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Based on observation, interview, and available record review the hospital failed to provide radiologic services in a safe manner as evidenced by:

1. Two hospital personnel (one Registered Nurse and one Patient Care Technician) entered Zone III with an Intensive Care Patient (ICU) on a ferromagnetic bed and were left unsupervised by MRI personnel. non-MRI (Magnetic Resonance Imaging) personnel while two staff (one registered Nurse , RN 1 and one Patient Care Assistant, PCT 1) and an one patient (P1) were in the Zone III of the MR area.
2. The entrance door to the Magnetic Room (Zone IV) was left opened.
3. The MRI safety alarm system, (called Ferroguard, a wall mounted metal detector that provides a clear, simple, early warning of risk items approaching the magnet room, together with lowest audible alarm rates), located oneither side of the entrance to Zone IV (area where the magnet is located) did not function when the hospital bed as pulled through the entrance to Zone IV.
4. The RN, PCT, and patient were not screened prior to entering Zone III, in accordance with the hospitals policy and procedure regarding screening.
5. The RN was level II MR safety trained and continued to move the patient in an ICU bed into Zone IV (area where magnet is located) without stopping in Zone III for a second screening and transferring patient to non-Ferromagnetic bed/table.
6. The MRI technician did not quench ("in MRI, quenching refers to rapid expulsion of the liquid cryogen used to maintain the MRI magnet in a superconducting state") the Magnet during an emergency situation in accordance with the hospitals policy and procedure "MRI Safety Guidelines..."
7. The hospital's policy and procedure did not include MRMD and MRSO required MR safety training in their policy and procedure "MRI Safety Guidelines..." and as referenced in the Academy of Radiology MRI Safety Guide as referenced in their policy and procedure for MRI safety Guidelines.
8. The required screening of one patient and two non-MRI personnel was not performed in accordance with the hospital's policy and procedure titled "MRI Safety Guidelines..."
9. The hospital did not have a patient interview/clinical screening area that provided privacy for patient's and non-MR personnel. Zone II (where screening of patient's and non-MR personnel takes place and provides an intermediary space or buffer between Zone I (general public area) and the more strictly controlled MRI zones III(area outside of the magnet room; restricted to only trained MR personnel who have successfully screened patients and non-MR personnel) and Zone IV (where the scanner/magnet is located). The facilities Zone II was located in a hallway used as a pathway by people entering the Radiology Department leading to other Radiologic services. (see hospital physical layout/Radiology Department) (refer to A-0535)

The hospital did not provide evidence of the MRMD/MRSO MR safety annual education or Level II MR safety training and did not provide the credential file for the MRMD/MRSO as requested. During an interview with the Imaging Director and the Assistant Medical Group Administrator on 3/13/23 at 13:30 stated that the MRMD was the Chief of Radiology. When queried about the appropriate training for the MRMD, the responsible person was changed to "two MRMD's." (see org chart for radiology). The Imaging Director indicated an MRMD for musculoskeletal imaging and an MRMD for Neurological imaging. (Refer to A0538).

During a review of the Imaging Services Redwood City MRI organizational chart showed the following: "Imaging Svcs Chief, MRI MSK Sub-Chief and Imaging Svcs Asst Chief, Neuro MRI Sub-Chief, CSP Rad Lead. The Imaging Director hand wrote the MRMD/MRSO designations for the Radiologist she was indicating as the two designated MRMD's. (refer to Imaging services org. chart). The Imaging Service Director indicated that one of the Radiologists was the MRMD and the MRSO. During an interview with the Chief of Radiology on 3/15/23 at 14:05, stated that the MRMD received MR safety training in their Residency and Fellowship programs. (Refer to A0538).

The cumulative effect of these systemic problems resulted in the facility's failure to provide care to their patients and hospital personnel in a safe environment.

Based on interview and record review, the facility failed to ensure the safety of the patient and staffs when:

1. There was no supervision of non-MRI (Magnetic Resonance Imaging) Personnel while two staff (one registered Nurse , RN 1) and one Patient Care Assistant, PCT 1) were in Zone III of the MR area.
2. The entrance door to the Magnetic Room (Zone IV) was left opened.
3. The MRI safety alarm system, (called Ferroguard, a wall mounted metal detector that provides a clear, simple, early warning of risk items approaching the magnet room, together with lowest audible alarm rates), located on either side of the entrance to Zone IV (area where the magnet is located) did not function when the hospital bed as pulled through the entrance to Zone IV.
4. The RN, PCT, and patient were not screened prior to entering Zone III, in accordance with the hospitals policy and procedure regarding screening.
5. The RN was level II MR safety trained and continued to move the patient in an ICU bed into Zone IV (area where magnet is located) without stopping in Zone III for a second screening and transferring patient to non-Ferromagnetic bed/table.
6. The MRI technician did not quench the Magnet during an emergency situation in accordance with the hospitals policy and procedure "MRI Safety Guidelines..."
7. The hospital's policy and procedure did not include MRMD and MRSO required MR safety training in their policy and procedure "MRI safety Guidelines..."
8. Required screening of patient and non-MRI personnel was not performed in accordance with the hospital's policy and procedure.
9. The hospital did not have a patient interview/clinical screening area (Zone II) that would facilitate full and complete patient and personnel disclosure of their medical history.

Findings:

During an interview with MRI Technologist on 3/13/23 at 13:15 stated that she opened the door to Zone III without first screening the nurse, patient, and patient care technician in Zone II. She indicated she informed the nurse "we're going in head first" and went back to the control room to "open the patient chart." She indicated she left the RN, patient, and PCT alone in Zone III. When queried why she did that, she stated she could not begin the procedure without first opening the chart. The control room is out of the line of sight to Zone III, and indicated she could not begin the procedure without opening the patient chart. When queried about what was priority, the patient or the patient chart, she stated "the patient." While at the computer, she indicated she heard "screaming" and ran out to see the RN pinned against the Magnet by the ICU bed. She did not recall hearing the Ferroguard alarm.

During an interview with the MRI Imaging Technician on 3/13/23 at 14:10 stated she had begun a call to another patient when the bell to Zone III rang. She asked the MRI Technologist if she should answer the door or continue with the telephone call. She indicated she was instructed to finish the call and the MRI Technologist would "get the door." The Imaging Technician stated she had just "finished with the call" when she heard screaming coming from outside the control room. She indicated she "did not hear the Ferroguard alarm." She stated the door should not have been left open and the bed should not have been in the doorway. The door to Zone IV should remain closed at all times.

-The hospital policy and procedure titled "MRI Safety Guidelines-NCAL Imaging Policy SAS-910 at 5.1.3" indicated "employees, visitors, or staff will not be allowed in the magnet area (Zones III and IV) without the appropriate screening, evaluation, and supervision." MR Level II trained personnel are to be with patients and other non-MR personnel in Zone III at all times.
-The hospital policy and procedure titled "MRI Safety Guidelines...5.9.1 indicated "patients and visitors will not be allowed in the MRI area (Zone III & IV) unless escorted and screened by an MRI technologist, radiologist, or other trained Level 2 MRI personnel."
-ACR (American College of Radiology) Manual on MR Safety indicated "MR Screening All non-MR personnel needing to enter Zone III must first pass an MR safety screening process...non emergent patients should be MR safety screened at least twice prior to being granted access to the MR environment (Zone III & IV). At least one of these screens should be performed by Level 2 MR personnel verbally and/or interactively. For example, the patient (or their health care proxy) may complete a screening form and subsequently have the responses and contents of that form reviewed together with a Level 2 MR Technologist.
-ACR recommendations for conscious, nonemergent patients are to complete written MR safety screening questionnaires prior to entering Zone III.

During an interview with the MRI Technologist and MR Imaging Technician on 3/15/23 at 14:00, both concurred that they did not hear the Ferroguard alarm.

During a concurrent interview with the Assistant Medical Group administrator and the Director of Imaging Services and record review of the "Ferroguard User Manual," on 3/16/23, both stated that the Ferroguard had not been serviced or maintained since the purchase and installation in 2014. the AMGA stated that the Ferroguard was proprietary and had to serviced by the companies (Metrasens) personnel. The hospital obtained a contract with the company and they will be sending a technician to check the Ferroguard.

-According to the Ferroguard User Manual, recommends the following: "approach (observe the Beacon displays when approaching the Ferroguard system) Look (if beacon turns amber or red STOP), Proceed (once the beacon remains green) proceed through the entryway, Listen (if audible alarm sounds as you pass through the Ferroguard, STOP). Three of three interviewed staff (MRI Technologist, Imaging Technician, and PCT) stated they did not hear the Ferroguard alarm during the ICU bed passing through the entryway.
-According to the Ferroguard User Manual recommends that annual testing by Metrasens approved Ferroguard technicians, daily qualitative checks, weekly/monthly checks and what to do if a fault is suspected. The facility failed to comply with these recommendations.

During an observation in Zone III on 3/13/23 at 11:10, the Ferroguard visual alarm displayed "amber" (indicates detection of moving ferromagnetic material). The audible alarm could not be tested, according to the Imaging Director.

During concurrent interviews with the MRI Technologist and Imaging Technician, the patient, RN, and PCT were not screened in Zone II (where written MR safety screening questionnaires are performed) prior to being allowed to Zone III (MRI environment for screened personnel and patients).

-The ACR Manual on MR safety indicated "...full stop and final check performed by the MRI technologist is recommended to confirm the satisfactory completion of MR safety screening for the patient, support equipment, and personnel immediately prior to crossing from Zone III to Zone IV.
-The hospital policy and procedure "MRI safety Guidelines...5.9.1" indicated "all patients and visitors will not be allowed in the MRI area (Zone III & IV) unless escorted and screened by an MRI technologist, radiologist, or other trained Level II MRI personnel.
-The hospital policy and procedure "MRI safety Guidelines...5.9.2 indicated all patients having MRI procedure will complete and sign an MRI safety Screening form before being allowed into Zone III." The patient's initial paper screening was unsigned and was in English, patient was Spanish speaking patient with little to no understanding of English. MRI technologist was supposed to have reviewed the initial screening of all non-MR personnel and the patient prior to allowing them into Zone III. This did not take place.

During an interview with the Director of Imaging on 3/14/23 indicated "during procedure the MRI Technologist, was feeling "rushed" because of a timed procedure set for 08:00. Review of the patient schedule did not indicate a timed procedure other than the patient brought to the MRI by the RN and the PCT. When queried whether the MRI technologist should have felt "rushed" or should have focused on patient safety, she stated "patient safety."

An interview with the RN was not conducted; nurse did not return request for interviews. The RN was Level II trained (meaning safety for herself, safety for others), despite the Level II training, she proceeded to enter Zone III without any screening and continued to enter Zone IV with a ferromagnetic ICU bed. This failure caused her to be pinned against the magnet by the ICU bed and sustained severe injury to her person, requiring surgical repair of multiple lacerations to her abdomen, mons, and left thigh, as well as removal of two embedded screws. The patient fell to the floor and did not sustain any injuries, the potential for patient severe injury was present.

An interview with the MRI Technologist regarding the "quenching" of the magnet, indicated that she did not quench the magnet immediately but had the Clinical Technologist notified to ask if she should do that. The nurse was forcibly removed from the the magnet while still pinned by the ICU bed, review of the nurse's in patient record the treating physician indicated this could have caused more damage to the areas where she sustained lacerations.

-The hospital's policy and procedure "MRI Safety Guidelines...5.6.1.13" indicated "staff initiated quench of the magnet only when the object held against the MRI scanner poses an imminent threat of injury or death, such as if a patient or staff member is pinned between the object and the magnet..."

An observation and concurrent interview on 3/13/23 at 11:30, Zone II is located in the hallway (pathway to other radiologic services) and offered no privacy for screening and wanding of a patient or non-MRI personnel. The Imaging Director stated the hospital did not have a separate area where MRI patients are screened, change clothing into non-ferromagnetic gowns prior to entering Zone III & IV.

The many safety failures by the MRI and non-MRI personnel created a culture of unsafe practices leading to the severe injury of one hospital personnel and the potential for injury to one patient.

Based on interview, and record review, the facility failed to provide evidence of the MRMD/MRSO MR safety annual education or Level II MR safety training and did not provide the credential file for the MRMD/MRSO as requested.

Findings:

During an interview with the Imaging Director and the Assistant Medical Group Administrator on 3/13/23 at 13:30 stated that the MRMD was the Chief of Radiology. When queried about the appropriate training for the MRMD, the responsible person was changed to "two MRMD's." (see org chart for radiology). The Imaging Director indicated an MRMD for musculoskeletal imaging and an MRMD for Neurological imaging.

During a review of the Imaging Services Redwood City MRI organizational chart showed the following: "Imaging Svcs Chief, MRI MSK Sub-Chief and Imaging Svcs Asst Chief, Neuro MRI Sub-Chief, CSP Rad Lead. The Imaging Director hand wrote the designations under each Radiologist's name to indicate their MRMD/MRSO designations. (refer to Imaging services org. chart). The Imaging Service Director indicated that one of the Radiologists was also the MRSO (Magnetic Resonance Safety Officer).

During an interview with the Chief of Radiology on 3/15/23 at 14:05, stated that the MRMD received MR safety training in their Residency and Fellowship programs.

-According to the ACR Manual on MR Safety, the MRMD is a licensed physician/radiologist with appropriate training in MR safety.
-The facility did not provide the requested documentation showing MR training for the MRMD and did not provide the credential file for Dr. Roberts, MRMD.
-According the the ACR Manual on MR safety indicated, "...the responsibility will be assumed by a licensed physician/radiologist with appropriate training in MR safety. MRSO responsibility will be assumed by a suitably trained individual...and all individuals responsible for safety in Zones III or IV of MR environment should be documented as having been successfully educated regarding MR safety issues..."
-According to the hospital's policy and procedure titled "MRI Safety Guidelines-...5.2.1" indicated "basic MRI safety education approved for all appropriate medical center staff employees and advanced MRI safety education for Level 2 MRI personnel will be conducted annually. "