36C24925R0015_0002.docx

36C24925R0015 Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C249 Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129

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 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

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

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

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

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

(1) Vendor must accept the system without the drive;

(2) VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

(3) VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

(4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

(a) The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

(b) Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

(c) A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. 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 COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

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

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

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

7. LIQUIDATED DAMAGES FOR DATA BREACH

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

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

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

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

(2) Description of the event, including:

(a) date of occurrence;

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

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

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

(6) Amount of time the data has been out of VA control;

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

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of 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.

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

9. TRAINING

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

(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 COR 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.

(End of Clause) Statement of Work 2/4/2025

Endoscope Lease, Comprehensive Service Agreement and Onsite Endoscopic Specialists

Introduction:

Tennessee Valley Healthcare System (TVHS) has a need for Karl Storz Endoscopic equipment for patient diagnosis and treatment. The Endoscope Original Equipment Manufacturer (OEM) equipment shall be leased, provides for Comprehensive Service Agreement (CSA) and Onsite Endoscopic Specialists (OES). Monthly payments shall be applied towards the purchase price at the end of the performance period and all endoscopic equipment may be owned by TVHS.

Purpose:

TVHS has an ongoing need to renew and upgrade equipment that is compatible with the Karl Storz Endoscopy equipment already in use. The camera equipment shall be compatible with the existing Karl Storz systems. The TVHS Nashville and Alvin C. York facility expansions require continued OEM Endoscopy lease, service, and support.

a. Equipment: includes existing roll over from previous contract and new upgrades.

b. Service: owned and new lease scopes and accessories.

c. Onsite Endoscopic Specialist support staff.

Background:

TVHS Surgical Care Services has utilized Karl Storz Endoscopes for several years to support surgery cases. The lease option reduces the initial cost, allowing for payments over the lease period, which helps with predictable financial obligations and budget planning. Leasing also enables the service to efficiently incorporate newer technology when it becomes available. Leased equipment provides the flexibility to integrate new equipment with existing systems currently in use. The Biomedical Department also uses the CSA for repairs and maintenance, as these devices cannot be repaired in-house.

Objective of Requirement:

The Contractor shall provide full equipment leasing, CSA, and OES support staff for all Endoscope equipment and accessories necessary to maintain proper usage, per the contract schedule and in accordance with the manufacturer’s specifications for TVHS Nashville and Alvin C. York Medical Centers. Medical centers include Ear Nose & Throat (ENT), Urology, Nashville operating room (capacity for Orthopedics), Urology, and Alvin C. York operating room.

Equipment Location:

Equipment is located at TVHS, VAMC 1310 24th Avenue South, Nashville, TN 37212 and 3400 Lebanon Pike, Murfreesboro, TN 37129.

Scope of Services:

This contract encompasses Karl Storz Endoscopy equipment leasing, CSA, and OES support staff to ensure the proper care, handling, and maintenance of scopes and equipment accessories. The Contractor shall provide all necessary services, personnel, equipment, supplies, materials, supervision, and non-personal services to perform services. The Government will not exercise supervision or control over the contract service providers. These providers are accountable solely to the Contractor, who, in turn, is responsible to the Government.

Work: The Endoscope lease contract shall ensure the instant availability of scopes and related equipment accessories to TVHS, Nashville, and Alvin C. York Veteran Administration Medical Center. The equipment does not connect to a computer or require software to operate from a computer-based operating system. The equipment, located in the ENT clinics at both facilities, does not store patient information. The devices are stored behind locked doors and require a secure password to access data. The Contractor shall ensure that repairs and maintenance services are performed by OEM-certified or trained specialists. If the equipment is deemed unrepairable, the Contractor shall provide a replacement or upgrade to an equivalent model.

OEM Comprehensive Service Agreement (CSA): The CSA covers repairs for both rollover and upgraded equipment, offering unlimited repairs and exchanges for the life of the equipment. All scheduled and unscheduled repairs costs shall be covered under CSA. The turn-around time for scope repair is 48 hours. TVHS uses a repair-exchange program that provides a new scope with evolutionary upgrades. Equipment will be exchanged for a like-new condition, with a new warranty on replaced items.

The Contractor shall ensure that equipment functions according to manufacturer specifications and the latest editions of NFPA-99 and OSHA standards. Test equipment shall be within manufacturer specifications and calibrated at required intervals. Calibration certificates shall be traceable to a national standard and provided to VA Biomedical Engineering, the Contracting Officer (CO), and Contracting Officer Representative (COR) upon request.

The Contractor shall notify the CO and COR in writing of any defects or required repairs within 24 hours of discovery of equipment which the Contractor considers out of scope under the terms of this contract.

Scheduled Service: All preventative maintenance (PM) services shall be completed in accordance with Manufacturer’s requirements and recommendations. A PM inspection shall include, at a minimum, the following:

Cleaning and calibration of equipment:

· Review of operating system and software application diagnostics and correction

· Remedial maintenance and lubrication

· Inspection and testing of all system components, hardware, electrical wiring and cables, and peripherals.

· Replacement of all worn and fault components, hardware, electrical wiring and cables and peripherals, including any of the above which are likely to become worn, faulty, or fail.

· Returning the equipment to manufacturer operational condition, as defined in Conformance Standards.

· Providing electronic documentation of all services performed to the end user, COR, and Biomedical Engineering

Unscheduled Service: All repair services shall follow the manufacturer’s requirements and conformance standards. The Contractor shall provide diagnosis and remediation to maintain operational equipment. Repair services may involve troubleshooting, component replacement, calibration, cleaning, adjustments, and, if necessary, unit replacement. All services shall be electronically documented and provided to the end user, COR, and VA Biomedical Engineering.

The Contractor must show satisfactory evidence to VA Biomedical Engineer that efforts and manpower are progressing to troubleshoot failure and identify a solution in a timely manner.

Documentation shall include detailed descriptions of the scheduled and unscheduled maintenance procedures performed. Procedures used for PM inspections shall be submitted with each report. The Contractor shall, at a minimum, thoroughly record the following items:

· Name of Karl Storz Contractor who performed the service.

· Date and time during which services were rendered.

· VA Karl Storz Endoscopy Lease Contract Task Order and IFCAP Obligation numbers associated with the services.

· Description of problem reported.

· Identification of equipment to be serviced, including model number, serial number, and any other identifying information.

· Itemized description of services performed.

· Signatures of Contractor and VA Biomedical Engineer who witnessed service.

Payment/Timely Invoicing: All invoices must be submitted through the Invoice Processing Payment System (IPPS) within 15 days of the monthly invoice. Payments will be certified upon receipt of a properly prepared invoice referencing the payment period. Invoices must include task order and IFCAP obligation numbers. The Onsite Endoscopic Specialist will provide an up-to-date inventory list, including exchange items with new serial numbers. Invoices shall be certified upon verification of submission of required documentation within 5 days of receipt.

Onsite Endoscopic Specialist: The OES will be contracted VA employees available Monday through Friday, 8:00 am to 5:00 pm (Central Time). The OES will manage all TVHS-owned and leased endoscopic equipment and Karl Storz surgical instruments. The OES shall provide oversight ensuring proper care, handling, and maintenance of endoscopes and equipment accessories for both locations. The OES shall provide education, inspection, maintenance, repairs, analysis, reporting and professional customer service. The OES shall provide operating room, clinic, and sterile processing supply support to include education and training. The OES shall provide inventory and asset management of all Endoscope contract equipment items. OES staff will have access to VA sensitive information to include patient name, social security numbers, date of birth, and scans that are stored on the leased towers.

More specifically, the OES provides:

· Certified, dedicated Karl Storz experts located at the facility full-time. OEM trained product experts knowledgeable of all Karl Storz Instructions for Use (IFUs) and reprocessing instructions to ensure that scopes, cameras, and instruments are reprocessed correctly and mitigate damage.

· The OES protects equipment by providing daily equipment maintenance and immediate support in the perioperative space. The OES provides daily setup of equipment needed in the OR and assist with room setup throughout the day to ensure no equipment delays. The OES is responsible for providing immediate equipment troubleshooting if issues arise.

· Supports OR Case Coverage. Helps surgeon and staff focus on patient care in the room, they are confident equipment works and they are supported.

· Equipment Management

· Facilitates Repairs & Exchanges. Expedites process; illuminates or mitigates VA employees engaging with customer support, provides liaison assistance between company and customer. Helps secure loaner equipment where needed and facilitates the procedural return.

· Data Collection & Analysis. Tracks repair trends and provides root cause analysis. Monitors mean time to repair. Provides weekly reporting to Surgical Service and Sterile Processing Service leadership.

· Education. Group, 1:1, competencies, “In the moment” education Streamlines operations, lowers costs, and contributes to overall customer satisfaction.

Personnel: The contract Onsite Endoscopic Specialist is required to complete a background evaluation. TVHS shall submit the required documents to VHA Service Center (VSC) to complete the background investigation application. Authorization requirements apply, and a Security Accreditation Package is required prior to local access of VA computer networks. Additionally, a Security Accreditation Package is mandatory for Personnel Identifier Verification (PIV) card issuance if working for the agency more than 180 aggregate days. A favorably adjudicated background investigation for the position risk level is required for logical access and any additional VISTA keys or physical access.

The Contractor shall cooperate in good faith with completing the security Accreditation Package, to include providing corrections and additional information as requested to complete the background investigation.

OF-306, Declaration of Federal Employment, VA0710, Special Agreement Fingerprint form, and Self-Certification of Continuous Service documents are required to initiate the background investigation process.

For the Contract Onsite Endoscopic Specialist to engage in work at VA, the Contractor is required to ensure the contract OES completes mandatory training requirements for Karl Storz Endoscopy Lease period of performance. The contract OES shall provide to the COR a copy of each completed mandatory training certificate. All mandatory training shall be required each 12-month ordering period.

Training:

Mandatory Training through Talent Management System (TMS)

This training is offered through the VA TMS, a system that offers web-based training to VA employees and its partners.

Contractor employee will self-enroll for a TMS training profile on the VA TMS by visiting https://www.tms.va.gov/plateau/user/login.jsp. Once there, the employee will follow the steps that follow to create a profile, launch the mandatory training, and complete the content prior to their next day at VA. Upon completion by all employees, the Contractor shall provide their Contracting Officer Representative with each employee's printed certificate of completion from the TMS. This certificate displays the employee's TMS User ID.

TMS Level 1 training is required for sterile processing supply (Course 1, Introduction) TMS ID# 22686 (Course 2, Microbiology) TMS ID # 22782 (Course 3, Decontamination) TMS ID # 22781 (Course 4, Surgical Instrumentation Part 1) TMS ID #22783 (Course 5, Surgical Instrumentation Part 2) TMS ID #22784 (Course 6, Packaging) TMS ID #22799 (Course 7, Sterilization) TMS ID # 22802 (Course 8, Cleaning and Sterilizing) TMS ID # 22796 (Course 9, Distribution) TMS ID # 22797 (Course 10, Inventory ) TMS ID # 22798 (Course 11, Anatomy and Physiology Part 1) TMS ID #22800 (Course 12, Anatomy and Physiology Part 1) TMS ID #22801

Schedule: Normal hours of coverage are Monday-Friday, 8:00 am to 5:00 pm (Central Time), based on the needs of the operating room excluding national holidays recognized by the Department of Veterans Affairs. All services shall be performed during normal hours of coverage unless requested and approved by the COR. Observed holidays include:

If VA determines the Contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the Contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. (VA Handbook 6500.6 Appendix C)

Reporting requirements:

a. The Contractor shall provide the COR with monthly updated asset listing for the duration of the contract to document inventory. These are due to the COR by the second workday following the end of each calendar month, throughout the project's duration. The COR is required to provide quarterly progress reports to the Contracting Officer by the tenth workday of the new calendar month.

b. The progress report shall cover all work completed during the preceding months and shall present the work to be accomplished during the subsequent months. This report shall also identify any problems that arose, along with a statement explaining how the problem was resolved. This report shall also identify any problems that have arisen but have not been completely resolved, with an explanation.

c. The Contractor must inform the COR when personnel are removed from the contract for any reason.

d. If a key person becomes unavailable to complete the contract, proposed substitutions of key personnel shall be made to the COR and CO.

Property Damage: The Contractor shall take all necessary precautions to prevent damage to any government property and shall notify the COR immediately if damages occur.

a. Service Quality: All services provided in this contract must meet the manufacturer's performance and technical specifications. The Contractor shall document all maintenance and provide documentation to the COR upon completion of service action.

b. Equipment Exchange: Timely documentation of serialized items shall include detailed descriptions of the equipment, product number, problem resulting in repair exchange, old and new serial numbers. Documentation shall be submitted with each exchange to the end user, VA biomedical Engineer service, sterile processing supply and COR.

c. Equipment Inventory: The Contractor shall provide a monthly inventory list of all Endoscope equipment, and equipment accessories physically in TVHS facilities.

Pictures: Taking of photographs, videos, or vocal recordings of any kind is PROHIBITED on VA premises unless pertaining to work…