D.37- RADIOLOGY, HEALTH, SAFETY AND CONSENT PROCEDURES FOR STAFF AND PATIENTS- JULY 2023.pdf

RADIOLOGY HEALTH, SAFETY, AND CONSENT PROCEDURES FOR STAFF AND

PATIENTS

SOP 528a7-114-011

Syracuse VA Medical Center Syracuse, NY 13210

Signatory Authority:

Chief of Imaging

Responsible Owner:

Imaging Manager

Service Line:

Imaging Service

Effective Date:

July 2023

Recertification Date:

July 2028

1. SUMMARY OF CHANGES

a. New SOP, replacing MCP 11-098, Imaging Radiation Health and Safety Rules for Staff and Patients. Added summary of changes section, service chief and all other staff responsibilities. Added into section 3 the need of intraoperative level verification expectations.

2. PURPOSE AND JUSTIFICATION

a. The purpose of this standard operating procedure (SOP) is to establish Syracuse VA Medical Center (SVAMC) radiation safety practices and procedures on how to conduct diagnostic imaging tests in a matter that maintains the radiation exposure to ALARA (As Low as Reasonably Achievable) levels for both patients and Imaging Staff.

This SOP must be followed by all Syracuse VAMC personnel.

b. This SOP sets forth mandatory procedures and processes to ensure compliance with VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation, dated February 5. 2015 which states the VA Facility Director is responsible for “Establishing and implementing radiation safety practices and procedures commensurate with the scope of use of machine sources of ionizing radiation”.

3. PROCEDURES

a. Radiation Health and Safety Procedures for Staff and Patients.

(1) Radiation Exposure.

(a) Environment.

1. The imaging department will provide an environment that takes in account high quality diagnostic images with a balance of providing the lowest radiation dose possible to patients and staff.

2. Ensure that all appropriate safety precautions are being followed during imaging

Attachment D.37 RFP 36C24224R0049

July 2023 SOP 528a7-114-011 exams by staff.

3. Offer an imaging study can be performed using any testing method other than Ionizing Radiation such as Non-Ionizing Radiation modalities (Ultrasound, Magnetic Resonance Imaging (MRI)), if possible.

(b) Communication and Protection for the Imaging Patient.

1. Explain the process, protection guidelines and address the patients concerns about radiation exposure to reduce the patient’s anxiety.

a. Assure that the patient is in charge and has the right to accept or refuse the treatment/test if so desired.

2. All patients that can bear children, aged 55 and under, will be questioned for any chance of pregnancy.

3. All patients will be shielded, regardless of age, when appropriate for the imaging exam.

a. Gonadal shields and or breast shields, and lead aprons will be used at the patient’s request.

b. Shielding must be arranged properly to eliminate compromise for patient diagnosis or visualization of the imaged body part.

c. Occasionally, patient shielding must be removed for the area of interest to provide diagnosis.

NOTE: Non-compliance with patient shielding may result in disciplinary action. Citing scatter as a non-factor or forgetfulness aren’t acceptable reasons for not shielding.

4. Always use collimation to reduce scatter.

a. Limit the primary beam to the smallest size necessary to include the area of interest unless the Radiologist states otherwise.

5. Keep the x-ray tube as far from the patient as possible and Image Intensifier or detector as close to the patient as possible.

6. The use of high dose pulse fluoroscopic rates and boost mode should be minimized whenever possible.

7. Radiation exposures of 3 Gy (Gray) or higher must be reported to the Radiation Safety Officer (RSO) including the Fluoroscopy Exposure Report & Skin Assessment Document completed by the operating Physician.

(c) Pregnancy.

Attachment D.37 RFP 36C24224R0049 https://dvagov.sharepoint.com/:f:/r/sites/vhasyracuseradiology/Shared%20Documents/Departments%20operations%20and%20policies/Radiation%20Protection?csf=1&web=1&e=jwBF06 https://dvagov.sharepoint.com/:f:/r/sites/vhasyracuseradiology/Shared%20Documents/Departments%20operations%20and%20policies/Radiation%20Protection?csf=1&web=1&e=jwBF06

1. Always inquire to patients who can bear children 55 and under if there is a chance of pregnancy. Documentation in the picture archiving and communication system (PACS) will be made stating the patient was questioned and the patient’s response.

a. If the patient is uncertain, a pregnancy test must be conducted.

2. If the patient refuses the pregnancy test, the imaging exam will be cancelled.

The Imaging Exam will be rescheduled only after the patient has consulted with the requesting physician.

3. In the event of an emergency where the imaging exam must be conducted, the Radiologist, in conjunction with the patient’s requesting physician, will determine if the exam could potentially be modified (a reduction of exposures, dose or area being irradiated). The patient will be advised of the potential hazards by the requesting physician. To proceed with the exam the following measures must be followed:

a. The Radiologist must determine the necessity of the exam (Medical Validity).

b. Once validated, determine if the exam could potentially be modified (a reduction of exposures, dose or area being irradiated).

c. If both conditions are met, the radiologist will confer with the technologist and provide the modifications for the exam.

d. The referring physician must inform the patient of the potential risks verses medical need. The patient must agree with the referring physician and sign an iMedConsent before the technologist can perform the modified exam.

e. The Radiologic Technologist must confirm that the patient has been informed and consented in iMedConsent.

f. The Radiologic Technologist will double shield the patient, if possible, annotate it’s use in the tech note including the technical factors and approving radiologist name.

g. The Radiologic Technologist who must perform an authorized medically necessary imaging exam on a pregnant patient will e-mail to the Radiation Safety Officer (RSO) the required information from the exam.

(1) The information will include the patient’s name, date, exam type, radiologist who approved it and the radiology technical factors used to determine potential exposure.

h. The collaboration with the referring physician and Radiologist must be completed before any procedure is performed on a pregnant patient.

(1) The referring physician should enter a Computerized Patient Record System (CPRS) note regarding this collaboration.

(d) Nuclear Medicine Patients.

1. The patient is the source of radiation emissions requiring a special environment to protect other patients, visitors, and staff. NOTE: Outpatient Nuclear Medicine patients report to a sequestered waiting room away from the general Imaging waiting room.

2. Nuclear Medicine patients should not bring their children with them. NOTE: The Nuclear Medicine department will not allow children in the Nuclear Medicine waiting room or access to the department.

3. All patients capable to bear children under the age of 55, must fill out and sign the pregnancy questionnaire.

a. The questionnaire asks if there is a chance of pregnancy, date of last menstrual cycle and if they are breast feeding.

(1) This information must then be documented in the picture archiving and communication system (PACS) and then the questionnaire is sequestered.

4. The bathroom in Nuclear Medicine (Room # A345) is intended for the exclusive use of Nuclear Medicine Patients only. NOTE: Visitors and employees are strictly prohibited from utilizing this bathroom to limit radiation contamination.

(e) Intraoperative Level Verification/Interpreting of Intraoperative Imaging

1. If level verification or intraoperative interpretation of imaging is required by a surgeon with a radiologist to confirm an anatomic location, there must be documentation of the conversation that occurred with the surgeon and radiologist in the medical record.

a. The radiologist must document the conversation either in the medical record either via Powerscribe, a note in PACS, or a note in CPRS.

b. The surgeon should verify with the circulating Registered Nurse (RN) in the operating room the conversation for proper surgical documentation.

(f) Imaging for the Retention of Surgical Instruments.

1. At the conclusion of a surgical procedure when there is unanimous agreement between the Surgeon, Circulating Nurse, and the Scrub Technician that there are too many instruments to count; the surgical instrument count is inaccurate; or the patient requires emergency care, a spot image (C-arm last image) and or radiograph taken for verification of absences of any surgical instruments post-operative.

2. A spot image will be taken once the patient has been closed prior to leaving the Operating Room Suite.

a. The Diagnostic Radiologic Technologist will save the image to the Picture archiving and communication system (PACS) in the event a Radiologist Review is required.

3. The use of fluoroscopy to check for the retention of surgical instruments is strictly prohibited, per the VA Central Office National Health Physics Program.

4. The requirement for the post-operative portable x-ray in the Recovery Room should be eliminated for those patients who have had the spot image taken in the Operating Room Suite to limit unnecessary radiation exposure.

(g) Protection for the Technologist.

1. Do not expose any part of your body to the primary beam.

2. Always remain behind the leaded control booth or a protective barrier while making an exposure in an examination room. Never make an exposure while another technologist is in the radiographic room.

3. When performing portable examinations, always wear a lead apron and stay as far away as possible from the radiation source.

4. During all fluoroscopic examinations, always wear lead aprons, thyroid shields and other radiation protection as needed.

a. Monitoring badges are supplied for your protection and must be always worn while on duty.

b. Pocket Dosimeters or spare badge dosimeters as provided by Radiation Safety Officer should be used by other personnel who are in the room during the procedure and are not assigned the Luxel dosimetry badge.

5. Use gloves, leaded protective devices, when handling radioisotopes for diagnostic and therapeutic use.

(h) Protection for Other Staff during Fluoroscopy.

1. During all fluoroscopic examinations, always wear lead aprons, thyroid shields and other radiation protection as needed.

a. Monitoring badges are supplied for your protection and must be always worn while on duty.

b. Pocket Dosimeters or spare badge dosimeters as provided by Radiation Safety Officer should be used by other personnel who are in the room during the procedure and are not assigned the Luxel dosimetry badge.

4. ASSIGNMENT OF RESPONSIBILITIES

a. Service Chief. The Service Chief is responsible for:

(1) Communicating this SOP and any changes to all appropriate staff.

(2) Reviewing and ensuring all appropriate changes are made to this SOP.

(3) Ensuring all information contained herein follows any, and all governing guidance where appropriate.

(4) Ensuring all appropriate staff adhere to this SOP.

b. Radiologist. The Radiologist is responsible for:

(1) Providing guidance to the technologist providing sound protocols to follow.

(2) Modifying the imaging procedure or protocol to minimize potential risks and better patient outcomes under mitigating circumstances.

(3) Asserting authority as the physician who has the final say whether an imaging exam can proceed.

c. Technologist. The technologist is responsible for:

(1) Communicating with the Radiologist to confirm the request and to follow any alteration to the exam.

(2) Always applying collimation. Limit the primary beam to the smallest size necessary to include the area of interest unless the Radiologist states otherwise.

(3) Communicating with the radiologist for instruction on performing exams with patients that present contraindications to radiation exposure such as positive pregnancy.

(a) If approved, ensure that the request includes the words medical necessity and the radiologist’s name with signature is on the request.

d. Referring Physician. The Referring Physician is responsible for:

(1) Providing a valid signed request, with the history clearly defined, including a number where to be reached with questions regarding the request.

(2) Consulting with the Radiologist when the patient has special circumstance in regards with radiation exposure where there is potential for higher radiation exposure risk to the patient or fetus to determine the best outcome for the patient.

(3) Indicating in the request that the exam is a “medical necessity” for a pregnant positive patient and refer to the Radiologist who was contacted for special instruction on modifying the exam.

(4) Obtaining a valid, signed iMedConsent for high-risk imaging procedures and exams such as patients who are pregnant or require pre-medication regimen for the

Imaging procedure.

e. Radiation Safety Officer (RSO). The Radiation Safety Officer is responsible for:

(1) Tracking and storing information sent by the technologist from modified imaging exams that were determined as medically necessary for radiation compromised patients or positive pregnancy patients.

(2) Evaluating the data to determine any follow up from the exam presented.

(3) Receiving reports of exposure rate greater than 3 Gy (Gray) and provide follow up on patient’s condition and documentation for any complications from radiation exposure.

f. All Other Staff. All Other Staff are responsible for:

(1) Adhering to this SOP.

5. DEFINITIONS

a. ALARA (As Low as Reasonably Achievable). Maintain radiation exposure to lowest reasonable levels for both patients and Imaging Staff.

b. Gray (Gy). A unit of radiation dose that measures the total absorbed energy of radiation to the body.

c. Picture Archiving and Communication System (PACS). An electronic patient archive system of diagnostic images for diagnosis and information retrieval.

6. REFERENCES

a. VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation, February 5, 2015, Direct Link. NOTE: This is an internal VA website that is not available to the public.

b. NUREG-0267-Principles and Practices for Keeping Occupational Radiation Exposures as Low as Reasonably Achievable (ALARA), https://www.nrc.gov/docs/ML0825/ML082560464.pdf. NOTE: This website is outside of VA control and may not be conformant with Section 508 of the Rehabilitation Act of 1973.

c. VHA Directive 1103 Prevention of Unintended Retained Foreign Items in the Operating Room, dated April 26, 2023. https://vaww.va.gov/vhapublications/index.cfm.

NOTE: This is an internal VA website that is not available to the public.

d. NRC Regulatory Guide 10.8-Guide for the Preparation of Applications for Medical Use Programs. (ALARA Philosophy), LINK. NRC Regulatory Guide 10.8-Guide. NOTE:

This website is outside of VA control and may not be conformant with Section 508 of the

Attachment D.37 RFP 36C24224R0049 https://vaww.va.gov/vhapublications/index.cfm https://vaww.va.gov/vhapublications/index.cfm https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=3081 https://www.nrc.gov/docs/ML0825/ML082560464.pdf https://vaww.va.gov/vhapublications/index.cfm https://www.nrc.gov/docs/ML0037/ML003740154.pdf

Rehabilitation Act of 1973.

7. REVIEW

At minimum at recertification, when there are changes to the governing document (for example, national policy or a health care accreditation body mandate), and any regulatory requirement for more frequent review.

8. RECERTIFICATION

This SOP is scheduled for recertification on or before the last working day of July 2028.

In the event of contradiction with national policy, the national policy supersedes and controls.

9. SIGNATORY AUTHORITY

MARISSA MINCOLLA, MD

Chief of Imaging Service Syracuse VA Medical Center Date Approved: July 28, 2023

NOTE: The signature remains valid until rescinded by an appropriate administrative action.

DISTRIBUTION: Automated distribution email sent weekly to VHASYR Managers & Supervisors email group at SYR-M&S@med.va.gov. SOPs are available at: Syracuse Medical Center Document Control SharePoint (DCS).

https://dvagov.sharepoint.com/sites/VHASYR/svdc. NOTE: This is an internal VA website that is not available to the public.

Attachment D.37 RFP 36C24224R0049 mailto:SYR-M&S@med.va.gov https://dvagov.sharepoint.com/sites/VHASYR/svdc/ https://dvagov.sharepoint.com/sites/VHASYR/svdc/