I. PURPOSE
To establish guidelines and ensure that each female subject is screened for the possibility of pregnancy prior to the performance of a MRI procedure.
II. POLICY
It is the policy of the Radiology Department to ensure that all female subjects between the ages of 12 and 60 are screened for the possibility of pregnancy prior to an MRI procedure.
III. PERSONS OR AREAS AFFECTED
This policy applies to all employees, Principal Investigators, and research affiliates and personnel of the Department of Radiology at Northwestern University responsible for monitoring documentation and confirming information and follow up where appropriate.
IV. RESPONSIBILITIES
- The Directors of the Center for Translational Imaging are responsible
for development and implementation of policies/procedures that address Departmental
issues and ensure compliance with University and Hospital standards. - The management team in the Radiology Department is also responsible for ensuring that
all employees comply with these policies and procedures. - Employees are responsible for being knowledgeable about and complying with University-wide and Department-specific policies.
V. PROCEDURES
Radiology staff will screen all females via safety questionnaire or pregnancy test (depending on the type of test non contrast or contrast MRI) between the ages of 12-60 to determine pregnancy prior to the start if the MRI exam.
VI. Exceptions:
-Female subject who have delivered a baby within the last 7 days are exempt from pregnancy testing.
-Females who have had a menstrual period within the last 4 weeks.
-Females who have had a menstrual period over 4 weeks and do not want to have a pregnancy test can sign a declination form.
-Female subjects who have undergone a hysterectomy are exempt from pregnancy testing.
-Female subjects between the ages of 51-60 who indicate they are not pregnant or trying to become pregnant are exempt from pregnancy testing.
-If the subject is unsure of whether or not they are pregnant and wishes to participate in the study it is up to the PI’s discretion to determine pregnancy with a urine pregnancy test or decline the subject’s participation.
-Subjects receiving contrast that do not fall under the exception policy will be given a pregnancy test to determine pregnancy.
-Subjects not receiving contrast that do not fall under the exception policy will be screened through the safety questionnaire.
-Pregnant subjects will not be scanned unless specifically indicated by IRB. These subjects will be scanned in accordance to the IRB specific guidelines.
-CTI policy represents a modification of NMH policy as applicable to non-pregnant subjects involved in research studies. Subjects known to be pregnant that are involved in pregnant study will be scanned with the documentation and approval of the IRB.
CROSS REFERENCE
NMH Policy: Method for Determination and Documentation for Patient
Pregnancy
Responsible Party: Alexander Korutz, MD Assistant Professor of Radiology
