36C24822Q1409_1.docx

36C24822Q1409

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

573-22-3-030-0274 36C24822Q1409 07-14-2022 Heidi Parrish 352-381-5730 07-20-2022

4:30 PM

EDT

36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Commerce Building 300 E. University Ave. Ste. 170 Gainesville

FL

32601-3460 X X Y 339112 1000 Employees N/A X Department of Veterans Affairs North Florida/South Georgia VHS Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville

FL

32608-1197 36C248 Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Commerce Building 300 E. University Ave. Ste. 170 Gainesville

FL

32601-3460

Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin

TX

78714-9971 See CONTINUATION Page See B.2 for Price/Schedule.

See CONTINUATION Page X John Shultzaberger Contracting Officer Table of Contents

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:

b. GOVERNMENT: Contracting Officer 36C248 John Shultzaberger Department of Veterans Affairs Network Contracting Office 8 (NCO 8) Commerce Building 300 E. University Ave. Ste. 170 Gainesville FL 32601-3460

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

3. INVOICES: Invoices shall be submitted in arrears:

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.

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/ ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF NEED

1. Title of Project: Pulmonary Endoscopy Imaging Equipment, Bronchoscopy and Tracheoscopy Scopes

2. Scope of Work: Pulmonary Section at the NF/SG Malcolm Randall VAMC is in need of Pulmonary Endoscopy Imaging Equipment, Bronchoscopy and Tracheoscopy Scopes. This equipment will support the launch of the Interventional Pulmonary program with enhanced imaging technology and meet the growth requirement of interventional procedures.

3. Background: Pulmonary Endoscopy Imaging Equipment is designed to provide an integrated camera system in 4K/3D technology that is used in Interventional Pulmonary endoscopy procedures that view the pulmonary anatomy for diagnosis and identification of pulmonary symptoms. This state-of-the-art technology will enhance imaging quality to provide better clinical outcome to Pulmonary patients.

The various Bronchoscopy and Tracheoscopy Scopes are designed to provide support to an Interventional Pulmonary program with endoscopy procedures that view the pulmonary anatomy for diagnosis and identification of pulmonary symptoms.

Imaging System shall meet or exceed the following specifications and salient characteristics:

· New condition; not refurbished

· Authorized distributor, if not acquired from manufacturer

· Minimum standard 1-year warranty

· Designed to provide an integrated camera system in 4K/3D technology that is used in Interventional Pulmonary endoscopy procedures.

· Hardware and Software requirements:

· Power Led 300

· 32" 4K/3D Monitor

· Light Cable, 3.5mm X 300cm (9.8')

· High-Definition Camera Sterilization Container

· Medical Grade Printer

· Compact Endoscopy Cart

· IV Pole Assembly

· Provides visualization capabilities for tissue differentiation:

· CLARA: homogeneous illumination

· CHROMA: contrast enhancement

· Compatible with other technologies: rigid, flexible, fluorescence, and 3D endoscopy

· Provides fluorescence imaging: NIR/ICG and PDD

· Automatic light source control

· 4K Camera Head:

· 4K, UHD camera head

· Provides S-technologies: CLARA and CHROMA

· Progressive scanning method

· Digital optical zoom

· Focal length: 18mm

· Able to be reprocessed with EO sterilization

· Power LED 300:

· Cold light fountain power LED 300

· Intelligent cooling management feature with laser light technology

· Light longevity up to 30,000 hours

· Low heat development

· 4K/3D Monitor:

· Software License

· Light Cable, 3.5mm X 300cm (9.8')

· High-Definition Camera Sterilization Container:

· Container system for camera heads,

· Medical Grade Printer

· Compact Endoscopy Cart:

· Includes drawer, keyboard, tray, and isolation transformer

· IV Pole Assembly:

· Includes 8.5” extension arm

· Security: VA standard IT, Privacy, and Network safeguards required

The Bronchoscopy and Tracheoscopy Scopes with accessories shall meet or exceed the following specifications and salient characteristics:

· New condition; not refurbished

· Authorized distributor, if not acquired from manufacturer

· Warranty: Minimum standard 1-year manufacturer’s warranty

· Designed to provide support to an Interventional Pulmonary program with endoscopy procedures that view the pulmonary anatomy for diagnosis and identification of pulmonary symptoms

· Bronchoscopes Size 14 – 7.5:

· Full Lumen Operating Bronchoscope Tube with proximal illumination, distal end with lateral vent holes, modified for stent applications, 45-degree oblique beak, length 43cm, size 14mm, color code red, compatible with Prismatic Light Deflector

· Full Lumen Operating Bronchoscope with proximal illumination, vent holes, length 43cm, size 12mm

· Full Lumen Operating Bronchoscope Tube with proximal illumination, distal end with lateral vent holes, modified for stent applications, 45-degree oblique beak, length 43cm, size 11mm, color code green, compatible with Prismatic Light Deflector

· Universal Adult Bronchoscope Tube with proximal illumination, without distal fiber optic light carrier, vent holes, length 43cm, size 7.5, 10.2mm x 43cm, compatible with proximally insertable Prismatic Light Deflector

· Hopkins Straight Forward Telescope 0-degree – autoclavable, fiber optic light transmission, size 5.5mm, length 50cm, color code green, compatible with bronchoscopes, optical forceps, and deflecting device

· Telescope guiding sheath – compatible with Hopkins Telescopes 10320AA/BA

· Tracheoscopes Size 14 – 6.5:

· Full Lumen Operating Tracheoscope with proximal illumination, without vent holes, size 14mm, length 33cm

· Full Lumen Operating Tracheoscope with proximal illumination, without vent holes, size 12mm, length 33cm

· Universal Adult Tracheoscope Tube without light carrier, without vent holes, size 8.5, length 33cm, 11.2mm x 33cm

· Universal Adult Tracheoscope Tube without light carrier, without vent holes, size 7.5, length 33cm, 10.2mm x 33cm

· Universal Adult Tracheoscope Tube without light carrier, without vent holes, size 6.5, length 33cm, 9.2mm x 33cm

· Hopkins Straight Forward Telescope 0-degree – autoclavable, fiber optic light transmission, size 2.9, length 36cm, color code green, can be fixed in scope with using telescope bridge, compatible with 30cm scopes

· Optical Forceps – Compatible with Hopkins Telescopes and Universal Scopes size 8.5 – 7.5

· Optical Alligator Forceps with spring-action handle (force limited), for hard foreign bodies, large jaws, includes cleaning adapter

· Optical Peanut Forceps with spring-action handle (force limited), for peanut and soft foreign bodies, includes cleaning adapter

· Optical Spoon-Shaped Forceps (circular cup) for biopsy, includes cleaning adapter

· Optical Large Jaws Forceps, includes cleaning adapter

· Optical Large Jaws Forceps for removing large fragments of tissue, sharp jaws, includes cleaning adapter

· Optical Forceps for repositioning and removing stents, one fixed jaw, includes cleaning adapter

· Light cable, bifurcated at Telescope end, 3.5mm x 180cm,

· Bronch-Tracheoscope Accessories:

· Prismatic Light Deflector – autoclavable, with connection to fiber optic light cable

· Injection Cannula – for positive pressure assisted ventilation only, luer-lock, outer diameter 3.5mm

· Instrument Guide – for suction catheter, without stem for adult bronchoscopes

· Seal Bonnet 50/5, 10 per package

· Sealing Cap – diameter 0.8mm, 10 per package

· Non-Optical Forceps:

· Forceps – alligator, for hard foreign bodies, double action jaws, 2.5mm x 55cm

· Forceps – pointed, serrated, for coins and flat foreign bodies, sharp rotatable double action jaws, 2.5mm x 55cm

· Forceps – for peanuts and soft foreign bodies, double action jaws, 2.5mm x 55cm

· Forceps – spoon-shaped, round for biopsy, double action jaws, 2.5mm x 55cm

· Forceps – straight scissors, for trituration of bone fragments, single action jaws, 2.5mm x 55cm

· Foreign Body Wire Basket:

· Foreign body basket with ring handle, proximal shaft angled 30-degrees, length 50cm

· Suction Catheters – Flexible:

· Flexible suction catheter – luer-lock, one-piece molded, 5 french x 60cm, sterile, 5 per package

· Flexible suction catheter – luer-lock, one-piece molded, 7 french x 60cm, sterile, 5 per package

· Flexible suction catheter – luer-lock, one-piece molded, 6 french x 60cm, sterile, 5 per package

· Flexible suction catheter – luer-lock, one-piece molded, 4 french x 60cm, sterile, 5 per package

· Suction Catheters – Rigid:

· Rigid suction tube – 4mm x 50cm

· Rigid suction tube – with cut-off hole, thumb control, 4mm x 50cm

· Rigid suction tube – 2.5mm x 50cm

· Monopolar Coagulation Suction Tube:

· Coagulating suction tube – insulated, with male connector pin for unipolar coagulation, 4mm x 50cm

· Unipolar High Frequency Cord – with 8mm plug, compatible with ValleyLab ESU and Autocon II SCB, 300cm

· Sponge Holder – with spring handle, cotton and sponge carrier, length 50cm

· AntiFog: Dr. Clear AntiFog Set, regular solution with alcohol, sterile, 20 per package

· Tray:

· Esophagoscope tray – 2.5” x 9.5” x 5”

· Extra-large container system for instruments to 43cm, 27” x 11” x 8”

· Universal Bronchoscope for adults with proximal illumination, without distal fiber optic light carrier, vent holes, size 8.5, 11.2mm x 43cm, compatible with proximally insertable Prismatic Light Deflector

· Universal Bronchoscope for adults with proximal illumination, without distal fiber optic light carrier, vent holes, size 6.5, 9.2mm x 43cm, compatible with proximally insertable Prismatic Light Deflector

· Optical Forceps for Hopkins Straight Forward Telescope 0-degree – autoclavable, fiber optic light transmission, size 4.5mm, length 50cm, color code green, compatible with bronchoscopes 10318 and Hopkins Telescopes

· Telescope Guiding Sheath – Compatible with Hopkins Telescopes 10328AA/BA

· Optical Forceps – alligator, for hard foreign bodies, with force limited handle, includes cleaning adapter

· Optical Forceps - with spring-action handle (force limited), for peanut and soft foreign bodies, includes cleaning adapter

· Optical Forceps - Spoon-Shaped Forceps (circular cup) for biopsy, includes cleaning adapter

· All reusable scopes and accessories are required to be compatible with VA sterile process procedures

· All scopes and accessories are required to be compatible with VA Pulmonary imaging equipment Specification for network integration:

Network integration is a component of this project and will require hardware and software. The Gainesville Pulmonary Section will be interfaced with Gainesville’s IT network to allow storage of images and interfacing with the electronic medical record (EMR).

· Physician review and interpretation access; allowance for concurrent users

· Gateway software for network interface.

· Report transmission to EMR

· Vendor should provide IT consultation services and assistance from beginning to end of integration project, assuring successful project implementation:

· Network/gateway configuration and implementation

· configuring databases

· migration of historical data

· data security

· interface of testing and interpretation workstations

4. Scheduling, Hours of Work, and Location: Deliver all line items specified under Data/Deliverables to point of contact during normal operating hours, M-F 8:00am – 4:30pm:

Malcolm Randall (NF/SG) VAMC – Jamie Dillard 1601 SW Archer Rd.

Gainesville, FL 32608

5. Privacy Requirements:

This is a request for hardware and software equipment. Software will connect to VA network and use privacy and sensitive information to connect the Pulmonary PACS for image transfers. Privacy and sensitive information will only be used internally at VA, there will be no external connections/support.

(1) GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

(2) ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative 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 must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination

(3) VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor 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 health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

(6) SECURITY INCIDENT INVESTIATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. 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 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.

(7) LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

a Nature of the event (loss, theft, unauthorized access);

b Description of the event, including:

i date of occurrence;

ii data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

iii Number of individuals affected or potentially affected;

iv Names of individuals or groups affected or potentially affected;

v Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

vi Amount of time the data has been out of VA control;

vii The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

viii Known misuses of data containing sensitive personal information, if any;

ix Assessment of the potential harm to the affected individuals;

x Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and xi Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

a Notification;

b One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

c Data breach analysis;

d Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

e One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and f Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

(9) TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

a Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

b Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

c Successfully complete the appropriate VA privacy training and annually complete required privacy training; and d Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, 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 training and documents are complete.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

FULL LUMEN OPERATING BRONCH TUBE W/VENT HOLES, F/STENTS, OD:14MM, LGTH:43CM

PRINCIPAL NAICS CODE: 339112 - Surgical and Medical Instrument Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

FULL LUMEN OPERATING BRONCH TUBE WITH VENT HOLES, OD:12MM, LGTH:43CM

FULL LUMEN OPERATING BRONCHOSCOPE FOR POLIFLEX STENT, 11MMX43CM

UNIVERSAL ADULT BRONCH TUBE W/O LIGHT CARRIER,VENT HOLES,SZ:7.5, 10.2MMX43CM

HOPKINS 0? TELESCOPE, 5.5MM X 50CM, AUTOCLAVABLE

TELESCOPE GUIDING SHEATH F/U/W 10320AA/BA HOPKINS TELESCOPES

FULL LUMEN OPERATING BRONCH TUBE W/O VENT HOLES, OD:14MM, LGTH:33CM

FULL LUMEN OPERATING TRACHEO TUBE W/O VENT HOLES, OD:12MM, LGTH:33CM

UNIVERSAL TRACHEO TUBE W/O LIGHT CARRIER W/O VENT HOLES, SIZE:8.5, 11.2MM X 33CM

UNIVERSAL TRACHEO TUBE W/O LIGHT CARRIER W/O VENT HOLES, SIZE:7.5, 10.2MM X 33CM

UNIVERSAL TRACHEO TUBE W/O LIGHT CARRIER W/O VENT HOLES, SIZE:6.5, 9.2MM X 33CM

TELESCOPE,HOPKINS,STRAIGHT,FORWARD

OPTICAL ALLIGATOR FORCEPS W/FORCE LIMITED HANDLE INCLUDES CLEANING ADAPTOR

OPTICAL PEANUT FORCEPS W/FORCE LIMITED HANDLE INCLUDES CLEANING ADAPTOR

OPTICAL BIOPSY CIRCULAR CUP FORCEPS A.F.DEVICE,INCLUDES CLEANING ADAPTOR

OPTICAL FORCEPS, LARGE JAWS INCLUDES CLEANING ADAPTOR

OPTICAL FORCEPS, LARGE, SHARP JAWS INCLUDES CLEANING ADAPTOR

OPTICAL FORCEPS F/REMOVAL OF STENTS INCLUDES CLEANING ADAPTOR

LIGHT CABLE BIFURCATED AT TELESCOPE END 3.5MM X 180CM (6')

DEFLECTOR,LIGHT,PRISMATIC,AUTOCLAVE

INJECTION CANNULA FOR POSITIVE PRESSURE ASSISTED VENTILATION ONLY, OD:3.5MM

GUIDE,WITHOUT STEM,FOR ADULT BRONCHOSCOPE

SEAL BONNET 50/5, 10/PKG

SEALING CAP, DIAMETER 0.8MM PACKAGE OF 10

ALLIGATOR GRASPING FORCEPS WITH DOUBLE ACTION JAWS, 2.5MM X 55CM

POINTED GRASPING FORCEPS WITH SHARP ROTATABLE DOUBLE ACTION JAWS, 2.5MMX55CM

PEANUT GRASPING FORCEPS WITH DOUBLE ACTION JAWS, 2.5MM X 55CM

BIOPSY FORCEPS WITH ROUND CUP DOUBLE ACTION JAWS, 2.5MM X 55CM

STRAIGHT SCISSORS WITH SINGLE ACTION JAWS, 2.5MM X 55CM

FOREIGN BODY BASKET WITH RING HANDLE PROXIMAL SHAFT ANGLED 30?, LENGTH:50CM

FLEX SUCTION CATHETER W/LUER-LOCK, ONE PIECE MOLDED, 5FR X 60CM, 5/PKG, STERILE

FLEX SUCTION CATHETER W/LUER LOCK, ONE PIECE MOLDED, 7FR X 60CM, 5/PKG, STERILE

FLEX SUCTION CATHETER W/LUER LOCK, ONE PIECE MOLDED, 6FR X 60CM, 5/PKG, STERILE

FLEX SUCTION CATHETER W/LUER LOCK, ONE PIECE MOLDED, 4FR X 60CM, 5/PKG, STERILE

RIGID SUCTION TUBE, 4MM X 50CM

TUBE,RIGID,SUCTION, WITH THUMB CONTROL

RIGID SUCTION TUBE, 2.5MM X 50CM

INSULATED SUCTION TUBE WITH MALE CONNECTOR PIN, LENGTH:50CM

MONOPOLAR HIGH FREQUENCY CORD W/8MM PLUG F/VALLEYLAB ELECTROSURGICAL UNITS, 300CM The kit part number is composed of the following products: 26006M MONOPOLAR HIGH FREQUENCY CORD W/8MM PLUG F/COVIDIEN ELECTROSURGICAL UNITS, 300CM

COTTON AND SPONGE CARRIER WITH SPRING HANDLE, LENGTH:50CM

DR. CLEAR ANTIFOG SET,REGULAR SOLUTION W/ALCOHOL, STERILE, PKG/20

TRAY, ESOPHAGOSCOPE DM: 25.5" X 9.5" X 5"

CONTAINER SYSTEM FOR INSTRUMENTS TO 43CM. 27" X 11" X 8"

UNIVERSAL ADULT BRONCH TUBE W/0 LIGHT CARRIER,VENT HOLES,SZ:8.5, 11.2MMX43CM

UNIVERSAL ADULT BRONCH TUBE W/O LIGHT CARRIER,VENT HOLES, SZ:6.5, 9.2MMX43CM

HOPKINS 0? TELESCOPE, 4.5MM X 50CM AUTOCLAVABLE

TELESCOPE GUIDING SHEATH F/U/W HOPKINS TELESCOPES

OPTICAL ALLIGATOR FORCEPS W/FORCE LIMITED HANDLE INCLUDES CLEANING ADAPTOR

OPTICAL PEANUT FORCEPS W/FORCE LIMITED HANDLE INCLUDES CLEANING ADAPTOR

OPTICAL BIOPSY FORCEPS INCLUDES CLEANING ADAPTOR

Imaging System for 4K camera head and related accessories

4K CAMERA HEAD

POWER LED 300

4K/3D MONITOR

SOFTWARE LICENSE FOR UPDATES AND UPGRADES

LIGHT CABLE

HIGH DEFINITION CAMERA STERILIZATION CONTAINER

MEDICAL GRADE PRINTER

COMPACT ENDOSCOPY CART W/DRAWER, KEYBOARD TRAY, AND ISOLATION TRANSFORMER

IV POLE ASSEMBLY

B.4 DELIVERY SCHEDULE

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

352-548-6000 x104388 jamie.dillard@va.gov

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

Malcom Randall VA Medical Center 1601 SW Archer Road Gainesville, FL 32608

USA

36C24822Q1409

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes.