36C24423Q1124.docx

36C24423Q1124

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. SIGNAT

URE 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

693-23-2-179-0094 36C24423Q1124 09-08-2023 Andrew Taylor | andrew.taylor3@va.gov 724-679-2327 09-15-2023

12PM

EDT

00244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Ave.

andrew.taylor3@va.gov Pittsburgh PA 15240 X 339112 Employees N/A X Wilkes Barre VA Medical Center 1111 East End Blvd, Wilkes Barre PA 18711 00244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Ave.

Pittsburgh PA 15240

Austin Payment Center Department of Veterans Affairs PO Box 149971 Austin TX 78714-9971

(877) 353-9791

(512) 460-5429 See CONTINUATION Page Infusion Poles Instruction to Vendors on page VA Directive 6550 (Attached) See CONTINUATION Page X X Andrew Taylor 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: Andrew Taylor Contracting Officer 36C244 Department of Veterans Affairs Network Contracting Office 4 1010 Delafield Ave.

andrew.taylor3@va.gov Pittsburgh PA 15240

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.

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

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

PLUM 360 INFUSION PUMPS

LOCAL STOCK NUMBER: 30010

MINI POLES FOR PLUM 360

LOCAL STOCK NUMBER: 13853-01

LIFECARE PCA PUMPS

LOCAL STOCK NUMBER: 20837

ICU MEDICAL MEDNETT IMPLEMENTATION (151-300 PUMPS) ONE SITE, ONE SERVER, ONE DRUG LIBRARY (ITEM 17544-03)

LOCAL STOCK NUMBER: 17544-03

ICU MEDICAL MEDNETT ONE YEAR LICENSE (151-300 PUMPS) (ITEM 16037-70)

LOCAL STOCK NUMBER: 16037-70

SMTH 4000-0106-01 MEDFUSION 4000 SYRINGE PUMP

LOCAL STOCK NUMBER: SMTH 4000-0106-01

SMTH 22-0014-0106-01 PHARMGUARD MEDICATION SAFETY SOFTWARE

LOCAL STOCK NUMBER: SMTH 22-0014-0106-01

SMTH 22-1050-51 ROTATING POLE CLAMP

LOCAL STOCK NUMBER: SMTH 22-1050-51

SMTH 22-0026-001 STARTER SOFTWARE IMPLEMENTATION

LOCAL STOCK NUMBER: SMTH 22-0026-001

SINGLE IV STAND 6-LEGS 25"(A)

LOCAL STOCK NUMBER: ICU3000-A

HORIZONTAL PUMP CARRIER

LOCAL STOCK NUMBER: ICU3PC

DUAL IV STAND W STEEL SUPPORT HANDLE (A)

LOCAL STOCK NUMBER: ICU6000-SH-A

POWER STRIP - 4 OUTLET

LOCAL STOCK NUMBER: 205

SHIPPING COST FOR LINES 10,11,12 AND 13.

LOCAL STOCK NUMBER: SHIPPING

B.3 DELIVERY SCHEDULE

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

570 824-3521 ext 27361 kathy.baronitislaskowski@va.gov

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

1111 East End Blvd.

Wilkes Barre, PA 18711 1111

USA

Statement of Need Department of Veterans Affairs VISN 4 Wilkes-Barre VAMC Infusion Pump System Procurement

1. General Information

1.1. Background: The Veterans Integrated Service Network 4 (VISN 4) Wilkes-Barre Veteran Affairs Medical Center Station 693 is dedicated to the provision of health care training and education using advanced technologies, sharpening the skill set of all VA staff to provide the best care to Veterans. Infusion pumps are important for every hospital. With Large Volume and syringe infusion pumps, patients can receive the necessary nutrients in their body.

1.2. Scope of Work: The contractor shall provide all labor, equipment, tools, materials, supervision, documentation, personnel, equipment required and other items necessary for LVP and PCA Smart Infusion Pumps Systems to be provided and implemented at VISN 4 Medical Center listed below. Required quantities for both LVP and PCA smart infusion pumps systems for each location are also provided. Wilkes-Barre VAMC has a need to also trade in all Alaris pumps for credit if possible.

1.3. VA Contracting Officer’s Point Of Contact (POC) will act as a liaison between the Wilkes-Barre VISN 4 facility dedicated representative.

2. General Requirements for all infusion Pump Systems The contractor shall provide all labor, equipment, tools, materials, supervision, documentation, personnel, equipment required and other items necessary for infusion pumps to the Wilkes-Barre VISN 4 Medical Center located at 1111 East End Boulevard, Wilkes-Barre PA 18711.

System devices must run on an operating system supported by the Operating System Manufacturer and be in accordance with VA Directive 6550

2.1. Must be FDA approved (Reference Federal Food Drug & Cosmetic Act (FD&C Act), Title 21 CFR Parts 800-1299)

2.2. Must be FIPS 140-2 certified with plan to transition to FIPS 140-3 (Reference: FISMA Federal Information Security Management Act, Federal Information Processing Standards Publications 140-2 and 140-3 (FIPS Pub), VA Directive 6550)

2.3. Must have wireless communication (Reference: VA Directive 6550, Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

2.4. Must be able to interface with CPRS along with being required to have Cerner capability (Reference: DUSHOM policy; Cerner CareAware Device List Q1 2022 pages 7,8,9)

2.5. System will not operate appropriately without ability to interface with Cerner. Would lose required smart pump features including auto-programming, auto-documentation, and alert management without compatibility with Cerner. ECRI Institute. Infusion pump integration: why is it needed, and what are the challenges? [guidance article]. Health Devices 2013 Jul;42(7):210-21. aami-infusion-anthology-10-8-20.pdf

2.6. Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

2.7. Must have ability to run multiple infusions concurrently with minimal control units

2.8. Must send infusion data wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

2.9. Must have primary and secondary infusion modes (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

2.10. Must have a minimum warranty of 1-year parts & labor (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

2.11. Contractor cannot propose a device that does not have anticipated parts support for the next 10 years.

2.12. Must be portable – transportable with battery backup (Reference: 8 hours (standard battery) 4 hours (wireless module) FDA-2006-D-0300 Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff

2.13. Must be mountable to an IV pole (Reference: Industry standard according to this publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

2.14. All our required needs must be met by only using 1 drug library

2.15. Must be able to trade in all our Alaris Pumps for credit

3. Service & Maintenance

3.1. Must be cleanable with hospital grade disinfectant

3.2. Must come with manuals (user, service, maintenance)

3.3. Must provide manufacturer training and service onsite

3.4. Must provide training for clinical end-users, BioMed and pharmacy staff prior to implementation

3.5. Must have company staff on site during implementation

3.6. Must provide 24/7 phone line for troubleshooting

3.7. Must have parts to support equipment repair at VAMC

4. Modules:

1.

2.

3.

4.

Large Volume Pump (LVP)

4.1. Must be FDA Approved

4.2. Must have FIPS 140-2 wireless capability

4.3. Must be able to download drug library updates wirelessly

4.4. Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (DUSHOM memo with direction -Bob Steldt)

4.5. Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

4.6. Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 1, 5, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

4.7. Must have fluid resistance ingress protection

4.8. Device must have flow rate specifications capability to range from 0.1-999 mL/hr. and in incremental rate minimum of 0.001 mL/hr.

4.9. Reference: Infusion Nursing Reference guide

4.10. ECRI comparison chart:

4.11. https://www.ecri.org/Components/HPCS/Pages/Infusion-Pumps,-Large-Volume.aspx?tab=2

4.12. ECRI publication:

4.13. ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.

4.14. Must default to the Dose Error Reduction System (DERS) upon startup

4.15. Must have free flow prevention mechanism

4.16. Must have the ability to set manual parameters within drug library

4.17. Must have anesthesia mode (market research needed to confirm not specific to singular mfr.)

4.18. Must have ability to change to different drug libraries

4.19. Must have secondary infusion capability

4.20. Must have automatic switching to battery power upon line-power interruption

4.21. Must have patient tampering safety feature

4.22. Must have loading dose capability

4.23. Must have alarm volume control and alarm momentary silence

4.24. Must be cleanable with hospital grade disinfectant

4.25. All our required needs must be met by only using 1 drug library

4.26. Must be able to trade in all Alaris pumps for credit

Syringe Pump

4.27. Must be FDA Approved

4.28. Must have FIPS 140-2 wireless capability

4.29. Must be able to download drug library updates wirelessly

4.30. Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows (DUSHOM memo with direction -Bob Steldt)

4.31. Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

4.32. Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

4.33. Must have fluid resistance ingress protection

4.34. Device must have flow rate specifications capability to range from 0.1-99mL/hr. and in increments of 0.1 mL/hr.

4.35. Must default to the Dose Error Reduction System (DERS) upon startup

4.36. Must have free flow prevention mechanism

4.37. Must have the ability to set manual parameters within drug library

4.38. Must have patient tampering safety feature

4.39. Must have loading dose capability

4.40. Must be cleanable with hospital grade disinfectant

4.41. Must have alarm volume control and alarm momentary silence

4.42. Must be able to accommodate various syringe volumes (minimum 10mL & maximum 60mL volumes)

4.43. All our required needs must be met by only using 1 drug library

4.44. Must be able to trade in all Alaris pumps for credit

Patient Controlled Analgesia (PCA)

4.45. Must be FDA Approved

4.46. Must have FIPS 140-2 wireless capability

4.47. Must be able to download drug library updates wirelessly

4.48. Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows

4.49. Must have automatic switching to battery power upon line-power interruption (Reference: ANSI/AAMI ES60601- 1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.”)

4.50. Must have low battery, depleted battery alarms

4.51. Infusion data sent wirelessly from equipment to central repository for analysis (Reference: Joint Commission Policy: NPSG.03.06.01 – MM.08.01.01, PI.01.01.01, EPs 12, 13, Industry standard according to publication: ECRI. Evaluation background: large-volume infusion pumps. Device Evaluation 2022 Mar 3.)

4.52. Must have fluid resistance ingress protection

4.53. Device must have flow rate specifications capability to range from 0.1-99mL/hr. and in increments of 0.1 mL/hr.

4.54. Must default to the Dose Error Reduction System (DERS) upon startup

4.55. Must have free flow prevention mechanism

4.56. Must have multiple infusion capability

4.57. Must have patient tampering safety feature

4.58. Must be cleanable with hospital grade disinfectant

4.59. Must have accumulated dose limit monitoring

4.60. Must have patient pendant for PCA dose requests

4.61. Must have bolus capability

4.62. Must have loading dose capability

4.63. Must have alarm volume control and alarm momentary silence

4.64. Must be able to accommodate various syringe volumes

4.65. All our required needs must be met by only using 1 drug library

4.66. Must be able to trade in all Alaris pumps for credit

5. Dose Error Reduction System (DERS):

5.1. Must be FDA Approved

5.2. Must be configurable with soft limits, hard limits, and/or soft limits nested within hard limits

5.3. Must have capacity to download drug library updates wirelessly

5.4. Must utilize Integrating the Healthcare Enterprise (IHE) Integration Profiles for standardized communication with hospital information systems

5.5. Must be able to customize DERS and drug library

Drug library and health record need to match what is in drug library in pumps

5.6. Must allow medication drug library catalog updates to be wirelessly pushed to devices

5.7. Must have ability to program custom dilutions for critical/dangerous medications

5.8. Must have anesthesia mode to run without EtCO2 monitoring

5.9. Must be able to edit as needed.

5.10. Must be able to program DERS limits and infusion devices which actively use DERS for:

5.10.1. Medication doses

5.10.2. Define minimum # of meds/care areas that need to be programmed (ECRI greater than 10 care areas needed) 5.10.2..1. Number of drug entries is greater than 400 5.10.2..2. With options for different care therapies (same drug different limits)

5.11. Medication concentration limits

5.12. Infusion rate limits

5.13. Titration limits

5.14. Continuous infusion limits

5.15. Intermittent and secondary infusion limits

5.16. Bolus dose and loading dose infusion limits

5.17. Patient weight for weight-based dosing

5.18. All our needs must be met by only using 1 drug library

5.19. DERS Software must be common across all pumps

5.19.1. PCA

5.19.2. Large Volume

5.19.3. Syringe

5.20. Configurable soft limits, hard limits, and/or soft limits nested within hard limits

5.20.1. Configurable alarm volume limits

5.20.2. Configurable infusion pauses duration limits and delayed start duration limits

5.20.3. Configurable clinical alerts to clinicians to be acknowledged during infusion device programming (example “requires central line”)

5.21. Must provide the following data analytics/DERS compliance reports:

5.21.1. Med specific compliance and alert reports

5.21.2. Total rates of alerts by med

5.21.2..1. Reports of meds with low use frequency and high alert rate 5.21.2..2. Rates of overrides by med 5.21.2..3. Infusion parameter specific alerts reports (dose-rate, concentration, duration alerts) 5.21.2..4. Facility compliance

5.22. Programming outside of DERS

5.23. Event logs - In the event of patient incident or near miss/close call event logs need to be available

5.23.1. Downloadable and printable after download using MS office or Adobe PDF

5.23.2. Events stored

5.23.2..1. Dose limit 5.23.2..2. Key presses, program settings, alarms, volume infused, dose limit warnings, 5.23.2..3. All timestamped

5.24. Must have DERS safety features available on infusion devices during network downtime

5.25. Must be validated with Cerner’s CareAware smart pump programming, infusion management, and event management workflows

5.25.1. Must provide the following EHR integration data analytics:

5.25.1..1. Integration compliance (rate of usage of smart pump workflows) 5.25.1..2. Auto-documentation mismatch 5.25.1..3. Failed auto-programming attempts

5.25.2. Adhere to IHE model for EHR infusion Pump Integration

5.26. Must provide network security documentation

5.26.1. Provide a list of Ports, Protocols, and Services required for network communications.

6. Alarms & Indicators for Overall System

6.1. Fault condition alarms

6.2. Vein and line blocked

6.3. Clamped secondary line alarm

6.4. Air is in the line for LV, PCA

6.5. Infusion completed alert

6.5.1. Infusion near end

6.6. Empty reservoir

6.7. Flow error

6.8. Set loaded improperly

6.9. Empty syringe

6.10. Plunger disengaged

6.11. Filter replacement

6.12. Pressure Sensor (high pressure/occlusion)

6.13. Occlusion upstream and downstream

6.13.1. Less than 15 psi for downstream

6.13.2. Detection mechanism

6.14. Door/latch open sensor

6.15. System Malfunction

6.16. Low battery/ Depleted battery

6.17. Volume control capability

6.17.1. Momentary silence less than 2 minutes

7. Pre-Deployment Requirements:

7.1. Must provide all necessary documentation to meet VA Directive 6550 and Enterprise Risk Assessment requirements MDS2 for each component

7.2. Topology Diagram

7.3. Hardware/Software Inventory

7.4. Provide a list of Ports and Protocols the systems use to communicate on the network

7.5. 6550 Appendix A for each component

7.6. Must follow all required VA Handbook 6500 requirements to provide remote support of server components of the system including but not limited to background investigations, MOU/ISA, PIV badge issuance, check-in requirements.

7.7. Must provide a listing of any required Government Furnished Equipment (GFE) and/or software if required including but not limited to server specifications, workstations specifications, software prerequisites that would be necessary for the infusion system and its associated information support systems.

7.8. Must participate in pre-implementation meetings with VA information security professionals to review system operation to obtain an ERA. A current ERA is required for these systems to operate on the VA network

8. Training and Support:

8.1. Must certify local Biomedical Engineering staff to perform maintenance and repairs on all equipment.

8.2. Must provide phone technical support during normal business hours 7am-5pm EST, Mon-Fri.

8.3. Must provide a list of approved sources to purchase necessary repair parts to ensure equipment operates to original manufacturer specifications.

Parts availability should be generally available next-day shipment.

8.4. Must comply with current FDA regulations pertaining to Recalls and Medical Device correction notices (site FDA regulation -- https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation)

8.5. Must provide training for clinical users

8.5.1. Initial training for frontline users will be onsite and conducted by company representatives

8.5.2. Remote training must be available over digital platform, recorded and available for future reference

8.5.3. Must provide access to clinical user education/reference materials via online company site and physical user manual and instructions for use.

8.5.4. Must have 1:1 support available

8.5.5. Must provide notices for software, IFU, user manuals updates

8.5.6. Must provide education on updates via company online site and physical user manual and instructions for use

8.5.7. Contractor must be here for the delivery and implementation of equipment.

Deliverables/Installation/Incidental Services: Contractor shall complete delivery, installation, and implementation of all equipment within 120 days of contract award Lift gate will be needed for delivery. Once Delivery dates are known serial numbers of the pumps should be emailed before delivery so our property managers can input the information into our inventory system as not to hold up delivery to each service once items are in our medical facility.

Delivery Requirement: Delivery should be made by going thru our warehouse and the hours of delivery are 8am to 4pm Monday thru Friday, excluding all Federal holidays. A lift gate will be needed to make sure ease of delivery.

36C24423Q1124 Warehouse POC: Kaitlyn Varneke, 821-3521 x 27179, Warehouse Supervisor.

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

1. 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).

2. SECURITY INCIDENT INVESTIGATION

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.

3. 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. 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:

(1) Notification;

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

(3) Data breach analysis;

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

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

4. 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:

(1) 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;

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

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) 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

CONTRACTOR RULES OF BEHAVIOR (Example)

This User Agreement contains rights and authorizations regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the Department of Veterans Affairs (VA). This User Agreement covers my access to all VA data whether electronic or hard copy ("Data"), VA information systems and resources ("Systems"), and VA sites ("Sites"). This User Agreement incorporates Rules of Behavior for using VA, and other information systems and resources under the contract.

1. GENERAL TERMS AND CONDITIONS FOR ALL ACTIONS AND ACTIVITIES UNDER

THE CONTRACT:

a. I understand and agree that I have no reasonable expectation of privacy in accessing or using any VA, or other Federal Government information systems.

b. I consent to reviews and actions by the Office of Information & Technology (OI&T) staff designated and authorized by the VA Chief Information Officer (CIO) and to the VA OIG regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA. These actions may include monitoring, recording, copying, inspecting, restricting access, blocking, tracking, and disclosing to all authorized OI&T, VA, and law enforcement personnel as directed by the VA CIO without my prior consent or notification.

c. I consent to reviews and actions by authorized VA systems administrators and Information Security Officers solely for protection of the VA infrastructure, including, but not limited to monitoring, recording, auditing, inspecting, investigating, restricting access, blocking, tracking, disclosing to authorized personnel, or any other authorized actions by all authorized OI&T, VA, and law enforcement personnel.

d. I understand and accept that unauthorized attempts or acts to access, upload, change, or delete information on Federal Government systems; modify Federal government systems; deny access to Federal government systems; accrue resources for unauthorized use on Federal government systems; or otherwise misuse Federal government systems or resources are prohibited.

e. I understand that such unauthorized attempts or acts are subject to action that may result in criminal, civil, or administrative penalties. This includes penalties for violations of Federal laws including, but not limited to, 18 U.S.C. §1030 (fraud and related activity in connection with computers) and 18 U.S.C. §2701 (unlawful access to stored communications)

f. I agree that OI&T staff, in the course of obtaining access to information or systems on my behalf for performance under the contract, may provide information about me including, but not limited to, appropriate unique personal identifiers such as date of birth and social security number to other system administrators, Information Security Officers (ISOs), or other authorized staff without further notifying me or obtaining additional written or verbal permission from me.

g. I understand I must comply with VA’s security and data privacy directives and handbooks. I understand that copies of those directives and handbooks can be obtained from the Contracting Officer's Technical Representative (COTR). If the contractor believes the policies and guidance provided by the COTR is a material unilateral change to the contract, the contractor must elevate such concerns to the Contracting Officer for resolution.

h. I will report suspected or identified information security/privacy incidents to the COTR and to the local ISO or Privacy Officer as appropriate.

2. GENERAL RULES OF BEHAVIOR

a. Rules of Behavior are part of a comprehensive program to provide complete information security. These rules establish standards of behavior in recognition of the fact that knowledgeable users are the foundation of a successful security program. Users must understand that taking personal responsibility for the security of their computer and the information it contains is an essential part of their job.

b. The following rules apply to all VA contractors. I agree to:

(1) Follow established procedures for requesting, accessing, and closing user accounts and access. I will not request or obtain access beyond what is normally granted to users or by what is outlined in the contract.

(2) Use only systems, software, databases, and data which I am authorized to use, including any copyright restrictions.

(3) I will not use other equipment (OE) (non-contractor owned) for the storage, transfer, or processing of VA sensitive information without a VA CIO approved waiver, unless it has been reviewed and approved by local management and is included in the language of the contract. If authorized to use OE IT equipment, I must ensure that the system meets all applicable 6500 Handbook requirements for OE.

(4) Not use my position of trust and access rights to exploit system controls or access information for any reason other than in the performance of the contract.

(5) Not attempt to override or disable security, technical, or management controls unless expressly permitted to do so as an explicit requirement under the contract or at the direction of the COTR or ISO. If I am allowed or required to have a local administrator account on a government-owned computer, that local administrative account does not confer me unrestricted access or use, nor the authority to bypass security or other controls except as expressly permitted by the VA CIO or CIO's designee.

(6) Contractors’ use of systems, information, or sites is strictly limited to fulfill the terms of the contract. I understand no personal use is authorized. I will only use other Federal government information systems as expressly authorized by the terms of those systems. I accept that the restrictions under ethics regulations and criminal law still apply.

(7) Grant access to systems and information only to those who have an official need to know.

(8) Protect passwords from access by other individuals.

(9) Create and change passwords in accordance with VA Handbook 6500 on systems and any devices protecting VA information as well as the rules of behavior and security settings for the particular system in question.

(10) Protect information and systems from unauthorized disclosure, use, modification, or destruction. I will only use encryption that is FIPS 140-2 validated to safeguard VA sensitive information, both safeguarding VA sensitive information in storage and in transit regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA.

(11) Follow VA Handbook 6500.1, Electronic Media Sanitization to protect VA information. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders.

(12) Ensure that the COTR has previously approved VA information for public dissemination, including e-mail communications outside of the VA as appropriate. I will not make any unauthorized disclosure of any VA sensitive information through the use of any means of communication including but not limited to e-mail, instant messaging, online chat, and web bulletin boards or logs.

(13) Not host, set up, administer, or run an Internet server related to my access to and use of any information assets or resources associated with my performance of services under the contract terms with the VA unless explicitly authorized under the contract or in writing by the COTR.

(14) Protect government property from theft, destruction, or misuse. I will follow VA directives and handbooks on handling Federal government IT equipment, information, and systems. I will not take VA sensitive information from the workplace without authorization from the COTR.

(15) Only use anti-virus software, antispyware, and firewall/intrusion detection software authorized by VA. I will contact the COTR for policies and guidance on complying with this requirement and will follow the COTR's orders regarding my access to and use of any information assets or resources associated with my performance of services under the contract terms with VA.

(16) Not disable or degrade the standard anti-virus software, antispyware, and/or firewall/intrusion detection software on the computer I use to access and use information assets or resources associated with my performance of services under the contract terms with VA. I will report anti-virus, antispyware, firewall or intrusion detection software errors, or significant alert messages to the COTR.

(17) Understand that restoration of service of any VA system is a concern of all users of the system.

(18) Complete required information security and privacy training, and complete required training for the particular systems to which I require access.

3. ADDITIONAL CONDITIONS FOR USE OF NON- VA INFORMATION TECHNOLOGY

RESOURCES

a. When required to complete work under the contract, I will directly connect to the VA network whenever possible. If a direct connection to the VA network is not possible, then I will use VA approved remote access software and services.

b. Remote access to non-public VA information technology resources is prohibited from publicly-available IT computers, such as remotely connecting to the internal VA network from computers in a public library.

c. I will not have both a VA network line and any kind of non-VA network line including a wireless network card, modem with phone line, or other network device physically connected to my computer at the same time, unless the dual connection is explicitly authorized by the COTR.

d. I understand that I may not obviate or evade my responsibility to adhere to VA security requirements by subcontracting any work under any given contract or agreement with VA, and that any subcontractor(s) I engage shall likewise be bound by the same security requirements and penalties for violating the same.

4. STATEMENT ON LITIGATION

This User Agreement does not and should not be relied upon to create any other right or benefit, substantive or procedural, enforceable by law, by a party to litigation with the United States Government.

5. ACKNOWLEDGEMENT AND ACCEPTANCE

I acknowledge receipt of this User Agreement. I understand and accept all terms and conditions of this User Agreement, and I will comply with the terms and conditions of this agreement and any additional VA warning banners, directives, handbooks, notices, or directions regarding access to or use of information systems or information. The terms and conditions of this document do not supersede the terms and conditions of the signatory’s employer and VA.

Print or type your full name Signature

Last 4 digits of SSN Date

Please complete and return the original signed document to the COTR within the timeframe stated in the terms of the contract

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

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.3 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (JAN 2011)

(a) The Contractor shall comply with agency personal identity verification procedures identified in the contract that implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201.

(b) The Contractor shall account for all forms of Government-provided identification issued to the Contractor employees in connection with performance under this contract. The Contractor shall return such identification to the issuing agency at the earliest of any of the following, unless otherwise determined by the Government:

(1) When no longer needed for contract performance.

(2) Upon completion of the Contractor employee's employment.

(3) Upon contract completion or termination.

(c) The Contracting Officer may delay final payment under a contract if the Contractor fails to comply with these requirements.

(d) The Contractor shall insert the substance of this clause, including this paragraph (d), in all subcontracts when the subcontractor's employees are required to have routine physical access to a Federally-controlled facility and/or routine access to a Federally-controlled information system. It shall be the responsibility of the prime Contractor to return such identification to the issuing agency in accordance with the terms set forth in paragraph (b) of this section, unless otherwise approved in writing by the Contracting Officer.

(End of Clause)

C.4 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause) C.5 VAAR 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL (MAY 2020)

(a) The Contractor shall comply with current Department of Veterans Affairs policy for personal identity verification of all employees performing under this contract when frequent and continuing access to VA facilities or information systems is required.

(b) The Contractor shall insert this clause in all subcontracts when the subcontractor’s employees will require frequent and continuing access to VA facilities or information systems.

(End of Clause)

C.6 VAAR 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE MANUALS (NOV 2018)

The Contractor shall follow standard commercial practices to furnish manual(s), handbook(s) or brochure(s) containing operation, installation, and maintenance instructions, including pictures or illustrations, schematics, and complete repair/test guides, as necessary, for technical medical equipment and devices, and/or other technical and mechanical equipment provided per CLIN(s) ALL. The manuals, handbooks or brochures shall be provided in hard copy, soft copy or with electronic access instructions, consistent with standard industry practices for the equipment or device. Where applicable, the manuals, handbooks or brochures will include electrical data and connection diagrams for all utilities. The documentation shall also contain a complete list of all replaceable parts showing part number, name, and quantity required.

(End of Clause)

C.7 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

(a) The Contractor shall conform to the standards established by: FDA as to ALL.

(b) The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement. Proof may also be furnished by the organization listed above certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards.

(c) Offerors may obtain the standards cited in this provision by submitting a request, including the solicitation number, title and number of the publication to: FDA

(d) The offeror shall contact the Contracting Officer if response is not received within two weeks of the request.

(End of Clause)

C.8 VAAR 852.212-71 GRAY MARKET AND COUNTERFEIT ITEMS (FEB 2023)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided. This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/ parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor, or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause) C.9 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED…