Statement of Work
Preventive Maintenance and Repair
For
Biofire FilmArray Equipment Service
Lebanon Veterans Affairs Medical Center (VAMC)
1700. S. Lincoln Avenue
Lebanon, PA 17042
Background:
The Lebanon VAMC Health Technology Management department has a requirement for a full-service preventive maintenance and repairs service contract for Biofire FilmArray equipment, as listed in Schedule A Equipment List.
Requirements: In accordance with the following specifications:
Preventive Maintenance Inspections and Services:
1.1 Vendor shall provide recurring scheduled maintenance and inspection services, including all labor, travel, and parts, on a firm-fixed price basis, for the biomedical equipment identified in Schedule A.
1.2 Preventive maintenance shall be in accordance with the manufacturer s recommended guidelines and shall include, but not be limited to, electrical safety testing, lubrication, adjustments, and calibration. Maintenance shall also include testing and replacement of faulty parts, and parts which are likely to fail, at no additional charge, returning the instruments and equipment to the operating conditions specified by the Manufacturer.
1.3 Scheduled preventive maintenance (PM) shall be in accordance with the quantities as specified in Schedule A Equipment List.
1.4 Vendor shall provide all personnel, parts, tools, test equipment, service manuals, computer software and schematics necessary to complete on-site, scheduled preventive maintenance services on all the identified equipment during normal business hours, 8:00 AM 4:30 PM, Monday through Friday, or at the convenience of the equipment operators. Preventive maintenance shall not be conducted on a federal holiday.
1.5 Within 30 days of contract award, the Contractor shall coordinate and schedule the dates and times for the various preventive maintenance inspections.
1.6 A copy of the Preventive Maintenance Inspection procedure (including Qualitative and Quantitative tests) used by the Field Service Representative (FSR) for each instrument and piece of equipment listed in the contract shall be made available.
For each service visit, a detailed Equipment Service Report will be required. Each service report shall include:
Name of the contractor and contracting number
Name of the Field Service Engineer (FSE) performing the services
Contractor Service Number/Log Number
Date, time (starting and ending), equipment downtime and hours-on-site for service call
Identification of equipment to be serviced, invoice or ID number, manufacturer s name, device name, model number, serial number and any other manufacturer s identification numbers
Description of problem reported by Technical Point of Contact (POC)/UserDescription of problem reported by POC/Technical Point of Contact (POC)/User
Signature from the FSE performing services described
Signature from the Technical POC/user who witnessed services described
Remedial Services and Emergency Repairs
2.1 Vendor shall provide unscheduled remedial services and emergency repairs, only when directed by the Contracting Officer or Technical POC to proceed. All equipment listed in Attachment A is covered for remedial services or emergency repairs and the Government is responsible for ensuring these services are only required by the authorized personnel.
2.2 FSR shall acknowledge receipt of a service call for remedial services and emergency repairs within four hours and shall arrive on the premises to inspect equipment within 24 hours.
2.3 Any changes to the SOW or outside the scope of this order shall be authorized and approved only through written correspondence via formal modification issued by the CO and agreed upon by the contractor through a bilateral modification.
2.4 Vendor shall order replacement parts within 24 hours after receiving notification to proceed.
General Responsibilities:
3.1 Written field service reports shall be available to a representative of Health Technology Management within five (5) business days after completion of any preventive maintenance, remedial service, and emergency repair at the following email address: VHALEBBiomed@va.gov.
3.2 Vendor has the option of providing scheduled preventive maintenance service at the same time as remedial service or emergency repair call, with the prior approval of the technical point of contact.
3.3 All replacement parts shall be certified and warrantied by the Original Equipment Manufacturer (OEM).
3.4 Biomedical equipment listed in Schedule A may fluctuate during the performance of this agreement due to situations such as the purchase of new equipment, expiration manufacturer s new equipment warranty, equipment upgrades, replacement, or removal of unsafe equipment from use. Any changes to biomedical equipment in Schedule A will be incorporated into the agreement via bilateral modification.
Qualifications:
4.1 All work shall be completed by fully qualified field service representatives and technicians. Fully qualified is based upon training and experience and is defined as follows:
Training Field service representatives and technicians shall have completed a formalized training program and be authorized by the Original Equipment Manufacturer (OEM) to perform repair service on equipment covered under this agreement. Field service representatives and technicians shall complete refresher training on an annual basis. Personnel with OEM equipment training are only authorized to perform tasks and all repairs shall be completed in accordance with manufacturer specifications.
Experience Field service representatives and technicians shall possess relevant prior experience in providing preventive maintenance, remedial repairs, and emergency repairs on the equipment covered in this agreement.
4.2 Factory certified training certificates and competencies for all field service representatives and technicians assigned to complete service and repairs of the specified equipment shall be provided in accordance with Joint Commission Standards. Certificates and competencies shall be submitted to Biomedical Engineering within 30 days from the date of contract award. Failure to provide required documentation will result in non-payment of invoices for service.
4.3 Subcontractors shall not be used in the performance of this service, unless authorized and approved in advance by the POC or Biomedical Engineering representative.
C. Performance Period:
Indefinite Delivery/Indefinite Quantity (IDIQ) contract. The ordering period for this contract is 09/01/2026 through 08/31/2027.
Ordering Period 1
September 1, 2026-August 31, 2027
Ordering Period 2
September 1, 2027-August 31, 2028
Ordering Period 3
September 1, 2028-August 31, 2029
Ordering Period 4
September 1, 2029-August 31, 2030
Ordering Period 5
September 1, 2030-August 31, 2031
Schedule A
Equipment List
Biofire FillmArray Equipment
Serial #
Functional Location Description
KTB01863
Torch Base
KTM02558
Torch Module
KTM06680
Torch Module
KTM04156
Torch Module
KTM03874
Torch Module
KTM24737
Torch Module
KTM24734
Torch Module
KTM24772
Torch Module
KTM24860
Torch Module
It has been determined that protected health information (PHI) may be used, disclosed, accessed, transmitted, created, stored/maintained, and/or destroyed (providing appropriate proof of destruction in compliance with VA Directive 6371, Destruction of Temporary Paper Records,) by the Contractor, and a signed Business Associate Agreement (BAA) will be required. The Contractor will adhere to the requirements set forth within the BAA, referenced in the solicitation, and shall comply with all applicable VA/VHA Directives. Once awarded, Contractor and Contracting Officer will collaborate with the appropriate Facility Privacy Officer at vhalebprivacy@va.gov to implement the appropriate BAA.
1. 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.
2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.
a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter contract ) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.
b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General.
c. VA information will not be co-mingled with any other data on the contractor s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.
d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.
e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.
f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.
g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.
h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.
i. The contractor s firewall and web services security controls, as applicable, shall meet or exceed VA s minimum requirements.
j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.
k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality-assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above-mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.
l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.
m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.
n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the POC/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 POC 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 POC/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the POC/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.
3. 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 POC/CO in writing prior to access being granted.
e. The contractor shall notify the POC/CO in writing immediately (no later than 24 hours) after personnel separation or occurrence of other causes. Causes may include the following:
Contractor/subcontractor personnel no longer has a need for access to VA information or VA information systems.
Contractor/subcontractor personnel are terminated, suspended, or otherwise has their work on a VA project discontinued for any reason.
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.
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.
Contractor/subcontractor personnel have their authorization to work in the United States revoked.
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 POC/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 POC/CO.
4. TRAINING. This entire section applies to all acquisitions which include section 3.
a. All contractors and subcontractors requiring access to VA information and VA information systems shall successfully complete the following before being granted access to VA information and its systems:
VA Privacy and Information Security Awareness and Rules of Behavior
course (Talent Management System (TMS) #10176) initially and annually thereafter.
(2) Sign and acknowledge (electronically through TMS #10176) understanding of and responsibilities for compliance with the Organizational Rules of Behavior, relating to access to VA information and information systems initially and annually thereafter; and
(3) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system or information access [to be defined by the VA program official and provided to the VA CO for inclusion in the solicitation document i.e., any role-based information security training].
b. The contractor shall provide to the POC/CO a copy of the training certificates and certification of signing the Organizational Rules of Behavior for each applicable employee within five days of the initiation of the contract and annually thereafter, as required.
c. Failure to complete the mandatory annual training is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the required training is complete.
5. SECURITY INCIDENT INVESTIGATION. This entire section applies to all acquisitions requiring any Information Security and Privacy language.
a. The contractor, subcontractor, their employees, or business associates shall immediately (within one hour) report suspected security / privacy incidents to the VA OIT s Enterprise Service Desk (ESD) by calling (855) 673-4357 (TTY: 711). The ESD is OIT s 24/7/365 single point of contact for IT-related issues. After reporting to the ESD, the contractor, subcontractor, their employees, or business associates shall, within one hour, provide the POC/CO the incident number received from the ESD.
b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved and the circumstances surrounding the incident, including the following:
(1) The date and time (or approximation of) the Security Incident occurred.
(2) The names of individuals involved (when applicable).
(3) The physical and logical (if applicable) location of the incident.
(4) Why the Security Incident took place (i.e., catalyst for the failure).
(5) The amount of data belonging to VA believed to have been compromised.
(6) The remediation measures the contractor is taking to ensure no future incidents of a similar nature.
c. After the contractor has provided the initial detailed incident summary to VA, they will continue to provide written updates on any new and relevant circumstances or facts they discover. The contractor, subcontractor, and their employes shall fully cooperate with VA or third-party entity performing an independent risk analysis on behalf of VA. Failure to cooperate may be deemed a material breach and grounds for contract termination.
d. VA IT contractors shall follow VA Handbook 6500, Risk Management Framework for VA Information Systems VA Information Security Program, and VA Information Security Knowledge Service guidance for implementing an Incident Response Plan or integrating with an existing VA implementation.
e. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG, and the VA Office of Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.
f. The contractor shall comply with VA Handbook 6500.2, Management of Breaches Involving Sensitive Personal Information, which establishes the breach management policies and assigns responsibilities for the oversight, management and reporting procedures associated with managing of breaches.
g. With respect to unsecured Protected Health Information (PHI), the contractor is deemed to have discovered a data breach when the contractor knew or should have known of breach of such information. When a business associate is part of VHA contract, notification to the covered entity (VHA) shall be made in accordance with the executed BAA.
h. If the contractor or any of its agents fails to protect VA sensitive personal information or otherwise engages in conduct which results in a data breach involving any VA sensitive personal information the contractor/subcontractor processes or maintains under the contract; the contractor shall pay liquidated damages to the VA as set forth in clause 852.211-76, Liquidated Damages Reimbursement for Data Breach Costs.
