S02 36C24522Q0580 0001.docx

36C24522Q0580

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)

06-16-2022

Department of Veterans Affairs

VAMC (613)

VISN 5 Contract Satellite Office 510 Butler Avenue, Building 306A Martinsburg WV 25405

Department of Veterans Affairs

VAMC (613)

VISN 5 Contract Satellite Office 510 Butler Avenue, Building 306A Martinsburg WV 25405 To all Offerors/Bidders

06-16-2022

X

X

See CONTINUATION Page

Title: Radiation Safety Program for Imaging Services at VAMC Martinsburg. All work shall be in accordance with the SOW.

This solicitation amendment updates the Statement of Work and the CLINs in response to the submitted questions and answers.

Please see the submitted Questions & Answers in Section D.2 below.

All final technical and price proposals are due no later than 12:00PM EST on Wednesday, June 22, 2022 to Phillip.Duba@va.gov.

Phillip G Duba Contracting Officer

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Perform duties as the RSO both radiation producing machines and radioactive materials programs (Official RSO Named on Permit). RSO 1 site-visit per month (6 hrs per visit) Contract Period: Base POP Begin: 07-01-2022 POP End: 06-30-2023 PRINCIPAL NAICS CODE: 621399 - Offices of All Other Miscellaneous Health Practitioners PRODUCT/SERVICE CODE: Q522 - Medical - Radiology

Occupational Exposure Monitoring Services 160 Whole Body dosimeters (badges) Contract Period: Base POP Begin: 07-01-2022 POP End: 06-30-2023

Occupational Exposure Monitoring Services 20 Extremity (ring) dosimeters Contract Period: Base POP Begin: 07-01-2022 POP End: 06-30-2023

Annual Exposure Summary Reports 180 reports (NRC Form 5 or Equivalent) Contract Period: Base POP Begin: 07-01-2022 POP End: 06-30-2023

Annual equipment evaluations of imaging equipment in accordance with the Statement of Work.

POP Begin: 07-01-2022 POP End: 06-30-2023

Annual CT Protocol Review consistent with ACR Standards 2 units Contract Period: Base POP Begin: 07-01-2022 POP End: 06-30-2023

Nuclear Medicine compliance audits (USNRC and NHPP requirements) 4 total quarterly Audits (6 hrs) Contract Period: Base POP Begin: 07-01-2022 POP End: 06-30-2023

Annual Survey Meter Calibration Services (3 meters), Annual Calibration Well Counters (2), Annual Calibration Thyroid Probe (1 probe).

POP Begin: 07-01-2022 POP End: 06-30-2023

Sealed source inventories and leak tests (25) Quarterly Contract Period: Base POP Begin: 07-01-2022 POP End: 06-30-2023

Assist the ARSO in the Development radiation safety training for radiation workers commensurate to their duties to be placed in the TMS system. Includes Nuclear Medicine Techs, x-ray techs, surgical staff

POP Begin: 07-01-2022 POP End: 06-30-2023

Assist the ARSO in the Development radiation safety training for workers who frequent areas where radiation is produced commensurate with their duties to be placed in the TMS system

POP Begin: 07-01-2022 POP End: 06-30-2023

X-ray shielding design calculations

POP Begin: 07-01-2022 POP End: 06-30-2023

Dose estimation for inadvertently exposed personnel or patients

POP Begin: 07-01-2022 POP End: 06-30-2023

Provide nuclear medicine technologists (up to five employees) with HAZMAT training for the shipping of radioactive materials consistent with DOT 49 CFR Subpart H and USNRC 10 CFR 71.5 on an annual basis

POP Begin: 07-01-2022 POP End: 06-30-2023

Perform duties as the RSO both radiation producing machines and radioactive materials programs (Official RSO Named on Permit). RSO 1 site-visit per month (6 hrs per visit) Contract Period: Option 1 POP Begin: 07-01-2023 POP End: 06-30-2024

Occupational Exposure Monitoring Services

Contract Period: Option 1 POP Begin: 07-01-2023 POP End: 06-30-2024

Occupational Exposure Monitoring Services

Contract Period: Option 1 POP Begin: 07-01-2023 POP End: 06-30-2024

Annual Exposure Summary Reports

Contract Period: Option 1 POP Begin: 07-01-2023 POP End: 06-30-2024

Annual equipment evaluations of imaging equipment in accordance with the Statement of Work.

POP Begin: 07-01-2023 POP End: 06-30-2024

Annual CT Protocol Review consistent with ACR Standards

Contract Period: Option 1 POP Begin: 07-01-2023 POP End: 06-30-2024

Nuclear Medicine compliance audits (USNRC and NHPP requirements)

Contract Period: Option 1 POP Begin: 07-01-2023 POP End: 06-30-2024

Annual Survey Meter Calibration Services (3 meters), Annual Calibration Well Counters (2), Annual Calibration Thyroid Probe (1 probe).

POP Begin: 07-01-2023 POP End: 06-30-2024

Sealed source inventories and leak tests (25)

Contract Period: Option 1 POP Begin: 07-01-2023 POP End: 06-30-2024

Assist the ARSO in the Development radiation safety training for radiation workers commensurate to their duties to be placed in the TMS system. Includes Nuclear Medicine Techs, x-ray techs, surgical staff

POP Begin: 07-01-2023 POP End: 06-30-2024

Assist the ARSO in the Development radiation safety training for workers who frequent areas where radiation is produced commensurate with their duties to be placed in the TMS system

POP Begin: 07-01-2023 POP End: 06-30-2024

X-ray shielding design calculations

POP Begin: 07-01-2023 POP End: 06-30-2024

Dose estimation for inadvertently exposed personnel or patients

POP Begin: 07-01-2023 POP End: 06-30-2024

Provide nuclear medicine technologists (up to five employees) with HAZMAT training for the shipping of radioactive materials consistent with DOT 49 CFR Subpart H and USNRC 10 CFR 71.5 on an annual basis

POP Begin: 07-01-2023 POP End: 06-30-2024

Perform duties as the RSO both radiation producing machines and radioactive materials programs (Official RSO Named on Permit). RSO 1 site-visit per month (6 hrs per visit) Contract Period: Option 2 POP Begin: 07-01-2024 POP End: 06-30-2025

Occupational Exposure Monitoring Services

Contract Period: Option 2 POP Begin: 07-01-2024 POP End: 06-30-2025

Occupational Exposure Monitoring Services

Contract Period: Option 2 POP Begin: 07-01-2024 POP End: 06-30-2025

Annual Exposure Summary Reports

Contract Period: Option 2 POP Begin: 07-01-2024 POP End: 06-30-2025

Annual equipment evaluations of imaging equipment in accordance with the Statement of Work.

POP Begin: 07-01-2024 POP End: 06-30-2025

Annual CT Protocol Review consistent with ACR Standards

Contract Period: Option 2 POP Begin: 07-01-2024 POP End: 06-30-2025

Nuclear Medicine compliance audits (USNRC and NHPP requirements)

Contract Period: Option 2 POP Begin: 07-01-2024 POP End: 06-30-2025

Annual Survey Meter Calibration Services (3 meters), Annual Calibration Well Counters (2), Annual Calibration Thyroid Probe (1 probe).

POP Begin: 07-01-2024 POP End: 06-30-2025

Sealed source inventories and leak tests (25)

Contract Period: Option 2 POP Begin: 07-01-2024 POP End: 06-30-2025

Assist the ARSO in the Development radiation safety training for radiation workers commensurate to their duties to be placed in the TMS system. Includes Nuclear Medicine Techs, x-ray techs, surgical staff

POP Begin: 07-01-2024 POP End: 06-30-2025

Assist the ARSO in the Development radiation safety training for workers who frequent areas where radiation is produced commensurate with their duties to be placed in the TMS system

POP Begin: 07-01-2024 POP End: 06-30-2025

X-ray shielding design calculations

POP Begin: 07-01-2024 POP End: 06-30-2025

Dose estimation for inadvertently exposed personnel or patients

POP Begin: 07-01-2024 POP End: 06-30-2025

Provide nuclear medicine technologists (up to five employees) with HAZMAT training for the shipping of radioactive materials consistent with DOT 49 CFR Subpart H and USNRC 10 CFR 71.5 on an annual basis

POP Begin: 07-01-2024 POP End: 06-30-2025

Perform duties as the RSO both radiation producing machines and radioactive materials programs (Official RSO Named on Permit). RSO 1 site-visit per month (6 hrs per visit) Contract Period: Option 3 POP Begin: 07-01-2025 POP End: 06-30-2026

Occupational Exposure Monitoring Services

Contract Period: Option 3 POP Begin: 07-01-2025 POP End: 06-30-2026

Occupational Exposure Monitoring Services

Contract Period: Option 3 POP Begin: 07-01-2025 POP End: 06-30-2026

Annual Exposure Summary Reports

Contract Period: Option 3 POP Begin: 07-01-2025 POP End: 06-30-2026

Annual equipment evaluations of imaging equipment in accordance with the Statement of Work.

POP Begin: 07-01-2025 POP End: 06-30-2026

Annual CT Protocol Review consistent with ACR Standards

Contract Period: Option 3 POP Begin: 07-01-2025 POP End: 06-30-2026

Nuclear Medicine compliance audits (USNRC and NHPP requirements)

Contract Period: Option 3 POP Begin: 07-01-2025 POP End: 06-30-2026

Annual Survey Meter Calibration Services (3 meters), Annual Calibration Well Counters (2), Annual Calibration Thyroid Probe (1 probe).

POP Begin: 07-01-2025 POP End: 06-30-2026

Sealed source inventories and leak tests (25)

Contract Period: Option 3 POP Begin: 07-01-2025 POP End: 06-30-2026

Assist the ARSO in the Development radiation safety training for radiation workers commensurate to their duties to be placed in the TMS system. Includes Nuclear Medicine Techs, x-ray techs, surgical staff

POP Begin: 07-01-2025 POP End: 06-30-2026

Assist the ARSO in the Development radiation safety training for workers who frequent areas where radiation is produced commensurate with their duties to be placed in the TMS system

POP Begin: 07-01-2025 POP End: 06-30-2026

X-ray shielding design calculations

POP Begin: 07-01-2025 POP End: 06-30-2026

Dose estimation for inadvertently exposed personnel or patients

POP Begin: 07-01-2025 POP End: 06-30-2026

Provide nuclear medicine technologists (up to five employees) with HAZMAT training for the shipping of radioactive materials consistent with DOT 49 CFR Subpart H and USNRC 10 CFR 71.5 on an annual basis

POP Begin: 07-01-2025 POP End: 06-30-2026

Perform duties as the RSO both radiation producing machines and radioactive materials programs (Official RSO Named on Permit). RSO 1 site-visit per month (6 hrs per visit) Contract Period: Option 4 POP Begin: 07-01-2026 POP End: 06-30-2027

Occupational Exposure Monitoring Services

Contract Period: Option 4 POP Begin: 07-01-2026 POP End: 06-30-2027

Occupational Exposure Monitoring Services

Contract Period: Option 4 POP Begin: 07-01-2026 POP End: 06-30-2027

Annual Exposure Summary Reports

Contract Period: Option 4 POP Begin: 07-01-2026 POP End: 06-30-2027

Annual equipment evaluations of imaging equipment in accordance with the Statement of Work.

POP Begin: 07-01-2026 POP End: 06-30-2027

Annual CT Protocol Review consistent with ACR Standards

Contract Period: Option 4 POP Begin: 07-01-2026 POP End: 06-30-2027

Nuclear Medicine compliance audits (USNRC and NHPP requirements)

Contract Period: Option 4 POP Begin: 07-01-2026 POP End: 06-30-2027

Annual Survey Meter Calibration Services (3 meters), Annual Calibration Well Counters (2), Annual Calibration Thyroid Probe (1 probe).

POP Begin: 07-01-2026 POP End: 06-30-2027

Sealed source inventories and leak tests (25)

Contract Period: Option 4 POP Begin: 07-01-2026 POP End: 06-30-2027

Assist the ARSO in the Development radiation safety training for radiation workers commensurate to their duties to be placed in the TMS system. Includes Nuclear Medicine Techs, x-ray techs, surgical staff

POP Begin: 07-01-2026 POP End: 06-30-2027

Assist the ARSO in the Development radiation safety training for workers who frequent areas where radiation is produced commensurate with their duties to be placed in the TMS system

POP Begin: 07-01-2026 POP End: 06-30-2027

X-ray shielding design calculations

POP Begin: 07-01-2026 POP End: 06-30-2027

Dose estimation for inadvertently exposed personnel or patients

POP Begin: 07-01-2026 POP End: 06-30-2027

Provide nuclear medicine technologists (up to five employees) with HAZMAT training for the shipping of radioactive materials consistent with DOT 49 CFR Subpart H and USNRC 10 CFR 71.5 on an annual basis

POP Begin: 07-01-2026 POP End: 06-30-2027

GRAND TOTAL

RFQ 36C24522Q0580

Health Physics Services Martinsburg VA Medical Center

This solicitation is for a Firm-Fixed Price, Base Plus Four (4) Option Periods for Health Physics Services for the Martinsburg VA Medical Center, the Martinsburg Vet Center.

This is a 100% Service-Disabled Veteran Owned Small Business (SDVOSB) set-aside.

The NAICS is 621399.

Submitted questions are answered – see Section D.2.

All final technical and price proposals are due on Wednesday, June 22, 2022, by 12:00PM EST.

All Technical Proposals must address the following (See Section E.3):

· Contractor must have at least one Qualified Physicist. Provide name(s) and certification certificates

· Provide an organizational chart

· Provide experience of performance testing on Dental X-ray units and standards used.

· Provide an explanation of experience with VHA Directives, ACR and Joint Commission requirements

· Provide a sample of formal documentation used for Radioactive Materials audits

· Provide documentation of the RSO meeting the requirements and duties defined in USNRC 35.50. A Radioactive Materials License from the USNRC, Agreement State or NHPP permit naming the proposed RSO will be sufficient.

· Ability to have the Radiation Safety Officer (RSO) onsite on a monthly basis

· Ability to have an auditor as described in the SOW onsite on a quarterly basis

· Provide method used by the RSO to provide verbal communication no later than 30 minutes when events involving radiation safety occur.

· Provide the methods used to have the RSO available 24 hours per day, 7 days per week.

· Provide an explanation of your ability to performance test specialized equipment such as the Spectrum Dynamics DSPECT unit utilizing CZT technology and NOVUS hand-held dental X-ray units.

· Provide an explanation of your ability to perform CT Protocol Review and CT Performance Improvement audits.

· Provide an example of your Annual ALARA audit documentation Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

TBD

b. GOVERNMENT:

Contracting Officer 36C245 Phillip G Duba Department of Veterans Affairs

VAMC (613)

VISN 5 Contract Satellite Office 510 Butler Avenue, Building 306A Martinsburg WV 25405

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of Page 1 of

B.2 STATEMENT OF WORK

1. OBJECTIVES:

The contractor will assist in developing, maintaining, and overseeing a comprehensive Radiation Safety Program for Imaging Services at Veteran Affairs Medical Center Martinsburg (VAMCM) 510 Butler Avenue, Martinsburg, WV consistent with the requirements and/or guidelines of:

A. US Food and Drug Administration (FDA) B. US Nuclear Regulatory Commission (NRC) C. VHA National Health Physics Program (NHPP) D. American College of Radiology (ACR) E. The Joint Commission (JC) F. VHA Directive 1105-Management of Radioactive Materials G. VHA Directive 1105.02- Nuclear Medicine and Radiation Safety Administrative Services H. VHA Directive 1105.04 -Fluoroscopy Safety I. VHA Directive 1105.05 D- Magnetic Resonance Imaging Safety J. VHA Directive 1129--Radiation Protection for Machine Sources of Ionization *VHA Directives shall be the latest version adopted

2. GENERAL PROVISIONS OF SERVICES:

A. The term Qualified Physicist used throughout this document is defined in Attachment A. This follows the guidelines of the American College of Radiology (ACR).

B. The contractor shall provide the Qualified Physicist(s) names and accreditation certifications and experience.

C. A schedule of Radioactive Material audits and performance testing shall be provided to the facility Associate RSO (ARSO) D. Performance testing of all imaging equipment shall be performed upon installation and after a repair that involves dose output or image quality. The performance testing shall be performed no later than 30 days upon installation or repair. A formal report shall be provided to the facility ARSO in a timely so that it can be presented in the next RSC meeting.

E. The contractor shall verbally brief the ARSO concerning any radiation safety issues found with performance testing or radioactive materials audit prior to leaving the facility.

F. The contractor must have experience providing performance testing on x-ray dental units in accordance with appropriate VHA directive of other governing regulatory body.

G. The Qualified Medical Physicist shall have the basic ability to operate the equipment with minimal input from VAMCM personnel.

H. Formal reports of Performance Testing will be provided by email separately per unit tested not in one combined document I. The contractor shall review the departments radiation safety policies and procedures on an annual basis to ensure compliance with current VHA Directives, ACR and JC requirements.

J. The contractor shall be able to operate Radimetrics to monitor exposure analysis of CT exams during quarterly onsite visits. A report of results shall be presented at each Radiation Safety Committee.

K. The contractor shall provide radiation dosimetry devices to employees designated by the facility as radiation workers in accordance with current USNRC regulations 10 CFR 10.1501, 10 CFR Part 20 and NRC Regulatory Guide 8.7 Instructions for Recording and Reporting Occupational Radiation Exposure Data. The radiation monitoring service shall be certified by the National Voluntary Laboratory Accreditation Program (NVLAP). The contractor shall provide an annual dose summary for radiation workers in accordance with Form 5 as required by the USNRC.

L. The contractor will provide consultation to the facility of any new requirements by any applicable regulatory agency M. The contractor shall provide an annual ALARA audit of the radiation safety program.

3. RADIATION SAFETY OFFICER (RSO) SERVICES

The contractor must provide an individual who meets the requirements outlined in USNRC Requirements 35.50 to perform duties as the RSO.

The contracted RSO will be on site, at a minimum, monthly to perform duties.

The RSO shall ensure compliance with all USNRC, USFDA, US DOT and NHPP regulations and current VHA Directives and ACR recommendations.

A. VHA Directive 1105 Management of Radioactive Materials B. VHA Directive 1129-Radiation Protection for Machine Sources of Ionizing Radiation C. VHA Directive 1105.04-Fluoroscopy Safety D. VHA NHPP Model Fluoroscopy Policy (Attachment A) E. VHA Directive 1105-05 - MRI Safety F. VHA Directive 1105.02- Nuclear Medicine and Radiation Safety Administrative Services G. Coverage shall be 24hrs per day 7 days per week.

H. The contracted RSO must provide effective means of verbal communication to ensure a prompt response time no greater than 30 minutes for incidents involving radiation safety.

I. During USNRC, NHPP or JC inspections the contracted RSO shall be available by telephone or TEAMs within 1 hour.

J. Shall brief the ARSO about any issues for RSC Meetings and EEOC meetings. The ARSO will attend these meetings.

K. The RSO will assist and provide expertise in the ACR accreditation processes.

L. The facility has the option of appointing a qualified facility RSO during the length of this contract. Evaluation shall be considered at the beginning of each Option Year.

4. EQUIPMENT LIST:

5. DIAGNOSTIC RADIOLOGY/ FLUORSCOPY

A. A Qualified Physicist will perform annual performance testing outlined in latest versions of VHA Directives 1129 “Radiation Protection for Machine Sources of Ionizing Radiation, VHA Directive 1505.04 “Fluoroscopy Safety”, ACR and JC requirements. For initial and repair of imaging equipment shall be performance tested no later than 30 days B. A formal report shall be provided to the ARSO in a timely manner to be presented in the next scheduled RSC meeting. The report will reflect items of required by ACR and JC requirements.

C. The survey criteria are those of the National Council on Radiation Protection, Report No. 102, "Medical X-ray and Gamma Ray Protection for Energies Up to 50 MeV"; Report No. 105, "Radiation Protection for Medical and Allied Health Personnel"; Report No. 147, "Structural Shielding Design and Evaluation for Medical X-Ray Imaging Facilities D. A contract Qualified Physicist develop training program in accordance with the guidance found VHA NHPP Model Fluoroscopy Policy outlined in Attachment B.

6. COMPUTER TOMOGRAPHY (CT)

A. A Qualified Physicist will perform annual performance testing outlined in latest versions of VHA Directives 1129 “Radiation Protection for Machine Sources of Ionizing Radiation, ACR and JC requirements. For initial and repair of imaging equipment shall be performance tested no later than 30 days B. A formal report shall be provided to the ARSO in a timely manner to be presented in the next scheduled RSC meeting. The report will reflect items of required by ACR and JC requirements.

7. CT PROTOCOL REVIEW

In accordance with ACR and JC Standards the contractor shall:

A. To ensure compliance with accreditation body standards, the contractor shall provide a Qualified Physicist to perform a review of all diagnostic CT imaging protocols for the number of CT scanners utilized at the facility.

B. The Qualified Physicist will complete an initial review of all the CT protocols within 3 months of initiation of the contract.

C. A Qualified Physicist will be available to meet in person or telephonically or Teams with the CT Protocol Committee. A formal report of these evaluations will be made. The parameters to be examined on an annual basis will be consistent with ACR and Joint Commission recommendations.

D. The meeting frequency and times will be mutually agreed upon. This shall be at least four (4) meetings per calendar year.

8. CT PERFORMANCE IMPROVMENT (PI) AUDITS

In accordance with ACR and JC Standards the contractor shall:

A. The Qualified Physicist will assist with the establishment of dose notification and dose alert values for diagnostic CT imaging protocols used at the facility for the number of CT scanners. On a quarterly basis B. The Qualified Physicist will perform an on-site review of diagnostic CT examinations performed at the facility. The review process will include an analysis and comparison of a representative sample of events where the radiation dose index exceeded expected dose index ranges identified in the imaging protocols and comparison of the data to established external benchmarks.

C. On a quarterly basis, conduct an on-site CT performance improvement audit to ensure the facility meets all performance standards and best practices recommended by various accrediting bodies.

D. Formal reports of these audits will be made

9. MAGNETIC RESONANCE IMAGING (MRI)

E. A Qualified Physicist will perform annual performance testing outlined in latest versions of VHA Directive 1105.15 “MRI Safety”, ACR and JC requirements. For initial and repair of imaging equipment shall be performance tested no later than 30 days F. A formal report shall be provided to the ARSO in a timely manner to be presented in the next scheduled RSC meeting. The report will reflect items of required by ACR and JC requirements.

10. ULTRASOUND

A. A qualified Health Physicist or A Qualified Physicist shall conduct annual performance testing of US equipment consistent with ACR and JC recommendations. This also includes initial or repair performance testing that interfere with image quality.

B. If the contractor choses to use a qualified Health Physicist to perform testing it shall be reviewed, approved and report signed by a Qualified Physicist.

C. The Performance Testing for initial installation and repaired equipment shall be done NLT 30 business days after installation and repair followed by a formal report shall be provided to the ARSO in a timely manner so that it can be presented in the next scheduled RSC meeting. The report will reflect items of required by ACR and JC requirements.

11. GAMMA CAMERA PERFORMANCE EVALUATION

A. A Qualified Physicist will perform annual performance testing of SPECT, planar and SPECT/CT gamma cameras The parameters to be examined will consist with most recent VHA Directives, ACR and JC requirements.

B. For initial and repair of imaging equipment shall be performance tested no later than 30 days. Repair performance testing will be tested on cameras repaired effecting image quality.

C. A formal report shall be provided to the Qualified Physicist in a timely manner to be presented in the next scheduled RSC meeting. The report will reflect items of required by ACR and JC requirements.

12. PET/CT SCANNER PERFORMACNE EVALUATION

A. A Qualified Physicist shall conduct annual performance testing of PET/CT equipment consistent with ACR and JC recommendations. This also includes initial or repair performance testing that interfere with image quality.

B. The Performance Testing for initial installation and repaired equipment shall be done NLT 30 business days after installation and repair followed by a formal report shall be provided to the Qualified Physicist in a timely manner so that it can be presented in the next scheduled RSC meeting. The report will reflect items of required by ACR and JC requirements.

13. DENTAL X-RAY MACHINES

The contractor shall provide QA testing for each machine in accordance with VHA Directives and applicable industry practice.

14. RADIATION SHIELDING PLANNING/ DOSE CALCULATION:

A. The contractor shall provide services by a Qualified Physicist to calculate radiation shielding requirements as needed B. Dose calculation for exposure of employees and patients to ascertain any overexposures

15. PERSONNEL DOSIMETRY PROGRAM:

A. The contractor shall provide a personnel radiation monitoring program in accordance with current NRC regulations 10 CFR Part 20 Standards for Protection Against Radiation and NRC Regulatory Guide 8.7 Instructions for Recording and Reporting Occupational Radiation Exposure Data.

B. In accordance with NRC 10 CFR 10.1501, the radiation monitoring service shall be certified by the National Voluntary Laboratory Accreditation Program (NVLAP).

C. The radiation whole-body personnel dosimetry shall contain optically stimulated luminescence (OSL) radiation detection technology or its equivalent. The equivalent shall have the following characteristics:

1. Must have a minimal reporting level of 1 mrem

2. No fade for longer wear frequencies

3. Tamper resistant

4. The contractor shall provide extremity monitoring (i.e., ring badges) to all personnel designated by the facility who can possibly receive 10% of the annual dose limit to extremities outlined in NRC 10 CFR Part 20.

5. Exposure reports shall be made available to the ARSO either paper form or electronically.

6. There are currently approximately 130 employees who are wearing whole body personnel dosimetry and 15 ring badges. The contractor shall consider an additional 20% to cover program expansion.

7. Annual dosimeter summary (NRC Form 5) or equivalent.

8. Radiation dosimetry shall be exchanged monthly.

9. The dosimetry shall be separated by category. Currently we have NM, Surgical Nurses, GI, Surgeons, Radiology, and Spares

16. RAM AUDIT- NUCLEAR MEDICINE

A. On a quarterly basis, a qualified health physicist or Qualified Physicist shall conduct radiation protection audits in the Nuclear Medicine Department to ensure compliance with USNRC and NHPP requirements. If a qualified health physicist performs the audit shall be reviewed, approved, and signed by a Qualified Physicist.

B. The formal report shall be provided in a timely manner to be presented in next Radiation Safety Committee meeting C. Prepare documentation or guidance to the ARSO for radioactive material licensure, to include license amendments, renewal applications, etc. Provide responses to and interpretation of regulatory action.

D. The contractor shall provide sealed source inventories and leak testing as required by the USNRC and NHPP.

E. The contractor auditor must have basic knowledge of the ec2 (NMIS) software for obtaining regulatory information.

17. NUCLEAR MEDICINE RADIATION SAFETY AND RADIATION MEASUREMENT EQUIPMENT CALIBRATION:

A. The contractor shall provide annual survey meter calibration services in accordance with USNRC regulations. Ideally, a loaner survey meter shall be provided during calibration of a facility survey meter B. The contractor shall perform annual calibration of well counters and thyroid probe in accordance with NRC CFR Part 20 & 35.

C. The contractor shall provide sealed source inventories and leak testing as required by the USNRC and NHPP.

18. RADIATION SAFETY TRAINING PROGRAM:

The contractor shall develop, conduct, and document a training program for the following:

1. Annual Radiation Safety Training program for facility employees that frequent areas where radioactive material or radiation producing devices are located. They include, but not limited to, x-ray technologists, nuclear medicine technologists, surgical staff, nursing staff, housekeeping, shipping, and receiving, and security staff. The training shall be commensurate with their job duties.

2. The contractor shall provide nuclear medicine technologists (NMTs) with HAZMAT training for the shipping of radioactive materials. The training shall be designed to train NMTs in the requirements of DOT 49 CFR Subpart H, and NRC 10 CFR 71.5. After successful completion the NMT shall be certified for a period of 3 years.

3. The facility TMS can be used for these purposes

19. HOURS OF OPERATION:

Routine work hours are Monday through Friday, 0800-1630. However, a flexible work schedule may be considered to accommodate the needs of the contractor and VAMCM.VAMCM is closed to observe the following Federal Holidays:

1) New Years’ Day

2) Martin Luther King Day

3) Presidents’ Day

4) Memorial Day

5) Juneteenth Day

6) Independence Day

7) Labor Day

8) Columbus Day

9) Veterans’ Day

10) Thanksgiving Day

11) Christmas Day

20. INVOICES:

Invoices shall be electronically entered into the Tungsten system and paid to the contractor monthly, in arrears, upon submission of a properly prepared invoice for services/ supplies during the period. All invoices will include name of company name and address, point of contact, contract number, dates of services, purchase order number, invoice number, and an itemized listing of charges.

Attachment A Definition of Qualified Physicist Within this Contract

Personnel Requirements for Medical Physicists and MR Scientists

Summary of Accreditation Program Requirements for Medical Physicists/MR Scientists

Certified in Diagnostic Radiological Physics or Radiological Physics by the American Board of Radiology; in Diagnostic Imaging Physics by the American Board of Medical Physics; or in Diagnostic Radiology Physics by the Canadian College of Physicists in Medicine

OR

Not Board Certified in Required Subspecialty

· Graduate degree in medical physics, radiologic physics, physics, or other relevant physical science or engineering discipline from an accredited institution, and

· Formal coursework in the biological sciences with at least

- 1 course in biology or radiation biology, and

- 1 course in anatomy, physiology, or similar topics related to the practice of medical physics

· 3 years of documented experience in a clinical CT environment

OR

Grandfathered Conducted surveys of at least 3 CT units between January 1, 2007 and January 1, 2010

Certified in Medical Nuclear Physics or Radiological Physics by the American Board of Radiology; in Nuclear Medicine Physics by the American Board of Medical Physics; in Nuclear Medicine Physics by the Canadian College of Physicists in Medicine; or in Nuclear Medicine Physics and Instrumentation by the American Board of Science in Nuclear Medicine

OR

Not Board Certified in Required Subspecialty

· Graduate degree in medical physics, radiologic physics, physics, or other relevant physical science or engineering discipline from an accredited institution, and

· Formal coursework in the biological sciences with at least

- 1 course in biology or radiation biology, and

- 1 course in anatomy, physiology, or similar topics related to the practice of medical physics

· 3 years of documented experience in a clinical NM environment

OR

Grandfathered Conducted surveys of at least 3 NM units between January 1, 2007 and January 1, 2010

Certified in Medical Nuclear Physics or Radiological Physics by the American Board of Radiology; in Nuclear Medicine Physics by the American Board of Medical Physics; in Nuclear Medicine Physics by the Canadian College of Physicists in Medicine; or in Nuclear Medicine Physics and Instrumentation by the American Board of Science in Nuclear Medicine

OR

Not Board Certified in Required Subspecialty

· Graduate degree in medical physics, radiologic physics, physics, or other relevant physical science or engineering discipline from an accredited institution, and

· Formal coursework in the biological sciences with at least

- 1 course in biology or radiation biology, and

- 1 course in anatomy, physiology, or similar topics related to the practice of medical physics

· 3 years of documented experience in a clinical PET environment

OR

Grandfathered Conducted surveys of at least 3 PET units between January 1, 2007 and January 1, 2010

MRAP

Medical Physicist Board Certified Certified in Diagnostic Radiological Physics or Radiological Physics by the American Board of Radiology; in Diagnostic Imaging Physics or Magnetic Resonance Imaging Physics by the American Board of Medical Physics; or in Diagnostic Radiology Physics or Magnetic Resonance Imaging Physics by the Canadian College of Physicists in Medicine

OR

Not Board Certified in Required Subspecialty

· Graduate degree in medical physics, radiologic physics, physics, or other relevant physical science or engineering discipline from an accredited institution, and

· Formal coursework in the biological sciences with at least

- 1 course in biology or radiation biology, and

- 1 course in anatomy, physiology, or similar topics related to the practice of medical physics

· 3 years of documented experience in a clinical MRI environment

OR

Grandfathered Conducted surveys of at least 3 MRI units between January 1, 2007 and January 1, 2010

· 3 years of documented experience in a clinical MRI environment

ATTACHMENT B

NHPP MODEL POLICY FOR THE SAFE USE OF FLUOROSCOPIC EQUIPMENT

PURPOSE: To establish procedures for the safe use of fluoroscopes that will maintain radiation exposures of patients, healthcare workers, and the general public As Low As Reasonably Achievable (ALARA) while achieving clinically-adequate image quality.

POLICY: To assure uniform safety and documentation for all fluoroscopic procedures, fluoroscopy training for employees, and appropriate follow up for patients who have received high doses of radiation.

PROCEDURE: In order to ensure the safe use of fluoroscopes, for both the patient and for the attending staff, the following criteria are to be met.

1. A record must be kept of each fluoroscopy procedure. See Appendix A for details.

2. Only trained physicians may perform or supervise fluoroscopy procedures. Registered and/or licensed radiologic technologists, radiation therapists, cardiac catheterization medical instrument technician, registered nurse, nurse practitioner, or physician assistant may perform fluoroscopy under the supervision of a physician who is personally (physically present) and immediately available.

3. All fluoroscopes must be properly maintained by biomedical engineering and inspected by a qualified medical physicist initially (prior to clinical use), annually, at intervals not to exceed 14 months, and after major repairs but prior to the return to clinical use.

4. An appropriate radiation monitoring program for patient and staff is established and results reviewed at least quarterly.

5. The principles of ALARA are followed.

TRAINING

a. Training of Physicians: Fluoroscopy safety training will be commensurate with the risk involved in the fluoroscopy procedures being performed. Physicians who perform potentially high dose procedures (e.g., TIPS creation, embolization (any location, any lesion), stroke therapy, biliary drainage, angioplasty with or without stent placement, stent- graft placement, chemoembolization, angiography and intervention for gastrointestinal hemorrhage, carotid stent placement, RF cardiac ablation, complex placement of cardiac EP devices, or PCI (single or multiple vessel)) must complete the VA Talent Management System (TMS) training course or equivalent prior to using fluoroscopes. All other physicians who perform fluoroscopy must complete a less intense version of the TMS fluoroscopy safety training course or equivalent.

(1) Each physician who uses or supervises the use of fluoroscopes must be trained in fluoroscopy operation and safety to include didactic lessons, hands-on-operation, and clinical operation under a preceptor physician.

(2) Didactic training need not be performed at or by the medical center, provided that the trainee demonstrates: evidence of the date(s) of training; the name(s) of the person(s) providing the training; the topics included in the training; the duration of the training; the test questions, if available; and evidence of successful completion. Didactic training must include the following topics: physics of x-ray production and interaction, the technology of fluoroscopy machines, including modes of operation, characteristics of image quality and technical factors affecting image quality, dosimetric quantities and units, biological effects of radiation, principles of radiation protection in fluoroscopy, applicable Federal regulations and VHA requirements, and techniques for minimizing dose to the patient and staff.

(3) Hands-on training should be conducted on the model of fluoroscope that is to be used. Training needs to encompass the use of controls, activation of various modes of operation, and displays.

(4) Preceptor training consists of clinical operation of the fluoroscope under the supervision of an experienced physician. Completion of this phase of training must include written confirmation, signed by the preceptor physician, that the individual has achieved a level of competency sufficient to function independently as a fluoroscope operator.

b. Training of Non-physicians

(1) Non-physicians who operate fluoroscopes must undertake didactic, hands-on, and preceptor training. Training requirements for non-physicians differ from physicians only in that the preceptor may be a physician, a DRT, register nurse, nurse practitioner, physician assistant, or a CCMIT who is trained to operate a fluoroscope.

(2) Technologists who are American Registry of Radiologic Technologists (ARRT) certified in radiography or radiation therapy, or who are registered cardiovascular invasive specialists with Cardiovascular Credentialing International are considered to have met the didactic portion of the training requirement. Training records will be maintained by the RSO.

c. Training of Resident Physicians. A resident physician may operate a fluoroscope, or may directly supervise the operation of a fluoroscope, provided the resident physician has completed fluoroscopy safety training as defined by the residency program, and is supervised, directly or indirectly, by an attending physician. Procedures that always require direct supervision of the resident for radiation safety purposes include any that have the potential to exceed a skin dose of 3 Gy (see potentially high-dose procedures in item a above).

d. Staff: All personnel who work in the room where fluoroscopy is performed must undergo initial radiation safety training. The training must be commensurate with risk to the staff.

e. Recurrent Training: Training will include regulatory reminders and updates as well as system-specific training for new equipment. Intervals between recurrent training will not exceed 1 year. Recurrent training is required for both physicians, non-physicians, staff present in the fluoroscopy suite.

SAFETY--All personnel in the fluoroscopy suite shall follow radiation safety practices as they pertain to their duties. See Appendices A and B for procedures.

RESPONSIBILITIES:

A: The Director is responsible for:

1. Appointing an RSO and providing the name of the RSO to the National Health Physics Program.

2. Ensuring that a fluoroscopy safety training program is established and training is required in order to operate a fluoroscope.

3. Ensuring that personal dosimeters and radiation protective apparel are provided to persons exposed fluoroscopic x-rays.

4. Ensuring that fluoroscopes are used in rooms with structural shielding when appropriate.

5. Ensuring that fluoroscopes are tested by a medical physicist initially, after repairs, and annually.

6. Promoting a safety culture where employees feel free to report radiation safety concerns.

7. Ensuring all precautions are taken for personnel and patient safety.

B: Radiation Safety Officer (RSO): The RSO is responsible for the day to day operations of the radiation safety program and is permitted to directly communicate with facility executive management. The RSO’s duties include but not limited to;

1.