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200 WEST ARBOR DRIVE

SAN DIEGO, CA 92103

PATIENT RIGHTS: CARE IN SAFE SETTING

Tag No.: A0144

Based on interview and record review, the facility failed to ensure a safe environment in the magnetic resonance imaging (MRI; referred to as equipment and/or medical imaging procedure that uses strong magnetic fields and radio waves to produce images of organs and internal structures of the body) suite when the facility failed to report an unusual occurrence to the California Department of Public Health (CDPH; government agency) after a magnetic step stool was brought into the room that housed the MRI magnet, during one patient's (Patient 1) scheduled MRI test.

This failure had the potential for CDPH to be unaware of the facility's gaps in safety (the discrepancy between current safety practices and required safety standards) that could cause Patient 1 and/or other patients physical/psychological harm and trauma.


Findings:

On 7/8/25, an unannounced visit was made to the facility to investigate a complaint about a step stool that was projected into the MRI magnet.

An interview was conducted on 7/8/25 at 10:05 A.M. with Senior Director of Radiology (SDR) and Director of Imaging Services (DIS). SDR stated that there was an employee who had sustained an injury when MRI technologist (MT) 1 brought an inappropriate (MRI-unsafe, magnetic) step stool from MRI zone 2 (an area that serves as a transition space between the public area and more strictly controlled zones) into MRI zone 4 (the strictly controlled area containing the MRI scanner itself, often referred to as the magnet room). SDR stated the inappropriate, magnetic, MRI-unsafe step stool looked like the "MRI-safe" step stool.

An interview was conducted on 7/10/25 at 10:10 A.M. with MT 3. MT 3 stated he was present during the incident on 5/29/25 when a magnetic step stool was brought into MRI zone 4, causing the MRI machine to be shut down when the magnetic step stool was forcibly drawn into the MRI machine, before Patient 1's MRI exam. MT 3 stated it was assumed that the environment was safe to do the MRI, as there were previous MRI procedures already completed that day. MT 3 stated that MT 1 grabbed the step stool, not knowing it was magnetic, and brought it into MRI zone 4. MT 3 stated the magnetic step stool looked identical to the MRI-safe step stool. MT 3 stated there were no markings on the magnetic step stool indicating that it was MRI-unsafe. MT 3 stated the magnetic step stool should not have been in any of the MRI zones. MT 3 stated that Patient 1 became more anxious and asked if this was a normal incident. MT 3 stated he informed Patient 1 that it was not normal. MT 3 stated Patient 1 appeared scared after the incident.

An interview was conducted on 7/10/25 at 10:37 A.M. with MT 1. MT 1 stated that Patient 1 was anxious prior to the MRI exam. MT 1 stated the step stool was brought in to assist Patient 1 to get on the (MRI) table. MT 1 stated the magnetic step stool "shot out" from his hand and was pulled into the MRI machine. MT 1 stated Patient 1 started crying.

An interview was conducted on 7/11/25 at 9:03 A.M. with Director of Regulatory Affairs (DOR). DOR acknowledged that the incident involving MT 1 bringing a MRI-unsafe step stool into MRI zone 4 while Patient 1 was waiting to enter MRI zone 4, was "definitely" an unusual occurrence. DOR stated the incident was not reported to CDPH because the patient was not on the MRI table.

A review of the facility's policy titled Serious Safety Event (Sentinel, Adverse, and Near Miss event) Activation Processes, dated 7/5/24, indicated " ...VI. Reporting to External Agencies (Attachment A) ...Attachment A ...CDPH Reportable Adverse Events ...Any occurrence such as ...unusual occurrence which threatens the welfare, safety, or health of patients, personnel or visitors shall be reported as soon as reasonably practical (not later than 24 hours after event has been detected)".

SAFETY POLICY AND PROCEDURES

Tag No.: A0535

Based on interview and record review, the facility failed to ensure a procedure room was safe for patients and staff when a magnetic step stool was inappropriately brought into the room housing the magnet used to complete a magnetic resonance imaging (MRI; equipment and/or medical imaging procedure that uses strong magnetic fields and radio waves to produce images of organs and internal structures of the body) test.

This failure had the potential to cause harm and injury to the patient and staff present in the room with the MRI magnet.

Findings:

On 7/8/25, an unannounced visit was made to the facility to investigate a complaint about a step stool that was projected into the MRI magnet.

An interview was conducted on 7/8/25 at 10:05 A.M. with Senior Director of Radiology (SDR) and Director of Imaging Services (DIS). SDR stated there was an employee who had sustained an injury when MRI technologist (MT) 1 brought an inappropriate (MRI-unsafe, magnetic) step stool from MRI zone 2 (an area that serves as a transition space between the public area and more strictly controlled zones) into MRI zone 4 (the strictly controlled area containing the MRI scanner itself, often referred to as the magnet room). SDR stated the inappropriate, magnetic, MRI-unsafe step stool looked like the "MRI-safe" step stool.

On 7/8/25 at 10:15 A.M., a tour of the facility's multiple MRI areas was conducted. An interview was conducted on 7/8/25 at 10:25 A.M with MT 2. MT 2 stated it was the facility's process not to bring anything into MRI zone 4 that did not have a sticker indicating that the equipment was "MRI-safe". MT 2 stated items that were MRI-unsafe should have a sticker that indicated the item should not be brought into MRI zone 4.

A follow-up interview was conducted on 7/9/25 at 8:17 A.M. with SDR. SDR stated that one of the facility's MRI machines was turned off because of an incident that occurred on 5/29/25, when MT 1 brought a magnetic step stool into MRI zone 4. SDR stated the magnetic step stool was not MRI safe. SDR stated the magnetic step stool had been used in zone 2 "forever". SDR stated the magnetic step stool should not have been brought into MRI zone 4. SDR stated the MRI-safe and the MRI-unsafe step stool looked alike, except for a sticker on the side of the step stool that indicated whether it was MRI safe or unsafe. SDR stated the facility needed a MRI-safe step stool that was clearly different from non-safe supply.

An interview was conducted on 7/10/25 at 10:10 A.M. with MT 3. MT 3 stated he was present during the incident on 5/29/25, when a magnetic step stool was brought into MRI zone 4, causing the MRI machine to be shut down after the magnetic step stool was forcibly drawn into the MRI machine, before Patient 1's MRI exam. MT 3 stated it was assumed that the environment was safe to do the MRI, as there were previous MRI procedures already completed that day. MT 3 stated that MT 1 grabbed the step stool, not knowing it was magnetic, and brought it into MRI zone 4. MT 3 stated the magnetic step stool looked identical to the MRI-safe step stool. MT 3 stated there were no markings on the magnetic step stool indicating that it was MRI-unsafe. MT 3 stated the magnetic step stool should not have been in any of the MRI zones. MT 3 stated Patient 1 became more anxious and asked if this was a normal incident. MT 3 stated he informed Patient 1 that it was not normal. MT 3 stated Patient 1 appeared scared.

An interview was conducted on 7/10/25 at 10:37 A.M. with MT 1. MT 1 stated that Patient 1 was anxious prior to the MRI exam. MT 1 stated the step stool was brought in to assist Patient 1 to get on the (MRI) table. MT 1 stated the magnetic step stool "shot out" from his hand and was pulled into the MRI machine. MT 1 stated that Patient 1 started crying. MT 1 stated his hand became swollen and he needed to wear a hand brace following the incident. MT 1 stated there was a gap in environment safety (the discrepancy between current safety practices and required safety standards) within the facility's MRI department. MT 1 stated the magnetic, MRI-unsafe step stool looked the same as a MRI-safe step stool. MT 1 acknowledged he should have checked the equipment before bringing it into MRI zone 4.

A review of the facility's Imaging Services MRI Safety Guidelines, dated 1/18/25, indicated "...This policy is intended to guide the provision of a safe environment for patients, visitors, and employees within the Magnetic Resonance Imaging (MRI) suite ...Definitions...MRI unsafe...any item that is known to pose hazards in all MRI environments. These are objects...and equipment that are not under any circumstances able to enter the MRI scan room. These are items that are highly magnetic...Missile Effect...The capability of the fringe field component of the static magnetic field of an MR system to attract a ferromagnetic object, drawing it rapidly into the scanner by force...XIII. Missile Effect Accident Prevention...The missile effect can pose a significant risk to the patient inside the MR system and/or anyone who is in the path of the projectile...5. Do not allow equipment and devices containing ferromagnetic components into the MR environment unless they have been tested and labeled MR safe...Use the MRI labeling classification system to clearly identify Safe, Unsafe, and Conditional equipment within the MRI environment. All equipment will be tested by the MRI staff to determine if it is safe to enter the magnetic field. Any equipment not labeled will be considered unsafe until appropriate testing has been completed..."