Attachment A - Statement of Work 36C25724Q0782 ver 070124.pdf

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Attached to
Medical Physicist Services NTX Federal contract opportunity
Solicitation number
36C25724Q0782
Issued by
Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 17

About this file

This document is a Statement of Work (SOW) for Medical Physicist Services at the VA North Texas Health Care System. The SOW details the requirements for providing annual diagnostic physics surveys and recertification of all listed diagnostic imaging equipment, as well as consultative services, at the VA North Texas Health Care System and associated off-site clinics. The contract has a base year from July 17, 2024 to July 16, 2025, with four one-year option periods. The contractor must have a master's degree, board certification, and 10 years of experience as a diagnostic qualified medical physicist. Key requirements include 24-hour emergency response, annual quality assurance testing of all diagnostic imaging equipment, consulting services to support the radiation safety program, and initial installation testing of new equipment. All testing must meet or exceed relevant industry guidelines and regulations. The contractor will also be responsible for providing structural shielding design plans and radiation protection surveys prior to new equipment installation.

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Attachment D Vendors Questionnaire for Technical Evaluation.pdf PDF
Attachment B - SCA Wage Determination No 2015-5227.pdf PDF
COMBINED SYNOPSIS SOLICITATION 36C25724Q0782.pdf PDF
Attachment C Cover Letter.pdf PDF

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Medical Physicist Services Revised 7/1/2024.

Statement of Work Medical Physicist Services

36C25724Q0782 VA North Texas Health Care System

I. Description of Services.

1. Purpose:

The overall purpose is to provide the Annual diagnostic physics surveys and recertification of all listed diagnostic imaging equipment and consultative services as required.

2. Scope of Work:

The contractor shall provide all labor, material, supplies, equipment, software, and ACR phantoms necessary for quality assurance testing of all diagnostic imaging equipment. Contract is for Veterans Affairs North Texas Health Care System (VANTHCS) and associated off-site clinics. Associated off-site clinics include Fort Worth VA Outpatient clinic, Bonham Sam Rayburn Memorial Veterans Center, Plano VA Outpatient Clinic, Garland VA Medical Center, Tyler Broadway VA Clinic, and Grand Prairie VA Clinic.

3. Performance Requirements:

Contractor shall provide twenty-four (24) hour emergency response time on unanticipated and/or emergent equipment needs. The contractor shall respond and be present at the VANTHCS facility within 2 business days to provide services for those tasks that have the potential to negatively impact patient access to health care services.

The diagnostic qualified medical physicist shall review CT protocols at least annually.

• Task 1: Annual quality assurance testing of all diagnostic x-ray and imaging equipment to (include

MRI). Evaluations shall be at least annually and no greater than 14 months from previous inspection. See Equipment Description for equipment list.

• Task 2: Annual quality assurance testing of mammography equipment. Recertification of equipment when required.

• Task 3: Required physics testing of diagnostic x-ray and imaging equipment following repairs that could affect patient dosimetry and/or image quality, as needed.

• Task 4: Consulting services shall be provided as needed to support the VANTHCS Radiation Safety

Office. Consulting services include but are not limited to:

• Attend appropriate VANTHCS committee meetings (i.e., Radiation Safety Committee, CT

Protocol Committee, Fluoroscopy Safety Subcommittee, Patient Dosimetry Subcommittee, Radimetrics QA Program) on a quarterly (4), or as needed basis.

• Review of VANTHCS overall technical quality assurance program for diagnostic x-ray and imaging equipment as requested.

• Perform patient dose evaluations, including fetal exposures, as needed and occasionally on an urgent basis.

• Perform personnel occupational dose evaluations, as needed.

• Task 5: Initial installation quality assurance testing of all new diagnostic x-ray and imaging equipment (to include MRI) on an as needed basis. See Future Equipment for estimated dates of arrival, list is subject to change due to delays, etc.

• Task 6: Initial installation quality assurance testing of new mammography equipment on an as needed basis.

• Task 7: Complete structural shielding design plans for the installation of new diagnostic or replacement x-ray and imaging equipment prior to first patient use.

• Task 8: Complete radiation protection surveys to verify the adequacy of installed shielding for new and/or refurbished rooms or replacement of equipment prior to first patient use.

4. Period of Performance:

Base Year: 17 July 2024 to 16 July 2025 Option Year 1: 17 July 2025 to 16 July 2026 Option Year 2: 17 July 2026 to 16 July 2027 Option Year 3: 17 July 2027 to 16 July 2028 Option Year 4: 17 July 2028 to 16 July 2029

Work shall be performed during normal work hours of Monday through Friday, 6:00 am – 4:30 pm.

However, a flexible work schedule will be considered due to patient volume and shall be arranged through the COR or Radiation Safety Officer.

5. Qualifications:

The Diagnostic Qualified Medical Physicist shall meet the following education, certification, and qualification standards (Documentation of qualifications of each QMP who works on VA equipment shall be submitted with quote):

• Hold a master’s degree in medical physics, Health Physics, or a related field.

• Hold current Board Certification by the American Board of Radiology (ABR) or American Board of

Medical Physics (ABMP). Appropriate subfield is Diagnostic Medical Physics for ABR certification and Diagnostic Imaging Physics for ABMP certification.

• Licensed by the State of Texas as a Professional Medical Physicist

• Meet all NRC, ACR, MQSA, FDA and TJC requirements for a qualified diagnostic medical physicist,

• Has ten years of experience providing diagnostic medical physics services, following board certification by either ABR or ABMP

• In addition, for MRI testing, have performed evaluations of at least 6 MRI systems under the direction of a Qualified Medical Physicist or MRI Scientist.

The Qualified MR Scientist shall meet the following education, certification, and qualification standards:

• Hold a graduate degree in a physical science involving nuclear MR or MRI.

• Have 3 years of documented experience in a clinical MRI environment.

• Knowledgeable in the field of nuclear MR physics and familiar with MRI technology, including the function, clinical uses, and performance specifications of MRI equipment, as well as calibration processes and limitations of the performance testing hardware, procedures, and algorithms.

Contractor employees providing services under the supervision or under the direction of a Qualified Medical Physicist are NOT acceptable (e.g., X-ray technologist) and are NOT permitted per VA contract. A physicist in training or a physicist under a temporary license shall be accompanied by and physically directly supervised by a Diagnostic Qualified Medical Physicist meeting all qualifications.

6. Reporting Requirements:

Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the Radiation Safety Officer (RSO/ARSO) prior to QMP leaving the facility. Deficiencies or non-conformances which represent unsafe conditions with the potential to adversely impact the facility radiation workers or patients shall be reported to the RSO/ARSO immediately upon discovery.

A written report of the results shall be provided to the RSO within 14 working days after completion of the inspection. Each written report must identify the X-ray and/or imaging equipment and include the EE number, serial number, equipment location (facility, building, room number).

A copy of the invoice shall be provided to the COR and include the following: contractor’s name and address, list date, invoice number, accurate purchase number, item, description (service provided, date of survey, and EE number), quantity, rate, amount, and total amount due.

7. Quality Assurance Testing:

All Quality Assurance Tests Shall meet or exceed ACR, CFR, FDA, TJC, MQSA, NRC, NHPP, AAPM and VHA directives requirements and recommendations, and the Conference of Radiation Control Program Director’s (CRCPD) Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays and Imaging Systems in the Healing Arts or current document.

• American College of Radiology (ACR)

• Code of Federal Regulations (CFR)

• US Foods and Drug Administrations (FDA)

• The Joint Commission (TJC)

• Mammography Quality Standards Act (MQSA)

• US Nuclear Regulatory Commission (NRC)

• National Health Physics Program (NHPP)

• AAPM Report 124, A Guide for Establishing a Credentialing and Privileging Program for Users of

Fluoroscopic Equipment in Healthcare Organizations

• VHA Directive 1105, Management of Radioactive Materials

• VHA Directive 1105.02, Nuclear Medicine, and Radiation Safety Administrative Service

• VHA Directive 1105.03, Mammography Program Procedures and Standards

• VHA Directive 1105.04, Fluoroscopy Safety

• VHA Directive 1105.05, MRI Safety

• VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation

8. Testing Requirements:

The contractor shall ensure the imaging equipment’s compliance with all applicable Federal regulations and ACR-AAPM recommendations, and shall include, but not limited to monitoring the following basic performance characteristics.

Diagnostic X-ray Equipment (Radiography)

Per CRCPD Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays, and Imaging Systems in the Healing Arts:

• Image artifacts

• Spatial resolution

• Contrast/noise

• Workstation monitors

• Exposure indicator constancy

Per the American College of Radiology (ACR-AAPM) Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic Equipment (2016):

• Visual equipment checklists

• Integrity of unit assembly

• Operation of alerts and interlocks

• Other radiation safety functions

• Acquisition display monitor(s) performance

• Image artifacts

• Appropriateness of adult protocols

• Radiation field size measurement

• Collimation and radiation beam alignment

• Automatic collimation accuracy

• Light beam and bucky alignment

• Air kerma or exposure (radiation output)

• Displayed radiation metrics accuracy.

• Exposure reproducibility

• Tube potential (kVp) accuracy and reproducibility

• Linearity of exposure versus mA or mAs

• Timer accuracy

• Minimum beam quality (half-value layer)

• Radiographic patient entrance exposure for a “typical” adult patient

• Automatic exposure control

• Image quality: system high contrast resolution

• Image quality: system low contrast resolution

• Repeat analysis.

• CR/DR exposure log analysis

Diagnostic X-ray Equipment (Fluoroscopy)

Per the TJC Standards Revisions for Organizations Providing Fluoroscopy Services (Issued June 25, 2018):

• Beam alignment and collimation

• Tube potential/kilovolt peak (kV/kVp) accuracy

• Beam filtration (half-value layer)

• High-contrast resolution

• Low-contrast detectability

• Maximum exposure rate in all imaging modes

Displayed air-kerma rate and cumulative-air kerma accuracy (when applicable)

Per CRCPD Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays, and Imaging

• A measurement of entrance exposure rates that covers the full range of patient thicknesses, including those that are expected to drive the system to maximum output in all modes clinically used, including fluoroscopy, high-level control, acquisition, digital subtraction, and CINE, when available. These measurements shall:

o For systems without automatic exposure control, be made utilizing a milliamperage and kVp typical of the clinical use of the fluoroscopic system.

o For systems with automatic exposure control, be made utilizing sufficient attenuating material in the useful beam to produce a milliamperage and kVp typical of the clinical use of the fluoroscopic system.

• A measurement and verification of compliance of maximum AKR for fluoroscopy and high-level control, if available. Measurements shall be made in accordance with Sec F.5e.iv.

• An evaluation of high contrast resolution and low contrast resolution in both fluoroscopic and spot-film modes

• An evaluation of the operation of the 5-minute timer, warning lights, interlocks, and collision sensors.

• An evaluation of the beam quality and collimation in the fluoroscopy and spot-film modes.

• An evaluation of the availability and accuracy of technique indicators and integrated radiation dose displays.

• An evaluation of any changes that may impact patient and personnel protection devices.

Per the ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Fluoroscopic Equipment (2016):

• Visual equipment checklists

• Integrity of unit assembly

• Operation of alerts and interlocks

• Other radiation safety functions

• Appropriateness of protocols (fluoroscopic and acquisition) – for selected uses

• Radiation field size measurement

• Acquisition display monitor(s) performance

• Collimation and radiation beam alignment

• Tube potential (kVp) accuracy and reproducibility

• Minimum beam quality (half-value layer) – for selected uses

• Image quality: system high contrast resolution

• Image quality: system low contrast resolution

• Displayed radiation metrics accuracy.

• Image receptor air kerma rate – for selected uses (Image Intensifiers)

• Patient entrance air kerma rate for a “typical” adult patient – for selected uses

• Maximum patient entrance air kerma rate

• Image receptor performance

• Image artifacts

Computed Tomography

Per the TJC Standards Revisions for Organizations Providing Fluoroscopy Services (Issued June 25, 2018) and Per the TJC Diagnostic Imaging Requirements (Issued August 10, 2015):

• Image uniformity

• Scout prescription accuracy

• Alignment light accuracy

• Table travel accuracy

• Radiation beam width

• High-contrast resolution

• Low-contrast detectability

• Geometric or distance accuracy

• CT number accuracy and uniformity

• Artifact evaluation

• Dosimetry o The diagnostic medical physicist measures the radiation dose (in the form of volume computed tomography dose index [CTDIvol]) produced by each diagnostic CT imaging system for the following four CT protocols: adult brain, adult abdomen, pediatric brain, and pediatric abdomen. If one or more of these protocols is not used by the hospital, other commonly used CT protocols may be substituted.

o The diagnostic medical physicist verifies that the radiation dose (in the form of CTDIvol) displayed by the CT imaging system for each tested protocol is within 20 percent of the CTDIvol displayed on the CT console. The dates, results, and verifications of these measurements are documented.

• Image acquisition display monitors o Maximum luminance o Minimum luminance o Luminance uniformity o Resolution

• Spatial accuracy

Per CRCPD Suggested State Regulations for Control of Radiation, Part F, Diagnostic X-rays, and Imaging

• Geometric factors and alignment including:

o Alignment light accuracy o Table increment accuracy.

• Image localization from scanned projection radiograph (localization image)

• Radiation beam width

• Image quality including:

o High-contrast (spatial) resolution o Low-contrast resolution o Image uniformity o Noise o Artifact evaluation

• CT number accuracy

• Image quality for acquisition workstation display devices

• A review of the results of the routine QC required under F.11a.iii

• A safety evaluation of audible and visual signals, posting requirements.

• Dosimetry

Per the ACR-AAPM Technical Standard for Diagnostic Medical Physics Performance Monitoring of Computed Tomography (CT) Equipment (2017):

• Alignment light accuracy

• Image localization from scanned projection radiograph (localization image)

• Table travel accuracy

• Radiation beam width (collimation)

• Image quality o High-contrast (spatial) resolution o Low-contrast sensitivity and resolution o Image uniformity o Noise o Artifact evaluation

• CT number accuracy

• Acquisition workstation display

• Radiation output or dosimetry o Measurement of radiation output of CT scanner (CT dose index [CTDIvol] or other metric accepted by a nationally recognized organization) o Measurement of doses for verification of scanner performance and to allow for calculation of dosimetry quantities relevant to patient examination estimates.

o Comparison of calculated values to scanner-reported values. These comparisons should include both

16-cm and 32-cm dosimetry phantoms, as appropriate for the CT system and for use with the indicated protocols.

• Limited protocol review o The Diagnostic Medical Physicist must review a selection of the most commonly used protocols. These should include head and abdomen protocols for adult and pediatric patients as applicable to the facility’s practice. In addition, facility protocols for very high dose procedures (e.g., brain perfusion) should be reviewed.

o The key elements associated with image quality and patient dose should be reviewed. These should include, but are not limited to:

• kVp

• mA

• Rotation time

• Detector configuration

• Pitch

• Reconstructed image thickness

• Appropriate use of automated settings, such as tube current modulation, kVp selection, and image reconstruction parameters

• Accuracy of indicated CTDIvol

• When possible, CTDIvol should be compared to established reference values.

• Safety Evaluation

• Visual inspection o Workload assessment o Scatter and stray radiation measurements (if workload and other related parameters have changed since acceptance testing) o Audible/visual signals o Posting requirements

• Other tests as required by state or local regulations.

Mammography

The qualified Diagnostic Medical Physicist inspecting Mammography Equipment shall meet the qualifications outline in the MQSA and shall provide the facility with up-to-date documentation demonstrating that the Diagnostic Medical Physicist is MQSA qualifies and eligible for the State of Texas.

Inspections of Mammography Equipment shall comply with the latest requirements posted on the ACR Web site for the manufacturer of the digital Mammography unit being inspected. The physics inspection will include all FDA/MQSA annual calibration requirements. Inspection items may include:

• Mammographic Unit Assembly Evaluation

• Collimation assessment

• Artifact evaluation

• kVp accuracy and reproducibility

• Beam quality assessment – HVL measurements

• Evaluation of system resolution

• Automatic Exposure Control (AEC) function performance

• Breast entrance exposure, AEC reproducibility, and average glandular dose

• Radiation output rate

• Phantom image quality evaluation

• Signal-to-noise ratio and contrast-to-noise ratio measurements

• View box luminance and room illuminance

• Review Workstation (RWS) tests

Magnetic Resonance Imaging (MRI)

The Physics Inspection shall conform to the most recent ACR Magnetic Resonance Imaging Quality Control Manual. The performance of each MRI Scanner shall be evaluated Annually.

This evaluation shall include, but not limited to, the following tests (as applicable).

• Magnetic field homogeneity

• Geometric accuracy

• Inter-slice RF interference

• Slice position accuracy

• High-contrast resolution

• RF coil performance o Volume coils’ signal-to-noise ratio o Volume coils’ image uniformity o Volume coils’ ghosting ratio o Phased array coils’ signal-to-noise ratio o Surface coils’ signal-to-noise ratio

• Slice thickness accuracy

• Low-contrast detectability

• Soft copy displays

• Technologist’s QC program

• Site phantom inventory

• Site RF coil inventory

Dental X-Ray

The Contractors Physics Inspection shall conform to the Conference of Radiation Control

Program Directors (CRCPD), Quality Control Recommendations for Diagnostic Radiography Volume 1 Dental Facilities July 2001. This evaluation shall include, but not limited to, the following tests (as applicable).

• Collimation

• Beam quality (half value layer)

• Timer Accuracy and Reproducibility

• kVp Accuracy and Reproducibility

• mA or mAs Linearity

• Exposure Reproducibility

• Entrance Skin Exposure Evaluation, with comparison to published diagnostic reference.

levels and achievable doses (e.g., NCRP Report No. 172)

• Technique Chart Evaluation

• Image uniformity (artifact evaluation)

Dental Panoramic/Cone Beam CT (CBCT)

The physics inspection shall conform with the VA Office of Dentistry Workgroup Charter Cone Beam Computed Tomography Recommendations. In addition, the manufacturer’s machine-specific QA tests shall be performed.

Structural Shielding:

For diagnostic and interventional x-ray equipment, ensure rooms where x-ray equipment is used are shielded per National Council on Radiation Protection and Measurements (NCRP) Report No. 147, Structural Shielding Design for Medical X-ray Imaging Facilities, or current document and documentation demonstrating compliance is maintained. [VHA Directive 1129]

For linear accelerators, ensure structural shielding design reports and shielding surveys conform to NCRP Report No. 151, Structural Shielding Design and Evaluation for Megavoltage X- and Gamma-Ray Radiotherapy Facilities, or current document. [VHA Directive 1129]

The design of shielding for and acceptance testing surveys of imaging rooms shall conform to National Council on Radiation Protection and Measurements (NCRP) Report No. 147, Structural Shielding Design for Medical X-ray Imaging Facilities. The shielding design calculations, as-built shielding plans, and the report on the acceptance testing of the structural shielding must be kept for the duration of use of the room for x-ray imaging. [VHA Directive 1105.04]

Review, prior to construction, plans for rooms in which ionizing radiation producing equipment is to be installed, including room layout, shielding, viewing, and communications systems. Perform radiation surveys after installation but before clinical use of the equipment. NOTE: For any room in which a fluoroscopic imaging system is installed, or in which a mobile fluoroscopic imaging system is frequently used, the doses to persons in adjacent areas, including any areas above and below, shall be evaluated by a Qualified Medical Physicist or Licensed Medical Health Physicist. [VHA Directive 1105.04]

Acronyms:

AAPM American Association of Physicist in Medicine ACR American College of Radiology

ARSO Associate Radiation Safety Officer CBCT Cone Beam Computed Tomography CFR Code of Federal Regulations COR Contracting Officer Representative CRCPD Conference of Radiation Control Program CT Computed Tomography CTDIvol Computed Tomography Dose Index (vol) EE VA Inventory number FDA Food and Drug Administration FOV Field of View HVL Half Value Layer IEC International Electrotechnical Commission MQSA Mammography Quality Standards Act MRI Magnetic Resonance Imaging NCRP National Council for Radiation Protection NRC Nuclear Regulatory Commission NHPP National Health Physics Program PET Positron Emission Tomography POC Point of Contact QMP Qualified Medical Physicist QA Quality Assurance RSO Radiation Safety Officer SOW Statement of Work SPECT Single-Photon Emission Computed Tomography TJC The Joint Commission VANTHCS VA North Texas Health Care System VHA Veterans Healthcare Administration

Equipment Description:

Annual evaluations must be performed at least annually and no greater than 14 months from the previous inspection. Estimated new equipment for 2024-2025 (list is subject to change due to replaced equipment and/or new equipment added).

Category, Radiation-Producing Machine QTY Future New

DALLAS VA Medical Center (64) Radiography Physics Test 9 Mobile Radiography Physics Test 9 Radiography and Fluoroscopy (R&F) Physics Test 1 Mobile R&F (C-arm) Physics Test (7 big, 3 mini) 10 Mobile R&F O-arm (R&F stage & CT stage) 1 Specialized R&F Machines Physics Test Catherization Biplane Lab 1 Catherization Single Lab (EP) 1 Catherization Lab (FD 20) Single Plane 1 Special Procedures Lab Single Plane (Angiography) 3 Vascular Surgery (OR 9) 1 1 Urology Lab Cystoscopic Unit (Fixed C-arm) 1 CT Machines Physics Test Therapy CT/Simulator 1 Diagnostic CT (Joint Commission Physics Survey) 5

Mammography Physics Test and 6 monitors

FFD Mammographic Calibration & Quality Assurance Evaluation 2

Stereo Mammography Physics Test (Faxitron Biopsy) 1 Dental Physics Test Intraoral Unit 10 Planmeca ProMax 3D Cone Beam CT (CT & Panorex) 1 Planmeca Promax Panoramic 1 NOMAD Handheld 3 MRI Joint Commission Physics Test 4 1 Structural Shielding Designs 2 Radiation Protection Surveys 2 Physics Tests following equipment repairs, as needed Consulting services at VA North Health Care System 4

BONHAM, Sam Rayburn Memorial Veterans Center (6) Radiography Physics Test Mobile Radiography Physics Test 1 Radiography and Fluoroscopy (R&F) Physics Test 2 Dental Physics Test Intraoral Unit 1 Planmeca Promax Panoramic 1 NOMAD handheld 1 Structural Shielding Designs Radiation Protection Surveys

GARLAND VA MEDICAL CENTER (4)

Radiography Physics Test 1 Mobile Radiography Physics Test 3 Dental Physics Test Planmeca Promax Panoramic 1 NOMAD handheld 3 Structural Shielding Designs Radiation Protection Surveys

FORT WORTH Outpatient Clinic (17) Radiography Physics Test 4 Radiography and Fluoroscopy (R&F) Physics Test 1 CT Machines Physics Test Diagnostic CT (Joint Commission Physics Survey) 2 Mammography Physics Test

FFD Mammographic Calibration & Quality Assurance Evaluation 1

Dental Physics Test Intraoral Unit 5 Planmeca ProMax 2D S3 Pano 1 Planmeca Promax Panoramic 1 MRI Joint Commission Physics Test (1 mobile) 2 Structural Shielding Designs Radiation Protection Surveys

PLANO Outpatient Clinic (1) Radiography Physics Test 1 Structural Shielding Designs Radiation Protection Surveys

TYLER Outpatient Clinic (8) Radiography Physics Test 1 CT Machines Physics Test Diagnostic CT (Joint Commission Physics Survey) 1 MRI Mobile Joint Commission Physics Test 1 Dental Physics Test Intraoral Unit 3 Planmeca ProMax S3 Panoramic 1 NOMAD handheld 1 Structural Shielding Designs Radiation Protection Surveys

GRAND PRAIRIE VA Clinic (1) Radiography Physics Test 1 Dental Physics Test 1 Structural Shielding Designs Radiation Protection Surveys

II. Contractor Personnel Security Requirements - Information Systems Access

Position Risk/Sensitivity. For all positions required under this contract, the position risk/sensitivity has been designated as: Low Risk/Non-Sensitive

Note: The COR/RSO will coordinate all work with Bio-medical engineering department which will grant access to equipment and spaces as necessary IAW established VA work schedule and with the approval of the Bio-medical Engineering Service Chief.

The diagnostic medical physicist working with the contractor may have access to sensitive patient information displayed on the control panel of X-ray equipment. However, contractor owned IT devices (such as laptop computer) shall not interface with any VA internet trusted (i.e., non-public) network.

Therefore, the certification and accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required. Contractor shall not print or copy any sensitive patient information.

III. Records Management Statement

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C.

552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VANTHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VANTHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VANTHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment.

Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the Statement of Work. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VANTHCS control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the Statement of Work. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VANTHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VANTHCS policy.

8. The Contractor shall not create or maintain any records containing any non-public VANTHCS information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VANTHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VANTHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers, and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

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