36C26325Q0207 0002 Amendment 2.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

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

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

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

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

E. IMPORTANT:

is extended,

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

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

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

15C. DATE SIGNED

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

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

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

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

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

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

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

(If other than Item 6)

(Specify type of modification and authority)

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

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

1 25

0002 437-25-2-032-0001 None

36C263

Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 111 South 18th Plaza, Suite C151/152 Omaha NE 68102-2077

36C263

Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 111 South 18th Plaza, Suite C151/152 Omaha NE 68102-2077

To all Offerors/Bidders 36C26325Q0207

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 12-23-2024 10AM CST

See CONTINUATION Page N/A

X 1(One)

THE PURPOSE OF THIS AMENDMENT IS TO EXTEND THE CLOSING OF THE RFQ TO DECEMBER 23, at 10AM CST and to revise The statement of work. See Change below:

The Equipment Testing Services for Specials/Multipurpose/ R&F Fluro Unit from 4 to 1, also highlighted in the statement of work.

Offerors shall sign the SF30 and return 1 (one) Copy to the Contracting Officer to be considered for this requirement, in addition to the original solicitation. The offer due date and time is 12/23/2024 @10AM CST

All other terms and conditions of the solicitation remain in full effect.

The government is no longer accepting technical questions for this requirement.

Melissa Garrett Contracting Officer

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

12.00 MO __________________ __________________

Radiation Equipment Testing by Physicist, as described in VHA Directive Contract Period: Base POP Begin: 01-01-2025 POP End: 12-31-2025 PRINCIPAL NAICS CODE: 541690 - Other Scientific and Technical Consulting Services PRODUCT/SERVICE CODE: H999 - Other Quality Control, Testing, and Inspection - Miscellaneous

Contract Period: Option 1 POP Begin: 01-01-2026 POP End: 12-31-2026 PRINCIPAL NAICS CODE: 541690 - Other Scientific and Technical Consulting Services

Contract Period: Option 2 POP Begin: 01-01-2027 POP End: 12-31-2027 PRINCIPAL NAICS CODE: 541690 - Other Scientific and Technical Consulting Services

Contract Period: Option 3 POP Begin: 01-01-2028 POP End: 12-31-2028 PRINCIPAL NAICS CODE: 541690 - Other Scientific and Technical Consulting Services

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

GRAND TOTAL

A.2 Statement of Work

Diagnostic Medical Physics Support/ Services medical equipment testing.

1. BACKGROUND. The contractor shall provide a board Certified or board eligible Medical or Health Physicist to provide services: on-site annual, as needed, and performance evaluation/testing of imaging, medical equipment producing radiation (including dental), radiofrequencies and routine, emergency services for the Fargo VA Health Care System (FVHCS), mileage, per diem and travel expenses should be included in all services solicitation. The FVHCS includes Fargo Medical Center and Community-Based Outpatient Clinics (CBOC) which have imaging services. The FVAHCS makes extensive use of ionizing radiation and radioisotope material in the diagnosis and treatment of disease in the veteran population.

The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site diagnostic medical physics support or services for the Veterans Health Administration (VHA), under the terms and conditions stated herein and must adhere to VHA Handbook 1105.04, Fluoroscopy Safety, dated June 21,2018, 1105.02, 1105.

The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO). Please See attached Directive 1105 .04

2. OBJECTIVES. The FVHCS is seeking a solution to provide Radiation equipment testing services (equipment testing, lead shield planning), as specified by the National Health Physics Program (NHPP). The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site diagnostic medical physics support or services for the Veterans Health Administration (VHA), under the terms and conditions stated herein and must adhere to VHA Handbook 1105.04, Fluoroscopy Safety, dated June 21,2018, 1105.02, 1105 or current version.

The Contractor shall comply with radiation protection standards in 29 CFR 1910.1096 and immediately report any unsafe conditions with the potential to adversely impact the facility radiation workers or patients to the Radiation Safety Officer (RSO). Please See attached Directive 1105 .04

3. QUALIFIED PERSONNEL: All Radiation Physicists performing services under this contract shall work under a board certified Medical/Health Physicist from one of the following boards: American Board of Radiology, American Board of Health Physicists or American Board of Medical Physicists.

For diagnostic computed tomography (CT), nuclear medicine, or MRI, a qualified medical physicist can meet requirements in lieu of board certification but must have all the below items:

• A graduate degree in physics, medical physics, biophysics, radiologic physics, medical health physics, or a closely related science or engineering discipline from an accredited college or university

• Formal graduate-level coursework in the biological sciences with at least one course in biology or radiation biology and one course in anatomy, physiology, or a similar topic related to the practice of medical physics.

• Documented 5 years of clinical experience in CT, nuclear medicine, or MRI.

The physicist must document the 3 years of experience for the modality being inspected.

The Contractor must meet state licensure to practice as medical health physicist and have membership (or eligibility for membership) to the American Association of Physicists in Medicine (AAPM). The Proposed Physicist must have minimum qualification requirements in Title 10, Part 35.50, of the Code of Federal Regulations (10 CFR 35). The Contractor shall provide personnel who is fully recognized and approved by the United States Nuclear Regulatory Commission (U.S. NRC).

Preference will be given to vendors having experience, knowledge within the federal health care systems, and experience, knowledge in North Dakota, Minnesota, and VA regulations, ACR recommendations regarding equipment testing standards for imaging equipment, and other equipment producing radiation, radiofrequency, etc. used for patients. The personnel will be identified in the proposal and shall be considered key personnel as essential for the successful completion of the work performed. Any changes to the assignment of personnel must be communicated to the Contracting Officer Representative (COR) and Imaging Supervisor at least 5 days before new personnel will visit the VAHCS. LAWS, PERMITS AND LICENSES: Services performed as part of this PWS, and contract must be in accordance with all applicable laws, ordinances, regulations, and service requirements as enforced by Federal, state, local and industry. The Contractor shall be following US NRC, to include obtaining and maintaining all required licenses and permits required by Federal, state, local and industry laws.

4. POLICY/HANDBOOKS. The Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide Radiation Equipment Testing services for FVAHCS, under the terms and conditions stated herein and must adhere to following directives/regulations/requirements by regulatory and accreditation bodies:

VHA Directive 1105 - Management of Radioactive Materials https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3080

VHA Directive 1105.02 Nuclear Medicine and Radiation Safety Administrative Service https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7519

VHA Handbook Directive 1105.04 - Fluoroscopy Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=7454

VHA Directive 1105.05 - Magnetic Resonance (MR) Safety https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=6430

VHA Directive 1129 – Radiation Protection for Machine Sources of Ionizing Radiation https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8273

VHA Directive 1663: Health Care Resources Contracting - Buying https://www.va.gov/vapubs/viewPublication.asp?Pub_ID=969&FType=2

VHA Handbook 1907.01: Health Information Management and Health Records:

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=3088

Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

VHA Directive 1004.08 Disclosure of Adverse Events to Patients and local Emergency, Radiation Disaster policies.

https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8120

10 CFR 35. 3045 Report and Notification of a medical of a medical event https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-3045.html

10 CFR 35.24 NRC Authority and responsibilities for the radiation protection program https://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035- 0024.html

VHA Directive 0320 VHA Comprehensive Medical Emergency Radiological Response Team Program https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8906

VHA Directive 0320.05, Medical Emergency Radiological Response Team https://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=8425

10 CFR 30.6 Communications NRC: https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0006.html

American College of Radiology Disaster preparedness for Radiology Professionals https://www.acr.org/-/media/ACR/Files/Legal-and-Business- Practices/Disaster-Preparedness/Disaster-Preparedness-for-Radiology- Professionals.pdf

U. S. Department of Health and Human Services: https://www.remm.nlm.gov/ 10 CFR 30.50 Reporting Requirements NRC. https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html 10 CFR 30.50 Reporting Requirements NRC. https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

5. DEFINITIONS/ACRONYMS. Terms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.

Contracting Officer (CO) – The person executing this contract on behalf of the Government with the authority to enter and administer contracts and make related determinations and findings.

Contracting Officer’s Representative (COR) – A person appointed by the CO to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non-compliance in order that appropriate action can be taken.

Veterans’ Health Administration (VHA): The central office for administration of the VA medical centers through throughout the United States. The VHA is in Washington, D.C.

Veterans Integrated Services Network (VISN): The regional oversight for the VA medical centers.

COS: Chief of Staff CPARS: Contractor Performance Assessment Reporting System EHR: Electronic Health Record - electronic health record system used by the

VA.

HIPAA: Health Insurance Portability and Accountability Act ISO: Information Security Officer POP: Period of Performance PWS: Performance Work Statement QA/QI: Quality Assurance/Quality Improvement QM/PI: Quality Management/Performance Improvement QASP: Quality Assurance Surveillance Plan ABHP: American Board of Health Physics ABRB: American Board of Radiology ACR: American College of Radiology ALARA: As Low as Reasonable Achievement ADP: Automated Data Processing AMA: American Medical Association CQI: Continuous Quality Improvement ISO: Information Security Officer JCAHO: Joint Commission on Accreditation of Healthcare Organizations NCQA: National Committee for Quality Assurance NRC: Nuclear Regulatory Commission OSHA: Occupational Safety and Health Administration PO: Privacy Officer PO: Purchase Order QA: Quality Assurance QI: Quality Improvement RSO: Radiation Safety Officer SDB: Small Disadvantaged Business USC: United States Code VA: Department of Veterans Affairs VA NHPP: VA National Health Physics Program VISN: Veterans Integrated Service Network VISTA: Veterans Health Information Systems & Technology Architecture

A3. SCOPE OF WORK:

a. The contractor shall furnish all labor, material, supplies, carry equipment onsite, and qualified personnel to provide on-site Radiation Physicist services (equipment testing) at the Fargo VA Health Care System (Fargo Medical Center), and CBOC’s if applicable, in accordance with the terms and conditions stated herein. VA may increase the number of equipment items or test covered under this contract at no change to the contract price schedule for up to 10 additional pieces of equipment per option year. If additional equipment beyond the additional 10 pieces of equipment is required to be added to the contract a modification will be negotiated at that time.

b. The onsite diagnostic physics services include the testing and inspection of equipment and programs including nuclear medicine cameras/SPECT CT, ultrasound units, MRI equipment, CT equipment, radiation producing equipment (neo probes) within the Fargo Health Care System (which includes imaging equipment at our sites within North Dakota, and Minnesota) assuring compliance with the American College of Radiology (ACR) and National Health Physics Program.

c. The contractor provides service of testing of radiology equipment to ensure the equipment is operating safely and the lowest possible dose to patients.

Inspection dates and times for equipment testing will be mutually agreed upon and established. Policy reviews may be provided via electronic means and submitted for recommendation.

d. Documented experience in a clinical CT environment conducting at least 10 CT performance evaluations under the direct supervision of a board-certified medical physicist.

e. Documented experience in a clinical MRI environment conducting at least 10 MRI performance evaluations on a 1.5 Tesla MRI unit under the direct supervision of a board-certified medical physicist with MRI safety experience.

f. Contractor staff performing inspection will be subject to a background investigation and must receive a favorable adjudication from the VA Security Investigations Center (07C). If security clearance is not completed prior to the start of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform services for the VAHCS.

g. The position sensitivity has been designated as low sensitivity. The level of background investigation is a National Agency Check with Written Inquiries. The level of risk associated with the contracted employee position is equivalent to the level required of a VA Employee working in such a position. Note: Level of Risk must be determined by the Information Security Officer (ISO) prior to submitting required investigations.

h. Contractor staff performing inspection will complete and sign VA’s national Rules of Behavior and Privacy Policy training prior to performing inspection.

i. Vendor will provide equipment calibration records for all equipment used to test equipment.

j. Vendor must have the ability to be at facility, or at VA community site for emergency testing for physics equipment testing within several hours of call requesting services.

k. Vendor must have ability to test several rooms at a time if necessary.

l. Vendor must have the ability to test imaging equipment, interventional radiology equipment at various sites in North Dakota and Minnesota for the Fargo VA Health Care System. Subcontracting of services will not be allowed due to the emergent need to test equipment when it goes down for the interventional radiology equipment.

m. Vendor must have the ability and experience in testing of neo probe equipment located in surgical operating room.

6. Diagnostic Physicists for equipment testing

a. QUALITY CONTROL: Work performed under this contract shall be subject to evaluation by the Contract Officers Representative (COR) in accordance with the contract terms and conditions.

b. PLACE OF PERFORMANCE: Fargo VA HCS (Fargo Veteran Affairs

Medical Center, 2101 North Elm Street, Fargo, ND 58103, Bismarck North Dakota CBOC, Bemidji Minnesota, CBOC, Grand Forks North Dakota CBOC, Fergus Falls Minnesota, CBOC.

c. EQUIPMENT. Contractor shall furnish all labor, material, supplies, equipment, and qualified personnel to provide on-site Radiation equipment testing services at the Fargo VHCS (Fargo Medical Center, and CBOC’s) in accordance with the terms and conditions stated herein. The FVHC will provide a person to operate the equipment and be present during the inspection.

TRAVEL: Travel expenses, per diem, will be covered under the contract.

HOURS:

VA Business Hours regular administrative working hours: 8:00 am – 5:00 pm Monday through Friday, excluding Federal Holidays. There may be times when the Contractor could be needed to work after regular working hours.

The certified Health Physicist or Medical Physicist shall respond to emergency situations and be on-site within 4 hours to accomplish the radiation testing of medical equipment when notified by the VA COR, Imaging Supervisor, Chief or VA designee(s) if necessary.

Routine service is scheduled by the VA COR, Imaging Supervisor, Chief or VA designee(s).

10 CFR 30.50 Reporting Requirements NRC.

https://www.nrc.gov/reading-rm/doc-collections/cfr/part030/part030-0050.html

FEDERAL HOLIDAYS: The holidays observed by the Federal Government are:

New Year’s Day

President’s Day

Martin Luther King’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving

Christmas

Juneteenth

Any other day specifically declared by the President of the United States to be a Federal Holiday

GENERAL PROVISIONS.

Services will be provided at the Fargo VA Health Care System (Medical Center 2101 N Elm Street Fargo, ND, Grand Forks, ND, CBOC, Bismarck, ND, CBOC, Fergus Falls, MN, CBOC, Bemidji, MN, CBOC. Services will be provided at during the hours of 8:00am – 5:00pm, Monday through Friday, excluding Federal Holidays. Inspection dates and times will be mutually agreed upon and established. Policy reviews may be provided via electronic means and submitted for recommendation. Fargo VAHCS will provide a qualified person to operate the equipment and be present during the inspection. VA may, from time to time, make changes to the Scope of Work under this Contract, through a written modification. A modification shall not modify the overall purpose of this Contract.

Change of times or dates of survey visits must be coordinated with the department at least two (2) weeks in advance.

Contractor staff performing inspection will be subject to a background investigation and receive a favorable adjudication from the VA Security Center (VSC). If security clearance is not completed prior to the start of the contract, the Contractor will be responsible for the actions of those individuals they provide to perform services for the VAHCS.

The position sensitivity has been designated as low sensitivity. The level of background investigation is a National Agency Check with Written Inquiries. The level of risk associated with the contracted employee position is equivalent to the level required of a VA Employee working in such a position.

Contractor staff performing inspections will complete and sign VA’s National Rules of Behavior and Privacy Policy training prior to performing inspections.

Contractor will provide equipment calibration records for all equipment used to test equipment.

VA may increase the number of equipment items or test covered under this contract at no change to the applicable contract price schedule.

VA may add additional CBOC sites for testing when imaging service is implemented with a modification to the current contract.

The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction, or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives.

Standards for conduct shall mirror those prescribed by current federal personnel regulations. Should the VA Imaging COS, supervisor or designee show documented clinical problems or continual unprofessional behavior/actions with any Contractor’s physicist (s), s/he may request, without cause, immediate replacement of said Contractor’s physicist (s). The CO and COR shall deal with issues raised concerning Contractor’s physicist (s) conduct. The final arbiter on questions of acceptability is the CO.

8. Duties and responsibilities

a. The qualified diagnostic medical physicist shall perform imaging equipment (x-ray equipment, nuclear medicine cameras, SPECT/CT cameras, ultrasound units, and MRIs) inspections to ensure compliance with the current American College of Radiology (ACR) requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the service supervisor or RSO prior to the qualified diagnostic medical physicist 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 immediately upon discovery. A written report of the results shall be provided to the service supervisor or RSO within 5 working days after completion of the inspection when unsafe condition is identified.

b. All imaging equipment (except ultrasound which is semi-annually, nuclear medicine cameras, and which are quarterly) shall be inspected at least annually.

c. The qualified diagnostic medical physicist will conduct acceptance testing of all new or relocated imaging equipment prior to first clinical use. The acceptance testing shall comply with ACR or MQSA requirements. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the service supervisor or RSO prior to the qualified diagnostic medical physicist 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 immediately upon discovery. A written report of the results shall be provided to the service supervisor or RSO within 30 working days after completion of the inspection.

d. The qualified diagnostic medical physicist will complete a full inspection of imaging equipment after repairs or modifications that may affect the radiation output or image quality. The inspection shall be completed within 48 hours after the facility contacts the contractor. If testing of equipment is based on emergency, the response time is within 4 hours. Any deficiencies or non-conformances discovered during the inspection shall be verbally communicated to the service supervisor or RSO prior to the qualified diagnostic medical physicist 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 immediately upon discovery. A written report of the results shall be provided to the service supervisor or RSO within 30 working days after performing of the inspection.

f. The qualified diagnostic medical physicist shall review CT protocol optimization at least annually and sign protocols which meet the required regulations.

g. The qualified diagnostic medical physicist will provide shielding design calculations for each new, replaced, or relocated x-ray imaging system. The calculations for each shall comply with the National Council for Radiation Protection and Measurements (NCRP) Report No. 147 or current documentation demonstrating compliance is maintained.

Dental units, NCRP Report No. 145 or current document, and 151 or current document and shall be documented in a written report which includes a diagram showing adjacent areas. The qualified diagnostic medical physicist shall perform a shielding survey to verify the structural shielding was installed per the shielding design report and complies with the design goals. A written report of the shielding survey shall be provided to the RSO within 30 workings days after the shielding survey has been completed.

i. The qualified diagnostic medical physicist shall perform a follow-up inspection to verify compliance of any necessary corrective action performed to correct deficiencies found.

j. Fargo VAHCS will provide a qualified person to operate the equipment and be present during the inspection.

k. VA may increase the number of equipment items or tests covered under this contract at no change for up to 10 additional pieces of equipment per option year. If additional equipment beyond the additional 10 pieces of equipment is required to be added via contract modification increase will be negotiated at that time.

l. If any change under this Article causes an increase or decrease in the cost of, or the time required for the performance of any part of the Services, an equitable adjustment in the compensation and schedule will be made in the modification, which shall be incorporated into this Contract by written modification. The Contractor shall not be entitled to make any changes in the Services or perform any Additional Services unless authorized in advance by written modification. Upon receipt of a modification approved by VA, the Contractor shall continue performance of the Scope of Work as modified by the modification.

m. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes that shall affect price, quantity, or quality of performance of this contract.

9. Equipment Inspections

The Contractor shall conduct equipment inspections or quality control surveys of the imaging equipment listed below. The Contractor shall ensure the imaging equipment’s compliance with applicable Federal regulations, the Joint Commission, and ACR recommendations, and shall include, but not be limited to, monitoring the following basic performance characteristics.

A. Radiographic and Fluoroscopic Equipment

Physics inspections of radiographic and fluoroscopic equipment shall comply with the ACR Technical Standard for Diagnostic Medical Physics Performance Monitoring of Radiographic and Fluoroscopic Equipment. The performance of each radiographic and fluoroscopic unit must be evaluated at least annually.

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

(1) Integrity of unit assembly.

(2) Collimation and radiation beam alignment.

(3) Fluoroscopic system resolution.

(4) Automatic exposure control system performance.

(5) Fluoroscopic automatic brightness control performance (high-dose-rate, pulsed modes, field-of-view [FOV] variation).

(6) Image artifacts.

(7) Fluoroscopic phantom image quality.

(8) kVp accuracy and reproducibility.

(9) Linearity of exposure versus mA or mAs.

(10) Exposure reproducibility.

(11) Timer accuracy.

(12) Beam quality assessment (half-value layer).

(13) Fluoroscopic entrance exposure. Maximum output for all clinically used settings.

(14) Image receptor entrance exposure.

(15) Equipment radiation safety functions.

(16) Patient dose monitoring system calibration.

(17) Video and digital monitor performance.

(18) Digital image receptor performance.

(19) Grids used with portable x-ray units shall be imaged for uniformity.

(20) Fluoroscopic High Contrast Resolution

(21) Fluoroscopic Low Contrast Resolution

(22) Fluoroscopic collimation

(23) Digital functions

(24) Fluoro Timer

(25) Fluoroscopic Generator assessment

B. Digital Radiography (DR) and Imaging Detectors.

Physics inspections of DR equipment and detectors shall comply with the American Association of Physicist in Medicine (AAPM) Report Number 93, Acceptance Testing and Quality Control of Photostimulable Storage Phosphor Imaging Systems. The performance of DR must be evaluated at least annually.

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

i. Component and Imaging detectors Physical Inspection and Inventory.

ii. Imaging detectors Dark Noise and Uniformity.

iii. Exposure Indicator Calibration.

iv. Linearity and Auto-ranging Response.

v. Laser Beam Function.

vi. Limiting Resolution and Resolution Uniformity.

vii. Noise and Low-Contrast Resolution.

viii. Spatial Accuracy-aspect ratio and accuracy of distance measurements

ix. High Contrast resolution

x. Aliasing/Grid Response.

xi. IP Throughput.

xii. Positioning and Collimation Errors.

xiii. Signal response linearity and slope

C. CT Scanners

The physics inspection shall conform to the latest ACR Computed Tomography Quality Control Manual, and Joint Commission, OIG standards. The performance of each CT scanner shall be evaluated at least annually. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Review of Site’s Clinical protocols and signed by physicist

(2) Scout prescription and alignment light accuracy

(3) Low contrast Detectability and CNR- image thickness-axial mode

(4) Table Travel Accuracy.

(5) CT scanner display calibration

(6) Spatial Resolution.

(7) CT Number Accuracy and Image Thickness

(8) Artifact Evaluation.

(9) CT Number Uniformity

(10) Dosimetry (the scanner displayed CTDIvol values must be within +/- 20% of the measured

(11) Gray Level Performance of CT Acquisition Display Monitors.

(12) slice position accuracy

(13) Exposure Performance 16cm Phantom

(14) Radiation beam width

(15) Gray Level Performance of CT Acquisition Display monitors calibration

(16) Annual scatter radiation measurements

(17) Low-contrast performance

(18) Adult Protocol Dosimetry

D. Dental

The 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. The performance of dental x-ray inspections shall be annually or every 2 years. This evaluation should include, but not be limited to, the following tests (as applicable).

(1) Collimation.

(2) Beam quality (half value layer).

(3) Timer Accuracy and Reproducibility.

(4) kVp Accuracy and Reproducibility.

(5) mA or mAs Linearity.

(6) Exposure Reproducibility.

(7) Entrance Skin Exposure Evaluation.

(8) Technique Chart Evaluation.

(9) Image uniformity (artifact evaluation).

Dental Acceptance and Performance Testing

i. Acceptance testing and measurements of air kerma at the isocenter for each kVp station for a range of clinically used mAs settings will be performed initially when the CBCT unit is installed and following any move of the CBCT to another area inside or outside the initial clinical site. The testing is that the equipment performance is tested within the manufacturer’s technical specifications.

ii. Each unit shall undergo periodic quality control tests for the performance of the machine has not significantly deteriorated and is operating within the manufacturer’s technical specifications. The performance testing is performed by a qualified expert annually, at intervals not to exceed 12 months, and after repairs to the unit that may affect the radiation output or image quality.

iii. Some manufacturers provide a phantom and procedures to perform machine specific quality assurance (QA) tests. In cases where the manufacturer provides a phantom and procedures to perform specific tests, but the tests are not included in this SOW, then the manufacturer’s machine-specific QA tests shall be performed in addition to the QA tests in this SOW.

Dental CBCT, Panorex Acceptance and Annual Physics Testing requirements

i. Radiation Output Repeatability. Make four measurements of the air kerma at the isocenter at a clinically used setting. The measurements should be less than +/-5% of the average of the five measurements and the measurements should be less than +/- 5% of the previous year’s measurement.

ii. Radiation Output Reproducibility. Measure the air kerma at the isocenter for each kVp station and a range of clinically used mAs setting. Compare the results to the baseline values established at the initial acceptance testing. The values should be +/- 5% of the baseline.

iii. kVp Accuracy. Measure the kVp at all clinically used settings. The measured kVp should be +/-5% of the selected kVp.

iv. kVp Repeatability. Make five kVp measurements each for two clinically used kVp settings. All measured values should be +/-5% of the mean kVp.

v. kVp Reproducibility. Measure the kVp at all available kVp settings. The measured values should be +/-5% of the baseline.

vi. Beam Quality. Measure the half value layer (HVL) for aluminum. The minimum shall comply with Section F.4.d of the Suggested State Regulations for Control of Radiation, Conference of Radiation Control Program Directors.

vii. Radiation field of view (FOV). Measure the width of the radiation field at the isocenter. The width of the beam should be 3 mm or 30% of the total nominal collimated width.

viii. Image Quality. Image the phantom provided by the manufacturer or another suitable phantom. Assess high contrast spatial resolution, uniformity of transaxial images, and image noise. Imaging uniformity shall be assessed over the entire range of axial images.

ix. Accuracy of Linear Measurements. Using images of an appropriate phantom, assess the accuracy of distance measurements.

x. Accuracy of Patient Dose Metric Indication. Assess the accuracy of the indicated dose metric (typically DAP).

xi. Patient Dose Assessment. From a scan or scans using the facility’s standard techniques, record the dose metric (typically DAP) and compare to achievable levels and diagnostic reference levels (if available)

h. Display Monitors.

Perform a visual analysis of the SMPTE test pattern.

Display the test pattern on the imaging console. Set the display window width/level to the manufacturer-specified values for the pattern. Do not set the window/level by eye; doing so invalidates the procedure.

Examine the pattern to confirm that the gray level display in the imaging console is subjectively correct.

E. MRI

The physics inspection shall conform to the latest ACR Magnetic Resonance Imaging

Quality Control Manual. The performance of each MRI scanner shall be evaluated at least annually.

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

i. Magnetic field homogeneity.

ii. Geometric accuracy.

iii. Inter-slice RF interference.

iv. Slice position accuracy.

v. High-contrast resolution

vi. RF coil performance.

(1) Volume coils’ signal-to-noise ratio

(2) Volume coils’ image uniformity

(3) Volume coils’ ghosting ratio

(4) Phased array coils' signal-to-noise ratio

(5) Surface coils’ signal-to-noise ratio

vii. Slice thickness accuracy

viii. Low-contrast detectability

x. Technologist’s QC program

xi. Site phantom inventory

xii. Site RF coil inventory

G. Nuclear Medicine

The physics inspection shall conform to the ACR annual performance tests for nuclear medicine cameras, SPECT, and SPECT/CT. The qualified diagnostic medical physics shall also perform the quarterly testing as outlined by the ACR.

The performance of each nuclear medicine scanner shall be at least annually.

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

(1) Intrinsic Uniformity: fail criteria: > 5.0%

(2) System Uniformity: fail criteria: > 5.0%

(3) Intrinsic or System Spatial Resolution: fail criteria: > 3.5 mm bars

(4) Relative Sensitivity: fail criteria: COV > 2.5%

(5) Energy Resolution: fail criteria: > 12%

(6) Count Rate Parameters: fail criteria

(7) Formatter/Video Display

(8) Overall System Performance for SPECT

(9) System Interlocks

(10) Dose Calibrators (Geometry, if applicable, Accuracy)

(11) Thyroid Uptake and Counting Systems

H. Ultrasound

The physics inspection shall conform to the ACR performance tests for ultrasound. On an ongoing basis (at least semiannually), the following tests should be done for each ultrasound unit. Testing should be done using two transducers commonly used with any unit employing more than one transducer. Data should be taken from testing of the transducers which are used for the most frequently occurring examination(s) at the site.

It is recommended that these be of different scan formats such as one linear (or curvilinear array), and one sector (mechanical, phased, or vector). i. System Sensitivity/Penetration. This test should be done with the following settings:

(1) maximums transmit power

(2) proper receiver gain and TGC that allows echo texture to be visible in the deep region

(3) transmit focus at the deepest depth

(4) The maximum depth of visualization is determined by comparing the gradually weakening echo texture to electronic noises near the bottom of the image.

(2) Image Uniformity

Adjust the TGC controls and other sensitivity controls to obtain an image as uniform as possible.

vertical or radially oriented streaks?

dropouts?

reduction of brightness near edges of the scan?

brightness transitions between focal zones?

(3) Electrical and Mechanical Safety and Cleanliness

Are all cords and cables intact (no frays)?

Are all transducers intact without cracks or delamination?

Are the transducers cleaned after each use?

Are the image monitors clean?

Are the air filters clean?

Are the wheel locks in working condition?

Are the wheels fastened securely to the US unit and do the wheels rotate easily?

Are all accessories (VCR, cameras, etc.) fastened securely to the US unit?

(4) Gray Scale Photography (if applicable) – Do either (a), (b), or (c).

(a) For Scanners with a Discrete Bar Pattern Count the number of distinct gray bar steps on the viewing monitor. Then count the number of steps visualized in the gray bar on the hard copy image.

(b) For Scanners with a Continuous Gray Bar Pattern Use calipers to measure the length of the black-to-white transition of the gray wedge on the viewing monitor. If the relative length of the black-to-white transition on the hard copy image is less, document how much is missing.

(5) Hard Copy Output Quality Test (Digital) (if applicable)

This test, or a similar test specifically recommended by the hard copy equipment manufacturer.

Required Test Equipment Densitometer SMPTE Test Pattern or another similar test pattern or phantom image having a wide range of gray scales.

The same test image should be used each time.

I. Display Monitors

The physics inspection shall conform to the AAPM On-line Report No. 03, Assessment of Display Perform for Medical Imaging Systems. The performance of each display monitor shall be evaluated initially, acceptance testing, and at least annually thereafter. This evaluation should include, but not be limited to, the following tests (as applicable).

Acceptance testing (Table 7 from AAPM On-line Report No. 03)

(a) Geometric distortions

(b) Reflection

(c) Luminance response

(d) Luminance dependencies

(e) Resolution

(f) Noise

(g) Veiling glare

(h) Chromaticity

Annual testing (Table 8c from AAPM On-line Report No. 03)

(a) Geometric distortions

(b) Reflection

(c) Luminance response

(d) Luminance dependencies

(e) Resolution

(f) Noise

(g) Veiling glare

(h) Chromaticity

Testing of the following Imaging items:

Description Un it Est Quanti ty

Equipment Testing Services

Description Un it

Est Quanti ty

Equipment Testing Services

Bone Densitometer (Dexa) EA 1

C-Arm EA 2

Mini C-Arm EA 1

CT Unit EA 2

CT Protocol Review optimization EA 1

SPECT/CT EA 2

Cystography Fluro in operating room EA 1

Dental Bitewing EA 12

Dental Bitewing Handheld EA 1

Dental Panalipse Panogram/Conebeam CT EA 1

IR Lab Room #18 angio fluro room EA 1

MRI and coils EA 1

MRI Audit EA 1

Neoprobe EA 2

DR Portable Radiographic EA 3

Triple DR Radiographic Room EA 1

Quad DR Radiographic Room EA 2

Floor mounted Dr radiographic room CBOC EA 4

Specials/Multi-purpose/R&F Fluro unit EA 1

Ultrasound EA 5

Lead garmet testing EA 1

Dose Calibrator EA 1

Well Counter HR 20

Perform lead shield testing/Plan Evaluation EA 3

Equipment additions/added for testing EA 10

10. TMS Training Required:

a) PDAT Determination

a. SAC (Fingerprints)

b. PIV Badge

b) TMS 10176 Infosec/ROB

c) TMS 10203 HIPAA

RECORDS MANAGEMENT OBLIGATIONS

NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

-Includes Department of Veterans Affairs records.

-Does not include personal materials.

-Applies to records created, received, or maintained by Contractors pursuant to their Department of Veterans Affairs contract.

-May include deliverables and documentation associated with deliverables.

C. Requirements

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. Fargo VA Healthcare System 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 Fargo VA Healthcare System 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 Fargo VA Healthcare System.

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 this contract vehicle. 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 Fargo VA Healthcare System 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 this contract vehicle. 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 Fargo VA Healthcare System 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 Fargo VA Healthcare System policy.

8. The Contractor shall not create or maintain any records containing any non-public Fargo VA Healthcare System 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 Fargo VA Healthcare System 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 Fargo VA Healthcare System 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.