Statement of Work - 26 JUL 2022.pdf

VETERAN’S ADMINISTRATION HEALTH CARE SYSTEM,

FORT HARRISON, MONTANA

Mobile Magnetic Resonance Imaging (MRI) patient scan services for the Montana VA Health Care System (MTVAHCS) at Fort Harrison VAMC

The Montana VA Health Care System (MTVAHCS) requires a qualified contractor to provide a mobile MRI scanning system in accordance with the Statement of Work (SOW), in an efficient, cost-effective manner in support of the VHA mission. Services are required for the period of performance and at the location outlined in this SOW.

1. CONTRACTOR PROVIDED SERVICES/EQUIPMENT

This is a non-personal services contract. The Contractor, it's employees, agents and subcontractors shall not be considered government employees for any purpose. Contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, mobile trailer, insurances, licenses, certifications, and supervision necessary to provide services in accordance with this Performance Work Statement (SOW). The Contractor is responsible for all charges, fees, applications and procurement of all permits, licenses, registrations, and certificates, pursuant to lawful application of the provision of services. For a contract of this size, scope and complexity, the successful Contractor must perform in a professional manner as recognized by commercial industry standards as good to excellent.

Price: Refer to the Price/Cost Schedule.

Period of Performance: Refer to the Price/Cost Schedule.

Location of Services: Refer to block 15, pg1, Sf1449

2. COMMENCEMENT OF SERVICES

Commencement of service date shall be coordinated with the Contracting Officer (CO). MRI scanning equipment in a trailer shall be on-site and available for patient services no later than 1 AUG 2022 unless otherwise agreed to in writing with the Contracting Officer.

3. THE MONTANA VA HEALTH CARE SYSTEM SHALL PROVIDE:

- Site location and infrastructure utilities required to connect and power contractor provided equipment to the local VA facility (to include electricity, telephone circuits, CAT 5 cable connection, and routers as necessary to transmit images) Site pad cross section is provided below:

Average slope of the pavement along the long axis of the parking area is

0.17 percent and the average cross slope in that area is 0.14 percent.

4. MRI EQUIPMENT/SERVICES/SUPPLIES

The Contractor shall provide MRI services with reliable, FDA approved equipment that provides image quality meeting or exceeding that of a 1.5 Tesla System and have magnetic resonance angiogram (MRA) capability. Equipment shall support 8-16 channel receiver coils and capable of parallel imaging, diffusion/ADC.

The Contractor will provide the proper inspection and acceptance survey of all MRI systems provided through this contract. The survey must be done by an ADBR certified Medical Physicist qualified to inspect MRI systems.

The MRI machine shall be capable of performing Magnetic Resonance Angiography and functional imaging capabilities with all necessary software, hardware, and power injector needed to perform bilateral-complete leg runoff and abdominal, thoracic, and cervical angiography.

The MRI equipment shall be capable of providing a full range of exams to include but not limited to the following:

MRI Brain

MRI any joint, upper extremity

MRI/MRA Pelvis

MRA Spinal Canal

MRI Orbit, face, neck

MRI other than joint, upper extremity

MRIMRA

Abdomen

MRA

Spectroscopy

MRI TMJ MRA upper extremity MRI Lumbar Spine

MRA Head

MRI/MRA Chest

MRI any joint, lower

MRI Thoracic

MRA Neck

MRI Cardiac

MRI other than joint, lower extremity

MRI Cervical

MRA lower

THE MRI SYSTEM MUST MEET OR EXCEED THE FOLLOWING TECHNICAL

SPECIFICATIONS:

- Minimum Bore Width of 50cm

- Minimum 16 Channels

- Minimum Gradient Amplitude and Slew Rate of 33/120

- Silent Scanning and/or Acoustic Reduction System technology

- Motion Correction software

- Lightweight and flexible coil system design

- Detachable exam couch or trolley system with minimum 500-pound patient weight limit

- Includes a pre-installed or free-standing MRI safe patient monitoring system rated for

5,000 Gauss, 7.2 uT B1 rms, 4W/Kg SAR, and 3T environment. This system must offer the following features:

o Wireless ECG o Wireless SpO2 o NIBP o CO2 o Temperature

A. ADDITIONAL MRI MODULE UNIT/ EQUIPMENT SPECIFICATIONS:

The following minimum performance characteristics of the MRI equipment are required:

- The unit(s) shall provide optimal quality images deemed technically acceptable by the on-duty VA radiologist. Images noted as unsatisfactory image quality directly related to the MRI equipment itself shall be considered non-performance under this contract and shall be remedied within 30 days of notification.

- The mobile building/unit(s) shall meet all federal, state, and local fire and safety requirements.

- Telecommunications: The mobile unit(s) shall be equipped with outlet jack connections capable of transmitting data and voice through Government provided category five (CAT 5) cable and dual pair phone cable. The Government shall provide the connection required for the transmission of images, data, and voice.

- The mobile unit shall support DICOM Modality Worklist (DMWL), for future use.

- The mobile unit shall be able to export DICOM images to at least one destination.

- System shall have the ability to create, store and export DICOM, JPEG and MPEG file formats.

- The mobile unit shall be equipped with CD-R/DVD burning capabilities as a backup to network transfer of data.

- The mobile unit shall be equipped with an Image Analysis Station for image registration quality assurance.

- The mobile unit shall be equipped with an MRI conditional I.V. contrast power injector which features the following capabilities:

Scan delay Multiphase option Protocol storing Pause hold functionality

- The MRI unit shall provide sufficient space and appropriate equipment for conducting cardiopulmonary resuscitation.

- The unit shall be ADA compliant and include an Intercom system between the control room and scanning room.

- The mobile unit(s) shall be ready for use regardless of outside environmental conditions. The coach shall maintain a proper temperature to ensure correct operation of the scanner without frequent calibration. The environmental HVAC system will be sufficient to maintain a comfortable ambient temperature for patient comfort.

- The mobile unit(s) shall meet all federal, state, and local fire and safety requirements.

- Contractor shall be held responsible for any damages, which may be done to VA property during delivery, hookup, and/or removal of equipment at the site. Any damages caused by the Contractor will be remediated/repaired at the Contractor’s expense to the satisfaction of the facility Chief of Engineering.

B. MOBILE MRI TRAILER LOGISTICS:

- The VA shall provide a designated docking pad area, standard 480V electrical connection hook up, CAT 5 data connection, and phone connection. There are no dedicated potable water or sewer service available at the dock area. There are freshwater spigots located near the designated parking pad.

- Communications systems shall be operational and successfully tested prior to commencement of imaging services.

- Contractor shall be responsible for leveling of the trailer at location designed by the

VA to assure safety of all VA patients. Appropriate utilities shall be connected for proper warm up of all on board systems.

- Proper installation/staging of the Contractor’s furnished equipment including the mobile trailer must be completed in accordance with industry standards, all OSHA regulations, and applicable manufacturer’s recommendations. The above must be completed prior to commencement of services. Dates and time for completion of the above shall be mutually agreed upon between the Contracting Officer, Contracting Officer’s Representative, and the Contractor.

- Ensure that all exam data is completely transferred to the medical center prior to securing operations for the workday.

- In cases when the MRI system is not sending exams to the MTVAHCS PACS system, patient exams shall be burned to a disc in DICOM format and labeled for archive. The discs will be delivered to a designated VA staff member for storage on site at the VA. The discs shall be the property of the VA. A log will be kept by the contractor of all discs generated. The log will contain the following information: who created the disc, who gave the disc to the VA, which VA staff member received the disc and the dates of the contents.

- All patient exam data is purged from contractor’s computer systems once it is verified that exams are viewable on the PACS.

- All connections from the trailer to VA property are properly disconnected prior to moving or removing the trailer.

An audit of the MRI service shall be accomplished at least annually by the site Radiation Safety Officer. This audit shall be scheduled with the contractor a minimum of two weeks in advance and will take no more than 60 minutes per period.

The Contractor agrees to ensure compliance/acceptance testing of the MRI equipment is performed on at least an annual basis or if major components of the machine are serviced or replaced. The compliance/acceptance tests will be done in accordance with nationally recognized standards (NCRP, AAPM) and meet or exceed TJC requirements.

The Contractor shall be responsible for ensuring the compliance testing of the MRI system is performed by a qualified medical physicist. A qualified medical physicist as defined is an individual who is certified by the American Board of Radiology, American Board of Health

Physics, or American Board of Medical Physics in the appropriate disciplines of radiologic physics and maintain state certification as a Health Physicist in the state of Montana.

The Contractor shall be responsible for maintaining all appropriate records and documentation relevant to compliance and performance of the equipment.

C. CONTRACTOR SECURITY REQUIREMENTS: (Handbook 6500.6)

i) The contractor, their personnel, and their subcontractors shall be subject to the

Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

ii) 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.

iii) 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.

iv) 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 employment. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

v) 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)

vi) 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.

vii) 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.

D. VA INFORMATION CUSTODIAL LANGUAGE:

i) 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.

ii) 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.

iii) 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.

iv) 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.

v) 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.

vi) 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.

vii) 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.

viii) 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.

ix) 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:

(1) In response to a qualifying order of a court of competent jurisdiction.

(2) 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.

x) 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.

xi) 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.

E. TRAINING REQUIREMENTS:

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:

i) 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

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

iii) Successfully complete the appropriate VA privacy training and annually complete required privacy training

iv) 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.

d) The C&A requirements do not apply, and the Security Accreditation Package is not required

F. MRI STRUCTURE/EQUIPMENT MAINTENANCE/EMERGENCY REPAIRS:

Equipment provided must be in good working order to provide high quality test and scans required under this contract. Contractor shall be responsible for the preventive maintenance, emergency, and scheduled repairs, safety, cleaning, and upkeep of all equipment furnished by the Contractor. Preventative maintenance and all repairs on the mobile unit(s) and all associated equipment shall be performed in accordance with the conformance standards and manufacturer’s recommendations.

In the event of equipment failure during normal working hours while in the performance of the Contractor’s services, the Contractor shall notify the COR or designee immediately after discovery of equipment failure and shall respond within 24 hours of notification. If maintenance is required to be performed on site after the normal working hours, the Contractor must notify the VA Police that services will be performed on-site. All emergency repairs are the responsibility of the contractor.

The COR shall determine if appointments previously scheduled should be cancelled and rescheduled because of the equipment failure. If the equipment fails and cannot be repaired, the Contractor must provide an alternate unit which will be available on the next scheduled day and meets all the requirements this contract.

Contractor agrees to reimburse the VA for costs over and above the contracted cost associated with obtaining exams though other sources which are necessary for cancelled or postponed appointments because of equipment failure.

G. DOCUMENTATION/REPORTS:

The Contractor shall provide to the COR equipment and maintenance reports as requested.

The Contractor shall also provide system pre-check and associated documentation at the time the unit is set up at the site where services are to be performed. The Contractor shall permit onsite inspection by personnel selected by the VA without prior notice to verify the Contractor’s equipment is operated in accordance with appropriate safety guidelines and/or regulations.

Additional reports/documentation shall be provided as requested/required by the CO prior to commencement of services of MRI technologist and equipment service records. The VA may require specialized documentation to satisfy the requirements of local state and federal government agencies, and independent consultants such as the Joint Commission, as well as for “services rendered” verification for payment of monthly statement. At a minimum, the following information shall be provided to the Contracting Officer:

- The government is not responsible nor liable for any damage or vandalism which may occur to the Contractor’s equipment while on federal property.

- Copy of appropriate business license – submitted with signed proposal.

- Contractor’s employees’ certifications/registrations, competency records and training certificates to be submitted with signed proposal as defined herein.

- A copy of the MRI trailer requirements for docking pad and infrastructure will be submitted with signed proposal.

- Documentation of a proposed schedule included in the submission along with maximum throughput of proposed system(s) will be submitted with signed proposal.

H. INSPECTION/ACCEPTANCE

Inspection and acceptance of all work performance, reports, and other deliverables under this contract shall be performed onsite.

Deliverables shall be inspected for content, completeness, accuracy, and conformance to contract requirements by the COR. Inspection shall include validation of information or software using automated tools and/or testing of the deliverables. The scope and nature of this testing shall be negotiated prior to providing services and shall be sufficiently comprehensive to ensure the completeness, quality, and adequacy of all deliverables.

Reports, documents, and narrative type deliverables shall only be accepted when all discrepancies, errors, or other deficiencies identified in writing by the government have been corrected.

Maintenance logs shall be available upon request for inspection.

Contractor shall be responsible for providing quality reviews to ensure adequate diagnostic image quality. The government reserves the right to require corrective action if image quality or other service problems are brought to the attention of the Contractor.

Non-conforming products or services shall be rejected. Unless otherwise agreed by the parties, deficiencies will be corrected within seven (7) days of the rejection notice. If the deficiencies cannot be corrected within seven (7) days, the Contractor will immediately notify the COR and the Contracting Officer of the reason for the delay and provide a proposed corrective action plan within seven (7) working days.

I. REMOVAL OF CONTRACTOR EQUIPMENT:

At the termination of the contract, the VA site will retain custody of all hard drives containing patient information covered under HIPPA regulations.

VA information retained by the MRI scanning systems and other contractor equipment shall be returned to the VA at the end of the contract and when no longer required for regulatory purposes. The contractor shall be responsible for and verifying all VA patient and other information is completely deleted from all equipment at the end of the contract.

The contractor will remove the trailer and mobile imaging systems from VA property within seven (7) business days after the end of the final Period of Performance.

Inclement/harsh weather conditions will be taken into consideration during installation and/or removal of contractor provided equipment. Requests for additional time may be submitted in writing to the Contracting Officer. The government reserves the right to approve/disapprove requests for additional time.

STANDARD BUSINESS HOURS: Standard business hours at this location occur between 8:00 a.m. to 4:30 p.m., Monday through Friday, excluding Federal holidays.

FEDERAL HOLIDAYS: Federal holidays are any calendar days designated by statute or executive order as federal holidays, and as presented on the OPM website for the respective year in which services are to be performed. Refer to U.S. Office of Personnel Management, at OPM.gov. Federal holidays consist of New Year's Day, Martin Luther King Jr's birthday, President's Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving and Christmas. Holidays that fall on Saturday are observed on the preceding Friday. Holidays that fall on Sunday are observed on the following Monday. In addition to the days designated as holidays, the Government observes the following days:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Any other day designated by the President of the United States to be a federal holiday.

Local VA Representatives Upon contract commencement, the Contracting Officer will notify the Contractor of a local VA staff to act as a point of contact assigned to this contract. Contractor shall only respond to requests for service from the VA locally assigned POC, as written in this contract, or the CO. If service is requested from any source, other than the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government. The Government reserves the right to inspect and test services in accordance with this SOW and the Contract.

Authority to Make Changes The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

Safety and Compliance The Contractor must perform services in accordance with:

a) local, state, and federal Occupational Safety and Health guidelines and legislation, which includes Occupational Safety and Health Administration (OSHA).

b) local, state, and federal guidelines and legislation, as well as VA Medical Center Directives and guidelines, relating to chemicals and usage of chemicals.

c) local, state, and federal Fire and Safety legislation and guidelines, to include VA Medical Center directives and legislation on Fire and Safety, as well as the latest published edition of NFPA-99 (Health Care Facilities Code); and

d) 29 CFR 1910.132, Personal Protective Equipment.

The contractor is also responsible for immediately notifying the local VA Local POC at the first instance a safety issue or risk is identified during the Service.

Remedy or Rework

Rework or Remedy is defined as performing the Service again until the Purpose of this SOW is achieved in full. This involves less than Satisfactory Service by the Contractor and as noted by the local VA POC.

Rework or Remedy must occur within 3 business days of the notice of the rework or remedy requirement from the local VA POC and at no additional cost to the Government.

Inspection and Acceptance of Services

The Government reserves the right to inspect in accordance with this SOW and the Contract.

The only individual authorized to officially accept services is the local VA POC. While inspection of services may be delegated by the local VA POC and a shared responsibility with departmental management staff, the local VA POC is ultimately the only authorized individual to approve and accept services on behalf of the VA.

Medical Center Policies

Each VA Medical Center has policies that are updated from time to time. The local VA POC can provide more detailed information to the contractor of these upon commencement of the contract and throughout the term of the contract, as needed, especially policies and constraints regarding parking, possession of weapons, cell phone use and photography as well as smoking on VA property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court.

Contractor Point of Contact (POC) The Contractor shall specify an individual who shall serve as a single point of contact for all contract issues (POC). Contractor must provide the COR and Contracting Office with the POC contact details, to include business phone number or cell phone number and email, as a minimum:

a) Within 5 business days of contract award,

b) Within 5 business days after renewal or extension of services in accordance with, and if permitted by applicable FAR clause, and

c) Within 5 business days prior to a change in the POC by the Contractor. The POC must be easily accessible by phone and return COR calls within 48 hours of a voice message left by the COR.

Contracting Officer’s Representative (COR) Upon contract commencement, the Contracting Officer will notify the Contractor in writing as to the COR assigned to this contract, and upon reassignment of a new COR, as applicable.

Contractor shall only respond to requests for service from the COR or the CO. If service is requested from any source, other than the COR or the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government. The COR will evaluate the contractor’s performance through review of the Contractor’s Quality Control Procedures in accordance with this contract and SOW.

Authority of the COR The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer. Any invoicing or charges resulting from unauthorized service will not be paid by the government.

Government Alternate Points of Contact (POC) – Emergencies Only The COR will identify Alternate Points of Contact (POC) to be used only for instances of emergencies when the COR is not easily contactable. These will be individuals in supervisory or managerial roles within the Biomed department. The contractor will be provided this information within 5 days after contract award and within 48 hours of a change to this information. An Alternate POC does not replace the COR, nor do they replace the Contracting Officer during the performance and administration of this contract, nor does it relinquish or diminish the Contractor’s requirements in relation to the performance of this Contract.

LIABILITIES AND INSURANCES

Protection from Damage Contractor shall provide all labor, materials, and equipment necessary for protection of VAMC personnel, furnishings, equipment, and buildings from damage, and shall replace or repair any damage due to work performed under this contract equal to its original construction and finish.

Liability Insurance Contractor must provide the COR and the CO with written confirmation that Contractor has adequate insurance protection against negligent work and other forms of liability.

DEFINITIONS

AAMI - Association for the Advancement of Medical Instrumentation Acceptance Signature - COR's signature; indicates COR accepts work status as stated in Service Report.

ANSI - American National Standards Institute

ASQ - American Society for Quality ASQ-CQI – ASQ Certified Quality Inspector

CDC – Centers for Disease Control and Prevention CO - Contracting Officer

Consumables – may be items, such as but not limited to, water additive chemicals, HV – lubricants (grease, oil), batteries, air filters, water filters, cleaning chemicals/materials Contractor Employees – has the same meaning as Contractor Personnel Contractor Personnel - has the same meaning as Contractor Employees COR – Contracting Officer’s Representative Equipment – means the FDA - Food and Drug Administration (U.S. Department of Health and Human Services) Field Technician or Field Service Engineer (FSE) - a person who is authorized by the contractor to perform PMR services on VA premises. Also known as Technically Trained Personnel.

IAHCSMM - International Association of Healthcare Central Service Materiel Management ISO - International Organization for Standardization Labor – refer to Technically Trained Personnel, also Field Technician NFPA - National Fire Protection Association.

O.E.M. or OEM – Original Equipment Manufacturer. The actual manufacturer and point of origin of the equipment. The OEM provides schematics and standards for maintenance and repair of the equipment and equipment shall be maintained in accordance with these practices. The OEM is identified in the Background section of this SOW.

OEM-trained Technicians – means contractor technicians (Technically Trained Personnel, FSE, Field Technicians), be they OEM or third party provided, who are formally trained to OEM standards to satisfactorily perform services on equipment in this SOW. Where OEM-trained technicians are required in the SOW it means that services are to be performed at no less than this criterion, for the period of performance at the location, to ensure the SOW Purpose is met in order to avoid future equipment breakdowns or malfunctions which could lead to the VA being accused of malpractice or negligence. This assists the VA in meeting its mission.

Original Equipment Manufacturer - OEM OSHA – Occupational Safety and Health Administration PMI - Preventive Maintenance Inspection Preventive Maintenance Repair (PMR) -- Services that are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or inoperative conditions.

SDS - Safety Data Sheet Service Report - a documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

Services – includes Preventive Maintenance and Repair for equipment and components listed in this SOW and in accordance with this SOW SR –Service Report Technically Trained Personnel – are personnel and/or employees who shall be suitably knowledgeable in the field related to the services in this SOW in order to satisfactorily perform services in accordance with the SOW. The contractor shall provide personnel experienced and qualified to perform the required services in accordance with industry practices and standards.

Technically Trained Personnel are also known as Contractor Personnel or Contractor Employees or Technicians.

UL – Underwriters Laboratories US FDA – US Food and Drug Administration VAMC – Veterans Affairs Medical Center VA Mission Statement: “To fulfill President Lincoln's promise “To care for him who shall have borne the battle, and for his widow, and his orphan” by serving and honoring the men and women who are America’s Veterans.”

VHA - Veterans Health Administration