36C26327Q0022 A0001.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

1 38

A0001 10/27/2026 unchanged none

36C263

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

DEPARTMENT OF VETERANS AFFAIRS

NETWORK CONTRACTING OFFICE 23

1303 5TH STREET, SUITE 300

CORALVILLE IA 52241

To all Offerors/Bidders

36C26327Q0022

10-21-2026

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 11-11-2026 12pm CST unchanged x 1

The purpose of this amendment is to:

1.Update section B.2 PWS see pages 2-38 for details.

2.Update all ordering periods to adjust 1 month out which will start each period on 12/4 and end 12/3 for each period.

3.Extend the close date from 10/28/2026 to 11/11/2026.

4.All other terms and conditions remain unchanged.

Joshua Imdacha Contracting Officer

B.2 Performance Work Statement (PWS) – updated 10/27/26

1. Project Title

FY27-FY32 IDIQ for VISN 23 Karl Storz Video Integration System Support & Service Contract

2. Procurement Type

This requirement will be fulfilled under a five-year Indefinite Delivery, Indefinite Quantity (IDIQ) contract. The procurement is Brand Name or Limited Sources, as the Karl Storz OR1 integrated operating room platform requires OEM-certified support, parts, software, updates, and cybersecurity compliance documentation.

3. Background & Purpose

VISN 23 operates multiple Karl Storz OR1 integrated surgical environments, including:

• NEO IP video routing and control systems

• AIR system components (E37, E38, E40, E41)

• 4K Boom Room configurations

• AIDA Bella recording modules

• StreamConnect servers and streaming nodes

• OR wall and surgical displays

• CollaboratOR hardware and collaboration modules

• Associated Uninterruptible Power Supply (UPS) units

These systems provide real-time video routing, surgical visualization, recording, integration with clinical systems, and support for intraoperative workflows. Maintaining these systems requires:

• OEM software updates, firmware patches, and version upgrades

• Preventive and corrective maintenance

• Replacement parts and calibrated test equipment

• Cybersecurity artifacts required by VA OIT

• Remote and onsite technical support

• Coordination with other VA and external vendors (e.g., Federal EHR)

VISN 23 requires standardized support to ensure system uptime, maintain cybersecurity compliance, and ensure all facilities have consistent access to OEM-supported maintenance and documentation.

4. Scope

This IDIQ contract covers Karl Storz Video Integration System Support & Service The Government may add new items that fall within the scope of this description during the contract period. Additions shall be made through contract modification and shall not exceed the maximum contract value. The Contractor shall provide proposals for added items upon request.

The Contractor shall provide comprehensive OEM-certified support for all Karl Storz OR1 integrated operating room systems installed across VISN 23. Support includes but is not limited to:

• Covered System Types — Based on system inventory and equipment descriptions:

o OR1 NEO IP Video Integration Systems (e.g., touch panels, converters, CanaryBox, patch software, overview cameras, recording modules, printers, displays, device control modules) o OR1 AIR Systems (e.g., video processor modules, SmartScreen touch modules, external touchscreens, converters, cameras, patch updates) o Uninterruptible Power Supply (UPS) Units — Include preventive maintenance, troubleshooting, repair, and replacement of UPS units associated with covered NEO IP and AIR integration systems, at no additional cost to the Government.

o OR1 4K Boom Room Systems o CollaboratOR hardware and CollaboratOR subscription o StreamConnect Servers and StreamConnect nodes o AIDA Bella Recording Modules o Surgical and wall displays

• Support Services Required — The Contractor shall provide:

o Preventive maintenance and inspection according to OEM standards o Corrective and unscheduled maintenance with OEM-certified repair technicians o Software and firmware updates, upgrades, and patches o Remote technical support and diagnostics o Onsite service when remote resolution is not possible o Replacement parts, tools, and calibrated test equipment o Documentation, release notes, and cybersecurity artifacts (e.g., MDS2, 6550 forms, network diagrams, TRM compliance details, FIPS certifications) o Coordination with VA for system downtime, upgrades, and EHR integration o Training for clinical, technical, and biomedical staff

5. Place of Performance

Services shall be provided across all VISN 23 operating facilities where Karl Storz systems are installed. These include, but are not limited to:

• Fort Meade VAMC (FTM): 113 Comanche Rd, Fort Meade, SD 57741

• Hot Springs VAMC (HS): 500 N 5th St, Hot Springs, SD 57747

• Des Moines VAMC (CIH): 3600 30th Street, Des Moines, IA 50310

• Fargo VAMC (FAR): 2101 Elm Street N, Fargo, ND 58102

• Iowa City VAMC (IOW): 601 Highway 6 West, Iowa City, IA 52246

• Minneapolis VAMC (MN): 1 Veterans Dr, Minneapolis, MN 55417

• Omaha VAMC (OMA): 4101 Woolworth Ave, Omaha, NE 68105

• Grand Island VAMC (GRI): 2201 North Broadwell Ave, Grand Island, NE 68803-2153

• Lincoln VA Clinic (LIN): 420 Victory Park Dr, Lincoln, NE 68510

• Sioux Falls VAMC (SUX): 2501 W 22nd St, Sioux Falls, SD 57105

• St Cloud VAMC (STC): 4801 Veterans Drive, St. Cloud, MN 56303

6. Period of Performance

The contract shall include a five-year ordering period (12/4/2026–12/3/2031) under an IDIQ structure, with each Task Order consisting of a one-year PoP unless otherwise specified.

7. Point of Contacts

• Upon award, the CO and COR shall provide updated POCs for:

o Clinical / Surgical Services o Biomedical Engineering / HTM o Logistics / Supply Chain

• The Contractor shall provide:

o A complete escalation pathway o Normal hours and after-hours support contacts o Points of contact for remote support, onsite dispatch, and service management

8. Equipment List and Change Management

• The Contractor shall support all Karl Storz OR1 equipment installed at VISN 23 facilities, including NEO IP, AIR, 4K Boom Room, StreamConnect, AIDA Bella, surgical displays, and associated accessories.

• Equipment details and estimated quantities are documented below:

Part Number Systems MIN STC FAR CIH IOW BHH SUX

Future Additional Estimated Quantities

Estimated Total

OR1-FS-IP24-1 NEO IP-24 4 3 5 5 6 5 28

OR1-FS-IP48-1 NEO-48 3 4 4 11

OR1-FS-AIR AIR 4 4 8

OR1-FS-BR4K 4K Boom Room 1 1 2

WUIS3642 StreamConnect Server 1 1 1 1 1 1 1 1 8

OR1-PWC-SCN StreamConnect Nodes 3 5 5 11 6 30

WU-MON Surgical Monitors 12 8 20 7 18 8 14 13 100

WU-AIDA AIDA Bellas 10 3 5 4 10 3 5 6 46

OR1-CPL-CB-SA CollaboratOR Hardware 3 4 4 11

WUIS3345 CollaboratOR Subscription 3 4 4 11

• Equipment may be added or removed at any time during the PoP at the discretion of the CO. Credits or modifications shall be applied consistent with PWS provisions for equipment changes.

9. Out of Scope Services

• The Contractor shall notify the CO and COR within 24 hours of discovering any defect, repair, or condition that is outside the scope of this PWS. Notification must include:

o A written description of the issue o A cost estimate (pricing is not included in this PWS text per direction) o A recommended corrective plan

• No out-of-scope work may be performed without prior CO approval.

10. Equipment Changes

The Contractor shall provide comprehensive OEM-certified support for all covered systems, including:

• Scheduled Preventive Maintenance (PM) — PM shall include:

o Cleaning, lubrication, calibration o Inspection of displays, cameras, converters, patch panels, processors o Review of system software diagnostics o Electrical safety inspection per NFPA 99

• Unscheduled / Corrective Maintenance — The Contractor shall:

o Provide unlimited corrective maintenance incidents o Restore systems to OEM performance specifications o Replace any irreparable hardware at no additional cost to the Government o Provide both remote and onsite service based on issue severity

• Spare Parts & Logistics — The Contractor shall maintain access to OEM spare parts required for maintenance and repair, with overnight/next-day availability when necessary.

• Third-Party Coordination — Contractor shall coordinate with VA, OIT, and other vendors (e.g., Federal EHR) to maintain system uptime and interoperability.

• Software Content & Device Updates — This includes updates to:

o System OS patches o Video routing firmware o AIDA Bella firmware and recording modules o StreamConnect servers and streaming nodes o AIR and NEO IP system patches

11. Conformance Standards

All service, maintenance, and installation work shall conform to:

• Manufacturer specifications

• NFPA 99

• OSHA requirements

• VA and VHA technical and safety policies

12. Test Equipment Calibration

• All test equipment used for PM or repairs shall:

o Be calibrated in accordance with NIST standards o Have current, valid calibration certificates o Be documented in each service report

• Equipment out of calibration shall not be used.

13. Contractor Qualifications / Requirements

• Contractor shall provide:

o OEM-certified OR1 technicians o Personnel trained in NEO IP, AIR, 4K systems, StreamConnect, and AIDA o Backup technicians available to support all VISN 23 sites

• Only personnel approved by the CO may perform services.

• Subcontractors are allowed only with CO approval and must meet the same qualification requirements.

14. Safety Requirements

• Contractor personnel shall follow all VA safety protocols, including:

o PPE requirements (may include contractor providing their own PPE) o Facility safety instructions o Onsite hazard mitigation o Immediate correction of any unsafe conditions identified by VA

• Failure to meet safety requirements may result in suspension of onsite work.

15. Security and Privacy Requirements

The Contractor shall comply with all VA, VHA, VISN, and facility-level information security, privacy, and network protection requirements when providing any services under this SOW/PWS. Upon request (if applicable) complete and return all required ERA/MOU-ISA/BAA forms and technical artifacts within ten (10) days of receipt from the VA.

• VA 6500 / 6550 Compliance and Required Security Documentation: Comply fully with VA Directive 6500 and VA Handbook 6500 series cybersecurity requirements governing information system security and data protection for all software, hardware, interfaces, and support activities.

o Complete and return all VA Form 6550 (Medical Device/Software Cybersecurity Analysis) documents: MDS2, network topology, data-flow diagrams, and all required technical artifacts upon request by the COR or ISSO.

• External Connections — MOU/ISA Requirement: Complete all required Memorandum of Understanding / Interconnection Security Agreement (MOU/ISA) documentation whenever integrating any product, interface, cloud service, remote access mechanism, or external connection with any VA network, server, endpoint, virtual machine, or information system.

o Work with VA OIT, ISSO, and the COR to complete the MOU/ISA prior to enabling any external connection.

o Ensure all external connections are explicitly approved by VA OIT and documented in a fully executed MOU/ISA.

o Maintain the MOU/ISA throughout the Period of Performance; keep it current.

o No external system may exchange data with VA systems unless covered by an approved, active MOU/ISA consistent with VA security policy.

• VA Handbook 6513 — Secure External Connections: Comply with VA Handbook 6513 (Secure External Connections) for all external or vendor-initiated connections to VA systems.

o Use only VA approved secure methods (e.g., VA approved Site to Site VPN) for remote access.

o Ensure vendor hosted/cloud hosted components, remote diagnostic tools, or SaaS elements meet external connection security requirements.

o Do not create unapproved tunnels, backdoors, ports, or pathways between contractor systems and VA systems.

o Submit all security artifacts required by Handbook 6513 (architecture diagrams, encryption documentation, authentication model, access controls, etc.) as part of the MOU/ISA package.

o Ensure Contractor personnel follow VA's secure external connection procedures when connecting to VA networks.

• Business Associate Agreement (BAA) Requirements — PHI/ePHI: If PHI or ePHI is processed, transmitted, accessed, or stored: follow the BD/CareFusion Business Associate Schedule (HIPAA Privacy Rule, Security Rule, HITECH), including minimum-necessary use, breach reporting, mitigation, subcontractor flowdowns, and PHI destruction/return obligations.

• Removable-Media Scanning: All Contractor-owned USB drives, external media, or service tools must be scanned by Biomedical Engineering prior to being connected to any VA system. Infected media shall not be used and constitutes a security breach.

• Hard Drive and Device Handling / EPHI Protections: Contractor shall not remove, copy, alter, or delete VA or patient data stored on VA systems. All replaced storage media must be surrendered to VA for decommissioning/destruction. Printers and devices capable of storing EPHI must be scrubbed according to VA procedures and remain VA property.

• FIPS Requirements: All cryptographic modules must be FIPS 140-3 validated or letter of attestation to upgrade before the 9/21/26 sunset (or current); Contractor shall provide certificate numbers.

• TRM Compliance: All software (if applicable) must be approved in the VA Technical Reference Model (TRM) or Contractor to assist VA in obtaining approval.

• Cloud Services (if any): If cloud components are used (PaaS, SaaS, or hosted services), they must follow VA Directive 6517 and the VA Enterprise Cloud Solution Intake process.

• SMAK-AM Deployment: Contractor shall allow installation of the System Monitoring and Accountability Knowledge – AntiMalware (SMAK-AM) toolset on all relevant devices prior to integration or operation.

• MAC Addresses: The Contractor shall provide to the VA all MAC addresses for each network-capable device, appliance, software-defined component, or virtual interface no later than one (1) week prior to delivery. This information is required for validation, network registration, address reservations, security controls, and compliance with VA network onboarding requirements.

16. Network and Hardware Baseline (VISN 23 Hosting)

All Karl Storz OR1 systems shall comply with VA, VHA, VISN 23, and facility-specific network and hardware requirements. This includes:

• VISN 23 Virtual Hosting Requirements — VISN 23 hosts server-based systems on its virtualized Nutanix HCI platform using the Acropolis hypervisor, which supports VMware OVA/VMDK packages but does not support Hyper-V deployments.

• Supported Operating Systems & Database Platforms — VA will provide:

o Windows Server 2019 (or currently supported OS) o Microsoft SQL Server 2019 (or supported DBMS) o The Contractor shall ensure the Karl Storz OR1 system software, middleware, and associated applications are compatible with VA-provided OS and DBMS environments.

• Directory Services Integration — The Contractor shall identify if OR1 systems support:

o Active Directory (AD) o LDAP o Single Sign-On (SSO) integration

• Workstation Requirements — Workstations shall comply with VISN 23 standards:

o Major brand (Dell/HP) o TPM module o SSD-based OS drives with encryption o Adequate RAM per OEM specs o FHD (1920×1080) displays o Current-generation CPU (Intel i5 or greater) o Contractor shall not apply OEM Group policies on the computers.

o Contractor shall provide all required hardware and software login credentials

17. Electrical/Power Requirements

• All components shall operate from standard 120 VAC, drawing <20 amps, utilizing existing VA electrical service.

18. Project Management and Milestones

The Contractor shall provide comprehensive project management for scheduled maintenance, upgrades, updates, recalls, installation changes, and all service activities.

• Contractor Project Management Plan (CPMP) — Within 2 weeks of award, the Contractor shall submit a CPMP including:

o Narrative project description o Gantt chart or equivalent timeline o Risks and mitigation o Roles/responsibilities o Reporting cadence o Technical plans o Security requirements

• Kickoff Meeting — Held within 3 weeks of award, including review of project plan, communication plan, escalation pathways, testing workflows, and upgrade schedules.

• Ongoing Project Meetings — Scheduled weekly or as needed, with:

o Agendas o Minutes o Attendance logs o Recording (when feasible)

• Documentation Requirements — Contractor shall provide:

o Daily onsite status reports with photos (when onsite) o Acceptance letters post-service o Lessons Learned report within 3 weeks of milestone completion

• Project Milestone Table o Award Notification & Initial Coordination — Contractor acknowledges award, reviews PWS obligations, receives facility POCs (clinical, HTM, logistics, OIT/ISSO), confirms communication paths. (Contractor & COR — Within 5 business days of award) o Submit Contractor Project Management Plan (CPMP) — Contractor submits CPMP including narrative, schedule (Gantt or similar), roles/responsibilities, risks, reporting cadence, security tasks, and technical approach. (Contractor — Within 2 weeks of award) o COR/Facility Review & CPMP Finalization — COR and facility POCs review, provide feedback, finalize CPMP with Contractor. (Contractor & COR — Within 3 weeks of award) o Kickoff Meeting — Formal kickoff to review CPMP, communication plan, update/upgrade processes, testing/validation workflow, security requirements, and escalation pathways. (Contractor & VA (COR/POCs) — Within 3 weeks of award) o Security Documentation Submission — Contractor submits VA Form 6550 (MDS2), network topology, data-flow diagrams, encryption details, TRM data, and initiates MOU/ISA requirements. (Contractor — Within 10 days of VA request) o Provide MAC Addresses — Contractor provides MAC addresses for all Karl Storz NEO IP, AIR, 4K, StreamConnect, AIDA, and networked components for VA onboarding. (Contractor — ≥1 week before delivery) o Hosting Readiness & Technical Validation — Validate VISN 23 virtual hosting (Nutanix/Acropolis), confirm OS/SQL support, verify AD/LDAP/SSO readiness, and ensure compatibility with VA-required configurations. (Contractor & VA OIT/ISSO — Prior to installation window) o Licensing / Entitlement Activation — Confirm active service entitlements and subscriptions for NEO IP, AIR, 4K Boom Room, StreamConnect, AIDA, and related modules. (Contractor — Before installation/configuration) o System Installation / Configuration — Implement OR1 upgrades or installations, configure routing, update firmware, calibrate displays, enable streaming/recording, and integrate peripherals. (Contractor — As scheduled with COR/POCs) o Remote Access Enablement — Complete S2S VPN or other VA-approved secure access, validate connection compliance with VA Handbook 6513.

(Contractor & VA OIT/ISSO — Before testing/integration) o Interface Configuration & Testing — Configure and validate interfaces for NEO IP, AIR, AIDA, StreamConnect, peripheral control modules, displays, cameras, and system workflows. (Contractor & VA — Before Go-Live or major update) o QA Testing & Validation — Conduct QA and functional testing; confirm conformance with manufacturer specs; perform connectivity and workflow validation; deliver release documentation. (Contractor — Prior to acceptance) o Training Delivery — Conduct clinical training (superusers, nurses, surgeons) and technical/Biomed training covering PM, troubleshooting, workflow setup, recording/streaming use, and service procedures. Provide quick reference guides. (Contractor — Before production use) o Go-Live & Acceptance — Systems enter production use. Contractor provides acceptance letters; COR and facility POCs verify compliance and operational readiness. (Contractor & COR — At completion of installation/testing) o Initial Stabilization Support — Elevated support period for early operational issues following upgrades/maintenance. (Contractor — First 30 days post-Go- Live) o Monthly Service Reports — Contractor submits monthly service summaries, ticket logs, issues, SLA metrics, update/patch notes, and trending data.

(Contractor — Monthly (first week)) o Quarterly Performance Reviews — Review uptime, service trends, recurring issues, and cross-facility patterns with COR. (Contractor & COR — Quarterly) o Updates, Upgrades & Patch Cycles — Provide and validate all NEO IP, AIR, 4K, StreamConnect, AIDA updates and firmware upgrades; test in nonclinical environment first; plan and schedule deployments. (Contractor — As required) o Annual Option Year Review — Validate all equipment lists, LINs, serials, supported devices, and identify EOL/EOS components for upcoming year.

(Contractor & COR — 150–180 days before PoP anniversary) o Lessons Learned / After-Action Report — Conduct lessons-learned meeting and submit written AAR following major upgrade cycles or annually. (Contractor

— Within 3 weeks of cycle completion)

19. Check-In / Check-Out and Badging

• Contractors must follow VA privacy training, safety requirements, parking restrictions, and local VA rules.

• All Contractor personnel must:

o Check in with facility POC prior to beginning work o Check out with facility POC prior to departure o Wear visible identification badges at all times o Submit fingerprints if required for VA-issued badges

• Removable Media Scanning o All removable media must be scanned by Biomedical Engineering prior to connecting to any VA network, system, or device.

o Infected media shall not be used.

20. Interface Cable and Cable Management

• Contractor shall provide all necessary interface cables and coordinate with VA to ensure safe and efficient cable routing, minimizing hazards and maintaining compliance with facility standards.

21. Remote Technical Support

• The Contractor shall provide 24/7/365 remote support for:

o System troubleshooting o Software issues o Configuration corrections o Interface troubleshooting o Content or workflow-related inquiries

• This includes remote diagnostics for NEO IP, AIR systems, AIDA modules, StreamConnect servers, routing devices, and integrated OR components.

22. Telephone / Online Support and Communications

• The Contractor shall supply:

o Toll-free contact numbers o Support email addresses o After-hours emergency contacts o Unlimited support requests from VA

• For each issue, the Contractor must communicate:

o Summary of the problem o Affected version/product o Whether patient care is impacted o Workarounds (if any) o Expected patch or release timelines

• Monthly service reports shall include known issues and systemic patterns.

23. Scheduled Maintenance Requirements

• Contractor shall perform scheduled PM in accordance with:

o OEM recommendations o Joint Commission EC.02.04.01 / EC.02.04.03 o ANSI/AAMI/ISO 13485 o VHA PM standards

• PM must include:

o Cleaning o OS/software diagnostic review o Calibration and lubrication o Electrical safety inspection

• Contractor shall schedule PM with COR and facility POCs and provide at least 60 days advance notice for downtime.

24. Unscheduled Maintenance Requirements

• Contractor shall provide unlimited unscheduled maintenance and corrective repair incidents.

• Requirements include:

o Troubleshooting, repair, and restoration to OEM specifications o Both remote and onsite service o Contractor responsibility for equipment replacement if repair is not feasible

• All support requests must be tracked in a ticketing system.

25. Service Levels (SLA)

• Priority Categories & Response Targets:

Priority Callback Remote Login Restoration Target

Urgent 1 hour 1 hour 8 hours

Priority Callback Remote Login Restoration Target

High 2 hours 2 hours 16 hours

Normal 2 hours 8 hours 40 hours

Low 4 hours 10 hours 48 hours

• If full performance cannot be restored by 50% of the response window, Contractor shall notify the Government with a revised ETA.

26. System Uptime target

• Maintain ≥ 98.9% operability (excluding scheduled maintenance), measured monthly during the initial support period.

• Uptime % = [(Total Time − Unscheduled Downtime) ÷ Total Time] × 100

Where:

• Total Time = the total number of hours in the measurement period (typically 30 days = 720 hours)

• Unscheduled Downtime = any time the system is unavailable for clinical use due to a Karl Storz-caused failure

27. System Testing and Validation

• Prior to deployment of updates, upgrades, patches, or configuration changes, the Contractor shall perform:

o Functional testing of OR1 NEO IP, AIR, and 4K Boom Room systems o Interface testing for StreamConnect, AIDA modules, overview cameras, routing engines, and peripheral converters o Connectivity validation for all integrated OR components o Testing of workflow-dependent items (e.g., recording, routing, preview displays)

• The Contractor shall coordinate all testing with the COR and facility POCs in both TEST (if applicable) and LIVE environments.

• Release documentation must be provided for all changes.

28. Updates and Upgrades

• The Contractor shall provide and install all OR1 system software and firmware updates, including but not limited to:

o NEO IP patches o AIR system patches and version upgrades o 4K Boom Room component updates o AIDA Bella recording module firmware o StreamConnect server and node updates

• All updates must be:

o Tested in nonclinical environments prior to release o Scheduled in coordination with the COR and facility POCs o Accompanied by updated release notes and user/technical documentation

• The Contractor shall maintain all systems at current security patch levels and communicate any known issues related to forthcoming updates.

29. Urgent Priority Updates

• Updates related to the following shall be treated as Urgent Priority:

o Patient safety o Regulatory requirements o Security vulnerabilities o VA EHR/VistA interface integrity

• The Contractor shall:

o Provide an action plan within 30 days of identification or notification o Implement the fix within a mutually agreed time frame o Coordinate deployment across VISN 23 o Ensure all supporting release notes and technical literature are updated

• Software shall not be self-canceling or time-disabled.

30. Interfaces

• The Contractor shall implement, test, support, and maintain all interfaces required for OR1 systems, including but not limited to:

o StreamConnect video streaming o AIDA recording integration o DICOM/HL7/VistA or EHR-related data pathways where applicable o NEO IP and AIR system bidirectional control integrations

• If VA or an external vendor changes a host platform (e.g., EHR migration), the Contractor shall work to restore functionality with reasonable commercial effort.

31. Service Reports and Electronic Service Log

The Contractor shall provide:

• Service Reports — A written service report must be submitted to the designated facility POCs within 72 hours of any remote or onsite service activity.

• Electronic Service Log — The Contractor shall maintain a VISN-wide service log that includes:

o Ticket numbers o Equipment details (description, model, serial number, barcode) o Failure date/time o Service date/time o Description of issue o Actions taken and parts replaced o Software/firmware version installed o Root cause analysis o Completion date o Remaining follow-up actions o Technician identification o Log must be web-accessible and approved by COR/POCs before use.

• Monthly and Quarterly Reporting — Contractor shall provide monthly service summaries and participate in quarterly performance reviews.

32. Product Modifications, Recalls, and EOL/EOS Notifications

• The Contractor shall notify the COR and facility POCs within 48 hours of any:

o OEM product recall o End-of-Life (EOL) or End-of-Service (EOS) notice o Safety alert o Required product modification

• Notification must include:

o Affected equipment identification o Reason for recall or modification o Required actions or replacement plans o Steps for credit, removal, or OEM-directed remediation

• The Contractor shall perform all required corrective actions across all VISN facilities.

33. Delivery, Shipping, and Materials

• The Contractor shall coordinate delivery with Supply Chain and facility POCs, including:

o Delivery schedules o Storage plans o Tracking information o No delivery more than one week prior to installation

• All equipment and materials must be:

o New o OEM packaged, unopened o Labeled with OEM model, serial, PO number, and technical POC o Tagged by area/room for installation

• Multiple-container shipments must include a "Package X of Y" indicator. Nonconforming items may be rejected.

34. Waste and Jobsite Cleanup

Contractor shall:

• Remove all packaging materials and waste daily

• Transport waste offsite

• Provide a waste removal plan to COR and facility POCs

35. Manuals, Release Notes, and Service Bulletins

• Contractor shall provide unlimited electronic access to:

o User manuals o System administration guides o Service manuals o Diagnostic codes and procedures o Release notes o Service bulletins o Training videos

• Service manuals must include schematics, parts lists, and diagnostic instructions equivalent to those provided to OEM service engineers.

36. Training Requirements

The Contractor shall provide comprehensive training including:

• Clinical Training o Superuser training for surgeons, nurses, and clinical staff o Training on video routing, recording, system controls, and workflows o Quick reference materials for each site

• Technical / Biomedical Training — Training shall include:

o Commissioning and PM requirements o System configuration o In-house repair procedures o Troubleshooting o Service passwords (where applicable) o Server and backup maintenance

• Contractor shall also provide:

o Optional offsite Biomed school training o Full service documentation equivalent to OEM field service resources

37. Invoicing and Payment

• The Contractor shall submit detailed invoices in arrears after VA acceptance of services or deliverables. Invoices shall include:

o Contract number and Task Order number o Purchase Order (PO) number o Line Items (LINs) linked to the services performed o Date(s) of service o Facility name o Description of service provided (PM, repair, update, upgrade, etc.)

• The Contractor shall reduce the number of invoices submitted by consolidating multiple line items for a given performance month into a single invoice.

• Invoices must be submitted electronically via the VA's FSC e-invoicing portal.

38. Warranty

• Hardware Warranty (Applicable to Replacement Units) o Any replacement Karl Storz hardware provided during the support period shall be covered under a 12-month warranty from date of acceptance, aligned with VISN 23 warranty expectations.

o Warranty service must be performed by OEM-certified or OEM-approved personnel, and includes all necessary parts, labor, and travel.

• Software Warranty o Karl Storz OR1 system software, including NEO IP, AIR, 4K Boom Room, and associated modules (AIDA, StreamConnect, etc.), shall:

Operate substantially in accordance with the documentation

Be updated or repaired if nonconforming o Warranty remedies are limited to repair or replacement.

39. Order of Precedence

• In the event of conflict, the following order of precedence applies:

o Federal law and regulation o Terms of the awarded VA contract o This Performance Work Statement (PWS) o Manufacturer (Karl Storz) schedules or licensing terms, but only as they relate to OEM technical requirements, cybersecurity obligations, and support entitlements o Contractor-provided documentation, only insofar as it does not conflict with higher-order documents

• Services not explicitly defined in this PWS shall be considered out-of-scope.

40. Abbreviations

• AAMI – Association for the Advancement of Medical Instrumentation

• AIDA – Karl Storz AIDA recording module

• AIR – Karl Storz OR1 AIR integrated system

• BAA – Business Associate Agreement

• CAP – College of American Pathologists

• CCE – Connectivity/Communication Enhancement

• CDRH – Center for Devices and Radiological Health

• CIH – Central Iowa Health Care System

• CO – Contracting Officer

• COR – Contracting Officer's Representative

• DBMS – Database Management System

• EHR – Electronic Health Record

• EPHI / ePHI – Electronic Protected Health Information

• FIPS – Federal Information Processing Standards (140-2 / 140-3)

• FSE – Field Service Engineer

• HCI – Hyperconverged Infrastructure (e.g., Nutanix)

• HTM – Healthcare Technology Management

• IOW – Iowa City VA Health Care System

• ISSO – Information System Security Officer

• LIN – Line Item Number

• MDS2 – Manufacturer Disclosure Statement for Medical Device Security

• MIN – Minneapolis VA Health Care System

• MOU/ISA – Memorandum of Understanding / Interconnection Security Agreement

• NEO IP – Karl Storz OR1 NEO IP routing/control system

• NFPA – National Fire Protection Association

• NWI – Nebraska-Western Iowa HCS

• OIT – Office of Information and Technology (VA)

• OS – Operating System

• PaaS / SaaS – Platform as a Service / Software as a Service

• PHI – Protected Health Information

• PoP – Period of Performance

• PWS – Performance Work Statement

• RCA – Root Cause Analysis

• SCB – Karl Storz Device Control Bus

• SLA – Service Level Agreement

• SMAK-AM – System Monitoring and Accountability Knowledge – AntiMalware

• SQL – Structured Query Language

• SSO – Single Sign-On

• STC – St. Cloud VA Health Care System

• StreamConnect – Karl Storz streaming platform (WUIS components)

• SUX – Sioux Falls VA Health Care System

• UPS – Uninterruptible Power Supply

• VHA – Veterans Health Administration

• VISN – Veterans Integrated Service Network

• VistA – Veterans Health Information Systems and Technology Architecture

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

LANGUAGE

APPLICABLE PARAGRAPHS TAILORED FROM: THE VA INFORMATION AND

INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE, VA HANDBOOK 6500.6,

APPENDIX C, April 22, 2024, VA INFORMATION AND INFORMATION SYSTEM SECURITY

AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE

B1. 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.

B2. 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 V 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.

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 to 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 to 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.

B3. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS. – This section applies when any 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.

B4.