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Based on interview with the Radiology Medical Director, policy review and record review, the Hospital failed to ensure that an informed consent was completed and reviewed with for 1 of 10 patients (Patient #2) prior to magnetic resonance imaging (MRI, use of a magnetic field to obtain images of the soft tissue) regarding the potential complications that could occur with a known foreign body present.

Findings included:

The American College of Radiology Guidance Document on MR (Magnetic Resonance) Safe Practices: 2013 and the Hospital ' s Policy/Procedure titled MRI Safety-Implants and Foreign Objects indicated that patients with a history of potential ferromagnetic foreign object penetration must undergo further investigation prior to the performance of MRI. Acceptable ferromagnetic foreign object screening included radiology films, prior computerized tomography (CT) scanning or prior MRI. Once positive identification of the potential ferromagnetic foreign object has been made, best effort assessments were to be made to identify MR compatibility. Final determination whether or not to scan was to be made by the MR Radiologist or the MR Medical Director.

The Hospital ' s Policy/Procedure titled MRI Safety-Implants and Foreign Objects indicated that if the MRI Radiologist determined the patient should have MRI with an implant/foreign object determined not compatible with MRI, the patient had to consent to the MRI using the MRI Consent Form.

Emergency Department (ED) Records dated 5/15/13 indicated that Patient #2 presented to the ED with facial, jaw, neck and bilateral ear pain and a feeling of a tight throat. The ED Records indicated that Patient #2 rated the pain as 10/10. The ED Records indicated a chest x-ray was obtained and revealed a retained bullet located in the left upper quadrant of Patient #2's abdomen.

The MRI Inpatient Scheduling Form, dated 5/15/13, indicated that Patient #2 had a retained bullet and had an MRI previously.

The Surveyor interviewed the Radiology Medical Director on 9/12/13 at 11:00 A.M. The Radiology Medical Director said he authorized Patient #2' s MRI because Patient #2 ' s bullet was not located near a vital organ and Patient #2 reported that he/she had a prior MRI without complications.

The Medical Director said bullets were made of lead and were considered to be nonferromagnetic.

The Reference Manual for MR Safety:2013 regarding bullets and pellets indicated that the majority of bullets tested in the MR environment were found to be composed of nonferromagnetic metals. The Reference Manual indicated that although the bullets were composed of nonferromagnetic metals they were often contaminated with ferromagnetic materials and therefore the risk verses the benefit should be carefully considered.

The Medical Director said he did not speak with Patient #2 or obtain a written informed consent for the MRI that identified the possible complications that could occur during the MRI with the retained bullet.

The Surveyor interviewed MR Technician #3 on 9/12/13 at 2:50 P.M. MR Technician #3 said she spoke with Patient #2 prior to MR regarding the what symptoms he/she was to look for and immediately report regarding the bullet. MR Technician #3 said Patient #2 informed her he had a prior MRI without complications. MR Technician #3 said during the MRI, Patient #2 reported increased pain in the area of the bullet and testing was stopped.

Radiology Report dated 5/20/13, indicated that a chest CT scan performed on Patient #2 following the MRI indicated the bullet was located in the anterior intercostal muscle anterior to the 7th rib and was similar in location as compared to the 5/15/13 chest x-ray.