25"W x 25"D x 65"H.

Austin Uro COMPACT LCD

MONITOR ARM

Features: Articulating arm for mounting a compact LCD monitor. Mounting: VESA compatible (e.g., 75x75 mm and 100x100 mm). Capacity: Supports monitors with a maximum screen size of 27 inches and a maximum weight of 15 lbs. Installation: Provides integrated cable management.

Austin Uro HD-SDI CABLE Type: High-Definition Serial Digital Interface (HD-SDI) cable. Length: ≥ 6 feet (1.8 meters). Connectors: BNC type connectors with a locking mechanism.

Performance: Ensures reliable transmission of high-definition video signals up to 3 Gbps.

SE SEMI INLINE RATCHET Length: 33 cm (approximately 13 inches).

Design: Modular, two-piece, clamshell handle with a semi-inline configuration.

Mechanism: Includes a semi-inline ratchet with a quick-release button.

Sterilization: Autoclavable for reprocessing.

SE MONOPOLAR

LAPROSCOPIC HAND

INSTRUMEN

Size: Ergonomic, large (L) handle design for user comfort. Configuration: Three-part modular design with at least two joint mechanisms. Type: Monopolar for use with laparoscopic instruments. The handle must be compatible with standard 5mm and 10mm shafts.

Sterilization: Autoclavable and designed for easy disassembly for cleaning.

SE DEACTIVATABLE

RATCHET

Size: Ergonomic, large (L) handle design.

Mechanism: Includes a deactivatable ratchet mechanism for enhanced control.

Configuration: Modular system compatible with laparoscopic instruments.

SE ENDOSCOPE

FLUSHING PUMP

Function: Endoscopic flushing pump for delivering irrigation fluid.

Compatibility: Compatible with standard endoscope channels (with channel diameters from 2.0 to 4.0 mm).

Performance: Provides controlled irrigation and aspiration with adjustable flow rates.

4. VHA Point of Contact: TBD

5. The C&A requirements do not apply. A security accreditation package is not required.

6. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

7. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO.

The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA. The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.)

used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

8. This section applies when any ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. person requires access to information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract.

a. A contractor/subcontractor shall request logical (technical) or physical access to

VA information and VA information systems for their employees and subcontractors only to the extent necessary to perform the services specified in the solicitation or contract. This includes indirect entities, both affiliate of contractor/subcontractor and agent of contractor/subcontractor.

b. Contractors and subcontractors shall sign the VA Information Security Rule of Behavior (ROB) before access is provided to VA information and information systems (see Section 4, Training, below). The ROB contains the minimum user compliance requirements and does not supersede any policies of VA facilities or other agency components which provide higher levels of protection to VA’s information or information systems. Users who require privileged access shall complete the VA elevated privilege access request processes before privileged access is granted.

c. All contractors and subcontractors working with VA information are subject to the same security investigative and clearance requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors shall be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office of Human Resources and Administration/Operations, Security and Preparedness (HRA/OSP) is responsible for these policies and procedures. Contract personnel who require access to classified information or information systems shall have an appropriate security clearance. Verification of a Security Clearance shall be processed through the Special Security Officer located in HRA/OSP. Contractors shall conform to all requirements stated in the National Industrial Security Program Operating Manual (NISPOM).

d. All contractors and subcontractors shall comply with conditions specified in VAAR 852.204-71(d); Contractor operations required to be in United States. All contractors and subcontractors working with VA information must be permanently located within a jurisdiction subject to the law of the United States or its Territories to the maximum extent feasible. If services are proposed to be performed abroad the contractor must state where all non-U.S. services are provided. The contractor shall deliver to VA a detailed plan specifically addressing communications, personnel control, data protection and potential legal issues. The plan shall be approved by the COR/CO in writing prior to access being granted.

e. The contractor shall notify the COR/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:

(1) Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.

(2) Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.

(3) Contractor believes their own personnel or subcontractor personnel may pose a threat to their company’s working environment or to any company owned property. This includes contractor-owned assets, buildings, confidential data, customers, employees, networks, systems, trade secrets and/or VA data.

(4) Any previously undisclosed changes to contractor/subcontractor background history are brought to light, including but not limited to changes to background investigation or employee record.

(5) Contractor/subcontractor personnel have their authorization to work in the United States revoked.

(6) Agreement by which contractor provides products and services to VA has either been fulfilled or terminated, such that VA can cut off electronic and/or physical access for contractor personnel.

f. In such cases of contract fulfillment, termination, or other causes; the contractor shall take the necessary measures to immediately revoke access to VA network, property, information, and information systems (logical and physical) by contractor/subcontractor personnel. These measures include (but are not limited to): removing and then securing Personal Identity Verification (PIV) badges and PIV – Interoperable (PIV-I) access badges, VA-issued photo badges, credentials for VA facilities and devices, VA-issued laptops, and authentication tokens.

Contractors shall notify the appropriate VA COR/CO immediately to initiate access removal.

g. Contractors/subcontractors who no longer require VA accesses will return VA issued property to VA. This property includes (but is not limited to): documents, electronic equipment, keys, and parking passes. PIV and PIV-I access badges shall be returned to the nearest VA PIV Badge Issuance Office. Once they have had access to VA information, information systems, networks and VA property in their possessions removed, contractors shall notify the appropriate VA COR/CO.

9. TRAINING. This entire section applies to all acquisitions which include section 3.

a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:

(1) VA Privacy and Information Security Awareness and Rules of Behavior course (Talent Management System (TMS) #10176) initially and annually thereafter.

(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and

(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document – i.e., any role-based information security training].

b. The contractor shall provide to the COR/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.

10. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT’s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711).

The ESD is OIT’s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the COR/CO the incident number received from the ESD.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:

(1) The date and time (or approximation of) the Security Incident occurred.

(2) The names of individuals involved (when applicable).

(3) The physical and logical (if applicable) location of the incident.

(4) Why the Security Incident took place (i.e., catalyst for the failure).

(5) The amount of data belonging to VA believed to have been compromised.

(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature

c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.

d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.

e. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG, and the VA Office of Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.

g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.

h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages— Reimbursement for Data Breach Costs.

11. Records Management NARA Records Management Language for Contracts (May 2017)

a. 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.

b. 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.

c. 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.

d. Central Texas Veterans Health Care System 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 Central Texas Veterans Health Care System 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 Central Texas Veterans Health Care System. The agency must report promptly to NARA in accordance with 36

CFR 1230.

e. 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 Central Texas Veterans Health Care System 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).

f. 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 Central Texas Veterans Health Care System guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

g. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Central Texas Veterans Health Care System policy.

h. The Contractor shall not create or maintain any records containing any non-public Central Texas Veterans…