36C24522Q0580_1.docx

36C24522Q0580

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.

Questions are due by 12:00PM EST on Wednesday, June 15, 2022.

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 Certified 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 quarterly 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

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24522Q0580 06-08-2022 Phillip G Duba 304-263-0811 X7610 06-22-2022

12:00PM

EDT

Department of Veterans Affairs

VAMC (613)

VISN 5 Contract Satellite Office 510 Butler Avenue, Building 306A Martinsburg WV 25405 X X 621399 $8 Million N/A X Department of Veterans Affairs Martinsburg VA Medical Center (613) Radiology Department (114) 510 Butler Avenue Martinsburg WV 25405 Department of Veterans Affairs

VAMC (613)

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

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp http://www.fsc.va.gov/einvoice.asp See CONTINUATION Page Title: Radiation Safety Program for Imaging Services at VAMC Martinsburg. All work shall be in accordance with the SOW.

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

Questions are due by Wednesday, June 15, 2022, no later than 3:00PM EST to Phillip.Duba@va.gov.

All final price and technical proposals are due by 12:00PM EST on June 22, 2022, to Phillip.Duba@va.gov.

See CONTINUATION Page X X Phillip G Duba Contracting Officer 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:

36C24522Q0580

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 Martinsburg will be seeking ACR Accreditation. All contained in the contract will be in accordance with ACR and VHA Standards.

2. GENERAL PROVISIONS OF SERVICES:

A. An organization chart shall be provided by the contractor.

B. The contractor shall provide the Certified 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 Certified 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 check the integrity of the lead aprons, skirts, vests, thyroid shields, and gloves on an annual basis. A detailed report shall be supplied to the RSC.

M. The contractor will provide consultation to the facility of any new requirements by any applicable regulatory agency N. 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, quarterly 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 attend quarterly Radiation Safety Committee Meetings K. Shall attend quarterly EEOC committee meetings to provide radiation safety report. This can be accomplished by telephone, TEAMs or onsite.

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

M. 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. An Certified 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 Certified Physicist develop training program in accordance with the guidance found VHA NHPP Model Fluoroscopy Policy outlined in Appendix A

6. COMPUTER TOMOGRAPHY (CT)

A. A Certified 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 Certified Physicist to perform a review of all diagnostic CT imaging protocols for the number of CT scanners utilized at the facility.

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

C. A Certified 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 Certified 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 Certified 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 Certified 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 Certified 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 an Certified 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 Certified Physicisty 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 Certified 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 Certified 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 Certified 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 any other regulatory body

14. RADIATION SHIELDING PLANNING/ DOSE CALCULATION:

A. The contractor shall provide services by a Certified 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. Must be able to differentiate between static (i.e., instantaneous) and dynamic (i.e., normal) exposure

3. No fade for longer wear frequencies

4. Tamper resistant

5. 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.

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

7. 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.

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

9. Radiation dosimetry shall be exchanged monthly.

10. 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 Certified 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 Certified 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.

D. The contractor shall perform annual calibration of the dose calibrator.

E. The contractor shall perform geometrical variation calibration of the dose calibrator when needed

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

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. To establish and implement radiation safety procedures and to review periodically their conformity with regulations, the requirements of VHA handbooks and directives, and good radiation safety and medical physics practices.

2. To ensure the instruction of personnel in regulatory requirements, the requirements of any pertinent VHA handbooks, and proper radiation protection practices initially and periodically thereafter. Ensure that required signs and notices are properly posted.

3. To ensure shielding evaluations and designs are performed for locations where fluoroscopes are used. To ensure radiation surveys are conducted where indicated and to keep records of such surveys and shielding tests.

4. To ensure prompt investigations are made of each known or suspected case of excessive exposure or sentinel event involving fluoroscopy, determine the causes, take steps to prevent recurrence, and monitor such corrective actions.

5. To ensure that required notifications and reports are made as required by regulations and VHA procedures.

6. Shall review reports of personnel doses for compliance with ALARA goals and limits in OSHA or NRC regulations which ever is applicable. The RSO shall ensure appropriate notifications are made if necessary.

C: Radiation Safety Committee (RSC): The RSC is responsible for overseeing the radiation safety program for radioactive materials and electrically produced sources of ionizing radiation. The RSC will have a representative from Radiology Service, Cardiology Service, and other services as appropriate to represent fluoroscopy users.

1. The RSC shall receive updates on the additional and deletion of x-ray equipment and locations throughout the facility including CBOCs and outlying facilities. The RSC shall provide oversight of x-ray equipment at CBOCs and other outlying facilities.

2. The RSC shall provide oversight of the fluoroscopy training program.

3. The RSC shall review occupational doses to fluoroscopy users at least quarterly and ensure that actions to reduce occupational doses are implemented when appropriate.

4. The RSC shall ensure that fluoroscopes are inspected by a qualified medical physicist at least annually, at intervals not to exceed 14 months.

D: Service and Section Chiefs: Service Chiefs (e.g., Chief of Radiology, Chief of Cardiology, and Chief of Radiation Oncology) are to ensure that fluoroscopic units under their purview, including fluoroscopic units in areas such as pain clinics, GI, Orthopedics, Vascular Surgery, General Surgery, Neuro Surgery, Endoscopy, Urology, Thoracic Surgery, Interventional Radiology (IR), and the Operating Room, are used consistently with the criteria set forth by this policy, the manufacturer, RSO and RSC, and will:

1. Ensure that a standard operating procedure (SOP) is available for fluoroscopic units within the department/service, and the SOP has been developed and reviewed/approved prior to implementation.

2. Ensure only trained and qualified staff perform fluoroscopy operations.

3. Maintain a list of workers (physicians and non-physicians) trained and qualified to use fluoroscopic units, and submit that list to the RSC annually.

4. Maintain a QA program that includes periodic reviews of patient dose indices and reviews of procedures whose dose indices exceed a threshold.

E: Biomedical Engineering: The Biomedical Engineering Service is responsible for the maintenance of fluoroscopic equipment, retaining historical maintenance records, and maintaining an inventory of all fluoroscopic equipment and their locations. They are responsible for contracting a qualified medical physicist to perform the required fluoroscopic equipment testing and performance monitoring. The inventory of all fluoroscopic equipment will be provided to the RSC quarterly and whenever equipment is added or deleted from service. Biomedical Engineering will support the RSO in addressing any quality control and assurance issues when they arise and inform the RSC of any inconsistencies.

F: Fluoroscopy User: This is a physician or non-physician who is trained to perform fluoroscopic procedures.

1. The physician is responsible for generating an order in Vista CPRS, the electronic medical record, for each fluoroscopy procedure.

2. The physician is responsible for knowing whether female patients of reproductive age undergoing abdomen or pelvic procedures may be pregnant. See Appendix A.

3. If a procedure may cause a cumulative air kerma equal to or greater than 3 Gy , prior to the exam, the physician should be aware of patient’s records regarding any fluoroscopic or radiation therapy procedures performed in the previous six months. For each patient procedure in which the cumulative air kerma might exceed 3 Gy to any single location on the patient’s skin, the deterministic risks of erythema and epilation must be discussed with the patient before the procedure begins.

4. The physician is responsible to ensure that all individuals in the room are wearing protective apparel. A protective apron is the minimum requirement. In the rare case that during an emergency event insufficient protective aprons are available, the user shall state what safety procedures and distances are required for the unprotected personnel.

5. The physician is responsible to ensure that all individuals in the room are wearing dosimeters.

6. The physician is responsible for recording the patient’s cumulative air kerma in the permanent medical record. If a 3 Gy skin dose to a single field is exceeded, the patient must be instructed in self-examination of the skin for erythema and to report any radiation effects to the physician. If 5 Gy skin dose to a single field is exceeded, arrangements must be made to have the patient examined by a health care practitioner approximately 4 to 8 weeks following the procedure, with subsequent examinations as appropriate and notify the RSO.

7. Any exposure that results in permanent skin damage or 15 Gy cumulative dose to single field is a sentinel event. The event must be reported to the RSO and to the Patient Safety Manager in accordance with VHA Handbook 1050.01. The Joint Commission interprets cumulative dose as the sum of doses over a 6 month to 1 year period.

REFERENCES:

U.S. Food and Drug Administration (FDA) Title 21 of the Code of Federal Regulations (FDA Regulations), Part 1000, Subpart C, Radiation Protection Recommendations.

Title 21 of the Code of Federal Regulations (FDA Regulations), Part 1020, Performance Standards for Ionizing Radiation Emitting Products.

Title 21 of the Code of Federal Regulations (FDA Regulations), Part 803, Medical Device Reporting.

U.S. Food and Drug Administration, Avoidance of Serious X-Ray-Induced Skin Injuries to Patients During Fluoroscopically-Guided Procedures, September 9, 1994.

U.S. Food and Drug Administration. Recording Information in the Patient’s Medical Record that Identifies the Potential for Serious X-Ray-Induced Skin Injuries Following Fluoroscopically-Guided Procedures, September 15, 1995.

American College of Radiology (ACR) ACR Practice Guideline for Diagnostic Reference Levels in Medical X-Ray Imaging ACR Technical Standard for the Diagnostic Technical Performance Monitoring of Radiographic and Fluoroscopic Equipment ACR Technical Standard for Management of Use of Radiation in Fluoroscopic Procedures ACR Practice Guideline for Imaging Pregnant or Potentially Pregnant Adolescents and Women with Ionizing Radiation National Council on Radiation Protection and Measurements (NCRP) NCRP Report No. 99, Quality Assurance for Diagnostic Imaging, 1988.

NCRP Report No. 102, Medical X-Ray, Electron Beam, And Gamma Ray Protection for Energies up to 50 MeV (Equipment Design, Performance, and Use), 1989.

NCRP Report No. 147, Structural Shielding Design for Medical X-Ray Imaging Facilities, 2004.

NCRP Report No. 168, Radiation Dose Management for Fluoroscopically-Guided Interventional Medical Procedures, 2010.

International Commission on Radiological Protection (ICRP) ICRP Publication 84, Pregnancy and Medical Radiation, Pergamon, 2000.

ICRP Publication 85, Avoidance of Radiation Injuries from Medical Interventional Procedures, Pergamon, 2000 Others Comprehensive Accreditation Manual for Hospitals, The Joint Commission Title 29 of the Code of Federal Regulations (OSHA Regulations), Part 1910, Occupational Safety and Health Standards Journal of Vascular and Interventional Radiology, Radiation Doses in Interventional Radiology Procedures: The RAD-IR Study Part I: Overall Measurements of Dose, 2003; 14: 711-727, Miller et al.

Journal of Vascular and Interventional Radiology, Radiation Doses in Interventional Radiology Procedures: The RAD-IR Study Part II: Skin Dose, 2003; 14: 977-990, Miller et al.

ACCF/AHA/HRS/SCAI Clinical Competence Statement on Physician Knowledge to Optimize Patient Safety and Image Quality in Fluoroscopically Guided Invasive Cardiovascular Procedures, JACC, 2004, 2259-2282.

Koenig TR, Wolff D, Mettler FA, Wagner LK. Skin injuries from fluoroscopically guided procedures, part I: characteristics of radiation injury. AJR 2001;177:3-11.

Koenig TR, Mettler FA, Wagner LK. Skin injuries from fluoroscopically guided procedures: part II, review of 73 cases and recommendations for minimizing dose delivered to patient. AJR 2001;177:13-20.

Balter S, Hopewell JW, Miller DL, et al. Fluoroscopically Guided Interventional Procedures:

A Review of Radiation Effects on Patients’ Skin and Hair. Radiology 2010; 254: 326-341.

Stecker MS, Balter S, Towbin RB, et al. Guidelines for Patient Radiation Dose Management.

J Vasc Interv Radiol 2009; 20:S263–S273.

Appendix A Patient Safety Procedures Pre-procedure

1. Medical staff should ask each female patient of reproductive age whether she might be pregnant prior to performing a fluoroscopy procedure. However, for procedures that may impart more than 100 mGy to the embryo or fetus, a serum pregnancy test should be obtained on the patient before proceeding with a non-emergent exam. If the patient is pregnant, if at all possible, consideration should be given to delaying the procedure until after completion of the pregnancy, or alternatively to using another modality without the risks of ionizing radiation (eg ultrasound). If the risk/benefit ratio still favors proceeding with the examination, appropriate informed consent should be obtained. Additionally, the physician should make reasonable modifications to the fluoroscopic procedure to protect the embryo or fetus whenever possible. The dose to the embryo or fetus can be minimized by using low-dose fluoroscopy modes, limiting the number of fluorographic images (or utilizing last image hold instead of obtaining spot images), beam collimation, and limiting the embryo or fetus exposure to scatter radiation only.

Although not all-inclusive, some examples of procedures that might impart doses exceeding 100 mGy to the abdomen or pelvis include the following:

1. Pelvic arterial embolization (trauma, tumor, fibroid, AVM, aneurysm)

1. Pelvic vein embolization (ovarian vein)

1. Any angioplasty, stenting or other vascular intervention in the abdomen/pelvic region

1. Interventional biliary or GU procedures (eg TIPS, percutaneous biliary drainage, percutaneous nephrostomy or nephrolithotomy)

1. Other procedures involving prolonged abdominal or pelvic fluoroscopy.

2. Review patient information regarding any fluoroscopic or radiation therapy procedures performed to the same body area, particularly in the previous six months. Verbally relay this information to the physician performing or supervising the fluoroscopy procedure.

3. Review the patient’s medical records and document any risk factors the patient has for increased radiosensitivity for the proposed procedure.

Conditions that Increase Radiosensitivity:

a. Diabetes mellitus

b. Concomitant use of any of the following medications:

· Actinomycin D

· Doxorubicin

· Bleomycin

· 5-fluorouracil

· Methotrexate

c. Genetic disorders that affect DNA breakage or repair

· Fanconi anemia

· Bloom syndrome

· xeroderma pigmentosum

· Familial polyposis

· Gardner syndrome

· heritable malignant melanoma

· dysplastic nevus syndrome

d. Overlapping skin folds

e. Compromised skin integrity

f. Autoimmune and connective tissue disorders

· scleroderma

· systemic lupus erythematosus

· possibly rheumatoid arthritis

g. Hyperthyroidism

h. Ethnic differences in skin coloration are also associated with differences in radiation sensitivity; individuals with light-colored hair and skin are most sensitive.

4. Patients undergoing potentially high dose fluoroscopy procedures must be informed and consented for a potentially high dose fluoroscopy procedure, prior to the procedure, of the potential for increased radiation exposure and risks. These procedures include:

a. TIPS creation,

b. embolization (any location, any lesion),

c. stroke therapy,

d. biliary drainage,

e. angioplasty with or without stent placement,

f. stent-graft placement,

g. chemoembolization,

h. angiography and intervention for gastrointestinal hemorrhage,

i. carotid stent placement,

j. RF cardiac ablation,

k. complex placement of cardiac EP devices,

l. PCI (single or multiple vessel)

5. If a procedure can be performed using test methods other than with ionizing radiation, (e.g., ultrasound, endoscopy, MRI) then those other methods must be considered.

During the procedure

1. The operator should always collimate the x-ray beam to the smallest area of interest consistent with clinical needs. The operator should use virtual collimation and semi-transparent attenuators when available.

2. Avoid beam angles that place radiosensitive organs, such as the eyes, gonads and female breasts, in the primary beam. Shield organs of the patient that are particularly radiation sensitive, such as the gonads and eyes, when they must be in the primary beam and such shielding will not compromise the clinical procedure. Shielding is to be on the x-ray source side of the patient.

3. During extended procedures in which cumulative air kerma exceeds 2 Gy, vary projection angles to avoid skin injuries.

4. Keep the x-ray tube as far from the patient as possible and the image receptor as close as possible to the patient. For C-arm fluoroscopes with the x-ray tube below the patient table, keep the table as high as possible. With c-arm fluoroscopes, avoid using the system with the x-ray tube above the table, when clinically possible. Imaging with the x-ray tube below the table is preferred.

5. Whenever possible, use x-ray beam angulations that minimize the path length of the x-ray beam through the patient’s body.

6. In lateral views, take precautions to ensure that the patient’s arms are not in the beam, as this can cause severe injury to the patient.

7. The number of static digital spot images recorded should be limited to the minimum that are clinically necessary. When recording dynamic image sequences (cinefluorography), use the lowest frame rate that is clinically acceptable, apply additional reduced-dose fluoroscopic modes that may be available. Also, minimize the length and frame rate for each cine run (e.g., 30 or 15 frames/s). In adult cardiology, the standard today is 15 frames/s. When possible, document with fluoro store and not cine images. Be aware of the increased dose rate and do not use digital acquisition or cine mode as a substitute for fluoroscopy.

8. The use of magnification modes should be minimized. When used, the lowest acceptable magnification mode should be used.

9. The use of high exposure rate mode or boost mode should be limited.

10. The operator should minimize beam-on time. Fluoroscopy should only be performed to observe motion, advance catheters or to position the imaging system for static spot images. The use of intermittent fluoroscopy (“tap fluoro”), low pulse rate fluoroscopy or single-pulse mode with last image hold should be used.

11. Fluoroscopy units should routinely be operated in automatic exposure rate control mode instead of manual mode. If manual fluoroscopy mode is needed in unusual circumstances, however, use as large a kVp as possible, consistent with adequate image contrast, maintaining the mA as small as possible.

12. Pulsed fluoroscopy at the lowest pulse rate that is clinically acceptable should be used.

13. During the exam the nurse or technologist will call out one the following dose indices to the person performing the fluoroscopic procedure:

a. If displayed by the fluoroscopy system, cumulative air kerma, when the air kerma (AK) reaches 2000 mGy, and then at 1000 mGy intervals after that; OR

b. If cumulative air kerma is not displayed, by the fluoroscopy system, dose area product (DAP) when DAP reaches 200,000 mGy•cm2 (or 20,000 2), and then at 100,000 mGy•cm2 (or 10,000 2) intervals; OR

c. If neither cumulative air kerma or DAP is displayed, total fluoroscopy time, at 5 minute intervals.

d. For bi-plane procedures, call-outs should be made for each tube.

Post procedure

1. Patient dose information must be recorded for each fluoroscopic procedure in the patient’s medical record. It must contain the date of the procedure, the procedure name, the fluoroscope used, the identity of the physician operating or supervising the operation of the fluoroscope, the cumulative air kerma (AK) if available, dose area product (DAP) if available, and cumulative fluoroscopy time. If static images and/or dynamic CINE series are acquired, the above dose data should include the combined cumulative air kerma, if available, and the combined dose-area-product, if available. Record the length and frame rate of CINE series. This record must be maintained for five years after the date of the procedure.

2. If the cumulative air kerma exceeds 3000 mGy, the responsible physician should make an entry in the patient’s medical record showing cumulative air kerma, beam entrance locations and arrange for follow-up of the patient.